Pfizer

Cardiovascular symptom reports

Male, 40 - 59 years

Age Reported Symptoms Notes
40 2021-01-04 blood glucose increased Pleasant 40-year-old male comes in the emergency room with concern related to allergic reaction. Pat... Read more
Pleasant 40-year-old male comes in the emergency room with concern related to allergic reaction. Patient had received his COVID-19 vaccination approximate 60 minutes ago, at approximate 45 minutes after vaccination he developed flank pain left greater than right rated a 3 out of 10 extending down to his thighs he also noted a scratchy type sensation in the back of his throat feeling as if he needed to frequently clear his throat. The symptoms have been ongoing now for the past 15 to 30 minutes with no increasing or change in symptoms. Has never had allergic reaction in the past, unsure of previous Covid 19 infection though he describes in February of last year having upper respiratory illness which time he lost his sense of taste and smell. Currently denies any fevers, chills, nausea or vomiting. Denies any diarrhea. Denies cough or shortness of breath. Denies any swelling of the lips, face, eyes or nose. Denies any rash. Upon presentation emergency room patient was seen, evaluated, treated following standards of care given. Given patient's presenting symptoms and the recent COVID-19 vaccination will treat patient as adverse allergic reaction. Patient was given 50 mg of Benadryl IV, 20 mg of Pepcid IV, 10 mg of Zyrtec p.o. and 125 Solu-Medrol IV. Patient was observed in the emergency room for minimum of 2 hours, with complete resolution of symptoms. Patient was discharged home on Zyrtec to take 10 mg by mouth daily as well as Pepcid 20 mg by mouth twice daily for minimum of next 14 days, prednisone 20 mg 1 by mouth daily x5 days. Patient was given a prescription for EpiPen should his symptoms return or progress, recommend he call 911 and return immediately. Risks and warnings were discussed in detail, all questions were answered, patient verbalized understanding agreement plan of care.
40 2021-01-05 heart rate increased, lightheadedness, palpitations heart palpitations; Hypoglycemia; Abnormal EKG; I had a near sick able episode and I had a rapid hea... Read more
heart palpitations; Hypoglycemia; Abnormal EKG; I had a near sick able episode and I had a rapid heart rate; I had a near sick able episode and I had a rapid heart rate; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number: EK5730, via an unspecified route of administration on 26Dec2020 as a single dose (age at vaccination: 40 years old), right arm for COVID -19 immunization. Medical history included chronic back pain. Concomitant medication included amitriptyline (AMITRIPTYLINE), cyclobenzaprine (FLEXERIL) for chronic back pain, and hydrocodone bitartrate, paracetamol (NORCO) for chronic back pain. On 26Dec2020, the patient had a "near sick able episode" and a rapid heart rate. The initial side effect was about 7 minutes after the patient had the vaccine, came on just very quickly. The place where they had the patient discharged him, allowed him to go home, but the rapid heart rate stayed with the patient for next 24 hours and he went to an urgent care and they sent him to emergency room. The patient went to the emergency room (27Dec2020) and they ran an EKG, X-ray, and did a COVID swab; everything came back negative. Lab work, X-ray everything came back fine, the only thing they found was hypoglycemia, heart palpitations, and abnormal EKG, which was described by the reporter as "normal sinus rhythm left axis deviation pulmonary disease pattern" and then at the bottom it said "abnormal EKG." Heart rate was 136/88 (as reported) so it was definitely improving, the highest it was at 189/110 (as reported). No treatment was received for the events. The clinical outcome of the events "near sick able episode," rapid heart rate, and palpitations was recovering, while the clinical outcome of hypoglycemia and abnormal ECG was unknown.
40 2021-01-05 hypotension Dizziness Lightheadedness Chills Sweating Hypotensive Monitored for 45 minutes. Placed in Trendel... Read more
Dizziness Lightheadedness Chills Sweating Hypotensive Monitored for 45 minutes. Placed in Trendelenberg position. BP 142/100 EMS was called to evaluated. Patient refused to go with.
40 2021-01-06 chest discomfort Patient was poorly responsive to her inhalers that she used for asthma; Persistent shortness of brea... Read more
Patient was poorly responsive to her inhalers that she used for asthma; Persistent shortness of breath and chest tightness starting within a few days after vaccine; Persistent shortness of breath and chest tightness starting within a few days after vaccine; This is a spontaneous report from a contactable physician (patient). A 40-year-old male patient received the first single dose of BNT162B2 (Solution for injection, lot number: EK5730, exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 18Dec2020 04:15 for COVID-19 immunization. Medical history included allergy induced asthma, allergies to cats and dust, and occasional seasonal allergies. Concomitant medication included other vaccine/s received within 4 weeks prior to the COVID vaccine: first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX, GlaxoSmithKline) administered as single dose via unspecified route of administration (vaccine location: left arm) on 08Dec2020. There were no other medications the patient received within 2 weeks of vaccination. The patient experienced persistent shortness of breath and chest tightness starting within a few days after vaccine (24Dec2020). Patient was poorly responsive to her inhalers that she used for asthma (onset date not reported). She rarely needed the, used about once or twice a year). It was constant, but with periods of improvement followed regression. Will likely seek medical evaluation as it's been over a week now and rather concerning. The patient did not consider the events shortness of breath and chest tightness as serious. Treatment for the adverse events shortness of breath and chest tightness included fluticasone propionate, almeterol (ADVAIR), albuterol, and unspecified anti-allergy medications. Patient did not have covid prior vaccination. Patient was tested for COVID post vaccination wherein patient tested negative for COVID via Covid test rapid on 30Dec2020. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of shortness of breath and chest tightness was not recovered and unknown for the other event.; Sender's Comments: Based on the time association, the possible contribution of BNT162B2 to the events shortness of breath , chest tightness and asthma aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
40 2021-01-12 heart rate increased High heart rate. 130+
40 2021-01-17 chest pain to ed with chest pain, diaphoresis and arms tingling
40 2021-01-17 inflammation of the heart muscle, hypertension, ejection fraction decreased, enlargement of the heart, heart failure, fluid around the heart Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort an... Read more
Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II, non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea. .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily. Per MD note. While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his "deconditioning" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.
40 2021-01-18 blood pressure increased, heart rate increased, fast heart rate 30 seconds after receiving vaccine, felt dizzy, HR / BP increase, and pressure in throat. RN at cl... Read more
30 seconds after receiving vaccine, felt dizzy, HR / BP increase, and pressure in throat. RN at clinic confirmed HR tachycardic, BP 170/98. Administered 50 mg IM Benadryl and transported to Hospital ER via wheelchair 2-3 minutes away.
40 2021-01-18 blood pressure increased, fast heart rate 30 seconds after receiving COVID19 Pfizer vaccine # 1, felt dizzy, felt HR and BP increase, and pres... Read more
30 seconds after receiving COVID19 Pfizer vaccine # 1, felt dizzy, felt HR and BP increase, and pressure in throat. RN at vaccine clinic confirmed HR to be tachycardic (rate unknown) and BP (170/98) to be elevated. 50 mg IM Benadryl administered and brought via wheelchair to ER which is connected to. ETA 2 -3 minutes.
40 2021-01-20 chest pain, troponin increased, heart attack Chest pains, trouble breathing . Diagnosis: Non ST segment elevation myocardial infarction
40 2021-01-24 transient ischaemic attack TIA/mini stroke; This is a spontaneous report from non-contactable consumer via Pfizer Sales Represe... Read more
TIA/mini stroke; This is a spontaneous report from non-contactable consumer via Pfizer Sales Representative. A 5-decade-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included insulin dependent diabetic in mid 40s. The patient's concomitant medications were not reported. The patient experienced TIA (transient ischaemic attack) /mini stroke on same day he received COVID vaccine. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-01-26 cerebrovascular accident Heart event stopped him from breathing; stroke; lack of air; This is a spontaneous report from a con... Read more
Heart event stopped him from breathing; stroke; lack of air; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm on 13Jan2021 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included nut allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included zolpidem tartrate (AMBIEN) and doxepin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 13:00, the patient experienced heart event that stopped him from breathing and the lack of air caused a stroke; all reported as life-threatening. On 14Jan2021, the patient underwent lab tests and procedures which included COVID-19 test which was negative. The patient was treated for the events which included being put on a ventilator and sedation. The clinical outcomes of the heart event stopped him from breathing, lack of air, and stroke, were not recovered.
40 2021-01-27 fainting Was at work on 1/26/21 and collapsed, no known complaints a the time. CRP was initiated immediatel... Read more
Was at work on 1/26/21 and collapsed, no known complaints a the time. CRP was initiated immediately, transported to ER and pronounced dead
40 2021-01-31 chest discomfort Headache, nerves in skin were raw and inflamed, agitated by touch. Fever, chills. Nausea. Chest co... Read more
Headache, nerves in skin were raw and inflamed, agitated by touch. Fever, chills. Nausea. Chest congestion, cough. Loss of taste and smell (this began on 01/31). All side effects symptoms are still present on 02/01.
40 2021-02-01 loss of consciousness About 2 to 3 minutes after receiving the injection I felt light headed and passed out. My wife said ... Read more
About 2 to 3 minutes after receiving the injection I felt light headed and passed out. My wife said my eyes were open but glazed over. I also started shaking. When I woke up I was confused and felt nauseated. A few minutes after I woke up the EMTs ran my vitals. My heart rate was in the 40s and my blood pressure was in the 90s. I have never had a reaction like this to any other shot/vaccines.
40 2021-02-02 fast heart rate Tachycardia that started approximately 23 hours after vaccination. I have a history of heart arrhyt... Read more
Tachycardia that started approximately 23 hours after vaccination. I have a history of heart arrhythmia (atrial flutter and atrial fibrillation) that were treated with ablation in July 2018. Periodically, I have tachycardia, so I am not sure if this is separate from the shot or not. Other symptoms are body aches.
40 2021-02-03 fainting dead; Collapsed; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; bnt1... Read more
dead; Collapsed; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; This is a spontaneous report from a contactable nurse. A 40-year-old male patient receive first dose of bnt162b2 (Lot number: EK9231, Brand: Pfizer), intramuscular in left arm on 21Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included immunocompromised w/ reportable conditions from an unknown date and unknown if ongoing, positive for Covid in September from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced dead, collapsed on 26Jan2021. Therapeutic measures were taken as a result of collapsed. The outcome of collapsed was unknown. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Received Covid vaccine here on 21Jan2021, was at work on 26Jan2021 and collapsed, no known complaints at the time, CPR (cardiopulmonary resuscitation) was initiated immediately, transported to ER (Emergency room) and pronounced dead. Unknown if other vaccine in four weeks. The patient had COVID prior vaccination. Unknown If COVID tested post vaccination.; Sender's Comments: Based on the information currently provided, the patient was immunocompromised and had prior COVID infection. The death and syncope more likely are associated with the patient underlying medical conditions. More information such medical history, concomitant medications, treatment indication and event term details especially death cause and autopsy results are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product 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.; Reported Cause(s) of Death: Dead
40 2021-02-10 chest discomfort Patient was observed for 30 minutes. After that time, patient stated to the observer, RN her left ar... Read more
Patient was observed for 30 minutes. After that time, patient stated to the observer, RN her left arm "hurt all the way down" and "chest felts heavy". Encouraged patient to go to ED, but patient declined. Nurse assessed patient who then felt short of breath. Two RNs took patient, via wheelchair, to ED. Husband was with patient. ED triage took patient back and husband checked in patient.
40 2021-02-12 cerebrovascular accident CVA/thrombotic event. R sided weakness and sensory deficit. No preexisting risk factors. Hyperco... Read more
CVA/thrombotic event. R sided weakness and sensory deficit. No preexisting risk factors. Hypercoaguable work up negative. Managed conservatively. Improvement without resolution of symptoms to date.
40 2021-02-14 blood glucose increased Within a few days of the first dose of the vaccine patient noticed extreme thirst, then increased ur... Read more
Within a few days of the first dose of the vaccine patient noticed extreme thirst, then increased urination frequency. Patient noticed unintended weight loss starting 2 weeks after first dose, and totaled 20 pounds in 5 weeks. Patient noticed some burry vision at night. Symptoms seems to lessen 2-3 weeks after first dose, but returned with increased intensity after second dose. Patient consulted a physician and lab work and blood sugar testing was ordered. Blood sugars were as high as 400 and A1C of 11. Patient went on a low extremely low carb no sugar diet for three days while waiting to see physician. Patient continued to monitor blood sugars. Blood sugars started to lower remained in the 170-260 range. Physician ordered repeat lab work and suspects Adult Onset Type 1 diabetes. Patient was placed on a long acting and quick acting insulin on 2-15-21. 23 Days after second dose.
40 2021-02-17 fainting Faint did not hit head. EMS eval. P60 O298% 96/50Stayed for 30minutes. BP 122/64. Home w family
40 2021-02-17 fast heart rate 2 days post vaccine Pt reports that he experienced sever flu like symptoms with the worse being fati... Read more
2 days post vaccine Pt reports that he experienced sever flu like symptoms with the worse being fatigue, tachycardia, and shortness of breath. He reports the symptoms lasted for about 1 day except the tachycardia and shortness of breath. He reports 8 days after onset of adverse symptoms with complaints of continue shortness of breath with walking or going up stairs. At time of visit Patient positive for tachypnea and tachycardia. Wheezes audible throughout lung fields.
40 2021-02-19 cerebral haemorrhage, blood pressure increased Patient woke up at 4am on Feb. 14th 2021 with extreme headache, nausea, dizziness, and blurry vision... Read more
Patient woke up at 4am on Feb. 14th 2021 with extreme headache, nausea, dizziness, and blurry vision. patients wife called 911 and patient was taken to Hospital ER for emergency evaluation. CT scan revealed a brain bleed. patient was rushed to Hospital Neuro ICU for immediate care. patient was at Hospital from Sunday Feb. 14th - Tuesday Feb. 16th. patient blood pressure (which is usually well controlled) had spiked up to dangerous level and caused a rupture to an AVM in the tegmentum region of his brain. hospital treated patient and got his blood pressure regulated. Patient discharged on Tuesday Feb. 16th 2021 with the expectation of making a full recovery after several weeks of rest.
40 2021-02-22 chest pain My chest has been burning since Sunday. Nipples are burning. No relief
40 2021-02-27 troponin increased, heart attack, inflammation of the heart muscle, chest pain Heart attack. Chest pain and numbness in both arms and back. The pain lasted from 3:00AM until 5:00A... Read more
Heart attack. Chest pain and numbness in both arms and back. The pain lasted from 3:00AM until 5:00AM at which time I as in the ER. Troponin levels were at 6.0 and I had a small abnormal finding on my EKG. The Cardiovascular physician on call said it could be something and they would do a cardiac cath to determine where a blockage may be. The angiogram cam back with no blockages. troponin levels reached a 10 by the end of the first day. The Echo the next day showed no issues in structure. The Cardiac MRI showed fluid and 4% of my heart had myocarditis from the issue. Troponin levels reduced to 7, then 6 by the end of the second day. On the third day I went home with new meds, an order for a follow up and cardiac rehab.
40 2021-02-28 fainting fainted with preceding anxiety after getting the vaccine
40 2021-03-02 chest discomfort Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with fatigue, chest tightness, back pain, myalgias, headaches, right arm soreness, and decreased concentration. Patient states had COVID-19 illness in October 2020 and current symptoms are similar. Patient denies facial/throat swelling, palpitations, rash, or lesions and reports some symptom improvement with acetaminophen. Vitals within normal ranges except blood pressure 141/84 attributed to white coat syndrome. Advised to continue acetaminophen and discharged to home stable.
40 2021-03-03 pallor After 5 min of receiving the vaccine, client became diaphoretic, pallor observed and reported numbne... Read more
After 5 min of receiving the vaccine, client became diaphoretic, pallor observed and reported numbness to bilateral hands. BP taken using manual cuff at 14:26 hrs and recorded 68/42, HR 51 bpm with O2 saturation of 98 % on RA. LCTA, S1 and S2 audible to L apex 4th intercostal space. Water was provided to the client. EMS was notified; EKG was obtained. Last V/S: BP of 103/68, HR of 79 bpm and RR of 18. Client declined EMS care and declined to go to the hospital. Client was discharged home with wife; ambulated to car with steady gait. Alert/ Oriented x 3.
40 2021-03-08 blood glucose increased began with dehydration - frequent urination, low fever - up all night due to stomach issues very tir... Read more
began with dehydration - frequent urination, low fever - up all night due to stomach issues very tired all of the time, drinking unreal amounts of water developed dangerously high blood sugar over the next week - diagnosed with diabetes on March 1
40 2021-03-08 palpitations, heart rate increased Within 8-10 minutes I had a wave of heat start from the back of my head to the front, like the feeli... Read more
Within 8-10 minutes I had a wave of heat start from the back of my head to the front, like the feeling you get right before you go under from anesthesia. My heart began to race and I was lightheaded. I reported the reaction and was given an oximeter to check oxygen and heart rate. Heart rate was 140, oxygen 99. BP was also checked and was normal. Was given water and sat for another 10 minutes. Felt better and heart rate was under 100 until another wave of lightheadedness came over me and heart rate spiked again to over 120. It came down again. A few minutes later lightheadedness came back, shaking started, and heart rate spiked again. It lasted about 10 minutes. After 55 minutes of staying at facility I was able to leave. However, did have one more brief episode of lightheadedness and heart rate spiking. Sore arm and extreme ringing in one ear were only side effect the following day.
40 2021-03-12 loss of consciousness Patient after couple of minutes post vaccination, passed out. BP was 68/32, HR58
40 2021-03-13 pallor Systemic: Dizziness/ Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Syst... Read more
Systemic: Dizziness/ Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Additional Details: Patient warned immunizer that he was anxious about receiving vaccine because he is scared of needles. Once he received the vaccine, he became nauseous, sweaty, clammy, dizzy and lightheaded. Pt explained to immunizer that he was switched to night shift and had taken his diabetic meds without food soon before his shift at 5:30pm. An EMT was on scene and she proceeded to call more medics. I checked on the pt and he was vomiting and very pale. Medics checked pt vitals and okayed him for work.
40 2021-03-17 heart rate increased, chest discomfort Rapid heart rate, strange feeling down his chest
40 2021-03-17 fast heart rate Headache, Sedation, Myalgia, Diarrhea, Tachycardia, "I feel like my heart is beating fast" "tired an... Read more
Headache, Sedation, Myalgia, Diarrhea, Tachycardia, "I feel like my heart is beating fast" "tired and sluggish and slow". Soreness in arm is painful and radiating to neck on left side Narrative: Advised to seek treatment from PCP or Emergency services if symptoms do not improve, worsen, or become severe Other Relevant History:
40 2021-03-18 lightheadedness vasovagal reaction
40 2021-03-20 blood pressure increased, heart rate increased cough; nasal congestion; didn't sleep well/He has sleep apnea; blood pressure went up to 121/63; his... Read more
cough; nasal congestion; didn't sleep well/He has sleep apnea; blood pressure went up to 121/63; his temp and it went up; pulse rate was up; very tired; He had COVID test and it came back positive; He had COVID test and it came back positive; This is a spontaneous report from a contactable Nurse (patient's mother). Report 3 of 3. MI filed on report 1 of 3. A 40-year-old-male patient received first dose of BNT162B2 (COVID VACCINE, Pfizer product, Formulation: Solution for injection, Lot: Number: EL3302, NDC number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. The patient's medical history included sleep apnea (he started with CPAP and technically it was a BIPAP machine), bipolar disease (took psychiatric medications), lost weight, blood pressure and liver enzymes. On 17Mar2020, he quit smoking. Concomitant medications were not reported. On 26Jan2021, the patient experienced nasal congestion and cough. He had COVID test and it came back positive. It was reported that, "they were vaccinated on 15Jan2021 with first dose. The Wednesday after which was about 5 days after the vaccine her husband got chills, sneezing, and fatigue. He did not call the doctor and did not get tested. About a week later her son had nasal congestion and cough. This was the third day for that. Called her son's doctor since this was the second person in the house to have symptoms. He had COVID test and it came back positive. Is the COVID vaccine enough to give a positive test. She had symptoms too, but she normally get sinusitis this time of year. No one had a fever. Her son was really congested. Maybe he will develop a fever down the line. She was at a quandary. She had to quarantine in case it was. Could the vaccination cause a positive COVID test result. She thought the symptoms should show up in 1 to 3 days. A week in between her husband and son and it was hard to believe. It should have been her to get it worse since she sleeps with her husband. Praise the Lord she had not. She and her husband had not been tested for COVID. Only her son was COVID tested. Wednesday morning he woke up and he was much more congested. He complained a little on Tuesday. He had sleep apnea and uses CPAP. He might have wanted cough medicine to help him sleep good. He said he did not sleep well. He was very tired and congested. On the evening of 26Jan2021 he was more congested than usual. He was tested yesterday and got positive results this morning. History and Investigations: he was in a lot better shape since living with them because he had lost over 100 pounds. He had sleep apnea. He started with CPAP and technically it was a BIPAP machine. They call it a CPAP. He was 355 pounds and now 228 pounds. Slowly loosing weight. He had bipolar disease and took psychiatric medications. Since he had lost weight he has had to decrease his doses. He was having problems with blood pressure in October. He was starting to feel faint and the doctor stopped his blood pressure medications. He had issues with his liver enzymes and he was not out of the woods yet. He had been a smoker on and off. He quit smoking on 17Mar2020. Caller declined to do provide information about her son's psychiatric medications and blood pressure medications for report. They bought a blood pressure cuff to keep track of his blood pressure. Since he got sick his blood pressure went up to 121/63. It was normally 110 to 114 over 63 to 70. She had also been keeping an eye on his temp and it went up about a degree. His pulse rate was up which you would expect. His pulse rate was usually between 55 and 68. That day it was 83. There was a product complaint. Caller was patient's mother. Vaccinated on 15Jan2021 with first dose. About a week later her son had nasal congestion and cough. This was the third day for that. Called her son's doctor since this was the second person in the house to have symptoms. He had COVID test and it came back positive. Is the COVID vaccine enough to give a positive test. Her son was really congested. Maybe he would develop a fever down the line. Could the vaccination cause a positive COVID test result. On the evening of 26Jan2021 he was more congested than usual. He was tested yesterday and got positive results this morning. Outcome of the events was unknown.
40 2021-03-21 blood pressure increased, heart rate increased Within few minutes, I started feeling high heart rate and dizzy. Notified health care professional a... Read more
Within few minutes, I started feeling high heart rate and dizzy. Notified health care professional and they took me in to observe vitals. Heart rate and blood pressure was higher than normal. EKG looked normal but with higher heart rate. Started feeling better in an hour and went home. The high heart rate recurred the next several days but would go away after few minutes. Occasionally I get a headache and feel resting heart rate is higher than before. Definitely feeling better after two weeks compared to day of the shot.
40 2021-03-26 pulse abnormal, loss of consciousness Patient came up to counter, stated he felt dizzy. Leaning to the left. Assisted patient into the cha... Read more
Patient came up to counter, stated he felt dizzy. Leaning to the left. Assisted patient into the chair. Patient proceeded to lose consciousness. Sternal rub ineffective. Weak pulse. Called for FNP (Clinic manager) who brought out Ammonia after assessing the patient. Patient came back around after approximately 60 seconds. Patient did lose control of bladder. Once patient came to, assited to lying down in an exam room for further observation. Patient ambulated out of clinic with father after about 45 minutes.
40 2021-03-29 loss of consciousness Patient passed out after standing post vaccination. Patient responsive after around 30 seconds. Aler... Read more
Patient passed out after standing post vaccination. Patient responsive after around 30 seconds. Alert and oriented. States he has done this in the past after "shots". Patient provided snack and water. Patient helped to wheelchair and monitored for 30 minutes. Patient states he has returned to baseline.
40 2021-03-30 pallor, fainting, pulse abnormal Systemic: Fainting / Unresponsive-Medium, Systemic: Pale, aware of surroundings-Medium, Systemic: Na... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Pale, aware of surroundings-Medium, Systemic: Nausea-Mild, Systemic: Weakness-Medium, Additional Details: Pt was sitting with wife about 10 minutes after vaccine became unresponsive. Wife got my attention. Had weak pulse, cold to touch, but was responsive to me. Knew his surroundings but said didnt feel 100%. Had NP from minute clinic look at him and called EMS for extra evaluation. Pt was transported to hospital
40 2021-03-31 lightheadedness Patient came to staff approximately 15 minutes after receiving his vaccine and stated that he was fe... Read more
Patient came to staff approximately 15 minutes after receiving his vaccine and stated that he was feeling lightheaded and believed he may pass out. Patient was seated then assisted to the floor as he had a brief (5 second) vasovagal response. EMS was activated and patient was assessed on scene. After speaking with paramedics and resting, patient stated that he was feeling perfectly fine and signed an EMS refusal of service, leaving on his own accord.
40 2021-04-01 loss of consciousness PT LOST CONSCIOUSNESS WITHIN 15 MIN OF ADMIN. PT WAS MILDLY DIAPHORETIC. VITALS WERE NORMAL. BP 124/... Read more
PT LOST CONSCIOUSNESS WITHIN 15 MIN OF ADMIN. PT WAS MILDLY DIAPHORETIC. VITALS WERE NORMAL. BP 124/75 HR 74 NO CPR NO EPI NEEDED. ICE PACKS APPLIED TO COOL PT . 911 CALLED PT WAS TRANSPORTED TO HCF by EMS. PER PT REQUEST.
40 2021-04-02 palpitations Anaphylactic reaction: palpitations, swelling, hives
40 2021-04-06 pallor, loss of consciousness Patient was witnessed on the ground following his vaccination. He has a loss of consciousness for a... Read more
Patient was witnessed on the ground following his vaccination. He has a loss of consciousness for about 30 seconds. we arrived to find the patient pale diaphoretic with abrasions on his left side of his face and his eye glasses broken. he was placed on the back board and taken to observation area two. He is currently alert and oriented and by 3. BP 133/90, HR 85, Resp 20, oxygen sat 100 on room air. once in the observation area patient removed from the backboard. he is sitting up on the bed and calling his significant other. He was given apple juice and crackers. he states he his feeling better. The medical team at this time is encouraging the patient to be seen in the emergency department due to the the unwitnessed fall from seating position and the fact that he had a positive loss of consciousness. Pt is not wanting to go to the ED due to the fact that he has bad insurance and currently unemployed. 12:50 Bp 138/86 HR 87 Resp18 Oxygen sat 100: on room air patient is feeling better however we are concerned about his LOC and wanting him to be evaluated. His partner arrived BP 133/87 pulse oxygen 100 HR 76. Once he was here he convinced pt to go to the ED. EMS was called and arrived to take patient to the ED at 1343
40 2021-04-06 low platelet count, fibrin d dimer increased Thrombocytopenia (109,000); elevated D dimer (3960); fatigue; subjective fever; headache; sweats; in... Read more
Thrombocytopenia (109,000); elevated D dimer (3960); fatigue; subjective fever; headache; sweats; injection site pain; paresthesias of hand on side of injection; This is a spontaneous report from a contactable physician (reporting for a patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), intramuscularly, administered in arm left on 15Mar2021 (at the age of 40-years-old) as single dose for COVID-19 immunization. Medical history included hypertension and COVID-19 prior to vaccination; patient had no known allergies. Concomitant medication included lisinopril. Patient had no other vaccine in four weeks and the COVID vaccine was received at a Public Health Clinic/Veterans Administration facility. On 15Mar2021, the patient experienced thrombocytopenia (109,000), elevated D dimer (3960), fatigue, subjective fever, headache, sweats, injection site pain and paresthesias of hand on side of injection. The adverse events resulted in emergency room/department or urgent care. The patient was tested for COVID post-vaccination through a nasal swab and Biofire PCR on 22Mar2021 which were both negative. Therapeutic measure taken as a result of the events included IV hydration. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product 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.
40 2021-04-07 chest discomfort Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of co... Read more
Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of control of lower right arm. Extreme fatigue unable to get up and move at times. Very light headed and on the verge of blacking out.. possibly Loss of consciousness. Extreme tightness in chest. Increase work of breathing. Confusion. Unable to keep eyes open and maintain alertness. Extremely tired Symptoms have gotten a little better throughout the day of april 8th with lots of rest and very little physical activity. I still have slight tightness in chest. Increase work of breathing. Still have tingling throughout body and am lightheaded. When doing any physical activity I become fatigued and lightheaded very fast and must stop after 5-10 minutes. Tongue is still tingling and metallic taste in moutg
40 2021-04-08 chest pain My feet are cold as well feeling of left foot tingling when sitting or laying down.; Chest pains; Li... Read more
My feet are cold as well feeling of left foot tingling when sitting or laying down.; Chest pains; Lightheadedness; My feet are cold as well feeling of left foot tingling when sitting or laying down.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EM9810, Expiration date was not reported), via an unspecified route of administration, in left arm on 19Feb2021 12:45 as single dose for covid-19 immunisation. Medical history included gout. Concomitant medication included allopurinol taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced Known allergy. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Patient experienced chest pains lasting 2 hours with light headedness, slow talking as well. Patient went to ER for this and when inlaid down the chest pain went away. ECG was normal as well as all blood work. Still feeling slight light headedness, the following day sporadically and my feet are cold as well feeling of left foot tingling when sitting or laying down on 23Feb2021 08:00 AM. Patient did not receive treatment for adverse events. The outcome of the events was recovering.
40 2021-04-08 pallor Became diaphoretic and pale. BP slightly elevated. Assisted to a sitting position on the floor. P... Read more
Became diaphoretic and pale. BP slightly elevated. Assisted to a sitting position on the floor. Provided with water and ice pack. Stayed in vaccination area for an extended period of time for continued monitoring.
40 2021-04-10 chest pain, inflammation of the pericardium, inflammation of the heart muscle Thursday, March 25th at 3:10pm I received my 2nd dose of the Pfizer vaccine. Thursday, March 25th at... Read more
Thursday, March 25th at 3:10pm I received my 2nd dose of the Pfizer vaccine. Thursday, March 25th at 9pm I had cold chills, headache, low grade fever, diarrhea, and fatigue. These symptoms lasted Thursday night, Friday, Saturday (March 25th - March 28th). Sunday, March 29th at 4am I woke up with severe chest pains, shortness of breath and light headed. At this time I went to the emergency room.
40 2021-04-10 coughing up blood, fibrin d dimer increased, blood clot, pulmonary embolism Pain underneath right rib cage and difficulty breathing. It got worse over two days and then I was h... Read more
Pain underneath right rib cage and difficulty breathing. It got worse over two days and then I was hospitalized. Coughed up blood. Tested with Heparin drip and now I?m on Xarelto. No previous history of blood clots. This happened three days after second vaccine
40 2021-04-11 chest discomfort Severe upper body muscle cramps, fever and chills, minor nausea. Cramping in chest and diaphragm cau... Read more
Severe upper body muscle cramps, fever and chills, minor nausea. Cramping in chest and diaphragm causing moderate to severe positional pain and some difficulty breathing. Self treated with advil and tylenol. Laid flat on the floor for several hours in a position causing least amount of pain, until cramping subsided. Cramping lasted a total of 10 to 12 hours starting some time overnight after injection.
40 2021-04-11 fainting Patient fainted and felt dizzy for ~15 minutes. no other symptoms. s/sx lasted ~15-20 minutes. pt r... Read more
Patient fainted and felt dizzy for ~15 minutes. no other symptoms. s/sx lasted ~15-20 minutes. pt refused medical treatment
40 2021-04-12 loss of consciousness, fainting Pt experienced fleeting moment of syncope 5secs while sitting on a chair in the recovery hall. He wa... Read more
Pt experienced fleeting moment of syncope 5secs while sitting on a chair in the recovery hall. He was aroused to consciousness when his name was called and chest rub applied. V/s bp 103/64, res 12, temp 94.8, hr 83, o2 97% RA. He was taken to a cubicle in a wheelchair and made to lay down on a cot for further observation. Pt was noted to be perspiring profusely. 2pkts of small apple juice and a bottle of water were offered, Pt drank all. At 10:15 a m v/s obtained read - bp 116/84, rr14,hr75, temp 96.6, O2 97% RA. Pt. verbalized feeling well, denied any pain. He was advised to see his caregiver for further medical evaluation .He walked away from the room unassisted at 10:28 a m.
40 2021-04-12 loss of consciousness passed out/stopped breathing for 15-20 seconds.; passed out/stopped breathing for 15-20 seconds.; Fe... Read more
passed out/stopped breathing for 15-20 seconds.; passed out/stopped breathing for 15-20 seconds.; Felt faint; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 25Mar2021 11:00 (Lot Number: EN6205) as single dose for covid-19 immunisation at age 40 years old. The patient's medical history was not reported. No known allergies. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medication included loratadine (CLARITIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 14:00 (lot no: EN6200) in left arm for COVID-19 immunization at age 40 years old. On 25Mar2021 11:15, the patient felt faint, had trouble breathing, and passed out/stopped breathing for 15-20 seconds. The adverse events resulted in emergency room/department or urgent care. Treatment for the events included EMT monitoring onsite, saline and other meds (unspecified). The patient recovered from the event passed out/stopped breathing on 25Mar2021; while recovered from other events on an unspecified date in Mar2021.
40 2021-04-12 pallor 1100 Pt reports increased in nausea and "feels like is going to throw up". Pale and diaphoretic. P... Read more
1100 Pt reports increased in nausea and "feels like is going to throw up". Pale and diaphoretic. Pt reports name and states has hx of vagal with injections/vaccinations and sutures-which occurred 2 years ago. EMS activated. Pt increase with diaphoretic and vomited x 2. EMS assessed and controlled situation. Pt appeared to recover without difficulty after 10-15 minutes. Drank 16.9 oz. bottle water. Ambulated independently without asst to exit. Pt reports he is not driving and he has a ride. Pt instructed to inform medical to lay down prior to 2nd/next injection/vaccination in 3 weeks. Pt verbalized understanding.
40 2021-04-12 platelet count decreased, low blood platelet count I have chronic ITP but platelets have been fine for 12+ years. After first dose two weeks later my p... Read more
I have chronic ITP but platelets have been fine for 12+ years. After first dose two weeks later my platelets dropped to 4,000 and had to be hospitalized
40 2021-04-12 transient ischaemic attack Transient Ischemic Attack (TIA)
40 2021-04-14 fainting syncope ... patient fainted about 5 minutes after vaccination in lobby of pharmacy under observation... Read more
syncope ... patient fainted about 5 minutes after vaccination in lobby of pharmacy under observation.
40 2021-04-15 fainting vasovagal syncope, known reaction to needles, rapid improvement, vital signs stable
40 2021-04-15 blood clot, pulmonary embolism, heart rate increased, hypotension On the evening of March 6, 2021, patient tried to exercise (consistent with regular routine) and cou... Read more
On the evening of March 6, 2021, patient tried to exercise (consistent with regular routine) and couldn't do more than 15 minutes. He was very winded. On March 7, we skipped exercise. On March 8, patient tried to do simple stretching exercise, and couldn't do it. He got winded and shaky. On March 9, he was seen at an urgent care where he was told he had an inverted T wave on his EKG and a very fast heart rate (125 resting pulse). He was told to not exercise and to make an appointment with a cardiologist. On March 9, I called the urgent care clinic to ask questions about monitoring his blood pressure and when to seek more medical care. I spoke with Dr, who prescribed Atenolol. Around 4:30 pm on
40 2021-04-16 palpitations, heart rate increased note I was moderately anxious prior to getting the vaccine and had a busy day the next day which was... Read more
note I was moderately anxious prior to getting the vaccine and had a busy day the next day which was worrisome in case of side effects. dizzy first day, chills, fast heart. Everyday so far feel off and on tired, dry mouth off and on, dehydrated? Felt tired within an hour of injection on Tuesday. I don't remember if my stomach was growling on the first night on the day I got injected and I just went to bed. The next morning I woke up really thirsty/hungry and tired. I slowly made myself breakfast. Sat down to eat on a stool and felt dizzy. My heart raced for 30 sec as I carefully made my way to the flow to be safe. I had the chills, a bit shaky for a short period. I called my doc who told me to stay hydrated. The clinic where I got injected DID NOT inform me about dehydration. As of today, I still have off and on a dry mouth, feel more of an empty stomach at meal time, tired off and on, and maybe dehydrated. I work from home so I am not pushing myself. I have not felt dizzy again and am decent at taking in water now.
40 2021-04-17 blood pressure increased Vivid/lucid dreaming with bright lights; Vivid/lucid dreaming with bright lights; light headiness a ... Read more
Vivid/lucid dreaming with bright lights; Vivid/lucid dreaming with bright lights; light headiness a feeling that i would pass out or die and tingling and shakimg; tingling and shaking throughout his body; tingling and shaking throughout his body; As he remained in a confused mental state; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; nocturnal panic attack with unknown trigger; Occasinally elevated blood pressure; slight markings of dehydration; hangover; This is a spontaneous report from a Contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer), second dose via an unspecified route of administration, administered in arm left on 24Mar2021 11:30 at age of 40-year-old (Lot Number: ER8733) at single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at Facility of Doctor's office/urgent care. Medical history included gout, anxiety, gastrooesophageal reflux disease, 'espoghutis'. The patient did not have allergies to medications, food, or other products. Concomitant medication within 2 weeks of vaccination included omeprazole; allopurinol; escitalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in arm left on 10Mar2021 11:30 at age of 40-year-old (Lot Number: En6206) at single dose for COVID-19 immunization. On 02Apr2021, the patient had vivid/lucid dreaming with bright lights and unusual feelings as he initially fell asleep. He was able to wake himself up but remained in between sleep and awake. This was accompanied by light headiness a feeling that he would pass out or die and tingling and shaking throughout his body as he remained in a confused mental state while his wife called an ambulance. In 2021, his vitals were fine with occasionally elevated blood pressure and slight markings of dehydration ( during the day following his second dose he felt like he had a bad hangover). The ER doctor thought the most likely explanation is sometime of nocturnal panic attack with unknown trigger. He had not previously sufferer anything like it. The events were reported as non-serious. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the adverse events which included: drugs to calm, fluids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events light headiness, tingling and shaking throughout his body, confused mental state, nocturnal panic attack with unknown trigger, vivid/lucid dreaming with bright lights, elevated blood pressure, slight markings of dehydration, hangover were resolving. Information on lot/batch number obtained. Further information is expected.
40 2021-04-17 loss of consciousness Patient fainted while sitting in observation area. Patient regained consciousness within a few secon... Read more
Patient fainted while sitting in observation area. Patient regained consciousness within a few seconds. Patient was assessed and left vaccination clinic in stable condition.
40 2021-04-19 fainting "Administered - 4/19, time unknown Adverse event started - 10:06 Patient had syncope, flushing/sweat... Read more
"Administered - 4/19, time unknown Adverse event started - 10:06 Patient had syncope, flushing/sweating. BP 109/53 -- > 114/55, HR 68 -- >64, RR 16 -- >16 , O2 100% -- > 99%, Temp 97.3F. Given PO juice, Graham crackers. Patient stable, released from vaccination site."
40 2021-04-19 fast heart rate dyspnea, tachycardia, pain in arm with swelling, numbness, bruising
40 2021-04-20 heart rate increased Noticeable headache, body aches, uncontrollable chills, rapid heart beat, some nausea.
40 2021-04-20 hypertension, chest pain PT reports chest pain & being dizzy. (More profound then 1st shot) Checked out. High BP. Abnormal ... Read more
PT reports chest pain & being dizzy. (More profound then 1st shot) Checked out. High BP. Abnormal EKG. Persistent cough present. IV administered on right ac. Transported to Hospital.
40 2021-04-20 pallor, lightheadedness I was called to see the patient in the vaccine area. He had a mild to moderate vasovagal episode pri... Read more
I was called to see the patient in the vaccine area. He had a mild to moderate vasovagal episode prior to his vaccine without syncope. He was dizzy, diaphoretic, and pale. He was repositioned and orally hydrated. Mild to moderate vasovagal episode without syncope. This was resolved with hydration and repositioning. He was returned home at baseline with a partner as the driver.
40 2021-04-22 fainting patient family called for help after patient fainted. Volunteer staff called EMS. EMS arrived at 134... Read more
patient family called for help after patient fainted. Volunteer staff called EMS. EMS arrived at 1340, left with patient at 1350. RN assessed patient at approximately 1335 - patient conscious immediately after syncopal event. Patient stated during nurse assessment that he had donated plasma that morning and had not eaten or had anything to drink that day. Also states he has needle phobia and has had syncope with previous plasma donations/etc. No difficulty breathing or other symptoms beyond syncope. EMS transported out of abundance of caution.
40 2021-04-24 chest pain Heart or chest pain, pleuritic chest pain, left side
40 2021-04-24 nosebleed Multiple nosebleeds flu like body aches. The multiple nosebleeds were the most concerning and unusua... Read more
Multiple nosebleeds flu like body aches. The multiple nosebleeds were the most concerning and unusual
40 2021-04-24 inflammation of the pericardium Pericarditis
40 2021-04-24 fainting Patient started feeling light-headed and fainted twice within 5 minutes.
40 2021-04-26 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Fell from chair and hit head on floor - small ga... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Fell from chair and hit head on floor - small gash on bridge of nose-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium, Additional Details: Within 5 minutes of vaccination, pt fell from sitting position in chair to the ground. Pt hit his head and had small gash on bridge of nose. When I got to him, his eyes openned and he knew what happenned. Called 911. He laid on ground while we had NP check blood pressure, pulse, and O2 levels. Pt was stable and walked out with EMS to be checked out.
40 2021-04-26 fainting Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Un... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Medium
40 2021-04-27 chest pain 4/24 - low-grade fever (99.5 F), muscle aches, headache, lasted all day + all night 4/25 - low grade... Read more
4/24 - low-grade fever (99.5 F), muscle aches, headache, lasted all day + all night 4/25 - low grade fever continued (99.5 F), sweats/chills, sharp headache, fatigue, muscle aches 4/26 - low grade fever continued (99.5 F, dropped to 99.3 F in evening), sweats/chills continued, sharp headache continued, fatigue + aches continued 4/27 - low grade fever (99 F), sharp headache, chest pain when coughing, developed sinus congestion, wet cough which produced mucous (clear), slight fatigue and aches (lessened), new symptom of low humming tinnitus in left ear only (when surroundings quiet) 4/28 - fever gone for 18 hours w/o fever-reducing medication, fatigue still present, cough with phlegm still present, slight headache, slight sinus congestion, low humming tinnitus in left ear continues (when surroundings are quiet)
40 2021-04-27 blood clot Multiple blood clots in the left leg had to be submitted to the Emergency Room at the hospital for i... Read more
Multiple blood clots in the left leg had to be submitted to the Emergency Room at the hospital for immediate treatment; This is a spontaneous report from a non-contactable consumer. A 40-years-old male patient received 1 dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE) lot number: ER2613 via an unspecified route of administration, in arm left on 12Apr2021 at the age of 40 years as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced multiple blood clots in the left leg and he had to be submitted to the emergency room at the hospital for immediate treatment on 16Apr2021 12:00 with outcome of recovering. The patient was hospitalized for 2 days and was treated with unspecified treatment. Covid test post vaccination: Nasal Swab on 20Apr2021 result Negative No follow-up attempts are possible. No further information is expected.
40 2021-04-28 pallor Pt was vaccinated with Pfizer brand of covid vaccine given intramuscular at his left deltiod adminis... Read more
Pt was vaccinated with Pfizer brand of covid vaccine given intramuscular at his left deltiod administered by LVN today 04/29/21 at 3:36 pm. At 03:48 pm I, RN (EOA) noticed pt was pale and diaphoretic, came near to pt and asked how he is doing pt verbalized he is okay, when I was about to move out he eventually stated that he is dizzy and nauseous. I took initial set of vitals at 03:49 pm BP 100/60mmhg, PR 60 bpm, RR20 cpm, Temp 96.1F, Spo2 98% at room air. I called for admin assistance from admin assisted me in monitoring the patient together with another RN. Pt was given water and felt relieved. Ice packs was placed on pt's nape and made him relaxed. Pt had no complaints of chest pain and SOB. Pt had no history of DM, no HTN, no known allergies and had not gotten any flu shot for long time. Pt also verbalized that he hadnt slept well for the past 2 days related to job adjustment and hadnt eaten since yesterday that might have contributed to his complaints of dizziness Reapeat set of vitals were taken at 3:58 pm BP 100/80, PR 64 bpm, RR 18 cpm, SPO2 99% at room air. Pt stated he is back to normal and no more complaints of dizziness or nausea. Pt refused to call 911 as well. at 4:06 pm latest BP 126/88 mmhg. At 4:20 pm pt was assisted by me RN to his car with resolved dizziness and nausea. Pt was advised to have an appointment with primary physician for wellness check and health teaching was given related to side effects of vaccine and when to contact 911. Pt verbalized understanding and is appreciative of the care provided.
40 2021-04-28 pallor Dizziness, pallor, sweating. BPs 74/52 (pulse 128), 118/77 (pulse 87). Given water, orange juice, an... Read more
Dizziness, pallor, sweating. BPs 74/52 (pulse 128), 118/77 (pulse 87). Given water, orange juice, and crackers.
40 2021-05-02 heart attack, chest pain, ejection fraction decreased Awakened at 2 am 5/1/21 with acute onset of chest pain, SOB, and diaphoresis. No cardiac history; n... Read more
Awakened at 2 am 5/1/21 with acute onset of chest pain, SOB, and diaphoresis. No cardiac history; no history of similar episode. Reported that, following his second dose of COVID vaccine, he was ill for 1 day with vomiting. Chest pain continued upon arrival to ER 5/1/21 about 7 am. EKG indicated STEMI. Adm with Acute ST elevation myocardial infarction.
40 2021-05-02 chest pain, heart attack Shortness of breath, chest pain- 4/28/21- 10:30pm continued through 4/29/21- 9:30am
40 2021-05-02 loss of consciousness Aprrox 5 minutes after getting the vaccine started to feel dizzy and light headed. I passed out for... Read more
Aprrox 5 minutes after getting the vaccine started to feel dizzy and light headed. I passed out for a couple minutes. Approx 10 minutes later I felt fine. Don't know if it was a reaction to the vaccine or the fact that I don't like shots all that well, but I was told to report it. This has happened before when I have gotten a shot but it doesn't always happen. I would say its 50/50
40 2021-05-02 troponin increased patient experienced onset of fevers, headache, neck pain, generalized malaise/fatigue/weakness, diar... Read more
patient experienced onset of fevers, headache, neck pain, generalized malaise/fatigue/weakness, diarrhea/abd pain, with 2 ED visits ultimately admitted to hospital and diagnosed with MIS-A with elevated bnp, troponin, and inflammatory markers, and treated with dex 6mg x 10 days with complete resolution on follow-up.
40 2021-05-03 chest pain One day after vaccination, Fatigue. 10 days after vaccine, shortness of breath and pain while breat... Read more
One day after vaccination, Fatigue. 10 days after vaccine, shortness of breath and pain while breathing. This happened both times with both shots. Fatigue the day after, shortness of breath/pain breathing on day 10 lasting 3-4 days.
40 2021-05-04 troponin increased, inflammation of the heart muscle Myocarditis
40 2021-05-06 skin turning blue Had a severe colonic seizure and stopped breathing. He said he felt funny after the shot, like he w... Read more
Had a severe colonic seizure and stopped breathing. He said he felt funny after the shot, like he was light-headed and dizzy. Then out of nowhere I heard him moan and saw he was foaming at the mouth and violently convulsing and turning blue. I did cpr and the paramedics arrived and took him to the hospital. We are following up with a neurologist tomorrow.
40 2021-05-06 inflammation of the heart muscle, chest pain Developed chest pains 48 hours after vaccination. Had chest pains daily for several days. 96 hours a... Read more
Developed chest pains 48 hours after vaccination. Had chest pains daily for several days. 96 hours after vaccination, went to clinic. Tests showed irregular EKG, confirmed myocarditis
40 2021-05-07 loss of consciousness, palpitations, heart rate increased Phizer shot 1 of 2 in the left arm on Thursday 5/6. I arrived home 45 minutes after the shot was ad... Read more
Phizer shot 1 of 2 in the left arm on Thursday 5/6. I arrived home 45 minutes after the shot was administered and went to the bedroom as my heart rate continued increasing until it was racing non-stop. As my rate increased, so did my breathing until it became rapid and shallow. It is difficult to describe how fast my heart was beating. The rapid heart rate and shallow breathing reminded me of how my breathing changed when I summited a 5800-meter volcano and there was insufficient oxygen near the peak. As my pulse increased I became weak and fell asleep, or fell unconscious. I awoke at 11:00 PM and my breathing was normal however my heart continued racing for an additional hour until midnight. I have experienced no other side effects except heart rate and breathing.
40 2021-05-07 blood clot, heart attack, chest pain This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 08:15 (Batch/Lot Number: EW0171) (at age 40 years old) as single dose for covid-19 immunisation. Medical history included high blood pressure, high cholesterol, carpel tunnel, absent vas deferens, all from unspecified dates. No COVID prior to vaccination. He underwent Covid test post vaccination (nasal swab) on 29Apr2021 with negative result. The patient's concomitant medications included unspecified prescribed and store-bought medications. No other vaccines in four weeks. On 28Apr2021 22:00, the patient experienced chest pains and shortness of breath testing of EKGs, echo, CT scan, and cardiac cath show- NStemi heart attack showing from damage to heart caused by blood clot. No problems with arteries or existing with heart. Also, lower lobe of left lung shows collapsed. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The events were considered serious: hospitalization (2 days), life threatening illness (immediate risk of death from the event), disability or permanent damage. Treatment included blood thinners- apixaban (ELIQUIS) and metoprolol. The patient was recovering from the events.
40 2021-05-10 inflammation of the pericardium I30.0 - Acute nonspecific idiopathic pericarditis
40 2021-05-11 low blood pressure Pt presents w/Dizziness & sweats, AOx4, VS@ 1025 BP 105/41, HR 60, RR 20 O2Sat 98%; VS @1035 BP 141/... Read more
Pt presents w/Dizziness & sweats, AOx4, VS@ 1025 BP 105/41, HR 60, RR 20 O2Sat 98%; VS @1035 BP 141/67, HR 59, RR 20, O2 sat 98%. Provider concerned about orthostatic hypotension, pt called friend to be taken to urgent care
40 2021-05-11 blood clot, cerebrovascular accident part of my left kidney was no longer receiving blood; blood clot; placed on stroke protocols.; I dev... Read more
part of my left kidney was no longer receiving blood; blood clot; placed on stroke protocols.; I developed severe abdominal pain in my left side during the evening; lack of appetite; bouts of severe discomfort; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0167) via an unspecified route of administration, administered in Arm Left on 28Apr2021 12:15 (40-years-old) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Vaccination Facility Type was clinic. Concomitant medications included ibuprofen (ADVIL); desloratadine (CLARINEX). The patient previously took first dose of BNT162B2 (lot number=EN6208) on 07Apr2021 01:15 PM (40-years-old) on Left arm for COVID-19 immunization. It was reported that the patient developed severe abdominal pain in my left side during the evening of Wednesday, 28Apr2021 19:00. The pain appeared sporadically throughout the evening and continued through Friday, April 30. During this time, he experienced a lack of appetite and bouts of severe discomfort. Tried treating with GasX and Tylenol. Duration of Hospitalization reported as 3 days. On Saturday, 01May2021, starting around 10:30 a.m., the pain in his left-side abdominal area intensified and did not diminish. After 6 hours, he visited the ER at hospital. After being admitted to the ER, a series of blood, urine and imaging tests were performed on me. The doctor on duty reported that a CT scan showed that part of my left kidney was no longer receiving blood (disability). He was placed on Heparin and admitted to the hospital. He was diagnosed with a blood clot and placed on stroke protocols. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse events was Heparin, fluids, blood work, urine analysis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events abdominal pain, lack of appetite, and bouts of severe discomfort was recovering; while other events was unknown. Events reported as serious due to hospitalization and life threatening.
40 2021-05-16 heart attack Heart Attack
40 2021-05-17 chest pain Started 5/11 in the morning with headache and dizziness. Left arm started feeling heavy and numb als... Read more
Started 5/11 in the morning with headache and dizziness. Left arm started feeling heavy and numb also finger tips got tingling. Started to get sharp chest pains near my heart then started to feel fatigue. Then my tongue started to get swollen/numb and I couldn't really talk. Went to urgent care and due to my condition they called the ambulance and went to hospital. They did an EKG/chest x-rays and blood work. Couple hours later they send me home with no diagnosis just to see primary doctor. Symptoms were mild for 2 days then again on 5/14 symptoms came back and went back to urgent care. They did an EKG/Covid test/ only and doctor just said it was a panic attack. I disagree I still don't feel completely right.
40 2021-05-17 deep vein blood clot, fibrin d dimer increased, haemoglobin decreased 40 y/o M with no PMHx, non smoker, takes Finasteride 1 mg for hair growth, nonsmoker, received firs... Read more
40 y/o M with no PMHx, non smoker, takes Finasteride 1 mg for hair growth, nonsmoker, received first Pfizer COVID-19 vaccine on 4/12/21 to left deltoid (had mild soreness x 2 days, without other sx) presented to ED 4/15/21. Presented to ED 4/20/21 with L calf pain x 4 days starting around the evening of 4/15 and into 4/16. Initially attributed symptoms to a muscle strain given pt bikes 25 miles a day and lifts/frequent exercise- was able to exercise on 4/16 but stopped after that to try to rest the leg. Has been applying ice and taking Aleve with no relief. Shortly after, noticed new swelling in the calf and this morning noted that swelling had also spread to the front of his shin. Denied numbness, tingling, weakness in the leg. Was advised by a family member who is radiologist to present to ED for further evaluation. Found on exam to have left calf swelling, Ultrasound Doppler with extensive deep venous thrombosis of the left lower extremity from the level of the posterior tibial extending proximally to the common femoral vein with areas of both occlusive and nonocclusive thrombus. Evaluated by interventional radiology, deemed no need for intervention. Initially treated with lovenox and then discharged from the ED on apixaban 5mg daily. Symptoms resolved in days after and as of 5/18 remains on apixaban symptom-free.
40 2021-05-18 palpitations After about 5 minutes of vaccine administration, patient complained of "feeling of passing out", swe... Read more
After about 5 minutes of vaccine administration, patient complained of "feeling of passing out", sweating hands and face, racing heart rate. Called 911. After EMT arrived, and checked patient for any issues. From EMT, patient had known history of "fear of needles" and had anxiety attack after the vaccine. After about 20 minutes, patient was stabled and got release by EMT.
40 2021-05-21 chest pain Chest pain that I have never experienced before. It has not been treated at the time of reporting.
40 2021-05-22 chest pain, anaemia, heart failure, troponin increased, fibrin d dimer increased, ejection fraction decreased Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to urgent care reporting shortness of breath... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to urgent care reporting shortness of breath, cough, and chest pain. Transferred to emergency department then admitted to current facility for a management of new onset heart failure with possible etiologies of myocarditis or sarcoid. Also found to have LV thrombus, anemia, and lymphadenopathy. Patient initiated on medications to manage heart failure and anemia and anticoagulated. Patient improved and discharged to home medically stable.
40 2021-05-22 lightheadedness Eleven (11) days after 2nd dose, nearly fainted on driveway after standing in sun too long and discu... Read more
Eleven (11) days after 2nd dose, nearly fainted on driveway after standing in sun too long and discussing medical issues. Called advise nurse and was advised to visit emergency department. Past medical history pertinent for hypertryglyceridemia, elevated BMI presenting to the ED with complaint of SYNCOPE (Pt. was talking with his parents about 'medical' stuff, and felt a little queezy, had brief near syncope episode, no full LOC. Scraped arm on a brick wall during episode as fell to ground)
40 2021-05-24 cerebrovascular accident woke up in the middle of the night with right side numbness, and drooping face. Was rushed to the ER... Read more
woke up in the middle of the night with right side numbness, and drooping face. Was rushed to the ER. Stroke team diagnosed and began treatment of stroke. Had multiple tests run to include arterial ultrasounds, internal echo cardio, and CT and MRI of the brain. Confirmed left side of brain stroke but causes are still unknown. all tests and bloodwork came back normal and within range of an above average healthy adult.
40 2021-05-25 loss of consciousness, fainting Patient experienced syncope after receiving 2nd Pfizer Covid-19 vaccine. He sat in the waiting area ... Read more
Patient experienced syncope after receiving 2nd Pfizer Covid-19 vaccine. He sat in the waiting area for approximately 2 minutes before coming back and knocking on the consult room door. When we opened the door he said he felt like he was going to pass out and then fell to the floor, hitting the left side of his head against the wall. He quickly regained consciousness after only a second or two and was able to scoot into the consultation room where we had him lie on his back and elevate his legs. We also gave him a cold compress for his head. We paged department and when AP arrived he contacted EMS to come check him over. The patient did not loose consciousness again and was able to hold a conversation with us while waiting. EMS arrived and checked his vitals and came to the conclusion that he did not need an ambulance. After EMS left the patient drank water and orange juice and sat in the consultation room with me for 20 more minutes before leaving. Patient has no previous history of vaccine reactions or history of fainting. He had no reactions to his first dose other than a sore arm.
40 2021-05-25 lightheadedness Vasovagal. Patient diaphoretic with decreased responsiveness. Resolved on own. Water and juice given... Read more
Vasovagal. Patient diaphoretic with decreased responsiveness. Resolved on own. Water and juice given. Normal vitals. Observed for 30 minutes and asymptomatic when released. Declined EMS
40 2021-05-26 fast heart rate, low blood oxigenation, hypertension, ejection fraction decreased, inflammation of the heart muscle SOB, Fever, fatigue, cough Hypoxia, tachycardia, HTN Admitted 5 days after the 2nd dose of vaccinati... Read more
SOB, Fever, fatigue, cough Hypoxia, tachycardia, HTN Admitted 5 days after the 2nd dose of vaccination Dx: Myocarditis and Pneumonitis RX: steroid, Diuretic
40 2021-05-26 transient ischaemic attack 50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after... Read more
50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after vaccine 2nd dose (April 27, 2021).; Strong pressure in head; loss of ability to support body in RL; Slurred speech; Difficulty in breathing; Cognitive difficulties; Extreme headache; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL7533) via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number EL8727) in the Left arm on 29Mar2021 16:00 at the age of 40 years for covid-19 immunisation. No known allergies. No vaccines were received within 4 weeks prior to the COVID vaccine. Healthy and no prior adverse event history. The patient experienced transient ischemic attack 1 week after vaccine 2nd dose, strong pressure in head, loss of ability to support body in RL, slurred speech, difficulty breathing, cognitive difficulties, extreme headache on 27Apr2021 16:30; visited emergency department. 2nd incident 02May2021- 50% loss of vision, tingling on one side of body, slurred speech, cognitive difficulties, extreme headache. The adverse events resulted in emergency room and healthcare professional office visit. Patient was treated with headache medications. It was reported that patient was recovered from events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.
40 2021-05-27 chest pain, loss of consciousness patient called 911 with shortness of breath and chest pain. When squad arrived, he was still oriente... Read more
patient called 911 with shortness of breath and chest pain. When squad arrived, he was still oriented and awake and told squad he had Pfizer vaccine the previous day. Thought was a pulmonary embolism had occurred. Then he lost consciousness and pulses. EMS started CPR. Despite aggressive ACLS maneuvers, the patient ultimately died.
40 2021-05-27 chest pain Patient reported sudden onset of chest pain while was waiting in observation room. He has no major ... Read more
Patient reported sudden onset of chest pain while was waiting in observation room. He has no major medical problem, HTN or DM. No prescribed medications were taken this morning. No dizziness, SOB reported. per patient he had headache, fever, body ache, and other flu like symptoms after taking the first dose, but no signs of allergic reactions. Vital signs: BP 150/100, HR 74, O2sat 98% on RA, Pain 5/10 consistent burning/sharp on left chest anterior. Called 911 , ECG was done and result normal sinus rhythm. Patient was instructed to follow up with his primary health care provider for further evaluation.
40 2021-05-27 loss of consciousness, hypotension Patient received Pfizer COVID-19 vaccine on 5/28/21 from Nurse. Felt fine right after the vaccine. H... Read more
Patient received Pfizer COVID-19 vaccine on 5/28/21 from Nurse. Felt fine right after the vaccine. He did tell the nurse that he is afraid of needles. While waiting the 15 minute observation period, patient came to the pick up window and stated " I do not feel well". He then squatted down and felt backwards onto his back. He was non responsive for around 30 seconds then regained consciousness. I proceeded to call ED and ran out to assist the patient. By the time I went out there, he regained consciousness. I instructed him to elevate his legs while lying down. Two fire department members assisted us while we waited for emergency services. Person declined to go to the hospital but emergency services advised him todo so since his blood pressure was low. Patient was taken by ambulance to the hospital
40 2021-05-28 pulse abnormal Walking to the observation room approximately 2 minutes post shot I felt extreme dizziness. Felt li... Read more
Walking to the observation room approximately 2 minutes post shot I felt extreme dizziness. Felt like I could potentially pass out so I waited 30 minutes in the observation room before leaving. After I was fairly confident I would not pass out I left the facility. When I made it outside it felt like the right side of my brain was "not there," like a portion of my brain was dead. While driving home approximately 45 minutes post shot I felt numbness and tingling on the right side of my face. Mental confusion also started. I don't recall the numbness and tingling in my face continuing at this time. Proceeded home, laid down on the couch to relax and about 3 hours post shot felt my heart racing. Checked heart rate with pulse oximeter and heart rate was 120 w/98 oxygen. 5 minutes later the heart rate went down to around 90 but blood oxygen went to 90. I sat up, drank water and pulse/oxygen returned to normal. The next day the mental confusion continued. Approx. 24 hours post shot tingling and numbness felt on right side of face. Couldn't move lips properly, communicate to my facial muscles. This lasted around an hour or two. 30 hrs post shot short term memory loss caused confusion when typing texts, following conversation, etc. Symptoms improved greatly over the next couple of days. Tiredness/general unwell feeling approximately 48hrs post shot but unremarkable. By the time I went to a GP 84hours post shot I felt 95%. Went to a neurologist 108hrs post shot who performed standard tests and all was well. 1 week post shot got into an argument and felt tingling and numbness on right side which lasted approximately 10 seconds.
40 2021-05-28 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: pt's forehead felt cold and sweaty and he tried to lift his legs up and kept his hands high - he described that he faints after a blood taken for a test or after a vaccing, and this might be a mental predisposition to this reaction. we called an embulance, but patient felt better in 5-7 min and requested to cancel embulance. He spent 10-20 min on the chair and felt ok to get up and walk around. He left stating he fill better.
40 2021-05-31 pallor, very slow heart rate, hypotension Bradycardia, hypotension Diaphoresis, pallor, visual disturbances - Patient treated for hypotension... Read more
Bradycardia, hypotension Diaphoresis, pallor, visual disturbances - Patient treated for hypotension via IV/Fluid administration. - Patient transported to Medical Center
40 2021-06-01 palpitations Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on... Read more
Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on the 4th day I had a general feeling of malaise, which worsened until I developed a fever. Severe fatigue and constant fever as high as 105 for three days, and finally went to the ER. Immediately treated for sepsis. Full blood panel, blood cultures, x-ray and CT scan. Also ran some additional cultures for respiratory pathogens. The Dr?s had a tough time determining what it was. They saw a very small area which they called pneumonia, however, I?ve had pneumonia and this was not what it was. Final discharge paperwork stated Systemic Inflammatory Response Syndrome.
40 2021-06-02 chest pain, heart attack, inflammation of the heart muscle Per Client received COVID 19 in right arm on 5/24/2021, soreness at injection site on same day of va... Read more
Per Client received COVID 19 in right arm on 5/24/2021, soreness at injection site on same day of vaccine. On 5/25/2021 around 4 am, started having chills and headache. On 5/26-5/27/2021 headache worsened and by Friday on 5/28/2021, along with headache, left sided pain in chest and arm. Per patient was taken to ER by wife and admitted to hospital on 5/28/2021. Per Client, was told first by hospital that he was having a heart attack. Client reported having labs collected, EKG, Catheterization and Ultra Sound. Per Client, later diagnosed with "myocarditis" and is now taking multiple mediations. Per Client was discharged from hospital on 5/29/2021, that evening. Will be following up with PCP in one week.
40 2021-06-02 deep vein blood clot Large DVT in left leg. Put on blood thinners in the ER. Still undergoing treatment
40 2021-06-05 heart rate decreased, chest pain, loss of consciousness Patient has a normal resting heart rate of approximately 60-65 bpm. The day after receiving the Pfi... Read more
Patient has a normal resting heart rate of approximately 60-65 bpm. The day after receiving the Pfizer covid vaccine, heart rate dropped to 25 bpm, and patient passed out. Heart rate remained between 30-40 bpm for approximately 1 1/2 hours. Patient continued to experience a low heart rate of approximately 45-50 bpm for a week, as well as swollen lymph nodes and mild chest pain. As the swollen lymph nodes resolved over the week, patient's resting heart rate started to get back to the normal 60-65 bpm. Patient reported to internal medicine clinic on May 7, 2021. Blood test performed on May 8, 2021 - results normal. Echocardiogram and halter monitor performed on May 24, 2021 - results normal. Cardiology visit on June 2, 2021. Cardiology suspected possible myocarditis, vagus nerve stimulation, and/or allergic reaction as result of first dose of vaccine.
40 2021-06-06 chest pain Loss of appetite, fever (102/103) and night sweats for the first 3 days. my chest pain on the left ... Read more
Loss of appetite, fever (102/103) and night sweats for the first 3 days. my chest pain on the left started the night of the shot around 2 am. The pain kept getting worse and worse each day. I finally had to drive myself to the emergency room (5/4/201) to get it checked out. It felt like something was squeezing my heart. i was super light headed and felt like i was going to drop on the floor dead. They gave me a chest x ray and took blood work. Everything cam back good and the doctor said if i kept getting those chest pain i should return. so they let me go. i still kept getting my chest pain for another week. however i didnt go back to the ER, because i was scared of getting a second bill as im not insured.
40 2021-06-07 chest pain, inflammation of the heart muscle Myopericarditis. Admitted to CCU. Monitored. Had echo and LHC performed which looked normal. Chest p... Read more
Myopericarditis. Admitted to CCU. Monitored. Had echo and LHC performed which looked normal. Chest pain improved but not completely resolved. Started on colchicine and indomethecin
40 2021-06-07 palpitations, chest discomfort, increased heart rate, chest pain 40 year old male without any prior medical history, followed by PCP for yearly exams, who presents w... Read more
40 year old male without any prior medical history, followed by PCP for yearly exams, who presents with complaints of chest pain for the past few days. Pain is described as left sided chest discomfort, first associated with exertion as it started with walking 2 days ago, symptoms resolved when he got home. Again yesterday symptoms returned with walking but after symptoms improved but remained, described some numbness to left hand. He denies SOB, DOE and syncope. He does report palpitations. He was seen by PCP and underwent EKG which was unremarkable however symptoms continued so he came to ED for evaluation. EKG with ST elevations ECG: Sinus tachycardia:Otherwise normal ECG Normal sinus rhythm with sinus arrhythmia:ST elevation, consider early repolarization, pericarditis, He had a stress test and an echocardiogram which were reassuring (see results below). Pain/ discomfort had almost entirely dissipated. He was discharged home with NSAID.
40 2021-06-07 troponin increased, chest pain, inflammation of the heart muscle Myocarditis, presented with chest pain ,troponin peaked at 19, had left heart cath that showed norma... Read more
Myocarditis, presented with chest pain ,troponin peaked at 19, had left heart cath that showed normal coronaries
40 2021-06-08 inflammation of the pericardium, chest pain, fluid around the heart Pericarditis/ pericardial effusion- chest pain that radiated to arm. difficulty breathing in. went t... Read more
Pericarditis/ pericardial effusion- chest pain that radiated to arm. difficulty breathing in. went to ER and had CT scans to verify this diagnosis. Was treated with Ibuprofen and colchicine
40 2021-06-12 chest discomfort Tightness, pressure on chest. Shortness of breath when I take short steps. Dizziness when I stand to... Read more
Tightness, pressure on chest. Shortness of breath when I take short steps. Dizziness when I stand too long and shortness of breath. Blurred vision
40 2021-06-16 ischaemic stroke Ischemic stroke
40 2021-06-17 chest discomfort Extreme discomfort/pressure in chest for 4 hours. Three weeks later the same intense pressure with n... Read more
Extreme discomfort/pressure in chest for 4 hours. Three weeks later the same intense pressure with nausea and cold sweat. Low energy and short of breath.
40 2021-06-17 chest pain Breathlessness and pain in chest a couple of days after the first vaccine shot.
40 2021-06-17 chest pain Sharp chest pain, shortness of breath, Extreme fatigue, pain with deep breath, lasted about five day... Read more
Sharp chest pain, shortness of breath, Extreme fatigue, pain with deep breath, lasted about five days. Took about 10 to 12 days to feel fully recovered
40 2021-06-19 chest discomfort Chills, severe headache, muscle pain, injection location pain, tight chest, fever, rash/bumps on the... Read more
Chills, severe headache, muscle pain, injection location pain, tight chest, fever, rash/bumps on the arm of the injection site, tiredness, drowsiness, dizziness and difficulty breathing. Symptoms lasted approximately 24-36 hours
40 2021-06-20 chest discomfort, palpitations Palpation, fluttering, weakness in heart.
40 2021-06-22 chest discomfort Patient reports chest and upper abdominal discomfort, fatigue and difficulty taking a deep breath si... Read more
Patient reports chest and upper abdominal discomfort, fatigue and difficulty taking a deep breath since receiving 2nd dose of Pfizer Covid vaccine.
40 2021-06-22 chest discomfort Ever since my second Pfizer vaccine shot on May 3rd, 2021, I gradually started feeling a little pres... Read more
Ever since my second Pfizer vaccine shot on May 3rd, 2021, I gradually started feeling a little pressure or heavy weight towards my upper left chest 4-5 days after the shot. I thought its temporary and not relevant, however, I still have this feeling since then on daily basis. I never had this feeling/ pressure ever before my second shot. Thank you
40 2021-06-22 chest pain Chest pain that was much more severe when sitting or sleeping. Sleep was disrupted nightly and I was... Read more
Chest pain that was much more severe when sitting or sleeping. Sleep was disrupted nightly and I was not able to sleep on my left side. The chest pain lasted about 6 weeks and occurred most severely 3-4 times per day. I visited my PCP and he said that he heard a loud murmur or wooshing sound. He checked for a fib but heart ECG was normal. We scheduled an echo but the echo was not performed until 2 months post onset of the symptoms. Symptoms seem to point to subacute pericarditis. Increase of Petechiae on the torso. One spontaneously bled. Seems to be fading after three months.
40 2021-06-23 chest pain, chest discomfort The shot was given at 2:30pm, within 5 minutes I started experiencing chest tightness and very acute... Read more
The shot was given at 2:30pm, within 5 minutes I started experiencing chest tightness and very acute pain, much less sever than after the first shot. The tightness and discomfort lasted less than 10 minutes and subsided and did not return.
40 2021-06-23 loss of consciousness PATINET FELL FROM CHAIR. BRIEF LOC , HIT RIGHT SIDE AND TOP OF HEAD. DIAPHORETIC. LAYED DOWN OF COT... Read more
PATINET FELL FROM CHAIR. BRIEF LOC , HIT RIGHT SIDE AND TOP OF HEAD. DIAPHORETIC. LAYED DOWN OF COT. ICE PACK TO HEAD. DRANK WATER. SAT ON EDGE OF COT. OBSERVED.
40 2021-06-24 chest pain Chest pains, left rib area won't stop hurting, a few days after shot felt like my abs were having a ... Read more
Chest pains, left rib area won't stop hurting, a few days after shot felt like my abs were having a charley horse. Back pain, nausea dizziness and confusion on a daily basis. Doctors have no idea what's wrong with me suggesting upset stomach, ulcer, heartburn, spinal issues., anxiety, depression. They are just guessing.
40 2021-06-24 pallor, loss of consciousness 6/25/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation... Read more
6/25/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: loss of consciousness. Assessment : Time of assessment 0831am. Pallor, Clammy and disoriented. Actions taken: Vitals sign taken EMS called at 0831. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 856am. Patient refuses EMS transport. Water given 0835- BP- 67/44, P- 39, O2- 100 %, recheck- at 0839- BP- 105/66 , 0915- bp 012/82, P- 44, O2- 100% Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. EMS accessed patient, patient refuses transport. Wife with patient. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 6/25/2021 8:27 AM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8736 NDC: 59267-1000-2
40 2021-06-27 platelet count decreased, palpitations, arrhythmia, chest pain Heart Palpitations, heart stopping, chest pain, chest irriation, heavy breathing
40 2021-06-28 chest pain vaccine May 15. awoke with chest pain and pain on movement on May 30, 2021. went to urgent care. neg... Read more
vaccine May 15. awoke with chest pain and pain on movement on May 30, 2021. went to urgent care. negative cardiac workup and treated for costochondritis. Second dose on June 5 with pain in chest on June 7. D dimer negative. EKG and xray negative. treated with naproxen and pain resolved, only to recur when he stopped taking medication on 6/17/21. pain subsequently improved.
40 2021-06-29 fast heart rate, heart rate increased I thought I was having a heart attack and went to the hospital; I had an SVT event and called 911 an... Read more
I thought I was having a heart attack and went to the hospital; I had an SVT event and called 911 and had an EKG in the ambulance; I was having increased heart rate and SVT after my vaccine; This is a spontaneous report from a contactable consumer consumer(patient) reported for himself that. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number Er8727, age at vaccination 40 years), dose 1 via an unspecified route of administration, administered in Arm Right on 25Mar2021at 12:30 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not diagnose with COVID-19 Prior to vaccination. The patient did not test for COVID-19 since the vaccination. On 27Mar2021 the patient experienced 2 days after 1st dose patient stated that he had an SVT event and called 911 and had an EKG in the ambulance. They said I was not having a heart attack, but we are not surprised that I was having increased heart rate and SVT after my vaccine. I have had several since. I went to the emergency room on 13Jun2021 after another event. I thought I was having a heart attack and went to the hospital. They want to monitor me with a Holter monitor for 15 days to see if they can catch an event when it takes place. The adverse event was resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. The patient underwent lab tests and procedures which included (EKG) electrocardiogram on 27Mar2021, (Holter monitor) electrocardiogram ambulatory on 13Jun2021 was unknown. The outcome of the events was not recovered. Information on batch/lot no. are available. Further information has been requested.
40 2021-06-29 cardiac arrhythmia, palpitations Palpitations, PVCS
40 2021-06-30 chest pain RANDOM CHEST PAIN AND SHORTNESS OF BREATH SINCE FEW DAYS AFTER THE SECOND DOSE OF VACCINE.
40 2021-07-06 fainting, hypotension Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Severe, Additi... Read more
Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Severe, Additional Details: Patient fainted 5 minutes after vaccine administered. Patient came to within a minute. Refused to be sent to the hospital. Patieent was given water and a ice pack. Girlfriend picked up patient.
40 2021-07-07 palpitations C/O increase palpitation/hear racing. VSS. hx of experiencing the same reactions post vaccination. P... Read more
C/O increase palpitation/hear racing. VSS. hx of experiencing the same reactions post vaccination. Provider at bedside and evaluated. extended obx addtional 30 mins. sx improved and sent home.
40 2021-07-08 nosebleed Nosebleed; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old adul... Read more
Nosebleed; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old adult male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 14:30 (at the age of 40-years-olds), as a single dose for COVID-19 immunisation. Medical history was not reported. Other medications received within two weeks of vaccination reported as not applicable (NA). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 18:00, the patient experienced nosebleed. The patient did not receive any treatment for the event nosebleed. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event nosebleed was resolving at the time of this report. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
40 2021-07-08 pallor Client reported feeling dizzy and nauseous after vaccination. On assessment client appeared pale, an... Read more
Client reported feeling dizzy and nauseous after vaccination. On assessment client appeared pale, and his skin was cold and moist. Client blood pressure was 98/54. Client responded appropriately to all questions. Client was given ammonia ampule, water and a lollipop. Client reported having eaten a sandwich earlier in the day. Client reported increased dizziness. Client was instructed to lie down and his legs were elevated. Client was monitored. Client's coloring improved and client reported feeling "better". Client's Blood pressure was taken again 140/80, Pulse 67.
40 2021-07-10 palpitations, chest pain, heart flutter ***Please ignore 2nd vaccine listed. Dont know how to delete it. Only recieved 2nd dose covid 19 vac... Read more
***Please ignore 2nd vaccine listed. Dont know how to delete it. Only recieved 2nd dose covid 19 vaccine on 6/30*** Heart inflamation with chest pain, a feeling of breathlessness and a pounding or fluttering heartbeat.
40 2021-07-13 fainting PATIENT WAS VERY NERVOUS ABOUT NEEDLES AND TOOK SHOT OK BUT FAINTED SHORTLY AFTER..RESCUE SQUAD CAME... Read more
PATIENT WAS VERY NERVOUS ABOUT NEEDLES AND TOOK SHOT OK BUT FAINTED SHORTLY AFTER..RESCUE SQUAD CAME AND CHECKED HIOM OUT AND RELEASED HIM AS BEING OK.
40 2021-07-15 chest pain Chest pain on the left side of sternum above nipple line, when inhaling.
40 2021-07-16 chest pain Chest pain persisted for ~3 day. Chest congestion for ~7 days with occassional heartburn-like pain. ... Read more
Chest pain persisted for ~3 day. Chest congestion for ~7 days with occassional heartburn-like pain. On 3/31/21, sharp pain in left arm and back.
40 2021-07-16 loss of consciousness I was hospitalized on 6/2/2021 due to viral Meningoencephalitis. Althought this was 6 weeks after 2... Read more
I was hospitalized on 6/2/2021 due to viral Meningoencephalitis. Althought this was 6 weeks after 2nd shot, was told I should still report it since it was caused by a virus that the hospital was unable to determine after negative tests for other viruses. Had high fever, which led to loss of consciousness and possible seizure. Experienced hallucinations and loss of self-awareness (forgot who I was). Taken to hospital, entered into ICU for 5 days. Spinal tap revealed viral infection. Throat culture revealed strep throat. Given antibiotics and IV fluids for several days. Restored self-awareness and fever disappeared after a few days. Intense headaches persisted for days. Was discharged from hospital on June 7, 2021 after 7 days. Experienced possible repeat seizure 5 days later in public, loss of sensation in legs, slurred speech. Was re-administered into different hospital on June 13, 2021. Spent ~5 days in that hospital, received EEG which showed brain damage on right temporal lobe. Received another spinal tap which showed infection was improving. Discharged on June 16, 2021.
40 2021-07-18 heart rate increased The time of the schedule appointment was for 3:00pm at the local Pharmacy). Once the vaccine was in... Read more
The time of the schedule appointment was for 3:00pm at the local Pharmacy). Once the vaccine was injected into my left arm, I was placed into a different seating placement, to be observe for any signs of side-effects that may occur form the injection. This seating area also displayed a digital clock to notify how long each patient must be stationed for (each station is registered for each patient to wait approximately 15 minutes after injection). Once placed in the seating area and the clock was started to examine my treatment, within the six minutes of observation, the following signs occurred: Rapid-Heart Rate, Short and Shallow Breathing, Sweaty Palms including Hot Flashes (lasting 4 seconds).
40 2021-07-19 heart rate increased, blood pressure increased Blood pressure went up to 160; My heart rate went up to 130/Rapid heart rate; disorienting; unable t... Read more
Blood pressure went up to 160; My heart rate went up to 130/Rapid heart rate; disorienting; unable to eat; post-nasal drip 'dripping' into my lungs; Occasional shortness of breath; Dizzy; Unable to eat and actually zero desire to eat; Sweating/ sleep sweat; sleeping off and on; Was just physically ill/ malaise; Chills; Fever; Extremely tired/ general fatigue; I throw up the water I have been drinking all day; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 13Apr2021 at 08:00 (at the age of 40-years-old) as single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). The patient stated that it was just a standard rescue inhaler 100 mcg. The patient was vaccinated on 13Apr2021 at 08:00 and within 5 minutes his blood pressure went up to 160 and heart rate went up to 130, so they called paramedics over, who were already on site and did pulse check and blood pressure check until they knew what heart rate, blood pressure and oxygenated blood was. They did not allow him to leave for an hour because it was so highly elevated, he felt so dizzy and very disorienting. His friend dropped him home because he could not drive, there was no way he could drive. After an hour the blood pressure got back down to 140 and heart rate was still about 120, it was lower, so he went home and immediately lay down and rest the entire day. He was just physically ill and experienced chills, fever, sleep sweat, extremely tired, strangely no arm soreness at all. He got every other possible side effect and that lasted until 01:30 in the morning, after he throw up, he was finally able to get some sleep. He took rest the entire day, sleeping off and on, unable to eat and actually zero desire to eat, rapid heart rate, sweating, and occasional shortness of breath. He used the rescue inhaler as treatment, that was probably because he laid on his back for so long and also probably just post-nasal drip into lungs. At 01:30 in the morning, he throw up the water he had drank all day and felt a bit better. It was probably because he did not eat all day. He slept until noon and didn't went to work because he felt malaise, general fatigue, his arm didn't hurt. He didn't feel great on the day of reporting, but it was not like the previous day. He had to go to the emergency room, as his mom kept pushing him to go and he was like not going. He had not eaten anything on the day of reporting, so he was looking for something to (incomplete sentence). The patient took 1 gm of Tylenol (over the course of maybe 14 hours) on 13Apr2021 and was advised not to take Advil for whatever reason. The patient underwent blood volume the previous month which was normal and no STDs. He was negative for COVID. That's why he felt okay with vaccine and then before that he did a PCR test which was also negative. The patient have been in 11 countries in the previous year and might have undergone 20 PCR test. He was kind of scared taking the second shot. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-07-21 very slow heart rate, heart rate decreased, palpitations Heart palpitations and dizziness. Bradycardia. Resting heart rate dropped as low as 40 beats per min... Read more
Heart palpitations and dizziness. Bradycardia. Resting heart rate dropped as low as 40 beats per minute.
40 2021-07-21 loss of consciousness Hallucinated after 1st shot then blacked out. Lost control of bladder functions. Disoriented and una... Read more
Hallucinated after 1st shot then blacked out. Lost control of bladder functions. Disoriented and unable to speak or hear for several minutes. Transported to emergency room. Still have hearing issues and headache a week later.
40 2021-07-21 fast heart rate, blood pressure increased Heart Rate for no reason would jump up to 180-200 beats per minute, confusion, high blood pressure. ... Read more
Heart Rate for no reason would jump up to 180-200 beats per minute, confusion, high blood pressure. Called 911 because I thought I was having a heart attack. I did not go to the hospital during that event. I told them I had a cup of coffee with breakfast and that I had my vaccine two days prior and they said it was probably from that. I had 20 other events the following months sometimes at night, same symptoms. The worst was on 6/13/21 I was helping my friend move and my heart rate jumped up and blood pressure went up as well. I called my wife to pick me up and I could not communicate my location, I was standing under a street sign in a neighborhood I am familiar with. I though I was going to lose consciousness. I called 911 and decided to go to the hospital and see what was happening to me. I have had several EKG and came back clean. The doctor said for some reason I am having episodes of SVT and that I need to wear a holter monitor to figure out what is happening to me. After that day I removed any and all alcohol and caffeine from my diet. Beers on the weekend and I would have one to two cups of coffee a day from our coffee machine at home. 6 weeks later the monitor has been approved and I am wearing it now. I set up a doctor because I did not one and had an EKG and explained my sysptoms and he said he has seen this happen to a lot of men specifically and it usually takes several months and it "should" go away. I meet with a Cardiologist on July 29th. Since removing alcohol and caffeine the episodes decreased and went away within a week and I have not had any episodes for the past 4 weeks.
40 2021-07-22 palpitations Severe dizziness, headache, loss of balance, heart palpitations, upset stomach, blurry vision and na... Read more
Severe dizziness, headache, loss of balance, heart palpitations, upset stomach, blurry vision and nausea.
40 2021-07-27 hypertension Patient developed new-onset hypertension the day after immunization that has persisted for the past ... Read more
Patient developed new-onset hypertension the day after immunization that has persisted for the past 4 days. Patient not having chest pain, shortness of breath, or palpitations. Patient does endorse forceful heartbeat.
41 2021-01-05 palpitations, chest pain I started having intermittent chest pain moderate in intensity and palpitations.
41 2021-01-07 low blood platelet count, platelet count decreased ITP Plt 2
41 2021-01-10 chest discomfort 1. Lethargy 2. Intense Migraine 3. Joint pain 4. Foggy Brain 5. Heavy Chest 6. Chills
41 2021-01-10 fast heart rate, hypertension Approximately 15 minutes after receipt of the vaccine, I experienced tachycardia and mild throat swe... Read more
Approximately 15 minutes after receipt of the vaccine, I experienced tachycardia and mild throat swelling. I was placed in the Immunizations Clinic treatment room, had my airway assessed, and vital signs taken. My initial vital signs at 0950 were BP 197/99, HR 106, O2 sat 99%, temp 98.3 F, and 0/10 pain. Over the course of the next 2 hours, I repeatedly had my vital signs taken, was monitored, was provided with water, and remained hypertensive and tachycardic, although down-trending. I also experienced cottonmouth and bilateral blurred vision/dry eye. At the end of the 2 hour monitoring, the throat swelling seemed to subside, my systolic BP in the mid 140s and diastolic BP was in the mid 90s. At time of release from monitoring, I felt better, but dry eyes and dry mouth continued without difficulty swallowing. I was instructed to report to the ER if my symptoms worsened and to consult by primary care manager about the incident. Upon walking back to my office, I realized I was experiencing dizziness as well and a mild headache. I attempted to submit this form online but I received an error message, so I completed the fillable version to upload, in case a partial duplicate record appears.
41 2021-01-12 chest pain 2 days later I developed pain in my chest, back, lats, and entire arm. I have sharp numbing pain per... Read more
2 days later I developed pain in my chest, back, lats, and entire arm. I have sharp numbing pain periodically from my armpit to my pinky finger. This pain has only grown worse since onset despite my doctor prescribing oral steroids and pain meds. Painful to sneeze, cough and laugh
41 2021-01-15 blood glucose increased, fainting After 2nd dose in the afternoon at 2:30pm pt collapse in the unit V/S was high blood sugar was high.... Read more
After 2nd dose in the afternoon at 2:30pm pt collapse in the unit V/S was high blood sugar was high. Pt was held over at work for 16 hours. Shot was given at 6:45am. Paramedics was called. Sent to ER.
41 2021-01-18 palpitations, hypertension Beginning 5 days later, and persisting for the last 3-4 weeks (on and off): GI issues, headaches, li... Read more
Beginning 5 days later, and persisting for the last 3-4 weeks (on and off): GI issues, headaches, lightheadedness, dizziness, palpitations, high blood pressure.
41 2021-01-20 heart rate increased Approximately 5 minutes after receiving injection, patient reported feeling mildly short of air. 141... Read more
Approximately 5 minutes after receiving injection, patient reported feeling mildly short of air. 1410-BP 132/89 HR 104 SpO2 99% 1420-BP 130/86 HR 85 SpO2 99% - reports that symptoms have resolved. Denies need for further intervention. Education provided to seek medical attention for further sx Pt was ambulatory and left the clinic.
41 2021-01-22 blood pressure increased, blood pressure decreased On 12/26 (Sat), heart rate increased to 170 and then calmed down. On Sun and Mon - vomiting, nausea ... Read more
On 12/26 (Sat), heart rate increased to 170 and then calmed down. On Sun and Mon - vomiting, nausea and HA on and off. On Mon heart rate increased again. Went to Urgent Care and tested covid negative. On Wed 12/30, BP at 180/105. Went to ED and BP eventually went down to 145/95. Dr is speculating that since patient had high antibodies from covid infection in August and still high antibodies in October that all of this is a wild immune reaction triggered by the vaccine.
41 2021-02-03 hypotension, loss of consciousness Patient received 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA at 2:04pm , <5 minutes after vacci... Read more
Patient received 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA at 2:04pm , <5 minutes after vaccine administration he developed hypotension with loss of consciousness for few seconds. He was sitting in a designated chair for the protocol 15 min observation and fell from the chair to the ground, hitting the right side of his temporal - redness noted around area with skin intact. Clinic staff immediately moved patient to be lying down on the ground with cervical spine precaution and lifted his legs up on a chair. Vitals: HR 78 and BP 118/72 taken in supine position on ground with legs elevated. Patient was transported by EMS to the ED at 2:45pm. ED note: Patient has Hx of vasovagal syncope in the past with similar symptoms after blood draws..Exam and workup shows well-appearing young man, nonfocal neuro exam, normal gait, cardiopulmonary exam unremarkable, no signs of trauma other than a small hematoma to the right forehead. After evaluation, their Canadian Syncope Risk Score is -3 indicating very low risk for 30 day serious adverse events (<1%). Telemetry monitoring during their ED stay has not captured any events. Discussed next steps with patient: given their low risk for 30 day serious adverse events (including death, serious arrhythmia, MI, PE, ICH), they would prefer to be discharged to continue their workup as an outpatient, rather than admission for observation. Patient was deemed stable to discharged from the ED at 5:57pm with counseling to follow up with PCP in the next 2 days and to return to the ED with any persistent or worsening symptoms.
41 2021-02-03 loss of consciousness, fainting, pallor Syncopal event after shot given . Clammy and diaphoretic , ashen appearance and announced he was abo... Read more
Syncopal event after shot given . Clammy and diaphoretic , ashen appearance and announced he was about to pass out before he passed out . Has had between 15-20 similar episodes describable and recallable in his lifetime . Awoke after a brief 10 sec loss of consciousness. Felt immediately better and no different than any other episode that occurred after seeing needles and getting shots. Drank some water and dc home after observation . Drove himself home . No sequelae.
41 2021-02-05 deep vein blood clot Developed DVT in left leg from groin to ankle. Diagnosed on 01/29/2021. Pain, swelling, and difficul... Read more
Developed DVT in left leg from groin to ankle. Diagnosed on 01/29/2021. Pain, swelling, and difficulty walking lead to emergency room visit, admission to hospital for 2 days.
41 2021-02-05 hypotension, pallor, fainting Patient became syncopal within 1-2 minutes of administration. He was lowered to the ground and evalu... Read more
Patient became syncopal within 1-2 minutes of administration. He was lowered to the ground and evaluated by medical team. When repositioned to seated position he again became syncopal, he was again lowered to the ground and placed in a recovery position. EMS assisted him to stretcher and he was transported to medical treatment area at the vaccination site, ECG and VS performed, patient was hypotensive, diaphoretic, and pale. He was ultimately transported to ED
41 2021-02-07 heart rate increased Roughly 12 hours after receiving the second dose of the vaccination, I began to be restless, especia... Read more
Roughly 12 hours after receiving the second dose of the vaccination, I began to be restless, especially when trying to sleep. I noticed that my resting heart rate was way above normal (normal = 76-80 bpm). My heart rate after about 10pm rose to about 115-120 bpm and stayed at that level for about 12 hours.
41 2021-02-07 pallor Patient screened for first dose of Pfizer vaccine. He checked no history of allergies or reactions t... Read more
Patient screened for first dose of Pfizer vaccine. He checked no history of allergies or reactions to medications or vaccines. In the initial screening he informed me he had a phobia of needles but this is usually with blood draws. He reported he should be fine with vaccinations. I inquired on previous reactions and he denied any allergic reaction just that he does not like them. I asked him how I can help give the vaccine. We had him look away and to think of a different situation. I asked him if he would like to know when I am administering or just use distraction. He chose to be informed when he would feel a slight poke. Vaccine was administered with no issues. Within the minute following the vaccine patient started to feel dizzy. Hung his head a bit but was responsive. I requested staff assistance to help the situation including RN to prevent any episodes of syncope. We provided water which he was able to drink. He was still seated and we suggested putting head between legs. This was not comfortable for him so we moved him to the floor. About 3-4 min in he began to sweat a bit more and appeared Pale. We obtained a BP and pulse. BP was 112/60 and pulse around 60. When he felt hot, sweaty and appeared pale we all decided to call EMS to be cautious. He maintained BP, no SOB, did not lose conscious. EMS evaluated him, med list provided and vitals. He was on medications for anxiety. They released him after about 30min and reported a panic attack and not related to the vaccine. Patient walked out of the clinic with his partner and was stable. He is requesting 2nd dose of the vaccine. I informed him nurse would review and would have a plan for future injection.
41 2021-02-17 chest discomfort Trouble breathing with chest pressure; Trouble breathing with chest pressure; Rash on face with swol... Read more
Trouble breathing with chest pressure; Trouble breathing with chest pressure; Rash on face with swollen fingers; Rash on face with swollen fingers; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose of BNT162B2 (Lot number: 9264), via an unspecified route of administration on 31Jan2021 10:15 at single dose in the left arm for covid-19 immunisation. Medical history included hypertension and penicillin allergy. The patient's concomitant medications were not reported. On 03Feb2021 09:30, the patient experienced rash on face with swollen fingers and trouble breathing with chest pressure. The events result in Emergency room/department or urgent care. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 03Feb2021. The outcome of the events was recovering. The following information on the lot/batch number has been requested.
41 2021-02-18 chest pain Initial adverse events: night sweats, fever, body aches, muscle aches (Back pain). These all occurr... Read more
Initial adverse events: night sweats, fever, body aches, muscle aches (Back pain). These all occurred about 12 hours after the second shot and subsided around 36 hours after the second shot. 8.5 days after the second shot I had throat and chest pain. This pain then continued and got worse to the point I went to the ER and was evaluated for potential heart attack. After testing - results were that I did not have a heart attack. I was still experiencing this pain, so the ER took a strep test. This was also negative. The diagnosis was "pulled chest muscle". I've had pulled muscles, I know what those feel like and it sure didn't feel like what I experienced on the night of the 16th and the day of the 17th of Feb. 2021.
41 2021-02-21 loss of consciousness, pulse abnormal Patients spouse reports he started to feel "funny" 5 mins post vaccination administration. Patients ... Read more
Patients spouse reports he started to feel "funny" 5 mins post vaccination administration. Patients spouse called for assist when he he became unconscious at 7:25pm. He was found unconscious and failed to respond to a sternal rub. EMS called. Initial assessment: HR-weak pulse-not palpable, agonal, shallow breathing, and unresponsive. VS- BP 160/100 HR- 100 Wife used smelling salt to arouse the patient. He was confused after regaining consciousness. 7:37pm- EMS arrived and assumed care, transferring patient to a higher level of care.
41 2021-02-23 troponin increased, chest pain Dose 2 of Covid vaccine given 2/18/2021, on 2/19/2021 felt bad, stayed in bed all day and that eveni... Read more
Dose 2 of Covid vaccine given 2/18/2021, on 2/19/2021 felt bad, stayed in bed all day and that evening had a sharp pain in chest. chest pain continued intermittent next day and then 2/22/2021 0200 it was a sharp crudhing pain that radiate down his L arm, same arm had the vaccine in, awoke him from sleep
41 2021-03-09 chest discomfort Pt received dose 1 of PfizerBiontech COVID Vaccine AT 1318. He was observed 30min without complaint ... Read more
Pt received dose 1 of PfizerBiontech COVID Vaccine AT 1318. He was observed 30min without complaint and left without incident. He returned at 1356 c/o" throat and chest tightness." Upon assessment, wheezing is noted bilaterally. Resp Rate and Work of Breathing Within Normal Limits. Denies any other complaints and exhibits no further signs or symptoms. Albuterol/Atrovent Neb as well as IV Benaryl 50mg administered on scene and patient states his tightness is improving/resolving. Continues to denye further Complaints. Responding units Fire Department and Ambulance arrive on scene and care handed over to crew. Assessments, care, and treatment continued enroute and patient transported to ED
41 2021-03-09 chest pain Extreme chest pain Hard to breath and painful
41 2021-03-09 chest pain He received first dose of Pfizer COVID vaccine 1/15. Next day, he felt right axilla and trunk numbne... Read more
He received first dose of Pfizer COVID vaccine 1/15. Next day, he felt right axilla and trunk numbness after that which lasted 2-3 weeks and was resolving. After the second dose early Feb 5th, he started having difficulty swallowing and SOB and felt a little better after a course of steroids and antibiotics but got a lot worse after finishing the course and presented to ED 2/16 and was found to have supraglottic edema requiring intubation and treatment with IV steroids. Was extubated on 2/19, in ICU until 2/21. He did well with treatment and was discharged 2/22. Patient received a dose of influenza vaccine (FLULAVAL - GSK lot: 7N43B) on 2/22/21 3/2 he started having burning pain in the right midthoracic area, the next day he noticed right hand weakness/numbness (4th and 5th digits), gradually progressed. 3/4 noticed right facial weakness, initially was lower face, Unable to drink without drooling. MRI brain was done 3/5 and was normal. 3/5 facial weakness progressed to upper face. Unable to close right eye for the last 24 hrs. He also reports numbness left 5th digit. Presented to the ED on 3/6. Found to have elevated transaminase in ED. Hospitalization continues at this time. Etiology of symptoms is unknow, but includes vaccine reaction, shingles or early stages of autoimmune disease.
41 2021-03-11 fast heart rate 20 minutes of monitored and recorded tachycardia (peak heart rate of 188) while at rest. Accompanied... Read more
20 minutes of monitored and recorded tachycardia (peak heart rate of 188) while at rest. Accompanied with perspiration, flushing, myalgia and malaise. Tachycardia resolved, other symptoms persisted for 12+ hours.
41 2021-03-12 cardiac arrest 2/27/21 Sudden cardiac arrest due to thrombosis in the LAD
41 2021-03-16 chest pain Significant chest pain in heart area 6 days after first shot, especially if I took a deep breath. I ... Read more
Significant chest pain in heart area 6 days after first shot, especially if I took a deep breath. I don't think it was even that bad when I suspect I first got Covid 1 year ago. Got mostly better by the next day.
41 2021-03-16 heart rate increased, blood pressure increased Narrative: Patient C/O mild itching 10 minutes after Pfizer covid vaccine administration. No berthi... Read more
Narrative: Patient C/O mild itching 10 minutes after Pfizer covid vaccine administration. No berthing issue or other symptoms. VS: BP 137/79, 96, PO2 100%. PE: Mild erythema on upper arms, no hives. Symptoms decreased significantly after 10 minutes if observation. Patient released with instructions to take Benadryl if itching recurs or repot to ED if worse symptoms develop.
41 2021-03-16 palpitations Tingling in ears and extremities, heart was racing, tickle in throat, dizzy, short of breath, nauseo... Read more
Tingling in ears and extremities, heart was racing, tickle in throat, dizzy, short of breath, nauseous
41 2021-03-17 haemoglobin decreased Second Pfizer COVID vaccine given 2/12/2021. Developed symptoms one day after 2nd Pfizer vaccination... Read more
Second Pfizer COVID vaccine given 2/12/2021. Developed symptoms one day after 2nd Pfizer vaccination with headache, body aches, chills, followed by abdominal pain, vomiting and diarrhea over the next 3 days, then became confused per wife so he came to ED for evaluation on 3/16/2021 and evaluated by me. Also had black stools and vomiting blood. Diagnoses: Septic shock, Gastrointestinal Bleeding with severe blood loss, Hepatitis with Hepatic Encephalopathy, Liver cirrhosis. Admitted to hospital 2/16/2021-discharged 2/21/2021. Since symptoms developed day after vaccination, I am compelled to report.
41 2021-03-18 blood pressure increased For the first 24 hours I had no symptoms other than arm pain. For the next 6 days experienced debili... Read more
For the first 24 hours I had no symptoms other than arm pain. For the next 6 days experienced debilitating headaches, which led to nausea (because they were so severe). Elevated blood pressure also coupled with headaches. I initially took Ibuprofen (which helped somewhat), whereas Tylenol did nothing. I also have a flexible ice pack that I placed over my head. That also helped a little. I went to the doctor on March 17th, but he was dismissive of the headaches being related to the vaccine. I have since been referred to a neurologist (April 1st appointment).
41 2021-03-23 chest discomfort Chest Tightness x 5 min Hx of irregular heart beat x 3yrs. Normal limits: V/S BP= 132/96; HR= 77; R... Read more
Chest Tightness x 5 min Hx of irregular heart beat x 3yrs. Normal limits: V/S BP= 132/96; HR= 77; RR= 20 No SOB
41 2021-03-23 deep vein blood clot, pulmonary embolism The patient is a 41 yo male with a history of seasonal allergic rhinitis who experienced DVT and PE ... Read more
The patient is a 41 yo male with a history of seasonal allergic rhinitis who experienced DVT and PE temporally related to Pfizer BioNTech COVID vaccine dose #2 receipt. He is a Service Member and reported high levels of baseline activity, including running 10 miles each Saturday. He received vaccine #1 25 JAN 21 (EN5318) without AE. He received dose #2 on 16 FEB 21, (EN6200). He experienced no immediate symptoms suggestive of IgE event. On day 1 he reports feeling cold, mild fatigue but no other symptoms. On day 2 he was baseline. On day 3 he noted numbness, tightness and discomfort to his right calf. On day 4 (Saturday), his usual long run day, he experienced dyspnea and lightheadedness after running 20-30 feet. He states he noted tightness in his calf and instead walked the track while his wife completed her run. He rested day 5. Day 6 he noted significant edema to his calf, which he describes as double normal in size, and iced it. Day 7, he tried to schedule with PCP and based on triage was sent to ER. ER diagnosed R DVT and bilateral PE's. He was admitted overnight, started anticoagulation therapy. He saw hematology, and the workup was negative for other causes.
41 2021-03-24 palpitations felt heart was racing, comes and goes. clammy hands, anxious. HR 92 BP 136/82
41 2021-03-26 hypotension low blood pressure and dizziness, diaphoresis. Taken to medical observation BP 110/60 At 0954 AM BP ... Read more
low blood pressure and dizziness, diaphoresis. Taken to medical observation BP 110/60 At 0954 AM BP was 120/70 Patient stable. Discharged to exit via wheelchair.
41 2021-03-28 heart rate increased Light head and dizziness, chills, slightly elevated heart rate
41 2021-03-30 nosebleed previous wounds that had not yet healed having extra bleeding; never get nosebleeds and had one unex... Read more
previous wounds that had not yet healed having extra bleeding; never get nosebleeds and had one unexpectedly; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 03Mar2021 09:00 (batch/lot number: EN9581) as single dose for covid-19 immunization in a workplace clinic. Medical history included ongoing wounds that had not yet healed. The patient's concomitant medications were not reported. The patient has no covid prior vaccination. The patient has no other medications in two weeks. The patient has no other vaccine in four weeks. On 04Mar2021, the patient noticed previous wounds that had not yet healed having extra bleeding. The patient informed that he also never got nosebleeds and had one unexpectedly 1 week after vaccine (Mar2021). The patient was not covid tested post vaccination. The patient had no treatment received due to the events. The outcome of the events was unknown.
41 2021-03-30 fainting vasovagal syncope, fully recovered after 10-15 minutes
41 2021-03-31 loss of consciousness NAUSEATED, BLACKED OUT, COLD SWEAT. CAME TO FINE WITHIN A FEW SECONDS EPISODE RESOLVED QUICKLY CLIEN... Read more
NAUSEATED, BLACKED OUT, COLD SWEAT. CAME TO FINE WITHIN A FEW SECONDS EPISODE RESOLVED QUICKLY CLIENT MONITORED FOR 30 MINUTES AND LEFT WITHOUT FURTHER INCIDENT.
41 2021-04-01 blood pressure increased Patient got their Pfizer covid-19 vaccine and during the 15 minute post vaccination waiting was noti... Read more
Patient got their Pfizer covid-19 vaccine and during the 15 minute post vaccination waiting was noticed to be lethargic and just didn't feel right. Upon checking vitals it was determined that the patient's blood pressure was a little high, but all other vitals were fine. Patient still said that he didn't feel right so EMS was called and the patient was transported to Hospital for further evaluation.
41 2021-04-04 heart rate increased Headache - 4 days and still comes and goes sometimes being very extreme. Fatigue - Started feeling t... Read more
Headache - 4 days and still comes and goes sometimes being very extreme. Fatigue - Started feeling tired around 5:00pm the day of the vaccine and I have continued to feel tired after 4 days. Muscle/Joint pain - Started getting sore arm first a couple hours after shot then progressively getting worse on my entire body for 3 days. On day two is was almost unbearable with my lower back being the most painful. I could not sleep because of the pain with no position that would relief it. Chills - Started getting chills on the evening of the vaccine. They came and went for 3 days. On the second day it was uncontrollable shakes no matter how many blankets I used. Fever - Started the night of my vaccine increasing to 102.4 and reaching the highest on the second day at 103.5. I took ibuprofen every 6 hours for two days straight with it staying steady at above 100. Nausea - Started the evening of the vaccine and got very severe. It has continued for 4 days. Fast Heartbeat - It has stayed consistently above 110 and sometime getting up to 130 while laying in bed shivering.
41 2021-04-05 heart rate increased Received Pfizer COVID-19 Vaccine (1st shot) at 10:20am. Dizziness for 5 minutes after receiving inje... Read more
Received Pfizer COVID-19 Vaccine (1st shot) at 10:20am. Dizziness for 5 minutes after receiving injection then it disappeared. When I arrived at home an hour and a half later I was dizzy again and experienced rapid heart beats. Symptoms lasted for 30 minutes and then the symptoms stopped. While I didn?t experience any more side effects today, I did notice that the are around the injection site is significantly swollen and sore. I?m using an ice pack to help bring the swelling down.
41 2021-04-07 loss of consciousness started to sweat and felt "not right" post injection a few minutes, states has happened several time... Read more
started to sweat and felt "not right" post injection a few minutes, states has happened several times in past when getting injections. staff assisted to floor and states did lose consciousness for a moment. felt better once in obs, 1517 bp 119/68 hr 83 rr 20 sats 98% on ra. 1530 bp 138/72 hr 67 rr 17 sats 98% on ra. states s/s resolved, stood up with no issues, escorted to personal vehicle with no issues.
41 2021-04-07 lightheadedness NEAR-SYNCOPAL EPISODE PT FELT LIGHT HEADED, WEAK VITALS: 90/PALP RESP. RATE: 20 REG PULSE: 110 REG
41 2021-04-07 lightheadedness After administering the vaccine, the patient experienced a severe vasovagal response approximately 5... Read more
After administering the vaccine, the patient experienced a severe vasovagal response approximately 5 minutes after receiving the vaccine. Diaphoresis was treated with ice packs. PulseOx was normal, blood pressure and heart rate were stable.
41 2021-04-10 chest discomfort on 4/11/2021 approximately 1pm , just left home from lunch and went back to work. started having c... Read more
on 4/11/2021 approximately 1pm , just left home from lunch and went back to work. started having chest tightness, chest pain, called wife -- he felt clammy and all around not feeling well and above symptoms. Advised him to come home- stayed on phone with him til he arrived home. took his blood pressure with wrist bp machine while sitting at dining table and it was 171/85 and pulse was 85 so called EMS.
41 2021-04-10 lightheadedness Presyncope (lightheadedness, nausea, blurry vision). Normal vitals. Symptoms improved with supine re... Read more
Presyncope (lightheadedness, nausea, blurry vision). Normal vitals. Symptoms improved with supine rest and oral rehydration.
41 2021-04-11 loss of consciousness I immediately past out twice and was told I had two minor seizures. I declined ambulance and have fe... Read more
I immediately past out twice and was told I had two minor seizures. I declined ambulance and have felt dizzy spells since. I have appointments to get checked out.
41 2021-04-12 chest pain Headache, diarehhia, fatigue, muscle and joint pain, swollen lymph nodes (arm pit on side of injecti... Read more
Headache, diarehhia, fatigue, muscle and joint pain, swollen lymph nodes (arm pit on side of injection), chest pain
41 2021-04-12 hypertension, blood clot Blood clot in right hand. Could not feel right thumb pointer and middle fingers and they turned purp... Read more
Blood clot in right hand. Could not feel right thumb pointer and middle fingers and they turned purple. Went to hospital and treated with Heprin. Outcome - still have the blood clot. Put on Eliquis. Also developed high blood pressure from event and put on valsartan
41 2021-04-12 loss of consciousness PATIENT LOST CONSCIOUSNESS FOR 10 SECONDS , 10 MINUTES AFTER RECEIVING VACCINATION. AFTER HE REGAIN... Read more
PATIENT LOST CONSCIOUSNESS FOR 10 SECONDS , 10 MINUTES AFTER RECEIVING VACCINATION. AFTER HE REGAINED CONSCIOUSNESS HE SAID HE HAD NOT EATEN BREAKFAST AND HAD NICOTINE GUM 10 MINUTES BEFORE GETTING THE VACCINE. ALSO HE MENTIONED THAT IT HAD HAPPENED TO HIM BEFORE WHEN HE GOT A VACCINATION. HE FAINTED WHILE THE NEEDLE WAS STILL IN HIS ARM. HIS BLOOD PRESSURE WAS 142/68. EMT ARRIVED AFTER 5 MINUTES AND TOOK HIM TO THE HOSPITAL
41 2021-04-13 chest pain Shortness of breath & chest pain ~36-48 hours post vaccination
41 2021-04-13 inflammation of the heart muscle, troponin increased mild myocarditis with fevers +constitutional symptoms, trop and BNP elevation (without other cause),... Read more
mild myocarditis with fevers +constitutional symptoms, trop and BNP elevation (without other cause), ekg abnormalities, EF wl
41 2021-04-14 chest discomfort, chest pain, troponin increased Patient developed Chest pain at 0700. Came on suddenly. Pressure, squeezing and tightness that rad... Read more
Patient developed Chest pain at 0700. Came on suddenly. Pressure, squeezing and tightness that radiated up to his shoulder.
41 2021-04-14 fainting Full syncopal episode lasting 15 seconds per vaccinator. Awake, alert and oriented upon med response... Read more
Full syncopal episode lasting 15 seconds per vaccinator. Awake, alert and oriented upon med response arrival. Pt states hx of syncope with blood draws and injections. denies having breakfast today. Denies any food or drink from medical staff. Symptoms resolved and pt left.
41 2021-04-15 chest discomfort Pt c/o chest tightness in middle are of chest Pt assessed: VS: 150/80 98HR 94% Rested for 10 min. A... Read more
Pt c/o chest tightness in middle are of chest Pt assessed: VS: 150/80 98HR 94% Rested for 10 min. After 10 min, VS: 142/80 O2Sat 95%, Denies chest tightness, pressure, heart palpitations.
41 2021-04-16 oxygen saturation decreased, heart flutter, chest pain Vaccine on the 6th Sore arm that day. That night before bed dizzy, tired, back muscles tightenin... Read more
Vaccine on the 6th Sore arm that day. That night before bed dizzy, tired, back muscles tightening. 7th. Dizzy , tight muscles, sore arm, that late afternoon i sneezed. My back went out. Severe spasms and pain from The 7th-16th. Late night on the 16th. Chest neck and shoulder pain. Heart flutters, tachycardia, oxygen levels dropping to 89. Hovering around 95. Severe nausea. Abdomen pain. Tight painful muscles in legs Same and worse today on the 17th , had ER visit Been taking Valium and Tylenol for pain and spasms per my PCP since April 15
41 2021-04-16 fainting Syncope, fainting leading to fall and head injury.
41 2021-04-17 loss of consciousness Sleep for a few minutes, I didn't pass out but it was similar; Was pulled over "for minor traffic v... Read more
Sleep for a few minutes, I didn't pass out but it was similar; Was pulled over "for minor traffic violation." He was told "to get out of the car and had a field sobriety test, and I looked intoxicated."; Felt heavy and tired/Run down; Had a headache; Upset stomach; sleep for a few minutes, I didn't pass out but it was similar/crashed for 4-5 hours in the middle of the day which I never do; aching; Over all weakness; Started feeling sick again at dinner; Woke up feeling really bad; Bad diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergic to sulfa, PCN and amoxicillin. The patients concomitant medications were not reported. On an unspecified date the patient experienced sleep for a few minutes, I didnt pass out but it was similar, was pulled over for minor traffic violation. He was told to get out of the car and had a field sobriety test, and I looked intoxicated, felt heavy and tired/run down, had a headache, bad diarrhea, upset stomach, sleep for a few minutes, I didnt pass out but it was similar, crashed for 4 to 5 hours in the middle of the day which I never do, aching, overall weakness, started feeling sick again at dinner, he went to the bathroom a few times, woke up feeling really bad. The patient was worried because everything was coming to a head right now. The caller got the first shot, he waited for 15 minutes and felt fine. As the caller walked to his car he began feeling heavy, had severe diarrhea, headache, aching, it was almost like he passed out, it felt like he went to sleep. The patient got home and crashed 4 to 5 hours in the middle of the day and woke up feeling really bad. The patient went to a very important dinner meeting that night. While the patient was at the meeting he went to the bathroom a few times and then excused himself because he felt so bad. The patient did not even finish one cocktail with dinner. The caller got pulled over for a minor traffic stop, cutting the corner and crossing the line or something small. The officers believed the caller was driving under the influence and started making him do a sobriety test with 40 degree wind gusts, the patient was miserable. The caller told the officers that he needed to seek medical attention but they ignored him. The officers forced the caller to do the urine test. It has been 5 days since his vaccination and he is just now feeling better. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
41 2021-04-18 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
41 2021-04-19 loss of consciousness Patient had an episode with convulsions and loss of consciousness lasting a couple seconds after eat... Read more
Patient had an episode with convulsions and loss of consciousness lasting a couple seconds after eating a marijuana edible.
41 2021-04-20 loss of consciousness Right after receiving the vaccine (approximately 5 minutes after), patient said they were feeling li... Read more
Right after receiving the vaccine (approximately 5 minutes after), patient said they were feeling light-headed. I went to go get patient water and a granola bar since he hadn't eaten breakfast and patient passed out. Patient was resting after receiving the 1st dose of the vaccine, and was propped against the wall in the corner on a chair, so he was just leaned up against the wall (didn't fall to the ground). Several patients helped me move the patient to the ground so he was lying horizontal and he woke up almost immediately (max 10 seconds). He wasn't quite oriented to what had just happened but knew he was on the ground. Within 1 minute, patient knew where he was, was feeling fine and wanted to sit back on the chair. He was carrying on a full conversation and did not feel feverish, sweating, tired, faint, or have a headache, just embarrassed. Patient stayed for a full 30 minutes and wanted to drive himself home because he felt completely back to normal. Vaccine administrator calling to check up on patient during next available break.
41 2021-04-22 nosebleed, fainting RN witnessed Patient syncope - fell face down out of chair, landed on forehead/nose area, very brief... Read more
RN witnessed Patient syncope - fell face down out of chair, landed on forehead/nose area, very brief tonic/clonic activity. Bloody nose, bleeding from cut on bridge of nose, abrasion above R eyebrow. Swelling on bridge of nose, appears that it may be broken. Patient conscious soon after syncopal episode and able to speak to RN and Medic. Patient notes history of syncopal episodes related to needles. Volunteer Medic applies pressure to cut and nose to stop bleeding. EMS called due to concern of patient hitting head during fall, possible broken nose. Patient hypotensive (90s/60s), blood sugar 76 - pt stated only black coffee to eat/drink today, slow to recover, dizzy, unable to sit up. EMS transferred to ED for assessment at ~1000.
41 2021-04-22 loss of consciousness, fainting Patient states he was sitting when he got very hot and nauseated before fainting. Staff saw patient ... Read more
Patient states he was sitting when he got very hot and nauseated before fainting. Staff saw patient fall to carpeted floor face first and ran to his side. Patient briefly non-responsive but almost immediately regained consciousness and turned over onto his back. Legs elevated to chair and patient instructed to remain supine. Vitals at 1:35pm 120/80, HR 91%, O2 level 97%. Patient states he tends to get very hot and nauseated with shots. 1:37 pm: c/o tingling in both hands and requested an ice pack. Obtained his wife's phone number and contacted her using his phone. Attempted to cleanse abrasions to (L) forehead and bridge of nose but he was not able to tolerate the smell. Drinking bottled water provided by staff. EMS enroute. 1:40 EMS arrived; BP 112/72, HR 89, O2 98%. Patient remains alert and oriented. Kept supine. Using his ice packs to hands. 1:57pm: Still has tingling and slightly nauseated. EMS requested privacy with patient.
41 2021-04-22 loss of consciousness About 10 minutes after receiving the vaccine. I felt hot and sick to my stomach. I couldn't breathe.... Read more
About 10 minutes after receiving the vaccine. I felt hot and sick to my stomach. I couldn't breathe. I took my mask off and fanned myself. I started to feel dizzy and then I fell to the floor and passed out. The paramedics did an ekg and thought I was having a heart attack. They rushed me to the Emergency Room and they performed more tests. The tests showed their was nothing wrong with my heart previously.
41 2021-04-22 fainting Approximately 5 minutes after injection, pt began complaining of "feeling warm." He was provided wit... Read more
Approximately 5 minutes after injection, pt began complaining of "feeling warm." He was provided with water by a staff member. The patient then fell to the floor from a seated position in a chair in the observation area. The EMT and Paramedic immediately responded to the patient. They assessed the patient and brought him into a wheelchair once he was feeling well enough to do so. The patient never lost consciousness. Initial vitals: BP 96/60, O2 95% on room air, RR 24, HR 64. The Paramedic took a 12-lead EKG, result was Sinus rhythm with apparent ST elevation. Subsequent EKG was sinus brady with apparent ST elevation. The patient was free of contusions or scrapes from his fall from the chair. PT initially refused transportation to the emergency department. After some convincing, the patient was agreeable to seek elevated medical treatment and was transported by ambulance.
41 2021-04-24 atrial fibrillation, heart rate irregular irregular heart beat/afib; Chills; fever; headache; body ache; upset stomach; irregular heart beat/a... Read more
irregular heart beat/afib; Chills; fever; headache; body ache; upset stomach; irregular heart beat/afib; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 08:15 at single dose for COVID-19 immunisation. The patient's medical history included hypertension and afib. Concomitant medications included lisinopril, acetylsalicylic acid (ASPIRIN), both taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior to vaccination and was not tested for COVID post-vaccination. The vaccination facility type was Urgent Care Center (reported as Doctor's office/urgent care). On 08Apr2021 at 02:30, the patient experienced irregular heart beat/afib, chills, fever, headache, body ache, and upset stomach. No treatment was received for the events. The patient underwent lab tests and procedures which included heart beat: irregular on 08Apr2021. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
41 2021-04-24 chest discomfort, chest pain Had extreme joint pain. Chest heaviness and chest pain. Potassium and sugar bottomed out to critical... Read more
Had extreme joint pain. Chest heaviness and chest pain. Potassium and sugar bottomed out to critical levels.
41 2021-04-24 chest pain About 40 minutes after vaccination the patient complained of L sided chest pain radiating to axilla/... Read more
About 40 minutes after vaccination the patient complained of L sided chest pain radiating to axilla/ No other symptoms including sob. EKG normal. BP 129/89 P 71 RR 18 O2 97%
41 2021-04-24 loss of consciousness collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneou... Read more
collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneous report from a contactable physician. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration on 04Apr2021 at a single dose for covid-19 immunization. Medical history included G72.3 periodic paralysis. Concomitant medication included diclofenamide (KEVEYIS) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received other vaccines within four weeks. It was unknown if the patient had covid prior vaccination. The physician stated that the patient received the Pfizer vaccine on Sunday 04Apr2021. The patient collapsed about an hour and half later and, has felt very weak and was experiencing muscle pain since then - all experienced on 04Apr2021. The patient has also been experiencing weakness, confusion, fatigue, and shortness of breath all since Sunday 04Apr2021. The physician reported that there were two different kinds of potassium in the vaccine which he felt was contributing to this. It was informed that the patient has been currently resting and will follow-up if his symptoms don't improve. The outcome of the adverse events was unknown. It was unknown if treatment was received for the adverse events. It was unknown if the patient was tested for covid post-vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product 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.
41 2021-04-26 chest pain, heart rate increased Shortness of breath, chest pain that feels like a heart attack, rapid heart rate, headache, muscle f... Read more
Shortness of breath, chest pain that feels like a heart attack, rapid heart rate, headache, muscle fatigue and extreme tiredness
41 2021-04-26 chest pain Difficulty breathing and chest pain. Elevated CRP. ON STEROIDS NOW. Suspect potential heart (or peri... Read more
Difficulty breathing and chest pain. Elevated CRP. ON STEROIDS NOW. Suspect potential heart (or peri) inflammation.
41 2021-04-27 nosebleed 24 hours later dizziness, fatigue, headache bleeding nose, sinuses swollen and plugged, bloody mucus... Read more
24 hours later dizziness, fatigue, headache bleeding nose, sinuses swollen and plugged, bloody mucus, bloody gums/tongue the next morning(heavy). Sinuses went down, bloody nose stopped in 3 hrs, and teeth stopped bleeding a few hours later. No more bleeding now, but still have a little headache.
41 2021-04-27 heart rate increased Pt called call center. Pt c/o fever since 04/22/2021 and headache since 04/23/2021.Also c/o rapid he... Read more
Pt called call center. Pt c/o fever since 04/22/2021 and headache since 04/23/2021.Also c/o rapid heartbeat. Stated sometimes not able to feel heartbeat on left side,sometimes very rapid. Pt concerned stated might be possible s/e from covid vaccine Pfizer he got on 04/19/2021This writer recommended pt to go to nearest ED/Express care for further evaluation as experiencing rapid heartbeat. Pt assure understanding s
41 2021-04-27 lightheadedness, loss of consciousness 3/26 @ 3:15pm ? Got the first dose of Pfizer COVID-19 vaccine for the 1:10pm appointment. However ac... Read more
3/26 @ 3:15pm ? Got the first dose of Pfizer COVID-19 vaccine for the 1:10pm appointment. However actual time received was around 3:15pm. No vaccine reaction was observed and drove back home. However did not eat or drink much from morning till 4:30pm due to the long line at the vaccination center 4/4 @ 9:00pm ? Experienced first sign of near-syncope at the dinner table upon picking up a glass of milk 4/6 @ 8:45am ? Experienced brain fog, to be exact head felt like it was filled with cotton candy, at the back and top of the head. Felt this way the entire day. Went to work as usual. Logged out at around 5:30pm 4/7 @ 9:00am ? dizziness started getting worse. Started feeling imbalance and started losing depth perception which climbing down staircase 4/8 @ 10:00am ? started to get easily startled by any unexpected trigger. Whole body would ?twitch? or ?startle? upon slightest unexpected event. For e.g., sound, touch, taste (hot/cold) 4/10 @ 12:00pm ? Went to ER. ER ordered series of book tests, EKG, chest x-ray. Everything came out normal. ER doctor said to wait it out and after a week symptom may go away. ER doctor felt body?s immune response was over-working due to the vaccine immune response and possibly pollen allergy I may have experienced right after getting the vaccine. No prescription meds give. Advised to take Meclizine 25mg and Zyrtec. Below are the symptoms experienced on 4/10: ? Lightheadedness/Sudden Jerking body movements when triggered/passing out momentarily for a second when taking strain/not in my elements ? Feeling extremely fatigued. Did not sleep well at night on 4/8 and 4/9 ? Head feels Intoxicated, foggy, lightheaded, as if stuffed with cotton candy. Startled when unexpected things happen like a sudden jerking movement along with momentary passing out while anything unexpected happens. E.g., when I am pushing myself on the sofa to re-position, I feel my whole body is turning off for a second. Simply does not feel normal ? Rubbery legs ? Worsens after shower. I feel like I need to lay down as the foggy feeling worsens after shower ? Lightheadedness. Losing control sometimes. ? I am easily startled when climbing down the stairs - no Depth perception. ? Don?t have the strength to blow nose or cough. Feels like momentary fainting when doing these activities ? Dis-equilibrium. Whole body is twitching when something unexpected happens to my senses. ? Unable to control while laughing feels like momentary faint. I have felt like this when I was down with a fever. Tickled easily ? Difficulty pulling myself out of bed. Felt like muscle was giving away ? Tingling feeling in the right abdomen area ? Difficulty staying alert or focused and random rather unpleasant thoughts constantly coming to mind. Felt a bit of panic attack. 4/11 ? Went to PCP. Body weakness and fatigue got worse. PCP did blood sugar test and flushed out the left ear. Ordered Brain MRI to see if structurally anything was wrong. Brain MRI came out OK as well however noticed minor sinusitis. Prescribed Amoxicillin antibiotics and nasal spray. Referred me to Neurologist and Head and Neck Specialist. 4/11 ? 4/15 - Above symptoms progressively got worse. Especially weakness in the arms and shoulders. Arms quivered every time trying to stand up and felt like fainting. Hand-eye coordination progressively got worse. For e.g., could not pick up water bottle, hands were quivering badly 4/15 ? Neurologist conducted certain diagnostic tests and concluded that there are no neurological issues. Said with rest and plenty of fluids it should get better. Spinal tap was not recommended and said if symptoms got worse a spinal tap can be done during the next visit. Follow up visit with neurologist scheduled on 4/27 4/15 ? 4/27 ? Weakness in arms got better. Arm strength and coordination has improved however it?s still not back to normal. Brain fog and dizziness still persists with no improvement. Left limb and arms are stronger than the left. Difficulty climbing up and down stairs. Dizziness worsens after shower. Not feeling myself. In addition, not able to multitask - getting startled and need to be deliberate about having to do everyday chores need to just focus on one task 100% completely and if something else comes up then my body just goes into a momentary shock. Mostly I can feel my head feeling heavy and my eyelids shutting down when something shocking happens ? a feeling like body is ?turning off?, almost a fainting or passing out feeling. Sometimes when I turn to one side and sleep, I can feel a flickering sensation in the ear. Still always feeling woozy and as if there is something in my head ? a medicated or intoxicated feeling in the head 4/27 ? Neurologist said she sees a lot of improvement and reiterated again that I don?t have any neurological issues. She said I can go back to work starting 5/1. She said I may have Conversion Disorder / Disequilibrium. It?s hard for me to fathom why she would diagnose me with Conversion Disorder when so many people are reporting very similar symptoms that I am facing on the below forum: https://www.drugdiscoverytrends.com/dizziness-among-common-covid-19-vaccine-side-effects/ 4/30 ? Next appointment with Head and Neck / Audiology
41 2021-04-28 heart rate increased Adverse effect started 24hrs after injection beginning on 24 April 2021. Trended normal resting hea... Read more
Adverse effect started 24hrs after injection beginning on 24 April 2021. Trended normal resting heart rate range is 55-66bpm; Noted elevated resting heart rate of 104bpm began at 12:00pm 24 April; experienced expected side effects of fatigue, soreness, feverish feeling concurrent to elevated resting heart rate. Heart rate remained high ranging from 88-103BPM throughout the day; took a nap from 430 - 530pm; at 5:20-5:30 heart rate measured 174 BPM. 6:00pm - 10:00pm heart rate ranged from 75-88 BPM; after 10:00pm heart rate returned to normal range. 25 April No side effects experienced Measured Heart rate range for the day was 56-73 BPM
41 2021-04-28 hypotension Systemic: Hypotension-Mild
41 2021-04-29 palpitations, hypertension At the medical facility, within minutes of taken the shot, my left eye vision started to get blurry.... Read more
At the medical facility, within minutes of taken the shot, my left eye vision started to get blurry. I started to sweat. Medical personnel took my blood pressure and said it was high. They had me rest on a bed for 10 minutes. They gave me water and juice. After 2 days of the vaccine, I feel strange heart palpitations every 1 or 2 hours. My blood pressure reading is at 147/88.
41 2021-05-02 heart attack Acute Myocardial Infarction
41 2021-05-02 chest pain After several days, severe chest pain developed upon waking up one morning. Pain radiated from the ... Read more
After several days, severe chest pain developed upon waking up one morning. Pain radiated from the approximate right rhomboid to the sternum. One saught emergency room care to address the pain after three days of intensification. A D-dimer test and chest x-ray were performed, both negative for thrombosis. Upon palpation by the attending physician, the origin of the pain on one's back was localized/identified. At this time, roughly 12 days post-vaccination, the pain is still present but slowly abating. IF the pain does not cease soon, one will seek further testing and treatment via a primary care provider.
41 2021-05-03 transient ischaemic attack TIA ( mini stroke) on fourth day after dose two.; This is a spontaneous report from a contactable co... Read more
TIA ( mini stroke) on fourth day after dose two.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6208 and expiration date not provided), via an unspecified route of administration, administered in Arm Right second dose on 25Mar2021 15:00 at single dose for covid-19 immunisation. The patient's medical history included Hypertension and Penicillin allergy. The patient's concomitant medications included lamotrigine (LAMICTAL) and bupropion hydrochloride (WELLBUTRIN). The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201 and expiration date not provided) via an unspecified route of administration administered in Arm Right first dose on 04Mar2021 administration time: 04:00 PM for covid-19 immunisation. On 29Mar2021 10:00, the patient experienced TIA (mini stroke) on fourth day after dose two. The event resulted in physician office visit, Emergency room visit, and hospitalization for 1 day. The patient was treated and was placed on three medication (unspecified). The patient underwent lab tests and procedures which included Spectrum DNA test: negative on 15Apr2021. The outcome of the event was recovering.
41 2021-05-06 deep vein blood clot Deep vein thrombosis in lower left leg (blood clot)
41 2021-05-06 heart attack, enlargement of the heart 8 days after receiving the shot I was out for a run and had a heart attack. The septal region of my... Read more
8 days after receiving the shot I was out for a run and had a heart attack. The septal region of my heart was enlarged but nothing else was showing... all arteries wide open, heart functioning at 55, cholesterol 171. My troponin levels were 76...
41 2021-05-09 heart attack heart attack, LAD stint inserted
41 2021-05-10 palpitations Nausea: 1hr Palpitations: 24hr Restlessness: 8hr Insomnia: 8hr Fatigue: 36hr Pain at injection site:... Read more
Nausea: 1hr Palpitations: 24hr Restlessness: 8hr Insomnia: 8hr Fatigue: 36hr Pain at injection site: 5hr Headache: 12hr
41 2021-05-14 blood pressure increased a potential false blood pressure readings/The readings were over 200/140/took it on his wrist and me... Read more
a potential false blood pressure readings/The readings were over 200/140/took it on his wrist and measured at 215/147; the pain at the location of the lower arm got near tremble; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Apr2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included blood pressure abnormal, blood cholesterol abnormal, deafness. The patient's concomitant medications included unspecified products received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 on 06Apr2021 01:15 PM at arm left for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, he has not been tested for COVID-19. The patient reported a potential false blood pressure readings on 29Apr2021, a day after administered 2nd dose. The readings were over 200/140 and he took it at home using a blood pressure reading device. He took it on his wrist and measured at 215/147. In his recent doctors visit prior to administer the 2nd dose, the accurate readings was 183/136 (estimated). With the false blood pressure readings, the pain at the location of the lower arm got near tremble due to the fact of the false readings has been taken. The events outcome was unknown. Information on the Lot/Batch number has been requested.
41 2021-05-19 heart rate increased Arm soreness started on May 18 @ 3:30pm. Went to sleep with same arm soreness at 11pm. Woke up at ... Read more
Arm soreness started on May 18 @ 3:30pm. Went to sleep with same arm soreness at 11pm. Woke up at 1:15am on May 19, walked approximately 12 feet started experiencing cold chills. At 1:20am, while standing and holding cellphone in right hand, started experience of convulsive seizure to the point of cellphone health stats saying i walked 103 steps while standing still convulsing. After calming down enough to sit, i sat on couch to sleep. Heart rate was still registering in 200 bpms for next couple hours. May 20, 2021 started experiencing sore throat at 5:30am. As day progresses am experiencing flu type symptoms.
41 2021-05-19 fainting Patient was given vaccine and while waiting the 15 minute monitoring period he fainted. He was respo... Read more
Patient was given vaccine and while waiting the 15 minute monitoring period he fainted. He was responsive right away and needed to throw up. We attended to him and called EMS. He said he had anxiety from the seeing the needle and is probably why he fainted.
41 2021-05-20 hypertension, skin turning blue Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: H... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Additional Details: blueish right calf
41 2021-05-21 palpitations Shortness of breath weakness tired chills achey heart palpitations headache dizzy confused lasted 2 ... Read more
Shortness of breath weakness tired chills achey heart palpitations headache dizzy confused lasted 2 weeks
41 2021-05-22 chest pain, heart attack Acute myocardial infarction in the LAD. Chest pain migrating to left arm down through elbow. Cardiac... Read more
Acute myocardial infarction in the LAD. Chest pain migrating to left arm down through elbow. Cardiac catheterization s/p DES-pLAD. Chest pain started roughly 19 hours after the first dose of the Pfizer vaccine.
41 2021-05-22 palpitations Male 41 year old complaining of feeling his heart racing. His stated feeling quizzy.
41 2021-05-22 fainting, chest pain, palpitations I felt faint about 20 minutes after I took the first vaccine shot on 4/1/2021. I felt like I had hea... Read more
I felt faint about 20 minutes after I took the first vaccine shot on 4/1/2021. I felt like I had heart palpitations, then a tingling feeling in my left arm. After the second shot, I felt like my balance was off if I laid down or looked down and then pulled my head up. That went away after the first day. Starting the following day, I had some chest pain over my heart, and at times, I would have a burning sensation in my heart. At times, I also felt a tingling down my left arm (sometimes out of nowhere). I would be very short of breath. These symptoms were on and off for the first two weeks after I took my shot. They have since completely gone away.
41 2021-05-22 fainting, hypotension Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe
41 2021-05-23 enlargement of the heart, palpitations, hypertension About a week after receiving the 1st Pfizer Covid vaccine, I started experiencing heart palpitations... Read more
About a week after receiving the 1st Pfizer Covid vaccine, I started experiencing heart palpitations and difficulty walking up stairs and/or hills. I visited the ER the following day because I did not have a doctor nearby. I was referred to a local doctor, who I visited May 6, 2021. He dismissed the notion that anything was caused by the vaccine and put me on a low dose (5mg) blood pressure medicine and a 81mg aspirin. Around 3-4 days after visiting the doctor, I started to feel normal again. Since then I have felt 100% and back to healthy eating and exercise routine. Nothing like this has happened to me before, and it was an abnormal situation. I have not received any other vaccines in many years.
41 2021-05-24 loss of consciousness Patient passed out after the vaccine....He had mentioned a history of vaso-vagel response when he go... Read more
Patient passed out after the vaccine....He had mentioned a history of vaso-vagel response when he got a shot as a teenager. He was sitting for about 5 minutes then told us he didn't feel well, then passed out. However, he came to very quickly. He was given a cold compress, some water and was sitting with legs up. We observed him for 45 minutes until he felt well enough to leave. I don't think this was a problem with the vaccine due to a similar history while receiving a different vaccine in the past.
41 2021-05-25 chest discomfort Patient complained of dizziness about 5 minutes after shot. Also stated felt shortness of breath des... Read more
Patient complained of dizziness about 5 minutes after shot. Also stated felt shortness of breath described as chest tightness but no wheezing. Offered water, Gatorade, and Benadryl. Patient took water and Gatorade. Stated was feeling better. Checked on patient minutes later and had another wave of the feeling. Spacing was further and less severe. At 9:53 am patient got another wave of dizziness/tightness and 911 was called at 9:57am. Patient reported no side effects to first dose but when EMS arrived they claimed experiencing this with the first dose but less severe. EMS took to ambulance to further evaluate.
41 2021-05-25 chest pain Had expected fevers and chills day following vaccine. Started approximately 12 hours after shot and ... Read more
Had expected fevers and chills day following vaccine. Started approximately 12 hours after shot and abated approximately 36 hours later. Of note, had a fever and chills when falling asleep night of 5/28 On 5/29 woke with specific chest pain localized to heart area. Waited approximately one hour to see if symptoms abated, then proceeded to ER to get checked out. EKG showed left branch block. Administration of Nitro and asprin alleviated chest pain. Was admitted to hospital for observation and testing to ensure heart functioning properly.
41 2021-05-25 inflammation of the heart muscle He had his 2nd pfizer vaccine on 5/3/21 The next day he felt tired 2 days later (on 5/5) he started ... Read more
He had his 2nd pfizer vaccine on 5/3/21 The next day he felt tired 2 days later (on 5/5) he started with fever, chills and body aches He then started with abdominal pain --hurt to take a breath in, he could not lay flat He went to Hospital and was dx with myocarditis He was started on ibuprofen (changed to naproxen for discharge), colchicine and protonix
41 2021-05-26 chest pain, chest discomfort, heart rate increased Labile BP; Rapid heart rate; Migraines; Body aches; Chest pain and tightness; Chest pain and tightne... Read more
Labile BP; Rapid heart rate; Migraines; Body aches; Chest pain and tightness; Chest pain and tightness; Inflammation; This is a spontaneous report from a contactable other hcp (parent). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), dose 1 intramuscular, administered in right arm on 22Dec2020 15:00 as 1st dose, single for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. There is no other vaccine in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, covid test type post vaccination was Nasal Swab on 29Dec2020, covid test result was negative. Starting 5 days post vaccine (26Dec2020 18:00), ongoing symptoms of labile BP; rapid heart rate; migraines; body aches; chest pain and tightness; inflammation. Now going on 6 months of ongoing issues that have resulted in 4 ED visits, multiple tests and numerous doctor's office visits. There is some treatment (Medication) for AE. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was resolving.; Sender's Comments: Based on known safety profile it is unlikely that the reported events were causally related to bnt162b2. These are probably intercurrent medical conditions. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product 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 Committees and Investigators, as appropriate.
41 2021-05-27 heart rate increased, palpitations, heart rate irregular Short-term (24-36 hours after both shots): Extreme fatigue, muscle pain/soreness, headache, fever, n... Read more
Short-term (24-36 hours after both shots): Extreme fatigue, muscle pain/soreness, headache, fever, nausea. Worst I've ever felt in my adult life, like my whole body was rebelling against me. Long-term (for roughly 10 days after both shots): Serious shortness of breath, irregular and very high heartbeat, extreme fatigue. Couldn't do any physical activity without immediately becoming out of breath (normally very healthy and active). Heart would race unpredictably, reaching 120 bpm (normal resting for me is 60-70). General malaise. Felt more like 80 years old than 40. Was unable to do normal physical activity and work for weeks. Feeling better overall, but still sometimes feel like I get tired unusually easily and heart behaves strangely now and then.
41 2021-05-31 cerebrovascular accident Stroke
41 2021-05-31 loss of consciousness Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vacc... Read more
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was traumatic hemorrhage of left cerebrum with loss of consciousness.
41 2021-06-03 chest pain Sharp chest pain near heart, difficulty breathing, shortness of breath
41 2021-06-07 inflammation of the heart muscle, heart attack, chest pain, troponin increased Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4/15/21 and 5/6/21. Patient presented to ED on 5/9/21 with complaints of acute onset substernal chest pain that woke him from sleep. Patient also endorses left arm pain, diaphoresis and nausea. No significant past medical history or family history of heart disease. ECG demonstrated inferior ST elevations. Patient was taken to cath lab and found to have no angiographic evidence of CAD. Patient discharged on aspirin 81 mg QD, Clopidogrel 75 mg QD, Metoprolol 12.5 mg BID, Rosuvastatin 5 mg QD.
41 2021-06-09 blood clot in the brain, cerebrovascular accident Blood clot in left side of brain resulting in stroke and reduced functionality of the right side of ... Read more
Blood clot in left side of brain resulting in stroke and reduced functionality of the right side of my body.
41 2021-06-10 cardiac arrest, chest pain, heart attack My brother started with some swelling in the legs/feet, followed by chest pains that led him into a ... Read more
My brother started with some swelling in the legs/feet, followed by chest pains that led him into a heart attack, followed by cardiac arrest. He was shocked back to life where he lay in a coma. His kidneys stopped functioning followed by his lungs and liver?he was kept alive on life support and dialysis, he died after having 4 more heart attacks back to back on June 4, 2021.
41 2021-06-12 fast heart rate Tachycardia, numbness in extremities, dizziness, shortness of breath. All intermittent for about 8 ... Read more
Tachycardia, numbness in extremities, dizziness, shortness of breath. All intermittent for about 8 hours following shot. Intense for a 2 hour period 4:30-6:30.
41 2021-06-13 chest discomfort, heart attack, chest pain 2nd dose of vaccine given 4/19/21. Developed URI symptoms (congestion) shortly after which coincided... Read more
2nd dose of vaccine given 4/19/21. Developed URI symptoms (congestion) shortly after which coincided with young kids having URI as well. On or around 5/10/21 he began noticing exertional chest pain and tightness. Symptoms progressed to occurring with less exertion. Admitted 6/2/21 with late-presentation anterior STEMI, underwent emergent angioplasty of multiple lesions.
41 2021-06-14 blood clot On May 18, 2021, Patient said he was experiencing severe back pain and that both of his arms had gon... Read more
On May 18, 2021, Patient said he was experiencing severe back pain and that both of his arms had gone numb and he had vomited. Patient called his mother to come help him with the baby because he wasn't feeling well. When she got there 30 minutes later he was not breathing. They were not able to revive him. He died of a blood clot in the front of his heart.
41 2021-06-15 chest discomfort Shortness of breath, gas, tighten chest, sweats
41 2021-06-16 chest discomfort, heart rate decreased 24hours after vaccine:headache, chill, muscle pain, tireness 48 hours after vaccine: Slow heart rate... Read more
24hours after vaccine:headache, chill, muscle pain, tireness 48 hours after vaccine: Slow heart rate below 50, chest pain, tightness of heart area from 7am-1pm
41 2021-06-16 fainting, chest discomfort, palpitations PATIENT STATED THAT HE RECEIVED THE VACCINE ON FRIDAY, AT THE END OF THE DAY ON SATURDAY, HIS CHEST ... Read more
PATIENT STATED THAT HE RECEIVED THE VACCINE ON FRIDAY, AT THE END OF THE DAY ON SATURDAY, HIS CHEST STARTED TO FEEL HEAVY AND HE HAS LABOR BREATHING. HE WOKE UP SUNDAY AND DIDN'T FEEL WELL. HE TOOK A NAP AT AROUND 4PM ,THEN WOKE UP AND COULDN'T BREATH WITH HEART PALPITATIONS. HE WAS ABLE TO ARRIVE TO THE EMERGENCY ROOM AND TRIED TO WALK HIMSELF IN. HE COLLAPSED ON THEIR YARD.
41 2021-06-19 chest discomfort, inflammation of the pericardium I don?t know if it?s caused by the vaccine or not as the timing is so apart, but it is crazy to have... Read more
I don?t know if it?s caused by the vaccine or not as the timing is so apart, but it is crazy to have something rare like pericarditis all of a sudden so I thought it best to submit to VAERS to let you review in case it was related or coincidental. I?ve had multiple covid tests that are negative but the current theory is this was from a virus I caught while traveling 6/14-6/16. Staring feeling ill 6/17, went to hospital with chest discomfort 6/19, admitted and run through a battery of tests to make sure I wasn?t having a heart attack.
41 2021-06-19 palpitations After about 15 Minutes after the injection, My Hands and Feet broke into a sweat, about 1 minute aft... Read more
After about 15 Minutes after the injection, My Hands and Feet broke into a sweat, about 1 minute after that the top of my head started to tingle ( like pins and needles) after about another minute it felt like I had to keep breathing on purpose. ( what I mean by that is I was aware of my breathing and had to knowingly take breaths it was like I had been under water and just come up for air) I don't remember the exact time maybe another minute or so, my heart started to race. This All went on for about 45 Minutes. When this first happened the Pharmacist told me that what was happening was common with vaccinations and had nothing to do with the covid 19 vaccination, I asked for the nurse that had provided the vaccine to me and was told she went to lunch. So there was no healthcare professional there to help me. The pharmacist just had me sit in a chair and told me to sit there until I felt better. This happened for both injections. I have never experienced this type of reaction with any other vaccine in my life.
41 2021-06-21 arrhythmia Heart issue; pain and arrhythmia
41 2021-06-23 hypotension, fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium
41 2021-06-23 loss of consciousness, hypotension PT REPORTED THAT APPROXIMATELY 6 HOURS AFTER GETTING THE SHOT HE LOST CONCIOUSNESS AND EMERGENCY SER... Read more
PT REPORTED THAT APPROXIMATELY 6 HOURS AFTER GETTING THE SHOT HE LOST CONCIOUSNESS AND EMERGENCY SERCIVES HAD TO BE CALLED. HE WAS FOUND TOP HAVE LOW PRESSURE. PT IS DOING OK NOW
41 2021-06-24 blood pressure increased, heart rate increased, chest discomfort About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has conti... Read more
About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has continued for two (2) months after the second injection. Additionally, patient has complained of excruciating headaches on the right side of the head, behind the eyes and behind the ear. Patient has throbbing head pain, and becomes lightheaded easy. Blood pressure has increased to a perceived new normal of 140/90+ on most days, even at rest. Patient is normally very active, exercising at least six (6) days per week doing cardio and strength workouts, however has not been feeling well since the second shot. Patient is very fatigued by the end of the day, which is not normal. Patient wakes up in the morning to pounding headaches, pain level 5-7, every single morning with a perceived fast heart rate. Pulsating tinnitus is very loud for patient, and he cannot hear out of that ear, and difficult to understand speech or other sounds. No change in diet, working conditions or lifestyle other than receiving the COVID-19 vaccination. Patient has been monitoring blood pressure at home with a machine and at the clinic. Average blood pressure is 143/90 with some readings as high as 160/95 and as low as 118/80 (after waking up on day 3 of a hospital stay). Patient was admitted to a hospital on 21JUN21 for abnormal ECG, high blood pressure and complaint of chest tightness, debilitating headache as well as pulsating tinnitus in head.
41 2021-06-24 heart rate decreased, hypertension As soon as the vaccine was completed and the bandaid was put on, the patient started having what loo... Read more
As soon as the vaccine was completed and the bandaid was put on, the patient started having what looked like seizures. He arched his back and reached his arms out to either side, lifted his head and started making a noise. He was sweating profusely. I held him and kept him from falling out of the chair and called for my technician to call 911. Once he called the patient came to after about 2 minutes. His breathing was not hindered so I felt it was not an allergic response. I checked his pulse and started asking him questions such as if he knew who he was and what was going on. I gave him some water and kept checking his pulse. I laid him on the ground while we waited for EMTs to arrive. Once they arrived they took over and checked his pulse and heart rhythm. His pulse was low (in the 40s and 50s) and his pressure was low. He denied going on the ambulance and his brother came and picked him up and took him to the hospital. Total time from beginning to end was about an hour.
41 2021-06-24 loss of consciousness Patient walked out the vaccination room for about a minute or so after 1st dose of Pfizer then sudde... Read more
Patient walked out the vaccination room for about a minute or so after 1st dose of Pfizer then suddenly blacked out, fell chin down to floor, got a cut on the chin and bleeding; patient sit up after the fall, was responsive, pain level 3-4 due to the cut on the chin, chilling and shaking. Paramedic arrived after 5 minutes and transferred patient to hospital
41 2021-06-26 heart rate increased, chest discomfort, palpitations Approximately seven days following second dose of Pfizer COVID vaccine, I began experiencing heart p... Read more
Approximately seven days following second dose of Pfizer COVID vaccine, I began experiencing heart palpitations, elevated heart rate, chest pressure, difficulty breathing, shortness of breath, and dizziness. Multiple "episodes" each day would occur without warning, did not relate to physical activity, or any other stimulus - would just happen throughout the day, often multiple times per hour. Even to this day, more than 90 days following the second dose of Pfizer, there are multiple times each day when I feel chest pressure, heart palpitations, and slight shortness of breath. It is not as common, or as severe as it was early on, but some symptoms remain.
41 2021-06-26 loss of consciousness, pallor vaccine was administered and patient lost consciousness. he began to turn red and did not breathe fo... Read more
vaccine was administered and patient lost consciousness. he began to turn red and did not breathe for several seconds at which we were about to administer an EpiPen. He then took a breath and started to convulse. he regained consciousness and was not coherent at first. He was sweaty and pale. Pt became alert and oriented and stayed in the room while we waited for the emt to arrive. He declined to be taken to the hospital. He moved to the waiting room and was monitored for 30 minutes before leaving
41 2021-06-26 pulmonary embolism, chest pain The 2nd dose of Pfizer vaccine was injected on May 3rd, 2021 at a clinic. Minor arm ache, fatigue, f... Read more
The 2nd dose of Pfizer vaccine was injected on May 3rd, 2021 at a clinic. Minor arm ache, fatigue, fever/chills felt for approx. ~1day post vaccination and then felt back to normal. Around day 3 post vaccination felt sudden, sharp, stabbing pain within chest cavity which forced me to take shallow, rapid breaths to avoid triggering pain. Lasted a few minutes before subsiding. Following day or so pain returned as a dull, diffused pain and was felt intermittently for several weeks. Generally I run fairly often for fitness, however activity level was reduced due the ongoing chest pain. Wanted to resume normal activity levels, but decided to consult a Doctor for peace of mind due to pain taking so long to resolve. Scheduled virtual appointment (06/24/21) who advised an ER visit due to it being a potentially risky chest issue, and the fact that they could run the appropriate tests to diagnose it relatively quickly. Walked over to a nearby ER that afternoon and was hospitalized for 1 night, who diagnosed an "Unprovoked VTE" with a "Pulmonary Embolism" in Right lung. Was treated with Lovenox injections at hospital and currently taking Eliquis medication. As a side note: my brother (43yrs old) who lives in another country, was administered the 1st dose of the AstraZeneca vaccine on 05/24/2021 and subsequently fell ill, went to the ER twice and was eventually diagnosed with VTE/Bilateral PE. He is also currently taking Eliquis medication.
41 2021-06-28 chest discomfort Fatigue, ache, Extreme swelling of the lips. 4 occurrences so far covering all 4 quadrants randoml... Read more
Fatigue, ache, Extreme swelling of the lips. 4 occurrences so far covering all 4 quadrants randomly. Numbness, tingling, itchy sensation. Last episode involved swelling of the cheek and eye on same side as lip. Chest and back tightness
41 2021-06-28 chest pain I experienced similar symptoms the day before the first vaccine - (Just the pain in the chest- like ... Read more
I experienced similar symptoms the day before the first vaccine - (Just the pain in the chest- like something sticking in my chest. More severe stuff was experienced after the second vaccine. After second vaccine, I had pain in my chest. I had a dull ache - like a broom stick stuck in chest - sometimes front and sometimes back and sometimes both. Goes up my spine into my neck sometimes. Sometimes it comes with shortness of breath. One point when it went down my left arm and into my hands. Dull pain. I have gone to medical center - Urgent Care twice and two different doctors and they haven't found anything yet. I woke up gasping for air - one time last weekend. That lasted for two hours - I was only getting 50% of breath when I breathed in. Today I woke up at 6 am (two hours earlier for me) and again had shortness of breath. The doctors have no idea what is going on. I have never had anything like this before. I'm not particularly stressed so I don't think it's anxiety like one doctor suggested. It's very physical and disturbing so I doubt it's anxiety. Muscular - Skeletal relaxant to take - and that didn't help and I stopped taking it because it didn't feel good to stay on it.
41 2021-06-29 cardiac arrest, heart attack, heart attack Cardiac Arrest/Heart Attack/STEMI
41 2021-06-29 heart flutter * I am having a fluttering heart problem. * This symptom has begun 10th day after the first dosage ... Read more
* I am having a fluttering heart problem. * This symptom has begun 10th day after the first dosage of Pfizer-BioNTech vaccination.
41 2021-06-29 palpitations Since having my second Pfizer Covid vaccination I have been experiencing heart palpitations. I was ... Read more
Since having my second Pfizer Covid vaccination I have been experiencing heart palpitations. I was seen by my PCP regarding this. I wore a 24 hour halter monitor and did not have any palpitations while wearing the monitor. I have not had any further testing and have not been evaluation by a cardiologist but I do continue to have palpitations.
41 2021-06-30 heart rate increased RAPID HEART RATE - MULTIPLE VISITS TO ER WITH EKG AND BLOOD TESTS -RESULTS NEGETIVE LIGHT-HEADINESS ... Read more
RAPID HEART RATE - MULTIPLE VISITS TO ER WITH EKG AND BLOOD TESTS -RESULTS NEGETIVE LIGHT-HEADINESS SEVER HEADACHE'S TROUBLE SLEEPING ANXIETY
41 2021-07-01 chest pain wife said approximately 6-17-21 they were camping and he started having chest pain. the following mo... Read more
wife said approximately 6-17-21 they were camping and he started having chest pain. the following monday they went to the ER. He got a complete check up and nothing was found to be wrong with his heart or health
41 2021-07-02 inflammation of the heart muscle Patient reports to pharmacy on June 29th 2021 that he had pain and inflammation in both arms after b... Read more
Patient reports to pharmacy on June 29th 2021 that he had pain and inflammation in both arms after both covid vaccines. He switched vaccine administration sites but still had pain/burning after both vaccines. He told the technician that he has myocarditis from the covid vaccine and that he saw a cardiologist.
41 2021-07-04 heart rate increased, chest discomfort, palpitations, heart flutter On Saturday July 3rd I noticed tightness in my chest, lightheadedness, and ringing in my ears. On Su... Read more
On Saturday July 3rd I noticed tightness in my chest, lightheadedness, and ringing in my ears. On Sunday, July 4th, I still had the lightheadedness, tightness in my chest, rapid heartbeat, and it was more difficult to breath unless I was sitting a certain way. On Monday, July 5th I had severe chest pain, difficulty breathing, fluttering and pounding heart, when I took a deep breath I would feel my heart pounding but at a much slower rate and then it would go back to normal beats, severe ringing in the ears, extreme tiredness. This lasted for about 1.5 hours and I went back to bed and when I awoke 4 hours later my heart seemed to beat fine. Chest pain lightened up a bit, but breathing is still difficult. I?m very healthy and have not had any health issues. The heart issue this morning was so bad that I?m not sure if I should get the second dose. If things worsen, I will contact my doctor. I?m hoping that it goes away soon and this will be alleviated on its own, but I?m really worried about getting the second dose even though I want it.
41 2021-07-05 chest pain, fainting Started with Tingling in Upper Right Leg, Chest Pain and Shortness of Breath, Constant Headaches. Pa... Read more
Started with Tingling in Upper Right Leg, Chest Pain and Shortness of Breath, Constant Headaches. Passing out, Light headed and dizziness. Joint Pain and All Day Headaches. More recently Been having Sharp pain in kidney areas and back pain and Constant headaches. Tingling throughout whole body at times.
41 2021-07-06 chest pain The night of July 3rd, I started getting severe chest pain, that was worse than before. As well as f... Read more
The night of July 3rd, I started getting severe chest pain, that was worse than before. As well as full body nerve pain, obsessive sweating, shaking, my back was twitching, which led to uncontrollable shaking that went into my legs like they were vibrating. It went all over my body, hands, feet, legs, arms, all over. When I tried to stand up I could barely walk, I went to the ER. They took at CT Scan, blood tests, and just sent me home to get checked by a Neurologist. Since then I continue to have these symptoms. Such as trimmers, in my hands and feet. Heat on my skin all over my body at random times of the day. As well as the sensation that I have water or sweat on random parts of my body. I go to the Neurologist, July 15th to do further testing.
41 2021-07-07 chest pain Pt called 5/13/2021 regarding of rescheduling of 2nd covid vaccine. Pt stated pt got 1st covid vacci... Read more
Pt called 5/13/2021 regarding of rescheduling of 2nd covid vaccine. Pt stated pt got 1st covid vaccine Pfizer at 12:05 4/23/2021 and next day pt felt soreness on left arm injection site and chest muscle soreness. pt stated it's not chest pain but felt subtle chest muscle soreness. Pt visited MD and done blood work, chest x-ray, ECG;normal. Pt stated pt feels slightly better chest muscle soreness than last week but still carry chest muscle soreness. Pt has scheduled allergy specialist at outside facility 5/19/2021. Noted pt is not taking any medication, no known allergies. Pt requested to reschedule 2nd covid vaccine d/t pt has scheduled allergy specialist.
41 2021-07-08 heart rate increased rapid resting heart rate (~110-130 bpm) for a couple of hours.; This is a spontaneous report from a ... Read more
rapid resting heart rate (~110-130 bpm) for a couple of hours.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included congenital/neonatal emphysema. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 10:15, around 15 minutes after vaccination, the patient experienced rapid resting heart rate of approximately 110-130 bpm for a couple of hours. The patient did not experience trouble breathing and relaxed at the store until the heart rate reduced below 100 bpm for a period of approximately 30 minutes. The patient's normal resting heart rate was 60-65 bpm. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the heart rate increased. The clinical outcome of the event heart rate increased was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2021-07-09 hypotension, fainting SYNCOPE, LOW BLOOD PRESSURE, PASS OUT APPROX 10 MIN AFTER ADMINISTRATION.
41 2021-07-11 heart rate increased, hypotension Patient reported that his heart rate has increased to 150 pm since the shot, also had shaking chills... Read more
Patient reported that his heart rate has increased to 150 pm since the shot, also had shaking chills and 103 fever, severe headache for 3 days
41 2021-07-11 palpitations, cardiac arrhythmia I started having palpitations and was diagnosed with pre-ventricular contractions.
41 2021-07-12 chest pain Chest pain
41 2021-07-17 atrial fibrillation Atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vac... Read more
Atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vaccine.; Tunnel vision; Extreme sense of coldness; Face planted to the floor.; This is a spontaneous report from a contactable consumer or other non hcp. This consumer(patient) reported for himself thata 41-years-old male patient received first dose of BNT162B2 (Formulation: Solution for injection, Batch/Lot number: 59267-1000-01), via an unspecified route of administration, administered in Arm Right on 25Jun2021 18:00 (Age at vaccination 41 years) as single dose for COVID-19 immunisation. Medical history included hiatus hernia and diverticulitis. Concomitant medication(s) included paracetamol (TYLENOL). Patient had no known allergies. On 25Jun2021 18:00, the patient experienced atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vaccine; tunnel vision; extreme sense of coldness and face planted to the floor. Patient was received treatment for events. It was reported that after patient received shot and exited the medical room, he had extreme sense of coldness come over me, tunnel vision, then face planted to the floor. Ambulance was called, patient regained consciousness about a minute or so later, and my chin was split open. They took me to ER, stapled my chin, and ran tests. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Other medications the patient received within 2 weeks of vaccination include Tylenol. Patient received Cardizem 1/day till doc follow-up visit. The clinical outcome of all events were unknown. Information on the lot/batch number has been requested.
41 2021-07-20 cardiac failure congestive, troponin increased, heart failure Acute on chronic congestive heart failure, unspecified heart failure type; Elevated troponin; SOB (s... Read more
Acute on chronic congestive heart failure, unspecified heart failure type; Elevated troponin; SOB (shortness of breath)
41 2021-07-23 excessive bleeding Immediately after administration the patient started bleeding and swelling/small bump appeared at t... Read more
Immediately after administration the patient started bleeding and swelling/small bump appeared at the injection site. The patient's arm was elevated and the bleeding stopped. An ice pack was applied to the swelling for about 20 minutes. The patient was observed for a total of 40 minutes by pharmacy team. No further bleeding occurred and swelling/bump was going down when patient left pharmacy and he was advised to continue applying ice pack and go to ER if any further swelling, redness, itch or trouble breathing occurred. Pharmacy followed up with patient the morning after vaccine administration and he reported no further bleeding or swelling had occurred.
41 2021-07-27 chest pain Loss of taste and smell, resolved within 2 weeks. Fatigue, intermitant dull pain left side chest. W... Read more
Loss of taste and smell, resolved within 2 weeks. Fatigue, intermitant dull pain left side chest. Worse at night laying down. Not as noticeable during the day. Fatigue and chest pain are ongoing.
41 2021-07-27 hypertension Allergic edema; Hearing loss; swelling at injection site after covid vaccination; vertigo; swelling ... Read more
Allergic edema; Hearing loss; swelling at injection site after covid vaccination; vertigo; swelling of hand; high blood pressure; rash on legs; This is a solicited report FACILITATED COLLECT based on the information received by Pfizer from biopharmaceutical company (MFR Control No. # 21K-163-3802407-00) from a non-contactable consumer (patient) A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 single intramuscular on 04Mar2021 (Batch/Lot number was not reported) at age of 41 years for covid-19 immunisation; adalimumab (HUMIRA), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg (40 mg,1 in 7 D) for ankylosing spondylitis . Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included omalizumab (XOLAIR) taken for an unspecified indication, start and stop date were not reported. The patient experienced hearing loss (medically significant) on Mar2021 with outcome of not recovered , swelling at injection site after covid vaccination (non-serious) on Mar2021 with outcome of recovering , vertigo (non-serious) on Mar2021 with outcome of not recovered , swelling of hand (non-serious) on Mar2021 with outcome of recovering , high blood pressure (non-serious) on Mar2021 with outcome of recovering , rash on legs (non-serious) on Mar2021 with outcome of unknown , allergy caused eye to swell (coded as allergic oedema) (non-serious) on an unspecified date with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: blood pressure measurement: high on 2021 . The clinical course was reported as follows: The patient had a relevant medical history of asthma.On an unknown date, the patient experienced allergy caused eye to swell. In March 2021, the patient experienced hearing loss, swelling at injection site after Covid vaccination, vertigo, swelling of hand, high blood pressure and rash on legs. Pfizer BioNTech Covid-19 vaccine was also considered suspect.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 04Mar2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer. On 04Mar2021, after taking Covid vaccine patient had swelling at the injection site, high blood pressure, hand swelling, rash on legs, hearing loss and vertigo. He had an allergy that caused eye to swell.The action taken with Humira was unknown The reporter stated that there is no reasonable possibility that the events are related to HUMIRA .While for Pfizer Biontech Covid-19 Vaccine reporter's causality was reported as probable for Hearing loss and vertigo and unknown for the other events. AbbVie's causality for all events vs Humira was reported as follows: No reasonable possibility The reporter's assessment of the causal relationship of all the events except for hearing loss and vertigo with the Pfizer suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment No follow up attempts are possible. Information about lot/batch number cannot be obtained; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events deafness, vaccination site swelling, vertigo, peripheral swelling, hypertension, rash, and allergic edema and the suspect drugs. The impact of this report on the benefit/risk profile of the Pfizer product 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.
41 2021-07-27 palpitations A small triangular patch was still swollen under my left eye; a racing heart; severe headache.; Dizz... Read more
A small triangular patch was still swollen under my left eye; a racing heart; severe headache.; Dizzy moments,; feelings of clumsiness; Chills; pain in right knee; pain in left shoulder; mouth and left side of face felt numb; mouth and left side of face started swelling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8737) via an unspecified route of administration in the arm left on 03Apr2021 at 09:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and general allergies. Patient had birch allergy (as child) and had reactions (fever) after vaccines as a young child. The patient did not have any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 09:45, the patient experienced numbness, swelling face, dizziness, clumsiness, chills, pain in knee and pain in shoulder and at 3:00 he experienced severe headache. On 04Apr2021, the patient experienced a racing heart and on 05Apr2021, the patient experienced eye swelling. 30 minutes after the vaccine, the patient noticed his mouth and left side of face felt numb and started to swell as he was driving. The sensation felt similar to dental work. It seemed to improve after 1-2 hours (went for a walk and started to do yard work). General numbness and swelling lasted all day. On day 2, a small triangular patch was still swollen under his left eye. In the night (of day1) he woke up at 3:00 with a racing heart and severe headache and had a restless night thereafter (which is highly uncommon). Heart beat went back to normal after waking up and walking outside. Other less severe and persistent symptoms included dizzy moments, feelings of clumsiness (fell playing sports with son, missed a stair), chills, pain in right knee, pain in left shoulder, The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache, dizziness, clumsiness, chills, pain in knee, pain in shoulder and eye swelling was recovering at the time of this report. The clinical outcome of the event numbness and swelling face was recovered on 03Apr2021 and racing heart recovered on 04Apr2021. No follow-up attempts are needed. No further information is expected.
41 2021-07-28 chest pain Chest pain; Headache; muscle fatigue; joint pain; muscle pain; muscle cramps; arm soreness; dizzines... Read more
Chest pain; Headache; muscle fatigue; joint pain; muscle pain; muscle cramps; arm soreness; dizziness; vertigo; blurry vision; tingly sensation in arm and leg; sharp toe pain; out of body experience; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 02May2021 at 14:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and acid reflux. The patient did not take any concomitant medications. The past drug history was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 18:45, the patient experienced chest pain, headache, muscle fatigue, joint pain, muscle pain and cramps, arm soreness, dizziness, vertigo, blurry vision, tingly sensation in arm and leg, sharp toe pain, out of body experience and brain fog. The clinical outcome of the events chest pain, headache, muscle fatigue, joint pain, muscle pain, muscle cramps, pain in arm, dizziness, vertigo, blurry vision, tingling sensation, pain in toe, out of body experience and foggy feeling in head were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
42 2021-01-04 chest discomfort Empoyee received his 1st dose of Covid-19 vaccine around 1535 on 12/17 at our vaccination clinic. A... Read more
Empoyee received his 1st dose of Covid-19 vaccine around 1535 on 12/17 at our vaccination clinic. Around 1545, while being monitored by a registered nurse, he leaned over and grabbed his head. The nurse asked if he was okay and he reported, "no". He stated that he felt nauseated. V/S obtained: B/P 158/80; pulse 99; resp 24; O2 sat 99% on RA; FSBS 267. Pupils were slow to react. Skin was flushed and red. Dr. was notified and assessed the employee. At 1558, the Dr. ordered Benadryl 50mg IM. This was given to employee in Left Deltoid IM at 1558 by RN. At 1559, patient complained of heache, chest tightness, being cold. At 1606, O2 sat was 99% on RA; B/P was 126/90. He reported that his headache was going away at that time and that the chest tightness was going away as well. Headache at that time was a 4/5 on pain scale. Recommended that he be checked at the ER. Between 1620-1625, first responders on site. At 1630, employee was transported to ER for evaluation. Status at time of transfer: Alert and Oriented; headache better, nausea getting better.
42 2021-01-07 chest pain complaints of a headache, right side face swelling and numbness, and right sided chest pain
42 2021-01-07 palpitations, chest pain Went to ED 6 days after vaccination. "42yoM with a hx of covid-19 infection in 3/2020 with sequelae... Read more
Went to ED 6 days after vaccination. "42yoM with a hx of covid-19 infection in 3/2020 with sequelae of chest pain, insomnia, SIBO, and distant hx of testicular malignancy who presents with chest pain and chest palpitations.  Pt received COVID vaccine on Monday, then started to have symptoms reminiscent of his original covid infection on Wednesday, including chills, myalgias, substernal chest pain, heart palpitations, and fatigue. Denies any fevers recorded at home. He feels like he has extra beats intermittently. Also reports some nausea, but denies vomiting or diarrhea. He has maintained good PO intake since symptoms started, but is worried he may be a bit dehydrated because he had a small AKI when he had covid back in March?. Etiology of chest pains unclear, but given all of the above workup, unlikely to be due to an acute cardiac or pulmonary etiology." He continued to have palpitations for the next week and had further EKG's don thru urgent care.
42 2021-01-09 fast heart rate, hypertension Dizziness, Diarrhea, HYPERtension & Tachycardia Narrative: Mild dizziness 5 minutes after vaccinatio... Read more
Dizziness, Diarrhea, HYPERtension & Tachycardia Narrative: Mild dizziness 5 minutes after vaccination. 167/110, heart rate 77 at 1408. 144/01, heart rate 68 at 1417. Reported mild anxiety. Observed 30 minutes. No e/o allergic reaction and anxiety resolved.
42 2021-01-12 blood pressure increased DEVELOPED DIZZINESS, EXTREME FATIGUE, CHILLS, WEAKNESS, NIGHTMARES AND ELEVATED BLOOD PRESSURES SINC... Read more
DEVELOPED DIZZINESS, EXTREME FATIGUE, CHILLS, WEAKNESS, NIGHTMARES AND ELEVATED BLOOD PRESSURES SINCE 1/12/2021 AT NIGHT. UNABLE TO GO TO WORK.
42 2021-01-13 sinus rhythm Pt complained of "warm rush feeling" similar to after first dose. No reports of pain or shortness of... Read more
Pt complained of "warm rush feeling" similar to after first dose. No reports of pain or shortness of breath, dizziness, rash, or itchiness. VS monitored, BP initially 196/106, resolved to 137/94 upon recheck. HR 90s- 120 sinus rhythm. PO fluids and supine position for one hour until resolution of symptoms. Discharged and advised to follow up with primary care and allergist as needed. Safety maintained.
42 2021-01-13 fainting States had a syncope event shortly after 2nd COVID vaccine. Vaccine administered approximately 10am... Read more
States had a syncope event shortly after 2nd COVID vaccine. Vaccine administered approximately 10am then about 40-45 minutes later had a syncope episode and fell from a standing position.
42 2021-01-20 blood pressure increased DRY MOUTH, PAIN OF SITE OFVACCINATION, INCREASE OF BLOOD PRESSURE
42 2021-01-20 chest discomfort Fever, body aches, and headache as expected starting about 9 pm on 1/17. On 1/18 in late afternoon ... Read more
Fever, body aches, and headache as expected starting about 9 pm on 1/17. On 1/18 in late afternoon developed severe cramping in stomach, chest and upper back. Did not eat after cramping started. Got worse at approx 11 pm. Resolved by at approx 3 am on 1/19, after fever broke. Have continued to have headache through time of this report submission.
42 2021-01-21 blood pressure increased 01/13:BODY ACHES, HEADACHE,FATIGUE, 01/14: FEVER AND CHILLS, 01/15: HIGH BLOOD PRESSURE,NAUSEA 01/1... Read more
01/13:BODY ACHES, HEADACHE,FATIGUE, 01/14: FEVER AND CHILLS, 01/15: HIGH BLOOD PRESSURE,NAUSEA 01/16: HEADACHE AND MINDGRAINE
42 2021-01-21 heart rate increased About 3 minutes after receiving the shot, I became dizzy. After 15 minutes, I was still dizzy. I h... Read more
About 3 minutes after receiving the shot, I became dizzy. After 15 minutes, I was still dizzy. I had a little shortness of breath and it felt like my heart was beating faster but this only lasted a few minutes. They had me wait an additional 10 minutes and the dizziness was better but not gone completely. I drove myself home and tried to work from home but was feeling confused. I took the rest of the day off. The next day (yesterday) I woke up exhausted. I took a sick day and slept until noon, which was about 14 hours in total. When I woke up, I felt okay but had no appetite and did not get out of bed for 5 hours. When I finally got up, I still felt dizzy. I ate dinner, watched some TV and went to bed. I woke up this morning without the fatigue but started to feel dizzy in the shower to the point where I almost lost by balance twice. I'm trying to work from home today but feel very dizzy and confused. I couldn't remember my office's phone number. I'm sweating but my temperature is 97.5.
42 2021-01-28 fast heart rate, atrial fibrillation Tachycardia, atrial fibrillation
42 2021-01-31 cardiac arrest, palpitations, chest discomfort 1/28/2021- Seen by FNP for indigestion, chest pressure and palpitations. EKG reviewed and referral ... Read more
1/28/2021- Seen by FNP for indigestion, chest pressure and palpitations. EKG reviewed and referral made to Cardiology. 1/29/2021-1800 Presented to ED in cardiac arrest-onset PTA. Patient was found unresponsive by his wife at their home. The last known well was at 1530 when she called him on the phone. The patient was pronounced at ~1850.
42 2021-02-09 pallor Pt sitting up in chair became pale, pasty, diaphoretic, states he isn't thinkin straight. Pt laid in... Read more
Pt sitting up in chair became pale, pasty, diaphoretic, states he isn't thinkin straight. Pt laid in floor, legs elevated. EMS activated, evaluated by paramedics, orthostatics negative, patient allowed to rest for until 1635. Patient color returned, states he felt better, ambulated out of clinic independently. Wife at side.
42 2021-02-10 fast heart rate I felt burning sensation at the injection site. Experienced tachycardia 200 lasted about an hour and... Read more
I felt burning sensation at the injection site. Experienced tachycardia 200 lasted about an hour and 160 HR 200 lasted about 10 minutes.
42 2021-02-11 coughing up blood Patient returned to vaccine clinic 1 hour and 45 min after Covid 19 vaccine reporting dizziness and... Read more
Patient returned to vaccine clinic 1 hour and 45 min after Covid 19 vaccine reporting dizziness and blood in sputum. Pulse Ox was 99%, Pulse was 113. No SOB. Per Protocol called 911 for transport to ED for evaluation
42 2021-02-18 blood pressure increased 1. That night I had an elevated blood pressure (around 140/100) but it did return to normal levels (... Read more
1. That night I had an elevated blood pressure (around 140/100) but it did return to normal levels (typically 125/80) the next day. 2. Also that night, I had significant body aches (joints and muscle) that was strong enough to effect my sleep. 3. I developed a sore throat 3 days post vaccine that persisted approximately 2-3 days.
42 2021-02-24 hypertension, fast heart rate I was tachycardia at 105/110, hypertensive at 180/110 , riggers and a temp at 102.4
42 2021-02-25 platelet count decreased I have a history of auto immune anemia and ITP. I checked with my hematologist when scheduled if I ... Read more
I have a history of auto immune anemia and ITP. I checked with my hematologist when scheduled if I should take the shot. They stated to take it as not enough data was present to prevent me to take. On 02/11, I spoke with doctors onsite and discussed my medical history. They advised to take the shot as not enough data was present to prevent me to take. On 02/14, I noticed bleeding in gums and petechiae at the injection site. I went to hematologist on 02/15, and platelets were at 2,000. I started 60 mg of prednisone immediately on 02/15. By 02/19, took blood sample and eceived one 70g dose of IVIG. Blood results came back on 02/20, and platelets were at 22,000 but did not cover results from after IVIG treatment. Hematologist decided to stop follow up IVIG treatment and stick to 60mg of prednisone daily as in the past my body has reacted well to it. On 02/24, platelet count went to 300,000. I've started to taper prednisone to 50mg and will continue with weekly blood tests to verify that platelets remain strong. Hemoglobin and all over blood levels in the CBC remained normal during this time. Hematologist has advised not to take second Pfizer COVID-19 shot due to risk.
42 2021-02-25 fast heart rate, hypertension Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Medium,... Read more
Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild
42 2021-02-28 blood glucose increased Blood glucose levels elevated to over 300 with in 4 hours of vaccination, and staying high, over 180... Read more
Blood glucose levels elevated to over 300 with in 4 hours of vaccination, and staying high, over 180 on an average. Fasting levels at 190-200. No change in medication, diet or health condition.
42 2021-02-28 loss of consciousness, heart rate decreased, pulse abnormal He first reported feeling dizzy and that his lips were tingling. His vital signs were monitored ever... Read more
He first reported feeling dizzy and that his lips were tingling. His vital signs were monitored every 5 minutes, and he was given 20 mL (50 mg) liquid Diphenhydramine. At 11:50 A.M., his heart rate dropped from 99 to 51, and he experienced a brief loss of consciousness for about 3 seconds. He also became diaphoretic and very pale at the same time. His pulse was weak but present, and his eyes rolled back in his head. 911 was immediately called, and a sternal rub was provided to help patient regain consciousness. EMS arrived at 11:56 A.M. and transported patient to the hospital for further evaluation. Patient was alert and talking upon transport.
42 2021-03-02 hypertension Dizziness; high blood pressure; dehydration; severe headache; This is a spontaneous report from a no... Read more
Dizziness; high blood pressure; dehydration; severe headache; This is a spontaneous report from a non-contactable 42-year-old male consumer reported for himself. A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN 6201), via an unspecified route of administration in Arm Left on 13Feb2021 12:30 at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no allergies to medications, food, or other products. Medical history included high bp, fatty liver. Concomitant medication included lisinopril (LISINOPRIL), hctz (HCTZ). The patient experienced dizziness, high blood pressure, dehydration, severe headache all on 14Feb2021 with outcome of recovering. The events were reported as non-serious. No treatment was received. No follow-up attempts are possible. No further information is expected.
42 2021-03-02 fainting, palpitations random heart-racing; random dizziness; occasional headaches; Temperature between 100-102 for 30hrs; ... Read more
random heart-racing; random dizziness; occasional headaches; Temperature between 100-102 for 30hrs; flu-like symptoms; extreme burning resulting in fainting; extreme burning; This 42-year-old male patient contactable consumer (reported for himself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EN5318,; expiration not provided), via an unspecified route of administration, on 14Feb2021, 12:00 PM (at the age of 42-year-old) as a single dose for COVID-19 immunization, in Left arm. The facility where COVID-19 vaccine was administered was at a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2 (Lot number: el8982) intramuscularly on 24Jan2021 at 09:00 am for COVID-19 immunization on left arm. The patient did not have any other vaccine within four weeks prior to the vaccination. No relevant medical history reported. Concomitant medication included: Levothyroxine 125 "mg", once a day. On 14Feb2021 at 12:15pm, the patient experienced extreme burning resulting in fainting. Ekg normal in ER. Day-2 flu-like symptoms, temp between 100-102 for 30hrs. Day-2 and now day-3, random dizziness, feeling of heart beat, random heart-racing, occasional headaches, no current fever. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The clinical outcome of the events extreme burning resulting in fainting, flu-like symptoms, temp between 100-102 for 30hrs, random dizziness, random heart-racing, occasional headaches, was unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
42 2021-03-07 lightheadedness Pre syncopal , dizzy, flushing, diaphoretic. Evaluated by EMS-Cleared
42 2021-03-10 chest discomfort Pt, Very anxious, dizziness,chest tightness. Vital signs taken 150/90 p80 r 16 145/100 80 r 16 160/1... Read more
Pt, Very anxious, dizziness,chest tightness. Vital signs taken 150/90 p80 r 16 145/100 80 r 16 160/100 p 81 r16 157/90 p 78 r16
42 2021-03-12 heart rate increased, fast heart rate Fever chills aches. Heart rate went into tachycardia with a heart rate up to 200BPM. Rush to the ER ... Read more
Fever chills aches. Heart rate went into tachycardia with a heart rate up to 200BPM. Rush to the ER by ambulance. Treated and sent home with a heart rate of 95-100BPM
42 2021-03-13 heart rate increased 1. Injection site pain ( no longer an issue) 2. Fast heart beat
42 2021-03-14 pallor Received 1st dose at mass clinic. After a few minutes while sitting in observation area, pat observe... Read more
Received 1st dose at mass clinic. After a few minutes while sitting in observation area, pat observed by Dr and med student to be very pale, dyspneic, lightheaded and complaining of nausea. BP 148/94 O2 applied at 1.5 LPN N/C. Pt able to sit in chair without problems, remained responsive. States he was fine until he saw others getting their vaccine and that made him anxious. Observed for 30 minutes, pulse ox 95%. Oxygen removed and pt was able to walk out without difficulty and go home after condition much improved. Local EMS on site with pulse and O2.
42 2021-03-14 lightheadedness presyncope, nausea, evaluated by EMS, refusal to transport.
42 2021-03-17 chest discomfort Deep itching; dry cough in lungs; chest tightness, heaviness; shortness of breath for 4 days after; ... Read more
Deep itching; dry cough in lungs; chest tightness, heaviness; shortness of breath for 4 days after; This is a spontaneous report from a contactable consumer reported for himself that a 42-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm on 25Jan2021 12:00 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. Medical history included Seasonal allergies, various surgeries. Concomitant medication included levocetirizine dihydrochloride (LEVOCETIRIZIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Deep itching dry cough in lungs and chest tightness, heaviness, shortness of breath for 4 days after, events start date provided as 07Feb2021 04:00 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered. The patient received the second dose of BNT162 on 13Feb2021 11:30 AM via an unspecified route of administration at Right arm for covid-19 immunization. Information on the lot/batch number has been requested.
42 2021-03-17 hypertension He was wearing many layers of clothes due to working in a cold environment prior to receiving vaccin... Read more
He was wearing many layers of clothes due to working in a cold environment prior to receiving vaccine. He was also sweating a lot. About 5 minutes after he was vaccinated, he began to drift in and out of consciousness. His blood pressure was high (165 systolic), but glucose was normal. EMS was called and it was determined to be related to blood pressure and a reaction due to the Pfizer Covid vaccine. Patient was released from hospital.
42 2021-03-18 loss of consciousness, pallor, fainting Client received vaccine at 13:50. Client immediately felt faint and presented with pallor and diapho... Read more
Client received vaccine at 13:50. Client immediately felt faint and presented with pallor and diaphoresis. Client lost consciousness and began to wheeze. Epi administered at 13:53 to right leg. Client then laid to floor and feet were elevated. Client soon recovered and transferred to hospital per protocol for post epinephrine injection. Client coherent, stable and able to independently ambulate.
42 2021-03-21 heart rate decreased, oxygen saturation decreased Intense flu symptoms for three days, to include fever chills, aches, swelling of face and neck. Subs... Read more
Intense flu symptoms for three days, to include fever chills, aches, swelling of face and neck. Subsequent to flu, low oxygen rates of 82-91, low resting heart rate of 48-54, extreme exhaustion, swelling of face and neck. General weakness.
42 2021-03-22 pallor, loss of consciousness Patient was normal upon administration. Was given instruction to wait 15 minutes in the pharmacy to ... Read more
Patient was normal upon administration. Was given instruction to wait 15 minutes in the pharmacy to monitor for adverse reaction, per protocol. Pharmacy staff was alerted by customer that patient was "not looking good". As we walked to patient, we slipped out of his chair and appeared to loose consciousness and/or have seizure-like symptoms. Patient looked very pale, perhaps had some minor foam at the mouth and was extremely hot. We stayed by patient, protected his head, allowed him to come to, took coat off and applied ice packs, took BP/pulse (normal) and patient was oriented x3. EMS arrived and took over.
42 2021-03-23 pulse abnormal, pallor Description of event: Patient received vaccine in his LUE and was instructed to wait in line to sche... Read more
Description of event: Patient received vaccine in his LUE and was instructed to wait in line to schedule next dose. While standing in line, patient was witnessed falling to the floor. He appeared to land on his hands, denies injury at this time. Patient responded verbally when asked if he was okay. Vitals recorded while patient sitting on floor 1500. Patient stated he was ok to sit in chair. Upon sitting in chair for approximately 30 seconds his head fell forward and he was unresponsive. Patient began agonal breathing, eyes were open with fixed pupils, pulse was weak. Staff assisted patient to floor where he regained consciousness after approximately one minute. Patient appeared diaphoretic and pale, but was responding appropriately. An ambulance was called during this time. The patient was able to give contact information for his wife. The patient personally spoke to her on the phone. Meanwhile patient was resting supine on the floor. Vitals at 1552 146/94 P 70, R 20, 98% RA. Approximately 15 min later patient returned to the chair and has been resting since. BP at 1615 119/65. He refused treatment from EMS and is currently calling his wife to pick him up as staff has advised him not to drive. Patient currently eating a snack and drinking water, states he is feeling better.
42 2021-03-23 fainting Pt. began to feel dizzy 10 min after vaccination. He had intermittent syncope, no AMS, symptoms reso... Read more
Pt. began to feel dizzy 10 min after vaccination. He had intermittent syncope, no AMS, symptoms resolved and pt. went home at 1801. BP: 102/67, HR 68, O2 95%
42 2021-03-24 fibrin d dimer increased, chest discomfort, palpitations 3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but stil... Read more
3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but still present. 3/9 Work up with terrible thoracic back pain with every breath. Went to ER and received shot of Toradol and chest x-ray (negative). Shortly thereafter, had chills and low grade fever. Alternated naproxen and tylenol for the next two days as fever persisted. 3/11 Moderate chest pressure when breathing. Went back to ER. Received COVID test (negative). No fever or chills. 3/12 Light headedness, racing heartbeat and chills early afternoon. Went back to ER. Received Flu test (negative). Blood work showed positive d-dimer test. CT scan showed small pneumonia in lower left lung. Started Amoxicillin and Z-pack. Symptoms improved over course of following 7 days.
42 2021-03-25 blood pressure increased, heart rate increased After receiving vaccine patient complaints of feeling unwell, diaphoretic, nausea, increased heart r... Read more
After receiving vaccine patient complaints of feeling unwell, diaphoretic, nausea, increased heart rate. BP elevated at 226/107 HR 140. Patient assisted to stretcher given oral fluids and reassessed. patient states he does have a history of SVT, which he takes diltazem and lisinopril for.
42 2021-03-26 loss of consciousness Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes.... Read more
Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes. Upset stomach with vomiting and diarrhea. Body was shaking and didn?t have a fever. Skin felt like it was burning whole body felt swollen. Started around 2:30am with the cramping. It woke me up. Once I got up everything came so fast. Was rushed to hospital where I was admitted very quickly. I was blacking out on the drive there and blacked out while in their care. This was from one dose of Pfizer vaccine for Covid. I was put on a GI, Allergy, and steroid medications. I was hooked up to an IV and 3 drugs were injected. I passed out numerous times but was discharged at 5am.
42 2021-03-27 loss of consciousness, pallor Pt. passed out for about 2 minutes. Skin and lips were very pale. pt hunched over to the right while... Read more
Pt. passed out for about 2 minutes. Skin and lips were very pale. pt hunched over to the right while in chair. eyes flattering and very diaphoretic. Pt was helped to lay down on the floor in supine with legs elevated. clothes loosened, applied cold icepacks and deep breaths were encouraged. Pt . gained consciousness and was able to retell what had happened.
42 2021-03-27 fainting syncope , lightheaded, dizzy history of H.S.P- AUTO IMMUNE RESP 104/70,70,16, BS 122 124/68,90,16
42 2021-03-27 fainting Patient received the vaccination and after he got up from the chair, he passed out and fell to the f... Read more
Patient received the vaccination and after he got up from the chair, he passed out and fell to the floor. The intern notified the pharmacist. When I went to see that patient, he was laying on the floor with his eyes rolled in the back of his head and was unresponsive. He was not alert. He started having a mild seizure and I rolled him over on his left side. While I was bracing the patient, pharmacist came in and administered an Epi-pen to his left thigh. Patient stopped seizing so I rolled him back on his back. He became alert and was able to provide me his name, DOB and what he was at the pharmacy for. I rested my hand under his head and monitored his pulse until the paramedics arrived
42 2021-03-28 chest discomfort Abdominal tightness with lower chest with tightness briefly lower chest that resolved with juice. Pt... Read more
Abdominal tightness with lower chest with tightness briefly lower chest that resolved with juice. Pt did not eat before coming out to vaccination center with pt feeling better on DC. Vitals stable
42 2021-03-29 chest discomfort Very anxious before vaccine; BP at home 154/90. Felt like "punched in face"/foggy; lightheaded. BP ... Read more
Very anxious before vaccine; BP at home 154/90. Felt like "punched in face"/foggy; lightheaded. BP 148/98; pulse 88; p ox 98%; gave water. Continued monitoring; after about 30 minutes, then noted chest "heaviness"; "sore throat"--no tightness, no vision changes. Rapid response evaluated; Patient refused ED; continued monitoring for 10-15. VSS; chest heaviness resolved. Accompanied to hospital entrance; had ride home.
42 2021-03-29 chest pain Patient states he received 2nd Pfizer shot 3/26 at approximately 10:40am, approximately 2 hours afte... Read more
Patient states he received 2nd Pfizer shot 3/26 at approximately 10:40am, approximately 2 hours after developed fatigue. At approximately 2:00pm on 3/29 developed chest pain and shortness of breath. Patient was referred to local emergency room for further evaluation.
42 2021-03-29 chest pain Chest pains, sporadic over 5 days. Center and both sides near center of chest
42 2021-03-30 chest discomfort, chest pain Fatigue, fever, chest pressure and pain, headache
42 2021-03-30 loss of consciousness Felt a large amount of sensation in my injection arm 1-2 minutes after shot. Started to feel faint a... Read more
Felt a large amount of sensation in my injection arm 1-2 minutes after shot. Started to feel faint and light-headed 3-4 minutes after shot. Passed out about 5 minutes after shot. Felt sweaty, disoriented, spacey, and nauseated shortly after coming back to consciousness. Went to hospital in an ambulance and released a couple hours later.
42 2021-03-31 hypertension Patient began to fill itchy at injection site, on lower back, and left wrist. His throat also felt i... Read more
Patient began to fill itchy at injection site, on lower back, and left wrist. His throat also felt itchy. His shot was at 10:55AM. Patient alerted us to symptoms at 11:15AM. Patient given 50mg diphenhyramine IM at 11:20AM in left deltoid. His blood pressure at 11:30AM was 144/92, which patient said wasn't abnormal for him. His symptoms did not progress and he was feeling fine other than mild itchiness when he left pharmacy at 11:45AM.
42 2021-03-31 fainting Fainted for a brief moment when see needles. 11:15am Patient reported feeling better.
42 2021-04-04 loss of consciousness Patient suddenly became diaphoretic eyes rolled back in head, almost passed out . Onsite EMS was cal... Read more
Patient suddenly became diaphoretic eyes rolled back in head, almost passed out . Onsite EMS was called vitals HR 42 BP 95/59 98% O2 refused glucose check. Patient felt better and reluctantly was transported to local hospital. No reaction to 1st vaccine on 3/12/21
42 2021-04-05 pallor, chest discomfort 3-5 MIN POST INJECTION, PT EXPERIENCED CHEST TIGHTTHROAT AND TONGUE TINGLING.hE DESCRIBED FEELING AS... Read more
3-5 MIN POST INJECTION, PT EXPERIENCED CHEST TIGHTTHROAT AND TONGUE TINGLING.hE DESCRIBED FEELING AS IF HE COULD NOT GET AIR. nO STRIDOR OR WHEEZING NOTED. PT.SPEAKING WITHOUT DIFFICULTY. PLACED ON STRETCHER, PALE, DIAPHOREETIC. EPI PEN INJECTED TO LEFT QUAD. BP 147/100sat 100% ON ROOM AIR HR 92. MD AT BEDSIDE AND PATIENT TRANSFERRED TO ER FOR EVALUATION.
42 2021-04-05 fainting Patient was given first dose of Pfizer COVID-19 vaccine. I counseled the patient on side effects an... Read more
Patient was given first dose of Pfizer COVID-19 vaccine. I counseled the patient on side effects and asked him to wait 15 minutes afterwards in our waiting area. After about 5 minutes, the patient starting complaining of feeling dizzy. We asked him to sit back in the chair and brought him a bottle of water. I asked the patient if he had eaten today and he replied no. I offered a snack and also a glucose tablet to help with shakiness. As I went to get a bottle of glucose tablets off the shelf, the patient fainted and fell out of his chair. I immediately ran to get an Epipen while my technicians called for a Code White and 911. I was about to inject the patient with the Epipen when he came to about 10 seconds later. He said he was really hot, sweaty, dizzy, and nauseous. Paramedics and AP arrived to evaluate him and take a statement. Patient left on his own will and received a ride home from his mother-in-law, who is an associate at our store.
42 2021-04-06 chest pain Paramedic called to observation for 42 YO male with dizziness, lightheaded, and anxiety. Upon arriv... Read more
Paramedic called to observation for 42 YO male with dizziness, lightheaded, and anxiety. Upon arrival PT found sitting in chair A&OX4, skins: pink/warm/dry, pupils: Equal and reactive. Pt speaks very little English and PT's wife translated for him. PT states that he started feeling symptoms 10 minutes after receiving his Pfizer vaccine. Upon assessment PT states he has 10/10 chest pain non radiating/dull in nature with increased pain on inspiration. Pt states that this has happed before a few months ago and was diagnosed with HTN but was not prescribed any medication by his primary care physician. PT does not take any medications and has no allergies. Pt status did not improve or decrease while in the care of the paramedic. Pt vitals then assessed and were as follows: 0943: BP 172/118, HR 71, RR 24, SPO2 99% RA, Lungs clear/equal bilaterally. 1002: BP 180/131, HR 80, RR22, SPO2 98% RA, Lungs clear/equal bilaterally. The paramedic made the decision to activate the EMS 911 system. Upon EMS arrival report given to responding paramedics and PT care transferred. EMS Paramedics began to treat patient for Chest Pain Protocol, and transported PT to Local ER.
42 2021-04-06 loss of consciousness After Vaccine Administration pt pulled to observation lot to wait 15 minutes for observation of adv... Read more
After Vaccine Administration pt pulled to observation lot to wait 15 minutes for observation of adverse reaction. He lost consciousness after becoming confused for 1 minute. He was assessed by a guardsman and EMS staff regaining conciseness within a few minutes
42 2021-04-06 loss of consciousness 10:45am patient became unconscious and was laid on the floor with legs elevated. Heartrate 50 BP 76... Read more
10:45am patient became unconscious and was laid on the floor with legs elevated. Heartrate 50 BP 76/60 10:50am BP systolic 90 HR 60 weakly responsive 10:52am BP systolic 92 10:55am More responsive, eyes open, speaking, HR 64, BP systolic 100. 10:58am EMS arrived, patient declined transport.
42 2021-04-08 blood glucose increased Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) from urgent care... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) from urgent care (UC) reporting six days of vomiting, fatigue, shortness of breath, dizziness, constipation, and polyuria starting one day after receiving vaccination. Initial vital signs blood pressure 127/96 mmHg, heart rate 119 beats per minute, temperature 35.9 degrees Celsius, respiratory rate 18 breaths per minute, oxygen saturation 97% on room air. Patient diagnosed with new adult-onset diabetes, diabetic ketoacidosis, and acute kidney injury and admitted to the hospital. Administered intravenous fluids and insulin with improvement in symptoms and lab values. Currently hospitalized.
42 2021-04-09 heart rate increased, chest discomfort small pneumonia in lower left lung; Light headedness; racing heartbeat; Moderate chest pressure when... Read more
small pneumonia in lower left lung; Light headedness; racing heartbeat; Moderate chest pressure when breathing; work up with terrible thoracic back pain with every breath; chills; low grade fever; Moderate stomach cramps; Much less arm pain then following first dose but still present; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203) via an unspecified route of administration in left arm on 03Mar2021 (at the age of 42-year-old) at single dose for COVID-19 immunisation. There was no medical history. The patient had no known allergies. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) on 10Feb2021 at 11:30 am in left arm for Covid-19 immunisation. There were no other vaccines in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had 3/4 moderate stomach cramps day after vaccine on 04Mar2021. Much less arm pain then following first dose but still present on 04Mar2021. The patient 3/9 worked up with terrible thoracic back pain on 09Mar2021 with every breath and went to emergency room and received shot of Toradol and performed chest x-ray which was negative. Shortly thereafter, the patient had chills and low grade fever on 09Mar2021. Alternated naproxen and tylenol for the next two days as fever persisted. The patient had 3/11 moderate chest pressure when breathing and went back to emergency room on 11Mar2021. There was no fever or chills but had 3/12 light headedness, racing heartbeat and chills early afternoon on 12Mar2021. The patient went back to emergency room. The patient's symptoms improved over course of following 7 days. The patient underwent lab test and procedure which included flu test and resulted negative; blood work which showed positive D-dimer test on an unknown date and CT scan showed small pneumonia in lower left lung on 12Mar2021. The patient started to receive amoxicillin and Z-pack. Since the vaccination, the patient had been tested for COVID-19 by nasal swab on 11Mar2021 and tested negative. Events resulted in emergency room/department or urgent care. The outcome of event pneumonia was unknown; for other events was recovering. No follow-up attempts are possible. No further information is expected.
42 2021-04-09 palpitations High fever, chills, body aches, extremely sore arm, heart racing.
42 2021-04-09 fainting syncope loss of vision and dizzy
42 2021-04-09 blood clot Approximately one week after my second dose my right leg began swelling. For three weeks after the s... Read more
Approximately one week after my second dose my right leg began swelling. For three weeks after the swelling began it would get better than get worse. On Tuesday, March 30, 2021 my entire leg swelled to twice its normal size at which time I went to the emergency room and a blood clot was diagnosed in my right leg. I completed a multitude of tests and bloodwork with a hematologist and there are no factors or reasons they can identify as to why I developed a blood clot.
42 2021-04-10 lightheadedness, loss of consciousness, pallor Individual felt pre-syncopal. Left obs area after 8 minutes to get fresh air. Sat down on grassy are... Read more
Individual felt pre-syncopal. Left obs area after 8 minutes to get fresh air. Sat down on grassy area and was found down, pale and diaphoretic. Suspect LOC. Recovered spontaneously. Normal mental status after event. Treated with oral rehydration. Declined further evaluation. Sent home by POV.
42 2021-04-12 fainting Patient fainted onto the floor within 15 minutes of vaccination. Patient transported to ER by EMS.
42 2021-04-15 heart rate increased 72 hours after receiving the shot I had debilitating vertigo and nausea, as well as rapid heartbeat.... Read more
72 hours after receiving the shot I had debilitating vertigo and nausea, as well as rapid heartbeat. I went to the ER and was admitted for 2 days. I am still currently experiencing dizziness on Friday April 16th 2021.
42 2021-04-15 fainting, loss of consciousness Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Swe... Read more
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: AFTER 5 MINUTES OF BEING VACCINATED, PATIENT WAS SEATED WAINTING FOR THE 15 MINUTES AND FAINT LOSSING CONSCIOUSNESS FOR 5 MINUTES, THEN AFTER RECOVERED HE WAS PALE, SWEATING, COLDNESS OF THE HANDS AND DIZZY. WHEN 911 ARRIVED, HE SAID THAT HAD NOT EATEN ANYTHING SINCE 5:00 AM, 10 HOURS BEFORE THE EVENT HAD PLACE, SO MAYBE HE EXPERIENCED A HYPOGLYCEMIC EVENT.
42 2021-04-15 fast heart rate, haemoglobin decreased, pallor, fainting, hypotension Patient started noticing dark stools the day after vaccination (4/15) and began vomiting blood on 4/... Read more
Patient started noticing dark stools the day after vaccination (4/15) and began vomiting blood on 4/16. One episode of vomiting resulted in a syncopal episode in which the patient hit their head, causing a laceration which required staples. The patient does report intermittent abdominal pain over the course of the past few weeks, but today is more severe and the first time he has experienced bloody emesis. Upon presentation patient was tachycardic, hypotensive, and pale. Patient reports he does not frequently consume alcohol. Patient received a pantoprazole bolus and drip, an octreotide drip, and PRBC. Patient also received several doses of ondansetron. Patient is being admitted for care.
42 2021-04-18 heart rate increased, hypertension, atrial fibrillation 3.5 hours after the vaccine shot my body shot full of adrenaline and my heart raced up to 150 beats ... Read more
3.5 hours after the vaccine shot my body shot full of adrenaline and my heart raced up to 150 beats per minute. I ended up checking myself into the emergency room 5 hours after the vaccine shot because my heart rate wouldn't slow down and my blood pressure increased. They found out my heart had gone into atrial fibrillation. I have had no known history of atrial fibrillation in the past and prior EKG's at physicals have been normal. I am an otherwise healthy individual.The doctor conducted an emergency Cardioversion to return the heart rhythm to normal.
42 2021-04-18 palpitations Palpitations, light-headedness while seated
42 2021-04-18 blood clot, cerebral haemorrhage, hypertension Pt was found in severe distress in the bathroom by his wife. He couldn't walk or stand, complained ... Read more
Pt was found in severe distress in the bathroom by his wife. He couldn't walk or stand, complained of being dizzy with slurred speech and was throwing up a lot. 911 was immediately called. The EMTs during their assessment said his BP was normal but when he was asked his name, he started saying the alphabet"ABC... XYZ". He was transported by ambulance to ER. Cat scan showed he had a bleed on the brain. The doctors told us it was because he had very high blood pressure, however where the bleed was, they said he wouldn't need surgery and that the body would reabsorb it over time. He was admitted to the ICU and has been there ever since. Several days later, he started having difficulty breathing and they discovered several blood clots in his right leg that had broken off into his heart and lungs. He had emergency surgery to remove the clots in his heart (approximately 10) and was given heparin in small doses over an 8 hour period so that it wouldn't cause the bleed in his brain to increase. The doctor should fill in the rest.
42 2021-04-18 blood vessels inflammation Patient started 2 days after vaccine with shortness of breath and fever/chills. He says he was unabl... Read more
Patient started 2 days after vaccine with shortness of breath and fever/chills. He says he was unable to get out of bed for 24 hours. He said the rest of the week he didn't feel quite right. A week after the vaccine he started with red capillary veins popping up all over his legs. By Saturday his legs were purple and swollen. He has multiple tests run at the hospital. They doctor believes it is vasculitis that has resulted from patient getting the covid vaccine.
42 2021-04-19 loss of consciousness, fainting While in waiting area client experienced loss of consciousness and seizure-like activity lasting app... Read more
While in waiting area client experienced loss of consciousness and seizure-like activity lasting approximately 48 seconds per nurse that responded to incident. Loss of bladder control noted. Squad responded and transported patient to the hospital via ambulance. Patient was coherent prior to transport. He states he was admitted to the hospital and Observation x 24 hours. He had a CT scan and bloodwork, both normal. Neurologist at the hospital told him he experienced syncope and no seizure activity was suspected. He states a history of feeling faint when he sees blood. He sates the Neurologist advised he get the second dose and lay down after the shot.
42 2021-04-21 fainting Syncope, dizziness, vitals wnl. Water and juice given.
42 2021-04-22 chest discomfort Patient got vaccinated at 10:22 a.m. At 10:35 a.m., patient reported severe headache, chest tightnes... Read more
Patient got vaccinated at 10:22 a.m. At 10:35 a.m., patient reported severe headache, chest tightness, difficulty breathing, feeling lightheaded. Patient noted to be diaphoretic, less responsive, and having left eye deviation. Patient assessed/examined by Dr. and Medics on site. Vital signs taken: at 10: 38 a.m., BP 177/126, HR 118; at 10:39 a.m., BP 172/120, HR 110, O2saturation 96% on room Air; at 10:41 a.m., BP 173/123, BG: 333, sinus rhythm on cardiac monitor. At 10:47 a.m., BP 158/78 (with manual cuff). Fire Metro Paramedics called; Patient transported to Hospital at 11 a.m.
42 2021-04-22 skin turning blue, pulse abnormal, pallor 42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. P... Read more
42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. Patient notified one of the observation nurses that he was not feeling well. The NP was assisting another patient but saw that the patient with his head back and pale. As soon as the NP was at the patient side, it was noted that the patient?s eyes were rolling back, his face was pale, and his lips were blue. The NP attempted a sternal rub with no response from patient. NP instructed police to please call Fire Rescue to transport patient to the ER. Patients left upper extremity was flexed at the elbow and stiff. At that time the patient was placed on the floor by several nurses and the paramedic and patient legs were elevated. Within 10-15 mins patient immediately sat up but was instructed to lay down. Patient was placed on 3L of O2 by nasal cannula and vitals were taken. Patient initial vitals 166/94 L Arm, 98% 3L O2, 84 Pulse and EKG was NSR. Patient no longer with pallor and lips were pink. Patient states that he isn?t feeling well and feels a nervousness throughout his body. Patient placed on stretcher in Trendelenburg. Vitals retaken, 137/97 BP, 98% 3L O2, 80 P. Patient pulses were thready and patient became diaphoretic. Fire Rescue arrive to site and transported patient to the ER. CNO and PM present during event and aware that patient transported to the ER for further evaluation
42 2021-04-23 loss of consciousness About six hours after receiving my shot, my arm became extremely sore, as to be expected. Circa 9pm... Read more
About six hours after receiving my shot, my arm became extremely sore, as to be expected. Circa 9pm I began to have significant trouble breathing, experienced acute pain in my abdomen, and began to hear ringing in my ears combined with feeling like I was going to pass out. I didn?t feel dizzy, rather I started getting tunnel vision that blocked out more of my field of view as the ringing increased. Circa 11pm, I lost consciousness while trying to move and collapsed on the floor. My wife called 911 while I was unresponsive, and I regained consciousness while being attended to by EMTs who checked my vitals. Around 12am I didn?t feel like I was going to lose consciousness again, and the EMTs recommended I be taken to the hospital. Since I was feeling better I politely declined. Today I am still feeling foggy and have joint pain (in addition to some bruising from falling after losing consciousness , but I no longer have the acute abdominal pain.
42 2021-04-24 hypotension, pallor, loss of consciousness Patient warned us before his covid vaccine that he has a severe needle phobia and has fainted after ... Read more
Patient warned us before his covid vaccine that he has a severe needle phobia and has fainted after vaccines. I gave him his immunization quickly and he did well. He stood up and watched as I immunized his wife. He said he was feeling okay afterwards so both him and his wife left the immunization room. Shortly after leaving he must have started getting dizzy, because next thing I hear is that there is an unconscious man in the waiting room. He is sitting in a chair with his head back unresponsive. His wife if rubbing his arms and lightly slapping his face. He comes to, and we decide to move him to the room that the clinic uses (we have a walk in clinic staffed with a NP). He lays on the floor, and within a minute he proceds to vomit approximately 4 times. He also lost control of his bladder. He was pale with cold and clammy skin. we moved him so we could put his feet up on a chair and allowed him to rest. Someone went to get him an ice pack to put on his head and chest. His blood pressure was low (90/50ish). He still was not feeling better after 30 minutes so we called the ambulance. He did not want to go to the hospital so the paramedics monitored him. his blood pressure slowly started going up and normalizing, and he left with his wife.
42 2021-04-26 blood clot Blood clot in leg; This is a spontaneous report from a non-contactable consumer reported for himself... Read more
Blood clot in leg; This is a spontaneous report from a non-contactable consumer reported for himself. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 01Apr2021 02:00 PM at 42-year-old at single dose for COVID-19 immunisation. Patient had known allergies (unspecified) and other medical history (unspecified). There was no covid prior vaccination. There is no other vaccine in four weeks. Other medications in two weeks included antibiotics. Patient experienced adverse event: blood clot in leg on 03Apr2021 02:00 AM. The adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Patient received treatment for events included blood thinners. Patient had covid tested post vaccination on 21Apr2021: Nasal Swab: Negative. Patient was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-04-27 palpitations Patient complained of Palpitations
42 2021-04-27 fainting This is a spontaneous report from a contactable consumer (the patient). A 42-year-old male patient r... Read more
This is a spontaneous report from a contactable consumer (the patient). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 13Apr2021 10:45 (at the age of 42-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: tonsils removed at age 6 and heart rate at rest low. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included: acetylsalicylic acid/ caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) and cetirizine hydrochloride (ZYRTEC), both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 23Mar2021 11:15 (at the age of 42-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated he fainted the morning after receiving the shot on 14Apr2021 06:00. No treatment was received for the event. The outcome of fainted was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.
42 2021-04-28 chest discomfort, chest pain initially began as what felt like jolts to my chest area from inside my chest over five days beginni... Read more
initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory. The X-ray and blood work came back negative per ER. Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour. 2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage. 3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs. 4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air. 6. Penis no longer has the same sensation and difficulty with erection.
42 2021-04-28 chest pain Patient received her second dose of the Pfizer vaccine on 4/28/21 at approximately 7pm. While waitin... Read more
Patient received her second dose of the Pfizer vaccine on 4/28/21 at approximately 7pm. While waiting in the waiting area for 15 minutes after getting the vaccine, she reported feeling chest pain and dizziness. She agreed to have us call the ambulance for her, they came quickly and took her to the hospital. I asked the EMT worker which hospital they were taking her to, but he said he cannot disclose the information. Patient also mentioned that she has hypertension and is on blood pressure medications.
42 2021-04-30 hypertension Personality changes; headaches; extreme fatigue; Also, I was unaware on conversations that I had.; I... Read more
Personality changes; headaches; extreme fatigue; Also, I was unaware on conversations that I had.; I had high blood pressure and insomnia.; I had high blood pressure and insomnia.; It would seem that I had cerebritis from the shot; This is a spontaneous report from a contactable physician (patient). A 42-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL1284, expiry date not reported), via an unspecified route of administration, administered in right arm (at the age of 42 years old) on 08Jan2021 14:30 as a single dose for covid-19 immunisation. There were no medical history (reported as none) and no concomitant medications. The patient had no known allergies. The patient had no covid prior vaccination. The patient received the first dose of bnt162b2 (brand as Pfizer) for Covid-19 immunisation on 18Dec2020 (at the age of 42 years old) at 03:30 PM administered on the right arm. The vaccine was administered on a hospital. The patient had no other vaccine in four weeks and no other medications in two weeks. On 08Jan2021 11:00 PM, the patient experienced personality changes, headaches, and extreme fatigue, and also was unaware on conversations that he had. The symptoms lasted about 24 hours acutely, but for the 3 weeks afterwards, patient had high blood pressure and insomnia (2021). It would seem that patient had cerebritis from the shot since an unspecified date in 2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. There were no treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was recovered with lasting effects.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available clinical data, the event encephalitis most likely represented an intercurrent medical condition not related to vaccination with BNT162B2. This case will be re-assessed when relevant follow-up information is received. The impact of this report on the benefit/risk profile of the Pfizer product 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.
42 2021-04-30 fainting The patient received his covid vaccine and minutes later, he had a syncopal episode. He recovered sh... Read more
The patient received his covid vaccine and minutes later, he had a syncopal episode. He recovered shortly after, but his heart rate was low at 44 bpm. EMT was called to the pharmacy for emergency assistance.
42 2021-04-30 blood clot, cerebrovascular accident Stroke caused by blood clot. Spent 6 days in medical facility as a result. Unknown if vaccine and b... Read more
Stroke caused by blood clot. Spent 6 days in medical facility as a result. Unknown if vaccine and blood clot are related - but it seemed wise to report for further investigation
42 2021-05-02 heart attack, inflammation of the heart muscle, chest pain On 25 April I woke up and felt fine and then at 10:30 am I started to feel weak. I had fever and chi... Read more
On 25 April I woke up and felt fine and then at 10:30 am I started to feel weak. I had fever and chills and couldn't get out of the bed until 4:00pm that day. I was dizzy and drove to the hospital. They did blood work and did two Covid 19 tests. They released me and the next day I developed Heavy pains. On 27 April I woke up and went back to the hospital. They said I had elevated enzyme levels when they drew blood and they started three iv?s. They said I was having a non emergency heart attack. They had me transferred by ambulance to the another Hospital. They drew more blood and did elf?s and ultra sounds. The next day they said they were going to put a stint in my heart. The next day I was prepped for the procedure and they went in and said my heart didn?t need it. The surgeon said I had Myocarditis and at 7:00 pm that night I was released. My nose broke out with acne bumps and it feels like I have a chest cold and cough.
42 2021-05-03 palpitations On 30 Apr, 2nd day after vaccination, I an episode of heart palpitations ("ventricular premature com... Read more
On 30 Apr, 2nd day after vaccination, I an episode of heart palpitations ("ventricular premature complexes in a pattern of bigeminy"). These were captured on an EKG during a VA disability exam, and started shortly after providing a blood sample (I'm nervous with needles). Previous day (1st day after vaccination) I had a fever of 101.5 F and was fatigued. Suspect the stress of the fever, immune response, and then blood sample caused a stress event that triggered an abnormal heart rhythm. Palpitations not accompanied by light headedness or shortness of breath, so no immediate medical care directed. Episodes of palpitations continued for 4 days, but have mostly disappeared since.
42 2021-05-03 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: pt was not feeling well, pharmacist saw patient slumped over in chair, we lowered patient to floor, flat on back, and pulled his knees up. Blood pressure was monitored. 911 was called, paramedics monitored pt and advised him to go to hospital. Patient refused to go to hospital. Pt was lucid, was given saltines/water, was monitored for 30-45 min longer, and was driven home by female companion.
42 2021-05-04 fainting Flu like symptoms followed by 4 episodes of orthostatic syncope
42 2021-05-06 chest discomfort Dizzy, headache, full body muscle aches, chills (over 36 hours), elevated temperate, tightness in th... Read more
Dizzy, headache, full body muscle aches, chills (over 36 hours), elevated temperate, tightness in the chest, fatigue. Symptoms started mild and by 12 hours after the shot full flu like symptoms last for over 48 hours. Did not subside until the Friday after the shot (60 hours after the shot). No treatment except rest and drinking plenty of fluids.
42 2021-05-06 fainting Syncope. Fell and hit head, woke up within 30 sec - 1 min. Abrasion to elbow and left forehead. EMT ... Read more
Syncope. Fell and hit head, woke up within 30 sec - 1 min. Abrasion to elbow and left forehead. EMT applied antiseptic ointment/bandage. Observed an additional 15-20min. Water, crackers given. Stable and released.
42 2021-05-07 ischemic chest pain, heart rate increased I read on the fact sheet that may be a sign I had an allergic reaction; Dull pain: Caller reported t... Read more
I read on the fact sheet that may be a sign I had an allergic reaction; Dull pain: Caller reported that on Wednesday, 14Apr2021, after his heart started beating fast and slowed itself down, it started to hurt; heart started to beat fast; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration, administered in right arm on 12Apr2021 12:50 (at the age of 42 years old), as single dose for COVID-19 immunization. The patient's medical history included high cholesterol from 2011 and ongoing. Concomitant medications were not reported. Patient stated that he got his shot on Monday 12Apr2021 (he confirmed it was his first dose of the PFIZER-BIONTECH COVID-19 VACCINE) and then went on 14Apr2021 his heart started to beat fast, he read on the fact sheet and he asked if that may be a sign he had an allergic reaction. He went to his doctor, her EKG came back normal, he saw a cardiologist. He asked if he should get second dose. Second was scheduled for 03May2021. He didn't know either. As per response it was reported that as noted in the fact sheet for recipients, patient should not get the PFIZER-BIONTECH COVID-19 VACCINE if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason could not be made by Pfizer. They referred him to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. His healthcare provider knew his health situation and had access to information that could better help inform this decision. The patient experienced dull pain: caller reported that on Wednesday, 14Apr2021, after his heart started beating fast and slowed itself down, it started to hurt. The patient reported that the dull pain was not as bad. The patient had EKG on 14Apr2021 with abnormal result (as reported). The outcome of the event 'dull pain: caller reported that on Wednesday, 14Apr2021, after his heart started beating fast and slowed itself down, it started to hurt' and 'heart started to beat fast' was recovering; outcome of the remaining event was unknown. Information about lot/batch number has been requested. Follow-up (22Apr2021): New information reported from a contactable consumer (patient) includes: reaction data (additional event: 'dull pain: caller reported that on Wednesday, 14Apr2021, after his heart started beating fast and slowed itself down, it started to hurt'), suspect product details (administration site and time), patient details (medical history and lab data) and event details (outcome of the events updated).
42 2021-05-07 fainting syncopal event in observation area, refused hospital transport
42 2021-05-09 fainting Patient fainted after vaccine but was assisted to the floor. States that he has anxiety. Patient car... Read more
Patient fainted after vaccine but was assisted to the floor. States that he has anxiety. Patient carefully watched in observation and did deep breathing exercises. He stated he felt better and vitals were within normal limits
42 2021-05-10 hypertension Ringing and buzzing in ears and head; insomnia; high blood pressure; This is a spontaneous report fr... Read more
Ringing and buzzing in ears and head; insomnia; high blood pressure; This is a spontaneous report from a contactable consumer reporting for himself. A 42-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 04Apr2021 12:00 (Batch/Lot number was not reported) as 2nd dose single for covid-19 immunisation (Age at vaccination 42 years) . The patient medical history was not reported. The patient received the first dose of BNT162B2 vaccine on 14Mar2021. The patient's concomitant medications were not reported. The patient experienced ringing and buzzing in ears and head on 06Apr2021 08:00 with outcome of not recovered , insomnia on 06Apr2021 08:00 with outcome of not recovered , high blood pressure on 06Apr2021 08:00 with outcome of not recovered. All the reported events were considered Important Medical Events. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 22Apr2021 Nasal Swab. The patient received prednison and zolpidem (AMBIEN) as a results of the event. Information on Lot/Batch number was available. Additional information has been requested.
42 2021-05-10 pallor, blood glucose increased Patient became diaphoretic, weak and pale. Blood sugar 254, B/P-134/85, P-62, O2 SAT-96% on room air... Read more
Patient became diaphoretic, weak and pale. Blood sugar 254, B/P-134/85, P-62, O2 SAT-96% on room air. Assisted patient to floor and elevated legs. Patient stated, "I'm ok." Wife present and stated, "He has done this before but he didn't do this with his first shot." Patient vomited once. Staff called EMS. Patient refused to go to the hospital. Wife drove patient home.
42 2021-05-11 cerebrovascular accident Stroke; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patie... Read more
Stroke; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0151), via an unspecified route of administration, administered in Arm Right on 13Apr2021 12:30 as 2nd dose, single for COVID-19 immunization in a pharmacy/drugstore. Medical history included allergies: sulfa from unspecified date. Concomitant medications included hydrochlorothiazide and metoprolol succinate (TOPROL) both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (Lot number: ER8727) on 22Mar2021 9:00 AM at 42 years of age in the right arm for COVID-19 immunization. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. On 25Apr2021 18:00 the patient had a stroke. The event required emergency room and physician's office visit and the patient was hospitalized for 1 day. The patient was treated with unspecified blood thinners. The outcome of the event was recovering.
42 2021-05-12 hypertension 20 mins after I gave him the vaccine, the patient blood pressure went high 142/90 and his pulse wa... Read more
20 mins after I gave him the vaccine, the patient blood pressure went high 142/90 and his pulse was 126. The patient was alert and oriented. He was stable. I kept checking his blood pressure every 15 -20 min until the pulse came down to 100. He was ok ,and went home with his wife. I called him this morning 05/13 and his blood pressure is now 120/80.
42 2021-05-12 fainting syncope
42 2021-05-13 chest discomfort Fever and chills: Night of 6May thru mid day 8 May Body Aches: 7May thru 8May Headache: 7May thru 8M... Read more
Fever and chills: Night of 6May thru mid day 8 May Body Aches: 7May thru 8May Headache: 7May thru 8May Chest tightness: 9May - still ongoing)
42 2021-05-13 heart rate increased 1) Rapid heartbeat, multiple incidences in the days after vaccination. No treatment, still in proces... Read more
1) Rapid heartbeat, multiple incidences in the days after vaccination. No treatment, still in process of experiencing these incidents. 2) Tinnitus
42 2021-05-13 pulmonary embolism Blood clots in lungs (PE).
42 2021-05-15 chest pain pain in the bones of the left arm and leg and chest persistent for 9 days so far, an e.k.g. was done... Read more
pain in the bones of the left arm and leg and chest persistent for 9 days so far, an e.k.g. was done showed abnormalities not seen in previous e.k.g. done about 2 weeks prior further testing has been set up echo an stress and ultrasound of the leg .
42 2021-05-17 nosebleed After receiving my second Pfizer Covid Vaccine shot last week (11-May-2021), I suffered nose bleed (... Read more
After receiving my second Pfizer Covid Vaccine shot last week (11-May-2021), I suffered nose bleed (left nose) on Saturday morning (15-May-2021) and didn't think much about it. This continued Sunday (16-May-2021), Monday (17-May-2021) and also today Tuesday afternoon (18-May-2021). The amount of bleeding increased significantly through to today and the last 3 times I noticed bleeding in the back of my throat. And I initially tried applying pressure to the nose section and now it is taking more than 15 - 20 minutes for this to stop. I am very concerned and will be contacting my Primary physician as soon as possible. Actually I had 2 other instances of nose bleeds after the first shot (14-Apr-2021) but I brushed it aside thinking it was due to cold weather or irritation from picking. I have not had nose bleeds prior to this event. I did not have any fever or chills from both vaccinations other than the sore left arm so this was not weighing my mind much. However, now I am concerned at the adverse events following Pfizer Covid vaccination shots.
42 2021-05-17 increased heart rate, deep vein blood clot, hypertension, blood glucose increased Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) sever... Read more
Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) several weeks ago. Pt states that after receiving his 2nd dose on 05/06, he noticed his leg stiffness got significantly worse. He tells me that he tried to "push through the pain" and mow his lawn but had to stop d/t severe cramping of the LLE and pelvis. He states he rested his leg and went to bed, and when he woke up he noticed that his left leg was severely swollen. Pt decided to take 3 days off work to continue to rest the leg, but ultimately came in for evaluation at the suggestion of his coworkers. Pt denies fever, chills, chest pain, or SOB. He denies history of smoking, prior clotting, long car travel, air travel, leg injury, or recent surgery. On exam, the left lower extremity is significantly swollen, erythematous, and hot to the touch. Physical exam otherwise unremarkable. Will admit to the hospitalist service for further medical management. ED Course: Hypertensive with BP 170/93. Initial workup significant for WBC 13, K 3.3, glucose 159. CT chest/a/p with findings suggestive of multiple PE's of the left and right lower lobes as well as extensive LLE DVT extending slightly into the IVC. Trop <0.03. BNP 66. ECG shows sinus tachycardia.
42 2021-05-19 chest discomfort Fever, tightness in chest, loss of energy, difficulty breathing
42 2021-05-19 loss of consciousness About 5 minutes AFTER RECIEVING THE PFIZER VACCINE 1ST DOSE, THE PATIENT STARTED TO SWEAT, FELT DIZZ... Read more
About 5 minutes AFTER RECIEVING THE PFIZER VACCINE 1ST DOSE, THE PATIENT STARTED TO SWEAT, FELT DIZZY AS HE SAT IN HIS CHAIR & PASSED OUT FOR 5-10 SECONDS... CAME BACK GAIN CONSCIENCE AS THE PERSON NEAR BY TAP HIM HIS SHOULDER & ASK IF HE WAS OK. SHE CAME TO GET ME & I GAVE THE PATIENT SOME WATER TO SIP A LITTLE WATER. HE SAID HE FEELS BETTER THAT HE'S OK, HAD NO SHORTNESS OF BREATH. I TOLD HIM I WILL CHECK ON HIM IN A FEW MINUTES AGAIN. A FEW MINUTES LATER, HE DECIDED TO GET UP SUDDENLY FELL TO THE FLOOR. 911 WAS CALLED & FRONT STORE SUPERVISER & I MONITOR UNTIL AMBULANCE CAME FOR HIM. PT JUST FELT WEAK, BUT O SHORTNESS OR BREATH . I HAD THE PATIENT STAYED LYING DOWN ON ONE SIDE, SO AIRWAY IS NOT BLOCKED. A CUSTOMER HELP TALK TO HIM TO MAKE SURE HE STAY CONSCIENCE UNTIL AMBULNACE ARRIVED & TOOK OVER.
42 2021-05-19 fainting, loss of consciousness, heart rate decreased, blood pressure decreased Within 10 minutes i felt clammy and light headed. I passed out in my chair. I awoke moments later ... Read more
Within 10 minutes i felt clammy and light headed. I passed out in my chair. I awoke moments later to fellow patients and staff tending to me. They attempted to move me to a place to lay down. I immediately passed out again trying to stand. I woke up covered in sweat lying flat on the concrete. Staff and customers did not let me fall so no trauma. They called an ambulance. My bp dropped fo 88/50 in the ambulance with a pulse as low as 36bpm. Chills and uncontrollable shivers started about 30 minutes in and lasted for 2 hours. By 3pm I felt better. 2 bags of IV, chest x-ray, and blood work showed everything normal. Home now and will update my report if anything changes. Feeling much better as of 7pm. I belive they called it normal Sinus rhythm with sinus arrythmia
42 2021-05-20 blood pressure increased Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild na... Read more
Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild nausea. Within an hour started having trouble with focusing his vision. Was given IV fluids at hospital in ER 5 hours after the injection, while leaving the hospital developed a slight limp on right leg Felt feverish when he got home, took Tylenol when he got home. Noted extreme fatigue. The next morning was lethargic, dizzy and right side of face felt heavy, around 11 am. Called for a telemedicine visit around 12:30p. Became weak and unable to use right side of body, upper and lower extremities and right side of face was drooping, visible to wife. Wife had support of right side of body to move around. Went to urgent care around 2p. During urgent care evaluation, his vision became more impaired and speech became unclear, had to really focus to speak. Transferred to ER. Lost ability to write name, couldn't respond when asked for SSN. Admitted as a "stroke 4". Had CT scan, CT angiogram, MRI, blood labs, cognitive tests, neurologic tests. Neurology consult. Had lost sensation to heat and pressure. All imaging and labs were normal. After MRI, had convulsions. Wasn't dx'd as a seizure. Neck felt tight afterwards. Admitted to hospital x 1 week. Had a burning, red, rash on hands, feet. No bumps, hives, but just a "splotchy" red discoloration on surface of skin that would burn and itch, often flaring at night. Rx'd ativan. Checked for autoimmune disease, Bell's palsy, followed by neurologists, repeat MRI normal. Started to improve, discharged after one week with no clear diagnosis. Discharged to rehab facility. Patient preferred to transfer care to outpatient rehab service closer to home with more social support. Repeat hospitalized 3 weeks later, less extreme, went back to ER, stroke eval neg. Developed more aphasia. Called back to ER for further evaluation of C-spine due to mild abnormality on first scan. On further evaluation not thought to be connected to symptoms. EEG report pending. +Right hemiplegia, aphasia persists. +Rash, itching, burning persist.
42 2021-05-20 chest pain Having long covid since May 2020, my lingering symptoms have been fatigue, shortness of breath, ches... Read more
Having long covid since May 2020, my lingering symptoms have been fatigue, shortness of breath, chest pain, loss of taste. All were subsiding and have come back since the first injection and have not abated for 2 weeks. Fatigue is particularly intense in the morning, loss of taste is now constant.
42 2021-05-22 chest discomfort, chest pain I woke up from sleeping with one big cough. I felt chest pressure and some pain, trouble breathing, ... Read more
I woke up from sleeping with one big cough. I felt chest pressure and some pain, trouble breathing, nausea but did not vomit. My wife called 911 and I was admitted to the hospital.
42 2021-05-22 chest discomfort, inflammation of the heart muscle, heart attack, troponin increased, heart attack - Uncomfortable feeling in chest around 8pm on 4/24, tried to sleep it off - Couldn't sleep very wel... Read more
- Uncomfortable feeling in chest around 8pm on 4/24, tried to sleep it off - Couldn't sleep very well, and woke up with a tightness of chest and unable to draw a full breath - Went to county ER and was advised I was suffering a heart attack (non stemi) (troponin levels were over 7,000) - transferred to hospital for further diagnosis and treatment - Had a echocardiogram, cardiac catheridisation and MRI, which found that I had inflammation of my heart muscles - treated symptoms with medication and was discharged after an overnight stay
42 2021-05-25 pulmonary embolism 3 pulmonary embolisms; he started having really bad headaches; he was complaining of the back of his... Read more
3 pulmonary embolisms; he started having really bad headaches; he was complaining of the back of his leg hurting; his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0172, Expiration Date 31Aug2021) via an unspecified route of administration, on 28Apr2021 at 09:00 (at the age of 42-years-old) as a single dose in the left "shoulder" for COVID-19 immunization. The patient's medical history and concomitant medications were denied (reported as "He has no medical conditions and does not take any regular medications"). The patient did not receive any other vaccinations within four weeks prior to the vaccine. The reporter says she is reporting on behalf of her husband with regard to the Pfizer COVID vaccination. She just wanted to report that her husband got the first shot 28Apr2021 and Friday 07May2021 he was admitted to the hospital with 3 pulmonary embolisms. When asked when the pulmonary embolism began she says the week before the hospitalization, so the week he actually got the first dose, he was complaining of the back of his leg hurting, in the upper calf area. She says it was either the day after the shot or the next day that he said his leg hurt but he did not think too much about it and it resolved after a couple days and then Wednesday, 05 May 2021 he started getting discomfort in his left upper quadrant, she clarifies his abdomen and rib cage area, and he started having really bad headaches Thursday that continued and during the night Thursday night his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as he had the severe headache so the doctor told him to go to the ER. The patient experienced three pulmonary embolisms on an unspecified date with outcome of not recovered. The patient was hospitalized for 3 pulmonary embolisms from 07May2021 to 08May2021. He also started having really bad headaches on an unspecified date with outcome of unknown and he was complaining of the back of his leg hurting on an unspecified date with outcome of recovered, his left shoulder started bothering him and it was radiating from his shoulder up to his chin on an unspecified date with outcome of unknown. The reporter commented that she and her husband wanted to report this because of the timing of getting the shot and they are waiting now to go see his primary care they are supposed to be calling to set up an appointment because he is supposed to be having the second dose 19May2021 so they do not know what is going to happen. Therapeutic measures were taken as a result of pulmonary embolism and included Eliquis which he would be on for at least 3 months.
42 2021-05-27 blood glucose increased He got his vaccine, his arm was a little bit sore. The next day he was unbelievably tired, wiped ou... Read more
He got his vaccine, his arm was a little bit sore. The next day he was unbelievably tired, wiped out at around 1:00 He also had a headache and also his blood sugar was elevated quite a bit, in the high 200's. Normal BS's are from 35-150. This lasted for approximately 8-9 hours after that, and was back to his normal self by 9-10:00 PM. He has done well since.
42 2021-05-27 chest pain 1st day - very sore arm of injection, dizziness, and fatigue. 2nd day - very sore arm, dizziness, e... Read more
1st day - very sore arm of injection, dizziness, and fatigue. 2nd day - very sore arm, dizziness, extreme muscle fatigue, headache, nauseous, shortness of breath, and chest pains radiating to my left shoulder/arm. At one point late in the evening of the 2nd day after the vaccine, I considered calling for medical assistnce. I was unable to sleep well for the first 3 days after the vaccine. 3rd day - sore arm, dizziness, extreme muscle fatigue, neck pain, headache, and nauseous. 4th day - fatigued and somewhat dizzy from time to time.
42 2021-05-31 brain sinus blood clot, blood clot in the brain This is not very clear that the Pfizer vaccine is actually the cause of the patient's Cerebral throm... Read more
This is not very clear that the Pfizer vaccine is actually the cause of the patient's Cerebral thrombosis, however, we are reporting to VAERS as this is a unique first case where the patient has Dural venous thrombosis within 2 weeks period of getting 2nd dose of Pfizer vaccine. 05/25/2021: CT HEAD/BRAIN W/ IV CONTRAST showed dural venous sinus thrombosis involving the superior sagittal sinus, right transverse, and sigmoid sinuses, extending into the proximal right internal jugular vein.
42 2021-05-31 palpitations Patient received vaccine at 14 days after first dose rather than at 21 days after first dose. Patien... Read more
Patient received vaccine at 14 days after first dose rather than at 21 days after first dose. Patient reported that he experienced left sided body muscle aches/spasms, fatigue, neck pain and visual disturbances on 5/29/21. Stated his heart felt like it was racing for a short time but it may also have been anxiety because he knew his dose was given early. Symptoms resolved by 5/30/21.
42 2021-06-01 chest discomfort, chest pain After injecting the second dose, on the 5th day I was getting to work, I went up some stairs and I n... Read more
After injecting the second dose, on the 5th day I was getting to work, I went up some stairs and I noticed a mild pain in the middle of my chest and a bit of fatigue. After eight days the pain has decreased, although it goes from the right side to the left side and towards the middle of my back. I am no longer tired but from time to time I feel a burning or discomfort in my chest and I have not gone to a doctor to examine it, since the pain is mild I would like you to tell me if this is a case of normal mild side effects or if I require urgent medical attention.
42 2021-06-01 pallor Patient was given has second dose of Pfizer. He did not have any reactions with his first dose. He f... Read more
Patient was given has second dose of Pfizer. He did not have any reactions with his first dose. He felt dizzy, nauseous and had a stomachache. He was also feeling hot and complained of feeling a tingling sensation in his fingers. This was a few minutes after the vaccine was given and he was sitting at the post-immunization area. We directed him to sit on the floor and gave him 2 cold packs to put on his neck. Patient looked pale and weak so we also gave him some cold water. After a few minutes of sitting, he asked for us to call 911. We called 911 and alerted management. After paramedics came, patient was taken away. Patient seemed to be doing fine as he was leaving. He regained color in his lips, but was still feeling the other symptoms.
42 2021-06-06 blood glucose increased Blood glucose elevated an average of 20-30 mg/dL
42 2021-06-06 palpitations "I feel short of breath, palpitations and I feel dizzy." RN put Client supine in gravity chair. RN ... Read more
"I feel short of breath, palpitations and I feel dizzy." RN put Client supine in gravity chair. RN provided juice and a protein bar. After 3 minutes, Client stated, "I feel better now, they symptoms are gone."
42 2021-06-09 chest discomfort, heart rate irregular, fast heart rate 3/21/21 - SVT event with easy exercise (2 weeks afer first vaccine) 3/23/21 - worst SVT event of lif... Read more
3/21/21 - SVT event with easy exercise (2 weeks afer first vaccine) 3/23/21 - worst SVT event of life with intense exercise. stopped exercising 4/12/21 - PVC 4 a minute never had them before. irregular rythm. feeling heart irritation (2 weeks after second dose) 4/25/21 - continues heart inflamation issues pvc's, rythm issues, chest tighteness, complete uncomfortableness 5/14/21 - after 3 weeks of absolute hell worst feeling of my life with my heart inflamation/irritation. test not showing anything I started 600mg of Ibuprofen 3 times a day. 5/18/21 - Cardiac MRI but most irritation was going away after ibuprophen 5/25/21 - EP study and SVT ablation. most issue had subsided before the proceedure from ibuprophen 6/5/21 - inflamation symptoms returned. possible due to proceedure 6/9/21 - 600mb ibuprohen 3x a day started again. conidtion starting to improve again I was running 40 miles a week for over 4 years with no issues. This all blew up shortly after starting vaccination and has been the most horrible experience of my life by far!
42 2021-06-10 chest discomfort Chest tightness
42 2021-06-10 heart attack Heart Attack on May 9th
42 2021-06-12 heart rate increased, oxygen saturation decreased Rapid resting heart beat, low O2 level, fever, chills, body aches and fatigue from 1 am to ongoing.
42 2021-06-12 hypotension Within 5 minutes very sleepy, 5-10 min nausea and fever with chills sweat. Loss of vision and dissy.... Read more
Within 5 minutes very sleepy, 5-10 min nausea and fever with chills sweat. Loss of vision and dissy. Medical staff checked and found skin changed color and very low blood pressure. After 25 minutes symptoms started going away.
42 2021-06-17 hypertension I had elevated level. I get feedback term but it appeared that my liver that is been stressed.; Bod... Read more
I had elevated level. I get feedback term but it appeared that my liver that is been stressed.; Body aches in my legs and more over back; Body aches in my legs and more over back; Body aches in my legs and more over back; Prolonged headache for about 2 weeks; Fatigue of head; Sore arm at the injection site; At my second ER visit they told me I had something called the bell's palsy; after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension; I have history of hypertension but it was under control prior to the taking vaccination."; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 intramuscular, administered in Arm Right on 29May2021 14:00 as (At the age of 42-years) 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. It was reported that patient had history of hypertension, but it was under control prior to the taking vaccination. Concomitant medication included hydrochlorothiazide taken at a dose of 50 mg once per day for hypertension; amlodipine taken at a dose of 5 mg once per day for High blood pressure. Patient did not take any vaccination 4 weeks prior to covid-19 vaccine. It was reported that patient have experienced side effects after taking the first covid vaccination and he visited the ER two times. Reportedly, after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension. He had a prolonged headache for about 2 weeks. Patient experienced fatigue of head, body aches in his legs and more over back. He had sore arm at the injection site and at his second ER visit they said that he had something called the bell's palsy. It was reported that when he went to ER they perform blood tests and COVID test which tested negative. It was reported that he visited his doctor, primary care physician, he ran another lab and he had elevated level. He got feedback term, but it appeared that his liver that was been stressed. It was reported that patient was not treated for liver, he was only treated for the hypertension, for the headache and body ache he was taking ibuprofen over the counter, ibuprofen and the hospital prescribed for the bell's palsy, there are three different medication here valacyclovir, its 1-gram tablet and he take 3 per day. Prednisone, its 20 mg tablet 3 times per day, Erythromycin. The patient underwent lab tests and procedures which included blood test, covid-19: negative, liver function test increased: elevated level on unspecified date. Reporter seriousness for the events was Unspecified. Patient did not got his vaccination card yet as he was not fully vaccinated. The outcome of events was unknown. Follow-up attempts are needed. Information on the lot/batch number has been requested.
42 2021-06-17 lightheadedness Nearly passed out; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-... Read more
Nearly passed out; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in right arm at the age of 42-year-old on 03Jun2021 (Batch/Lot Number: ER8736) as single dose for COVID-19 immunisation. Medical history included None. There were no concomitant medications. The patient experienced nearly passed out on 03Jun2021. As reported as follows: Transferring agent stated, "I have the caller on the line. The reason for this transfer is because he nearly passed out after receiving the first Covid vaccine about 2 hours ago and he wants to know if he should take the second vaccination and if this vaccination card that he received from his first vaccination will be valid for him to get the second one." When paraphrased the concern, consumer stated, "Yes that was half of my question. I wanted to consult with my physician but it is a little late in the day today, so I couldn't get a hold of him after I received it. But I am pretty sure that the second dose probably will not necessarily have this circumstances now, am I correct?" The patient underwent lab tests and procedures which included laboratory test: unknown results in May2021 (3 weeks ago). Not received treatment for the event. The outcome of event was unknown.
42 2021-06-18 inflammation of the pericardium Pericarditis; This is a spontaneous report from a contactable consumer (patient). A 42-years-old mal... Read more
Pericarditis; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 08:00 (Lot Number: EN6260) age at vaccination 42 years as 1ST DOSE, SINGLE for covid-19 immunization. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were none. The patient experienced pericarditis on 30Mar2021 02:00. The patient was hospitalized for pericarditis for 3 days. Event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. Patient received anti-inflammatory mesicarions to treat pericarditis. The patient underwent lab tests and procedures which included Both nasal and blood test: negative on 30Mar2021. The outcome was recovered.
42 2021-06-23 hypertension, heart rate increased Heart rate speed up to over 180 beats a minute. Fatigue. Out of breath. Felt horrible for two d... Read more
Heart rate speed up to over 180 beats a minute. Fatigue. Out of breath. Felt horrible for two days prior to ending up in hospital for heart.
42 2021-06-24 palpitations, atrial fibrillation, blood pressure increased, heart rate increased Pt states 04/11/2021 groggy, fatigued. May 5th high grade fever for 3 days continuing, ER visit with... Read more
Pt states 04/11/2021 groggy, fatigued. May 5th high grade fever for 3 days continuing, ER visit with Negative Covid-19 test. Antibiotic prescribed and sent home. 04/17/2021 HBP, high pulse rate, A-fib, 06/11/2021 admitted into ICU for a week with palpations. Discharged 06/16/2021. Sent home with recommendation for follow up with Cardiologist. Currently in A-fib, July 7th appt. set to decide how to correct heart A-fibrillation.
42 2021-06-25 chest discomfort, chest pain Chest pain/tightness
42 2021-06-25 hypertension I've had to increase dosage on my blood pressure meds since vaccination AND I've had to add another ... Read more
I've had to increase dosage on my blood pressure meds since vaccination AND I've had to add another BP med, and still my blood pressure is not controlled; This is a spontaneous report from a contactable consumer. This 42-year-old male consumer (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6208), via an unspecified route of administration on 11Mar2021 at 17:00 hours (at the age of 42-years-old) in right arm as dose 2, single for COVID-19 immunization. Medical history of the patient included HIV infection, aortic valve disease, hypertension (start date and ongoing status unknown). The patient's concomitant medications were not reported. It was mentioned that the patient received other vaccines on 11Mar2021. He did not get other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination, had not been tested for COVID-19 since the vaccination, had no known allergies. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: E19266) via an unspecified route of administration on 18Feb2021 (at the age of 42-years-old) in right arm as dose 1, single for COVID-19 immunization. On 12Mar2021 , patient experienced and had to increase dosage on my blood pressure meds since vaccination and he had to add another BP med, and still his blood pressure was not con-trolled. he believe the correlation might be the vaccine along with his pre-existing heart disease. A bi cuspid aortic valve. Patient had attended doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Congenital anomaly or birth defect. Patient had received treatment for the event as Increase dosage of BP meds and additional BP med a. The Device timestamp was12Jun2021. Outcome of event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
42 2021-06-28 chest discomfort Diarrhea, Chest Discomfort, Tiredness
42 2021-06-28 chest pain Severe pain in left arm and chest. Labored breathing. Cold sweats.
42 2021-07-01 haemoglobin decreased, platelet count decreased generally feeling unwell with weakness, body aches, headache since 2nd vaccine on 6/9/21 dizziness s... Read more
generally feeling unwell with weakness, body aches, headache since 2nd vaccine on 6/9/21 dizziness started 7/1/21. presented to ED on 7/2/21 and found to have low Hgb, elevated liver enzymes
42 2021-07-01 heart rate decreased, chest pain On June 08 I started to have a cardiac episode with severe chest pain, low heart rate, and lighthead... Read more
On June 08 I started to have a cardiac episode with severe chest pain, low heart rate, and lightheadedness. I walked to the ER from my office where an EKG was performed and my heart rate was 47. My blood was tested and my troponin levels were 47. I was given aspirin and waited for 11 hours to be seen before going home and arranging through work to see a cardiologist on Thursday, June 10th. I was given a heart monitor and an Angiogram was ordered. The angiogram came back clear. No blockages and no calcium build-up. An Echocarido was done and shows minimal tricuspid regurgitation. Prior to June 8th, I've never had heart issues. My physical fitness is good. My average resting heart rate is in the upper 50's or lower 60's normally. Now the week following my cardiac episode walking half a mile my heart rate was 125 to 175 where it would normally not be above 90. Over the past 3-weeks I've had less chest pain, my heart rate has risen back to normal levels and my walking heart rate is now in the 90's
42 2021-07-05 pallor, hypotension Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: T... Read more
Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: 10 minutes after receiving vaccine patient experienced shakiness, tingling, weakness, sweating and appeared pale. Checked blood pressure initial reading 96/68. Second BP taken 15 minutes later BP 107/72. Pulse stable at 68 BPM. Patient stayed 35min for oberservation and seemed to feel much better when he left. Water provided to patient.
42 2021-07-05 palpitations, ischemic chest pain Heart Palpitations; severe Angina was completely out of the norms; Heart Palpitations; severe Angina... Read more
Heart Palpitations; severe Angina was completely out of the norms; Heart Palpitations; severe Angina was completely out of the norms; Kidney Problem; This is a spontaneous report from a contactable consumer. A 42-year- old male patient received BNT162B2 (sPFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot no: EW0183), via unspecified route as dose 1, single, on on 18Jun2021 for COVID-19 immunisation.The patient had had Covid in Feb2020 and he sustained at the time that he had really severe kidney pain. The patient concomitant medication was not reported. On 18June2021, the patient stated that Within 3 hours of vaccination, he experienced heart palpitations raised, severe Angina because that completely out of the norms for him and he never had a heart problem that kind of result and he was in the Emergency Room of the Hospital The patient was out of the Emergency Room by 10 o clock (18Jun2021) but now he has same kidney problem that he had half and Year ago, severe kidney pain. He had been experiencing that kidney issue all over again. When probed for any treatment for the problems (events), reporter stated, The local Hospital said to take Ibuprofen, lots of water and bed rest but he has not taken anything yet and also on Pedialyte Electrolyte. He was released from the Hospital at 10 o clock on 18Jun2021 because the heart palpitations and severe Angina resolved itself over about the period of about 4 hours. The outcome of events kidney pain was reported as unknown. No follow-up attempts are possible. No further information is expected.
42 2021-07-07 pallor PT WALKED UP OBS NURSE TO REPORT FEELING DIZZY AND LIGHT HEADED. PT LOOKED PALE. LOWER PT TO THE F... Read more
PT WALKED UP OBS NURSE TO REPORT FEELING DIZZY AND LIGHT HEADED. PT LOOKED PALE. LOWER PT TO THE FLOOR KEPT PT IN OBSERVATION FOR EXTRA TIME/ UNTIL PT VOICE AND DISPLAY THAT SYMPTOMS RESIDES.
42 2021-07-08 chest discomfort, fast heart rate Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightnes... Read more
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: patient describes shakiness, anxiety, swelling under and around arm, and pain. Reports taking 600 mg ibuprofen on tues and wed (600 mg po bid on Tues and Wed) "went away a bit and came back a little bit"
42 2021-07-09 chest discomfort 2nd day after final dose woke up with severe vertigo. Lasted for 5 days. Since then have had inc... Read more
2nd day after final dose woke up with severe vertigo. Lasted for 5 days. Since then have had increasing chest discomfort and muscle spasms. Left shoulder and arm still hurt 2 and a half weeks after dose.
42 2021-07-09 heart rate irregular, blood pressure increased Rather intense headache and fatigue night of vaccination, but that was expected. Since then (from d... Read more
Rather intense headache and fatigue night of vaccination, but that was expected. Since then (from day 2 up till now), persistent headache (dull at the back of the head), neck and shoulder ache. Very annoying and makes it difficult to think and/or concentrate. Also having strange inflammation (both in the head and cardiac) and erratic heartbeat, likely contributing to increased blood pressure.
42 2021-07-09 fainting SYNCOPE WITHIN 5 MINUTES OF VACCINATION, LASTED LESS THAN A MINUTE. PATIENT WAS ABLE TO PROCEED OUT ... Read more
SYNCOPE WITHIN 5 MINUTES OF VACCINATION, LASTED LESS THAN A MINUTE. PATIENT WAS ABLE TO PROCEED OUT OF THE PHARMACY ON HIS OWN. NO TREATMENT NECESSARY.
42 2021-07-14 chest pain Two weeks after second dose I started experiencing pain in my right hand and muscle twitching. By we... Read more
Two weeks after second dose I started experiencing pain in my right hand and muscle twitching. By week 3 the pain began in my left hand and wrist. By June 22nd, I began having severe hand and wrist pain, numbness and tingling in my fingers toes, left pain in my forearm that is sensitive to touch. On June 30th, I had to go to ER due to chest pain and severe night sweats. On July 8th, I developed Shingles. As of today, July 15th, I am experiencing debilitating pain in my hands, wrists and am still recovering from Shingles.
42 2021-07-15 sinus rhythm Burning pain in the middle of my chest along with shortness of breath. Pain spreads from my chest t... Read more
Burning pain in the middle of my chest along with shortness of breath. Pain spreads from my chest to my right arm and makes the muscles in my right arm sore.
42 2021-07-17 chest pain, inflammation of the heart muscle Myocarditis; Chest pain; high fever; Inflamed lymph nodes; This is a spontaneous report from a conta... Read more
Myocarditis; Chest pain; high fever; Inflamed lymph nodes; This is a spontaneous report from a contactable other hcp.A male patient of 43 years old received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 26Jan2021 13:00 (Batch/Lot Number: EL3249) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included splenectomy from 1995 to an unknown date, mildly high cholesterol.He gets the Pneumovax because he is immunocompromised and gets kind of sick feeling. He gets it every 5 years and does get a fever afterwards; he got the Flu vaccine in Sep2020 or early Oct2020.he got the Flu vaccine in Sep2020 or early Oct2020.The patient's concomitant medications were not reported. Patient previously received the first dose of bnt162b2 on 05Jan2021 for covid-19 immunization. The patient experienced myocarditis in Mar2021 with outcome of recovered, high fever on 27Jan2021 with outcome of recovered, inflamed lymph nodes on 27Jan2021 with outcome of recovering, chest pain in Mar2021 with outcome of unknown. Stated that he received his 2nd dose on 26Jan2021 and had really inflamed lymph nodes and a very high fever. He didn't have chest pain until 4-6 weeks later; around Mar2021. Stated that his lymph nodes were really inflamed for about 2 months after the 2nd dose. They were so inflamed that he said he had a hard time turning his head. States that the other day he was saying that his lymph nodes were still inflamed. He had a very high fever for about 2 days. States this was concerning because they were told that if he had a high fever he would need antibiotics right away because of his splenectomy. He was having chest pain every night when he laid down, but then it got severe, and normally he doesn't complain of anything. He went to the doctor the next day and had an EKG and blood work. Caller states that she doesn't remember the date this occurred, only that it was probably sometime in Mar2021. States that they weren't worried about anything on the EKG, and he had mildly high cholesterol. His doctor put him on Lipitor and Prilosec OTC, but now they are questioning whether he needs to be on them. Stated that about a month later it came out that myocarditis was a side effect of the vaccine. When they read the symptoms they realized that's what he had because every symptom matched, but at the time the doctor didn't know to be looking for that.Stated that the symptoms have gradually gone away. The patient underwent lab tests and procedures which included blood test: unknown, electrocardiogram: unknown. Therapeutic measures were taken as a result of myocarditis, chest pain. The causality between BNT162B2 and Inflamed lymph nodes, high fever was related.
42 2021-07-18 heart flutter, palpitations Headache, body aches, fever/chills, injection site soreness, muscle aches, joint pain, heart flutter... Read more
Headache, body aches, fever/chills, injection site soreness, muscle aches, joint pain, heart flutters/palpitations .
42 2021-07-18 chest pain I had a shape left chest pain that lasted for almost 2 weeks starting in the first week of June. The... Read more
I had a shape left chest pain that lasted for almost 2 weeks starting in the first week of June. The pain started to ease and now I feel it every now and then. I talked to my doctor this morning and he recommended I do the heart echo and report this here.
42 2021-07-21 chest pain I started with left sided chest pain, which was worse when I was laying down or taking deep breaths.... Read more
I started with left sided chest pain, which was worse when I was laying down or taking deep breaths. I was out of the county when I experience it. We came home early. Motrin helped a little. I keep getting worse I went to my doctor, and they did an x-ray and EKG which both came back normal. Those were done on May 20th. By the 23rd I couldn't walk with chest pain. The cardiologist did a scan of my heart, and they found a small left sided pleural effusion. They still do not know why I have that pleural effusion. They check my labs which I had a small elevated inflammatory lab. Over the next few days after that it went way, and I was able to go back to my normal activities. I have not had problems since.
42 2021-07-27 chest discomfort, atrial fibrillation, inflammation of the pericardium, fluid around the heart, inflammation of the heart muscle, chest pain New onset atrial fibrillation; Myocarditis/inflammation of the heart; pericardial effusion/he had a ... Read more
New onset atrial fibrillation; Myocarditis/inflammation of the heart; pericardial effusion/he had a significant amount of inflammation and fluid around the heart; pericarditis; Tightness of chest; He went in for difficulty breathing; very tired; chest pain; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer sponsored program. A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 42 years on an unspecified date (Batch/Lot number was not reported) at 14:00 as single dose for covid-19 immunisation. Medical history was none. No family medical history relevant to AEs. There were no concomitant medications. The patient experienced new onset atrial fibrillation (AFib) since 27Apr2021 and hospitalized form 29Apr2021, myocarditis/ Inflammation of heart (2021), pericarditis (2021), and pericardial effusion (2021) after receiving second dose of the Pfizer BioNTech Covid-19 Vaccine. Patient sought medical treatment and was hospitalized twice, the first time being 29Apr2021. The patient was still dealing with issues and went into hospital 27Apr2021 (as reported). Since then, he has been going back and forth to hospital and was admitted twice for the same issues. He was diagnosed with Afib and inflammation of the heart. Reporter just wanted to know who needs to talk to because it seemed to be vaccine related. Patient has had to take time off of work and reporter has had to take time off work to take care of him. Patient stayed a week for the first AFib hospitalization. He got out of the hospital (2021) and was at home for a week. That Friday, he went back and was hospitalized for another week (2021). That admission was for both AFib and inflammation of the heart. They saw the inflammation the first time, but it was not a lot and said it was probably normal because of the AFib. When he went back for follow up, he had a significant amount of inflammation and fluid around the heart (2021). He was still dealing with it. He had another issue with going to ER and this was Friday before last. He went in for difficulty breathing (2021) and was told he had more fluid around the heart. He was not admitted for that one. They gave him more medication to control the fluid. Reporter later stated it was prednisone and she did not have a dose, lot or expiration. She then said the dose was increased after he went for follow up and had more fluid. The first time patient was taken to the emergency they could not find anything and the next day, she (reporter) called 911 from her home and saw that he was experiencing some cardiac issues and saw that he was admitted and told he had AFIB. When she called 911 from her home, they transported by ambulance to (#) Hospital in (#), (#) and that was when he admitted and diagnosed with AFIB. Since # was out of their network, he was transferred to # that same evening or day to # and he was there about a week. Then he was released after a week and still had a hard time breathing and walking a few steps with trying to catch his breath and had chest pain and was very tired (2021). Then he went to a follow up that Friday after being released. Unknown doctor in (#) and then he was readmitted at the follow up appointment to #. He was in the hospital for a week that time as well. He was discharged and they prescribed him medication and then he came back home on medication and he has been on several medications. The one to reduce inflammation, starts with a P and she cannot remember name. He finished it and went to a follow up. After he finished medication, he was experiencing side effects (2021) such as chest pain, difficulty breathing and tightness of chest. She then remembered it was Prednisone that he was on, unknown dose, and it is in pharmacy vial with no lot or expiration. There was no seal, and count size is unknown. He no longer has any left. He went to the ER in (#) because he was experiencing the same symptoms. They saw more fluid collecting and put him on the same medication but a higher dosage of Prednisone. This dose is 10mg, 4 tablets by mouth daily. It was also in a pharmacy vial with no lot or expiration. This was where he was now. He has been out of work and so has reporter. The patient had MRI, XRays, Echo, Blood Test and was still doing blood test (in 2021). He has to go back this week. Everything came back as unknown for what caused this. The outcome of events myocarditis/ Inflammation of heart and AFib was recovered/resolved with sequel in 2021, of other events was unknown. Information on the lot/ batch number has been requested.
42 2021-07-27 chest pain, arrhythmia All issues are still present to this day: Fatigue, lethargic, Brain fog, mild Vertigo, hands and le... Read more
All issues are still present to this day: Fatigue, lethargic, Brain fog, mild Vertigo, hands and leg numbness (feels like they are asleep), out of breath, can't think of simple words or statements, forgetting what I am doing in the middle of a process (simple stuff), heart arrhythmia.
42 2021-07-27 nosebleed Bloody nose. Have not had one in years; This is spontaneous report from contactable consumer or othe... Read more
Bloody nose. Have not had one in years; This is spontaneous report from contactable consumer or other non-HCP (patient). A 42-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 21May2021 (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 vaccine, via an unspecified route on an unspecified date (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included Claritine (Loratadine). Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, the patient experienced Bloody nose. Have not had one in years. No treatment was received. The outcome of the event was recovered on an unspecified date May2021. Information on the lot/batch number has been requested.
42 2021-07-27 heart rate increased Tired; Not wheezing but breathing fast; Heart beat was pumping; This is a spontaneous report from a ... Read more
Tired; Not wheezing but breathing fast; Heart beat was pumping; This is a spontaneous report from a contactable consumer. This 42-year-old male consumer (patient) reported. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 as dose 1, 0.3 ml single for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. It was reported that the patient got some kind of side effect that's why he was calling to record. He was in bed and he could feel his heartbeat was pumping (on06May2021) after that day in the evening until Saturday night between 08May2021 and 09May2021. On 10May2021 in the morning he felt normal. . After the first dose, for two days he was so tired (on 07May2021). He saw that it was one of the side effects. The patient also experienced not wheezing but breathing fast on 07May2021 after his first dose. The patient asked if he could take the second dose or not. Someone in his family was a doctor and he said to call that number to see if anyone had the symptoms. The patient did not want medication, he wanted to know if he should move to second dose or not. On 10May2021, the events were resolved. No follow up attempts are needed. No further information is expected.
43 2021-01-03 blood pressure increased, heart rate increased 10 min after injection, my mouth started getting hot, then it moved down my throat and it was diffic... Read more
10 min after injection, my mouth started getting hot, then it moved down my throat and it was difficult and painful to swallow. I got quite dizzy. They initiated rapid response, when they came they simply monitored symptoms and Vitals. Blood pressure and Heart rate were elevated. after about 10 min the symptoms eased, but swallowing was still difficult and slightly painful. then a second wave of dizziness hit me and I nearly passed out. my heart rate was elevated once again and had ringing in ears. these symptoms lasted another 5-10 min then eased. I then had a headache. The symptoms didn't return, just a headache and fatigue the rest of the day. i was then given option to go to ED, which i didn't feel at that time I needed, so I left. The next day, i had some standard symptoms of pain in left arm from injection, and fatigue, but then toward the evening i developed a fever of 101 deg F than continued for a couple of hours. I used ibuprofen and Tylenol rotating to keep the fever down. On day 3 only mild fatigue.
43 2021-01-04 chest discomfort Client started c/o headache, tightness in chest, and was anxious. He was helped out of his truck and... Read more
Client started c/o headache, tightness in chest, and was anxious. He was helped out of his truck and taken to triage where they administer o2 4Liters via nasal cannula. He self administered his albuterol inhaler. He admits to having anxiety issues. He was monitored for 20 mins and no other problems arose and he felt better after that. He has had no other problems related to the vaccine since that occasion. He did not contact his doctor.
43 2021-01-07 palpitations Palpitations facial warmth Narrative:
43 2021-01-12 heart rate increased, heart rate irregular heart is racing; face felt hot; irregular heartbeat; This is a spontaneous report from a contactable... Read more
heart is racing; face felt hot; irregular heartbeat; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left shoulder on 06Jan2021 at a single dose for covid-19 protection. Medical history included with irregular heartbeat (diagnosed years ago). There were no concomitant medications. The patient stated that his heart was racing. He was sleeping and woke up to heart racing 130-140. He had irregular heartbeat and his face felt hot the morning of 07Jan2021. He did not know if it was his heart, nerves or what. was his first dose. He got the vaccine on his job and stated that sometimes his heartrate goes up and down not to this magnitude and not while sleeping. He had asked one of the nurses during vaccination about having irregular heartbeat and taking the vaccine and was told that one could die of much worst than this. Patient wanted to know if he should go to the doctor and what to do. Outcome of the event heart racing was recovering while for face felt hot was recovered on the same day of 07Jan2021, and for the remaining event was unknown. Information on the lot/batch number has been requested.
43 2021-01-19 heart rate increased A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i ... Read more
A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i noticed that my heart rate would increase when walking around and that the heart beat felt heavy. If i was lying down the heart rate would be slightly elevated compared to normal resting heart rate. The heart rate beat felt heavy. I went to bed early and slept through the night. I woke up the next morning and felt fatigued, dizzy, slight body ache and nauseated. no fever, no headache. i tried to take a shower but symptoms got worse. i was unable to go to work that day. I took a few naps during the day and by late afternoon most symptoms where going away. the last symptom was the issue with the hands and feet. Heart rate returned to normal. The next day i was able to return to work.
43 2021-01-20 heart rate increased, palpitations About 4 hours after injection. My heart started to race and it progressively increased to the point... Read more
About 4 hours after injection. My heart started to race and it progressively increased to the point where the resting rate was anywhere from 130-160 beats per minute. When I would move it would increase to the 180s. As of today, the 21st, my resting heart rate has decreased to the 100s and when I move it increases to the 110s.
43 2021-01-30 chest discomfort Erythema to upper chest, diffuse bibasilar diminished breast sounds with subjective chest tightness ... Read more
Erythema to upper chest, diffuse bibasilar diminished breast sounds with subjective chest tightness requiring diphenhydramine IM once and albuterol nebulized treatment once with complete resolution of symptoms.
43 2021-02-02 loss of consciousness I had some sort of reaction. I was glad to get the shot and was not nervous about getting the shot.... Read more
I had some sort of reaction. I was glad to get the shot and was not nervous about getting the shot. 5 minutes after the shot I felt something cold go down my left arm from my shoulder to my hand. A minute or two after that both my hands went numb, then both my arms went numb. I asked others around me if anyone felt anything and everyone else was fine. A minute or two after that both my legs went numb. I started to black out but made it to a chair before this happened, I drank some cold water and felt awake about 5 minutes later. 30 minutes after that i felt comfortable enough to walk. For the rest of the day i felt like i was legally drunk and felt lots of pins and needles on the back of my hands and feet. I did not feel dizzy or nauseous at that time. i also felt a lot of pressure on the inside of my skin all over my body. I've never felt anything like that and it was a bit uncomfortable. The next day i was too dizzy to walk without becoming very nauseous. I still had pins and needles on my feet. i had chills as well which i guess is a good sign. my appetite was fine. i felt clear-headed as well. Two days after the shot i felt slightly dizzy and by the third day i felt fine except for minor muscle cramps all over my body. For the three days after the shot i also had some pretty strong forearm and calf muscle cramps and my arms (biceps and triceps) felt pumped up like i just had a great arm workout, but they weren't swollen at all.
43 2021-02-04 pallor, fainting, loss of consciousness Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal respo... Read more
Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal response (previous history of syncope with vaccinations/procedures). Patient received 1st dose of Pfizer vaccine around 11am today. Within 2 minutes of receiving the vaccine, he started to feel dizzy and passed out for around 45 secs. He had cold extremities, looked pale and was sweating. He was immediately transferred from chair to floor and his legs were raised. Cold towel was placed on his head. He regained consciousness but was confused for less than a 1min. Vitals were checked and his BP was 95/50's and HR was around 56. Pulse O2 was 99% during entire event. He was able to converse well after that and was oriented. He informed having anxiety/panic attacks, had taken his medication that morning. He reported similar syncopal episodes in the past. He was monitored in same posture. He was gently hydrated orally with water and soda. He was given sublingual zofran due to nausea and retching. He did not vomit. We continued to monitor his BP on regular intervals. He had slow improvement in BP and after 2 hrs while sitting his BP was 104/65, pulse 56/min (reports being an athlete and previous records show baseline bradycardia). He denied any symptoms and was awake, alert, oriented. As he was not accompanied by anyone, his wife was contacted who came to clinic in 10mins and helped to drive him home. He was transported by wheelchair till entrance of clinic. He reported feeling better and thanked for helping. He does not have any contraindications to receive 2nd dose of vaccine.
43 2021-02-08 pallor Approx 10-15 minutes after the shot client started c/o severe nausea and did vomit. He was sweating,... Read more
Approx 10-15 minutes after the shot client started c/o severe nausea and did vomit. He was sweating, and c/o throat tightening, was pale and still nauseated. Benadryl 50 mg Im given. His brother in law was called to drive him home. After he was stable, and no longer c/o any symptoms he was release to his brother-in=law. He says he went home and slept 3 hours and then slept til noon the next day which is not normal for him.
43 2021-02-10 fainting s/p first injection c/o feeling faint, dizzy, and pressure above eyes
43 2021-02-11 loss of consciousness Woke up the next morning feeling a little weak, muscle soreness, and slight sore throat. About 30 mi... Read more
Woke up the next morning feeling a little weak, muscle soreness, and slight sore throat. About 30 minutes after waking up I passed out and fell while taking a shower. I have no history of passing out for any reason and have had no side effects with any other prior vaccinations.
43 2021-02-12 blood glucose increased I noticed on Thursday and Friday that my blood sugar levels were elevated. I didn't eat anything unu... Read more
I noticed on Thursday and Friday that my blood sugar levels were elevated. I didn't eat anything unusual and my increased blood sugars did not respond to my insulin as I would expect. The highest my blood sugar got to was 250. Wasn't a huge deal and today is Saturday and my blood sugar is back to normal.
43 2021-02-17 heart rate decreased Vomiting. He anxiety with symptom vomiting. Heart rate decreased as relax sat in lobby away from pe... Read more
Vomiting. He anxiety with symptom vomiting. Heart rate decreased as relax sat in lobby away from people and felt better went home
43 2021-02-20 blood pressure increased, heart rate increased Lips went numb, partial tongue numbness, spread to the face, elevated blood pressure 180/130, elevat... Read more
Lips went numb, partial tongue numbness, spread to the face, elevated blood pressure 180/130, elevated heart rate 131 at its highest.
43 2021-02-22 hypertension Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Hypertension-Medium, ... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Hypertension-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
43 2021-02-23 blood pressure increased, chest discomfort Woke up at 4 am on 01/31/2021 with muffled hearing and numbness on left side of body. BP increased t... Read more
Woke up at 4 am on 01/31/2021 with muffled hearing and numbness on left side of body. BP increased to 150/100. Vomiting and diarrhea. Went to ER on 02/01/2021 and had MRI of the brain to check for stroke/TIA. Had an EKG and carotid artery scan. All tests came back normal. Continued to have neuropathy only on the left side of the body since 01/31/21. Pain travels from nerve to nerve. Occasional HA with pain only on the left side of the head. Cold tightness in chest. Seen PCP numerous times and had bloodwork done, Symptoms have continued since onset on 01/31/21 with no increase or decrease in severity. PCP has referred him to a neurologist.
43 2021-02-24 loss of consciousness Pt reported before shot that has had history in past of fainting after vaccinations. After receivin... Read more
Pt reported before shot that has had history in past of fainting after vaccinations. After receiving the shot, had him sit in a chair next to the table for a few minutes to see if would occur again. After about 2 minutes, pt began reporting that he felt that he was about to faint again. He began to dry heave and passed out momentarily for 2 seconds before coming back to. Pharmacist caught him before he fell. Gave pt water and took blood pressure. Patient began to feel better. Sat for 30 minutes and then he felt fine to leave.
43 2021-02-25 heart rate increased Pt reported increased HR, anxiety, and sweaty.
43 2021-02-28 hypotension, pallor Pt received their second dose of the vaccine in a recliner from a physical therapist at approximatel... Read more
Pt received their second dose of the vaccine in a recliner from a physical therapist at approximately 08:50am. Pt reported Hx of vasal vagal response with shots in general. A RN took over monitoring the pt. The pt reported feeling light headed. Vitals were obtained and showed the patient was hypotensive. The team lead was notified and 911 was called. Pt vitals were obtained frequently, water was provided, and feet were elevated. EMS arrived at 09:07 and took over. Pt refused EMS care and went home after waiting an additional 10 minutes.
43 2021-03-02 heart rate increased, chest discomfort After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensati... Read more
After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensation done both arms and my tounge. My heart was beating fast and I was struggling to get my breathing under control. My throat also got tight or warm and that feeling seem to go down through my chest. The monitor told me to take off my mask and gave me water. Shortly after I started to gag and almost vomited. The monitor checked my blood pressure and it was 180 over 120. I was admitted to the ER. I stayed there for about an 90 minutes as was released as the symptoms seemed to leave. While driving home many of the symptoms resurfaced. When I returned home I took a zyrtec and an anxiety medication. A day after I am light headed and a little nautilus but otherwise ok.
43 2021-03-02 fainting, pallor Patient found on ground by bystander. Patient responsive, alert and oriented. States does not know w... Read more
Patient found on ground by bystander. Patient responsive, alert and oriented. States does not know what happened. Patient stood and sat in chair. A few seconds later patient had syncopal episode and nursing staff assisted him to the ground. BLS provided, airway maintained. Patient pale, diaphoretic and clammy. BP 110/60, P 51, O2 98%, T 96.3. Monitored until EMS arrived. Paramedics on scene. Vitals BP 89/60, P 67, O2 100%, Blood sugar 81. Patient taken to hospital via ambulance.
43 2021-03-04 heart rate increased Increase heart rate indicated by Apple Watch. Highest recorded was 148 BPM and it slowly decreased ... Read more
Increase heart rate indicated by Apple Watch. Highest recorded was 148 BPM and it slowly decreased over a period of 3 hours back to normal. No other issues noticed at the time such as shortness of breath, chest pains, dizziness, etc.
43 2021-03-04 loss of consciousness Per patient, left site feeling fine, after being monitored for 15 minutes per protocol. Claims he fe... Read more
Per patient, left site feeling fine, after being monitored for 15 minutes per protocol. Claims he felt light headed, nervous, and blacked out and hit a car in front of him. Per client, he was taken to the hospital and all tests came back clear. He later walked to another mini pod and reported the incident to them.
43 2021-03-05 loss of consciousness Light headed followed by losing consciousness for about a minute. Then nausea and throwing up. Fat... Read more
Light headed followed by losing consciousness for about a minute. Then nausea and throwing up. Fatigue rest of the day.
43 2021-03-10 chest discomfort, palpitations Patient experiencing shortness of breath, on Friday 3/5 heart beating real hard, felt weak, fatigue,... Read more
Patient experiencing shortness of breath, on Friday 3/5 heart beating real hard, felt weak, fatigue, lasted about 15 minutes, called ems went to ed, was given prednisone, calmed down, helped with inflammation but still lethargic, chest pressure, and pain, stomach pain, feels like a weight and pressure in chest, feels like sinus infection in head, mucus in them morning was red and thick, also having night sweats
43 2021-03-11 loss of consciousness, pallor Patient passed out immediately , pale Patient regained consciousness within a minute. No further is... Read more
Patient passed out immediately , pale Patient regained consciousness within a minute. No further issues.
43 2021-03-11 pallor Pt. looked pale & sweating, RN asked if he was okay, stated he felt like he was going to pass out. ... Read more
Pt. looked pale & sweating, RN asked if he was okay, stated he felt like he was going to pass out. Pt clampy and sweating. HR 47, Osat 97%. Pt had difficulty breathing with conversation. @1354 Lowered to the floor to lay flat. 1355 BP 101/62, HR 78, O2Sat 98%. @ 1403 BP 100/68, O2Sat 96%, HR 79, pt sitting. @ 1405 pt states "feels ok now" Sitting on the floor 1410 HR 85, O2Sat 94%, Pt remained talkative, alert & oriented sitting on the floor until 14:32. Pt standing 1433 "feels fine" alert and oriented x 3. Pt discharged 14:42. HR 82, Osat 98%
43 2021-03-15 blood pressure increased Became very dizzy within moments after administration. Sudden onset. Reported to attending medical... Read more
Became very dizzy within moments after administration. Sudden onset. Reported to attending medical staff who held me for evaluation. During evaluation BP was found to be elevated (160 or 180+/100+ approximately (don't recall exact numbers). Within an hour subsided enough for me to return to work, and dizziness subsided over the next several days. Similar reaction to booster dose on 2/16/21; less acute but dizziness continues 1 month later. Severity is not debilitating at this time.
43 2021-03-17 blood pressure decreased @ 0830, Mr. Started complained of feeling chills, and burry vision. Upon assessment, patient was dia... Read more
@ 0830, Mr. Started complained of feeling chills, and burry vision. Upon assessment, patient was diaphoresis, minimum tremors, AO x 4 time, place, date and situation. VS taken @ 0830 BP 56/38, HR 65, O2 sat 98%. Patient was offered water to drink and wet towel was applied to front head. Another set of VS was taken @ 0837 with BP 92/50. 911 was called @ 0850 and AMR (department #338) arrived @ 0855. Patient was assessed by medic, 12 leads EKG was done NSR. Patient denied transfer to the hospital. Medic left @0900 after explaining to the patient the risks and need to go to the hospital. Patient called his wife. Wife came at 0903. Patient was assessed, no complains of dizziness, was able to walk steadily, before leaving with wife @ 0905.
43 2021-03-19 heart rate increased Body aches, fever (+/- 101°), back ache, chills, severe headache, slightly elevated heart rate, fat... Read more
Body aches, fever (+/- 101°), back ache, chills, severe headache, slightly elevated heart rate, fatigue. Symptoms lasted approximately 24+ hours. Moderate to severe arm soreness at site of vaccination for >36 hours and continuing
43 2021-03-20 blood clot I had experience of muscle cramps of left calf muscle in Feb / march and observed 3-4 times over a ... Read more
I had experience of muscle cramps of left calf muscle in Feb / march and observed 3-4 times over a period of 2 months . I was thinking that could be due to dehydration . On 03/ 14 /21 morning , I got severe left leg pain and could not able to walk. I took pain killers and did not subside and that end up going to hospital emergency . I was diagnosed with 2 blood clots in left leg . I do not have family history of clots nor any h/o major medical issues . All my previous and recent blood reports normal . I am currently in use of blood thinners
43 2021-03-21 chest discomfort, palpitations, heart rate increased Heart palpitations. Chest discomfort and tightness, elevated pulse rate
43 2021-03-21 loss of consciousness Passed out 9 hours after injection on 03Mar2021; This is a spontaneous report from a contactable con... Read more
Passed out 9 hours after injection on 03Mar2021; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 03Mar2021 18:00 (Batch/Lot number was not reported) as SINGLE DOSE, and dose 1 via an unspecified route of administration, administered in Arm Right on 10Feb2021 18:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient experienced passed out 9 hours after injection/also reported as 03Mar2021 03:30. The outcome of the event was recovering. The patient did not receive treatment for the event. Information on the Lot/Batch number has been requested.
43 2021-03-24 heart rate increased High Fever (102 versus normal of 96), high heart rate (135 to 150 for 12 hours at rest including sle... Read more
High Fever (102 versus normal of 96), high heart rate (135 to 150 for 12 hours at rest including sleeping), chills, and tiredness. I went to the emergency room to get it checked out. Received Toradol for headache, ice pack and IV fluids. Heart rate reduced to 100 and temperature down to 97. HR elevated throughout Sunday (80 to 100 at rest) I was symptom free from AS with Enbrel treatment, but after adverse event severe inflammation in chest and upper left quadrant. Restarted enbrel use but flair up worse than anything seen throughout 8 week cessation of Enbrel usage.
43 2021-03-24 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patie... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient experienced syncope briefly he thinks due to sudden drop in blood pressure but recovered within minutes.
43 2021-03-25 fast heart rate That evening had tachycardia symptoms and trichina symptoms (about 12 hours after vaccine). I had fa... Read more
That evening had tachycardia symptoms and trichina symptoms (about 12 hours after vaccine). I had fatigue and headache the following morning. Severe myalgias - in the epigastric cisternal area and in the back of my shoulder blades. 36 hours later - low grade temperature. At 48 hours I felt normal. Eye - 10 days later (vaccine) - I noticed a visual deficit in the left eye along with a line and the following day - on the 17th, I saw my ophthalmologist - left branch retinal vein occlusion. Since then I've had an Forestine Angiogram: and a video of my retina - branch retina arterial occlusion - so they are having trouble telling the difference between the two. I still am being followed for my eye. They did a carotid ultrasound - my carotids are fine. I am due to get an echo cardiogram. I am taking baby aspirin mg for now - not sure if it's helping or not. It takes a year and a half to go away.
43 2021-03-28 chest discomfort 3/13/21 - 3:00 PM. LEFT EAR ACHE 5:00 PM. ARM HURT WHERE I GOT THE SHOT. TOOK 2 ADVIL 9:00 PM. HEA... Read more
3/13/21 - 3:00 PM. LEFT EAR ACHE 5:00 PM. ARM HURT WHERE I GOT THE SHOT. TOOK 2 ADVIL 9:00 PM. HEAD AND THROAT ACHE 10:00 PM. CHILLS AND SWEATS 12:00 PM. EYES WATERING 3/14/21 THROUGHOUT THE DAY. SWEATS AND CHILLS, WATERING EYES, HEADACHE, FATIGUE TOOK 2 TYLENOL EVERY 4 HOURS 3/15/21 8:00 AM - SLIGHT WATERY EYES. 9:00 AM - UPPER LIP BEGAN TO SWELL, TOOK TWO ALEVE 10:00 AM. UPPER LIP COMPLETLY SWOLLEN AND ON FIRE. TOOK 2 BENADRYL 11:00 AM. FATIGUE 12:00 PM. CHEST BEGAN TO TIGHTEN AND SHORTNESS OF BREATHE, TOOK 2 BENADRYL 4:00 PM. TIGHTNESS OF CHEST AND BREATHING WORSENED 4:30 PM. WENT TO EMERGENCY ROOM. 3/16/21 - 3/20/21. FATIGUE, SWELLING OF UPPER LIP, TIGHTNESS OF CHEST, SHORTNESS OF BREATHE 3/22/21 - PRESENT. TIGHTNESS OF CHEST, SHORNESS OF BREATHE
43 2021-03-29 very slow heart rate, fainting Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Syncope-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Bradycardia
43 2021-03-30 heart attack Myocardial infarction
43 2021-03-30 deep vein blood clot, pulmonary embolism, fainting, loss of consciousness Patient reports he has noticed over the past week increased shortness of breath on exertion--at base... Read more
Patient reports he has noticed over the past week increased shortness of breath on exertion--at baseline able to exercise with walking 45-60 minutes without dyspnea, however noticed over the last week getting some shortness of breath even walking to the garage. No chest pain, no fevers, chills, cough. He saw his PCP for these symptoms who ordered EKG and CXR 1 day PTA which per patient were normal--plan was for referral to cardiologist. However on the morning on presentation around 6:45 AM after taking an elevator for work he began feeling lightheaded and lost consciousness, awakening on the floor. He went home as he was not feeling well however proceeded to have another 2-3 episodes of loss of consciousness at home witnessed by his girlfriend--the later 2 occurred while lying down and were not clearly associated with any presyncopal symptoms.
43 2021-03-31 chest discomfort skin was burning itchy and red; skin was burning itchy and red; sunburn; trouble breathing; tongue s... Read more
skin was burning itchy and red; skin was burning itchy and red; sunburn; trouble breathing; tongue swelling and discoloring; tongue swelling and discoloring/ he saw that his tongue was dark chocolate like he had just eaten a black licorice; felt like breaking out in hives/chest was beat red was referring to hives; chest started to get broken out and got beat red; allergic reaction; got beat red; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the first dose of BNT162B2 (BNT162B2, lot number: EP6955), via an unspecified route of administration in the left arm, on 15Mar2021 3:00 PM (received at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included Attention deficit disorder, cholesterol, benign heart palpitations. He also had a previous reaction to insect bites and followed up with an allergist. He went over a decade ago for the insect bite, they gave him epinephrine at the urgent care and said to call or come back if it worsened. The next morning, his symptoms from the insect bite were worse and the urgent care told caller to go to the ED (emergency department). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from an unspecified date and ongoing for Attention deficit disorder; metoprolol from an unspecified date and ongoing for benign heart palpitations; simvastatin from an unspecified date and ongoing for cholesterol; vitamins and minerals; ubiquinol from an unspecified date and ongoing; fish oil from an unspecified date and ongoing. The patient previously had a flu shot in Aug2020. The patient previously took epinephrine and experienced insect bite were worse, and metoprolol and experienced reaction linger. The stated he thought he had an allergic reaction to the Pfizer covid19 vaccine on 15Mar2021. He states that his tongue was swollen (15 min after receiving the vaccine, at 03:15 PM), he broke out into hives. He was in the restroom of the facility where he received the vaccine and that he did not have hives yet after getting the vaccine, but then asked the nurse if he could take Benadryl and was told yes. He states they then let him go because he had no trouble breathing at that time. He drove home and was going to reroute to hospitals if needed. He took 50 mg fast melt Benadryl as soon as walked out of the facility. He drank water, drank two larger bottles of water. His chest started to get broken out and got beat red. He took another 25 mg of Benadryl and then drove home. He then proceeded with Benadryl 50 mg every 6 hours. At 1 AM, the next morning (16Mar2021), he woke up with trouble breathing and tongue swelling and went to ER. They gave him Prednisone 60 mg and then started on 5 days of prednisone. They told him to continue Benadryl, and water and to follow up at hospital if worsens and to follow up with his physician. He stated that he had a previous reaction to insect bites and followed up with an allergist. He went over a decade ago for the insect bite, they gave him epinephrine at the urgent care and said to call or come back if it worsened. The next morning, his symptoms from the insect bite were worse and the urgent care told caller to go to the ED. He added that this experience with the Covid19 vaccine was milder comparatively as they gave him just steroids and not epinephrine this time, and, they told him he was not having trouble breathing this time. Last night, 16Mar2021, at around 10:30 pm, a half hour before next dose of 6 hour Benadryl was due, his skin was burning itchy and red so he took Benadryl a half hour early and set alarm to wake up before next dose. He woke up 4 hours later and waited to see if he would have a reaction and he has not taken it since. He took the morning dose of Prednisone with improvement and is carrying Benadryl in his pocket just in case. He later clarified that he took his 11 o'clock dose last night and then set a 2:30 am alarm to see if it was worse again or about the same. Regarding the allergic reaction, he first noticed around 3 pm Monday 15Mar2021. Within 15 minutes after the vaccine, he was going through his phone and thought he felt strange while waiting at (Name) after the vaccine to see if he had a reaction. This feeling continued until 11 pm last night, 16Mar2021. He took 50 mg of Benadryl when this first happened on 15Mar2021 and then took another 25 mg 15 minutes after the first initial dose. At the time of call, he notices no redness or itchiness or swelling of the tongue. He feels like he is going in the right direction. He noticed tongue swollen within 15 minutes of receiving the vaccine and that it was also discolored (15Mar2021 15:15) and asked a friend who has allergic reactions if this happens and the friend told him that it sometimes happens to other people with allergic reactions. He went to the ER on Tuesday 16Mar2021 at 3 am, exactly 12 hours after he received his shot, because of the swelling of the tongue. This was his first-time experiencing difficulty breathing and gasping for air as well. States that he does not have it now. Prednisone and Benadryl have knocked it out. He was not admitted and was released from the ER about an hour and a half after he got there (discharged at 4:30 am from the ER). He did notice at 3:30 pm that his chest was beat red. He was hanging out and his body would tell him when it was close to 6 hours that he needed to take Benadryl because he would be breaking out in hives. He has to take Benedryl within 6 hours. This is ongoing but he has not had any today. He clarifies that the chest was beat red was referring to hives. He felt yesterday 16Mar2021 that he had a sunburn and that his face was kind of red but he had not been in the sun. He clarified on timeline that he went to check for swelling and hives in bathroom after receiving the vaccine on 15Mar2021. At that time, he saw that his tongue was dark chocolate like he had just eaten a black licorice. There was no redness or anything but he felt like it was going to be occurring so he asked the facility if he could take Benadryl. He is scheduled for his second dose of the vaccine on 05Apr2021 and may be possibly returning but is not sure. He also noticed on Tuesday 16Mar2021 that while sleeping on the couch at 3 am he was going to take the next dose of Benadryl and woke up gasping for air. He got up to drink more water and took a shower and made coffee. Then, he went to the ER. He was really tired. He wanted to be alert to drive. It seemed like the water helped and he drank a lot of water. He did not want to take the next dose of Benadryl. He noticed that it did get better, and he did not want to stay home so he went to the ER. Outcome of the event allergic reaction was recovered with sequel on 16Mar2021. Outcome of swollen tongue, skin was burning itchy and red, got beat red and hives was recovering. Outcome of other events was unknown.
43 2021-04-01 pallor Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient turned pale. Color resumed a... Read more
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient turned pale. Color resumed after sitting for ~15 min. was okay when left the facility
43 2021-04-01 fainting Upon presentation to Tent 4, participant identified himself as being, "a big baby when it comes to n... Read more
Upon presentation to Tent 4, participant identified himself as being, "a big baby when it comes to needles". Received vaccine to LUE and was waiting in Obs area with son (who reported only being seated for approx 5 mins.). A loud noise was heard and participant was observed laying out prone on the floor. Clinicians assisted him to roll over where his eyes were red, wide-open gaze, and diaphoretic but was not responding to commands. After turning him to his Rgt side he began to sit up and became slightly combative and was able to be calmed down. Moved to Tent 6 to cot via wheelchair where is RUE BP was 180/100 at 11:09, and Lft radial pulse taken by MD was "60 and weak", Resp 16 and unlabored so no oxygen in use but nearby. Upon further assessment, participant repeatedly stated that, "he just did not feel well" and when probed, c/o frontal headache, nauseated (but did not vomit), and weak. Offered water to sip and by now lip no longer bleeding. When asked, "what did you feel prior to falling out of your seat?", he stated, "I just remember that you all were around me asking me questions...hence could not recall moments leading up to being found on the floor and no type of aura was identified as well. Reported a h/o HTN but did not take his medication today...other history is unremarkable. Ambulance arrival approx 11:13, VS taken, assessed and transported to nearest facility. Family returned and later reported that he sustained only a large "goose-egg" on the forehead and fat lip but otherwise was treated and released.
43 2021-04-01 fainting Patient developed signs of syncope within five minutes of receiving the second dose of the Phizer CO... Read more
Patient developed signs of syncope within five minutes of receiving the second dose of the Phizer COVID-19 vaccine. Patient stated he ate little that day and often has similar episodes after giving blood. The patient also stated a fear or needles and taking a look at the needle today caused anxiety.
43 2021-04-02 blood clot I have blood and blood clot in my urine.
43 2021-04-03 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: After patient had vaccine sat down, then felt light headed and broke out into a sweat. Pulse very shallow = 60bpm. Would get better than worse again. Called emt's, came w/i 15 minutes. Said had high bp, but on no meds. when emt's came he passed out and pulse down to 40bpm, emt's gave epinephrine. pulse back up to 60, put on stretcher, passed out again. Took to local hospital/ER
43 2021-04-04 heart rate increased Very fast heartbeat. Sweating hands And a light dizziness
43 2021-04-05 nosebleed intense fever, chills, nose bleeds, dizziness going on 4 days
43 2021-04-05 hypertension, chest discomfort On March 24 I got the first dose of the Pfizer COVID-19 vaccine and I experienced side effects almos... Read more
On March 24 I got the first dose of the Pfizer COVID-19 vaccine and I experienced side effects almost immediately. By the time I got to the resting/observation area I felt that the site of the injection got really warm and I became dizzy/lightheaded and started to feel heavy on the chest and little problem in swallowing and breathing. I was taken to the paramedics on site, they checked my blood pressure (which a little high 150/90), oxygenation, pulse, and EKG (which were normal). It did not became too bad after and was allowed to come back home. However, the heavy chest and swallowing problem lasted for three days. The heaviness in the chested turned into a sensation of feeling like my trachea or the anything under the sternum area was behind strangled. Although I felt like this my breathing and swallowing was almost normal. Every now and then when I swallowed I felt some pain but I could withstand it.
43 2021-04-05 lightheadedness, hypotension Client became dizzy and lightheaded in the observation area, "he was seeing stars". On exam, no evid... Read more
Client became dizzy and lightheaded in the observation area, "he was seeing stars". On exam, no evidence or symptoms of an allergic reaction. BP 70/50, O2 sat= 80%, Pulse=50. Skin= pasty gray. EMS was called due to low O2 sat and hypotension but client was not transported. No chest pain was reported. After 20 minutes, he felt better and BP responded to hydration with water. Skin color returned to normal. Wife drove client home. Client disclosed he recently lost 10lbs and though he was dehydrated. Advised to eat salty foods and drink lost of fluids. Assessment: vasovagal reaction secondary to vaccination, worsened by dehydration prior to clinic.
43 2021-04-07 very slow heart rate, hypotension, lightheadedness, fainting Within 15-minutes of vaccination, the patient experienced a syncopal event. EMS evaluated the patien... Read more
Within 15-minutes of vaccination, the patient experienced a syncopal event. EMS evaluated the patient on-site. The patient was hypotensive (54/31) and bradycardic (42bpm). EMS transferred the patient to Medical Center Emergency Department. In the ED, the patient reported a syncopal event that lasted 1-minute. Th patient was resting comfortably in no acute distress and reported feeling improved. Physician administered 1L IV normal saline. After noted improvement, the physician discharged the patient with diagnoses of Vaccine reaction and secondary Near syncope.
43 2021-04-07 heart rate increased, hypertension, chest pain I woke up at 2am, with a fever, flu like symptoms, and a bad headache. I took a nap from 8-10am tha... Read more
I woke up at 2am, with a fever, flu like symptoms, and a bad headache. I took a nap from 8-10am that morning and woke up at 10am with repeating, recurring chest pain every 2-3 minutes, the pain would only last a second then go away. My BP and pulse were very high. This all continued through out the day. I went to a walk-in urgent care clinic around 4PM, and then to the ER around 6PM.
43 2021-04-07 pallor, fainting Flush, faint, sweaty and pale
43 2021-04-07 fainting Patient has a history of fainting after vaccination. Had patient sit for awhile before releasing him... Read more
Patient has a history of fainting after vaccination. Had patient sit for awhile before releasing him to the recovery room. He informed the vaccinator he was fine and was released to the recovery room. Just about to sit down, fell over off chair to the left. Had patient lay on his back and elevated his feet. Checked BP several times 130/70 then 170/100 then 142/100 and finally 150/100. Pulse ox readings were 97 then 99 SpO2. Pulse was 90 and fell to 82. Patient was stable and had a friend give him a ride home.
43 2021-04-09 heart rate increased 44 y/o male presents for HA, fast heartbeat and L arm numbness/tingling 10 min. Pt has hypertension... Read more
44 y/o male presents for HA, fast heartbeat and L arm numbness/tingling 10 min. Pt has hypertension and DM2. BP 178/96, HR 105, o2 98% RA BP 156/85, HR 100, 02 98% RA Pt states he feels better and ready to go.
43 2021-04-10 palpitations Patient received vaccine at 1144a, left site, started feeling palpitation and drove back to site. M... Read more
Patient received vaccine at 1144a, left site, started feeling palpitation and drove back to site. MD assessed, O2 at 93%, O2 4L initiated by onsite Paramedics. Pt vomited and stated he feels dizzy and has SOB. Ambulance called, vitals taken: BP 159/96, HR 88, 98% 4L NC. Last taken BP was 133/66, patient stated he was feeling anxious, recommended to go to the hospital for further assessment. Patient was driven by his wife.
43 2021-04-11 chest discomfort Shortness of breath, tight chest, burning sensation in the eyes, significant fatigue, and joint pain... Read more
Shortness of breath, tight chest, burning sensation in the eyes, significant fatigue, and joint pain in all fingers, hands, knees, toes and neck.
43 2021-04-11 hypertension Hx of HTN, Baseline BP 140/90, did not take BP meds the night prior. Reported dizziness, BP 169/114 ... Read more
Hx of HTN, Baseline BP 140/90, did not take BP meds the night prior. Reported dizziness, BP 169/114 HR73 RR18, then second reading 153/109 HR83 RR18, left in stable condition
43 2021-04-11 heart attack Massive Heart Attack. Was given stent and Dr believed the injection possibly pushed me over the edge... Read more
Massive Heart Attack. Was given stent and Dr believed the injection possibly pushed me over the edge with blockage
43 2021-04-11 lightheadedness, pallor Patient received dose at 1:19pm walked to OBs area, sat in chair. Started texting, noted weakness, ... Read more
Patient received dose at 1:19pm walked to OBs area, sat in chair. Started texting, noted weakness, c/o sweaty feeling, alerted staff. Placed in WC, back to Med Eval tent where he was diaphoretic, pale. Did not lose consciousness. Patient admits to not eating or drinking today at all, very stressed about vaccine. Drank a bottle of water, and gatorade, fan for air circulation. Patient recovered well on cot in supine position, walked out without incident. Likely vasovagal response without syncope. NP
43 2021-04-13 chest pain, troponin increased, heart attack Cold sweats starting Thursday evening, Friday sweating at night, and Saturday morning ~6:00 am with ... Read more
Cold sweats starting Thursday evening, Friday sweating at night, and Saturday morning ~6:00 am with chest pain and sweats. Pain intensified and brought to Urgent Care at 8 am where an EKG was completed and showed signs of a heart attack. Was rushed to Hospital Emergency room. Admitted and examined. Completed an angiogram and noted that there was a blood clot that appeared to dissolve. Troponin levels were high showing damage to the left artery. Spent the night in the hospital. Prescribed medication for cholesterol, blood thinners, and seeing a cardiologist.
43 2021-04-13 pallor Nurse was called to check on a patient in the vaccination area. Patient was given his first dose of ... Read more
Nurse was called to check on a patient in the vaccination area. Patient was given his first dose of Covid vaccine . He immediately stated he needed to lay on the floor. Patient was diaphoretic and pale. P. McGrath RN obtained vitals: 112/68, HR 62, pulse ox 97% room air. Patient's wife stated he has these episodes all the time. Patient stated he felt fine and wanted to get up. Patient was assisted up. VS rechecked 112/80, HR 66, 98%. Patient was given water and escorted to the monitoring area. Patient was monitored for an additional 30 minutes without further incident
43 2021-04-14 hypertension 43 y/o male, past medical history of Hypertension (untreated) presents with numbness to the left ear... Read more
43 y/o male, past medical history of Hypertension (untreated) presents with numbness to the left ear, left neck and left upper arm shortly after vaccination. Vaccination site was the left deltoid. NP and Paramedics at side. Negative Stroke Scale. Vitals taken and patient noted to be hypertensive with BPs ranging between 145/94-166/114, all other vitals normal. Advised patient on the need to transport to the ER via Fire Rescue due to symptoms and bps. Fire rescue arrive on scene where patient refused transport. Patient signed our AMA form in addition to Fire Rescues AMA form. Patient left on his own account.----------------------End.
43 2021-04-14 pulmonary embolism, low blood oxigenation Bilateral pulmonary embolism which was diagnosed on 4/14/21 after 2 days of severe shortness of brea... Read more
Bilateral pulmonary embolism which was diagnosed on 4/14/21 after 2 days of severe shortness of breath. Associated with hypoxia requiring supplemental oxygen. Patient is morbidly obese which is only other risk factor for pulmonary embolism. He denies history of increased sedentary activity, denies recent travel, denies known history of a hypercoagulable disorder or family history of blood clots. No other causative factors for the pulmonary emboli have been identified.
43 2021-04-15 loss of consciousness, fainting Fainting. It was sudden onset, I felt fine for 24h after the injection (and had no side effects to t... Read more
Fainting. It was sudden onset, I felt fine for 24h after the injection (and had no side effects to the first dose), then felt very suddenly dizzy and lightheaded, then passed out for a few seconds. After I came to, I was able to quickly catch my breath and recover with no additional episodes. Beyond this, I had a mild fever but no other serious adverse effects.
43 2021-04-15 pallor Patient received COVID19 Pfizer BioNTech vaccination approximately 1:10p. After vaccination administ... Read more
Patient received COVID19 Pfizer BioNTech vaccination approximately 1:10p. After vaccination administering RPH requested patient wait for 15 minutes prior to leaving. Approximately 1:20p patient began to feel faint - lightheadness, clammy skin, and pale skin. RPH took pulse over 30 second time period and reported HR of 44. Patient was offered water and RPH assisted patient to lay on the floor with legs raised above head. Skin color slowly returned. Pulse was taken again and came back up to the low 90s. Patient laid on floor for 15 minutes prior to being assisted by RPH to sit in chair. Patient then sat in chair for approximately 10 minutes prior to feeling comfortable leaving. EMS was not called to scene. Patient stated that he had not eaten prior to vaccination. RPH counseled patient to eat prior to receiving second vaccine and to inform vaccinator prior to second dose of previous reaction.
43 2021-04-16 chest discomfort, heart rate increased One minute following the shot, began to experience rapidly increased heat and pressure from my chest... Read more
One minute following the shot, began to experience rapidly increased heat and pressure from my chest/breastbone area. Akin to having a heart attack with a feeling of a die pumped from a CAT scan. Sweating, dizziness, and rapid heart beat. Paramedics on site measured my vitals within 3 minutes and reported pulse over 100, BP at 160/100. This feeling gradually subsided over the next 15 minutes but the chest felt as if it was punched. Day 2 and day 3. Extreme fatigue and uncontrolled Heartburn. Was unable to quench heartburn that radiated through my neck, face, whole chest. Took 4000 mg of tums and Pepsid 20mg . Heartburn feeling persisted for 5-7 hours both days.
43 2021-04-17 blood pressure decreased, fainting Vasovagal syncope; Blood pressure drop - fainting; This is a spontaneous report received from a cont... Read more
Vasovagal syncope; Blood pressure drop - fainting; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP6955), via an unspecified route of administration on arm left on 31Mar2021 08:00 AM at single dose for COVID-19 immunization. The patient medical history included methylenetetrahydrofolate reductase gene mutation from an unknown date and unknown if ongoing , wolff-parkinson-white syndrome from an unknown date and unknown if ongoing , blood cholesterol increased from an unknown date and unknown if ongoing , gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient concomitant medications included omeprazole (ZEGERID [OMEPRAZOLE]) taken for an unspecified indication, start and stop date were not reported; ubidecarenone (COQ10 [UBIDECARENONE]) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported, fish oil, quatrefloic within 2 weeks of vaccination. The patient previously took ampicillin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 08:30 AM, the patient experienced Blood pressure drop, fainting, vasovagal syncope.The seriousness criteria of the events has not resulted in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The event was assessed as serious based on seriousness criteria. The patient did not receive any treatment for the events. The outcome of the events was unknown.
43 2021-04-17 inflammation of the heart muscle, troponin increased, chest pain Chest Pain as a Result of Elevated Troponin Levels Caused by Myocarditis; Chest Pain as a Result of ... Read more
Chest Pain as a Result of Elevated Troponin Levels Caused by Myocarditis; Chest Pain as a Result of Elevated Troponin Levels Caused by Myocarditis; Chest Pain as a Result of Elevated Troponin Levels Caused by Myocarditis; This is a spontaneous report from Pfizer Sponsored Patient Support Program. A contactable consumer (patient) reported for himself that a 43-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202), via an unspecified route of administration at the age of 43-year-old at arm left on 09Mar2021 14:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. The patient wasn't allergies to medications, food, or other products. Concomitant medications included metoprolol tartrate and vitamin D NOS. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6202) at left arm on 15Feb2021 6:00 PM for COVID-19 immunisation. The patient experienced chest pain as a result of elevated troponin levels caused by myocarditis on 27Mar2021 14:00. The events were serious for being hospitalized (duration 3 days). The adverse events result in Emergency room/department or urgent care. Facility where the most recent COVID-19 vaccine was administered in hospital. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests included nasal swab: negative on 29Mar2021. The patient was received treatment (Heparin, Nitroglycerin and Cardiac Catheterization) for events. The outcome of events was recovering.
43 2021-04-18 chest pain, chest discomfort received vaccine pfizer 4/18 reports cramping to forearms and calves; soreness to neck, shoulders, c... Read more
received vaccine pfizer 4/18 reports cramping to forearms and calves; soreness to neck, shoulders, chest. Used no meds to Tx. Denies SOB, flutters, palpitations. States his chest discomfort feels like muscle pain after lifting or a rigorous workout rather than cardiac in nature. Referred to ER
43 2021-04-18 loss of consciousness Patient presented with HR of 38 and BP was 90 palp. Loss of consciousness. HR returned to 60s . Pati... Read more
Patient presented with HR of 38 and BP was 90 palp. Loss of consciousness. HR returned to 60s . Patient refused transport.
43 2021-04-18 fainting Pfizer-BioNTech COVID-19 Vaccine EUA - About 10 minutes after receiving the first dose of the Pfizer... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - About 10 minutes after receiving the first dose of the Pfizer COVID-19 vaccine, pt complained of being dizzy and faint. Pt broke out in a sweat and complained of tingling down his left arm (site of administration was left deltoid) and into his fingers. Pt was instructed to lay down on his side and was given an ice pack to apply to his wrist for the sweating. He was also offered water and to call EMS, which was refused. At this time his blood pressure was checked reading, 102/63 pulse 62. Pt continued to be closely monitored for 30 minutes. During this time he was able verbalize symptoms and continued to complain of dizziness and generalized weakness. After 30 minutes pt sat up and waited an additional 15 minutes before he decided to stand up and at that time decided he was fit to leave. Another blood pressure reading was taken 110/64 pulse 67. He stated that a normal blood pressure reading for him was around 135mmHg systolic.
43 2021-04-19 pallor 1110: Alerted that we had a medical patient. 1111: At patient side to find the patient wa slouched ... Read more
1110: Alerted that we had a medical patient. 1111: At patient side to find the patient wa slouched over and having snoring respiration?s. The patient appeared pale and diaphoretic. 1112: Contacted Safety Supervisor and also contacting 911. 1113: The patient was seated upright to open airway and asked if he could wake up. Patient was breathing on his own, eyes open, but not tracking. The patient was not responding to painful stimuli. 2 person lift assist to get the patient off the chair and laying on the floor. The patient then had seizure like activity, arms clenched at his side. 10 second passed by, the patient having minimal postictal phase, and the patient immediately sat upright, asking what happened. The patient informed mobile crew that he started to feel hot and dizzy before he started to dream. Vitals taken: BP: 110/54, HR: 40, R: 18, SPO2: 99%, CBG: 108. 1116: Patient care transferred to paramedic unit to transport to closest hospital.
43 2021-04-19 superficial blood clot The same day, I was exhausted. It lasted 2 days. After that, on the 2nd or 3rd day after my shot, my... Read more
The same day, I was exhausted. It lasted 2 days. After that, on the 2nd or 3rd day after my shot, my right calf began to hurt. I knew it was connected to the vaccine, but I figured it would go away. Once the information came out about blood clots and my calf still hurt and didn't get better, I decided to go and get it checked out.
43 2021-04-20 blood pressure decreased, loss of consciousness passed out; body temperature rose fast; sweating; blood pressure and ECG went low; blood pressure an... Read more
passed out; body temperature rose fast; sweating; blood pressure and ECG went low; blood pressure and ECG went low; This is a spontaneous report received via COVAES from a non-contactable consumer (patient). A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, first dose via an unspecified route of administration, administered in right arm on 01Apr2021 10:00 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included allergies to penicillin. Concomitant medication(s) included diphenhydramine hcl. Side effects started about 4 minutes after getting the shot. At first, the body temperature rose fast, and patient started sweating. Then, patient passed out, and both blood pressure and ECG went low. Patient was sent to the emergency room and released a few hours later. AE resulted in Emergency room/department or urgent care. Treatment included fluids. No Covid prior vaccination. No Covid tested post vaccination. The event outcome for events was recovered. No follow-up attempts are possible. No further information is expected.
43 2021-04-20 loss of consciousness Patient given vaccine, was 10 minutes into the waiting period, passed out of his chair, appeared to ... Read more
Patient given vaccine, was 10 minutes into the waiting period, passed out of his chair, appeared to have a seizure. Myself and the RN on duty giving vaccines provided first aid to make sure breathing, heartbeat, etc. Kept airway open. He came out of it in about 3-4 minutes and was coherent before the paramedics arrived (6-7 minutes) and was conversing with us and the paramedics. They took him to the ambulance to be checked out.
43 2021-04-21 heart rate decreased, chest pain I had trouble after the shot, with a chronic headache that started a couple hours after the shot and... Read more
I had trouble after the shot, with a chronic headache that started a couple hours after the shot and wouldn?t break no matter what I took or did. I also had chest soreness and a reduced heart rate that started about 4 days after the second shot, which was similar to what I felt when I thought I had COVID in 2020 (my doctor denied my request to be tested and told me to just quarantine until my symptoms were gone for 48 hours). I tried everything to resolve my symptoms. I could get my heart rate up with vigorous exercise (mountain biking), and it would recover just fine, but the chest soreness and headache persisted. After a week, I called my doctor?s office to get in for an evaluation, thinking my thyroid medication needed adjustment. The doctor who saw me sent me to the ER because she had no answers as to the headache and very low heart rate, which kept dropping into the 30?s... normal is around 50 for me. She thought I could be having a heart attack. After 4 hours and a couple tests, the ER released me with no trouble found. I still had the headache, and slow heartrate with mild chest soreness. The headache subsided about 4 days later, and my heart rate returned to normal. The chest soreness continued for 4 weeks, and is still present, but slowly improving I think.
43 2021-04-22 blood glucose increased, platelet count decreased The next day after the second shot, my right foot got acute pain. I had some fatigue on my left fo... Read more
The next day after the second shot, my right foot got acute pain. I had some fatigue on my left foot on the day I took vaccine and I had got it examined by the doctor, He did. To find any issue on my left foot and suggested it might be a regular sprain. He also examined throughly the right foot and it was perfectly fine in the day time of vaccinations. The pain on right foot joints got so acute that I could not move out of my bed. I waited for two days hoping that the vaccine effect will go in couple of days.but it became unbearable. I saw my pcp and the blood work showed erratic inflammatory markers and unusable high glucose very low platelets and I was given steroid for six days. The inflammation was coming down when I was on med and bed rest, last Saturday my right heel started showing a new and sharp throbbing pain. I went the ortho and they found that possibly my burssaties sack is inflameated. The pain is so unbearable that I am, prescribed some opioid based pain killers, the PCP and hematologists had a discussion , I was told that I may be developing auto immune disorder. I never had a history of ITP. I am still hopi g it is a shock and body will calm down soon but I am on so much in pain and in a small place to get an immediate medical attention is so hard.
43 2021-04-23 pallor Post vaccination patient started to feel flushed, light headed and dizzy- Patient skin pale vitals T... Read more
Post vaccination patient started to feel flushed, light headed and dizzy- Patient skin pale vitals T 98.7, 113/56, HR51, B/S144, 02 96
43 2021-04-24 cardiac arrest Patient experienced a seizure resulting in cardiac arrest. Witnesses described patient "began convul... Read more
Patient experienced a seizure resulting in cardiac arrest. Witnesses described patient "began convulsing and then tipped over". AED applied with no shock advised. Unknown down time prior to initiation of CPR. Rhythm PEA upon arrival of EMS. 7 mins CPR before ROSC obtained. Initial troponin 12. 12 lead EKG without ischemic changes, arrhythmia, etc. Transthoracic echo without regional wall abnormalities or significant findings. CT of head negative for acute intracranial process. No history of seizure, cardiac issues, drug use, etc.
43 2021-04-24 inflammation of the heart muscle myocarditis; severe pain in my left shoulder, radiating down my left arm all the way to my fingertip... Read more
myocarditis; severe pain in my left shoulder, radiating down my left arm all the way to my fingertips; severe pain in my left shoulder, radiating down my left arm all the way to my fingertips; severe pain in my left shoulder, radiating down my left arm all the way to my fingertips; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration at the age of 43-years-old, administered in Arm Right on 26Mar2021 12:30 (Lot Number: EA8732) as single dose for COVID-19 immunization. Medical history included allergies, asthma, genetic predisposition to heart disease. Concomitant medication included unspecified medications. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 43-years-old, administered in Arm Right on 05Mar2021 12:30 (Lot Number: EN6199) as single dose for COVID-19 immunization. The patient reported, "I had severe pain in my left shoulder, radiating down my left arm all the way to my fingertips. The pain was severe enough to be admitted to a hospital, where they performed an angiogram and MRI, resulting in a myocarditis diagnosis. The doctors suspect that these symptoms may have been at least partially triggered by." The patient experienced myocarditis and severe pain in my left shoulder, radiating down my left arm all the way to my fingertips on 28Mar2021 18:00. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the events for 3 days. The patient underwent lab tests and procedures which included angiogram: myocarditis diagnosis on 28Mar2021, MRI: myocarditis diagnosis on 28Mar2021, SARS-CoV-2 test: negative on 02Mar2021. Therapeutic measures were taken as a result of the events which included Ibuprofen, Colchicizine, and Metoprolol. The outcome of the events was recovered/resolved with sequel on an unspecified date. No other vaccine in 4 weeks. Not diagnosed with COVID prior vaccination.
43 2021-04-24 fainting Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient was coherent after shot sat down passed out. Hit head trauma scrape on head and knees and called ems showed up 5 minutes took pt walking away.
43 2021-04-25 fainting, blood pressure increased, lightheadedness Pt. had a Syncopal episode post 10 from vaccination. Was lowered to floor without injury .Did not re... Read more
Pt. had a Syncopal episode post 10 from vaccination. Was lowered to floor without injury .Did not recover immediately . Became nauseous and shaky then began vomitting. Pt remained lightheaded and near syncopal whenever brought to a sitting position or standing position. Pt. refused Benadryl . Pt. admitted having nausea and diarrhea for past 1-2 days intractable vomitting 5 yrs ago Agreed to EMS transport to ED
43 2021-04-25 fainting painted fainted, woke up in under a minute, checked by EMS, refused to go to hospital because said ... Read more
painted fainted, woke up in under a minute, checked by EMS, refused to go to hospital because said was ok
43 2021-04-27 chest pain Sharp, quick pain in L pinky finger, repeating at intervals over the course of the day. Slight L-sid... Read more
Sharp, quick pain in L pinky finger, repeating at intervals over the course of the day. Slight L-side chest pain.
43 2021-04-27 heart attack massive heart attack; knee pain; This is a spontaneous report from a contactable consumer (patient).... Read more
massive heart attack; knee pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206 and expiration date not provided) via an unspecified route of administration, administered in right arm on 12Mar2021 12:00 as a single dose for COVID-19 immunisation. Medical history included heart attack in 2019, heart disorder (Heart), Blood cholesterol abnormal (cholesterol), hurt his knee at work prior and torn meniscus. Concomitant medications included ongoing ticagrelor (BRILINTA) for the heart; ongoing atorvastatin for cholesterol and ongoing carvedilol (COREG) for the heart. The patient previously took clopidogrel (PLAVIX) for heart attack. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. No adverse events following prior vaccinations. The patient called about the COVID 19 vaccine. He received his first COVID-19 vaccine on 12Mar2021 and suffered a massive heart attack on the same day. After the event, his cardiologist reviewed video from the heart catherization to open the blockage and the cardiologist indicated that the area that was obstructed with this heart attack had not been obstructed 2 months ago. The cardiologist believed that the COVID 19 vaccine is the culprit in causing the massive heart attack. The cardiologist believed the area of the blockage was too dramatic. The cardiologist encouraged the caller to report the event and the cardiologist will offer his expertise in this matter if needed. The patient also tried to report to his local health department but is waiting on a call back from them. He reported that he had a heart attack in 2019. He was taking Plavix but after this heart attack his cardiologist has changed some of his medications. He reported he believes his medications were changed at his follow up visit with the cardiologist on 23Mar2021. He reported that he had continuous blood work done while in the hospital. They were monitoring his troponin levels. He also had a chest X-Ray, EKG and after the heart attack he had an echocardiogram to monitor the extent of the damage caused by the heart attack. He clarified that he did go to the emergency department on 12Mar2021, the same day he received the Covid 19 vaccine, but for knee pain. He received a pain relief injection of fentanyl that day. He had hurt his knee at work prior. He had previously had an MRI of his knee that showed a torn meniscus. He does not believe his knee pain on 12Mar2021 is related to the Covid 19 vaccine as he had already had an MRI that showed a torn meniscus. He had gone to the emergency department for pain management of his knee. He thought he would be given a lower strength pain medication but received Fentanyl. While the patient was at the emergency room for his knee, he suffered a massive heart attack. The patient clarified that he went to the emergency department because of pre-existing knee pain and while at the emergency department caller suffered a massive heart attack. The patient was hospitalized for massive heart attack from 12Mar2021 to 18Mar2021. The outcome of the event heart attack was recovering while the outcome of the event knee pain was unknown.; Sender's Comments: Based on temporal association, the causal association between BNT162B2 and the massive heart attack cannot be completely excluded. The knee pain was assessed as an intercurrent condition and is unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate.
43 2021-04-27 inflammation of the heart muscle, haemoglobin decreased, chest pain, heart attack, fluid around the heart Pt received Pfizer COVID vaccine on 3/26 at facility. Pt presented to the ED on 3/30 for evaluation ... Read more
Pt received Pfizer COVID vaccine on 3/26 at facility. Pt presented to the ED on 3/30 for evaluation of chest pain at around 0722 on 3/30. Per ED provider note, "This patient is a 43 y.o. male who presents to the ED for evaluation of chest pain. The patient drove here two days ago and was feeling well when he went to sleep. He was awoken from sleep early yesterday morning with "intense" left sided chest pain with radiation and tingling sensation down his left arm. The patient says that his pain has since been fairly constant, waxing and waning in intensity. He says that his chest pain is still currently present, mostly localized in his left shoulder, but improved when compared to the pain that woke him up again this morning around 03:00. No reported vomiting, abdominal pain, fevers, chills, cough, or shortness of breath. Patient notes that he received the second dose of the COVID-19 vaccine 4 days ago. Patient reports family history of cardiac disease in his father. He denies any personal history of cardiac disease, and says that his last cardiac work up was a couple years ago for PVCs. The patient is not a smoker and denies any history of diabetes, hypertension, or high cholesterol. There are no other complaints. There are no other exacerbating or alleviating factors. There are no other reported associated signs or symptoms" Pt was given nitroglycerin ointment and aspirin chewable 324mg in the ED. " In addition, "This is a 43-year-old male presenting to the emergency department with just over 24 hours of left-sided chest pain with radiation into the left shoulder and down the left arm. Symptoms were more severe prior to the patient's arrival to the hospital. He was given nitroglycerin and aspirin upon arrival here. EKG shows subtle ST abnormality in the inferior lateral leads. Troponin is elevated at 11. Differential includes non ST-elevation myocardial infarction, myopericarditis. Patient will be admitted to telemetry. He will undergo a cardiac catheterization today." Pt was admitted, and per hospitalist note on 4/1, "Patient presented hospital with chest pain and EKG changes-there was initial concern for NSTEMI. Had cardiac catheterization with clean coronaries. Then thought to have pericarditis. Patient had trivial pericardial effusion on echocardiogram. Had MRI that demonstrated myocarditis as well. Patient improved on colchicine and NSAID therapy. Discussion had with cardiology will continue this and to be tapered in the office setting. Will continue NSAIDs for approximately 2 weeks then begin tapering. Will likely need colchicine for approximately 3 months. Patient was placed on beta-blocker to help with symptomatic treatment and help alleviate plain. Patient was started on metoprolol, was cautioned side-effects of hypotension, bradycardia, exercise intolerance .Patient should monitor heart rate and blood pressure daily. Hold if heart rate <50 or blood pressure less than 100 systolic and notify provider. Patient was advised he may follow-up with Dr. Caution GI upset, nausea vomiting diarrhea. If diarrhea with colchicine would recommend back down to daily from b.i.d. treatment. Patient was ambulatory and functional without significant symptoms, vital signs within tolerable limits, and agreeable to discharge plan.. Patient ultimately discharged in stable condition. All questions answered to apparent satisfaction. Patient cautioned side effects of medications. Patient was instructed if reoccurrence or any concerning symptoms to contact provider or present to nearest emergency department based on acuity. Patient and family voiced understanding of recommendations and in agreement with discharge plan."
43 2021-04-29 pallor, fainting, hypertension, heart rate increased, fast heart rate Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hype... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypertension-Severe, Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Severe, Additional Details: Patient was unconscious for few seconds after the shot administration. he then became conscious but was dizzy, weak, pale. He was given water and sat down for few minutes. we called 911 and he continued to feel weak and dizzy. EMS said he had high blood pressure, high heart rate , they thought he possibly was in cardiac arrest. Patient was taken to the hospital via ambulance
43 2021-05-02 heart rate increased Full Body Hives over 90% of body. Redness, itching. Temp of 102.5. Elevated abnormal heart rate o... Read more
Full Body Hives over 90% of body. Redness, itching. Temp of 102.5. Elevated abnormal heart rate of 132 BPM Treated with antihistamines: cetirizone, famotidine, and hydroxzine. Hive were much less significant after 24 hour with continued use of antihistamines but still present 4 days later at the time of this reporting.
43 2021-05-02 fainting, palpitations About 10 minutes after first dose (lot EN 6202, 2/25/21), briefly felt very flush in the face and fa... Read more
About 10 minutes after first dose (lot EN 6202, 2/25/21), briefly felt very flush in the face and faint. That passed quickly. Then had extreme burning sensation near injection site for about a minute. Did not report this at the time or before the second vaccine for fear of not being given the second injection. About 10 minutes after second dose, suddenly realized it was difficult to breathe. Removed mask. Started to feel better after a few minutes, replaced bottom, more breathable mask (did not report to observers). Was urged to leave vaccination site due to backlog of patients, so walked back to car. Began to feel pretty out of it (faint again, plus heart racing) on the way back to the car. Considered getting the shuttle back to the injection site, but instead sat in the car until it passed. About 25 minutes after the vaccine, started feeling very hot all over. 30-40 minutes after the vaccine, all reactions seemed to have passed and drove home without incident.
43 2021-05-02 fast heart rate Systemic: Dizziness / Lightheadness-Mild, Systemic: Tachycardia-Mild
43 2021-05-03 chest pain, inflammation of the heart muscle myocarditis; Chest pain; This is a spontaneous report from a contactable Physician. A 43-year-old ma... Read more
myocarditis; Chest pain; This is a spontaneous report from a contactable Physician. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 2 intramuscular on 23Apr2021 (43-year-old at time of vaccination) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no prior vaccination. Patient had no known allergies. Patient previously took dose 1 of BNT162B2 (lot number: not available/provided to reporter at the time of report completion) for COVID-19 immunisationThe patient presented with chest pain found to have myocarditis on 27Apr2021. The patient was hospitalized for myocarditis and chest pain for 2 days. Patient resulted visiting emergency room and physician office due to myocarditis. Patient had test post vaccination test which is nasal swab (COVID-19 virus test) on 27Apr2021, and the result was negative. Outcome of the event s was not recovered. The events assessed serious as these caused hospitalization, disability and was life threatening. Information on the lot/batch number has been requested.
43 2021-05-03 heart rate increased Right after receiving the vaccination began to develop very high resting heart rate(150bpm), along w... Read more
Right after receiving the vaccination began to develop very high resting heart rate(150bpm), along with dizziness and some mild shortness of breath, along with an out of body feeling. Some muscle tightness in neck. Took one benadryl after 15min, began feel better after 1hr. Then had more common reactions later that evening. Regular bpm is 55-60.
43 2021-05-03 pallor Pt had sudden onset of diaphoresis, pallor to face, left hand tingling and nausea @ 1135.BP 99/69, H... Read more
Pt had sudden onset of diaphoresis, pallor to face, left hand tingling and nausea @ 1135.BP 99/69, HR 78, RR 16, temp 97.8. Pt provided bottled water and consumed 2 bottles, tolerated well. Color returned to normal and no longer diaphoretic. Patient nausea and left hand tingling resolved.
43 2021-05-06 blood glucose increased, platelet count decreased Decreased blood platelet counts; spiked up glucose; immobility; foot joint pain; This is a spontaneo... Read more
Decreased blood platelet counts; spiked up glucose; immobility; foot joint pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 43-years-old via an unspecified route of administration, administered in arm left on 12Apr2021 11:30 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Medical history included blood cholesterol increased (other medical history: High cholesterol) from an unknown date and unknown if ongoing. The patient has no covid prior to vaccination, has not been tested post vaccination and has no known allergies. There were no concomitant medications. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 43-years-old on 03Mar2021 11:00 (lot number: EN6204) on the left arm for covid-19 immunisation. The patient reported soon after his vaccination, he was in acute foot joint pain on 13Apr2021 03:45. Immobilized depending on she'll chair (for further clarification). His blood report on an unspecified date showed decreased blood platelet counts and spiked up glucose and so many other bio markers. He was on steroid and painkiller to manage the pain but he was not getting relief. New pains coming up. He was loosing lots of employment and fun actionable opportunities due this pain and immobility. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient underwent lab tests and procedure which included platelets: decreased and glucose: spiked up on an unspecified date. Therapeutic measures were taken as a result of foot joint pain and immobile which included steroid, Tylenol 3000 mg, Diclofenac 150 mg. The patient did not recover from the events.
43 2021-05-06 palpitations, chest discomfort during the following 3 weeks, I'd experienced weird things like anxiety( excessive worries about any... Read more
during the following 3 weeks, I'd experienced weird things like anxiety( excessive worries about anything, feeling of my heart beating fast, sometimes feeling my breathing is very fast, chest tightness or heaviness, and feeling that I'm losing control for few seconds, feeling cold that I put on the heavy jacket that I never used except in cold winter! feelings of boneaches especially in my fingers joints, some days I'd nausea and feeling that my stomach torture me! All the previous symptoms were on and off many times per day, I was using Tylenol and Ibuprofin almost every day. lately, I'd 4 days of continuous symptoms, that I feel like panic and cold with all the above symptoms.(from 29th April to May 3rd).
43 2021-05-06 fainting syncopal episode; mild seizure activity; This is a spontaneous report from a contactable healthcare ... Read more
syncopal episode; mild seizure activity; This is a spontaneous report from a contactable healthcare professional. A 43-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ew0161) at the age of 43-years-old, intramuscular in left arm on 20Apr2021 at 11:00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. He has no COVID prior to vaccination and denied being allergic to anything. There was no other vaccine in four weeks and no other medications in two weeks. The patient received his first dose of COVID-19 vaccine in a workplace clinic on 20Apr2021 and experienced syncopal episode with mild seizure activity at 11:15, within the 15-minute period post vaccination (as reported). No treatment was given in response to the events. It was unknown if the patient was tested for COVID post vaccination. The outcome of the events was unknown.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on close temporal relationship and lack of alternate explanation at this time. However, the information provided is very limited and does not allow for a complete medical assessment. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product 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.
43 2021-05-07 palpitations Ventricular arrhythmia; Heart palpitations - ventricular arritmia; This is a spontaneous report from... Read more
Ventricular arrhythmia; Heart palpitations - ventricular arritmia; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: 92EL9267) via unspecified route of administration on left arm on 11Feb2021 at 12:00 (at the age of 43 years) as single dose for COVID-19 immunisation. The patient had no medical history and allergy. The concomitant medications the patient received within 2 weeks of vaccination included Vitamin C and D. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not tested for COVID-19 since the vaccination. On 14Feb2021 at 00:00, the patient experienced heart palpita-tions - ventricular arrhythmia. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received amioadoron as treatment. The outcome of the events was unknown.
43 2021-05-09 pallor client received of 1st dose Pfizer Covid Vaccine approximately 1400. Ancillary signaled PHN client ... Read more
client received of 1st dose Pfizer Covid Vaccine approximately 1400. Ancillary signaled PHN client was not feeling good. Client sitting in chair, pale, stated feeling dizzy and seeing blurry. EMT began taking vitals at 1405: blood pressure 142/110, pulse 75, oxygen 98%. Per client had just received vaccine. Client able to transfer self to anti-gravity chair at 1407. Client asked for water, PHN advised to take small sips. Vitals 1410: blood pressure 140/110, pulse 77, oxygen 99%. Per client vision slightly better, dizziness same, new onset of headache and nausea. PHN gave client emesis bag. Per client no pertinent medical history, no current medication and no history of allergies. Per client does not know if he has hypertension, does not regularly follow up with provider. No history of vision problems. Vitals at 1415: blood pressure 138/110, pulse 75, oxygen 98%. Client stated feeling the "room was spinning", nausea. Vitals at 1420: blood pressure 138/108, pulse 77, oxygen 97%. Per client dizziness, nausea same, vision improving slightly. PHN asked client if someone would be able to pick him up, per client no one, he would drive home. Vitals at 1425: blood pressure 140/106, pulse 74, oxygen 97%. Client stated headache to temporal and occipital area. 1430 client stated feeling eyesight heavy. Client alert and oriented. Vitals at 1431: blood pressure 134/108, pulse 75, oxygen 97%. Per client when he moves head quickly is when dizziness worsens. Client denied history of vertigo. 1434 PHN offered client paramedics so client could be further evaluated, client denied. Vitals at 1435: blood pressure: 132/103, pulse 73, oxygen 97%. Per client blurry vision, nausea and dizziness same. Per client wanted to leave facility and go home. PHN advised client to stay longer in observation as symptoms had not resolved and he wanted to drive home. Client declined, stated he felt well enough to drive. PHN asked client to stand by chair to see check dizziness and if client could walk without complaints. Client was able to stand and take steps without assistance. PHN gave client ER precautions, asked client if he wanted to anyone else to pick him up and he declined. Client left facility with steady gait at 1441 against medical advise, symptoms had not resolved.
43 2021-05-10 heart attack, chest pain Per patient: Patient received vaccine around noon on the 12 of March 2021 at Community Church. Patie... Read more
Per patient: Patient received vaccine around noon on the 12 of March 2021 at Community Church. Patient states about 10 -12 hrs later, began an adverse cardiac event. Patient states the day before he injured his knee at work and went to ED from an injury the day before. At the ED they gave Fentanyl and he got sick and told the nurse that he was experience chest pain. Felt burning or falling asleep sensation in arm and chest. Told the nurse he felt like he was having a heart attack. They came in ED with crash cart and confirmed that he was having a heart attack while in ED. Transported from church to hospital.
43 2021-05-10 heart attack Myocardial Infarction
43 2021-05-11 palpitations At 1935 received the first dose of Pfizer at 1935. At 1952, the client's partner approached the EMT ... Read more
At 1935 received the first dose of Pfizer at 1935. At 1952, the client's partner approached the EMT table to report the client was complaining of his "heart racing." EMT responded at that time. The client was sitting in his seat in no obvious distress, no swelling observed around his mouth or tongue, skin color appeared normal. At 1955, the client's vital signs were as follows: heart rate 65, respiratory rate 12, O2 96%, and blood pressure 110/palpable (the client continued to move his arms during the blood pressure reading.) Per the client, he did eat breakfast that day, but no dinner, and he just drank some coffee. The client stated that he has no medical history, takes no medications, and has no allergies. At 2001, the client's heart rate was 70 and his O2 was 97%. The client stated that his symptoms had resolved at this time and refused Benadryl. The client stated that he wanted to go home and his partner stated she would drive him. Education provided regarding recommended 30 minute observation, AMR activation and emergency management,, and primary care follow up. The client left the building at 2005 accompanied by his partner, ambulating with a steady gait.
43 2021-05-12 loss of consciousness -Patient received vaccine -Sat in observation area -Passed out and slumped over, was prevented from ... Read more
-Patient received vaccine -Sat in observation area -Passed out and slumped over, was prevented from falling by wife and pharmacist. -Patient appeared to be sleeping but was roused after a minute or 2. -Paramedics were called and examined the patient, gave fluids and took to hospital -Patient called back and said they were released shortly after (low glucose and BP)
43 2021-05-16 loss of consciousness 18 hours after receiving the vaccine, passed out while walking in my house. No signs of dizziness or... Read more
18 hours after receiving the vaccine, passed out while walking in my house. No signs of dizziness or nausea preceded the episode. Lost consciousness for about 10 seconds, then was disoriented for about 2 minutes before being able to get up with assistance and move to my bed.
43 2021-05-18 chest pain Severe cough, runny nose, hot flashes, pain in chest
43 2021-05-18 fainting fainted; fell to the floor; hit his head; This is a spontaneous report from a contactable pharmacist... Read more
fainted; fell to the floor; hit his head; This is a spontaneous report from a contactable pharmacist. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the left arm on 30Apr2021 at 12:15 PM (Batch/Lot Number: EW0172) as the 2nd dose, single for COVID-19 immunization. The vaccination facility type was reported as the pharmacy/drug store; the vaccine was not administered at the military facility. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. Relevant medical history included past experience with fainting on an unknown date. The patient had no known allergies. The patient's concomitant medications were not reported. The patient had vaccination on 30Apr2021 and then proceeded to the front of the store to check-out. On 30Apr2021 at 12:20 PM, he fainted and fell to the floor and hit his head. The 911 was called immediately. The reporter checked the blood pressure and gave patient some water. The paramedics arrived and took over. The patient refused paramedic transport to hospital. The patient's father picked him up from the store. It was unknown if the patient has ever had an adverse event following any previous vaccine. The patient underwent lab tests and procedures, which included blood pressure with unknown results on 30Apr2021. The outcome of the events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Faint cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
43 2021-05-23 heart rate increased Increased heart rate a couple of minutes after the shot. Unusual sensation. Had to lower my mask fo... Read more
Increased heart rate a couple of minutes after the shot. Unusual sensation. Had to lower my mask for additional air. Symptoms subsided completely after about 5 minutes following the shot. Remained in the lobby area for a few minutes past my required 15 minutes. After leaving I felt fine. No symptoms hours later or to this point, 5/24/2021 other than pain at the injection site for 2-3 days.
43 2021-05-24 chest pain, troponin increased, inflammation of the heart muscle Presented to ER 5/9/21 with chest pain for 2 days. Noted fever day one and two after 2nd Covid Vacc... Read more
Presented to ER 5/9/21 with chest pain for 2 days. Noted fever day one and two after 2nd Covid Vaccine 5/4/2021. T max 102. Abnormal EKG with inferior and lateral TWI. Elevated Troponin, peak 9.69 ng/ml. Cardiac catheterization -Normal coronaries, mild hypokinesis anterolateral wall. Echocardiogram - normal. Diagnosis - Myocarditis
43 2021-05-24 inflammation of the heart muscle Myopericarditis.
43 2021-05-25 pallor, hypotension Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in f... Read more
Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in face. Severe fatigue, low blood pressure readings of 112/60 and 110/90. Hot flashes and nausea. Non-coherent with glassy eyes with no awareness. Fluctuations in symptoms and slept for Three days in and out. Pt. Took approx. Three days to feel back to himself.
43 2021-05-26 chest discomfort Three days after my second shot (on 05/03/2021) I started to feel pain in my left arm, tightness in ... Read more
Three days after my second shot (on 05/03/2021) I started to feel pain in my left arm, tightness in chest, and I became very light headed. I tried to go to shower but I could not walk and laid down. My ears felt very tingly and I thought I was going to pass out but as far as I know, I did not. I went to my primary care doctor and he has me taking baby aspirin daily (in case blood clot) and wanted to see if it got better I am going to follow up with a cardiologist. I've never had a problem with heart before and get an annual physical at work.
43 2021-05-30 pallor, blood pressure increased client had reported effects after 1st dose and medical team had approved for client to receive 2nd d... Read more
client had reported effects after 1st dose and medical team had approved for client to receive 2nd dose today. Baseline vitals: blood pressure 162/90, pulse 94, oxygen 97%. Within 5 minutes of receiving vaccine client reported feeling dizzy, nausea, and blurry vision. Upon arrival client sitting in anti-gravity chair, pale, with mild diaphoresis. Client alert and oriented x4. RN took vitals at 1610: blood pressure 140/80, pulse 85, oxygen 97%. 1613 client reported blurry vision had resolved. Vitals at 1615: blood pressure 150/85, pulse 82, oxygen 97%. Per client dizziness and nausea had also resolved, skin color normal for ethnicity. Client denied chest pain, shortness of breath, headache, palpitations. Per client history of hypertension but provider had removed medication years ago as it resolved. No allergies. Client reported not following up with provider after first dose or for regular check-ups. Vitals at 1620: blood pressure 170/110, pulse 79, oxygen 97%. Retake blood pressure 172/110. Per client "feels fine". Vitals 1625: blood pressure 168/118, pulse 84, oxygen 95%. Per client no symptoms at this time. PHN advised client to follow up with provider regarding blood pressure. ER precautions given. Per client would make appointment with primary. Last vitals at 1653: blood pressure 160/110, pulse 80, oxygen 97%. Client able to stand with no complaints of dizziness, blurry vision, or nausea. Client denied chest pain, palpitations, headache, blurry vision at this time. Client stated drove alone and felt fine to drive. Client left facility with steady gait at 1640.
43 2021-05-31 inflammation of the pericardium, chest discomfort Pericarditis. Pressure in upper chest, trouble breathing, slight fever, rapid heartbeat. Given 800mg... Read more
Pericarditis. Pressure in upper chest, trouble breathing, slight fever, rapid heartbeat. Given 800mg Ibuprofen 3 times a day for 5 days and doing much better.
43 2021-06-01 chest pain, chest discomfort chest pain made him go to the emergency room because it was too much, it was multiple throughout the... Read more
chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time; his penis sensations are a lot different; has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen; when he falls asleep he wakes up in an hour; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; limbs twitch; This is a spontaneous report from a contactable consumer. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021), 1ST DOSE SINGLE via an unspecified route of administration, administered in Arm Left on 27Mar2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time, has had a bad headache where it feels like he has vibrating inside of his head, in his chest and on 31Mar2021, when he falls asleep he wakes up in an hour 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, limbs twitch on 31Mar2021, his penis sensations are a lot different. It was reported that 5 days after he got the first dose of the COVID vaccine he started getting pains and the major thing is at night. If he falls asleep, he wakes up in an hour and that has been every night for a month and a half. That is the main thing that is pissing him off. He confirms that he is having issues with his chest and his intestines like he mentioned previously and he has started keeping track and has kept a journal of the pains. This stuff is new. He has never experienced this before and it has been happening every day starting 5 days after when he got the COVID vaccine. He had the COVID vaccine on 27Mar2021 and on 31Mar2021 he got the first shock in his chest at 0120 in the morning when he was sleeping. Then that went on for a week, he had it on 31Mar2021, 01Apr2021, 02Apr2021, 03Apr2021 and 04Apr2021 where he was getting shocked in the middle of the night when he is sleeping. On 04Apr2021 he had to go to the emergency room and have them look at him. But since 31Mar2021 he has been getting up every hour after he falls asleep. This was all worse when it first started because he has never experienced anything like this. The first shock he had was a hard feeling in his chest and then he couldn't go back to sleep. It is so bad. After he went to the emergency room, that is when it started being not as much of a shock pain that woke him up but he was still waking up every hour. The pains are in his upper chest and in his intestines. Also his limbs twitch and he has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen. He confirmed that these also began on 31Mar2021 and have been happening whenever they want and he has never experienced all of that before. Never. Everything has all stayed the same. The sad part is that he just thinks that he is getting used to this "new normal" because he is now going on the second month of this and his body is adapting but this is not normal. Also, he guesses that he shouldn't be shy now but the last thing is that his penis sensations are a lot different and he didn't notice until the first time that he was having relations with his wife after the COVID vaccine and it is all different. He noticed and she did too as far as whenever they were trying to have relations. It has been more than once, it has been every time they have tried afterwards. He says his doctor is going to send him to a sleep lab but he wasn't expecting that. He thought that maybe he would need to go somewhere else. But there he will go to sleep and be hooked up and they will read his whole body and tell the reason why he is waking up every hour. The outcome of the event headache, sleep disorder, chest discomfort, muscle twitching was not recovered and penis order, headache was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
43 2021-06-01 chest pain On 5/3/2021, patient called hospital call center to report side effects experienced 4/17 from 1st do... Read more
On 5/3/2021, patient called hospital call center to report side effects experienced 4/17 from 1st dose Pfizer vaccine. Patient denied emergency symptoms at time of call. Patient only wanted to report symptoms experienced in the past. Advised by PCP to report side effects. 3 days after 1st dose Pfizer vaccine on 4/13, patient reported having pain and numbness in both arms and hands, pain in legs after walking and chest pain. Patient states he did not seek emergency attention on 4/17, but later scheduled an appointment with his outside PCP. Patient underwent blood tests and reports being prescribed a stronger dose of Ibuprofen for 2 weeks.
43 2021-06-01 fainting PATIENT DID WELL UPON IMMEDIATE RECEIPT OF VACCINE. MOVED PATIENT TO OBSERVATION AREA. WITHIN 10 MI... Read more
PATIENT DID WELL UPON IMMEDIATE RECEIPT OF VACCINE. MOVED PATIENT TO OBSERVATION AREA. WITHIN 10 MINUTES PATIENT FAINTED ONTO FLOOR,HIT HEAD AND BECAME NONRESPONSIVE. WE CALLED 911. WITHIN SECONDS HE BECAME RESPONSIVE AND DID NOT WANT EMS TO COME. WE GOT ICE PACKS FOR THE BACK OF HIS NECK AND FOREHEAD AND MADE HIM COMFORTABLE ON THE FLOOR. HE CONTINUED TO SAY HE WAS FEELING BETTER AND THAT IT JUST CAME ON VERY QUICKLY. AFTER 20MINUTES HE WANTED TO SIT UP IN THE CHAIR. AFTER A FEW MINUTES WE MOVED HIM TO A MORE COMFORTABLE CHAIR. PATIENT CONTINUED TO TALK AND RESPOND. AFTER 15 MORE MINUTES HE DECIDED HE WAS GOOD ENOUGH TO LEAVE.
43 2021-06-03 heart rate increased Increase Heart Rate of 148 BPM about 15 minutes after injection; This is a spontaneous report from a... Read more
Increase Heart Rate of 148 BPM about 15 minutes after injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration in the left arm on 26Feb2021 09:45AM (at the age of 43-years-old) as first dose, single dose for COVID-19 immunisation at a workplace clinic. Medical history included Sulfa allergy from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA-D) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug allergy. No other vaccine was given to the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. On 26Feb2021 10:00AM, about 15 minutes after injection, the patient experienced an increase in heart rate of 148 beats per minute. No treatment was taken as a result of the event. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included heart rate: 148 beats per minute (increase in heart rate) on 26Feb2021. The outcome of the event, which lasted for three hours, was recovered on 26Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
43 2021-06-07 chest discomfort, chest pain Dryness in his throat/ extremely, extremely sore and dry throat; Headaches; Feeling terrible; Fever;... Read more
Dryness in his throat/ extremely, extremely sore and dry throat; Headaches; Feeling terrible; Fever; Chills; Chest pain; Oppression in his chest that does not allow him to breathe normally/ pressure in his chest not letting him breathe normally; Sore throat/ extremely, extremely sore and dry throat; Chest pain is like a pressure; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 43-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 27May2021 09:00 as 2nd dose, single dose (at the age of 43-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Patient mentions that yesterday (27May2021) he got the second dose of the Pfizer covid vaccine at 9 am and since then he had fever, chills, sore throat, chest pain like a pressure in his chest, oppression in his chest that does not allow him to breathe normally. On 28Feb2021, experienced dryness in his throat (extremely sore and dry throat), headache, feeling terrible. He wants to report the situation. Patient what should he do, does he need to go to a hospital. Communication included Advising patient to seek medical attention or the care of a doctor. The outcome of the events was unknown. No further information is provided or obtained. Information on lot/Batch number has been requested.
43 2021-06-07 fainting, loss of consciousness Pt fainted shortly after vaccination and remained unconscious for approximately 30 seconds to 1 minu... Read more
Pt fainted shortly after vaccination and remained unconscious for approximately 30 seconds to 1 minute. Was fine afterward.
43 2021-06-09 chest pain Left chest pain similar to pericarditis in my medical history from 2005/06. Additionally, experience... Read more
Left chest pain similar to pericarditis in my medical history from 2005/06. Additionally, experienced body aches, headache, chills, fever and sweating episodes for several days.
43 2021-06-09 increased heart rate Developed right neck swelling/adenopathy which spread to the left. Significant to impair neck mobil... Read more
Developed right neck swelling/adenopathy which spread to the left. Significant to impair neck mobility. Developed high fevers roughly 12 hours later with rigors. Was seen in the emergency department. Found to be febrile, significantly tachycardic (sinus) . Was given vancomycin, ceftriaxone empirically. Felt ill for the next 48 hours afterwards with weakness, slow to resolve tachycardia and cough. Neck swelling subsided however, right neck lymphadenopathy persisted for well over a month. Was sent home from ED with Bactrim and keflex for coverage of possible neck cellulitis. However, I do not believe it was a cellulitis. Neck was not tender, not indurated nor erythematous. I am a hospitalist and had colleagues take a look as well.
43 2021-06-09 fast heart rate Tachycardia, shortness of breath, right heart strain evident on EKG. Follow-up tests showed no bloc... Read more
Tachycardia, shortness of breath, right heart strain evident on EKG. Follow-up tests showed no blockages or anatomical abnormalities. Symptoms are resolving.
43 2021-06-10 ejection fraction decreased, heart failure Patient had systolic and diastolic heart failure on 02/20/2021 possibly related to COVID-19 Vaccinat... Read more
Patient had systolic and diastolic heart failure on 02/20/2021 possibly related to COVID-19 Vaccination given 12/30/21 & 2nd Dose on 01/20/21 (heart inflammation?); Grade III left ventricular diastolic dysfunction was observed during hospital stay; cause unknown; EF of Lt. Ventricle has increased form 21% on 02/22/21 to 33% on 04/29/21 per two echocardiograms on each date. Pt. was given meds for Heart Failure, BP and Hyperlipemia; Pt. had a Cardiac Cath of Rt. & Left Heart on 02/23/21; no signs of coronary disease. Pt. is receiving ongoing outpatient chronic care treatment for issue.
43 2021-06-11 heart rate increased A few days after the second shot lymph nodes under arm very very swollen under left arm as large as ... Read more
A few days after the second shot lymph nodes under arm very very swollen under left arm as large as an apple now several months later lymph nodes are still swollen and resting heart rate is quite high and wife has cystic acne also months after and NEVER had acne previously.
43 2021-06-12 chest pain Started out as strong flu-like symptoms for several days starting about 54hrs after first Pfizer inj... Read more
Started out as strong flu-like symptoms for several days starting about 54hrs after first Pfizer injection 5/26. Fever 101+, body termperature regulation out of whack (intense chills or sweating) body aches and soreness intense headaches and sharp pains in head. Aceteminophin and Ibuprofen alternated and symptoms would subside for a couple hours at a time. Into the second week still had more mild flu-like symptoms that have persisted to today, 18 days after shot. These include headahce, low-grade fever (99-100), continuous tiredness and fatigue, strong aches in lower back, and occasional sharp pains in head, aching behind eyes and occasional chest pain.
43 2021-06-13 chest discomfort Pt presented with an itchy throat and forearms approx 15 min post vaccination. Pt was given 25mg iv ... Read more
Pt presented with an itchy throat and forearms approx 15 min post vaccination. Pt was given 25mg iv benadryl. Pt stated that the benadryl helped but did not completely resolve the issue. Pt remained for approx. 30 minutes. Pt complained of chest discomfort. 911 was called. EKG was normal along with vitals. Pt refused transport and treatment. PT was advised to follow up with his PCP before his next shot.
43 2021-06-13 heart rate increased, blood pressure increased Vertigo, dizziness, on-a-boat feeling, headache, sinus pressure, brain fog, elevated blood pressure,... Read more
Vertigo, dizziness, on-a-boat feeling, headache, sinus pressure, brain fog, elevated blood pressure, elevated pulse. Most symptoms lasted for 6-9 weeks. Dizziness, on-a-boat feeling, occasional headaches continue still (3 month after)
43 2021-06-14 chest discomfort Chest tightness, shakiness, OFF balance (almost fell when trying to go to bathroom), Fever <100F,.
43 2021-06-20 pulmonary embolism Multiple Subsegmental pulmonary emboli. Treated with anticoagulation. Doing well.
43 2021-06-21 blood pressure increased After 2nd dose following events occur deteriorating overall health. I don't have any preexisting hea... Read more
After 2nd dose following events occur deteriorating overall health. I don't have any preexisting health conditions. 1. On May 24th at around 12.15 am, I started experiencing 100 degree fever followed by chills. The blood pressure shot up to 165-95 and heart rate was around 140. Was feeling breathless and sweaty and was being rushed to ER . 2. On 30th May again experienced BP at 165-90 and pulse was at 150 and rushed to ER 3.Again on May 31st, BP shoot up to 170-90 and pulse 145 and ER visit. 4. Consulted cardiologist and on Metoprolol medicine 5. Always feeling dizzy and lightheaded with unprovoked rise in BP and pulse. 6.Unable to resume regular day to day activities including office work. 7. Daily fluctuation in BP and pulse observed till now since 2nd dose of vaccine.
43 2021-06-21 low blood pressure, fainting Dizziness and Orthostatic hypotension, feinted
43 2021-06-22 chest pain Developed mild pain in the chest the day following the first vaccine dose, painful muscle cramps at ... Read more
Developed mild pain in the chest the day following the first vaccine dose, painful muscle cramps at arm/injection site, muscle cramps in feet, and very painful colon inflammation which made it difficult to move around. Also felt feverish for two nights after the injection but did not take temperature to confirm. All other symptoms and body inflammation appeared to have resolved with the exception of painful inflammation in the knees which appeared after all other inflammation symptoms at various other body sites dimminished.
43 2021-06-23 anaemia Was admitted to the hospital with anemia in mid April don?t think related to vaccine
43 2021-06-23 chest discomfort, inflammation of the heart muscle, arrhythmia, chest pain Fever, severe chest pain/throbbing of the chest area, heart arrhythmia. Fever began Thursday 5/13, w... Read more
Fever, severe chest pain/throbbing of the chest area, heart arrhythmia. Fever began Thursday 5/13, with the chest pain, throbbing and arrhythmia following early morning on Friday 5/14. 911 was called Saturday afternoon, 5/15. Was taken by ambulance to hospital, after which several tests were administered including a chest X-ray, blood tests, heart stress test, as well as an ultrasound of the heart/chest area. Stayed in hospital for from Saturday 5/15 to Monday, 5/17. Was released 5/17 at approximately 6:00 pm. Further treatments included prescriptions of Amoxicillin, Atenolol, and Ibuprofen.
43 2021-06-28 heart rate increased, chest discomfort, chest pain, loss of consciousness tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stingi... Read more
tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stinging sensations localized; chest had a weird feeling like pressure, along with some stinging sensations localized; passed out while he was sitting and hit his head that left a bloody scrape; felt dizzy, hot, clammy; felt dizzy, hot, clammy; felt dizzy, hot, clammy; heart rate increased; felt anxious; passed out while he was sitting and hit his head that left a bloody scrape; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received BNT162B2 (Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in arm right on 11Jun2021 15:00 (at the age of 43-year-old) as single dose for covid-19 immunisation. Medical history included slight heart myopia, high tryglicerides that medicine was keeping at normal levels. No past drug history. Concomitant medication included atorvastatin and fenofibrate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Within 5 minutes of the injection (11Jun2021 15:05), the patient felt dizzy, hot, clammy, his heart rate increased and felt anxious, then he passed out while he was sitting and hit his head that left a bloody scrape. Then it took about 45 minutes to feel a little better. Then 24 hours later (12Jun2021) the patient really was tired, headache, fatigue, soreness, and his chest had a weird feeling like pressure, along with some stinging sensations localized. The outcome of events felt dizzy, hot, clammy, heart rate increased, felt anxious, passed out while he was sitting and hit his head that left a bloody scrape were recovering, the rest of events were unknown. No follow-up attempts are possible. No further information is expected.
43 2021-06-29 chest discomfort First four days normal symptoms. Patient started having tremors and shakes. Patient felt somethin in... Read more
First four days normal symptoms. Patient started having tremors and shakes. Patient felt somethin in his lung almost like he had Pneumonia. Patient stated that he would go to sleep and wake up disorientated. patient is experiencing neck stiffness and tightness in his right arm.
43 2021-07-04 fainting Collapsing or losing conscious; Lightheadedness.
43 2021-07-05 blood clot Over a period of about a month I had 3 superficial blood clots the first being in the left leg and t... Read more
Over a period of about a month I had 3 superficial blood clots the first being in the left leg and the 2nd 2 in the right leg each about a week apart.
43 2021-07-06 deep vein blood clot, fibrin d dimer increased Deep vein thrombosis affecting the left internal jugular, axillary, subclavian and brachial veins.
43 2021-07-07 hypertension Intense joint pain lasted over 2 months. Had to have a steroid prescribed to combat the pain and sym... Read more
Intense joint pain lasted over 2 months. Had to have a steroid prescribed to combat the pain and symptoms. Blood pressure went from normal to being high, I had to have medication prescribed. 3 months after the second dose, I still don't feel back to normal.
43 2021-07-11 cerebrovascular accident, ischaemic stroke Left MCA ischemic stroke
43 2021-07-11 chest pain Fever, coughing up mucus, extreme fatigue, chest pain trouble breathing/respiratory infection
43 2021-07-12 blood pressure decreased, fainting Kind of fainted because he was not able to say anything/severe pass out and couldn't see anything li... Read more
Kind of fainted because he was not able to say anything/severe pass out and couldn't see anything like everything was black/Suddenly all stuff fell off on floor, started reacting very bad; Blood pressure went down; Suddenly he started sweating/sweat the entire body; He started shaking his body head, hands and feet; Dizzy/Kind of fainted because he was not able to say anything; Slight headache on and off; Weakness; This is a spontaneous report from a contactable consumer (wife of the patient). A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0171), via an unspecified route of administration, administered in Arm Left on 27Apr2021, at 12:30, as dose 1, single (age at the time of vaccination: 43 years), for covid-19 immunization. Medical history was not reported. The patient concomitant medication included multivitamins (he just takes multivitamin) taken for an unspecified indication, start and stop date were not reported. The patient experienced kind of fainted because he was not able to say anything/severe pass out and couldn't see anything like everything was black/suddenly all stuff fell off on floor, started reacting very bad, blood pressure went down, suddenly he started sweating/sweat the entire body on 27Apr2021 12:45, he started shaking his body head, hands and feet, dizzy/kind of fainted because he was not able to say anything, slight headache on and off, weakness on 27Apr2021. The wife stated that, her husband took covid19 vaccination and it was his first dose. When he had his vaccine he came out and was sitting on the chair, as was asked to stay for 15 minutes. After 5 minutes of chitchat, he was just kind of holding some stuff, the paper they gave and water bottle and some stuff in his hands and suddenly all of the stuff fell off on the floor and he started reacting very bad to the vaccination and he started shaking his body head, hands and feet. Reportedly, the pharmacist was there and he came and asked the patient whether he need water or juice something and after few seconds he responded that he would have juice, but then again like second time the patient could not see anything like everything was black and got dizzy and kind of fainted because he was not able to say anything. Reportedly, within 5-10 minutes of vaccine, at 12:45 PM, the patient had a severe pass out and his blood pressure went down and suddenly he started sweating and sweat the entire body. The pharmacist was really not sure what to do for that. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Upon further inquiry, it has been reported that the patient was just having the normal side effects like slight headache on and off and some weakness. Reportedly, no other lab tests were done. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, patient has not been tested for COVID-19. The seriousness criteria was reported as non-serious. The patient underwent lab tests and procedures which included blood pressure measurement: went down on 27Apr2021 within 5-10 min. severe pass out, Blood pressure went down. Treatment was reported as Monitoring of all the body in the hospital for the events: the patient had a severe pass out and his blood pressure went down and suddenly he started sweating and sweat the entire body and no treatment was received for the rest of the events. The outcome of the events: the patient had a severe pass out and his blood pressure went down and suddenly he started sweating and sweat the entire body was recovered and recovering for the rest of the events.
43 2021-07-13 blood pressure increased Patient called in stating his arm and top of shoulder are swollen and "bruised" from vaccine, no arm... Read more
Patient called in stating his arm and top of shoulder are swollen and "bruised" from vaccine, no arm/back pain, felt like his blood pressure was raised and slight fever. Just discovered today that his back looks "bruised". Denied emergency symptoms, but states wants to be seen in person. Offered urgent care provider appointment 5/30/21, but declined, wants to go to emergency room to be seen in person.
43 2021-07-19 hypertension High blood pressure; This is a spontaneous report from a contactable consumer (patient). A 43-year-o... Read more
High blood pressure; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on 03Mar2021 (Batch/Lot Number: EN6202), as dose 1, single, at age 43 years old, for COVID-19 immunisation, at a hospital. Medical history included sciatica from an unknown date, not reported if ongoing or not. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 04Mar2021, the patient experienced high blood pressure which has not gone away since. The event resulted to emergency and physician's office visits. Treatment for the event included clonidine. The outcome of the event was not resolved. No follow-up attempts are needed. No further information is expected.
43 2021-07-22 chest pain Bad intermittent headache resembling a migraine; Felt a pain in chest each time patient breathed in;... Read more
Bad intermittent headache resembling a migraine; Felt a pain in chest each time patient breathed in; Felt a consistent heaviness orpressure in my lungs; Occasional shortness of breath.; Minor nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Mar2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not had any relevant medical history. The patient was not allergic to food, medications, or other products. The patient did not receive any medications within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 10:30, the patient felt a consistent heaviness or pressure in lungs, occasional shortness of breath and minor nausea which was present at times. On the same day at 10:45, within 15 minutes of receiving the vaccine, the patient felt a pain in chest each time the patient breathed in which lasted for an hour. On 01Apr2021 and 02Apr2021, the patient had bad intermittent headache resembling a migraine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event felt a pain in chest each time the patient breathed in was resolved on 26Mar2021 in about one hour. The clinical outcome of the events occasional shortness of breath, minor nausea, bad intermittent headache resembling a migraine, and consistent heaviness or pressure in lungs were not resolved at the time of this report No follow-up attempts are needed; information about lot/batch number cannot be obtained.
43 2021-07-22 heart rate increased, blood clot I start having SOB and fast heartbeat around the end of April. It got worst through May. I went to... Read more
I start having SOB and fast heartbeat around the end of April. It got worst through May. I went to the ER They did blood work, that came back abnormal. So, they did a CT scan, it show that a had pulmonary embolism, which confirmed that I had a blood clot. The blood clot caused a strain on my right side of my heart. I am not taking blood thinners. I have never had blood clots before the vaccination.
43 2021-07-24 fainting, heart rate increased, lightheadedness, pallor Patient experienced vasovagal symptoms, dilated pupils, increased HR, syncope, and had pale skin ton... Read more
Patient experienced vasovagal symptoms, dilated pupils, increased HR, syncope, and had pale skin tone within less than 1 minute of administration.
43 2021-07-26 heart rate increased, fainting Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old... Read more
Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old daughter who was with me. Apparently I fainted but she described me as twitching and having my hands up and my head to the side with my eyes closed. I can remember a repetitive loop that I was experiencing. It was an image that was distorted and I could not control it and I could not get out of it I could hear my daughter but not control my actions. After I came to a few moments later my legs felt tingly and tired and were shaking like they had the chills. Was advised to go to hospital by EMS Still having very achy joints all over my body. Diarrhea, sweats/chills
43 2021-07-26 fainting Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Med... Read more
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Patient received vaccine and 10 minutes later, he fainted. We sat with patient until emergency services arrived. Patient reporst history of fainting for the past 10 years and takes no medication. Patient was breathing normally and regained consciousness fully AxO x3 after recovering from fainting. Patient drank water. After emergency services arrived, patient began vomiting under their care. Patient ended up leaving with the emergency crew.
44 2021-01-05 lightheadedness PRESYNCOPE, RIGHT SIDED FACAIL NUMBNESS
44 2021-01-10 palpitations 1) Palpitations 2) Abdominal Pain 3) Nausea
44 2021-01-11 blood pressure increased extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple lin... Read more
extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple line; BP was 180/110 / BP stayed around 160/100; felt an "amped" feeling; felt flush; uncomfortable; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, intramuscularly on 21Dec2020 14:00 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten allergy with causes dermatitis herpetiformis, osteoporosis, and fibromyalgia. The patient previously took Benadryl and experienced allergies. Concomitant medications were not reported. The patient reported that immediately after receiving vaccine on 21Dec2020, he felt an "amped" feeling and felt flush. It was uncomfortable but not alarming at first. About ten minutes after shot, he started to have extremely bad dry mouth. He went back to work, but he went back downstairs after feeling like he was getting seriously ill and his lips were going numb. His BP was 180/110. The facial numbness went away but his BP stayed around 160/100. He was asked to go to ER, but he refused because he would have to pay for it and he was feeling better. He also noticed after going back upstairs that he had a rash from his neck to his nipple line. The doctor asked for Benadryl, but he was not given due to possible Benadryl allergy. He went home and his BP returned to normal 2 hours later. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. The outcome of the events was recovered in 21Dec2020 for blood pressure increased and facial numbness, and recovered on an unspecified date for the other events. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the BP increased and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
44 2021-01-11 blood pressure increased Dizziness-10 min post injection resolved within 60 min, headache-10 min post injection resolved with... Read more
Dizziness-10 min post injection resolved within 60 min, headache-10 min post injection resolved within 60 min Rash, neck and chest area 50 min post injection resolved with 30 mg Claritin reditabs 90 mins post injection Body ache- few hours post injection resolved in 24 hrs Injection site/arm pain 20 min post injection resolved in 3 days Blood pressure increased to 170/100 30 min post injection resolved 60-90 min
44 2021-01-11 pallor PATIENT BECAME DIZZY, LIGHTHEADED AND PALE. PATIENT LAYED IN SUPINE POSTION AND GIVEN FOOD. BP OF 99... Read more
PATIENT BECAME DIZZY, LIGHTHEADED AND PALE. PATIENT LAYED IN SUPINE POSTION AND GIVEN FOOD. BP OF 99/69, HR 72, O2 100% RA BS 159. CALLED 911- PATIENT REFUSED TRANSPORT. PATIENT MONITORED AN ADDITIONAL 15 MINS WITHOUT ANY PROBLEMS. ALL SYMPTOMS RESOLVED.
44 2021-01-12 heart rate increased, hypertension, fast heart rate onset of body aches, fatigue, tachyccardia a few hours after receiving his second vaccine dose on 1/... Read more
onset of body aches, fatigue, tachyccardia a few hours after receiving his second vaccine dose on 1/8/21. onset of and L3 dermatome shingles on 1/10/21 pulse was 138 on presentation for evaluation 1/13/21. Hypertensive 170/80
44 2021-01-12 heart rate increased his arm being sore from the vaccination; experienced increased heart rate/Heart rate went up; Mouth ... Read more
his arm being sore from the vaccination; experienced increased heart rate/Heart rate went up; Mouth dry; He was calling because he is wondering if this is (increased heart rate, mouth dry) considered a severe allergic reaction; This is a spontaneous report from a contactable physician who reported for himself. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) 1st dose via an unspecified route of administration on 17Dec2020 in the evening time (around 6-7 or maybe a little later) at single dose on arm for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. After getting the COVID Vaccine that same day, his heart rate went up and then it came down and he was fine. Later that night while sleeping he got up again because he could feel his heart rate going up. It was not way up, but he could tell it was up. He was trying to catch an actual reading on the monitor of his heart rate, but he was not able to before it came back down. He was calling because he is wondering if this was considered a severe allergic reaction. He got the vaccine and was able to walk to his car. His mouth got dry right after the vaccine within a minute or two and noticed his heart rate went up. Treatment: He took some deep breaths and drunk water and it got better. He drove home, but that at nighttime while sleeping he noticed his heart rate went up a couple of times, but then it came back down. He could not get a reading of heart rate right away. The highest he saw on the monitor that he was able to capture was 101 and then it came back down. He was not sure if this was because he was nervous. He just had a couple of episodes that night and then nothing again. He also experienced his arm being sore from the vaccination. However, he stated that is to be expected. He stated the arm sore started a few days after getting the COVID Vaccine and then it was gone. Stated he was calling because he was concerned because Pfizer said to report any issues. He started to feel better and added this may not even be an issue. He just got concerned. Mentioned he was not sure if real side effects or if he was over thinking things. Outcome of the events was resolved.
44 2021-01-12 fast heart rate Mild Tachycardia, small SOB, diaphoretic for 5 min, digits tingly , very dizzy
44 2021-01-13 palpitations I experienced a fast heartbeat at about 10 minutes after the shot. I did a few deep inhale/exhale re... Read more
I experienced a fast heartbeat at about 10 minutes after the shot. I did a few deep inhale/exhale repetitions to calm it down. I think this lasted less than 1 minute. I did not have other symptoms.
44 2021-01-14 chest pain, chest discomfort Chest tightness, spasmodic retrosternal pain. Occurred within 24 hours after first dose and 48 hours... Read more
Chest tightness, spasmodic retrosternal pain. Occurred within 24 hours after first dose and 48 hours of second dose.
44 2021-01-21 heart rate increased About 5 minutes after getting the vaccine injection my heart rate suddenly increased (My heart rate ... Read more
About 5 minutes after getting the vaccine injection my heart rate suddenly increased (My heart rate went back down to normal about 2 or 3 minutes after it initially increased), I was short of breath, and slightly dizzy. The night of and the next morning after the injection, I have been tired, my left arm of the injection site, left shoulder, and lower back have been aching. The next day after the shot, I have been unusually tired, also.
44 2021-01-21 lightheadedness 10 min after vaccine-twitch in left calf, quad twitching, bicep, glute--only twitching on left side ... Read more
10 min after vaccine-twitch in left calf, quad twitching, bicep, glute--only twitching on left side for first 30 min following vaccination Then after 30 minutes it switched to right side twitching (twitching not painful) Employee also had trouble breathing at that moment and was diaphoretic--Rapid Response Called VSS--employee returned to work Two hours later employee experienced diaphoresis, presyncope--went to Emergency Dept at this time--all labs and tests came back WNL 1/7: Fever 100, twitching continues (superficial) 1/7-14-superficial twitching throughout body 1/14-1/15?twitching seems to go deeper--in intestine, deep in LRQ 1/22 still having these twitches (not painful, just disturbing/odd)--Employee estimates these twitches happen 20x an hour
44 2021-01-22 troponin increased, inflammation of the heart muscle, chest pain s/p vaccination with 2nd Covid Vaccine dose, developed low grade viral type illness with fevers up t... Read more
s/p vaccination with 2nd Covid Vaccine dose, developed low grade viral type illness with fevers up to 102 with myalgias, fatigue. Began to recover, teh awoke in the morning of 1/16/20 wtih crushing, substernal chest pain. Presented to the emergency department. Was admitted to he hospital - diagnosed with myopericarditis. Stayed in the hospital one night, and discharged the next day.
44 2021-01-24 fainting Syncope, hospitalization for GI bleed for 4 days. probable diagnosis diverticulosis bleed
44 2021-01-26 blood pressure increased Elevated blood pressure (180/116 highest recorded); dizziness; weakness lasting several hours; This ... Read more
Elevated blood pressure (180/116 highest recorded); dizziness; weakness lasting several hours; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 20Jan2021 14:15 at single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR), 40 mg daily, butalbital, caffeine, paracetamol (FIORICET). The patient experienced elevated blood pressure (180/116 highest recorded), dizziness and weakness lasting several hours on 20Jan2021 14:30 with outcome of recovering. The events were considered life-threating (immediate risk of death from the event) and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
44 2021-01-27 chest pain Pt reports that from day 7-10 (post vaccine) he had a 'cytokine like response" with redness, swellin... Read more
Pt reports that from day 7-10 (post vaccine) he had a 'cytokine like response" with redness, swelling and pain extending from left shoulder to under arm and chest area. Did not see PCP. Took OTC analgesic, resoled on day 10 post vaccine the response dissipated.
44 2021-01-27 pallor Pt became pale, diaphoretic, dizzy and light headed. Pt moved to recovery area and laid on cot, vita... Read more
Pt became pale, diaphoretic, dizzy and light headed. Pt moved to recovery area and laid on cot, vitals done Pt after 15 minutes states he fell fine and left the area on his own power.
44 2021-01-28 fast heart rate Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wake... Read more
Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wakes up; Tachycardia; His CRP was up a little at 1.1; Nausea; Shortness of breath; Fatigue; Pain at injection site left shoulder; This is a spontaneous report from a contactable physician reporting for himself. A 44-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 28Dec2020, at a single dose on the left shoulder (arm left) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 28Dec2020. Since receiving the vaccine, he has experienced multiple side effects at varying time points: pain at injection site left shoulder (experienced pain first day of receiving vaccine on 28Dec2020 and couple of days after fever (unspecified date) resolved (on an unspecified date); he was currently experiencing intermittent minimal pain especially when he wakes up; feels something is different; fever (experienced 08Jan2021); fatigue (developed 07Jan2021). He went to the ER on 08Jan2021 when he developed fever, nausea and shortness of breath which also resolved that day. When he went to ER, his CRP was up a little at 1.1. His PCR and antigen test was negative at that time (08Jan2021); a retest of PCR done 5 days after sxs started (unclear of time window) was negative. He was concerned that he had the fever many days after the vaccine. HCP was asking if any cases of fever and fatigue reported after 7 days (around the 10 day mark) of receiving the first dose. He stated that he is planning on taking the second dose. The patient is a physician calling about the Pfizer covid vaccine. He received his first dose on 28Dec2020. He had a little bit of pain in his left arm on same day, but it went away. About 10 days later, 07Jan2021, he had fever and fatigue. On 08Jan2021, he went to the ER with a temp of 101. He had tachycardia, nausea and shortness of breath. He was not admitted, stated his fever was controlled and his breathing was better. His oxygen was 100% and everything was ok and he was sent home. In the ER he had xrays and labs and everything was ok, except his CRP was a bit up. In the ER he had an antigen and pcr covid test (08Jan2021) and they both came back negative. About 4 or 5 days after the symptoms started, he had an outpatient repeat pcr test and nucleic acid rapid test (unspecified dates) and they both came back negative. He is on his way to get his second dose and he is asking if the symptoms could be side effects from the vaccine. Outcome the event fever was recovered on an unspecified date. Outcome of nausea and shortness of breath was recovered on 08Jan2021, while outcome of pain at injection site left shoulder was recovered on 28Dec2020. Outcome of the remaining events was unknown. Information about lot/batch number has been requested.
44 2021-02-05 chest pain, fibrin d dimer increased, pulmonary embolism I developed acute right posterior pleuritic chest pain and shortness of breath. Diagnosed with mult... Read more
I developed acute right posterior pleuritic chest pain and shortness of breath. Diagnosed with multiple pulmonary emboli (see below). I was started on Eliquis initially, but then had worsening symptoms on 2/4/21 and switched to Lovenox injections. Symptoms have been slowly improving since then.
44 2021-02-21 blood glucose increased, heart rate increased The morning after receiving vaccine I worked out lifting weights and jumping rope. After about a ha... Read more
The morning after receiving vaccine I worked out lifting weights and jumping rope. After about a half hour I suddenly stopped sweating became very chilled (shivering), weak, very nauseous, felt rapid heart rate.
44 2021-02-22 blood pressure increased Started itching of mouth face and upper body within 10 minutes of injection. Became dizzy with tunne... Read more
Started itching of mouth face and upper body within 10 minutes of injection. Became dizzy with tunnel vision. Went to urgent care had elevated blood pressure of 178/110. Receive steroid injection and prescription for hydroxyzine.
44 2021-02-22 chest discomfort, blood pressure increased Patient states he had vaccination at 1030 today and did not want to wait the recommended observation... Read more
Patient states he had vaccination at 1030 today and did not want to wait the recommended observation time of 15 minutes in the hospital lobby. He is currently a highway patrol officer. While driving in his patrol car, at 1035, he felt tightness in the back of his neck and tightness to his airway- he described it feeling like someone hit him in the neck. He denied having any trouble breathing. Later, he noted his hand was twitching. 1045, he came back to lobby and made an RN aware who brought him to employee health. He declined to go to ED (I found out later). BP was 153/115 HR 102 initially, no hx of high bp. No noted hives or swelling to face or mouth/tongue or L deltoid region. Pt. denied feeling any itching anywhere. Pt. rested for about 15 minutes on exam table. Re-check of BP was 151/113 HR 84. Pt. states he feels better and feel like that feeling of tightness in his neck is decreasing. Made aware to follow up with PCP regarding BP and giving informational handout regarding blood pressure. RN recommended he go to any ED if he has any trouble breathing, swelling of tongue, etc at any time after he leaves this hospital. Pt. verbalized understanding.
44 2021-02-22 fainting, loss of consciousness Patient had recieved vaccine and was walking toward the waiting area in the bleachers. He began to f... Read more
Patient had recieved vaccine and was walking toward the waiting area in the bleachers. He began to feel dizzy and light headed. He syncopized and struck his head on a concrete stair. He was immediately seen by provider who was at a nearby table. The patient regained consciousness within moments without any evidence of post ictal confusion. He suffered a laceration to the head. Bleeding was controlled, EMS was contacted expiditiously, and the patient ambulated from the building approximatelyh 20 minutes later and was brought by EMS to the nearest emergency department to be evaluated.
44 2021-02-23 loss of consciousness, pallor The patient is a 44-year-old male that after receiving the vaccine (IM) in the left-deltoid muscle (... Read more
The patient is a 44-year-old male that after receiving the vaccine (IM) in the left-deltoid muscle (13:20) proceeded to walk to the observation room where the Paramedic noticed him pale and having difficulty walking (13:21). The patient requested a chair to sit down and the Paramedic assisted the patient to do so. The patient expressed verbally to the Paramedic having a difficulty with needles and subsequently the patient lost consciousness while on the chair but maintaining a pulse and a hoarse respiration (snoring). Thereafter the patient was placed on a medical code in supine position with an immediate clearing of hoarse respiration. Evaluation by the Paramedic revealed an intact HEENT, (continued on page 2)...
44 2021-02-25 chest pain On the 8th day after shot I started getting pain under left armpit. The pain became worse over the n... Read more
On the 8th day after shot I started getting pain under left armpit. The pain became worse over the next several days resulting in what I'd describe as an electrical shock/burning feeling whenever I moved my left arm the wrong way (seemingly pinching the lymph nodes). I'm currently on day 5 of the pain and it's still present although it has lessened on the 5th day. On the 2nd day the pain started to move down from the armpit closer to the pectoral.
44 2021-02-26 blood pressure fluctuation My blood pressure shot up to 155/105, I got flush, dizzy and had a headache. I had a tingling sensa... Read more
My blood pressure shot up to 155/105, I got flush, dizzy and had a headache. I had a tingling sensation around my nose and upper lip. Prior to this, my blood pressure had been in the 120's / 70's. I went to the emergency room and was sent home 4 hours later. I had headaches every day, multiple times a day, for the next 10 days and my blood pressure was fluctuating between 130/90 to 150/99 during that time. On February 25, my blood pressure dropped back down to 123/88 in the morning, but shot back up to 152/93 by the evening. My blood pressure continues to fluctuate from 124/89 to 146/106.
44 2021-02-28 lightheadedness Pfizer-BioNTech COVID-19 Vaccine EUA: During observation, vaccine recipient had a near syncope event... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: During observation, vaccine recipient had a near syncope event. They were diaphoretic. They were monitored by the EMS. No further intervention.
44 2021-03-01 chest pain, heart attack small heart attack; myocardial/paracardial issues.; My injection location had redness, hardness; My ... Read more
small heart attack; myocardial/paracardial issues.; My injection location had redness, hardness; My injection location had redness, hardness; pains in chest; headache; chill; running nose; shortness of breath.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 19Feb2021 17:45 at single dose for COVID-19 immunisation at hospital. Medical history included coronary artery disease. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unknown date for covid-19 immunisation. The patient did not have covid before vaccination. The patient experienced small heart attack and myocardial/paracardial issues on an unspecified date with outcome of unknown. These events were serious as life threatening, disability and requiring hospitalization from 21Feb2021 till 23Feb2021 at 14:00. On 20Feb2021 07:00 the patient experienced headache, chill, running nose, shortness of breath with outcome of recovering. The patient experienced also pains in chest on 21Feb2021 11:00 with outcome of recovering and injection location had redness, hardness on an unspecified date with outcome of recovering. Clinical course was as follows. 19Feb2021-5:45pm the patient went to receive vaccine shot. 20Feb2021 the patient had headache, chill, runny nose, and shortness of breath. 21Feb2021 11am still had shortness of breath and pains in chest. Went to clinic had a rapid Covid test come back negative, pain increased and he went to emergency room. The patient was admitted to the hospital with small heart attack and myocardial/paracardial issues. Inflammatory response seems to possibly triggered possible underlying issue of minor heart disease. Then induced heart attack and myocardial issue. The patient would gladly be admitted to a clinic for observation and testing to assist Pfizer in understanding this unfortunate situation. The injection location had redness, hardness. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment due to the event which included multiple lab tests, Angiogram, CR scan and pain medicine.
44 2021-03-02 loss of consciousness Patient received a dose of the Pfizer COVID-19 vaccine. Before he could exit the room to begin the o... Read more
Patient received a dose of the Pfizer COVID-19 vaccine. Before he could exit the room to begin the observation period, the patient became unconscious and slipped into a seizure. Uncertain if it was hypersentivity coupled with vasovagal response, an epi pen was primed but not administered. The patient was unresponsive for a minute then came out of his apparent seizure
44 2021-03-05 fast heart rate Dry mouth, tachycardia, weakness, lightheaded. Cleared by medics.
44 2021-03-07 pallor Pale, diaphoretic (reacted this way in past with other vaccines) - placed in gurney. Juice provided.... Read more
Pale, diaphoretic (reacted this way in past with other vaccines) - placed in gurney. Juice provided. Vitals within normal limits.
44 2021-03-12 chest discomfort, chest pain Pain and tightness in chest. Fatigue
44 2021-03-14 blood pressure increased sitting in car in 30 min line, got dizzy, thought was because of playing on phone, then mouth went n... Read more
sitting in car in 30 min line, got dizzy, thought was because of playing on phone, then mouth went numb, tongue swelling and lower jaw numbmess. Notified the MD's taken out of car had BP given claritin was being monitored and BP kept rising given epipen. The epipen helped felt swelling go down started to relax. Taken by ambulance to hospital. Treated with Steroid and benadryl and prevacid. No breathing treatments given epipens there and taken home prescribed. after he went home sore arm, dizzy, tired then symptoms started to come back took steroids and bendadryl which helped the reaction to go away. sx lasted 2-3 days. mild towards the end.
44 2021-03-14 fainting, loss of consciousness Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Patient ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Patient was feeling paralized. However, we can cleary see the patient moving all his extremities-Mild, Systemic: Headache-Mild, Systemic: Weakness-Mild
44 2021-03-18 chest discomfort Received vaccine at 8:45am, at 09:00am began feeling "woozy" then complained of chest tightness. Vi... Read more
Received vaccine at 8:45am, at 09:00am began feeling "woozy" then complained of chest tightness. Vital signs checked, HR & SpO2 . 911 called. EMS transported patient to area emergency room.
44 2021-03-18 loss of consciousness, fainting pt got vaccine and was sitting for observation. Pt thought he was having a panic attack so he put h... Read more
pt got vaccine and was sitting for observation. Pt thought he was having a panic attack so he put his head between his knees, he fainted, hit is head on the floor, and a witness said he was shaking on the floor. The patient came to quickly and said he passed out due to stomach cramps . EMS was on site and did an evaluation. Pt was given ice for his head and had vitals checked and and EKG done. EMS recommended hospital transport but patient refused.
44 2021-03-21 heart rate increased RACING OR ACCELERATED HEART BEAT EARLY AM LASTING BETWEEN 30-40 MINUTES NUMBNESS OF TONGUE AND FINGE... Read more
RACING OR ACCELERATED HEART BEAT EARLY AM LASTING BETWEEN 30-40 MINUTES NUMBNESS OF TONGUE AND FINGERS LASTING ABOUT FORTY FIVE MINUTES. SEVERE VERTIGO LASTING AROUND ONE MINUTE PER EPISODE EXPERIENCING FIVE EPISODES SO FAR OCCURRED AFTER FIRST WEEK OF VACCINATION 1ST DOSE.
44 2021-03-22 deep vein blood clot DVT left leg within few days
44 2021-03-22 pallor P found in car sweaty, pale. VSS. No breathing difficulty, weak. hx of anxiet and passing out with ... Read more
P found in car sweaty, pale. VSS. No breathing difficulty, weak. hx of anxiet and passing out with shots. 911 called. vss. pt tried to stand causing sx to return. pt transported to hospital via ambulance.
44 2021-03-26 fainting, loss of consciousness lightheaded with fainting episode from seated position hitting head on ground, unconscious about 10 ... Read more
lightheaded with fainting episode from seated position hitting head on ground, unconscious about 10 seconds, evaluated by EMS, recommended transport but refused
44 2021-03-29 loss of consciousness Patient felt unconscious for 5 seconds and slide off his chair at observation area after vaccination... Read more
Patient felt unconscious for 5 seconds and slide off his chair at observation area after vaccination. No allergic reaction noticed to injection site. Gained consciousness soon and was alert and oriented x 4. no visible trauma, v/s stable during the triage period. Patient stated that he did not eat breakfast and not well hydrated, is taking anti anxiety medication on regular basis. Patient has history of passing out during blood draw (acc to him). A bottle of water and juice given to drink. Pt had mild redness at right elbow after fall, no swelling noticed, icepack applied, no pain, no skin tear. Patient felt better and walks comfortably through the hall to parking lot after 25 min of incident.
44 2021-03-30 fainting Syncopal episode. Evaluated by EMS-Refusal to transport.
44 2021-03-31 pallor, loss of consciousness Nnurse was called to assist a patient that had left the monitoring area. Upon arrival, patient was s... Read more
Nnurse was called to assist a patient that had left the monitoring area. Upon arrival, patient was sitting in mall with back leaning on wall. Patient was AAAx3. He was pale and diaphoretic. Patient stated he waited his 15 minutes and felt fine. Patient received dose 1 of Pfizer Covid Vaccine (Lot #EN6207, Exp 5/31/21). When he was walking back to his car he "blacked out" and fell to the floor. Patient stated he hit his head on the ground. No visible injury to back of head was observed. Patient reported he did not eat or drink anything prior to coming. He stated it was warm in the mall and he was having difficulty breathing with the mask on. Patient was instructed to take his mask off. VS were assessed: 98/68, HR 82, pulse ox 98% room air. Patient was given water and some chocolate. Patient stated he started to feel better. Patient was assisted into wheelchair and continued to be observed. Patient stated he initially started to feel better, but then felt lightheaded again. VS reassessed @ 0948 BP 92/64, HR 72, pulse ox 98% room air. This nurse advised patient EMS should be called for further evaluation. Patient refused and stated he did not want to go to the hospital. Nurse again advised that his blood pressure remained low and he should be further evaluated. Patient continued to refuse. Patient was advised to call someone for a ride home as it was advised he should not drive at this time. Patient called his father for transport home. Patient was given a sprite to drink while waiting for his ride. Patient was accompanied by monitor until ride arrived. Patient was picked up and left without further incident.
44 2021-03-31 fainting, pallor After dose administration, while waiting during the 15 min observation period, the patient stated th... Read more
After dose administration, while waiting during the 15 min observation period, the patient stated that he did not feel well. The pharmacist asked the patient to have a seat and applied a cold, wet towel to the back of his neck. While seated the patient became pale, began sweating and became unresponsive for about 10- 15 seconds. After the 10-15 seconds the patient began to rise up and response to his name being called. 911 was called and the patient was evaluated for vitals. The patient declined hospital transfer and waited for his with to pick him up.
44 2021-04-02 heart rate increased Fatigue, Increased heart rate, Nausea, Vomiting, Headache
44 2021-04-02 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received a pfizer covid19 vaccine and sat on the floor during the monitoring period due to dizziness. Patient was given a bottle of water and reported fainting briefly before resuming consciousness. Patient waited at the pharmacy and was given a protein bar and gatorade to help because he reported not eating or sleeping. Blood pressure was taken and was 155/75 mmHg which then decreased to 119/82 mmHg a few minutes later and then normalized to 121/82 before the patient left. Full recovery
44 2021-04-03 palpitations Urticaria, palpitations, hives worsened.
44 2021-04-05 blood clot After the shot, which I received on a Saturday, I developed pain and redness in my right leg. Two da... Read more
After the shot, which I received on a Saturday, I developed pain and redness in my right leg. Two days later, on Monday morning, I contacted my primary care physician's office, who told me to go to the ER to be evaluated for a blood clot. At the ER, they performed a doppler ultrasound on my right leg and found a superficial clot in the greater saphenous vein of my right leg. There was no evidence of a DVT in the right leg.
44 2021-04-07 chest pain, chest discomfort Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: ANXIETY-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient drank water as we talked to him. He started to look and feel better after a few minutes. He was able to hold a steady conversation throughout event. Within 5 minutes of being notified of event, patient was scrolling through his phone with no difficulty. We made patient wait for 20 additional minutes while monitoring him and patient stated \"I feel back to normal\" before leaving.
44 2021-04-09 chest discomfort couldn't sleep one night; have had a tightening in the chest; This is a spontaneous report received ... Read more
couldn't sleep one night; have had a tightening in the chest; This is a spontaneous report received from contactable consumer (patient). This 44-year-old-male patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6206) via an unspecified route of administration on 04Mar2021 at 13:30 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure and COVID-19 diagnosis on an unspecified date prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included lisinopril and hydrochlorothiazide from unknown dates for unknown indications. On 07Mar2021 at 23:00, the patient could not sleep one night and since had a tightening in the chest. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of couldn't sleep one night and tightening in the chest were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
44 2021-04-10 skin turning blue, hypertension, excessive bleeding He had his first vaccine March 19th, 2021 at 12:15, same lot as above, and 24 hours later he had dif... Read more
He had his first vaccine March 19th, 2021 at 12:15, same lot as above, and 24 hours later he had difficulty breathing, shortness of breath, fatigue, shakes, chills and feeling of weakness/dizziness. It lasted a few days. Then, April 9, 2021, he received his second Covid19 Pfizer shot, same lot at 12:15 pm and the next morning, Saturday, April 10th around 9 am Ira felt the same symptoms from shot 1, but more intense. He was feeling weak, had chills, shakes, profuse sweating, difficulty breathing, shortness of breath, dizziness and vomiting. He was unable to keep water down and stayed in bed. A little after 12pm, he complained of difficulty breathing and possibly not getting enough oxygen so I grabbed my equipment (since I'm a CNA) and checked his vitals. His B/P was very high ( 166/107), no fever (96.7), pulse was normal 72, and low respiration but oxygen was above 90. He said he needed to use the bathroom, I suggested using his urinal but he said he needed to have a bowel movement. Once he was in the bathroom, I went downstairs for a glass of water and then suddenly I heard a huge thump. I ran upstairs, knocked on the bathroom-no response but I could hear noises, so I opened the door and I saw he was face down on the floor, head under the bathroom sink counter, blood everywhere, and he was convulsing. I grabbed him immediately and moved him to his side (I had my fitbit on, it said it was 12:30pm), and he kept seizing. He looked discolored almost blueish color. I held him on his side, he vomited, making noises, but unable to speak, continuing to have a seizure. Seizure lasted three minutes. At 12:33pm, once he had calmed, I ran downstairs to find my phone. I was back at his side calling 911 at 12:35. Paramedics arrived 9 minutes later and took him to the hospital. My brother picked me up and took me to the hospital. Once outside his door, I noticed he was finishing taking X-Rays when he suddenly had another seizure.
44 2021-04-11 hypertension Severe headache that started the day after the shot, developed change in taste, neck muscle pain. S... Read more
Severe headache that started the day after the shot, developed change in taste, neck muscle pain. Symptoms progressed until 4/8/2021 and woke up with left sided facial drooping. He was seen and in the ER and diagnosed with bell's palsy. Was hypertensive 180/110
44 2021-04-13 bleeding on surface of brain, cerebral haemorrhage Patient was seen at Hospital for seizure, fall and head injury. Subsequent workup following transfe... Read more
Patient was seen at Hospital for seizure, fall and head injury. Subsequent workup following transfer to another hospital revealed L frontal lobe parenchymal hematoma with overlying subarachnoid hemorrhage, no underlying aneurysm or vascular malformation. He had MRI with and without contrast revealing partial occlusion and thrombus of the superior sagittal sinus with adjacent hemorrhage and edema. Treated with heparin, transitioned to coumadin.
44 2021-04-14 chest pain, blood clot March 14 2021 - 2 days after first vaccine shot, leg pain, 1-3 days later diagnosed with superficial... Read more
March 14 2021 - 2 days after first vaccine shot, leg pain, 1-3 days later diagnosed with superficial blood clot in left leg via ultrasound, treated with baby aspirin for 3 days and heat pad, symptoms slowly lessened till 2nd dose of vaccine on April 2nd, after second dose symptoms worsened again, both legs still fatigue very quickly to this day (April 15 2021) when I'm sitting down on chairs, seats etc. April 8 2021, 12:30pm - heart pain for 30 minutes, felt very weak, similar to light heart attack, ER visit later that day couldn't find any explanation
44 2021-04-14 fainting, troponin increased Acute kidney failure, unspecified Hypocalcemia Hyperkalemia Syncope ARF (acute renal failure) Abnor... Read more
Acute kidney failure, unspecified Hypocalcemia Hyperkalemia Syncope ARF (acute renal failure) Abnormal EKG Elevated troponin Elevated LFTs
44 2021-04-15 heart rate increased Client got Pfizer COVID vaccine at 1405, started feeling light headed, dizzy, and sweaty with a rapi... Read more
Client got Pfizer COVID vaccine at 1405, started feeling light headed, dizzy, and sweaty with a rapid pulse at around 1410. Client was unresponsive and out of it like he passed out for a few seconds and came out of it and was coherent and responsive again. Client was safe, with three EMTs and lead nurse alongside him. Vital signs taken at 1414, BP 138/88, O2 99%, and P 80. Client started feeling better, no longer sweaty or dizzy at around 1415. Client informed healthcare staff that he had not eaten or had any water since 0800. Vital signs taken again 1425, BP 140/90, O2 100%, and P 72. Client was stabilized and ambulated out of the facility and driven home by his mother at 1430.
44 2021-04-15 fainting As I was administering the vaccine I was discussing with the patient the adverse reactions I wanted ... Read more
As I was administering the vaccine I was discussing with the patient the adverse reactions I wanted to monitor after the injection. The patient winced as the vaccine was being injected and said it was more painful than the last time he go it. He immediately stated he didn't feel well. I applied a little pressure to the injection site which he said made it feel better but he was starting to feel flushed and faint. I kept the patient in the chair and got him some water. He reported that he had experienced this before with vaccines but it had been a long time. He asked to lay on the floor so we got him into a prone position on the floor on his right side. He laid there for a few minutes then drank some more water and laid back down. After a few more minutes he was ready to sit up. He moved to a chair in our waiting area left when he felt well enough. I called patient 2 hours later to check on himand he reports he is doing fine.
44 2021-04-17 chest discomfort Mild Chest Pressure Urgent care and ER visit. Abnormal EKG. Follow ups with cardiologist still pend... Read more
Mild Chest Pressure Urgent care and ER visit. Abnormal EKG. Follow ups with cardiologist still pending. Change diet to eliminate possible acid reflux symptoms.
44 2021-04-17 chest pain, palpitations, chest discomfort, heart rate irregular As soon as pt received vaccination, he said he felt tightness in his chest, heart racing, irregular ... Read more
As soon as pt received vaccination, he said he felt tightness in his chest, heart racing, irregular heart rate, SOB, nurse noted he was ?swallowing hard?. EMS called ASAP, BP 172p (pt obese) hr 108 sao2 98%. He was soon able to get out of the drivers seat to allow is mother to drive, moved for further obs. Stated chest felt intermittently tight and burning. No rash, swelling of tongue lips or airway noted, pt admitted to h/o anxiety, next vitals similar, pt released after 30 min by EMS into the care of his,other
44 2021-04-18 lightheadedness Patient passed away on 4/13 after presenting to local hospital with near syncope and AKI. Records f... Read more
Patient passed away on 4/13 after presenting to local hospital with near syncope and AKI. Records from local hospital are unavailable, unclear regarding cause of death and circumstances thereforth.
44 2021-04-19 fainting Vaccine administered 13:54, adverse event started 13:55 same day. Patient had syncopy, flushing/swea... Read more
Vaccine administered 13:54, adverse event started 13:55 same day. Patient had syncopy, flushing/sweating. BP 115/72 -- > 101/67 -- > 110/78, HR 64 -- > 58 -- > 60, O2=100% -> 97% -- > 98%, RR = 16, Temp 95.1F -- > 96.6F -- > 97.3F. At 15:01, Patient stated no longer lightheaded, patient stable, released from vaccination site.
44 2021-04-19 troponin increased, chest discomfort Chest discomfort intermittently over next 48 hours worse with exetion
44 2021-04-20 pallor Pt fell out out of chair onto floor. Was pale and clammy. 4:26 BP 89/50, P 83, o2 95% 4:28 BP 91/54... Read more
Pt fell out out of chair onto floor. Was pale and clammy. 4:26 BP 89/50, P 83, o2 95% 4:28 BP 91/54, P 83, O2 95% 4:31 BP 120/82 4:39 92/62 , BG 113 Vaccine site closed at 5 , Pt had no one to contact for a ride home. Transported to hospital via ambulance for further eval, discharged home from ER.
44 2021-04-20 fast heart rate, pallor 4/21/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening ... Read more
4/21/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, he experienced an adverse reaction with the following symptoms: nausea and tingling and numbness to cheeks and tongue/ c/o of tiredness. Assessment : Time of assessment *1634. Alert and oriented, Tachycardia, Pallor, Diaphoretic, Clammy and Nausea. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Water x 2 and 1 juice, VS taken at 1634- BP- 141/89, P- 110, O2- 98%, 1642, BP- 139/88, P- 102, O2- 100 %, 455pm, BP- 123/78, P- 97, O2- 100%, 514pm, BP- 123/81, P- 100, O2- 100% Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 1645. Administered by RN. Famotidine (Pepcid) 10 mg by mouth. Time: 1645. Administered by RN. Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: x 2 doses at 1634 and 1645. Administered by RN. Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Wife with patient. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/21/2021 4:16 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8735 NDC: 59267-1000-2 Electronically signed at 4/21/2021 5:33 PM Immunization on 4/21/2021 Detailed Report Note shared with patient
44 2021-04-21 hypotension Pt became diaphoretic and light-headed 5 minutes after vaccine was administered. He requested water... Read more
Pt became diaphoretic and light-headed 5 minutes after vaccine was administered. He requested water and as I was giving it to him he started to pass out. He was conscious but slightly convulsing. He appeared to have a minor seizure for approximately 5-10 seconds. He was transferred to a wheelchair and sent into our recovery room. As we were transporting him, he had two episodes of vomiting and continued to feel diaphoretic and weak. He rested laying down but was not feeling better. He could not tolerate any water or juice.
44 2021-04-22 heart rate abnormal, heart rate decreased, hypotension Dizziness, light headedness, nausea, cold sweat, fatigue, sleepiness accompanied by low blood pressu... Read more
Dizziness, light headedness, nausea, cold sweat, fatigue, sleepiness accompanied by low blood pressure of 90/59 and a low pulse rate of 50 bpm 10 minutes following injection. Symptoms alleviated within 30 minutes of onset except fatigue without further intervention.
44 2021-04-22 hypotension Patient received 1st Pfizer dose of Covid-19 vaccine at approximately 9:55am. Patient reported feel... Read more
Patient received 1st Pfizer dose of Covid-19 vaccine at approximately 9:55am. Patient reported feeling lightheaded and dizzy and "not right" at approximately 10:00am. Pharmacist took blood pressure reading (90/59 with pulse of 50) and initiated emergency response system (911). Paramedics arrived at approximately 10:05am and assessed the patient. After approximately 5 minutes under paramedic observation, the patient stated he was feeling better and the paramedics assessed the patient's blood pressure was normalizing. After another 5 minutes, the paramedics left when they thought the patient was fine. We kept the patient under observation for another 15 minutes and the patient, who was back to normal, left.
44 2021-04-25 chest discomfort Pt received Covid vaccine complained of pounding headache, dizziness, chest pressure, feeling hot a... Read more
Pt received Covid vaccine complained of pounding headache, dizziness, chest pressure, feeling hot all over. BP 131/87. HR 82, RR 18, O2 sat 98%, temp 98.3. Pt taken to Emergency Department to further care required.
44 2021-04-25 fainting syncope. Evaluated by EMS-Cleared.
44 2021-04-26 lightheadedness, fainting With first vaccine on 3/11/21 pt. had syncope due to vagal response-has "needle phobia". Second vac... Read more
With first vaccine on 3/11/21 pt. had syncope due to vagal response-has "needle phobia". Second vaccine was given 4/1/21, while supine, with no problems. Two days later he began experiencing shortness of breath which lasted about 5 days. He was about to call his doctor when it subsided. He is a runner and has no health problems (except seasonal allergies) and does not take any regular medications. He was not experiencing seasonal allergy symptoms during the episode of SOB.
44 2021-04-28 chest pain, hypertension Patient started feeling sweaty and clammy about 20 minutes after his second vaccination. We were wat... Read more
Patient started feeling sweaty and clammy about 20 minutes after his second vaccination. We were watching him for 30 minutes. He asked to have his blood pressure checked. He was cold and sweating and said he was having chest pain. We called 911. his blood pressure was high but his pulse was normal. The EMT took the patient to run tests.
44 2021-04-28 fainting Client fainted after receiving the COVID-19 vaccine. Attending nurse administered ammonia inhalant.... Read more
Client fainted after receiving the COVID-19 vaccine. Attending nurse administered ammonia inhalant. Client woke up. Fire Rescue arrived to evaluate. Clients vitals all within normal limits. Client showed no other signs of distress. No further evaluation needed as per Fire Rescue. Client was released to home at 10:05am.
44 2021-04-29 pallor Sweaty, pale and Dizzy reports has not eaten. Has a hx of anxiety b/p 110/78 PSO2 98% pulse 64 r... Read more
Sweaty, pale and Dizzy reports has not eaten. Has a hx of anxiety b/p 110/78 PSO2 98% pulse 64 respirations 14 monitored condition improved. informed to seek medical attention with any further problems.
44 2021-05-06 pulse abnormal A couple minutes after patient got the first dose of Pfizer vaccine, patient complaint not feeling w... Read more
A couple minutes after patient got the first dose of Pfizer vaccine, patient complaint not feeling well, sweating, tongue feeling funny and not able to see. My technicians laid him down on the floor and contacted 911 to send medics. Patient was still alert but later complaint difficulty breathing. Pharmacist notice swelling around pt's neck area and weak pulses. Pharmacist administered an epipen and stayed with patient. A few minutes later, patient symptoms subsided , medics arrived and brought him to the hospital.
44 2021-05-08 pulmonary embolism, deep vein blood clot Developed Deep VEIN thrombosis (DVT) in the left leg and a Pulmonary Embolism. Was hospitalized f... Read more
Developed Deep VEIN thrombosis (DVT) in the left leg and a Pulmonary Embolism. Was hospitalized for 5 days and had to have a surgical procedure to insert a screen into my inferior vena cava
44 2021-05-08 low platelet count, nosebleed, low blood platelet count, platelet count decreased ITP - he received the Pfizer COVID vaccine the day prior to admission. He subsequently felt fatigue... Read more
ITP - he received the Pfizer COVID vaccine the day prior to admission. He subsequently felt fatigued and awoke this morning with intermittent petechiae. While golfing, he subsequently noticed increased bruising over his left shoulder. He had two episodes of epistaxis for which urgent care and then ED evaluation revealed evidence of thrombocytopenia. Platelets found to be 3,000, normal Hb, normal WBC, no splenomegaly, no lymphadenopathy,. Oncology saw recommended decadron 40mg daily for 4 days
44 2021-05-10 nosebleed I got a very bad nose bleed that has been bleeding for about 30 minutes now; This is a spontaneous r... Read more
I got a very bad nose bleed that has been bleeding for about 30 minutes now; This is a spontaneous report from a contactable consumer, the patient. This 44-year-old male patient reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0170) via an unspecified route in the left arm on 22Apr2021 at 15:30 (at the age of 44-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have any known allergies. The patient did not receive another vaccine within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via unspecified route in the left arm on 30Mar2021 as a single dose for COVID-19 immunization. Concomitant medication included fluticasone propionate (FLOVENT). On 24Apr2021 at 22:00, the patient experienced a very bad nose bleed that had been bleeding for about 30 minutes now. When he put gauze up his nose to try and stop it the blood clotted into a very thick globule but it was continuing to bleed. The patient was not treated for nose bleed. The clinical outcome of nose bleed was not recovered. The patient was not tested for COVID post vaccination.
44 2021-05-12 lightheadedness Onset of warmth, dizziness, sweating after the vaccine. No Syncope. Felt better quickly when supine.... Read more
Onset of warmth, dizziness, sweating after the vaccine. No Syncope. Felt better quickly when supine. VSS No orthostasis before dismissal. Self resolving vasovagal reaction.
44 2021-05-13 low platelet count Patient is a 44 y/o gentleman with acute renal failure, elevated BNP and LE edema. Pulmonary consult... Read more
Patient is a 44 y/o gentleman with acute renal failure, elevated BNP and LE edema. Pulmonary consulted for medical management. Thrombocytopenia: - plt count stable today, Hgb stable - hematology consulted, appreciate recs: plan to send for serum antibodies to test for drug induced thrombocytopenia for carbamazepine and valproic acid - will hold protonix as possible offender - peripheral smear (Mercy OKC, 5/8/21): macrocytic red blood cells, moderate thrombocytopenia, rare focal platelet clumping present - less likely vaccine induced TCP---usually this is seen with the AstraZenca and Johnson and Johnson vaccine, not in Pfizer vaccine - if plt remains stable, may d/c home with plan for f/u with Dr outpt COVID-19: - case discussed with Health Department, COVID test for variant testing sent 5/6 - for now, will cont care in isolation - patient with positive COVID-19 test - positve COVID-19 test in January 2021, negative COVID-19 screen in April 2021 - pt with no active respiratory sx AMS: unchanged - waxing and waning mental status - improved AMS with improved renal fxn Acute renal failure: improving - Cr: 1.64, cont PO intake LE edema: - unchanged, low albumin levels, need to increase protein intake Chronic systolic heart failure: stable - cont to hold diuresis Disposition: - cont care in COVID unit, Pulmonary to follow Estimated length of stay is 5 day(s).
44 2021-05-14 chest pain Full body rash with swelling and hives and pain in his foot hands torso legs. He was given 100 mg of... Read more
Full body rash with swelling and hives and pain in his foot hands torso legs. He was given 100 mg of Benadryl by mouth and partial Medrol pack by family. Then later that day he went to the emergency room and was only treated with Decadron 10 mg and Benadryl 50 mg. He was discharged with a Medrol dose pack. Continues to have hives and pain all over his body.
44 2021-05-15 palpitations Heart racing Pulse: 87 Respirations :16 SPO2: 100% BP 130/78 Drunk water, rest to normal then discha... Read more
Heart racing Pulse: 87 Respirations :16 SPO2: 100% BP 130/78 Drunk water, rest to normal then discharged tp home
44 2021-05-16 chest discomfort, inflammation of the pericardium Intermittent pain in left arm/shoulder and left breast, internal, feeling like spasm in vein or simi... Read more
Intermittent pain in left arm/shoulder and left breast, internal, feeling like spasm in vein or similar, middle of night, woke me up from sleep, also slight heaviness in chest feeling, but no other symptoms
44 2021-05-16 pulmonary embolism Patient hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was multiple subsegmen... Read more
Patient hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was multiple subsegmental pulmonary embolism.
44 2021-05-23 stroke 5/24/21 - 44-year-old male with a past medical history significant for nicotine dependence, marijuan... Read more
5/24/21 - 44-year-old male with a past medical history significant for nicotine dependence, marijuana use, who presents for slurred speech. Accompanied by wife. Patient was in his normal state of health until Friday when he got his Pfizer Covid vaccine. About 5 hours later he was noted to have a headache and some slurred speech but patient and wife did not think anything of it. They went to some graduation parties this weekend and his speech continued to get worse which is what prompted them to present to the ED today. He denies that this is happened before. Feels like it is difficult for him to find words but not to actually say words. He does surf but denies being in murky water or swimming in fresh water. He denies IVDU. No underlying coagulopathy or cardiac history.
44 2021-05-24 chest pain chest pains during breathing (harshness of this has subsided), severe joint pain, chest pains what f... Read more
chest pains during breathing (harshness of this has subsided), severe joint pain, chest pains what feels like behind my heart, and it comes and goes
44 2021-05-24 fainting Patient had syncopal episode within 15 minutes of vaccination. Had history of similar episodes afte... Read more
Patient had syncopal episode within 15 minutes of vaccination. Had history of similar episodes after previous vaccinations. Patient felt better and was released to home.
44 2021-05-25 chest discomfort, fainting, loss of consciousness Fainting; Remained unconscious for a few seconds; Sweating; Minor tightness in the chest; Blurred vi... Read more
Fainting; Remained unconscious for a few seconds; Sweating; Minor tightness in the chest; Blurred vision; This is a spontaneous report was received from a contactable consumer (patient). A 44-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8734), via an unspecified route on 08Apr2021 at 13:15 as 1st dose, single in the left arm for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included Betamethasone Dipropionate Cream USP 0.05%. The patient had known allergies with Keflex (cephalexin). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 (5 minutes after vaccination), the patient experienced sweating, minor tightness in the chest and blurred vision followed by fainting and remained unconscious for a few seconds. After regaining consciousness, continued sweating for maybe 10 minutes. The patient visited emergency room. The patient did not receive any treatment for the events. On an unspecified date in APR-2021, the patient had recovered from the events.
44 2021-05-25 heart attack, cardiac arrest Got swelling of the heart that gave me a heart attack causing my heart to stop.
44 2021-05-27 blood pressure increased Patient experienced apprehension, flushing and numbness and tingling. Patient verbalized "Throat ti... Read more
Patient experienced apprehension, flushing and numbness and tingling. Patient verbalized "Throat tightness" and elevated BP even though pt reports being on BP medications. O2 sat and pulse remained normal. Lungs CTA. Patient has a history of reactions to bee stings. Pt was given 50mg Diphenhydramine observed by staff and released
44 2021-05-27 loss of consciousness Pt felt dizzy immediately after injection, pt had a slight tremor and labored breathing, counselled ... Read more
Pt felt dizzy immediately after injection, pt had a slight tremor and labored breathing, counselled pt to take deep breaths and stay seated, pt tried to stand and fell to the floor unconscious where he remained breathing but unresponsive for over 1 minute, came to on his own.
44 2021-05-31 heart flutter, palpitations, chest pain Would occasionally have difficulty catching my breath while not doing anything. I occasionally felt... Read more
Would occasionally have difficulty catching my breath while not doing anything. I occasionally felt my heart flutter or it would possibly skip a beat. Mild chest pain below above the sternum but I get that feeling from my Eosinophilic Esophagitis. I've become more concerned recently as I almost fainted once on 5/19 while working at my computer. I've had two other instances of feeling faint, most recently occurring on 5/27. I historically have had no heart issues and can ski and hike all day and feel great so this recent change has been concerning. After reading articles on the covid vaccines I realized that my symptoms are similar to the heart related issues and took ibuprofen when I felt additional chest pressure. That has helped to alleviate the pressure at least.
44 2021-05-31 chest pain 1st shot 4/13, no issue with injection site. About a week later had trouble breathing, chest pain, f... Read more
1st shot 4/13, no issue with injection site. About a week later had trouble breathing, chest pain, felt like lungs were hurting in my back, weak, tired, couldn't catch my breath when i went upstairs and almost passed out. 2nd shot 5/04, felt pain at injection site (that was expected), that night started to get a bad headache and got worse and worse. Next morning, whole body aching, upper body, lower back, bad headache, Left underarm (lymph) swollen. 2nd day slight headache, neck ache, left underarm swollen. That night had rash on arms, chest, and stomach. 3rd day, nighttime rash arms, chest, stomach. Still red where band aid was over injection site. Over a week later still have redness shape of band aid, Seems I have sensitive skin since the 2nd covid shot. 10 days after 2nd shot I still have redness the shape of the Band Aid on my left arm. Got a red spot on my nose (looks like Rosacea). 4 weeks later, still have a red spot on my nose. I have itchiness between fingers left hand, on my face left side, neck, arms (left wrist, right arm in places) redness on chest, and rashes on back, left buttocks, and itchiness on legs. i noticed that it gets worse at night. As far as i know i did not get the Covid Virus, i did the rapid test and regular test and both were negative. But i was very sick with my stomach and had issues breathing in late 2019 and again early 2020, took medication (antibiotics) both times. I had to write on this form over and over again kept getting frozen with error from the PDF. Even if I hit OK, it keeps popping up and does not let me finish, so I can imagine that lots of people gave up, like I may. Pfizer 4/13/2021 EW0162. After 5pm Pfizer 5/04/2021 EW0170. After 2pm
44 2021-05-31 troponin increased, hypertension Patient presented to the ED on 5/8/21 with hypertensive emergency. Per ER provider's notes: He was a... Read more
Patient presented to the ED on 5/8/21 with hypertensive emergency. Per ER provider's notes: He was at the VA today getting his 2nd Covid vaccine (Pfizer) and during the post vaccine waiting period, he developed frontal headache and transient L arm tingling. He was sent to ED in Superior and BP was as high as 219/114. He was given amlodipine and toradol and dilaudid and BP did not come down. He also had a slight elevation in troponin and had second episode of L arm tingling. Decision was made to not give ntg since he already had a headache. No chest pain or other neuro sx. Head CT neg for bleed. No chest pain. Patient presented to the ED again on 5/11/21 with similar symptoms as previous visit.
44 2021-06-01 chest discomfort, heart rate increased rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/proble... Read more
rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/problems with sleep; felt movements in his chest at times; felt like he had COVID all over again/ if he possibly has COVID-19 again; soreness; heart rate accelerated; some swollen in lymph nodes; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer sponsored program. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 at around 13:00 or 13:30 (at the age of 44 years old) (Lot Number: EP7534, unknown expiration) as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 in Nov2020; sneezing and runny nose both on 21Mar2021. The patient's concomitant medications were not reported. The patient reported that he received his first dose of Pfizer COVID vaccine on 22Mar2021. He felt fine after receiving the vaccine, but there was little bit rash on arms just afterwards and felt maybe a little restless but felt fine and went for a walk on 22Mar2021. As the night went on, he really noticed how sore his arm was/pain in his arm and when he was sleeping, he had trouble sleeping/problems with sleep (Mar2021) and felt movements in his chest at times (Mar2021). It felt like he had COVID all over again and had chills, soreness, and his smell was kind of gone in Mar2021. He was previously feeling pretty good. He had COVID-19 in Nov2020, and his symptoms feel very similar including loss of sense of smell but no coughing. He had a fever but that has gone away in Mar2021 and he did not take aspirin or anything for it. He also had fatigue, some swollen in lymph nodes, and his heart rate accelerated in Mar2021. He had sneezing and runny nose the day prior to receiving the vaccine. The patient would like to know if his symptoms are related to the vaccine or if he possibly has COVID-19 again. His symptoms are the same as COVID as far as what he can see, and his symptoms are really high. He would like to know if he can still receive the second dose of the vaccine if he has a positive COVID test after the first dose of the vaccine. The patient mentioned that there was very pretty high percentage of people having the symptoms after having the vaccine, kind of virus "causing". The patient asked if he needs to be tested to see if he had the virus before he was vaccinated and to know if these are one of the side effects or one of the symptoms of the virus, and to make sure that these are not actually corona virus. The patient recovered from fever in Mar2021, while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.
44 2021-06-02 chest pain Pain in both shoulders, neck and chest. Shortness of breath and lethargy
44 2021-06-02 low platelet count, platelet count decreased Thrombocytopenia
44 2021-06-03 chest discomfort Headache, stomachache, tightness in chest, shortness of breath, onset at ~2:30am, approx. 14.5 hrs a... Read more
Headache, stomachache, tightness in chest, shortness of breath, onset at ~2:30am, approx. 14.5 hrs after first shot. Headache lasted approx. 3 hours. At time of this report, the stomachache, chest tightness, and shortness of breath are continuing.
44 2021-06-03 platelet count decreased, low platelet count, troponin increased Patient who had been infected with COVID19 in December 2020 and received bamlanivimab therapy. After... Read more
Patient who had been infected with COVID19 in December 2020 and received bamlanivimab therapy. After recovery he received his COVID-19 vaccine series 4/1/2021 & 4/22/2021 with Pfizer-BioNTech. Patient then developed headache, chills, fever, body aches, thrombocytopenia, and elevated troponin levels on 5/10 and was admitted to the hospital 5/14. Concern for COVID-19 vaccine induced MIS-A or myocarditis. Patient received IVIG after ruling out other diagnosis and had a good recovery resulting in discharge home.
44 2021-06-08 fainting fainted three times felt heavy tunnel vision and ringing in my ear 10 minutes after receiving the va... Read more
fainted three times felt heavy tunnel vision and ringing in my ear 10 minutes after receiving the vaccine
44 2021-06-10 chest pain Tingling hands and feet started same day. Continues off and on for 6 weeks now. Chest pain upon eve... Read more
Tingling hands and feet started same day. Continues off and on for 6 weeks now. Chest pain upon even mild exertion like walking around the block. Lasted for a few weeks. Right arm bone pain severe lasted for about 3 weeks Spine felt swollen near coccyx/sacrum and C7-C6 pain. Feeling of Lower spine swelling and pain started less than 24 hrs. after. Lasted approx 2 weeks. Extreme tiredness lasted 2 weeks Baseball shaped raised area on chest near right arm(vaccinated arm) started perhaps a week in and lasted about a week.
44 2021-06-10 blood clot Blood clotting; This is a spontaneous report from a contactable consumer (patient). A 44-year-old ma... Read more
Blood clotting; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 21Apr2021 at 09:00 (at the age of 44-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and COVID-19 from an unknown date and unknown if ongoing. Concomitant medication included desvenlafaxine succinate (PRISTIQ) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: FR2613), administered in arm left on 25Mar2021 at 09:30 AM, for COVID-19 immunisation. The patient experienced blood clotting on 16May2021 at 22:00. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on an unspecified date (prior to vaccination). There was no treatment received for the event. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.
44 2021-06-12 chest discomfort, heart rate increased, ischemic chest pain, blood pressure increased WITHIN MINUTES OF TAKING THE FIRST DOSE, MY BLOOD PRESSURE AND PULSE DRAMATICALLY INCREASED. I FELT ... Read more
WITHIN MINUTES OF TAKING THE FIRST DOSE, MY BLOOD PRESSURE AND PULSE DRAMATICALLY INCREASED. I FELT DIZZY, AND MY FACE WAS NUMB. WITHIN MINUTES OF TAKING THE SECOND SHOT, MY BLOOD PRESSURE AND PULSE SPIKED. SINCE THE SHOTS, I HAVE EXPERIENCED DIZZINESS, FEELING OF FAINTING AND ELEVATED BLOOD PRESSURE. I HAVE EXPERIENCES PIERCING PAIN IN MY HEART, PRESSURE IN MY CHEST AND INCREASED PULSE EVEN WHEN RESTING. I HAVE EXPERIENCED HEADACHES, BLURRED VISION.
44 2021-06-14 heart rate increased Heart rate increased (sitting heart rate jumped to at least 110), breathing felt slightly more labor... Read more
Heart rate increased (sitting heart rate jumped to at least 110), breathing felt slightly more labored. Visited emergency room and underwent tests, no specific treatment given. Outcome is heart rate slightly lower, but still appears to be higher than previously observed.
44 2021-06-14 fainting Patient feeling faint and dizzy. Relieved within 10 minutes via cold compress and hydration.
44 2021-06-16 nosebleed Sore at injection site; Bloody nose; Diarrhea; Fatigue; This is a spontaneous report from a non-cont... Read more
Sore at injection site; Bloody nose; Diarrhea; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). This 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9810), via an unknown route, on 02Feb2021 11:30 (at the age of 44-year-old) as single dose for COVID-19 immunisation, administered at hospital. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. The patient did not have a relevant medical history and concomitant medications. On 03Feb2021 at 10:00, the patient developed sore at injection site, bloody nose, diarrhea, and fatigue. The patient was not treated for the events. The patient had recovered from the events on unknown date in 2021. No follow-up attempts are possible. No further information is expected.
44 2021-06-20 fibrin d dimer increased, chest pain, fast heart rate Waxing/waning constellation of symptoms that include shortness of breath, chest pain, tachycardia, a... Read more
Waxing/waning constellation of symptoms that include shortness of breath, chest pain, tachycardia, and fever along with recurrent eosinophilic pleural effusions.
44 2021-06-22 chest discomfort Altered sense of taste and smell. Things tasted different. I had a very dry mouth as well. I also sm... Read more
Altered sense of taste and smell. Things tasted different. I had a very dry mouth as well. I also smelled things that were not there. I lost my sense of smell 10 years ago due to sinusitis. I experienced lethargy about 5 days after the shot up to 4 weeks after. I had some tightness in my chest, my albuterol inhaler helped with that. The tingling in my hand and feet happened on a few occasions. I had numbness that lasted about an hour. I had frequent night sweats that woke me. I had muscle tightness in my leg and abdomen. I also had soreness in my arm, which made it hard to grasp a pen. I did test my reflexes which were normal.
44 2021-06-24 loss of consciousness loss of consciousness, shortness of breath was prescribed antibiotics they did not work.
44 2021-06-30 chest pain, hypotension, heart rate increased Interrupted his sleep; Stuff in his throat/weird stuff on his throat; Cough; weird stuff on his thro... Read more
Interrupted his sleep; Stuff in his throat/weird stuff on his throat; Cough; weird stuff on his throat; Rapid heart rate; really bad chest pains; vomit; nausea; gasping for air; Neck spasms; Blood pressure, clarified as low blood pressure; It was like he was catching pneumonia but then his nose was running,; severe congestion, like bad stuff in his chest and lungs; severe allergies; tired; he got really sick; It was like he was catching pneumonia but then his nose was running,; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and from a Pfizer sponsored program. A 44-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0167, Expiry date: UNKNOWN, NDC number: Unknown), via an unspecified route of administration at the right arm on 29May2021 11:15 as a SINGLE DOSE for covid-19 immunization. Medical history included myocardial infarction from an unknown date and unknown if ongoing, illness from Feb2020 to an unknown date, whole family was sick in February, palpitations from an unknown date and unknown if ongoing. History and investigation included "he said he had nothing to add during that time. But about a year ago he had gone to the emergency room for a heart attack scare. he thought, because this was when COVID first started happening, his whole family was sick in February and they would not test them at that time because they had not been to China and they never found out if they had it but he ended up getting tested for COVID when he was sick like 6 months later and then that went away and he started having heart palpitations and then after that he thought he would get a COVID antibody test and that came back negative, they told him by the time he got the antibody test, they told him he could have had it but it is not showing up on their antibody rapid test thing. He confirms this all occurred last year in 2020, he thinks it was almost a year ago. He would be sitting on the couch and his heart started racing like crazy. He did not know what that was all about". He said he had no discomfort at all. Concomitant medications were not reported. On an unspecified date in 2021 patient experienced it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running, on an unspecified date in 2021 severe allergies, on 29May2021 rapid heart rate, really bad chest pains, stuff in his throat/weird stuff on his throat , cough, on an unspecified date in May2021 vomit, nausea, on an unspecified date in May2021, gasping for air, on an unspecified date interrupted his sleep. Caller received his first dose and was experiencing symptoms such as rapid heart rate and neck spasms and blood pressure. He was too tired to go to the emergency room. He had the weird cough and also stated he had weird stuff on his throat and severe allergies. Regarding his second dose, he wanted to receive but he wanted to know if he could receive a half dose. He also had really bad chest pains and he was going to go to the emergency room but he was too tired to even go. The other reason for calling, he was trying to find out because he was afraid to take the second dose, he wanted to know if he could take a half dose or something, he was trying to find out what he should do. Severe allergies, caller clarified it was like severe allergies or like hay fever kind of, but it was different. Rapid heart rate: He said this began happening the same day as the dose was given, 29May2021, 4 hours after he got the shot. It was not ongoing, it lasted about a day. The rapid heart rate went away the next morning, it stopped doing the crazy things it was doing the next morning, 30May2021. He confirmed that has recovered completely. The chest pain coincided with the rapid heart rate. It went way the same time as the rapid heart rate. It seemed like they both would come and go until the next morning, He confirmed that had recovered completely. He said then the low blood pressure was going on too. It was like it interrupted his sleep, he did not know how to explain it, like he had low blood pressure or like his heart would stop beating and he would wake up gasping for air. It was kind of like a nauseous feeling, he wanted to vomit. It happened with the low blood pressure and was mostly when he was sleeping and a little through the day, the nausea he means, it lasted about a day and a half. The nausea went away on the 30May or the 31May he cannot remember for sure. The cough and stuff in his throat began at the same time the heartbeat stuff started and the cough went away after 2 days. He felt pretty good for about 3 days and then he got really sick, with severe congestion, like bad stuff in his chest and lungs. It was like he was catching pneumonia but then his nose was running, it felt weird like a sickly poison kind of feeling like after he got the shot, he could not tell but it seemed like severe allergies or like hay fever kind of but it was different, it was a weird feeling. He had taken a bunch of herbal remedies Benadryl took herbal allergy stuff and it worked really fast and after like 3 days it was gone. He does not know what that was but it was pretty intense. No further information provided. It was reported that, caller got his first dose of the Pfizer Covid-19 vaccine on 29MAY2021 and had side effects. He wanted to know if he could get only a half dose of the COVID-19 vaccine. He also wanted to know if there was any correlation to having COVID-19 and having more of a reaction. Caller wanted to know if there was a correlation between having COVID-19 and having more side effects to the vaccine. He stated that his Pharmacist said there might be a correlation to people having COVID before getting the vaccine and having more problematic side effects from the first vaccine instead of the second. Response was given as "he should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. He was referred to speak to healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider would have known the health situation and could access to information that better help inform the decision. From the CONS document on efficacy. Two shots were generally needed to provide the best protection against COVID-19 and the shots were given several weeks apart. The first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response. Side effects after the second shot might be more intense than the ones experienced after the first shot. The side effects are normal signs that body is building protection and should go away within a few days". The patient underwent lab tests and procedures which included sars-cov-2 antibody tested negative. Therapeutic measures were taken as a result of severe allergies (drug hypersensitivity). He visited emergency room due to the event chest pain. On an unspecified date in 2021 the outcome of the events it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running was unknown, on an unspecified date in 2021, severe allergies was recovered, rapid heart rate, really bad chest pains, cough was recovered on 30May2021, on an unspecified date in May2021 vomit, nausea was recovered, gasping for air, interrupted his sleep and stuff in his throat/weird stuff on his throat was unknown. Information on the lot/batch was available, Additional information has been requested.
44 2021-07-01 chest discomfort, chest pain experience chest pain and tightness. He had some dyspnea. This occurred for the next week or so wi... Read more
experience chest pain and tightness. He had some dyspnea. This occurred for the next week or so with the patient. He suspected it may be a myocarditis event. The pain is no longer present in
44 2021-07-01 chest pain Headache, congestion, aches and pains, joints, loss of energy, Concentration, loss of testosterone, ... Read more
Headache, congestion, aches and pains, joints, loss of energy, Concentration, loss of testosterone, chest pain, heart
44 2021-07-02 heart flutter, chest discomfort Throbbing in my head as if to start a headache, shortness of breath, pressure in the chest, dizzines... Read more
Throbbing in my head as if to start a headache, shortness of breath, pressure in the chest, dizziness, fluttering of the heart, feeling agitated.
44 2021-07-11 cardiac arrest Cardiac arrest, followed by seizure and death. Pt was hospitalized, undetermined cause of death, ca... Read more
Cardiac arrest, followed by seizure and death. Pt was hospitalized, undetermined cause of death, case send to a medical examiner. Case was noted upon chart review by reporter.
44 2021-07-15 ischemic chest pain Large rash on chest, pain through the body, wakes up drenched in sweat, low grade fever and chills, ... Read more
Large rash on chest, pain through the body, wakes up drenched in sweat, low grade fever and chills, sensations throughout body, feels as though electricity is going throughout body, stabbing pains in veins, heart pains, organ pains, reflux in veins and legs stabbing pains in eyes, double vision, blurred vision, light headed and dizzy, allergic reactions to foods. Doctor's were unable to diagnose him with anything. He stated that he has a history of mental illness,
44 2021-07-15 cerebral haemorrhage Severe stiffness and pain in upper neck/base of skull. Severe headaches. Blurred vision. No treat... Read more
Severe stiffness and pain in upper neck/base of skull. Severe headaches. Blurred vision. No treatment.
44 2021-07-15 fainting Pt fainted falling on L/side of head in 15 minute waiting area after vaccination. BP112/62 P62 R16... Read more
Pt fainted falling on L/side of head in 15 minute waiting area after vaccination. BP112/62 P62 R16 O2 SATS 96%. Red bump noted on L/side of head. Moved to resting are via w/c. 3:45PM Alert & talking. Left w/o assistance.
44 2021-07-17 heart flutter Numb face for ~2 hours. Heart fluttering. Right calf pain.
44 2021-07-18 hypotension The patient stated he was getting tunnel vision. At this point I came to the site of the patient and... Read more
The patient stated he was getting tunnel vision. At this point I came to the site of the patient and his pupils dilated. He became unresponsive. The patient started responding after about 1 minute. When the patient finally became responsive he began sweating quite a bit. We immediately began the emergency response and called 911 and called for store help. I stayed with the patient and when the paramedics got there they took over in the patient's care. The patient remained hypotensive, so the paramedics advised him going to the hospital. The patient agreed and was taken to the hospital.
44 2021-07-19 chest pain daily fever of 103.3, cough, diarrhea, chest pain, SOB, sore throat
44 2021-07-19 fainting, loss of consciousness Patient received Pfizer BioNTech COVID-19 Vaccine at approximately 9:43am. Patient was then sitting ... Read more
Patient received Pfizer BioNTech COVID-19 Vaccine at approximately 9:43am. Patient was then sitting in the post-vaccination waiting area in a chair and at approximately 9:46am when patient had syncopal episode and fell to the floor off of his chair. Pharmacist ran out to help patient who came to after approximately 5 seconds of being unconscious. Patient rested on floor for approximately 30 minutes before he felt comfortable enough to rise. At this time the patient's mother presented to the pharmacy to help. Mother reported that the patient and his sister have had previous episodes of syncope. Previous episodes were not reported by patient on consent form prior to vaccination. Patient left the store with his mother declining to fill out accident form with store management.
44 2021-07-21 deep vein blood clot Extensive right lower extremity DVT; "Extensive occlusive thrombus in multiple calf veins extending ... Read more
Extensive right lower extremity DVT; "Extensive occlusive thrombus in multiple calf veins extending throughout the external iliac vein and becomes partially occlusive in the distal common." found July 22. Likely developed much sooner.
44 2021-07-22 heart rate abnormal, blood pressure increased, heart rate decreased This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2, via an unspecified route of administration, administered in Arm Right on 21Apr2021 (Lot Number: EN6204) as DOSE 1, SINGLE at the age of 44 years old for COVID-19 immunization. Medical history included iodine dye sea salt allergy from an unknown date. Concomitant medications included testosterone taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. The patient has not been COVID-19 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 21Apr2021, the patient experienced having blood pressure stayed about 161/110 for 4 days until given steroid shot. Sea salt allergy went from mild to anaphylaxis in 2021. Trip to ER on 29May2021. Two trips to ER in June with abnormal heart beat and breathing issues in 2021. Now having diabetes issues in 2021. Doctors are puzzled that it all started with first Pfizer shot. No blood pressure issue at that time. Blood pressure randomly goes high and pulse will drop as low as 36 bpm in 2021. The events resulted in doctor or other healthcare professional office/clinic visit; and emergency room/department or urgent care. The outcome of the events was not recovered. No treatment given to the patient for the events.
44 2021-07-22 heart rate decreased, heart rate irregular, hypertension Blood pressure randomly goes high and pulse will drop as low as 36 bpm; Blood pressure randomly goes... Read more
Blood pressure randomly goes high and pulse will drop as low as 36 bpm; Blood pressure randomly goes high and pulse will drop as low as 36 bpm; Now having diabetes issue; Two trips to ER in June with abnormal heart beat and breathing issues; Two trips to ER in June with abnormal heart beat and breathing issues; Having reactions to anything with sodium over 50mg.; Sea salt allergy went from mild to anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12May2021(age at vaccination:44 Years) as single dose for covid-19 immunization. Patient didn't received other vaccination within 4 weeks prior to vaccination. Medical history included iodine allergy from an unknown date and unknown if ongoing, food allergy sea salt allergy from an unknown date and unknown if ongoing. Concomitant medications included testosterone (TESTOSTERONE) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested to COVID-19 to post vaccination. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number EN6204) via an unspecified route of administration in Arm Right on 21APR2021 as single dose for covid-19 immunisation. It was reported that blood pressure stayed about 161/110 for 4 days until given steroid shot. Sea salt allergy went from mild to anaphylaxis. Trip to ER on 29May from Turkey with sea salt. Since then having reactions to anything with sodium over 50mg. Went on low sodium diet. Two trips to ER in June with abnormal heart beat and breathing issues. Now having diabetes issues. Doctors are puzzled that it all started with first Pfizer shot. Was given Benadryl shot with second Pfizer shot on 12May2021. No blood pressure issue at that time. Blood pressure randomly goes high and pulse will drop as low as 36 bpm. Patient went for Emergency room and physician office visits for the events. The outcome of the events anaphylactic reaction, diabetes mellitus, heart rate irregular, dyspnoea, hypertension, heart rate decreased, reaction to food additive was not recovered. Information on the lot/batch number has been requested.
44 2021-07-22 palpitations, palpitations Profound malaise, nausea, vomiting within 24 hours afterward. Then ongoing cardiac palpitations and... Read more
Profound malaise, nausea, vomiting within 24 hours afterward. Then ongoing cardiac palpitations and a sense of skipped heart beats and vague dyspnea, still ongoing as of 7/23/2021 here in urgent care.
44 2021-07-23 blood glucose increased, chest discomfort About 15 minutes after vaccine was given, patient started feeling numbness and pain in right upper a... Read more
About 15 minutes after vaccine was given, patient started feeling numbness and pain in right upper arm where vaccine was given. Patient has a PMH of stroke on the right side and diabetes. Patient also reported itchiness in right leg and dizziness. Vitals were taken and neuro exam performed. Patient given water and snack but started feeling stiffness in neck. Referred to ED for evaluation of symptoms.
44 2021-07-23 loss of consciousness passed out; twitching; Gasping for air on the ground for less than a minute.; This is a spontaneous ... Read more
passed out; twitching; Gasping for air on the ground for less than a minute.; This is a spontaneous report received from a contactable consumer or other non hcp. A 44-years-old male patient received the second dose of bnt162b2 (COMIRNATY,Batch/Lot Number: Ew0168), via an unspecified route of administration, administered in Arm Left on 27May2021 09:00 as a single dose, and dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 09:15 (Batch/Lot Number: Ew0171) as a single dose for COVID-19 immunization . Medical history included blood cholesterol increased from an unknown date and unknown if ongoing and High cholesterol and triglycerides , blood triglycerides increased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On the third day after the second shot the patient did some yard work and then after coming inside passed out and was twitching and gasping for air on the ground for less than a minute. I then sat up took some juice and was fine. The patient experienced passed out (loss of consciousness) , twitching (muscle twitching) and gasping for air on the ground for less than a minute (dyspnoea). patient underwent lab tests and procedures which included blood cholesterol: high on High cholesterol and triglycerides , blood pressure measurement: fine and blood triglycerides. Prior and since the vaccination, patient was not tested for COVID-19. The patient didn't take any other vaccines 4 weeks before the COVID vaccine. The patient took the covid19 vaccine in hospital. Device date reported to be 11Jul2021. Follow-up actions are needed. Further information has been requested. Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.
44 2021-07-27 chest pain Blurred vision, dizziness for several days. Developed Ringing of the ears and some chest pains. Vi... Read more
Blurred vision, dizziness for several days. Developed Ringing of the ears and some chest pains. Vision disturbance and ear ring still present on this date Of report.
44 2021-07-27 hypertension Hypertension; Tiredness; Weakness; losing some muscles; He is also experiencing muscle deterioration... Read more
Hypertension; Tiredness; Weakness; losing some muscles; He is also experiencing muscle deterioration (no muscle pain); he's been feeling a light body (not hard to move); elevated liver enzymes; he told him he doesn't get enough sleep; nervous; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration on 22Apr2021 (at the age of 44-year-old) as dose 2, single for covid-19 immunisation. Medical history included, hypertension from 29Apr2021 to an unknown date, glucose tolerance impaired from 2010 to an unknown date Verbatim: Prediabetes, haemorrhoids from 09Mar2021 to an unknown date Verbatim: Hemorrhoids, hypovitaminosis from an unknown date and unknown if ongoing, asthenia from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) taken for haemorrhoids, pain, start and stop date were not reported; ascorbic acid, biotin, folic acid, iron, nicotinic acid, pantothenic acid, pyridoxine, riboflavin, vitamin b1 nos, vitamin b12 nos, vitamin e nos (CENTRUM ADULT B+ IRON) taken for hypovitaminosis from an unspecified start date and ongoing; ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) taken for covid-19 immunisation from an unspecified start date and ongoing; vitamin b complex (VITAMIN B) taken for asthenia from an unspecified start date and ongoing. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 01Apr2021 (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. On 25Apr2021, patient experienced losing some muscles, 0n 26Apr2021, patient experienced weakness, on 27Apr2021, patient experienced tiredness, on 29Apr2021, patient experienced hypertension. on an unspecified date in 2021, patient experienced muscle deterioration, he's been feeling a light body, elevated liver enzymes, he told him he doesn't get enough sleep, nervous. The patient underwent lab tests and procedures which included aspartate aminotransferase: 28 on 22Sep2020 Normal, aspartate aminotransferase: 46 on 30Apr2021 slightly elevated, blood test: elevated liver enzymes on 30Apr2021. Therapeutic measures were taken as a result of hypertension included losartan 25mg. The outcome of the events losing some muscles, tiredness, weakness were not recovered and the outcome of the remaining events were unknown.
45 2021-01-03 hypotension, heart rate decreased Patient became unresponsive for 10-15 seconds. Medical emergency called, along with 911. Upon reob... Read more
Patient became unresponsive for 10-15 seconds. Medical emergency called, along with 911. Upon reobtaining consciousness, patient was diaphoretic and clammy. Vital signs obtained - SBP in the 70s and HR in the 40s. Patient transport to the ED.
45 2021-01-04 blood pressure increased, chest discomfort, palpitations palpitations, chest tightness/heaviness, scratchy throat/frequent throat clearing, head heaviness, b... Read more
palpitations, chest tightness/heaviness, scratchy throat/frequent throat clearing, head heaviness, blurred vision, elevated blood pressure. Evaluated in ED received solumedrol, benadryl. Discharged home and returned to hospital as direct admit due to continued symptoms. Pertinent labs reveled AKI, elevated LFTs. AKI and LFTs improved with IVFs.
45 2021-01-04 chest discomfort 12/23/2020 sharp pain left lower breast, chest constriction lasted approx for 2 days on and off. 12/... Read more
12/23/2020 sharp pain left lower breast, chest constriction lasted approx for 2 days on and off. 12/26/2020 swollen left armpit, resolved 01/04/2020. Antibiotic prescription provided.
45 2021-01-06 blood glucose increased Patient received vaccination approximately at 10:45 am, he had told immunizer he had felt nervous ... Read more
Patient received vaccination approximately at 10:45 am, he had told immunizer he had felt nervous and had fainted previously with other vaccinations. Patient was monitored after vaccination patient said he felt dizzy, approximately 11:15 am he feel forward from chair and was attended to by staff. EMTs were called and patient was taken to hospital for observation. After vaccination pt had blood pressure readings of 130/80 5 min after 150/80 15 minutes after his blood sugar readings reported by family member on scene were 325 the previous evening and 255 the morning before he came in. EMTs took a blood sugar reading 365 upon their arrival.
45 2021-01-07 fainting While on duty and in uniform as an emergency paramedic I received my second scheduled covid19 vacci... Read more
While on duty and in uniform as an emergency paramedic I received my second scheduled covid19 vaccination. Approximately five minutes after receiving C19 dose 2 vaccination (1335hrs). I experienced a syncopal episode while walking back to my work area and was lowered to the ground by another EMS provider. I was then placed in a wheelchair by the EMS provider and an RN and taken to the emergency department at Medical Center. (1337hrs) I regained alertness and felt severe nausea and general weakness and was assisted into in ER bed. Staff doctor attended along with RN . An assessment was completed, 12 lead EKG completed, IV established, 8mg Zofran administered, 1000ml of Normal Saline was bolused. Labs were drawn. ED staff continued to monitor me for the next 2 plus hours I was monitored for anaphylaxis and other symptoms. My symptoms of nausea mostly resolved and my strength returned. A Resident MD completed a final evaluation and determined it was safe for me to be discharged. (1607hrs)
45 2021-01-09 heart rate increased, blood pressure increased Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swoll... Read more
Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swollen lower lip, nauseated, weird sensation of not feeling right almost like out of body
45 2021-01-09 fast heart rate Diaphoresis, petechiae, and tachycardia. onsent post vaccine, Benadryl 25 mg by mouth, 2nd round of ... Read more
Diaphoresis, petechiae, and tachycardia. onsent post vaccine, Benadryl 25 mg by mouth, 2nd round of sweating onsent: Benadryl 25 mg by mouth. Lower lip swelling, administered Epi-pen, called rapid response. Transferred to ED at 09:11am
45 2021-01-11 cardiac arrhythmia Frequent unifocal premature ventricular contractions; This is a spontaneous report from a contactabl... Read more
Frequent unifocal premature ventricular contractions; This is a spontaneous report from a contactable other healthcare professional. A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 21Dec2020 09:30 at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included fish oil (FISH OIL), zinc (ZINC). The patient previously took amoxicillin and experienced allergies. The patient experienced frequent unifocal premature ventricular contractions on 01Jan2021 12:00 AM. Patient reportedly lost his card. No treatment received for the adverse event. The outcome of the event was not recovered. The event was assessed as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
45 2021-01-12 hypertension Rash/rash on his forearm that went to both forearms; elevated blood pressure/He already has high blo... Read more
Rash/rash on his forearm that went to both forearms; elevated blood pressure/He already has high blood pressure and it was elevated after the vaccine; felt warm inside; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), via an unspecified route of administration in left arm, on 06Jan2021, at single dose, for COVID-19 immunization. Medical history included high blood pressure from Apr2020 and ongoing. Ongoing concomitant medication included lisinopril from Apr2020 for blood pressure/high blood pressure. The patient received the vaccine between 1:30-2:00pm yesterday afternoon (06Jan2021). He waited for 15 minutes after receiving the vaccine and he was ok. Later, on 06Jan2021, he developed a rash on his forearm that went to both forearms. He already has high blood pressure and it was elevated after the vaccine. During the night he felt like he was warm inside. He took a low dose Bayer Aspirin. The outcome of the event rash and hypertension was not recovered, and the outcome of the event feeling hot was recovered on 07Jan2021. Information on the lot/batch number has been requested.
45 2021-01-18 heart rate increased Patient received a shot at 12:12. This was his second shot in the series. By 1530, his heart rate... Read more
Patient received a shot at 12:12. This was his second shot in the series. By 1530, his heart rate was elevated (120 to 130 beats/minute) . He was afebrile, with no shortness of breath or chest pain. He came back and reported the problem without wanting to go to the ED. He decided to go home. By later on that evening, his heart rate was normal. To note: He stated that with his first shot, he had nausea, fever and fatigue.
45 2021-01-25 heart rate increased, heart flutter, blood pressure increased PT C/O FLUTTERING HEART, HEART BEATING FAST, DRY MOUTH, TINGLING IN CHEEKS. 1140: V/S TAKEN BP:158/1... Read more
PT C/O FLUTTERING HEART, HEART BEATING FAST, DRY MOUTH, TINGLING IN CHEEKS. 1140: V/S TAKEN BP:158/100 P: 110 RESP 16 SPO2 99%, ELEVATED BP AND PULSE. 1145: ADMIN OTC BENADRYL x 2 CAP PO. PT TOLERATE WELL. 1148: V/S TAKEN BP:150/96 P: 92 RESP 12 SPO2 99%. 1150: PT STATES THAT HE IS FEELING BETTER. A&Ox4. 1153: V/S TAKEN BP:150/96P: 92RESP 12 SPO2 99%. 1200: V/S TAKEN BP:146/92P: 91RESP 12 SPO2 98%. PT INSTRUCTED NOT TO DRIVE, AND F/U WITH PCM IN REGARDS TO H/O OF TIA WITH TODAYS V/S ELEVATED BP AND PULSE. PT WAS FEELING BETTER AND STABLE.
45 2021-01-26 heart attack, fast heart rate, chest pain, troponin increased coronary spasm; STEMI COVID vaccine induced; slight 1-2/10 substernal chest pain on/off; fever of 10... Read more
coronary spasm; STEMI COVID vaccine induced; slight 1-2/10 substernal chest pain on/off; fever of 101 to 101.7; diffuse severe muscle aches; tachycardia of 110 to 130; painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN); This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included benign prostatic hyperplasia (BPH). Concomitant medication included alfuzosin. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) in the left arm on 23Dec2020 16:00 at the age of 44 years old for COVID-19 immunization. On 14Jan2021, the patient started having fever of 101 to 101.7, diffuse severe muscle aches, and tachycardia of 110 to 130. Thursday evening (14Jan2021) through Sunday (17Jan2021), the patient also had painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN). Thursday evening (14Jan2021), the patient had slight 1-2/10 substernal chest pain on/off. Friday evening around 23:30 (15Jan2021), the patient had chest pain substernal 7-8/10 that lasted for one hour. The burning sensation was worse with cold air. It resolved with paracetamol (TYLENOL) and ibuprofen. Monday early morning at 04:00 (18Jan2021), the patient experienced STEMI COVID vaccine induced wherein the patient woke up with 10/10 chest pain and shoulder pain which lasted for 30 to 40 minutes and resolved with paracetamol and ibuprofen. The patient also decided to check blood work Monday morning (18Jan2021) while in the hospital. Trop came back 16.28 ng/ml. This is the old trop not high sensitivity. Normal high is 0.30 ng/ml. The patient went to the hospital. ECG showed ST elevation inferior lead. Left heart catheterization was done. The patient have clean coronaries. No evidence of any atherosclerosis. Echocardiogram showed normal EF. No wall motion abnormality. It was concluded that the patient also had coronary spasm. The patient underwent other lab test and procedure which included nasal swab COVID test showed negative on 18Jan2021. Outcome of the lymphadenopathy was recovered on 17Jan2021, of the chest pain was recovered on Jan2021, of the coronary spasm and STEMI was recovering, while of the remaining events was unknown. The events coronary spasm and STEMI resulted in hospitalization and life threatening illness.; Sender's Comments: The reported coronary spasm with chest pain and suspected STEMI were likely related to the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship, and no evidence of any atherosclerosis during left heart catheterization. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
45 2021-01-27 pulmonary embolism, deep vein blood clot The next morning I started to have some pain in my right calf which worsened throughout the day. Th... Read more
The next morning I started to have some pain in my right calf which worsened throughout the day. The following day I went to the ER with a DVT. I was given Xarelto for treatment.
45 2021-01-30 blood pressure increased Approximately 5 min after receiving dose, I felt dizzy/lightheaded and asked the nurse to check my ... Read more
Approximately 5 min after receiving dose, I felt dizzy/lightheaded and asked the nurse to check my BP. BP was markedly elevated at 188/96. Waves of dizziness every 5-10 minutes for an hour, and became milder through the day. BP remained elevated 140s-150s SBP until next day when back to normal at 115-125 SBP.
45 2021-01-30 hypertension, lightheadedness, heart rate increased approximately 30 minutes after injection of shot, felt dizzy, confusion, face and throat swelling, ... Read more
approximately 30 minutes after injection of shot, felt dizzy, confusion, face and throat swelling, rapid heart rate, feeling on the verge of passing out. Was driving home at the time and pulled over to call 911. 3 to 4 minutes of very intense reactions, had initial difficulty calling 911 and driving off the road to pull over. Paramedics arrived 10 minutes after the initial call to 911, symptoms had improved greatly after 3 to 4 minutes and after 10 was starting to feel back to normal.
45 2021-01-31 chest pain, arrhythmia I received the first dose on 12/23/20 and 1/13/21. 1-2 weeks after the first injection, I started to... Read more
I received the first dose on 12/23/20 and 1/13/21. 1-2 weeks after the first injection, I started to have occasional cardiac arrhythmia but I did not pay attention to. After the second dose, I found I have more frequent cardiac arrhythmia and now it is more frequent. Sometimes I also felt chest pain. As a scientist, I started to think about the possibilities. I think my current heart problem is associated with COVID-19 vaccine. It is possible antibodies raised against the spike protein generated from muscle cells cross-react with a protein in the heart and cause the problem. I am going to visit a family doctor or cardiologist to see what is going on in my heart.
45 2021-02-01 nosebleed Fever of 103-104 degrees for 10-12 hours; chills; congestion with bloody mucous; congestion with blo... Read more
Fever of 103-104 degrees for 10-12 hours; chills; congestion with bloody mucous; congestion with bloody mucous; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Jan2021 at 08:30 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included GERD and sleep apnea, both from unspecified dates and unspecified if ongoing. It was reported that the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported; however, it was reported that there were no other medications taken in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 27Dec2020 at 08:15 (at the age of 45-years-old) in the left arm for COVID-19 vaccination. On 16Jan2021 at 03:00 the patient experienced fever of 103-104 degrees for 10-12 hours, chills and congestion with bloody mucous. It was reported that the patient did not receive treatment for the events. The clinical outcomes of the events fever of 103-104 degrees for 10-12 hours, chills and congestion with bloody mucous were all recovered/resolved on unspecified dates in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
45 2021-02-08 pallor Patient presented in normal healthy condition. After describing side effects and precautions, patien... Read more
Patient presented in normal healthy condition. After describing side effects and precautions, patient was administered vaccine through intermuscular route. Patient appeared to have a normal response to the administration and showed no reaction. The patients wife was the administered the vaccine within 2-3 minutes in the same treatment room. After her administration, the patient was noted with his head positioned forward, pale skin color and no response to questioning. At that point an emergency response was called. The patient remained unresponsive. At the time he was seated. Within about 2 minutes, the patient was laid on the floor and quickly returned to normal consciousness. The emergency squad was called and responded in about 10 minutes. By the time the emergency arrived the patient was fully recovered; he did not require further medical intervention.
45 2021-02-08 low platelet count, platelet count decreased, blood glucose increased 45-year-old male follow-up from the ER. He received a COVID-19 vaccine on 1/22/2021. This was his fi... Read more
45-year-old male follow-up from the ER. He received a COVID-19 vaccine on 1/22/2021. This was his first dose. He began having bilateral lower extremity pain the following evening. In addition to the pain, he has been dealing with headaches, dizziness, auditory hallucinations, and large areas of redness and warmth on the left upper extremity and bilateral lower extremities. He went to the ER on 1/27/2021. Upon review of those records, he had microscopic hematuria. The patient states that he passed some kidney stones this week. Other abnormal labs include very elevated liver enzymes which the patient has not had before. He does not drink any alcohol. No new medications. He also had thrombocytopenia. O) Gen: Patient is in a wheelchair during today's exam. This is the first time he ever been in the exam room in a wheelchair. He required assistance to stand up. He says the pain is what makes it so difficult to stand up. Skin: On the left forearm, there is a large area of redness and swelling. The redness is relatively faint. On the lateral aspect of the right thigh, there is a large area of redness and swelling which is more prominent. ASSESSMENT 1. Severe myalgias 2. Elevated liver enzymes 3. Thrombocytopenia PLAN 1. Check sed rate and CRP. 2. Recheck CMP along with viral hepatitis panel and lipase. 3. Recheck CBC with differential. 4. Further recommendations based on these results. ADDENDUM Patient called on 2/1/2021 and reports his pain is getting worse to such an extent that he has been unable to make it to the bathroom fast enough and has been having accidents.
45 2021-02-11 inflammation of the heart muscle, ejection fraction decreased, hypotension, fluid around the heart, inflammation of the pericardium Pt received vaccine on 1/22/21. On 1/31/21 he presented to urgent care with fever and morbiliform r... Read more
Pt received vaccine on 1/22/21. On 1/31/21 he presented to urgent care with fever and morbiliform rash. He tested negative for the flu and was given empiric oseltamivir. He had persistent fever and was given doxycycline and ceftriaxone by urgent care on 2/2. On 2/4 at urgent care he was noted to be hypotensive and referred to ER. He had findings of cardiogenic shock and intra-aortic balloon pump was placed. He was treated for acute heart failure with improvement in symptoms. He was also treated for pneumonia with piperacillin/tazobactam as well as amoxicillin / clavulanic acid. He was discharged with resolved fever, resolved rash, and improvement in EF based on cardiac MRI. Workup for other viral causes of myocarditis was negative.
45 2021-02-17 fainting fainted; nausea; left arm began to tingle; dizziness; Broke out in a cold sweat; chills; Lost contro... Read more
fainted; nausea; left arm began to tingle; dizziness; Broke out in a cold sweat; chills; Lost control of my bladder.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL6269), via an unspecified route of administration in Left arm on 04Feb2021 15:00 (at the age of 45-years-old) at SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. 51 hours after receiving the vaccine, the patient was sitting down watching a film. His left arm began to tingle, and he felt a wave of dizziness and nausea come over him. He stood up, walked a few steps and sat back down. He broke out in a cold sweat, chills, and saw stars. He leaned forward with his head in his hands, and apparently fainted for a moment and lost control of his bladder. All events started on 06Feb2021 06:00 PM. No treatment received for the events. The outcome of the events was recovered in Feb2021. No covid prior vaccination, no Covid tested post vaccination, no known allergies.
45 2021-02-18 chest pain, palpitations 2 days after 2nd dose of vaccine, there were vision changes (blurred vision), pressure in head, and ... Read more
2 days after 2nd dose of vaccine, there were vision changes (blurred vision), pressure in head, and palpitations. Vision (only have one eye) has been hazy when looking at computer. This is still on going. Work up done by optometrist at this point eye checks ok but problem persist. Referral to ophthalmologist is place. Feeling of fogginess in head - "drunk like feeling" persisted for several weeks. This still seems to be on going. Palpitations and some check pain. - This was never a finding prior to 2nd dose of vaccine. This has resolved.
45 2021-02-21 heart rate increased Patient received his first dose on 2/1/21 and was observed for 15 minutes. He reported that after r... Read more
Patient received his first dose on 2/1/21 and was observed for 15 minutes. He reported that after returning home he has dizziness and weakness that lasted 45 minutes and then resolved without treatment. He did not seek care. On the day of his second shot (2/22/21) he said he had not taken his blood pressure medication that morning. His blood pressure was143/98 and pulse 70 prior to vaccination. At 10 minutes after the injection he reported feeling dizzy and having shortness of breath and feeling dry mouth. His O2 sat was 98%. Pulse had increased to 82 and then several minutes later was 110. He was placed on a monitor but a large size cuff was not available at the vaccination site. He continued to feel weak and more short of breath, so he was given a dose of epinephrine by autoinjector and EMS was called to transport him to the ER. At the ER, he was given diphenhydramine and his condition continued to improve. He was observed in the ER for 3 hours and discharged home.
45 2021-02-23 blood pressure increased, heart rate increased Roughly 30 minutes after administration of vaccine patient endorsed weakness, dizziness and shortnes... Read more
Roughly 30 minutes after administration of vaccine patient endorsed weakness, dizziness and shortness of breath. His blood pressure and heart rate increased during the event. He was treated with epinephrine 0.3mg IM due to concern for anaphylaxis and transferred to the ER via EMS. In the ER his vitals were stable and he was observed in the ER for 3 hours, with improvement in his symptoms. During the course of his stay he was treated with Benadryl, dexamethasone and albuterol. He presented with no hives, pharyngeal edema, wheezing, hypoxia or nausea/vomiting/diarrhea.
45 2021-03-02 chest discomfort, heart rate increased Extreme fatigue, Joint Pain full body, muscle pain, rapid heart rate, chest discomfort onset within ... Read more
Extreme fatigue, Joint Pain full body, muscle pain, rapid heart rate, chest discomfort onset within 2-3 hours. Progressive joint pain and headache within 24 hours, chest discomfort in and around the heart. Sought medical treatment after pain discomfort dis not alleviate within 3 days, on 3/1/21. Dr. prescribed steroid injection for inflammation, ordered cbc (negative) with follow up. Possible indications of possible Pericarditis. Follow up within 24-48 hours. Joint pain has lessened from total body to being located in wrists, knees, ankles, toes. Pressure/discomfort around heart/chest has lessened but not been eliminated. Awaiting possible ECG/EKG
45 2021-03-09 loss of consciousness patient was sitting after the shot in the waiting area for 15 min after the shot and one of his coll... Read more
patient was sitting after the shot in the waiting area for 15 min after the shot and one of his college who is sitting near by called me and said he passed out twice but when I went with the nurse he was ok and he said he did not. but his friend said no he did. we kept watch him closely for one hour. no symptoms observed. no sob , we offer him epipen or bendryl but he refused. I asked to call his family dr of pcp he said he does not have one. I called the patient on his sell phone after 6 hr of incident and he said he had no issue after that
45 2021-03-10 blood glucose increased Recipient stated began feel bad almost immediately after his injection, stayed 15 minutes and left v... Read more
Recipient stated began feel bad almost immediately after his injection, stayed 15 minutes and left vaccination area but waited in the parking lot and reported back into the vaccination clinic approx 45 minutes. Reported feeling very bad all over, trembling, glucose per his report of 148. skin was somewhat clammy to touch, bp 150/105 and 5 minutes later 170/110, hr 120s, rr 20, referred to PCP
45 2021-03-10 blood pressure increased Recipient reports feeling bad all over started immediately, shaking but waited in his car in the par... Read more
Recipient reports feeling bad all over started immediately, shaking but waited in his car in the parking lot after the 15 minute waiting period. Reported back into the vaccination site approx 45 minutes after his injection. Elevated BP 150/105, few minutes later was 170/110 hr 125 rr 20 skin clammy at intervals. Glucose 148 per his report from his insulin pump. No hypertension history or meds per his report.
45 2021-03-10 blood clot Acute right index finger digital ischemia after initial complete numbness from PIP joint distally ab... Read more
Acute right index finger digital ischemia after initial complete numbness from PIP joint distally absent any previous symptoms ever. Recurrence Jan 20 of same symptoms. Suspect antibody complex clot blocking terminal branches of digital arteries.
45 2021-03-19 loss of consciousness, lightheadedness pt felt lightheaded and was taken to triage area. vitals taken and were bp 147/83, HR 86, Po2 97. pt... Read more
pt felt lightheaded and was taken to triage area. vitals taken and were bp 147/83, HR 86, Po2 97. pt had a vasovagal episode and lost consciousness for 1 second. regained consciousness. pt states this has happened before. last time was 1 .5 years ago at work. pt states he is feeling well and feels fine to go home.
45 2021-03-20 fainting 45 yo M had syncopal episode after getting vaccine. Has hx of vasovagal syncope, usually with medica... Read more
45 yo M had syncopal episode after getting vaccine. Has hx of vasovagal syncope, usually with medical procedure or blood draws. Passed out for about 40 seconds, witnessed by son who was in the car. On my evaluation, symptoms had resolved,pt was asymptomatic, vitals unremarkable. Given juice, and observed in car. Subsequently discharged home.
45 2021-03-21 loss of consciousness 6 min after receiving vaccine dose, patient stood up, reported feeling light-headed and lost conscio... Read more
6 min after receiving vaccine dose, patient stood up, reported feeling light-headed and lost consciousness, striking his head while falling to floor. LOC x 10-15 sec, regained consciousness on own and was speaking immediately after. EMS was activated and patient was transported to local ER for eval via ambulance.
45 2021-03-21 palpitations After 2nd dose, I did not have a high fever but been fatigue and lightheaded/energy drained for 3 da... Read more
After 2nd dose, I did not have a high fever but been fatigue and lightheaded/energy drained for 3 days with heart palpitations like If I had OD on energy drinks. The symptoms disappeared on 4th and 5th but returned the 6th day morning ... feeling like I woke up after 2 tablets of Bynadril
45 2021-03-23 fast heart rate, blood pressure increased A few days after receiving the vaccine my blood pressure became elevated to 190. If I calmed down it... Read more
A few days after receiving the vaccine my blood pressure became elevated to 190. If I calmed down it got better. I felt like my heart rate raised a couple of times a day. The spikes in my blood pressure and heart rate lasted about four days. It felt a little like an anxiety attack. I was prescribed a Diuretic which I took for a week. When you got the second dose I did not have any of the same symptoms.
45 2021-03-25 blood pressure fluctuation Nausea, denies chest pain, SOB, no difficulty swallowing. Initial BP 143/87 (pulse 64), 100% O2 sat.... Read more
Nausea, denies chest pain, SOB, no difficulty swallowing. Initial BP 143/87 (pulse 64), 100% O2 sat. Final BP 133/89 (pulse 63), 100% O2 sat.
45 2021-03-25 fainting After vaccine vaccination, patient has vasovagal syncope. Patient states swelling of tongue, blurry ... Read more
After vaccine vaccination, patient has vasovagal syncope. Patient states swelling of tongue, blurry vision, nauseous hands tingling, dizzy and lightheaded. Called code green, paramedics arrived. Laid patient down flat down on cot. Patient is stable. BP 106/67 98% o2sat HR 65 RR 16
45 2021-03-27 pallor 0950 pt reported feeling "hot and sweaty and dizzy " 10 minutes after receiving vaccine dose. Instru... Read more
0950 pt reported feeling "hot and sweaty and dizzy " 10 minutes after receiving vaccine dose. Instructed to lay down on floor as also reported "feeling like I am going to pass out". Pt placed on gurney via backboard and placed in Trendelenburg position. transported to medical observation area. vs taken upon arrival to medical observation BP 116/79 P 93 pox 95%, strong pulse, pallor noted. Pt stated "feeling better" and color improved to pink , strong pulse noted. Pt placed in supine position on gurney. 0958 Pt continued to improve with HOB elevated to 45 degrees and pt given graham crackers and 4 0z apple juice . BP 133/89 P 90 pox 95%. 1010 Pt reports feeling much better, drank 4 oz water and ate more graham crackers. Pt reported that he had not eaten breakfast and only drank a cup of caffeinated coffee prior to receiving vaccine. Reports "feeling much better" with the water , juice and crackers. BP 124/84 P 89 pox 97%. 1025pt sitting in chair and reportins feeling "back to normal" BP 125/84 P 83 pox 96%. Pt discharged with instructions to f/u with pcp if any other symptoms today. instructed to remain hydrated today and to eat healthy lunch and dinner.
45 2021-03-28 fainting Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Fainting / Unresponsive-Medium
45 2021-03-28 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium
45 2021-03-30 loss of consciousness Patient told the monitoring nurse he is going to pass out; monitoring nurse stayed with patient and ... Read more
Patient told the monitoring nurse he is going to pass out; monitoring nurse stayed with patient and called paramedics for help; while waiting for paramedics patient passed out in the nurse?s arms; patient did not hit the ground; patient woke up after 30 seconds; paramedics arrived in two minutes; patient was offered Gatorade; patient rested and was not transported.
45 2021-03-30 fainting I fainted about 5 minutes after the injection. When I awoke, my fingers tingled, I was hot, and my b... Read more
I fainted about 5 minutes after the injection. When I awoke, my fingers tingled, I was hot, and my breathing was labored.
45 2021-03-31 loss of consciousness, heart rate decreased, pallor, hypotension A few minutes after shot administered pt slumped in seat was unconscious for a short time. he came t... Read more
A few minutes after shot administered pt slumped in seat was unconscious for a short time. he came too was embarrassed said he felt fine but a few minutes after he stated he was not feeling well at all. pt became pale, extreme sweating, and low blood pressure/pulse with BP machine. at that time paramedics was called and arrived when patient was beginning to feel better. Paramedics offer to take to hospital but pt declined and could walk with not feelin dizzy. followed up with patient this evening and he is feeling much better. Patient contact his MD and discussed with him. His MD advised him to receive shot lying down for second shot.
45 2021-04-01 fainting Several minutes after receiving his vaccination, he had a brief episode of syncope.
45 2021-04-03 heart rate increased slight elevated heart rate, nauseated, light headed, dizzy
45 2021-04-03 hypotension Within 3 minutes of receiving vaccine I had Instant fever, nausea, arm pain, face and lips numb, diz... Read more
Within 3 minutes of receiving vaccine I had Instant fever, nausea, arm pain, face and lips numb, dizziness, blood pressure low, chills. The pharmacy had to call 911 for a paramedic. I'm still feeling symptoms almost 24hrs later. I chose not to go to hospital in ambulance.
45 2021-04-05 blood pressure increased Within 60 seconds of receiving the injection, I experienced moderate breathing difficulty. After 1... Read more
Within 60 seconds of receiving the injection, I experienced moderate breathing difficulty. After 10-20 minutes, I noticed that my throat felt slightly swollen (slight difficulty swallowing). Due to a hyperallergic event that occurred about 12 years ago, I occasionally run into something that triggers the respiratory effect - although usually the reaction is milder than that caused by the vaccine. However, the throat swelling is new. I took a single puff of an Albuterol inhaler around 5 minutes after the injection, but it had no effect (usually the case for me when the cause is allergic in nature). About 37 minutes after the injection, medical staff advised me to take an antihistamine. I took approximately 6 mg of doxylamine succinate (orally). However, by this point, the breathing had already started to ease slightly. Approximately 30 minutes later, my breathing was back to normal and the throat inflamation was gone. It's uncertain how much of that would have occurred through time alone and how much of it was the antihistamine starting to take effect. My BP was very high when measured during treatment. Partially explained by the albuterol inhaler combined with pseudoephedrine taken earlier in the day, along with anxiety and exertion from the event itself.
45 2021-04-07 chest discomfort Reports had covid in Janurary. Complained of being lightheaded. Came in waves. Chest tightness 5 min... Read more
Reports had covid in Janurary. Complained of being lightheaded. Came in waves. Chest tightness 5 minutes. 1040 b/p 136/100 pulse 74 1050 b/p 126/78 pulse 62 1100 b/p 130/90 pulse 67 respirations even and unlabored.
45 2021-04-09 blood pressure increased, pallor Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely naus... Read more
Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely nauseous, weak, excruciating headache and dizzy. Unable to stand, had to crawl to nearby chair and call for wife. Thought might be dehydrated, extremely pale, tried to drink water, but began vomiting. BP was elevated, but no temperature. Tried to eat crackers and drink more water, but continued to violently vomit. Never felt so badly in entire life. No strength to stand or get up the stairs to be taken to ER, so had to call paramedics. When they arrived, BP had come down, but they felt needed to be transported to ER, so they took to healthcare facility at about 1:30 pm.
45 2021-04-10 pallor, fainting On initial assessment, client found sliding downwards from the chair, skin pale, diaphoretic, cool ... Read more
On initial assessment, client found sliding downwards from the chair, skin pale, diaphoretic, cool to touch, speech slurred. Client aroused to verbal stimuli. Client transferred to cot after ~ 15 seconds. Able to ambulate to observation with assistance.
45 2021-04-11 lightheadedness Vasovagel
45 2021-04-12 chest pain first, 2 days arm soreness, the 4th 5th 6th continued, nausea throwing up, chills, chest and body pa... Read more
first, 2 days arm soreness, the 4th 5th 6th continued, nausea throwing up, chills, chest and body pain when coughing, headache, light shortness of breath.
45 2021-04-13 chest pain chills, fever, shortness of breath, headache, vomiting, nausea, chest and rib pain when coughing, sw... Read more
chills, fever, shortness of breath, headache, vomiting, nausea, chest and rib pain when coughing, sweating
45 2021-04-14 deep vein blood clot, pulmonary embolism DVT in calf that turned in to substantial pulmonary embolisms in both lungs with no prior blood clot... Read more
DVT in calf that turned in to substantial pulmonary embolisms in both lungs with no prior blood clot history. Treatment included a TPA to dissolve clots as well as vascular surgery to remove clots not dissolved in the left lung.
45 2021-04-15 ejection fraction decreased, chest pain, heart attack, pallor - In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restle... Read more
- In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restlessness, pallor, R arm pain. - Telephone visit 4/14/21 complained of chills, nausea, vomiting, abdominal cramping, diarrhea. Fluids and rest recommended. - 4/15/21 presented to Kaiser with chest pain, shortness of breath, abdominal pain. Diagnosed with late presentation of acute coronary syndrome / anterior ST elevation MI. Echo with low EF < 25%, LV apical thrombus - 4/16/21 heart catheterization showed 100% occlusion of LAD treated with PCI / DES x 2, IABP. Endotracheal intubation for respiratory failure.
45 2021-04-15 ischaemic stroke Suffered ischemic pontine stroke 4 days after vaccine received. Does have significant risk factors ... Read more
Suffered ischemic pontine stroke 4 days after vaccine received. Does have significant risk factors including DM2, HTN, hyperlipidemia, family history of stroke.
45 2021-04-15 loss of consciousness HE PASSED OUT ABOUT 7 MINUTES AFTER RECEIVING THE VACCINE. ON SITE EMS RESPONDED. VITALS LISTED BELO... Read more
HE PASSED OUT ABOUT 7 MINUTES AFTER RECEIVING THE VACCINE. ON SITE EMS RESPONDED. VITALS LISTED BELOW. HE SAYS HE HAS A HISTORY OF PASSING OUT. HE RECOVED AND DID NOT WANT TO GO TO ER, SO HE WAS RELEASED TO HOME.
45 2021-04-15 fainting Suddenly got violently ill. Illness caused an episode of syncope while driving
45 2021-04-17 fibrin d dimer increased, pulmonary embolism Patient received his second Pfizer vaccine on Friday. Saturday he came down with symptoms that we co... Read more
Patient received his second Pfizer vaccine on Friday. Saturday he came down with symptoms that we considered were like the stereotypical second dose. Fever, cough, shortness of breath, coming and going. It lingered until Tuesday, at which time he got a Covid test- negative. Went to dr, and he said there was a possibility of blood clots. Tests showed that he had severe pulmonary embolisms in both lungs- the main and 3 secondary arteries.
45 2021-04-17 loss of consciousness passed out; fingers were tingling on both hands; very hot and sweating; breathing was labored; very ... Read more
passed out; fingers were tingling on both hands; very hot and sweating; breathing was labored; very hot and sweating; This is a spontaneous report received from a contactable consumer (patient) . A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EP7533) as single dose (at the age of 45 years old) for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included magnesium citrate taken for an unspecified indication, start and stop date were not reported. It was reported that about five minutes after the shot, the patient passed out in the observation area. When he awoke, his fingers were tingling on both hands, a was very hot and sweating, and his breathing was labored. Events onset date was 27Mar2021. The patient received lactated ringers as treatment. The outcome of the reported events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
45 2021-04-19 blood glucose increased, oxygen saturation decreased 3/28/21 Patient presented to ED w/SOB x 5 days, fever and cough for one day. RA pulse ox 42%. CXR sh... Read more
3/28/21 Patient presented to ED w/SOB x 5 days, fever and cough for one day. RA pulse ox 42%. CXR showed bilateral infiltrates. Pt refused intubation and was started on BiPAP w/FiO2 of 100%. Given Remdesivir and Decadron. Was placed in ICU. Also covered with zithromax and rocephin which was stopped after procalcitonin found to be normal. 4/1 Pt was weaned off BiPAP to HFNC 4/3 Pt was weaned off HFNC to 4L per NC. From 4/3-4/5 he had significant improvement. On 4/5 did not require O2 at rest but still had desaturation to 88% with ambulation. The team wanted to keep him an additional night but he demanded D/C. He finished 5 day course of Remdesivir prior to D/C and was to finish 10 course of Decadron after discharge
45 2021-04-19 deep vein blood clot DVT identified in the Left Gastrocnemius vein in the posterior medial calf
45 2021-04-20 blood glucose increased Day after shot, progressively felt sicker and more sore throught the day. Had a slight fever at 4 pm... Read more
Day after shot, progressively felt sicker and more sore throught the day. Had a slight fever at 4 pm. By 630 pm at a 102 fever. Very high blood sugars that I couldn't manage for the day. Night sweats and fever over night but fever broke by morning. Felt off on the third day. On the fourth day woke up with a locked neck which never happens and felt ill, tired, sore, had a cough and mild vertigo for next 4-5 days.
45 2021-04-20 chest pain, chest discomfort ~2230 chest tightness/pain (unlike asthma) that radiated to neck and left arm with left arm numbness... Read more
~2230 chest tightness/pain (unlike asthma) that radiated to neck and left arm with left arm numbness, anxiety He had taken 325mg of ASA 4x that day d/t right shoulder pain from previous injury
45 2021-04-20 chest pain Coughing, shortness of breath, aches/pains, chest tightness
45 2021-04-20 inflammation of the heart muscle, chest pain, heart attack 8 hours after 2nd pfizer covid vaccination. Fever 101.3 , chest pain with diaphoresis, trended tropo... Read more
8 hours after 2nd pfizer covid vaccination. Fever 101.3 , chest pain with diaphoresis, trended troponins to a nadir of 19.0. EKG changes with ST changes in 3 non-contiguous leads. Initially treated for an NSTEMI with heparin. Transitioned to colchicine and ibuprofen for myocarditis.
45 2021-04-21 skin turning blue Patient experienced a headache within 4 hours of vaccination. Took recommended dose of Tylenol. 4 h... Read more
Patient experienced a headache within 4 hours of vaccination. Took recommended dose of Tylenol. 4 hours after that (8 hours after vaccination) he was still experiencing extreme headache and also vomiting and took another dose of Tylenol. Was still feeling poor at 1am but coherent and talking, not thinking that it was serious enough to warrant going to hospital, as he believed it was just a bad headache and the vomiting was from the headache. At 6am, he was found blue/dead in his bed.
45 2021-04-22 troponin increased, inflammation of the heart muscle Acute Myocarditis
45 2021-04-24 transient ischaemic attack mini stroke; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male ... Read more
mini stroke; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm, on 30Mar2021 at 09:00, as a single dose, for COVID -19 immunisation. The patient's medical history included slight issues with cholesterol and pre diabetic, but the patient has been healthy. The patient has no known allergies and other medical histories. Concomitant medication was not reported. On 03Apr2021, 4 days after the patient received the vaccine shot, he was diagnosed with a mini stroke. The patient was shocked as he was too young and have had no medical issues in his entire life, only change was the shot. The patient also experienced numbness in his right arm and hand which subsided but he still has some numbness on the right side of this face. The patient was hospitalized for 1.5 days and treatment included taking low dose aspirin and Lipidore (as reported). The patient had no COVID prior vaccination and no COVID tested post-vaccination, the patient also had no other vaccine in four weeks and other medications in two weeks. Outcome of the event was recovering. Event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and disability or permanent damage. Information on the Lot/Batch number has been requested.
45 2021-04-25 heart rate increased rapid heart rate (100 beats per minutes) during April 25 (one day after vaccination).
45 2021-04-26 troponin increased, inflammation of the heart muscle, chest pain Symptoms consistent with myocarditis; EKG showed very subtle diffuse ST elevations; chest pain; dysp... Read more
Symptoms consistent with myocarditis; EKG showed very subtle diffuse ST elevations; chest pain; dyspnea; Troponin trended to 19; This is a spontaneous report from a contactable physician. A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Apr2021 (Batch/Lot number and Expiration date were not reported) as a single dose for COVID-19 immunization. Relevant medical history included chronic back pain, degenerative disc disease, and Clostridium difficile (C. Diff) colitis; the patient had no risk factors for cardiac disease other than obesity; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took cyclobenzaprine and pregabalin (LYRICA) and experienced allergies. It was unknown if the patient had other vaccine in four weeks. The patient had no COVID-19 prior vaccination. On 08Apr2021, 8 hours after the 2nd Pfizer vaccine was received, the patient developed chest pain with dyspnea. It was also reported that on 08Apr2021, troponin trended to 19; electrocardiogram (EKG) showed very subtle diffuse ST elevations; and the symptoms were consistent with myocarditis. All the adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit; an emergency room/department or urgent care; and hospitalization on an unspecified date for 3 days. The patient underwent lab tests and procedures, which included other/Xpert Xpress SARS-CoV-at assay: negative on 10Apr2021 (post vaccination). Therapeutic measures were taken as a result of all the events, which included colchicine and ibuprofen. The patient was recovering from all the events. Information on the batch/lot number has been requested.; Sender's Comments: Information provided was so limited to prevent a meaningful medical assessment. Other than a temporal association, there was no evidence or argument suggesting a causal relationship for BNT162B2 in the reported events, serious due to hospitalization. Otherwise, this patient did not show risk factors for cardiac disease, except for obesity. The impact of this report on the benefit/risk profile of the Pfizer product 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.
45 2021-04-27 cerebrovascular accident Dizziness, left arm/leg loss of movement. Confirmed stroke
45 2021-04-28 loss of consciousness, very slow heart rate After being seated for monitoring period after 2nd dose, patient was witness to loose consciousness.... Read more
After being seated for monitoring period after 2nd dose, patient was witness to loose consciousness. When nurse arrived to assist patient, patient took a deep, snoring breath and regained consciousness. After being placed on monitor, patient noted to be bradycardic with HR as low as 36. Pulse palpable. O2 sats remained stable. BP noted to be 80 palp. Blood glucose level noted to be 91. Patient coloring noted to be very dusky originally and patient noted to be clammy. Patient oriented when regaining consciousness. O2 applied via nasal canula and HR returned to low 70's. Patient given Gatorade and monitored by EMS. Patient declined transport to hospital and left ambulatory without any lasting symptoms.
45 2021-04-28 heart attack MYOCARDIAL INFARCTION on 4/23/2021
45 2021-04-28 pulmonary embolism acute dyspnea started 4/10, 1 day after second vaccination, no other provoking factors, symptoms per... Read more
acute dyspnea started 4/10, 1 day after second vaccination, no other provoking factors, symptoms persisted for 3 days, CT chest 4/13 showed extensive bilateral PE
45 2021-04-29 blood pressure increased Fever Cough Fatigue Muscle or body aches Elevated BP Shortness of breath Congestion or running n... Read more
Fever Cough Fatigue Muscle or body aches Elevated BP Shortness of breath Congestion or running nose
45 2021-04-29 cardiac arrest, cardio-respiratory arrest Pt presented to the hospital after a cardiac arrest. Work up showed renal artery thrombosis b/l cau... Read more
Pt presented to the hospital after a cardiac arrest. Work up showed renal artery thrombosis b/l causing renal failure and hyperkalemia. ROSC was achieved and pt coded multiple times after. We were unable to obtain CT A 2/2 to pt being unstable so only U/S imaging with doppler was used for diagnosis. Pt was treated with heparin gtt., hematology work up was sent but cause not identified. ECHO did not show thrombosis in the heart. CCRT was attempted but pt expired.
45 2021-04-30 cerebrovascular accident stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor functi... Read more
stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor function including movement and speech/couldn't speak; head was very tingly; speech was not slurred but more like there was an impediment; he couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to; Caller states he thought he was going to die, his body was shutting down; behavior change; his legs are shaky; eyes feel a little dry; thumbs weren't working right; rule out MS or Parkinson's; rule out MS or Parkinson's; I have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head; he was a little dry thought he may be dehydrated; very tired; pounding headache in the back of his head constantly; he was twitching; really off-feeling; digestive issues/digestive problems; eyes were real mucusy/First week mucous in my eyes/could be allergy; eyes were real mucusy/First week mucous in my eyes/could be allergy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 25Mar2021 as single dose for COVID-19 immunization on an unspecified facility. There were no medical history. No known allergy. The patient had no health issues with any severity, he is pretty athletic, pretty healthy. The patient's concomitant medications were not reported. No COVID-19 prior to vaccination. On 26Mar2021, the patient had digestive issues/digestive problems, eyes were real mucus, first week mucous in my eyes which could be allergy which resolved on 01Apr2021. On 06Apr2021 08:00 the patient reported that he couldn't move/loss of motor function and movements were off but his cognitive functions were fine, loss of motor function including movement and speech/couldn't speak, had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, suffered a stroke or mini stroke and was sent to the emergency room. On 06Apr2021 at unspecified time the patent couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, head was very tingly, speech was not slurred but more like there was an impediment, very tired, pounding headache in the back of his head constantly, he was a little dry thought he may be dehydrated, he was twitching, really off-feeling, and states he thought he was going to die, his body was shutting down. On an unspecified date, the patient had eyes feel a little dry, thumbs weren't working right, his legs are shaky, and noticed behavior change. The patient was hospitalized for 3 days from 06Apr2021 to 09Apr2021 due to thought he was going to die, his body was shutting down, stroke/mini stroke, couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak. The patient underwent lab tests and procedures which included IGG antibody test: positive and IGM antibody test: negative both on 19Apr2021, computerised tomogram: showed nothing on 06Apr2021, echocardiogram: unknown result on unspecified date, magnetic resonance imaging brain: showed nothing both on an unspecified date in Apr2021 (not sure if 15Apr2021 or 16Apr2021) and on 07Apr2021, COVID-19 test: negative on 06Apr2021, repeat COVID-19 test: negative on 07Apr2021. Therapeutic measures were taken as a result of stroke/mini stroke, loss of motor function including movement and speech/couldn't speak have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head which includes TPA and digestive issues/digestive problems were treated with high fiber diet. The outcome of the event he was going to die, his body was shutting down, stroke/mini stroke, he couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak, have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, very tired, pounding headache in the back of his head constantly was not recovered, for the events digestive issues/digestive problems, eyes were real mucusy/first week mucous in my eyes/could be allergy was recovered on 01Apr2021, while for the rest of the events was unknown. Caller states he has an appointment with a neurologist and he's trying to get it moved up. Caller states his doctor wants to do a lumbar puncture to rule out MS or Parkinson's that sort of thing. Caller states but at this point they are trying to rule things out. Caller states he doesn't have a family history of really either them. Caller states there was no diagnosis. Caller states the doctor said he was pretty sure its a stroke, mini stroke, but his general practitioner doesn't think its a mini stroke. Caller states the effects are so long going and they will improve and fall back and then the doctor also said at the fact that has been cognitively aware the whole time, so there's been no official diagnosis yet.
45 2021-04-30 chest discomfort It's difficult to pinpoint the exact time the symptoms started, but they were definitely present by ... Read more
It's difficult to pinpoint the exact time the symptoms started, but they were definitely present by the time I awoke the following morning. No arm pain -- but nine days of brain pain, waking up feeling like my head was split, at least five days of altered vision, and most disturbed were my breathing and my heart. I felt for many days like I had a Brillo Pad in my lungs and heart, as well as lots of pressure in the chest and shortness of breath/labored breathing. Two days ago I thought I might be having a heart attack. The symptoms lightened yesterday morning (day nine) though I still have strange sensations in the head and taking a full, deep breath is not totally easy yet. .
45 2021-04-30 blood clot three blood clots in right leg; This is a spontaneous report from a contactable consumer. A 45-year-... Read more
three blood clots in right leg; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613, Expiry date not reported), via an unspecified route of administration, administered in the left arm on 25Mar2021 15:00 (age at vaccination was 45 years) as single dose for COVID-19 immunization. Medical history included drug hypersensitivity (sulfonamide allergy) from an unknown date and unknown if ongoing, and seasonal allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included fluticasone propionate taken for an unspecified indication, start and stop date were not reported; olopatadine hydrochloride (PATADAY) taken for seasonal allergy, start and stop date were not reported. The patient experienced three blood clots in right leg on 09Apr2021 20:00 with outcome of recovering. Therapeutic measures were taken as a result of three blood clots in right leg (thrombosis) that included blood thinners (Eliquis). The event was reported as serious, medically significant. No follow-up attempts are possible. No further information is expected.
45 2021-05-01 palpitations Developed heart palpitations 1 week after 2nd COVID vaccine
45 2021-05-04 anaemia fever and malaise began 4/12/21 followed by migratory headaches and myalgia, several days morbillifo... Read more
fever and malaise began 4/12/21 followed by migratory headaches and myalgia, several days morbilliform rash, brief diarrhea and abdominal pain
45 2021-05-06 inflammation of the heart muscle, deep vein blood clot Myopericarditis with fatigue, myalgias, joint pains, and dispnea on exertion since his second COVID ... Read more
Myopericarditis with fatigue, myalgias, joint pains, and dispnea on exertion since his second COVID 19 shot. Pt also found to have a DVT.
45 2021-05-07 chest pain, fainting nearly fainted twice; I've been having weird pains in several spots inside my muscles all over the p... Read more
nearly fainted twice; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; pains in chest; catching my breath; very cold and clammy; This is a spontaneous report from a contactable consumer (the patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0169), via an unspecified route of administration, on 14Apr2021 at 11:30 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing, irregular heart beat and depression from an unknown date and unknown if ongoing. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient did not have any other vaccines within four weeks prior to the vaccination. The patient stated that when he first got the shot he actually nearly fainted twice and had to lay on the floor for a while. It was very scary, he thought he was going to die. He got very cold and clammy and had pains in chest and had a hard time catching his breath. They checked his vital signs a couple times and said they looked good. But he still felt sick and they said if he did not feel better soon they may have to call for an ambulance for him. Eventually he felt better enough to where he was able to get up off the floor and on handicap cart to drive out of there. Also, he's been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his left hand ring finger tip. It's pain that is in spots, it feels like mini-charley-horses that lasts anywhere from 20 something to 30 something seconds. Now it's mostly continuous pains in his thigh muscles between his legs. And a pain in one spot in his left arm bicep. This has been happening for days." The patient experienced "nearly fainted twice" on 15Apr2021 with outcome of not recovered, chest pain, got very cold and clammy and had a hard time catching his breath on 15Apr2021 with outcome of not recovered. He also reported that he has been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his left hand ring finger tip. it's pain that is in spots, it feels starting on 15Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included unspecified investigation: myalgias on an unspecified date . Therapeutic measures (unspecified) were taken as a result of the events.
45 2021-05-09 fibrin d dimer increased, deep vein blood clot Deep vein thrombosis (DVT). Woke up on 4th day after vaccine (May 5, 2021) with pain in calf. Swelli... Read more
Deep vein thrombosis (DVT). Woke up on 4th day after vaccine (May 5, 2021) with pain in calf. Swelling continued to get worse. Went to an emergency room just over one week after vaccine (May 8, 2021) and was diagnosed with DVT in the lower left calf (after D Dimer test and ultrasound). No family history of clotting issues. And no personal history of clotting issues. Currently on Rivaroxaban (Xarelto), 15 mg twice per day. Will be on for at least 3 months (moving to 20 mg once per day after the first 21 days).
45 2021-05-09 fainting Syncopal Episode with seizure episode then syncope again. EMS at vehicle. Close to refused transport... Read more
Syncopal Episode with seizure episode then syncope again. EMS at vehicle. Close to refused transport to hospital. Called emergency contact after EMS checked client out.
45 2021-05-11 pulmonary embolism, fainting patient was Diagnosed with Pulmonary Embolism after her second covid vaccine. patient symptoms were ... Read more
patient was Diagnosed with Pulmonary Embolism after her second covid vaccine. patient symptoms were dyspnea and syncope . Patients treatment is to take Eliquis everyday.
45 2021-05-12 stroke Tiny small vessel acute infarct within the left dorsal midbrain
45 2021-05-12 chest discomfort about 10 minutes after the shot his fingers felt "strange". Soon after his chest felt tight and he ... Read more
about 10 minutes after the shot his fingers felt "strange". Soon after his chest felt tight and he felt weak. No SOB. No tongue or month swelling. He felt faint, but did not have a syncope episode. Vitals were taken x 2 )201/106 pulse 117 pulse ox 97%. Patient was A&Ox3 and laid down on a cot. He was sent to hospital via ambulance. EMS called at 1202 and arrived at 1215. left facility at 1220.
45 2021-05-19 blood clot pain in his leg that felt like a clot; pain in his leg; This is a spontaneous report from a contacta... Read more
pain in his leg that felt like a clot; pain in his leg; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on Mar2021 at 11:15 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing venous insufficiency since 2019. Concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks of the vaccine. The patient stated that he received his first dose on 30Mar2021 or 31Mar2021. On an unspecified date, the next day after the first vaccination, the patient experienced pain in his leg that felt like a clot for the first week and a half to two weeks. Then, the patient got a little bit better, even though he had almost gone to the emergency room, but he got better after a couple weeks. The clinical outcome of "pain in his leg that felt like a clot " was resolved on Apr2021. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021507016 Same patient/drug, different dose/event
45 2021-05-20 fainting, pallor Shortly after receiving the vaccine the patient fainted and bumped his head from the fall. He was ve... Read more
Shortly after receiving the vaccine the patient fainted and bumped his head from the fall. He was very pale, clammy, hot and somewhat disoriented from the reaction. After some water, food, and sitting patient recovered almost fully. He does report having similar reactions to other vaccines/blood draws. He was checked on by phone that same night and about 36 hours later and overall was doing ok.
45 2021-05-23 arrhythmia, heart rate increased, atrial fibrillation Developed high heart rate >150bpm with irregular rhythm on 5/16 around 12:00pm, Sought care at Emer... Read more
Developed high heart rate >150bpm with irregular rhythm on 5/16 around 12:00pm, Sought care at Emergency Department, diagnosed with paroxysmal atrial fibrillation, first known occurrence. Treated with metoprolol and metoprolol tartrate, and returned to normal rate and sinus rhythm by 3:00pm.
45 2021-05-25 chest pain Significant increase in neuropathic pain lasting over 45 days. Breathing difficulties, daily nausea... Read more
Significant increase in neuropathic pain lasting over 45 days. Breathing difficulties, daily nausea episodes, upper right abdominal pain, muscle weakness, increased pain to all areas below T6, inability to breath without pain. Fatigue. Lasted acutely for over 30 days. Symptoms including breathing difficulty, nausea, and increased peripheral nerve pain continue to linger.
45 2021-05-25 ejection fraction decreased From hospital discharge summary: "45 y.o. right-hand-dominant male who presents with few hours of i... Read more
From hospital discharge summary: "45 y.o. right-hand-dominant male who presents with few hours of improving left arm heaviness/left hand cramping in the setting of getting his second Pfizer COVID-19 vaccination in his right arm 3 days ago and 3 weeks of mildly increased exercise/intermittent fasting. The patient reports getting his first Pfizer COVID-19 vaccination on April 7, 2021. Reports some mild symptoms afterwards. Around that same time, the patient reports having a checkup with his primary care doctor that was notable for a cholesterol elevation to 200. This prompted him to try and lose weight including intermittent fasting and increase in exercise, especially for exercises and cardio. The patient reports approximately 20 pound weight loss over the past 3 weeks. 3 days ago, the patient reports getting his second Pfizer COVID-19 vaccination in his right arm. Reports fever (maximum 103 Fahrenheit) and mild headache the subsequent 2 days after the vaccine. Last night, the patient went to sleep on his left side at around 8 PM. He woke up at 4 AM with significant left arm heaviness and left hand cramping. He tried to massage his hand with some slight improvement of the symptoms but otherwise the symptoms persisted. Hence, this morning, he called his PCP, who told him to come into the ER for further evaluation. Here, the patient reports improving left arm heaviness/left hand cramping. He also does report family history of heart attack and an uncle at a similar age and massive heart attack of his grandfather in their 60s. He denies fever, anorexia, unexpected weight change, headache, blurry vision, sinus pressure, cough, hemoptysis, orthopnea, PND, SOB, DOE, chest pain, pleurisy, changes in taste/smell, N/V/D, abdominal pain, flank pain, urinary sxs, genital sxs, black stools, incontinence, absence of flatus, calf pain, leg swelling, numbness/tingling, streaking redness/rash/skin changes, easy bruising. Also, deny history of HTN, DM, smoking, prior MI, prior PCI, prior CABG, prior TIA/CVA, or history of PAD. Further, denies recent trauma/fall, history of cancer, blood thinner use, recent drug use, recent travel, sick contacts, family history of connective tissue disease/congenital aortic anomaly, or family history of similar sxs. --- Hospital Course by Problem # Troponinemia (Likely myopericarditis) The patient has a family history notable for MI and CABG in relatives aged 50-70 on his mother's side. The patient notes that most of these family members were heavy smokers and drinkers, which he is not (never-smoker, rare EtOH, never illicit drugs). His symptoms are notable for L arm heaviness/cramping that began around 8pm on 4/30/21 at 9/10 severity and subsequently was 3-4/10 severity on presentation to ED and is 0-1/10 severity at time of admission to the floor; he has no associated numbness, weakness, coolness, or pallor. His symptoms are non-exertional. He denies CP, SOB, lightheadedness, nausea, jaw pain, abdominal pain, fatigue. He noes that he recently got the second COVID shot in the R arm, and had a post-vaccine course notable for Tmax 103 ~3d ago and 101 as recently as yesterday. His EKG was notable for ST-elevation in II/III/aVF and his troponins were elevated 305 -- > 298 -- > 328. Of note, his CRP was elevated at 69. The patients symptoms and findings could certainly be compatible with atypical ACS and, given the low risk of bleeding associated with heparin, he was treated conservatively upon admission with heparin infusion, metoprolol tartrate 6.25mg q6h, atorvastatin 80mg (he received ASA 325mg in the ED). However, given his recent covid vaccination and elevated CRP and reported fevers, this could also be compatible with myocarditis or other inflammatory etiology. TTE on 5/3 demonstrated preserved EF 55% with no WMA. Given reassuring TTE, a cMRI was ordered to assess for myocarditis vs scar tissue from recent ischemic event. Cardiac MRI on 5/5 was notable for finding consistent with myopericarditis (see below). Aspirin and atorvastatin was stopped on discharge. Patient was discharged with metoprolol 25 mg daily."
45 2021-05-25 pallor A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel rig... Read more
A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel right and hands were very sweaty cold his eyes rolled back in head. Lost his color loss control of bodily functions( urine). Throwing up hard. EMT were called vitals were alright. Once we were home vomiting subsided and he slept hard.
45 2021-05-27 chest pain chest pain, shortness of breath. Occurred within 48 hours of injection. Lasted 7 days.
45 2021-05-27 deep vein blood clot LLE popliteal DVT
45 2021-05-27 pallor, loss of consciousness Approximately 5 minutes after administering the vaccine, he was waiting in his car with a friend, He... Read more
Approximately 5 minutes after administering the vaccine, he was waiting in his car with a friend, He became unresponsive and appeared to have lost consciousness. Upon arrival to the vehicle he looked to be having a seizure. Did not respond to verbal commands but did respond to sternal rub. EMS called. BP 118/58 and pulse 60. He was diaphoretic and pale. EMS arrived and during their interview he had another more intense and longer seizure. Transported to the Emergency Room.
45 2021-05-27 troponin increased, chest pain, heart failure Eosinophilic myocarditis presenting as pleuritic chest pain, elevated troponin and cardiogenic pulmo... Read more
Eosinophilic myocarditis presenting as pleuritic chest pain, elevated troponin and cardiogenic pulmonary edema related to heart failure, ejection fraction and improved and patient successfully discharge from the hospital. Of note, patient also tested positive for rhino/entero on RVP and FIP1L1-PDGFRA rearrangement.
45 2021-05-29 body temperature decreased Symptoms: chills, low body temperature (especially at night, last night's measure: 96.2 F), muscle p... Read more
Symptoms: chills, low body temperature (especially at night, last night's measure: 96.2 F), muscle pain (particularly around kidneys' area), joint pain, and headaches. Treatment: after 3 days of persistent symptoms, I talked to a doctor who recommended taking ibuprofen. I took ibuprofen for 3-4 days which mitigated the symptoms. Symptoms returned after a few days and persisted until now (17 days after vaccination)
45 2021-06-01 blood pressure increased, chest pain Shortness of breath when physically active. Chest pains, pain / numbness in arms. Elevated Blood Pre... Read more
Shortness of breath when physically active. Chest pains, pain / numbness in arms. Elevated Blood Pressure, sweating, light headedness, dizziness, nasuea.
45 2021-06-02 blood clot -tightness in inner thigh- day or so after first dose -tightness in calf worsened over the course of... Read more
-tightness in inner thigh- day or so after first dose -tightness in calf worsened over the course of a couple weeks -swelling and soreness in calf gradually increased until doctor visit -doctor visit and ultrasound found multiple blood clots in mid thigh and calf -doctor prescribed blood thinner -continued swelling and tightness in thigh and calf
45 2021-06-03 heart rate increased Unwell feeling; Nausea; diarrhea; heart beats a bit higher than normal at rest (+10 mre than usual);... Read more
Unwell feeling; Nausea; diarrhea; heart beats a bit higher than normal at rest (+10 mre than usual); This is a spontaneous report from a contactable Other Healthcare Professional. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on Left arm on 11Feb2021 at 02:30 PM, (at the age of 45-years-old) as a 1st dose single for COVID-19 immunization at Public Health Clinic The patient's other medical history was not reported. Patient had Advil PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) the day before, and a Pre-workout supplement in two weeks both on unspecified dates. Patient did not have any known allergies. The patient did not receive any vaccine within 4 weeks prior to the dose of vaccine. He did not have covid prior vaccination. On 12Feb2021 patient experienced Unwell feeling. Nausea, diarrhea and heart beats a bit higher than normal at rest (+10 mre than usual). Patient did not have any treatment for the events. He had tasted for covid post vaccination for Nasal Swab, on 02Jul2020 which was Negative. The Outcome of the events was not recovered. Information about lot/batch number has been requested. Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
45 2021-06-03 platelet count decreased I woke up with petechiae on 5/10. By 5/11 the petechiae developed into thrombocytopenia purpura with... Read more
I woke up with petechiae on 5/10. By 5/11 the petechiae developed into thrombocytopenia purpura with a platelet count fo 1000, including mouth lesions and prolonged mucosal bleeding. Admitted Hospital for treatment on 5/11. Treatment included a high dose of oral dexomethasone for four days, IVIG transfusion for two days, and a single platelet transfusion. Fluid developed in the lungs, but that was determined to be a byproduct of treatment, and not part of the adverse reaction. By the time of discharge on 5/14, platelet count had risen to 88000. One week later at outpatient, platelet count had risen to 180000.
45 2021-06-03 lightheadedness Vasovagal episode following vaccination. Spontaneous resolution once placed in supine position. Para... Read more
Vasovagal episode following vaccination. Spontaneous resolution once placed in supine position. Paramedics on site. No treatment required.
45 2021-06-07 chest pain Two to Three days after my 2nd dose of the Pfizer vaccine I woke up around 4 am by a foul odor taste... Read more
Two to Three days after my 2nd dose of the Pfizer vaccine I woke up around 4 am by a foul odor taste and or smell i stayed in bed the smell and taste got very bad for 2 weeks and went away on it's own,on the 4th day after vaccine i woke up and went to brush my tooth It Felt like I pour acid into my mouth with a severe burning feeling followed by severe gum and tooth pain also some sporadic chest pain.I looked into my mouth and noticed my entire mouth looks like bumps and or hives looking about 7 days later most of the bumps/hives turned into ulcers.this symptoms is still present,also around day 4 or 5 I shaved my short beard and noticed a tiny balled patch of beard under my chin ever since this is getting worse and it is about the size of a quarter or more.I went to see my Family Physician and was told these symptoms i having could be from nasal polyps and or sinuses she did blood work to check for sickness everything came back negative,i was told to talk to my Immunologist and or an ENT I went 05/25/2021 to see the Immunologist and he said their was no evidenvce of nasal polyps that the vaccine must have did something to my immume.
45 2021-06-07 nosebleed severe headache by night time; got a light nosebleed; This is a spontaneous report from a contactabl... Read more
severe headache by night time; got a light nosebleed; This is a spontaneous report from a contactable consumer (patient himself). A 45-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8737; Expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 07May2021 as single dose for COVID-19 immunization. Patient medical history included food allergy, allergic to aspirin and shellfish, everybody got COVID-19 in the house from, local anaesthesia from 07May2021 to 07May2021, Caller stated he had a dental cleaning that same morning as the vaccine with anesthesia that was local, from 07May2021 to 07May2021. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was not provided. The patient had not any other products. The patient had not received any other vaccines within 4 weeks of COVID vaccine. The patient's concomitant medications were not reported. The caller reported that he was about to get his second dose of the vaccine and the nurse asked about his first dose. On 07May2021 after first dose he had a severe headache by nighttime about an hour later which lasted for 4 days. Caller stated the nosebleed started on the same day 07May2021 as receiving the vaccine around 10:00-10:30 which lasted until Sunday. The pharmacist asked him to call us to see if he could get the second dose. They did not know what could happen to him with his second dose because of this. He stated he was really allergic to aspirin and shellfish too and didn't know if that was the problem. The caller wanted to know if shellfish was a part of the vaccine. It was enquired that, Pfizer-BioNTech COVID-19 Vaccine contain aspirin or not. Patient was not visited to Emergency Room/ Physician Office. Reporter seriousness for headache and nosebleed was Unspecified. AE(s) following prior vaccinations was not provided. Caller stated he just took Tylenol for side effects and went to bed. Patient had not any relevant tests. The outcome of event headache was recovered on 09May2021 and nosebleed on 10May2021. Information about lot/batch number available, no further information is expected.
45 2021-06-07 transient ischaemic attack 1 day after receiving vaccine I experienced "brain fog". Approximately 10 days afterwards (around 2... Read more
1 day after receiving vaccine I experienced "brain fog". Approximately 10 days afterwards (around 2/25), I experienced symptoms of a minor stroke - I experienced lack of coordination in typing and later that evening experienced difficulty with speaking and comprehension, but only for a few minutes. A few days later, that weekend, I had some issues playing songs on the piano I had played before, making a lot of mistakes. About another 2 weeks afterwards, on 3/9/2021, I experienced more symptoms of stroke. For most of the day I had issues with typing, and later that evening I had some coordination issues with closing a soda bottle. On the morning of 3/10/2021, I continued to experience issues with typing and also had difficulty speaking and understanding my wife. At this point I went to the emergency room and was found/diagnosed to have experienced multiple TIA strokes.
45 2021-06-10 chest discomfort 15 - 20 min post vaccine, patient complained of bilateral hand/feet tingling/numbness. Vague heavine... Read more
15 - 20 min post vaccine, patient complained of bilateral hand/feet tingling/numbness. Vague heaviness across chest and throat. Feels warm and anxious. Treated with diphenhydramine 25 mg po x 1, diphenhydramine 25 mg IV x 1, Diphenhydramine 50 mg IV x 1 (had developed angioedema/throat swelling). Admitted to hospital and then transferred to another facility.
45 2021-06-10 heart rate decreased, fainting, hypotension I almost got fainted or black out; My blood pressure and heart rate dropped to 76/55/42 respectively... Read more
I almost got fainted or black out; My blood pressure and heart rate dropped to 76/55/42 respectively; My blood pressure and heart rate dropped to 76/55/42 respectively; Sweaty; Clammy; This is a spontaneous report from a contactable consumer. This 45-year-old male consumer (patient) received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration administered in arm right on 27May2021 12:26 (Batch/Lot Number: EW0180) as single dose for covid-19 immunisation. There was no medical history or concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received first Pfizer dose in his right arm at 12:26 PM on 27May2021. even minutes after vaccination, at 12:33 PM, he almost got fainted or black out. His blood pressure and heart rate dropped to 76/55/42 respectively. The patient was sweaty and clammy for about 3 minutes. At 12:40 PM, his blood pressure and heart rate elevated to 103/69/65. At 1:05PM, his blood pressure and heart rate came back to normal 120/84/67. The patient drove home afterwards without further reaction. He was a heathy male with no underline health condition. The patient have been testing for COVID-19 once a week since 07May2021 and all test results came back negatives (on 28May2021). The events result Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The outcome of blood pressure and heart rate dropped was recovered on 27May2021 1:05PM, of other events was recovered in May2021. No treatment was received for the events.
45 2021-06-10 palpitations 6/11/21: heart palpitations followed by subconjunctival hemorrhage in left eye. Never had one before... Read more
6/11/21: heart palpitations followed by subconjunctival hemorrhage in left eye. Never had one before. My wife had exact same thing happen to her on 6/6/21, but in addition to palpitations and burst eye vessel, she had temporary high bp/pulse. I did not measure mine. Reporting because we both had same vaccine not terribly far apart and now both of us got burst veins in our sclera. Not sure if just odd coincidence or something more, so reporting it. We both will be getting COVID testing to rule that out.
45 2021-06-10 inflammation of the pericardium, heart attack NSTEMI, Systolic CHF, postmyocardial infarction, pericarditis
45 2021-06-10 inflammation of the pericardium Acute pericarditis; This is a spontaneous report received from a contactable consumer (patient). A ... Read more
Acute pericarditis; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0162), via an unknown route in the left arm, on 15Apr2021 (at the age of 45-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER8730) administered in Mar2021 for COVID-19 immunisation. No relevant medical history was provided. The patient was not diagnosed with COVID-19 before vaccination. The patient did not have concomitant medications. No other vaccine was received in four weeks. On 13May2021 at 13:00, the patient was found to have acute pericarditis. The event was assessed serious because requiring hospitalization. An angiogram was done, and results were not provided. On 14May2021, a Nasal Swab was done and resulted negative. The patient was recovering from the event.
45 2021-06-15 heart rate increased Severe migraine severe dizziness vertigo brain fog it?s relentless nonstop 24 seven from the time I ... Read more
Severe migraine severe dizziness vertigo brain fog it?s relentless nonstop 24 seven from the time I wake up until the time I go to sleep severe pain in every single droid back arms legs feet it doesn?t matter I literally can?t function thank you I really appreciate the vaccine and went along way to help give me Covid symptoms is what I did I?m beyond frustrated every single day I can?t go to work I can?t do anything I can?t live I can?t function I?m in chronic pain. Let?s not forget the increased heart rate where I feel like I?m going to die Please get this poison out of me help me The pain is relentless in all my joints I can?t function why did I take this my push something. Everywhere I?ve ever had a problem from concussion two herniated disc it seems like the pain is exacerbated in all these areas even my notes wrist arms. I was perfectly fine until I got the shot. Oh I also can?t look at a cell phone I can?t look at screens that makes the migraines worse. 2 months of daily suffering thanks
45 2021-06-15 fainting Symptoms started morning after 1st shot and increased in severity through out the day. Vertigo, diz... Read more
Symptoms started morning after 1st shot and increased in severity through out the day. Vertigo, dizziness, light headed and fainting. Mobility was mildly impaired in the morning. By midday mobility was severely impaired, not able to walk straight, head spins, mild nausea.
45 2021-06-17 chest pain - Chest pain after 1.5 months from the second shot - Left arm numbness - Shortness of breadth - Har... Read more
- Chest pain after 1.5 months from the second shot - Left arm numbness - Shortness of breadth - Hard to stay asleep - Lack of energy
45 2021-06-23 palpitations, blood pressure decreased After the 1st dose (3/29/2021), neck inflammation started on the right-side of the neck. The neck in... Read more
After the 1st dose (3/29/2021), neck inflammation started on the right-side of the neck. The neck inflammation got worse after the 2nd dose (4/19/2021). The neck inflammation is still present. Starting 5/11/2021: Intense adrenaline surges started happening every night between 3 am-7 am. My heart feels like it is beating extremely hard. I have checked my pulse and it is normal during the events (ranges from 65-90 bpm). I have checked blood pressure and it is usually in the 120/80 range (normal for me). However, there have been occasions where blood pressure drops to 100/70. These adrenaline surges and hard heart beats tend to get better if I stand up and move around. It will get worse again if I lay down. I have these on occasion during the day, but I am usually able to calm myself down. I have had scenarios where I feel fine during the day, but will lay down. The hard heart beats start almost immediately. I'm also exercise intolerant now. If I do anything more than a brisk walk, I feel very terrible and faint with a hard heart beat. One interesting data point, my father has the same symptoms and his started about the same general timeframe after his second dose of the Pfizer vaccine.
45 2021-06-25 chest discomfort No side effects after the 1st vaccine. No noticeable side effects until 58 hours after the 2nd vacci... Read more
No side effects after the 1st vaccine. No noticeable side effects until 58 hours after the 2nd vaccine. Fatigue most likely started until 48 hours after the shot. At hour 58 post-vaccine and for the next 36 hours: fever up to 102F, chills, cold sweat, muscle pain. Headache (pain level 4). At hour 96 post-vaccine and for the next 36 hours: urinary incontinence, cluster headaches (pain level 8, which required a tele visit and a Diclofenac prescription). An easy exercise outdoor (a walk) was attempted on day 6 after vaccine; abandoned after 0.25 of a mile due to chest tightness and a discomfort in the heart area. Slow return to easy exercises attempted again on day 8 after the vaccine. Max athletic output at 50% of capabilities prior to the vaccine. As of June 10th chest tightness and dull pain in the center/right side of the chest still experienced, which was reported to the primary physician during the annual checkup. As of June 21th chest tightness and dull pain in the center/right side of the chest still experienced; in addition ? a dull pain in the shoulder blade area when air was inhaled and held. As of June 25th max athletic output at 80% of capabilities prior to the vaccine.
45 2021-06-25 heart rate irregular, atrial fibrillation After receiving my first dose of the Pfizer vaccine I experienced erratic heartbeats/afib. It start... Read more
After receiving my first dose of the Pfizer vaccine I experienced erratic heartbeats/afib. It started on Saturday, two days after receiving the shot and I debated on whether to go to the ER. I ended up seeing my cardiologist the following week but by then was feeling better. The irregular heartbeats last about 3 days, getting progressively better by the third day, but it was a very slow process. Obviously very scary since it was pretty severe at first and I didn't know if I was having a cardiac event.
45 2021-06-25 inflammation of the pericardium PERICARDITIS; This is a spontaneous report from a contactable pharmacist (patient himself). A 45-yea... Read more
PERICARDITIS; This is a spontaneous report from a contactable pharmacist (patient himself). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13Jan2021 at 13:00 (Batch/Lot Number: EL3248) (at the age of 45-years-old) as unknown, single dose for COVID-19 immunisation. Medical history included blood pressure. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. On 13Feb2021 at 09:00, patient experienced pericarditis. The event resulted emergency room/department or urgent care. Patient was given Naproxen 500mg twice a day as treatment. Outcome of event was recovering. Since the vaccination, patient has not been tested for COVID-19.; Sender's Comments: Based on the information currently available, a causal association between the reported event pericarditis and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and investigators, as appropriate.
45 2021-06-25 fainting Site: Pain at Injection Site-Mild, Additional Details: Patient was sitting in chair and fainted appr... Read more
Site: Pain at Injection Site-Mild, Additional Details: Patient was sitting in chair and fainted approx 5 mins after vaccination. His mother got my attention after he picked himself off the floor. Pt reported blacking out and falling on the carpet. He had a small bruise with a little bleeding (from carpet burn). His mother gave him water and I got him some paper towels to wipe off the small amount of blood on forehead. I asked pt if history of fainting and he said yes. He said he didn't mention it because the more it is discussed, the worse it is.
45 2021-06-30 chest discomfort Shortness of breath, pounding chest. Seems like myocarditis.
45 2021-07-01 hypotension, fainting Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Medium
45 2021-07-03 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild
45 2021-07-05 fainting patient came in for his second dose of the Pfizer covid vaccine, patient stated on their intake form... Read more
patient came in for his second dose of the Pfizer covid vaccine, patient stated on their intake form that the TDAP vaccine had caused him to faint in the past. after discussion with the patient, he stated that the first dose of the Pfizer vaccine did make him dizzy for a few minutes after the vaccine, but he did not faint following the first dose. After the first dose, because of his history with TDAP, patient was asked to stay for 30 minutes on site, after 30 minutes not further side effects other than the temporary dizziness. After that discussion it was decided to administer the second dose. Immediately after the dose, patient appeared to suffer from syncope, immediately becoming dazed and his eyes closing, within 1 to 2 minutes he became alert, aware of name and dob, etc. Patient's pulse and vitals were WNL. Offer was made to call ambulance for further evaluation, but patient declined. The pharmacist, remained with patient for 30 minutes to monitor, he continued to be fine.
45 2021-07-07 excessive bleeding First dose, I only had a sore arm, second dose, I had fever beginning ~12 hours after injection and ... Read more
First dose, I only had a sore arm, second dose, I had fever beginning ~12 hours after injection and lasting until ~36 hours after. The subsequent illness I reported in V-safe seems unrelated to my vaccination. I experienced fever (up to 102 degrees) and general malaise for three successive nights starting on June 4th, 2021 (2+ months after second dose). The fever only came at night and broke in the early morning each night. I had two COVID screenings on June 7th, both came back negative. The final fever occurred the night of June 6th. I continued experiencing malaise and general weakness and had some bloodwork done. My bloodwork came back indicating Fe deficiency anemia, and I have been experiencing this condition since. The cause is suspected to be due to overuse of NSAIDs in dealing with a bulging disc in my cervical spine from early March onward. I am scheduled for endoscopy to further investigate whether I am having bleeding issues causing the anemia. as previously mentioned, seems unrelated to vaccination.
45 2021-07-15 lightheadedness, chest pain Chest pain (heart area), waves of extreme fatigue, occassional tingling in legs, three instances of ... Read more
Chest pain (heart area), waves of extreme fatigue, occassional tingling in legs, three instances of pre-syncope.
45 2021-07-18 chest pain, enlargement of the heart On 10/1/21 I got the flu shot at High School. 1.5 weeks later I had debilitating left chest pain whe... Read more
On 10/1/21 I got the flu shot at High School. 1.5 weeks later I had debilitating left chest pain where I felt crippled. It last for about 3 days. I felt it on and off but did not get treatment. I then received the Pzifer vaccine and 3 weeks after the 2nd one I had the same pain. I went to the doctor and said I had all of the symptoms of myo or peri-carditis. Doctor didn't think it was that and ordered XRays for that day and a Echocardiogram 2 weeks later (first available appt). Results showed very mild enlarged heart but nothing major. I know it was from the vaccines. My heart rate was 35-36 at the time of the tests. I am very healthy and physically fit. The only thing that the chest pain could be from is from the vaccines, both the flu shot Oct. 2020 and the Pfizer Covid vac 4/2021.
45 2021-07-18 deep vein blood clot Within 48 hours of receiving Pfizer vaccination on 4/7/21, I developed a significant DVT blood clot ... Read more
Within 48 hours of receiving Pfizer vaccination on 4/7/21, I developed a significant DVT blood clot in my right leg, which I've been receiving treatment for ever since. No prior condition/diagnosis of this. Noticed on 4/9/21, didn't hurt, but it felt like there was something in my leg. Woke up 4/11/21 and could barely walk. Thought I strained my calf/leg. Had to travel for work. Returned home on 4/25/21. Took myself to ER on 4/27/21 and received treatment, including diagnosis, ultrasound, eliquis. Have been seeing vein doctor monthly ever since.
45 2021-07-22 loss of consciousness Patient experienced loss of consciousness, difficulty breathing, muscle rigidity, nausea and vomitin... Read more
Patient experienced loss of consciousness, difficulty breathing, muscle rigidity, nausea and vomiting. 911 was called. Patient declined transport to hospital.
45 2021-07-23 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: After adminstration during obeservation ... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: After adminstration during obeservation period, patient briefly fainted fell from chair and scraped head slightly. Patient sat up on own back into chair, gave some water and did some deep breathes to help relax. Continued to observe no further symptoms, patient was anxious before adminstration.
45 2021-07-27 superficial blood clot Partial clot; has been experiencing pain and aching in his leg; didn't sleep at all that night; hear... Read more
Partial clot; has been experiencing pain and aching in his leg; didn't sleep at all that night; heart was feeling weird; having pain in the vein; Venous insufficiency; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date : unknown), dose 2 via an unspecified route of administration, administered in arm right on 27Apr2021 11:15 as dose 2, single for covid-19 immunisation. Medical history included peripheral venous disease from 2019 and ongoing. The patient's concomitant medications was not reported. Historical vaccine of BNT162B2 for COVID-19 immunization on Mar2021 at the age of 45-year-old as per first dose. Prior Vaccination (within 4 weeks prior): None. He has no family medical history, just his personal medical history. He already had venous insufficiency to some degree present but the COVID vaccine made it worse. He was diagnosed in 2019. Caller says that he got the Pfizer COVID vaccine and he is having some little adverse events. He has called a couple doctors today for an appointment to go in and be seen and they all suggested for him to call Pfizer as well. He clarifies that his adverse event is that he has a little bit of venous insufficiency already but it was relatively okay but with both doses of the COVID vaccines, immediately it was like a a switch. As soon as he got the COVID vaccines the situation got much worse for him. He had pain in his leg that felt like a clot for the first week and a half to two weeks after his first dose. Then he got a little bit better, even though he had almost went to the emergency room but he got better after a couple weeks. After his second COVID vaccine, starting that same night, last Tuesday, to now he has been experiencing pain and aching in his leg and he feels like his venous insufficiency went from a 5 to a 10 and it doesn't seem to be getting better so he is going to go see a doctor but they suggested for him to let Pfizer know about this. It was reported that first dose, his pain began the day after he had his COVID vaccine. His second dose was on 27Apr2021 and his 1st dose was 4 weeks before that, so his first dose was either on 30Mar2021 or 31Mar2021. His clarifies that his pain actually began the second day after his first dose. Second dose, the same day of his COVID vaccine, 27Apr2021, he felt pain in his legs and his whole body was flushed and he felt hot. He also didn't sleep at all that night and his heart was feeling weird. He had read that the racing feeling is part of the initial reaction so he had let it go. Then the next couple of days he had felt better and then he started having this feeling of stinging, burning pains in his leg where he knows that vein is, it's his superficial great saphenous vein. He has been having pain in the vein and it has been stinging, burning and aching and he can't sit for more than 20 minutes. He has been exercising every day, drinking water, elevating his leg on the wall to drain it but as soon as he sits again it starts hurting. He feels like it could be a partial blockage but he doesn't really know. He doesn't know if it is actually a partial clot or if it is just his venous insufficiency to such a degree that the fluid pressure inside is making it hurt. It has been this way everyday even though he has been exercising. Honestly, before the COVID vaccine he could exercise and his circulation would be fine that night and for about the next 3 days with no problems but since the COVID vaccine he has been exercising everyday and it doesn't seem to make a difference. He already had a situation but then the vaccine was like a switch and instantly made it worse both times. Probed for 2nd dose outcome and he says that when he is moving around, exercise is the only thing that provides relief, but after that he typically would of been okay for the next few days, but when he gets home from the gym tonight he knows his legs are going to start hurting as soon as he sits down. Even though he sits on his bed and elevates his legs on the wall he knows that as soon as he stands up his legs will start hurting. That's what has happened every day since last Tuesday. Therapy start date populated as Mar2021 since caller is unsure of the exact date of his first COVID vaccine and the therapy stop date populated as the date for his second COVID vaccine. History/ Investigations showed probed for test results, medical conditions or concomitant products and caller says no, there has been nothing out of the ordinary. Anatomical Location of Administration of Pfizer vaccine considered as suspect: right arm for both. No, but he is waiting for the doctor's office to call back him back to schedule for testing. He spoke with them and they said that if it gets worse or continues like it is for another day then he needs to go to the emergency room. The outcome of event pain and aching in his leg was recovered. The outcome of remaining events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-28 chest pain migraine; slight burning in chest; body aches; warm/hot feeling on arm where the dose was administer... Read more
migraine; slight burning in chest; body aches; warm/hot feeling on arm where the dose was administered; nauteous feeling; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 16:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 17:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation and Buckwheat. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 06:00 the patient experienced migraine, slight burning in chest, body aches, warm/hot feeling on arm where the dose was administered, nauseous feeling which lasted most of the day, until around 19:00. The clinical outcome of the events migraine, slight burning in chest, body aches, warm/hot feeling on arm where the dose was administered and nauseous feeling was recovered on 01May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 2021-07-28 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Was walking around and started to get dizzy, and blacked out fell. He woke up and thought he hit his head and yelled for help. Called an ambulance and they took to the ER. No trouble breathing.
46 2021-01-04 blood pressure increased, heart rate increased, chest discomfort Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR e... Read more
Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR elevated at 110bpm; Severe allergic reaction with symptoms that include/ rash all over his body including his throat, chest, and inner legs.; Right side of neck was swollen and sore; Right side of neck was swollen and sore; his neck was stiff to turn; he feels "really weak and tired"; he feels "really weak and tired"; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19. The patient's medical history and concomitant medications were not reported. Patient is a 46y/o male certified nursing assistant (CNA). He received his first dose of Pfizer-Biontech Covid19 vaccine, yesterday 29Dec2020. On an unspecified date in Dec2020, patient experienced severe allergic reaction with symptoms that include: felt like his whole body was on fire, chest tightness, BP of 170/104, HR elevated at 110 bpm, rash all over his body including his throat, chest, and inner legs. Right side of neck was swollen and sore. Both sides are swollen, today, and his neck was stiff to turn, he feels "really weak and tired". Patient was taken by ambulance to the emergency room. Patient then asked if he should get the second dose of the vaccine. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of severe allergic reaction with multiple symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product 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.
46 2021-01-04 body temperature decreased Patient describes being very fatigued and a low grade headache, patient also said he was advised tha... Read more
Patient describes being very fatigued and a low grade headache, patient also said he was advised that his body temperature is lower than normal
46 2021-01-04 fast heart rate tachycardia(HR-90's to 130) for 3 days; injection site discomfort; myalgias; fatigue; This is a spon... Read more
tachycardia(HR-90's to 130) for 3 days; injection site discomfort; myalgias; fatigue; This is a spontaneous report from a non-contactable physician (patient). A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular at right arm on 21Dec2020 09:30 at single dose for COVID-19 immunization at a hospital. The patient's relevant medical history was reported as none, other medical history was none. No allergies to medications, food, or other products. Concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. It was reported that the patient got the vaccine on Monday (21Dec2020). On 21Dec2020 13:00, the main symptom that he was having was tachycardia (HR-90's to 130) for 3 days. Only other symptoms were injection site discomfort, myalgias and fatigue. The above events resulted in doctor or other healthcare professional office/clinic visit. No treatment was taken for the above events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
46 2021-01-07 chest discomfort, blood pressure increased pt resturned several hours after injection and stated that he was feeling chest tightness, and sligh... Read more
pt resturned several hours after injection and stated that he was feeling chest tightness, and slightly SOB Pt was taken to ER for evaluation
46 2021-01-08 pallor c/o tingling in both hands, light headed, profuse sweating and color pale. 120/68, 83, 28, 98%O2 sat... Read more
c/o tingling in both hands, light headed, profuse sweating and color pale. 120/68, 83, 28, 98%O2 sat. T 97.7 Narrative: c/o tingling to both hands, light headedness, profuse sweating, and color pale. 120/68, 83, 28, 98%O2 sat.; 122/62, 84, 24, 98% O2sat.; 119/60, 82, 20, 97% O2sat. ; at discharge 125/88, 78, 18, 98% O2 sat.. 09500: Recovered and "feeling better."
46 2021-01-11 pallor 13days following injection noted to have 4x5cm round erythematous plaque at injection site. Blanches... Read more
13days following injection noted to have 4x5cm round erythematous plaque at injection site. Blanches. Resolved nearly completely by 1/11 with only 1 dose of Claritin in on 1/8.
46 2021-01-14 chest discomfort chest pressure; his psoriasis scars were red; This is a spontaneous report from a contactable pharma... Read more
chest pressure; his psoriasis scars were red; This is a spontaneous report from a contactable pharmacist. A 46-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283, expiry date not reported), intramuscular in the left arm on 08Jan2021 10:30 at a single dose for COVID 19 immunization. Medical history included Type 2 DM (diabetes mellitus), HTN (hypertension), and psoriasis. The patient had no covid prior to vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA) at 60 mg, amlodipine besilate (NORVASC) at 5mg, losartan at 100 mg, glipizide at 5mg, fenofibrate, hydrocodone bitartrate, paracetamol (NORCO) at 7.5 mg, as needed; and methotrexate weekly (unsure of dose); all reported as medication within two weeks of vaccination. The patient previously took phenylpropanolamine and sulfamethoxazole, trimethoprim (SEPTRA), and experienced rash from both of these drugs. The patient received first dose of bnt162b2 (lot number: EK5730, expiry date not reported) intramuscularly on 18Dec2020 as COVID 19 immunization. The patient did not receive any other vaccine in four weeks. The vaccinations were given in the hospital. Patient was vaccinated at 10:30 on 08Jan2021and observed for 15 minutes. Patient came back and reported shortly after leaving he developed chest pressure and noticed his psoriasis scars were red. He was transported to ED (emergency department) (2 min). ER workup on 08Jan2021 included CBC within nl (normal) limits and EKG that showed no abnormal findings. Plan was to observe and discharge pt. Plan was to observe and discharge patient. The patient did not receive treatment in response to the events reported. The events resulted in emergency room/department or urgent care. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient was not tested for COVID post vaccination. The outcome of the events chest pressure and psoriasis scars were red was recovered in Jan2021.
46 2021-01-23 chest discomfort Complained of chest pressure within 5 minutes of receiving vaccine. Pulse=90. Team was called and ta... Read more
Complained of chest pressure within 5 minutes of receiving vaccine. Pulse=90. Team was called and taken to ER.
46 2021-01-23 heart rate increased The next morning after the vaccine I began feeling light-headed and weak. Over the next few hours s... Read more
The next morning after the vaccine I began feeling light-headed and weak. Over the next few hours symptoms worsened to include fever of 102.3, chills, body-aches and extreme fatigue. I was coughing more as well. Heart rate elevated to 110 bpm. These symptoms lasted about 12 hours. By the next morning, approx 24hrs after symptoms started, I was back to normal.
46 2021-01-24 chest pain Sunday, Jan 24th 2:22 am - woke to violent, uncontrollable chills/shivers - lasted for 8 minutes bef... Read more
Sunday, Jan 24th 2:22 am - woke to violent, uncontrollable chills/shivers - lasted for 8 minutes before stopping. Severe migraine-level headache. 6:30 am - thoracic muscle pain/soreness, occasional chills continued, axillary temp 100.4 F. 17:35 pm - repeat episode of violent chills/shivering - lasted for 5 minutes, severe headache continued, axillary temp 101.8 F. Monday, Jan 25th 3:30 - woke with continued severe headache and mild chills. Axillary temp 100 F.
46 2021-01-25 chest pain That evening extreme funny feeling in left arm. Next day chills. After slight pain above chest and b... Read more
That evening extreme funny feeling in left arm. Next day chills. After slight pain above chest and below neck. Lathirgec and joints creeking. These feelings off and on even to today. Unable to go to work and stayed in bed with very little movement for over 12 hours. Able to function once I got up.
46 2021-01-27 blood glucose increased subject developed hives/itchy bullae over trunk and extremities. over the next few days, despite usi... Read more
subject developed hives/itchy bullae over trunk and extremities. over the next few days, despite using diphenhydramine, also had swelling of lips and sensation that his throat was closing. Voice was slightly hoarse. Was seen in clinic and ER. was given steroids.
46 2021-01-28 heart rate increased 30 minutes after injection started feeling extreme anxiety, panic, and feelings of doom. Fast heart... Read more
30 minutes after injection started feeling extreme anxiety, panic, and feelings of doom. Fast heart rate, headache, and fatuige.
46 2021-02-03 blood pressure increased Elevated BP 176/108 , shakiness, didn?t ?feel right?, several episodes of vomiting.
46 2021-02-04 palpitations Heart palpitations/ dizziness lasting most of the day
46 2021-02-07 blood glucose increased At 1700 01/10/2021, he began to feel numbness in his left lip, like he was given a numbing shot at t... Read more
At 1700 01/10/2021, he began to feel numbness in his left lip, like he was given a numbing shot at the dentist. Over the next hour, it traveled superiorly up to his left cheek and to the inferior ear. He had a steroid and antihistamine sent in to the pharmacy and took this once he got home about 1930. Shortly thereafter, he started developing tongue numbness. He woke up in the middle of the night to use the restroom and reports he nearly fell into the bathroom wall due to the intensity of vertigo he was experiencing. The vertigo worsened throughout the day and he is very unsteady on his feet, requiring assistance and support from his wife to ambulate. He is unable to drive and reports exacerbation of dizziness when moving his head side to side. His wife reports he had a fever throughout the night 01/10/2021-01/11/2021. He feels the left eye is dryer and a bit weaker than usual and he has had to administer drops to help keep it moist.
46 2021-02-07 chest discomfort, chest pain tightness on the chest; chest was hurting and felt like it has been compressed; congested; body ache... Read more
tightness on the chest; chest was hurting and felt like it has been compressed; congested; body aches/ his body is still aching/ body was aching/ achy; headaches; fever/ he has a temperature at 100; tired; felt weak; feeling kind of hot and achy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL9261, expiry date unknown) via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient had no medical history and no known allergies. There were no concomitant medications. The patient did not receive medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 29Dec2020, 11:00AM at a single dose on the left arm for COVID-19 immunization. The patient reported he is probably 160 pounds, 5ft 6 inches; he received the second dose of the COVID-19 vaccine on 20Jan2021, while being due for it on 19Jan2021. He explained having body aches, headaches, fever, tired, and felt weak the following morning (21Jan2021, 04:30 AM) and therefore went to the ER. He had blood works and an X-ray done on 21Jan2021 (results unknown) and they said he had no COVID. Today, 22Jan2021, he has a temperature at 100, his body is still aching, the headaches are there along with a tightness on the chest that concerns him. He also described it as his chest was hurting and felt like it has been compressed. Patient asked what to do. He then mentioned that the nearby urgent care had refused to take him because the vaccine is still 'under investigation' and the ER is far away. Patient also reported that he was feeling kind of hot and achy, body was aching on 21Jan2021.Today, 22Jan2021, he was still the same. He got a fever, was congested, and his body is aching. Patient did not received treatment for the events. Outcome of the events 'body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, felt weak, 'feeling kind of hot and achy,' and congested was not recovered. Outcome of the other events was unknown. The events body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, and felt weak required Emergency room visit and were reported as medically significant.
46 2021-02-10 pulmonary embolism experienced significant shortness of breath, heavy wheezing, and coughing on the weekend of 2/6/2021... Read more
experienced significant shortness of breath, heavy wheezing, and coughing on the weekend of 2/6/2021. Slight wheezing had been ongoing for months (difficulty breathing in January of 2020 when diagnosed with influenza A and intermittent slight wheezing continued throughout the year). Symptoms became worse throughout the weekend. I did continue my normal routine (taking trash to the dump, helped move a heavy tank out of a walkout basement, and moving twelve 40 pound bags of wood pellets from store into truck then from truck into my home on day of hospitalization) Hospitalized on 2/7/2021
46 2021-02-11 heart rate increased 12/15 vaccination 1/1 4:30 started having tingling and numbness in face, L side. Felt 'off'. My le... Read more
12/15 vaccination 1/1 4:30 started having tingling and numbness in face, L side. Felt 'off'. My left arm started to tingle and numb. Didn't last very long. Would come and go. Laid down. Ate some dinner; queasy. 1/2 Still felt 'off' 1/3 Symptoms occurred again with the numbness; face down to arm. HR was high for resting; 130's. BP 200/100. ED - CTA head/neck EKG, blood panel Symptoms resolved in ED; vitals normal 1/7 Neurology. Normal exam. MRI of brain; normal. Referral to cardiologist. Echocardiogram; normal Heart Monitor - waiting on results COVID - negative *DR/MGR of vaccine clinic
46 2021-02-12 hypertension At 10:30pm (received vaccine shot #2 at 8:18am), i stood up and immediately felt chilled to the bone... Read more
At 10:30pm (received vaccine shot #2 at 8:18am), i stood up and immediately felt chilled to the bones and started shaking/shivering uncontrollably for 5min. Took temp, no fever. No other issues
46 2021-02-15 chest pain Chest pain, shortness of breath, LEFT arm pain
46 2021-02-16 nosebleed Got vaccine at 9:41AM on Monday Feb. 15. In the evening of the same day, around 7h30 PM while I was ... Read more
Got vaccine at 9:41AM on Monday Feb. 15. In the evening of the same day, around 7h30 PM while I was sitting on a table talking to my parents, I had a nosebleed, not very bad, just about 10 drops of blood. I had not had nosebleed for 8 or 10 years before that night. I thought it might be because of the dryness in my house, humidity dropped to 30% from the normal range of 40%-60%. However, last night (Tuesday night) around the same time 7:00pm ~ 7:30pm, I had a nosebleed again while having dinner with my family, a bit less blood dropping this time, but it makes me worried a little bit. Other than the nosebleed, I don't have any other symptoms, the soreness on the injection arm is close to nothing and I usually forgot about it.
46 2021-02-22 atrial fibrillation, fast heart rate Atrial fibrillation; ventricular arrythmias; mild fever; Cough; Short of breath; Fatigue; Tachycardi... Read more
Atrial fibrillation; ventricular arrythmias; mild fever; Cough; Short of breath; Fatigue; Tachycardia; This is a spontaneous report from a contactable consumer and a contactable nurse. This 46-year-old male patient received the second dose of BNT162B2 (PFIZER BIOTHCH MRNA VACCINE, LOT: EL3302), via an unspecified route of administration on 25Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included lone atrial fibrillation, IgA nephropathy. No Covid prior vaccination. No known allergy. Concomitant medication included metoprolol, lisinopril and acetylsalicylic acid (BABY ASPIRIN). The patient did not received other vaccine in four weeks. The patient previously received the first dose of Pfizer BNT162B2 (Lot number=ZK9231) on 04Jan2021 on right arm for COVID-19 immunization. On 26Jan2021, after 2nd vaccine, the patient had mild fever, cough and short of breath. He went to urgent care, chest X-ray clear, Covid test negative. Mild fever subsided after one day, but short of breath and cough continued. Covid test again negative. PCP prescribed azithromycin (Zpack) and methylprednisolone sodium succinate (SOLUMEDROL). Short of breath and cough continue and amoxicillin / clavulanic acid (AUGMENTIN) and prednisone prescribed. Short of breath, cough, and fatigue. Reported to ER on 15Feb2021. The patient had atrial fibrillation, tachycardia, ventricular arrythmias and were treated and admitted for further evaluation. Covid test collected again-negative. Currently in the hospital at time of this report. All of the events were on 26Jan2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 3 days, Life threatening illness (immediate risk of death from the event). Treatment included diltiazem hydrochloride (CARDIAZEM), enoxaparin sodium (LOVENOX), furosemide (LASIX). Covid test type post vaccination included nasal swab on 26Jan2021 with result negative, nasal swab on15Feb2021 with result negative, blood test on in Feb2021 with result negative. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events pyrexia, cough, fatigue and short of breath. The events atrial fibrillation, ventricular arrhythmia and tachycardia are considered not related to BNT162B2, but rather due to underlying medical conditions. The impact of this report on the benefit/risk profile of the Pfizer product 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.
46 2021-02-25 arrhythmia, palpitations heart dysrhythmia; period of palpitations; This is a spontaneous report from a contactable nurse (re... Read more
heart dysrhythmia; period of palpitations; This is a spontaneous report from a contactable nurse (reporting for himself). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number: EL3246, expiry date unknown), via an unspecified route of administration in the right arm on 05Jan2021, 10:30AM (at 46 years old), at single dose for COVID-19 immunization. The patient's medical history included high cholesterol (treated with statin medications) and seasonal allergies, both from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, ashwagandha, and ergocalciferol (VIT D). At 46 years old, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number and expiry date unknown), via an unspecified route of administration in the left arm on 15Dec2020, 10:00AM at single dose for COVID-19 immunization. The patient has not received other vaccine in four weeks prior to vaccination. Patient did not have COVID prior to vaccination and has not tested for COVID after vaccination. In the morning of 07Jan2021 (approximately 9 am), the patient experienced a period of palpitations, and heart dysrhythmia lasting for approximately 1 hour. The episode resolved on its own and has not returned. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events; patient had echocardiogram, EKG, and 7 days heart monitoring from an unspecified date. The patient recovered from "heart dysrhythmia" on 07Jan2021, 10:00AM, and recovered from a period of palpitations an unspecified date. Information on lot/batch number (first dose) has been requested.; Sender's Comments: Based on the available information, a causal relationship between event heart dysrhythmia and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
46 2021-02-27 pallor Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Ref... Read more
Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Refused transport.
46 2021-03-01 cardiac arrest Patient had an unwitnessed cardiac arrest while outside walking his dog. AED in the field initially... Read more
Patient had an unwitnessed cardiac arrest while outside walking his dog. AED in the field initially advised shock and was shocked 3 times without effect. At the time EMS ALS arrived, patient was in PEA arrest. He was transferred to Hospital with CPR in progress. Time of death called at 1857.
46 2021-03-03 atrial fibrillation Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient himself). A 4... Read more
Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient himself). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration at Left arm on 23Feb2021 12:00 pm (at 46-year-old) at single dose for COVID-19 immunisation in hospital. Medical history included Seminoma from 2011, Suframides allergy. The patient's concomitant medications were not reported. The patient experienced Atrial fibrillation on 25Feb2021 02:30 am. No other vaccine in four weeks. No Other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. The events were not resulted in emergency room visit or physician office visit. No treatment received. The outcome of the event was Recovered on 25Feb2021. Information on the lot/batch number has been requested.
46 2021-03-04 lightheadedness, very slow heart rate Patient received his Pfizer vaccine at 08:10 and at 08:25 he started feeling light headed and nausea... Read more
Patient received his Pfizer vaccine at 08:10 and at 08:25 he started feeling light headed and nauseated and had a vagal response. Episode lasted about 40 seconds but he did not become cyanotic or stop breathing. Pt denies any chest pain but was diaphoretic after episode. Called EMS for transport to CPH. Pt had syncopal episode with persistent Bradycardia. Current VS are P=40 R=22 BP 101/63 Pt A&O x4 with no focal neural deficits. Pulse ox is 100% on RA and pt states still feels a little "foggy". No rash or evidence of an allergic reaction.
46 2021-03-05 fast heart rate Immediate metallic taste, flushing, sweating, itchiness. Patient progressed to itching in throat an... Read more
Immediate metallic taste, flushing, sweating, itchiness. Patient progressed to itching in throat and mouth, mild SOB, tachycardia, nausea, and rash over chest, abdomen, upper arms, and back over the next 30-60 minutes. Treatment: Benadryl 50 mg PO, Zofran 4 mg PO, Loratidine 10 mg PO, ranitidine 150 mg PO. Repeat doses of Benadryl, Zofran, and Loratidine given later that day. Patient stated improved symptoms within a few hours. The facial redness and rash on chest persisted until the next morning.
46 2021-03-11 heart rate increased Lightheaded, elevated HR, evaluated by EMS-cleared
46 2021-03-11 pallor Immediately after receiving first dose of vaccine, pt felt lightheaded and started sweating profusel... Read more
Immediately after receiving first dose of vaccine, pt felt lightheaded and started sweating profusely. Pt also became pale. Immediately had patient lay down on the bed and elevated bilateral legs. Pt reports feeling better shortly after.
46 2021-03-17 fainting, blood pressure increased Patient fainted, laid patient down immediately -HR 46, Oxygen 99%, Blood Pressure 100/70 at 11:46 co... Read more
Patient fainted, laid patient down immediately -HR 46, Oxygen 99%, Blood Pressure 100/70 at 11:46 continued to monitor 11:48 HR 48, BP 110/80, O2- 98% 11:51 HR 51, BP 100/70, O2- 99% 11:56 patient sat up and drank some water, HR 54, BP 122/80, O2-99% 12:08 HR 45, BP 116/76, O2-99% patient waited and felt better. Wheeled to car and wife drove him home.
46 2021-03-17 fainting, palpitations pt had adverse rxn after his covid vac. he told me he felt hot, and his heart was racing. had him pu... Read more
pt had adverse rxn after his covid vac. he told me he felt hot, and his heart was racing. had him put his feet up, and take off his coat. we took bp @1pm=156/98, 1:08=150/96, 1:16 158/109, 1:30 139/92, 142Pm 134/91. We gave him benadryl 15 mls at 1:05pm.I gave him 3 benadryl 25mg for tonight if needed same with 3 ibuprofen 400 mg tablets. I called him at 2:20 pm to see if he got home okay. he did and was feeling better. he takes diabetic medication but doesn't know the names of the medications. he had eaten breakfast before his vaccine. dx syncope.
46 2021-03-18 blood pressure increased Progress Notes (Nurse Practitioner) Family Medicine Cosigned by: MD at 3/18/2021 2:57 PM Expand All... Read more
Progress Notes (Nurse Practitioner) Family Medicine Cosigned by: MD at 3/18/2021 2:57 PM Expand AllCollapse All Subjective male who was seen at Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness. He denied rash, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension and rapid progression of symptoms. Pmh: htn, hld and sleep apnea. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches (negative for headaches) Denies vision changes.: +lightheaded, lips tingling: Previous Reactions: none Objective Vitals Vitals: 03/16/21 1429 03/16/21 1432 BP: (!) 182/96 (!) 173/105 Pulse: 86 SpO2: 99% Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is obese. He is not ill-appearing. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds and air entry. Skin: General: Skin is warm. Coloration: Skin is not pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Tingling resolved. Still feeling lightheaded. Pt rested and had snacks and water. Slowly lightheadedness was reducing in severity. After 15 minutes of observation, he was able to stand w/o increased lightheadedness. He ambulates the bay w/o difficulty. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Lightheadedness/elevated bp. Anxiety as well. Review of his prior bp numbers in epic records show fluctuation of his bp ranging from 180's to 140's. Recommended that he monitor bp at home. He doesn't have red flag symptoms related to elevated bp. He's to follow up with pcp accordingly. Electronically Signed 3/16/2021 2:29 PM
46 2021-03-18 deep vein blood clot Had fatigue and myalgias and low-grade fever, so stayed in bed most of the next day. Developed calf ... Read more
Had fatigue and myalgias and low-grade fever, so stayed in bed most of the next day. Developed calf pain 2 daysafter that. Was diagnosed with DVT via Doppler ultrasound on Monday, March 8, 2021.
46 2021-03-19 pallor After receiving first dose of pfizer covid vaccine, patient alerted EMS he didn't fell well. When EM... Read more
After receiving first dose of pfizer covid vaccine, patient alerted EMS he didn't fell well. When EMS responded to the patient the patient went unresponsive slumped over in his chair with seizure like activity. Patient was being moved when he regained consciousness. Patient was moved to EMS area. Patient was pale, lightheaded and nauseous. Blood pressure was taken as well as oxygen and heart rate. Blood sugar was checked and an IV was started. Patient was stable and transported.
46 2021-03-20 lightheadedness vasovagal with N/V resolved after no treatment within one hour
46 2021-03-21 arrhythmia Cardiac arrythmia occurring twice each for a period of approximately 1-2 hours. Each time the arryth... Read more
Cardiac arrythmia occurring twice each for a period of approximately 1-2 hours. Each time the arrythmia resolved on its own.
46 2021-03-21 pallor, blood glucose increased Patient developed severe dizziness, sweating, and became very pale as soon as the pharmacist gave hi... Read more
Patient developed severe dizziness, sweating, and became very pale as soon as the pharmacist gave him the injection. We put the patient on the floor and elevated his legs and feet. His color came back to normal. Paramedics were dispatched because of his underlying medical condition. Paramedics checked his blood sugar and it was 145. Patient became very dizzy again when paramedics helped him to sit in a chair so patient decided to go to hospital with them to be checked out.
46 2021-03-21 pallor, oxygen saturation decreased Patient complained of feeling nausea and lightheaded around 3:54 pm. The patient was assisted to pat... Read more
Patient complained of feeling nausea and lightheaded around 3:54 pm. The patient was assisted to patient room and sat in chair. Patient began to sweat and skin was pale. The patient verbalized he felt like he was "going down". EMS called. Vital signs at 3:56 pm were blood pressure 82/50, pulse 58, oxygen saturation 95%. 0.3 mg of epi administered intramuscularly to right arm at 3:58 pm. Patient verbalized improvement in symptoms around 4:03 pm. Oxygen dropped to about 88% and back up to 96% and heart rate 88. EMS arrived around 4:10 pm and took blood pressure of 133/86. Patient transported to ER for further evaluation. Patient alert and oriented x4 at time of transfer.
46 2021-03-22 blood pressure decreased Chills, BP drop, and flush after Covid-19 vaccine
46 2021-03-22 chest pain Within hours of second dose(3/10/2021) in the right arm on 3/11/2021 I started feeling pain on the ... Read more
Within hours of second dose(3/10/2021) in the right arm on 3/11/2021 I started feeling pain on the underside of my left arm. As the days have gone on it?s gotten a little worse. Left under arm pain, armpit area, left chest (pectoral) pain. Just lingering pain. Very sensitive to the touch. I also developed a rash on the left side of my spine between the shoulder blades. It showed up this past weekend or the end of last week. It?s more of a painful rash than itchy. It?s very uncomfortable to lean against or lay on. This is all 13 days after the second shot. I have just been taking ibuprofen for the pain. Going to see my doctor today.
46 2021-03-22 loss of consciousness Lost consciousness; fell face first onto floor; Arm pain; Chills shivering; This is a spontaneous re... Read more
Lost consciousness; fell face first onto floor; Arm pain; Chills shivering; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, administered in right arm on 05Mar2021 08:45 as single dose for COVID-19 immunization at a hospital. The patient has no medical history. Concomitant medications were not reported. Patient has no known allergies. The patient previously received the first dose of bnt162b2 (lot number: EL9264) on 12Feb2021 14:30 (2:30 pm) for COVID-19 immunization. The patient did not received other vaccines in four weeks. No COVID-19 test post vaccination was done. On 06Mar2021 at 13:45 (1:45 pm), the patient lost consciousness and fell face first onto floor. The patient also experienced arm pain and chills shivering. No treatment was received. The event required doctor's office visit. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate.
46 2021-03-23 palpitations facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety;... Read more
facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety; chills; This is a spontaneous report from a contactable consumer(patient) reported for himself. A 46-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 06Mar2021 12:00 at single dose for covid-19 immunisation. Medical history included left kidney missing. Patient had allergies to Ambroxol, levofloxacino, cefalosporina, hidrocortizona. The patient's concomitant medications were not reported. First symptom took place 5 minutes after receiving the vaccine, it started with a severe dizziness followed by body weakness, quite accelerated and uncontrolled palpitations, tingling and extremities numbness, mild right-sided facial paralysis, panic feeling and anxiety. Finally, severe chills. Full recovery after 40 minutes with a mild lightheadedness for a few hours. Vital signs kept stable at all times according to paramedics' diagnosis. Patient received treatment for these events. Outcome of events was recovered. Information on the lot/batch number has been requested.
46 2021-03-24 cerebrovascular accident left pontine stroke patient had right sided weakness of upper and lower extremity 3 days after vacc... Read more
left pontine stroke patient had right sided weakness of upper and lower extremity 3 days after vaccination and presented to the emergency department on day 6 when he was found to have a stroke on MRI
46 2021-03-29 blood glucose increased Patient stated he didnt feel well, had no t eaten since 10AM
46 2021-03-29 blood pressure increased, atrial fibrillation, hypertension, heart rate increased Rapid heart rate triggered an A Fib needed to be hospitalized and put on medic to lower blood pressu... Read more
Rapid heart rate triggered an A Fib needed to be hospitalized and put on medic to lower blood pressure and fix heart rythm . I currently still have elevated blood pressure. Never had a fib before never was on meds for heart.
46 2021-03-29 blood clot Within an hour of receiving the vaccine I felt a sharp pain shoot down the back of my knee to my hea... Read more
Within an hour of receiving the vaccine I felt a sharp pain shoot down the back of my knee to my heal. I continued to work with the pain. The next day my knee and calf was sizeably larger. I went to the urgent care on March 19, 2021. Then to the Emergency room on March 20, 2021. They performed an ultrasound of my leg and found a blood clot. It is in a superficial vein. Followed up with a vein doctor and will go again in three months for another follow up.
46 2021-03-30 excessive bleeding On or about 0845 am, RN administered Covid vaccine (2nd one for patient). Attempted administration w... Read more
On or about 0845 am, RN administered Covid vaccine (2nd one for patient). Attempted administration with syringe (a Haiou, 1ml, 23g, 1'', Lot 20JC2, Exp: 10-17-25) resulted in needle going into patient's arm, but the 2 piece retractable distal needle and hub separated from the proximal tube part of the syringe resulting in COVID vaccine dose being lost. None of the 1st dose entered patient's arm. With needle and distal hub still fully immersed in patient's arm, RN removed it and held pressure on bleeding. RN informed patient that needle failed, to which pt stated he was "shocked," and felt an "electric" sensation when needle was inserted. Patient tolerated well. Bleeding abated. RN administered a 2nd dose of vaccine to the patient with no problems on the same LUE, more medial by about 2 inches than the first attempt. Bandage applied to both sites due to scant bleeding. Patient tolerated well, but showed no emotion. Pt complied with all instructions, and RN thanked patient for coming in.
46 2021-03-30 loss of consciousness, fainting, pallor Client received 1st Pfizer dose and approx. 7 minutes later c/o being "light-headed", having "tunnel... Read more
Client received 1st Pfizer dose and approx. 7 minutes later c/o being "light-headed", having "tunnel vision" and was observed to be diaphoretic and pallor. He was led to a zero gravity chair by EMT and experienced syncope for several seconds. When he regained consciousness, V/S were taken every 5 mins, all WNL. At 9:50am, he reported feeling a little better but a light headed. At 10am, he was observed to have normal skin tone, no diaphoresis, and walked away unassisted with a friend who came to pick him up. He reported "feeling better." Client reported to RN that he has a history of "passing out when giving blood." No medication was given.
46 2021-03-30 fainting drive-through vaccination POD. Patient was in truck In monitoring area feeling a little bit faint af... Read more
drive-through vaccination POD. Patient was in truck In monitoring area feeling a little bit faint after vaccination; then he actually fainted. Nurses called code green for paramedics; patient laid down on a cot for evaluation by paramedics. Not transported
46 2021-03-31 pallor, fainting syncope sp vaccine diaphoretic pale, VSS with EMT, monitored for 30 min, refused hospital, wife drov... Read more
syncope sp vaccine diaphoretic pale, VSS with EMT, monitored for 30 min, refused hospital, wife drove home. hx of syncope sp vaccines blood drawl
46 2021-04-01 blood pressure increased, blood glucose increased Received first Pfizer Covid-19 vaccination today and shortly thereafter with tightness in throa... Read more
Received first Pfizer Covid-19 vaccination today and shortly thereafter with tightness in throat, itching. No generalized rash, itching, dyspnea, wheezing, swelling of lips, tongue and no dizziness. Has not seen a provider for a while. Medication name: benadryl inj Dose: 50mg/1ml Route: IM DIAGNOSIS Adverse reaction to Pfizer Covid-19 vaccine Hypertension Obesity DM type 2 PLAN: Feels better after RX. Has HTN and DM type 2. Begin Lisinopril, Metformin, follow-up with PCMC, would defer 2nd Covid vaccine unless premedicated and in monitored setting. Per Dr. Note Site: right deltoid Time of administration: 0908 Medication name: solu-medrol inj Dose: 125mg/2ml Route: IM Site: right glute maximus Time of administration: 0910
46 2021-04-01 chest discomfort 12:24PM HAS CHEST TIGHTNESS AND SOB. A/O, PINK, W/D, RESP REG WITH EASE. VITAL SIGNS STABLE. TO SQUA... Read more
12:24PM HAS CHEST TIGHTNESS AND SOB. A/O, PINK, W/D, RESP REG WITH EASE. VITAL SIGNS STABLE. TO SQUAD PER WHEEL CHAIR TO GO TO ER. 12:26PM BP 121/74, HR 81, R 16. 12:30PM BP 121/80, HR 83, R 16. 4-2-21 10:20AM PATIENT: STATES HE IS DOING BETTER. SAW PCP AND IS TAKING PREDNISONE X5 DAYS AND WILL HAVE A STRESS TEST.
46 2021-04-02 blood pressure increased Body has been weak and shaky since I got the vaccine. I have had 2 episodes where I am short of brea... Read more
Body has been weak and shaky since I got the vaccine. I have had 2 episodes where I am short of breath and my blood pressure has gone up. The doctor has put me on anxiety medication but I still feel no difference. I have not been able to work for the past 3 weeks.
46 2021-04-02 palpitations Same day experienced heart racing and palpitations on a regular basis, usually every 40 min.- 1 hr. ... Read more
Same day experienced heart racing and palpitations on a regular basis, usually every 40 min.- 1 hr. Since that first day, heart has felt enlarged.
46 2021-04-04 chest pain DIFFICULTY BREATHING, SEVERE CHEST PAIN, STOMACH ACHE, HEADACHE, JOINT PAIN WENT TO EMERGENCY ROOM T... Read more
DIFFICULTY BREATHING, SEVERE CHEST PAIN, STOMACH ACHE, HEADACHE, JOINT PAIN WENT TO EMERGENCY ROOM THAT EVENING ON 3/15/2021 WENT TO BED WITH CHEST PAIN AND DID NOT WAKE UP THE NEXT MORNING PARAMEDICS WERE UNABLE TO REVIVE HIM, PRONOUNCED HIM DEAD AT THE SCENE.
46 2021-04-06 blood glucose increased Sore arm; Muscle cramps all over the body; Sugar was very high; Dehydrated; This is a spontaneous re... Read more
Sore arm; Muscle cramps all over the body; Sugar was very high; Dehydrated; This is a spontaneous report from a contactable consumer (patient's mother). A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 27Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included heart attack (at the age of 39) and had couple of stents (and the things done) later after that, and Lyme disease (past this Summer). The patient was taking several concomitant medications (unspecified). The patient's mother was calling for her son (patient) as he works out on the road, but he has had a heart attack at 39 years old and has had some other problems. The patient got his first Pfizer shot and about 2 to 3 days later while he was working, he first just had the sore arm on 03Mar2021. The patient worked in fiber glass repair on pools and it was very warm, and he started having muscle cramps all over the body on 03Mar2021. The patient ended up in the hospital on 03Mar2021 and his sugar was very high, and he was dehydrated. As treatment taken for the events, they gave him fluids through an IV and they gave him metformin medication 500 mg. The patient underwent laboratory tests and procedures (his doctor did the laboratory work), and they did laboratory work at the hospital where he went. It was clarified that they just did blood work on 03Mar2021, but the patient's mother didn't know what it was. The patient was just held for observation and was out the next day (04Mar2021). That was only the first shot, so the patient was really afraid to get the second shot one. The patient's mother told him she will try to find out something about it. patient's mother looked up the side effects and she did not see that as a side effect. At the time of reporting, the patient still had cramps once in a while. The patient had not recovered from "Muscle cramps all over the body". The outcome of the other events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
46 2021-04-06 deep vein blood clot Patient received COVID immunization #1 on 3/17/2021, then on 4/1/2021 he started having right calf p... Read more
Patient received COVID immunization #1 on 3/17/2021, then on 4/1/2021 he started having right calf pain and swelling. Got worse over the following 3 days so he presented to Urgent care. DVT was identified in UC on bedside ultrasound, started on Eliquis that day.
46 2021-04-07 fainting, hypotension Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventil... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium
46 2021-04-07 fainting, hypotension Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
46 2021-04-08 lightheadedness, very slow heart rate patient admits to vagal response and passing out in past. few mins after vaccine became diaphoretic ... Read more
patient admits to vagal response and passing out in past. few mins after vaccine became diaphoretic and near syncopal. arrived to obs and placed in tredelenberg, bp 119/80 hr 58 rr 18 sats 98% on ra. offered snack and water, refused snack. few mins later, diaphoresis resolved. stretcher sat up, bp 123/78 hr 50 rr 18 sats 98% on ra; states baseline is bradycardic around 50's. sat up to side of bed with feet dangling, bp 116/81 hr 52, then 112/80 hr 58, then standing bp 104/70 hr 63, patient started to feel dizzy and needed to lie back down, once laying down bp returned to 123/81 hr 50. 5 mins later, sitting bp 118/81 hr 53, standing 111/75 hr 58, few mins of standing had bp 90/63 hr 57, tingling in fingers and dizziness, causing patient to need to lay back down. few mins later lying bp 109/69 hr 59 sitting bp 113/70, 114/79, 121/86. standing bp checks 121/87, 114/82, and stabilized with final bp at 117/83. no further s/s of issues or orthostatic hotn. escorted with spouse, who was driving, to exit with no issues.
46 2021-04-08 fainting, loss of consciousness, fast heart rate, atrial fibrillation Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: ... Read more
Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium, Additional Details: PT HAD FLUSHING AT 9 PM HEADACHE AND PASSED OUT FRACTURING HIS MANDIBLE IN PROCESS. PT HAD ATRIAL FIBRILLATION PT IS IN STABLE CONDITION ON DILTIAZEM HAD NO HX OF HEART DISORDERS PRIOR TO VACCINE
46 2021-04-08 fast heart rate Flushed and Tachycardic
46 2021-04-09 chest pain, palpitations headache; Shortness of breath; Chest pain; Difficulty breathing; Heart palpitations; Aches; Extreme ... Read more
headache; Shortness of breath; Chest pain; Difficulty breathing; Heart palpitations; Aches; Extreme fatigue/fatigue; This is a spontaneous report received from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch ER2613), via an unspecified route of administration in left arm on 19Mar2021 09:45 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Medical history: hodgkins lymphoma survivor (1996), splenectomy. Concomitant medication was not reported. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. The patient experienced extreme fatigue on 19Mar2021 at 07:00 PM, aches on 20Mar2021, chest pain, difficulty breathing and heart palpitations on 22Mar2021, first episode of shortness of breath and headache on 24Mar2021. The patient assessed events as non-serious. Treatment received for the adverse event was unknown. Test Name: RT-PCR. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021. The patient was recovered from the event headache where not recovered from the events extreme fatigue, aches, chest pain, difficulty breathing, heart palpitations and first episode of shortness of breath.
46 2021-04-09 heart rate decreased, loss of consciousness, very slow heart rate, pallor, fainting syncopal episode x3. Loss of consciousness each time less than 1 minute. pale, diaphoretic. Brady... Read more
syncopal episode x3. Loss of consciousness each time less than 1 minute. pale, diaphoretic. Bradycardic, HR low 50's. Blood pressure stable. Neurologically intact. EMS notified and transported to Hospital for further evaluation. 7:36 to 800:
46 2021-04-10 loss of consciousness Pfizer-BioNTech COVID-19 vaccine EUA Patient passed out after waking up at 3 AM the day after the sh... Read more
Pfizer-BioNTech COVID-19 vaccine EUA Patient passed out after waking up at 3 AM the day after the shot was administered. Symptoms included nausea and dizziness. Fever around 100°F begin the following day April 11, 2021 and persisted throughout the day.
46 2021-04-11 lightheadedness VASOVAGAL- Treatment cold packs - laid supine with feet elevated - hydration 20 fl oz water.
46 2021-04-12 heart rate increased, chest discomfort Patient began experiencing feeling hot and flushed approximately 10 minutes after injection. He fel... Read more
Patient began experiencing feeling hot and flushed approximately 10 minutes after injection. He felt it was similar to his anxiety attacks he had in past. He had multiple "waves" where he said he would feel anxious, his heart rate would increase. His vital signs remained stable. At 09:26 am, he had a tightness in chest and states he normally gets that with his anxiety. Site captain consulted and continued to monitor patient and vitals. At )9; 33 a.m. he had chest pressure, and tightness. Described the pressure was 'different' than his usual. EMS was called and recommended follow up at hospital since his father died of heart attack at age 38, and he has had no follow up with heart since he was in high school. Patient refused EMS transport but his wife said she would drive him to be evaluated. EMS loaded patient into private vehicle.
46 2021-04-14 fainting Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhau... Read more
Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: difficulty walking had to call 911-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: per Nurse, pt developed severe vertigo and pt had developed weakness and lead to difficulty walking
46 2021-04-15 heart attack, chest pain Patient presented to Hospital 5 days after second Pfizer dose with myocardial infarction involving t... Read more
Patient presented to Hospital 5 days after second Pfizer dose with myocardial infarction involving the Left Anterior Descending artery. He had no significant risk factors for coronary artery disease. He reports feeling very fatigue and dyspneic after first dose, and started to have chest pain after second dose.
46 2021-04-15 bleeding on surface of brain, hypertension a 46-year-old male with no known past medical history who initially presented complaining of headach... Read more
a 46-year-old male with no known past medical history who initially presented complaining of headache and neck stiffness with onset the morning of 04/03/2021. The patient states that his headache was initially gradual in onset and eventually decreased in severity on 4/5 however, on 04/06 after a day at the beach the patient developed a severe headache with rapid onset that he described as the worst headache in his life. He did try to medicate himself at home with 600-800 mg of ibuprofen every 6 hr with minimal decrease in his headache pain. As result he presented to urgent care for initial evaluation who sent him to the emergency department for possible brain bleed. On arrival to the emergency department the patient had a head CT which showed trace subarachnoid hemorrhage in the basilar cisterns likely due to ruptured cerebral aneurysm. He was transferred to for continued workup of the subarachnoid hemorrhage with CTA and possible IR intervention. At time my evaluation patient was resting comfortably in the bed. He continued to complain of severe headache and neck stiffness. He additionally notes that light and loud sounds make his headache worse. He denied any focal weakness, paresthesia's, numbness, speech difficulty, visual changes, or any other concerning neuro symptoms. Patient was hypertensive during my evaluation despite being on a Cardene drip. Patient's mother was at bedside and was able to assist with history.
46 2021-04-16 chest discomfort A 46 y.o. male who presents today with numbness in both legs, difficulty concentrating and forgetful... Read more
A 46 y.o. male who presents today with numbness in both legs, difficulty concentrating and forgetfulness, and cough with chest tightness. Covid symptomatic in November. Received Covid Pfizer vaccine on 4.13.21 at 1pm. Felt fine headed into the vaccine. He completed the observation period and felt chest tightness after about 5 minutes similar to Covid in November. He felt slightly better and went to work. At work his cough and chest tightness worsened. Very tired, unable to eat with no appetite. Extreme fatigue Wednesday sleeping most of the day. Cough and chest tightness and feeling he cannot catch breath like being submerged in a pool. On 4.15.21 his feet became numb and tingling bilaterally. He felt more confusion, forgetting what he was doing, left frozen food in the sink and unable to recall why. He is also having headache posteriorly 7-8/10 which began on 4.14.21. He reports headache is not common, now 3-4/10 and feels very similar to Covid in November. Does have some mild neck stiffness associated. Chest tightness almost identical to Covid in November. Reports numbness and tingling in the feet has been ascending in nature. He felt unsteady on his feet yesterday morning. He is having tingling and cramping in the bilateral calf muscles today. His cough continues with no phlegm. Comes in coughing spells with chest tightness. He also noted cough is worse with exertion. Fever 99.8 yesterday. No diarrhea. No loss of smell or taste. In ED noted to have right LE weakness. Wife reports that he seemed unsteady while walking Kept for observation. difficulty concentrating - back to baseline 4/17/21 at 3:26 pm assessment SOB: CTA thorax 4/16/21 unremarkable CT angiogram thorax Symptoms began approximately 5 minutes after his Pfizer. Reports that his cough and shortness of breath now seems to be improving. Continues to have some mild chest tightness, intermittent cough. Robitussin significantly helped. Extensive workup including CT angiogram of the thorax reveals no evidence for pulmonary embolism or infiltrate. COVID-19 PCR testing is negative x2, severe respiratory isolation has been discontinued. Patient has a negative D-dimer, LDH, ferritin, CRP. Cardiac troponin has been negative x2. Patient does have some wheeze, after cough, suggesting some bronchospasm. Will trial albuterol inhaler q.i.d.. Patient does report a history of what sounds like an environmental triggers asthma like event in the past, though reports that he has undergone evaluation for asthma and was told that he does not carry a diagnosis of asthma. Patient is currently on room air. I have reviewed the reported adverse reactions from the Pfizer vaccine and coughing shortness of breath are not listed. Continue supportive care, with Tessalon and Robitussin, IS
46 2021-04-16 platelet count decreased 14 days after last dose, routine blood work was performed and showed elvated ALT's and slightly low ... Read more
14 days after last dose, routine blood work was performed and showed elvated ALT's and slightly low platelet count. All other reviewed numbers were normal. No previous lab work had shown any abnormal numbers.
46 2021-04-17 nosebleed I started my symptoms on third but only morning on the fourth I started to get bleeding through my n... Read more
I started my symptoms on third but only morning on the fourth I started to get bleeding through my nose I woke up and somebody was coming out from the liquid was coming out from my nose so I went to the bathroom and signed a glass of wine with the bleeding and then I cleaned it out I put some ice I took a Tylenol and then I?m gonna contact the city is the Pfizer . Pfizer customer service representative took down my details what happened and all the symptoms and he told me that one of their medical team will call me to discuss about it but nobody called me so afterwords I call the CDC and ask them if this is normal they told me that it is all listed on the list which they have of the side effects then I called the nurse helpline and she told me that I was the second third patient who?s complaining about a nose bleeding she asked me whether I had any allergies or in anything like that but I don?t have no allergies at this the first time it started and since then my nose is bleeding at least twice but rice a day deal dated and I?m off from work from there
46 2021-04-17 loss of consciousness Blacked out/Was out for over 2 minutes; This is a spontaneous report received from a contactable con... Read more
Blacked out/Was out for over 2 minutes; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8733, on 30Mar2021 15:45 at single dose in left arm for Covid-19 immunization. Medical history was none. Concomitant medications were none. The patient previously received barium and had Allergies. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was Blacked out on 30Mar2021 15:45 and was taken to hospital by ambulance. Was out for over 2.minutes. No other reaction. Duration of hospitalization was 1 day. The event resulted in Emergency Room Visit and Physician Office Visit. No treatment was received. The outcome of the event was resolved.
46 2021-04-18 deep vein blood clot Patient received #2 of Pfizer COVID vaccine on 2/12/2021, reports that 2-2.5 weeks later he had bila... Read more
Patient received #2 of Pfizer COVID vaccine on 2/12/2021, reports that 2-2.5 weeks later he had bilateral leg pain + swelling. He was seen in hospital ER on 3/8/2021 and diagnosed with non occlusive dvt in distal fem vein of Right lower extremity
46 2021-04-18 heart rate increased, palpitations, blood pressure increased On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the ... Read more
On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the left side of my neck and head. By March 28 the pain had become so excruciating I went to an Urgent Care facility and they sent me to the Emergency Room. While in the ER I had blood tests and a CT scan which all came back negative. I was given Oxycodone-Acetaminophen for the pain and prescribed Cephalexin in case there was some type of infection. They also ruled out Shingles. I continued to have pain and contacted my Primary Care Physicians Office and spoke with one of the Physician Assistants two times the next week. She prescribed Baclofen 10 mg and took me off the Cephalexin and put me on Amoxycillin because we thought the problem might have been an ear infection. The next week I spoke with my Primary Care Physician, and he believed I was suffering from Trigeminal Neuralgia, so he put me on Carbamazepine 200 mg twice a day. That same week, on April 9, I was finally able to meet with the Physician Assistant at the Neurologists office and she also believed I was suffering from Trigeminal Neuralgia. I continued to take the Carbamazepine daily and the Baclofen and Oxycodone-Acetaminophen as needed. On Monday April 12 I informed the nurses at the Neurologist office that I was experiencing several symptoms/side effects that included dizziness, weakness, difficulty swallowing and a pounding heartbeat. The nurses talked with the PA and the PA took me off the Carbamazepine and put me on Oxcarbazepine 150 mg twice a day and she prescribed Methylprednisolone 4 mg. On Thursday April 15 I began to have intense prolonged pain behind my left ear down to the neck and in the Trigeminal nerves in the forehead and top of the head on the left side. I was in so much pain I slept for less than 2 hours. The next morning, I vomited and went to the Emergency Room again. At the ER they treated my pain with a headache IV cocktail that included Ibuprofen, Benadryl, an anti-nausea medication, Fentanyl, and a steroid. Within an hour my pain level dropped from a 9 to a 3 and I was released. The ER prescribed Gabapentin 300 mg (3 times a day) which I started the evening of April 16. I have had less constant pain since leaving the ER and starting the Gabapentin, but I continue to have pain in the Trigeminal nerve areas and neck with some flare ups that reach a 7 out of 10 in pain. I am scheduled for an MRI on April 23 and a visit with the Neurologist on May 10.
46 2021-04-18 pulmonary embolism Multiple pulmonary embolism in both lungs; This is a spontaneous report from a contactable consumer ... Read more
Multiple pulmonary embolism in both lungs; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 10:00 (Batch/Lot Number: Ew6202) as single dose, for covid-19 immunisation at a pharmacy/drug store. Medical history included diabetes. The patient has no known allergies and no COVID prior to vaccination. The patient has other medications in two weeks but no other vaccine in four weeks. The patient experienced multiple pulmonary embolism in both lungs on 28Feb2021 08:00. The patient was hospitalized for multiple pulmonary embolism in both lungs for 3 days. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit, and considered life threatening illness (immediate risk of death from the event). The patient was treated with blood thinners. The patient had the second dose of BNT162B2 on 18Mar2021 at 11:00 am in the left arm. The patient was tested for Covid post vaccination via nasal swab (rapid) on 10Apr2021 which was negative. The outcome of the event was not recovered.
46 2021-04-18 fainting Faint high pitched ringing; Faint high pitched ringing; Higher pitches not audible; This is a sponta... Read more
Faint high pitched ringing; Faint high pitched ringing; Higher pitches not audible; This is a spontaneous report from program. A 46-year-old male consumer (patient) reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 01Apr2021 13:30 (Batch/Lot Number: EP6955) at a single dose for covid-19 immunisation. The patient medical history was not reported. Patient did not receive any other vaccine within 4 weeks prior to Covid vaccine. He was not also diagnosed with COVI-19 prior and since vaccination. He has not been tested positive with Covid-19. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin and experienced penicillin allergy. The patient experienced faint high pitched ringing and higher pitches not audible on 02Apr2021 02:00 with outcome of not recovered. In addition, it was also described as faint high pitched ringing began about 12 hours after administration. Persists. Frequency ~ 13kHz (I do music/audio stuff so checked against tone generator). Higher pitches not audible, unknown if related to the symptom or simply age.
46 2021-04-20 chest pain Started with dizziness then anaphylaxis like symptoms and lymph node symptoms of tingling lockjaw ha... Read more
Started with dizziness then anaphylaxis like symptoms and lymph node symptoms of tingling lockjaw hard to swallow very difficult to breathe a little bit of chest pains, called EMS and paramedics to took blood oxygen levels, blood pressure which were all normal by then the symptoms had started to subside
46 2021-04-21 blood pressure increased, pallor Patient was initally a 15 minute observation period after his first vaccine. Around his 15 minute ti... Read more
Patient was initally a 15 minute observation period after his first vaccine. Around his 15 minute time, he started to complain of itching and nausea. His vitals were taken and were stable, but elevated Blood pressure of 160/98. Patient was given 50mg of PO Benadryl and monitored for an additional 2 hours with no resolve of symptoms. Denied complaints of chest pain or shortness of breath, but continued to have itching, nausea and appeared pale even after prolonged time to lay down. VSS. Sent to the ER for further evaluation via private vehicle after refusal for 911 to be called. Last BP: 130/78, RR=20, HR=90 and 95% on RA. Patient walked without assistance to his fathers vehicle and verbally commited to going straight to the ER.
46 2021-04-21 chest pain very painful swollen lymph node under arm pit, sometime with sharp stabbing pains that radiates... Read more
very painful swollen lymph node under arm pit, sometime with sharp stabbing pains that radiates through chest
46 2021-04-21 pallor Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand ... Read more
Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand and stated he felt weak. He was pale and diaphoretic. Helped him to ground and allowed to rest. Felt better. Pt evaluated by paramedics. VS @ 1107 HR 68, OxSat 99%, BP 96/47. @1115 Sit in chair. BP 104/56, HR 70, OxSat 100%. @ 11:45 Pt ambulated w/o difficulty. Taking bus home. Told to call nurse when he arrives home.
46 2021-04-22 atrial fibrillation AFIB event confirmed via Smart Device.
46 2021-04-25 cerebrovascular accident I had a stroke. Assumed blood clot traveled from my leg, up through a hole that was discovered in my... Read more
I had a stroke. Assumed blood clot traveled from my leg, up through a hole that was discovered in my heart (PFO) and to my brain.
46 2021-04-26 blood clot Blood clots in left leg
46 2021-04-27 blood glucose increased Headache 4/10 left side. Pt. stated that he still had a headache. pt. informed that if symptoms pe... Read more
Headache 4/10 left side. Pt. stated that he still had a headache. pt. informed that if symptoms persist or worsen to call 911. Pt. told to follow up with primary care provider. Pt. verbalized understanding. Pt. A+Ox3.
46 2021-04-27 hypertension Within 15-minutes of vaccination, the patient reported dizziness, but they did not syncopize. EMS ev... Read more
Within 15-minutes of vaccination, the patient reported dizziness, but they did not syncopize. EMS evaluated the patient on-site. The patient was slightly hypertensive (147/92). EMS transported the patient to Emergency Department. In the ED, the patient presented with dizziness and confusion. Physician administered 1L normal saline bolus. Labs and imaging were unremarkable. Physician spoke with patient's mother who stated that the patient is at baseline given significant psychiatric history. Patient was discharged with a diagnosis of dizziness.
46 2021-04-27 hypotension, fainting, haemoglobin decreased Tinnitus, fainting, low blood pressure. Chills when IV was administered. Two bags of IV administere... Read more
Tinnitus, fainting, low blood pressure. Chills when IV was administered. Two bags of IV administered. As of today, day five, still have ringing in the ears (tinnitus).
46 2021-04-27 palpitations After both shots. About 1-2 minutes after I started feeling nauseous, shaky, dizzy and then my heart... Read more
After both shots. About 1-2 minutes after I started feeling nauseous, shaky, dizzy and then my heart pounding out of my check for 30-40 seconds. My heart settled down and I was shaky and jittery the rest of the day.
46 2021-04-27 fainting Cough and diarrhea the day after receiving vaccine. The next day, had difficulty breathing and coll... Read more
Cough and diarrhea the day after receiving vaccine. The next day, had difficulty breathing and collapsed.
46 2021-04-27 blood clot, cerebrovascular accident I started to have weakness on my left side around 9 hours after receiving the vaccine. I went to the... Read more
I started to have weakness on my left side around 9 hours after receiving the vaccine. I went to the hospital and was told I had a stroke in the right side of my brain from a clot in my brain, which they took the clot out using a catheter through my leg. I am currently undergoing rehabilitation at a rehab hospital.
46 2021-04-28 anaemia, chest pain, platelet count decreased, haemoglobin decreased 46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, a... Read more
46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, and cirrhosis suspected 2/2 schistosomiasis, who presents with 1wk of dyspnea, w/ waxing waning subjective fevers. Per ED Note: Endorses chronic fatigue until 4/16 when he received first dose of Covid vaccine (Pfizer). Since then, pt reports persistent dyspnea, worsening fatigue. Reports 2 days of left-sided chest pain w/ periumbilical abd pain and enlarging abdomen. Pt believes these are 2/2 covid vaccination. Chest pain is described as constant generalized discomfort under left breast that worsens with pressure. Also worse with deep inspiration. No radiation or migration since onset. Pt describes abdominal pain as periumbilical tightness, "pain". Describes subjective, unmeasured fevers that "come and go" over last week. When asked to repeat the story of what happened on arrival to the unit, wife speaks for the patient since he is slightly dyspnic. States this morning, went to small clinic, husband had a headache and slight fever. Clinic said to come in to the big hospital. Fever and pain in legs and head, started a few days after he got the covid vaccine. The fever came and went. Didn't measure the fever. Also has some problems with Abdominal pain - doesn't know how to describe it. Feels like stomach ache. Stomach pain is getting better. Has since gone away since arriving to the hospital. He denies any cough, denies chills, denies nausea or vomiting. States he took some medications at home for constipation because he felt like he couldn't go. From the conversation it appears he does not take lactulose for HE, more for constipation. ED workup included an Xray, CT C/A/P with multifocal lung lesions suspicious for multifocal pneumonia. Lactate of 16. Na of 124. Noted to be anemic and thrombocytopenic. UA cloudy, pyuric, w/protien >100. Chest and abdominal pain resolved by the time pt was examined on the floor. Still tachypnic and tachycardic. Stated most bothersome was feeling anxious. Has anxiety at a baseline. Not complaining of any pain at the moment. Cannot describe chest pain in more detail, put his hand over the right side of his chest and presses on it but does not say if it hurt more when he would press on it, does not say it was reproducible. Not painful when he touches or presses on it now. Per chart, patient recently re-established care after long-time from follow up during pandemic. At visits last month c/o gingival bleeding, fatiguem & found to have Hgb drop from 13 in 2018-> 9.7 on 3/2/21. Referred for EGD but cancelled due to anxiety. I am the Infectious Diseases attending asked to see him for septic shock. He developed septic shock and respiratory failure requiring mechanical ventilation and 3 vasopressors. He has evidence of DAH, DIC, acute renal failure, progressive liver failure and he has Klebsiella pneumoniae bacteremia.
46 2021-04-28 blood pressure fluctuation Patient received first dose of Pfizer vaccine and started to feel dizzy, weak, nauseous, and have sl... Read more
Patient received first dose of Pfizer vaccine and started to feel dizzy, weak, nauseous, and have slight chills about 5 minutes after receiving vaccine. Patient's symptoms were on and off. Blood pressure was taken and fluctuating. Paramedics were called per patient's request. Patient did not leave with paramedics and signed waiver. BP 1: 90/60 Pulse 1:104 BP 2: 124/86 Pulse 2:74 BP 3: 114/74 Pulse 3: 61 BP 4: 109/75 Pulse 4: 84
46 2021-04-28 hypertension Patient presented to the ED and was subsequently hospitalized for 3 days on 1/9/2021. On 1/21/2021 h... Read more
Patient presented to the ED and was subsequently hospitalized for 3 days on 1/9/2021. On 1/21/2021 he presented to the ED with rash and hypertension. On 1/23/2021 patient presented to the ED and was subsequently hospitalized for 6 days for SIRS.
46 2021-04-28 blood clot Regular pain feeling; Headache; Muscle pain; Calf feels tight, stiff, it feels like dead weight; Cal... Read more
Regular pain feeling; Headache; Muscle pain; Calf feels tight, stiff, it feels like dead weight; Calf feels tight, stiff, it feels like dead weight; Pain running up the right arm up to the shoulder/Calf pain; He asked if someone can tell him if it is a blood clot in the back of his calf; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm (shoulder) on 12Mar2021 10:07 (Lot Number: EN6202) as single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient has no prior vaccinations within 4 weeks. The patient was not sick at time of vaccination. The patient reported that on 12Mar2021, he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes. However, he said that the last few days (2021), there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping. His calf feels tight, stiff, it feels like dead weight. It wakes him up at times. He also reported pain running up the right arm up to the shoulder on unknown date in 2021. He was just curious in terms of what that might be. He asked if someone can tell him if it is a blood clot in the back of his calf. The headache went away after 2-3 days. He also reported that his eyes also hurt a little bit and was the same time frame as the headache (onset date reported as 12Apr2021: after the second dose, pending clarification). He stated that those things were just mild, nothing major. He did not take anything for these. He confirmed he no longer had muscle pain. He just has pain behind the calf and right arm up to his shoulder. His calf pain, started to feel tight, started within the last 2- 3 weeks (2021). The arm pain in right arm up to shoulder started maybe within 2 days. The patient received the second dose on 02Apr2021. Outcome of the events muscle pain and headache was recovered in Mar2021, events pain running up the right arm up to the shoulder/Calf pain was not recovered, and outcome of other events was unknown.
46 2021-04-29 arrhythmia, heart rate increased, chest pain Fever - 99 degrees F for about day and a half. Chills - about day and a half. Accelerated heart rate... Read more
Fever - 99 degrees F for about day and a half. Chills - about day and a half. Accelerated heart rate & skipped heart beats, i.e. arrhythmia - for about 7 days but improving each day. Terrible, splitting, constant headache - 2 days. Stuffy nose - 1 day. muscle pain, chest, both shoulders, arms - 4 days. Joints pain - 2 days. Pain in the lymph nodes - 2 days. Pain in the lower back around kidneys - 1.5 days. Fatigue - 3 days Nausea and stomach ache - could not eat protein of any kind, only bread and cheese for 4 days.
46 2021-04-29 cerebrovascular accident Stroke
46 2021-04-29 loss of consciousness I experienced mild fatigue and chills about 12 hours after the shot. No treatment necessary. I wok... Read more
I experienced mild fatigue and chills about 12 hours after the shot. No treatment necessary. I woke up at approx. 1:30 am feeling very warm. I got out of bed. While in the bathroom, I began to feel very lightheaded and passed out while I was washing my hands. My wife heard me crash to the floor. I returned to consciousness but passed out again while trying to stand, unresponsive to my wife. I returned to consciousness after about 1 minute. I stayed sitting for several minutes while my wife brought me some water. I felt thirsty and it's possible I was dehydrated, but I had been drinking fluids (water) the day before as normal. Due to the two fainting spells and a possible head injury, I went to the Emergency Room for treatment at approx. 2 am.
46 2021-04-30 chest discomfort Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins... Read more
Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins; right lower extremity weakness; cough; shortness of breath; chest tightness; confusion; This is a spontaneous report from a contactable physician reporting for a patient. A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 13Apr2021 13:00 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation at 46 years old. Medical history included DJD cervical spine and Raynaud's Phenomenon from an unknown date. Concomitant medications included amlodipine taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and paresthesia bilateral feet and shins; right lower extremity weakness, cough, shortness of breath, chest tightness, confusion on 13Apr2021 13:15. Treatment included albuterol. The patient was hospitalized for the events on an unspecified date for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab): negative on 16Apr2021 and 17Apr2021, and blood test (SARS-CoV-2 antibody test) negative on 16Apr2021.Outcome of the events was recovered with sequelae (Recovered with lasting effects) on an unspecified date in 2021.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available information and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-04-30 blood clot calf feels tight, stiff, it feels like dead weight/started within the last 2- 3 weeks; calf feels ti... Read more
calf feels tight, stiff, it feels like dead weight/started within the last 2- 3 weeks; calf feels tight,; pain running up the right arm up to the shoulder; pain running up the right arm up to the shoulder/his calf pain, started to feel tight, started within the last 2- 3 weeks; He asks if someone can tell him if it is a blood clot in the back of his calf; his eyes also hurt a little bit; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 02Apr2021 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. There was no medical history reported. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 (lot number: EN6202) at the age of 46-years-old for covid-19 immunisation and experienced If it is a blood clot in the back of his calf, Regular pain feeling, Headache, Muscle pain, Calf feels tight, stiff, it feels like dead weight, Pain running up the right arm up to the shoulder and Calf pain, started to feel tight. The patient reported that he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes on 12Mar2021. However, he says that the last few days there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping on an unspecified date. It wakes him up at times. He also reports pain running up the right arm up to the shoulder on an unspecified date. He says he is just curious in terms of what that might be. He asks if someone can tell him if it is a blood clot in the back of his calf on an unspecified date. The headache went away after 2-3 days. He says his eyes also hurt a little bit on 12Apr2021 and was the same time frame as the headache. He says those things were just mild, nothing major. He did not take anything for it. He confirmed he no longer has muscle pain. He just has pain behind the calf and right arm up to his shoulder. He says his calf pain, started to feel tight, started within the last 2- 3 weeks. The arm pain in right arm up to shoulder started maybe within the last 2 days. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.
46 2021-05-01 chest pain, chest discomfort, deep vein blood clot, pulmonary embolism Patient presented to the emergency department on 4/10 with a complaint of left leg pain. Patient re... Read more
Patient presented to the emergency department on 4/10 with a complaint of left leg pain. Patient reports onset of symptoms on Wednesday (4/7). He states that initially it just felt like a cramp in his calf. He states that over the past couple days, the pain has gotten significantly worse. He states the pain is now sharp and severe in nature. He states that he is having due to the severity of the pain. He states the pain is now moving up into his medial thigh. Patient states that around noon on 4/10, he began having chest pain and shortness of breath. Patient describes a tightness across his chest and states that he cannot breathe associated with this. Patient does have a history of asthma and states that he has had a couple of episodes like this in the past. Patient also reports a history of diabetes, hypertension. Patient does report a family history of coronary artery disease as well as a family history of blood clots. He received his Pfizer Covid vaccine 2nd dose on 4/9/2021 (Lot # ER8729) and 1st dose (Lot # EN6204) given on 3/12/2021 at an outside facility He does report arm soreness but is otherwise doing well. No recent travel. No recent immobilization. Upon evaluation in the ED, he was noted to have positive US for DVT in the LLE. Follow up CTA Chest was positive for bilateral lobar and segmental PE with right heart strain. CVM was consulted for possible PE intervention evaluation. Patient started on therapeutic Lovenox, but discharged home on 4/11 with Eliquis. . The next day 4/12/21 he returned to ED for SOB/Wheezing and LLE pain. On 4/15/21 he underwent EKOS, IVCF and iliac stent placement per Vascular surgery and subsequently sent home on Eliquis 4/16/21. Pt returned to the ER again 4/21/21 for recurrent SOB. CTA chest with no significant change in clot burden, no associated hypoxia.
46 2021-05-01 heart rate increased I had my second Pfizer vaccine on 1pm April 23rd. I had headache, nausea and tired feeling from Frid... Read more
I had my second Pfizer vaccine on 1pm April 23rd. I had headache, nausea and tired feeling from Friday afternoon and it improved Saturday afternoon. Sunday I had a slower but normal day. Monday morning I felt normal but by 2pm I started to feel drowsy and by 4pm the headache and nausea returned to the point I had to go to sleep. This morning I have a light headache and nausea. I have taken Tylenol. Thursday I went to the gym and had higher than normal heartbeat and would get lightheaded. Went to gym today and all is was back to normal.
46 2021-05-02 heart attack Acute Myocardial Infarction
46 2021-05-03 blood clot in the brain, cerebrovascular accident I had a Stroke; Blood clot travelled to my brain; effected left side of my body; ability to speak; T... Read more
I had a Stroke; Blood clot travelled to my brain; effected left side of my body; ability to speak; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER 8729), via an unspecified route of administration in left arm on 10Apr2021 (at the age of 46-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a pharmacy/drug store. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not have covid prior vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had a stroke. Blood clot travelled to his brain and effected left side of his body and ability to speak on 15Apr2021 at 17:30. The events resulted to emergency room/department or urgent care, hospitalization for 3 days, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received unspecified treatments for the event. Covid test post vaccination on 15Apr2021 with result of negative. The outcome of the events was recovering.
46 2021-05-03 chest pain Within 5 minutes after receiving the shot, patient started having headache & heartache on and off fo... Read more
Within 5 minutes after receiving the shot, patient started having headache & heartache on and off for about 10 minutes. Patient also complaint about his throat/mouth was dry. 15 minutes after he started to have numbness around his mouth and on tip/ middle part of his tongue. Numbness lasted for about half an hour. That night he vomited and has chills. Next day he had very mild fever, pain in the right lung when he sneezed / coughed. He didn't have much symptoms on the 3rd day except for an sore arm and tireness.
46 2021-05-04 blood clot This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male pati... Read more
This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:20 (Lot Number: EW0162) (received at the age of 46-years-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included right knee pain. Concomitant medications were not reported. The patient received the Pfizer 1st shot 18Apr2021 11:20 am. On 19Apr2021, at midnight, he had low grade fever then swelling right leg. On the day of the report, 20Apr2021, he had swelling to both legs. The patient had taken ibuprofen as treatment beside propping legs up. The reporter wanted more information on the swelling and if it's related to taking ibuprofen. It was further reported that the patient experienced severe swelling from the knees down to the calves on both legs on 19Apr2021. He also experienced night sweats, fever, lightheadedness and dizziness on 19Apr2021. They want to know if there are any reports regarding the swelling side effects and if it is from the vaccine. The first dose of the vaccine was given 2 days ago (18Apr2021) and the second dose is due on 09May2021. The patient got his first shot on 18Apr2021 about 11:20am. After about 15 hours he developed swelling in one leg, she later clarified this to be his right leg, and now reports that both of his legs are swollen at the time of report (20Apr2021). She noted that patient told her his legs are not painful. She doesn't know if it's a blood clot or if they needed to go to the hospital. She also wanted to know if there is information about this as a side effects or if other people are having this too. She then reported that the patient started experiencing a fever, profuse sweating, and was spacey about 12 hours after the vaccine, a little after midnight 19Apr2021. She doesn't know if the dehydration made it worse. His fever was low-grade 99.8 degrees and lasted 4 and a half to 5 hours and has now resolved. When asked if patient received any treatment for fever, caller said it was so recent, and that was listed as a common side effect that goes away. Reported the patient drank fluids and she kept an eye on him. Leg swelling was about 15 hours after the vaccine, early morning 19Apr2021. She noted that the swelling in the right leg got bigger and didn't go down, but the left leg did. But today the left was more swollen and more prominent today. She further clarified that the patient takes ibuprofen for pre-existing right knee pain. Caller also reported that the patient propped his legs to alleviate the swelling, it has improved some but the swelling did not go away. The adverse events did not require a visit to the physician office or emergency room. Outcome of the event fever was resolved on 19Apr2021 (lasted 4 and a half to 5 hours); outcome of the event "severe swelling from the knees down to the calves on both legs" was not resolved; outcome of the remaining events was unknown.
46 2021-05-05 blood glucose increased Prior to vaccination patient experienced dizziness and feeling "sick". Denies symptoms of active ill... Read more
Prior to vaccination patient experienced dizziness and feeling "sick". Denies symptoms of active illness. Blood glucose level 280. Patient stated he would be more cautious and take his prescribed medications.
46 2021-05-05 fluid around the heart, chest discomfort, chest pain, hypertension About 12 days after the vaccine, I woke up in the middle of the night with sharp pain in my chest. ... Read more
About 12 days after the vaccine, I woke up in the middle of the night with sharp pain in my chest. Since then I have had heaviness in my chest and other symptoms like difficulty breathing while walking or talking, etc. I was otherwise previously healthy -- non-smoker, drink very occasionally, mostly vegetarian, light on sugar consumption, daily exercise. I went to the doctor and then the ER at a local hospital on April 28. They found fluid and possible inflammation around the hearth along with very high blood pressure. Since then I have had medication for inflammation and high BP. They are still doing tests to figure out what is wrong with me.
46 2021-05-06 loss of consciousness LOSS OF CONSCIOUSNESS , DIZZNESS,
46 2021-05-07 cerebrovascular accident, blood clot He completely lost mobility on the left side of his body; Stroke; They found they clot, but could no... Read more
He completely lost mobility on the left side of his body; Stroke; They found they clot, but could not extract it from what he understood; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 46 years old) for COVID-19 immunisation. The patient has no medical history. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported. Since his stoke, he is doing better. He completely lost mobility on the left side of his body. His mobility on the left side of his body is slowly coming back. His job is in jeopardy. The doctors told him that there is no guarantee that he will regain full mobility. They did not give him a patient record card. If they did give him one, he left it at the house. He has been in the hospital ever since his stroke. They put him on blood thinners after his stroke. Whenever he was in the ambulance, he did not have high blood pressure. They were able to catch his stroke quick. They found they clot, but could not extract it from what he understood. Adverse events reqiored Emergency Room. The patient was hospitalized on 01Apr2021. The outcome of clot was unknown and other events was recovering. Information on the lot/batch number has been requested.
46 2021-05-07 chest pain, inflammation of the pericardium, inflammation of the heart muscle Chest pains started on 5/5/21 around 4pm and worsened through 9pm. The next morning chest pains con... Read more
Chest pains started on 5/5/21 around 4pm and worsened through 9pm. The next morning chest pains continued to the point where I went to the Emergency Room. There, a cardio ultrasound, blood work and a cardio catheter were performed. Tests for all respiratory viruses all came back negative. I was taken to the Critical Care Unit and remained under supervision overnight and through the morning 5/7/201, when I was discharged. I was diagnosed with Myocarditis and Pericarditis.
46 2021-05-07 hypertension, fainting, loss of consciousness Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic:... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Pt apeared to have HTN crisis / seizure like aftivity 3 min after injection. Airway and then consiousness was lost with no breathing. EMS was called pt was assisted to floor and after opening airway and stimulation regained consiousness.
46 2021-05-09 chest pain, inflammation of the pericardium Complaining of chest pain, dsypnea, and pericarditits since receiving his 2nd COVID dose
46 2021-05-10 chest discomfort contracted the Covid 19 virus; body aches; chills; sinus pressure; headaches; cough; chest congestio... Read more
contracted the Covid 19 virus; body aches; chills; sinus pressure; headaches; cough; chest congestion and tightness; chest congestion and tightness; This is a spontaneous report from a contactable consumer (patient) through a Pfizer-sponsored program. This 46-year-old male patient, weight: 90.72 kg & height: 180 cm, received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 02Apr2021 11:30 (at the age of 46-year-old) as single dose for COVID-19 immunization. Medical history included sinus infection with his seasonal allergies. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D) taken to manage his sinus flare ups and drainage during the allergy season. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no predisposing factors. The patient was not enrolled in the clinical trial. The patient received his first COVID 19 vaccine on 02Apr2021 and subsequently contracted the COVID 19 virus and tested positive for the COVID 19 virus on 12Apr2021 with a rapid test at a physician's office. During the first full week of Apr2021, he started having symptoms: body aches, chills, sinus pressure, headaches, cough, chest congestion and tightness but he did not have a fever. It went on for about 2 weeks, with some varying between his symptoms during that time. He reported that he normally has seasonal allergies and all of his symptoms were coinciding with his typical allergy symptoms. The chills dissipated during the first 3 days following the COVID 19 vaccine and the chills subsided. Then the sinus drainage and all the other symptoms kicked in. He thought maybe his symptoms were from the COVID 19 vaccine but he also thought it could be the sinus symptoms he has in the spring time. Obviously, his symptoms continued, and he knew it was not related to his seasonal allergies. He usually would get a sinus infection with his seasonal allergies, bacteria would jump in his sinus issues, and he didn't have that. His sinus infections can be. That's when he knew what he had was not related to his seasonal allergies. The patient stated that he is due to receive his second COVID 19 Vaccine on 23Apr2021 or if he needs to reschedule the vaccine considering his second vaccine is such close proximity to his COVID 19 diagnosis. The event, chills, was resolved in Apr2021 while the clinical outcome of the events, contracted the COVID 19 virus, body aches, sinus pressure, headaches, cough, chest congestion and tightness were unknown.
46 2021-05-10 hypotension, fainting Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium
46 2021-05-12 ejection fraction decreased Death
46 2021-05-12 blood clot Blood clot in left leg; This is a spontaneous report from a contactable consumer (patient). A 47-yea... Read more
Blood clot in left leg; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 25Jan2021 10:30 (lot: EL3302) as 1ST DOSE, SINGLE then on 17Feb2021 10:30 (lot: EL9264) as 2ND DOSE, SINGLE; both via an unspecified route of administration in left arm (at the age of 46-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Medical history included covid-19 (prior to vaccination, diagnosed with COVID) and no past drug event. The patient's concomitant medications were not reported. The reported event was blood clot in left leg on 18Apr2021 at 22:00. The event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event was an unspecified medication. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.
46 2021-05-13 loss of consciousness, fainting Approximately 6 minutes after vaccination, patient experienced a syncopal event and passed out. He b... Read more
Approximately 6 minutes after vaccination, patient experienced a syncopal event and passed out. He became nauseated after the event then vomited. Pt was seen in the emergency department, patient admitted to hospital for overnight observation.
46 2021-05-15 chest pain Symptoms for 4 days...Pt reported rashes that would come and go every 5 to 10 minutes, itching on ha... Read more
Symptoms for 4 days...Pt reported rashes that would come and go every 5 to 10 minutes, itching on hands and feet, itching/burning inside lungs, and swelling of jaw.
46 2021-05-15 blood clot Blood Clot in my lower right leg. Which can be life threatening if it were to dislodge and travel to... Read more
Blood Clot in my lower right leg. Which can be life threatening if it were to dislodge and travel to the lungs and or Heart. Treatment: 30 day starter pack Eliquis 5mg tabs blood thinner, Methylprednisone 4mg dospak 21s, Acetaminophen 325mg 2@-6hrs or as needed
46 2021-05-17 lightheadedness After recommended monitoring time, Patient?s reaction to COVID-19 Vaccination: dizzy , lightheaded, ... Read more
After recommended monitoring time, Patient?s reaction to COVID-19 Vaccination: dizzy , lightheaded, probable vasovagal: was sent EMS to the ER.
46 2021-05-18 fainting Patient fainted after 2nd dose for a couple of seconds. He was placed on a strecher with legs elevat... Read more
Patient fainted after 2nd dose for a couple of seconds. He was placed on a strecher with legs elevated. He stated that he has fainted before at a doctors office. Patient monitored for a total of 30 minutes until symptoms resolved. Patient was given water and stated he felt good before he left.
46 2021-05-21 heart rate increased, loss of consciousness, fainting Almost fainting 3 minutes/Almost fainted/Really close to blacking out; Almost passed out; Nauseated/... Read more
Almost fainting 3 minutes/Almost fainted/Really close to blacking out; Almost passed out; Nauseated/Swirling strong nausea through the body up to the chest; Rapid heart rate; Hyperventilation; Labored breathing; 5-10 minutes before able to uncramp his hands; Waves of the feelings came throughout the day; This is spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 15Apr2021 11:00 as single dose for covid-19 immunization. Medical history included sensitivities to ephedrine from an unknown date and unknown if ongoing. The patient had no concomitant medications. The patient experienced almost fainting 3 minutes/almost fainted/really close to blacking out, nauseated/swirling strong nausea through the body up to the chest, rapid heart rate, hyperventilation, labored breathing, 5-10 minutes before able to uncramp his hands, waves of the feelings came throughout the day, almost passed out/ really close to blacking out; all on 15Apr2021. The events were not required a visit to emergency room, nor physician office. Caller is a 47 years old patient who received the 1st dose of the Pfizer Covid vaccine on 15Apr2021. He complained of feeling nauseated, and rapid heart rate, with hyperventilation, and almost fainting 3 minutes after the 1st dose of the Pfizer Covid vaccine. This lasted approximately 15 minutes. 3 minutes after receiving a vaccine. He started to complaint about feeling nauseated. He started rapid heart rate which caused him to have hyperventilation and almost fainted. The episode last for 15 minutes and he just want to go and report it. Consumer confirmed it was the Pfizer Covid19 vaccine. The consumer wasn't still experiencing the side effects. They lasted to 5pm. I got my shot at 11am. The event was no longer persisting but he was wanting to understand the effect of the second shot, the consumer wasn't took any treatment for adverse event. Caller states that he is calling about the Covid Vaccine. Says with the first round of the vaccine he had an adverse event. He is looking to Pfizer and his doctor for some feedback to understand whether or not he should get the second dose. Says that about three minutes after the vaccine he felt a swirling, strong nausea throughout his body up to his chest. He had labored breathing and a really fast uncontrolled heart rate for about 5 minutes. States he was hyperventilating and almost passed out. He had to sit on the ground of the parking garage where he had gotten his vaccine. About 5-10 minutes later he was finally able to uncramp his hands. States that before the vaccine he was calm and not at all in an elevated state. States he is wondering about the second dose being stronger. He almost blacked out after the first dose. States it was close to the limit of what he could tolerate. States he needs further details. He was reading about clinical trials and some doctors. States that he did not have all the symptoms of anaphylaxis that they described. Says his symptoms lasted about 5 minutes or so. About 10-15 minutes later he was recovered. Says waves of these feelings came over him throughout the day. Says they decreased each time and ended that evening around 1700. Caller says he did not go to the Emergency Room when it happened. The nurses at the vaccination site attended him. At the end of the call the caller mentions that he has a sensitivities to ephedrine. States he does not take any Sudafed or Dayquil or anything like that. States he didn't know if that was relevant to mention or if anything like that is in the vaccine to make him have the response that he did. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No prior Vaccinations (within 4 weeks). No family medical history relevant to events. No Relevant Tests. The outcome of events was resolved on 15Apr2021.
46 2021-05-21 inflammation of the heart muscle, heart attack, chest pain, ejection fraction decreased Patient with no known past medical history received his 2nd dose of Pfizer COVID-19 vaccine on 3/29/... Read more
Patient with no known past medical history received his 2nd dose of Pfizer COVID-19 vaccine on 3/29/21 presented 5/19/21 with sudden chest pain presented to ED via EMS with acute inferior ST elevation MI. Cardiac cath reveled 95% ostial stenosis not consistent with ECG changes. Treated for myopericarditis with NSAIDs and steroids with resolution of chest pain.
46 2021-05-22 heart rate increased, arrhythmia, heart rate irregular Approx 27hrs after 2nd dose I felt my heart suddenly started irregular beats, arrhythmia with dizzy ... Read more
Approx 27hrs after 2nd dose I felt my heart suddenly started irregular beats, arrhythmia with dizzy feeling, flush on face which lasted a minute or 2 followed by very rapid / hard beating of my heart (I could see my shirt move on my chest from the beating). This lasted for almost 10 minutes. Very scary. Paramedics were called about 5 minutes into the episode. (I had a similar reaction of dizzy, flush with rapid and hard heart beat reaction after 1st dose about 5 minutes after it was given which lasted couple minutes then subsided). When the paramedics arrived, I was laying down in my bed trying to relax and breath. By then the rapid and very hard beating of heart was calming down but was still elevated pulse for a resting position...~128bpm. My BP was measured at 154/87. They connected the 12point electrodes and the reading came back normal...only elevated pulse. Paramedics ran 3 more scans during the 20 minutes they were there for...all came back normal. My O2 was 100%. I elected to no go to ER since we live only 2 miles from the local hospital and I was feeling much better by then...but would go if I had another heart episode. I have had none since. Only other strange side effects was sore arm for 2 day and I notice is constant ringing in my ears all the time...strange. I hope that will go away soon...very annoying.
46 2021-05-22 increased heart rate Signs and symptoms of Orthostatic intolerance, new (not happened before) Sinus tachycardia with sinu... Read more
Signs and symptoms of Orthostatic intolerance, new (not happened before) Sinus tachycardia with sinus arrhythmia - confirmed, new (not happened before) Signs and symptoms of Postural orthostatic tachycardia syndrome (not happened before) Exertional dyspnea Tachycardia associated with ordinary and routine activities Hypovolemia Acute renal insufficiency (never happened before)
46 2021-05-23 chest discomfort Facial numbness on and off for 10 days. Hands and Feet numbness approximately 9 days after injection... Read more
Facial numbness on and off for 10 days. Hands and Feet numbness approximately 9 days after injection. Chest pressure, including pressure into my back directly behind the heart and my left shoulder 9 days after injection. Went to the Emergency Room and had 3 EKGs, a chest x-ray, and blood work. Chest, Back, and Shoulder pressure continues on and off to this day - over one month since the injection.
46 2021-05-23 chest pain Pt states that approximately 24 hours after receiving his first dose of the Pfizer vaccine he began ... Read more
Pt states that approximately 24 hours after receiving his first dose of the Pfizer vaccine he began having 8/10 chest pain and feels like he cannot take a deep breath.
46 2021-05-24 chest discomfort Shortness of breath, heavy weight on my chest, feeling weak, needed to sit or lay down.
46 2021-05-24 chest pain, hypertension Chest Pain, High Blood Pressure, Shortness of breath
46 2021-05-24 fainting Syncope 10 seconds
46 2021-05-25 inflammation of the heart muscle, heart attack nstemi; Myocarditis; This is a spontaneous report from a contactable physician. A 46-year-old male p... Read more
nstemi; Myocarditis; This is a spontaneous report from a contactable physician. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) via an unspecified route of administration on 26Apr2021, SINGLE for covid-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 27Apr2021, the patient reported to the hospital with complaints of chest pain with electrocardiogram (EKG) showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers. On 27Apr2021, the patient experienced non-ST-elevation myocardial infarction (NSTEMI) and myocarditis. The patient was hospitalized for one day. and the event required an emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood test: negative on 02May2021, covid-19: negative on 02May2021, electrocardiogram: unknown showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers, myocarditis: unknown. Cath report did not reveal coronary artery disease (CAD). Therapeutic measures were taken as a result of NSTEMI (acute myocardial infarction), myocarditis (myocarditis), chest pain (chest pain), EKG showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers. The outcome of non-ST-elevation myocardial infarction (NSTEMI), myocarditis, chest pain and electrocardiogram (EKG) showing non-diagnostic diffuse ST elevations and elevated cardiac biomarkers was recovered on an unknown date. It was also reported that since the vaccination, the patient was tested for COVID-19 on 02May2021 and was negative. Information on lot number/batch number was requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on currently known drug profile it is unlikely that events non-ST-elevation myocardial infarction (NSTEMI) and myocarditis are related to BNT162B2. This case will be re-evaluated upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and investigators, as appropriate.
46 2021-05-25 inflammation of the heart muscle, inflammation of the pericardium Patient developed a fever to 103 and pleuritic positional chest pain the day after receiving dose #2... Read more
Patient developed a fever to 103 and pleuritic positional chest pain the day after receiving dose #2. He presented to the ED 2 days later on May 21, 2021. An ECG showed acute pericarditis. His TnI was mildly elevated. An echocardiogram showed mild LV dysfunction with LVEF 40-45%. He was diagnosed with myopericarditis. Treatment included NSAIDS and colchicine and metoprolol. He was not admitted to the hospital.
46 2021-05-26 heart flutter, arrhythmia heart arythemia, random fluttering in chest feeling.
46 2021-05-27 blood pressure increased, chest discomfort My blood pressure rose 30 points on both systolic and diastolic pressures to 160/130 with tightening... Read more
My blood pressure rose 30 points on both systolic and diastolic pressures to 160/130 with tightening of my chest. EKG showed no sign of heart attack and I was released from the emergency room after 3 hours of monitoring at which time the blood pressure normalized to 130/90. 12 hours after the injection I had pain at the injection, extreme full body aches, mild headache and slight nausea. All side effects were gone within 36 hours.
46 2021-06-03 fast heart rate, chest pain Chest pain, difficulty breathing (SOB), and tachycardia. Evaluated by EMS-Cleared.
46 2021-06-07 blood pressure increased, chest pain He started having chest pain and shortness of breath. Arm was sore and felt lightheaded. Blood press... Read more
He started having chest pain and shortness of breath. Arm was sore and felt lightheaded. Blood pressure increased. So he went to the hospital. They did chest x-rays and lab work. Monitored for about four hours for blood pressure. Gave him an IV.
46 2021-06-07 chest discomfort Compromised breathing; Tight chest; Dry cough; This is a spontaneous report received from a contacta... Read more
Compromised breathing; Tight chest; Dry cough; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199), via unspecified route of administration in left arm on 01Mar2021 03:15 PM (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. Vaccination facility type was reported as hospital. The patient's medical history was not reported. No COVID prior vaccination was reported. No concomitant medications were taken by the patient within 2 weeks. No other vaccine was administered within 4 weeks. On 03Mar2021 08:00 AM the patient experienced tight chest, dry cough, and compromised breathing. No treatment was received due to the events. Patient was not tested for COVID post vaccination. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
46 2021-06-07 fibrin d dimer increased, palpitations Initially, fatigue, joint pain, injection location soreness, then 3 days later I started getting hea... Read more
Initially, fatigue, joint pain, injection location soreness, then 3 days later I started getting heart palpitations that lasted for 2+ days (Thurs, Fri and part of Sat.), continued fatigue and shortness of breath.
46 2021-06-08 chest pain Five days after receiving the vaccine, I began to experience extreme chest and back pain in the area... Read more
Five days after receiving the vaccine, I began to experience extreme chest and back pain in the area of my heart. I did not feel as if I were having a heart attack, yet I experienced intense pain that was amplified when I would lie down - it was aggravated by even subtle movements. Self guided research brought be to, "Pericarditis," as a very plausible explanation as the symptoms mirrored online descriptions. I did contact my primary care provider, however did not schedule an office visit as symptoms were manageable and improved across a period of several days.
46 2021-06-08 loss of consciousness Passed out; Warm sensation; Sweating; This is a spontaneous report from a contactable consumer, the ... Read more
Passed out; Warm sensation; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 01Apr2021 (at the age of 46-year-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 01Apr2021 (10 mins after receiving the vaccine), the patient passed out, had warm sensation and sweating. Patient was later transported to medical centre. Outcome of the events was unknown. Information on the lot/batch number has been requested.
46 2021-06-08 blood clot, hypertension blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's re... Read more
blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's received 6 times over the amount; didn't dilute it and he's received 6 times over the amount; Diarrhea; real tired; his blood pressure was real high; breathing problems; This is a spontaneous report received via a Pfizer-sponsored program. A contactable consumer reported that a 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on 20Apr2021 (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, patient experienced diarrhea, was real tired and his blood pressure was real high. It was also reported that the vaccine wasn't diluted and the patient received 6 times over the amount on 20Apr2021. On an unspecified date, patient had sore arm and his muscles ached. On Apr2021, patient had breathing problems and was treated with breathing treatments three times a day and was put on steriods and inhalers. On May2021, patient had a lab work that confirmed that he had a blood clot in his leg, which has worsened because he has some swelling in his leg, the same leg that they found the blood clot in. The patient was hospitalized for the event blood clot in his leg and was given blood thinners. The patient underwent lab tests and procedures which included CAT scan of head and lungs both with unknown results on May2021. Outcome of the events blood clot in his leg, swelling in his leg and breathing problems was not recovered while outcome of all other events was unknown. Information on the lot/batch number has been requested.
46 2021-06-08 cardiac arrhythmia PVCs to the heart; light headedness
46 2021-06-09 cerebrovascular accident Pt got the shot in his left arm and developed a stroke on his right side the following day.
46 2021-06-09 deep vein blood clot Deep vein thrombosis in left gastrocnemius vein; This is a spontaneous report from a contactable con... Read more
Deep vein thrombosis in left gastrocnemius vein; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 20Apr2021 at 11:00 (at the age of 46 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included drug hypersensitivity (known allergies: Penicillin) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Apr2021 at 03:00, the patient experienced deep vein thrombosis in left gastrocnemius vein. Therapeutic measures taken as a result of the event deep vein thrombosis in left gastrocnemius vein included apixaban (ELIQUIS). The outcome of the event deep vein thrombosis in left gastrocnemius vein was recovering. Since the vaccination, the patient had not been tested for COVID-19.
46 2021-06-11 pallor The patient began shaking and had trouble standing. Had shortness of breath and was very pale.
46 2021-06-12 chest pain Mr arm And injection site hurt for a few days and then from that spot my arm got numb and the pain s... Read more
Mr arm And injection site hurt for a few days and then from that spot my arm got numb and the pain spread to my chest on the left side. It felt like nerve damage and felt like when an arm falls asleep And starts to awake. My family worried I was having chest issues and went to Urgent Care for a ekg which was fine. I knew it was from the shoe because the pin spread from the injection site and my left arm and chest felt numb and like nerve issues. It?s not a month later and I still can feel the nerve issues but not as bad. Went to doctors and waiting on blood work . Maybe an autoimmune Response since I have an auto immune condition?
46 2021-06-14 loss of consciousness, pallor Pt. became light headed, pale, and diaphoretic minutes after vaccine. Pt. reports it is not unusual... Read more
Pt. became light headed, pale, and diaphoretic minutes after vaccine. Pt. reports it is not unusual for him to pass out while getting an injection. Pt back to normal in 5 to 10 minutes. Pt was observed post vaccination and released home.
46 2021-06-15 loss of consciousness, heart attack Pt passed out unconscious with no pulse. A neighbor who is an ER doctor performed CPR for 5 minutes... Read more
Pt passed out unconscious with no pulse. A neighbor who is an ER doctor performed CPR for 5 minutes, then paramedics tried to resusitate Pt and took him to local Hospital ER, less than a mile away. He was not resusitated. No cause of death was found - doctor said it was likely a heart attack.
46 2021-06-16 chest pain Some chests pain. I had a headache. I went doctor, thought it was a chest inflammation. He did an ... Read more
Some chests pain. I had a headache. I went doctor, thought it was a chest inflammation. He did an EKG that came back negative. He did some muscle movements in chest. He also stated if I had any tingling in my arm to get to the ER. He also did some blood work. He did give me a presentation to take.
46 2021-06-16 hypertension, cardiac arrhythmia High blood pressure, premature ventricular contraction both quite high; High blood pressure, prematu... Read more
High blood pressure, premature ventricular contraction both quite high; High blood pressure, premature ventricular contraction both quite high; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10May2021 12:45 (at 46-year-old) (Lot Number: EW0167) as 2nd dose, single in arm left for COVID-19 immunisation. Medical history included ongoing sulfonamide allergy. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as 1st dose, single for COVID-19 immunisation. The patient experienced high blood pressure, premature ventricular contraction both quite high after 2nd dose on 13May2021 13:00. No treatment received. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events was resolving. Additional information has been requested.
46 2021-06-22 ischemic chest pain ***Was not checked by doctor*** Experienced angina type pain approximately 2-3 days after initial in... Read more
***Was not checked by doctor*** Experienced angina type pain approximately 2-3 days after initial injection. Have had angina in the past and has always been brief and episodes were far between (not even once per year) but this would last for an hour, onset was independent of stress, either physical or mental with daily recurring episodes for approximately 2 weeks. Pain returned after second dose and remained for approximately 2.5 weeks with a gradual decline in severity/length as time passed. No symptoms for several weeks at date of this report. Possibly completely unrelated but including for completeness, severe pain in elbow and shoulder of injection arm coinciding with date of injection and persisting to his day with no lessening of symptoms which include severe pain when joint(s) moved under stress, stiffness, reduced strength and general soreness even at rest.
46 2021-06-22 blood pressure increased Blood pressure has increased substantially. I have been checking my blood pressure every day. It has... Read more
Blood pressure has increased substantially. I have been checking my blood pressure every day. It has increased to over 160 lower 100. Treatment: Hydrochlorothiazide
46 2021-06-24 fainting Syncope while riding bicycle (multiple serious injuries incurred) exactly 2 weeks after second dose ... Read more
Syncope while riding bicycle (multiple serious injuries incurred) exactly 2 weeks after second dose suspected to be related to vaccine. At the time I considered myself exceptionally fit, healthy with no recent history or forewarning of passing out.
46 2021-06-26 fainting Systemic: Fainting / Unresponsive-Severe
46 2021-06-27 inflammation of the pericardium Pericarditis. Patient developed symptoms 4-5 days prior to ED visit on 6/28/21. Patient was discharg... Read more
Pericarditis. Patient developed symptoms 4-5 days prior to ED visit on 6/28/21. Patient was discharged home on prednisone and colchicine.
46 2021-06-28 platelet count decreased I am unable to locate my vaccine card for that information but the adverse event started about a wee... Read more
I am unable to locate my vaccine card for that information but the adverse event started about a week after my vaccine. So after I had the second dose, my blood platelet count dropped dramatically, also my ammonia levels were elevated. Normal ammonia levels are 11-32 MM/L and my ammonia levels spiked up to the 70s on 4/29/2021. My vaccination was received on the 19th of April I think, I am not positive. So my levels spiked and I became hallucinogenic. It was quite an event, I had three police officers in my house. So we have had problems controlling my ammonia levels since then. My iron levels are also elevated and my platelet count is way way down as well. The vaccine may have triggered some sort of autoimmune response is kind of what my DRs are thinking right now. Once we get more information on that then we will be able to see why my body reacted the way it did. I went to the ER on 4/29/2021 and they did tests and then they sent me home. I have follow up appointments with DRs.
46 2021-06-30 cerebrovascular accident, blood clot in the brain On April 17, 2021 following my initial vaccine shot on May 29, 2021 I had a stroke requiring emergen... Read more
On April 17, 2021 following my initial vaccine shot on May 29, 2021 I had a stroke requiring emergency surgery for removal of the blood clot in my brain. I was hospitalized in icu for two days and am currently receiving follow up care. Testing shows that it was not heart nor genetically related.
46 2021-07-01 chest pain Left under arm pain; chest (pectoral) pain; Lymphadenothopy.; Developed rash on left side of spine b... Read more
Left under arm pain; chest (pectoral) pain; Lymphadenothopy.; Developed rash on left side of spine between shoulder blades.; This is a spontaneous report received from a contactable consumer, the patient. A 46-years-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in right arm on 10Mar2021 at 16:00 (at the age of 46 years old) hours as single dose, for COVID-19 immunisation. No known Medical history. The patient did not have any allergies to food, medications, or other products. The patient previously took of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9262) via an unspecified route of administration in left arm on 10Feb2021 at 16:00 hours as single dose, for COVID-19 immunisation and the events were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. No Concomitant medication. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. On 11Mar2021 at 5:00 hours, the patient experienced Left under arm pain and chest (pectoral) pain, Lymphadenothopy. Developed rash on left side of spine between shoulder blades. It was a painful bumpy rash about the size of a silver dollar. The lymph node issues began within hours of second shot and had not improved in 2 weeks. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for events. The clinical outcome of events painful left arm, chest pain, lymphadenopathy and rash were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
46 2021-07-02 chest pain light headache lasting over 5 days, fatigue lasting over 5 days, initial back and chest pain 30 minu... Read more
light headache lasting over 5 days, fatigue lasting over 5 days, initial back and chest pain 30 minutes after vaccine followed by dizziness and nausea. the back and chest pain come and go.
46 2021-07-03 chest discomfort, heart rate increased Pressure in upper chest left and right side, sometimes moves toward back left. Sensations in heart,... Read more
Pressure in upper chest left and right side, sometimes moves toward back left. Sensations in heart, tightness. Coughing related to fluid in chest. While sleeping on side, can feel heart beating inside against chest. Elevated heart rate resting. Dizziness upon standing. Appears to be a correlation with headache pressure: forehead, brain stem region. Professional cyclist in excellent health, overall fitness.
46 2021-07-04 hypertension Patient had seizure and was rushed to hospital. He stayed in the hospital over night for high blood ... Read more
Patient had seizure and was rushed to hospital. He stayed in the hospital over night for high blood pressure after seizure.
46 2021-07-06 chest pain, palpitations chest pain, palpitations, muscle strain
46 2021-07-09 skin turning blue, loss of consciousness Patient received the first COVID Pfizer vaccine, left the immunization room, walked to a chair, and ... Read more
Patient received the first COVID Pfizer vaccine, left the immunization room, walked to a chair, and sat down. Less than a minute later, patient lost consciousness (not sure if just passed out or had seizure), lips turned blue, was gurgling, pupils were dilated, and went limp. His companion helped me get him to the floor, where he was breathing. He remained unconscious for less than a minute longer. We called 911, who instructed us to leave him on the floor until help arrived. His blood pressure was normal when they arrived and patient refused to be further evaluated in the ambulance and refused to go to the hospital. Patient walked out of the store.
46 2021-07-09 fast heart rate, chest discomfort Rash eczema/psoriasis behind left knee and by right knee. Knee pain including significant swelling b... Read more
Rash eczema/psoriasis behind left knee and by right knee. Knee pain including significant swelling behind left knee which has resolved. Rash behind left knee resolved but right knee rash (burning/itching) has persisted but improved and using topical steroid. Severe diffuse headache, difficulty concentrating, slow performance, tachycardia to 120's mainly and some shortness of breath and left sided chest pressure for 48 hours along with fatigue. June 01, had tinnitus for a day. June 07, general intense feeling of not feeling well and headache. June 15, developed severe left leg pain and malaise. June 23, 8-9/10 pain behind left thigh and difficulty walking. Later developed exacerbation of prior mild right knee pain of recent onset to point could not walk.
46 2021-07-14 fainting, excessive bleeding, nosebleed Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: After giving the vaccine to the patient he fainted and fell off the chair hitting his head on the floor. This was a few minutes after the vaccine was administered. After fainting the pt was a little out of it and was bleeding on his nose/forehead. I gave him a water and ice pack for his head. I had him stay sitting on the floor and after 20 mins we decided to the ambulance because his family was not coming. He was checked out and decided not to go to the hospital.
46 2021-07-19 heart rate increased, lightheadedness Dose 1: 4/10/21, Dose 2: 5/3/21 hx obtained 6/24/21: per wife: was out of town, came home 6/13. 6/1... Read more
Dose 1: 4/10/21, Dose 2: 5/3/21 hx obtained 6/24/21: per wife: was out of town, came home 6/13. 6/17 went to casino, came back 6/18. ate a bag of sausage. dog bite that Friday. stomach felt weird. 3 days of HA, stomach ache, vomiting started Monday, went to urgent care the 21st - noticed some nystagmus, given tdap, given meclizine. was told if still not better, to ER. ER yesterday - was told dehydration, got IV fluids, got zofran IV, no imaging, had bloodwork and urine (WBC normal, h/h normal, abn neutrophils/lymphocytes. normal CMP), per wife was told blood in urine. since yesterday, continued HA, nausea, vomited in ER x 1. after zofran no vomiting today was ok, was getting out of car, felt like tripped, then almost fainted. no head trauma, no LOC. heaving. no chest pain, no shortness of breath, has not eaten today. Did take Tylenol today. 325 mg x 1. and ibuprofen 200 mg x 1. 730 am. since out of town, has been drinking couple drinks per day. marijuana gummies. marijuana from dispensary. no other drugs, no cigarettes. no hx of HA or lightheadedness sometimes when flying gets sinus HA on landing. no fever did have 99F when sleeping/hot, normal since then no blood in stools. primary sx is HA - constant throbbing 10/10 (currently 6/10) b/l frontal HA, nonradiating, better with lying down. +light sensitivity. no sound sensitivity. +nausea, +vomiting, several times per day. 2 episodes in 24 hours. no abdominal pain. has had lower back pain. tolerating PO. has had zofran and Tylenol. 2 days ago also had meclizine x 1. per pt always had low HR. no other changes to diet/medications. no facial droop, no one-sided weakness no speaking nonsense. several weeks ago "my heart felt like constant adrenaline" thought was stress - felt like something scared you adrenaline, lasted several days, coming on for several minutes at a time. last dose tadalafil was 1 week ago Pt sent to ER after this visit, but was then discharged home. pt presented to urgent care couple days later and was transferred to hospital after findings below
46 2021-07-21 blood pressure decreased Severe shortness of breath with BP drop with small exertion. I am not out of shape.
46 2021-07-21 excessive bleeding, blood glucose increased, haemoglobin decreased 46 Y male with a PMHx of HTN, HLD, DM, hypoT, stage II NLPHL with concomitant low grade B-cell lymph... Read more
46 Y male with a PMHx of HTN, HLD, DM, hypoT, stage II NLPHL with concomitant low grade B-cell lymphoma (dx 5/19/21) (5/2021, chemo scheduled later this month) presents with cough and SOB x6 days. 1) COVID Pneumonia, Acute hypoxemic Respiratory failure - Symptom onset on 7/15. COVID positive on 7/16. Pt was fully vaccinated on 4/1/21. Pt presented satting 88%. In the ED, he was put on 2L O2, solumedrol, remdesivir, and offer tocilizumab, which he refused at first. Pt took Tocilizumab at night. Pt now on 12L oxymizer. Offered tocilizumab again and increased methylprednisolone to Q6h. - 12L Oxymizer. Goal SpO2 >92%. Consider ICU evaluation if requiring >40LPM and 60% FiO2 for SpO2 >/= 90% - Self-proning as tolerated for O2 req >3L - Methylprednisolone 125mg IV Q6h for 5 days (7/21 - 7/25) and taper down - Remdesivir 200mg IV x1, followed by 100mg IV daily until clinical improvement or 5 days (7/21 - 7/25 ) - f/u daily LFTs. Hold Remdesivir if ALT >10xULN or CrCl<30 - CRP, D-dimer, LDH, ferritin elevated. Trend QOD - Lovenox 40mg SQ BID and hold for Plt <25k, Fibrinogen <100, active bleeding - Tocilizumab 600mg IV x2 - Tessalon for cough - Encourage IS - Isolyte 500cc x1
46 2021-07-22 chest discomfort, chest pain He developed some chest pain that created discomfort, then went away after a day. Expressed concer... Read more
He developed some chest pain that created discomfort, then went away after a day. Expressed concern with second dose side effects. Let him know that if any symptoms exist after dose on 7/22/21 to please call us for non-urgent advice and if pressing to go to the emergency department right away.
46 2021-07-27 heart rate irregular, palpitations heart palpitation; irregular heart beats/irregular beats that happening and seems like it's like eve... Read more
heart palpitation; irregular heart beats/irregular beats that happening and seems like it's like every 20 minutes; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number ER2613, expiration date was not reported) via an unspecified route of administration in the left arm on 02Jun2021 (at the age of 46-years-old) at single dose for covid-19 immunisation. The patient medical history and concomitant therapy were none. The patient was fine on the weekend and he didn't get any adverse side effect things, so he was noticing some heart palpitation, the heart was not regular pattern, irregular heart beats, he was noticing some irregular beats that happening and seemed like it was like every 20 minutes, he wanted to know this was normal or not and the only thing he took over the counter was some Advil (Ibuprofen ) just because of this irregular heart beat thing. No treatment received for the event heart palpitation. The outcome of the events was unknown.
46 2021-07-27 loss of consciousness, atrial fibrillation Increase of Atrial Fibrillation (Afib) events and severity. For the 20 years preceding the Covid sho... Read more
Increase of Atrial Fibrillation (Afib) events and severity. For the 20 years preceding the Covid shot, I had 1-2 Afib events in low severity about every 8 months and only one severe event in 2008. Since getting the Covid shot, I've had 1 event every week with 2 severe events and 2 emergency room visits. Three cardiologists have confirmed my condition and verified my event history and the increase in frequency. My workouts have been relatively the same for 3 years. Now, after any workout that I push to failure, onset of Afib occurs approximately 4-6 hours later with a medium to high severity. Afib Severity: Low; occasional light headed when exerting. Medium; weakness, need to sit. Severe; semi/or unconscious.
46 2021-07-28 chest pain extreme pain in his stomach with swelling and bloating; painful to breath because his abdomen was sw... Read more
extreme pain in his stomach with swelling and bloating; painful to breath because his abdomen was swollen/ extreme pain in his stomach with swelling and bloating; Dry heaves; painful to breath because his abdomen was swollen; sciatica to hurt and aggravated his lower back pain; sciatica to hurt and aggravated his lower back pain; hip pain; The pain was high up under his rib cage; Stomach discomfort; tenderness at the injection site; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6204; Expiration date: unknown), via an unspecified route of administration, administered in arm left on 13Mar2021 at 11:00 (at the age of 46-years-old) as dose 1, single for COVID-19 immunisation at hospital. Medical history included systemic herpes zoster infection (disseminated varicella zoster virus infection), ongoing HIV infection (he has been positive for HIV for 30 years) and previously had hip injury. Concomitant medications included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV infection from an unspecified start date and ongoing (taking for 3 years); aciclovir sodium (ACYCLOVIR [ACICLOVIR SODIUM]) taken for disseminated varicella zoster virus infection from an unspecified start date and ongoing (taking for 6 years). There was no history of any previous immunization with the Pfizer vaccine considered as suspect and no prior vaccinations within 4 weeks. The patient did not receive any additional vaccines on same date of the Pfizer suspect. There was no family history. The patient experienced tenderness at the injection site on 13Mar2021, diarrhea, stomach discomfort on 13Mar2021 at 18:00, extreme pain in his stomach with swelling and bloating, dry heaves, painful to breath because his abdomen was swollen, sciatica to hurt and aggravated his lower back pain, hip pain, the pain was high up under his rib cage on 14Mar2021. Patient stated recently had the Pfizer COVID 19 vaccine on Saturday and had some side effects that he had not read about. The patient clarified that he received the first dose of the Pfizer COVID 19 vaccine 13Mar2021 at 11:00 AM in the left arm. He reported that there was a little tenderness at the injection site, but it was no big deal. Then at 18:00 he noticed some stomach discomfort and had one episode of diarrhea. Then at midnight he woke up with extreme pain in his stomach with swelling and bloating. He couldn't stand up with the pain, it was at his limit. He added that his roommate wanted him to go to the emergency room, but he didn't want to go to a rinky dink hospital in the middle of the night, so he stayed home. Stated that he started to have dry heaves and brought up some fluid then it was just violent dry heaves then finally he was able to bring up air. It was painful to breath because his abdomen was so swollen, and he felt like he was exhaling forcefully. The pain was high up under his rib cage. This all continued until around noon on Sunday when air finally came up. He laid on his stomach on a heating pad and by afternoon he was better; by Sunday evening the swelling had mostly subsided. Patient stated that when he had the swelling and bloating it felt hard up under his rib cage. It pushed his ribcage out of position and caused his sciatica to hurt and aggravated his lower back pain. Mentioned he had a previous hip injury and the swelling that caused his back to be out and also caused hip pain. He further stated that his stomach was still irregular and making noises. And then at the time of this report, stated that he could do his usual stretches. Mentioned he got an email from the hospital and he reported his symptoms to them, but this was the first time to call Pfizer. He was scheduled to receive the second dose on 05Apr2021. He asked what to do to prepare for the second dose. The adverse events did not require a visit to physician or emergency room. The patient did not undergo relevant test. The outcome of the events tenderness at the injection site, diarrhea was resolved on 13Mar2021; events of extreme pain in his stomach with swelling and bloating, dry heaves, painful to breath because his abdomen was swollen was resolved on 14Mar2021 and outcome of rest of the events was resolving. No follow-up attempts are possible. No further information is expected.
47 2021-01-06 heart rate increased Dizziness Narrative: About 20 min after injection felt pulse fast, and light headed dizzy, put ice ... Read more
Dizziness Narrative: About 20 min after injection felt pulse fast, and light headed dizzy, put ice pack on back of neck stayed extra 25 min with resolving b/p 151/80 pulse was 101 98 percent oxygen sats on room air, last b/p 130/83 pulse 80. No further symptoms or complaints all resolved. Left clinic with instructions to go to the ED any worsen symptoms.
47 2021-01-07 fast heart rate Myalgia, Tachycardia, fatigue, soreness at the injection site. Narrative: 12/21 employee received v... Read more
Myalgia, Tachycardia, fatigue, soreness at the injection site. Narrative: 12/21 employee received vaccine at 0930 - later in the afternoon he noted tachycardia to about 100. He was watching the rate on his Apple watch. The highest rate was 130. His only other symptom was fatigue which was bad enough on 12/22 that he had to go home. He saw his PCP on 12/22 for the tachycardia who ordered labs which were all normal. He is a resident so he asked anesthesia to do an EKG which showed sinus tachycardia. On 12/23 his heart rate average went down to 100. Today (12-28) his resting heart rate is 70-80 which is his baseline. He has not had recurrence of the tachycardia since 12/23. He also reports he had soreness at the injection site and myalgias both of which have since resolved.
47 2021-01-08 heart rate decreased, very slow heart rate Dizziness, Seizures, Syncope, Bradycardia, cold, clammy Narrative: 10 mins after administration, Emp... Read more
Dizziness, Seizures, Syncope, Bradycardia, cold, clammy Narrative: 10 mins after administration, Employee began expressing lightheadedness, Employee assessed, employee was cold and clammy. Employee then began to have a seizure which last approx 30 sec. Vital signs assessed BP 110/80 HR 87 then dropped to 50 which is unusual for employee. o2 sat 94% on room. Employee regained consciousness and was able to state name, time and place. Reported no previous history of seizures. Employee handed off to ER staff for further eval.
47 2021-01-12 fainting Approximately 13 hours after receiving the vaccine I became overwhelmingly tired. Went to get ready ... Read more
Approximately 13 hours after receiving the vaccine I became overwhelmingly tired. Went to get ready for bed by first going into the bathroom. While getting ready I passed out (micturation syncope). Hit my head on the floor and sustained a concussion. I am still experiencing post concussive symptoms but this is to be expected as it has been less than a week.
47 2021-01-14 nosebleed Day of the vaccination, patient went home and developed a bilateral nosebleed and had a seizure. Pat... Read more
Day of the vaccination, patient went home and developed a bilateral nosebleed and had a seizure. Patient continues to feel poorly as of 1/15/2021 but has returned part time to work.
47 2021-01-14 loss of consciousness, blood pressure decreased, heart rate decreased Pulse dropped to 30. Low pressure too. Brachycardia. Lost consciousness. Did not seem to be Vasovag... Read more
Pulse dropped to 30. Low pressure too. Brachycardia. Lost consciousness. Did not seem to be Vasovagal. Saline IV. Blurred vision. Very. Strange. Girl friend said I seemed catatonic for about 5-10 seconds. Cold sweat. Dizziness. Immediate Symptoms lasted about an hour. Injection site very sore 10 hours later. Body pains.
47 2021-01-15 heart rate increased, increased heart rate, fast heart rate, blood pressure increased Patient complained of feeling light-headed and a little dizzy at 10 minutes post-administration. Pu... Read more
Patient complained of feeling light-headed and a little dizzy at 10 minutes post-administration. Pulse-oximetry applied revealed normal spO2, but tachycardia to 140bpm (this patient's resting HR is approximately 55-65). Apple Watch data confirmed rapid increase in HR at that moment. BP increased from normal baseline to about 150-160 SBP. No chest pain reported. No signs/symptoms of anaphylaxis (rash, wheezing, etc.). HR gradually recovered to normal levels within 30 minutes and patient was released after 60 min observation. Patient reported generalized fatigue in weeks following injection. Nineteen (19) days after injection, patient developed unprovoked resting tachycardia to approximately 180bpm (following some moderate weigh-lifting exercise). Symptoms did no resolve sufficiently and patient was transported by EMS to ER for evaluation
47 2021-01-20 chest pain Pt was screened prior to receiving covid 19 vaccine. He received vaccine and was being observed for ... Read more
Pt was screened prior to receiving covid 19 vaccine. He received vaccine and was being observed for 30 min. During wait time he informed the observation staff that he had pain in upper R side of chest his closest to his R axilla. RN was notified and assessed the pt. At time of assessment pt stated the pain stopped after receiving the vaccine. Described pain as an aching, on scale 1-10 was at a 6. BP taken 110/70 LA, P 64, rr 16. No sob, no diaphoresis, no pain at time of nurses assessment. Denied hx of similar pain, cardiac or injury to upper chest. Pt denies feeling anxious prior to receiving vaccine. Not aware of an injury but admits
47 2021-01-21 loss of consciousness, hypertension About 4 am the night after the vaccination, I developed significant left arm pain. Hurt; throbbed ... Read more
About 4 am the night after the vaccination, I developed significant left arm pain. Hurt; throbbed and didn't want to use it. Went to work but about 7:00 am- I noticed my right arm began to work as well - almost in the the same severity. Spell- lose consciousness alost- had bad headache; - it abated and it happened again - almost lost consciousness. It left. And it happened again a third time and went to a stretcher - nurse took my BP 220/110 - blood pressure - very high for me and laid on the stretcher and had nurses hook me up ot monitors; No change on cardiogram and my oxygen saturation level never altered and never dropped; My BL remained elevated - significantly. 180/90 before I went home. Continued to check my BP when I went home - queasy; nauseated - upset stomach and then fever the following day - remained for 4-5 days. Fever was one day and got 100.5 and then was gone after that day. BP continued to check regularly through next few days - it did improve a bit but was still elevated - 180/150 (systolic) and 110/95 (Diastolic) - Slowly got back to normal by day 7 after vaccination. Went to work the 30th the day before New Year's Eve, finally and had dizziness never got quite as severe - 50% but left arm pain very very painful - almost numb; right arm hurt some, too. Blood 190/110 .Oxygen Saturation remained good. Arm pain very bad - ordered EKG - was normal Admitted my self to ER - Had a full work up - repeated EKG - negative; two sets of troponins - negative; chest x-ray - nothing - BMP - elevation in my creatine which I've never had before. CBC - normal; They treated me with fluid hydration; Tylenol; fentanyl and hours later I felt a bit better. Things calmed down and I was released. BP remained elevated for next two days. I got better after two days _ enough to work - but still would get a little disequilibrium not enough to pass out but just like an odd feeling and then it would go away after a few seconds. And that is only recently disappeared - within the last week or so. I feel better now but my BP remains elevated - 160/140 (systolic) over 105/95 (dystolic) - that's al new for me. I have declined the second vaccination. Have sort of recovered but it did come back after time and so it may come back again - don't know. I may have been exposed to COVID the week before my vaccination. About 4 days after the severe symptoms that lead to my leading to take off work; I took test for COVID - PCR at CVS (returned positive) and COVID test PCR and rapid antigen (returned negative) at Public Health -
47 2021-02-03 atrial fibrillation, inflammation of the pericardium Pleuritic chest pain. Admitted due to acute pericariditis. Course complicated with new onset atrial ... Read more
Pleuritic chest pain. Admitted due to acute pericariditis. Course complicated with new onset atrial fibrillation.
47 2021-02-04 nosebleed PT had a bloody nose, it resolved quickly, then had a funny sensation in the back of the neck.
47 2021-02-05 lightheadedness, loss of consciousness Vasovagal post vaccination. Pt passed out and lost consciousness.
47 2021-02-09 palpitations, heart rate increased, chest pain Shortness of breath; palpitations/increased heart rate; palpitations/increased heart rate; Immediate... Read more
Shortness of breath; palpitations/increased heart rate; palpitations/increased heart rate; Immediate left arm/chest pain; Immediate left arm/chest pain; fatigue; body aches; This is a spontaneous report from a contactable physician. A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via intramuscular, on 18Jan2021 at single dose on the left arm for COVID-19 immunisation, administered at Hospital. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided. No other vaccine was received in four weeks. The patient developed immediate left arm/chest pain, and fatigue/body aches. On 23Jan2021 (5 days later), he developed shortness of breath and palpitations/increased heart rate. Post-vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.
47 2021-02-14 fainting Patient reported Syncope/Fainting on site EMS was required. SBP 118, Oximetry 98, EMS/on site physic... Read more
Patient reported Syncope/Fainting on site EMS was required. SBP 118, Oximetry 98, EMS/on site physician decided No treatment was needed transported to local hospital.
47 2021-02-15 chest discomfort I woke up with ringing in my ears at 4 AM and this is ongoing at times. Seems like it may be the lef... Read more
I woke up with ringing in my ears at 4 AM and this is ongoing at times. Seems like it may be the left ear. I also experienced headache, vertigo, chest heaviness, vertigo, and chills for 3 days following the vaccine. Still have the ringing. I cancelled the 2nd vaccine.
47 2021-02-15 deep vein blood clot, pulmonary embolism Had daily headaches after first dose of vaccine. For 3 weeks. Decided to skip the second dose becaus... Read more
Had daily headaches after first dose of vaccine. For 3 weeks. Decided to skip the second dose because of that. Then had leg pain after nearly a month of the vaccine. Thought it was muscle pain but landed up in ER with shortness of breath and was diagnosed with DVT and large PE.
47 2021-02-17 fainting I was dizzy all along and almost fainted; I was dizzy all along and almost fainted; migraine; This i... Read more
I was dizzy all along and almost fainted; I was dizzy all along and almost fainted; migraine; This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Jan2021 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; high cholesterol; borderline diabetes. Concomitant medications included losartan; alirocumab (PRALUENT, injection) on 20Jan2021. Since 23Jan2021, patient was dizzy all along and almost fainted and was still having symptoms of mild migraine and he don't know like some light sensitivity. Doctor believed it was from vaccine. Patient was wondering how long was this going to be last as he had second shot coming out. He didn't think it was an adverse reaction and he thought he should get the second shot. But this was continuing to me and it had already been two weeks and patient still having symptoms of mild migraine. Patient was worried about taking the second shot as a result. He had never had a migraine before and was told it was probably from the vaccine and that was not something he wanted to hear. Patient wanted to know if this was normal to still be having this side effect for this long. Patient was taking acetaminophen (for migraine), it was not a TYLENOL, it was from a different brand. Patient did liver and cholesterol test and blood test in Jan2021 at Cardiologist and they came back fine, nothing was found there. The outcome of event migraine was not resolved. The outcome of rest events was unknown. Information on the lot/batch number has been requested.
47 2021-02-22 pallor 0720: pt c/o feeling "faint, lightheaded, dizzy" 10 minutes post second dose of Pfizer COVID-19 vacc... Read more
0720: pt c/o feeling "faint, lightheaded, dizzy" 10 minutes post second dose of Pfizer COVID-19 vaccine. pt appears pale and diaphoretic. laid to the ground with bilateral lower extremities elevated above level of heart. pt states he feels better a few minutes after intervention. VS BP 121/76, HR 68, RR 16, SPO2 96 on RA, T 97.9.
47 2021-02-24 lightheadedness ~10 minutes after receiving second dose of Pfizer COVID vaccine while sitting in the waiting area, I... Read more
~10 minutes after receiving second dose of Pfizer COVID vaccine while sitting in the waiting area, I started feeling light headed and I thought I was going to pass out. Medical personnel in the waiting area came over, had me lay down and provided cold packs. They stated this was likely a vasovagal like response. When I have donated blood in the past I have had a very similar reaction.
47 2021-02-24 blood clot, cerebrovascular accident Stroke on January 20th, 2021. Unknown cause for blood clot.
47 2021-02-28 fainting, loss of consciousness Pt developed syncope and LOC for ~ 3 min. VS WNL when monitored.No other adverse reaction noted.
47 2021-03-02 pallor, fainting Patient received 1st dose of his Covid vaccine; after~10 min, during observation period, he was not... Read more
Patient received 1st dose of his Covid vaccine; after~10 min, during observation period, he was noticed to become pale ,diaphoretic and with decreased level of responsiveness; was put on the stretcher. Physician who was monitoring the vaccination area reported: "BP 110/64 HR 76 Sat 95% Patient was feeling better upon being placed supine and was verbalizing as well. Denied chest pain and shortness of breath. Just felt dizzy and weak." Patient was taken to ER; CBC,CMP,ECG- all normal and he was discharged after 2 hrs of observation with diagnosis of Vasovagal Syncope. Today, patient is well and went to work as per his spouse. Patient has history of similar syncope or near syncope events in the past during stressful situations, like seen blood .
47 2021-03-05 pallor Complaint of dizziness. Pale and diaphoretic. BP 108/60, P 53, R 16, T 96.8, O2 98%. Monitored in po... Read more
Complaint of dizziness. Pale and diaphoretic. BP 108/60, P 53, R 16, T 96.8, O2 98%. Monitored in post vaccination area and discharged without any complaints.
47 2021-03-11 cerebrovascular accident About a week and a half after receiving the second Pfizer vaccine my husband had a stroke
47 2021-03-16 loss of consciousness Patient received vaccine. He preceded to wait area. Within minutes he slid out of his chair and hit ... Read more
Patient received vaccine. He preceded to wait area. Within minutes he slid out of his chair and hit his head on the floor. He appeared to be unconscious and possibly seizing. He came to. We asked him his name, date, and where he was. He was able to answer all questions. Said his head hurt. Medics arrived and took over
47 2021-03-17 blood pressure increased Patient received COVID vaccine (Pfizer, lot# ER2613, exp 7/2021) at 3:00pm. EMT asked patient how he... Read more
Patient received COVID vaccine (Pfizer, lot# ER2613, exp 7/2021) at 3:00pm. EMT asked patient how he felt at 3:27 during his 30min observation, patient report he felt "spacey" because he had not eaten since breakfast. EMT alerted PHN'S. 3:30 blood pressure 200/130, pulse 86, respirations 18, O2 93%. Patient was A&Ox4, denied headache, dizziness, swelling, tingling, altered vision. Medications: simvastatin, amlodipine, gabapentin, methocarbinol, vitamins. Medical conditions include kidney problems, hypertension, polycythemia, spinal fusing, chronic pain. Patient receives therapeutic phlebotomy and is 1 week overdue. 3:35 blood pressure 182/120, pulse 88, O2 99%, respiratory rate 20. 3:40 blood pressure 192/119, repiratory rate 24, paitent reported anxiety and lightheadedness, continued to deny headache, blurry vision. PHN called 911 at 3:42, offered Bendaryl to patient who declined. 3:50 911 assumed care, reported blood pressure 210/palpated and temp 101.1. Patient's partner arrived. Patient declined 911 transport at 3:53. Patient reported he would have his partner drive him to urgent care. Patient left with steady gait at 4:09.
47 2021-03-17 chest discomfort, fainting Pt. was monitored for 15 minutes after receiving the first dose of the COVID-19 vaccine, Pfizer. Com... Read more
Pt. was monitored for 15 minutes after receiving the first dose of the COVID-19 vaccine, Pfizer. Complained of chest discomfort, tightness, diaphoresis, and syncope when attempting to stand. HR was 166 at initial presentation, BP was 117/75, SPO2 98% on room air, R 18 equal and unlabored.
47 2021-03-17 heart rate decreased Patient received vaccine and while waiting his 15 minutes he reported feeling dizzy and was sweating... Read more
Patient received vaccine and while waiting his 15 minutes he reported feeling dizzy and was sweating. The nurse called for the EMTs and they took him in hall to take his vitals. His HR was in the 40s to 50s so they did an EKG. He has a history of heart disease and had an ablation about a year ago. The paramedics took him to a nearby hospital.
47 2021-03-18 heart rate increased, blood pressure increased After leaving facility, had numbness in tongue, trouble swallowing. Waited 20-40 more minutes, then ... Read more
After leaving facility, had numbness in tongue, trouble swallowing. Waited 20-40 more minutes, then felt dizzy and began to have hives in addition to previous reactions. I went to Urgent Care where they took vitals. Blood pressure and heart rate were elevated, throat was abnormal, and I had hives. They gave me antihistamine and steroid shot. After 30minutes - and hours, vitals returned to normal.
47 2021-03-21 chest pain, blood pressure increased Elevated blood pressure, dizziness, chest pain
47 2021-03-21 excessive bleeding Notes: APRN (Nurse Practitioner), Cosigned by: MD at 3/19/2021 9:22 AM, COVID VACCINE CLINIC 3/18/20... Read more
Notes: APRN (Nurse Practitioner), Cosigned by: MD at 3/19/2021 9:22 AM, COVID VACCINE CLINIC 3/18/2021 Patient/Date: 3/18/2021 Subjective: a 47 y.o. male who was seen at SVH COVID Vaccine Clinic today for his first dose of the COVID Pt is a 47 y.o. male who was seen at COVID Vaccine Clinic for his first does of COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Pt received shot and complained of being hot and sweaty. He was laid on the floor in injection room 5, with his feet elevated, some water was given and once pt was feeling better he was transferred to the ER bay for observation. He refused a wheelchair and walked to the bay with help. After sitting for awhile we cooled down and he was allowed to leave. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness, and hot and sweaty: CONT negative, HENT negative, Eyes negative, Respiratory negative, Skin negative, GI negative, Musculo negative, Previous Reactions: None, Objective: Vitals - There were no vitals filed for this visit. Physical Exam - Constitutional: Appearance - He is well-developed. HENT: Head -Normocephalic and atraumatic. Right Ear- External ear normal. Left Ear: External ear normal. Nose - Nose normal. Eyes - Conjunctiva/sclera: Conjunctivae normal. Pupils - Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm - Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort - Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: General -Normal range of motion. Cervical backN -normal range of motion and neck supple. Skin: Coloration: Skin is pale. Neurological: Mental Status - He is alert and oriented to person, place, and time. Assessment/Plan: Treatment include - water and snacks. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash). Pt was released at 3:26, he was accompanied by his wife. APRN Electronically Signed 3/18/2021 3:19 PM
47 2021-03-21 pallor, hypotension Pt appeared dizzy, cold and clammy, pale, and flushed. Paramedics accessed pt, found out he was hypo... Read more
Pt appeared dizzy, cold and clammy, pale, and flushed. Paramedics accessed pt, found out he was hypotensive. MD on site examined pt and called management. Pt was transported to Hospital via ambulance, accompanied by wife. Pt was alert and oriented x3, EKG done on sinus rhythm .
47 2021-03-22 chest discomfort Patient reports feeling "weird" and "rushing in chest", tingling and numbness near trachea
47 2021-03-22 loss of consciousness, pallor Patient stated prior to vaccine he has a history of fainting after vaccination. About 1 minute after... Read more
Patient stated prior to vaccine he has a history of fainting after vaccination. About 1 minute after vaccination he became pale, clammy, and lightheaded. Spoke with patient while someone else retrieved an ice pack and water. About 2 minutes after vaccination patient became unconscious and upper body had seizure like activity. Patient was moved to the floor immediately regained consciousness. Event lasted approximately 15-20 seconds. After regaining consciousness, stated he felt better. Remained on the floor for about 5 minutes, EMS was called as precaution. EMS stated vital signs and blood sugar were stable. Patient refused transport to hospital. Instructed to follow up with PCP.
47 2021-03-25 hypertension Patient reports 2/10 headache following vaccination. Took patient vitals to find him hypertensive. p... Read more
Patient reports 2/10 headache following vaccination. Took patient vitals to find him hypertensive. patient refused transport to ED
47 2021-03-27 arrhythmia, palpitations Heart arrhythmia and palpitations 96 hrs post-vaccine; Heart arrhythmia and palpitations 96 hrs post... Read more
Heart arrhythmia and palpitations 96 hrs post-vaccine; Heart arrhythmia and palpitations 96 hrs post-vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 09:00 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunization. Medical history of the patient was reported as none. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 16Jan2021 09:00 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunization. On 14Feb2021 14:00 patient experienced heart arrhythmia and palpitations 96 hrs post-vaccine. Treatment included EKG, cardio. Consult, Holter Monitor, stress test. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. Patient did not had COVID prior vaccination and didn't tested covid post vaccination. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected
47 2021-03-28 heart flutter, heart rate irregular I started having heart palpitations/irregular heartbeats on the night of 03/23 until I fell asleep.... Read more
I started having heart palpitations/irregular heartbeats on the night of 03/23 until I fell asleep. I had a few heart palpitations on 03/24 during the day and when I laid down for sleep my heart palpitations were non stop all night. It felt like every few minutes my heart would stop, then flutter, them resume normal beating. This was the worst episode This lasted all night until the morning, after I got a little sleep. Since 03/25 the episodes are getting fewer but still linger.
47 2021-03-28 loss of consciousness Patient called into clinic to report about two hours after receiving vaccine he passed out and the p... Read more
Patient called into clinic to report about two hours after receiving vaccine he passed out and the person that was with him said he had a seizure. Patient reported feeling fine after about an hour, but was very tired and had a headache.
47 2021-03-30 cerebrovascular accident Had a stroke; This is a spontaneous report from a contactable consumer (patient). A 47-years-old mal... Read more
Had a stroke; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at 09:00 (age at vaccination: 47-years) at a single dose for COVID-19 immunization. Medical history included diabetes, high blood pressure, kidney disease, Penicillin allergy and Covid-19 prior vaccination. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); trazodone; insulin aspart (NOVOLOG); insulin lispro (HUMALOG); and pantoprazole. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 at 08:00, the patient had a stroke. The event resulted to hospitalization on an unspecified date. The patient received an unspecified treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering. Information about the lot/batch number has been requested.
47 2021-03-30 hypertension, chest discomfort Got my first Pfizer shot on March 24 at 2 pm. The first day I felt way off like I was drunk or on so... Read more
Got my first Pfizer shot on March 24 at 2 pm. The first day I felt way off like I was drunk or on some kind of drug that gets you high with bouts of dizziness and some major hypertension. My back and chest were very tight the whole time. The tension finally subsided around 11 pm that night but I was still uneasy. The 2nd day I felt ok in the morning and throughout the day until about 3 or 4 pm I started getting really nauseated and tired. I went to lay down to sleep and felt a little better when I woke an hour later. Day 3 I started feeling extremely tired and fatigued with some major chills. Basically slept most of that evening and throughout the night. Woke that next day and couldn't get that dizzy foggy feeling out of my head the whole day. Day 4-5 still bouts of dizziness, chills and fatigue with some nausea also I noticed I developed a wheezing dry cough which points towards respiratory distress. Day 6 still feeling yucky, tired, fatigued, some nausea and that dam cough. Today 03-31-21, still feeling weak and tired with some episodes of dizzy spells, nausea and respiratory distress cough. Also forgot to mention on day 2 and 3 I had some major tingling on the right side of my head for most of the day. Felt like spiders crawling on my head and face. The last time I felt tingling like that I got shingles which also got me very sick and put me in the ER and ICU years ago. So there is also some post traumatic stress from that as well. Made an appointment to see a Doctor on 03-30-21 to have my blood pressure checked and get an overall check up. My blood pressure is elevated and stress levels are high with anxiety. Dr prescribed me some anxiety medication. No other recommendations from the Doctor.
47 2021-03-31 lightheadedness Vasovagal response after standing at completion of 15 minute observation period.
47 2021-04-02 blood pressure increased Pt reports feeling slightly light headed which prompted him to check his BP. Pt reports he noticed ... Read more
Pt reports feeling slightly light headed which prompted him to check his BP. Pt reports he noticed his BP going up 150/100 then 160/100.
47 2021-04-04 blood pressure fluctuation 3/31 pt call: Pt states he's has progressively worsening nausea for over a week. Woke up this mornin... Read more
3/31 pt call: Pt states he's has progressively worsening nausea for over a week. Woke up this morning and could hardly get out of bed. Denies abdominal pain but feels nauseated and has been vomiting off and on all day. No other GI sx. Pt has known hiatal hernia but doesn't take anything for GERD right now because he doesn't have heart burn sx. Denies chest pain. Gets sweaty randomly and chilled, but this is more chronic. Sees neuro for early onset parkinson dx but no change in medicine in over a month. No new supplements. Denies dark stools. Pt taking all his medications with compliance. Has been getting more headaches lately too but thinks this is stress and from wretching. Has chronic headaches. Pt has OSA and has been wearing his Cpap with compliance. Gave patient zofran, prilosec, carafate for suspected gastritis sx. Recommended he come get labs in the morning as well. Pt agreed. 4/1 ER HPI: 47 y.o. male who presents with complaints of nausea vomiting abdominal pain ongoing now for the past day reports that is better with rest worse with movement denies any other complaints issues 4/1 Admission HPI: 47 y.o. male that was recently diagnosed with Parkinson's disease. He presented to the emergency room with the a several day history of fluctuating blood pressure and nausea/vomiting and generally feeling very poorly. He has been having a lot of new onset health issues lately and so his wife and family were concerned. He was brought into the emergency room. He denies any severe abdominal pain. However, he states he has been feeling extremely nauseous. He is vomited at least once a day for the last 5 days. He does admit that he is under an extraordinary amount of stress between his new onset Parkinson's, his insurance business, and his full-time job as a pastor. The patient also does have a history of alpha-gal allergy. He states it is possible he ate some cross contaminated meat, but states that this nausea and vomiting does not act like his typical response to eating something that he is allergic to. The patient states that about a month and a half his neurologist did increase his Requip up from 0.5 mg 3 times a day to 1.5 mg 3 times per day. However, it has never made him nauseous before. He denies any definite chest pain. He denies any exertional dyspnea. He does admit that his blood pressure has been fluctuating for quite some time. He states he was having a skin biopsy done last week and they almost abandon the procedure because his blood pressure was so high. He currently takes a combination of Benicar and hydrochlorothiazide. In the emergency room his lipase was found to be a little bit elevated. Creatinine was found to be a little bit elevated. His blood pressure was very elevated in the systolic 170 range and he did require some IV labetalol. The patient states he really has not missed any doses of his medications.
47 2021-04-05 loss of consciousness arm pain, dizziness, passed out x2. Evaluated by EMS-Refusal to transport.
47 2021-04-05 fainting, pallor Pfizer-BioNTech COVID- 19 Vaccine EUA: Paramedic noticed vaccine recipient's eyes roll back, and mil... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA: Paramedic noticed vaccine recipient's eyes roll back, and mild brief tonic (arms) preceding syncopal x1 activity, patient was pale, clammy. Paramedic held patient up in chair to avoid fall. Patient taken to OBS medic tent for observation for syncopal event. Observed, water offered, orthostatic positioning, rest. Patient walked out after recovery.
47 2021-04-06 loss of consciousness, lightheadedness While standing at the check out desk, patient experienced dizziness with fall and loss of conciousne... Read more
While standing at the check out desk, patient experienced dizziness with fall and loss of conciousness for ~30 seconds. He was not observed to hit his head and reported no headache or feeling of brusing of his head Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Patient was taken to the observation area where he was observed for 40 minutes. He reported resoluation of any dizziness and reported prior vasovagal events from other vaccinations/blood draws.
47 2021-04-07 chest pain Chest pain just below sternum for over 24 hours. Started about 18 hours after the vaccine and soon ... Read more
Chest pain just below sternum for over 24 hours. Started about 18 hours after the vaccine and soon after eating breakfast. Checked blood pressure this morning approximately 26 hours after the symptoms began and it is very elevated 155/75. It normally runs 115/65
47 2021-04-08 loss of consciousness Received pfizer vaccine and began to feel dizzy, reports "a few seconds" of loss of consciousness. B... Read more
Received pfizer vaccine and began to feel dizzy, reports "a few seconds" of loss of consciousness. Brought to the Emergency room.
47 2021-04-08 loss of consciousness Started to feel light headed and passed out within 5 minutes.
47 2021-04-08 loss of consciousness Patient was sitting in a chair drinking a soda being observed for 15 minutes after his first shot. ... Read more
Patient was sitting in a chair drinking a soda being observed for 15 minutes after his first shot. Ten minutes into his observation time, he started feeling sweaty, dropped his soda, started shaking and fell out of is chair face down. He gained cosciousness, turned onto his back and put his knees up. His blood pressure was 132/108. The ambulance was called. The patients vitals were normal whe the emt evaluated the patient. The patient refused treatment and called his wife to come pick him up and agreed to follow up with his primary care physician Monday.
47 2021-04-08 pallor Client was in the observation area with his spouse post vaccination. Wife reported client dropped hi... Read more
Client was in the observation area with his spouse post vaccination. Wife reported client dropped his paperwork and became pale, diaphoretic and unresponsive. EMS responded immediately at which time the client was responsive, awake, alert and oriented. Client assessed and found to have vital signs within normal limits. 12 lead EKG performed and normal. Residual leg weakness improved quickly and patient was counseled regarding transfer to Emergency Department which was declined.
47 2021-04-09 chest pain, chest discomfort, pallor Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Vision changes-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient presented with sweating, and pale face. Chest pressure/pain and left arm pain. Face was pale. Pt reported nausea and vision bluring in and out. Reported unable to stand and verbalized the desire to call an ambulance to evaluate. 911 was called and all advice followed until EMS arrived. Rph remained with patient until EMS arrival. Pt had NO swelling of lips/eyes or difficulty breathing. No hives. Unable to reach patient to assess curent status
47 2021-04-11 low blood oxigenation Symptoms developed on 3/29/21 after exposure to COVID positive person and was tested. Was found to b... Read more
Symptoms developed on 3/29/21 after exposure to COVID positive person and was tested. Was found to be positive for COVID-19 on 3/29/21. Presented to emergency department on 4/1/21 for worsening symptoms including fever, hypoxia, and cough and was not admitted. Patient presented to ED on 4/5/21 for worsening symptoms and was admitted to the ICU.
47 2021-04-11 palpitations Patient reported that he felt like he was having heart palpitations that started the evening of the ... Read more
Patient reported that he felt like he was having heart palpitations that started the evening of the day after his vaccine. He stated that he had a history of atrial fibrillation in the past, and that this did not feel the same. Patient consulted his primary care physician.
47 2021-04-12 palpitations Pain from injection. Lasted 2 days. Bad dreams 12 hours after injection. Very low energy 30 hours a... Read more
Pain from injection. Lasted 2 days. Bad dreams 12 hours after injection. Very low energy 30 hours after injection with a metallic taste in my mouth, Aches and pains, diarrhea, nausea, racing heart, confusion, exhaustion, 5 days after injection energy is better. All other symptoms are slowly subsiding.
47 2021-04-12 fainting 1430 PT SITTING IN POST VACCINE WAITING AREA AND HAD SYNCOPAL EPISODE. FALL TO FLOOR FROM CHAIR SITT... Read more
1430 PT SITTING IN POST VACCINE WAITING AREA AND HAD SYNCOPAL EPISODE. FALL TO FLOOR FROM CHAIR SITTING POSITION. PT TURNED TO BACK WITH ASSISTANCE FROM STAFF. PT QUICKLY REGAINED CONSCIOUSNESS AND NOTED TO BE WITH DILATED PUPILS AND TRYING TO FOCUS. NOTED CLAMMY SKIN. VS WITH HEART RATE IN 40'S WEAK RADIAL. BP 122/76. NOTED APPROX 1/2 INCH ABRASION TO RT TEMPORAL AREA FOREHEAD. PT ORIENTED TO SURROUNDINGS AND SITUATION. STATES "I TRIED TO RAISE MY HAND TO TELL NURSE I FELT FUNNY, THEN I FELT LIKE I WAS IN A DREAM AND WOKE UP WITH YOU ALL AROUND ME" EMS NOTIFIED IMMEDIATELY. PT DENIES ANY MEDICAL HX. VS MONITORED WITH BP 90/36 ON 2ND CHECK. EMS HERE AND TOOK POSSESSION OF PT
47 2021-04-13 heart rate abnormal, fast heart rate Mild tingling in the right foot, tachycardia during the first 15 minutes after getting vaccinated. S... Read more
Mild tingling in the right foot, tachycardia during the first 15 minutes after getting vaccinated. Severe pain and swelling of the left shoulder, tachycardia or change in heart rate, mild swelling of the hands, mild headache, weakness and tiredness for 48 hours after the first 5 hours of getting the vaccine.
47 2021-04-13 fainting On 4-11-21 at approximately 5 pm, I fainted while in the bathroom at home.
47 2021-04-13 fast heart rate severe headaches, tachycardia at rest
47 2021-04-14 blood pressure increased, blood glucose increased Patient received his first dose of Pfizer vaccine on 4/14/21 around 4pm and the next day on 4/15/202... Read more
Patient received his first dose of Pfizer vaccine on 4/14/21 around 4pm and the next day on 4/15/2021 woke up with left deltoid soreness at the site of injection which pt. expected but otherwise felt well until around 11am when he developed lightheadedness, became clammy and diaphoretic and felt feverish. His temp was 98.0 (oral) during evaluation and Blood pressure slightly elevated 140/80s (did not take his BP meds yet) but otherwise unremarkable vitals with no orthostatic hypotension. Random finger stick glucose was 142. Pt. given Tylenol 2 tabs PO in clinic and a hydration pack with water and allowed to lay down in clinic. Pt. monitored for 1.5 hours and Vitals remained stable, lightheadedness resolved. Pt. still felt warm but no longer diaphoretic and remained afebrile and d/c home in stable condition. Symptoms reported via V-safe app by patient.
47 2021-04-14 cardiac failure congestive Patient experienced abdominal distention about a week after receiving the COVID vaccine, with progre... Read more
Patient experienced abdominal distention about a week after receiving the COVID vaccine, with progressive jaundice, feeling unwell and eventually went to the hospital, found to be in cardiogenic shock with bi-ventricular failure, acute liver failure and acute kidney failure. Currently still hospitalized for workup of his cardiomyopathy.
47 2021-04-14 chest discomfort, blood pressure increased, chest pain Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: complained of heart burn and blood pressure rose
47 2021-04-15 blood clot Lower left leg pain, swelling and redness 3 days after 2nd dose of Pfizer Covid vaccine. Ultrasound... Read more
Lower left leg pain, swelling and redness 3 days after 2nd dose of Pfizer Covid vaccine. Ultrasound confirmed superficial blood clot from ankle to knee.
47 2021-04-17 chest discomfort 20 minutes after the patient received the second vaccine the patient experienced a mild headache, ti... Read more
20 minutes after the patient received the second vaccine the patient experienced a mild headache, tightness in chest and tingling in the throat. The issue resolved without concern.
47 2021-04-18 loss of consciousness Systemic: After patient was directed to sit down for 15 min to be observed. A few min after patient ... Read more
Systemic: After patient was directed to sit down for 15 min to be observed. A few min after patient sat down in chair he passed out and fell off his chair. Nurse gave epipen called 911. Had scrape on R front scalp and some blood on nostril.-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported that he had a phobia of needles prior to vaccination. Vaccine was given at approximately 2:50pm. After he fell, the nurse noted he was face down. The nurse asked him to roll on his back and he responded after a few moments. His skin was red, blotchy, and sweaty. Patient said that he was ok and didn't want to get sent to ER. Epipen was administered at 3:02pm on 3/17/21 and ambulance arrived 3:07pm. The nurse noted some improvement but pt was complaining of hand and arm pain.
47 2021-04-18 loss of consciousness Extreme nausea, followed by immediate passing out on bathroom floor. I hit my face on the floor and... Read more
Extreme nausea, followed by immediate passing out on bathroom floor. I hit my face on the floor and woke moments later after my wife found me. I got in bed and had the chills for 30-60 minutes and neck pain.
47 2021-04-20 loss of consciousness Flu-like symptoms; Rhabdomyolysis; loss of consciousness; dehydration; This is a spontaneous report ... Read more
Flu-like symptoms; Rhabdomyolysis; loss of consciousness; dehydration; This is a spontaneous report from a contactable consumer. A 47-years-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 26Mar2021 at 12:00 (at the age of 47-years old) as single dose for COVID-19 immunisation. The patient received the first dose on 05Mar2021 in arm left (lot number EN6198). Medical history included hypertension and gastrooesophageal reflux disease (GERD). The patient had n known allergy. He did not have COVID prior vaccination and he was not COVID tested post vaccination. Concomitant medications included omeprazole and hydrochlorothiazide/losartan potassium (LOSARTAN HCTZ). The patient experienced flu-like symptoms starting 6-8 hours after shot and continuing into the following day, rhabdomyolysis, loss of consciousness and dehydration. Adverse event start time was reported as 06:30 PM. The patient was hospitalized 3 days in ICU, plus 3 additional days. The events resulted in resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization and life-threatening illness (immediate risk of death from the event). The events were treated with IV Fluids and treatment to raise sodium. The outcome of event was recovering.
47 2021-04-21 blood glucose increased Pt complained of blurry vision for four days, went to Urgent Care. At UC, blood glucose was >600 and... Read more
Pt complained of blurry vision for four days, went to Urgent Care. At UC, blood glucose was >600 and pt stated that his PCP was investigating possible type 2 DM. Pt was sent to ED. Blood glucose 652 in ED. Pt admitted to hospital with dx hyperosmolar hyperglycemic state.
47 2021-04-22 heart rate increased, chest pain 5:41 patient mentioned feeling dizzy, weak and lightheaded. He sat down in a chair and began monitor... Read more
5:41 patient mentioned feeling dizzy, weak and lightheaded. He sat down in a chair and began monitoring symptoms. He said he has a history of seizures. At 5:45 after making sure he could take deep breaths and his airway was cleared, he took a sip of water. At 5:47 he mentioned having an increased heart rate. At 5:49, he willingly laid on the floor. At 5:51 he said his chest hurt and had a headache. At 5:53 he then sat up and took a few more sips of water. He felt comfortable enough to stand back and go home. He and his fiancé left the building. He vocalized that his fiancé will be driving him home.
47 2021-04-22 fainting, hypertension Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-M... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Additional Details: Patient reported that he had difficulty hearing. Patient sat in the chair and then lost conciousness. He was laid down on the ground, vitals were checked, and water was given. Noted high blood pressure. Patient regained conciousness within 3-5 minutes. Vitals were rechecked and returned to normal.
47 2021-04-25 blood pressure increased client complained of left hand tingling after receiving 2nd Pfizer. Client informed EMTs of new ons... Read more
client complained of left hand tingling after receiving 2nd Pfizer. Client informed EMTs of new onset of symptoms. PHN joined team shortly after. Per client had been in waiting area 20mins and new onset 8 mins ago. First vitals 1303: blood pressure: 130/90, pulse 74, oxygen 97%. Per client sensation to left hand as if "hand had fallen asleep". Sensory and motor intact on left hand. Client received vaccine in left deltoid. Client denied pain or radiation past wrist. Per client no reactions to first dose. Vitals 1308: blood pressure 120/80, pulse 71, oxygen 98%. Per client tingling sensation lessened. Medical history of diabetes, takes metformin. No history of allergies. at 1313 client ready to leave. Per client felt fine. EMT advised client to seek medical care of worsened symptom. Last vitals: blood pressure: 120/80, pulse 72, oxygen 98%. Client left facility with steady gait at 1315.
47 2021-04-25 chest pain Pleurisy of my lungs, or known as Pleuritis. I was treated but undiagnosed in the ER. I experienced... Read more
Pleurisy of my lungs, or known as Pleuritis. I was treated but undiagnosed in the ER. I experienced sudden sharp chest pain and shortness of breath. I thought it was a cardiac event. The ER did not figure out what it was. My doctor was able to diagnose it a day or so later. Almost 3 full weeks now and I still have symptoms, mostly pain in my chest.
47 2021-04-25 deep vein blood clot Blood Clot a Localized Vein in the Gastrocnemius Muscle
47 2021-04-26 palpitations, arrhythmia, palpitations arrhythmia; Heart palpitations; additional heartbeats 10% of the time during 5 days monitor; This is... Read more
arrhythmia; Heart palpitations; additional heartbeats 10% of the time during 5 days monitor; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the first dose of bnt162b2, via an unspecified route of administration on 30Mar2021 11:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Stage two kidney disease, LBBB, covid prior vaccination. Concomitant medication included metoprolol; atorvastatin. The patient experienced heart palpitations/arrhythmia did monitor for 10 days and had additional heartbeats 10% of the time during 5 days monitor. ECG and echo done and her monitor for 5 days. The events were occurred on 31Mar2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. Information on the Lot/Batch number has been requested.
47 2021-04-26 heart rate decreased, heart rate increased Rapid heart rate, slight nausea, slight numbness to front right cheek and lips. Onset within 1 minu... Read more
Rapid heart rate, slight nausea, slight numbness to front right cheek and lips. Onset within 1 minute of injection. No treatment given. Heart rate started to decrease after 10 minutes and returned to normal within 30-40 minutes. Numb areas returned to normal within 45-60 minutes. Slight feeling of anxiety for several hours, but this could have been simply from stress from the initial reaction. I also occasionally have random panic attacks and could have potentially had a small one at the onset of my face going numb which could have contributed to the length of unease.
47 2021-04-26 pallor, fainting At 1118 patient fainted, had fixed shaking, pale, loss of speech. Once patient reactted he was able ... Read more
At 1118 patient fainted, had fixed shaking, pale, loss of speech. Once patient reactted he was able to speak and gave Past medical history of Asperger syndrome and no fainting spells before. Patient complained of stomach pain. numb lip, tingling sensation on fingers. Hands began to flexion and tense up. Vital signs were with in normal range. clinet began to show normalized sign and symptoms. Ems was still called and was taken to hospital for furhter observation at 1153.
47 2021-04-27 atrial fibrillation AFIB; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male pati... Read more
AFIB; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8730), via an unspecified route of administration, administered in the left arm on 25Mar2021 17:45 as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing , atrial fibrillation (AFIB) from an unknown date and unknown if ongoing, surgery from an unknown date and unknown if ongoing, ablasion completed in 15Apr for AFIB. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPRIN) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (CARTIA [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; ubidecarenone (COQ10 [UBIDECARENONE]) taken for an unspecified indication, start and stop date were not reported; omega-3-acid ethyl ester (LOVAZA) taken for an unspecified indication, start and stop date were not reported; ramipril (RAMIPRIL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had an ablasion completed in 15Apr2021 for AFIB and had no symptoms since. On 02Apr2021, he had a routine electrocardiogram (EKG) and it showed AFIB was back. He had no symptoms prior. The onset date of afib was reported as 02Apr2021 at 09:00. There was an emergency room (ER) or physician office visits. The patient underwent lab tests and procedures which included electrocardiogram: afib was back on 02Apr2021. Therapeutic measures taken as a result of afib included dronedarone hydrochloride. The outcome of afib. was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
47 2021-04-27 heart rate increased Difficulty operating a motor vehicle at speeds over about 45 mph. I drove to the first vaccination a... Read more
Difficulty operating a motor vehicle at speeds over about 45 mph. I drove to the first vaccination appointment that morning (3/2/2021) and everything was fine. Driving home from the jab I started to experience trouble driving my car when crossing a major bridge in Pittsburgh. The feeling was akin to the anticipatory feeling of being on a climbing roller coaster or drop ride in an amusement park. Elevated heart rate; disorientation and a sort of adrenaline like rush. The feeling returns every time I attempt to drive on a freeway/bridge/etc though local driving is fine. (I was driven to the 2nd jab.) The issue continues now, close to 2 months after it began 45 minutes after receiving the 1st jab. In the several months prior to the jab I was driving extensively with no issues.
47 2021-04-27 pulmonary embolism, deep vein blood clot pt start to feel leg pain 10 days after the injection and then shortness of breath a week later pt ... Read more
pt start to feel leg pain 10 days after the injection and then shortness of breath a week later pt was found with DVT and PE
47 2021-04-27 fast heart rate Patient experienced dyspnea and tachycardia after receiving the vaccine.
47 2021-04-28 deep vein blood clot DVT behind left knee detected at ER on 08Apr. Pain behind left knee started on 4Apr; This is a spont... Read more
DVT behind left knee detected at ER on 08Apr. Pain behind left knee started on 4Apr; This is a spontaneous report from a contactable consumer (patient himself). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 02Apr2021 at 12:00 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunization. Relevant medical history included prior deep vein thrombosis (DVT) behind right knee from an unspecified date in 2010 to an unknown date. Concomitant medication included finasteride (PROPECIA) taken for an unspecified indication, start and stop date were not reported. The patient previously took ibuprofen (ADVIL), acetylsalicylic acid (ASPIRIN), and unspecified salicylates, from which the patient had known allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 at 12:00 PM (lot number: EN6204) at the age of 47 years, administered in the left arm for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient had DVT behind left knee detected at the emergency room (ER) on 08Apr2021; the pain behind left knee started on 04Apr2021. The adverse event (AE) resulted in an emergency room/department or urgent care. Therapeutic measures were taken as a result of the event, which included that the patient was prescribed apixaban (ELIQUIS). The patient was not recovered from the event.
47 2021-04-29 arrhythmia Heart arrhythmia, skipping beats every 10-20 beats. This was noticed the night I received the vaccin... Read more
Heart arrhythmia, skipping beats every 10-20 beats. This was noticed the night I received the vaccine, but it may have started before the vaccine and be unrelated. But, after 3 days, the arrhythmia stopped, and my heart beat is back to normal, so my doctor says perhaps it WAS related to the vaccine.
47 2021-04-30 cerebrovascular accident he was having trouble walking, he would get out of bed and take a couple steps and his legs would gi... Read more
he was having trouble walking, he would get out of bed and take a couple steps and his legs would give out and he would try to get back up and would walk a few steps and fall again; fall; presuming he had a stroke; This is a spontaneous report from a contactable consumer (reporting for her fiance). A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205), via an unspecified route of administration, administered in the right arm (in his right arm up by the shoulder joint) on 06Apr2021 at 14:30 (at the age of 47-years-old) as single dose for COVID-19 immunization (to stay safe and so he doesn't get it). The patient's medical history included diabetic for years, and End stage renal disease. There were no concomitant medications. There were no additional vaccines administered on the same date as BNT162B2. There were no prior vaccinations within 4 weeks. The reporter stated that they were presuming he had a stroke and were doing diagnostics. Everything was pointing to a stroke. The reporter stated it started Monday, 12Apr2021, he was having trouble walking, he would get out of bed and take a couple steps and his legs would give out and he would try to get back up and would walk a few steps and fall again. This started Monday evening. The reporter stated that she called 911 as she couldn't get the patient to the car. He kept falling and there was something clearly wrong. The patient was taken to the ER and was admitted around 1am on Tuesday morning (13Apr2021) and was still hospitalized. The patient has had lots of blood work to include checking electrolytes, thyroid, and vitamin and mineral deficiencies; all with unknown results on an unspecified date. Additional lab tests included Computerized tomogram (CT) scan on 13Apr2021, Electrocardiogram (EKG) on 13Apr2021, and Magnetic resonance imaging (MRI) on 15Apr2021; all with unknown results. The outcome of the events was unknown.
47 2021-05-02 fainting, loss of consciousness, pallor Pt Pt became pale & diaphoretic, losing conciousness for 2-3 seconds. Transported to Observation Ar... Read more
Pt Pt became pale & diaphoretic, losing conciousness for 2-3 seconds. Transported to Observation Area. BP 118/72 P60 R16. Says has a history of fainting with IV's. Pt stabilized & released & he notified wife that he was coming home.
47 2021-05-03 hypotension, blood glucose increased Pt describes feeling unwell that night, nausea and vomiting next day, general body aches, hypothermi... Read more
Pt describes feeling unwell that night, nausea and vomiting next day, general body aches, hypothermic, 3 days later seen in ED, hypotension, septic shock, and DKA/AKI. Also noted to have mild prominence of right oropharyngeal well with normal epiglottis and larynx on CT. There is noted uvular edema of unknown etiology
47 2021-05-03 loss of consciousness passed out; extreme nausea; hit the bathroom floor; have a cut lip; extreme chills; This is a sponta... Read more
passed out; extreme nausea; hit the bathroom floor; have a cut lip; extreme chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 18Apr2021 10:45 (Lot Number: EW0164) as single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome and allergy. Concomitant medications included chlordiazepoxide, clidinium bromide (LIBRAX), Multi-Vitamin, colecalciferol (D3), ascorbic acid (VIT C), fish oil. No other vaccine was received in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient received first dose of BNT162B2 (lot# ER2613) in left arm on 27Mar2021 12:00 PM for COVID-19 immunization. The patient experienced extreme nausea 19Apr2021 00:30, then he passed out and hit the bathroom floor. The patient woke up a few moments later, when her wife found him. The patient had a cut lip. The patient then had extreme chills for 30-60 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. It's unknown if treatment was received. The outcome of events was recovering.
47 2021-05-06 atrial fibrillation, palpitations Random Heart palpitations. Eventually 2 separate issues of atrial fibrillation. One on April 4th and... Read more
Random Heart palpitations. Eventually 2 separate issues of atrial fibrillation. One on April 4th and one on the 11th. No previous history of palpitations.
47 2021-05-07 loss of consciousness patient lost consciousness at about 1038 am, I laid him down on the floor called ems, he came to I h... Read more
patient lost consciousness at about 1038 am, I laid him down on the floor called ems, he came to I had him rest for a few minutes and sat him up, gave him some water he stated he had not had anything to eat that morning EBS cam took vitals and released him. he said he felt fine waled around the store for a few minutes and drove himself home. I told him if he had any other problems to call 911
47 2021-05-09 heart rate irregular Light headed, dizzy night of shot. Went to bed. 400 am fever and shivers for 5 hours. Massive hea... Read more
Light headed, dizzy night of shot. Went to bed. 400 am fever and shivers for 5 hours. Massive headache. Lymph nodes and testicles swelled. All pounded to my heart beat. Kept taking Tylenol and didn?t seem to matter. Last for 5-6 hours. Massive headache continued...tired but hard to sleep sleep and in zombie like state. Woke up Friday feeling a little better. Went downhill about 5pm Friday. Headache returned. Tired and couldn?t sleep much. Brain in fog. Went to bed. Woke up with headache on Saturday. A wave of fatigue came over Saturday around 3pm. Tried to nap but couldn?t sleep. Persistent dry cough developed Saturday night. Lasted through Sunday. This is all to the best of my recollection.
47 2021-05-09 loss of consciousness, blood clot Patient was found at home Saturday afternoon passed out. Patient was rushed to the hospital where it... Read more
Patient was found at home Saturday afternoon passed out. Patient was rushed to the hospital where it was discovered he had a blood clot. He is going to hospitalized for a few days per patients mother.
47 2021-05-10 low platelet count E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified
47 2021-05-11 heart rate increased Elevated heart rate; disorientation and a sort of adrenaline like rush; Elevated heart rate; disorie... Read more
Elevated heart rate; disorientation and a sort of adrenaline like rush; Elevated heart rate; disorientation and a sort of adrenaline like rush; I started to experience trouble driving my car; sort of adrenaline like rush; This is a spontaneous report received from a contactable consumer, the patient. This 47-year-old male patient reported for himself that he received the first dose of BNT162b2 (PIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in the left arm on 02Mar2021 at 10:15 as a single dose and the second dose of BNT162b2 (PIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in the left arm on 23Mar2021 at 10:15, both doses at the age of 47-years-old, both for COVID-19 immunization. Medical history included high blood pressure, pre-diabetic, and overweight. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine besylate 5mg and ibuprofen (ADVIL). On 02Mar2021 at 11:00, the patient experienced difficult operating a motor vehicle at speeds over about 45 mph. He drove to the vaccination appointment that morning and everything was fine. Driving home from the jab, he started to experience trouble driving his car when crossing a major bridge. The feeling was akin to the anticipatory feeling of being on a climbing roller coaster or drop ride in an amusement park described as elevated heart rate; disorientation and a sort of adrenaline like rush. He was driven to the second jab. The events were reported as serious for Disabling/Incapacitating and resulted in disability or permanent damage. The patient reported that the issue continues now, close to 2 months after it began 45 minutes after receiving the first jab. He stated can drive on local streets but not on a freeway or significant bridge. In the several months prior to the jab, he was driving extensively with no issues. The patient was not treated for difficult operating a motor vehicle/ trouble driving my car, elevated heart rate; disorientation and a sort of adrenaline like rush. The clinical outcome of events difficult operating a motor vehicle/ trouble driving my car, elevated heart rate; disorientation and a sort of adrenaline like rush was not recovered. It was also reported, "Device Date: 28Apr2021" (not further specified). Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162b2 , was not provided and will be requested during follow-up.
47 2021-05-23 pallor Patient had become extremely paleness, sweating, coldness of the hands, light headed, dizziness, wea... Read more
Patient had become extremely paleness, sweating, coldness of the hands, light headed, dizziness, weakness, shaky like trembling sign of minor seizures.
47 2021-05-25 chest pain SHORTNESSS OF BREATH AND CHEST PAINS
47 2021-05-25 heart rate increased nausea; vomiting; diarrhea; rapid heart rate; severe dehydration; unable to eat or drink; Extremely ... Read more
nausea; vomiting; diarrhea; rapid heart rate; severe dehydration; unable to eat or drink; Extremely fatigued all day; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 28Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included spinach allergy, UC (Ulcerative colitis). Concomitant medication included mesalamine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 07Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 29Apr2021 01:00, less than 24 hours of second vaccine there was nausea, vomiting, diarrhea and a rapid heart rate and severe dehydration. This progressed and led to hospitalization from Saturday 01May2021 to 04May2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient also experienced unable to eat or drink and extremely fatigued in 2021. As of this message (10May2021), still unable to eat or drink without vomiting and hear rate up to 170+. This was up from a normal resting heart rate of near 60. Extremely fatigued all day, vomit several times per day and loose stool to diarrhea multiple times per day. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19, covid-test (blood test) on 02May2021: negative. Treatment was received for all events. The outcome of the events was not recovered. Information about batch/ Lot number has been requested.
47 2021-05-25 inflammation of the pericardium, chest pain pericarditis diagnosed in setting of positional chest pain, minimal EKG changes, trop negative, + le... Read more
pericarditis diagnosed in setting of positional chest pain, minimal EKG changes, trop negative, + leukocytosis
47 2021-05-25 pulmonary embolism, chest pain The Covid vaccine was given April 20 of 21 within eight days of having the vaccine I started to deve... Read more
The Covid vaccine was given April 20 of 21 within eight days of having the vaccine I started to develop shortness of breath fatigue chest pain, I ended up at our local emergency room and was admitted with pulmonary embolism, blood clots in both lungs I stayed a total of three days hospitalized.
47 2021-05-26 blood clot Sustained blood clots in left calf area approximately 6 days after receiving 1st dose.
47 2021-06-01 blood pressure increased, heart rate increased Post COVID vaccination, the patient started to seem sweaty; increased HR (117), elevated BP (174/93)... Read more
Post COVID vaccination, the patient started to seem sweaty; increased HR (117), elevated BP (174/93). The patient declined Benadryl and continued to have her feet up on the recliner. Around 02:45 pm, the patient walked out of the clinic without dizziness.
47 2021-06-01 chest discomfort 1732: Pt administered the vaccine. 1735: Pt had SOB, Dizziness, Chest tightness .1739: VS noted as B... Read more
1732: Pt administered the vaccine. 1735: Pt had SOB, Dizziness, Chest tightness .1739: VS noted as BP 200/100, SPO@ 97% on RA, HR 92 1745: Pt developed hives on chest, shoulders. 1746: Epipen was administered 1749: Benadryl 50 mg IM was administered. 1751: VS noted as BP 200/130, SPO2 99% on RA, HR 89 1756: Solumedrol 125 mcg administered IM. 1758: 20G RAC IV inserted by RN. 1800: VS noted as BP 218/130, HR 72, SPO2 98% on RA. Pt complained of chest tightness again, 2 liters of oxygen via NC administered. 12 lead EKG performed, EMS arrived at the scene and Pt. transferred to Hospital
47 2021-06-02 chest pain Patient presented to the ED with mild chest pain and hypertensive urgency and was subsequently hospi... Read more
Patient presented to the ED with mild chest pain and hypertensive urgency and was subsequently hospitalized.
47 2021-06-03 blood pressure decreased, hypotension, pallor Patient became diaphoretic, pale, hypotensive, BP dropped to 86/ 43, HR: 41 SaO2: 98%. patient was p... Read more
Patient became diaphoretic, pale, hypotensive, BP dropped to 86/ 43, HR: 41 SaO2: 98%. patient was placed in a Trendelenburg position, O2 via nasal canal at 2 liters per min. administered IV line with normal salin given. BP recovered ( 137/94) he was transferred to ED in stable condition
47 2021-06-06 deep vein blood clot DVT in left leg, painful swelling still today
47 2021-06-09 chest pain symptom: chest pain, pain in my left arm approximately 4 inches from my arm pit (injection side), sh... Read more
symptom: chest pain, pain in my left arm approximately 4 inches from my arm pit (injection side), shortness of breath, heart felt as though rhythm was off a bit. This happened about three days after my first dose for about 4 days. Starting to feel better now though. I didn't know what was happening and was tempted to go to the emergency room a couple of times but didn't. I'm just finding out about this from an article I'm just reading about 30 minutes ago and thought I should report this. I've only had my first dose and now I'm very concerned about the second due June 22nd.
47 2021-06-09 heart rate increased, hypertension Blood pressure and it was 179/91/still 150 over 70 over 69 which is quite high for me; I felt feveri... Read more
Blood pressure and it was 179/91/still 150 over 70 over 69 which is quite high for me; I felt feverish; Rash with bumps on my forehead/Broken out rash, turned red; Face was red; Heart rate has also been high; Head hurt; My arm was a little sore; I was a little tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8736), via an unspecified route of administration on 30Apr2021 (at the age of 47 years) as a 2nd dose, single dose for COVID-19 immunisation. The patient medical history included over active autoimmune disease, Rheumatoid arthritis. The patient concomitant medication included adalimumab (HUMIRA, Lot number and expiration date was unknown) 0.4 ml, once a week, a shot in his belly or leg all around for rheumatoid arthritis and Methotrexate (Lot number and expiration date was unknown) 2.5mg, took 6 of them once a week for rheumatoid arthritis and autoimmune. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8731), via an unspecified route of administration on 09Apr2021 as a 1st dose, single dose for COVID-19 immunisation. On 30Apr2021, the patient at first experienced arm was a little sore and little tired. On 04May2021, patient felt bad, felt feverish. On Wednesday, he got a rash with bumps on his forehead. The BP was 179/91. Heart rate has also been high and this morning BP was 150/71. Patient was send home from work and he was feeling that from two days after he got the shot but it's been couple of days ago. The patient went in upstairs and then was sent to medical to that they said his face was red, "I didn't look like, look good" and took blood pressure and it was 179/91 and patient was sent home and told to stay home today (06May2021). Patient called his doctor and he said 'it would be risky' for a couple of days. This morning my blood pressure has come down some but it was still high, it wasn't near high as it was, run like 129, 130 over 58 or some like that and this morning it was still 150 over 70 over 69 which is quite high. But it has still come down a lot that's the reason patient called the doctor and he said take it easy, stay out of sun don't work stay at home and her said if you want to call Pfizer call them. The events have improved since yesterday, patient kept thinking he was running fever because his head hurt. But it started on Tuesday and it was Wednesday when someone sent me when the second time patient had broken out rash again and it has turned red. But yesterday (05May2021) it was 170 and 150 is way better today (06May2021. Patient informed that as directed he did not to take his medications, the Methotrexate and Humira. He did not take it within 7 days of taking the shot because he was told not to take it within 7 days of taking the shot, so he got off the medicine for the shot. The patient went for one actually two weeks ago or three weeks ago for his heart checkup and all that stuff, everything was fine, cholesterol was fine, everything was good. The outcome of the events was recovering. Follow up (06May2021 and 06May2021): This is a follow up spontaneous report from a contactable consumer (patient): Added product details (Expiry date, lot details), Concomitant drug details, events (face was red, broken out rash, turned red, blood pressure was 179/91/ run like 129, 130 over 58 or some like that and this morning I was still 150 over 70 over 69 which is quite high for him, fever, head hurt), reporter's comments and clinical course and narrative was amended accordingly. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
47 2021-06-10 heart rate increased Rapid heartrate started 13 hours (11:00pm on 6/1/2021) after vaccine was administered (10:00am 6/1/2... Read more
Rapid heartrate started 13 hours (11:00pm on 6/1/2021) after vaccine was administered (10:00am 6/1/2021) and lasted consistently for 18 hours (5:00pm on 6/2/2021), even while sleeping through the night.
47 2021-06-11 chest pain 12:30 mobile team alerted me to head out to see a patient, once I arrived the mobile team told me he... Read more
12:30 mobile team alerted me to head out to see a patient, once I arrived the mobile team told me he reported to have a sudden new onset of chest pain and body aches12:32 Called EMS to the site12:36 Vitals were taken Blood pressure-148/80, Pulse-94, Temperature- 98.1F, Respirations-14, SPO2-98%, pain 4/10 numeric scale chest area that was sharp, patient was A&Ox4 person, place, time and situation, no labored breathing, equal rise of chest wall, denies shortness of breath, skin pink with no discoloration, patient was able to follow commands when performing the assessment, will continue to monitor until the arrival of EMS 12:39 EMS arrived at the site 12:43 EMS took the patients vitals Blood pressure-137/92, Pulse- 95,Respiations-15, Spo2-99%, pain 0/10 on the numeric scale, patient claims that his chest pain has resolved, denies shortness of breath, EKG was within the normal sinus rhythm when the EMS performed it, equal rise of chest wall, no labored breathing, skin pink with no discoloration, A&O x 4 to person, place, time, and situation, patient was able to answer and follow all commands of the EMS team, the patient denied treatment and transportation to the hospital by the EMS team, 12:48- EMS left the site, provide education the patient has sudden chest pain again and or trouble breathing to call 911, patient verbalized understanding
47 2021-06-11 heart rate increased, dilation of blood vessels Headache 3 weeks, severe fatigue 3 weeks. Immediate reaction numbness in extremities, bulging veins... Read more
Headache 3 weeks, severe fatigue 3 weeks. Immediate reaction numbness in extremities, bulging veins in hands, increased heart rate.
47 2021-06-15 chest pain I started to get chest pains 4 days after receiving my 2nd dose of the vaccine. I went to immediate... Read more
I started to get chest pains 4 days after receiving my 2nd dose of the vaccine. I went to immediate care and they thought I had Pleurisy. The pains did not improve and kept getting worse. I went to my regular doctor and then had a stress test done. My heart was fine but I had imflamation in my chest walls. The doctor said it was either pericarditis or costochondritis. She put me on Naproxen for 5 days. This seemed to help some but had to come off of it due to it causing issues with my Kidneys as I am stage 3 kidney disease. I am still having chest pains but they are getting better daily.
47 2021-06-16 inflammation of the pericardium, chest discomfort Pt received 2nd COVID vaccine in May of 21, reports that 1-2 weeks later began to exhibit chest tigh... Read more
Pt received 2nd COVID vaccine in May of 21, reports that 1-2 weeks later began to exhibit chest tightness with shortness of breath. Pt presented to ED at the Medical Center where an EKG showed ST elevation in V1-V2 concerning for pericarditis with negative troponin. Pt underwent left heart cath and diagnosis was confirmed.
47 2021-06-17 chest pain, chest discomfort chest pain/discomfort
47 2021-06-22 chest pain, heart rate irregular, inflammation of the heart muscle I experienced chest and arm pain and pressure, irregular heart beats, and myocarditis. I had the Pf... Read more
I experienced chest and arm pain and pressure, irregular heart beats, and myocarditis. I had the Pfizer dose.
47 2021-06-23 heart attack Patient had an acute MI died after within 8 weeks of last vaccine patient had been complaining of di... Read more
Patient had an acute MI died after within 8 weeks of last vaccine patient had been complaining of dizziness and feeling different since second vaccine
47 2021-06-23 heart rate increased, chest discomfort A few seconds after I took the vaccine shot I felt pressure in my chest area, as if i was having anx... Read more
A few seconds after I took the vaccine shot I felt pressure in my chest area, as if i was having anxiety or a panic attack without being anxious. I felt like my heart rate increased. There was also muscle pressure in my jaws. The chest pressure disappeared after a few minutes and my heart rate calmed down.
47 2021-06-23 heart attack Heart Attack. A feeling of burning in my arms and mouth of the stomach, in addition to fatigue when ... Read more
Heart Attack. A feeling of burning in my arms and mouth of the stomach, in addition to fatigue when walking, started on June 12, 2021. I never had such pain before and thought it's just a stomach virus or so. As the pain continues, I called my primary-care Dr. early morning of June 17 and scheduled appointment for a week later. But around 9:30 pm that day, June 17, the pain became so severe, in addition to nausea and shortness of breath. I went to emergency room and have been told that there is acute heart attack in progress and was moved to the Critical Care Unit in the Heart and Vascular Center. A blockage has been removed and a stent was installed in morning of June 18, through heart catheterization procedure. As there was damage to the heart muscle due to the heart attack, I am supposed to go back later, in 4-6 weeks, to remove couple more blockages and install stents.
47 2021-06-23 palpitations Heart Racing, Pounding in Chest. 4 Hours
47 2021-06-24 pallor Patient came in to receive his first Pfizer vaccination. The patient was signed up and vaccinated li... Read more
Patient came in to receive his first Pfizer vaccination. The patient was signed up and vaccinated like normal. About 5 minutes after administering the vaccine to the patient, he stood up and came to the window to tell the technician on duty that he was not feeling well. He appeared sweaty and pale. The technician immediately advised the patient to sit down and called for the pharmacist on duty. The pharmacist went into the vaccine area and when she reached him, he went into a seizure-like state. He was foaming at the mouth, his hands were spasming, and he went stiff. The technician immediately called 911 and advised them of the situation. The employees stayed with the patient until the emergency services arrived approximately 7 minutes later.
47 2021-06-27 loss of consciousness, pallor Patient reports feeling dizzy, lightheaded, then lost consciousness for approx. 20 secs., skin color... Read more
Patient reports feeling dizzy, lightheaded, then lost consciousness for approx. 20 secs., skin color pale then reddish, eyes rolled back. Patient then regained consciousness.
47 2021-07-01 heart attack, chest discomfort About 3 days after the 2nd dose, I started to feel chest pressure like a muscle pull on the chest. ... Read more
About 3 days after the 2nd dose, I started to feel chest pressure like a muscle pull on the chest. About 7 days after the vaccine, it started to worsen. I felt pain, chest pressure, back shoulder pain, jaw pain, and shortness of breath. I called the main local hospital number and was instructed to go to the ER. I did go to the ER and they did blood work, EKG which confirmed that I was having a heart attack. I was stabilized and was then transferred my via ambulance to A Medical Center which is bigger hospital and better equipped. I was admitted and the next day, I had surgery for a heart catheter. They also placed 2 stents in my heart. I was in the hospital for 4 days and was discharged with a prescription for Furosemide 40mg, rest, cardiac rehab, and to follow up with cardiologist. Prior to the heart attack, I only had hypertension.
47 2021-07-02 chest pain, blood pressure increased Blood pressure was elevated; having daily mild chest pain; mild left neck tension/warm sensations; m... Read more
Blood pressure was elevated; having daily mild chest pain; mild left neck tension/warm sensations; mild left neck tension/warm sensations; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:00 (at the age of 47-years-old) (Batch/Lot Number: ER8737) as single dose for COVID-19 immunisation. Medical history included Allergies to medications, food, or other products: Yeast intolerance. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. 10 days after 1st dose vaccination, on 10Apr2021, the patient started having daily mild chest pain and mild left neck tension/warm sensations. This was still continuing at this date. Blood pressure was elevated and saw physician and had blood work. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was Unknown. Outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
47 2021-07-05 chest discomfort, heart rate increased difficulty breathing/had a very difficult time breathing; fast heart rate/rapid heart rate; contract... Read more
difficulty breathing/had a very difficult time breathing; fast heart rate/rapid heart rate; contraction in the chest near the heart or the abdomen; some muscle tightness/tightness in the chest that was muscle tightness; This is a spontaneous report from a contactable consumer (patient's wife) reported for a patient. This is the first case out of two cases. A 47-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0187, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 19Jun2021 in the evening (age at vaccination was 47 years) as 1st dose, single for COVID-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. The reporter stated that she was calling because her husband and she went to the (Facility Address), yesterday at 1 O' Clock and got a shot for COVID and she had 2 side effects but she was okay, her husband had some side effects that were not really listed here under severe or more common side effects. On 19Jun2021 at 21:30 pm, last night the patient had tightness in the chest that was muscle tightness difficulty breathing and a rapid heart rate. They give them a paper work after getting the shot which listed some common side effects but not all possible side effects. It just listed few of the severe ones and then some common less severe side effect but it did not mention anything about some muscle tightness, contraction in the chest near the heart or the abdomen and difficulty breathing and a fast heart rate which was what her husband had been experiencing since last night had a very difficult time breathing but he was not allergic, he was not swelling, he didn't have a rash. The reporter confirmed that it was Pfizer COVID 19 Vaccine. No treatment was received for the adverse events. The reporter stated that it has not been resolved and it was still persisting the last time he had checked his heart rate because he was a runner and right now its 101 that was the resting heart which was high for him he normally had very low heart rate like 67 it was 136 about 20 minutes ago, it was raising without exercising. The reporter was informed about the Pfizer Medical Information. The reporter was also advised to visit nearby healthcare profession in the case of emergency. This case LRN W2021388441 was cross linked with LRN W2021388442. The outcome of the event fast heart rate/rapid heart rate was not resolved. The outcome of the other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
47 2021-07-05 inflammation of the heart muscle, chest pain Pt developed chest pain a day later on 6/27. He came to Hospital ER for chest pain. He was found to ... Read more
Pt developed chest pain a day later on 6/27. He came to Hospital ER for chest pain. He was found to have myocarditis. Cardiac catherization showed no obstructing CAD. Coxsackie antibodies were positive but old infection suspected. Infectious disease consultation suspects more vaccine related myocarditis than infections. Pt is being treated with NSAIDs and colchine. He did have prior Covid infection. He is has been hospitalized for 10 days so far but prolonged stay related to setting up home NIV not from myocarditis.
47 2021-07-06 cardiac arrhythmia After a couple of days of receiving second dose of covid vaccine, I experienced very high rate of pr... Read more
After a couple of days of receiving second dose of covid vaccine, I experienced very high rate of premature ventricular contractions PVCs - cardiologist found normal echocardiogram but 7-day cardiac a; This is a spontaneous report received from a contactable consumer (patient himself). A 47-year-old male patient bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: Unknown and Expiry Date: Unknown) via unspecified route of administration on 01May2021, (at the age of 47-years-old) as Dose 2, Single for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: Unknown and Expiry Date: Unknown) via unspecified route of administration on an unspecified date (at the age of 47-years-old) as Dose 1, Single for COVID-19 immunization.Patient's medical history and concomitant medications were not reported. He had no known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks of vaccination. After a couple of days of receiving second dose of COVID vaccine, on 05May2021, he experienced very high rate of premature ventricular contractions PVCs; cardiologist found normal echocardiogram but on 7-day cardiac ambulant EKG monitor showed PVCs at 6% of the time.The adverse events caused doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.Treatment regimen was not given as a result of the adverse events. The patient underwent lab test which included ECG monitoring on unspecified dates.Device date was given reported as 22Jun2021.The outcome of event was recovered on an unspecified date. Information about lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that event ventricular extrasystole were related to suspect drug based on the temporal relation between the vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product 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.
47 2021-07-08 blood pressure increased A pharmacy student accidentally administered 0.3ml of undiluted vaccine to the patient. Approximatel... Read more
A pharmacy student accidentally administered 0.3ml of undiluted vaccine to the patient. Approximately 10 minutes later, I discovered the error and called the patient to return to the pharmacy so I could monitor him closely for any complications. His BP was slightly elevated (likely due to anxiety of being informed of the error) and he was provided water. At the time no other signs or symptoms were evident. He was counseled on what to watch for and how to treat common vaccine side effects.
47 2021-07-09 cardiac arrest Had 2nd vaccine a few days earlier and died of cardiac arrest. Was healthy and active prior to vacc... Read more
Had 2nd vaccine a few days earlier and died of cardiac arrest. Was healthy and active prior to vaccine with no known health problems.
47 2021-07-16 chest pain Fatigue, muscle aches, bone pain, headache for 2 consecutive days (7/10 and 7/11) after COVID shot.... Read more
Fatigue, muscle aches, bone pain, headache for 2 consecutive days (7/10 and 7/11) after COVID shot. Symptoms resolved on 7/12 w/o intervention On 7/14/21, new symptoms of chest pain and shortness of breath started. Still experiencing chest pain and shortness of breath as of 7/17/2021. I have not sought out any medical attention
47 2021-07-20 loss of consciousness, cardiac arrest At Midnight I was going to sleep, I was sweating profusely and could not feel my pulse. When I asked... Read more
At Midnight I was going to sleep, I was sweating profusely and could not feel my pulse. When I asked my wife to call 911, I went into the bathroom to change into clothes to get ready to go. I do not remember going to get dressed, I passed out and 911 had arrived and they believed I was in cardiac arrest. I went to the ER, there was a right artery blockage and put in a stint. They also found out I had 8 facial facial fractures due to the fall I had. I was all swelled up in my face so in May I went back for surgery on my face to fix the multiple facial fractures. And now I am back to normal, except I am on blood thinners. The DR could not find anything wrong after follow up, so no one knows why the cardiac happens.
47 2021-07-21 heart rate increased feeling incredibly sick; achy muscles; nausea; diarrhea; foggy memory; extreme fatigue; very bad hea... Read more
feeling incredibly sick; achy muscles; nausea; diarrhea; foggy memory; extreme fatigue; very bad headache; sore neck muscles; sneezing; runny nose; brief periods of rapid heart rate; no appetite; Sometimes it felt like a specific part of body was under attack, i.e. GI tract, various muscle groups, sinuses; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical fusion C3-C7. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (ADVIL) both for an unknown indication. The patient's history of allergies to medications, food or other products was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 10:00, approximately 20 hours after injection, the patient experienced feeling incredibly sick with no fever, but achy muscles, nausea, diarrhoea which still continued, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite and sometimes it felt like a specific part of the body was under attack, i.e., GI tract, various muscle groups, sinuses. The patient reported that likely forgot some symptoms, but these ranks among the worst that patient ever felt in life without running a high fever. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events feeling incredibly sick, achy muscles, nausea, diarrhoea, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite, felt like a specific part of my body was under attack, i.e., GI tract, various muscle groups, sinuses was resolving at the time of report. No follow-up attempts are needed. No further information is expected.
47 2021-07-21 hypertension Experiencing unusually high/extremely high blood pressure.
47 2021-07-22 blood pressure increased, heart rate abnormal, heart rate decreased, heart rate increased, palpitations his liver panel showed issues; Graves' disease; white blood cells came down; loss of appetite; weak;... Read more
his liver panel showed issues; Graves' disease; white blood cells came down; loss of appetite; weak; Diarrhea; he would get tired very quickly.; spiking fevers; Increased blood pressure; high resting heart rate; baseline heart rate was over 105/his heart rate from 60 to about 80 in the month of April.; his pulse is starting to slow; They did the TSI test on the patient and noticed an extreme increase; having thyroid issues; blood sugar was dropping; The caller's symptoms went from being mild to very acute.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; Palpitations/extreme palpitation in his chest and aorta that would pulsate; Weight loss; Sinus pain; Eye irritation; restlessness at night; extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in left arm on 27Mar2021 as dose 2, single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, he was diagnosed from 4 years (in 2017). The patient no other products taken. Prior to March the patient had no problem (before vaccination). About 2 weeks after the second dose of the vaccine on 11Apr2021, the patient had extreme nausea, palpitations, baseline heart rate was over 105 and lost 40 pounds. Patient also started having sinus pain and eye irritation, and restlessness at night and started waking up very early. The caller had a weight loss of 8 pounds for the month of April without changing his lifestyle. Patient had a slow increase in his heart rate from 60 to about 80 in the month of April. Towards the beginning of May the patient had loss of appetite and he would get tired very quickly. When it all hit the patient at once it was around May202, he started spiking fevers, nausea, extreme palpitation in his chest and aorta that would pulsate, and increased blood pressure. The patient went and saw his doctor and checked his thyroid levels that were normal nearly 6 months prior. The patient's T3 and T4 were extremely high and his TSH was extremely low. They did the TSI test on the patient and noticed an extreme increase and then diagnosed him with Grave's disease. The patient did all of the scans. The patient was hospitalized for nearly 6 days because they put him on methylprednisolone and had a toxic effect on his system. The caller's white blood cells came down, it attacked his bone marrow, his liver panel showed issues. The caller was hospitalized on 27Jun2021 to 02Jul2021 for this. The patient had never had any indications of having thyroid issues or Grave's disease prior to this event. The patient's symptoms went from being mild to very acute. The patient was weak right now (at the time of report) because of the weight loss, his pulse was starting to slow and still has palpitations and his nausea was still there and lots of diarrhea. Everything had worsened until now that he had sought treatment (at the time of report). The patient's blood sugar was dropping during this time and had an A1C of 6. The patient underwent lab tests and procedures which included blood sugar was dropping during this time and had an A1C of 6: positive on 07Jul2021, TSH (thyroid stimulating hormone): .008 on 07Jul2021, radioactive iodine uptake assays: show diffuse uptakes of the radioactive tracers and is consistent with Grace's disease on 07Jul2021, 08Jul2021 and 09Jul2021, free thyroxine: >30 on 07Jul2021, T3 (tri-iodothyronine): >8 on 07Jul2021, Free T3 (tri-iodothyronine free): > 32.6 on 07Jul2021, patient's CBC and platelets were in the normal range. Outcome of the event grave's disease was resolving; weak, diarrhea and pulse was starting to slow was unknown and outcome of rest of the events was not resolved. Follow-up attempts are needed. further information is expected.
47 2021-07-22 chest discomfort I experienced chest tightness and mild pain. I just recently went to the doctor within the last mont... Read more
I experienced chest tightness and mild pain. I just recently went to the doctor within the last month. My doctor ordered a series of tests and found that an abnormality of my heart and placed me on a beta blocker and baby aspirin. I had to have a cardio-angiogram performed as outpatient surgery. I also had an antibodies test performed last month.
47 2021-07-22 chest pain, chest discomfort I was fatigue, hard to swallow, headaches, sweaty palms, chest pressure pain.
47 2021-07-28 hypertension, fast heart rate Tachycardia, hypertension
48 2021-01-06 chest discomfort Fatigue that requires daily naps and 12-14 hours of sleep daily. Shortness of breath, despite normal... Read more
Fatigue that requires daily naps and 12-14 hours of sleep daily. Shortness of breath, despite normal saturation 97% on room air. Dyspnea with exertion with normal sinus rhythm rate in 80s. Cheat tightness.
48 2021-01-07 heart attack I had a myocardial infarction on December 27, 2020. I had received my first vaccination for COVID-19... Read more
I had a myocardial infarction on December 27, 2020. I had received my first vaccination for COVID-19 on December 22, 2020. Not sure if these are related but I felt I should report it.
48 2021-01-10 chest discomfort SkinRash Chest tightness Narrative: Due to history of LATEX ALLERGY carrying EpiPen, immunization... Read more
SkinRash Chest tightness Narrative: Due to history of LATEX ALLERGY carrying EpiPen, immunization done in ER. Almost immediately developed chest tightness extreme fatigue and erythema off chest & face; pt says she was told by staff she was "Red as a Lobster" O2 Sat fluctuated 87-93% Treated with Benadyl 50-mg IM. Discharged with Prednisone 20-mg po daily x 3 and Benadryl 50-mg PO TID prn. Today feels normal.
48 2021-01-17 fast heart rate During 15 minute observation period post vaccine individual became slightly diaphoretic and felt wea... Read more
During 15 minute observation period post vaccine individual became slightly diaphoretic and felt weak. He does comment that he has not had much to eat or drink. Was offered juice and a snack which he tolerated and improve his symptoms. Vital signs were taken stable with slight tachycardia that improved at second set of vitals. Seen by provider on site and physical exam was benign. No medication intervention was needed. Left observation on own recognizance
48 2021-01-18 palpitations, heart rate irregular After the administration, I was monitored for 15 minutes and I was fine. I left the hospital, start ... Read more
After the administration, I was monitored for 15 minutes and I was fine. I left the hospital, start driving, and suddenly felt that my right arm was heavy, numb, with a tingling sensation. I stopped the car and called the nurse and I was told that it will go away, and I can take a tylenol/motrin. It improved over the next hour and I felt it resolved a few days later but then it returned on 1/18 but not to the same extent, and I also felt intermittent tingling and numbing in my right foot. I also experienced intermittent episodes of fast heartbeats and missing heartbeats since the vaccine almost daily. I was fatigued and extremely thirsty for 3 days but that resolved completely.
48 2021-01-19 heart rate increased Severe side effects - Swollen facial features especially evident in lips; began approximately 0730, ... Read more
Severe side effects - Swollen facial features especially evident in lips; began approximately 0730, 14JAN21 - 17JAN14; used diphenhydramine (50 mg ) at night to control swelling - weakness - fast heartbeat Side effects (each of the side effects lasted around the same time period, 13JAN21-17JAN21; alternated acetaminophen and ibuprofen to try and relieve symptoms -injection site pain (began about 1 hour after injection) -headache (severe) -muscle pain -chills - joint pain (severe), began during sleep and I first felt it in my hands - fever (even while taking acetaminophen and ibuprofen, I still had a fever of 100.6 degrees) -injection site swelling (13JAN21-19JAN21) -injection site redness
48 2021-01-21 pallor Within 5 minutes Patient became, pale, light headed with nausea.
48 2021-01-27 chest pain 1/20/21 vaccinated. 1/21 afternoon-itchy feeling on top of buttocks, tingling sensation consistent w... Read more
1/20/21 vaccinated. 1/21 afternoon-itchy feeling on top of buttocks, tingling sensation consistent with herpes II/Zoster, nerve down right leg tingling, testing for all venereal diseases June 18, 2015, July 2015-Present married to wife no sexual activity outside of marriage, hyper sensitive to venereal disease. Wife is negative, PT is negative for IGA and IGE, PT received vacc and is now showing symptoms positive for herpes 2, PT is waiting for results as to if he is POSTIVE, blister on right side of penis-clear fluid filled, right sores/blisters crusty on buttocks, right inner thigh leg blister on scrotum with red dots in the middle, nothing on glands penis/urethra or anus. Thursday night, pt had intimacy and it was dryer than normal, uncomfortable on the right side with penetration-skin is compromised. Saturday, PT was not feeling great, shaft not showing, in a rush to urinate, scrapped scrotum and now has lesions. Sunday, fatigue, outbreak/whelp on legs, PT wore gauze/bandages to prevent chafing. Monday, shaft not showing, patient went to urgent care. PT was told it presented as Zoster. Nothing on penis at this point in time. Penis issues did not show until 1/26/2021. EX wife had herpes II. PT again was tested after in 2015 and was negative for IGE and IGA. Tuesday, patient started meds from urgent care. Wednesday morning, chest pain/pleurisy like-pain across chest. Arm vaccination site sore, bruised to this day. Herpes Zoster not typically going to end up on shaft, its unusual, PT is probable he has cross contaminated by itching his buttocks and then going to the restroom and touching right side of penis.
48 2021-01-28 hypotension aches, low blood pressure
48 2021-02-01 chest discomfort Tightness in right side of my chest; This is a spontaneous report from a contactable consumer (patie... Read more
Tightness in right side of my chest; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1695 or EL1695 and Expiration date 31Mar2021) on 06Jan2021 (at 48 years of age) as single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient experienced tightness in right side of chest on an unspecified date. Patient called to see if this was a common event as patient was going to the hospital shortly to be sure nothing was wrong. Outcome of event tightness in right side of chest was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
48 2021-02-07 skin turning blue Hands and feet turned pale blue and were numb to touch 3 days after vaccine. Hands and feet swelled... Read more
Hands and feet turned pale blue and were numb to touch 3 days after vaccine. Hands and feet swelled 5 days after vaccine and alternate between normal and swollen (cannot wear rings). Day 7 noticed nerve tingling sensations at random sites (arms, legs, back, hips). Random 'pop-up' welts that subside after 20-30 minutes. Tingling and random swelling inside lips.
48 2021-02-08 chest discomfort Shortness of breath, tight lungs, tingling of face, tight lips, very dizzy, and extremely fatigued.
48 2021-02-08 chest discomfort tight lungs, shortness of breath, tingling face, tight lips, extreme fatigue, dizziness
48 2021-02-11 nosebleed Within 30 seconds pain on my arm and it increased slightly. I was able to do my work. But every time... Read more
Within 30 seconds pain on my arm and it increased slightly. I was able to do my work. But every time I was stable and tried to use it again I felt pain again. Pain was always there - it was tolerable. I was told to take Ibuprofen about three hours later. Second day, I could feel it but I didn't take medication. It slowly went away. No swelling, nothing. On January 4th started having symptoms nose bleeding; diarrhea; cold sweats; had a fever - but I didn't take it to know what it was. I very tired/ extremely sleepy; my eyes started feeling warm- these symptoms creeped up on me. It started around 10:00 am and within an hour an a half I had to tell my boss and they told me to leave work - but I couldn't drive. I stayed in my car and just slept and I was extremely tired. I had a coworker keep an eye on my because I looked really bad. I slept two or three hours in my car. I was still tired and I couldn't drive yet. So I stayed in my car a little longer until I felt stronger and drove home. I had started coughing and knocked out - but I was beginning to coughing a lot on drive home- the first hour I couldn't sleep because I was coughing so much - lasted an hour. Chest coldness for a couple of days - cold chest. It wasn't tight. Next day, January 5, 2021 - went to doctor and they ordered COVID test. Dr thought I had a stomach virus. Diarrhea continued for two days. Weak and fatigue for 5 days. My Fever - temperature was on the first day was one day only. Second day, I did have a lot of fatigue and I was coughing a lot. The fatigue lasted 10 days.
48 2021-02-12 fainting Two episodes of syncope within 15 seconds of one another.
48 2021-02-15 atrial fibrillation Patient was diagnosed with first occurrence of atrial fibrillation in June 2017 with no episodes sin... Read more
Patient was diagnosed with first occurrence of atrial fibrillation in June 2017 with no episodes since. he received his first dose of COVID-19 vaccine on 1/30/21. Eleven days later on 2/10/21, he developed atrial fibrillation.
48 2021-02-16 heart rate increased I awoke from sleep freezing cold. Colder than I have ever felt. violent shakes. So much that I wa... Read more
I awoke from sleep freezing cold. Colder than I have ever felt. violent shakes. So much that I was worried my muscles would begin to sieze up and cramp. I had warm clothes and 5 blankets and could not get warm for over 2 hours. Elevated heart rate and breathing. Nothing warmed me. Eventually (and with ibuprofen) the incident subsided. I felt weak and just "off" with slight body aces and fatigue for the next day and a half.
48 2021-02-16 loss of consciousness passed out; terrible headache; still some body aches; general bad feeling all over; nausea/tremendou... Read more
passed out; terrible headache; still some body aches; general bad feeling all over; nausea/tremendous chills and nausea; tremendous chills and nausea; low grade fever 99.5; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 48-year-old) on 02Feb2021 at 10:30 AM as a single dose for COVID-19 immunisation, lot number: EL9262. Medical history included high cholesterol and allergies to some seaweeds. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 via an unspecified route of administration in Left arm (at age of 48-year-old) for COVID-19 immunisation, lot number: EL3246. Concomitant medications in two weeks prior to the vaccination included atorvastatin and multi- vitamin. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient started about 12 hours after getting vaccinated (reported as 02Feb2021 at 10:00 PM) with a general bad feeling all over, 15 hours after (03Feb2021 at 01:00 AM) patient got out of bed because of nausea and passed out, his wife found he on the floor. Patient had tremendous chills and nausea with a low grade fever 99.5 for several more hours, maybe 6 hours, (onset date 02Feb2021) the next morning patient had a terrible headache and still some body aches. Patient was treated with extra strength paracetamol (TYLENOL) and ondansetron (ZOFRAN). Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events, at the time of the report.
48 2021-03-03 heart rate increased, chest pain During observation period after receiving vaccine, client became nauseous, short of breath, and itch... Read more
During observation period after receiving vaccine, client became nauseous, short of breath, and itchy. Our staff moved patient to lay down on a mat, shortly after that pt was no longer oriented x2. Client quickly became oriented x3 after that but began complaining of intermittent chest pain. SP02 was 94%, HR 94-97, client still short of breath and diaphoretic. Gave Bendadryl around 5:15pm with resolution of itchiness. Patient rated chest pain as 10/10 specifically on right side and his back. Complained of metalic taste in mouth. Heart rate up to 114 and SP02 sitting around 96%. Ambulance arrived at 5:25pm and took pt to hospital.
48 2021-03-07 palpitations Flushing/sweating, racing heart, and warmth over entire body. Initial BP 158/89 (pulse 80), 99% O2 s... Read more
Flushing/sweating, racing heart, and warmth over entire body. Initial BP 158/89 (pulse 80), 99% O2 sat. Final BP 135/80 (pulse 76), O2 sat 100%.
48 2021-03-15 fainting Patient fainted in store shortly after the dose of vaccine.
48 2021-03-16 chest discomfort, troponin increased, heart rate increased 2nd Dose of Pfizer vaccine administered at 9:30 am on Saturday 3/6. Saturday afternoon through Sunda... Read more
2nd Dose of Pfizer vaccine administered at 9:30 am on Saturday 3/6. Saturday afternoon through Sunday evening felt feverish, chills, body aches. Felt fine Monday morning. Monday about 11 am began to feel tightness in chest, thought it was bad heartburn. Pain kept me awake Monday night, and continued into Tuesday morning. Called the doctor, was sent to urgent care. Urgent care detected elevated tritonin and had me transported to the emergency room. Elevated heart rate and rising tritonin levels had me admitted to the hospital. Given heperin and a beta-blocker, given a CT scan, and monitored over night. On Wednesday had a echocardiogram and then a heart catherter and imaging, which showed a healthy heart, no plaque, no blockages. Tritonin levels and heart rate returned to normal. Released from hospital on evening of 3/10.
48 2021-03-16 fainting, loss of consciousness 48-year-old male who received his Covid vaccine states that he waited the mandatory 15 minutes and a... Read more
48-year-old male who received his Covid vaccine states that he waited the mandatory 15 minutes and actually stayed over a few extra minutes after the vaccine and felt fine got in his car and decided to attempt to drive home when he was driving he became somewhat sweaty diaphoretic and felt lightheaded states that he thought himself he should probably pull over but proceeded to continue driving for short distance until he states the last thing he remembers was thinking he needed to merge into this traffic and then the next thing he knows he woke up to the onstar representative asking if he is okay he noted that he had struck a tree when EMS arrived the patient was approximately quarter of a mile into a field and then struck a tree. The patient states he was ambulatory at the scene he was having right-sided chest wall pain especially with movement or breathing he is noted to have seatbelt sign to that side. The patient denies being on blood thinners denies any other complaints at this time. Restraints: air bag deployed, lap and shoulder. Do to the severity of his syncope, he was admitted for observation overnight.
48 2021-03-17 fainting Received vaccine, proceeded to observation area, while setting there started reading the material re... Read more
Received vaccine, proceeded to observation area, while setting there started reading the material regarding the product, started to feel lightheaded got up to alert someone and fainted. Lowered to the floor, HR 78, 98% O2, BP 118/80. At 4:09 BP 116/82 sat patient up and gave water. HR and O2 remained the same. after 15 minutes stood patient up. After a few minutes had patient walk around supervised for 5-10 minutes.
48 2021-03-18 excessive bleeding I administered dose to patient and then he stood up and was going to go to the next station to sch... Read more
I administered dose to patient and then he stood up and was going to go to the next station to schedule his second appointment and he fell straight back and hit his head on concrete which caused bleeding. He was conscious and asking what happened by the time I could get to him. He remained alert. An ambulance was called and he did go to ER to be checked out.
48 2021-03-21 fast heart rate 104 fever, dangerous tachycardia, incessant vomiting, dehydration, difficulty breathing. Urgent care... Read more
104 fever, dangerous tachycardia, incessant vomiting, dehydration, difficulty breathing. Urgent care immediately called ambulance and taken to ER. Admitted to step down unit to reduce fever and monitor dangerous. tachycardia. Ruled out bacterial, fungal or viral infection.
48 2021-03-23 lightheadedness Patient sweated and almost passed out after received the shot. He recovered after 10 minutes and BP ... Read more
Patient sweated and almost passed out after received the shot. He recovered after 10 minutes and BP resumed normal.
48 2021-03-24 chest pain, fast heart rate, chest discomfort Systemic: Chest Tightness/Heaviness/Pain-Medium, Systemic: Tachycardia-Medium.
48 2021-03-24 palpitations Client began complaining of shortness of breath, and feeling like his heart was racing. Vitals: 139/... Read more
Client began complaining of shortness of breath, and feeling like his heart was racing. Vitals: 139/90, HR 83-90, 95% RA. Lung sounds were reported as being mostly clear. An ice pack was given.
48 2021-03-27 fainting Directly after receiving vaccine pt became disorriented for approximately 15 seconds and then had sy... Read more
Directly after receiving vaccine pt became disorriented for approximately 15 seconds and then had syncopal episode for approximately 60 seconds., pt was layed down. EMS called initial BP 92/69 P- 58 with pt awake stating this happens everytime he gets any vaccine. After continued observation Bp 123/80 P- 64 and pt stating he feels fine. Pt taken to high obs for additional 30min obs and released.
48 2021-03-28 chest discomfort Patient had his second Covid vaccine 3/25 at covid vaccination site. Initially had redness at injec... Read more
Patient had his second Covid vaccine 3/25 at covid vaccination site. Initially had redness at injection site (patient thinks as hives) immediately after administration, but subsided within 15 minutes on its own. Patient reports he really started having symptoms 72 hours after vaccination, including: Dizzy spells, sore throat comes and goes, headache comes and goes, occasional chest tightness. Patient states he did also have these symptoms with the 1st dose as well. Patient is still able to eat and drink fine. Taking Tylenol during the day, and Benadryl before bed for some relief. Patient is monitoring at home, drinking lots of water and will seek care if symptoms to not dissipate or worsen in any way. No shortness of breath, difficulty swallowing or breathing, rashes, etc at this time.
48 2021-03-28 pallor After receiving the 1st dose of Pfizer COVID-19 vaccine, the patient moved to the observation area. ... Read more
After receiving the 1st dose of Pfizer COVID-19 vaccine, the patient moved to the observation area. After 5 min, patient reported feeling light-headed and tried to stand up. The patient sat down on the floor and leaned against the wall. Patient was able to stand and walk to the provider room for closer observation. Patient felt hot and looked pale. The provider placed a blood pressure cuff on the patient, at which point the patient slumped forward and stopped breathing. A carotid pulse was not able to be appreciated. The patient was pulled to the floor, positioned airway open and was given oxygen. BP was 96/40. Blood sugar was checked (104) and the AED pads were placed. EMS was called. AED advised no shock, patient had a pulse and was breathing. Patient gradually became alert, though reported not feeling well. Patient was disoriented and was not aware of passing out nor the current event. Repeat BP 115/50. Patient began vomiting (~300-400 mL). Patient left with EMS to be evaluated at local Emergency Department. Of note, patient reports history of vasovagal syncope events 2/2 to various situations.
48 2021-03-29 heart rate increased Dizziness- Heavy dizziness for three days and continued dizziness since vaccine. Rapid Heart Beat- R... Read more
Dizziness- Heavy dizziness for three days and continued dizziness since vaccine. Rapid Heart Beat- Rapid Heart Beat came in waves for 1 day. I didn't time the rapid heart beat events. Lower back pain- still experiencing Muscle aches come is waves
48 2021-03-29 fainting, pallor, hypotension PT was administered vaccine at 1025 and shortly there after started to shake, felt sweaty and just f... Read more
PT was administered vaccine at 1025 and shortly there after started to shake, felt sweaty and just felt weird. Then passed out. PT was quickly assisted by vaccination staff at car side and then medical staff was notified. Upon arrival PT was very pail and lacked color, but was awake and stated that he has never had that happen before. Denies any history of having adverse effects to medications. NKDA. Ambulance was called. 1045 Vitals BP: 80/60 Pul: 68 Sp02: 97 1045 Ambulance arrived 1050 BP: 92/58 PT was taken to local ER for further observation.
48 2021-03-30 skin turning blue, blood pressure increased, fainting, pallor After receiving the Pfizer vaccine in the Left arm, patient bled from the site after the syringe was... Read more
After receiving the Pfizer vaccine in the Left arm, patient bled from the site after the syringe was pulled out. About 20 seconds later, patient said he was nervous and started sliding down in the chair. Patient was guided to the ground by vaccinating nurse. Patient was unresponsive for about 5 seconds, pulse present, face and lips blue for about 3 seconds and then transitioned to pale. Patient did not fall and did not hit his head. Vitals assessed, BP 152/93, Pulse 78, Temp 98.1, RR 17, SaO2 98%. Patient able to respond shortly after fainting, answered questions correctly. Patient stated he has a phobia of needles and has fainted in the past when getting blood drawn. 911 called by another vaccinating nurse during this time. Paramedics arrived at 1304. Patient safety and comfort maintained. Patient treated by paramedics. Vitals stable, EKG showed no abnormalities. Patient refused to be taken to the hospital after incident. Patient stayed moved from the vaccination area to observation without incident. Patient tolerated water and sitting up-right in chair. Patient monitored by RN and LVN. Vitals at 1328 BP 143/88, SaO2 98%, Pulse 98, Temp 98.1, RR 18. Patient tolerated waiting 15 minutes in observation and requested to ?get some fresh air.? Patient tolerated standing outside with two nurses observing him at that time. Patient was stable to leave site. Last vitals @ 1345 BP 148/94, Pulse 83, Temp 97.1, SaO2 97%. Patient left site without further incident.
48 2021-03-30 heart rate decreased, blood pressure decreased, hypertension Client became hypertensive and diaphoretic after vaccine administration. BP was 69/49, HR 42, Gluco... Read more
Client became hypertensive and diaphoretic after vaccine administration. BP was 69/49, HR 42, Glucose 136. Client was evaluated by Fire Rescue. Fire Rescue called and patient declined transport to Medical Center ER at 1:58 pm.
48 2021-03-31 palpitations Patient reports sensation of heart racing as well as feeling clammy. He states that he is not light ... Read more
Patient reports sensation of heart racing as well as feeling clammy. He states that he is not light headed and does report history of anxiety, stating that he takes Xanax as needed. Symptoms come in waves and are short lasting. Patient was given juice and crackers and was monitored in medical observation. Reports feeling a "twinge" in vaccinated arm. BP 122/74
48 2021-04-01 blood pressure increased, chest pain pt is deaf. as soon as shot was administered pt was holding his heart and made a motion that he ha... Read more
pt is deaf. as soon as shot was administered pt was holding his heart and made a motion that he had chest pain. pt became diaphoretic. he wrote on a piece of paper that he had chest pain. plain twp ems assessed him. he did have elevated blood pressure of 130/90 as well. squad took him to the hospital.
48 2021-04-01 cerebrovascular accident documented MRI stroke; Appears to be thromboembolic; This is a spontaneous report from a contactable... Read more
documented MRI stroke; Appears to be thromboembolic; This is a spontaneous report from a contactable physician (reported for himself). A 48-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in right arm on 04Jan2021 07:00 as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. On 27Jan2021 14:00, it was reported that patient had documented MRI stroke, and appeared to be thromboembolic. Patient have no risk factors for CVA, and stroke occurred. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): stroke on 27Jan2021. Events resulted in doctor or other healthcare professional office/clinic visit, emergency visit and disability or permanent damage. Therapeutic measures were taken in response to the events which included patient had started on aspirin. The patient was not tested for covid post vaccination. The outcome of the events stroke and thromboembolic was recovering. Information about lot/batch number is requested.; Sender's Comments: The causal association cannot be excluded between the reported events of "MRI stroke and appeared to be thromboembolic" and BNT162B2 use. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. 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.
48 2021-04-01 chest pain chest pain
48 2021-04-01 heart rate increased Pt stated he was admitted to the hospital with blood pressure issue 180/120, rapid heart rate of 118... Read more
Pt stated he was admitted to the hospital with blood pressure issue 180/120, rapid heart rate of 118, general body aches and pains.. Given fluids. All Scans and EKG were clear.
48 2021-04-02 fainting 10 minutes after shot got dizzy, syncopized. now asymptomatic. no allergic symptoms.
48 2021-04-05 cerebrovascular accident C?O numbness in legs, became confused, disoriented. Transferred to Emergency Department. Diagnosed ... Read more
C?O numbness in legs, became confused, disoriented. Transferred to Emergency Department. Diagnosed with CVA event. Still being treated at this time.
48 2021-04-05 chest discomfort Headache, Fever, soreness in joints and muscles, dizziness, heavy chest, slowed reaction time
48 2021-04-07 blood glucose increased Extreme fatigue. Inability to stay awake past 5:00 PM in the afternoon. Very high blood sugar.
48 2021-04-08 hypotension, pallor, fainting 5 minutes after receiving the vaccine, the client fainted. Attending nurse performed a sternum rub ... Read more
5 minutes after receiving the vaccine, the client fainted. Attending nurse performed a sternum rub and administered an ammonia inhalant. The client woke up pale and diaphoretic. Fire Rescue responded. Client presented hypotension, Client's vitals recovered to normal limits. Client was released to home at 4:45pm. No further evaluation needed as per Fire Rescue.
48 2021-04-08 loss of consciousness Dose was administered at 0805, patient passed out at 0810. Patient reported that he had worked all n... Read more
Dose was administered at 0805, patient passed out at 0810. Patient reported that he had worked all night and hadn't eaten for a while. He also said he has passed out from blood draws before.
48 2021-04-09 chest discomfort shortness of breath; tight chest/lungs; tingling in face; tight lips; dizziness; fatigue; This is a ... Read more
shortness of breath; tight chest/lungs; tingling in face; tight lips; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in right arm on 06Feb2021 at 05:30 PM at single dose for COVID-19 immunisation. Medical history included allergies to macadamia and brazil nuts, and was on medication for a few health issues. Concomitant medications included unspecified medication (medications in two weeks). No other vaccine received in four weeks. Patient has not tested COVID prior vaccination. The patient experienced shortness of breath, tight chest/lungs, tingling in face, tight lips, dizziness, fatigue on 06Feb2021 at 06:15 P.M. Events resulted in visit to doctor or other healthcare professional office/clinic. No treatment was given for events. Patient has not tested COVID post vaccination. The outcome of events was recovered with sequel. No follow-up attempts are possible. No further information is expected.
48 2021-04-09 chest pain Pt received 1st dose Pfizer vaccine, completed 15 min observation and then started to feel intermitt... Read more
Pt received 1st dose Pfizer vaccine, completed 15 min observation and then started to feel intermittent dull chest pain. Pt denies SOB, non diaphoretic, denied any other health conditions, alert and oriented. Pt ambulated with steady gait. Medics called to assess Pt and was cleared to go home by EMTs after evaluation. Per EMTs Pt asymptomatic upon release. Vitals 1505 BP 142/94 HR 69 RR 18 Temp 97.4F temporal O2 sat 98% on RA
48 2021-04-09 loss of consciousness Patient stated he was sitting in the chair and he started feeling clammy tunnel vision and blacked o... Read more
Patient stated he was sitting in the chair and he started feeling clammy tunnel vision and blacked out. he doesnt remember being brought over to the observation room. He was encouraged to drink fluids, patient stated he was feeling better and reported no further tunnel vision, he was escorted out with his son accompanying him. vital signs @ 1024 HR 62, BO 98/60 RR 18, pulse ox 96%, at 1027, HR 81, BO 111/65, RR 18 and pulse ox 95% on RA, at 1044 HR 62, BP 111/ 69, RR 18 and Pox 97%. He was released at 1045 by himself to the exit of the facility.
48 2021-04-13 loss of consciousness, pallor Five minutes after receiving dose, stated he started to feel warm and light headed, so he sat down. ... Read more
Five minutes after receiving dose, stated he started to feel warm and light headed, so he sat down. He then lost consciousness, falling out of his chair and hitting his head. Staff at his side immediately; pale and extremely diaphoretic; started to come to after 10-20 seconds. He sat up immediately on his own. He was oriented to self, place, date. After about 30 seconds, stated he thinks he should lay down again. Lowered his head to the floor, blanket placed under his head and feet elevated using a chair nearby. BP 120/52 Sats 100%, HR 72. Cool packs applied to his neck and forehead. After 2-3 minutes requested to move him to the medical area. Got up to wheelchair, but lost consciousness again; head fell forward, appeared as if upper extremities stiffened and contracted, like sz activity. When in medical evaluation area, client was conscious, but starring blankly and not responding verbally. At 3:02, with assist of 2, moved to the cot to elevate his feet, but again, not responding to requests, such as lay down or elevate your feet, so assisted client to this position. Continues to be diaphoretic, pale and ashen. 911 called at 3:07. Informed him of this and the plan. Friend is by his side. Client denies allergies, states he takes meds for hypertension. 3:15 BP 100/56, HR 52, Sats 92%, hands cool to the touch. EMS here at 3:23; report given and client transferred to Hospital via ambulance.
48 2021-04-13 blood clot I got my second Pfizer covid shot on 2/17/21. Since then I have ahad 2 large blood clots form in my ... Read more
I got my second Pfizer covid shot on 2/17/21. Since then I have ahad 2 large blood clots form in my lower right leg. I had one in the same place 24 years ago.
48 2021-04-14 lightheadedness Post vaccine pt developed dizziness, nausea and became sweaty. Pt transferred via wc and arrived to ... Read more
Post vaccine pt developed dizziness, nausea and became sweaty. Pt transferred via wc and arrived to obs at 0905. Vitals obtained and monitored. Symptoms resolved. Per physician, pt experienced classic non syncopal vasovagal reaction - resolved. Pt released to home by self at 0920. Vitals as follows: 0909 Lying BP 123/83 HR 67 RR 20 SPo2 96 0915 Sitting BP 134/84 HR 67 RR 18 SpO2 99 0916 Standing BP 119/83 HR 70 RR 18 SpO2 98
48 2021-04-15 chest discomfort, pulmonary embolism The night after my first shot, I felt pressure on my lungs, It felt as if I had the onset of Pleuris... Read more
The night after my first shot, I felt pressure on my lungs, It felt as if I had the onset of Pleurisy as I have had that issue in the past. I figure I would wait to get it treated as it is not always picked up in the x-ray in its infant stages (based on past experience). On March 2, the pain became unbearable and I went into a urgent care center to get an x-ray and something to help with my issue. The urgent care did not take my x-ray they immediately sent me to the hospital strongly intimating that the problem was probably more serious than I thought. I was in the emergency room, they ran tests and made me comfortable enough as they also gave me a ct-scan which is when they found the bi-lateral pulmonary embolisms. I have since gone to my primary care physician and he directed me to a hematologist/oncologist. The event was found to be unprovoked. I am on blood thinners for 6 months.
48 2021-04-15 heart rate irregular I recently began monitoring my blood pressure at home with an Omron Platinum series monitor. On the ... Read more
I recently began monitoring my blood pressure at home with an Omron Platinum series monitor. On the morning of Wednesday, April 7, I received a reading of an irregular heartbeat. I also received a reading of an irregular heartbeat on the evening of April 7, the morning of April 8, the evening of April 8, and the evening of April 9. I reported this information to my doctor who suggested I wear a Holter monitor for 48 hours to see if I had any issues with my heart. The result of the Holter monitor showed that I am having PVCs less than 1% of the time. Since I got so many readings of irregular heartbeat in a short amount of time on my monitor, I thought the irregular heartbeats may be related to the vaccine which was administered the afternoon before I began getting the irregular heartbeat notifications.
48 2021-04-17 cardiac arrest, loss of consciousness Heart stopped 6 times; unresponsive; soreness; felt like unwell; vomiting; Body aches; achiness; pas... Read more
Heart stopped 6 times; unresponsive; soreness; felt like unwell; vomiting; Body aches; achiness; passed out 7 times; fever; chills; Left arm soreness at injection site and up back of shoulders; Left arm soreness at injection site and up back of shoulders; This is a spontaneous report from a contactable consumer.A 48-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, Lot Number: EN5318), intramuscular, administered in left arm on 27Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included asthma, myocarditis and allergies to Fruit or nut that grows on trees. Concomitant medication included esomeprazole magnesium (NEXIUM). The patient's heart stopped 6 times on 29Jan2021, he had a low grade fever, achiness and chills at 01:30, but they were gone the next day. Basically, at first, he took the shot and got the reactions that everyone else does, right arm soreness 01:30. On 07Jan2021 17:00, patient took the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, Lot Number: EL1042), intramuscular, administered in left arm. No prior vaccination was given within 4 weeks. He fell in the shower and passed out and hit his head at 18:00. He was not hooked up to a machine. About 18:30, his wife got him to the couch. He drank carrot juice and ate a granola bar. At 18:30 his eyes were wide open, but he was unresponsive. About every 30 minutes, he was going down. The third one came about 18:45-19:00. The pass outs lasted 15-20 seconds. and all he remembers was waking up to her screaming at him. The next one came at 19:15 and was in the ambulance on the way to the hospital and that is when he vomited in the ambulance and on the couch. Pass out number 3 was at home and 4 was in the ambulance. There was vomiting with both of them. Pass out number 5 was in the hospital when she was getting in the bed and was not hooked up in the room yet. Finally, they got him hooked up to a machine at 20:30 and into a room. They said if you feel dizzy, press the button. He found out his heart rate went from 80's down to 30's. That was the 6th pass out. This was the first time he was on a machine. His heart did not actually stop, it just went down to 30's and would come back. Then, it happened one more time on the machine and at that point, they were hooking him up to an IV and giving him medication to keep him from vomiting. He does not have the name of that medication or the dose or lot or expiration. He got stabilized but they had him hooked up shockpads in case anything happened. They recorded his heart stopping 6 times during the night and of those 6 times, he does not have the times.2 seconds was the longest time of all of the stops. He does not know how many each were. This was when he woke up on 30Jan2021. He later stated he was hospitalized 28Jan2021 at 7pm and those 6 stops occurred 29Jan2021 through the night previously. The patient was hospitalized for heart stopped 6 times from 29Jan2021 and discharged on 01Feb2021. The patient underwent lab tests and procedures which included body temperature was low grade fever, echocardiogram, brain scan and electrocardiogram shows normal,heart rate: 80 beats, heart rate was down to 30 on his heart beat. They gave shot in the leg for blood clots, nausea medication and a bunch of pills given as treatment. The outcome of heart stopped 6 times was recovered with Sequel, patient passed out 7 times, body aches, fever and chills, left arm soreness at injection site and up back of shoulders was recovering, unresponsive and soreness next day felt like unwell and vomiting was unknown, achiness was recovered. No follow-up attempts are possible. No further information is expected
48 2021-04-17 loss of consciousness Extreme dizziness and nausea resulting in fainting twice and hitting chin on furniture. Diarrhea al... Read more
Extreme dizziness and nausea resulting in fainting twice and hitting chin on furniture. Diarrhea all night at least once per hour. Chills and shaking. Sweats, very fatigued, no appetite, no sleep. Rested all Sunday, no more chills but still nauseous, diarrhea all day. No energy or appetite.
48 2021-04-17 pulmonary embolism, chest pain, deep vein blood clot 4/11/21 generalized fatigue 4/14/21 shortness of breath and chest pain 4/15/21 right lower extremit... Read more
4/11/21 generalized fatigue 4/14/21 shortness of breath and chest pain 4/15/21 right lower extremity Deep vein thrombosis and bilateral Pulmonary emboli 4/16/21 mechanical thrombectomy of pulmonary emboli 4/15/21 - 4/18/21 treatment with heparin infusion which was transitioned to eliquis
48 2021-04-19 loss of consciousness, fainting Patient reported a history of anxiety related to vaccine injections and a history of fainting post v... Read more
Patient reported a history of anxiety related to vaccine injections and a history of fainting post vaccination. Patient was brought to a private room for the vaccination and did faint about 5 minutes post vaccination. Patient was brought to the ground. Patient was able to respond to questions and only lost full consciousness for about 10 seconds. Patient recovered from the event after about 15 minutes and waited at our clinic 30-40 minutes post vaccination. By the time the patient left, he had fully recovered.
48 2021-04-20 heart attack Heart Attack, 100% blockage with blood clot. I had to have three stents put in, but survived. I wa... Read more
Heart Attack, 100% blockage with blood clot. I had to have three stents put in, but survived. I was in hospital for 2 days,
48 2021-04-20 pulmonary embolism, deep vein blood clot, fibrin d dimer increased Patient presented to ER with left leg swelling, diagnosed with extensive Left leg DVT and extensive ... Read more
Patient presented to ER with left leg swelling, diagnosed with extensive Left leg DVT and extensive bilateral pulmonary emboli
48 2021-04-20 pulmonary embolism pulmonary embolism-2 weeks later
48 2021-04-21 excessive bleeding He was immunized by our pharmacist . He was told to sit in the observation area. After 10 minutes , ... Read more
He was immunized by our pharmacist . He was told to sit in the observation area. After 10 minutes , One other person came to our terminal reported that there is a person on the floor. I rushed to check on him. He was on the floor flat . I asked him if he is ok and if I can call 911. He said he is fine . He was helped to sit on the chair. He was wearing a black mask and seating. I asked him if he wants to me to call 911. He said he is feeling better. There was blood dripping out the mask. I asked him to check . His lips were split and his mouth was bloody. He fell flat on his face, that resulted in the bloody mouth. I gave him a ice pack and sat next to him . He called his wife and waited in the same area. I sat next to him. His wife came in and took him to the immediate care .
48 2021-04-21 heart rate increased About ten minutes after getting the shot I got a weird feeling in my chest and then within a few min... Read more
About ten minutes after getting the shot I got a weird feeling in my chest and then within a few minutes a rapid heart rate. My normal heart rate is around 72 and my heart rate after the shot was 110. The symptoms lasted for about an hour. In 2011 I experienced the same exact symptoms from intravenous benadryl and the both contain Polyethylene glycol.
48 2021-04-21 fainting Syncope, flushing/sweating, dizziness. Patient fainted. BPs 99/57 (pulse 64), 103/61 (pulse 67). Giv... Read more
Syncope, flushing/sweating, dizziness. Patient fainted. BPs 99/57 (pulse 64), 103/61 (pulse 67). Given water, juice, crackers.
48 2021-04-24 chest pain, palpitations Chest pain; Palpitations; Shortness of breath; Cant Sleep; This is a spontaneous report from a conta... Read more
Chest pain; Palpitations; Shortness of breath; Cant Sleep; This is a spontaneous report from a contactable consumer reporting for himself. A 48-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 17:00 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation (Age at vaccination 48 years) . Medical history included anxiety,Post traumatic stress disorder , hypertension , blood cholesterol increased. On 24Feb2021 the patient received the first dose of BNT162B2 vaccine. Concomitant medication included clonazepam (CLONAZEPAM) taken for anxiety, start and stop date were not reported. The patient previously took penicillin b. The patient experienced chest pain , palpitations , shortness of breath , cant sleep all on 23Mar2021 with outcome of not recovered. Course of events. This past Sunday would be 3 weeks post receiving his vaccine. Since he got the vaccine, about 3 days later he experienced chest pain, palpitations, Shortness of breath. He checked his own Blood pressure and its not high and his pulse is normal also. He's not a doctor and he doesn't know if its anxiety, but he also cant sleep, he's been getting like 4 hours of sleep every night since this started. No follow-up attempts are needed. No further information is expected. Lot information already received.
48 2021-04-24 nosebleed his is a spontaneous report from a contactable consumer (patient's wife) via Medical information tea... Read more
his is a spontaneous report from a contactable consumer (patient's wife) via Medical information team. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:00 (Lot Number: EN6207) as SINGLE DOSE for COVID-19 immunization. Medical history included back pain from an unknown date and unknown if ongoing , COVID-19 from Nov2020 to an unknown date and family history of Amyotrophic lateral sclerosis (ALS) from an unknown date and unknown if ongoing. The patient previously had dose 1 of BNT162B2 (lot number: EN6198) on 17Mar2021 in left arm as single dose for COVID-19 immunization. Concomitant medications included ibuprofen taken for back pain, start and stop date were not reported and probiotics twice a day. The patient had fever that reached 101.5°F on 07Apr2021 and last night when he laid down in his stomach he got nosebleeds on 08Apr2021 until this morning. The patient was given Tylenol and the fever has receded and the nosebleeds have stopped and he can get upward. She is just concerned about the nosebleeds of the patient and she would like to know if this has been reported as a side effect since she was not able to find anything about this. The patient has been having a pretty rough fever of 102 today, which was higher than last time. States that the patient did get a little fever last time but was still able to work. If the patient lays on his stomach, it just drains out and if he lays on his back, he is basically swallowing it. The patient has been having other symptoms, like aches, pains and 102 fever but is most concerned about the nosebleeds. The patient was feeling feverish last night. States that temperature was 101 or something two hours ago and went checked 15 minutes ago, was 102. States that it has raised in the last couple of hours. The patient just took Tylenol when temperature was 102 as treatment. The nosebleeds started this morning and is still going on now. Drainage is not as much but still has drainage and is now sitting upright. States that when he lays on his stomach, it starts flowing. States that when he came to bed this morning, he suddenly felt like his nose was draining. Explains that he just took another nap on his stomach and found a little blood on the sheets. The patient had no emergency room visit or visit to physician's office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event fever was not recovered and outcome of the rest of events was unknown.
48 2021-04-24 heart rate increased Regular - Arm pain. Adverse - Abdominal pain / pressure, green stools, dizziness, fast heartbeat, a... Read more
Regular - Arm pain. Adverse - Abdominal pain / pressure, green stools, dizziness, fast heartbeat, anxiousness, irritation, body hyper alert, triggered.
48 2021-04-24 heart attack Heart attack a two weeks after 1st dose of vaccine; This is a spontaneous report from a contactable ... Read more
Heart attack a two weeks after 1st dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 48-Year-Old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727) via unspecified route of administration in the left arm on 21Mar2021 at 12:45 PM at single dose, for COVID-19 immunization. The relevant medical history included diabetic and high blood pressure from unspecified date. Concomitant medications included insulin, empagliflozin (JARDIANCE), atorvastatin, lisinopril. No other vaccine in four weeks. The patient experienced heart attack a two weeks after 1st dose of vaccine on 06Apr2021 at 08:00 AM. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and life threatening illness (immediate risk of death from the event). The patient had hospitalization for 3 days. The patient received treatment including stent for the event. No covid prior vaccination and no covid tested post vaccination. The outcome of the event was recovered with sequel.
48 2021-04-24 blood clot, heart attack, pulmonary embolism NSTEMI; Pulmonary Embolism; left upper arm thrombosis; This is a spontaneous report from a non-conta... Read more
NSTEMI; Pulmonary Embolism; left upper arm thrombosis; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Mar2021 (at the age of 48-years-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other vaccine received in four weeks. On 15Apr21, the patient presented to hospital with complaints of dyspnea, chest pain and arm swelling. The patient was found to have left upper arm thrombosis, pulmonary embolism, and NSTEMI. The adverse events started on 15Apr2021 and resulted in emergency room/department or urgent care visit, hospitalization on 15Apr2021 and life-threatening illness (immediate risk of death from the events). An unspecified treatment was received in response to the events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-04-25 body temperature decreased Within 10 minutes of COVID #2 Pfizer vaccine at about 10:18am, patient developed lightheadedness, co... Read more
Within 10 minutes of COVID #2 Pfizer vaccine at about 10:18am, patient developed lightheadedness, cold sweats, and throat swelling sensation. Patient's temperature was low at 95.8 to 96.2.
48 2021-04-26 very slow heart rate, arrhythmia, ejection fraction decreased, low blood oxigenation, increased heart rate, fast heart rate Please note that I am the patient in question here, but also an physician, so I will write this in t... Read more
Please note that I am the patient in question here, but also an physician, so I will write this in technical terms as best as I understand what happened. For background, my cardiac history is important. I had a work-up for palpitations performed more than a year ago that revealed normal cardiac function (EF > 65% by NM myocardial perfusion study), normal coronary arteries, and significant exercise tolerance (I maxed out the treadmill test). Usuallly I have to engage in vigorous exercise to raise my heart rate > 160 bpm. My resting heart rate is typically in the 50s or less. On Jan 15, 2021 I had an elective cerebral angiography and embolization procedure performed. I was asymptomatic prior to this procedure. The procedure requires general anesthesia for several hours. I have had the procedure conducted a few months previously and it typically has an unremarkable recovery, one night required in the hospital. After the procedure and following extubation, I had hypoxia on room air, tachycardia, wheezing and fatigue. The working cause for this was suspected atelectasis due to general anesthesia and I was given bronchodilators. While my breathing improved overnight, I was very tachycardic even while sleeping ? pulse greater than 130. Overnight telemetry noted arrhythmias with sinus tachycardia. The tachycardia persisted long after prior albuterol use so I had CTA chest on 1/16. No PTE was noted, though some basilar atelectasis and mild upper lobe ground glass opacities. I was discharged but due to continued mild hypoxia overnight, low grade fever (< 101F), and persistent tachycardia with any movement, I went to the ED on 1/17 for additional evaluation. In the ED, I had tachycardia with arrhythmias noted (rate up to 160). Sinoatrial exit block noted on EKG and telemetry. COVID-19 testing was negative by nasopharyngeal PCR and antigen testing. Resting heart rate was > 90 even when sleeping. Follow-up echocardiogram on 1/21/21 revealed depressed ejection fraction (40-45%). Cardia MRI on 2/1 was performed to evaluate for cardiomyopathy. Symptoms at this point were fatigue, dyspnea with even mild activity (e.g. walking), and tachycardia > 140 bpm with even just walking. My resting heart rate improved to 40s-50s. It showed normal wall motion and ventricle size with slightly reduced ejection fraction. Cardiology recommended cardiac event monitoring which I wore for 28 days. It only revealed sinus tachycardia and bradycardia. I still don?t feel great but able to do more physically than a couple of months ago. I await further f/u cardiac imaging to see if there has been improvement in the heart function.
48 2021-04-26 chest pain, chest discomfort Tightness and mild pain in the left side of the chest; Tightness and mild pain in the left side of t... Read more
Tightness and mild pain in the left side of the chest; Tightness and mild pain in the left side of the chest; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 11:45 (at the age of 48-years old, reported as 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4-weeks prior to the COVID vaccine. On 26Mar2021 at 22:45 the patient experienced tightness and mild pain the left side of the chest. No treatment was received for the events. The clinical outcomes of tightness and mild pain the left side of the chest were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed; no further information is expected.
48 2021-04-27 atrial fibrillation This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient rece... Read more
This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Jan2021 (Batch/Lot Number: el1284) as single dose for covid-19 immunisation at a hospital. Medical history included hypertension. The patient has no covid prior to vaccination and no known allergies. Concomitant medications included bisoprolol fumarate (CONCOR), amlodipine and metformin. The patient has no other vaccine in four weeks. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: eh8899) on 18Dec2020 in the left arm for Covid-19 immunization. On 03Feb2021 (also reported as "21 days after vaccination"; pending clarification), the patient had Afib episode and ACS needed a coronary stent. The patient was hospitalized for 2 days. The patient was tested for covid post vaccination via nasal swab on 06Mar2021 which was negative. The outcome of the events was recovered with sequel.
48 2021-04-28 nosebleed Choking; Coughing out foamy mucus from his mouth and throat; soreness at the injection side; Neck st... Read more
Choking; Coughing out foamy mucus from his mouth and throat; soreness at the injection side; Neck stiffness; slight fever; sore throat; slightly bloody, foamy mucus from his nose; slight cough; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 48-year-old via an unspecified route of administration, administered in Arm Right on 13Apr2021 14:00 (Lot Number: Ew0153) as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder, and post-traumatic stress disorder (Adhd and ptsd). There was no covid prior vaccination, and no covid tested post vaccination. No other vaccine in four weeks. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); marijuana; calcium; acetylsalicylic acid (ASPRIN); acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE); acetaminophen; MULTIVITAMINS [VITAMINS NOS] all in two weeks. The patient experienced choking, coughing out foamy mucus from his mouth and throat on 14Apr2021 02:00, he said it took him several hours to cough out the foamy mucus and also cleared out a significant about of slightly bloody, foamy mucus from his nose. He said all of the foamy mucus felt like it was in his throat and nose but not in his lungs. He fell back asleep, after clearing the mucus and slept another 6 hours and the foamy mucus did not return during the second sleep session. Other symptoms he experienced were soreness at the injection side, neck stiffness, slight fever, sore throat and slight cough on 14Apr2021 02:00. No treatment was received. The events outcome was recovered in Apr2021.
48 2021-04-28 pallor, fainting, hypotension, very slow heart rate Client fainted after receiving the COVID-19 vaccine as per the vaccinating nurse. Attending nurse a... Read more
Client fainted after receiving the COVID-19 vaccine as per the vaccinating nurse. Attending nurse administered an ammonia inhalant. The client woke up, Fire Rescue arrived to evaluate client. Showed symptoms of weakness, diaphoresis and paleness. Client presented hypotension and bradycardia. Client needed to be transported to a hospital as per Fire Rescue. Client was transferred to Clinic by Fire Rescue at 3:27pm.
48 2021-04-29 palpitations 7 days after vaccine I had a pretty intense, unprovoked anxiety attack. I was not under any stress, ... Read more
7 days after vaccine I had a pretty intense, unprovoked anxiety attack. I was not under any stress, have never had anything like this occur, was not doing anything strenuous and all of a sudden had what I thought might even be a stroke or heart attack. I walked back to the house and took BP and it was 172/75 and pulse rate was only 64...but I was sweating, faint feeling, blurred vision, completely exhausted and it felt like my heart was pounding...but it wasn?t.?? I took BP multiple times but it was fine. Just a really strange anxiety attack I guess that lasted a few hours. I wasn?t worried about it and was t going to report it but have had 3 other people who unsolicited told me about their anxiety attack between 5 -7 days after shots. Two were phizer and one was Modena. Figured I would report it in case it helped someone else to not panic if they had an event like this. It was quite scary and I don?t get worried about things like that!
48 2021-04-30 pallor Patient reported to PHN during his observation time that he was feeling lightheaded and feeling like... Read more
Patient reported to PHN during his observation time that he was feeling lightheaded and feeling like he" was going to pass out". PHN requested for assitance of lead clinic and had patient lay on the floor and put his feet up on the chair. PHN had ice placed on patients head and behind his neck. Patient appeared pale but PHN did not notice patients previous face color prior to entering observation. PHN took patents BP which was 125/90 and pulse 75. Oxygenation was 100%. Patient given water and after about 10 minutes patient felt better and returned to sitting position in chair.
48 2021-04-30 fainting, hypotension, heart rate decreased syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; bo... Read more
syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; body pain; headache; felt uneasy; nausea/Felt like throwing up; dizzy/lightheaded; Profuse sweating; EKG showed low heart rate, blood pressure; EKG showed low heart rate, blood pressure; feeling weak; could not stand; Feeling worse; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Cholesterol (blood cholesterol abnormal) from an unknown date. There were no concomitant medications. The patient previously received first dose of BNT162B2 for covid-19 immunisation on 24Mar2021. The patient also previously received naproxen and experienced allergies. The patient experienced syncope, soreness overnight in left arm, expanding pain to left shoulder, strong fever/low fever, body pain, headache, felt uneasy, nausea/felt like throwing up, dizzy/lightheaded, profuse sweating, ekg showed low heart rate, blood pressure, feeling weak, could not stand and feeling worse all on 15Apr2021 at 13:00. All the reported events caused hospitalization for 1 day. It was reported that After receiving Pfizer vaccine at 4pm developed Soreness overnight in left arm, expanding pain to left shoulder. Strong Fever and body pain in morning. Feeling worse throughout morning after breakfast of tea and fruits. While having lunch at 1.30 pm felt uneasy and nausea and could not complete lunch. Felt like throwing up and got up feeling dizzy and lightheaded. Experienced syncope and had to lie down on kitchen floor. Tried to get up with help from family members but could not stand and had to lie down again on floor. Profuse sweating. Wife called 911 and ambulance who arrived and checked pulse, EKG showed low heart rate, blood pressure. Taken by ambulance and paramedics to hospital Emergency where IV fluids were given to stabilize and discharged after 4 hours of observation. Still feeling weak, headache, low fever. Taking Tylenol and fluids while recovering. Adverse event start date: 15Apr2021. Adverse event start time: 01:00 PM. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): low on 15Apr2021, EKG (electrocardiogram): showed low heart rate, blood pressure on 15Apr2021 and pulse/heart rate (heart rate): low on 15Apr2021. Therapeutic measures were taken as a result of all the events which includes IV fluids and Tylenol. Outcome of all the events was recovering Information on batch/lot number was requested.
48 2021-05-02 heart rate increased Insomnia, being "jolted" awake or just waking up at random times and unable to go back to sleep. Ver... Read more
Insomnia, being "jolted" awake or just waking up at random times and unable to go back to sleep. Very tired and groggy most days. Hard to concentrate at work. Depression, excessive anxiety. Always worried about there not being a cute for this. Tingling, burning back, shoulder, and neck pain. Never too severe, but there a lot. Painful to sleep after a few hours. Nausea over half the time. Loss of appetite. Eating significantly less. Lost 15 lbs in two months. Fatigue, brain fog, dizziness, lightheadedness. Extremely tired. Originally neck pain in the front, now teeth/jaw hurt in the mornings. Random sensitivity to cold/hot foods. Unpredictable desire to have a bowel movement or to urinate. Usually unproductive. Sweaty hands/feet. Elevated heart rate randomly. Skin tingling/burning on the tops of arms and cheeks. Numbness in fingers. Originally ring/pinky, now thumb/index/middle finders. Mostly left side. Tinnitus, ear pain. Has gotten slightly louder and more noticeable. Symptoms appeared starting a few days after vaccine #1 and are still ongoing as of date of VAERS report.
48 2021-05-03 deep vein blood clot, pulmonary embolism Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Inje... Read more
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: PE and DVT more prominent in/on the right side of body than left-Severe, Systemic: Vomiting-Medium, Systemic: Weakness-Severe, Additional Details: patient was diagnosed with COVID-19 in October 2020, but asymptomatic with underlying cough
48 2021-05-03 inflammation of the heart muscle, heart attack On day following, suffered high fever and aches for the following 36 hours. On Sunday, experienced ... Read more
On day following, suffered high fever and aches for the following 36 hours. On Sunday, experienced NSTEMI due to myocarditis (not previously diagnosed) and remained hospitalized for two days following.
48 2021-05-04 chest pain the patient complained of feeling a quick twinge and shortness of breath that lasted seconds. He wa... Read more
the patient complained of feeling a quick twinge and shortness of breath that lasted seconds. He was observed for 30 minutes and evaluated by the doctor. No medical intervention was required and the patient was discharged to home.
48 2021-05-04 fast heart rate Pt became tachycardic following vaccination (Hr=140's). Pt monitored by medics and med provider for ... Read more
Pt became tachycardic following vaccination (Hr=140's). Pt monitored by medics and med provider for 45 minute but pt's HR remained 115-120's. Pt refused ambulance transport to hospital . AMA form signed by pt after medical provider explained risks.
48 2021-05-05 chest pain 48-year-old male healthy presented with increased shortness of breath. He mentioned he had COVID-19... Read more
48-year-old male healthy presented with increased shortness of breath. He mentioned he had COVID-19 vaccine first dose almost 3 weeks ago then symptoms started of having shortness of breath with swollen upper and lower extremity not improving since it started. One week after vaccine developed generalized swelling in hands and feet up to thighs with firey red rash now on arms and inner thighs, felt warm. No itching. Reports some shortness of breath and chest pain. Treated outpatient with lasix without improvement, therefore required hospitalization for generalized anasarca. CT- pulmonary edema. Urine Protien/Cr ratio 0.16 - nephrotic syndrome unlikely, B/L lower extremity duplex negative for DVT, 2D echo showing normal EF of 60%
48 2021-05-10 loss of consciousness passed out; felt dizzy; Felt fatigue; headache which lasted about 10 hours; This is a spontaneous re... Read more
passed out; felt dizzy; Felt fatigue; headache which lasted about 10 hours; This is a spontaneous report from a contactable consumer report for self. A 48-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 23Apr2021 08:30 as single dose for covid-19 immunisation. None Medical history reported. No covid prior vaccination. No other vaccine in four weeks, no Other medications in two weeks. Patient received first dose of bnt162b2 (Lot number=ER8733) on 26Mar2021 03:30 PM in left arm. About 20 hours (on 24Apr2021 04:00 AM) after injection felt dizzy, passed out. Felt fatigue and headache which lasted about 10 hours. No treatment received, Patient recovered from the events. Patient has not been tested for COVID-19 Since the vaccination.
48 2021-05-10 pulmonary embolism, chest pain, deep vein blood clot, heart attack, blood clot Patient is a 48-year-old male with patient history significant for CAD, CHF, ICD, HTN, hyperlipidemi... Read more
Patient is a 48-year-old male with patient history significant for CAD, CHF, ICD, HTN, hyperlipidemia, and smoking who presented to the ED yesterday morning with 1 day history of chest pain. Patient described the CP as moderate aching in the substernal area that did not radiate. The pain was intermittent, with each episode lasting 1-2 minutes. The CP was associated with LUE numbness and SOB on exertion. The chest pain and LUE numbness have now resolved. Patient also reports a three week history of RUE swelling. The swelling gradually worsened and is now associated with pain and proximal RUE bruising. RUE pain is rated 5/10. In the ED, patient was found to have NSTEMI and small right lower lobe segmental pulmonary artery embolus. Venous Doppler was positive for occlusive thrombosis in the R subclavian, basilic, and cephalic veins. Patient was started on IV heparin. Patient is scheduled for cardiac cath today. Hematology is consulted regarding PE and RUE DVT. Patient denies personal or family history of blood clots or recent travel. Reports receiving COVID vaccine in LUE approximately three weeks ago. Also admits to being more sedentary recently due to being unemployed. Denies nausea, vomiting, bleeding, bowel changes, fever, or chills. Significant PE findings: RUE edema, firm and tender to palpation, ecchymosis on proximal RUE, distal sensation and active ROM intact
48 2021-05-11 nosebleed Nosebleeds for 3 days after getting the vaccine. One bleed per day
48 2021-05-11 transient ischaemic attack TIA with aphasia/right hand weakness- fully recovered. On 5/7/21, took a nap after work, when he wo... Read more
TIA with aphasia/right hand weakness- fully recovered. On 5/7/21, took a nap after work, when he woke at 6:45PM, realized he couldn't read - knew it was words, but seemed jumbled, so went to talk to his wife but he was speaking jumbled words. He could understand her speaking and hear himself, just couldn't respond in words. Wife called 911, by the time EMS arrived sx were resolving. When EMS arrived, he was evaluated and found that his right hand was slightly tingly/tired. ABCD2 score of 5 for HTN BP>140/90, speech disturbance , weakness, sx <60 min.
48 2021-05-13 heart rate increased dizziness patient feels his heart beat increased. BP: 126/68 for few secs. Patient stayed in obse... Read more
dizziness patient feels his heart beat increased. BP: 126/68 for few secs. Patient stayed in observation area for 30 minutes. -advised him to drink fluids -patient feels better after 10 minutes and left for home when observation period over. -patient stated he had same symptoms from 1st dose too. - advised patient to consult PHP if symptoms persist. - patient stated PHP is aware of symptoms from 1st dose. Vitals: BP:110/72 Pulse 72 o2-99% Patient stated these are his baseline vitals. He feels better - no more symptoms.
48 2021-05-13 increased heart rate, chest pain Post vaccine pt complained of chest pain. Denied other symptoms. Pt noted symptoms worsened with sit... Read more
Post vaccine pt complained of chest pain. Denied other symptoms. Pt noted symptoms worsened with sitting/leaning and improved while standing. EMS evaluation revealed sinus tachycardia, HR 140, BP 164/94. Repeat vitals normal sinus rhythm. Symptoms resolved and pt went home.
48 2021-05-14 blood glucose increased Then a sudden spike in my blood sugar. It was almost 600; This is a spontaneous report from a contac... Read more
Then a sudden spike in my blood sugar. It was almost 600; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:00 (Batch/Lot Number: Er8727) (at 48 years old) as unknown, single for covid-19 immunisation. Medical history included Type 2 diabetes for about 10 years. But always well maintained. Concomitant medication included metformin. No problem the first 5-7 days. Then a sudden spike in patient's blood sugar. It was almost 600 on 07Apr2021 12:00. Treatment Received was IV and insulin. Patient visited Doctor and was brought to Emergency room/department or urgent care. Patient was hospitalized for 1 day. The outcome of the event was unknown. Prior to vaccination,the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
48 2021-05-14 hypertension I felt fine after the shot, but two hours later, my throat felt like it was closing and it hurt in a... Read more
I felt fine after the shot, but two hours later, my throat felt like it was closing and it hurt in a way I've never felt before. I had a bad migraine and my whole body was sore. My blood pressure was high for me at 143/94 with a heart rate of 94. I trend at 120/80 with a heart rate around 90. I take my blood pressure regularly to help manage Type II Diabetes. I was concerned with my throat, as the other symptoms seemed normal for the vaccine. It was very uncomfortable. I phoned the nurse line and was told to have someone bring me to the ER to check me out and take a Benadryl. I took the Benadryl and packed for the ER with meds and ID and my friend drove me. I was still uncomfortable enough to warrant wanting to go and had become very dizzy. When we got to the ER there was a wait and I went to my friend's car until called. After about 30 minutes (about 45 minutes after the Benadryl) my throat released and felt much better. My vitals were taken and seemed normal. The normal aches of the vaccine didn't concern me enough to stay, so I returned home. My symptoms remain what seem to be normal reactions to the vaccine: sore joints, slight headache, slightly sore throat, Charlie horse feeling at the injection site. Nothing of major concern. My largest worry was with the throat feeling closed, but it appears the Benadryl took care of it.
48 2021-05-14 palpitations, heart rate increased heart beat is going to 144 and 120; his body is a heavy weight/he is very tired; his body is very pa... Read more
heart beat is going to 144 and 120; his body is a heavy weight/he is very tired; his body is very pain; has a headache in his head; when he wants to walk he feels dizzy; forgot a lot of things after the vaccine and he forgot his wife.; feel his heart go bum bum bum, too fast; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 24Apr2021 as single dose for COVID-19 immunisation. The patient medical history included inflammatory bowel disease- IBA colon and blood pressure. Concomitant medication included enalapril 5mg for blood pressure. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration as single dose for COVID-19 immunisation. On 25Apr2021, at 04:00, the patient started experiencing symptoms, the body was heavy weight and his heart beat was going to 144 and 120, very tired. Patient did not know what was going on as he was heavy for too long, which he though will last for 2 days but it was 7 days now. The patient heart beat fast and when he slept he could feel his heart go bum bum bum, too fast. Patient had body pain and headache. He felt dizzy when he wants to walk. Patient informed that he cannot go to his work and he wanted to know what to do next as the symptoms continue day by day to today. Patient started to forget lot of things after vaccine and he forgot his wife. The patient stated that the symptoms are getting worst and he wants be normal as he finds it very hard to play with his children and that when he stands up to walk his heart goes bum bum bum. The patient underwent lab tests and procedures which included heart rate: 144 and 120 on 25Apr2021. The patient spoke to his primary doctor and was informed to take Tylenol. The patient took Tylenol 2 tablets 500 mg, 1000mg and it was no benefit. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
48 2021-05-14 transient ischaemic attack Mini Stroke; Weakness on left side; memory loss; This is a spontaneous report from a contactable con... Read more
Mini Stroke; Weakness on left side; memory loss; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0153) via an unspecified route of administration, administered on the left arm on 20Apr2021 10:30 1st dose, single for COVID-19 immunisation. Medical history included COVID (prior to vaccination), pre-diabetic, anxiety, chest tubes and chest pain. The patient's concomitant medications were not reported. On 29Apr2021 22:00, the patient had a Mini Stroke. Also have weakness on left side and memory loss. The events resulted in Emergency room/department or urgent care visit/hospitalization. The patient was hospitalized for 2 days. Treatment was received for the events which included bloodwork, MRI, CT scan. Since the vaccination, the patient has not been tested for COVID-19. The facility where the vaccine was administered was in a pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered.
48 2021-05-15 blood clot, fibrin d dimer increased On May 9th I began to experience severe pain in my back extending down my left side. The pain was se... Read more
On May 9th I began to experience severe pain in my back extending down my left side. The pain was severe enough to prevent sleeping that night. The pain continued throughout May 10th becoming worse with deep breaths or any type of internal strain (cough, sneeze, etc). That evening, I took two Tylenol and later two Ibuprofen and was able to sleep. The pain persisted for the next week, slowly improving but not fully going away. On May 15th I conducted a telemedicine appointment and was advised to go to either Urgent Care or the ER. I chose the ER at Hospital. A D-Dimer test showed elevated results and a CT scan was ordered. The CT revealed blood clots in my right lung, specifically "Subpleural conslidation in the posterior basilar segment the right lower lobe is present, compatible with pulmonary infarct. Question additional pulmonary infarct in the lateral basilar segment the lower right lobe. Probable atelectasis in the left lung base." MD prescribed Eliquis @ 10mg 2x daily and I was discharged with a referral to .
48 2021-05-17 chest pain, dilation of blood vessels On the first night at around 11pm started to experience left sided chest/muscle pain. The next day 4... Read more
On the first night at around 11pm started to experience left sided chest/muscle pain. The next day 4/30, I noticed my veins in my hands were bulging and others around noticed as well. Both hands affected, very uncomfortable and this continued until the 3rd or 4th day and then slowly over the next couple weeks were lessening, still experiencing the swollen veins as of today 5/18/21. On Day 2 I also started experiencing left upper leg pain as well as the chest pain. All left sided, even though my shot was in my right arm.
48 2021-05-17 loss of consciousness, pallor Patient told pharmacist he has habit of passing out when giving blood or getting shots. He was nerv... Read more
Patient told pharmacist he has habit of passing out when giving blood or getting shots. He was nervous. He did well getting shot, set in room for 5 min., then moved him to waiting room where I asked him to stay 15-20 more min. Over a few min he looked very pale, we offered him water. (he barely sipped any). after 5 min he started sweating. He did not call for help, but technician on duty saw him put his head in his lap. We both went out to tend to him. While we were talking to him, he passed out. We called 911. While giving vitals and info to 911, he came to before they got on scene. While paramedics were assessing him, after about 5-10 more min...he passed out again. This time when he came to, seconds later...he projectile vomited on the paramedics. They tended to him until about 1:15-1:30. PT refused their suggestion and urging to go with them to hospital. Paramedics left him in pharmacy to leave facility on his own will. Pt refused our suggestion to call someone to come pick him up and not drive. After sitting outside to get some fresh air, PT came through our drive thru to tell us he was much better and leaving Store. We told him we would call and check on him 5/17/2021. We have called now 2 days (5/17/ and 5/18) and can not get him to return our call.
48 2021-05-17 loss of consciousness Pt states he passed out & not feeling good. Diaphoretic. BP 102/67 Via w/c taken to Observation are... Read more
Pt states he passed out & not feeling good. Diaphoretic. BP 102/67 Via w/c taken to Observation area to lie down. Feeling cold, tingly all over & "wiped out". 3:25PM Taking juice & crackers. Still dizzy when tried to stand up. BP 127/92 3:40PM Left w/o assistance. Feeling much better
48 2021-05-19 blood glucose increased My sugar level used to be between 100 to 129 before the shot. after taking covid 19 vaccine when i g... Read more
My sugar level used to be between 100 to 129 before the shot. after taking covid 19 vaccine when i got my blood test it came around 266.; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration administered in left arm on 29Mar2021 13:30 (Batch/Lot Number: EP7534) (age at vaccination: 48 years old) as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had previously received the first dose of BNT162b2 on 10Mar2021 07:30 (Batch/Lot Number: EN6206) for COVID-19 immunisation. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported. The patient's sugar level used to be between 100 to 129 before the shot. After taking the COVID-19 vaccine, he got blood test it came around 266, on 04May2021 07:45. No treatment was received for the event. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.
48 2021-05-20 loss of consciousness, bleeding on surface of brain Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after post-vaccination 15 minute observation period pa... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after post-vaccination 15 minute observation period patient experienced loss of conscioussness and a fall from standing. Patient transported by ambulance to emergency department alert and oriented with stable vital signs reporting headache. Patient found to have moderate right subarachnoid hemorrhage, extensive facial and mandibular fractures, bilateral nasal fractures, and right ribs six and seven fractures. Patient determined not to be a candidate for surgery and admitted for pain control, antibiotics, and monitoring. Discharged medically stable on antibiotics with neurology and oral maxillofacial surgery follow-up in place.
48 2021-05-22 chest discomfort Shortness of Breath when doing aerobic exercises. Chest tenderness around heart. Going to ER on ... Read more
Shortness of Breath when doing aerobic exercises. Chest tenderness around heart. Going to ER on 5/23.
48 2021-05-26 chest pain, fluid around the heart Patient was admitted 5/24/21 ~2-3 weeks after his 2nd dose of pfizer vaccine. Stated that he had had... Read more
Patient was admitted 5/24/21 ~2-3 weeks after his 2nd dose of pfizer vaccine. Stated that he had had shortness of breath and chest pain that started a few days after vaccine that never really got better. He was found to have pericardial effusion and pleural effusion of unclear etiology. Did not have evidence of myocarditis on EKG or imaging, but findings suspicious for pericarditis.
48 2021-05-26 deep vein blood clot diagnosed with a Deep Vein Thrombosis since the clot was in his vein/Arm starting swelling specifica... Read more
diagnosed with a Deep Vein Thrombosis since the clot was in his vein/Arm starting swelling specifically in his wrist and forearm; This is a spontaneous report initially directly from a contactable consumer (the patient), and then received from a Pfizer sponsored program. A 48-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0164) via an unspecified route of administration, administered in left shoulder on 20Apr2021 at age of 48-year-old at singe dose for COVID-19 immunization. The patient had no medical history (including any illness at time of vaccination). No family medical history relevant to AE(s). The patient did not receive any concomitant medications (reported as "the patient did not receive other products"). No relevant tests. No prior vaccinations (within 4 weeks). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150) via an unspecified route of administration in his left shoulder on 30Mar2021 at age of 48-year-old for COVID-19 immunization and experienced no adverse event. Caller stated he was calling about the COVID 19 vaccine. Caller stated he got the second dose about 3 weeks ago and about 10 days or 11 days after the second dose (01May2021) his arm starting swelling specifically in his wrist and forearm. Caller stated he went to the emergency room and there was a blood clot found in his left arm. Caller stated he was diagnosed with a deep vein thrombosis since the clot was in his vein. Caller stated everything was going better but the emergency room doctor told him he should probably report this to Pfizer to let Pfizer know. Caller clarified that he was released from the emergency room and was never admitted to the hospital. Treatment received for the event included blood thinner. The event required a visit to emergency room, and the caller stated he went to physician office today. The outcome of the event was recovering.
48 2021-05-26 palpitations, heart flutter no symptoms till 26 hrs after 2nd shot. severe heart palpitations - felt like heart was going to ex... Read more
no symptoms till 26 hrs after 2nd shot. severe heart palpitations - felt like heart was going to explode. went to ER, normal EKGs and nothing found in ER. since episode - have had mild heart flutters for 10 days now. during covid illness - had 1 hard palpitation - and some mild flutters. nothing nearly as severe as after the shot.
48 2021-05-29 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Patient ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Patient began to fall back in chair, with help of son, got -Mild
48 2021-05-31 palpitations heart palpitations, shortness of breath, dizziness
48 2021-06-01 inflammation of the heart muscle Myocarditis
48 2021-06-02 heart rate increased cranial pressure; has a burning pressure sensation in his head/ cranial pressure/ burning sensation ... Read more
cranial pressure; has a burning pressure sensation in his head/ cranial pressure/ burning sensation in forehead; the pain can move from one place on his head to another; has a burning pressure sensation in his head; fever; elevated heart rate; headache after second dose; experienced arm pain; arm soreness; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 20Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included eczema, psoriasis, neuropathy peripheral feet. The patient's concomitant medications were not reported. The patient previously took amoxicillin, bnt162b2, 1st dose, Batch/lot number: EL9264 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received various vitamins within 2 weeks of vaccination. Caller reported adverse events following his second dose of the Pfizer COVID-19 vaccine. He had the second dose of the vaccine on 20Feb2021. He said that he has a burning pressure sensation in his head and it is still ongoing. He said the pain can move from one place on his head to another. He wanted to know if that has been reported as an adverse event for the Pfizer COVID-19 vaccine (immediate and long term). He added that he never experienced anything like it. He said that he did not have any lifestyle change, no diet change, and no change in supplements. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. The patient experienced cranial pressure/ burning sensation in forehead accompanied by headache pain in forehead and other areas of head with varying degrees of intensity starting approximately a week after the second vaccination. For the past 11 weeks the symptoms have been constant with varying levels of intensity. The adverse event result in doctor or other healthcare professional office/clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced cranial pressure on 27Feb2021 with outcome of not recovered, has a burning pressure sensation in his head/ cranial pressure/ burning sensation in forehead on 27Feb2021 with outcome of not recovered, the pain can move from one place on his head to another on 27Feb2021 with outcome of not recovered, has a burning pressure sensation in his head on 27Feb2021 with outcome of not recovered, experienced arm pain on 20Feb2021 with outcome of recovered, fever on 21Feb2021 with outcome of recovered, elevated heart rate on 21Feb2021 with outcome of recovered, arm soreness on 30Jan2021 with outcome of recovered, bad headache after second dose on 20Feb2021 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14May2021. Information on Lot/Batch number was available. Additional information has been requested.
48 2021-06-02 pulmonary embolism, chest pain pulmonary emboli: chest pain the day of admission
48 2021-06-09 heart attack, chest pain, heart rate irregular, hypertension Heart attack in right carotid artery. Severe chest pain, shortness of breath, clammy, sweat for abou... Read more
Heart attack in right carotid artery. Severe chest pain, shortness of breath, clammy, sweat for about 45 minutes. Then irregular heart beat and significantly high blood pressure (over 190). Stent put in.
48 2021-06-10 enlargement of the heart, palpitations Heart Palpitations at night. Heart feels enlarged within the chest cavity. Heart beat is harder than... Read more
Heart Palpitations at night. Heart feels enlarged within the chest cavity. Heart beat is harder than usual without activity.
48 2021-06-10 chest pain About 14 days after the first vaccine dose ( Pfizer) patient presented to the ER with severe ches... Read more
About 14 days after the first vaccine dose ( Pfizer) patient presented to the ER with severe chest pain. He was sent home after labs, EKG and CT chest were reported as normal. He was told that he had a hiatal hernia. One week later he was found by his wife expired in his bedroom late morning. Patient had no medical problems such as hypertension and never smoked. He was very active and played sports such as pickle ball.
48 2021-06-10 loss of consciousness Patient passed out, fell over out of chair, hit his head, then had a seizure. 911 was called. Patien... Read more
Patient passed out, fell over out of chair, hit his head, then had a seizure. 911 was called. Patient refused to go to the hospital. Incident happened about 5 minutes after vaccine was given.
48 2021-06-13 chest pain, lightheadedness, palpitations, heart rate increased - presents with a cc of chest and shoulder pain - he had the 2nd dose of covid vaccine pfizer May 7t... Read more
- presents with a cc of chest and shoulder pain - he had the 2nd dose of covid vaccine pfizer May 7th and then soon after started having chest pain into his back, both shoulders, and down both arms; also into his neck and head and jaw; pain is constant and worsening - pain is achy; it is worse with sitting and walking around/standing makes it better - denies numbness but has has tingling in his arms - sometimes his heart is beating fast, has palpitations - feels overall weak - reports lower back pain for a while prior to the vaccine, sometimes this goes down his legs bilaterally, he is not worried about - HA is hard to describe, he has never had headaches before the vaccine; sometimes his head feels light, other times it feels heavy; hurts all over his head and into his neck; turning his head makes his head worse; pain is constant - sometimes he has blurry vision, not currently - sometimes he feels presyncopal but has not actually passed out; he sits down and feels better; its a fleeting sensation - symptoms are worse with sitting, moving around makes all his symptoms better - has intermittent room spinning sensation - has general overall fatigue and weakness, nonfocal - denies dyspnea on my exam - denies rash - feels intermittent diaphoresis and chills/rigor like shaking - reports he was evaluated by an ER since the symptoms started (5/28) and also has seen his pcp who is working him up for fibromyalgia - reports brain fog and feels slower and harder time with his memory
48 2021-06-15 pallor 48 y/o M presented to receive first dose of Pfizer vaccine. Pt received vaccine at 0915 to LD, pt pr... Read more
48 y/o M presented to receive first dose of Pfizer vaccine. Pt received vaccine at 0915 to LD, pt presented with symptoms shortly after vaccine at 0918. Symptoms included pallor, weakness, nausea, and diaphoresis. RN attended to patient immediately- ice pack applied to back of neck, pt asked to take off mask to allow increased tissue perfusion, ice water offered and pt only able to take a few sips due to nausea. Vital signs were obtained (while patient was sitting up in chair) as the following 76/49 BP, HR 53, SpO2 at 97% at 0923. Vital signs were repeated at 0930 while patient was laying on gurney. Vital signs recorded as the following 101/54 BP, 53 HR, 94% SpO2. RN stat called at 0925, staff arrived to assist patient. Pt taken to treatment room for further observation. Upon arrival to treatment room, vital signs obtained and recorded as the following at 0935 BP 102/70, HR 61, SpO2 96%, RR 20. Pt stated symptoms has improved significantly.
48 2021-06-18 heart attack This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 48-ye... Read more
This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 at around 9:00 to 10:00 (at the age of 48-years-old) as 1st dose, single dose for COVID-19 immunization. The patient had no medical history. The patient had no family medical history relevant to adverse event. There were no concomitant medications. The patient had no other products. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks). It was reported that, the patient was calling about the Pfizer covid vaccine. Unfortunately, he had a heart attack in Apr 2021. It turns out the day before his heart attack, he received the first dose of the covid vaccine. He had a heart attack on Saturday, 10Apr2021 at around 16:30 to 17:00. He was sitting down eating dinner and had a heart attack. The patient required emergency room and physician office. He was hospitalized for the heart attack on 10Apr2021. His cardiologist suggested that he call to report this to Pfizer. His cardiologist told him that he has cardiac ectasia, which may have been exacerbated by the first dose of the covid vaccine. He actually feels good now. He feels good and was not getting worse. He was not cleared for physical activity from his cardiologist, so he cannot work out yet. He was starting to put weight back on. Whenever he left the hospital, he was 211 pounds. Now he was 215 pounds. It may be water weight; may his sodium be high. But he was starting to increase in weight. His wife was older. He has a 92-year-old mother-in-law with health issues that lives downstairs. He runs basketball training and was around a lot of kids. He has no idea he had any heart conditions. His wife had gotten the COVID-19 vaccine, and his wife let him know that he was getting it too. The patient had no relevant test done. The patient was remained in the hospital for 6 days and discharged on 15Apr2021. The outcome of the event heart attack was recovered on an unspecified date in 2021. The outcome of the events Weight increased and cardiac ectasia was unknown. Follow up needed, further information was requested.
48 2021-06-20 chest pain Large red spot 4 inches below injection site, slightly sore. Also burning chest sensations. As of t... Read more
Large red spot 4 inches below injection site, slightly sore. Also burning chest sensations. As of today spot is gone. Chest burning is not.
48 2021-06-20 palpitations, heart rate increased Facial numbness, hot flash, Sweating, increased heart rate, palpitations, shortness of breath, Dizz... Read more
Facial numbness, hot flash, Sweating, increased heart rate, palpitations, shortness of breath, Dizziness, faintness, nausea, headache, fullness in the ears, lightheadedness, stomach pain.
48 2021-06-21 blood clot Superficial blood clot left wrist, hand and arm
48 2021-06-23 atrial fibrillation, heart rate increased get in to the hospital due to my heart, AFib; Shortly after, his heart rate went up/Heart beat jumpe... Read more
get in to the hospital due to my heart, AFib; Shortly after, his heart rate went up/Heart beat jumped so fast, sudden rapid heartbeat; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 48-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 13:30 (Batch/Lot Number: EW0151) as single dose for covid-19 immunisation. Patient received the first dose on 14Mar2021 at the age of 47years old. The patient medical history was not reported. The patient's concomitant medications were not reported. Shortly (about an hour) after vaccination, his heart rate went up to 190 bpm and into atrial fibrillation. Heart beat jumped so fast, sudden rapid heartbeat. Caller sought medical care via emergency department, and went to doctor couple of times specially to heart doctor to make sure things are good. Patient was hospitalization for event Atrial fibrillation. Patient had Echocardiogram and PET scan on unknown date with result unknown. Outcome of events was unknown. Follow up needed, further information was requested.
48 2021-06-23 chest discomfort, arrhythmia, heart rate increased, palpitations Phase 1. Injury (6 APR) Pain during Injection (tip of needle) and immediate flinch/twitch in heart ... Read more
Phase 1. Injury (6 APR) Pain during Injection (tip of needle) and immediate flinch/twitch in heart area. Racing heart, Intensity of beat, Severe tinnitus left ear only, adrenaline, Can?t sleep; Symptoms worst when I get into bed Phase 2. (10 APR) Urgent Care Visit: Chest very weak, each day gets worse; inflammation left side of body (chest, hand, face), felt like hole in heart, shortness of breath, numb hand, easy to excite, pain when lean forward; heart out of rhythm; Phase 3: (13 APR) Nighttime rushed by wife to ER due to symptoms of a heart attack couldn?t breathe, numb hands, shivering, heart going berserk, dizzy, aggressive, heart out of rhythm. Did EKG and diagnosed with Arrhythmia and Palpitations Phase 4: 14 APR Condition Stabilizes with bed rest; heart speed and intensity reduces slightly, heart still out of rhythm; ringing in left ear continues; noticed left hand, face, chest all swollen, out of breath walking to mailbox; can?t breathe deeply; Chest begins to bubble, gargle, fizzle when I lay down. Palpitations in throat, legs, need to drink a lot water; can?t sleep due to heart racing then sore and breast bone enlarged; chest tenses up often. Phase 5: Visit to Cardiologist (26 APR) He mentions potential Nerve damage with injection and prescribes Ultrasound. Days later I have second ?ER like? Scare and confirm in my mind this also nerve related. Phase 6: Mid May Start Recovery: Chest still tenses up doing emails, phone, late at work; easily excited; Each night total relaxation; start to feel nerves twitching like electric pulses in left chest; Feels like Electric Pulses/Pain from injection site to location of original twitch in heart area. Lean forward pain/discomfort; Still very weak chest muscles that get painful and sore easily Phase 7: Early June: Ultrasound at Heart Dr. (2 JUN) looks better /normal size. Heartbeat steadier and quiet but palpitations persist (extra heart beats felt in my throat); Overall body feeling stronger but chest muscles still weak and sore after ultrasound experience. Ringing in the left ear is better and milder twitches in chest at night. Teeth sensitive to cold liquids and Numb hands while walking esp 4 June; tense chest at work/home and need to step away and breath; Heart faster; long time to calm after warm/hot bath Currently late June still suffer from muscle weakness especially left chest, left arm where shot went in. Hands are still numb and Heart races when in bed.. Chest also still freezes up during work. Have to focus on breathing calmly. Overall though my condition continues to improve.
48 2021-06-23 inflammation of the heart muscle, chest pain Within 15 minutes of 2nd shot had significant pins and needles (and some numbness) in right leg most... Read more
Within 15 minutes of 2nd shot had significant pins and needles (and some numbness) in right leg most significantly below knee in calf to foot area - this persisted for approximately 24 hours. Typical flu like symptoms (aches)/fever along with slight cough with phlegm occurred from 18-48 hours as these resolved patient was left with significant and persistent pain in chest on day 3 post vaccination. This pain persisted and spread to neck, back, jaw. Ultimately due to persistent pain patient went to a hospital emergency room for evaluation. Nuclear stress came back abnormal and patient was admitted for further evaluation but eventually released to follow up with cardiologist. Patient currently following up with medical professionals for continuing care for suspected myocarditis.
48 2021-06-26 inflammation of the pericardium Pericarditis: Onset on May 14th
48 2021-06-28 heart rate increased Crohn's Flare Up; Brain Fog; fever; cramps and major abdominal pain; cramps and major abdominal pain... Read more
Crohn's Flare Up; Brain Fog; fever; cramps and major abdominal pain; cramps and major abdominal pain; heart rate increased; neck area twitching and in face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Jun2021 15:00 (Batch/Lot number was not reported) at the age of 48 years old as dose number unknown, single for COVID-19 immunization. Medical history included ongoing Crohn's. The patient's concomitant medications were not reported. The patient previously took fexofenadine (ALLEGRA) and fluoxetine (PROZAC), with known allergies to both. No other vaccine was received in four weeks. No other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Jun2021 19:00, the patient experienced Crohn's flare up, brain fog, fever, cramps and major abdominal pain, heart rate increased, and neck area twitching and in face. Adverse events (AE) resulted in doctor or other healthcare professional office/clinic visit. No treatment received for AE. Outcome of events was recovering. Information about batch/lot number has been requested.
48 2021-06-28 loss of consciousness shortly after receiving the vaccine the patient passed out briefly in the waiting area, He quickly ... Read more
shortly after receiving the vaccine the patient passed out briefly in the waiting area, He quickly came to and did not want us to call 911
48 2021-06-30 arrhythmia, ischemic chest pain, heart flutter 2 weeks following second Pfizer shot, started experiencing fluttering sensation in my heart. Happen... Read more
2 weeks following second Pfizer shot, started experiencing fluttering sensation in my heart. Happened to be in the hospital for something unrelated, so my sensation was detected by the hospital's heart monitor. They followed up with an echocardiogram and confirmed that I have developed a Left Atrial Flutter. Now I am wearing a heart rate monitor for 30 days and it is tracking data for my cardiologist. Have been experiencing periodic pain in my heart. Prior to the Pfizer shots, I never experienced any symptoms. Also, I have 2+ hears of heart rate data available from my Smart Watch and can make that available. Everything is different after that second Pfizer shot.
48 2021-07-01 chest discomfort, chest pain Stated that he had shot on May 15, 2021 and had flu like symptoms for 48 hours afterward (fever, bel... Read more
Stated that he had shot on May 15, 2021 and had flu like symptoms for 48 hours afterward (fever, belly aches, very tired-and slept for 14 hr.) Seven days later he noticed feeling dizzy, having chest pain described as very heavy feeling in chest, light-headed and exhausted. Had biometric screening done at work on 6/29/21 and began to "feel faint". BP 73/42. He layed supine on floor, took deep breaths and drank apple juice and felt better. He said he had gone to the ER on 6/28/21 with shortness of breath and chest pains. BP went up to 98/66 and he was sent home from work. He went to his family doctor who did x-rays and referred him to cardiologist. Has an appt. with Dr., cardiologist, on July 12, 2021.
48 2021-07-04 chest pain Three weeks after the first Vaccine, I developed numbness in both feet between the big toe and the n... Read more
Three weeks after the first Vaccine, I developed numbness in both feet between the big toe and the next one. This numbness/Cold feeling/Tingling slowly started spreading up my legs and seemed to settle the thigh area for a short time which even caused my clothes that touched it to generate a strange sensation (Almost like a hyper sensitivity) and it was a constant feeling. Then the feeling/numbness started affecting my calves and shin areas to a greater degree where they both feel like I have some fatigue and after walking or using them for a short time I feel like I have been running a marathon. At this point the skin around my ankle would come and go with becoming numb to the touch. As the numbness continued to spread further up to my waist area It eventually started to affect my abs, back and around the right and left outside edges of my chest. They have strange sensations and occasionally I can feel them as numb or some sort of sensory deprivation with the exception of my chest area which was sensitive to the touch (Pain). Continuing further I now have the same tingling/cold issues with both of my arms and there have been instances where both of my shoulders feel weak along with the numb behavior. This has all been going on over the past 6 months and is still continuing. I have been to multiple Urgent Care facilities, Doctor Visits, Whole barrage of tests: MRI's, Cat Scans, EMG's, Blood Work, Spinal Tap, etc. And so far all tests have come back normal. Jan 14 -- Trip to Urgent Care for numbness -- They said that I got too cold / did an X-Ray of my back.. Everything looked fine they said. Jan 25th -- Trip back to Urgent Care, numbness getting worse. Around Jan 28th -- MRI of lower Lumbar area. Nothing found Feb 17 -- Initial Consult Dr. Neurologist -- Orders Complete Bloodwork and does basic nerve tests Feb 12th -- Bloodwork done Health -- All normal Feb 22 -- Office Visit Dr. Neurologist -- Electromyogram of both legs. All normal Feb 24 -- MRI Lumbar Spine -- nothing that could cause the issues noted. March 10 -- Office Visit March 22 -- MRI Brain with and without contrast -- nothing that could cause the issues noted. April 16 -- Office Visit May 3 -- MRI - Neck area --nothing that could cause the issues noted. May 17 -- Office Visit -- Electromyogram (EMG) of arms and hands -- all Normal. May 21 -- ER visit -- Bowel issues, tiredness, fatigue ? Cat Scan performed.. All tests normal and released May 26 -- Gastro visit to make sure the numbness had not affected bowel control May 28 -- Dr. -- Changed Neurologists --- Scheduled Spinal Tap (Suspected MS even though nothing was showing up in all tests) June 3 -- Spinal Tap -- Everything normal not showing any signs of MS or any other disease. June 10 -- Spinal Headaches (received Blood Patch) June 18 -- Office Visit -- Doctor suggested could be Covid Vaccine related but sending to Medical Center and giving medicine in case it is Lyme disease
48 2021-07-06 heart rate increased My heartrate was beating really fast. I went to the hospital that following day. The Doctor performe... Read more
My heartrate was beating really fast. I went to the hospital that following day. The Doctor performed a EKG and I was told that it just means the vaccine is working.
48 2021-07-07 atrial fibrillation atrial fibrillation crisis, which improved after a day of admission to the hospital
48 2021-07-08 loss of consciousness, cerebrovascular accident Two months after receiving my second dose of the Pfizer COVID19 vaccine, I suffered a stroke. Sympt... Read more
Two months after receiving my second dose of the Pfizer COVID19 vaccine, I suffered a stroke. Symptoms included vision loss, complete left-side paralysis, loss of cognition, and loss of consciousness. Within ~15 minutes of the event, I was transported by ambulance to the nearest hospital and provided care. Within 3 hours of the event, I received tPA (Tissue Plasminogen Activator), and recovered fully.
48 2021-07-12 fast heart rate @1045 Nurse was called to the hallway because pt was feeling tachycardic. C/O dizziness, SOB, tachyc... Read more
@1045 Nurse was called to the hallway because pt was feeling tachycardic. C/O dizziness, SOB, tachycardia with rate of 100s+ Upon seeing pt, he reported that the HR is better. C/O feeling hot, dizzy, numbness and weakness to bilat hands, SOB. Resp even and unlabored. RR22. VS 170/95 (110) 59 98%. Team alert was initially called but pt refused to go to the ED. Team alert cancelled. Pt wants to rest and wait it out. Assisted back to room. Pt ambulated with supervision and support of RN. Pt refused to use the wheelchair. Water provided. Pt was able to ambulate towards to room without any difficulties. Able to speak in full sentences. @VS 1117 VS 150/89 59. Pt's symptoms are starting to get better. Dizziness is really mild. Denies SOB. Slightly better numbness and weakness to hands. Instructed to increase fluid intake. @1125 VS 140/92 (107) 60 97%RA. Pt is feeling better. Denies dizziness, tingling to hands. C/O mild weakness to hands but able to move it better than initial encounter. Pt stated that he wishes to leave, go to cafeteria and eat. Pt is confident of going home. Pt has a ride home, mother will drive him home. Checked with the Dr. Per MD, okay to go home. Encourage pt to follow up with PMD and to go to the ED for new symptoms or worsening symptoms. Pt verbalized understanding. @1142 VS 151/82 (109) 61 Pt stood up. Feeling better. Gait stable. Denies any dizziness. Mild weakness to bilat hands. No sob noted. No s/sx of distress noted. Resp even and unlabored.
48 2021-07-13 platelet count decreased, haemoglobin decreased, fluid around the heart 48 year-old man referred for admission from outpatient echo appointment after finding of large peric... Read more
48 year-old man referred for admission from outpatient echo appointment after finding of large pericardial effusion. Patient's history includes iron-deficiency anemia from hiatal hernia and season allergies. Was in usual state of health until received second Pfizer mRNA Covid-19 vaccine 5/18/21. A few days later developed cough, 'brain fog,' dyspnea. Had remote outpt visit and treated with abx for sinusitis. Covid test was negative 5/28/21. Symptoms worsened and developed swelling of legs and abdomen, worse exertional dyspnea and had to sleep sitting up due to orthopnea. Began on lasix 20 PO BID as outpt with significant improvement in swelling and other symptoms over past week - thinks he lost 20 lbs. Still feels more bloated than usual. Had outpt echo as part of eval and sent to ED. Denies chest pain, palpitations, dizziness. Brain fog is improving. Mildly constipated. No black or bloody stools. No abd pain. PERICARDIAL EFFUSION (6/15/2021) Assessment: echo Large pericardial effusion noted mostly post and no echo evidence of tamponade. Smaller in size. no need for pericardiocentesis Discharge home on lasix 20 mg daily Net neg 5.4 L chest xray looks improved unbale to get thoracentesis due to not enough fluid Vitals stable
48 2021-07-17 chest discomfort heaviness that feels like he needs to cough/Kind of heaviness on my chest like I have to cough or so... Read more
heaviness that feels like he needs to cough/Kind of heaviness on my chest like I have to cough or something; every joint hurts and aches; He also has headache, nausea which was on and off; He also has headache, nausea which was on and off; trouble sleeping because of the neck and joint pain; having trouble sleeping because when he lays his head on the pillow, because his neck is hurting, it's very uncomfortable to sleep at night; he was in so much pain that he can't work; feeling awful/miserable; its like every joint and muscle in his body, he literally feels everything and it aches; cough; that his muscles just kind of tense up from lack of sleep; he's so tired; unable to work; This is a spontaneous report from a contactable consumer (patient) and nurses via Medical Information Team. A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 11Jun2021 13:00 (Batch/Lot Number: EW0167) (at the age of 48-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no prior vaccinations in 4 weeks. Medical history included high blood pressure for years and high cholesterol about 2, maybe 3 years ago. Family history also includes high blood pressure and high cholesterol, both on his dad's side and also reported that diabetes was really high on his dad's side of the family. Ongoing concomitant medications included lisinopril taken for blood pressure and atorvastatin taken for cholesterol. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8736) administered in left arm on 21May2021 (at the age of 48-year-old) as DOSE 1, SINGLE for covid-19 immunization where patient experienced arm just got a little swollen from 22May2021 to May2021; also received flu shots and pneumonia shots for immunisation and never had any problems. He received the second dose of the bnt162b2 on 11Jun2021 and the next day or 12Jun2021, he said that every joint hurts and aches. He also has headache, nausea which was on and off, heaviness that feels like he needs to cough, and trouble sleeping because of the neck and joint pain. He said that he was unable to work. He had COVID pay for the first 2 weeks but in the third week he's not getting paid. Starting on Sunday he stop getting paid. He wanted to know what he needs to do and how long the symptoms will last. He already contacted his doctor and was advised to call Pfizer because his doctor doesn't know what to do either. He was asking if his doctor can call Pfizer. Additionally, patient reported that he has been seeing his doctor for about 3 weeks now and his doctor does not know what to do, so he advised the caller to contact Pfizer. Patient reported that he got his first dose of the Covid-19 vaccine back in May2021 and then 3 weeks later, he came in on 11Jun2021 and got the number two shot. Patient got the number two Covid-19 shot on 11Jun2021. Patient reported that he came home, everything was fine, he woke up the next morning, and he's been feeling god awful for 3 weeks. Patient stated that basically what was happening was, its like every joint and muscle in his body, he literally feels everything and it aches. He stated that every joint and muscle in his body he literally feel everything and it aches: patient reported that the only way he can describe it was when you've been in a car ride for many hours and you get the leg jerks. That's what his entire body feels like. Patient reported that his shoulder are and then going up his neck, that's where the aggravation was so bad that it actually hurts. Patient reported that he was having trouble sleeping because when he lays his head on the pillow, because his neck was hurting, it's very uncomfortable to sleep at night. Also, patient has had a mild headache this entire time. Patient reported that every once in awhile, the headache will actually get worse. When the headache gets worse, he can literally feel the blood pumping in his temples. That's how bad it gets. The headache getting worse has only happened a couple of times. He has had a mild headache for 3 weeks now. The patient also reported that he has had nausea and a kind of heaviness on his chest like he has to cough or something. Patient reported that from talking to his doctor, the first thing that he had the patient do was take another Covid test. Patient reported the Covid test came back negative. Patient reported that his doctor then turned around and had him to see the practices urgent care. Patient reported that the doctor from urgent care said that, most likely from the way it was sounding, most side effects of the Covid-19 vaccine either happen immediately or within 12 hours. Patient reported that the urgent care physician informed him that the patient going to bed the night of 11Jun2021 and waking up the next morning and feeling awful, that coincides with possible side effects to the Covid-19 vaccine. The urgent care physician informed the patient that the side effects were going to last roughly 2 weeks. Patient reported that its been past 2 weeks and he's still feeling miserable so he went back to the doctor Monday, 28Jun2021, and his physician ran some blood tests. Patient reported that his physician did a complete blood count (CBC), sedimentation (sed) rate, and also did an electrocardiogram (EKG). Patient reported that his sed rate was elevated but all his other stuff looked pretty decent. Patient reported that he called his physician's nurse and asked what they do now because the caller was still in a lot of pain. Patient reported that his physician's nurse stated that he had not heard of anyone having these kinds of side effects and stuff, and recommended that the patient contact Pfizer. Patient reported that his physician's nurse gave him the number for Pfizer and instructed the caller to call and ask what Pfizer thinks he should do. Patient reported that he only got Covid pay for 2 weeks at work, and since this is his third week off, he was not getting paid. Patient stated that whatever he needs to do to get better because he needs to go back to work as he has a wife and child to support. Patient reported that right now he was in so much pain that he can't work. Caller stated so we've got to figure something out. Furthermore, patient reported that he has been experiencing nausea off and on. Patient reported that his physician gave him these pills that dissolve in your mouth. When he talked to the doctor about it, he said they're nasty but they give those to people that are recovering from cancer. His physician instructed him not to be alarmed, but it was just the best medicine they could give him to get rid of the nausea. The medication instructions state not to take the medication with water and let it dissolve in your mouth, but it just tastes nasty so he takes it with water. Patient reported that the nausea was getting slightly better. Patient reported that at first, he was so nauseous that he was afraid to eat anything. Patient reported that now he gets a little nauseous when its time to eat but as soon as he eats he feels better, so he's not having to take those dissolving pills as much anymore. Patient reported that he was prescribed Ondansetron 8 mg. Patient reported that the urgent care physician also prescribed him Fluticasone 50 mcg spray, 16 count. The patient also reported that he was having trouble sleeping because when he lays his head down on his pillow, it puts pressure on his neck and it hurts. Patient reported that he was only averaging 5-6 hours of sleep per night. Patient reported that his trouble sleeping was basically the same. Patient reported that since he's not working, he has been sleeping on and off all day long. Patient reported that he has been having some car trouble and needs to get new tires and brakes on his car, but he hasn't been able to do it because he's so tired. The patient also reported that the heaviness on his chest was why his doctor did an EKG. Patient reported that he tried telling his doctor that for years, every time his chest gets tight its normally because of lack of sleep. Patient reported that his muscles just kind of tense up from lack of sleep. Patient reported that his doctor informed him that they just wanted to check him out anyway. Furthermore, patient reported that his physician ran a CBC and there was one thing that was slightly above the green. Patient reported that the way his physician was acting with all the others, he was not concerned about it. Patient reported that his sed rate was 28 and the normal was 0-15. Patient reported that his physician instructed him not to be concerned about the result. Patient reported that he asked if his physician was sure the result was ok as his sed rate was almost double the normal range and his physician instructed him not to freak out and informed the patient that he was not concerned. CBC on 28Jun2021 showed the following results: white blood cell (WBC): 9.3, red blood cell (RBC): Within green range; Hemoglobin: Normal; Hematocrit: Normal; mean corpuscular volume (MCV): Normal, patient reported it was lower on the green scale; mean corpuscular hemoglobin (MCH): normal; mean cell hemoglobin concentration (MCHC): Normal; red distribution width (RDW): patient reported that between 11 and 15 was normal and his was 15.7, so it was slightly up; Platelets: 253; mean platelet volume (MPV): 8.1; Neutrophils: 68; Lymphocytes: 24; Monocytes: 6; Eosinophils: 2; Basophils: 0; Absolute (Abs.) Neutrophil count: 6.31; Abs. Lymphocyte count: 2.2; Abs. Monocyte count: 0.51; Abs. eosinophil count: 0.2; and Abs. basophil count: 0.03. The patient also reported that his Covid-19 test was collected on 15Jun2021 and he got the results on 17Jun2021. Patient reported that the results stated SARS Cov-2 not detected. Patient reported that he had a Zoom call with his physician and his physician instructed the patient to go get tested for Covid. Patient reported that the test results came back negative and his physician instructed him to come into the office, but it was Thursday night and there were no appointments for the next day. Patient reported that his physician instructed him to go to urgent care. Patient reported that when he went to urgent care, the physician informed the patient that him getting the Covid-19 vaccine and waking up the next day coincides with what they've seen with side effects. Patient reported that the physician informed him that he would be miserable for 2 weeks, some people feel better sooner and some people it takes longer, but the average length of time for side effects was 2 weeks. The events "every joint and muscle in my body I literally feel everything and it aches, headache, nausea, heaviness on chest" did not require emergency room visit, but did require physician office visit. Additionally, the nurse reported that the patient said that they have the ongoing symptoms and patient was frustrated and he wanted to know what was causing the patients symptoms. He has ongoing joint aches, Headache, nausea on and off, neck pain, and cough. The doctor has run tests and labs, showing nothing and was asking. The outcome of the event nausea was recovering; outcome of feeling awful/miserable and tiredness was unknown, while outcome of the rest of the events was not yet recovered.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
48 2021-07-17 hypertension, chest discomfort High blood pressure, blood in urine , chill, body ache,pressure on the chest, nausea,
48 2021-07-18 fast heart rate, blood pressure increased, heart rate increased Acute tachycardia, rate up to 105 bpm accompanied with a rise in blood pressure with a maximum readi... Read more
Acute tachycardia, rate up to 105 bpm accompanied with a rise in blood pressure with a maximum reading of 155/98. My normal blood pressure reading is 130/80 with a pulse rate of 70 bpm. Accompanied with a body wide tingling sensation like an adrenal release.
48 2021-07-20 pulmonary embolism, chest pain Although it has been four months since I received the vaccine, I wonder if there is a connection. On... Read more
Although it has been four months since I received the vaccine, I wonder if there is a connection. On 7/7/2021 I went to the emergency room with chest pain. They were able to rule out a heart attack, and with a CT scan discovered I had an acute pulmonary embolism in the lower lobe of my left lung. There is no explanation for where the blood clot came from as I am healthy and active, have had no recent surgeries, no evidence of blood clots elsewhere in the body, and no long trips that could explain the development of a blood clot. I am undergoing lots of tests but so far no underlying health condition has been discovered that would explain how a blood clot got into my lung. Treatment = Xarelto (blood thinner).
48 2021-07-25 chest discomfort, chest pain After receiving the vaccine I had the occasional sore arm and pain at the vaccination site. The seco... Read more
After receiving the vaccine I had the occasional sore arm and pain at the vaccination site. The second day after I started to feel my chest started to burn, which was accompanied by trouble breathing. It was a pain that I have never experienced before in my chest it felt tight and was burning very bad. I started to feel light headed as if I was going to faint while doing my normal daily activities. I decided to stop doing anything that caused my heart to beat too fast. So later on that night i decided to go to the ER, where they did an ekg and some blood work. They also did a scan of my chest where the doctor said everything came back and looked normal. Over time the pain and everything I was experiencing started to get better. I still have a hard time breathing every now and then. Also after the vaccine I experienced a slight cough and runny nose.
48 2021-07-28 heart rate increased, palpitations, heart rate decreased, hypertension heart rate went from the 50s to the 120s; Heart racing; His heart rate went from 120 beats to in the... Read more
heart rate went from the 50s to the 120s; Heart racing; His heart rate went from 120 beats to in the 70s and 50s; blood pressure and it was 138/90 which is high for me lately; Dizzy; whole body is weak; my legs were kind of weak; my arm was a little tender, little sore; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 13Jul2021 at 12:05 PM (Batch/Lot number reported as EW0181 or FW0181) single, for COVID-19 immunization (also reported as to be precautionary and his wife is a teacher). Medical history included blood pressure high from 2018 to an unknown date (the caller has been on the lisinopril since 2018 and started at 40 mg and went down to 5mg), high cholesterol from 2018 to an unknown date, back pain from 03Jul2021 to an unknown date, rib fracture from an unknown date and unknown if ongoing, and fall from 03Jul2021 to an unknown date. Concomitant medications included lisinopril taken for hypertension from 2018 and ongoing; and ibuprofen taken for pain from 03Jul2021 to an unspecified stop date. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect, did not have additional vaccines administered on the same date of the Pfizer vaccine, and did not have prior vaccinations (within 4 weeks). The patient had whooping cough vaccine 6 years ago and had a sore arm for 3 days. The patient experienced 'muscular weakness' and 'pain in extremity' on 13Jul2021; and 'heart rate increased', 'palpitations', 'heart rate decreased', 'hypertension aggravated', 'dizziness', and 'asthenia' on 14Jul2021. The patient inquired about additional information regarding side effects of the Pfizer COVID-19 vaccine. He received his first dose on 13Jul2021 and reported that this morning, while taking a shower, his heart rate went from the 50's to the 120's. The patient stated that yesterday (13Jul2021) about 12 in the afternoon, he got his first dose of the vaccine. He sat in the place for 30 minutes after the fact, the only thing was his legs were kind of weak but the tech said that was normal so he walked out and continued his day. He drank an electrolyte drink and around about a gallon of water. The patient didn't have a fever, sweats, or chills. He did cardio (stationary bike ride) for about 30 mins, but he'd been taking it easy because on 03Jul2021, he injured his ribs from a fall down a flight of stairs. There were no fractures and he has been taking ibuprofen 600mg twice a day for pain. The pain wasn't bad enough to take that, so he discontinued taking it 5 days ago. He had nothing in his system except for lisinopril that he takes for high blood pressure. The patient further stated that about 8 hours after the vaccine, he had a few glasses of wine last between 6pm-7pm and his arm was a little tender, little sore, but everything else was fine. He was inquiring if there were other reports of this happening. The patient didn't have any rapid pulse when he got the vaccine. His legs feeling weak was improved but after that episode with his heart his whole body was weak, he hasn't felt right since that happened. According to the patient, he did his normal routine this morning. The patient woke up this morning at 7:00am and felt okay. He went to take a shower and his heart rate went from his average of 50-55 beats per minute and started racing. The patient checked his pulse it was about 125 and rapidly getting faster. Also stated that when he was turning the shower on this morning and was washing his hair and face, he could feel his neck pulsating where his pulse was. The caller felt weak and dizzy and then his heart rate went from 120 beats to in the 70s and 50s. Stated that he doesn't drink coffee, but drinks herbal tea. As soon as he got in the shower, he was washing his face and hair and he felt his neck (where you take a pulse), it felt like it was beating fast. He checked it and it was 115, 120. He has a monitor that he wears. It was just out of the blue. He had no stress and no anxiety. It happened all of a sudden, it was strange. The patient didn't know if it was a combination of the few glasses of wine or what. This reaction was so long after the fact and he took his blood pressure medicine at 5:30 last night. Stated that he has been on lisinopril since 2018 and started at 40 mg and went down to 5mg. He tried to calm down, he took the electrolyte drink, a Xanax, and drank water and then in 15-20 minutes, it calmed his heart rate down. The patient's heart rate was back down in the 50s but he didn't feel 100%. The caller's blood pressure was okay. He thought he would go to the ER so he started driving and saw his heart rate going down so he drove home and checked his blood pressure and it was 138/90 which was high for him lately. But his pulse started coming down so he rechecked his blood pressure and it was 130-135/75 with a pulse around 55-65. It's been like that since and stated that he's fine. He was asking why it took almost 24 hours for these to happen. The events did not require a visit to the Emergency Room or Physician's Office. The patient's heart rate and blood pressure had been fine since the episode. The patient underwent laboratory tests and procedures which included blood pressure measurement: 130-135/75 and 138/90 on 14Jul2021, heart rate: 115, 120, 55-65, his heart rate went from the 50s to the 120s on 14Jul2021. The patient stated that he was scheduled for an ECHO and stress test on Friday, but wanted to call Pfizer too. Outcome of the events heart rate increased was recovered on an unspecified date, for hypertension was recovered in Jul2021, for palpitations was not recovered, for muscular weakness was recovering (also reported as ongoing), while for the other events was unknown. Information regarding the batch/lot number has been requested.
48 2021-07-28 fainting, hypotension Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: EMS arrived on scene, gave patient o2 and monitored vitals until stable
49 2021-01-03 chest discomfort On December 23, 2020 she had the Pfizer COVID-19 vaccination at 7:30 p.m. She then worked her shift ... Read more
On December 23, 2020 she had the Pfizer COVID-19 vaccination at 7:30 p.m. She then worked her shift as a dialysis nurse and went home the following morning. She did not have any symptoms until 5:00 p.m. the following afternoon when she woke up. She developed itching of her back and a mild erythematous rash across her chest. That evening around 7:00 p.m. she noticed a rash on her arms that was itching. At 7:30 p.m. she had tightness in her chest and a nonproductive cough. She attributed the symptoms to her asthma. Her symptoms improved throughout the night. She went home on Christmas morning and went to bed. She woke up at around 5:00 p.m. She had swelling of her eyelids and an urticarial rash across her face and chest. She did have some mild throat itching. She reported to work at 7:00 p.m. but continued to have symptoms with increasing shortness of breath. She reported to the emergency department and was evaluated. She was given famotidine, Methylprednisolone, and hydroxyzine. She was also given ipratropium/albuterol nebulized. Her respiratory symptoms did improve, and she was discharged around midnight. She continued to have a slight erythematous rash that was present until she went to bed the following morning. When she woke up it had resolved.
49 2021-01-03 fast heart rate Background, I had Covid back at the end of May/beginning of June with 1 week of constant fevers (wit... Read more
Background, I had Covid back at the end of May/beginning of June with 1 week of constant fevers (with 500mg tylenol q6), shortness of breath, fatigue, but no real cough. O2 sats somtimes in low 90's . I am one of the radiology faculty at the hospital I work at. Received my 1st dose of the Pfizer vaccine on Friday Dec 18 at about 21:30. After the injection, I had moderate pain at the site of injection about 6 hours later, not unexpected. However, the next evening, I was feeling fatigued and went to bed at about 7 p.m. For the next three hours, I felt chills and finally at about 10 p.m. I took my temp after I felt that my fever had "broke" and temp was 101.9. Used a finger pulse ox just to make sure sats were ok, they were at 97%, but unexpectedly, resting heart rate was 130 bpm. I took some tylenol and called the ER, and they suggested calling the covid hotline pager and coming in if I did not improve. I called the hotline pager, and we discussed things and eventually decided that I should go to the ER as temp remained at 101.6. By the time I reached the ER, my temp was down to 100.8, but pulse still 122 (EKG with no other abnormalities) and BP was 165/100. I had no other symptoms to account another infection. Over the next two hours, vitals became more normal with HR down to 95 to 100, and BP down to 145/85 or so without any other intervention. Sunday, still with some mild low grade temps of 99.8, but heart rate at 85 to 90 (I'm usually at about 80). In the ER, we came to the conclusion that my body mounted a significant immune response to the production of antigens after processing the mRNA given the lack of alternative diagnosis and the improvement of sx without any other intervention besides the 500 mg of tylenol I took before coming in.
49 2021-01-04 heart rate increased about 3 minutes after receiving vaccine, heart rate jumped to extremely high. Patient did not repor... Read more
about 3 minutes after receiving vaccine, heart rate jumped to extremely high. Patient did not report until today so we were not able to get actual heart rate. This lasted for about 30 seconds, then went back to normal.
49 2021-01-05 heart rate increased Fever, feeling flushed, tunnel vision, light headedness, headache/pressure, chills, elevated pulse r... Read more
Fever, feeling flushed, tunnel vision, light headedness, headache/pressure, chills, elevated pulse rate, elevated blood pressure. Took migraine medication for headache, outcome unknown
49 2021-01-05 palpitations after 5 minutes states her fingers felt weird -numb and felt like her hear was racing, very anxious ... Read more
after 5 minutes states her fingers felt weird -numb and felt like her hear was racing, very anxious started to hyperventilate. Took her to ER via WC . During transfer stated her fingers were twisting (noticed definite contractures in both hands. States her heart was beating very fast. Denies any allergies but did states she has history of low potassium and has had issues with medications nad vaccines in the past. However no sx like this but does get "a little loopy" even when taking motrin. Instructed her to notify any provider prior to any vaccinations of the above sx. If I would have know any off this I would have highly recommended her to get authorization from her PCP prior
49 2021-01-06 heart rate increased Had a slight headache a few hours after the injection, three hours later felt tired and headache wor... Read more
Had a slight headache a few hours after the injection, three hours later felt tired and headache worsened but improved with 500mg Tylenol. That night fatigue got worse but headache improved. Went to bed at 9pm and had severe chills and shaking, heart was beating fast. Chills lasted for several hours. Increased heart rate all night and could not sleep at all. Fitful night sleep and started to sweat in the Early morning. Woke up for work at 5:30 am and had headache, dizziness, and flu-like symptoms with joint and muscle aches. Had sweats all day today. Went home early from work and slept from 9:30 am to 4:30 pm. Most symptoms improved now but feel like I still have a fever and sweats.
49 2021-01-10 heart rate increased, blood pressure increased The reason I'm reporting is that how I felt was similar to my sensitivity to Claritin: increased lev... Read more
The reason I'm reporting is that how I felt was similar to my sensitivity to Claritin: increased level of alertness, difficulty falling asleep; minor anxious feeling with diastolic BP in low 90's/ high 80's( usually in 70's) on home electronic BP cuff, and increased feeling of feeling my heart beat in my chest. It's now 6 days later and I feel about 50% better, but with continued elevated diastolic BP at similar levels.
49 2021-01-13 fainting, heart rate increased Rapid heart rate, dizziness, light headed, felt like i was going to pass out - lasted a few minutes... Read more
Rapid heart rate, dizziness, light headed, felt like i was going to pass out - lasted a few minutes then went away. Maybe I was having a panic attack?
49 2021-01-17 chest discomfort Chest tightness, Chills, Dizziness, 'cold sweats'
49 2021-01-17 heart rate increased, chest discomfort instant metallic taste in mouth, heaviness in chest, and fast HR. Taken to ED for further evaluatio... Read more
instant metallic taste in mouth, heaviness in chest, and fast HR. Taken to ED for further evaluation.
49 2021-01-18 blood vessels inflammation Vasculitis of hands and feet. Symptoms first noted in hands on 1/17/2021 - intermittent - adverse re... Read more
Vasculitis of hands and feet. Symptoms first noted in hands on 1/17/2021 - intermittent - adverse reaction on 1/18/2021 at 11:08 pm - hands became bright red as well as feet. Burning sensation (similar to taking Niacin) Color changed in feet from bright red to dark red with some purple in digits 2 and 3 of both feet. Appears swollen. I was informed on 1/12 (4 days after being vaccinated) that my daughter had been exposed to COVID. We family quarantined. The adverse reaction led me to go to an urgent care clinic to be tested for COVID. I had the POC test performed and came back positive. My temperature was recorded at 99.3 F.
49 2021-01-20 palpitations Increased level of alertness; Difficulty falling asleep; Increased diastolic blood pressure(high 80'... Read more
Increased level of alertness; Difficulty falling asleep; Increased diastolic blood pressure(high 80's/low 90's) which is usually in 70's; feeling heart beat in chest; Minor anxious feeling; This is a spontaneous report from a contactable other HCP (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no: EK9231, expiry date: unknown), via unspecified route of administration on left arm on 05Jan2021 08:15 at a single dose (1st dose) for Covid-19 immunization. The patient received the vaccine in a hospital. There were no other vaccine administered in the last four weeks. The patient's medical history included penicillin allergies, seasonal asthma, and increased cholesterol. Concomitant medications included Fish oil, D3, Vitamin C, Bilberry, Chromium. On 05Jan2021 20:15, patient experienced increased level of alertness, difficulty falling asleep, increased diastolic blood pressure(high 80's/low 90's) which is usually in 70's feeling heart beat in chest and minor anxious feeling. There was no treatment given for all reported adverse events. It was unknwon if patient had COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of all events was recovering.
49 2021-01-24 nosebleed 49 yo male h/o coumadin for DVT 2013 and family hx of leukemia vaccinated 01/14/2021 and noted purpu... Read more
49 yo male h/o coumadin for DVT 2013 and family hx of leukemia vaccinated 01/14/2021 and noted purpuric rash and nose bleed without clos 01/18/2021 but denies bleeding gums or blood in stool or blood in urine. denies asa or nsaid usage . platelet count on cbc drawn 01/21/2021 was normal
49 2021-01-25 palpitations, hypertension, blood pressure fluctuation Patient had racing heart beat and fluctuating BP. ED, they did not treat the symptoms they just obs... Read more
Patient had racing heart beat and fluctuating BP. ED, they did not treat the symptoms they just observed and monitored him for 4 hours and called it palpations. Did confirm it to be reaction to vaccination. Pressure went really high and went back to normal several times.
49 2021-01-28 palpitations At 0905, Pt c/o heart palpitations, felt lightheaded, dizziness, and R knee felt tight. At the back ... Read more
At 0905, Pt c/o heart palpitations, felt lightheaded, dizziness, and R knee felt tight. At the back of the head, felt pulsating like his heartbeat. Transferred to private monitoring room, to gurnee. Lowered hob to 30 degrees. Heart rate: 71, BP 156/90, Resp 20, Puse ox 97% At 0915, BP 136/86/ heart rate 72, pulse ox 97%. Pt states his head is starting to feel better, but knee remains feeling tight. Denies heart palpitations now. At 0925 NBP 138/87, heart rate 64 pulse ox 96%. At 0927, sitting at edge of bed without complaints: BP 133/88, heart rate 78. Pulse ox 98%. Still c/o feeling lightheaded. R knee remains tight. At 0930, still light headed, but with R side of head felt heavy. Lighter on L side of head. Knee improving significantly. Patient states he feels well enough to return home. Pt returned home
49 2021-01-29 pallor Pt was sitting in the 15 min waiting area after getting his vaccination. Pt stated that he began to ... Read more
Pt was sitting in the 15 min waiting area after getting his vaccination. Pt stated that he began to feel dizzy. Pt presented pale and diaphoretic. Pt's states that this happens when he donates blood. Pt was wheeled to the cot. Pt was seated on the cot. Pt states that he feels better when laying supine. Pt's vitals are normal. Pt states he is no longer dizzy and only feels fatigued. Pt's skin is now warm pink and dry. Pt is now able to stand. PT refused transport to hospital.
49 2021-02-01 pallor Pale and started to faint . Put in a lying position. B /p 87/55 lying down, up to 128/75 prior to ... Read more
Pale and started to faint . Put in a lying position. B /p 87/55 lying down, up to 128/75 prior to discharge. Drank some water and feeling better. Discharged home
49 2021-02-02 chest discomfort 3 days after vaccine I developed edema in left hand and wrist, unable to make a tight fist+ swollen ... Read more
3 days after vaccine I developed edema in left hand and wrist, unable to make a tight fist+ swollen left neck supraclavicular lymph nodes+ left side/flank/chest (muscular) tightness. Visited PCP. Clear chest Xray, scheduled arm ultrasound to rule out blood clot
49 2021-02-02 chest pain 49 year old male, history of hypertension and high cholesterol 3:15 Vaccinated 3:25 complained of f... Read more
49 year old male, history of hypertension and high cholesterol 3:15 Vaccinated 3:25 complained of feeling lightheaded and anxious, escorted to medical tent 3:35 BP 153/88, P 108, 02 96% now complaining of chest pain 6/10 O2 via nasal cannula, EMS notified One paramedic placed monitor 3:45 BP 153/88, P 108 ? O2 100% 4:05 EKG rate- 104, possible L atrial enlargement 4:12 Staff arrived and ordered transport to hospital 4:20 Transported
49 2021-02-02 fast heart rate, palpitations, heart rate increased Patient reported that 2-3 minutes after vaccination, he felt his heart racing. He reports he checked... Read more
Patient reported that 2-3 minutes after vaccination, he felt his heart racing. He reports he checked his apple watch and saw his HR go up to 113. He reports his HR is normally in the 50s/60s. Tachycardia
49 2021-02-04 oxygen saturation decreased oxygen dropping to 89; causing me to have breathing problems; heavy breathing when I walked and wore... Read more
oxygen dropping to 89; causing me to have breathing problems; heavy breathing when I walked and wore the mask; sensitivity to the cold; had instances where I felt an unusually high chill on my chest and wavy feeling; fever rising as high as 100.4; had instances where I felt an unusually high chill on my chest and wavy feeling; was told that I looked red; Had soreness on site the night of the injection; headaches; tiredness; This is a spontaneous report from a contactable contactable consumer (patient) . A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at left arm on 14Jan2021 14:30 at SINGLE DOSE for COVID-19 immunization.Medical history included Type one diabetes, obesity, high cholesterol.No COVID prior vaccination . Facility where the most recent COVID-19 vaccine was other .The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. No Concomitant medications reported.Clincal course was reported as follows: on 14Jan2021 I had soreness on site the night of the injection, had headaches, tiredness, and was told that I looked red and was not myself beginning on the next day. I have had sensitivity to the cold, which I never had before, and heavy breathing when I walked and wore the mask. I had instances where I felt an unusually high chill on my chest and wavy feeling, causing me to have breathing problems. I have had fever rising as high as 100.4, and oxygen dropping to 89. The events were reported as non-serious. The patient went to Emergency room/department or urgent care and was treated with Prednisone, inhaler and Tylenol.The patient had been tested for COVID post vaccination (Nasal Swab(20Jan2021) :unkonwn results).Outcome of the events was recovering. Information on lot/batch number has been requested.
49 2021-02-08 deep vein blood clot swollen left calf that was DVT, deep vein thrombosis; This is a spontaneous report from a contactabl... Read more
swollen left calf that was DVT, deep vein thrombosis; This is a spontaneous report from a contactable Other Health Professional. A 49-year-old male patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248), via an unspecified route of administration on 11Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included hypothyroidism and high cholesterol. Patient had no known allergy. No COVID prior vaccination. No COVID tested post vaccination. Historical vaccine included 1st dose of bnt162b2 (lot: EK5730) via intramuscular on 23Dec2020 at 15:30 at single dose on left arm for COVID-19 immunisation. Concomitant medication included levothyroxine and atorvastatin. 1 week after receiving the 2nd dose, patient woke up with a swollen left calf. Ultrasound the same day (19Jan2021) showed that was DVT, deep vein thrombosis. Patient started taking apixaban (ELIQUIS) (blood thinner) the same day. Event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the event was resolving. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
49 2021-02-11 chest pain ABD pain Narrative: Patient received 2nd dose COVID vaccine. Patient states "My chest hurts" poin... Read more
ABD pain Narrative: Patient received 2nd dose COVID vaccine. Patient states "My chest hurts" points to left side of substernal area and reports pain . States he feels "that someone is punching me in my chest." Patient also complains of abdominal pain. Denies SOB, N/V, dizziness, no radiating pain. States pain is a 6 on scale of 1-10, BP 145/68, HR -75, RR - 18, 94% on room air. Rapid response team called; patient escorted to ER Dept. by team staff.
49 2021-02-15 loss of consciousness, excessive bleeding 1/6/2021 vaccination; Later that afternoon, I started to go into a 'fog', tired, HA. I could functi... Read more
1/6/2021 vaccination; Later that afternoon, I started to go into a 'fog', tired, HA. I could function but nothing seemed 'clear' or 'sharp', 1/7/2021 fatigue, arm sore. The 'fog' was worse; 1/8 fog was really bad; forgetting conversations. 1/9 2:45 in morning. Went to bathroom. Walking, about 1/2 way there, felt like a 'spike' and instant HA. I went to bathroom, door closed, I got sick/vomiting. The shiver, shakes, and fever spiked. I bent down to throw up and I cant relieve. I fell into the wall, pushed self to stand up. Was back in bedroom, laying on floor and passed out. Wife woke me, I was bleeding. Don't know how long I was on the floor. BP144/78, 133 blood sugar, O2 was 98%, temp 98.1. 3:45 I decided to go to hospital, EKG, CT scan, Xray, etc. 'Just fainted' *PCP stated it was due to shot / vaccine. **busted lip, ER bill ***2nd vaccine; minor side affects (slight HA, )
49 2021-02-17 chest pain Difficulty breathing, sharp pains in the center of the chest, and tingling in the throat. Patient wa... Read more
Difficulty breathing, sharp pains in the center of the chest, and tingling in the throat. Patient was offered ambulance transport and denied due to no insurance, his daughter took him immediately to the ER net door to be seen.
49 2021-02-20 lightheadedness Pt reports feeling light headed, instructed patient to lay down with feet elevated r/t vasovagel res... Read more
Pt reports feeling light headed, instructed patient to lay down with feet elevated r/t vasovagel response to Covid Vaccine. Pt reports this happening each time he receives a injection.
49 2021-03-10 chest discomfort Pt very anxious after receiving the pfizer covid vaccine c/o itchy throat and chest tightness. VSS ... Read more
Pt very anxious after receiving the pfizer covid vaccine c/o itchy throat and chest tightness. VSS on RA color pink throughout. Pt encouraged to take deep breaths and relax. Given water to drink. Tolerated well. Then given Benadryl 25 mg PO and observed for 15 mins more. Pt calmed down and denied further symptoms and went home without issue.
49 2021-03-16 platelet count decreased Platelet Count dropped to 23 from a previous count the Thursday before 03/11/2021 of 131.. the dro... Read more
Platelet Count dropped to 23 from a previous count the Thursday before 03/11/2021 of 131.. the drop may have been attributed to counts already falling as the counts three weeks before on 02/18/2021 were 484. I am now on120mg of prednisone daily to try to reverse the effects and will have a repeat CBC on Friday 03/19/2022
49 2021-03-17 pallor, fainting Systemic: Fainting / Unresponsive-Medium, Systemic: loss of color, unresponsive, sweating. epipen gi... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: loss of color, unresponsive, sweating. epipen given. ems evaluated and determined stress rxn and sent home. -Medium, Systemic: Flushed / Sweating-Medium
49 2021-03-17 fainting 11:06 am Experience syncope episodes after receiving vaccine. Vital signs BP 102/55, HR 65. Sweaty... Read more
11:06 am Experience syncope episodes after receiving vaccine. Vital signs BP 102/55, HR 65. Sweaty and dizzy (afraid of needles). BP 127/75, HR 73, O2 sat 99 RA Accucheck 103. Client request to go home w/ spouse. Cleared by EMT.
49 2021-03-18 excessive bleeding bleeding; my skin on my hands and the bottom of my feet started to peel off; very painful in the fin... Read more
bleeding; my skin on my hands and the bottom of my feet started to peel off; very painful in the fingers and the feet; This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249, expiration date not reported) via unspecified route of administration in the arm right on 21Jan2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. The patient previously took iodine and experienced drug allergy; also received first dose of bnt162b2 (Lot number: EJ1685) via unspecified route of administration in right arm on 30Dec2020 14:00 for COVID-19 immunization. Facility type vaccine: clinic. It was reported that on 23Jan2021, couple of days after the second shot, patient experienced skin on hands and the bottom of my feet started to peel off and bleeding and very painful in the fingers and the feet. The events resulted in both: Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. It was unknown if treatment received for the events. Outcome of all events was recovering.; Sender's Comments: Based on plausible temporal relationship and known drug profile, a contributory role of the suspect BNT162B2 cannot be excluded in the development of bleeding, skin exfoliation and pain in extremity. The impact of this report on the benefit/risk profile of the Pfizer product 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.
49 2021-03-18 low blood platelet count SEVERE ITP PLATELET TRANSFUSION, IVIG X 2, PULSE DEX X4 DAY RITUXIMAB, PREDNISONE, PROMACTA SPLENECT... Read more
SEVERE ITP PLATELET TRANSFUSION, IVIG X 2, PULSE DEX X4 DAY RITUXIMAB, PREDNISONE, PROMACTA SPLENECTOMY 3/8/21
49 2021-03-18 pallor Post vaccination, patient sitting in waiting area for observation. Staff informed nurse that patient... Read more
Post vaccination, patient sitting in waiting area for observation. Staff informed nurse that patient appeared was not feeling well and appeared to have difficulty breathing. Attempt to move patient to assessment area, unable to ambulate and laid down flat. Appeared weak and pale, diaphoretic and labored breathing. Administered epinephrine per protocol and transported to nearest Emergency Department via EMS.
49 2021-03-22 atrial fibrillation, arrhythmia I went into atrial fibrillation/flutter within hours after the shot. I was totally fine and in sinu... Read more
I went into atrial fibrillation/flutter within hours after the shot. I was totally fine and in sinus rhythm prior to the shot.
49 2021-03-22 heart rate increased, atrial fibrillation With no previous heart issues. Heightened hear rate started on evening after the vaccine, topped ou... Read more
With no previous heart issues. Heightened hear rate started on evening after the vaccine, topped out at a resting heart rate of over 160bpm. Went to primary health care physician, he did EKG, then ordered me to Emergency Room. Was diagnosed with Atrial Fibrillation with RVR, prescribed Apixban (Eliquis) 5mg oral tablet, 1 tab 2 times a day, prescribed Metoprolol (metrolrolol succinate 50mg extended relese) 50mg 1 cap per day. Given diltiaZEM 10mg via IV push while at the hospital. Continue to have increased heart rate and have not returned to a normal sinus rhythm as of 3/23. Scheduled for follow-up with EP on 4/9 to review heart rhythms.
49 2021-03-24 pallor Approximately 5 minutes after vaccination was administered, patient was diaphoretic, pale in color, ... Read more
Approximately 5 minutes after vaccination was administered, patient was diaphoretic, pale in color, and unable to speak. Blood pressure was taken (48/28) with a pulse of 24. Patient stated that he had not eaten anything that day prior to coming to get his vaccination.
49 2021-03-27 heart rate increased Fever 99.7F,Headache, muscle soreness, tiredness/fatigue , sleepy, fast heartbeat (60 normal,to 85-9... Read more
Fever 99.7F,Headache, muscle soreness, tiredness/fatigue , sleepy, fast heartbeat (60 normal,to 85-90). Sore throat after 30 hours
49 2021-03-28 anaemia, low platelet count Thrombocytopenia (CMS/HCC) Hypomagnesemia Alcohol abuse Alcoholic hepatitis Hyponatremia Renal insuf... Read more
Thrombocytopenia (CMS/HCC) Hypomagnesemia Alcohol abuse Alcoholic hepatitis Hyponatremia Renal insufficiency Symptomatic anemia
49 2021-03-28 blood glucose increased, heart rate increased, blood pressure increased, palpitations 3/25: Approx 5 mins after injection, started breathing quickly and became lightheaded. Moments later... Read more
3/25: Approx 5 mins after injection, started breathing quickly and became lightheaded. Moments later, heart rate elevated north of 190 bpm and blood pressure went up to approx 180/100. Developed dry mouth (was very thirsty) and shaking/chills. Took about 60 minutes to stabilize. Went to ER for evaluation and tests around 2:30P. Received a liter of fluid. Both EKG and Bloodwork was indicated as normal. Released from hospital around 6P. Slept through most of the night. 3/26: heart rate was erratic all day. Would race and then stabilize throughout the day/night. Extremely lethargic. No trouble breathing (was able to breathe and take deep breathes) but took effort to breathe. 3/27: 1:40A woke up heart began racing at close to 200 bpm. Dry mouth, shakes. Similar to what I experienced immediately following the vaccine shot. Went to ER out of precaution. Symptoms stabilized after about an hour. Hospital did EKG, blood work and chest X-ray. all were normal, lungs were clear. However, glucose and bilirubin were both slightly elevated. 3/29: Still feeling lethargic. Heart rate has stabilized some but is still erratic. It easily increases from simply walking around the house (much more than usual). 3/30: Scheduled appointment with primary care physician 3/31: Scheduled appointment with cardialogist
49 2021-03-28 blood clot Blood clot; Unable to use arm at all; This is a spontaneous report from a contactable consumer (pati... Read more
Blood clot; Unable to use arm at all; This is a spontaneous report from a contactable consumer (patient, self-reported). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, in arm left, on 09Mar2021 02:15 AM, as single dose for COVID-19 immunization. Patient's medical history included Fibromyalgia. Concomitant medications were not reported. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Patient did not receive other vaccine in four weeks of vaccination. On an unknown date in Mar2021, patient had Blood clot and patient was unable to use arm at all. Patient resulted in Emergency room/department or urgent care, Disability or permanent damage in Mar2021. Patient did not receive treatment for adverse events. Seriousness of the events reported as hospitalization and disability. Outcome of the events was not recovered. Information about lot/batch number has been requested.
49 2021-03-29 hypotension, low blood oxigenation Shortness of breath, hypoxia, low blood pressure, was admitted to hospital
49 2021-03-30 chest pain, chest discomfort pt. c/o of pain in the chest. heavy chest like someone is standing on my chest- pt. said. lt. hand... Read more
pt. c/o of pain in the chest. heavy chest like someone is standing on my chest- pt. said. lt. hand cold and numbness dizziness, blur vision. His leg numbness.
49 2021-03-30 nosebleed Spontaneous, and heavy nosebleed.
49 2021-03-31 chest discomfort BP 150/98. HR 96. Chest tight Throat felt tight at first now continues with chest tightness. Pt felt... Read more
BP 150/98. HR 96. Chest tight Throat felt tight at first now continues with chest tightness. Pt felt like chest is getting better after few minutes History of possible vasovagal reaction after getting shot
49 2021-04-06 blood glucose increased Flushing/sweating, dizziness, chills. Initial BP 151/80 (pulse 80). Glucose 285. F/u BP 112/74 (puls... Read more
Flushing/sweating, dizziness, chills. Initial BP 151/80 (pulse 80). Glucose 285. F/u BP 112/74 (pulse 72). O2 sats 93% and 95%.
49 2021-04-06 hypotension Minutes after vaccination patient began feeling hot, was diaphoretic, hypotensive, and was placed in... Read more
Minutes after vaccination patient began feeling hot, was diaphoretic, hypotensive, and was placed in trendelburg position
49 2021-04-06 sinus rhythm, atrial fibrillation, heart rate increased Atrial Fibrillation / diagnosed with Atrial Fibrillation with RVR; heart rate heightened (topped out... Read more
Atrial Fibrillation / diagnosed with Atrial Fibrillation with RVR; heart rate heightened (topped out at a resting heart rate of over 160 bpm)/ up to 160 (high /bpm)/ continued to have increased; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, administered in the left arm on 20Mar2021 18:15 (batch/lot number: ER2613 and expiry date unknown) at 49 years old at a SINGLE DOSE for COVID-19 immunization. The patient was vaccinated at the Hospital. The patient's medical history included obesity from an unknown date and unknown if ongoing. Patient had no previous heart issues and had no known allergies. There were no concomitant medications or other medications in two weeks of vaccination. The patient did not receive other vaccination within 4 weeks prior to the BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 21Mar2021, 12:00 am, patient went into atrial fibrillation with a high heart rate up to 160 bpm. It was reported that the heightened heart rate started on evening after the vaccine (on 20Mar2021), it topped out at a resting heart rate of over 160 bpm. Patient went to a primary health care physician, he did EKG (results unknown), then ordered patient to Emergency Room (Hospital name). The patient was diagnosed with Atrial Fibrillation with RVR. The patient was prescribed Apixaban (Eliquis) 5 mg oral tablet, 1 tab 2 times a day and Metoprolol (metoprolol succinate 50 mg extended release) 50 mg 1 cap per day. Patient was also given Diltiazem 10 mg via IV push while at the hospital. It was reported that patient continued to have increased heart rate and have not returned to a normal sinus rhythm as of 23Mar2021. The patient underwent lab tests and procedures which included EKG: unknown result on Mar2021; heart rate: heightened (topped out at a resting heart rate of over 160 bpm ) on 20Mar2021, up to 160 (high /bpm) on 21Mar2021 and heart rate: continued to have increased on 23Mar2021; and sinus rhythm: have not returned to normal on 23Mar2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and patient was hospitalized for one day. The outcome of the events was not recovered.
49 2021-04-08 loss of consciousness I went with my wife, whom we were more concerned about possible reactions to the vaccine given her h... Read more
I went with my wife, whom we were more concerned about possible reactions to the vaccine given her history of anaphylaxis reactions to bee and wasp stings, has had to carry a Epi-pen always, so we stayed an additional 15 minutes for 30 minutes total before we left. She was completely fine throughout, I however as we were walking out I began to feel a little ?Off?, not necessarily nauseous or dizzy, just a bit Off. Told my wife that and that I wasn?t sure I should drive us home (I drove us there), so she drove. About 15-20 minutes into the drive, it got worse and I passed out. My wife says my eyes rolled in the back of my head with my eyes open but no responsive. She says she kept hitting my chest but I didn?t respond. I came to about 2 minutes after passing out. She asked me if I felt like I needed to goto the hospital, I told her I needed to eat, that I felt like what I needed was food, then we go from there. I did eat breakfast, an English muffin at about 8am that morning, it was almost 12:30 by that point. When I finally got food in me I felt much better and have had no adverse reactions since.
49 2021-04-09 fast heart rate, palpitations 3/30/21 at 1:30 am until 4/1/21 approximately noon: 103 F fever, chills, joint aches, extreme fatigu... Read more
3/30/21 at 1:30 am until 4/1/21 approximately noon: 103 F fever, chills, joint aches, extreme fatigue, loss of appetite, difficulty sleeping, headache, brain fog. 4/1/21 until present: tachycardia / racing heart rate as high as 125 bpm, feeling flushed as though I have sunburn but without any sun exposure, forgetfulness / trouble focusing / brain fog , Insomnia and frequent awakenings from sleep, feeling dehydrated and head achy or thirsty frequently, more frequent than normal urination, urine clear or pale yellow.
49 2021-04-10 hypotension, loss of consciousness Lost consciousness, awoke with vomiting and nausea, low blood pressure, and shortness of breath. Ne... Read more
Lost consciousness, awoke with vomiting and nausea, low blood pressure, and shortness of breath. Never had previous issues with any vaccines or injections, and never previously had vasovagal response. Since injection, I was constipated for 3 days and suffering extreme muscular/skeletal pain and headaches.
49 2021-04-11 hypertension Within 10 minutes patient with complaints of shortness of breath, tongue discomfort and roof of mout... Read more
Within 10 minutes patient with complaints of shortness of breath, tongue discomfort and roof of mouth discomfort. Patient states that he also had a weird taste in his mouth. NP and paramedics at patient side. Patient appeared anxious. Lungs clear, posterior pharynx normal, uvula with no inflammation noted. Legs elevated. Patient placed on O2 and initial vitals normal. Patient then became hypertensive with SOB. Patient states that he can not take Benadryl because his doctor advised him not to ever take it. Patient is unsure if allergy. Initial EKG patient with inverted Twaves on 4 lead, then patient with normal EKG with 12 lead. Patient given 0.3mg of Epi and fire rescue notified. Fire Rescue arrived at 1256 and patient transported to ER at 1pm. Patient remained with weird feeling to tongue and roof of mouth on transport, shortness of breath was improving.
49 2021-04-11 loss of consciousness Pt states that he passes out just about every time he gets bloodwork and vaccination. Pt lost consci... Read more
Pt states that he passes out just about every time he gets bloodwork and vaccination. Pt lost consciences: blood down heart rate up: Pt was never unstable, maintained sat greater than 95%. Pt quickly became alert and oriented xs 3: responding well within minutes. vital signs stable. pt talking immediately: BP stabilized. drove home. pt refused transport to hospital by ambulance.
49 2021-04-11 palpitations Chills and body ache for 18 hours since symptoms started. Low energy and fatigue since the day aft... Read more
Chills and body ache for 18 hours since symptoms started. Low energy and fatigue since the day after the second dose of vaccine. Dizziness, stomach ache 10 days after the vaccine. A mont later after the vaccine (3/30) I had headache, body ache and chills for 6 days. COVID test was negative Palpitations started on 4/4. Dizziness, chills, dry eyes, weakness and fatigue until today.
49 2021-04-11 fainting I counselled the patient prior to giving him the Pfizer Covid19 vaccine. He received the vaccine at... Read more
I counselled the patient prior to giving him the Pfizer Covid19 vaccine. He received the vaccine at 10:10am. During the 15 minute observation period, one of my technicians was standing next to him talking to another patient. She saw some papers slip out of patient's hand and noticed he was unresponsive when she tried to talk to him. She yelled out for help and I ran out and saw his head rolled back, eyes open, and he sounded like he was snoring. He never left the chair--just his head rolled back. We tried to rouse him awake and I had my other technician call 911. I also called for a store manager. The patient came to about 15-30 seconds later. I asked him his name, what day it was, and if he knew where he was. He answered all questions correctly. He told me that he's fainted before after vaccines, however he never disclosed this to me prior to the vaccine and had answered "no" under the question if you've ever had a serious reaction to the vaccine. We gave him some water and a cold paper towel. The paramedics came and evaluated him. He declined to go to the hospital and his wife came and picked him up.
49 2021-04-12 chest discomfort, heart attack, chest pain He had been experiencing chest discomfort after eating and activity for a month, that resolved with ... Read more
He had been experiencing chest discomfort after eating and activity for a month, that resolved with rest. Family history of ischemic heart disease. Pt is a smoker, HTN and dyslipidemia. I was just informed a patient received the Pfizer vaccine yesterday @ 1129. Arrived to ER @1700 with a STEMI. He went for a heart cath yesterday and CABG this morning. Per the cath report his LAD was occluded. I believe he was more aware of his symptoms after receiving the vaccine and that is why he finally came in.
49 2021-04-12 bleeding on surface of brain Had subarachnoid hemorrhage 1 hour after getting shot. Ended up in hospital for 13 days. Had drain ... Read more
Had subarachnoid hemorrhage 1 hour after getting shot. Ended up in hospital for 13 days. Had drain placed in head and multiple CT scans and MRI exams while there. Discharged with home PT and neurologist follow ups. Experiencing left side weakness and head fogginess still.
49 2021-04-14 deep vein blood clot Swelling left leg. Femoral vein DVT identified on ultrasound on April 5, 2021 (partially occluded cl... Read more
Swelling left leg. Femoral vein DVT identified on ultrasound on April 5, 2021 (partially occluded clot). hematologist switched me from Eliquis to starter pack of Xarelto.
49 2021-04-14 pulmonary embolism pulmonary embolism
49 2021-04-15 chest pain, chest discomfort Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Mild
49 2021-04-17 chest pain trouble breathing/shortness of breath; terrible headache; I had chest pains; This is spontaneous rep... Read more
trouble breathing/shortness of breath; terrible headache; I had chest pains; This is spontaneous report from contactable consumer (patient). A 49-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW6H02, expiry date not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 17:00 as single dose for covid-19 immunization. The patient medical history included allergies to IVP dye (reported as "die"). Prior to vaccination, the patient was not diagnosed with COVID-19.Concomitant medication included insulin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took penicillin, codeine, and atorvastatin (LIPITOR) and experienced allergies to them. On 26Feb2021, the patient had chest pains, and on an unspecified date in 2021, had trouble breathing, terrible headache, and shortness of breath which lead to surgery. The events were reported as serious life-threatening and had caused hospitalization on unknown dates. It was reported that for the event chest pains the patient was hospitalized for 5 days, while for the other events it was not provided how many days the patient was hospitalized. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19 on 20Mar2021 which was negative nasal swab. Therapeutic measures were taken as a result of the event shortness of breath which included surgery, and chest pains. The outcome of the event chest pains was recovering while the outcome of the other reported events was unknown.
49 2021-04-18 loss of consciousness Pt. While waiting in 15 min waiting area lost consciousness, fell forward in chair, and hit his fore... Read more
Pt. While waiting in 15 min waiting area lost consciousness, fell forward in chair, and hit his forehead. Pt lost consciousness for 10-20 seconds. Discharge RN's rolled patient over to assess airway. Pt regained consciousness and reported no chest pain. Alert and oriented x4. VS: BP 125/70 HR: 39 O2: 98% R 14. EMS called and transported to hospital. Pt reported baseline HR in 50's,
49 2021-04-18 palpitations The evening of the shot my body basically turned on itself and began an all out mission to rid the v... Read more
The evening of the shot my body basically turned on itself and began an all out mission to rid the vaccine. Of course, that couldn't happen, but my body was going to proceed until I was dead or recovering. I began having severe chills, roasting heat flashes, headache, and body ache. Every sweat gland turned on full blast and did not turn off. I began to vomit in outrageous fashion. As violent as I've ever experienced. I had "sessions" of vomiting at least thirty times from Thurs night to Monday afternoon. When I could get out of the bathroom, I would collapse back into my sweat soaked bed. I would have an awful time trying to catch my breath. It would be up to ten minutes of hyperventilating and racing pulse, until it would suddenly normalize. And then I'd be utterly exhausted and slip into some kind of semi-sleep coma. This would not last even an hour before I'd be racing to the bathroom again. This was the first sixty hours. Vomit. Hyperventilate. Wish for death. Sleep coma. Repeat. About 24 hrs in I added severe diarrhea that was a part of every bathroom journey from then on. Ate nothing. Couldn't take normal meds. Sipped some pedialite. Late Sunday I turned a corner and felt like I wouldn't die. Took a full seven days for me to get any energy back and feel human again.- Every single symptom besides headache, was the worst I've ever experienced.
49 2021-04-20 nosebleed Bloody nose. Woke up, blew nose, and noticed blood in mucus. Also spit some phlegm out from mouth a... Read more
Bloody nose. Woke up, blew nose, and noticed blood in mucus. Also spit some phlegm out from mouth and noticed small amount of blood there, too. Since I have below normal platelet counts, nose bleeds are a cause of concern.
49 2021-04-22 lightheadedness, pallor Two 10 second convulsions followed by paleness and sweating. Patient was anxious prior to shot and w... Read more
Two 10 second convulsions followed by paleness and sweating. Patient was anxious prior to shot and was not responsive during convulsions. Wife stated that he "always has this reaction". Nurse Practioner that administered the vaccine stated that it was congruent with classic vasovagal symptoms after immunization. EMS arrived but patient did not want to go with them.
49 2021-04-23 pallor After about 5 minutes of receiving his covid vaccine the patient became pale and was sweaty. I took ... Read more
After about 5 minutes of receiving his covid vaccine the patient became pale and was sweaty. I took his blood pressure and it was 105/64 with a pulse of 62. I brought him a cold pack from fridge to put on his wrist and neck. We watched him closely afterwards. I asked that he wait for 30 minutes so we could watch him. He felt better before he left and had a healthy appearance.
49 2021-04-24 chest discomfort low grade fever; felt pressure on chest; slight difficulty breathing; This is spontaneous report rec... Read more
low grade fever; felt pressure on chest; slight difficulty breathing; This is spontaneous report received from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:45 (Lot Number: EP6955) (Age at vaccination: 49 Years) as single dose for covid-19 immunisation. Medical history included Psoriasis; psoriatic arthritis; No Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included rosuvastatin; valacyclovir [valaciclovir]; finasteride; vitamin d [vitamin d nos]; cetirizine hydrochloride (ALLERTEC, OTC allergy medication)). The patient previously received the first dose of bnt162b2 (lot number: EP6955) in Left arm on 17Mar2021 10:00 for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Apr2021 14: 00 (also reported as 13 minutes post injection), the patient felt pressure on chest/slight difficulty breathing for 15-20 minutes. On 08Apr2021 20:00 (one day post injection) had a low grade fever. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of events felt pressure on chest/slight difficulty breathing was recovered on 07Apr2021, of low grade fever was recovered on 08Apr2021. No follow-up attempts are needed. No further information is expected.
49 2021-04-24 hypertension, heart rate increased High blood pressure and heart rate elevated tired and very irritable this lasted 4 days with the 2... Read more
High blood pressure and heart rate elevated tired and very irritable this lasted 4 days with the 2nd and 3rd days being very bad.
49 2021-04-24 heart attack Heart attack and death; This is a spontaneous report from a contactable Nurse. A 49-year-old male pa... Read more
Heart attack and death; This is a spontaneous report from a contactable Nurse. A 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Ej1685) intramuscular in left arm on 18Dec2020 at 11:00 AM at single dose for COVID-19 immunisation. Medical history was none, no known allergies. No other concomitant medications in two weeks. No other vaccine in four weeks. The patient experienced heart attack at 05:30 pm on 06Apr2021 and the event caused patient death. No treatment for the event. Autopsy results was available. Autopsy remarks: heart attack. No COVID prior vaccination, no COVID tested post vaccination. The patient died on 06Apr2021. An autopsy was performed and the reported cause of death was heart attack.; Sender's Comments: Myocardial infarction occurred 3 months and 19 days after BNT162B2 vaccine administration. The event is considered unrelated to suspect drug being rather an incidental occurrence. The impact of this report on the benefit/risk profile of the Pfizer product 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.; Reported Cause(s) of Death: Heart attack and death; Autopsy-determined Cause(s) of Death: Heart attack
49 2021-04-25 chest discomfort Chest congestion, weight in center of chest, little coughing, breathing ok Pfizer-BioNTech COVID-19 ... Read more
Chest congestion, weight in center of chest, little coughing, breathing ok Pfizer-BioNTech COVID-19 Vaccine EUA
49 2021-04-26 chest discomfort, blood pressure increased moderate fatigue lasting 7 days, mild nauseous especially post eating lasting a few days, heavy ches... Read more
moderate fatigue lasting 7 days, mild nauseous especially post eating lasting a few days, heavy chest pressure (still experiencing this after 30 days) with mild labored respiratory breathing and increased blood pressure to clinical high. Low grade headache (everyday for past 30-days).
49 2021-04-27 lightheadedness, pallor The patient experience a vasovagal reaction approximately 8 minutes after his injection. He reporte... Read more
The patient experience a vasovagal reaction approximately 8 minutes after his injection. He reported he felt fine, then started feeling dizzy, then fell out of his chair in the waiting room after passing out. He came to quickly. He looked pale and had lost control of his bladder. After a few minutes his color returned and he was able to sit up. His blood pressure, taken about 4-5 minutes after his incident, was 141/78. He returned to a chair where he waited an additional 10 minutes before leaving.
49 2021-04-27 fainting PATIENT REPORTED FEELING LIGHT HEADED. HE HAD SYNCOPAL EPISODE WITH OBSERVER PRESENT FOR 2-3 SECOND... Read more
PATIENT REPORTED FEELING LIGHT HEADED. HE HAD SYNCOPAL EPISODE WITH OBSERVER PRESENT FOR 2-3 SECONDS. HE ALSO REPORT FEELING NAUSEA WITH SWEAT. HE HAD A HEART RATE 63 WITH OK PULSE . HE HAS NOT TAKEN ANY MEDICATION , NO ALLERGIES. PATIENT WAS ADVICED TO LIE FLAT WITH FEET ELEVAT AND STAY HYDRATED. PATIENT ADVICED TO NOTIFY IF NO IMPROVENT IN SYMPTOMS. WHEN SYMPTOM NOT IMPROVING, HE WAS BROUGHT TO THE TENT. BP:127/87 HR :55 . PATIENT REPORTED IMPROVEMENT IN NAUSEA, DIZZINESS AND BY 13:20PM . AT 13:27 , PATIENT LEFT WITH WIFE AFTER SYMPTOM WAS RESOLVED
49 2021-04-28 heart rate increased, hypertension Hypertension spike since 1st dose of vaccine (averaging 150/100) since getting vaccine. Lightheaded... Read more
Hypertension spike since 1st dose of vaccine (averaging 150/100) since getting vaccine. Lightheaded, shortness of breath. No history of Hypertension (though always on the borderline (averaging 120/80).
49 2021-04-28 heart rate increased, palpitations Increased resting heart rate. Noticed that my heart started to pump harder, first during an afterno... Read more
Increased resting heart rate. Noticed that my heart started to pump harder, first during an afternoon while sitting, no stress or agitation. The next morning, I woke up in the middle of the night due to some discomfort. I was at 100 BPm (normally at 60).
49 2021-04-28 hypotension, fainting, pallor, heart rate decreased Patient just got the vaccine and was standing near pharmacy and fell to the ground. On his way down... Read more
Patient just got the vaccine and was standing near pharmacy and fell to the ground. On his way down he hit his head on the shelf and cut his head in 2 places. When I got to him he was still out of it and within seconds he came to. I had him stay laying down and he was very pale and sweaty. We called 911 and they came within 5 minutes. In that time frame I took his BP and pulse and it was low. Ems took him to the hospital.
49 2021-05-02 hypertension high pressure, throat sore, ringing in the ear, pressure in the head whenever having intercourse, di... Read more
high pressure, throat sore, ringing in the ear, pressure in the head whenever having intercourse, dizziness
49 2021-05-03 pulmonary embolism, deep vein blood clot DVT left lower extremity; Bilateral Pulmonary Emboli; first dose: 23Feb2021; second dose: 16Mar2021;... Read more
DVT left lower extremity; Bilateral Pulmonary Emboli; first dose: 23Feb2021; second dose: 16Mar2021; first dose: 23Feb2021; second dose: 16Mar2021; This is a spontaneous report from a contactable nurse (patient). A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199 and expiration date not provided) intramuscular, administered in the left arm on 16Mar2021 13:30 as a single dose for COVID-19 immunization. The patient has no relevant medical history. Family history included diabetes (mother). The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200 and expiration date not provided) Injected intramuscularly in left upper arm on 23Feb2021, 13:30 for COVID-19 immunization and experienced DVT symptoms, soft tissue injury, muscle pull and ankle strain. The patient experienced DVT left lower extremity and bilateral pulmonary emboli on 23Apr2021. The patient called regarding the Pfizer COVID vaccine. He had adverse events to report. He has a DVT on his left calf, which he later clarified was left lower extremity. He is currently on double dose of apixaban (ELIQUIS) since Friday. He finally went and got it looked at. He is still being treated and will be seeing a hematologist. He stated that DVT symptoms occurred after first dose and was undiagnosed. He treated it as soft tissue injury and thought it was a muscle pull and ankle strain. Eliquis was started on 23Apr2021 and dose is 5 mg. He is taking two tablets twice daily for 7 days and then 1, 5mg tablet bid (twice a day) as well. No emergency room or physician's office required but Urgent care facility was visited on 23Apr2021. During this visit, they did Lab work, D Dimer results 1590 on 23Apr2021; Venous Doppler resulted in positive DVT in Left Lower Extremity. Chest CT resulted in positive peripheral defects in small branches of the lower lobes bilaterally, left greater than right, consistent with Pulmonary Emboli. Left sided pleural effusion and left basillary infiltrate, possibly atelectasis or developing infarct. Few pleural based nodular densities at right lung base, again atelectasis versus developing infarcts. The rest just states what was normal. Eliquis was prescribed on 23Apr2021, 5 mg two tablets twice daily for 7 days, then regular dose times 7 days. He is to report to hematologist on 29Apr2021. The outcome of the events deep vein thrombosis and pulmonary embolism was unknown. The reporter assessed the events as serious (life-threatening).; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events DVT of legs and Pulmonary embolism cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
49 2021-05-03 pulmonary embolism, fainting Shortness of breath followed by sudden collapse followed by death.
49 2021-05-05 coughing up blood, fast heart rate 4:40pm: Patient complained of arms cramping, back of head pounding, coughing blood, tachycardia; 1... Read more
4:40pm: Patient complained of arms cramping, back of head pounding, coughing blood, tachycardia; 16:48pm EMS called. 17:08 EMS Arrived; Vitals: 16:50pm 148/90 101 18 O2 100%; 1700pm 144/100 100 20 O2 100%; 1730pm EMS departed to hospital. Pt. status when transported to hospital: Stable, no longer vomiting.
49 2021-05-05 heart rate increased Cramps on leg, cold sweats on hand and feet, heart beat faster than usual and dizzy when that happe... Read more
Cramps on leg, cold sweats on hand and feet, heart beat faster than usual and dizzy when that happens, discomfort in the stomach, symptoms of insomnia, weakness in the whole body, pain in the thighs, knees, and calves
49 2021-05-06 blood pressure increased, chest discomfort, chest pain 36 hours after vaccination, I woke up at 3am with ringing in both ears for the first time in my life... Read more
36 hours after vaccination, I woke up at 3am with ringing in both ears for the first time in my life. I've seen two ENTs and a chiropractor. My hearing test was normal and showed no loss of hearing. The ENT said the pressure test was normal. I have had periods of ear pressure, clogging and the feeling of water in the ears. Over the past 10 weeks, those specific symptoms have diminished and only now happen a few times a week, but the ringing in the ears persists. It is constant. I have gotten more used to it, and there are times when it's louder and times when it's less loud, but I cannot say that it is "disappearing". The ringing is definitively not resolved. I have tried prescription nasal spray and allegra, which possibly help. In addition, 13 days after vaccination, I started experience chest tightness, sternum pain, aches and pains throughout my upper body: both arms, back. The tightness in the chest is exacerbated by exercise. Those symptoms have diminished over time but have not resolved. I have not gone back to exercise. Chest xray was negative and stress test was normal. Transthoracic Echo showed some abnormalities. Blood pressure became elevated post vaccination and remains elevated.
49 2021-05-06 loss of consciousness Client verbalized feeling light headed after receiving the vaccine Client stated, "I passed out, bu... Read more
Client verbalized feeling light headed after receiving the vaccine Client stated, "I passed out, but this is normal for me after receiving any shots or seeing blood." Client refused medical evaluation from Fire Rescue. Client was educated on the importance of a full evaluation by rescue. Client exit location at 12:20pm.
49 2021-05-07 deep vein blood clot DVT symptoms occurred after first dose and was undiagnosed; soft tissue injury; muscle pull and ankl... Read more
DVT symptoms occurred after first dose and was undiagnosed; soft tissue injury; muscle pull and ankle strain; muscle pull and ankle strain; This is a spontaneous report from a contactable nurse. A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 23Feb2021 at 13:30 (Batch/Lot Number: EN6200) at a single dose for COVID-19 immunization. Medical history included a family history of diabetes - his mother had diabetes. The patient's concomitant medications were not reported. DVT symptoms occurred in Feb2021 after the first dose and was undiagnosed. He treated it as soft tissue injury and thought it was a muscle pull and ankle strain. The outcome of the events was unknown. Information on the batch/lot number has been requested.
49 2021-05-07 heart rate irregular, chest pain, blood pressure decreased Chest pain; Had irregular pulse; BP dropped; Patient felt faint minutes after receiving second dose ... Read more
Chest pain; Had irregular pulse; BP dropped; Patient felt faint minutes after receiving second dose of vaccine; Diaphoretic; This is a spontaneous report received from a contactable nurse. A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 30Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 09Apr2021 for covid-19 immunisation. The patient experienced Patient felt faint minutes after receiving second dose of vaccine, BP dropped, had irregular pulse, became diaphoretic and complained of chest pain on 30Apr2021. The events assessed as non-serious. Unknown patient received any other vaccines within 4 weeks prior to the COVID vaccine. Unknown list of any other medications the patient received within 2 weeks of vaccination. Unknown prior to vaccination, was the patient diagnosed with COVID-19. Unknown since the vaccination, has the patient been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered included Workplace clinic. The events were resulted in Emergency Room Visit. The outcome of the events was reported as unknown. Information about batch no/lot no has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events blood pressure decreased, irregular pulse, chest pain and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
49 2021-05-07 fast heart rate Beginning the day of the 2nd dose I had elevated BPs (160s/110s) and tachycardia (100s) while at res... Read more
Beginning the day of the 2nd dose I had elevated BPs (160s/110s) and tachycardia (100s) while at rest, no matter from which arm or position taken). It has taken approximately 3 weeks for my HR to return close to baseline at rest but my diastolic BPs remain in the 90s (my resting baseline is 120-130/70-80 BP, 60-70 HR). I am now 4 1/2 weeks post-2nd dose and still 130-140/90s but HR 70s. Also, I had been diagnosed with CIDP earlier in the year and since the 2nd dose I have been increasingly fatigued and have pronounced hand and foot weakness each passing week--I have walking difficulty at this time and am unable to grasp and lift even 3# weights.
49 2021-05-08 loss of consciousness Second vaccine was on 04/15/2021. Lost my breath and could not breathe for a moment, I went to the ... Read more
Second vaccine was on 04/15/2021. Lost my breath and could not breathe for a moment, I went to the ground , almost blacking out. Paramedics came and my vitals were very high. I don't know if it was because of the vaccine, but wanted to report it.
49 2021-05-09 enlargement of the heart He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even ... Read more
He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even joked he probably would die that night. He also complained that despite his protest, the person who administered the shot insisted to inject on his shoulder joint. He developed a bigger-than-quarter-size bruise on his right inner arm the next day. He was feeling tired the following days. On May 4 around 3:30, I heard he was making loud noises. I came to his side immediately. At the time I thought he was making louder than usual snores. I nudged him gently but he didn't respond. After about 15 seconds, the sound stopped, and he had no breath. I then called 911 within 10 seconds, tried to do CPR on him. It took EMS 6 minutes to arrive even though we live very close to a fire station in a well-accessed urban area. EMS worked on him for about 30 minutes before transported him to hospital. They continued to work on him for a while. He never regained breath.
49 2021-05-09 chest pain, palpitations, chest discomfort Experience two large heart palpitations and what seemed stopped beating for a second, this was follo... Read more
Experience two large heart palpitations and what seemed stopped beating for a second, this was followed by tremendous pressure in my head, I thought I was experiencing a stroke. I felt like I was going to black out and was having tightness in my chest , my wife took me to the E.R. I had an EKG done and it not show any arrhythmia and CT scan of my head did not show any abnormality. They scheduled me to follow up with cardiologist. The whole week I experienced the following symptoms: Tightness and sharp pains in chest; Difficulty breathing, especially at night (had to sleep sitting up on couch one night and another night woke up with difficulty breathing , appeared to be the biggest problem when laying flat). Would get out of breath walking up stairs; Moments I would get really light headed with a feeling like I could pass out; Symptoms last until the 4/16 , when they finally went away. Follow up with Cardiologist, who scheduled an electrocardiogram and stress tests on 5/7. The tests results showed that I had a healthy heart and no underlying conditions. I'm 49 and never have experienced any cardiac events. before or have a family history of cardiac disease. I have no known allergies either.
49 2021-05-11 blood clot, chest pain have some clots; Neuropathy; autoimmune disorder; Fell and hit elbow and 3 ribs on left side; lost 6... Read more
have some clots; Neuropathy; autoimmune disorder; Fell and hit elbow and 3 ribs on left side; lost 6 (lbs) pounds/Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight; falling; felt super strong; dizziness; failed all the tests for motor skills for his arms and legs; Fell and hit elbow and 3 ribs on left side; Fell and hit head; Sensory nerves are all gone; Fatigue; scabs; delusional; tore tendons in between ribs; They are tender(ribs); hurting all over; Cannot walk or lift anything; chest pain; his arm was sore a little; Left arm injection site pain; Disoriented; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 03Feb2021 (batch/lot number and expiration date not reported) at the age of 49 years old, as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date, vascular disease, bilateral stents placement, cataracts since he was born. Concomitant medication included gabapentin taken for an unspecified indication from an unspecified start date and ongoing. On 04Feb2021, the patient experienced left arm injection site pain. The patient experienced dizziness, falling, and couldn't go to work on unspecified date. He was treated by his (MD) physician, was given a CT scan, echocardiogram, and found to have some clots. He stated he has a history of vascular disease and had bilateral stents placed a year ago. He was placed back on an aspirin/Plavix regimen and referred to a neurologist because he has no motor skills anymore. He stated he failed all the tests for motor skills for his arms and legs. He was advised not to take the second dose of the vaccine and was diagnosed with neuropathy and autoimmune disorder (caller does not specify which disorder). He reported being positive for Covid-19 in Dec2020. He wanted to know what else he can do for his symptoms and is offering to be tested by Pfizer for treatment. The symptoms come in really hard seven days later. He actually had to go to the (ER) emergency and they worked on him and a whole string of doctors. He went to the emergency room and something was going on and wanted him to go to a family practitioner. They sent him to vascular, neurological and now they want to send him to a research center. It was a whole week after receiving vaccine before he began having symptoms. With the neuropathy and autoimmune, he cannot work like he did. He can hardly walk. Unspecified autoimmune was diagnosed last week. He can't remember the name of it. They told him not to take second one because the first one did what it did to him. It hurt a little and it was quick. The next day (04Feb2021), he said his arm was sore a little. He is only taking 4 medications and they looked it up. He did not think they were relevant. He was disoriented and fell and hit his head a couple of times. They ran an MRI on his head trying to figure that part out. That was done last week. He doesn't know the date and said it may have been on Friday. Results were good. The date he was disoriented was Wednesday 03Feb2021, when he took the shot. He has been disoriented and has been that way ever since. They kept him for 15 minutes to make sure no one passed out. He has been disoriented since then. He could not think clearly, and he could not do his job. He tore tendons in between ribs. He first thought he actually broke his ribs, but did not. There were two different falls. He cannot feel feet or anything. His motor skills are OK but when they did neuropathy test, they put needles in and shocked him to make his motor fire. His reflexes were really bad. He fell and hit elbow to keep from falling on face and twisted going down hitting 3-4 ribs on left side. It has been over 3 weeks now for his ribs. They are tender but they are not like the initial blow. It feels like they are healing. He fell and hit head a week ago. He was unsure of the exact date. He did not go to the emergency room with this one because the bed caught him. He fell and hit his head. All he has left is scabs. He cannot walk or lift anything (11Feb2021). That next Wednesday, he got ready to go to work and was so delusional and could not go in. He slept from 5:30 all that day and all that night. Then Thursday, he gets up and goes to work and goes slower, just to see what happened on Wednesday. He had fatigue and was disoriented. He did not provide start date or outcome for fatigue. He walked in and said either call an ambulance or he would go home. He went home and that was the last day of work. He then stated he laid in the car for 30 minutes and he said he is going to the emergency room. He went straight there that day. He had stents put in lower part of his body a year before. The neuropathy and the autoimmune kicked in 7 days later after the shot. The reason he went to the ER is because he thought it was his stent. He had bilateral, 4 of them. He was having chest pain and hurting all over on 11Feb2021. He thought he was having a heart attack. He was seen in the emergency room and released. It depends on how far he goes, how the chest pain worsens. Right now, he is ok, but when he gets up and moves around, it does the same thing. Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight. He was about 200 something and was kind of built and now is skin and bones. He lost 6 (lbs) pounds within a week and is eating like crazy. Sensory nerves are all gone. If hit with a baseball bat and he would not feel it. It came on slowly almost that he did not know it was happening. That is why they want to send him to Privacy for a research center and he does not want to go. He never had this happen before. ER or physician's office required: 1st date was on Thursday, 11Feb2021, when he went to Privacy. He was having chest pain and hurting all over. He thought he was having a heart attack. He was released. The patient stated he wanted to change the information he had provided since he was not in his right mind since he had taken the wrong medication dose than the doctor had given him. He stated the medication dosage he wanted to change was for Amiripyin. He stated he wanted to say he told the representative the symptoms he had experienced was enhanced which they were yesterday because he was trying to fight everything and stay awake. COVID 19 vaccine: he stated the doctor did not want him to take the second dose of the vaccine. He stated one of the symptoms he had experienced after the vaccine that he wanted to change the outcome for is the neuropathy. He stated he is back to where he used to be and yesterday it was bad he could hardly walk or talk. He stated also the other symptoms he wanted to change the outcome for is the autoimmune. The patient has not recovered from neuropathy, autoimmune disorder, disoriented, can't walk or lift anything, chest pain, and sensory nerves all gone; while outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
49 2021-05-16 hypotension Five minutes after receiving vaccination patient off from his chair. he was diaphoresis & hypotensiv... Read more
Five minutes after receiving vaccination patient off from his chair. he was diaphoresis & hypotensive. RN checked VS( BP 56/30)
49 2021-05-17 deep vein blood clot, blood clot Patient had vaccine on the 12th. Leg pain three days later. Diagnosed with DVT six days later. No ri... Read more
Patient had vaccine on the 12th. Leg pain three days later. Diagnosed with DVT six days later. No risk factors for DVT. Unknown lot number for vaccine. Not done at my faciluty
49 2021-05-19 palpitations, loss of consciousness Pt was sitting in post-vaccinating area after a covid shot. Suddenly he felt his heart racing, start... Read more
Pt was sitting in post-vaccinating area after a covid shot. Suddenly he felt his heart racing, started hearing noises, feeling dizziness, and he passed out briefly.
49 2021-05-20 hypotension, pallor Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotensi... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Severe, Additional Details: Shortly after receiving his first shot the patient started to feel severely light headed while being observed. He was not able to walk over to the bench from his seat, so I had to help him from his seat onto the floor to lay down. After laying down and drinking water, he started to regain color to his face. After laying down for roughly 30 minutes he felt strong enough to stand up and walk to the bench where he then sat for an additional 20 minutes.
49 2021-05-20 hypotension Patient readmitted on 5/19 who was just discharged on 5/15. Patient initially presented with fever, ... Read more
Patient readmitted on 5/19 who was just discharged on 5/15. Patient initially presented with fever, SOB, lymphadenopathy, diffuse maculopapular rash. He had his first dose of COVID vaccine (Pfizer) on 4/23, and his symptoms began on 4/29. He was itchy all over, but when he developed fever and SOB he came to the ER on 5/2 and was discharged on prednisone. His symptoms continued and so he came back to the ER and was admitted. He had a lymph node biopsy to rule out lymphoma (pathology returned negative for lymphoma). He was treated empirically with ceftriaxone and doxycycline. He tested + for EBV IGG but not IGM. EBV PCR was pending upon discharge. He had a borderline positive lyme serology. He was discharged on doxycycline and steroids with improved symptoms. He returned to the ER with again worsening SOB, night sweats, worsening rash, recurrence of fever. He denies sore throat or any sick contacts. He reports a normal appetite. He was found to be hypotensive and in AKI.
49 2021-05-20 loss of consciousness Patient received second dose of Pfizer vaccine, moved to recovery area and passed out while sitting ... Read more
Patient received second dose of Pfizer vaccine, moved to recovery area and passed out while sitting in chair; patient fell from chair to ground. Per witness, patient slightly broke his own fall, however he did hit head on ground. Pt found lying on the ground, conscious and easily holding conversation. VS taken - 151/93, 80bpm, 95% on RA. Patient denied other symptoms, stated this has never happened before. EMS called to assess neuro status after hitting head. Pt refused transfer to hospital.
49 2021-05-20 fainting dizziness. Had syncope episode, was snoring and twitching. Very diaphoretic. Less than 1 minute rega... Read more
dizziness. Had syncope episode, was snoring and twitching. Very diaphoretic. Less than 1 minute regained consciousness. Patient was assisted to floor on his side. Patient able to answer questions.
49 2021-05-21 blood glucose increased This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consum... Read more
This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consumer (Patient's wife) reported for her husband that a 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 via an unspecified route of administration, administered in arm left on 22Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus from 2004 to an unknown date Verbatim: diabetes, hypertension from 2003 to an unknown date Verbatim: Blood pressure high. Concomitant medications included metformin (METFORMIN NDC: 65862-0010-05, LOT: MTSC20156a, EXP: discard by April 2022) 1000mg a day by mouth taken for diabetes mellitus from 2004 to an unspecified stop date for almost 20 years since approximately 2004; Humalog Kwikpen insulin lispro (INSULIN LISPRO, Manufacturer: Lilly, NDC: 0002-8799-01, LOT: D255549C, EXP: June 2023) 3mL(caller says he has been taking this two days), taken for diabetes mellitus from May 2021 to an unspecified stop date; amlodipine (AMLODIPINE) taken for blood pressure measurement for 10 years, start and stop date were not reported; glipizide (GLIPIZIDE, Manufacturer: Apotex Corporation) taken for diabetes mellitus, start and stop date were not reported; lisinopril (LISINOPRIL, Manufacturer: Lupin) taken for blood pressure measurement, start and stop date were not reported; apixaban (ELIQUIS, Manufacturer: Bristol-Meyers, NDC: Unknown, LOT: ABQ4087S, EXP: April 2023) taken as a blood thinner, start and stop date were not reported; dulaglutide (TRULICITY) taken for an unspecified indication, start and stop date were not reported. The patient experienced high blood sugars after first dose of vaccine/high blood sugars of 300-350/waking up with blood sugars from 300-400, his sugar right now is 298/blood sugar was 382 when he woke up this morning (blood glucose increased) (medically significant) on 23Apr2021. The caller says that her husband's blood sugars have been high since the next day after the shot, and have not been better. The patient underwent lab tests and procedures which included blood glucose increased: 382 on 06May2021, blood glucose increased: 298 on 06May2021. Therapeutic measures were taken as a result of high blood sugars after first dose of vaccine/high blood sugars of 300-350/waking up with blood sugars from 300-400, his sugar right now is 298/blood sugar was 382 when he woke up this morning. His normal blood sugar is 160. The clinical outcome of high blood sugars was unknown. The reporter seriousness for high blood sugars after first dose of vaccine was unknown. Information about lot/batch number has been requested.
49 2021-05-22 haemoglobin decreased Post vaccine #2 on 5/18 he developed hives, shortness of breath and reportedly did not feel with fat... Read more
Post vaccine #2 on 5/18 he developed hives, shortness of breath and reportedly did not feel with fatigue. Symptoms worsened and he was admitted to ICU on May 21st via the ED for multiorgan failure including respiratory failure with R pneumonia, Shock, Renal failure, Disseminated intravascular coagulation, shock liver failure requiring invasive vent support and treatment for septic shock including vasopressor support and antibiotic therapy. He was started on CRRT on the 22nd. His INR continues to rise and Hb dropping consistent with worsening DIC. Blood cultures are positive for MRSA. He will likely die from progressive septic shock and MSOF.
49 2021-05-23 heart attack, chest pain Serious chest pains began 5 days post receiving 2nd vaccine. 3 days later ended up in hospital with... Read more
Serious chest pains began 5 days post receiving 2nd vaccine. 3 days later ended up in hospital with massive heart attack.
49 2021-05-30 palpitations Odd taste in mouth, heart racing, sweating. Next day developed tinnitus and pain in right ear/eye. ... Read more
Odd taste in mouth, heart racing, sweating. Next day developed tinnitus and pain in right ear/eye. Fatigue and brain fog. Severed headache. Felt like stabbing pain in head. Saw ENT 6 days later. Was prescribed steroids and ear drops. Have hearing loss in right ear and tinnitus
49 2021-05-31 loss of consciousness After receiving the second dose of the Pfizer vaccine, in the observation area the patient vomited a... Read more
After receiving the second dose of the Pfizer vaccine, in the observation area the patient vomited and lost consciousness. EMS treated the person at the scene and was transported to a medical facility.
49 2021-06-01 blood pressure fluctuation, loss of consciousness, heart rate decreased Patient was given the second dose of Pfizer Covid 19 vaccine on 6/2/21 at 12:29pm and was asked to w... Read more
Patient was given the second dose of Pfizer Covid 19 vaccine on 6/2/21 at 12:29pm and was asked to wait for 15 minutes to watch how the patient reacts with the vaccine. He didn't have any side effect on his first dose. After 3 minutes of getting the vaccine, his wife notified me that she needs assistance. He was sweating profusely and was about to lose consciousness. His wife and I kept saying his name to check his response. He could not response or was about to faint. His pulse is slow, and his face is red. Since there was other customers waiting for shots in the clinic, I asked the technician to ask for pharmacy manager assistance. He came in the clinic, and checked patient's pulse and blood pressure. The blood pressure was high (170/89). We checked his blood pressure again, and it was lower after couple minutes. Patient started to have consciousness and understand what we are talking. He told us that he always had the same reaction after getting his blood drawn. We asked him to sit down and was monitored by us in the clinic. After 30 minutes, he said that he was feeling fine without any problems and decided to leave. He can breathe ok and didn't have any adverse reactions such as swelling of throat and lip or hives. His wife and he didn't eat anything before getting the vaccine. I checked his blood pressure again, and it was 130/80. Will follow up on him this evening and tomorrow.
49 2021-06-01 blood pressure increased Blood pressure spike, took a month to get back to normal with meds. Stuffy ears/constant headache/ti... Read more
Blood pressure spike, took a month to get back to normal with meds. Stuffy ears/constant headache/tinnitus, still on-going.
49 2021-06-01 cerebrovascular accident Patient presented to the ED and was subsequently hospitalized for Acute CVA (cerebrovascular acciden... Read more
Patient presented to the ED and was subsequently hospitalized for Acute CVA (cerebrovascular accident) within 6 weeks of receiving COVID vaccination.
49 2021-06-01 fibrin d dimer increased, chest pain Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever l... Read more
Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever like 99; Dimer test showed kind of high levels with mainly blood clot; some fiber or Fibrogen which was for thickening of blood/ supposed to be between 400 and 420, his was 879; have COVID, it was positive COVID antigen test; have COVID, it was positive COVID antigen test; felt pressure in his back almost like pneumonia; Chills; sweat; Hot flashes; Stomach was cramping/ hurt right below my chest and in stomach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right shoulder single dose for COVID-19 immunization; second dose with lot number: EV10161 on 22Apr2021, first dose with lot number: EP7533 on 01Apr2021, at 49-year-old. Medical history and concomitant medication were not reported. The patient was non-smoker, non-drinker. The patient had a little headache with the second shot but 2 weeks later on 03May2021 started having chills every night and would sweat. He was having chills and hot flashes and stomach was cramping and when inhaled like taking a deep breath, felt pressure in his back almost like pneumonia like lungs were filling with fluid or clotting. On the 07May2021, he took a little flu medication Theraflu over the counter (treatment) thinking that'd clear it up. Every time he took a deep breath, it'd just hurt right below my chest and in stomach and skin became extremely prickly. He'd have like a low-grade fever like 99. This was 2 weeks after the second shot, so he went to the ER on 07May2021 and was given a COVID test, a fluid test and lab work trying and figure what he was having. One of his blood test - Dimer test showed kind of high levels with mainly blood clot so they gave him a CT scan, scan showed no blood clots, no kidneys stones or anything like that should had any sweating. ER doctor gave him an antibiotic (ciprofloxacin) for infection like diverticulitis or diverticulosis. The doctor said the patient did not have a stomach infection, his tests showing such high levels for clots so the doctor did more lab work a PRC, CRT, TRP or CPR, a CRT lab work and some fiber or Fibrogen which was for thickening of blood. Those numbers are supposed to be between 400 and 420, his was 879 today (17May2021). The patient did have COVID, it was positive COVID antigen test, I got those results today (17May2021). Outcome of the events was unknown.
49 2021-06-01 heart rate irregular, atrial fibrillation Irregular heartbeat started shortly after the vaccine and continued from then until now and is still... Read more
Irregular heartbeat started shortly after the vaccine and continued from then until now and is still occurring. Comes with occasional fatigue and several episodes of afib
49 2021-06-03 ischaemic stroke Acute ischemic stroke; This is a spontaneous report from a contactable consumer (patient). A 49-year... Read more
Acute ischemic stroke; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 04May2021 08:00 (at age 49-years-old) (Batch/Lot Number: ER8735) as 2nd dose, single for covid-19 immunisation. The first dose was received on 13Apr2021 (lot number: ER8735) on the left arm at age 49-years-old. Medical history included high cholesterol and penicillin allergy. Concomitant medication included rosuvastatin. No other vaccine was received within 2 weeks of vaccination. The patient experienced acute ischemic stroke which started afternoon of 05May2021 13:00. Patient visited ER on 06May2021 at 07:00 and was hospitalized for stroke from 06May2021 to 07May2021. He started physical therapy to rebuild strength and coordination in left arm and leg. Treatment atorvastatin 40,aspirin 81,Hydrochlorothiazide 25 was given. Patient was not diagnosed with covid prior to vaccination and has been tested on 06May2021 (nasal swab): negative. Outcome of the event was recovering.
49 2021-06-06 cerebrovascular accident Hositalized for Stroke on May 5, 2021. Patient dismissed from hospital May 12, 2021. Under continuin... Read more
Hositalized for Stroke on May 5, 2021. Patient dismissed from hospital May 12, 2021. Under continuing treatment to reduce blood clots.
49 2021-06-07 hypotension hypotension; acute renal failure; fever; rigors; persistent rash; He had an IgG and PCR positive for... Read more
hypotension; acute renal failure; fever; rigors; persistent rash; He had an IgG and PCR positive for EBV; This is a spontaneous report from a contactable pharmacist. A 49-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 49-years-old, via an unspecified route of administration on 23Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Pharmacist stated that a patient received the first dose of the Pfizer Covid-19 vaccine on 23APR2021 and a week after he presented fever, rigors and persistent rash. He was the discharged and then presented acute renal failure and hypotension on 19May2021. He had an IgG and PCR positive for EBV. Pharmacist would like to know if there are reports of EBV (Epstein-Barr virus) reactivation. They have a patient who was admitted to the hospital and was wondering if Pfizer has any reports of reactivation of EBV after receiving the vaccine. She is not sure if it is related to the vaccine or not. The first hospital admission was because of continued fevers, rigors and rash. Patient received first dose on 23 Apr 2021, and then rash started on 29 Apr 2021. It is unknown when fever and rigors started. Patient was readmitted for same thing and is sicker. She then clarified that this admission was for hypotension with acute renal failure. The patient is now in ICU. The rash is still there and it is worse. The patient still has fevers. Reporter seriousness for Persistent Fevers, Rigors and Rash: Hospitalization. Patient was in hospital for Persistent Fevers, Rigors and Rash from 2 May 2021 to 15 May 2021. Reporter seriousness for Hypotension and acute renal failure: Hospitalization. Patient was in hospital for Hypotension and acute renal failure from 19 May 2021 to Ongoing. Event outcome of fever and rash was not recovered, the other events was unknown.; Sender's Comments: Based on the narrative information provided and the known drug safety profile, the reported events Pyrexia, Chills and Rash are considered as related to bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine). A causal association between the reported events Hypotension and Acute kidney injury and bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate.
49 2021-06-08 excessive bleeding Bleeding; Losing skin on hands and feet; Losing finger and toe nails; Excessive pain; Allergic react... Read more
Bleeding; Losing skin on hands and feet; Losing finger and toe nails; Excessive pain; Allergic reaction; Eczema; This is spontaneous report received from a contactable consumer (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EL3249), via an unspecified route of administration on 21Jan2021 on the right arm at 02:00 pm as a single dose for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EJ1685), via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient's medical history and concomitant medications were not reported. On 23Jan2021, the patient experienced bleeding, was losing skin on hands and feet, losing finger and toenails. The patient also had excessive pain, and also had a allergic reaction. Caller stated that he had an allergic reaction to the vaccine in January and was still having these side effects. The patient visited emergency room and physician office due to the events. The case was assessed as serious (medically significant). Patient's lab tests and Investigation results on an unknown date on Biopsy of skin on hands and feet revealed Eczema. Lot of blood work (uknown) done. The patient did not receive any treatment for the events. The outcome of the events was not resolved. Follow-up attempts needed. Additional information has been requested.
49 2021-06-10 blood pressure increased wife is reporting that his right arm felt like it was on fire and like he had hot fingers. About 30... Read more
wife is reporting that his right arm felt like it was on fire and like he had hot fingers. About 30 hours after taking the vax he felt hot at the core and felt like his breath was hot when he was breathing out. He went to PCP. had blood work with normal results. He has not developed chest pains and a feeling of heaviness on the left side of this body. He is feeling weak, tired and BP is elevated. He went to medical facility. He had a CTA. He was discharged to go home and FU w/ PCP where the test results were sent.
49 2021-06-11 chest pain Patient received first dose COVID vaccine (Pfizer, lot#EW0185) in the left arm on 05/22/21 at 11am f... Read more
Patient received first dose COVID vaccine (Pfizer, lot#EW0185) in the left arm on 05/22/21 at 11am from vaccinator, RN. During the client's second dose appointment on 06/12/2021, client reported to vaccinator RN that he experienced intermittent chest pain with mild SOB approximately 2.5 weeks after receiving the first dose and persisting for 5 days. RN reported information to, Lead RN. RN completed a medical consult. Client reported pain level 3/10, denied radiating pain, denied lightheadedness, dizziness, difficulty swallowing, slurred speech, and numbness or tingling to the extremities. RN received clearance by MD to vaccinate for second dose Pfizer on 06/12/2021.
49 2021-06-14 heart flutter, chest discomfort Heart flutters, chest discomfort, and numbness left side of face
49 2021-06-23 fast heart rate, haemoglobin decreased Day 2- slight red rash on chest. Day 3 - severe vomiting, Day 5 - called 911 taken to the Emergency... Read more
Day 2- slight red rash on chest. Day 3 - severe vomiting, Day 5 - called 911 taken to the Emergency Room for supraventricular tachycardia, Heart Rate of 158. Day 9 - had an additional SVT, Heart Rate 171. Day 10 - additional SVT, Heart Rate 150. Have not been able to engage in pre-vaccine regular life activities without my heart rate severely rapidly increasing. I had to quit my job. Saw my doctor on Day 9 who examined blood levels from ER visit on Day 5, and ordered an echocardiogram. I have an echocardiogram scheduled in the next 3-4 weeks, which was the soonest I was able to be seen.
49 2021-06-24 chest discomfort "Pt w/ allergy to Penicillin (hives). PMH Psoriasis, HTN, HLD, GERD, CAD (NSTEMI 1/20), anxiety, car... Read more
"Pt w/ allergy to Penicillin (hives). PMH Psoriasis, HTN, HLD, GERD, CAD (NSTEMI 1/20), anxiety, carpal tunnel. PSH Nerve repair Left index finger, Cardiac Cath. 1/2020 hospitalization for NSTEMI: s/p cardiac cath on 1/30/2020, which showed dominant RCA with proximal 70% lesion followed by 99% mid RCA lesion (LM/LAD/LCx without significant CAD) now s/p PCI of mid RCA with 3.0 x 15 mm Onyx DES and PCI of proximal RCA with 3.5 x 22 mm Onyx DES. Today, via Spanish interpreter) , he reports that he has localized right chest discomfort 2/2 right arm tingling and pain when he received the vaccine today. Pt also has flushing/sweating. He is alert and oriented x 4. He was very ""anxious"" and tears in his eyes. He states that he has ""panic attacks"" in the past and he feels very ""anxious"" after getting the shot. C/o tingling and pain right arm. Pt given 2L O2 via NC. Slowly sx of chest discomfort resolved after 5 min. Pt stable and released from the vaccination site. Pt verbalized ""he feels fine now"". VSS. His is back to baseline. Right arm pain resolved, tingling improved. Denies CP, dizziness, HA, or palpitations. His son is driving him home. Instructed patient to rest at home. He has NTG prn for CP. ED precautions discussed. If CP recurs, he agrees to call 911. FU with PCP if right arm numbness and tingling are worsening or persist after 3 days or CP/pain/palpitations/HAs/syncope. Current medications: acetaminophen (TYLENOL) 500 MG tablet Take 1 tablet by mouth every 6 (six) hours as needed for Pain. adalimumab (HUMIRA) 40 mg/0.8 mL subcutaneous injection pen kit Inject 0.8 mLs into the skin every 14 (fourteen) days. aspirin 81 MG EC tablet Take 1 tablet by mouth daily. atorvastatin (LIPITOR) 40 MG tablet Take 1 tablet by mouth at bedtime. carvedilol (COREG) 6.25 MG tablet Take 2 pills by mouth in the morning and 1 pill in the evening famotidine (PEPCID) 20 MG tablet Take 1 tablet by mouth 2 (two) times daily. gabapentin (NEURONTIN) 300 MG capsule Take 1 capsule by mouth 3 (three) times daily. For hand numbness hydrocortisone 2.5 % cream Apply to affected areas 2 (two) times daily. lisinopril (PRINIVIL,ZESTRIL) 10 MG tablet Take 1 tablet by mouth daily. loratadine (CLARITIN) 10 mg tablet Take 1 tablet by mouth daily. nitroglycerin (NITROSTAT) 0.4 MG SL tablet Dissolve 1 tablet under tongue every 5 minutes as needed for chest pain, max 3 tablets. If pain continues 5 minutes from first dose call 911 "
49 2021-06-25 heart attack, hypertension Massive heart attack; Diabetes; High blood pressure; High cholesterol; Achy; Fever; slight pain wher... Read more
Massive heart attack; Diabetes; High blood pressure; High cholesterol; Achy; Fever; slight pain where the shot was given; after the second one he was very tired; he was sweating; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172), dose 2 via an unspecified route of administration, administered in Arm Right on 28Apr2021 at 10:15 (at the age of 49-years-old male) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Vaccine was not administered at military facility. History of all previous immunization with the Pfizer vaccine was not considered as suspect. Patient had no other vaccine prior this vaccinations within 4 weeks. Patient had no medical history including any illness at time of vaccination. No family medical history relevant to AE. The patient had received dose 1 via an unspecified route of administration, administered in Arm Right on 03Apr2021 at 15:10, for covid-19 immunisation and experienced diabetes and extreme tiredness. 07May2021, the patient experienced massive heart attack, diabetes, high blood pressure, high cholesterol, on 28Apr2021 slight pain where the shot was given, achy and fever, on an unspecified date "after the second one he was very tired" and "he was sweating ". The patient was hospitalized for massive heart attack from 07May2021 to 09May2021. Reporter (patient's wife) stated her husband had no heart issues or blood pressure and he had to have emergency surgery and has two stents in heart now to open his heart and was diagnosed with high blood pressure, diabetes, and high cholesterol. Fever was overnight and did break in the morning all for the COVID vaccine. Reporter stated the doctor asked for her to call to make this report due to it being possible from the vaccination. The patient is now in the lower range because he went from taking no medication to taking 5 pills in the morning and 3 pills at night. Reporter stated the doctors are tying to adjust his blood pressure medication as it is a little low at this time and trying to see what might happen. Reporter stated they do not know what diabetes was caused from. The patient had a blood test that indicated he still was a diabetic but now they want to wait 3 months again and see what the numbers are since it was so high when he had the heart attack. The event caused emergency room visit. Reporter stated her husband went to the cardiologist the week after and he just went to the endocrinologist yesterday for diabetes. Reporter stated extremely tired started immediately after the second vaccination. The patient after the second one he was very tired and he went to lay down and she noticed he was sweating because he had a temperature. A couple of days after the second dose of the vaccine it stopped and her husband was getting better each day and was not taking naps as often. Patient was given a lot of water and refueled and he slept through the night. He experienced slight pain where the shot was given in his arm but that was nothing that alarmed them. It stopped a couple days after. The reporter wanted feedback. The reporter has seen on the news how there are issues and heart issues and is there any feedback or any other contact she needs to make. NDC Number and expiry date was unknown. The patient underwent lab tests and procedures which included blood test: on May2021. He still was a diabetic but now they want to wait 3 months again and see what the numbers are since it was so high when he had the heart attack. Treatment was given for the event hypertension. outcome of the event heart attack, pain, fever, vaccination site pain was recovered. Blood pressure high, High cholesterol ,Diabetes was not recovered. Outcome of the event fatigue and sweating was recovered on an unspecified date in 2021. Information on Lot/Batch number was available. Additional information has been requested.
49 2021-06-25 heart attack This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old male p... Read more
This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: ED6955), dose 1 via an unspecified route of administration, administered in Arm Right on 03Apr2021 15:10 as 1st dose single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.Reporter stated on 03Apr2021 her husband had his first shot and on 28Apr2021 he had the second shot, then on 07May2021 he had a massive heart attack husband was hospitalized for three days and has not recovered completely also her husband is 49 years old with no heart issues or blood pressure and he had to have emergency surgery and has two stents in heart now to open his heart and was diagnosed with high blood pressure, diabetes, and high cholesterol. Reporter stated the doctor asked for her to call to make this report due to it being possible from the vaccination. Reporter stated her husband is now in the lower range because he went from taking no medication to taking 5 pills in the morning and 3 pills at night. Reporter stated the doctors are trying to adjust his blood pressure medication as it is a little low at this time and trying to see what will happen. Reporter stated they do not know what this was caused, had a blood test that indicated he still was a diabetic but now they want to wait 3 months again and see what the numbers are since it was so high when he had the heart attack, couple of days after the second dose of the vaccine it stopped, and her husband was getting better each day and was not taking naps as often, slight pain where the shot was given in his arm: Reporter stated this was just a couple of days after the first dose and then it happened again after the second dose on 28Apr2021 but stopped a couple days after. On 7May2021,The patient experienced massive heart attack, high blood pressure was unknown, Diabetes, High cholesterol not recovered, extremely tired, achy and slight pain where the shot was given in his arm was resolved. Follow-up attempts are needed. Additional information has been requested.
49 2021-06-26 inflammation of the heart muscle, chest pain MYOCARDITIS shortness of breath, brain Fog, chest Pain pain left shoulder and Arm i gave blood and a... Read more
MYOCARDITIS shortness of breath, brain Fog, chest Pain pain left shoulder and Arm i gave blood and alot of chest pain has decreased.
49 2021-06-26 fainting, pallor Syncope symptoms; became pale; sweating; dizziness. Recovered in 15 minutes. Fire department came to... Read more
Syncope symptoms; became pale; sweating; dizziness. Recovered in 15 minutes. Fire department came to check all the vitals. Patient and his wife declined to go to the hospital. His wife reported that he ate the night before and was on empty stomach. The same symptoms occurred when patient received the tetanus vaccine before.
49 2021-06-27 chest pain Pleuritic pain in left portion of chest and back. Pain is located in the lower anterior chest and l... Read more
Pleuritic pain in left portion of chest and back. Pain is located in the lower anterior chest and left back. Pain is worse with deep breaths. Patient is treated with ketorolac, morphine, and ondansetron.
49 2021-06-27 fainting About a week after shot 1 I started to feel very fatigued and run down. I was able to function but ... Read more
About a week after shot 1 I started to feel very fatigued and run down. I was able to function but got tired easily. On May15, I received shot 2 and my fatigue got worse. I started to get tremors and shakes in my hands and arms. Legs felt weak, its difficult to hold my arms up at times. I felt hyper, yet weak. Unable to stay asleep. On June 6 I took a hot shower and barely made it out before collapsing. I went to the emergency room .
49 2021-06-28 chest pain Shortness of breath, Dizziness, Sharp pain on the chest, Lasts 30min to 1hr. Been in ambulance 5 tim... Read more
Shortness of breath, Dizziness, Sharp pain on the chest, Lasts 30min to 1hr. Been in ambulance 5 times with same symptoms,
49 2021-06-28 inflammation of the pericardium I30.9 - Acute pericarditis, unspecified
49 2021-06-30 chest pain Nausea; Fever; Fatigue; Chest pain; Difficulty breathing; This is a spontaneous report from a contac... Read more
Nausea; Fever; Fatigue; Chest pain; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: Er2613) via an unspecified route of administration administered in Arm Right on 24Mar2021 and second dose (#lot: Er8629) via an unspecified route of administration administered in Arm Right on 14Apr2021 as single dose (at the age of 49-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea, fever, fatigue, chest pain and difficulty breathing on an unspecified date. The patient did not report this because he didn't think it was relevant until recent media about myocarditis. He was close 3x to dialing 911 thought was having heart attack. The outcome of all the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
49 2021-06-30 deep vein blood clot Since vaccination patient has been treated in office for swollen lymph nodes, shingles and DVT righ... Read more
Since vaccination patient has been treated in office for swollen lymph nodes, shingles and DVT right lower extremity
49 2021-06-30 hypotension, fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Head... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Additional Details: Patient recieved covid shot, and fainted within 8-15 minutes. He bumped his head while falling and had redness at the site. We called the ambulance to make sure patient will be okay. Paramedics mentioned that his blood pressure was low.
49 2021-07-01 haemoglobin decreased, platelet count decreased Platelet count of 4,000
49 2021-07-01 fluid around the heart, chest pain, excessive bleeding, cardiac arrest, loss of consciousness, hypotension 49yom with PMH HTN presents with CP and SOB. Ddx includes but is not limited to: ACS, PE, PNA, aorti... Read more
49yom with PMH HTN presents with CP and SOB. Ddx includes but is not limited to: ACS, PE, PNA, aortic dissection, pericarditis, myocarditis. On arrival, patient appeared critically ill with cool, clammy skin, diaphoretic, complaining of chest pain. Patient initially able to answer simple questions, however quickly became unconscious, witnessed having tonic colonic seizure activity. Patient given 2 mg of lorazepam which aborted the seizure, however he remained unresponsive. IV fluids were started, and patient remained hypotensive after 3 L of fluids. Bedside cardiac ultrasound was performed which showed a large pericardial effusion with tamponade physiology. We continued fluid resuscitation and patient was intubated, while stat Cardiology consult was called. Patient suffered a cardiac arrest shortly after intubation. Cardiology performed emergent pericardiocentesis at the bedside which showed hemopericardium with output of greater than 500 mL of blood. ROSC was achieved following pericardiocentesis, and we continued resuscitative measures. Emergent arterial line and central venous lines were placed. Patient began to have profuse bleeding from all orifices, and massive transfusion protocol was initiated. Patient was stabilized enough to be taken to CT scanner which showed an extensive aortic dissection extending into the RCA, abdominal aorta, brachiocephalic artery, common carotids, and into the abdominopelvic vasculature. Cardiac and vascular surgery were consulted stat, and the decision was made to take the patient emergently to the OR. We were informed shortly after that the patient had expired en route to the operating room and they were unable to obtain ROSC. Final impression: type A aortic dissection, cardiac tamponade. Second dose of mRNA vaccine (unknown if Pfizer or Moderna) received two days prior to event.
49 2021-07-04 loss of consciousness While getting my hair cut the following day I was sitting in my chair and started to feel intoxicate... Read more
While getting my hair cut the following day I was sitting in my chair and started to feel intoxicated for about 2 minutes and then started to sweat, I then passed out and started to shake as if I were having a seizure. This went on for about a minute I was told.
49 2021-07-05 cardiac failure congestive AFTER 2-3 WEEKS AFTER THE SECOND DOSE, STARTED FATIGUE, SOB, COUGHING CAME TO SEE ME, HAD CHF , REF... Read more
AFTER 2-3 WEEKS AFTER THE SECOND DOSE, STARTED FATIGUE, SOB, COUGHING CAME TO SEE ME, HAD CHF , REFERRED TO A CARDIOLOGIST DR, MD, WHERE HE HAD ECHO DONE WITH NML CHF AND SEVERE LVH. HE HAD A COVID TEST NEGATIVE.
49 2021-07-07 hypertension SMV: Pfizer Dose 1 (EN6206, exp 6/30/2021) on 3/25/2021 SMV: Pfizer Dose 2 (ER8731, exp 8/31/2021) ... Read more
SMV: Pfizer Dose 1 (EN6206, exp 6/30/2021) on 3/25/2021 SMV: Pfizer Dose 2 (ER8731, exp 8/31/2021) on 4/15/2021 Symptom onset 06/10/2021 (same day as admission to inpatient) of sore throat, fatigue, cough, nausea/vomitting, and headache. Hospital records request shows treatment for DM2 uncontrolled with hyperglycemia, AKI, Dehydration, and uncontrolled hypertension. COVID Pneumonia listed as active diagnosis: 1 dose of dexamethasone on June 11, 2021 and then dexamethasone was discontinued. Patient is also not on remdesivir. Patient denies shortness of breath or cough.
49 2021-07-09 blood clot Intense abdominal pain that required hospitalization from Sunday, May 16, 2021 until Friday, May 28,... Read more
Intense abdominal pain that required hospitalization from Sunday, May 16, 2021 until Friday, May 28, 2021 due to portal vein thrombosis as well as other abdominal blood clots. No clots were found in extremities and no genetic reason for occurrence. Patient left hospital with Xarelto medication for thrombosis treatment. Patient is still under medical care by hematologist and primary care physician to date for treatment of the blood clots.
49 2021-07-10 fibrin d dimer increased, platelet count decreased headaches, fever, heavy sweats at night, chills (which lasted for 8 days), shortness of breathing, r... Read more
headaches, fever, heavy sweats at night, chills (which lasted for 8 days), shortness of breathing, red patches spread over cheeks, neck and body (which started on the 5th day and most visible on the 8th day). Up to today (July 11th), still experiencing shortness of breath, fatigue, lack of focus, and mild coughing
49 2021-07-10 palpitations Pt. received the 1st dose COVID vaccine (Pfizer, Lot# EW0191, Exp. 09/30/2021) at 1210 in the L arm.... Read more
Pt. received the 1st dose COVID vaccine (Pfizer, Lot# EW0191, Exp. 09/30/2021) at 1210 in the L arm. At 1218, client reported he has "a racing heart rate and is feeling really nervous" Observer. Observer provided translation. Observer reported findings to Co-Lead who immediately assessed client, transferred client to zero-gravity chair, and provided him with a bottle of water. The patient was A&O to person, time, place, and situation. No loss of consciousness or dizziness occurred. At 1220 vitals were taken by observer with BP 148/98 in R arm laying down, HR 98, O2 Saturation 98%, and RR 20. At 1225 client reported that he was feeling better but had a "dry throat". Co-Lead assessed throat and observed no swelling. Client denied swelling or any trouble swallowing. At 1228 the patient denied numbness, tingling, or shortness of breathe. Client denied taking medication, denied any significant medical history, and has NKDA. Client reported to Co-Lead that he has a history of anxiety including a racing heart rate and feelings of nervousness. Client has no hx of fainting or dizziness with other vaccines or needles. At 1230 client said he was feeling better and his heart was no longer racing and his "throat feels fine now". Client continued to take sips of water. Vitals at 1250 were BP 128/88 in R arm laying down, HR 76, O2 Saturation 98%, and RR 18. At 1255 client was stable and Co-Lead educated about V-safe information, ER precautions, and when to follow up with PCP. Patient ambulated with even and symmetrical gait when leaving site at 1305.
49 2021-07-17 blood glucose increased, heart rate irregular, heart rate increased, blood pressure increased Significant fatigue; Extremely Lethargic; Erratic heart rate; No appetite; Chills; Glucose and bilir... Read more
Significant fatigue; Extremely Lethargic; Erratic heart rate; No appetite; Chills; Glucose and bilirubin slightly elevated; Glucose and bilirubin slightly elevated; Extremely rapid heart rate; Elevated blood pressure; Dry mouth; Lightheaded; Shakes; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of BNT162B2 via an unspecified route of administration at arm left on 25Mar2021 13:15 (age at 49 years old, Batch/Lot Number: EP6955) as single dose for COVID-19 immunisation. Medical history reported as none. The patient was not diagnosed with COVID-19 prior to vaccination and the patient did not test for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC); vitamins nos (MULTIVITAMIN); fish oil; all as supplement. About 5 mins after injection (25Mar2021 13:30), the patient developed extremely rapid heart rate and elevated blood pressure, dry mouth, lightheaded and shakes. The patient went to emergency room (ER), heart rate stabilized after about 60 mins. Blood work and EKG were normal on 25Mar2021. Next day on 26Mar2021, the patient developed extremely lethargic, erratic heart rate, no appetite. The following evening, the patient had another the same episode as post injection, rapid heart rate, chills, elevated blood pressure. The patient went to ER, EKG/Chest x-ray/blood tests all normal (glucose and bilirubin slightly elevated) on 26Mar2021. 4 days post injection (29Mar2021), heart rate still erratic and significant fatigue, heart rate spiked with little effort. The events required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received iv fluids as treatment. All events were not recovered.
49 2021-07-17 heart rate increased, blood pressure increased Heart is racing all day. 144/82; Heart is racing all day. 144/82; This is a spontaneous report from ... Read more
Heart is racing all day. 144/82; Heart is racing all day. 144/82; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL3247) via an unspecified route of administration on 23Feb2021 at 14:00 (at age of 49-year-old), as dose 1, single in left arm for COVID-19 Immunization. Patient's medical history includes Penicillin allergy. Concomitant medications include omega-3-acid ethyl ester (LOVAZA); Atorvastatin; and ascorbic acid, biotin, calcium pantothenate, cellulose microcrystalline, copper sulfate, folic acid, magnesium stearate, nicotinamide, pyridoxine hydrochloride, riboflavin, silicon dioxide, thiamine disulfide, vitamin b12 nos, vitamin e nos, zinc oxide (CENTRUM B); all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021, 1 day and 10 hours after vaccination, patient's heart was racing all day 144/82. Patient received treatment for event with beta blocker Metoprolol. Patient had to visit health professional office due to events. The patient underwent lab tests and procedures performed on 25Feb2021 included blood pressure measurement: 144/82, increased; and heart rate: increases. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was not resolved. No follow-up attempts are needed. No further information is expected.
49 2021-07-17 heart rate irregular Fever (102.5F); Headache; Muscle pain; Fast heartbeat; This is a spontaneous report from a contactab... Read more
Fever (102.5F); Headache; Muscle pain; Fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 29Mar2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Mar2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Mar2021 at 18:00, the patient experienced fever (102.5F), headache, muscle pain, fast heartbeat. On an unknown date, the patient underwent body temperature measurement and the result was 102.5F. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures taken for the events. The clinical outcome of the event fever (102.5F), headache, muscle pain and fast heartbeat was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
49 2021-07-19 chest pain chest pain; uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 49-... Read more
chest pain; uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0162; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in left upper arm on 20Apr2021 09:30 as dose 1, single and dose 2 via an unspecified route of administration, administered in arm left on 19May2021 09:30 (Batch/Lot Number: EW0183; Expiration Date: 31Aug2021) (at the age of 49-years-old) as dose 2, single for COVID-19 immunization (He discussed it with his 21 year old daughter and wife). Caller wanted to get back and do some things. He felt that if he got Covid after the vaccine, he would not get as many side effects. He did get his flu shot and the experience had always been positive. His daughter also got flu shot and had positive experience. Caller thought that most people who didn't get shots was because they were afraid of needles. He thought maybe there was a different way to administer it so more people were taking it. Medical history included ongoing hypertension (About 14 years). He did not have high blood pressure if he was exercising. It was in good control. When caller was asked if he had a family history related to reactions to any vaccines, he stated that both his mother and father got the vaccinations. They were the first ones in the elderly group. His dad got sick and got a little lethargic and out of it for a day or so. He was not feeling well. His Mom just had a sore arm. Caller declined to do report on his parents. Concomitant medication included olmesartan medoxomil (BENICAR) taken for hypertension from an unspecified start date and ongoing, he said he really didn't needed to take it anymore, but he still took it and had been taking it for about 14 years. The patient experienced chest pain on 30May2021 around 22:00 and was uncomfortable on an unspecified date with outcome of unknown. Caller stated his first dose was on 20Apr2021 and his second dose was 19May2021. Caller stated on 30May he started having chest pain, so he went to the ER and was at the hospital for a day and a half for observation. Caller stated he now had a cardiologist appointment on 05Aug2021 and even though all of the tests came back negative, they put him on low dose aspirin. Caller stated he had seen the studies about 19-39-year-olds having chest pain and inflamed hearts and would like to know if there was information based on his age. Caller asked if there was anything he could do or take for the chest pain. Caller stated that it had been going on for a while and he was very uncomfortable. Stated that Pfizer cannot make treatment recommendations. Stated that caller got both doses of the Pfizer Covid vaccine. He experienced lots of chest pain. It was a dull achy pain near his heart in his chest. It occurred a week later after his second shot. Caller wanted to know if Pfizer offered assistance. He said that he was going to accrue a great deal of expenses. He had an appointment with a cardiologist on 05Aug2021. His appointment was so far out as that was what he could schedule. Caller also said that he was at the ER for a day and a half as they wanted to remove all life threatening possibilities such as the risk of a heart attack. They could not find a heart attack. He's never had a heart attack, but from what people described to him, that feeling in his chest.ck. When caller was asked if he was a healthcare provider, he said that he had done First aid, but he was not a healthcare provider. Caller did not want to provide email address. Caller clarifies that he had chest pain on Sunday night, around 22:00. He was sitting on his couch watching TV. Outcome: States it is persisting, then states he felt that there was a slight improvement at this time. He did not feel it around the clock like he did the first week when it was constant pain. It was coming and going very frequently. Caller stated that the only thing they told him to do was take a baby Aspirin 81mg. They told him he could resume activities. He walked and hiked a lot. He was hesitant to hike with altitude. He did outdoor activities like cutting the grass. There was no difference in the feeling of the chest pain whether he was doing activity or resting. It didn't make it better or worse. Caller stated that they did several tests on his heart when he was at the ER. His heart was strong. They could not find anything. They wanted him to go to the cardiologist to get an EKG and sonogram. He would have those done 05Aug2021 before his meeting with the cardiologist. His blood pressure in the ER when he arrived was 133/89 approximately. It lowered as they kept taking it. Caller stated that he knew probably 10 to 15 black males who took shot. None of them had this problem. They had normal side effects such as sore arm and lethargic feeling after the second dose. He was talking to them to see if anyone had anything like this. None of them had chest pain. Some of them were big men like 270 to 280 pounds. Caller declined to do reports on these men. No further information provided. It was a park that had everything there. He had to schedule the appointment. It was a very legitimate site. Caller provided the address as (address withheld). When caller was asked if he had any adverse reactions to any other shots, he said he had the flu shot and was fine. He had been getting that done forever and he had a sore arm only. Caller stated that the purpose of his call was two-fold. First, he wanted to know about assistance with his expenses. Second he wanted to provide information. He did not know about inflammation in the heart. He heard about CDC report of inflammation in the heart in age group 18 to 39 but not in his age group. Blood pressure of patient was 133/89 approximately. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
49 2021-07-21 cardiac arrhythmia, heart attack, arrhythmia At the beginning of April I stated having arrhythmia so I went to a cardiologist. The cardiologist s... Read more
At the beginning of April I stated having arrhythmia so I went to a cardiologist. The cardiologist said it was just PVC's. On May 29th I suffered a heart attack. I had stent put in. I now take aspirin, brilinta, lostartin, atorvastatin, metoprolol. I still have an arrhythmia as I recover from my heart attack.
49 2021-07-22 hypertension 7/7 - about 9am or 10 am in morning, his face on the right side began to droop. He felt as though... Read more
7/7 - about 9am or 10 am in morning, his face on the right side began to droop. He felt as though he may be having stroke, as known from prior event. Yet, he drove himself to the ER. A stroke event was ruled out. He was diagnosed with Bell's Palsy syndrome with numbness and paralysis on the right side of his face. Treatment include high dose steroid Prednisone for 5 days. Adjustment with increase in this blood pressure medication, as his blood pressure was running in the 210s/110s. (extremely high). Prior to this event - pt traveled under the false security that he was okay to mingle since he had been vaccinated. (Currently, the place he traveled to is showing a COVID surge). Now today on 7/22 -patient still is suffering from the Bell's Palsy side effect. Slowly he is regaining feelings and very slight movement of his face.
49 2021-07-25 blood clot, cerebrovascular accident arm pain from the moment he received tie injection. Hands and fingers went numb. was told arthritis ... Read more
arm pain from the moment he received tie injection. Hands and fingers went numb. was told arthritis in shoulder. Went to Er on the 20th of july and a CT scan was done . Had stroke on the 21st . two blood clots were found
49 2021-07-27 troponin increased, heart attack, chest pain Sudden onset of chest pain, EKG proven acute myocardial infarction with fresh thrombus in right coro... Read more
Sudden onset of chest pain, EKG proven acute myocardial infarction with fresh thrombus in right coronary requiring cardiac cath and stenting
49 2021-07-29 blood pressure increased, chest discomfort Ringing in both ears; Ear pressure, clogging and the feeling of water in the ears; Chest tightness; ... Read more
Ringing in both ears; Ear pressure, clogging and the feeling of water in the ears; Chest tightness; Sternum pain; Aches and pains throughout my upper body, exacerbated by exercise; Transthoracic Echo showed some abnormalities.; Blood pressure elevated; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 49-year-old male patient received first dose of bnt162b2 (Covid 19, Brand Pfizer, Solution for Injection, Lot Number: EN6202), via an unspecified route in the left arm on 27Feb2021 at 14:15 (age at vaccination: 49-year-old), as a single dose for covid-19 immunization. Medical history included high cholesterol. Concomitant medication included atorvastatin calcium (LIPITOR). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 01Mar2021, 36 hours after vaccination, patient woke up at 03:00 am with ringing in both ears for the first time in his life. Patient have seen two ENTs and a chiropractor. Patient have had periods of ear pressure, clogging and the feeling of water in the ears. In addition, 13 days after vaccination on an unknown date, patient started experienced chest tightness, sternum pain, aches and pains throughout his upper body, exacerbated by exercise, transthoracic echo showed some abnormalities and blood pressure elevated, still. Therapeutic measures taken as a result of the events included nasal spray, allegra, chiropractor and acupuncture. Patient has received second dose of bnt162b2 (Covid 19, Brand Pfizer, Solution for Injection, Lot Number: EN6206), via an unspecified route in the left arm on 20Mar2021 at 12:45, as a single dose for covid-19 immunization. The patient underwent lab test and procedure which included hearing test was normal and showed no loss of hearing, pressure test was normal, Chest xray and stress test was normal, transthoracic echo showed some abnormalities, blood pressure elevated, PCR (SARS-CoV-2 test) nasal swab: negative on 10Mar2021 and 20Mar2021. The clinical outcome of periods of ear pressure, clogging and the feeling of water in the ears have diminished over the past 12 weeks and only now happen a few times a week, but the ringing in the ears persists. It was constant but he has gotten more used to it, and there are times when it is louder and times when it is less loud, chest symptoms have mostly resolved, blood pressure elevated, still, sternum pain, aches and pains throughout upper body, exacerbated by exercise was not recovered. Follow-up attempts are completed. No further information is expected.
50 2021-01-03 fibrin d dimer increased, inflammation of the pericardium Acute Pericarditis. Patient was admitted from 12/27-12/28/2020 at hospital by cardiology team who st... Read more
Acute Pericarditis. Patient was admitted from 12/27-12/28/2020 at hospital by cardiology team who strongly felt the acute pericarditis was due to the Pfizer Vaccine (Dr. was senior cardiologist).
50 2021-01-04 hypertension eye irritation; eyes turn red; blurry vision; difficulty keeping eyes open; BP 160/85; This is a spo... Read more
eye irritation; eyes turn red; blurry vision; difficulty keeping eyes open; BP 160/85; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old male patient received bnt162b2 (lot number: EL0140), intramuscularly at arm left, first dose on 28Dec2020, at single dose, for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the within 2 weeks of vaccination. The patient experienced eye irritation, eyes turn red, blurry vision, difficulty keeping eyes open, BP 160/85 on 28Dec2020. No treatment received for the adverse event. The event was reported as non-serious. The outcome of the events was recovering.
50 2021-01-05 pallor Cough; Flu like symptoms; It hurts to walk; I have a stuffed up nose, I did not have it yesterday; P... Read more
Cough; Flu like symptoms; It hurts to walk; I have a stuffed up nose, I did not have it yesterday; Pale; I felt weak; Bones ache; Have not been feeling good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 28Dec2020 at single dose on arm for suppress the COVID-19 (COVID-19 immunization). The patient's medical history included blood pressure, stomach ulcer and psoriatic arthritis. The concomitant drug was reported as colecalciferol (VITAMIN D), potassium citrate, multivitamin, etanercept (ENBREL) at once a week, pen shot in stomach, omeprazole (PROTONIX) at once a day for stomach ulcer and blood pressure medications. The patient was a correction officer, patient work at the prisons in (state name) and were given vaccination of Pfizer on Monday and he did that on Monday and have been getting sick and it's getting worse everyday, so yesterday at work everything was fine and he went home at 8 'O' clock at night because he was getting pale, felt weak, bones ache and have not been feeling good and today he called it in because he woke up with the cough, flu like symptoms. And it's worse today than it was yesterday. Consumer stated today, bones ache was worsening of like weaker, it hurts to walk and bone ache was really, today was worse than yesterday for the bone. Today flu like symptoms was worse, today patient have more heavier cough, was coughing more today and have a stuffed up nose, I did not have it yesterday. Wanted to know if this was a side effect or is that normal with that vaccine. Start date of events was on 28Dec2020. When patient started feeling some symptoms that started getting progressively worse on 29Dec2020. Treatment included Tylenol for bone pain and hurts to walk. Lab test blood work done in Dec2020, once a month through psoriatic arthritis doctor. The outcome of events, weak, Bone pain, Cough, Flu like symptoms, was not recovered. The outcome of other events was unknown. Information on Lot/batch number has been requested.
50 2021-01-05 fast heart rate Neck and Face flushing. Tachycardia with rate of 120 for 1.5 hours.
50 2021-01-07 chest pain sharp pains on left side of chest/ when taking a deep breath there is a little soreness right below ... Read more
sharp pains on left side of chest/ when taking a deep breath there is a little soreness right below the ribcage; received shot and felt soreness/like with a tetanus shot; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at site of left arm at 09:00 on 29Dec2020 at single dose for COVID-19 immunization. Medical history included colitis (in remission right now). There were no concomitant medications. The patient received shot and felt soreness on 29Dec2020, had sharp pains on left side of chest on 30Dec2020, and when taking a deep breath there is a little soreness right below the ribcage. Clinical course: patient got the vaccine on 29Dec2020 and felt soreness, like with a tetanus shot. On the 30th2020 he was kind of sore and then by midday all of a sudden felt the sharp pain in his chest, and once in a while when taking a deep breath there is a little soreness right below the ribcage. He went to the emergency room on 01Jan2021 and they first did the EKG, then the X-ray and they both were normal. To rule out pulmonary embolism they did CT scan and that was all fine. He also just wanted to rule out heart or lung problems since he is pretty healthy. He did not receive any other vaccines the same day and none 4 weeks prior. Vaccination facility type in hospital. The outcome of events was unknown.
50 2021-01-07 palpitations, heart rate abnormal, cardiac arrhythmia I developed symptomatic palpitations that started on 12/23 in the early morning, awaking me from sle... Read more
I developed symptomatic palpitations that started on 12/23 in the early morning, awaking me from sleep. Palpitations became so frequent that I went to my PCP's office, where I was found to have an abnormal rhythm on my EKG (non-sustained V-tach, runs of 4-5 beats at a time). I then went to hospital where I was admitted to observation in the ED for monitoring.
50 2021-01-07 palpitations Heart was little bit racing; This is a spontaneous report from a contactable physician report for se... Read more
Heart was little bit racing; This is a spontaneous report from a contactable physician report for self. This 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 in the morning at single dose for COVID-19 immunization. Medical history included borderline hypertension. There were no concomitant medications. Patient probably took some medication in the past but nothing now. The patient took the vaccine in the morning on 30Dec2020, after took the vaccine he sit in the room for monitoring for 15 minutes, after 1 or 2 minutes patient felt like heart was little bit racing, he didn't have any other problems like no shortness of breath, no difficulty breathing, no rash or anything like that and he took some bottled water and started drinking, few minutes later, it may have lasted for 5 minutes, it subsided. No emergency room or physician office visited. The patient's question was whether he could take second shot or not which is probably given in 3 weeks. The outcome of event was recovered on 30Dec2020. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
50 2021-01-08 chest pain Sharp piercing left sided chest pain that radiated to left shoulder and back 7-8/10 on pain scale. ... Read more
Sharp piercing left sided chest pain that radiated to left shoulder and back 7-8/10 on pain scale. Taking a deep breath made pain worse but no associated shortness of breath. Pain worsened with attempting to eat food. Severe symptoms lasted 2-3 hours and then subsided. Troponin and other cardiac markers negative. No history of GI, cardiac, or pulmonary disorders. Mildly present the first half of the next day (1-2/10) until afternoon then completely resolved
50 2021-01-08 heart rate increased, palpitations 12 minutes after receiving the 2nd covid vaccination, I felt flushed and became diaphoretic. I felt ... Read more
12 minutes after receiving the 2nd covid vaccination, I felt flushed and became diaphoretic. I felt heart palpitations and checked my heart rate which was 117, increasing to a max of 123. I was placed on a pulse ox monitor, which showed 93%, BP was elevated at 146/85. I was not given any medical treatment, and was placed on a monitor for one hour. Once my hr and 02 stas were at my baseline, I was allowed to be discharged. I went back to my department and decided to go home, as I felt tired and was mildly nauseous.
50 2021-01-10 fast heart rate Patient experienced lip swelling, tachycardia and flushing after vaccine administration. Patient was... Read more
Patient experienced lip swelling, tachycardia and flushing after vaccine administration. Patient was evaluated and treated in the ER and has been discharged at this time.
50 2021-01-13 chest pain, chest discomfort, inflammation of the pericardium Feverish feeling and chills with myalgias and weakness at 4am on 12/18/2020. Took 800mg advil and 10... Read more
Feverish feeling and chills with myalgias and weakness at 4am on 12/18/2020. Took 800mg advil and 1000mg tylenol. Felt perfect by 7 am. Despite this, fearing covid, I did not go to work, was rapid trsted covid negative that day and pcr tested that day retirning negative 2 days later. Days later I began to have vague nagging chest pain with occasional sharp chest pain over my heart. I had what I would describe as chest tightness in addition in which it felt hard for me to expand my chest fully like pressure without being short of breath. This would last at most several minutes and perhaps occurred three or four times over a seven day period. Throughout this. I could exercise with no chest pain no increasing shortness of breath, including a PR on Peloton and two hours of tennis without cardiac symptoms. Yesterday, my smart internist heard a split S2 heart sound as I lay on my left side and held my breath; the EKG showed a depressed PR interval ad some ST elevstions consistent with pericarditis, which I am treating with motrin. I assume this is a viral pericarditis. I had two types of Covid tests during that time period. My second dose of the vaccine was January 8. The feverish feeling occurred before dose 2, as did some of the chest oains and tightness.
50 2021-01-13 heart rate increased Anaphylactic reaction - swollen lips, dizziness, flushing, rapid heart rate
50 2021-01-20 fast heart rate 130 Per min heart rate , was diagnosed with tachycardia Chills, headache, fatigue 103.1 Fever
50 2021-01-20 fast heart rate 130 Per Minute Heart rate , Diagnosed with tachycardia Muscle Aches , chills 103.1 Fever Pain at th... Read more
130 Per Minute Heart rate , Diagnosed with tachycardia Muscle Aches , chills 103.1 Fever Pain at the injection site Sweats
50 2021-01-30 chest pain After 12 hours I was awoken with painful large swelling and lymphadenopathy in left axillary area. A... Read more
After 12 hours I was awoken with painful large swelling and lymphadenopathy in left axillary area. Area swollen caused pain in lateral, external chest area and axillary area with swelling approximately 10 x 6 cm. Area still swollen and painful 48 hours after vaccination on 29 JAN 2021 prompting report.
50 2021-02-02 nosebleed Had a vaccination in the morning. Took a nap before work that evening and woke up with a nose bleed.... Read more
Had a vaccination in the morning. Took a nap before work that evening and woke up with a nose bleed. That night discovered blood in the urine.
50 2021-02-02 pallor At 10:35am patient received Pfizer vaccination , Patient ambulated to the chair and at approximatel... Read more
At 10:35am patient received Pfizer vaccination , Patient ambulated to the chair and at approximately 10:40 am patient was sitting in chair appearance pale, diaphoretic, with complaints of dizziness , Patient remain Alert and oriented x 3 no loss of consciousness . Patient stated he have history of known needle phobia . Denies any past medical history. Patient also stated did not receive adequate breakfast or sleep. Water was given and also candy to increase blood sugar. Patient blood sugar and color improved after 10 minutes and also stated to feel back to his normal . Patient able to stand and walk on his own . EMS arrived on scene at 1050 am. Patient RMA. Vital signs 97.4 , 98, 74,112/74.
50 2021-02-03 palpitations Ectopy with skipped heart beats/Ectopy; myalgias; Fatigue; cough; Sore throat; This is a spontaneous... Read more
Ectopy with skipped heart beats/Ectopy; myalgias; Fatigue; cough; Sore throat; This is a spontaneous report received from a contactable physician (who is also the patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date unknown), via an unspecified route of administration in the left arm, on 21Dec2020 10:00, at single dose, for COVID-19 immunization, in the hospital. There was no medical history and no known allergies. The patient did not have COVID-19 prior to vaccination. There were no concomitant medication/other medications in two weeks. On 22Dec2021, the day after vaccination, the patient experienced ectopy with skipped heartbeats/ectopy along with myalgias, fatigue, cough and sore throat. The events resulted to "Doctor or other healthcare professional office/clinic visit". No treatment was provided for the events. The patient underwent COVID-19 test (nasal swab) on 25Dec2020 and was negative. The patient had not recovered from ectopy with skipped heartbeats/ectopy but recovered from myalgias, fatigue, cough, sore throat on an unspecified date (reported as "everything but ectopy has resolved").
50 2021-02-08 fainting, sinus rhythm About 5 minutes post vaccine, reports vasovagal syncope. Was taken to ED and treated with Zofran for... Read more
About 5 minutes post vaccine, reports vasovagal syncope. Was taken to ED and treated with Zofran for nausea. EKG showed HR of 30's but sinus rhythm. Hydrated with PO fluids and discharged home.
50 2021-02-11 nosebleed Received vaccination today 02/12/2021 at11 am. Around 10 pm I had epistaxis only in the left nostril... Read more
Received vaccination today 02/12/2021 at11 am. Around 10 pm I had epistaxis only in the left nostril. Stopped after three min. No trauma to the nose.
50 2021-02-18 atrial fibrillation An hour after 2nd dose, I experienced atrial fibrillation for the first time ever.
50 2021-02-22 very slow heart rate, pallor Flushed, pale, diaphoretic, bradycardic. Epi administered and RRT called. Admitted to hospital with ... Read more
Flushed, pale, diaphoretic, bradycardic. Epi administered and RRT called. Admitted to hospital with cardiac cath - likely unrelated.
50 2021-03-03 chest discomfort, chest pain The evening of the 2nd vaccine started having numbness in left shoulder and progressed to hand. The... Read more
The evening of the 2nd vaccine started having numbness in left shoulder and progressed to hand. Then numbness also affected left side of face and neck and left anterior chest wall. Intermittent pain in chest wall with intermittent resolve of numbness. The worst of it lasted a week. After a week, numbness started to resolve, but still have residual numbness in left hand. Did have headaches as well for that week and then headaches resolved after a week.
50 2021-03-03 fainting, pallor, blood pressure decreased Pt. stated he was feeling "woozy" to RN, pt. appeared pale and and his eyes were closing. Moments l... Read more
Pt. stated he was feeling "woozy" to RN, pt. appeared pale and and his eyes were closing. Moments later pt. had syncopal episode, Pt. was sitting in chair and was held in place by RN. Syncopal episode lasted about 30 seconds. His legs were elevated on nearby chair, inital BP was 71/36. NC cannula with 2 liter 02 placed. Pt. slowly woke up but blood pressure dipped to 51/21, HR 48, at that time pt was assisted to the floor and his legs were raised above his heart. 3 minutes later BP was 90/50 HR 55, and pt. was completely awake. 3 minutes later BP 103/57 HR 67, 5 minutes still on the floor, but sitting up BP 119/73 HR 74, given juice, pt. talking, laughing, color returned to normal. 5 minutes later, pt. sitting up in chair, BP 109/73 HR 73, 98% RA. During entire event SPO2 did not drop below 98%, Observed for total of 45 minutes.
50 2021-03-04 chest discomfort About an hour after the shot, I felt some tingling in my face; that was followed by a few odd sensat... Read more
About an hour after the shot, I felt some tingling in my face; that was followed by a few odd sensations, all of which are basically the same as when I have a flu shot. Eight hours after the shot, I noticed that I was smelling smoke; my sense of smell started to do weird things an hour before (for example, smelling rotten food in the fridge), but this became clear when the smoke smell started. Over the first 48 hours, my left arm was sore (sore to touch at 24 hours, gone at 48), and I had some mild flu symptoms (sore throat, stuffy nose, fatigue), plus some chest "tightness" which I have been feeling from time to time since March 2020. The flu-like symptoms were all basically gone except the stuffy nose. I still have a slight stuffy nose, and the strange smell issue. I have been able to smell things fine all along, it's just overlaid with a smell that started as smoke or BBQ, and varies in strength; it's a bit like smelling dirt now. It's always possible this is coincidental, but I wasn't exposed to smoke or anything that I think could cause my nose to go haywire.
50 2021-03-07 nosebleed Woke up with a nose bleed that afternoon; discovered blood in the urine; This is a spontaneous repor... Read more
Woke up with a nose bleed that afternoon; discovered blood in the urine; This is a spontaneous report from a contactable nurse. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK 4176, intramuscular, in the right arm, on 02Feb2021 09:00 at SINGLE DOSE for covid-19 immunization. Patient has no relevant medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. On 02Feb2021,the patient woke up with a nose bleed that afternoon then went to work that night and discovered blood in the urine. The outcome of events was unknown. The patient did not receive any treatment due to the events. Follow-up attempts are completed. The information on the batch/lot number has been obtained.
50 2021-03-11 fainting, pallor Patient "near-syncopal" per EMS. Patient stated light-headed, nauseated. EMS stated patient pale. Vi... Read more
Patient "near-syncopal" per EMS. Patient stated light-headed, nauseated. EMS stated patient pale. Vitals monitored by EMS in post vaccination waiting area. Patient then stated that he was feeling better. Patient released to go home in personal vehicle with spouse driving.
50 2021-03-11 fast heart rate, blood pressure increased Patient received dose 1 of the Pfizer vaccine at a clinic. After the dose was administered the patie... Read more
Patient received dose 1 of the Pfizer vaccine at a clinic. After the dose was administered the patient experienced tachycardia (pulse 110), elevated BP (measured with arm cuff at ~180/120), headache, and warmth. The patient was offered a cold pack, given water, and was taken away to a secluded room to relax under supervision. After about 1.5 hours the patient improved (BP 120/76 and pulse 85). The patient informed me that his rheumatologist recently had him stop his treatments for Crohn's disease in preparation to receive the vaccine. He stated that he had similar symptoms before when trying different treatment regimens for his underlying condition. The patient left on his own and no further adverse effects were reported.
50 2021-03-12 hypotension, lightheadedness Pt reported dizziness and nausea. BP borderline low 90/50s resolved with repeat reading 113/70. Sx l... Read more
Pt reported dizziness and nausea. BP borderline low 90/50s resolved with repeat reading 113/70. Sx likely secondary to vasovagal response. Pt was observed in car for 30 minutes
50 2021-03-14 blood pressure increased At 09:21 am Stated tightness in throat, diaphoresis, and nausea. At 09:24 am was given; 1 ml Benedry... Read more
At 09:21 am Stated tightness in throat, diaphoresis, and nausea. At 09:24 am was given; 1 ml Benedryl IM left deltoid. Started feeling relief at 09:30 am, then approximately 14 minutes later had tightness in throat again, stated having no difficulty breathing or swallowing. Called 911 at 09:45 am. O2 sat and heart rate were within normal range, elevated BP 153/93 lying and 163/103 sitting left arm. Agreed to go to ED with medical team at 09:55 am. walked out with paramedic.
50 2021-03-16 heart rate increased Tingling up left shoulder, neck and head approximately 1 minute post injection. Followed by flushi... Read more
Tingling up left shoulder, neck and head approximately 1 minute post injection. Followed by flushing, nausea and trembling. Approximately 5-7 minutes post injection experienced onset of difficulty swallowing and rapid heartbeat. 10-12 minutes post injection sensation of throat closing with some difficulty breathing, difficulty swallowing increased. 15-17 minutes post injection, paramedics arrived. Blood pressure was 169/113. Dizzy upon standing. 20 minutes post injection paramedics administered 50mg Benadryl due to difficulty swallowing and sensation of throat closing however it wasn?t worsening. Paramedic asked me to rate the swallowing difficulty (1-10) which was a 5-6 but never exceeded that. Transported to Emergency Room.
50 2021-03-16 hypotension, fainting Client had syncopal episode, diaphoretic, n/v assessed by Lead RN & EMS , EMStransported client for... Read more
Client had syncopal episode, diaphoretic, n/v assessed by Lead RN & EMS , EMStransported client for hypotension and weakness.
50 2021-03-19 blood pressure increased COVID-19 VACCINE. BLOOD PRESSURE INCREASE. 4 DAYS AFTER INJECTION,
50 2021-03-19 loss of consciousness Light headed Stomach upset Headache Passed out and shook on the ground Called paramedics
50 2021-03-19 fainting, hypotension, loss of consciousness 50 year old male patient with a history of well controlled T2DM and HLD who presents to the Emergenc... Read more
50 year old male patient with a history of well controlled T2DM and HLD who presents to the Emergency Department with chief complaint of syncope after 1st dose of Pfizer COVID-19 vaccine 30 minutes prior to arrival. Patient reports that while he was waiting after receiving his first dose of the COVID-19 vaccine, he developed a feeling of dizziness and reports that "things were going black slowly". He called for help. Per triage note, he was observed by the staff passing out. He did not fall/there was no head strike. He was found to be hypotensive with SBP of 69, followed by an SBP of 100 after sitting up, then again to the 60s. He received 250cc bolus fluid en route. Patient remembers feeling better after sitting up and now reports that he is at his baseline mental status and feels "completely normal". Patient received 1L normal saline in the ED.
50 2021-03-23 cardio-respiratory arrest, fainting Pt received vaccine on Friday, March 19th. On Monday, March 23rd, t was hiking with boy scout troop... Read more
Pt received vaccine on Friday, March 19th. On Monday, March 23rd, t was hiking with boy scout troop, became short of breath, collapsed and went into full arrest. BLS done on scene, transported to local ER where pt was pronounced dead.
50 2021-03-23 heart rate increased Every since getting my vaccine I have been having these symptoms. I received my first dose of phize... Read more
Every since getting my vaccine I have been having these symptoms. I received my first dose of phizer on 1/22/21 and a second dose 21 days later but was given Moderna not phizer. I continue to have headaches on and off all day, they are short but intense lasting about 5-10 minutes, sometimes hour or two between. Also shortness of breath and increased heart rate with just slight activity. Going up a flight of stairs my heart rate will quickly increase to 130-140 BPM which has never happened before. I have a fitness tracker on my watch so I watch it closely every day and it was never that high. My heart rate will recover fairly quick if I sit and it will come down to 80-90 BPM, at night when relaxed for a while the lowest I see it is about 70-75 BPM, sleeping it will be around 65 bpm.
50 2021-03-26 loss of consciousness Patient has a phobia of getting any kind of shots.. he passed out but still had a pulse.. we woke hi... Read more
Patient has a phobia of getting any kind of shots.. he passed out but still had a pulse.. we woke him up by yelling his name and his eyes fluttered and he was then able to talk and wanted water.. EMT came but patient denied services
50 2021-03-28 chest discomfort Patient felt pressure in the chest, tingling in the right leg and watery eyes after receiving the va... Read more
Patient felt pressure in the chest, tingling in the right leg and watery eyes after receiving the vaccine. After drinking water the patient felt better. Heart rate and breathing were fine
50 2021-03-28 palpitations Part of the face started to clench a little, don't know if that's part of Bell's palsy or that was j... Read more
Part of the face started to clench a little, don't know if that's part of Bell's palsy or that was just; Heart palpitations; Chills; This is a spontaneous report from a contactable consumer, who reported for himself. A 50-years-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6206), via an unspecified route of administration, on 03Mar2021 at 3:15 pm (at the age of 50-years-old) as a single dose for COVID-19 immunization, in left arm. Relevant medical history included cholesterol. Concomitant medications included: Rosuvastatin 20mg, once a day for cholesterol, started a year ago and Vitamin C. On 03Mar2021, the patient had heart palpitations that lasted multiple days. I went to a cardiologist and he wasn't sure whether I should do a second vaccine dose, given that was one of the side effect. He gave me metoprolol which took down the heart rate. But I had the chills, I had part of the face started to clench a little. I don't know if that's part of Bell's palsy or that was just, I just don't know. It wasn't strong, it went away relatively quickly, within 4 hours. Treatment for heart palpitation: Metoprolol Tartrate, 25 mg, one. No treatment received for chills. The clinical outcome of the events Heart palpitations and chills was recovered on 11Mar2021, the outcome of the event face started to clench a little was recovered on 03Mar2021.
50 2021-03-28 lightheadedness Patient had a vasovagal response. He became lightheaded. He laid down on stretcher. Gave him juice. ... Read more
Patient had a vasovagal response. He became lightheaded. He laid down on stretcher. Gave him juice. Symptoms improved.
50 2021-03-30 cerebrovascular accident Thrombus of right middle cerebral artery at bifurcation of M1 and M2 causing stroke
50 2021-03-30 heart rate increased Fast heart beat for about 1 minute max.
50 2021-03-30 heart attack 2 days after 1st shot I felt extreme fatigue and shortness of breath for several days. Got tested fo... Read more
2 days after 1st shot I felt extreme fatigue and shortness of breath for several days. Got tested for COVID with negative results. Went to hospital on 16th of February and was admitted due to heart condition and recent heart attack. I told them my next vaccine was due on the 18th and they gave it to me while I was admitted. Within 24 hours I had another heart attack. I was sent to another hospital for an Angiogram where they expected to find blockage and prepared to install a stint. They found no blockage. There is no medical explination.
50 2021-03-31 lightheadedness Responded to Nurse Alert in Covid vaccine clinic Department. Interventions: IV NS 0.9% started ... Read more
Responded to Nurse Alert in Covid vaccine clinic Department. Interventions: IV NS 0.9% started @ rate: Bolus , time: NA, per instruction (Verbal Order) by Dr. Blood Sugar Reading (per accucheck): 106 mg/dl; Nourishment offered: no Baseline and succeeding Vital Signs: Time Taken 1945 Temperature na Pulse Rate 42 Respiration Rate 16 Blood Pressure 96/62 O2 Saturation 72 Quick Nursing Assessment at the Scene: Pt was dysphoretic, A&Ox3 gray in color. Cold and clammy. Pt reports feeling dizzy and almost falling in the bathroom. During assessment Pt want unresponsive. Pt never lost his pulse. Nurses alert was called than 911. Pt was A&Ox3 when EMS arrived. 2L of O2 NC was placed on Pt and SPO2 increased to 100%. 20G IV was started in the left AC and NS bolus was rendered. EMS ALS took Pt to the nearest hospital. Pt did receive 0.3 second dose of Pfizer vaccine. Patient Disposition: 911 called.
50 2021-04-01 chest discomfort Starting 3/30/21 head and whole body paresthesias with mild chest tightness. Still present 4/2/21 a... Read more
Starting 3/30/21 head and whole body paresthesias with mild chest tightness. Still present 4/2/21 and symptoms about the same. No weakness, change in mental status, shortness of breath or loss of any function.
50 2021-04-01 low blood oxigenation Patient reports feeling unwell for approximately 2 weeks, but began having fevers, body aches, and c... Read more
Patient reports feeling unwell for approximately 2 weeks, but began having fevers, body aches, and chills about 5-6 days prior to ED presentation. Also reports cough and headache. Patient hypoxic to 87% requiring 2L O2 via nasal cannula. Patient febrile at 101.4 F. Patient to be admitted to the hospital. The patient has received dexamethasone, along with medications for symptom management including acetaminophen, ketorolac, and benzonatate.
50 2021-04-02 palpitations Headaches Bodyaches Vomiting Fever Shakiness Heart racing
50 2021-04-05 hypotension Patient presented to ED with two day history of hives over body. Received treatment for anaphylaxis... Read more
Patient presented to ED with two day history of hives over body. Received treatment for anaphylaxis in ED including Epi-Pen, Pepcid, Benadryl, and Solumedrol. Patient initially hypotensive.
50 2021-04-06 hypertension Flushing, headache, and hypertension Treated with intravenous ketorolac and famotidine Flushing, hea... Read more
Flushing, headache, and hypertension Treated with intravenous ketorolac and famotidine Flushing, headache, and hypertension improving
50 2021-04-07 chest discomfort pt stated that right after he got the vaccine, "within a few minutes", started to have chest tightne... Read more
pt stated that right after he got the vaccine, "within a few minutes", started to have chest tightness. they didn't tell him that it was a concern. Pt states that the chest tightness has gotten worse as the day went on , and had to come outside to get some air and it hasn't helped.
50 2021-04-07 palpitations Fever and chills beginning approximately 14 hours after second shot. Insomnia and racing heart all ... Read more
Fever and chills beginning approximately 14 hours after second shot. Insomnia and racing heart all night. Body felt extremely cold, and I had to add three layers of sweatpants/sweatshirts/socks to stay warm. Headache and fatigue lasted approximately 48 hours. Took 72 hours to feel back to 100%
50 2021-04-08 blood pressure increased, fast heart rate Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mi... Read more
Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: patient described as an almost panic attatck reaction - shakiness, dizziness, blurry vision, nausea. Blood pressure and heart rate not elevated. SAt for 20 minutes and started feeling better then got the chills and more shakiness
50 2021-04-08 blood pressure increased 2nd phizer vaccine- normal side effects started around 9-10 am but progressively got worse during da... Read more
2nd phizer vaccine- normal side effects started around 9-10 am but progressively got worse during day and into evening. Aches, chills, fever, headache- around 5:30 pm had an issue with blurred vision in my left eye for approx 15 mins, similar to a migraine apparently (never had one before)- blood pressure spiked to 164/104 and resting heart rate was between 90-104, normally 52-60. Headache persisted for nearly 9-10 hours and all symptoms improved dramatically after two Tylenol
50 2021-04-09 blood pressure increased Elevated blood pressure 15 minutes after vacine administered. 168/113 HR 75. Checked into Emergency ... Read more
Elevated blood pressure 15 minutes after vacine administered. 168/113 HR 75. Checked into Emergency Room for observation. Blood work results for target vitals normal EKG normal. Blood pressure normalized after 4 hours.
50 2021-04-10 chest pain, chest discomfort Vaccine administered 9.20am. Fatigue shortly after vaccine was administered - slept most of afternoo... Read more
Vaccine administered 9.20am. Fatigue shortly after vaccine was administered - slept most of afternoon. Injection site pain - feels like been punched in arm. Headache in the evening. Night chills and complained of "tight" (not acute) chest pain... but no breathing problems. Morning fever of 101F. Headache, Dizzy, Fatigue, Muscle Pain (esp in legs, asif he had "run a marathon"). He spent most of the day "resting". Evening on day two, we noticed a large bump under his vaccinated arm. Radius about 5cm - larger than what I know swollen lymph nodes to look like - almost looks like a bicep between his armpit and nipple. Tender to touch. Morning of day three (48 hours after vaccine) bump under his arm remains and all other symptoms seem milder.
50 2021-04-12 heart rate increased Roughly 30 mins (10:30am) after I received my 2nd Pfizer vaccine shot, I was about 5 mins from my ho... Read more
Roughly 30 mins (10:30am) after I received my 2nd Pfizer vaccine shot, I was about 5 mins from my home and began to feel tingling/numbing in my mouth and tongue. I got in my house and told my wife I was not feeling right and started to notice a dizziness coming on. I was to call the pharmacy to find out what I should do, but noticed my heart rate was up, I looked at my Apple watch monitor and my BPM was 164. I felt flush and told my wife to call 911. Ambulance arrived and took my vitals and ( I do not recall the blood pressure, but it was high for me) when they put me into the ambulance I began to shake uncontrollably and then began to sweat profusely. They took me to the emergency room, but did not administer any drugs. The Dr. came in and said he did not think it was related to the vaccine, but my personal Dr. agreed with me based on my medical history that it had to be related to the vaccine. My resting heart rate (I monitor this daily) is between 45 - 60 and my last blood pressure reading at my yearly physical on April 2nd, 2021 was 100/70.
50 2021-04-13 fainting Patient had a syncopal episode post vaccine, as well as dizziness, diaphoresis.
50 2021-04-14 blood pressure increased Approx. 30 min after receiving 2nd dose of COVID vaccine pt stated feeling "dizzy and flushed." Pt t... Read more
Approx. 30 min after receiving 2nd dose of COVID vaccine pt stated feeling "dizzy and flushed." Pt taken by wheelchair to private observation area and VS assessed by RN. Pt noted to have an elevated BP outside of normal parameters. Pt aox4, denies any pain, sob, chest pain or difficulty breathing. Pt continued to monitored and assessed by RN over a period of approx. 30 min. and BP remained elevated outside normal parameters. Pt agreeable to be treated in Emergency Room. Pt taken by wheelchair to ED by charge nurse and another ED staff member. Pt able to follow commands and able to ambulate on his own to wheelchair. Pt denies any dizziness, blurred vision, nausea, sob, head/chest pain or difficulty breathing.
50 2021-04-14 chest discomfort Pt began to have chest tightness around 15 mins after vaccine. Pt stated his throat felt scratchy. P... Read more
Pt began to have chest tightness around 15 mins after vaccine. Pt stated his throat felt scratchy. Pt had clear lungs bilaterally and good heart sound. No stridor noted in the neck and tongue. Throat appeared clear at time of observation.
50 2021-04-14 chest pain, deep vein blood clot, pulmonary embolism developed chest pain and shortness of breath 12 hours after vaccination and went to ED and hospitali... Read more
developed chest pain and shortness of breath 12 hours after vaccination and went to ED and hospitalized with PE and DVT and now on xarelto
50 2021-04-14 lightheadedness Patient presents with a potential reaction to the COVID19 vaccine. I was called to evaluate the pati... Read more
Patient presents with a potential reaction to the COVID19 vaccine. I was called to evaluate the patient in the car lineup into the monitoring area. The patient had a moderate vasovagal episode without syncope. He was given oral hydration, placed supine, and moved to the monitoring area. He improved rapidly. With close monitoring and hydration, he improved to baseline and was returned home with his wife as the driver.
50 2021-04-15 blood pressure increased, heart rate increased Patient became dizzy, heart rate became elevated, and blood pressure became elevated. Patient did no... Read more
Patient became dizzy, heart rate became elevated, and blood pressure became elevated. Patient did not improve after 15 minutes. EMS was activated and at scene in 10 minutes. Patient was walked out by EMS.
50 2021-04-15 heart rate increased Severe allergic reaction anaphylactic shock Hives, rash,swelling, headache, stomach ache, body aches... Read more
Severe allergic reaction anaphylactic shock Hives, rash,swelling, headache, stomach ache, body aches, elevated heart rate, uncontrollable body spasms, loss of appetite
50 2021-04-15 pallor Patient made an appointment for the COVID-19 vaccine (Pfizer). Patient let us know that he has medic... Read more
Patient made an appointment for the COVID-19 vaccine (Pfizer). Patient let us know that he has medical induced anxiety. He has passed out from random medical appointments in the past. Patient was sitting within eye view of the pharmacy. A passing by gentleman said "Dude, are you ok?". I looked over and the gentleman was no longer in his chair. Customer helped gentleman into the chair. The nurse who administered the shot and myself (pharmacist) ran out with the emergency kit. Patient was conscious, but had no color in his face. We gave him water, orange juice, and moist towel for his forehead. Nurse took pulse, it was within normal range. Called 911, EMTs arrived. Patient declined any more help. He walked out of the pharmacy area. Total time of event: 15 minutes.
50 2021-04-16 atrial fibrillation Within a couple of hours of second Pfizer shot I experienced symptoms of Atrial Fib and sought treat... Read more
Within a couple of hours of second Pfizer shot I experienced symptoms of Atrial Fib and sought treatment at the local healthcare facility. After 13 hours of treatment my heart ?coveted ? and was released for the hospital. I received meds and tests to make the conversation happen
50 2021-04-16 fainting, loss of consciousness syncopal episode 1 minute after receiving second Covid vaccine dose. Patient had head down and slump... Read more
syncopal episode 1 minute after receiving second Covid vaccine dose. Patient had head down and slumped over, was diaphoretic. Patient also had a syncopal episode after his first dose at the end of March, and at that time fell and hit his head, requiring a CT head. Additionally at that time patient continued to have persistent nausea and vomiting afterwards requiring numerous antiemetics and IV fluids. He also had a full work-up, which did not reveal any concerning signs in relation to his syncopal event. Before syncopized today, patient denies experiencing any chest pain, palpitations, shortness of breath, nausea. He said he began to experience some lightheadedness, and then lost consciousness. This was witnessed by his husband, who is with the patient today. Denies any head trauma, neck trauma. He spontaneously regained consciousness shortly after, and felt clammy, however was not experiencing any other symptoms. Patient currently denies any symptoms. Endorses compliance with his medications.
50 2021-04-19 chest pain I was woke up out of my sleep at 2:00 a.m. with terrible pain in back and chest around the heart. I... Read more
I was woke up out of my sleep at 2:00 a.m. with terrible pain in back and chest around the heart. It felt like I was having a heart attack.
50 2021-04-20 chest pain I started having a pain in my chest and I noticed a rush which was very very itchy, painful in a cir... Read more
I started having a pain in my chest and I noticed a rush which was very very itchy, painful in a circle right in the middle of my chest. I though it was shingles since I had ir before, I went to the doctor and he prescribed some mediction and a cream, I still have the circle and it still itches, looks better but today I am supposed to get the second Pfizer shot.
50 2021-04-20 loss of consciousness Patient passed out after receiving first dose of Pfizer COVID19 vaccine. He did not hit the ground a... Read more
Patient passed out after receiving first dose of Pfizer COVID19 vaccine. He did not hit the ground as someone else caught him. His BP was taken and read 70/59 originally and then came back up to 144/83 after laying on floor with feet on chair. Patient said that this has happened before when giving blood or dealing with needles.
50 2021-04-20 pulmonary embolism pulmonary embolism; shortness of breath; This is a spontaneous report from a contactable consumer (p... Read more
pulmonary embolism; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ep7534), via an unspecified route of administration, administered in right arm on 16Mar2021 15:00 as single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included verapamil. The patient previously took lisinopril and experienced allergies. The patient received first dose of bnt162b2 on 23Feb2021, 13:00 for Covid-19 immunization. On 19Mar2021, the patient started having challenges with shortness of breath. On 31Mar2021, after the challenge continued to grow he was checked into the hospital and was diagnosed with pulmonary embolism. Despite no travel nor history of family blood clots, nor was he was genetically dispositioned. The events resulted in emergency room/department or urgent care. Therapy for the events included Blood thinner. The patient had no other vaccine in 4 weeks, and no Covid prior vaccination. The patient was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab was negative on 31Mar2021. Outcome of events was recovering.
50 2021-04-21 platelet count decreased, low blood platelet count Bleeding of the gums began followed by black bloody mouth and lip blisters followed by small red/bro... Read more
Bleeding of the gums began followed by black bloody mouth and lip blisters followed by small red/brown dots all over my lower legs and arms followed by black and blue bruises on legs and arms. Went to ER seven days after first noticed symptoms. Was admitted to ICU with platelet level near 2,000. Complete blood workup was done and everything was eliminated except Immune Thrombocytopenic Purpura (ITP). I was treated intravenously with immunoglobulin and steroids. On 4/21/21 I was released from the hospital with my platelet level near 49,000. Following up with hematologist on 4/26/21 for further testing and evaluation.
50 2021-04-21 pulmonary embolism Patient presented to ED for c/o SOB 4/17/21. He was diagnosed with PE. Also for completion, patient ... Read more
Patient presented to ED for c/o SOB 4/17/21. He was diagnosed with PE. Also for completion, patient did have shoulder surgery 6 weeks ago without complication.
50 2021-04-22 low blood oxigenation Pt received his first dose of Pfizer COVID vaccine on 4/10/21 and started having myalgias and cough ... Read more
Pt received his first dose of Pfizer COVID vaccine on 4/10/21 and started having myalgias and cough on 4/14. He was tested for COVID on 4/16 and received the positive result on 4/19. He then developed fever, loss of taste, nausea, and shortness of breath which prompted him to present to urgent care, and they told him to go to ED on 4/22/21. Patient was found to be hypoxic and was admitted to the hospital for COVID treatment.
50 2021-04-22 palpitations Shortness of breath, heart palpitations, vertigo/dizziness, phantom body pains appearing and disappe... Read more
Shortness of breath, heart palpitations, vertigo/dizziness, phantom body pains appearing and disappearing in various places, occasional itching sensation, numbness, brain fog, double-vision, extreme tiredness. Symptoms tapered off over 3-5 days. Similar experience with 2nd vaccine but less pronounced with a shorter timeframe, tapering off after 2-3 days. Strongest side effects after first vaccine, symptoms did not become noticeable until a couple of hours after it was administered, increasing next 24 hours before lessening over time. Basically identical to long covid symptoms but lasting only for a few days after vaccinations and not before.
50 2021-04-23 chest pain Vomiting and severe chest pain. 9 out of 10.
50 2021-04-23 loss of consciousness at 5am this morning i woke up with a severe headache and feeling nauseous. I sat at the end of my b... Read more
at 5am this morning i woke up with a severe headache and feeling nauseous. I sat at the end of my bed and then do not remember anything until my head hit the bathroom floor. My wife said i stumbled across the bedroom into the bathroom and it looked as if i just passed out and fell to the ground.
50 2021-04-23 pallor, fainting, hypotension Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: anxious before the shot. started sweating and felt dizzy 2-3 minutes after the shot. gave water to patient and asked them to take deep breaths. patient then started to become unresponsive,pale with no blood flow to face. no improvement was seen and then epinephrine shot (adult) was administered. patient started to regain consciousness and became slightly responsive after a couple minutes. had the patient sit down and put theit legs up on a chair. EMT arrived and out of caution took them to ER.
50 2021-04-25 hypertension Flu like systems, started with soreness in the morning, than escalated to chills, fever, hypertensio... Read more
Flu like systems, started with soreness in the morning, than escalated to chills, fever, hypertension.. A couple of coughs and sneezes and overall fatigue and eventual exhaustion all signs were present on the Friday throughout the day, by Saturday morning, all but the soreness cleared up.
50 2021-04-26 very slow heart rate, lightheadedness, pallor Vasovagal episode Pt became pale bradycardic and diaphoretic He responded with juice and crackers R... Read more
Vasovagal episode Pt became pale bradycardic and diaphoretic He responded with juice and crackers Repeat vital signs BP 124/64 P 74 97% on RA
50 2021-04-26 chest pain Lower back pain (continuous as of today however less than before), fatigue (7 days), mid-chest pain ... Read more
Lower back pain (continuous as of today however less than before), fatigue (7 days), mid-chest pain (1.5 days), intermittent dull pulse pain?right leg calf (continuous)
50 2021-04-27 blood pressure increased, heart rate increased Awoke to uncontrollable spasmatic shivering, ice cold feet, increased heart rate of 110, increased b... Read more
Awoke to uncontrollable spasmatic shivering, ice cold feet, increased heart rate of 110, increased blood pressure 151/84. Worst of it lasting over 1 and a half hours before extreme shivering subsided with continued stress.
50 2021-04-27 pulmonary embolism, deep vein blood clot I received the Pfizer vaccine on 21 December 2021. On December 27 I developed a fever, cough and wa... Read more
I received the Pfizer vaccine on 21 December 2021. On December 27 I developed a fever, cough and was diagnosed with Covid-19. About 14 days later I started to get a rash on hands and feet with burning sensation. I was evaluated and diagnosed with Covid toes. About 1 week later I developed a fever and was evaluated and diagnosed with pneumonia, pulmonary embolism, and a DVT. I continue to get worse to include arthritis in hands, wrists, feet and ankles. I was admitted to the hospital with worsening pneumonia, reactive arthritis and a rash on elbows, knees, hands and feet. I was in the hospital for about 5 days. I have been evaluated by rheumatology, pulmonary and dermatology since. The ongoing theory is I have a reactive arthritis from COVID and may have developed psoriasis/psoriatic arthritis.
50 2021-04-28 blood pressure increased, hypertension On April 1, 2021, I received my 1st dose of the Pfizer vaccine at the Center and the only side effec... Read more
On April 1, 2021, I received my 1st dose of the Pfizer vaccine at the Center and the only side effect from the vaccine at that time was localized soreness at the injection site of my left shoulder. On April 2, 2021, earlier that day the soreness at the injection site began to dissipate after doing push-ups and massaging my left arm. After going to bed last night and that night is when the additional side effects started. I was awakened by itching on both arms which had formed whelps from my shoulder to my forearm. For the next 13 days, the whelps and itching were sparsely during the day (which had consumed my legs, upper torso as well as arms) as they presented the illusion to be getting better but would flare up at night while sleeping. I attempted to do home remedies from Calamine lotion, Benadryl and cold showers but nothing seemed to effectively work against the itching and the whelps that resembled Hives. On April 13, 2021, while at work a new side affect began which was the swelling of my bottom lip (particularly the right half) along with itching in my throat. The swelling reduced itself as I continued to work through the night but the discomfort in my throat continued. The whelps and itching were still sparsely present as well. On April 14, 2021, later that morning, post work, the reduced swelling of my lower lip and throat discomfort I decided to go to the ER. While enroute to the ER, my top lip began to tingle and swell. These events made me more concerned about the severity I was experiencing since receiving the vaccine. After checking into the ER and being triaged, the doctor informed me that I would be hospitalized overnight due to the swelling of my upper lip, elongated tonsils, elevated blood pressure and the diagnosis of whelps as Hives. For the next three nights I was intravenous administered Epinephrine, Benadryl and Prednisone. On April 16, 2021, the third night I was discharged from the hospital with the same medications and informed to follow up with an allergist.
50 2021-04-29 chest discomfort Had normal side effects for 24 hrs after vaccine(pain, chills, headache, tiredness). 2 days after va... Read more
Had normal side effects for 24 hrs after vaccine(pain, chills, headache, tiredness). 2 days after vaccine, starting with significant runny nose, mild cough, mild sore throat, and some mild chest discomfort during physical activity.
50 2021-05-02 palpitations Heart palpitations at night 1 day after receiving 2nd Pfizer dose. Lasted about 12 hours.
50 2021-05-03 chest pain Pt says that he has had "fuzzy thinking," having trouble recalling words and was off balance. He ha... Read more
Pt says that he has had "fuzzy thinking," having trouble recalling words and was off balance. He had slurred speech. He also had left side chest pain and trouble breathing.
50 2021-05-03 pallor Palor, lightheadedness
50 2021-05-03 pulmonary embolism 8 days post vaccine patient developed rash on left arm that spread to b/l arms and legs. Over the n... Read more
8 days post vaccine patient developed rash on left arm that spread to b/l arms and legs. Over the next few days developed increased fatigue, severe joint pain, fever and worsening rash. Was seen in ER on 4/23/2021. Extensive work up showed increased CRP, Eosinophilia, increased LFTs, increased WBC. Skin biopsy was taken and revealed Superficial and deep perivascular and interstitial dermatitis, histiocyte-predominant and with eosinophils. ANA was positive 1:640, Ferritin was elevated. The patient was admitted. . Patient had CT scan of the chest on 4/28/2021 which showed bilateral pulmonary embolism and possible mass in the right side of the liver. Patient was started on anticoagulation. Next day, patient had severe abdominal pain with pain in the right lower quadrant. He as found to have Ogilivie's Syndrome with colon ischemia and peritonitis. Now s/p resection with septic shock. The patient is in the ICU and intubated.
50 2021-05-04 pallor Was feeling fine and health when prior to the shot. We were directed (wife and I) to sit down for 1... Read more
Was feeling fine and health when prior to the shot. We were directed (wife and I) to sit down for 15 minutes before leaving. For the first 13 minutes I was talking to my wife, joking, etc. I felt fine. However, after 13 minutes or so, I started to felt light heading and week. Then started to sweat and then I couldn't speak. I felt like passing out. My wife told me that the a man was trying to told we up and prevent me from falling. I could hear what others were saying. My wife states I turned pale, eyes looked stright ahead, and my mouth was distorted. This came all at once and within a minute experienced all these symptoms. The pharmacy staff gave me an eppy shot to get me back, then I was told to lay down on the floor. I came to withing a minute or two and felt much better. They had called 911 for an ambulence to come out. The responders checked me out (vitals) and all looked fine, but I was highly advised to go with them to the ER to get checked out.
50 2021-05-05 loss of consciousness Patient came in to get his second pfizer vaccine. He waited his 15 minutes of observation, I told hi... Read more
Patient came in to get his second pfizer vaccine. He waited his 15 minutes of observation, I told him his time was up and he walked around the pharmacy area a little bit and talked with one of the technicians. He left the store and passed out in the parking lot. An ambulance was called because he was not coherent and the EMS said his blood pressure was over 200 systolic. We informed them he was a diabetic but we weren't told what his blood sugar level was before taking him to the hospital.
50 2021-05-09 cerebrovascular accident CEREBROVASCULAR ACCIDENT R56.9 - Seizure (CMS/HCC)
50 2021-05-09 blood clot Blood clot
50 2021-05-10 chest pain Presented to ED today with complaint of right-sided CP onset yesterday. Patient has history of renal... Read more
Presented to ED today with complaint of right-sided CP onset yesterday. Patient has history of renal cell carcinoma with metastatic disease to the liver. He has had recurrent pleural effusions involving the right lung. Has worsened pain with breathing. Had a R tube placed due to pleural effusion and last week when the tape was taken off it pulled and caused pain. Endorses SOB. No significant cardiac history. No h/o DVT, PE. Has renal CA and had L kidney removed. Patient admitted. Pulmonary/critical care was consulted regarding Pleurx catheter. It is felt that his pleural effusion had decreased in size, and the catheter was likely contributing to his right-sided pleuritic chest pain. Catheter is removed with good results of his pain. Patient however did have recurrent fevers. Empirically placed on Rocephin. With this, he did improve. He was discharged in stable condition.
50 2021-05-11 cerebrovascular accident Brain inflammation; Stroke like event/seizure; Stroke like event/seizure; This is a spontaneous repo... Read more
Brain inflammation; Stroke like event/seizure; Stroke like event/seizure; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration, administered in left arm on 19Apr2021 16:00 (Lot Number: ER8731) 2ND DOSE, single for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received 1st dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, lot number: EP6955) on 29Mar2021 01:00 PM in the left arm for COVID-19 immunization and experienced stroke like event/seizure. The patient had stroke like event/seizure following first and second injections. The patient also had brain inflammation. Events onset date reported as 22Apr2021 11:00. The events were reported as serious due to hospitalization in Apr2021 for 5 days. Events resulted in doctor or other healthcare professional office/clinic visit and a visit to emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient been tested for COVID-19 since the vaccination. Outcome of events was unknown. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Apr2021. No treatment received for the events. Further information has been requested.
50 2021-05-12 cerebrovascular accident seizure; Stroke like event; This is a spontaneous report received from a contactable consumer (Patie... Read more
seizure; Stroke like event; This is a spontaneous report received from a contactable consumer (Patient) reporting for himself. A 50-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 29Mar2021 01:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date. The patient's concomitant medications were not reported. The patient experienced seizure and stroke like event on 22Apr2021 at 11:00. The patient was hospitalized for seizure and stroke like event for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Apr2021. Outcome of the events was unknown Information on Lot/Batch number was available. Additional information has been requested.
50 2021-05-12 troponin increased, inflammation of the heart muscle Myocarditis
50 2021-05-16 low blood oxigenation Patient with Hodking's lymphoma (bendamustine and brentuximab since 4/28/21), admitted for subacute ... Read more
Patient with Hodking's lymphoma (bendamustine and brentuximab since 4/28/21), admitted for subacute onset of SOB and hypoxia w/ CT showing bilateral pulmonary opacities concerning for pneumonitis or infection.
50 2021-05-19 hypertension Pt felt dizzy after vaccine. Asked pt if had history of hypertension. Pt said yes. Asked if was c... Read more
Pt felt dizzy after vaccine. Asked pt if had history of hypertension. Pt said yes. Asked if was compliant. Pt stated had not been adherent for 1 week. Onsite EMS Checked bp, it was greater than 170/90. pt was recommended to go to urgent care by family member who was going to pick him up. Pt was escorted out of building by onsite ems.
50 2021-05-21 blood clot, cerebrovascular accident nurse stated it could possibly be blood clots; Patient is afraid he is going to have a stroke or sca... Read more
nurse stated it could possibly be blood clots; Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines; blurred vision in right eye that comes and goes; ringing in his left ear; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Fullness in face; Body aches; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; feeling dizziness/had to stop driving; This is a spontaneous report from a contactable consumer (patient's wife). A 50-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 (may have been in morning) (Batch/Lot Number: Unknown; Pfizer COVID-19 vaccine) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 50 years old. The patient's medical history and concomitant medications were not reported. History and Investigations: Doesn't take any medications. Has no medical conditions, unless age was considered a medical condition. Historical vaccine included first dose of COVID-19 Vaccine reported as on Third Friday in Feb2021 (First dose: between 1430-1530), and experienced AEs: Brain fog; Headache: Thinks in the back of the head, but moved around too, sometimes in the front. Has affected his balance. Dizziness: Had to stop a couple times while driving home from vaccine facility. Aches and pains. All symptoms from the first dose went away within 3-4 days. Caller would say patient recovered completely from symptoms associated with first dose. The patient experienced nurse stated it could possibly be blood clots on an unspecified date with outcome of unknown, patient is afraid he is going to have a stroke or scared he had one after the covid-19 vaccines on an unspecified date with outcome of unknown, brain fog: at times he can't do the simplest things. he will look at the clock on the wall and says he knows what it is, but can't find the words to say. cannot carry on a conversation intelligently on 12Apr2021 with outcome of not recovered, headache all over the back of his head/affecting his balance. in back of head, moves around, sometimes the front on 12Apr2021 with outcome of not recovered, feeling dizziness/had to stop driving on 12Apr2021 with outcome of not recovered, blurred vision in right eye that comes and goes on an unspecified date with outcome of not recovered, ringing in his left ear on an unspecified date with outcome of not recovered, fullness in face on 12Apr2021 with outcome of not recovered, body aches on 12Apr2021 with outcome of not recovered, very fatigued throughout the day, sleeping a lot/tired and sleeps a lot on an unspecified date with outcome of not recovered, date received first dose: third friday in feb2021/received second dose on 12apr2021, six weeks after first dose on an unspecified date with outcome of unknown. Patient was caller's husband. Had both doses and had the same problem. His experience is very bad with the second dose and has had it for a month. Within a day after the first dose, had brain fog, headache, and dizziness where he had to stop driving a couple times. This went away within a few days. Patient and caller were concerned about the second dose. They spoke with patient's doctor and the local Health Department, both said it couldn't be from the vaccine. Patient was advised to get the second dose. Had the same symptoms with second dose, but occurred within an hour of received second dose. Symptoms have continued. Also experiencing blurred vision in right eye that comes and goes. Patient had an appointment with his doctor this week, but the doctor basically didn't look at him. Doctor advised patient to see a neurologist. Another nurse stated it could possibly be blood clots. Caller is trying to find help. Caller wanted to add with the second dose, patient experienced ringing in his left ear, fullness in his face, and headache all over the back of his head. Was feeling dizziness after second dose and had to stop driving. Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines. If the COVID-19 Vaccines woke up some other health issues, patient wants to get it taken care of. Received second dose on 12Apr2021, six weeks after first dose. Got second dose at a different location. Second dose COVID-19 Vaccine AEs: Started experiencing symptoms within an hour. Headache: Affecting his balance. In back of head, moves around, sometimes the front. Comes and goes. Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently. Dizziness. Blurred vision in right eye: Doesn't know if this started on 12Apr2021 or a couple days after. States as the day goes on and he gets tired, it will worsen. It comes and goes. Ringing in left ear: Began on 12Apr2021 or a few days after. Fullness in face: Stated this comes and goes, but has stayed the same. Documented as provided. Body aches: Comes and goes. Seems to worsen as the day goes on. Very fatigued throughout the day, sleeping a lot: He's tired and sleeps a lot. It was hard for him to get out of bed. Caller stated patient's symptoms worse as the days goes on. Patient never experienced pain at the injection site. Guesses patient received COVID-19 vaccines in his left arm because the county was doing a dive-thru clinic. Since he didn't get out of his car, she believed patient would have received the vaccines in the left arm. The events REQUIRE A VISIT TO Physician office: Doctor doesn't think anything is wrong. ER: Not yet. Is considering going to the ER today. PRIOR VACCINCATIONS WTIHIN 4 WEEKS was None. RELEVANT TESTS: None. Events Clot blood and stroke considered medically significant. Follow up attempts are needed. Information of Lot/Batch number has been requested.
50 2021-05-22 platelet count decreased Pfizer covid series 3/24/21, 4/19/21 presented to office on 4/21/21 with petechial rash (which may h... Read more
Pfizer covid series 3/24/21, 4/19/21 presented to office on 4/21/21 with petechial rash (which may have preceded 2nd vaccine) and was admitted to hospital 4/21- 4/24 with platelet count 2000. He continues to be seen by hematologist for ITP
50 2021-05-22 fainting, hypotension Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypo... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium
50 2021-05-24 palpitations, palpitations, cardiac arrhythmia March 8th - Dizziness, heart palpitations, skipped beats, tunnel vision, hypotension. This was follo... Read more
March 8th - Dizziness, heart palpitations, skipped beats, tunnel vision, hypotension. This was followed by 2 weeks of regular PAC's and PVC's noted by my self. This did not seem to be related to any kind of anxiety since I have never had anxiety problems. I eventually had an echo cardiogram on 03/30/2021 which resulted as normal I also wore a Ziopatch for 2 weeks from 03/30/2021 which resulted as normal. By the time I was able to be tested most of my symptoms had resolved.
50 2021-05-28 palpitations Flu like symptoms for two days once those subsided then shortness of breath and heart palpitations b... Read more
Flu like symptoms for two days once those subsided then shortness of breath and heart palpitations began and have not subsided.
50 2021-05-31 cerebrovascular accident I63.9 - CVA (cerebral vascular accident) (CMS/HCC) I63.9 - Cerebrovascular accident (CVA), unspecifi... Read more
I63.9 - CVA (cerebral vascular accident) (CMS/HCC) I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC
50 2021-06-01 palpitations, arrhythmia, palpitations Six days after receiving the second vaccination, I had a night of non-stop heart arrhythmia which co... Read more
Six days after receiving the second vaccination, I had a night of non-stop heart arrhythmia which consists of the heart seemingly skipping a beat and then the next beat is very heavy. It lasted throughout the night. I have had an arrhythmia sporadically in my past, but I don't recall it ever being this pronounced or sustained. I had the same exact thing happen 12 days after a positive COVID test in which I exhibited mild symptoms.
50 2021-06-03 fainting Patient fainted within 15 minutes of vaccination. Patient recovered and was released to home.
50 2021-06-07 chest pain Developed chest pain on 5/26
50 2021-06-07 deep vein blood clot Pt had first episode of DVT- symptoms started 10 days after initial vaccine dose.
50 2021-06-07 inflammation of the heart muscle Severe chest pain at heart. Was taken to ER and given Morphing for pain. Was diagnosed with Myocardi... Read more
Severe chest pain at heart. Was taken to ER and given Morphing for pain. Was diagnosed with Myocarditis.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN6205), via an unspecified route of administration on 26Feb2021 at 07:00 am on the left arm as a single dose for COVID-19 immunisation. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EN6201), via an unspecified route of administration on 05Feb2021 at 07:00 am on the left arm as a single dose for COVID-19 immunisation. The patient had no known allergy. The patient's medical history included IGA. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medications two weeks prior vaccination included Losartan, Atorvastatin, Atenolol. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 28Feb2021 at 06:00 pm, the patient experienced Severe chest pain in the heart. The patient was taken to ER was and given Morphine for pain. Patient was diagnosed with Myocarditis. The case was assessed as Serious (Myocarditis). The patient visited the emergency room for the events. The patient was treated with morphine and inflammation drugs for the events. The outcome of the events was resolved.
50 2021-06-08 heart attack, low platelet count Pneumonia, unspecified organism Non-ST elevation (NSTEMI) myocardial infarction Gastrointestinal hem... Read more
Pneumonia, unspecified organism Non-ST elevation (NSTEMI) myocardial infarction Gastrointestinal hemorrhage, unspecified Thrombocytopenia, unspecified
50 2021-06-08 chest pain Pt developed dizziness, lightheadedness, sob after receiving vaccine. Then reported mild chest pain,... Read more
Pt developed dizziness, lightheadedness, sob after receiving vaccine. Then reported mild chest pain, headache, neck pain, weakness in lower extremities. BP 220/112, HR 86, O2sat 99 RA. Pt escorted to ER via wheelchair.
50 2021-06-08 low platelet count Thrombocytopenia, unspecified
50 2021-06-12 ischaemic stroke Cryptogenic Ischemic Stoke. At approximately 11am on the morning of the incident I felt the blood le... Read more
Cryptogenic Ischemic Stoke. At approximately 11am on the morning of the incident I felt the blood leaving my arms and legs, began to feel feint. Laid down on ground with legs elevated. Began shaking. Called 911. Was taken to the hospital by ambulance. Once at hospital, felt arms and legs were numb. After a period of time going through testing at the ER, feeling returned to all but left leg. Stayed overnight, went home on 5/6/2021. Strength returned to left left over the next several days. Since 5/6/2021. Have been dealing with increasing debilitating anxiety, as well as photosensitivity, insomnia, and other related issues since returning home.
50 2021-06-14 hypertension Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Hypotension-Medium, Sy... Read more
Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: at 5:15 pt was sweating through shirt, put on fan took bp1:80/60 pulse 70, had pt elevate legs, also had visual changes bp2: at 5:25pm 195/126 pulse 73, bp3: 185/124 pulse 79, pt has history of high bp, told pt to follow up with md if bp is elvated later today and tomorrow
50 2021-06-15 chest pain Pt received vaccine on 6/14 at 2 pm. Pt woke up that night with arm pain but thought it was normal i... Read more
Pt received vaccine on 6/14 at 2 pm. Pt woke up that night with arm pain but thought it was normal injection site reaction. She woke up 6/14 with a swollen arm, unable to lift or move arm, wit radiating pain to the head, neck, and chest.
50 2021-06-16 chest pain PT called call center on 5/18/21 states he has pain on the right shoulder/arm 8/10 and sometimes ra... Read more
PT called call center on 5/18/21 states he has pain on the right shoulder/arm 8/10 and sometimes radiates to the chest area for a month after vaccine. Pt states right shoulder/arm pain goes away with lotion and exercise but would come back. Advised pt to go to ED immediately for evaluation and explained the importance of going for evaluation and pt verbalized understanding but states he will go tomorrow morning. Received vaccine from outside pharmacy
50 2021-06-16 palpitations Shortness of breathe, heart palpitations.; Shortness of breathe, heart palpitations.; This is a spon... Read more
Shortness of breathe, heart palpitations.; Shortness of breathe, heart palpitations.; This is a spontaneous report. A contactable male consumer (patient) reported a 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm single dose for COVID-19 immunization on 20May2021 11:00, at 50-year-old. No medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications received within 2 weeks of vaccination. The patient previously first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm for COVID-19 immunization on 30Apr2021 11:30, at 50-year-old. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced shortness of breathe, heart palpitations; both were on 23May2021 15:00 with outcome of not resolved. Information lot/batch number has been requested.
50 2021-06-23 chest pain HE HAD CHEST PAIN AT THE NIGHT OF VACCINATION AND IT WENT THROUGH FOR 6 HOURS. FELT BAD FOR 2 DAYS,... Read more
HE HAD CHEST PAIN AT THE NIGHT OF VACCINATION AND IT WENT THROUGH FOR 6 HOURS. FELT BAD FOR 2 DAYS, AND STILL FEEL BAD
50 2021-06-23 chest pain Facial edema, angioedema, urticaria with pruritus, and chest pain
50 2021-06-26 loss of consciousness First: I had the coronavirus infection at the end of December/beginning of January. Second: I recei... Read more
First: I had the coronavirus infection at the end of December/beginning of January. Second: I received my First dose of the Pfizer shot on May 24th. Got a fever and body aches for about 24 hours. Thursday June 24th: T-0: Received PFIZER-BIONTECH COVID-19 VACCINE (Link is to the Pfizer Factsheet) T-11.5: Began having fever of 100°F and chills. Took a dose of Nyquil. T-14: Woke up in a daze and was half sleep walking around the room. While walking around in the room I passed out and fell to the floor. Was out for about 10 seconds. My wife woke me. I then passed out a second time and experienced a mild incontinence for about 15 seconds, came out of it and then went to the bathroom. When in the bathroom I passed out on the toilet for about 30 seconds, I experienced incontinence of everything left in me, bowel and bladder, I experienced convulsions and altered state(thousand yard stare). When I came too I began vomiting and had extreme body shakes. Some of this information was relayed to me by my wife obviously. T-15.3: Arrived at hospital and during check in I had another episode. (15 seconds) T-25: In hospital bed I had another episode duration unknown, no one saw me go out but I recall regaining consciousness. T-29: In hospital bed I had another episode duration unknown, no one saw me go out but I recall regaining consciousness. I passed out a total of 6 times.
50 2021-06-28 deep vein blood clot, pulmonary embolism R leg DVT with extensive bilateral pulmonary emboli and saddle PE
50 2021-06-28 fainting patient collapse with subsequent EMS transport to ED, multi organ system failure, coagulation issues... Read more
patient collapse with subsequent EMS transport to ED, multi organ system failure, coagulation issues, required mechanical ventilation
50 2021-06-28 blood vessels inflammation bilateral lower extremity vasculitis
50 2021-07-03 chest pain Difficulty Breathing (Labored Breathing) Chest Pain June 26, 2021 *Pleurisy treatment with Prednis... Read more
Difficulty Breathing (Labored Breathing) Chest Pain June 26, 2021 *Pleurisy treatment with Prednisone, Ibuprofen, Pantoprazole Not better after steroid, Went back to dr. Sent to do a CT Angiogram Chest Pulmonary Embolism with and without contrast July 2, 2021 Results showed Pleurisy and Calcification on left lungs. Referred to do a Full PFT pre and post bronchodilation / to a pulmonologist.
50 2021-07-05 blood glucose increased Developed symptoms after 2nd Covid vaccine dose: dry mouth, fever, sweats, thirst, dizzy. Symptoms p... Read more
Developed symptoms after 2nd Covid vaccine dose: dry mouth, fever, sweats, thirst, dizzy. Symptoms persisted for over 3 weeks.
50 2021-07-06 chest pain, troponin increased, inflammation of the heart muscle Chest pain, elevated cardiac markers, diagnosed with perimyocarditis
50 2021-07-06 chest pain Chest pain, irregular blood pressure, mostly high.
50 2021-07-08 fainting Vasovagyl Syncope
50 2021-07-08 troponin increased, chest pain, hypertension Chest pain; Shortness of breath/could not breathe while sweating profusely; Shortness of breath/coul... Read more
Chest pain; Shortness of breath/could not breathe while sweating profusely; Shortness of breath/could not breathe while sweating profusely; He turned white as a ghost; The patient all of the sudden didn't feel right; troponin was elevated; The patient's blood pressure has never been high but it was high when he got to the hospital; The doctors are leaning more toward myocardiopathy; This is a spontaneous report from a contactable consumer (wife of the patient). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8737; Expiration Date: 31Jul2021), via intramuscular route of administration, administered in left arm on 31Mar2021, as dose 2, single (age at vaccination: 50 years), for covid-19 immunization. Medical history included type 2 diabetes mellitus which was diagnosed about 3-4 years ago and sleep apnoea which was diagnosed about 10 years ago and the patient sees a lung doctor for this yearly and uses CPAP machine (both are unknown whether ongoing or not) and the patient has never smoked or done drugs. The patient did not administer any vaccinations within four weeks prior or on same date of the Pfizer Suspect. There was no family medical history relevant to adverse events. The patient concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206, expiration date 30Jun2021) on 10Mar2021, administered on right arm muscle as dose 1 single, (age at vaccination: 50 years), for covid-19 immunization and had no adverse effect. Patient's wife said that nothing like this has happened in the past. The patient was sitting at the kitchen table at about 5:30 pm and it was about an hour since they ate. The patient all of the sudden didn't feel right, couldn't breathe, was having chest pains, and was white as a ghost, started sweating profusely. The reporter and the patient got in the car and went to the hospital and they did a cardiac work up on him, they gave him nitro paste on his chest and was hospitalized or admitted because of the events. All the symptoms started at the same time. On 26Jun2021, they did an electrocardiogram/EKG which was fine (normal) but the patient's troponin was elevated. They transferred the patient to another hospital. The patient had a stress test on 27Jun2021, which was normal (They took pictures of the patient's heart during the stress test). Reportedly, the patient's blood pressure had never been high but it was high when he got to the hospital. The patient is not back to normal but was not complaining of anything. They put the patient on a heparin drip at the hospital for the troponin levels. The doctors are leaning more toward myocardiopathy and think it was related to the vaccine. The hospitalization duration was of 2 days, i.e., from 26Jun2021 to 27Jun2021. The patient was going to see a cardiologist on Tuesday. The outcome of the events: The doctors are leaning more toward myocardiopathy, blood pressure has never been high but it was high when he got to the hospital and troponin was elevated reported as unknown and the outcome was assessed as resolving for rest of the events. Information on Lot/Batch number was available. Additional information has been requested.
50 2021-07-12 blood pressure increased the patient reported that after he received his second done he stated experiencing numbness and ting... Read more
the patient reported that after he received his second done he stated experiencing numbness and tingling in his face and his legs feel "funny" and get swollen from time to time
50 2021-07-12 deep vein blood clot, blood clot, pulmonary embolism Five days later pains in leg, three weeks later diagnosed with with DVT and PE
50 2021-07-15 deep vein blood clot DVT Blood clot left popliteal vein. Pt is healthy adult male road cyclist. No other risk factors f... Read more
DVT Blood clot left popliteal vein. Pt is healthy adult male road cyclist. No other risk factors for DVT blood clot.
50 2021-07-17 cerebrovascular accident stroke; This is a spontaneous report from a contactable consumer (patient self). A 51-year-old male... Read more
stroke; This is a spontaneous report from a contactable consumer (patient self). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration, administered in Arm Left in Apr2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 50-year-old) for COVID-19 immunisation. The administration time was 10:00 AM. Medical history included arthritis and gastrooesophageal reflux disease (GERD). Concomitant medications included ASA; celecoxib; esomeprazole sodium (NEXIUM). The patient previously received BNT162B2 dose 1 in Mar2021 at the age of 50-year-old for COVID-19 Immunization. There was no other vaccine in four weeks. The patient did not have Covid prior vaccination. No known allergies. The patient suffered a stroke on 23Jun2021, with very little to other known risk factors which resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized in Jun2021 for 2 days. Treatment received inluced hospitalization, multiple tests, and new Rxs. Outcome of the event was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-07-17 chest discomfort Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; ... Read more
Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN), via an unspecified route of administration, administered in left arm on 17Mar2021 at 15:45 (at 50 years old) as Single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There were no medical history and concomitant medications. The patient had no known allergies. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath which continued from 19Mar2021 to 30Mar2021. Start date of the events was reported as on 17Mar2021 at 18:00. No treatment received for the events. Outcome of the events was not recovered. Information about Lot/Batch number was requested.
50 2021-07-17 pulmonary embolism Pulmonary Embolism Requiring hospital stay; This is a spontaneous report from a contactable consumer... Read more
Pulmonary Embolism Requiring hospital stay; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 2021 (also reported as Mar2021) at 50 years old as dose 2, single for COVID-19 immunization. Medical history included blood pressure abnormal, atrial flutter, heartburn, and penicillin allergy from an unknown date. Concomitant medications included ciclosporin (CYCLOSPORIN) taken for an unspecified indication, start and stop date were not reported. Other concomitant medications include unspecified blood pressure meds, and atrial flutter meds. The patient previously received the first dose of bnt162b2 (lot number: EW0169) on 16Apr2021 at 50 years old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 11Jun2021 16:00 the patient experienced pulmonary embolism requiring hospital stay. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit and was considered by the reporter as serious for requiring hospitalization for 4 days and life-threatening illness (immediate risk of death from the event). The patient was given an unspecified blood thinner as treatment. The outcome of the event was recovered with sequelae (lasting effects). Information on the lot/batch number has been requested.
50 2021-07-18 chest pain Approximately 18 hours post 1st injection of Pfizer vaccine, patient developed 103.5 fever with the ... Read more
Approximately 18 hours post 1st injection of Pfizer vaccine, patient developed 103.5 fever with the following additional symptoms which lasted approximately 24 hours: numbness tingling in toes teeth and gums hurt blood vessels in eyes felt like they were spasming felt brief momentary pains up through legs and in chest
50 2021-07-20 chest pain 1st shot 3/25/21 2nd shot 4/15/21 Within a couple minutes of shot, sharp pain in center chest to the... Read more
1st shot 3/25/21 2nd shot 4/15/21 Within a couple minutes of shot, sharp pain in center chest to the left. A strange confusion and unknown stress/anxiety within 15 minutes, couldn't find the door easy to exit the convention center. Within 1-7 days, a internal trembling or pulsating of inner tissue, muscles and organs. Within 2 months, twitching of muscles when put under strain or exercise Within 2-3 months, visible shaking when fingers extended for instance onto a cell phone Within 3-4 months, symptoms seem to be getting worse or evolving into other related inner and very subtly outer shaking or trembling Within 4-5 months, overall feeling of body shaking getting worse. Please contact so that I can get help.
50 2021-07-21 pallor Patient stated feeling nauseated within minutes of receiving first dose of Covid19 Pfizer-BioNTech v... Read more
Patient stated feeling nauseated within minutes of receiving first dose of Covid19 Pfizer-BioNTech vaccine. Patient simultaneously presented pallor and diaphoresis. Patient consumed apple juice, received ice compress, was placed in the supine position to prevent vasovagal syncope and was monitored. No dyspnea, urticaria or anaphylaxis present. No other therapy administered. After 20 minutes patient was able to sit and walk unassisted.
50 2021-07-25 chest pain Pretty severe case of Shingles including chest and back pain followed by rash and blisters. Severe p... Read more
Pretty severe case of Shingles including chest and back pain followed by rash and blisters. Severe pain lasting several weeks.
50 2021-07-26 troponin increased, heart attack, heart failure Patient presented to the ED with NSTEMI on 4/20/2021. Patient hospitalized on 4/27/2021 for heart fa... Read more
Patient presented to the ED with NSTEMI on 4/20/2021. Patient hospitalized on 4/27/2021 for heart failure, nonischemic cardiomopathy and elevated troponin due to type 2 myocardial infarction.
50 2021-07-28 chest pain, inflammation of the pericardium Immediately after receiving the injection, I felt pain/sore that traveled from the injection site, w... Read more
Immediately after receiving the injection, I felt pain/sore that traveled from the injection site, went through and across my left pectoral and ended at center of my chest/heart area. I waited 15 minutes in the observation area to see if symptoms would get worse, but they did not; and so I left the facility and drove home. On my way home, about 45 minutes after receiving the shot, I felt my throat tightening up a bit, and my left hand and eyelids began to cramp up. I stopped at a pharmacy and bought some Benadryl. After 30 minutes, the pain in my chest began to feel better, and the cramping had disappeared. At about 6 pm that same day, my chest pain returned; and so I took one more Benadryl. The pain/soreness began to disappear after about 30 minutes. I felt fine for exactly two weeks. On Thursday, April 1st, I woke up with severe abdominal pain, diarrhea, and constant vomiting for about 12 hours. Went to urgent care and received an anti-nausea shot. The vomiting stopped, but the abdominal pain continued until the next morning. The weekend of April 10th, I experienced the chest pain again. This time it was very concerning because I felt very lightheaded, short of breath and faint. I checked myself into ER two days after.
51 2021-01-02 heart rate increased 11 minutes after vaccine administration I began experiencing prickling sensation of mouth lips follo... Read more
11 minutes after vaccine administration I began experiencing prickling sensation of mouth lips followed by prickling sensation of my tongue, increased heart rate and for a few seconds felt my throat tightening. Symptoms lasted a few minutes. By the time I was evaluated at the emergency department a few minutes later I was feeling much better. I did not need to take any medications. 7 hours later I began experiencing itching all over my body however, I never developed a rash. My heart rate slightly increased. Simply did not feel well. Symptoms lasted a few minutes and again resolved without having to take any medications.
51 2021-01-09 lightheadedness, heart rate increased 3 hours after 2nd dose almost fainted when exercising. 4 hours after injection started to feel ache... Read more
3 hours after 2nd dose almost fainted when exercising. 4 hours after injection started to feel achey, headache, and stiff neck. 12 hours after injection started shivering and increased heart rate. Took advil which helped, but shivering resumed 18 hours later. Took more advil. Body aches, sore arm, and headache continued for 48 hours. I still don't feel great 48 hours later but much better
51 2021-01-10 heart rate increased, blood pressure increased After the vaccine, I was tired and slept with chills. On Saturday I developed a cough. I went to my ... Read more
After the vaccine, I was tired and slept with chills. On Saturday I developed a cough. I went to my PCP on Dec 28, 2020 where they performed a FLU /COVID swab. The flu was NEG and the COVID 19 was POS. I had an elevated BP & heart rate.
51 2021-01-12 chest pain Symptoms - ?approximately 1 hour after vaccination, mild HA. Approximately 3 hours after vaccinatio... Read more
Symptoms - ?approximately 1 hour after vaccination, mild HA. Approximately 3 hours after vaccination, worsening HA and generalized body aches. Approximately 7 hours after vaccination: chest soreness and achiness, denies airway issues or SOB. Last day of work and shift ? currently at work Home remedies? - naproxen 500 mg at 0730 Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor symptoms and to call vaccine support line with further questions or concerns. EE verbalized back understanding and denied further questions at this time.
51 2021-01-12 fast heart rate tachycardia (HR110-120); left arm soreness; This is a spontaneous report from a contactable physicia... Read more
tachycardia (HR110-120); left arm soreness; This is a spontaneous report from a contactable physician (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at the left arm on 16Dec2020 14:00 (lot number: EH9899) at a single dose, then intramuscular at the left arm on 05Jan2021 16:00 (lot number: EK9231) at a single dose for COVID-19 immunization in the hospital. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. Concomitant medications included allopurinol and atorvastatin. The patient experienced left arm soreness and tachycardia with hr of 110-120 on 06Jan2021 16:30. No treatment was given in response to the events. The patient assessed the events as non-serious. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.
51 2021-01-19 palpitations palpitation (likely PACs)
51 2021-01-24 palpitations I went surfing after vaccine, it was not until 8:00 that night that I experienced a racing heart ... Read more
I went surfing after vaccine, it was not until 8:00 that night that I experienced a racing heart beat. The following night, I had a rash on left side of my face with raised area and had heart palpitations. The rash went away soon there after and I took some benedryl just incase
51 2021-01-25 heart rate increased After receiving vaccination, I started experiencing intermittent bouts of anxiety, rapid heart rate,... Read more
After receiving vaccination, I started experiencing intermittent bouts of anxiety, rapid heart rate, sleeplessness and "dark thoughts." This symptoms began approximately a week after the vaccination. I have no history of any of these conditions.
51 2021-01-26 palpitations Day 8, I woke with a headache, chills, vomited 4 times, muscle aches, and heart palpitations all day... Read more
Day 8, I woke with a headache, chills, vomited 4 times, muscle aches, and heart palpitations all day until around 8 pm. I couldn't keep food down until then. From Day 8 until yesterday (Day 11), I have been having intermittent episodes of heart palpitations, which is my only serious concern. I have had a declining number of heart palpitations today, Day 12, but felt I should report these heart palpitations in case this is a sign of a serious complication. Should I avoid receiving the second dose?
51 2021-01-29 chest discomfort Began with a slight headache that eventually got worse. Started, when treated, at a 5 of 10. Left ... Read more
Began with a slight headache that eventually got worse. Started, when treated, at a 5 of 10. Left facility with a 7 of 10 headache. Then I had a weird taste in my mouth (metallic like). My tongue started to tingle and was a bit numb. Eventually after Doctor at facility took me in, I was given benedryl 50 mg and an antacid. After a few minutes the right side of my mouth became itchy but the tingling stopped. The itch was not unbearable but it was getting there. I was already having a slight difficulty breathing but that was from the morning even with inhalers. As an instrument player a doctor said I have super lungs so my results would be skewed due to how much air I take in. But any loss of air, although in the safe range for others, is like breathing through a straw for me. My blood pressure was 139/90 at the time. My normal blood pressure is 117/70. I went home feeling cold and just not feeling well, relatable to flu symptoms. This is the next day after taking benedryl every 6 hours at 50mg/dose. My breathing is slightly labored. I feel ok but my arm hurts, I have been moving it around a lot just to get it mobile. My chest feels like there is a slight weight on it which is weird for me. At the moment my pulse is 81bpm and my oxygen is at around 96. My norm is around 70bpm and oxygen at 99. No temperature is consistent at 97.3. I feel a little weird today. I am stiff all over as well. Little aches here and there but that is a norm. Doing my stretches and exercise is not a go today. Can't breathe as normal.
51 2021-02-05 chest pain fever 102, headache, muscle aches, chest pain
51 2021-02-08 palpitations, blood pressure increased Approx 14 minutes after receiving the vaccine, client felt like his heart was racing and his blood p... Read more
Approx 14 minutes after receiving the vaccine, client felt like his heart was racing and his blood pressure elevated, and dizzy. vital signs monitored, his BP was 150/108. He was clammy and shaky He was taken behind the white curtain and took his mask off, which he said helped tremendously. He was monitored. BP down to 140/100. He recently started BP medication. Told to discuss this episode with his PCP.
51 2021-02-09 nosebleed Severe bloody nose, diaphoresis, dizziness. No history of nosebleeds. Occurred 7 hours after recei... Read more
Severe bloody nose, diaphoresis, dizziness. No history of nosebleeds. Occurred 7 hours after receiving 1st dose of Phizer vaccine. Presented to ER. EKG and bloodwork within normal limits.
51 2021-02-10 low blood platelet count, platelet count decreased, nosebleed Nose bleed started on 2/1/21 that would not stop for 2 days. Labs checked - Platelets dropped from b... Read more
Nose bleed started on 2/1/21 that would not stop for 2 days. Labs checked - Platelets dropped from baseline of 210 to "4" - sent to hospital on 2/2/21, required ICU Admission with dx of unspecified ITP. There are no other changes of medications or regimen prior to incident. Hospital notes also suspect from COVID vaccine as otherwise unexplained. Has not fully recovered, still in ICU.
51 2021-02-13 deep vein blood clot, superficial blood clot Deep Vein Thrombosis; Superficial Thrombophlebitis. Treatment: Xarelto. Outcome: Resolved
51 2021-02-16 chest discomfort felt rush in chest and then "felt Off"
51 2021-02-20 hypertension Systemic: Chills-Mild, Systemic: Ringing in ears, chills,then feeling flushes. No obvious signs of ... Read more
Systemic: Chills-Mild, Systemic: Ringing in ears, chills,then feeling flushes. No obvious signs of diaphoresis-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Tinnitus-Mild, Additional Details: Report. 20 min post admin, Aid ckd BP and reported 204/134. Rpt ringing in ears, chills, then warm sensation all over. BP 5-10 min later in other arm, reported 213/162. Gave Pt water. COO at facility to call paramedics to assess. Lied pt down for 5 min, rck BP 180/117. Pt reported feeling fine w/ occasional chill. Waiting on Paramedics. Approx 5 min, pt sat up complaining of headache. Paramedic arrived about 5 minutes later, assessed pt, bp 232/120?. To Hospital
51 2021-02-25 blood pressure increased Received 2nd dose of Pfizer on January 19, 2021. 3 days post vaccination (January 22, 2021) I deve... Read more
Received 2nd dose of Pfizer on January 19, 2021. 3 days post vaccination (January 22, 2021) I developed right eye discomfort/irritation, prickly sensations in throat. On Jan 25, 2021 I developed tinnitus in right ear which has still not resolved. On January 30, 2021, went to ED with elevated BP 170/110, abdominal pain and tinnitus. Had an abdominal CT scan with contrast which showed mesenteric inflammation (idiopathic etiology). Was seen and evaluated by GI and had colonoscopy and endoscopy with no significant findings. Took solu-medrol dose pack and abdominal pain symptoms improved, but still not fully resolved. On Feb 16 was seen by PCP for persisting, unilateral tinnitus. Sent for MRI Brain which was normal . Referred for further evaluation by audiologist and otolaryngologist . Was seen on February 25, 2021 for right ear fullness, tinnitus. Hearing test normal. Diagnosed with right sided tinnitus.
51 2021-02-25 loss of consciousness, coughing up blood, excessive bleeding At about 2am on 2/10/21, Patient got up from bed and fell down a flight of stairs. He was initially ... Read more
At about 2am on 2/10/21, Patient got up from bed and fell down a flight of stairs. He was initially bleeding and unconscious and was brought by EMS to the hospital. Upon arrival at the hospital he had a temperature of 40 C. He was found to have 2 small left temporal hemmorhagic contusions on CT scan. He had a seizure during the hospitalization. He was initially treated for HSV encephalitis but it is not clear if that was confirmed. The hospital team may not have known of the recent vaccination. He improved during the hospitalization, but remained with a very unsteady gait. He could not return to the group home. He was transferred to a rehab facility to receive PT on 02/16/2021. He remains at rehab. Prior to the fall, on the 3rd day after vaccination, on 2/8/21 at about 10 am, the patient coughed and had a small blood on the inside of his face mask while at his day program. He was seen by his PCP and had no abnormal findings. He had a CBC, BMP and CXR and all were unremarkable.
51 2021-03-03 heart rate increased Patient felt weak and lightheaded immediately after receiving vaccine Heart Rate increased to 122 BP... Read more
Patient felt weak and lightheaded immediately after receiving vaccine Heart Rate increased to 122 BPM. BP 180/80. Other vital signs normal After 45m obs v/s HR 96 O2 98% room air, PB 110/60. Patient stated she felt she felt too sick for discharge home and requested EMS be called. EMS responded and xported to hosp
51 2021-03-03 heart rate increased Dizziness/felt woozy/light headed; Weakness; vision changed; increased heart rate/heart rate went up... Read more
Dizziness/felt woozy/light headed; Weakness; vision changed; increased heart rate/heart rate went up slightly; had pressure in his head; pressure in his hands and feet like he could not move his feet; pressure in his hands and feet like he could not move his feet; headache; muscle tightness/muscles tightened in his back and in his calf muscles/tightness in his neck; he felt like he was just not himself; lethargic; lump in his throat; lymph nodes got tight on the same side as the vaccine/lymph node on his left side was tight throughout his neck; cringing in his stomach muscles; kind of like a muscle spasm in his stomach; didn't sleep that well last night; wobbly; back was hurting; muscle pain; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ9261, expiry date: unknown), via an unspecified route of administration, from 01Feb2021, at single dose, for COVID-19 immunization. Medical history included anemia (anemic), inflammation, acid reflux (esophageal), pain, on blood thinner, high cholesterol, sinus disorder (sinuses), overactive bladder/bladder control, acid reflux, stools hard (to soften stool), nerves, blood pressure high (high bp), car accident, and costochondritis in chest. Concomitant medication included atorvastatin calcium for high cholesterol from an unspecified date and ongoing; docusate sodium to soften stool; famotidine to soften stool from an unspecified date and ongoing; garlic [allium sativum] as blood thinner from Nov2020 (3 months ago) and ongoing, gabapentin for nerves from an unspecified date to an unspecified date and from Nov2020 (got back on this 3 months ago) and ongoing; hydrocodone for pain; iron for anemia from Nov2020 (been taking this for the last 3 months) and ongoing; meloxicam for inflammation, omeprazole (PROTONIX) for acid reflux from an unspecified date and ongoing; tadalafil for overactive bladder/bladder control from an unspecified date and ongoing; vitamin c (ascorbic acid), colecalciferol (VITAMIN D), vitamin b for trying to build up his immune system; ranitidine hydrochloride (ZANTAC) for sinuses; "One a Day Men's" from 2016 and "50+" (as reported, pending clarification). On 01Feb2021, after the shot, the patient experienced dizziness/felt dizzy and had weakness. When he walked to the desk to check out he felt his vision changed and his heart rate went up slightly but it did go down once he sat down but he felt woozy and had pressure in his head and pressure in his hands and feet like he could not move his feet. He was kind of like dizzy and light headed. He walked somewhere to sit down, he stayed 30 minutes and left after and sat 30 minutes in the car and he got a headache and his muscles tightened in his back and in his calf muscles and he felt like he was just not himself. He felt lethargic and felt like his lymph node on his left side was tight throughout his neck. He felt like his lymph node was getting tight and he just sat until he felt like his symptoms had dissipated. He also had lump on his throat. He had stuff going on with his stomach like cringing in his stomach muscles, it was kind of like a muscle spasm in his stomach. He didn't sleep that well last night (01Feb2021) as he felt some symptoms come on again, the tightness in his neck again and when he sat up, he got dizzy and wobbly, his back was hurting, his calf muscle was tight. He felt more muscle pain. He checked his blood pressure and it was good, but he just felt a little dizzy on 02Feb2021. The patient stated that all his symptoms have improved since 01Feb2021. The patient also mentioned that the girl looked really young (referring to the person who administered the vaccine), "maybe she jacked it up, he knows it supposed to be a very little bit, maybe she put more in him than she was supposed to". He went back to his doctor as he wants to come off of some of his medications because he is supposed to have another shot and he want to take the second shot. He wanted to stop taking all the medications around the second shot in case it was his medications that caused it. The patient asked since he had complications with the fist dose, should he still take the second dose. The patient was recovering from the events.
51 2021-03-07 deep vein blood clot DVT left leg with no prior history and no risk factors
51 2021-03-08 chest pain, blood pressure increased, palpitations A few days of heart palpitations - consistent through the day. And then blood pressure spiked. I was... Read more
A few days of heart palpitations - consistent through the day. And then blood pressure spiked. I was taking Blood pressure and the cuff detected an arrhythmia and so I went to ER on the 12th. Cardiologist dr visit was on 14th of January. I was put on blood pressure medicine - a second one (I was already on one) - Metoprolol ER Succinate. I had my second dose on January 15, 2021. After my second dose, I had pain in my upper part of my chest - left side - and it went away.
51 2021-03-08 chest pain 20 hours after the vaccine, at 3:00 PM on 16th I had small a fever and chills. Those symptoms laste... Read more
20 hours after the vaccine, at 3:00 PM on 16th I had small a fever and chills. Those symptoms lasted until 05:00 PM on 17th. I had a sharp pains in my chest that would come and go. That lasted for three to four days. Then they just went away. I just kept taking my meds. It wasn't clear if it was a muscle pain or inside my chest - it wasn't bad enough to hinder me or for me to see a doctor.
51 2021-03-08 troponin increased, chest pain, ejection fraction decreased The night after receiving the second dose of the Pfizer Covid , the patient developed severe headach... Read more
The night after receiving the second dose of the Pfizer Covid , the patient developed severe headache, who body myalgias, severe fatigue, and fevers. The next day he also developed pleuritic chest pain and shortness of breath. He described the chest pain as like a heart burning sensation, worse lying down and better sitting up. He documented a fever to 100.8 deg F. By the thord day the fever had resolved but the chest pain persisted, leading him to present to the emergency department. On exam he had BP 113/84, HR 95, RR 18, O2Sat 95% on RA, Temp 97.5 F. His lungs were clear to auscultation. Heart was RRR, S1, S2 WNL without MGR. ABD was soft, without tenderness, masses or HSM.
51 2021-03-09 loss of consciousness 3 hours post vaccine, patient passed out and lost consciousness, demonstrating seizure like activity
51 2021-03-10 palpitations Had a high heart rate at rest. While sitting, not moving, I recorded 160 BPM and it would go as high... Read more
Had a high heart rate at rest. While sitting, not moving, I recorded 160 BPM and it would go as high as 178 BPM. Periodically sweating, dizziness and sick to my stomach. This lasted until 0830 the next day. I had no other issues. For most of this period my heart rate was around 120-140. If I just stood up, it would go right up to 160-170. This lasted approximately 19 hours...
51 2021-03-11 heart attack ACUTE ST ELEVATION MYOCARDIAL INFARCTION SPONTANEOUS DISSECTION OF CORONARY ARTERY
51 2021-03-14 fainting, loss of consciousness Diaphoretic, syncope, unresponsive, evaluated by EMS, transported to ER
51 2021-03-16 fainting 51 y/o male sitting in car, observation area post vaccination. Witnessed syncopal by RN, lasted 1 mi... Read more
51 y/o male sitting in car, observation area post vaccination. Witnessed syncopal by RN, lasted 1 minute, no complaints. Fully recovered upon EMS arrival. States has history of syncopal reactions to injections. Fully alert and oriented. Refused transport.
51 2021-03-17 heart rate increased Pt c/o difficulty breathing, esophageal spasms, severe coughing for hours during the night; resolved... Read more
Pt c/o difficulty breathing, esophageal spasms, severe coughing for hours during the night; resolved by 1400 on 3/15/21. 98% sat on ra; increased RHR of 86 bpm (normal is 48-52bpm) -
51 2021-03-18 pallor, fainting 3-17-21 1:10PM PT STATES HE 'DOESN'T FEEL WELL'. SYNCOPE APROX 1 MIN - WIFE HELD PT IN CHAIR. RN ... Read more
3-17-21 1:10PM PT STATES HE 'DOESN'T FEEL WELL'. SYNCOPE APROX 1 MIN - WIFE HELD PT IN CHAIR. RN X3 AND MEDIC ASSISTED PT TO FLOOR AND ELEVATED LEGS. PT BECAME RESPONSIVE. PT PALE AND DIAPHORETIC. 1:16PM ASSISTED PT TO CHAIR 'FEELS BETTER NOW'. A/O, PINK, W/D, RESP REG WITH EASE. WIFE HERE TO DRIVE PT HOME. 3-19-21 3:30PM TC: PT STATES 'FULL RECOVERY'.
51 2021-03-20 loss of consciousness About 10 minutes after the shot I started feeling hot, started sweating, clammy hands, dizzy and the... Read more
About 10 minutes after the shot I started feeling hot, started sweating, clammy hands, dizzy and then I passed out walking to get help. I hit my head on a chair when I was falling and cut my head. I stayed laying down because I was still dizzy and hot. They called the squad and did vitals and I was fine. I sat there for about another half an hour and I went home. I have felt fine ever since. Only thing that hurt was my head from the fall.
51 2021-03-21 blood pressure decreased, heart rate increased, heart flutter Fast heart beat/flutter, with some low blood pressure incidents.
51 2021-03-21 nosebleed 36 hours after vaccination experienced nose bleed after sneezing . I am not prone to them normally ... Read more
36 hours after vaccination experienced nose bleed after sneezing . I am not prone to them normally very rare . Thought I should report it as it took awhile to stop bleeding .
51 2021-03-21 pulmonary embolism, cardiac arrest suspected pulmonary embolism; shock; cardiac arrest; This is a spontaneous report from a non-contact... Read more
suspected pulmonary embolism; shock; cardiac arrest; This is a spontaneous report from a non-contactable consumer (patient's wife). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 04Mar2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history reported as none. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced a suspected pulmonary embolism on Monday 08Mar2021 at 11:30 AM. Embolism led to shock and cardiac arrest. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received unspecified treatment for the events. The patient died on 08Mar2021 at 11:30 AM. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: suspected pulmonary embolism; shock; cardiac arrest
51 2021-03-22 ischaemic stroke Patient was found in the bathroom , urinating , walked to the wheelchair complaining of numbness ove... Read more
Patient was found in the bathroom , urinating , walked to the wheelchair complaining of numbness over his whole right side denies any chest pain no tingling no trauma no incontinenc
51 2021-03-24 cerebrovascular accident After covid second shot I had fever i took Tylenol, fever gone. 01/08/2021 I went to work. Next morn... Read more
After covid second shot I had fever i took Tylenol, fever gone. 01/08/2021 I went to work. Next morning 01/09/2021 . I was stroked out taken to er. Still I have weakness on left , hearing loss, loss taste, even I drink water taste bitter. Loss smell. I am doing physical and speech therapy. Still not recovered.
51 2021-03-24 chest pain The patient is a 51 yo old reservist with a history of hypercholesterolemia with an onset of illn... Read more
The patient is a 51 yo old reservist with a history of hypercholesterolemia with an onset of illness 10 days after Pfizer vaccine (lot #2 ELI283) on 6 JAN 2021, where he was on 87 day active duty orders with Medical Task Force - COVID mission. He denies any AE after dose #1 (Dec 17 lot #ELD140). He denies any immediate symptoms suggesting IgE event(pruritis, urticaria, SOB, wheezing, oral, facial throat, tongue swelling etc.) and denies any local site reaction. He reports about 10 days later he experienced severe nausea vomiting and diarrhea, CP and SOB. He was seen in ER 3 times where he was found to have Acute Kidney injury, and treated with IVF, odansetron meclizine dicyclimine. After the third ER visit he was admitted where he subsequently developed GI pain. He has continued to have significant health issues, but no unifying diagnosis has been identified. He would like to know if this was related to his Covid vaccine receipt. He reports no one else in his group will ill and they were otherwise isolated for travel related Covid quarantine. Per review of records he presented to ER 17 JAN 2021 (day 11) with complaints of nausea global weakness, watery diarrhea, and shortness of breath . He had a acute kidney injury with cr 1.4. A non contrast ABD CT was normal. He was diagnosed with viral gastroenteritis, treated with hydration, Zofran and Bentyl. He returned to ER 19 JAN (day 13) with a complaint of same with severe dizziness. A noncontrast head CT was normal He had a positive Dix-Hallpike and he was diagnosed with benign positional vertigo. On 1/20/21 (day 23) he continued symptoms with tachypnea on minimal exertion noted in ER. CXR demonstrated lateral RLL opacity and he was treated with Rocephin and azithromycin. He developed vague abdominal pain and was transferred to MTF. 26 JAN 21 GASTROENTEROLOGY: EGD - 'marked chronic active gastritis' - blood, stool sample and gastric biopsies are negative for H pylori infection - Protonix 40mg BID CT of kidney showed cyst on the left and nonobstructive 3mm stone and creatinine on is 0.9 (0.7-1.2).
51 2021-03-24 heart rate increased Headache. Dizzy. Itching on right side. Rash on right cheek. Aching In upper back right side. Errati... Read more
Headache. Dizzy. Itching on right side. Rash on right cheek. Aching In upper back right side. Erratic racing pulse.
51 2021-03-24 hypertension shortness of breath; high blood pressure; This is a spontaneous report from a contactable consumer (... Read more
shortness of breath; high blood pressure; This is a spontaneous report from a contactable consumer (patient's friend). A 51-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on 17Mar2021 (at the age of 51-years old) as SINGLE DOSE for COVID-19 immunisation. Medical history included cardiac event and stent placement in Jan2021. The patient's concomitant medications were not reported. On 18Mar2021 at 10:30am, patient was admitted to the ER (Emergency Room) due to shortness of breath and high blood pressure. He had cardiac event and a stent placed in Jan2021. Patient was admitted due to not knowing if the issues were due to the COVID shot or the recent heart issues. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room or urgent care and hospitalization on 18Mar2021. The patient was not tested for COVID prior to vaccination. Patient was tested for COVID (Nasal swab) post-vaccination on 18Mar2021, results pending. The outcome for both events was unknown. Information about Batch/Lot number has been requested.
51 2021-03-24 pulmonary embolism Pulmonary embolism. SOB; Left upper extremity dialysis graft occlusion necessitating balloon and ste... Read more
Pulmonary embolism. SOB; Left upper extremity dialysis graft occlusion necessitating balloon and stent; This is a spontaneous report from a contactable physician. A 51-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in arm right on 25Feb2021 at single dose for COVID-19 immunisation. Medical history included end stage renal disease (ESRD) on HD due to hypertension (HTN), and morbid obesity. The patient was allergic to Levaquin, NSAIDs. Concomitant medications included acetylsalicylic acid (ASPIRIN), atorvastatin, clonazepam, dutasteride, escitalopram, metoprolol, nifedipine, sevelamer, torsemide, cetirizine hydrochloride (ZINE). On 25Feb2021, the patient had left upper extremity dialysis graft occlusion necessitating balloon and stent on the day of the vaccine administration. Pulmonary embolism developed 3 weeks after the first vaccine dose (Mar2021). No leg swelling, no long-distance travel, no immobilization or other cause of pulmonary embolism identified. No cough or fever. Shortness of breath (SOB) developed the day before the Pulmonary embolism (PE) was diagnosed (Mar2021). AEs resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized for 2 days, received Heparin drip followed by Xarelto as treatment. Events outcome was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided the company cannot completely exclude a contributory role of BNT162b2 administration in the development of the reported 'complication associated with device and pulmonary embolism', with SOB as initial sign and symptom associated with pulmonary embolism. The impacts of this report on the benefit/risk profile of the Pfizer product 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.
51 2021-03-25 blood pressure increased 1055: Patient in 15 minute observation called for medical with c/o dizziness and diaphoretic. Patien... Read more
1055: Patient in 15 minute observation called for medical with c/o dizziness and diaphoretic. Patient taken to first aid station for further assessment by Physician and EMS on Duty. Patient denies eating an AM meal. Patient given water 8oz able to drink water without issues. VS: 182/90 patient states that his pressure normally runs high. EMS on duty rechecked b/p-190/102. Patient requested CBG check once EMS on duty went to take CBG patient "I think were making too much of a fuss" Patient refused further treatment and left AMA.
51 2021-03-28 chest pain chills, shivers, cold sweats, dizziness, headache, joint and nerve pain above baseline, hands and fe... Read more
chills, shivers, cold sweats, dizziness, headache, joint and nerve pain above baseline, hands and feet completely numb more than baseline, chest (rib cage) pain when breathing, weakness, fell several times, LOC x 1, gas, crawled instead of walked at times, bloating, abdominal cramps, diarrhea every 1-3 hours, slept the rest of the time, was able to drink Gatorade, pedialyte, water, ginger ale for hydration, no vomiting,
51 2021-03-29 hypertension It was reported to me as the vaccine administration site that this person who was vaccinated last we... Read more
It was reported to me as the vaccine administration site that this person who was vaccinated last week developed very high blood pressure yesterday and was admitted to the hospital. He is currently an inpatient at medical center. I have not other information other than this.
51 2021-03-29 hypotension, blood pressure increased, chest discomfort 2.8kg 51 yo M with hx of hypothyroidism and allergy to pencillin was given his first Pfizer vaccine ... Read more
2.8kg 51 yo M with hx of hypothyroidism and allergy to pencillin was given his first Pfizer vaccine around 0915 3/27 at Medical Center (lot # not reported). Within 5 minutes he states he felt a "jolt" throughout his body and became very nervous and had sweaty hands. Patient reported symptoms at the vaccination location. Blood pressure was reportedly "low" and patient was told he could leave if he felt better. After about 30 minutes from the injection, patient decided to go home but continued to feel nervous and was twitching all over and decided to come to urgent care. He presents with chest pressure (4/10), muscle tremors, mouth dryness and mild dizziness. Denied any history of Covid.Denied any previous reactions to any vaccines. Denied any shortness of breath/trouble breathing, lightheadedness, nausea, or vomiting. No history of high blood pressure or high cholesterol. Denies any history of anxiety or nervousness. States he felt fine prior to the vaccine. Patient did drink his coffee and have a flour tortilla along with a breakfast bar today. HR 82 but BP elevated 199/122.at 1125. BP treated with SL nitroglycerin and four 81mg aspirin. Chest pain improved 1/10. EKG showed inverted T waves V4-V6 with no ST elevation or depression. Sent to ED where EKG was repeated. Incomplete right BBB. BP 128/73 and pulse 47. CXR negative. Unknown if patient was admitted. ED was at Medical Center.
51 2021-03-29 pulmonary embolism Pain in left arm . Tension in arms and shoulders. Shortness of breath. On 3/19/2021 I was diagnose... Read more
Pain in left arm . Tension in arms and shoulders. Shortness of breath. On 3/19/2021 I was diagnosed with pulmonary embolisms in both lungs and right leg
51 2021-03-30 loss of consciousness High fever and passing out
51 2021-03-31 hypertension Pt arrives to the observation are after his injection feeling a little dizzy and experiencing scratc... Read more
Pt arrives to the observation are after his injection feeling a little dizzy and experiencing scratchiness in his throat. He arrives via wheelchair eating gold fish and drinking water. 1338 BP 144/97 HR 78 Oxygen room air 98% 1345 pt states he is feeling better "back to normal" 1350 pt released from observation to exit with wheelchair
51 2021-04-01 heart rate increased Unusual impotence; Extreme night sweats; Elevated heart rate resting rate of 100. My normal is 74 BP... Read more
Unusual impotence; Extreme night sweats; Elevated heart rate resting rate of 100. My normal is 74 BPM; Shortness of breath; This is a spontaneous report from a contactable other health care professional. A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 02Mar2021 16:00 (at the age of 51-years-old) (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took tylenol and experienced allergies. The patient did not receive other vaccines in four weeks, and other medications in two weeks. On 12Mar2021 16:00, the patient experienced Elevated heart rate resting rate of 100. My normal is 74 BPM. Shortness of breath. Extreme night sweats. Unusual impotence. All started 10 day after injection. The outcome of the events was not recovered.; Sender's Comments: The company does not attribute the unusual impotence (PT: Erectile dysfunction) to BNT162b2, considering the event being an intercurrent disorder. The impact of this report on the benefit/risk profile of the Pfizer product 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.
51 2021-04-01 hypertension has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringin... Read more
has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringing; stomach pain; high BP; sore arm; tinging in in throat and right side of face,; irritated right eye; Right Ear ringing worsened culminated in 8 days of insomnia from severe ringing; mesenteric inflammation; This is a spontaneous report from a contactable nurse (patient) and a consumer. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 29Jan2021 (Batch/Lot Number: EL3247) at single dose for COVID-19 immunization. Medical history included sciatica (resolved), and the patient took the first dose of BNT162B2 (lot/batch number: EL0142) at 15:00 on 29Dec2020 administered in arm right for COVID-19 immunization and developed paresthesias in right arm, into axilla, nex and right side of face and burning irritation of right eye, both on 24Jan2021. The patient's concomitant medications were not reported. Clinical course: 3 days after vaccination, patient developed sore arm, tinging in in throat and right side of face, irritated right eye. 6 days after vaccination, patient woke up with tinnitus in right ear, stomach pain and high BP. On 30Jan2021 (as reported), patient went to Emergency Room. CT scan showed mesenteric inflammation. Right Ear ringing worsened which culminated in 8 days of insomnia from severe ringing. Tinnitus continues to persist. He also had a constant severe headache. All events were reported as serious and seriousness criteria were disability. No allergies to medications, food, or other products. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
51 2021-04-05 hypertension, fast heart rate Tachycardia, hypertensive spike with dizziness lasting approximately one hour. Extreme nausea and ac... Read more
Tachycardia, hypertensive spike with dizziness lasting approximately one hour. Extreme nausea and acute headache lasting two hours after onset. Extreme fatigue lasting 4 hours with moderate headache and fatigue lasting into the night.
51 2021-04-06 blood clot Currently, developed 3 blood clots in right arm 4 days after receiving the vaccination. First was ... Read more
Currently, developed 3 blood clots in right arm 4 days after receiving the vaccination. First was noticed on the morning of April 6, the second in the evening of April 6, and the third was noticed on the morning of April 7. First one has appearance of cellulitis located on the forearm. Doctor issued treatment for cellulitis on April 6. Reddish/purple skin colored with grey edges in a circle. Second clot is below the skin with slight bulge closer to the elbow than the first. The third indication is in the upper arm above the elbow on inside of arm. Appearance marked by 2 curved lines similar to varicose veins just below where the clot is bulging the skin. No discoloration of the 2nd and 3rd indications of clot.
51 2021-04-08 excessive bleeding, loss of consciousness I received the vaccine at 12:15 PM. I was a little tired but generally fine the rest of the day. I ... Read more
I received the vaccine at 12:15 PM. I was a little tired but generally fine the rest of the day. I woke up at 2:30 and didn?t feel well. I got up to go to the bathroom. I started getting the chills and feeling dizzy. I passed out. My wife found me passed out on the ground and bleeding. I needed six stitches in my head and have a black eye as well as other facial lacerations. I have no recollection of anything until my wife woke me. I have never passed out in my life prior to this.
51 2021-04-11 heart rate increased SORE ARM, EXHAUSTED ON SATURDAY. SUNDAY MORNING TEMP OF 102, NAUSEA, CHILLS, JOINT PAIN ITCHING LEFT... Read more
SORE ARM, EXHAUSTED ON SATURDAY. SUNDAY MORNING TEMP OF 102, NAUSEA, CHILLS, JOINT PAIN ITCHING LEFT NECK AND LEFT FACE FAST HEART RATE (102 AT REST NORMAL IS 60 AT REST) CONTINUED TO MONDAY MORNING.
51 2021-04-11 fast heart rate, palpitations After getting his first Covid- 19 immunization, pt noticed his heart racing. Here was no SOB, chest ... Read more
After getting his first Covid- 19 immunization, pt noticed his heart racing. Here was no SOB, chest pain or dizziness. Vitals were b/p 123/73, pulse 67 and SaO2 98%. He felt better after eating and drinking. He was monitored and discharged stable Tachycardia
51 2021-04-12 chest discomfort, pulmonary embolism Pt received dose of vaccine on Sunday. Had business trip on Thursday. After flight became short of b... Read more
Pt received dose of vaccine on Sunday. Had business trip on Thursday. After flight became short of breath and had discomfort in the chest. Worsening on trip back
51 2021-04-12 troponin increased Vomit, cough, tired, diarrhea for 3 days. Edema, hospital ization
51 2021-04-14 chest pain, heart failure, low blood oxigenation Chest pain Acute kidney failure, unspecified DOE (dyspnea on exertion) Hypoxia Bilateral pleural eff... Read more
Chest pain Acute kidney failure, unspecified DOE (dyspnea on exertion) Hypoxia Bilateral pleural effusion Chronic obstructive pulmonary disease, unspecified COPD type Chronic kidney disease, unspecified CKD stage Acute on chronic heart failure with preserved ejection fraction
51 2021-04-15 stroke Cryptogenic stroke. Experienced garbled speech for a period of less than one minute. Symptoms resolv... Read more
Cryptogenic stroke. Experienced garbled speech for a period of less than one minute. Symptoms resolved on their own. Went to ER and had an MRI showing three spots for affected tissue.
51 2021-04-15 chest pain Within 24 hours I developed chest pain about 2 inches to left of sternum. Within another 24 hours th... Read more
Within 24 hours I developed chest pain about 2 inches to left of sternum. Within another 24 hours the pain shifted another 2 inches towards my left armpit. Pain can be slight to intense at times requiring me to sit down. Within 24 hours I developed a painful bump in the trapezoid about halfway between neck and shoulder. The bump has gone down now (day 10) but the pain continues. It?s relatively constant throughout the day but gets severe enough towards the evening to stop or minimize the use of my left arm. It seems to be activity related. The more I need to do that day, the worse it is in the evening. Pain in left arm has been as expected but continues at day 10. It is slowly subsiding and is minimal compared to the other two pain locations.
51 2021-04-15 blood clot Systemic: Blood Disorder (diagnosed by MD)-Severe, Additional Details: Patient hospitalized for blo... Read more
Systemic: Blood Disorder (diagnosed by MD)-Severe, Additional Details: Patient hospitalized for blood clot (called pharmacy @ 835pm on 4/15/21). Asked by hospital to contact pharmacy. Patient called from personal phone number.
51 2021-04-17 nosebleed This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A 51-yea... Read more
This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A 51-years-old male patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, Product: Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced nose is bleeding. Caller, inquiring on behalf of her husband, would like to know whether their side effect; bloody nose, was related to the COVID-19 vaccine. She stated they already reported AE to previous agent. Caller reports that her husband received the Pfizer covid vaccine yesterday at about 1:00. At 10:00, last night, his nose started bleeding and has not stopped. He received the vaccine on his left side and only the left side of his nose is bleeding. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
51 2021-04-18 blood clot Blood Clot/The Blood clot was in the legs and went to his lungs; Blood Clot/The Blood clot was in th... Read more
Blood Clot/The Blood clot was in the legs and went to his lungs; Blood Clot/The Blood clot was in the legs and went to his lungs; fell; Leg pain; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included thrombosis from 2020 to an unknown date, it was Months ago in 2020, He was prescribed a medicine for blood clots, but since then he has had no issues, anxiety from an unknown date and unknown if ongoing. Her brother in law had anxiety about even getting the vaccine. The patient experienced leg pain on Mar2021 , pulmonary thrombosis, leg thrombosis and fall on an unspecified date. The patient died on 02Apr2021. An autopsy was not performed. The clinical course was the following: The Blood clot was in the legs and went to his lungs, his leg never got red or anything and it was a blood clot. He was having such bad leg pain, it's too bad, had there been some sort of warning, he would have thought to wait till next year. There was nothing the day he got vaccine, but that night his leg started hurting, his girlfriend said let me go get a cold wrap and she wrapped it, he's a farmer. He wakes up the next day and his leg is still hurting, the 3rd day it goes on, his leg still hurting and no one is thinking it a blood clot, he calls the doctor and tells the doctor his leg is hurting, they suggest ibuprofen for inflammation, the next day thought maybe it's better, by Friday he was making breakfast, fell and died. With his girlfriend she said what's going on, and he went straight to hospital, they said the clot in his leg went to the lung. The Blood clot when it was in the leg it never got hot, red, or anything like that. He had the vaccine in the morning and on that same day the leg pain started later that night. It Started out with Leg Pain, she does not know if it was right or left but it was just one leg.; Reported Cause(s) of Death: Thrombosis pulmonary; Thrombosis leg; Fall; Leg pain
51 2021-04-19 troponin increased Sudden cardiac arterial dissection
51 2021-04-21 loss of consciousness i experienced cold sweats and an unwell feeling shortly after injection. I passed out at the vaccina... Read more
i experienced cold sweats and an unwell feeling shortly after injection. I passed out at the vaccination site and was taken by ambulance to the medical center yesterday, april 21st around 356pm.
51 2021-04-21 heart attack, blood clot Blood clot causing heart attack
51 2021-04-24 blood glucose increased Patient had first dose on 4/1/21 he developed fatigue and muscle cramps lasting about 36 hours Pati... Read more
Patient had first dose on 4/1/21 he developed fatigue and muscle cramps lasting about 36 hours Patient had second dose 4/22/21 and once again developed muscle cramps. He also started to have vision changes, increase thirst, and blood sugar spikes between 400-500. He is not a diabetic
51 2021-04-24 pulmonary embolism Week after vaccine developed shortness of breath and pain breathing. Trip to ER and admitted to hos... Read more
Week after vaccine developed shortness of breath and pain breathing. Trip to ER and admitted to hospital. Diagnosed with Pulmonary Embolism. Blood clots both lungs.
51 2021-04-25 chest discomfort Extreme joint pain tiredness fingers felt cold and ached to touch anything sore neck in lymphnode ar... Read more
Extreme joint pain tiredness fingers felt cold and ached to touch anything sore neck in lymphnode area then the headaches started a few days later like 5 days i felt very tired weak not sick to stomach but felt like blood was dirty hard to explain right kidney hurt then weeks of headaches felt like head was bleeding it hurt so bad chest felt like just got over a chest cold or bronchitis or ran out in cold weather and also very cramped feet some of this still happening but most has subsided . The scariest part was the feeling of my headache terrible .i never went to a er or doctor but almost did.
51 2021-04-25 fainting, hypotension syncope, followed by profuse sweating, patient fainted twice., very low blood pressure, severe migr... Read more
syncope, followed by profuse sweating, patient fainted twice., very low blood pressure, severe migraine and vomiting EMS called after prolong time of syncope and vomiting. Patient refused travel to ER. I followed up a call to the patient later in the day and patient was tired but had fully recovered.
51 2021-04-26 chest pain chest pain. anxiety -- resolved
51 2021-04-26 pallor Skin became severely dry and itchy. Rash and nonspecific skin eruption. Blanching erythematous papul... Read more
Skin became severely dry and itchy. Rash and nonspecific skin eruption. Blanching erythematous papules and excoriation on arms and upper back. No rash in groin. Well developed, well nourished, male in no acute distress, oriented and without outward signs of anxiety or depression. Complete examination of the scalp and hair, head, face, ears, nose, lips, eyelids and conjunctiva, neck, chest, breasts and axillae, back, abdomen, right and left arms, digits/nails, right and left legs was normal except for the following significant findings: - Erythematous papules coalescing in areas into nummular plaques with scattered excoriations on the back, flanks, lower legs. Eczematous dermatitis - Start Triamcinolone acetonide 0.1% ointment BID over affected area, no more than 2 weeks per month. - Reviewed side effects of prolonged steroid use including skin atrophy, telangiectasia, hypopigmentation, and striae. - Recommended bathing with lukewarm water, using minimal fragrance-free soap only in intertriginous areas. Options include Cetaphil and Dove. - We discussed the importance of regular moisturizing (2-3x per day) with an emollient (Hydrolatum or Aquaphor) or thick cream (Cetaphil, CeraVe, Vanicream, Eucerin etc) even when eczema seems to be doing well. - For itch and poor sleep, start hydroxyzine 25 mg PRN at bedtime. Reviewed potential SE including sedation.
51 2021-04-26 fainting, blood pressure decreased 03/23/21 at approximately 2:00 pm. After recieving vaccine client had a vasalvagal/syncopy espisode... Read more
03/23/21 at approximately 2:00 pm. After recieving vaccine client had a vasalvagal/syncopy espisode. Drop in blood pressure recorded. Return to normal limits within a minute. Client stated they were a self-proclaimed fainter
51 2021-04-26 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: nurse instructed pt to call for ride hom... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: nurse instructed pt to call for ride home pt declined and said he did not feel the need. he hais he feel better and pt discharged
51 2021-04-28 blood pressure increased, increased heart rate, blood glucose increased, palpitations 50 y/o male, with past medical history of HTN, who presents with dizziness, palpitations and diaphor... Read more
50 y/o male, with past medical history of HTN, who presents with dizziness, palpitations and diaphoresis onset post vaccination. Patient states that this is his first vaccination in the two-dose series. Patient received the vaccination to his R arm. NP and Paramedics at patient side. Patient provided with bottle of water and legs were elevated. Patient initial BP was elevated, 159/96, but states that is normal for his history of Hypertension; all other vitals within normal limits (97% RA, 78 HR, Resp 14). Patient glucose was 131 but states that he had a protein shake prior to arrival. Approximately after 10 mins of observation patient stated that he was getting better but then developed chills and palpitations continued. Patient at this time placed on stretcher and was moved to a private area. EKG was obtained and patient noted to be Sinus Tachycardia with HR of 111. Patient with diaphoresis again and BP increased to 158/104. It was determined at this time by the NP that patient needed to be transported to the ER. Fire rescue arrived at site. Patient was evaluated, EKG was obtained and normal. Patient stated that he felt better, and all symptoms resolved. Patient stated that he did not wish to be transported to the ER. Patient signed out AMA with Fire Rescue as well as with the NP. CNO and PM aware.
51 2021-04-28 chest pain, hypertension, pulmonary embolism, troponin increased BRIEF OVERVIEW: Bilateral PE Discharge Provider: MD Primary Care Provider at Discharge: NP Admissi... Read more
BRIEF OVERVIEW: Bilateral PE Discharge Provider: MD Primary Care Provider at Discharge: NP Admission Date: 4/26/2021 Discharge Date: 4/26/2021 Active Hospital Problems (Diagnosis Date Noted) ? Pulmonary embolism without acute cor pulmonale, unspecified chronicity, unspecified pulmonary embolism type (HCC) 04/26/2021 Resolved Hospital Problems No resolved problems to display. CONSULTS: None INPATIENT PROCEDURES: None DETAILS OF HOSPITAL STAY: Patient is a 51 y.o. male with a past medical history of psoriasis, environmental allergies who presents today with sudden shortness of breath, left side pleuritic chest pain 7/10, worsened with deep inspiration. No recent travel, no family history, no history of malignancies, no immobilization or surgeries. He had his 2nd dose of Pfizer COVID vaccine on April 1. He does not have a history of COVID-19 infection, and COVID-19 PCR test was negative in ER. His blood pressure is a little high at 170 6/83 mm, pulse 76 per minute saturating 96% on room air, troponin less than 6, BNP 16, WBC 12.3,, EKG without any significant ST T-wave changes. CT angiogram of the chest shows nonocclusive thrombi in almost all the lobes, there is no saddle embolus noted. There is no evidence of right heart strain. Echo: The technical quality of the exam was limited due to suboptimal acoustic windows. The left ventricle is normal in size. There is normal left ventricular wall thickness. The left ventricular ejection fraction is 60%. Regional wall motion abnormalities cannot be excluded due to limited visualization. The right ventricular size, thickness, and function are normal. No significant valvular pathology identified with Doppler examination. There was insufficient tricuspid regurgitation envelope detected to calculate right ventricular systolic pressure. Injection of contrast documented no interatrial shunt. There is no comparison study available. He was started on Heparin gtt. And admitted for observation. He required no supplemental oxygen. He was discharged later pm on Eliquis 10 mg bid for 7 days, than 5 mg bid for 3 months. I am questioning did he had COVID-19 vaccine related bilateral PE. His hypercoagulable profile is pending. He has no sign of malignancy, no new symptoms, no weight loss. He had normal colonoscopy 2 yrs ago. He should follow up with his PCP. He was given work excuse from 4/26-5/3/21. She shouldn't take non steroidal anti-inflammatory (Ibuprofen (Motrin), Naproxen, Naprosyn, Voltaren, Relafen ... meds because of blood thinner Eliquis. He can take Tylenol 500 mg 1-2 tabs 3-4x a day as needed. He was also prescribed Lidoderm patch. For HTN he was started on DASH diet and Norvasc 5 mg daily. He should follow up with PCP next week. Also he was instructed to quit smoking.
51 2021-04-28 chest pain, troponin increased, hypertension, transient ischaemic attack, chest discomfort Within 30-minutes of vaccination, the patient reported a headache, slurred speech, and right side we... Read more
Within 30-minutes of vaccination, the patient reported a headache, slurred speech, and right side weakness. EMS evaluated the patient on-site. The patient was hypertensive (197/129) with a FSBG of 95mg/dL. During stroke assessment, the patient had new onset facial palsy/droop and need speech abnormality which signaled a stroke alert. 12-lead EKG was unremarkable. EMS transported the patient to Emergency Department. In the ED, the patient presented with a headache, chest heaviness, and slurred speech, but no aphasia. NIH stroke scale was 0. Patient remained hypertensive (170/109). Labs, tests, and imaging did not indicate rtPA administration. ED physician administered 0.4mg SL Nitroglycerin, 10mg IV Hydralazine, and 325mg PO Aspirin prior to admission for suspected Transient Ischemic Attack. Upon admission, differential was TIA vs. CVA vs. ACS. Admitting physician ordered HbA1C, lipid panel, MRI brain, CTA head/neck, 2D echo, and neurology consult. Throughout course of admission, patient had recurring midsternal chest pain that was relieved with Nitroglycerin. Imaging ruled out CVA. Given elevated TGs and Cholesterol, patient was started on Atorvastatin 40mg PO. Suspected TIA and ACS. Neurology consult reviewed the labs and imaging, and stated the episodes of stuttering are most commonly associated with anxiety or stress reaction. Neuro did not recommend any further workup unless this happened again unprovoked. Patient was discharged after a 3-day admission with diagnosis of cerebrovascular disease, unspecified. The patient was prescribed 81mg PO Aspirin, 20mg PO Lisinopril, and 40mg PO Atorvastatin.
51 2021-04-28 deep vein blood clot he reports discoloration resolved but developed worsening bilateral lower extremity edema; lower ext... Read more
he reports discoloration resolved but developed worsening bilateral lower extremity edema; lower extremity pain and swelling; lower extremity pain and swelling; blue toes on both feet; extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy; legs were cool to touch; This is a spontaneous report from a contactable physician reporting for a patient. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 51 years old. Medical history included triplegia, neurogenic bladder, hyperlipidaemia, chronic abdominal pain, type 2 diabetes mellitus, chronic opioid use, known allergies: Latex from an unknown date and unknown if ongoing. No other vaccine in four weeks. No COVID prior vaccination and was not tested for COVID post vaccination. The patient's concomitant medications were not reported. The patient previously took sulfamethoxazole;trimethoprim and experienced allergies to Sulfamethoxazole-trimethoprim. The patient experienced lower extremity pain and swelling, lower extremity pain and swelling, blue toes on both feet, extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy, legs were cool to touch on 02Apr2021; and he reported discoloration resolved but developed worsening bilateral lower extremity edema on an unspecified date. Clinical course was reported as follows: The patient presented to the hospital on "4/7" (as reported) with lower extremity pain and swelling. Patient reports received 1st dose on pfizer vaccine on 4/2 (as reported) and immediately noticed blue toes on both feet and legs were cool to touch. He reports discoloration resolved but developed worsening bilateral lower extremity edema. Imaging revealed extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 07Apr2021, and sars-cov-2 antibody test (nasal swab): negative on 13Apr2021. Treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (Apr2021). Outcome of the events was recovering. Information on the lot number has been requested.
51 2021-04-28 fainting, loss of consciousness PATIENT FELT DIZZY, FAINTED AND WAS NOT RESPONSIVE FOR FEW MINUTES. LATER HE REGAINED CONSCIOUSNESS... Read more
PATIENT FELT DIZZY, FAINTED AND WAS NOT RESPONSIVE FOR FEW MINUTES. LATER HE REGAINED CONSCIOUSNESS, FELT COLD , CONFUSED AND WAS SWEATING. CALLED EMS AND THEY DID A ROUTINE CHECK, ALL VITALS WERE NORMAL AND PATIENT REFUSED HELP
51 2021-04-28 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: Fainted five minutes after receving 2nd ... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Fainted five minutes after receving 2nd dose. Hx of fainting due to needles. Reported not eating or drinking prior. Fainted from the chair and broke small fragment of glasses. Did not injure his head. Interventions: bottle of orange juice and water, lifting legs and having him laydown/ sit up for 15 minutes. Walked him to car with his partner ensuring safety. First set of vital signs taken at 1800 (3pm): 96 degrees F, 55 bpm, 102/62, 14 RR. 1815 vitals: 66bpm, 16 RR, 96.8F, 118/84 BP.
51 2021-04-29 fainting PATIENT RECEIVED FIRST DOSE OF COVID VACCINE AROUND 10 AM ON 4/30/21. DURING THE 15 MINUTE OBSERVATI... Read more
PATIENT RECEIVED FIRST DOSE OF COVID VACCINE AROUND 10 AM ON 4/30/21. DURING THE 15 MINUTE OBSERVATION PERIOD, PATIENT FAINTED IN HIS CAR. BP WAS 88/32, O2 WAS 88, AND PULSE WAS 88. OXYGEN WAS GIVEN AND 911 WAS CALLED. AMBULANCE ARRIVED BUT PATIENT DID NOT REQUIRE TRANSPORTATION TO EMERGENCY ROOM. PATIENT WAS OBSERVED FOR 30 ADDITIONAL MINUTES AND RETURNED TO WORK.
51 2021-05-01 arrhythmia Approximately 24-36 hours after receiving my second dose of the Pfizer COVID-19 vaccine I started ha... Read more
Approximately 24-36 hours after receiving my second dose of the Pfizer COVID-19 vaccine I started having three noticeable side effects: pronounced exhaustion, occasional mild headaches, and a transient heart arrhythmia usually lasting 5-15 seconds. These symptoms have not subsided and the arrhythmia became persistent enough last night that it required a trip to the local ER. The first doctor I spoke to, informed me that he had been out of work for a week following his second dose of the Pfizer vaccine due to transient, but consistent, heart palpitations, which ultimately brought him into the ER to take his own EKG. He advised me that a number of other patients with identical complaints had come to the ER over the last 4-5 weeks. Ultimately he referred me to a local cardiologist and told me not to worry about the arrhythmia, that it would clear up in a few days. I?m curious why this isn?t listed as a common side effect of the vaccine, had it been, I would not have been so concerned about it.
51 2021-05-01 low blood platelet count Idiopathic Thrombocytopenia
51 2021-05-03 pallor, fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Anixety-Mild, Systemic: Flushed / Sweating-Mediu... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Anixety-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: Patient discussed vaccination with immunizer for a few minutes before injection was given. After the injection was given, patient experienced brief syncope episode with brief 2-3 seconds of "seizure-like" activity. Patient woke back up and was pale and diaphoretic. EMS services were activated and patient rested, given water and orange juice. Maintained a slow, steady heart rate of 48 bpm while awaiting EMS. EMS evaluated patient and transported to hospital
51 2021-05-04 deep vein blood clot DVT developed in Right Calf approx 24 hours after the vaccine administration; This is a spontaneous ... Read more
DVT developed in Right Calf approx 24 hours after the vaccine administration; This is a spontaneous report from a contactable physician. This Physician reported for a 51-year-old male patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included kidney stone from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not receive any vaccine in four weeks. Patient did not receive any vaccine in four weeks. The patient developed DVT in right calf approximately 24 hours after the vaccine administration on 12Mar2021 with outcome of recovering. Therapeutic measures were taken as a result of event included Xarelto. Patient was not tested for covid post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event DVT cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
51 2021-05-05 loss of consciousness Patient was seated for 15 minutes following the vaccination and when he got up to retrieve his vacci... Read more
Patient was seated for 15 minutes following the vaccination and when he got up to retrieve his vaccination record card he passed out onto the floor. He was attended to by the nurse on staff as well as myself. Reported no pain, knew his name and where he was. Stated no history of seizures and was not diabetic. Stated he has not eaten today, only a Starbucks. We got him up to a chair after a few minutes and attempted to take his blood pressure. He passed out a second time and we got him to the floor. He was alert shortly after getting him to a laying position. Ambulance was called and he was taken to be checked out. Patient did return the next day to thank us and let us know he had a CT and labs done. His physician thought it was a vasovagal episode. He is to follow up with his primary physician soon.
51 2021-05-06 chest pain Post nasal drip, sore throat, cough, sinus pressure, nasal irritation, fatigue, night sweats, burnin... Read more
Post nasal drip, sore throat, cough, sinus pressure, nasal irritation, fatigue, night sweats, burning in chest stay well-hydrated and well-nourished while resting appropriately For cough: honey 1 to 2 teaspoons every 4 hours can help to quiet a cough buPROPion SR (WELLBUTRIN SR)
51 2021-05-06 blood clot Tinitus in left ear as of 4/13/21. And disgnosed with a blod clot in right calf symptom of clot fel... Read more
Tinitus in left ear as of 4/13/21. And disgnosed with a blod clot in right calf symptom of clot felt on 4/17/21
51 2021-05-07 chest pain, blood clot I had an ultrasound done on my leg where a blood clot was found. I had a chest CT performed where se... Read more
I had an ultrasound done on my leg where a blood clot was found. I had a chest CT performed where several clots were found; Two days after my vaccine I began having severe pain in my right leg in the calf area and pain in my chest when I took a deep breath or coughed. Over the weekend it got worse and worse, on Tuesday th; Pain in my chest; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 14Apr2021 13:00 (Batch/Lot Number: Ew0153) (at the age of 51 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included duloxetine; trazodone; pregabalin (LYRICA); oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]); and meloxicam, all taken for an unspecified indication, start and stop date were not reported. The patient previously took vancomycin and daptomycin and experienced drug allergy to these medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Apr2021 09:00, two days after the vaccine, the patient began having severe pain in his right leg in the calf area and pain in his chest when he took a deep breath or coughed. Over the weekend, it got worse and worse, on Tuesday 20Apr2021, the patient had an ultrasound done on his leg where a blood clot was found. He had a chest computerized tomography (CT) performed where several clots were found. The event resulted in doctor or other healthcare professional office/clinic visit. The treatment included blood thinners. No COVID prior vaccination and not COVID tested post vaccination. The case was assessed as non-serious by the reporter. The outcome of the event was not recovered.
51 2021-05-08 troponin increased, ischemic chest pain, fast heart rate, heart attack Patient with no family or personal cardiac ischemic history, appropriate diet. Prior evaluation 6 ye... Read more
Patient with no family or personal cardiac ischemic history, appropriate diet. Prior evaluation 6 years prior showed 10% stenosis. Performs regular cardiovascular exercise (Peloton). No smoking or drug or alcohol history. Normal lipids before and after event. Normal lipid subfractions (MRI advanced profile). Pfizer Vaccine Dose #1 received 12/31/2020. First mild angina episode 1/17/2021. Pfizer Vaccine Dose #2 received 1/21/2021. Increasing angina developed 1/22/2021 through 1/27/2021. Normal echocardiogram 1/27/2021. NSTEMI occurred 1/28/2021 at 3:30am necessitating Emergency room visit, Catheterization demonstrating a new 95% LAD stenosis and stent placed. Patient subsequent developed questionable dysautonomia (tachycardia and insomnia of unknown etiology). Currently in recovery.
51 2021-05-09 chest pain chest pain
51 2021-05-11 hypertension Organ Failure following Second Shot - otherwise healthy person - Kidneys showed failure on 5/3/2021 ... Read more
Organ Failure following Second Shot - otherwise healthy person - Kidneys showed failure on 5/3/2021 at an ER visit- Blood Pressure became elevated- Kidneys have been failing since second shot
51 2021-05-12 chest pain, fast heart rate ED to Hosp-Admission Discharged 2/23/2021 - 2/25/2021 (2 days) Treatment team Costochondritis Princ... Read more
ED to Hosp-Admission Discharged 2/23/2021 - 2/25/2021 (2 days) Treatment team Costochondritis Principal problem Discharge Summary (Physician Assistant) ? ? Internal Medicine Cosigned by: MD at 2/27/2021 4:06 PM Discharge Summary Hospitalist Medicine Admission Date: 2/23/2021 Length of Stay: 0 Days Discharge Date: 2/25/2021 Admission Diagnosis Hospital Problems POA * (Principal) Costochondritis Yes COVID-19 Yes Problem List Resolved POA Resolved Problems Atypical chest pain 2/25/2021 Yes SIRS (systemic inflammatory response syndrome) (CMS/HCC) 2/25/2021 Yes Hyponatremia 2/25/2021 Yes Dehydration 2/25/2021 Yes Home Or Self Care CODE STATUS: Full Code Active Issues Requiring Follow-up Test Results Pending at Discharge Pending Labs Order Current Status Blood culture x 2 SETS Preliminary result Blood culture x 2 SETS Preliminary result Hospital Course Hospital Course: Please refer to the admitting providers H&P for full history. Patient is a 51-year-old male with a PMHx significant for hemochromatosis, sarcoidosis and morbid obesity who initially presented to the ED for evaluation of chest pain, cough and shortness of breath. On presentation, vitals were mostly unremarkable other than some mild tachycardia and tachypnea. Patient was able to maintain adequate oxygenation on room air but was placed on supplemental oxygen for comfort. Blood work was mostly unremarkable. ABG was not particularly concerning. Troponin was negative x3. Patient underwent chest CTA which showed basilar atelectasis bilaterally and scattered groundglass opacities and scattered borderline size hilar and mediastinal lymph nodes consistent with patient's known sarcoidosis. Patient was treated with supportive care and monitored overnight. He was able to maintain sufficient oxygen levels. On the time my evaluation, patient continues to complain of bilateral rib pain worse with deep breaths consistent with costochondritis. I discussed with the patient that he will need to continue to take NSAIDs on a scheduled basis to help with his discomfort. Additionally I offered to prescribe cough medicine. I discussed possibly discharging the patient on steroids however he states that he makes a point to avoid taking steroids due to his history of hemochromatosis. At this point, patient no longer requires care in the hospital and can be discharged home. Patient is agreeable with the plan and all questions have been answered appropriately.
51 2021-05-13 pulmonary embolism Developed bilateral pulmonary emboli
51 2021-05-14 arrhythmia transient heart arrhythmia usually lasting 5-15 seconds.; pronounced exhaustion; occasional mild hea... Read more
transient heart arrhythmia usually lasting 5-15 seconds.; pronounced exhaustion; occasional mild headaches; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 26Apr2021 17:00 (at the age of 51-year-old) at single dose for COVID-19 immunization. The patient medical history included insomnia. The patient had no known allergies. Concomitant medication included mirtazapine taken as sleep aid. The patient previously received the first dose of BNT162B2 (Lot Number: ER8734) administered in left arm on 05Apr2021 18:00 (at the age of 51-year-old) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Apr2021 19:00, the patient experienced pronounced exhaustion, occasional mild headaches, and a transient heart arrhythmia usually lasting 5-15 seconds. These symptoms have not subsided, and the arrhythmia became persistent enough last night that it required a trip to the local ER. The consistent heart palpitations which ultimately brought him into the ER. The patient was referred to a local cardiologist and was told not to worry about the arrhythmia, that it would clear up in a few days. The reported events resulted in Emergency room/department or urgent care. There was no treatment received for the events. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.
51 2021-05-15 fast heart rate Supraventricular Tachycardia, cardioversion(adenosine), released from ER after observation.
51 2021-05-16 chest pain Chest cough Chest pain - mild Headache Fever Sweats Chills Aches Fatigue
51 2021-05-17 blood glucose increased, palpitations Shot 1 taken on 4/22/2021. Shot 2 taken on 5/13/2021. (side effects) (both shots) ? Extreme Dry Mo... Read more
Shot 1 taken on 4/22/2021. Shot 2 taken on 5/13/2021. (side effects) (both shots) ? Extreme Dry Mouth for approx. 24-36 hours ? Headache (top of the head only) for approx. 7 hours. intermediate ? Arm pain at the injection spot (onset occurred 8 hours later) (side effects) (2nd shot only) ? Extreme exhaustion and tiredness (felt like I could sleep for days) ? Elevated Sugars (bgs) for 13 hours (could have impacted the sleepiness feeling above) ? Palpitations (still ongoing) but Sinus Pause only ? micro events ? Tinnitus (very loud ringing in my ears) ? loudness comes in waves but is constant now and won't go away.
51 2021-05-20 palpitations An employee felt heart palpitation after her 2nd shot of Pfizer. We took her blood pressure reading ... Read more
An employee felt heart palpitation after her 2nd shot of Pfizer. We took her blood pressure reading and it was normal, then told her to rest more, drink fluid. Then 5-10 minutes later, she felt itchiness on her right leg. I checked and it was red and had 2 bumpy spots from her scratches. We gave her diphenhydramine 50mg/ml with 1 ml IM. I told her to rest and warned her of drowsiness. After 5 minutes, she started feeling better wanted to leave (used uber) before she get too drowsy.
51 2021-05-20 palpitations Having adult onset severe asthma I am prone to lung inflammation from a number of sources including ... Read more
Having adult onset severe asthma I am prone to lung inflammation from a number of sources including some foods and allergens as well as viruses and smoke of any kind. I had been doing fine that week until the day after the second shot. I had severe shortness of breath, bad enough to keep me home and using my rescue inhaler several times that next day. This also occured when I had Covid in November 2020. It took me longer to test negative, 3 weeks. I believe that the shot caused an immune reaction, like it should, but also triggered an asthma attack that lasted several days but progressively reduced as time went on. Last week I had dizziness and heart palpitations. I have no idea if it was the shot still or the meds for my asthma, but I thought I should include it.
51 2021-05-22 palpitations recommended emergency room evaluation . which the caller has refused
51 2021-05-24 palpitations, heart rate increased heart races a little; feels flushed; checked his pulse and it was a little elevated; eyes are tingly... Read more
heart races a little; feels flushed; checked his pulse and it was a little elevated; eyes are tingly; feeling feverish but no fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9262) via an unspecified route of administration administered in Arm Right on 25Jan2021 14:00 (at the age of 51-years-old) as single dose for covid-19 immunisation. The patient's medical history included blood pressure. The patient's concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) ongoing at 12.5 of unknow units once daily for blood pressure and tamsulosin. The patient underwent lab tests and procedures which included heart rate: little elevated. He checked his pulse and it was a little elevated. It was reported as the patient received the first dose of the pfizer covid 19 vaccine on Monday 25Jan2021 but did not have any symptoms until Thursday 28Jan2021. The patient reported feeling feverish but no fever, heart races a little, eyes are tingly and feels flushed. The patient wants to know if what he is experiencing normal. The patient wanted to know if the rumor is true that the second dose has more side effects. He has had no allergic reactions to medicine. He takes a blood pressure medicine, anti-anxiety medicine, and cholesterol medicine. Starting yesterday he started to feel feverish but had no fever. His eyes started to feel tingly, like a feverish feeling. This started after lunch time. He took a nap for like an hour, slept fine, and then the feeling was gone and he was okay. Today, he woke up this morning around 6:30 AM and was fine. It was not until later this morning around 11 AM when he started to feel the same way again. It was like his heart raced a little. He checked his pulse and it was a little elevated, but nothing crazy. He felt flushed. His eyes were tingly. It is like something does not feel right. He was calling to see if these were side effects. Feeling like his heart was racing has subsided. It was worse earlier. The feeling flushed is minor now. The eyes tingly has almost subsided, but still there. The patient experienced feeling feverish but no fever, eyes are tingly on 28Jan2021, heart races a little, feels flushed and checked his pulse and it was a little elevated on an unspecified date. The outcome of the events heart races a little and eyes are tingly and feels flushed was recovering, while the outcome of remaining events was unknown. Follow-up attempts are completed. No further information is expected.
51 2021-05-25 chest discomfort fever , cough, tiredness , body aches Office Visit 4/30/2021 Urgent Care CRNP Family Medicine COVI... Read more
fever , cough, tiredness , body aches Office Visit 4/30/2021 Urgent Care CRNP Family Medicine COVID-19 Dx Cough Reason for Visit Progress Notes (Nurse Practitioner) ? ? Family Medicine ? ? Encounter Date: 4/30/2021 ? ? Signed Expand AllCollapse All History Chief Complaint Patient presents with ? Cough Lingering fatigue, fever Positive Covid test 4-26-21 Patient is a 51 y.o. male HPI Patient is a 51-year-old male who presents with continued Covid symptoms. Patient was diagnosed on April 26. He is currently on day 9 of symptoms. Patient continues to have low-grade fevers. Wife and patient would like the cough is worse. He has been taking over-the-counter medications with minimal relief. He denies history of pneumonia or asthma. Symptoms started suddenly and have been persistent. Tmax at home = 100.4 F Admits to nasal congestion, rhinorrhea, sinus pressure, nonproductive cough Denies ear pain, sore throat The cough is worse at nighttime. Admits to occasional mild chest tightness.
51 2021-05-25 oxygen saturation decreased I the pharmacist was not there for the care of the patient. The clinics directed all of the care an... Read more
I the pharmacist was not there for the care of the patient. The clinics directed all of the care and I was not tol dabout it until 2 hours post event. Patient presume dbetween 20 minutes to 2 hours post vaccination (undetermined as ressources mixed) had a pulse ox decompensation in the 70s.
51 2021-05-25 pallor AE: Diaphoretic( at 12pm). patient is Type II diabetic and has not eaten today. Treatment: no medica... Read more
AE: Diaphoretic( at 12pm). patient is Type II diabetic and has not eaten today. Treatment: no medication was given. patient was under observation. Graham crackers and water improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.
51 2021-05-26 increased heart rate, pulmonary embolism, atrial fibrillation, heart rate decreased, cardiac arrest, very slow heart rate On 5/20/21 the patient was at home with his mother when he had acute nausea, light-headedness, and a... Read more
On 5/20/21 the patient was at home with his mother when he had acute nausea, light-headedness, and abdominal pain. He presented to the ED by ambulance. Excerpt from ED notes od MD follows: "Initial ED interventions: iv fluids, low dose iv ativan, iv toradol, iv zofran. ED course: patient arrives very anxious, writhing on bed, difficult to redirect. With chronic tonicity, not seizing. Mother arrives, and he recognizes her, seems to be consoled somewhat by her presence, but she is unable to direct him, and describes his behavior as irregular, and events acute this evening at her home. Patient rests, and then HR decrease to 50s on monitior and patient found to be pulseless - I immediately start chest compressions, and achieve ROSC after PEA arrest with administration of EPI/compressions. Patient intubated per procedure note without complication. L femoral central attained per procedure note without complication. CPR performed over ED course intermittently (always PEA arrest) with ROSC achieved with administration of EPI, EPI drip started in addition to sedation meds, and iv fluids. No obvious STEMI on ECG to administer lytics, with suspicion of dissection and AAA prominent. I am able to stabilze and accompany patient to CT suite, where I recognize B/L massive PE immediately. I discuss with Dr. of Cardiology, who agrees with admininstration of alteplase. I disucss risks with mother who consents verbally. Patient without response to alteplase, and with continued pattern of PEA arrest following bradycardia. I discuss etiology of presentation with mother,and that patient is with very poor prognosis of survival, and likely poorer prognosis of neurological status, and patient is made comfort care, and fentanyl drip increased, patient is taken off of ventilation and drips. Pronounced deceased at 22:00. MDM: Initial concern for but not limited to appendicitis, AAA, diverticulitis, renal stones, pyelonephritis, musculoskeletal pain, pancreatitis, toxic ingestion, ACS, obstruction, perforation, sepsis (2/2 PNA, UTI, meningitis, intra-abdominal infection), AAA, dissection, PE - as ED course progresses, differential narrows and consider more likely PEA arrest secondary to ACS, PE, dissection, AAA, necrotic pancreatitis, tension PNX (less likely). Considered but do not suspect seizures, stroke. Imaging studies reviewed - CXR with ETT in place, no acute pathology. CTA chest/A/P remarkable for massive proximal B/L PE. Labs reviewed. ECGs without STEMI, with sinus tach initially, LBBB after initial ROSC, and then AFib in RVR on subsequent ECG. Per above, patient suffered massive B/L PE, with subsequent cardiac arrest, despite heoric efforts including thrombolysis. Death called art 22:00. Diagnosis: massive B/L PEs, PEA arrest. Disposition: deceased."
51 2021-05-26 blood vessels inflammation adverse reactions appears 5/21 after first dose received 5/9. Reactions include peripheral vasculiti... Read more
adverse reactions appears 5/21 after first dose received 5/9. Reactions include peripheral vasculitis, the size of a quarter, appearing above interior of right wrist. Site also has some pain similar to that of a bruise. Also had blood in urine, which did not reoccur after initial incident.
51 2021-05-27 deep vein blood clot a DVT in his left calf after the second vaccine; This is a spontaneous report from a contactable con... Read more
a DVT in his left calf after the second vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 18:15 (Batch/Lot Number: ER8735) at the age of 51-years-old as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications was none, patient did not received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Lot number: ER8733) on 01Apr2021 16:00 at the age of 51-years-old in Left arm for covid-19 immunization and experienced a superficial blood clot in his left calf. The patient experienced a deep vein thrombosis (DVT) in his left calf after the second vaccine on 16Apr2021 6:30 PM. Event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the events included had a shot of enoxaparin sodium (LOVENOX) and am taking rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood test: negative on 06May2021, Nasal swab covid-19 test: negative on 27Apr2021. The outcome of the event was not recovered.
51 2021-05-27 blood clot had a superficial blood clot in my left calf between the first and second vaccines; This is a sponta... Read more
had a superficial blood clot in my left calf between the first and second vaccines; This is a spontaneous report from a contactable consumer (Patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 16:00 (Batch/Lot Number: ER8733) at the age of 51-years-old as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medication was none, patient did not received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a superficial blood clot in his left calf between the first and second vaccines on 16Apr2021. Event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the event included had a shot of enoxaparin sodium (LOVENOX) and am taking rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood test: negative on 06May2021, Nasal swab covid-19 test: negative on 27Apr2021. The outcome of the event was not recovered.
51 2021-05-28 deep vein blood clot Occlusive deep venous thrombosis in left anterior tibial vein
51 2021-05-30 low blood pressure, lightheadedness Pre-syncope after exercise. found to have orthostatic hypotension and dysautonomia, diagnosed in the... Read more
Pre-syncope after exercise. found to have orthostatic hypotension and dysautonomia, diagnosed in the weeks following the second vaccination. Persistent light headedness, urinary symptoms, weight loss. Possible pure autonomic failure. Evaluation ongoing.
51 2021-06-01 ischaemic stroke, blood clot in the brain Exactly 5 days after the second dose of the Pfizer covid-19 vaccine, I suffered an ischemic stroke. ... Read more
Exactly 5 days after the second dose of the Pfizer covid-19 vaccine, I suffered an ischemic stroke. There was a blood clot in my brain that was broken up after tPA was administered about 2 hours after the symptoms of the stroke set in. To date (May 30) I have had many tests, including 2 MRIs, CT scans, TEE, heart monitoring etc. So far, it has been called a "cryptogenic stroke" because there is no cause. The only thing different was the vaccine I received 5 days before the stroke.
51 2021-06-03 heart rate increased Rapid heart rate. Resting rate of 120 to 130 beats per minute for at least 2 days. Then 100 to 110 f... Read more
Rapid heart rate. Resting rate of 120 to 130 beats per minute for at least 2 days. Then 100 to 110 for another 2 days. After 2 weeks still having trouble with normal activities. Heart beat feels different and I get weak whenever moving quickly for example doing laundry or cleaning the house.
51 2021-06-07 palpitations Slight dizziness; a slight breathing difference; heart palpitations; soreness in arm and shoulders; ... Read more
Slight dizziness; a slight breathing difference; heart palpitations; soreness in arm and shoulders; soreness in arm and shoulders; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration: not reported), via an unspecified route of administration, administered in arm right on 06Mar2021 10:45 as single dose for covid-19 immunisation (at the age of 51-year-old). The patient's medical history was none. Concomitant medication(s) included nortriptyline (as other medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks, no covid tested post vaccination, no covid prior vaccination and no known allergies. Previously, the patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration, administered in arm right on 13Feb2021 10:45 as single dose for Covid-19 immunisation (at the age of 51-year-old). On 06Mar2021 11:30, the patient experienced slight dizziness, a slight breathing difference and heart palpitations, and soreness in arm and shoulders, with tiredness. Not major issues but the patient thought should report them. No treatment taken. The outcome of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
51 2021-06-08 heart attack, chest pain thought it might be a heart attack; Sharp pain in center of chest. Noticed mild pain first; This is ... Read more
thought it might be a heart attack; Sharp pain in center of chest. Noticed mild pain first; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Apr2021 09:30 (Batch/Lot Number: ew0167) (at the age of 51 years old) as 2nd dose, single dose for COVID-19 immunization. Medical history included T1 diabetic. Concomitant medications included insulin lispro (HUMALOG) and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient received the first dose of BNT162B2 in left arm on 02Apr2021 09:30 (lot: er8734) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Apr2021 22:30, the patient experienced sharp pain in center of chest. Patient noticed mild pain first, he considered going to hospital at peak, thought it might be a heart attack. Patient didn't have any other symptoms and it subsided so he didn't think to do anything. There was no treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered on unspecified date in Apr2021.
51 2021-06-09 ischemic chest pain I have sever lower back problems from time to time and the first vaccine, in March, triggered sever... Read more
I have sever lower back problems from time to time and the first vaccine, in March, triggered severe spasms and fatigue which I reported. The second shot triggered a reaction similar to being stung by a wasp, I am allergic to wasps and carry an epipin; however, I broke out in a red rash all over my body and remained very red Saturday and Sunday and now months later, I have unexplained rashes which pop up on my arms from time to time. Thankfully, they go away within a day or so, but the rashes are annoying, especially bc they seem to be spontaneous. Also, when I got the second shot, it felt like someone was grabbing my heart from time to time on the morning of my shot. Sorry for only reporting this now.
51 2021-06-11 fainting Fainting spell that resulted in head injury. Within 15 minutes of first fainting spell and getting ... Read more
Fainting spell that resulted in head injury. Within 15 minutes of first fainting spell and getting assistance from family members, two additional fainting spells.
51 2021-06-13 cerebrovascular accident Massive Blood Clot in the carotid Artery that blocked all blood flow to the brain
51 2021-06-15 chest pain patient complained of dizziness, patient became lethargic, diaphoretic, patient complained of nausea... Read more
patient complained of dizziness, patient became lethargic, diaphoretic, patient complained of nausea vomit, chest pain, shortness of breath. PATIENT TAKEN TO HOSPITAL .
51 2021-06-17 lightheadedness After 2nd shot of Pfizer was given patient sat for 10 minutes before stating he was dizzy and felt l... Read more
After 2nd shot of Pfizer was given patient sat for 10 minutes before stating he was dizzy and felt like he was going to faint. At that point he was instructed to lay down and vital signs were monitored. An ambulance was called and EMT's took over monitoring. Patient subsequently recovered and hospitalization was not necessary
51 2021-06-20 heart flutter COMPLAINED OF "FEELING LIKE HEART IS FLUTTERING" . STATED HE DID NOT TAKE HTN MEDICATION. OBSERVED
51 2021-06-22 cerebrovascular accident Runny nose and eyes, itch deep in left palm, stroke and loss of use in left hand
51 2021-06-23 heart rate increased Two times my smart watch has alerted me of high resting heart rate. Both times the resting heart rat... Read more
Two times my smart watch has alerted me of high resting heart rate. Both times the resting heart rate was around 115 bpm. The first event lasted 6 hours and the second event about 2 hours. No other symptoms occurred and I would not have known about the elevated heart rate without my smart Watch. I had never had an elevated heart rate at rest before getting the vaccine. The first events date was 4/19/21 and the second event was 6/23/21.
51 2021-06-23 palpitations, heart rate increased Symptoms: rapid, pounding heartbeat when lying down; occasional cough at night; shortness of breath ... Read more
Symptoms: rapid, pounding heartbeat when lying down; occasional cough at night; shortness of breath when trying to sleep.
51 2021-06-24 ischemic chest pain Heart pain, tiredness, dizziness. I had a stress test and have scheduled a CT scan of the heart for ... Read more
Heart pain, tiredness, dizziness. I had a stress test and have scheduled a CT scan of the heart for July 17.
51 2021-06-24 chest pain Sharp chest pains, shortness of breath.; Sharp chest pains, shortness of breath.; This is a spontane... Read more
Sharp chest pains, shortness of breath.; Sharp chest pains, shortness of breath.; This is a spontaneous report from a contactable consumer (patient reported on himself). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN0199, Pfizer NTEC), via an unspecified route of administration, administered in left arm on Mar2021 07:00, as 1st dose, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: RE8734, Pfizer NTEC), via an unspecified route of administration, administered in left arm on Mar2021 07:00 (at the age of 51-years-old), as 2nd dose, single for covid-19 immunization. The most recent COVID-19 vaccine was administered in the hospital. Medical history included abdominal discomfort from an unknown date. Concomitant medication(s) included omeprazole (PROTONIX [OMEPRAZOLE]), pseudoephedrine hydrochloride (SUDAFED 12 HOUR), glucosamine (GLUCOSAMINE), l-arginine (arginine), ascorbic acid (VITAMIN C ACID) and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously took PCN (penicillin nos). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. In Mar2021, the patient experienced sharp chest pains and shortness of breath. The patient did not receive any treatment. The clinical outcome for the events was not recovered.
51 2021-06-26 palpitations The first dose resulted in Graves disease, with an acute hyperthyroidism , palpitations, fatigue, ne... Read more
The first dose resulted in Graves disease, with an acute hyperthyroidism , palpitations, fatigue, nervousness, anxiety and irritability. Unintentional severe weight loss and imsomnia. Coughing, and bronchitis
51 2021-06-29 hypertension At 1327 client reported to EMT he was feeling nausea for 30 mins. EMT did first vitals at 1329: blo... Read more
At 1327 client reported to EMT he was feeling nausea for 30 mins. EMT did first vitals at 1329: blood pressure 160/100, pulse 65, oxygen sat 99%. EMT did first assessment. Client reported medical history of diabetes, hypertension and unspecified thyroid condition. Current medications: Lisinopril, Metformin, and Levothyroxine. Client reported no known allergies. PHN arrived at 1335. Client sitting upright in chair, alert and oriented x4. Client aware blood pressure is high and reported he took his medication today. Client reported only reaction to 1st Pfizer Covid vaccine was muscle pain, numbness to arm where vaccine was given and has followed up with provider. Vitals at 1339: blood pressure 160/98, pulse 68, oxygen sat 99%. Client reports nausea same and stated "I can tolerate it, I will not throw up". Client denies chest pain, shortness of breath, headache, or blurry vision. Vitals at 1349: blood pressure: 150/92, pulse 68, oxygen sat 97%. Client reports new onset of lightheadedness and nausea same. Client informed staff he wanted to leave. PHN asked client if someone could pick him up as symptoms had not resolved. Client stated " I can drive, if not I will contact someone when I am in my car". PHN advised client to follow up with provider and gave ER precautions. Client left facility with steady gait at 1358.
51 2021-06-29 hypertension BP increased to 215/115 before I went to ER and then administered intravenous drugs and nitroglyceri... Read more
BP increased to 215/115 before I went to ER and then administered intravenous drugs and nitroglycerin cream over heart area.; This is a spontaneous report received from agency, This is a spontaneous report from a contactable consumer or other non-health care professional. A 51-years-old male patient received dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration and administered in left arm on 22Mar2021 12:30 as 1 st dose, single for COVID-19 immunization. The patient didnot receive any other vaccines within 4 weeks prior to the COVID vaccine and didnot have any allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination patient didnot test for COVID-19. The patient medical history includes border hypertension. The patients concomitant medication included lisinopril (LISINOPRIL) 20mg and it was other medications the patient received within 2 weeks of vaccination. The patient experienced increased in blood preasure to 215/115 before he went to Emergency room/department or urgent care on 22Mar2021 and then treated with intravenous drugs and nitroglycerin cream over heart area. The outcome of event was recovered. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
51 2021-06-30 blood clot, pulmonary embolism June 15 - Right side lower rear rib cage pain. June 17 - Lightheaded. June 20 - shortness of breat... Read more
June 15 - Right side lower rear rib cage pain. June 17 - Lightheaded. June 20 - shortness of breath and weakness. Symptoms progressively get worse and increase in intensity. June 26 - go to Emergency Room. CT scan with contrast revealed a blood clot in each lung of moderate size and several small clots. Diagnosis was pulmonary embolism. Put on Heparin and admitted to hospital. Administered Heparin for 2 and 1/2 days. Upon discharge (June 29) was prescribed Eliquis.
51 2021-07-01 hypotension Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemi... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe, Additional Details: Fully recovered
51 2021-07-02 heart flutter, heart rate increased, hypotension heart flutter; Fast heart rate; some low blood pressure incidents; This is a spontaneous report from... Read more
heart flutter; Fast heart rate; some low blood pressure incidents; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 and expiration date was not reported), second dose via an unspecified route of administration, administered in arm left on 08Mar2021 13:00 (at the age of 51 years) single for covid-19 immunisation. Medical history included drug hypersensitivity of known allergies that is Sulfa from an unknown date and unknown if ongoing. Concomitant medication(s) included fluticasone, azelastine, pseudoephedrine hydrochloride (SUDAFED 12 HOUR), cholecalciferol (VIT D3) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Historical Vaccine received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EM9809 and expiration date was not reported), first dose via an unspecified route of administration, administered in right arm on 15Feb2021 15:30 single for covid-19 immunisation. On 17Mar2021 14:00 the patient experienced fast heart rate, flutter, some low blood pressure incidents. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
51 2021-07-05 chest pain Within an hour of the second dose, I was so tired that I fell asleep and slept over 24 hours. When ... Read more
Within an hour of the second dose, I was so tired that I fell asleep and slept over 24 hours. When I awoke, I had soreness in my muscles and cramps. The cramps migrated to my chest area and I have had severe chest pains, soreness in the back of my neck on the left side and in my left chest with occasional tingling in my right arm. The pains have slowly subsided and went away for about 5 days and returned fiercely last Friday in the middle of the night. It hurt so bad I couldn't sleep, so I took an Advil and after 30-45 minutes, the pain subsided. When the Advil wore off, the pains returned, so I attempted to contact a walk in clinic, they referred me to an urgent care facility. The urgent care facility took my vitals, asked about my symptoms and then hooked me up to an EKG. They told me I have an abnormal T-wave and sent me to the emergency room. The emergency room triaged me, took blood samples, reviewed my EKG and took chest X-rays. After several hours, they ruled out heart conditions and sent me home with a prescription for heartburn medicine. I do not have heartburn, I have symptoms that mirror Myocarditis/Pericarditis.
51 2021-07-06 blood pressure increased weakness, body aches, headaches, increased BPs (checked by wife at home), chills, sweats at night, y... Read more
weakness, body aches, headaches, increased BPs (checked by wife at home), chills, sweats at night, yellowing of eyes, nausea, intermittent cough
51 2021-07-07 chest pain Fever, coughing, body ache, head ache, congestion, chest pain, death
51 2021-07-07 chest pain Shingles; rash on left side of chest under arm extending to sternum, deep chest and abdominal pain, ... Read more
Shingles; rash on left side of chest under arm extending to sternum, deep chest and abdominal pain, minor skin itching; lasted three weeks
51 2021-07-07 heart rate irregular Altered cardiac performance. Previously tracked normal levels of exertion and corresponding heart r... Read more
Altered cardiac performance. Previously tracked normal levels of exertion and corresponding heart rates have become altered. Established aerobic exercise routine that produced a sustainable 80% of max heart rate, now routinely produces a greater level of perceived exertion and an irregular rhythm at the upper end of effort along with a reduced max attainable effort and heart rate. This set of symptoms appeared first during a workout session 3 days following 2nd dose, and has lingered for the subsequent 3 months. Irregular heart rhythms also occur at random during normal activity.
51 2021-07-09 haemoglobin decreased, platelet count decreased, cardiac failure congestive, hypotension Household contacts had covid 4/15/21 (PCR+) when pt had cough/fatigue. He got 1st Pfizer dose 5/11/... Read more
Household contacts had covid 4/15/21 (PCR+) when pt had cough/fatigue. He got 1st Pfizer dose 5/11/21. 5/24 he develops abdl pain, nausea, vomitting; seen in ED 5/28 w/ WBC cnt 17k CRP 197 but neg CT abdomen. Our ED on 5/31—hypotensive, temp 101.8, pulse 130s, COVID PCR neg, CXR normal. Despite fluids, needed pressors. Next day, still on pressors, new CHF, pulmonary opacities on XR, Echo with severe biventricular hypokinesis(EF 20%). Inflamm markers elevated: WBC 19k , 92% polys, hgb 11, plts 73k, CRP 334 mg/L, COVID spike Ab 1568, COVID NP index 233. Rx with IVIg for MIS x 1 dose, steroids, rapidly improved. On 6/11, 6/24 EF 60%, inflamm markers, CBC normalized. Now well, off steroids. MIS likely due to vac
51 2021-07-11 chest pain, chest discomfort Chest pain, tightness while walking on April 22. Subsided after about an hour. Again on April 24 w... Read more
Chest pain, tightness while walking on April 22. Subsided after about an hour. Again on April 24 while walking, subsided after about an hour. April 26, woke up around 4am with chest pain. Called 911 and went to emergency room. EKG and triponin negative for heart attack. Discharged and told to follow up with family doctor when I return home. April 27 saw family doctor. EKG taken and no concerns. Referred to cardiologist. May 12 saw cardiologist. Said all symptons describe a cardiac event but I don't fit the profile. No family history, healthy and fit. May 21, CT scan of heart. Results showed no blockages of any kind.
51 2021-07-13 cerebrovascular accident, heart attack Patient suffered a Heart Attack 13 days after receiving his second covid vaccine. The heart attack w... Read more
Patient suffered a Heart Attack 13 days after receiving his second covid vaccine. The heart attack was unknown and presented as the flu at the time. 9 days later he had a second event that finally drove him to the hospital. A bout 3 days after entering the hospital he suffered a dual hemispherical stroke. NOTE: this report is being filed by me as POA as requested by his family.
51 2021-07-13 hypertension Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium,... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient compained of shakiness immediately after receiving immunization. Had patient sit for 10 minutes. CHecked blood pressure and was elevated (156/80) and patient reports usual BP around 110/80. Had patient sit for awhile longer and symptoms continued to worsen. After another 15 minutes BP was up to 158/84 with a pulse of 98. Adminstered benadryl 25mg and had patient sit for additional 20 minutes. No change in blood pressure and pateint continued to have shakiness, but no worsening symptoms.
51 2021-07-15 chest discomfort Shortly after receiving the second Pfizer shot I developed extremely severe spasms and cramping thro... Read more
Shortly after receiving the second Pfizer shot I developed extremely severe spasms and cramping throughout my chest and back. The pain level is profound and unrelenting and has not changed in two months. Pain free time is rare, 50% of every day is spent trying to survive the pain, but I am frequently at the hospital. I cannot eat or sleep or work and dropping weight dangerously fast. I am completely incapacitated and now have a caretaker
51 2021-07-17 pallor, pulse abnormal I lost the feeling in my left finger tip all 4 fingers except the thumb went numb; I lost sensation ... Read more
I lost the feeling in my left finger tip all 4 fingers except the thumb went numb; I lost sensation in my right hand and my right arm is very very weak and it really started getting scary; my right arm is very very weak; He noticed visible blanching in my fingers; my pulse is extremely weak on my right side; Treatment for the rashes; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0178, expiration date: unknown), via intramuscular, administered in left arm on 26May2021 13:30 (at the age of 51-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown, expiration date: unknown) on an unspecified date. The patient's medical history includes hypertension and Lyme disease. Concomitant medications include BENAZEPRIL HYDROCHLORIDE 10 mg once daily and AMLODIPINE BESILATE 5mg once daily, both for hypertension and unspecified antidepressants. No other vaccines prior to 4 weeks. On 28May2021, 1 day 10 hours after the vaccination, the patient experienced loss of feeling in left fingertip, all 4 fingers except the thumb went numb, later, on an unknown date, patient experienced loss of sensation in right hand and right arm is very weak, patient's doctor noticed visible blanching in fingers, extremely weak pulse on right side and rashes. Patient visited her doctor and his doctor marked it as adverse COVID 19 vaccine reaction and patient was waiting for the specialist to watch in. The outcome of the events was not recovered. No follow-up attempts are possible. No further information was expected.
51 2021-07-23 hypotension, loss of consciousness pt passed out approximately 2 minutes after receiving pfizer covid vaccine. he slid down his chair ... Read more
pt passed out approximately 2 minutes after receiving pfizer covid vaccine. he slid down his chair onto the floor. we immediately called 911. Pt woke up and started talking. Pt stayed on the floor until the paramedica arrived a few minutes later. The pt's blood pressure was low. He told them he didnt eat anything all day. They started an iv and pt was going to the hospital to evaluate him further. He said he has had this happen before when he had to draw blood.
51 2021-07-24 atrial fibrillation, arrhythmia Mild cardiac arrhythmia/AFib for the last 4 days+
52 2021-01-05 palpitations Employee became diaphoretic, stated he felt his heart was racing, and that he was very anxious. Stat... Read more
Employee became diaphoretic, stated he felt his heart was racing, and that he was very anxious. Stated he has history of fear of needles. He also does extreme exercise program. Evaluated by EMT's BP 152/97, HR 56, SpO2 100% After 15 extra minutes observation employee stated he felt fine to go to work.
52 2021-01-06 hypertension Headache, NauseaVomiting, Hypertension, lightheadedness Narrative: 51 year old female presented to ... Read more
Headache, NauseaVomiting, Hypertension, lightheadedness Narrative: 51 year old female presented to ED post first dose of COVID-19 vaccine on 12/28/20. Sxs reported include feeling lightheaded, mild nausea and headahce. Nausea resolved 45 minutes after injection, but headache persisted, no facial swelling or difficulty, swallowing, no continued nausea or abdominal pain. Patient was administered a one-time dose of ibuprofen 800mg in the ED at 1510, recovered, and was discharged from ED on 12/28/20 at 1535.
52 2021-01-07 hypertension Dizziness & HYPERtension Narrative: Patient reports light headedness, dizziness, "heavy" feeling to ... Read more
Dizziness & HYPERtension Narrative: Patient reports light headedness, dizziness, "heavy" feeling to monitoring staff. Patient given some water and monitored for 30 minutes by monitoring staff. BP 139/111 HR 75, recheck BP 141/99 HR 80 reported to this RN. Event reported to this RN at 1350, patient returned to workstation.
52 2021-01-07 palpitations Patient spoke to me this morning regarding some symptoms he had after his Pfizer COVID 19 vaccinatio... Read more
Patient spoke to me this morning regarding some symptoms he had after his Pfizer COVID 19 vaccination yesterday. He said he had some pain at the injection site and mild headache in the afternoon; however, around 12 to 1 am in the morning, he was feeling heart palpitation and he felt his muscle twitching from his upper torso which went down to his thigh and no loss of consciousness. He said he checked his heart rate and it was 70 and he did not have any problems breathing. He said his heart palpitation felt better after taking some deep breaths. He said he no longer had heart palpitations or muscle twitching any more. He denied any other symptoms. Generally, he appeared well, no facial drooping, awake, alert, oriented, speech clear, and normal gait. (Today)
52 2021-01-11 hypotension Headache, Myalgia, Arthralgia, Angioedema, Nausea Vomiting & HYPOtension Narrative: Extensive >4 day... Read more
Headache, Myalgia, Arthralgia, Angioedema, Nausea Vomiting & HYPOtension Narrative: Extensive >4 days symptoms, lost work time
52 2021-01-12 pallor Systemic: Chills, Systemic: pale in color, increase hr; symptoms lasted 1 day
52 2021-01-18 hypotension EE woke up on 12/22/2020 experiencing diarrhea, facial flushing and swelling, lip/brow swelling, han... Read more
EE woke up on 12/22/2020 experiencing diarrhea, facial flushing and swelling, lip/brow swelling, hands started swelling, edema, redness/rash. Patient was evaluated at local EC and was found to have low BP. EE was treated with Solumedrol, Benadryl, and Pepcid. Patient was discharged home from EC after 2 hours with PO steroids x4 days.
52 2021-01-19 increased heart rate, heart rate increased, hypertension Staff member notified DON of Hypertensive state at 0830 on 1/20/2021. Staff member has no PMH of HTN... Read more
Staff member notified DON of Hypertensive state at 0830 on 1/20/2021. Staff member has no PMH of HTN and does not take any Rx medications for any disease processes. Staff member checked BP with multiple cuffs which were consistently read in the range of 160-180 SBP, 98-104 DBP with an elevated pulse >100 as well. Staff member reported an accompanying mild headache and lightheadedness. Sent to ED for evaluation of new onset HTN per Medical Director advice. Staff member was released from ED with orders to f/u with PCP for further evaluation of HTN persists
52 2021-01-24 palpitations Headache, diarrhea, fatigue, Pounding Heart, Muscle/joint pains, stomach cramps, sore/swollen throat... Read more
Headache, diarrhea, fatigue, Pounding Heart, Muscle/joint pains, stomach cramps, sore/swollen throat, difficulty swallowing, trouble staying awake, gassy
52 2021-01-26 body temperature decreased he got real cold and shaky and couldn't get warm; he got real cold and shaky and couldn't get warm; ... Read more
he got real cold and shaky and couldn't get warm; he got real cold and shaky and couldn't get warm; temperature was low at 96 degrees Fahrenheit; He got nauseous with it; He had severe fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140) via an unspecified route of administration on left arm on 11Jan2021 at 9:15 at single dose for COVID-19 immunization. The relevant medical history included Covid-19 from 17Jul2020 to 14Aug2020, he didn't get hospitalized but was pretty sick. He had circulation issues with it. He had numbing and tingling in his left three fingers (clarified left three fingers as his middle finger, index finger, and ring finger) and numbing and tingling in his toes as well. Concomitant medications included ubidecarenone (COQ-10), acetylsalicylic acid (BABY ASPIRIN), rosuvastatin and monascus purpureus (RED YEAST RICE). The patient previously received the first dose of BNT162B2 at the age of 52 years old on 23Dec2020 at single dose for COVID-19 immunization. With second dose the patient thought he would be better, but about 12 hours later he got real cold and shaky and couldn't get warm. He checked his body temperature and he didn't have a temp. His temperature was low at 96 degrees Fahrenheit. He tried to keep himself warm. He got nauseous with it. Basically he looked on line and was having them. Today he started to feel better, but still a little nauseous. He had severe fatigue. He didn't realize he could go fill out something on the website for CDC. He knew he had wanted the vaccine because he had some severe symptoms when he had COVID. He didn't want to get COVID again. His hospital frustrates him sometimes. They didn't put the date on there when he was to come back for the second dose. They didn't tell him to come back on the 13th. He had to figure the dates from the website and emails. He talked it over with his wife. He came in contact with it every night. He was taking care of people that were critical. He worked in the intensive care unit. Even the people he took care of that didn't have it, ended up with it. He wore a mask. He used hand sanitizer. He didn't want to get it again. People were shocked when he got it the first time. He did verify that he got the second dose one day sooner, instead of the three day window. He was sick with the first and was expecting to be more sick with this one. He wanted to give himself an extra day before he had to go back to work. He had a couple of emails where they discussed increasing the window to do it a day sooner. He was going to have to go an hour an half a way to get the second dose and he didn't want to do that. The patient underwent lab test included height was approximately six two, weight was about 194 lbs on an unspecified date, and body temperature showed 96 degrees Fahrenheit in Jan2021. The outcome of the event he got real cold and shaky and couldn't get warm, temperature was low at 96 degrees Fahrenheit was recovering, for the events he got nauseous with it and he had severe fatigue were not recovered.
52 2021-01-27 chest pain 10 days after injection developed sharp pleuric pain first on the right then 3 days later moved to ... Read more
10 days after injection developed sharp pleuric pain first on the right then 3 days later moved to the left axila and left anterior chest. Worsened with cough sneeze and supine position. Relieved with sitting up and leaning forward. Very suggestive of acute pericarditis. At one point cause moderate squeezing pain on inspiration. Resolved in additional 10 days with high dose NSAIDs.
52 2021-01-28 loss of consciousness trouble breathing; severe body aches; fevers and chills; extreme fatigue; headaches; passed out/ whe... Read more
trouble breathing; severe body aches; fevers and chills; extreme fatigue; headaches; passed out/ when trying to return to bed, passed out a second time; This is a spontaneous report from a non-contactable physician. A 52-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 07:30 at a single dose for COVID-19 immunization at the workplace clinic. The patient's medical history was not reported. Patient has no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR). Patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date. On 15Jan2021 04:00, patient had severe body aches, followed very quickly by fevers and chills. At 4:45am started to have trouble breathing. Patient was concerned about respiratory symptoms, and woke his spouse, then stood up to try and breathe better, took a couple steps, and passed out. When the patient woke, when trying to return to bed, passed out a second time. Over the next few hours respiratory symptoms improved. Remainder of day characterized by extreme fatigue, body aches and headaches. Patient had an unspecified over the counter anti-inflammatory medication. The patient has a negative COVID 19 test via a nasal swab on an unknown date. Patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported passed out and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product 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 RA, IEC, as appropriate.
52 2021-01-30 cerebrovascular accident Diagnosed day after 2nd shot with opthalmic artery thrombus causing vision loss/change in left eye. ... Read more
Diagnosed day after 2nd shot with opthalmic artery thrombus causing vision loss/change in left eye. I did get shot series on 12/22/2020 #1 and 1/10/2021 and was diagnosed with Covid-19 on 12/13/2020. My internist MD did not feel the vaccine caused the thrombus /Stroke but I wanted to report it as it was associated with the vaccine administration (symptoms of vision loss within 24 hours of the vaccine #2 administration).
52 2021-02-04 chest pain, increased heart rate, fast heart rate On set of substernal chest pain and sweating 2 hours after administration of the vaccine. Patient re... Read more
On set of substernal chest pain and sweating 2 hours after administration of the vaccine. Patient returned to clinic 24 hours later with continued pain . Reported mild cough. Vitals stable except for mild tachycardia at 109 and temperature of 100.3. Normal EKG except for sinus tach. Patient transferred to ER via EMS due to chest pain with risk factors including positive cardiac family hx, age and male.
52 2021-02-06 cerebrovascular accident 2 weeks after my second shot, I had a CVA causing complete loss of sensation in my left arm. I am i... Read more
2 weeks after my second shot, I had a CVA causing complete loss of sensation in my left arm. I am in good health and do not have multiple risk factors for CVA. While the scans showed evidence of a CVA, no underlying cause has yet to be determined.
52 2021-02-11 cardiac arrest *Please note it is not known if event was related to vaccine* On 2/10/2021, at approximately 5:30 A... Read more
*Please note it is not known if event was related to vaccine* On 2/10/2021, at approximately 5:30 AM, patient began to experience dizziness and shortness of breath. Per witnesses, he then began to have seizure activity followed by cardiac arrest. He was treated with CPR and 1 shock from the AED, which resulted in spontaneous return of circulation. He was awake and confused after return of pulse and sent to Hospital Emergency Room. This event occurred 19 days post first vaccine. He was scheduled to get his second dose on 2/12/2021, but did not receive it due to event.
52 2021-02-15 chest discomfort Patient is allergic to cats, had tightness in chest, unable to breathe. Took a benadryl- it went awa... Read more
Patient is allergic to cats, had tightness in chest, unable to breathe. Took a benadryl- it went away, eyelids was swollen. Sx did improve- eyelids are still swollen. Received #2 COVID 1/19/21 at 8am. Had a dental appt that afternoon for extraction, given Lidocaine w/out Epi, took Ibuprofen after visit. Reports acute onset chest tightness, SOB, audible wheezing at 5pm (approx 9 hrs post vaccine), then felt anxious. Took Benadryl 25mg and started feeling better in 20 min with resolution of wheezing and chest tightness after 1 hour. Also reports left eye swelling the same evening that has gradually decreased, now only mild with itching. Had similar eye swelling, however bilateral, after first vaccine dose. No SOB or wheezing noted since eve of 1/19/21. Denies hx asthma. NKDA. Allergic to cats. Denies swelling of lips, tongue, throat or rash. Reports feeling well today. Denies Covid-like sxs.
52 2021-02-19 lightheadedness, hypotension, loss of consciousness, fainting Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Additional Details: About 5 minutes after receiving vaccine, patient was seated in observation area and notified facility staff member who was in charge of observing patients that he felt faint. Staff member reported patient quickly turned extremely red and was showing seizure-like activity, unconscios. She alerted the pharmacists to come over I came over and patient appeared bright red, pupils extremely dilated and was not conscious, grabbed pt arm he woke up and then showed typical vasovagal symptoms thereafter.
52 2021-02-22 chest discomfort, chest discomfort A few minutes after receiving the vaccine, patient reported 1/10 chest pressure to left chest, to le... Read more
A few minutes after receiving the vaccine, patient reported 1/10 chest pressure to left chest, to left shoulder, improving after 15 minutes. No nausea, light headedness. Non-smoker, no HTN or DM.
52 2021-02-25 palpitations Palpitations. BP 142/95 (pulse 160), 100% O2 sat. Follow-up BP 134/91 (pulse 104), O2 sat 100%. Of n... Read more
Palpitations. BP 142/95 (pulse 160), 100% O2 sat. Follow-up BP 134/91 (pulse 104), O2 sat 100%. Of note, had COVID-19 pneumonia in December 2020.
52 2021-02-26 heart rate increased Within 5 minutes of shot had rapid heart beat and trouble breathing. Removed face mask and heart ra... Read more
Within 5 minutes of shot had rapid heart beat and trouble breathing. Removed face mask and heart rate and breathing returned to normal within 5 minutes
52 2021-03-02 blood glucose increased 52-year-old male reports developing multiple HSV simplex lesions around his upper lips within 24 hou... Read more
52-year-old male reports developing multiple HSV simplex lesions around his upper lips within 24 hours of receiving the second Covid 19 vaccine. Patient has had HSV-1 lesions before but never to this extent; patient is otherwise stable and afebrile. He has no radicular pain. Labs are ordered for CBC and a CMP. The vaccine support center was called at approximately 3:35 PM and message left. The vaccine support center was called again on February 26, 2021 at approximately 9:20 AM. Provider spoke with NP for consultation. VAERS CDC report advised. No further action required. Antiviral medication was not offered due to the fact that patient was on day 6 post outbreak and out of the window of opportunity to treat acutely.
52 2021-03-02 nosebleed runny nose, metallic taste in mouth, headache, nose bleed
52 2021-03-05 heart flutter, palpitations Heart fluttering/skipping beats shortly after receiving and periodically continuing up to this date.... Read more
Heart fluttering/skipping beats shortly after receiving and periodically continuing up to this date. Numbness feeling in face and jaw several hours after receiving that continues today. Feel pressure on forehead and nostril area.
52 2021-03-07 blood pressure increased, palpitations Goosebumps tingly sensation in head; Blood pressure and palpitation/heart rate/heartbeat is getting ... Read more
Goosebumps tingly sensation in head; Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher.; Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher.; feeling weak; Heaviness in the head; Feeling anxiousness in the brain; Localized soreness and pain; This is a spontaneous report from a contactable consumer reported for himself. A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 18:00 (Lot number: EL9263) via unspecified route of administration in the left upper arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included ongoing diabetes (Due to diabetes has low testosterone), High cholesterol both from 2005, Colitis ulcerative from 1999, Glaucoma from 2010, Enlarged prostate gland from 2018 and Chronic sinus infection, Acid reflux and GERD from an unknown date and unknown if ongoing. The concomitant medication included Janumet (Metformin hydrochloride/sitagliptin) ongoing for diabetes mellitus at (50/1000 one tablet twice daily), amoxil (amoxicillin) for low testosterone via topical route at 4 pumps, azelastine at two sprays twice a day for chronic sinus infection, crestor (rosuvastatin calcium) ongoing at 5 mg once a day blood cholesterol increased, tamsulosin ongoing at 0.4mg once a day for enlarged prostate gland, dexilant (dexlansoprazole) at 30 mg once a day for acid reflux and GERD, lialda (mesalazine) ongoing at 4.8 mg, once a day (1.2gram 4 tablets once a day) for colitis ulcerative, canasa (mesalazine) ongoing 1 g once a day (at night time) for colitis ulcerative, timolol ongoing at one drop both eyes at once a day for glaucoma, lumigan (bimatoprost) ongoing for at one drop both eyes once a day for glaucoma, melatonin ongoing at 5mg once a day for insomnia, zyrtec (cetirizine hydrochloride) ongoing at 10 mg (on of them) for insomnia, xanax (alprazolam) 1 mg at 1mg at night time and 1 mg as needed for generalized anxiety and blood pressure, 5-hydroxytryptophan ongoing at 100mg for anxiety, carvedilol ongoing at 25 mg, once a day (12.5mg in the morning 12.5 at night) for blood pressure measurement, valsartan ongoing at 160 mg, once a day (160mg one tablet once day in the morning) for blood pressure measurement, hydrochlorothiazide tablet ongoing at 12.5 mg, once a day for blood pressure measurement, Vitamin E at 400 international units; one capsule once a day, ongoing ambozil for low testeterone, clonidine ongoing at 0.1 mg as needed for blood pressure measurement. History of all previous immunization with the Pfizer vaccine considered as suspect: None, this was the first dose. No other vaccine administered on the same date. The patient had no events prior vaccination within 4 weeks. In all his life. He had vaccines that received and had no adverse event or side effect whatsoever. He had had the regular flu vaccine early November. The patient experienced feeling anxiousness in the brain, Heaviness in the head, feeling weak in Feb2021, Localized soreness and pain in Jan2021, Goosebumps tingly sensation in head, Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher on 04Feb2021. The patient could not take Benadryl as he cannot tolerate Benadryl. With Zyterc he does not have secondary effects like he does with Benadryl. The first week after getting the vaccine he only had kind of had localized soreness and pain in the area. He later clarified it was in the area where got the injection, vaccine. He just had pain soreness in that area. Other than that he had no side effects at that time. The third week, initially stated as, about 5-7 days ago he started to have a feeling of anxiousness in the brain. He could feel anxiousness and sensation in his brain that he did not feel before. It was like he had the flu kind of thing, but he did not have a temperature. However, the feeling is in his head. It is like heaviness feeling from the flu in his head. He has been having the heaviness in the head feeling for 4-5 days. He later further clarified and initially clarified the localized pain and soreness was noticed the second day, the day after getting the vaccine. This only lasted a few days. He does not remember exactly when this ended. He did not take anything for the localized pain and soreness in the same area as the injection. He confirmed he has recovered completely from this event. Caller further clarified the feeling of anxiousness started Thursday or Friday of last week, maybe 05Feb2021. Stated it was like this feeling is getting worse and worse. Stated it was hard to explain, but he started to feel a goosebumps tingly sensation in his brain in head, in scalp Thursday of last week first. It started with that and slowly over the past few days it has changed and transformed into this heaviness feeling that one would feel from the flu, but he has no fever or anything; it is just in his head. Also, along with that feeling at the same time his blood pressure and palpitation/heart rate/heartbeat was getting higher and higher. His regular blood pressure medications won't work anymore to bring it down. His blood pressure typically ranges in the 130/85 or less range with all the blood pressure medications he was taking. Once he started having this tingling sensation in his head he had the higher blood pressure and higher heart rate. Now his blood pressure would average being about 170/110 to 180/115. This was like the upper and lower range. His heart rate was typically around 70-75 and now it goes about 80-85. Later during call, he also added, every six months or so his blood pressure may be elevated on these medications. Sometimes his blood pressure was not maintained by the three different blood pressure medications he takes. He was also prescribed two other medications for emergent use Clonidine and Xanax. Usually every six months he would have to take Clonidine and Xanax and typically in an hour to two hours the blood pressure would come down and it's good. However, this time, he took two Clonidine and Xanax starting last Thursday when had the high blood pressure episode and they were failing to bring the blood pressure down. He further explained it would bring it down for some time, but then it would go back high. The Clonidine is no longer working for the last six days. When probed for labs/testing he sated he could not work anymore due to the events reported. He was feeling weak. He could not really walk. He took time off from work. He went to see his primary care provider on Monday. On Monday the doctor doubled the dose of Carvedilol. Since then instead of taking 12.5 twice a day, he is now taking 25mg twice a day. On Tuesday, yesterday, he went to get blood work done. Blood was drawn but has no results yet. Localized pain and soreness time of onset didn't remember, stated he may have had a little pain right after getting the vaccine, but it was around 21:00 25Jan2021 he really noticed the soreness and pain. The following morning around 9 AM it woke him from his sleep and he could feel it more compared to the first day. Anxiousness in the brain around 16:00. The patient had no emergency visit. Stated he almost felt like going when his blood pressure was 182/116 on Saturday night of last week. He was about to go to the ER but decided not to. He ended up taking two Clonidine and one Xanax, laid down, and eventually his blood pressure came down a little. Therefore, he did not go. The patient had physicians office visit. After getting the vaccine he mentioned started to have a feeling of anxiousness in the brain that was getting worse. He could feel anxiousness and sensation in his brain that he did not feel before. Also, his blood pressure and palpitation/heart rate/heartbeat was getting higher and higher. His regular blood pressure medications won't work anymore to bring it down. Later during call, he also added, every six months or so his blood pressure may be elevated on these medications. Sometimes his blood pressure was not maintained by the three different blood pressure medications he takes. He was also prescribed two other medications for emergent use Clonidine and Xanax. Clonidine: 0.1mg only during times he has episodes of high blood pressure. Usually every six months he would have to take Clonidine and Xanax and typically in an hour to two hours the blood pressure would come down and it's good. However, this time, he took two Clonidine and Xanax starting last Thursday when had the high blood pressure episode and they were failing to bring the blood pressure down. It would bring it down for some time, but then it would go back high. The Clonidine was no longer working. The patient experienced side effects on the 3rd week after getting vaccinated and had already made a report. The patient's second dose was scheduled for 21Feb2021 which was 28 days after the first dose. The outcome of the event Feeling anxiousness in the brain was not recovered, Localized soreness and pain recovered in 2021 and outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.;
52 2021-03-13 blood pressure increased Patient was lightheaded, felt funny and had a very elevated blood pressure.
52 2021-03-15 fainting After receiving the vaccination, he started feeling lightheaded, then started sweating. He asked for... Read more
After receiving the vaccination, he started feeling lightheaded, then started sweating. He asked for water and drank water prior to a brief episode of syncope. He denies any trauma to his head or any part of his body. No mental status changes. He was assisted to the supine position on the floor, then was able to ambulate to a private section of the area and lay recumbent on an EMT gurney. He has a history of syncope with needlesticks.
52 2021-03-18 chest discomfort 3-16-21 2:11PM PT STATES 'CHEST DISCOMFORT AND FELT HOT FOR 1 MIN AFTER GETTING SHOT'. STATES 'NO P... Read more
3-16-21 2:11PM PT STATES 'CHEST DISCOMFORT AND FELT HOT FOR 1 MIN AFTER GETTING SHOT'. STATES 'NO PAIN OR DISCOMFORT NOW'. A/O, PINK, W/D, RESP REG WITH EASE. AMBULATORY TO EXIT - GAIT BRISK AND STEADY. HOME WITH WIFE. NO ACUTE OR OBVIOUS DISTRESS. 3-17-21 1:28: PT STATES HE 'WENT TO THE ER WITH CHEST TIGHTNESS AND LIGHTHEADED. WAS THERE 5 HR AND WAS CHECKED OUT - EVERYTHING WAS OK'.
52 2021-03-18 loss of consciousness Patient received vaccine at 3:42 pm. At 3:50pm, patient was unconscious but breathing in his chair ... Read more
Patient received vaccine at 3:42 pm. At 3:50pm, patient was unconscious but breathing in his chair in the post-vaccine waiting area. 911 was called. Patient was placed on the floor in the recovery position, he regained consciousness after about 1 minute. He stated that he has passed out previously after giving blood as he has a fear of needles. EMS took his BP several times (last reading at 4:13 pm was 96/63) after arriving at 3:57pm. At 4:13 pm he signed a waiver that he did not want to go to the ER.
52 2021-03-19 deep vein blood clot On 1/27/2021, after having received Dose #2 of Pfizer Covid-19 vaccine on 01/07/21, I experienced se... Read more
On 1/27/2021, after having received Dose #2 of Pfizer Covid-19 vaccine on 01/07/21, I experienced severe calf pain while playing soccer. Over the next 2 weeks I experienced vascular claudication in that leg and was eventually diagnosed with arterial thrombus in Left tibioperoneal, anterior tibial/dorsalis pedis and posterior tibial arteries. I do not have any known predisposing conditions for arterial thrombus and no history of thromboembolic disease.
52 2021-03-21 chest pain EUA Pfizer-BioNTech vaccine reaction About 101 min after receiving vaccine, patient complained of ch... Read more
EUA Pfizer-BioNTech vaccine reaction About 101 min after receiving vaccine, patient complained of chest pain rated 7/10.
52 2021-03-23 chest discomfort Pain at injection site expanded to joints and muscles in all parts of the body. Mild sense of swelli... Read more
Pain at injection site expanded to joints and muscles in all parts of the body. Mild sense of swelling in arms and legs and face, numbness and tingling in extremities. Slight tightness in chest.
52 2021-03-24 fast heart rate, hypertension HTN, Dizzy, Tachy
52 2021-03-25 pallor, blood pressure increased Patient had pallor, reported lightheadedness, felt jittery. Patient reports not having breakfast. Ju... Read more
Patient had pallor, reported lightheadedness, felt jittery. Patient reports not having breakfast. Juice given and calming techniques provided, did not resolve symptoms. Denies throat swelling or difficulty breathing. Blood pressure elevated, denies history of hypertension. Other vital signs stable.
52 2021-03-25 fainting Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: purfuse sweating, lose of sight left eye, dizziness, nausea-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient began to fell better about 5 minutes after epinephrine was administered. EMS was called but did not transport.
52 2021-03-26 fainting Patient displayed bruise and swelling at injection site immediately after shot. Patient became limp ... Read more
Patient displayed bruise and swelling at injection site immediately after shot. Patient became limp and eyes rolled back and he collapsed to the floor. Epi pen admitted at that time. Patient immediately regained consciousness and said he felt ok. He was sweating heavily. Paramedics arrived and took him to hospital after taking vital signs and interviewing him.
52 2021-03-27 hypertension High Blood Pressure: 135-91, numbness and tingling in my left hand, and itchiness in my right foot. ... Read more
High Blood Pressure: 135-91, numbness and tingling in my left hand, and itchiness in my right foot. I also experienced pain and swelling in the injection site.
52 2021-03-28 arrhythmia, chest pain, arrhythmia 12 days after first shot, I experienced extreme chest pain and heart arrhythmia. I has to go to the... Read more
12 days after first shot, I experienced extreme chest pain and heart arrhythmia. I has to go to the emergency room and was hospitalized overnight. They performed echocardiogram, ct of chest, labs and venous dopplar. I was Diagnosed with new onset atrial fluttering and now seeing a cardiologist. I wore a heart monitor for 2 days and was told my heart paused/stopped 6 times and longest being for 8.6 seconds. I am scheduled for a TEE with cardio aversion, then a cardio ablation and /or pacemaker.
52 2021-03-29 chest discomfort After 1st dose - stomach began churning constantly within a week, scalp and side of face tingling oc... Read more
After 1st dose - stomach began churning constantly within a week, scalp and side of face tingling occasionally, After 2nd dose - stomach churning increased, scalp and face tingling more pronounced within 1st week, occasional nausea and tingling in pinky fingers and lack of appetite 2nd week, occasional tingling in pinky toe and sides of ankles as well as more nausea and chest discomfort during 3rd week when resting (1st ER visit), pronounced tingling in fingers and feet as well as farther up legs 4th week when experienced difficulty walking after one night where entire legs had formication and calf cramping (2nd ER visit). Symptoms then dissipated on their own approx 8 weeks after first appearing
52 2021-03-30 chest discomfort Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: All... Read more
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Additional Details: Patient had shortness of breath, chest tightness and throat swelling (uncomfortable feeling described by patient). Paramedics took the patient with them. Patient came to the pharmacy 3 hrs later and informed us that he was doing okay and his breathing was better.
52 2021-03-30 fainting Patient fainted and fell off chair and hit head on floor. Patient was treated by paramedics. The p... Read more
Patient fainted and fell off chair and hit head on floor. Patient was treated by paramedics. The patient recovered from faint and did not need go to the hospital. The time was 12:10 PM.
52 2021-03-31 chest pain, heart attack Chest pain and had STEMI. Patient had RCA occlusion and got a DES placed.
52 2021-03-31 palpitations I got my first Pfizer vaccine injection on 3/23/2021 and felt no immediate side effects, but almost ... Read more
I got my first Pfizer vaccine injection on 3/23/2021 and felt no immediate side effects, but almost exactly 1 week later I noticed slight dizziness. Yesterday it was more apparent and today I woke up with it worse. It worried me and I found myself a bit panicky and my heart was racing. When I calm down, heart rate is fine. It's more noticeable today. Not to the point of nausea, nor full vertigo, but I feel kinda foggy and unsure about my balance
52 2021-03-31 inflammation of the pericardium Pt experienced an episode of pericarditis 2 days after receiving vaccine; had been dealing with on a... Read more
Pt experienced an episode of pericarditis 2 days after receiving vaccine; had been dealing with on and off pericarditis but this was worst episode he had experienced
52 2021-04-01 nosebleed Several days after receiving the vaccine, I began experiencing nose bleeds from my right nostril. O... Read more
Several days after receiving the vaccine, I began experiencing nose bleeds from my right nostril. Only occurs during the evening around bedtime or while I'm sleeping, and occurs every other day. Blood is a steady stream that begins with no warning. Blood flow stops after I push tissues up my right nostril and apply gentle pressure for 15 minutes or so. I have never experienced this before.
52 2021-04-01 heart attack heart attacks; bad immune system; lethargic; mild headache; feeling not well; soreness in the arm in... Read more
heart attacks; bad immune system; lethargic; mild headache; feeling not well; soreness in the arm initially; may be dehydrated; This is a spontaneous report received from contactable consumer (patient) via medical information team. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration at the age of 52-years, on 20Mar2021 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that on 20Mar2021, he had the Pfizer covid vaccine and experienced lethargic, mild headache, feeling not well, soreness in the arm initially on an unspecified date. The patient also stated that he had heart attacks, has a bad immune system on an unspecified date and may be dehydrated. The outcome of the events was unknown. Information on the lot/batch number has been requested.
52 2021-04-04 atrial fibrillation Upper respiratory infection followed by sudden return of Afib.
52 2021-04-04 blood glucose increased, loss of consciousness Pt got his first dose of Covid 19 vaccine with a Pfizer brand administered intramuscular at left arm... Read more
Pt got his first dose of Covid 19 vaccine with a Pfizer brand administered intramuscular at left arm at 01:11 PM. Pt sat down at 01:20 PM and pt verbalized that he is feeling light-headed/ dizzy. The EOA, , RN stayed with the pt and asked admin to help patient lay on the floor. At 01:22 PM pt passed out. Admin placed pt laying on the floor with legs elevated and head on the side. Pt was unconscious with pulse and with breathing. Vital signs was checked BP 102/60 mmhg; PR 83 ppm; RR 18cpm, T 97.6 F, Oxygen sat 98% at room air, Blood sugar 128 as taken by RN. After 30 seconds pt regained consciousness, pt is alert oriented to self, time, place, date and location. Pt stated no complaints of chest pain or SOB. EOA assesses muscle streghth in both upper ad lower extremity and is 5/5. EOA assigned RN to continuously monitor pt every 15 mins until stable. Pt was advised to call family for us to inform and EOA highly recommended to have a family member stay with him. Admin called the wife and wife stated that she will here in an hour. Pt refused to call 911 as well but pt was advised to have a follow up appointment with primary care doctor. Pt stated he has an appointment the next day. Pt also stated he has no history of him passing out after any vaccination. Pt was transitioned from laying to sitting with latest vitals of110/ 68mmh, oxygen sat 99% at room air, PR 72 ppm, RR 10, T 97.6 F. No complaints of of dizziness . RN (EOA), and a admin stayed with the patient util family member arrives. By the time family member arrives, RN (EOA) discharged pt without any discomforts.
52 2021-04-04 loss of consciousness Pfizer-BioNTech Covid-19 Vaccine. I received the 1st dose at approximately 11am on April 2nd. I we... Read more
Pfizer-BioNTech Covid-19 Vaccine. I received the 1st dose at approximately 11am on April 2nd. I went to sleep and woke at approximately 4am on April 3rd with a sharp pain/ache in my side. I went to the bathroom and began to experience chills and started sweating. I was sitting on the toilet and passed out. My wife heard me hot the ground and I came to. I had had another experience passing out while on the toilet a month earlier, for which I went to the ER and was discharged. Test run on the early occasion were all negative. I did not seek any medical attention immediately following this event but will be following up with my primary physician.
52 2021-04-05 chest pain Patient presented 4/3 stating received Pfizer COVID-19 vaccine on Monday and began having sympoms ab... Read more
Patient presented 4/3 stating received Pfizer COVID-19 vaccine on Monday and began having sympoms about Wednesday. Developed fever by Thursday and cough/nausea/vomiting by Friday. Cough ongoing and feels like he should have production but is not able sputum out. The pain is chest is described as not being able to fully expand his lungs when he tries to inhale. Patient presented 4/6-DOA
52 2021-04-06 loss of consciousness anaphylactic shock Began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd co... Read more
anaphylactic shock Began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at me in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. went unconscious, - after recovery I had tremors for a few hours such that I could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired.
52 2021-04-07 heart rate increased Dizziness, rapid heart beat for around 10 minutes.
52 2021-04-08 heart rate decreased, hypotension Patient began to feel lightheaded, diaphoretic, vital signs: 94/60, hr 48, saturation 94%. Paramedic... Read more
Patient began to feel lightheaded, diaphoretic, vital signs: 94/60, hr 48, saturation 94%. Paramedics called to assess for low heart and low blood pressure.- Patient feeling better, encouraged to call family or friend for drive home, patient insisted on driving self home. Patient encouraged to follow up with primary MD.
52 2021-04-08 fainting, arrhythmia Syncope, Diaphoretic, Flush, arrhythmia
52 2021-04-09 hypotension, palpitations palpitations, hypotension
52 2021-04-09 fluid around the heart I do not know if there is any correlation to the vaccine or not. Probably not, but i thought best t... Read more
I do not know if there is any correlation to the vaccine or not. Probably not, but i thought best to report it in case others have had similar medical issues coincidentally with getting the shot. One week after the shot I was hospitalized with a Pericardial Effusion and required a Pericardiocentesis procedure.
52 2021-04-09 lightheadedness, hypertension almost blacked out; blood pressure was 185/127; This is a spontaneous report from a contactable cons... Read more
almost blacked out; blood pressure was 185/127; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported)), dose 1 via an unspecified route of administration, administered in left arm on 21Mar2021, at 14:30 as single dose for covid-19 immunization. Medical history included colon cancer from an unknown date, chemotherapy in 2017 to an unknown date. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization in 26Feb2021. The patient previously took codeine and caffeine and experienced drug allergies. On 21Mar2021, at 15:00 patient experienced blood pressure was 185/127 and almost blacked out. The details were noted as follows: after the injection as the patient was driving he almost blacked out. He parked his car and went back to the site; paramedics assisted him. His blood pressure was 185/127 on 21Mar2021 . He noted that he almost blacked out a second time. Doctor visits two days and three days after injection day was noted. The outcome of events was recovering, with no noted treatments. No Covid test post vaccination was noted. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
52 2021-04-10 transient ischaemic attack, cerebrovascular accident Stroke tia
52 2021-04-11 blood glucose increased Blood sugar readings have increased 15% since having COVID-19 vaccine. Have not returned to normal. ... Read more
Blood sugar readings have increased 15% since having COVID-19 vaccine. Have not returned to normal. Severe symptoms lasted 48 hours High fever Chills Aches Lethargy
52 2021-04-11 lightheadedness, blood pressure increased Vasovagal reaction, laid on floor for about 40 minutes with feet elevated. During the 40 minutes, m... Read more
Vasovagal reaction, laid on floor for about 40 minutes with feet elevated. During the 40 minutes, my blood pressure measured in the range of 112-119/69-74 and my heart rate ranged from 44 to 49 bpm. 1 hour after the start of the event, my blood pressure was 120/75 with a heart rate of 62 bpm. 3.5 hours after the start of the even my blood pressure was 109/62 and my heart rate was 63.
52 2021-04-12 cerebrovascular accident On 31 Mar he suffered a stroke and was admitted to the hospital until 2 Apr 2021; He tested positive... Read more
On 31 Mar he suffered a stroke and was admitted to the hospital until 2 Apr 2021; He tested positive for Covid19 on 30Mar2021; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199), via an unspecified route of administration, administered in arm left on 19Mar2021 (at the age of 52-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid19 on 30Mar2021. On 31Mar2021, the patient suffered a stroke and was admitted to the hospital until 2Apr2021. He was scheduled for second dose and he got COVID, so would like to know the protocol and ins and outs and steps for that. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Mar2021. The patient did not receive any treatment for the events. The clinical outcome of the On 31 Mar he suffered a stroke and was admitted to the hospital until 2 Apr 2021 and He tested positive for Covid19 on 30Mar2021 were unknown. No follow up attempts are possible.
52 2021-04-12 loss of consciousness tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went ... Read more
tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority. Information on the lot/batch number has been requested.
52 2021-04-13 pallor, loss of consciousness 52 y/o (M/F) with PMHx of chronic lower back pain began to feel lightheaded 1 minute after receiving... Read more
52 y/o (M/F) with PMHx of chronic lower back pain began to feel lightheaded 1 minute after receiving the Covid vaccine (2nd dose). He LOC for 10 seconds. He became diaphoretic and pale. Denies headache, vertigo, seizures/PMHx of seizures, numbness/tingling/parasthesias, throat irritation, throat tightness, SOB, dyspnea, palpitations, chest pain, chest tightness/heaviness, hives, rash, peripheral or facial edema, nausea, vomiting. Patient was immediately assessed by EMT and clinical leads. Vitals were taken immediately. Given oral fluids (water/orange juice) and cookies.
52 2021-04-13 pallor, loss of consciousness 52 y/o (M/F) with PMHx of chronic lower back pain began to feel lightheaded 1 minute after receiving... Read more
52 y/o (M/F) with PMHx of chronic lower back pain began to feel lightheaded 1 minute after receiving the Pfizer vaccine (2nd dose). He LOC for 10 seconds. He became diaphoretic and pale. Denies headache, vertigo, seizures/PMHx of seizures, numbness/tingling/parasthesias, throat irritation, throat tightness, SOB, dyspnea, palpitations, chest pain, chest tightness/heaviness, hives, rash, peripheral or facial edema, nausea, vomiting. Patient was immediately assessed by EMT and clinical leads. Vitals were taken immediately. Given oral fluids (water/orange juice) and cookies.
52 2021-04-13 fainting Diarrhea since 04/06/2021 everyday two times per day. On April 8th developed heavy abdominal pains ... Read more
Diarrhea since 04/06/2021 everyday two times per day. On April 8th developed heavy abdominal pains and fainted became rigid, clenched fists, and shook like a seizure. My wife stood by my side and witness me waking up pale and confused after about 10 seconds of episode. I continue to have diarrhea.
52 2021-04-15 palpitations headache, body aches, very large swollen lymph nodes under arm (swelling is the size of my fist), ra... Read more
headache, body aches, very large swollen lymph nodes under arm (swelling is the size of my fist), racing heart
52 2021-04-16 heart rate decreased I work 3rd shift Started with chills about 11pm same day as shot, then by 3am my heart rate dropped ... Read more
I work 3rd shift Started with chills about 11pm same day as shot, then by 3am my heart rate dropped to 48 bpm and extreme shivering. (My normal resting rate is about 80 bpm). Heart rate came back up shortly but still below my normal bpm. When I got home at 7am was very weak and chilled, and on both hands my fingers turned completely white like they wasn?t getting circulation and were very cold.. I went to bed feeling horrible hoping it wasn?t serious and after I slept more than normal, I feel good now. Can?t say my heart rate going that low wasn?t kinda scary.
52 2021-04-17 cerebrovascular accident Systemic: Stroke-Medium
52 2021-04-19 fainting I received my second COVID vaccination in the afternoon and started to experience side effects from ... Read more
I received my second COVID vaccination in the afternoon and started to experience side effects from the shot around 1:00 in the morning. When I woke up to go to the bathroom at 4:30 in the morning I was not feeling well in my stomach and I felt a little dizzy. On my way back to bed from the bathroom I fainted and fell face first into the wall heater and then to to the floor. This action fractured my nose and gave me multiple bruises and cuts in my face and upper body.
52 2021-04-22 blood glucose increased, chest pain 4/15 immediate post-injection reaction: "Patient evaluated for chest pain after vaccine. Patient wit... Read more
4/15 immediate post-injection reaction: "Patient evaluated for chest pain after vaccine. Patient with L sided chest pain and back pain immediately after vaccine. Patient had identical reaction after first dose. When patient was laid in bed and given oral hydration, pain resolved. Patient felt confident that this was anxiety as with his first vaccine. VS and exam WNL. 2 lead EKG showed NSR with no clear ST changes. Patient was returned home with wife as driver. " 4/16 reaction: patient contacted PCP with complaints of "Nausea, stomach ache, headache, injection site discomfort, fatigue, some diarrhea." Patient requested something for nausea. Provider prescribed ondansetron. 4/22: patient contacted PCP with complaints that since 2nd dose, he has felt "Fatigue and feet pain with swelling and intermittent numbness . Also since then has not been able to control CBG, in AMs >200, using medications as prescribed." PCP monitoring; no medication treatments.
52 2021-04-23 heart rate increased I would describe symptoms as ?mild?, but as this was only the first shot, I thought they were worth ... Read more
I would describe symptoms as ?mild?, but as this was only the first shot, I thought they were worth reporting. From 12 hours after my shot to about 48 hours afterwards, I experienced extreme fatigue, irritating rashes on the backs of my hands (which now went away), stomach pain, and a racing heart beat. All of which are also symptoms of mild covid. I seem OK 2 days afterwards.
52 2021-04-25 pulmonary embolism, chest pain At approximately 10AM CDT on 13 March 2021, I started having upper left-side chest pain. The pain in... Read more
At approximately 10AM CDT on 13 March 2021, I started having upper left-side chest pain. The pain increased as the day progressed. By 4PM CDT, the pain was bad enough that co-workers insisted I go to the hospital for evaluation. At approximately 4:30PM CDT, a co-worker drove me to the hospital. I was admitted at 5:16 PM CDT on 13 March 2021 to Medical Center, to treat multiple, bi-lateral pulmonary embolism. While still in the emergency room, I was injected with a blood thinner. I was released from the hospital on 15 March 2021, with a prescription for APIXABAN (Eliquis), which I am required to take for 6-months. I was directed to see my primary care physician within 3-weeks of being discharged.
52 2021-04-27 haemoglobin decreased This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the fi... Read more
This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization, and to Prevent getting COVID. Medical history included sickle cell trait, diabetes and was obesity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 06Apr2021, the patient experienced bleeding from the anus. Did colonoscopy and found that he had diverticulitis, sent home after 3 days in the hospital. On 11Apr2021, patient was bleeding from anus again where he went to ER that day and was admitted to the hospital. Basically, they haven't made any progress but his hemoglobin was 7 (hospital was talking about a blood transfusion). He had sickle cell trait, the hospital was fixed on diverticulitis. It was reported that patient was due to have another shot and was afraid it's going to start over again. The outcome of the events was unknown. Information on the lot/batch number has been requested.
52 2021-04-27 fainting, very slow heart rate Patient experienced two syncopal episodes in short succession while in the observation lot following... Read more
Patient experienced two syncopal episodes in short succession while in the observation lot following vaccination. He was evaluated by EMTs and found to be bradycardic. He vomited after the second episode. He was transported to Hospital for evaluation in the ER.
52 2021-04-28 deep vein blood clot Acute DVT of left calf
52 2021-04-28 hypertension Pt reported itchiness at 1345. BP was 162/100 mmHg, HR 73 bpm, and spo2% 96%. Patient given water. P... Read more
Pt reported itchiness at 1345. BP was 162/100 mmHg, HR 73 bpm, and spo2% 96%. Patient given water. Patient given oral dihpenhydramine oral solution 25 mg/10 ml (2 doses). Patient reassessed at 1408: BP 190/108 mmHg, HR 70 bpm, and spo2 98%. Patient reassessed at 1423.: BP 148/94, HR 69, spo2 98%. Patient educated on seeing primary care provider for high blood pressure and reaction to shrimp. Patient educated on carrying bendaryl with him. At approx. 1424, pt left facility with steady gait and unlabored respirations.
52 2021-04-28 pallor Pt received vaccine, wife was receiving her vaccine and pt became unresponsive, diaphoretic. 1150: C... Read more
Pt received vaccine, wife was receiving her vaccine and pt became unresponsive, diaphoretic. 1150: Code Medical called immediately. Car seat reclined.. BP 92/50, HR 40, RR18. Pt pale and diaphoretic. 1152: Pt arousing but unable to communicate clearly. BP 98/48, HR 40, RR1. Able to drink OJ, small sips. 911 activated. 1154: Pt removed from car and placed on cot awaiting EMS. 1156: Pt answering questions, remains pale and diaphoretic. BP 102/62, HR 54. Alert & Oriented X3. 1202: EMS arrived and walked pt to ambulance. BS 102, BP 114/68, HR 51. Skin warm and dry. Alert & Oriented. Pt to be transported to ED secondary to decreased Heart Rate.
52 2021-04-28 pulmonary embolism Pulmonary Emboli, unprovoked, diagnosed on the 19th. Vaccine administered on the 15th
52 2021-04-29 loss of consciousness Patient passed out while driving home from vaccination appt. event occurred approximately 45 minute... Read more
Patient passed out while driving home from vaccination appt. event occurred approximately 45 minutes after vaccine given.
52 2021-04-30 anaemia fever, chills, joint and muscle aches, night sweats, fatigue, lightheadedness, foggy headedness, - 3... Read more
fever, chills, joint and muscle aches, night sweats, fatigue, lightheadedness, foggy headedness, - 3 days in a row starting April 8 then subsided and started again a few days later
52 2021-05-01 nosebleed PFIZER-BioNtech COVID-19 Vaccine EUA Experienced first nose bleed in life over night after receivin... Read more
PFIZER-BioNtech COVID-19 Vaccine EUA Experienced first nose bleed in life over night after receiving vaccine. I have had 8 subsequent nose bleeds since. I have also had foul malodorous change to my olfactory senses, not loss of smell but change in everything I smell.
52 2021-05-02 blood clot Blood clotting in the left leg, Use ultrasound to identify and confirm clotting locations in the le... Read more
Blood clotting in the left leg, Use ultrasound to identify and confirm clotting locations in the left calf leg. Cramp like pain in the left calf with blue-ish/purple color in the ankle and left foot. Foot and leg was cold to the touch with extraordinarily strong migraines. Person leads healthy lifestyle and is physically and athletically fit. I was given Gemtesa to treat the clots, 150mg x2 a day for 7 days then to 75mgx2 a day for an unknown period. First dose on 3/24/ 2021 Pfizer Lot#EN6205 Second Dose ON 04/14/2021 LOT#EW0161 10:30AM
52 2021-05-02 blood clot Blood clotting in the left leg, Use ultrasound to identify and confirm clotting locations in the le... Read more
Blood clotting in the left leg, Use ultrasound to identify and confirm clotting locations in the left calf leg. Cramp like pain in the left calf with blue-ish/purple color in the ankle and left foot. Foot and leg was cold to the touch with extraordinarily strong migraines. Person leads healthy lifestyle and is physically and athletically fit. I was given Gemtesa to treat the clots, 150mg x2 a day for 7 days then to 75mgx2 a day for an unknown period. First dose on 3/24/ 2021 Pfizer Lot#EN6205 Second Dose ON 04/14/2021 LOT#EW0161 10:30AM.
52 2021-05-03 chest pain The first 2 days had fever chills fatigue teeth hurt headache tiredness. 4 days after shot have dev... Read more
The first 2 days had fever chills fatigue teeth hurt headache tiredness. 4 days after shot have developed a cough left side chest pain at times twitching in left shoulder area headaches and now have a difficult time doing anything physical like simple walking feel out of breath.
52 2021-05-04 chest pain Patient presented for first dose Pfizer COVID vaccine; vaccine administered at 1315. At approximate... Read more
Patient presented for first dose Pfizer COVID vaccine; vaccine administered at 1315. At approximately 1330, patient reported 7/10 chest pain associated with shortness of breath, stated symptoms unlike previous chest pain episodes. Patient transported from vaccine clinic to private room via wheelchair, EMS called at 1335. Upon EMS arrival at 1342, patient reported chest pain had decreased to 1/10, still reported shortness of breath. Patient transferred from wheelchair to EMS stretcher, transferred to ED via EMS.
52 2021-05-05 palpitations heart palpitations: started 5/3/21 around 7am, early beat every ~10 beats. Later in morning 9am, ski... Read more
heart palpitations: started 5/3/21 around 7am, early beat every ~10 beats. Later in morning 9am, skipped beat every ~10 beats. symptoms stopped around 12pm.
52 2021-05-06 pallor Nausea, sweating, pallor. BPs 185/121 (pulse 110), 167/113 (pulse 80). Patient advised to take blood... Read more
Nausea, sweating, pallor. BPs 185/121 (pulse 110), 167/113 (pulse 80). Patient advised to take blood pressure medications.
52 2021-05-06 blood clot Swollen red left arm. Diagnosed with blood clots in all his veins in left arm and spent 4 days in ho... Read more
Swollen red left arm. Diagnosed with blood clots in all his veins in left arm and spent 4 days in hospital on blood thinners and had 2 surgeries to remove them
52 2021-05-07 fainting, heart rate decreased This is a spontaneous report from a contactable consumer (patient's husband). A 52-year-old male pat... Read more
This is a spontaneous report from a contactable consumer (patient's husband). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in Arm Right on 01Apr2021 14:00 (Lot Number: ER8727) as SINGLE DOSE for COVID-19 immunization. The patient previously took BNT162B2 (lot number: EN6198) in the right arm via intramuscular dose 1 on 10Mar2021 14:00 for COVID-19 immunization at 52 years old and experienced passed out, fell to floor and was unresponsive for multiple minutes, syncope, feeling of nausea and lightheadedness before passing out and mild sore arm. The patient's medical history and concomitant medications were not reported. Three days post vaccination, the patient experienced dizzy potential syncope on 04Apr2021 20:00, BP was 115/70 and heart rate: 48 bpm. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
52 2021-05-08 blood pressure increased The day after vaccination I had significant headache.. I have measured my blood pressure and it show... Read more
The day after vaccination I had significant headache.. I have measured my blood pressure and it showed 200/107.. My usual blood pressure baseline at that time was ~130/~87
52 2021-05-09 loss of consciousness Pt vaccinated on 5/5/21. On 5/6/21 he developed fatigue, body aches and chills. In the early morning... Read more
Pt vaccinated on 5/5/21. On 5/6/21 he developed fatigue, body aches and chills. In the early morning of 5/8/21 (around 3am), he woke up from a sleep in his armchair and stood up, at which time he lost consciousness and passed out, hitting his head. He does not recall anything after that until he woke up in bed in the morning.
52 2021-05-09 pallor, loss of consciousness Patient was sitting in observation and felt dizzy and passed out. Patient fell forward out of chair... Read more
Patient was sitting in observation and felt dizzy and passed out. Patient fell forward out of chair and hit the right side of his forehead on the floor. 11:34 am patient laying on ground, unconscious and pale. Vital signs: BP R arm 112/70, 77 HR, 94% RA. 1136 sitting up. Vital signs: BP 119/78, 86 HR, 93% RA. Ambulance was called. Paramedics showed up at 1145 and evaluated him. Patient refused to go to hospital. Patient stable, given water. Patient requested to leave on his own. Patient was wheeled out to his car.
52 2021-05-10 deep vein blood clot pt woke up Friday morning (after having had vaccine on Wednesday evening) with R calf pain and swell... Read more
pt woke up Friday morning (after having had vaccine on Wednesday evening) with R calf pain and swelling. He was sent to ER, where he was diagnosed with DVT
52 2021-05-11 chest discomfort Virtually no symptoms from first vaccine or in first 72 hours after 2nd injection. Approximately 74... Read more
Virtually no symptoms from first vaccine or in first 72 hours after 2nd injection. Approximately 74 hours after 2nd injection I noticed some slight nausea and body aches. Within a few hours I was severely tired, weak stomach, had short, shallow breathing, tight chest and body aches. This has gone on continuously until this morning, 5 days after vaccine.
52 2021-05-12 chest discomfort A lingering and recurring soreness in left shoulder and arm. Occasionally, it was almost to a debil... Read more
A lingering and recurring soreness in left shoulder and arm. Occasionally, it was almost to a debilitating extent. The past few days my left chest or pectoral area is feeling odd. I have inquired with several different nurses from several different agencies/offices and the consensus is possible nerve damage from the injection. It is because it is recurring that I am reporting this.
52 2021-05-12 chest pain body aches, loss of taste and smell, tired, congested, shortness of breath, fatigue, cough, chills, ... Read more
body aches, loss of taste and smell, tired, congested, shortness of breath, fatigue, cough, chills, fever, chest pain
52 2021-05-13 chest pain, fibrin d dimer increased, pulmonary embolism Chest pain started two days after 2nd vaccine. CT scan of the chest showed nonocclusive subsegmental... Read more
Chest pain started two days after 2nd vaccine. CT scan of the chest showed nonocclusive subsegmental pulmonary embolism. Started on heparin infusion initially and transitioned to Xarelto.
52 2021-05-13 inflammation of the pericardium New onset peripheral edema, found to have pericarditis and bilateral pleural effusions without appar... Read more
New onset peripheral edema, found to have pericarditis and bilateral pleural effusions without apparent underlying cardiac pathology, infection, or malignancy. Inflammatory markers also elevated.
52 2021-05-17 loss of consciousness On 5/15/21 pt was in a drive through vax site. He says immediately after he got the vax he was tryi... Read more
On 5/15/21 pt was in a drive through vax site. He says immediately after he got the vax he was trying to drive away from the vax site but he has to pull over since he was passing out. He came to so put his car in park and then passed out again. He said he was nauseated, dizzy, and lightheaded. He kept going in and out. He blew the horn and got someone's attention. EMTs loaded him into an ambulance then he started vomiting. They took him to the Medical Center. They did multiple tests. He was admitted for further testing which had normal results. Pt was discharged after about 28 hours. Pt says he could stand up about 4 hrs after inj but the symptoms lasted about 18 hours total.
52 2021-05-17 fast heart rate, pallor, hypotension On 11/08/20 the client had symptoms of fever up to 103.5 F, chills tachycardia 117 bpm, O2Sat nadir ... Read more
On 11/08/20 the client had symptoms of fever up to 103.5 F, chills tachycardia 117 bpm, O2Sat nadir of 85%, respiratory rate 22, development of hypotension with BP 85/55 bpm with weakness, drowsiness, chills, flushed skin, bilateral edema both lower extremities with wheezing and rhonchi throughout both lungs and was sent to a local medical hospital for treatment where he tested positive for COVID and was returned to the psychiatric hospital after a 3 day stay and 2 administrations of remdesivir on 11/09/20 and 11/10/20 improved. The client subsequently received the Pfizer COVID19 vaccinations on 12/29/20 and 01/19/21 from different lot numbers noted above. On 5/16/21 the client began to have respiratory symptoms including temp of 99.5, pulse 103 O2 Sat of 85% with rhonchi responsive to albuterol inhalation and subsequently albuterol nebulizer treatment; however the following day symptoms progressed with weakness, wheezing, cough, shortness of breath, pallor and O2 saturation 77% unresponsive to albuterol nebulizer treatment. He was was transferred to a local medical hospital for treatment of severe respiratory symptoms and tested positive for COVID a second time and after the complete Pfizer COVID19 vaccination series approximately 4 months prior. He is still hospitalized at the medical hospital at the time of this report (2 days).
52 2021-05-19 chest pain, palpitations Within one day of receiving the 2nd shot started having heart palpitations in the middle of the nigh... Read more
Within one day of receiving the 2nd shot started having heart palpitations in the middle of the night, Went to Urgent care, not help. Went back to hospital and a got a heartmonitor and wore that for a week. Thenon Friday, May 7th went to the emergency with sweats and almost passed out. They kept him there for over a day, ran tests, etc. Blood work came out fine. He was released the following day. No answers. One doctor there admitted that he believed it's related to the vaccine. Now here we are, May 20th, no answers and feeling the same, but now chest pain, shortness and breath. Never had ANY HEART PROBLEMS BEFORE THIS!
52 2021-05-19 loss of consciousness, fainting I passed out or fainted; I passed out or fainted; Hand and feet were extremely cold; This is a spont... Read more
I passed out or fainted; I passed out or fainted; Hand and feet were extremely cold; This is a spontaneous report from a contactable consumer. A 52-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Right arm on 04May2021 (Batch/Lot Number: EW0164; Expiration Date: Aug2021) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 05May2021, 1 day after the administration of vaccine the patient experienced I passed out or fainted and Hand and feet were extremely cold. Clinical course reported as I passed out or fainted and my hand and feet were extremely cold before fainting. Patient stated, that he had been trying to report an adverse reaction to the Pfizer COVID 19 Vaccine, the second shot through the 'portfolio' on the website and he tried 3 times and for whatever reasons it just won't transmit the information. So he was wondering, it is possible to report that with a live agent today. The outcome was not recovered for Hand and feet were extremely cold and unknown for rest of the events.
52 2021-05-19 oxygen saturation decreased, chest discomfort, fast heart rate, enlargement of the heart, chest pain Clinical Support 3/31/2021. Exposure to SARS-associated coronavirus +1 more. Dx Labs Only. Reason fo... Read more
Clinical Support 3/31/2021. Exposure to SARS-associated coronavirus +1 more. Dx Labs Only. Reason for Visit ED Discharged 4/30/2021 (2 hours) Treatment team. Providers COVID-19 Clinical impression, Fever, Generalized Body, Aches, Chills. Chief Complaint Patient presents with Fever, Generalized Body Aches, Chills. HPI: 52-year-old male with history of diabetes, hypertension, obesity presents the emergency department with gradual onset of moderately severe generalized nasal congestion with associated cough unproductive of sputum and fever, T-max 103.8 at home the patient states began approximately 1 week prior to arrival. The fever worsened today and he decided to be seen at that time. He states he had his first dose of Pfizer COVID-19 vaccine 3 weeks ago. Denies sick contacts, chest pain, shortness of breath, syncope, dizziness, lightheadedness, numbness, focal weakness, abdominal pain, nausea, vomiting or diarrhea, changes in bowel or bladder habits or other complaint. No other signs or symptoms and no treatment prior to arrival. ED Discharged 5/1/2021 - 5/2/2021 (5 hours). Last attending Treatment team COVID-19 +1 more. Clinical impression, Chest Discomfort, Chief complaint. ED Provider Notes. Expand AllCollapse All. HPI. Chief Complaint Patient presents with. Chest Discomfort. Patient History. 52-year-old male with history of asthma, diabetes, heart murmur, hypertension, obesity, sleep apnea and was seen in the emergency department yesterday complaining of generalized nasal congestion, fever and cough and was discharge with a diagnoses of COVID-19 4/30/2021 presents to the emergency department with complaint of chest tightness. The patient states that tonight he developed chest pain which woke him from sleep. He describes the pain as burning. He states the pain is similar to the pain he had when he had a gallbladder attack. He also states the pain is well localized and does not radiate. Initially the pain was 10/10 initially and is currently a 4/10. He took his temperature and states he had a fever of 101.6 and took 1,000 mg of tylenol just prior to arrival. His O2 saturation today has not gone under 90%. Medical History. Past Medical History: Diagnosis Date Asthma 5/29/2017, Diabetes mellitus, Heart murmur, Hypertension, Obesity, Sleep apnea, obstructive. APAP 8-20CM WME AIRVIEW. Surgical History. Past Surgical History: Procedure Laterality Date CARDIAC CATHETERIZATION 03/2004. OTHER SURGICAL HISTORY ear surgery as a baby. STRABISMUS SURGERY repair of congenital strabismus-childhood. Family History. Problem Relation Age of Onset. Hypertension Mother. Diabetes Father. Hypertension Father. Hearing loss Other. Kidney disease Other. Social History. Tobacco Use. Smoking status: Never Smoker. Smokeless tobacco: Never Used Vaping Use. Vaping Use: Never used. Substance Use Topics. Alcohol use: No. Drug use: No. Review of Systems. Constitutional: Positive for fever. Respiratory: Positive for chest tightness. Cardiovascular: Positive for chest pain. All other systems reviewed and are negative. ED to Hosp-Admission. Discharged 5/4/2021 - 5/6/2021 (2 days) Hospital. Last attending Treatment team Acute hypoxemic respiratory failure due to COVID-19. Principal problem. Presenting Problem/History of Present Illness/Reason for Admission. Acute hypoxemic respiratory failure due to COVID-19. Hospital Course. Patient is 52 yo BMI around 40, presents to the hospital with severe sepsis secondary to COVID-19 pneumonia. He was first positive on 04/30, had progressive shortness of breath with weakness and worsening cough. He presented to the hospital originally on 05/04, and desaturated to 85% on room air. He admitted to the medicine service, pulmonology was consulted. Severe sepsis (tachycardia, tachypnea, and fevers with acute hypoxemic respiratory failure) secondary to COVID-19 pneumonia. He was started on dexamethasone IV, and transition to oral dexamethasone. He will continue 7 more days at home to complete 10-day therapy. He was started on remdesivir therapy and received 3-day treatment. Pulmonary consulted, as he was a possible candidate for Actemra, however his inflammatory markers including D-dimer, ferritin, CRP improved, and his oxygen requirements also improved. On discharge, he will continue with oxygen supplementation 2 L with rest, 4 L with activity, 2 L with sleep to be infused into his CPAP therapy. Hyperlipidemia. Continue rosuvastatin 10 mg Monday, Wednesday Friday. Benign essential hypertension. Holding hydrochlorothiazide Continue lisinopril and metoprolol.
52 2021-05-20 cardiac arrest The patient had Covid 19 from approximately January 28, 2021 through early February 2021. He receive... Read more
The patient had Covid 19 from approximately January 28, 2021 through early February 2021. He received the first dose of the Pfizer Vaccine on March 26, 2021. On March 27, 2021 at approximately 7:30 PM, the patient suddenly became unable to speak clearly and walk normally. The ambulance was called at approximately 7:45 PM. The patient was evaluated and placed in the ambulance by approximately 8:15 PM. He stopped breathing in the ambulance. He was resuscitated and placed on a ventilator at some point. After evaluation at the hospital, it was found that he had suffered a pontine hemorrhage. He was kept alive until his heart stopped on March 29, 2021.
52 2021-05-22 fast heart rate, heart rate irregular Irregular, tachycardic heart rhythm lasting several hours on the second night after vaccination; thi... Read more
Irregular, tachycardic heart rhythm lasting several hours on the second night after vaccination; this did not recur with the second dose of the same vaccine which was from Lot #EL9266.
52 2021-05-24 troponin increased, chest pain I had COVID in early December 2020. I waited a few months to get the vaccine. I was fine the day o... Read more
I had COVID in early December 2020. I waited a few months to get the vaccine. I was fine the day of the vaccine 16 MAR. I took the next day off 17 MAR because I was running a fever and and had body aches. I did not have any alcohol on St Patty's day. I pretty much slept the whole day. I went back to work on 18 MAR and was feeling better with only a mild ever. The night of 18 MAR I began to run a fever and had body aches. The body aches worsened during the night I could not sleep. The body aches became centralized in my upper back and shoulders, My neck was hurting too. I began to feel chest pains. The chest pains increased in intensity. I researched the symptom's which suggested I was having a heart attack. I took some aspirin to try to alleviate the pain. The pain continued and more severe so I drove myself to hospital. The staff gave me an EKG and took blood samples for testing. The EKG was normal. The blood test came back with elevated levels of Troponin. The Dr. advised that the Troponin level indicated that I probably had a heart attack. the first hospital did not have a cardiac unit so I was transferred to downtown location. The staff there ran more test. The EKG was again normal and the Troponin elevated so a Coronary angiography was conducted with catheter and dye. The angiography was also normal with no sign of a heart attack the doctor said I probably had a reaction to the vaccine. He suggested that I still get the second vaccine. I did get the second vaccine. After the second vaccine I only had fever and body aches, I pre0-gamed with aprin and plenty of rest for the second vaccine.
52 2021-05-25 chest pain, chest discomfort Patient had his 2nd dose of the pfizer vaccine 05/25/2021. Patient is c/o left arm pain and chest pa... Read more
Patient had his 2nd dose of the pfizer vaccine 05/25/2021. Patient is c/o left arm pain and chest pain with pressure that started since last night, 05/24/2021. He denies any SOB, fevers, abdominal pain, or swelling, redness, or tenderness at injection site on the left upper arm. Told the patient to please go to the nearest ER for evaluation of the chest pain; patient verbalized understanding and states that someone will take him to the ER
52 2021-05-25 heart rate increased Elevated heart rate about 5 mins after injection. Sat in medical area and talked to patient. Heart r... Read more
Elevated heart rate about 5 mins after injection. Sat in medical area and talked to patient. Heart rate came down to normal limits within 5 mins.
52 2021-05-27 lightheadedness vasovagal 10 mins after vaccine shot
52 2021-05-27 transient ischaemic attack, hypertension signs of a transient ischemic attack; lost control of the left side of the face and possibly of the ... Read more
signs of a transient ischemic attack; lost control of the left side of the face and possibly of the left side of his body; lost control of the left side of the face and possibly of the left side of his body; elevated blood pressure 180/100 and came down to 140/100 after the one-hour long episode; weakness; This is a spontaneous report from a contactable consumer (patient's son) via Medical Information team. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08May2021 at 15:30 (at the age of 52 years old) (Batch/Lot number: EW0176, Expiration date was unknown) as the 2nd dose, single for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number: ER8730, Expiration date was unknown) on 17Apr2021 at 2:30 PM (at the age of 52 years old) for COVID-19 immunization. The vaccine was not administered at the military facility. Relevant medical history included ongoing high cholesterol, ongoing high low density lipoproteins (LDLs), ongoing high triglycerides, and patient might have borderline diabetes, possibly prediabetic, but the reporter was not quite sure. The patient had family history of heart problems. The patient was taking unspecified concomitant medications, but the reporter did not know the medications that the patient was taking. It was also reported that the patient was not completely compliant with his medications. The patient had no additional vaccines administered on the same date of the Pfizer suspect. Prior to vaccinations (within 4 weeks), the patient had no other vaccinations and there were no adverse events (AEs) following prior vaccinations. The reporter stated that in the morning at the time of the report on 13May2021, about 5 days after the second COVID-19 vaccine, the patient had signs of a transient ischemic attack; he lost control of the left side of the face and possibly of the left side of his body; he had elevated blood pressure 180/100 and came down to 140/100 after the one-hour long episode; and he experienced weakness, but was able to move around. At the time of the report, the patient was on his way to the emergency room (ER). The event "loss of control of left side of face" did require a visit to the emergency room. It was further reported that the patient had signs of a transient ischemic attack and loss of control of the left side of his face and maybe the left side of his body, but the reporter was not sure; he also had some weakness and this episode lasted about an hour during which time the patient's blood pressure was 180/100. After the hour, his blood pressure came down to about 140/100. The patient was able to move around and on the way to the emergency department. No further information was available regarding the patient's visit to the emergency room at the time of the report. The reporter was asking for information on transient ischemic attacks and the Covid 19 vaccine and if there were reports of strokes as well. The reporter stated his family called several doctor friends and doctor relatives and based on the patient's symptoms, it seemed likely that he had a transient ischemic attack. The outcome of the events was unknown.
52 2021-05-28 chest pain Numbness/tingling right arm since vaccine. Sweaty palms since vaccine. Chest pain starting 18MAY, sh... Read more
Numbness/tingling right arm since vaccine. Sweaty palms since vaccine. Chest pain starting 18MAY, shortness of breath associated with it 20MAY, continued chest pain with relief when leaning forward- concern for pericarditis
52 2021-05-30 cerebrovascular accident, heart attack Massive heart attack. He was in Icu with a ECCMO and Impella machine. The highest life support was g... Read more
Massive heart attack. He was in Icu with a ECCMO and Impella machine. The highest life support was going to get a heart transplant but hes life ended with a stroke while under sedation for 5 days
52 2021-05-30 heart rate increased * Fever and coughing, which is very rare at the first shot. My temperature was 38.3 C. The fever las... Read more
* Fever and coughing, which is very rare at the first shot. My temperature was 38.3 C. The fever lasted for two days. But the coughing stayed for over a month. As of today (5/31/2021), I still cough occasionally. * Fast heart beat. My normal heart beat is 57-60 per min. After the first shot, my heart beat went to 70 above, some times 80 and above. The fast heart beat stayed for weeks. That was why I was hesitant to take the second shot. Eventually I took the second shot on 5/26/2021, 33 days after the first shot. I did not have much side effect for the second shot, except sleepiness. Ironically, on 5/30/2021, I suddenly felt much better after getting up from the bed. I measure my heart beat, it was below 60, back to normal. Fatigue. I did not feel the same as before after the first shot. I felt fatigue. Un thet weenkend after my second shot, I was back to normal. No fatigue any more.
52 2021-05-30 loss of consciousness Received the vaccine and then sat in waiting area with no immediate issues. After about 10 minutes ... Read more
Received the vaccine and then sat in waiting area with no immediate issues. After about 10 minutes started to feel flushed and a couple seconds later blacked out. When coming around, felt disoriented and nurse was asking me questions as I was still sitting in chair. My wife reported that I was having a seizure and stiff against the wall with eyes rolled back and unresponsive for about a minute. My right arm was cramping, BP 220/180 and pulse 44. The clinic staff laid me on the floor and call an ambulance that took me to the ER for observation and testing.
52 2021-05-30 pulmonary embolism, chest pain ? 5/21/21: Pulmonary Embolism o Presented with chest pain, abdominal pain, breathing problems o CT s... Read more
? 5/21/21: Pulmonary Embolism o Presented with chest pain, abdominal pain, breathing problems o CT showed pulmonary embolism o Stable for outpatient anticoagulation. Started on 10 mg Eliquis BID x 7 days and then 5 mg BID thereafter.
52 2021-05-30 fainting, cardiac arrest 04/23/2021 13:00 Cardiac arrest from ventricular fibrillation. Collapsed, had immediate bystander CP... Read more
04/23/2021 13:00 Cardiac arrest from ventricular fibrillation. Collapsed, had immediate bystander CPR and EMS arrived quickly. His initial rhythm was VF. 5 shocks were delivered as well as 2 rounds of epinephrine and 2 boluses of amiodarone. ROSC was achieved
52 2021-05-31 excessive bleeding Heavy clotting issues in my left kidney through my bladder which is causing urinary issues; Urinatin... Read more
Heavy clotting issues in my left kidney through my bladder which is causing urinary issues; Urinating large blood clots; Hemorrhaging blood clots/ bleeding; This is spontaneous report from a contactable consumer, the patient. A 52-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 21May2021 10:10 (reported as 10:10 EST) (at the age of 52-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 22May2021, the patient called to report an adverse reaction to 1st dose of vaccine, and currently in the emergency room (ER) at the hospital, in a bed with heavy clotting issues in his left kidney through his bladder which was causing urinary issues, literally urinating large blood clots. He currently had a catheter in, they have done blood work and CT scan, but no results provided. The patient had no issues with anything with prostate or kidney but hemorrhaging blood clots. The patient was not yet admitted to the hospital, just in the ER somewhere around 10:00 in the morning. The patient had a follow up and still at home had a catheter and still he was bleeding and follow up tomorrow with Urology department at 10:00; had full blood work follow up tomorrow and had a CT scan. Everything came back as normal as far as his organs go. The patient added, "I would appreciate it if someone would call me with some professional advice what I should do about this whether I need to take the second dose. I need some clarification on what is going on with this and then I need to have a discussion on whether I should take the second dose or not." The outcome of the event was not recovered, at the time of this report. The seriousness of the events was unspecified by the reporter. There is a medical information request included Caller (male, age 52 years)- his question was the first and 2nd dose the same. Tomorrow he should have the full make up back and causes of this from the doctor. It has been a rather traumatic event which he thought was going to be nothing." Due date of second dose. Response included: As noted in the Fact Sheet for Recipients, the patient should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They refer him to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. His healthcare provider knows your health situation and has access to information that can better help inform this decision. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine." and from VR-As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with doctor/healthcare provider about what he had experienced/were experiencing. Information on Lot/Batch number has been requested.
52 2021-06-02 lightheadedness, loss of consciousness dizziness; nausea; He did not feel well at all and was not able to feel well enough to stand up.; de... Read more
dizziness; nausea; He did not feel well at all and was not able to feel well enough to stand up.; definite lack of coordination; he vomited on himself; his cholesterol was high at 208.; had very little strength; started feeling like something was wrong; just had sort of a feeling like being really drunk; passed out (fainted) in his car 3 times; He was told he had a vasovagal reaction; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15May2021 10:50 (Lot Number: EW0173; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included vasovagal reactions in high school. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. Within 2 minutes of receiving the Covid 19 vaccine he started feeling like something was wrong. He pulled to the side in the parking garage and as soon as he stopped the car he passed out. He woke back up and was able to put the car in park and he passed out a second time. He woke up again and his foot was on the gas pedal and he tried to roll down the window. He was able to roll down the window but he wasn't able to get anyone's attention. He passed out a third time. When he woke up again he wasn't able to get the door open and he was nauseated. He basically had nausea, dizziness, and a definite lack of coordination. He just had sort of a feeling like being really drunk. He doesn't drink. He had very little strength but he was able to push his car horn. He was out of it. He could see someone in his car mirror a little ways behind his car and the horn didn't get the person's attention so he honked a second time and someone came to help him, maybe from the fire department and maybe some emergency medical technicians. He was placed on a golf cart or ATV to be transported downstairs to a waiting ambulance and while on the ride he vomited himself. He mentioned that the EMTs called it a vasovagal reaction. He was brought to the hospital in which he had a lot of tests done. He did not feel well at all and was not able to feel well enough to stand up. He had tests done at the hospital, a chest x-ray and his blood was drawn. He had a cardiac ultrasound later in the afternoon the next day on 16May2021. The doctor's didn't find anything wrong other than his cholesterol was high at 208. He was admitted to the hospital on 15May2021. He continued to have his blood drawn through the night and the next morning, on 16May2021, he had a CAT scan. For his cholesterol he was told to eat better and maybe follow up with a doctor in a couple months to check his cholesterol again. No one had any answers to the effect of what happened to him. Everything was fine, his tests were normal. He was told he had a vasovagal reaction. He's had vasovagal reactions before and he can tell this was much different than the vasovagal reactions he's had before. In the past when he's had vasovagal reactions the world went black like looking through a small circle, his vision got blacker and blacker and then he'd pass out. He did not have this feeling with the Covid 19 vaccine. He can only describe this feeling that he had like an occasion in his past when he's drank to much and he's stumbling around. He may have passed out briefly to someone helping him move to a bed and his arms are weighted and he can't lift them and he's disoriented but still has a sense of what's going on but he feels like he could vomit at any second. He's comparing his experience to the Covid 19 vaccine to drinking to much alcohol and then falling asleep or passing out. He was pretty much out of it for 5 hours. Between the fourth and fifth hours after receiving the Covid 19 vaccine he was comfortable enough to stand on his own for brief moments. He was feeling better and was able to use the restroom. By the next day, around the 24 hour period after the vaccine he was feeling almost normal. He was released from the hospital the next day, 16May2021 at around 4:00PM. He was maybe in the hospital for about 27 to 28 hours. At the hospital he had all these tests and he was found to be healthy with no problems. He also had a Covid 19 virus test, he never asked what the results were but he's going under the assumption that if he was Covid 19 virus positive the hospital staff would have told him. Passing out, nausea, dizziness required a visit to Emergency Room. The outcome was unknown.
52 2021-06-03 heart attack death - Non-ST elevation (NSTEMI) myocardial infarction
52 2021-06-03 hypertension Patient presented symptoms of high blood pressure three days after receiving the vaccine (05/31/21).... Read more
Patient presented symptoms of high blood pressure three days after receiving the vaccine (05/31/21). Seven days later, the wife tells the pharmacy that she has a headache in the left back, has a droopy eyelid on the left side and numbness in the left area of ??the face. He was advised to visit his doctor, and his wife indicated that the patient was going to go that same day (04/06/2021).
52 2021-06-08 hypertension Severe headache; Whole body pain; All day Vomiting; Nausea; Muscle Spasms; Intense Chills; fever cyc... Read more
Severe headache; Whole body pain; All day Vomiting; Nausea; Muscle Spasms; Intense Chills; fever cycle; Very High blood pressure; This is a spontaneous report from a contactable patient. A 52- year-old male patient received first dose of BNT162B2 (Pfizer BioNTech covid 19 vaccine) (Lot no.: EN6207) via an unspecified route of administration in right arm on 12Mar2021 at 12:00 PM (at the age of 52-years-old) as a single dose for COVID-19 vaccination. Medical history included high blood pressure and thyroid disorder. He also thought he had a false negative covid test in Jul2020, and actually did have covid in Jul2020. The patient did not have any allergies to medications, food and other products. Concomitant medication lexapro, losartan, DIM (as reported, unspecified), retinol (vitamin A), vitamin d and phytomenadione (VITAMIN K), trazadone within 2 weeks of vaccination for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient was not tested positive for COVID-19. On 13Mar2021, patient trip to the emergency room (ER) for severe headache, whole body pain, muscle spasms, intense chills and fever cycle, very high blood pressure, all-day vomiting and nausea. Nothing they tried eased any of the symptoms. There is no amount of ibuprofen or acetaminophen. He threw up nausea medicine. Two doses of morphine at the ER took the pain from a 10 to a 7. He had never, ever felt this badly. The clinical outcome of the events severe headache, body pain, muscle spasms, intense chills, fever, very high blood pressure, vomiting and nausea was not resolved. No follow-up attempts are possible. No further information is expected
52 2021-06-10 blood pressure increased pain; pain was causing blood pressure to be elevated/blood pressure elevation; Headache; injection p... Read more
pain; pain was causing blood pressure to be elevated/blood pressure elevation; Headache; injection pain/injection site extreme pain; pain was so bad could not sleep at night/sometimes he is not going to sleep until 02:00 the next mor; This is a spontaneous report received from a contactable consumer (patient's spouse) via a Pfizer-sponsored program. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 23Apr2021 (lot number: EN0170), as 2nd dose, single dose, at age 52 years old, for COVID-19 immunisation, at a pharmacy/drug store. Medical history and concomitant medications were not reported. Historical vaccine included the first dose BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), administered in the left arm, on 24Mar2021 (lot number: EP6955), at age 52 years old, for COVID-19 immunisation. The patient did not have prior vaccinations within four weeks of BNT162B2. On 23Apr2021, the patient received his second dose of BNT162B2. On 23Apr2021 at 19:30, the patient experienced injection pain/injection site extreme pain. The patient did not act on it because he knew the injection site may be sore for a week. On 24Apr2021, the injection site was hurting bad but again he did not act on it because he knew it may sore but it had been a whole month and it was concerning. The reporter stated that the pain was causing the patient's blood pressure to be elevated. The reporter noticed the blood pressure elevation about 2 weeks after the second injection in the morning time (May2021). The patient also experienced headache at the same time as when the patient's blood pressure was elevated around the morning time, about 2 weeks after the second injection (May2021). It was reported that the pain was so bad that the patient could not sleep at night within a week of the second injection (Apr2021), time of onset was reported as "around 15:00 or 16:00 and as it goes over to the night 190:0 or 20:00, sometimes he is not going to sleep until 02:00 the next morning"). The events required physician's office visit on an unspecified date (reported as "the other day") and the reporter brought the events to the doctor's attention and stated that the patient was in pain throughout the day. The reporter was thinking of taking the patient to urgent care. Treatment for the event "injection pain/injection site extreme pain" and "pain" included heating pads, ice packs, lidocaine patches, unspecified cream and rubbing lotion to try and ease the pain. The reporter was thinking about Advil and asked every how many hours should the patient take the Advil. The outcome of the events was not recovered. Follow-up attempts are needed. Further information is expected.
52 2021-06-10 heart rate increased, hypotension, palpitations Caller stated he got the second shot two days ago and that next day he had a rash.; when he is in a ... Read more
Caller stated he got the second shot two days ago and that next day he had a rash.; when he is in a hot room like 78 degrees with the window open he can not take the heat like he used to; Hot flashes; rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing; Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging; felt like he was drugged; pulse rate has been a little elevated; Palpitations: Caller stated this started the same day 10 to 12 hours after getting the first shot. Caller stated it was getting somewhat better but after the second shot it got worse.; getting out of breath was reported as worsened; felt like there was pressure in his skull; he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall ove; Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine; This is a spontaneous report from a contactable consumer (patient, self-reported). A 52-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0183; expiry date: 31Aug2021) via unspecified route of administration in left arm on 01Jun2021 as single dose of COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0173; expiry date: 31Aug2021) via unspecified route of administration in left arm on 11May2021 as single dose of COVID-19 immunization and experienced palpitations, felt like he was drugged, felt like there was pressure in his skull, getting out of breath, rash got bright pink, respiratory rate was somewhere around 16, blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle. On an unspecified date in Jun2021, after second dose of vaccination, the patient experienced palpitations, getting out of breath like when he was walking up and down the stairs especially when carrying laundry or a garbage can and he never had this problem doing that unless he had an upper respiratory infection and prior to the vaccine he was perfectly fine, palpitations was reported as worsened, getting out of breath was reported as worsened, rash on his left side where he got the shot on his hand, specifically the top of hand and on his first, second, third, fourth, and fifth finger was reported as worsened, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle was reported as worsened, crack in the knuckle area on the second finger was reported as worsened, rash got bright pink was reported as worsened, felt like he was drugged, Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, felt like there was pressure in his skull, felt like he was going sideways, and on 01Jun2021 experienced hot flashes. On 02Jun2021, he was in a hot room like 78 degrees with the window open he cannot take the heat like he used to. On an unspecified date in Jun2021, patient stated that palpitations got worse after the second shot it was started on the same day of first shot of vaccination, 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse. On 03Jun2021, that next day of vaccination, patient had a rash and explained that on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle, this stopped a week to ten days after the first dose and then it came back after the second. Patient had a crack in the knuckle area on the second finger: patient stated he was scheduled for the dose around 12:20 and they had to get more vaccines and so he had to get it around 3:00pm. The patient stated this started to feel bad in the first two hours. For the event of rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing. Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging. For the event "felt like he was drugged" patient stated this started within 4 hours of first dose, he started to feel better in 5 days and then 10 days after he was completely better and stated he got this again from the second shot and it was getting better but the more he exerts himself the slower he feels but he does not feel like he is on anesthesia. The patient stated that his pulse rate has been a little elevated, stated on the following day after first dose his pulse rate was 114 and 120 was the highest. He stated after the first dose it was between 116 to 120 and after the second dose it was slightly elevated like 90 or something. The patient stated but his pulse rate has been 86, 87, 90 so the pulse rate has been a little elevated. The patient reported he also had hot flashes. He felt like there was pressure in his skull, 10 to 12 day after the first vaccine and this got better, then within 7 to 10 days after the second shot he got it again and he anticipates that for 7 to 10 days he will have to deal with the same crap. The patient felt like he was going sideways, this stopped within two days after the first dose and then it happened within one day or a day in half after the second shot. The patient stated that hot flashes lasted a day or day in a half. The other problem he had noticed is when he is in a hot room like 78 degrees with the window open, he cannot take the heat like he used to. Reportedly, after the second shot they had the patient sit for 15 minutes and so he went to the hospital main area after to get a pass to eat and he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over. He stated the first hour or so after the vaccine he felt like he was drug and he even had caffeine and got his car cleaned, but he felt like his body was behind him like woozy to stomach like in slow motion with exertion and it felt like he was drugged. The patient stated he just wished the vaccine dosage had a high of like if it was 0.3 maybe should be 0.2. The patient stated there should be a different regimen based on height and weight. The outcome of the event "hot flush" was resolved on 01Jun2021, for the event "Palpitations: The patient stated this started the same day 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse", "getting out of breath was reported as worsened", "The patient stated he got the second shot two days ago and that next day he had a rash", "he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over", "felt like there was pressure in his skull", "Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine", "felt like he was drugged", "pulse rate has been a little elevated", "when he is in a hot room like 78 degrees with the window open he cannot take the heat like he used to" was not resolved and for the event "Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging" was unknown, for the event "rash got bright pink, the patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing" was recovering.
52 2021-06-15 deep vein blood clot 3-4 weeks after his second Pfizer covid 19 vaccination, patient developed a spontaneous DVT in his r... Read more
3-4 weeks after his second Pfizer covid 19 vaccination, patient developed a spontaneous DVT in his right peroneal vein. He was treated with Eliquis (current still taking this) and his pain has resolved. He will be seeing a hematologist.
52 2021-06-15 blood clot After receiving the vaccine I had the soreness in my arm and a small fever of 99. Over the course o... Read more
After receiving the vaccine I had the soreness in my arm and a small fever of 99. Over the course of the next few weeks I was experiencing severe eye pain which caused me to start losing site in my right eye and also microclots in my eyes, my eye doctor stated that the vaccine was not the cause of my conditions with my eye. But other than the soreness of my arm where the vaccine was administered and a slight fever I really didn't have any other problems.
52 2021-06-16 chest pain Chest pain in the upper right chest; Restlessness; Upper right shoulder pain; burning sensation; Thi... Read more
Chest pain in the upper right chest; Restlessness; Upper right shoulder pain; burning sensation; This is a spontaneous report from a contactable consumer (patient). This is Report 1 of 2. A 52-years-old male patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number: EW0179, expiration date: unknown), via an unspecified route of administration, administered in right upper arm on 20May2021 as 2nd dose, single dose; and previously took first dose of BNT162B2(Lot number: EW0172), via an unspecified route of administration, administered in left upper arm on 29Apr2021 as 1st dose, single dose for COVID-19 immunization. Medical history included Depression diagnosed at 4 years old as he was adopted and everything, and had Previously heart attack on 23Oct2003, high cholesterol, and a finger cut off. Patient states it was work related and accidental, he put his hand in the wrong spot, the actuator came down, and took his finger off. States that was years ago, they were able to stitch it back on. Patient reported him and his wife are allergic to cottonwood and he don't know what treatment to take. Patient also reported after forty there is two things that happen, one you start losing your memory, and second you can not remember the other one, and that is exactly what happened to him. Concomitant medications included FLUOXETINE, 40 mg, 2 capsules once a day, every morning, he thinks he takes for cholesterol; ATORVASTATIN, 20 mg daily, he thinks he takes for depression; AMITRIPTYLINE HCL, 25 mg. Takes 3 at night which helps him sleep; LISINOPRIL, 20 mg tablet once daily, taken for an unspecified indication; since 1.5 years and start and stop date of all concomitant medications were not reported. No prior Vaccinations within 4 weeks of vaccination. The patient on an unknown date in May2021, woke up in the middle of the night, he was experiencing restlessness, and not really chest pain, almost like a shoulder pain, up in the shoulder, not like a heart attack or anything and chest pain in the upper right chest which is bearable, but annoying. Patient stated pain comes and goes. Chest pain is still persisting, and started about 2-3 days of second vaccination and has not improved, it is still steady, a burning sensation, and always in the upper right shoulder, above the male breast, up above that, up in the clavicle. The patient underwent lab tests and procedures which included blood cholesterol: only two points up. No investigation assessment. No Emergency Room or Physician Office visits. The outcome of chest pain in the upper right chest was not recovered, upper right shoulder pain was recovering; restlessness and burning sensation was unknown. Information on Lot/Batch number was available. Additional information has been requested.
52 2021-06-23 hypertension about 2 weeks after the 2nd dose became lethargic, no appetite, sleepy, swelling in feet, painful to... Read more
about 2 weeks after the 2nd dose became lethargic, no appetite, sleepy, swelling in feet, painful to walk, hands occasionally also hurt, nausea on/off, diareaha
52 2021-06-24 chest pain, blood pressure increased Went to hospital with elevated blood pressure, chest pain, pulse in left finger tips and numbness in... Read more
Went to hospital with elevated blood pressure, chest pain, pulse in left finger tips and numbness in left arm. Heart / troponin levels were normal but kept for additional testing. Echocardiogram was performed and diagnosed with severe hypertrophic cardiomyopathy.
52 2021-06-25 cerebrovascular accident Had clots in his lungs / blood clots; Stroke; He received his first dose on 27Feb2021 and second dos... Read more
Had clots in his lungs / blood clots; Stroke; He received his first dose on 27Feb2021 and second dose on 26Apr2021; This is a spontaneous report from a contactable consumer(patient). A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 at his 52-year-old (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He previously received his first dose BNT162B2 for Covid-19 immunization on 27Feb2021 at his 52-year-old. The patient experienced stroke on 07May2021 with outcome of unknown , had clots in his lungs/blood clots on an unspecified date with outcome of unknown. The clinical course was reported as follows: After her received his second dose of the Pfizer COVID-19 vaccine he ended up with a stroke. He had clots in his lungs and one broke off and gave him the stroke. He was just looking to see if there have any information about long term events occurring with blood clots, like is this a one time event or is there a potential for it to keep happening now that he had the vaccine in his system. He received his first dose on 27Feb2021 and second dose on 26Apr2021 and had stoke on 07May2021. He had a stroke after Pfizer shot, now coincidentally he had no other health issues. He did not know if it was related to vaccine COVID may not have been. He was healthy 52 year old male, no medicines no nothing headed with the stroke, they developed a blood clot in his lung ended up with the stroke. Information about batch/ lot number has been requested.
52 2021-06-28 heart attack NSTEMI (non-ST elevated myocardial infarction).
52 2021-06-29 palpitations Short term rapid racing of heart; This is a spontaneous report received from a contactable consumer,... Read more
Short term rapid racing of heart; This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 20Mar2021 at 14:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes and colitis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) for unknown indications from unknown dates. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Mar2021 at 15:15, the patient experienced short term rapid racing of heart after the 15-minute wait time, around the 30-minute mark after the first dose, like being over caffeinated. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event short term rapid racing of heart. The clinical outcome of the event short term rapid racing of heart was recovered on 20Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.
52 2021-06-30 blood pressure increased BP shot up to 197/130; Throbbing headache; Nausea; Tingling in both arms and fingers; Itchy tongue; ... Read more
BP shot up to 197/130; Throbbing headache; Nausea; Tingling in both arms and fingers; Itchy tongue; Iitching all over body; Clamminess; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration, administered in left arm on 18Mar2021, 15:30 (age at vaccination was 52-year-old) as single dose for covid-19 immunization at hospital. Medical history included hypertension. The patient concomitant medication included Hydrochlorothiazide. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient did not diagnose with COVID-19. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. On 18Mar2021 at 15:45 Within 60 seconds of vaccine, I got an immediate throbbing headache, nausea, tingling in both arms and fingers, itchy tongue, itching all over body, BP shot up to 197/130, clamminess, and fatigue. Patient received a treatment with Antihistamine given during episode for the events. The patient underwent lab test and procedures which included blood pressure measurement: 197/130 on unspecified date in Mar2021. The outcome of the events was not recovered. Additional information is excepted. Follow up is requested.
52 2021-06-30 inflammation of the pericardium, chest pain, fast heart rate Pt had shot on 6/10/21 , pt developed chest pain/lung pain on 6/28 and also tachycardia rate into th... Read more
Pt had shot on 6/10/21 , pt developed chest pain/lung pain on 6/28 and also tachycardia rate into the 120s at times, pt's chest pain/lung pain improved with sitting upright and bending forward. Pt came to primary care office on 6/29 and had evaluation by chest x-ray, and ekg done in office. pts symptoms and ekg were confirmatory for pericarditis.
52 2021-06-30 fast heart rate, hypotension 24 hours: Chills and mild tachycardia (HR 111) 48 hours: Continued mild tachycardia (HR 105-117), ... Read more
24 hours: Chills and mild tachycardia (HR 111) 48 hours: Continued mild tachycardia (HR 105-117), tmax 100.2,chilles, headache and bodyaches 72 hours: tmax 102.4, tachycardic (HR 141), hypotensive (low SBP 73), sepsis trigger from MEWS 7 at 0545 on 6/21, procalcitonin increased to 111.66 ng/mL right upper quadrant pain. Blood cultures drawn. 96 hours: ongoing hypotension, lactic acid increased to 4.0. Admit to hospital for pressor support. Suspected cholecystitis w/drain placement. Blood cultures drawn at 72 hours showing GNR. Eventually confirmed as Klebsiella oxytoca
52 2021-06-30 blood clot 3 days after vaccine pt woke up to swollen arm . Blood clot had developed in left arm.
52 2021-07-01 increased heart rate Patient complained of body aches starting after receiving his vaccine on that day. Throughout the we... Read more
Patient complained of body aches starting after receiving his vaccine on that day. Throughout the weak worsening joint and body pain and after 5 days began form oral lesions. He eventually presented to the ED on 6/11/21 HPI taken from ED Documentation: 52 yo male with no chronic medical problems presents to ED with complaints of body aches, weakness, and mouth sores. Also presents with fever (101.7) Denies any shortness of breath, chest pain, abdominal pain, nausea or vomiting.
52 2021-07-05 loss of consciousness Sever Symptoms of Sinus infection, resulting in sore throat, sinus drainage, dizziness, loss of apat... Read more
Sever Symptoms of Sinus infection, resulting in sore throat, sinus drainage, dizziness, loss of apatite. symptoms are preistent and ongoing.
52 2021-07-06 chest pain I had positive COVID infection 12/13/2019 and was in the ICU and hospitalized multiple times. I had... Read more
I had positive COVID infection 12/13/2019 and was in the ICU and hospitalized multiple times. I had no adverse events or symptoms with the 1st dose (lot ER732 IM RA). The 2nd vaccine 5/24/2021 (lot EW0187 IMLA), the next day my arm was sore. I felt extremely tired all day. The 2nd day, I had extreme fatigue and could not go to work. My arm was still sore and I had flu like symptoms. These symptoms lasted for 5 days. I started to feel better for a couple days and go to bed and wake up still completely exhausted. I just wanted to sleep all the time. Since the 2nd vaccine, I have lost sense of smell and appetite and don't have the energy to do anything else. I have lost a total 25 pounds since getting the vaccine. My initial weight was 175 lb, my weight now is 149 lbs. My other symptoms include: difficulty regulating my body temperature, cold sensitivity, muscle pains in my hands, shoulders, chest and top of legs thighs. "I feel like my body is eating myself away." I also have confusion, depression, difficulty focusing and brain fog.
52 2021-07-06 deep vein blood clot acute DVT on right and noted to have chronic DVT on left on 5/25/21
52 2021-07-06 hypertension, chest pain, heart rate increased On night of April 25th I went to ER with a sudden and intense chest pain that brought on high heart ... Read more
On night of April 25th I went to ER with a sudden and intense chest pain that brought on high heart rate, high blood pressure, head ache, dizziness, sweating and nausea. I was admitted into ER and tested for a heart attach which I did not have. I was released from ER in the early morning hours. Since my first dose, I have had persistent brain fog (fuzzy thinking), trouble concentrating, and strange bouts of fatigue. The second dose was a hard recovery with extreme fatigue lasting over 4 days but the strange bouts of fatigue are random and not just after the second dose.
52 2021-07-07 chest pain, troponin increased, chest discomfort Reports hot/cold shivering started 6/25 then started with nausea, vomiting & Diarrhea. Chest pain/pr... Read more
Reports hot/cold shivering started 6/25 then started with nausea, vomiting & Diarrhea. Chest pain/pressure started 6/29 and went to hospital. MD reports increasing Troponin so admitted to hospital for ECHO & Cardiac Cath. Discharged on 6/30. Still reports Fatigue
52 2021-07-07 chest pain I have severe pain in my leg muscles and bi-ceps in both arms, I'm extremely lethargic at all time... Read more
I have severe pain in my leg muscles and bi-ceps in both arms, I'm extremely lethargic at all times of day. I also have burning sensation in my leg calf nerves and forearms. I have also slight pain in my chest. I also have finger cramping when I wake up in the morning. slight lost in memory.
52 2021-07-07 hypertension That night I got night threats, no fever. The next day I started coughing, wheezing, short of breath... Read more
That night I got night threats, no fever. The next day I started coughing, wheezing, short of breath. The next day I saw my Dr., she listened to my chest, and checked my blood pressure and it was 160/100. I have never had high blood pressure before. She prescribed losartan potassium 60 mg tablet. I take 1 every morning now. And cough medication: benzonatate 200 mg tablets 1 every 8 hour now. The cough and the blood pressure is still ongoing. There is no pneumonia. I had a Bilateral hip replacement, total hip replacement on both legs, it has become very sensitive and painful after the vaccine. I take the 4 Advils for the pain in my hips. The doctor is trying to determine if I'm a long-hauler of COVID related. I have never had Covid-19 virus, not to my knowledge.
52 2021-07-12 fast heart rate, cardiac arrhythmia pac,pvc, SVT, shortness of breath may 23 2021
52 2021-07-13 blood pressure increased Patient received vaccine and seat to wait for 15 minutes, then started feeling dizzy and sweating. T... Read more
Patient received vaccine and seat to wait for 15 minutes, then started feeling dizzy and sweating. Took patient's blood pressure and was slightly elevated, revised blood pressure and after third reading BP was lower and patient started feeling better.
52 2021-07-15 chest pain Patient reported deceased to public health today. Date of death: 7/15/2021. Sister of patient repo... Read more
Patient reported deceased to public health today. Date of death: 7/15/2021. Sister of patient reports that case reported chest pain while at home walking on his treadmill, he then had to lie down and sister asked him if he was having pain and wanted ambulance called. Reports that patient declined 911 call. Sister then reports that patient had what looked like a seizure, but then went completely unresponsive, so she initiated CPR and called 911. Reports that CPR and 911 response was not successful and patient passed away.
52 2021-07-17 chest pain Started developing breathlessness/Breathlessness while sleeping, running and biking (active athelete... Read more
Started developing breathlessness/Breathlessness while sleeping, running and biking (active athelete).; chest pain; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 01Apr2021 at 15:00 PM, at patient age of 52-year-old, as single dose (Lot number EW0150) for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient's medical history was none. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medications within 2 weeks of vaccination. The patient started developing breathlessness, chest pain around 10Apr2021 (10 days after 1st dose). Breathlessness while sleeping, running and biking (active athelete). The patient went to ER on 26Apr2021 unable to breathe. Stress test/EKG, CT Scan of lung, Covid all normal. Breathless still exists during physical activity & sometimes while sleeping. The event onset date was reported as 10Apr2021 at 13:00 PM. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was treated with inhaler for breathlessness. The outcome of the events was not resolved. COVID was not tested post vaccination. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08May2021 at 13:00 PM, at patient age of 52-year-old, as single dose (Lot number EW0173) for COVID-19 immunization.
52 2021-07-17 deep vein blood clot, pulmonary embolism Bilateral pulmonary embolisms; DVT in right leg from groin to behind knee; This is a spontaneous rep... Read more
Bilateral pulmonary embolisms; DVT in right leg from groin to behind knee; This is a spontaneous report from a contactable consumer or other non health care professional (Patient). A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 08:00 (Batch/Lot Number: ER8727) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Right on 18Mar2021 (Batch/Lot Number: ER8729) as DOSE 2, SINGLE for covid-19 immunization at Hospital.. The patient past Medical history included Migraine and treated with topimax. Concomitant medication included topiramate (Topimax) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 09Apr2021, at 19:00, the patient experienced Bilateral pulmonary embolisms and DVT in right leg from groin to behind knee. The patient visited Doctor or other healthcare professional office/clinic visit and went to emergency room and Hospitalized for 5 days. The patient underwent lab tests which included: On 31Mar2021 sars-cov-2 test Result: Negative (Nasal Swab mako PCR). On 17Apr2021 Nasal Swab: Result: Negative and on 30Apr2021 Nasal Swab: Result: Negative. The patient treated with Heparin IV, Díaz CT, ultrasounds, echo, endo and colo. The event outcome was recovering.
52 2021-07-19 chest pain Vaccinated 7/16, 7/17 developed mild chest pain, fever and body aches. 7/19 developed dizziness in a... Read more
Vaccinated 7/16, 7/17 developed mild chest pain, fever and body aches. 7/19 developed dizziness in addition to previously reported symptoms. 7/20 developed right leg numbness and reported symptoms to this clinic. Was escorted to ED
52 2021-07-19 blood clot, deep vein blood clot Developed noticeable DVT in the right leg with left leg also having a clot.; Developed noticeable DV... Read more
Developed noticeable DVT in the right leg with left leg also having a clot.; Developed noticeable DVT in the right leg with left leg also having a clot.; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 52-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0168, Expiration Date: Aug2021) via an unspecified route of administration, administered in left arm on 03May2021 (age at vaccination was 52 years) as dose 2, single for COVID-19 immunization. The patient did not have any relevant medical history and concurrent conditions. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EP7533, Expiration Date: Jul2021) via an unspecified route of administration, administered in left arm on 05Apr2021 at 16:00 pm (age at vaccination was 52 years) as dose 1, single for COVID-19 immunization. The patient previously took Sulfa drugs and experienced known allergies to it. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17May2021, the patient developed noticeable DVT in the right leg with left leg also having a clot. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment with blood thinners for the adverse events. The device date was reported as 06Jul2021. The events were reported as serious (disabling/Incapacitating). The outcome of the events at the time of last observation was not resolved. Follow-up actions are completed. Further information has been requested.
52 2021-07-20 heart attack Patient presented to the ED on 6/2/2021 for covid-19 infection. On 6/9/2021 patient presented to the... Read more
Patient presented to the ED on 6/2/2021 for covid-19 infection. On 6/9/2021 patient presented to the ED and was subsequently hospitalized for pneumonia due to covid-19 virus. On 6/16/2021 patient presented to the ED with STEMI and was subsequently hospitalized. These visits are within 6 weeks of receiving first dose of covid vaccination.
52 2021-07-21 deep vein blood clot DVT
52 2021-07-27 cerebrovascular accident Had 4 strokes/My girlfriend took me to the hospital to find out I suffered 4 strokes. 2 were 2 weeks... Read more
Had 4 strokes/My girlfriend took me to the hospital to find out I suffered 4 strokes. 2 were 2 weeks old.; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; Didn't feel well for 2 weeks; the next day didn't know anything, couldn't speak, shaking, weakness; the next day didn't know anything, couldn't speak, shaking, weakness; the next day didn't know anything, couldn't speak, shaking, weakness.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received bnt162b2 (Pfizer, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in arm left on 01May2021 as dose 1, single for covid-19 immunization. Other medical history was none before the covid shot, was healthy and now he lost his business and no income. Not known allergies. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. The patient experienced had 4 strokes/my girlfriend took me to the hospital to find out i suffered 4 strokes. 2 were 2 weeks old, few hours after 1st shot severe headache and vomiting/didn't feel well for 2 weeks till i got the severe vomiting and headache again, didn't feel well for 2 weeks, the next day didn't know anything, couldn't speak, shaking, weakness all on 01May2021. The events were serious per hospitalization, disability. The patient was hospitalized for these events. Had 4 strokes, few hours after 1st shot severe headache and vomiting. Didn't think too much about it since they said 50 + men don't get reactions. Didn't feel well for 2 weeks till he got the severe vomiting and headache again, and the next day didn't know anything, couldn't speak, shaking, weakness. His girlfriend took him to the hospital to find out he suffered 4 strokes. 2 were 2 weeks old. Backing it up till 01May2021 when he has the first covid shot. Therapeutic measures were taken as a result of events (Treatment for strokes). The adverse event result in doctor or other healthcare professional office/clinic visit and a visit to Emergency room/department or urgent care. Duration of Hospitalization was 5 days. Hospitalization was not Prolonged. Facility where the most recent COVID-19 vaccine was administered was hospital. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was resolved with sequelae.
52 2021-07-27 hypertension, heart rate increased Back in June I noticed I wasn't feeling well in the morning when I woke up, I was hot. General not f... Read more
Back in June I noticed I wasn't feeling well in the morning when I woke up, I was hot. General not feeling well. My blood pressure was really high 179/about 100 and pulse rate was about 110. I let it go on for a couple of days to make sure it wasn't something> I went to see my Cardiologist and he started me on blood pressure medications. It's gone down. But I've had blood pressure issues before so it's kind of out of the blue. Blood pressure seems to be controlled now.
52 2021-07-29 palpitations Dizziness; Brain fog; Tinniutis; Unsure of balance; Disequilibrium almost to the point ofvertigo; He... Read more
Dizziness; Brain fog; Tinniutis; Unsure of balance; Disequilibrium almost to the point ofvertigo; Heart Racing; Bizarre nightmares; Benign hypertensive levels; Anxiety; Chills; Fatigue; Muscle Aches; Some burning in leg muscles; Severe joint inflammation in knees and ankles; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included essential hypertension, benign. The patient has taken unspecified concomitant medications. It was unknown whether the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced severe joint inflammation. On 31Mar2021, the patient experienced dizziness, foggy feeling in head, tinnitus, loss of balance, disequilibrium, heart racing, nightmares, benign hypertensive heart disease, anxiety, chills, fatigue, muscle aches and burning in leg muscles. It was reported that the patient experienced 3 days after vaccination, severe joint inflammation in knees and ankles, like a gout attack starting 7 days after vaccination dizziness, brain fog, tinniutis, unsure of balance, disequilibrium almost to the point of ,vertigo, for example at any time, with eyes closed and head up, my body will rock on his heels noticeably, heart racing, especially at night when trying to sleep or stay asleep, waking up numerous times, bizarre nightmares BP elevated above his essential benign hypertensive levels, anxiety starting 7 days after vaccine, but faded chills, fatigue required 2 days of rest muscle aches, some burning in leg muscles inflammation. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event dizziness, foggy feeling in head, tinnitus, loss of balance, heart racing, nightmares benign hypertensive heart disease and anxiety was not resolved. The clinical outcome of the event chills, fatigue, muscle aches, burning in leg and joint inflammation was recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
53 2021-01-07 blood pressure increased, chest discomfort within 10 minutes of receiving vaccine, patient reported having neck tightness and chest tightness; ... Read more
within 10 minutes of receiving vaccine, patient reported having neck tightness and chest tightness; patient was feeling warm and blood pressure was elevated; diphenhydramine 25mg was given and patient was taken to ER. ER reported it was a mix of a slight reaction and anxiety from receiving the vaccine. Patient was sent home from ER and is doing fine.
53 2021-01-08 blood pressure increased, hypertension Dizziness & HYPERtension Narrative: Employee felt dizy had his b/p went up to 152/89 pulse 55 then ... Read more
Dizziness & HYPERtension Narrative: Employee felt dizy had his b/p went up to 152/89 pulse 55 then 143/83 oxygen sats 97 percent on room aiar at 1218
53 2021-01-08 palpitations Complaint of racing HR, no other symptoms, no SOB. Verbalized feeling nervous/anxious with some visi... Read more
Complaint of racing HR, no other symptoms, no SOB. Verbalized feeling nervous/anxious with some vision changes. PMH: HIV+ and hyperlipidemia. 0735: HR 110, BP 125/80 L arm, RR 17. 0740: HR 98. Did not take am medications, no breakfast or water, only 2 sips of coffee. Gave him water and he stated feeling better at 0800 and left site and stated partner would drive him home. No treatments administered.
53 2021-01-10 fast heart rate severe shortness of breath, tachycardia, fever
53 2021-01-12 platelet count decreased Vaccine was given on 12/23/20 on 01/07.21 went to get a routine physical and received an emergency c... Read more
Vaccine was given on 12/23/20 on 01/07.21 went to get a routine physical and received an emergency call that my pallet blood count was around 10K instead of 150k. Was instructed to go to the ER asap. However didn't received the message until the next morning at 6:30am. Was checked into the E.R. , given sterioids, pallets, hemogolibin. Stayed overnight in the hospital was able to leaved the next day around 1pm with pallets at 47k.
53 2021-01-16 palpitations, atrial fibrillation Atrial fibrillation, onset of palpitations 13-14 hours after vaccination, managed with diltiazem wit... Read more
Atrial fibrillation, onset of palpitations 13-14 hours after vaccination, managed with diltiazem with resolution.
53 2021-01-17 cerebrovascular accident acute loss of vision-stroke like symptoms
53 2021-01-18 nosebleed I have had 5 nose bleeds in the past 2 weeks, the first occurring 8 days after dose 1 of the Pfizer ... Read more
I have had 5 nose bleeds in the past 2 weeks, the first occurring 8 days after dose 1 of the Pfizer COVID vaccine. I hadn?t had a nose bleed prior to that for at least 10 years and I?ve been on the same low dose aspirin dose once daily for several years. No petechiae, bruising or other bleeding.
53 2021-01-24 platelet count decreased, low platelet count Onset of hemmoragic oral bullae after eating very hot cheese toast 1-20-2021 Widely scattered pete... Read more
Onset of hemmoragic oral bullae after eating very hot cheese toast 1-20-2021 Widely scattered petechiae lower and upper extremeties 1-21-2021 Extensive petechaie lower extremities and a few on trunk face 1-22-2021 CBC in ER showed severe thrombocytomenia with platelets less than 2000 1-22-2021 Admitteed and treated with Decadron 40 mg IV, and IVIG infusions once daily Jan. 23rd and 24th 2021 Hepatiitis pannel negative EBV negative, COVID Nasopharengeal negative, splenic U/S upper limit of normal but unchanged on comparison with old imaging. With treatment platlets increased to 65,000, Discharged from hospital. IVIG discontinued Oral decadron 40mg will continue for 2 days with CBC hematology f/u in 36 hours
53 2021-01-31 nosebleed had 5 nosebleeds in the past 2 weeks; This is a spontaneous report from a contactable physician (pat... Read more
had 5 nosebleeds in the past 2 weeks; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140 and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Dec2020 10:00 at a single dose for COVID-19 immunization. Medical history included asthma and hypertension. Concomitant medication included acetylsalicylic acid (ASPIRIN), atorvastatin, benazepril hydrochloride, hydrochlorothiazide (LOTENSIN HCT), and verapamil. The patient previously took cefuroxime axetil (CEFTIN) and experienced allergy. Patient had 5 nosebleeds in the past 2 weeks on 29Dec2020 12:00, after not having a single one for 10+ years. Nasal saline and Afrin was given as treatment for the event. Outcome of the event was not recovered.
53 2021-02-02 pallor, fainting, loss of consciousness Pt. had syncopal episode as dose was being administered, became diaphoretic, pale and lost consciou... Read more
Pt. had syncopal episode as dose was being administered, became diaphoretic, pale and lost conscious. transferred to triage area where patient was monitored. Pt. symptoms resolved but then became nauseated. Every time patient sat up he became nauseated and would have a bout of emesis. 1900 patient continues to feel nauseated when sitting up but family here to pick patient up and patient escorted out to wife's car with Dr. approval
53 2021-02-02 fainting, loss of consciousness Syncope/a complete syncopal episode while standing. Then a 2nd one on return; unconscious approxima... Read more
Syncope/a complete syncopal episode while standing. Then a 2nd one on return; unconscious approximately 30 seconds each time; chills; fatigue; muscle aches; joint aches; headaches; extreme dizziness and nausea; extreme dizziness and nausea; injure a knee when my legs pretzeled on the 2nd syncopal episode.; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 53-year-old male patient received second dose of BNT162B2 (COVID-19 Pfizer/Biontech, Lot#: EL3248), via an unspecified route of administration on 13Jan2021 11:00 AM on Left arm at single dose for COVID-19 immunisation. Medical history included Controlled hypertension and known allergies: Hypersensitive to narcotics. Concomitant medications included Amlodipine, Irbesartan and Atoravastin. The patient previously took first dose of BNT162B2 (COVID-19 Pfizer/Biontech, Lot#: EK9231), via an unspecified route of administration on 23Dec2020 11:00 AM on Left arm at single dose for COVID-19 immunisation. Facility type Vaccine was Hospital. No Other vaccine in four weeks. The patient experienced Syncope. He had the most common severe reactions (chillls, fatigue, muscle aches, joint aches, headaches). But when he walked to bathroom, he had extreme dizziness and nausea, then a complete syncopal episode while standing. Then a 2nd one on return. His wife said he was unconscious approximately 30 seconds each time. EMS was called but refused transport since ERs full. The patient did also injure a knee when his legs pretzeled on the 2nd syncopal episode. The events started from 16Jan2021 01:30 AM. The outcome of th events was recovered. No treatment received. No Covid prior vaccination. No covid tested post vaccination.
53 2021-02-03 blood glucose increased blood sugar has been out of control ranging from 250-300; This is a spontaneous report from a contac... Read more
blood sugar has been out of control ranging from 250-300; This is a spontaneous report from a contactable consumer. A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration, on the right arm, on 14Jan2021 at a single dose for Covid-19 immunization. Medical history included type 2 diabetes mellitus from Sep2019 and ongoing. There were no concomitant medications. On 14Jan2021, it was reported that 8-10 hours after getting the vaccine, his blood sugar was out of control ranging from 250-300. On 15Jan2021, he has taken his blood sugar twice at the time of report. He took it when he woke and it was 207. Two hours after eating a light breakfast it was 242. The outcome of the event was not recovered. Information about lot/batch number has been requested.
53 2021-02-04 blood clot, fibrin d dimer increased Headache the next morning after receiving vaccine that hasn?t gone away, fluid in left lung, blood c... Read more
Headache the next morning after receiving vaccine that hasn?t gone away, fluid in left lung, blood clots in right lung and leg.
53 2021-02-12 blood pressure increased elevated BP, headache
53 2021-02-20 pallor Systemic: mentioned a fear of needles after talking with the patient-Mild, Additional Details: 2/20/... Read more
Systemic: mentioned a fear of needles after talking with the patient-Mild, Additional Details: 2/20/21 app 11:45am received his second COVID vaccination. He was seated for 20 minutes after his shot. He described himself as feeling nauseous, sweaty, and \"pale\". He went out for 20 seconds, when his coworker called his name. He quickly responded. He was then walked to the RN office of the facility. She took vitals BP 148/82, 58 heart rate, 99% pulse ox. He started back\r\nto work. At 3 pm I checked in and he responded he was feeling fine.
53 2021-02-21 blood pressure increased, chest pain Patient was hospitalized with chest pain and elevated BP. Patient's blood pressure medication regime... Read more
Patient was hospitalized with chest pain and elevated BP. Patient's blood pressure medication regimen was optimized and patient was discharged
53 2021-02-24 blood clot Within a week after receiving the first round of vaccine I have developed two blood clots in my left... Read more
Within a week after receiving the first round of vaccine I have developed two blood clots in my left leg.; This is a spontaneous report from a contactable consumer (patient) A 53-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) on 21Jan2021 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. The patient didn't have medical history or concomitant medications. On an unspecified date in Jan2021 within a week after receiving vaccine patient developed two blood clots in his left leg. As treatment patient was currently on blood thinners. At the time of the reporting event outcome was unknown.
53 2021-02-26 palpitations Heart palpitation, once to three times a day. I have yet to see a doctor since I am currently workin... Read more
Heart palpitation, once to three times a day. I have yet to see a doctor since I am currently working in another city. I am planning to see my doctor back in Oxford during the spring break, March 15.
53 2021-03-02 heart rate increased, atrial fibrillation, heart rate irregular, palpitations Following vaccination, patient felt achy and mildly feverish. During the night, he got up to use the... Read more
Following vaccination, patient felt achy and mildly feverish. During the night, he got up to use the restroom and felt palpitations and lightheadedness, which persisted during the morning. A colleague at work evaluated the patient's pulse, noting it to be irregular and fast, so patient went to the ED for evaluation. EKG was performed and patient was found to be in new onset atrial fibrillation. Patient was given fluid boluses, 10mg IV diltiazem, and a diltiazem infusion, during which the patient converted to normal sinus rhythm. After stabilization, he was discharged with new prescriptions for metoprolol tartrate 25mg BID and apixaban 5mg BID, to follow up with cardiology.
53 2021-03-03 loss of consciousness On February 15, 2021, had fever and MASSIVE HEADACHE. Got worse each day. Went to ER on 2/19/21, was... Read more
On February 15, 2021, had fever and MASSIVE HEADACHE. Got worse each day. Went to ER on 2/19/21, was treated and release. Found unconscious in home on 2/20/21. Was hospitalized on 2/20/2021. Was diagnosed with varicella meningitis on 2/22/2021. Hosptalized till 2/25/2021. Still not well
53 2021-03-05 blood pressure decreased Acute rash , hives, pruritic ~ 3 hrs later. Has history of progression to SOB/throat swelling and ... Read more
Acute rash , hives, pruritic ~ 3 hrs later. Has history of progression to SOB/throat swelling and ER care, so we gave Epipen Autoinjector and Benadryl 50 mg IM x1. Vital signs stabilized after a BP drop. He clinically remained stable with improvement in itch/rash/hives.
53 2021-03-05 chest discomfort I ate nothing that morning of the shot. The first day: I took the covid-19 vaccine Pfizer shot on T... Read more
I ate nothing that morning of the shot. The first day: I took the covid-19 vaccine Pfizer shot on Thursday the 4th of March; there was pain at the injection site just as any other vaccine I have been administered during military service. After the shot I felt tied, and my left arm did hurt from the shot, I started to feel irritable (angry or even aggressive), my chest became tight and my heart rhyme felt somewhat off causing me to start coughing and sometimes uncontrollable to the point I could not catch my breath I thought about seeking medical attention but did not.. The second day: Pain in my left arm went away at the injection site, tiredness went away, and the feeling of irritable (angry or even aggressiveness) went away, tightness in my chest and coughing went away. I have been having a chronic pain in my left arm for about a year and after the shot the pain was gone I noticed that on the second day. I did notice my body temperature was up and down showing symptoms of histamine reaction but not out of control.
53 2021-03-06 fainting Diaphoretic, syncope for approximately 2 minutes, panic attack, rapid breathing. Transported to near... Read more
Diaphoretic, syncope for approximately 2 minutes, panic attack, rapid breathing. Transported to nearest ER by EMS.
53 2021-03-10 palpitations Patient complained of "heart racing" after receiving vaccine. HR 131, BP 164/94. Transported to emer... Read more
Patient complained of "heart racing" after receiving vaccine. HR 131, BP 164/94. Transported to emergency room for evaluation. ER record indicates no cardiac event or arrhythmia. Patient had not been taking prescribed blood pressure medication.
53 2021-03-12 palpitations Started with itching burning rashes neuropathy headaches fatigue and dizziness. Now have mouth sores... Read more
Started with itching burning rashes neuropathy headaches fatigue and dizziness. Now have mouth sores that won?t heal and debilitating malaise fatigue A few days later: Joint pain and air hunger A few days later: Numb extremities Two weeks to date: Body temp regulation issues , heart pounding, face flush. Sleep disturbance entire time. Extreme fatigue.
53 2021-03-13 blood pressure increased dry throat, dizziness, felt like bp was high. Evaluated by EMS-Refusal to transport.
53 2021-03-14 coughing up blood On the 2nd after the shot I had sinus problems with a sore throat. On the 3rd day and for 4 days aft... Read more
On the 2nd after the shot I had sinus problems with a sore throat. On the 3rd day and for 4 days after the violent un-controlled coughing . Coughing up blood and fluid, not food.
53 2021-03-16 chest pain, pallor Arm pain began evening of vaccine. About 48 hours after vaccine patient felt light headed and dizzy... Read more
Arm pain began evening of vaccine. About 48 hours after vaccine patient felt light headed and dizzy. He drank water and sat down. Then felt like he needed to lay down. About 1/2 hour later his heart rate was up and oxygen levels low. His blood pressure was also high. He was pale and pasty looking. No fever. This lasted about 1/2 hour but he still didn?t feel right. He felt fine about 2 hrs after the incident. Then he experienced chest pain In the middle of the night .
53 2021-03-16 heart rate increased, hypotension Extremely High Pulse Rate & Low Blood Pressure
53 2021-03-17 fainting Per patient report, 30 minutes after vaccine administration patient began feeling nauseated and dizz... Read more
Per patient report, 30 minutes after vaccine administration patient began feeling nauseated and dizzy. Patient called wife while driving home on the highway to tell her of the symptoms. Patient had a syncopal event which resulted in a car wreck. I followed up with the patient's wife by phone, she reported he had a split lip and was still nauseated. Patient sent home by EMS.
53 2021-03-19 blood pressure decreased Felt weird 5 minutes after shot. 10 minutes after shot I called over a tech and said I didn't feel ... Read more
Felt weird 5 minutes after shot. 10 minutes after shot I called over a tech and said I didn't feel right. The took my vitals and found the my blood pressure had dropped to 85/45. They called 911 and hit me with an EpiPen. I never blacked out. After another 10 minutes the fire department arrived and they took vital signs; all normal. Another 10 minutes and ambulance arrived. Vitals in the back of the ambulance were fine. Got to the emergency room and vitals were fine including ekg. Was released from the hospital about 4.5 hours after the initial shot. I feel a little sluggish today but otherwise fine.
53 2021-03-19 hypotension patient had dizziness,nausea, and low blood pressure after injection. took about 5 min.s to occur. p... Read more
patient had dizziness,nausea, and low blood pressure after injection. took about 5 min.s to occur. pharmacists at clinic monitored blood pressure and breathing. gave pt water and called ems. pt stated he felt like he may pass out. ems monitored pt and took pt to hospital pt call store aprox. 4 hrs letter. pt stated he was released from hospital and was ok. wanted us to know that he was ok
53 2021-03-19 ischaemic stroke I am 53, very healthy and had a small ischemic stroke 4 days later.
53 2021-03-21 blood glucose increased Patient feels hot, dizzy, lethargic
53 2021-03-21 heart rate decreased ?Pfizer-BioNTech COVID-19 Vaccine EUA? I noticed significantly lowered heartrate following the vacc... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA? I noticed significantly lowered heartrate following the vaccine administration. My average resting rate is 79 bpm, but on the 2nd night following the shot, my heart rate fell into the 30's for several days (shot on March 1, sleeping heart rate substantially drops at night March 3-7).
53 2021-03-23 fast heart rate The evening of the vaccine I had minor tongue swelling. The next night after eating Tuna I had the ... Read more
The evening of the vaccine I had minor tongue swelling. The next night after eating Tuna I had the tongue swelling again with some Tachycardia and a severe headache with red welts all over my body. I also had tightness in my throat. I went to the Urgent Care where they gave me Antihistamine, Prednisone, something for headache and IV Fluids. I was discharged after three hours and felt better within a few hours. I took Prednisone for five days.
53 2021-03-30 nosebleed Excessive nose bleeding, without explanation/reason.
53 2021-03-30 hypotension, hypertension 3/26/2021 @ 0930 hrs, covid 19 dose 1 Pfizer received. 3/26/2021 @ 1430 hrs; sweats, chills, body a... Read more
3/26/2021 @ 0930 hrs, covid 19 dose 1 Pfizer received. 3/26/2021 @ 1430 hrs; sweats, chills, body aches, fatigue, dizziness, nausea, possible siezure or stroke while driving on I-10; weight loss, loss of appetite, hypertension/hypotension, 3/27/2021 - sweats, chills, body aches, fatigue, dizziness, nausea, weight loss, loss of appetite, hypertension/hypotension 3/28/2021 - sweats, chills, body aches, fatigue, dizziness, nausea, weight loss, loss of appetite, hypertension/hypotension 3/29/2021 - sweats, chills, body aches, fatigue, dizziness, 3/30/2021 - chills, body aches, fatigue 3/31/2021 - body aches, fatigued, dizziness
53 2021-03-30 loss of consciousness dizziness, sweat passed out, seizures
53 2021-04-04 chest discomfort Pfizer COVID-19 Vaccine EUA Approximately 5-10 minutes post vaccination patient experienced chest t... Read more
Pfizer COVID-19 Vaccine EUA Approximately 5-10 minutes post vaccination patient experienced chest tightness, shortness of breath, and tongue swelling. Initially treated with epinephrine by EMS with some resolution, but symptoms returned. Patient transferred to emergency department and treated with epinephrine 0.3 mg, famotidine 20 mg, diphenhydramine 25 mg, and methylprednisonole 125 mg. Observed patient for over 2 hours, symptoms resolved with treatment, and discharged home.
53 2021-04-04 pallor, hypotension a few minutes after receiving the vaccine, the patient became flush and lightheaded. He was lowered... Read more
a few minutes after receiving the vaccine, the patient became flush and lightheaded. He was lowered to the floor where he never went unconscience, but did get very pale and sweaty. His blood pressure was low at 99/60. He reported he had not eaten. He was given glucose tabs and after 15 minutes began to feel better. he drank water and was observed for 30 minutes. He did not report this had happened previously, but did say he did not like needles or blood.
53 2021-04-04 inflammation of the pericardium Pt developed acute pericarditis 6 days after receiving COVID 19 vaccination.
53 2021-04-06 heart attack He has a bad /slow heart, he had a heart attach after 1st dose. He doesn't feel it's related to the ... Read more
He has a bad /slow heart, he had a heart attach after 1st dose. He doesn't feel it's related to the vaccine. It was the heart attack was why he missed his 4 week window. He called the Dept. of Health and they said he needed to start the series over. I explained the series is now complete.
53 2021-04-06 palpitations On April 6th, after 30 hours of receiving the first dose of the vaccine. Approximately at 5:00PM , t... Read more
On April 6th, after 30 hours of receiving the first dose of the vaccine. Approximately at 5:00PM , there was a little bit of heart racing, shortness of breath and dizziness. It lasted only 3 minutes or so. It didn't need any medical attention. The anxiety continued till 7:00PM. With this event, do I still have to obtain the second dose after 21 days?
53 2021-04-07 low platelet count, blood clot in the brain Thrombocytopenia; Blood clots in brain; This is a spontaneous report from a contactable consumer (pa... Read more
Thrombocytopenia; Blood clots in brain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 13:00 (Batch/Lot Number: EN6206) as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Mar2021, patient developed thrombocytopenia and was brought to emergency room/department or urgent care leading to admission, surgery was performed (mechanical thrombectomy) on 30Mar2021 at 10am to address blood clots in the brain. Patient was currently in ICU until he fully recovered. Patient was hospitalized in Mar2021 for 2 days. The events were reported as life-threatening and have caused disability. Outcome of the events was unknown. Information on lot/batch number has been available. Additional information has been requested.
53 2021-04-08 heart rate increased Patient experienced extreme increase of heart rate. Doctor verbally advised patient to take his carv... Read more
Patient experienced extreme increase of heart rate. Doctor verbally advised patient to take his carvedilol which he did. He felt better after 3 doses and about 3 hours later. He was not seen by a doctor for this.
53 2021-04-12 deep vein blood clot, pulmonary embolism 4/1/2021: SEVERE LEG PAIN, PRESENTED TO HOSPITAL ER AND WAS FOUND TO HAVE ACUTE DEEP VENOUS THROMBOS... Read more
4/1/2021: SEVERE LEG PAIN, PRESENTED TO HOSPITAL ER AND WAS FOUND TO HAVE ACUTE DEEP VENOUS THROMBOSIS LEFT LOWER EXTREMITY. 4/4/2021: SEVERE SHORTNESS OF BREATH, SQUEAD WAS CALLED AND HE WAS TAKEN TO HOSPITAL ER WHERE HE WAS FOUND TO HAVE BILATERAL PULMONARY EMBOLISM
53 2021-04-12 heart rate increased Shaking Chills Body Ache Rapid Heartbeat, my normal is 56-61, during reaction it was 81-88 checked ... Read more
Shaking Chills Body Ache Rapid Heartbeat, my normal is 56-61, during reaction it was 81-88 checked every hour Fever 99-100.1 Treatment: Fluids, Acetaminophen, Rest
53 2021-04-13 heart rate decreased, blood pressure fluctuation Beginning one day after receiving my second dose of the Pfizer vaccine for Covid-19 I began to have,... Read more
Beginning one day after receiving my second dose of the Pfizer vaccine for Covid-19 I began to have, what I perceived as adverse events different from what is listed as common side effects. 1. Slower heartbeat then what I normally run. 2. Slower breathing and respiratory response 3. Very low energy 4. Loss of appetite 5. Abnormally wide fluctuation of blood pressure while not exerting myself. For example, higher blood pressure readings (155/95) with a slower pulse (60). 6. Difficulty relaxing and sleeping
53 2021-04-13 palpitations Intermittent heart palpitations - no treatment - for three or four days; no pattern to it.
53 2021-04-13 palpitations Intermittent heart palpitations - for three or four days; no pattern to it. This time they gave me ... Read more
Intermittent heart palpitations - for three or four days; no pattern to it. This time they gave me a heart monitor and they monitored for three weeks and they found they were benign. There was no treatment.
53 2021-04-14 deep vein blood clot Received the first shot of Pfizer Covid Vaccine at 10:00 AM on 3/21/21. Aside from some drowsiness ... Read more
Received the first shot of Pfizer Covid Vaccine at 10:00 AM on 3/21/21. Aside from some drowsiness I felt fine the entire day. Then that night I woke up at 2:30 AM with severe pain in my right knee. I was unable to bend the knee or walk for the next 36 hours. After that the pain transitioned to the back of my calf muscle for the next few days. The pain then went back to my knee for a day and then returned to the back of my calf muscle. On 3/30/21 I saw my primary care physician who then sent me to get an ultrasound which determined that the pain in my knee and calf were caused by blood clots (DVT). I was then prescribed Eliquis 5 mg blood thinners.
53 2021-04-15 body temperature decreased Left Arm Pain Approx 5 hrs post vaccination lasting 48 hrs. Headache, shoulder, neck and back muscle... Read more
Left Arm Pain Approx 5 hrs post vaccination lasting 48 hrs. Headache, shoulder, neck and back muscle aches developing overnight. Fatigue next day (approx 18 through 36 hrs post vaccination), ongoing muscle aches, low body temperature accompanied with chills (96.7-97.7°F) 30-36 hrs post vaccination.
53 2021-04-15 fluid around the heart, inflammation of the pericardium, chest pain Patient received 1st COVID vaccine on 3/17. On 3/24, he experience pleuritic chest pain and was admi... Read more
Patient received 1st COVID vaccine on 3/17. On 3/24, he experience pleuritic chest pain and was admitted to the hospital for pericarditis confirmed by EKG. During this hospitalization, he was incidentally found to have left main stenosis 60-70% on the LHC, requiring PCI. Patient did not have an acute MI - hence Dressler Syndrome was thought to be less likely. He was discharged after a week on 3/30/21 with colchicine and other cardioprotective medications. He received his 2nd vaccine on 4/7/21. On 4/14/21, patient was readmitted for pleuritic chest pain attributed to recurrent pericarditis.
53 2021-04-20 blood clot in the brain, cerebral haemorrhage, cerebrovascular accident stroke; Brain bleed; Brain blood clot; This is a spontaneous report from a contactable consumer via ... Read more
stroke; Brain bleed; Brain blood clot; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program named Corporate (Pfizer) Social Media Platforms. A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 13:15 as single dose for covid-19 immunisation. Medical history reported as none. The patient's concomitant medications were not reported. The patient experienced brain blood clot on 25Mar2021 08:00 , stroke and brain bleed on an unspecified date. The patient was hospitalized for brain blood clot, stroke, brain bleed for 7 days. Therapeutic measures were taken as a result of brain blood clot, stroke, brain bleed included Ventillator. The patient died on 02Apr2021. An autopsy was not performed. The outcome of events was fatal. No other vaccine in four weeks; No covid prior vaccination. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Brain blood clot; stroke; Brain bleed
53 2021-04-20 coughing up blood Recent admit for upper GI bleed and pneumonia (3/27/2021 to 4/7/2021), was receiving IV antibiotics,... Read more
Recent admit for upper GI bleed and pneumonia (3/27/2021 to 4/7/2021), was receiving IV antibiotics, seen in the EC 4/15/2021 for cough and not admitted to the hospital, returned to EC 4/19/2021 for cough, now with some tinge and dark blood (streak), discharged home
53 2021-04-21 heart rate increased A week later I am driving on the highway and I started to feel shortness of breath, within 2-3 minu... Read more
A week later I am driving on the highway and I started to feel shortness of breath, within 2-3 minutes I got out via an exit and park at a gas station, I palpated my chest and felt a weak but rapid heart beat. I ingested the carvedilol 6.25mg, I felt dizzy but walked in the gas station to got a granola bar and chocolate milk drink went back to the car. Twenty five minutes after taking the first carvedilol, I felt no changes in heart rate & shortness of breath and took an additional 6.25mg of carvedilol. I then called my wife and talk to her (and my children) about what was happening and where I was. I asked to call 911 if I loose consciousness. At about fity five-Sixty minutes went by and symptoms were unchanged and I took third dose of 6.25 mg of cavedilol. At approximately 75-80 minutes after onset of symptoms my hear rate went down and shortness of breath improved to normal. I contacted my doctor the next day
53 2021-04-21 loss of consciousness, heart rate decreased He felt nauseous, got up to go to kitchen sink and passed out for a few seconds. When I got to him,... Read more
He felt nauseous, got up to go to kitchen sink and passed out for a few seconds. When I got to him, he was on the ground, eyes open, but seriously disoriented. He got up to the couch. He was very, very clammy and his heart rate was 44 bpm. I held three fingers for him to identify, he correctly answered. He has a small gash on his forehead. His heart rate came up to 70, 20 minutes after episode. Refused to go to urgent care.
53 2021-04-22 blood clot One week after injection woke up with a blood clot in left calf. No history of clots. No injury or... Read more
One week after injection woke up with a blood clot in left calf. No history of clots. No injury or muscle strain, etc. Just happened out of no where.
53 2021-04-24 blood clot, loss of consciousness Blood clots in right leg below knee; he passed out from pain; pain in his right knee; he couldn't be... Read more
Blood clots in right leg below knee; he passed out from pain; pain in his right knee; he couldn't bend his knee at all; knee was swollen; couldn't walk/limping around; his knee more stiff; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6206), via an unspecified route of administration, administered in the right arm on 21Mar2021 at 10:00 as a single dose for COVID-19 immunization. Medical history included ongoing Factor V Leiden heterozygous, allergies to mushrooms from an unknown date and unknown if ongoing and a torn meniscus in his right knee and he had surgery 3 to 4 years ago. The patient's concomitant medications were not reported. The patient previously took Cephalexin and Percocet and experienced allergies. The patient did not have COVID prior to vaccination and has not been tested post vaccination. On 22Mar2021 at night around 2:30AM, the patient woke up and started walking to the bathroom and he passed out from pain. He had pain in his right knee. He thought he had torn his knee again. He had surgery 3 or 4 years ago for a torn meniscus in his right knee and he thought he had torn his meniscus again. He passed out, his wife found him and he went back to bed. In the morning, his knee was still very very sore, he couldn't bend his knee at all. He took an Advil between 6:30AM and 8:00AM. He hadn't taken any medications prior to the COVID-19 vaccine. His knee was swollen but the pain was manageable. He couldn't walk, he was on crutches for about 24 hours then the swelling started coming down and he put a brace on his knee. He could then walk without the crutches but it was still painful. The next day he had pain in the back of his knee. He thought the pain was caused because he had put the brace on and had been using the crutches. Like he had made his knee more stiff from not using it. He was limping around and the pain was bearable. At that point, the pain was maybe a 4 on a scale of 1-10 where his pain had been a 9 on a scale of 1-10. He took another Advil and he realized the pain in the back of his knee wasn't going away. He went to see his family doctor and his doctor was able to get him in that same day for an ultrasound. The ultrasound showed 2 blood clots behind his right knee. The patient had blood clots in right leg below knee. The week of the report, he got an appointment with a hematologist. The hematologist reviewed his case and the doctor isn't 100% sure the blood clots were from the Pfizer COVID-19 vaccine but the doctor isn't ruling it out either because it happened within 24 hours of receiving his first COVID-19 dose. He hadn't done anything strenuous before getting the COVID-19 vaccine, nothing that he thinks would have caused the blood clots. He would like to add, what he thinks is relevant, is that he is positive for Factor V. He reports he has one copy and Factor V only impacts about 3% of the population. The hematologist thought that he might be prone to developing blood clots. The hematologist reports that he has had patients who have had the COVID-19 virus who have developed blood clots. Maybe it's possible that the COVID-19 antibodies were trying to build up his immune system to COVID-19 and it created something similar to having the COVID-19 virus. If he is predisposed to blood clots then the COVID-19 vaccine may have precipitated the blood clots. His second COVID-19 vaccine is scheduled for Sunday, 11Apr2021. He had talked to both his family doctor and his hematologist and they both thought he should be ok in getting the second COVID-19 vaccine. He was prescribed blood thinners. If the second COVID-19 vaccine caused more blood clots the blood thinners would help him. He was asking if there is any additional information or guidance on receiving the second COVID-19 vaccine after his reaction. The pharmacist told him that the COVID-19 vaccine trials were all done in the left arm. He received his vaccine in his right arm and his right knee was affected. If he gets the second COVID-19 vaccine he's getting it in his left arm. He was prescribed Eliquis 5mg take one tablet twice daily. The outcome of the event blood clots in right leg below knee was recovering while the outcome of the other events was unknown.
53 2021-04-25 blood pressure increased swelling and pain in the arm, High blood pressue104/148
53 2021-04-27 hypertension Blurred Vision, Acute Cataract, Higher Blood Pressure
53 2021-04-27 fast heart rate 3 days after vaccine, developed tachycardia, intermittent, resting to 130bpm. No Shortness of breath... Read more
3 days after vaccine, developed tachycardia, intermittent, resting to 130bpm. No Shortness of breath or chest pain. No abnormal rhythm. Recurred day 4, 5, 6 in the mornings only. No change in diet or caffeine intake.
53 2021-04-28 blood pressure increased two days after receiving vaccine arm became really swollen. On day 3 pt. had slight headache which c... Read more
two days after receiving vaccine arm became really swollen. On day 3 pt. had slight headache which continued. On 4/25/21, headache became worse and on 4/26/21 pt. checked BP and noticed it was rising. On 4/26/21 pt. was sent home from work. Pt. was taken to Urgent Care that evening where BP was recorded as 205/89. Pt. was given unknown shot and instructed to take Ibuprofen. on 4/27/21 pt. followed up with PCP, who prescribed Hydrochlorothiazide daily and Norco prn for pain. On afternoon of 4/27/21 after taking HCT and BP remained elevated at 190/93. Pt. instructed to go to ER. Per wife upon arrival to hospital BP was 129/90. On the morning of 4/28/21 BP was down slightly to 189/90's
53 2021-04-28 deep vein blood clot Patient develop swelling in right leg. Doppler was preformed and DVT was discovered. Patient was pla... Read more
Patient develop swelling in right leg. Doppler was preformed and DVT was discovered. Patient was placed on Eliquis.
53 2021-04-28 deep vein blood clot DVT left leg 10 days post
53 2021-04-30 fainting, loss of consciousness 1. Felt flu-like symptoms (fatigue, weakness, muscle aches) starting around 8:00pm the day of the va... Read more
1. Felt flu-like symptoms (fatigue, weakness, muscle aches) starting around 8:00pm the day of the vaccination. The next morning, after waking and getting out of bed around 6:50am, continued to feel flu-like symptoms. Began feeling light headed and fainted. Fell on bathroom floor and was unconscious for approximately 1-2 minutes. 2. Two days after vaccination (4/23/21 around 7:00pm), developed rash on both feet. Rash improved by next morning and was gone by the day after (4/25).
53 2021-05-01 fainting 3.30.21 vasovagal syncope, dyspnea during jiujitsu. General fatigue, thought from vaccine. 4.1.21 s... Read more
3.30.21 vasovagal syncope, dyspnea during jiujitsu. General fatigue, thought from vaccine. 4.1.21 same 4.3.21 same 4.6.21 same 4.8.21 same 4.11.21 same but during boxing 4.12.21 same but during jumping rope 4.13.21 second vaccine Pfizer same clinic at 12:00pm ER2613 4.14.21 same but during boxing 4.15.21 same but during, boxing, jumping rope, and rowing 4.18.21 same but during bike ride and walking 4.19.21 same but during coaching 4.20.21 admitted to ED 4.22.21 diagnosed with third degree heart block and dual chamber pacer fitted 4.23.21 DC
53 2021-05-02 loss of consciousness Patient received PFIZER vaccine and was in waiting room. He came up to nurse and stated that he was... Read more
Patient received PFIZER vaccine and was in waiting room. He came up to nurse and stated that he was not feeling well as he was stating this, he began leaning over table, then began to fall to floor but was assisted to floor by nurse. Medical alert called. Patient did not bump his head. Patient loss consciousness for about 3-5 seconds, and then began to open his eyes. Patient was able to answer questions regarding his name, the date, and place. Initial vitals (10:00 AM), BP 102/51, HR 55, O2- 96. 2nd set of vitals (10:03 AM) 120/58, HR 84, O2-99. Patient stable and taken to ED via wheelchair.
53 2021-05-03 heart attack, blood clot 5-6 Blood clots, blood clots were present; heart attack; This is a spontaneous report from a contact... Read more
5-6 Blood clots, blood clots were present; heart attack; This is a spontaneous report from a contactable consumer reporting for himself. A 54-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Mar2021 12:00 on left arm at single dose for COVID-19 immunization. Facility type vaccine was at Pharmacy or Drug Store. Medical history included high blood pressure, high cholesterol. Concomitant medications included atorvastatin (LIPITOR), amlodipine besilate (NORVASC). Historical Vaccine included first dose of BNT162B2 on 08Mar2021 12:00 on left arm for COVID-19 immunization. The patient experienced 5-6 Blood clots, had heart attack and blood clots were present on 14Apr2021 13:00. The events were resulted in Emergency Room Visit, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment was received for the events included Stent. The outcome of the events were resolving. Information on Lot/Batch number has been requested.
53 2021-05-03 fainting Pfizer 1st dose: 3/11/2021(Lot #EN6208). Pfizer 2nd dose: 4/23/2021 (Lot # EW0171). Patient report... Read more
Pfizer 1st dose: 3/11/2021(Lot #EN6208). Pfizer 2nd dose: 4/23/2021 (Lot # EW0171). Patient reported having syncopal episode after the first dose and second dose of COVID vaccine. Patient presented to ED on 4/24/21 and complained about prolonged syncopal episode. Per report, patient developed syncope within hours after receiving 2nd dose. EKG showed no evidence of arrhythmia. ECHO showed an EF of 60-65 %, small LV, chamber that was hyper dynamic and proximal septal thinning and akinesis.
53 2021-05-04 blood pressure fluctuation, heart rate increased, chest discomfort, chest pain, hypertension, heart rate irregular Strong chest pressure; fluctuating heartbeat; slower breathing and respiratory response; slower brea... Read more
Strong chest pressure; fluctuating heartbeat; slower breathing and respiratory response; slower breathing and respiratory response; Extreme fatigue; very low energy; Loss of appetite; loss of weight; Abnormally wide fluctuation of blood pressure while not exerting myself; Difficulty relaxing and sleeping; Nausea; dizziness; Stomach pain; diarrhea; Headaches; low grade fever; shortness of breath; intense , powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of my head at the cerebellum.; intense , powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of my head at the cerebellum.; sudden increased heart rates and high blood pressures reading; spikes his heart rate/sudden increased heart rates; intestinal discomfort/strong stomach discomfort; intense chest pressure and some pain; This is a spontaneous report received from a contactable consumer (the patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0151) via an unspecified route of administration in right arm on 09Apr2021 12:30 at age of 53-year-old at single dose for COVID-19 immunisation. Medical history included high cholesterol, anxiety disorder, known allergies: Clonazepam (KLONOPIN), food allergies: sea bass and orange roughy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication from an unspecified date; lovastatin taken for an unspecified indication from an unspecified date; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified date; ibuprofen taken for an unspecified indication from an unspecified date; fluoxetine hydrochloride (PROZAC) taken for an unspecified indication from an unspecified date. The patient previously took the first dose of BNT162B2 (Pfizer Covid-19 Vaccine, lot number EP7534) via an unspecified route of administration in right arm on 18Mar2021 11:00 AM at age of 53-year-old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was currently 11 days out from receiving his second COVID vaccine and he was still having very strong side effects. This included an emergency room visit on 16Apr2021. He was generally very good health and he exercised regularly including running so these were very abnormal effects for him. Beginning one day after receiving his second dose of the Pfizer vaccine for COVID-19: 1. Strong chest pressure and fluctuating heartbeat. 2. Slower breathing and respiratory response. 3. Extreme fatigue & very low energy (for example, walking up two flights of stairs made him very tired and spikes his heart rate, abnormal for him). 4. Loss of appetite and loss of weight. 5. Abnormally wide fluctuation of blood pressure while not exerting himself. For example, higher blood pressure readings (155/95) with a slower pulse (60) or the opposite scenario, (110/89) elevated pulse 98. 6. Difficulty relaxing and sleeping. 7. Nausea and some dizziness. 8. Stomach pain and diarrhea. 9. Headaches. 10. Low grade fever. As of 26Apr2021, it stated the day after the patient received his 2nd dose of the Pfizer Covid-19 vaccination (10Apr2021 12:00 PM), he began to have side effects which he expected to some extent. However, as of today, he has 17 days straight of side effects or perhaps an adverse event. His symptoms began mildly the day after but suddenly increased greatly within the next couple days and he had been dealing with this ever since. He had made two emergency room visits, seen his general practitioner, and as of today (26Apr2021) a cardiologist who ordered imaging. His symptoms range from, extreme fatigue, nausea, strong stomach and intestinal discomfort, weight loss, shortness of breath, sudden increased heart rates and high blood pressure readings, intense chest pressure and some pain, powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of his head at the cerebellum. His life was basically come to a screeching halt and he was searching for answers! The doctors he had spoken to were unclear as to what was wrong with him and why. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for the events. COVID tested post vaccination on 17Apr2021 included PCR and Nasal Swab, both showed negative result. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
53 2021-05-04 chest pain Chest pain; Back pain; The chest and back pain has worsened; Sore throat, like when you get a cold a... Read more
Chest pain; Back pain; The chest and back pain has worsened; Sore throat, like when you get a cold and it's kind of hard to swallow; Came back positive was the inflammation test; Couldn't walk; back inflammation; Diabetes is out of whack; Every joint hurt badly; This is a spontaneous report from a contactable consumer (patient). This 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EW0151), via an unspecified route of administration, on 05Apr2021 (at the age of 53-years-old) as a single dose for COVID-19 vaccination, in left arm. The medical history included: Diabetes. Concomitant medications not reported. The patient reported that he got the first shot on 05Apr2021 and something went wrong. Every joint hurt really bad (From: Apr2021 To: 18Apr2021, duration 17 days), and he couldn't walk. So, he went to the emergency room and the ER people told him he had arthritis and to go home and take Tylenol. He came home, took Tylenol, and then his chest and back started hurting. He went to the doctor and the doctor ran an arthritis test, lupus test, and all these tests, and it came back negative. The only test that came back positive was the inflammation test. He had 3 times the normal amount of inflammation a person is supposed to have. He stated his chest hurts really bad and his back hurts really bad. He keeps going to the hospital and then they keep sending him home. Caller states he is not sure if he's not going to die but all of his other items are out of whack, like his diabetes is out of whack. He can confirm after all the joint pain went away, then the chest and back pain/inflammation popped up. The chest and back pain has worsened. It's worse than yesterday. He has not taken any aspirin or anything. The back pain has worsened. It feels like he did chest exercises. It hurts to the touch. He has back inflammation. Treatment: He clarified that he was instructed to take Tylenol Arthritis and not aspirin. He confirmed he was taking Tylenol Arthritis. No additional details provided. He mentioned that someone told him he could not take Aleve. He does not know what to do and what he can and cannot take also has diabetes and his blood sugar seems to be extremely high, which it never is. They are working on getting his blood sugar under control, but it seems like it's been out of whack for a little bit. He later clarified that he switched medications prior in March and he is on some new stuff and he expected it to be out of whack. He also adds that it's like he has a sore throat but he doesn't have a sore throat, it's like when you get a cold and it's kind of hard to swallow. He explains when arthritis issue/joint stuff cleared up, he had the sore throat, the chest pain and sore throat appeared. It's been 3 or 4 days and it has not gone away. ER Dates - 15Apr2021. Doctor's office - 16Apr2021. Lab tests included: 16Apr2021Test: Muscle enzyme Result: normal; Thyroid test Result: normal; blood cell count result: normal; rheumatoid arthritis test Result: negative; Lupus test Result: negative; Inflammation Marker Blood test Result: High; 3x normal; EKG Result: Fine. The clinical outcome of the event Diabetes is out of whack, chest and back pain has worsened, Came back positive was the inflammation test, Couldn't walk, back inflammation was unknown; Every joint hurt badly was recovered; Chest plates, back pain, sore throat was not recovered. No follow-up attempts are possible. No further information is expected.
53 2021-05-04 pallor Patient stated he felt dizzy after injection. Had the patient take slow deep breaths. Patient began ... Read more
Patient stated he felt dizzy after injection. Had the patient take slow deep breaths. Patient began to lightly shake, then patient was unresponsive with blank stare. Pt clammy, pale, and diaphoretic, Pt transferred via w/c and taken to medical monitoring.
53 2021-05-04 fainting DIZZY, DIAPHORETIC, EYES FLUTTERING, SYNCOPE, SEEN BY PARAMEDICS, BP 171/90 HR 97, BS: 99. PT HAS NO... Read more
DIZZY, DIAPHORETIC, EYES FLUTTERING, SYNCOPE, SEEN BY PARAMEDICS, BP 171/90 HR 97, BS: 99. PT HAS NO HX OF SYNCOPE, REFUSED TRANSPORT, AMA SIGNED.
53 2021-05-05 pulmonary embolism 3/12/21 had few minutes of speaking incorrect words which led to eval for TIA 3/17/21 had dopplers o... Read more
3/12/21 had few minutes of speaking incorrect words which led to eval for TIA 3/17/21 had dopplers of carotid with unequal blood velocities 3/24/21 covid vaccine #1 4/15/21 covid vaccine #2 4/21/21 CTA chest to look for cause of carotid velocities being different and pulmonary emboli were found
53 2021-05-09 palpitations 5 mm purple flat macule on left lower lip edge (non-tender, no symptoms). mild palpitations, upper ... Read more
5 mm purple flat macule on left lower lip edge (non-tender, no symptoms). mild palpitations, upper back pain, and sore throat for a day after vaccination.
53 2021-05-10 atrial fibrillation Atrial Fibulation- that is still not resolved
53 2021-05-10 chest pain, deep vein blood clot DVT causing Muscle cramps; DVT causing Muscle cramps; fever; chest pain; This is a spontaneous repor... Read more
DVT causing Muscle cramps; DVT causing Muscle cramps; fever; chest pain; This is a spontaneous report received from a contactable healthcare professional (patient). A 53-year-old male patient received the second dose of BNT162B2 (lot number: EL9261), intramuscularly in left arm on 03Feb2021 13:00 at single dose for COVID-19 immunisation. Medical history included gout. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EL0142), intramuscularly in left arm on 06Jan2021 13:00 for COVID-19 immunisation. The patient experienced deep vein thrombosis (DVT) causing muscle cramps, chest pain, fever, etc 2-3 weeks after the second dose on 24Feb2021 12:00. Patient did not receive any treatment for the adverse events. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not resolved.; Sender's Comments: Considering a positive temporal association, a causal relationship between the event deep vein thrombosis and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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
53 2021-05-10 deep vein blood clot Developed RLE pain and swelling on Friday. Progressed over the weekend. Evaluated on Tuesday. Found ... Read more
Developed RLE pain and swelling on Friday. Progressed over the weekend. Evaluated on Tuesday. Found to have distal DVT. Started on anticoagulation.
53 2021-05-10 heart rate increased, fluid around the heart, inflammation of the pericardium Shortness of breath; pericardial effusion requiring drainage/fluid around the heart that made the he... Read more
Shortness of breath; pericardial effusion requiring drainage/fluid around the heart that made the heart beat super fast to pump up blood; inflammation of the heart sac; fluid overload on the lung; fluid around the heart that made the heart beat super fast to pump up blood; This is spontaneous report from a contactable consumer (patient) reported for himself. A 53-year-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in left upper arm at 53 years old on 20Mar2021 08:00 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included ongoing high blood pressure from 2018, he says he has had this for roughly 3 years. Concomitant medication included amlodipine at 5mg once a day for high blood pressure from an unspecified start date in 2018 and ongoing, he says he has been taking this for a few years, maybe 3 years. No additional vaccines were administered on Same Date of the Pfizer Suspect or within 4 weeks. He was not sick at the time of vaccination previously. The patient was calling about the Pfizer COVID vaccine. He says he is just trying to get answers because what he experienced was very alarming to him. He got the vaccine at 8:00 in the morning. He says a student did it, she took a long time, she was very timid. He says she was being supervised by an RN. He experienced shortness of breath on 07Apr2021, he says it was in the morning that the shortness of breath started, because he did make an appointment to go the the COVID test, he got the COVID test around noon that same day. He says he was diagnosed with pericardial effusion requiring drainage and inflammation of the heart sac. He says he had fluid overload on the lungs that required IV diuretics. He says the symptoms started after the vaccine, and these symptoms were what was causing the shortness of breath. He says the fluid around the heart made the heart beat super fast to pump up blood. He says the fluid triggered the shortness of breath. He says when they removed fluid the breathing got easier but then it settled into the lungs. He says Tuesday he dropped off the cliff, Tuesday or Wednesday night, one of them, for two nights he was on oxygen, they gave him a diuretic for the lungs, after 12 hours he started feeling better, continued to get better and better after they moved the fluid from the lungs with Lasix through the IV. He says he doesn't fit the profile of someone who would develop these issues, he has no history, no cancer, no autoimmune disorders. He says they say well maybe it is the virus but the doctors currently have no specific answers for the caller. He says they told him that someone having this would be the profile of an IV drug user. He says he never uses drugs, he does not fit a profile like this. He says he wants to be fully vaccinated. He says the timing is suspicious with the vaccine shot. He says it is 50/50 on the doctor's opinions, half say to get the shot, the other half say don't do it. He says they say the second shot is worse. He says he is confused as to what to do, that he understands this is a big experiment, he wants the vaccine but not at the cost of another visit to the hospital. He says he was at the hospital on oxygen, he couldn't get out of bed for a day. He says the doctor said there was a study in (Withheld), the caller says he did a lot of research in the hospital for 6 days, that says the demographic is younger but it is heart issues with men for the heart with the Pfizer vaccine. He says they are studying it. He says a couple of doctors referred to that, the ones that say don't get the shot, not yet. He says he can't pinpoint it exactly. He says it could have been a fluke but the timing is very suspicious. He says that because of some of the side effects, his week in hospital, he was concerned for his life, he wants to be fully vaccinated but not at the cost of going though this or cost of killing him. He says he does not want to go through this again, he will not get vaccinated unless he is comfortable. He asks should he switch to (Withheld), is that a safer bet, (Withheld), should he just skip it all together or not. He says he knows they are a different type of vaccine. He says they had to remove fluid form his pericardial sac, he had 2 days of draining, they drained a liter from around the heart so it could beat normal again. He says apparently some of the fluid went to the lungs so he needed oxygen. He says this all happened Tuesday morning, he came back home yesterday, he looks pretty good. He says he just wants to do the vaccine and asks should he take the second one or not. He would like to get any information. He says the fluid in his heart was starting to build up on 05Apr2021 or 06Apr2021, he started getting symptoms that come and go. He says he was admitted to the hospital on 19Apr2021 and his procedure was on 20Apr2021 so his shortness of breath resolved the day after the procedure. He says he was hospitalized from 19Apr2021 to 25Apr2021. After reporting shortness of breath he says that was it, basically. He says he went to the nurse treatment center on 19Apr2021 because he thought it might be COVID but this event landed him in the hospital. The events required a visit to emergency room, he said he went to the emergency room on 19Apr2021 and a doctor told him he might not make it. The patient said he was scared and he didn't know why the doctor would have said that to him. He said he did not have an appointment date to physician office yet, he was waiting to get a call back. Relevant Tests included: Rapid COVID test, Date 07Apr2021 Result negative, Date 15Apr2021 Result negative, Date 19Apr2021 at Patient First Result negative, Date 19Apr2021 at the hospital on admittance, Result negative. Standard COVID test, Date 19Apr2021 Result negative, Date 15Apr2021 Result negative. He says at the hospital there was a lot of tests done on his heart and lungs, nothing was coming back scary, they were coming back as perhaps viral markers. The outcome of shortness of breath was recovered on 21Apr2021, of other events was unknown.
53 2021-05-10 heart attack, heart attack I21.4 - Non-ST elevation (NSTEMI) myocardial infarction
53 2021-05-12 blood clot possible thrombosis reaction; Unexpected bruising near injection site.; Bruise was purple and red sp... Read more
possible thrombosis reaction; Unexpected bruising near injection site.; Bruise was purple and red splotches and has now progressed to mostly yellow/discoloration; Bruise was purple and red splotches and has now progressed to mostly yellow/discoloration; minimal pain/stiffness following the shot; minimal pain/stiffness following the shot; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 53-year-old via an unspecified route of administration, administered in Arm Left on 20Apr2021 11:15 (Lot Number: EW0153) at 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included famotidine (PEPCID AC). The patient previously took flu shot in Oct2020, prilosec [omeprazole magnesium] for seasonal allergy and experienced drug hypersensitivity. The patient experienced unexpected bruising near injection site. Bruise was the size of the bandaid, approximately 1" x 2". Bruising had persisted for more than a week now. The patient had never experienced bruising like this with other vaccines. He would like to rule out possible thrombosis reaction before second shot. He did not have bruising at any other locations other than the injection site. Bruise was purple and red splotches and has now progressed to mostly yellow. He believed the discoloration was a reaction to the vaccine and not the result of the needle. The shot itself was painful but patient felt minimal pain/stiffness following the shot. The event start date was on 20Apr2021. No treatment was received. The outcome was unknown.
53 2021-05-17 heart rate increased, chest discomfort 6 hours after receiving 2nd dose, develped a fever (99.8), dizziness, chest tightness (lungs felt co... Read more
6 hours after receiving 2nd dose, develped a fever (99.8), dizziness, chest tightness (lungs felt constricted), trouble breathing, coughing, and very fast heartbeat. Took Tylenol, the next day fever was gone but chest tightness and cough persisted. On 5/11/21 checked into Urgent Care facility because fast heartbeat and chest tightness did not subside. Dr. checked my pulse (at 99 beats) and gave me a PCR test for Covid. Coved test came back negative. On 5/16/21 at 1:00am, chest tightness felt like it was getting worse. Checked into Urgent Care ficility again. Dr. took a check x-ray and EKG. Both came back normal with nothing unusual found. Dr. prescribed Zithromax and Prednisone in case of bacterial infection and the Sterol to help with my breathing.
53 2021-05-17 hypertension Lethargy immediately after injection and arm soreness at injection site. Approximately one week late... Read more
Lethargy immediately after injection and arm soreness at injection site. Approximately one week later I experienced left ear infection/fluid in ear causing hearing loss and mild dizziness. Hearing loss, ringing in ear and dizziness are still on-going.
53 2021-05-17 pallor, fainting My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My lower extre... Read more
My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My knees also hurt; Dizziness; Skin was very pale and cold to the touch.; Profuse sweating.; Fatigue; Muscle Pain; Fainting 9 hours after administration; I had my first headache.; I had pins and needles in fingers 4 and 5 in the arm of vaccine administration; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 11:30 (Lot Number: EW0170), at age of 53 years old, at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took asparagus for Allergy. Reported Event: Immediately after the vaccine, I had pins and needles in fingers 4 and 5 in the arm of vaccine administration. 3 hours after vaccine, I had my first headache. Severe headache, dizziness, fainting 9 hours after administration. During fainting episode, skin was very pale and cold to the touch. Profuse sweating. This was on the same day as vaccine administration. For the next 3 days, I laid in bed with fatigue, severe headache, and muscle pain. After 10 days, I still feel weak, I get tired after walking half a mile, and I have episodes of dizziness during the day. My lower extremities, from the knee down, are weak and sometimes it is hard to walk. My knees also hurt. This is still present 10 days after the vaccine. Outcome for events was unknown. Prior to vaccination, whether the patient was diagnosed with COVID-19 Was Unknown, and Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.
53 2021-05-17 lightheadedness, pallor Within 5 minutes of receiving vaccine patient complained to wife of feeling lightheaded, became awak... Read more
Within 5 minutes of receiving vaccine patient complained to wife of feeling lightheaded, became awake but not responsive for about 5 minutes, slurring words not getting any communication out, clammy/muggy, pale, refused to move onto the floor, was dead weight when trying to move. Blood pressure was 100/50 HR 60. Wife said he was not anxious walking in, later he said he has "white coat syndrome". Paramedics were called, was evaluated by paramedics and they attributed it as a vasovagal response. Patient finally after 10 minutes came around.
53 2021-05-19 heart rate decreased Significantly lowered heartrate; This is a spontaneous report received from a contactable consumer, ... Read more
Significantly lowered heartrate; This is a spontaneous report received from a contactable consumer, the patient. A 53-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown, Dose number: 1) via an unspecified route of administration in the left arm on 01Mar2021 at 05:45 pm (at the age of 53-years old) as a single dose for COVID-19 vaccination. Medical history included Type 2 diabetes, hypertension and apnea. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications in two weeks. On 03Mar2021 at 10.00 pm, the patient experienced lowered heart rate following the vaccine administration and average resting rate was 79 bpm, but on the 2nd night following the shot, heart rate fell into the 30's for several days (shot on March 1, sleeping heart rate substantially drops at night March 3-7). No therapeutic measures were taken for the event. The clinical outcome of the event lowered heart rate was resolved. Action taken with BNT162B2 was not applicable Information about lot/batch number cannot be obtained. No further information is expected.
53 2021-05-19 loss of consciousness, hypotension Patient was seated in waiting area post vaccination. communicated to technician he felt dizzy. Pharm... Read more
Patient was seated in waiting area post vaccination. communicated to technician he felt dizzy. Pharmacist came to patient's side. Patient slowly went unconscious, folding forward in chair for about 30 seconds. Pharmacist kept patient in chair and called for technician to call 911. patient regained consciousness and pharmacist talked patient down to the ground for safety and rested against wall with head by knees. patient stayed conscious until paramedics arrived. they tested vitals and patient's blood pressure was very low. patient loaded onto a gurney and taken to unknown hospital.
53 2021-05-21 heart rate irregular 4/22/21 about 1:55 pm I got the shot, 2:45 got a bad headache, dizzy, feeling flush and upset suma... Read more
4/22/21 about 1:55 pm I got the shot, 2:45 got a bad headache, dizzy, feeling flush and upset sumac I left work at 4 pm and when home. around 6 pm i started to get joint pain in my arms, legs and hip. by 730 pm I got the chills, shivers and got extremely tired. I when to bed around 8 pm and woke up around 730 am on 4/23/21. I felt like I was cold till Sunday (4/25/21), The headache remained till Wednesday (4/28/21). I don't know if this is related but I would like to provided the information. Prior to the shot my blood press was between 112 to 120/ 70 to 80. after the shot my blood pressure has been 140 to 150/ 80 to 93. am monitoring my blood pressure, adjusting my diet & trying to start a exercise regiment to address the blood pressure. I did have a epatch right before the shot from 4/19/21 to 4/22/21. .
53 2021-05-22 heart attack 4 days later suffered Acute Myocardial Infarction involving the left anterior descending (LAD) coron... Read more
4 days later suffered Acute Myocardial Infarction involving the left anterior descending (LAD) coronary artery
53 2021-05-22 palpitations, chest pain 1st day after vaccine. Chills, fever, fatigue, headache, 2nd day- stiff neck, headache. 3rd day afte... Read more
1st day after vaccine. Chills, fever, fatigue, headache, 2nd day- stiff neck, headache. 3rd day after vaccine - left side of face sore, headache, earache. 4thday -Chest pains,- very quick, sharp, very tired, had heart skip/ palpations went to ER @ 11:30pm. Had EKG, blood work, stress test from cardio dept. Followed up with Dr. with cardio dept. received Zio patch Heart Monitor and wore for 2 weeks. Currently waiting the results.
53 2021-05-23 chest pain Chest and back pain radiating into right arm
53 2021-05-25 heart attack, heart attack, chest pain Heart Attack, burning from center of chest expanding to back like a dagger and outwards 1 stent plac... Read more
Heart Attack, burning from center of chest expanding to back like a dagger and outwards 1 stent placed to stop it 2 more stents the next day preventative Now attending cardiac rehab New meds prescribed
53 2021-05-25 blood pressure increased Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like s... Read more
Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips/ Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Left eye pain and dryness; Left eye pain and dryness; Headache behind eye; Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Elevated blood pressure; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) at the age of 53-years-old, intramuscular in left arm on 22Apr2021 at 14:00 at 2nd dose, single for COVID-19 immunization. Medical history was reported as none. The patient has no known allergies. It was unknown if the patient has COVID prior to vaccination. Concomitant medication included macrogol 3350 (MIRALAX). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 53-years-old, via an unspecified route of administration on 26Mar2021 at 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy/ drug store. On 25Apr2021, the patient experienced Bell's palsy-like symptoms: left eye lid drooping and numbness in left check and lips. He also experienced left eye pain and dryness; headache behind the eye; left shoulder, arm, hand, and left leg numbness and tingling; and elevated blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given in response to the events. The patient underwent lab tests and procedures which included PCR nasal swab for COVID: negative on 15Apr2021 and blood pressure: elevated on 25Apr2021. The outcome of the events was not recovered. Information on the lot/ batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
53 2021-05-30 heart rate irregular, heart rate increased Immediately after receiving my first shot , I had noticed that I had an super fast irregular heart r... Read more
Immediately after receiving my first shot , I had noticed that I had an super fast irregular heart rhythm. This lasted for about 4 hrs after the shot, but was most noticed directly after the shot. I did not say anything because I blew it off as me bei g nervous about the shot, but Im not really ever apprehensive or nervous during shots. The exact same thing happened for the second shot, little more intensely thi, but was ready for reaction so did not make fuss about it an did not contact nurse on duty or my doctor afterwards, but noticed that other people were having heart reactions with the Pfizer Vac, so thought should let you know about my reactions even tho molder than those reported.
53 2021-06-01 inflammation of the pericardium, chest pain Consistent pain in the chest area around two days after 2nd shot- light shortness of breath . Pain ... Read more
Consistent pain in the chest area around two days after 2nd shot- light shortness of breath . Pain became severe May 10th - Saw my doctor and was sent to the emergency room. Diagnosis was Pericarditis
53 2021-06-02 blood pressure increased He was tired; Felt discomfort; Feel numbness and swelling in his toes and hands/feel a numbness on f... Read more
He was tired; Felt discomfort; Feel numbness and swelling in his toes and hands/feel a numbness on fingers of hand and feet; Feel numbness and swelling in his toes and hands; Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp; Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp; Inflammation in the stomach; Abdominal pain; Sometimes his blood pressure increases; couldn't sleep with the symptoms; He was not feeling well; He woke up with inflammation in his fingers and toes; This is a spontaneous report from contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8731 and Expiration date not reported), via unknown route on his right arm on 16Apr2021, (at the age of 53 years) as a 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8733 and Expiration date not reported), via unknown route in left arm on 26March2021, (at the age of 53 years) as a 1ST DOSE, SINGLE DOSE for COVID-19 immunization. After the first dose patient had only pain in arm. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced to feel numbness and swelling in his toes and hands, began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensa-tion and transforms into a cramp, he also presents inflammation in the stomach and abdominal pain for which it has already been prescribed with acetaminophen that calmed his symptoms a little, when he gets wet with hot or cold water feels all the discomfort described previously, he had never felt such symptoms, the patient is concerned that sometimes his blood pressure increases. The patient describes the experience as something similar to an allergy to some food that holds up for a long time and feels that its symptoms have increased, the symptoms diminish when performing his normal activities, today he was unable to work because he woke up with inflammation in his fingers and toes. The patient states, that the timing was normal, he just had the pain as normal, like everyone else getting the vaccine at that time, but with the second it became stronger, but still common with everyone else. Then he started to feel them with much more frequency. Numbness on fingers of hand and feet: the second dose he felt that, alongside the abdominal pain, he was generally not feeling good. He took Acetaminophen and it decreased, when the medication is active, then he goes back to normal, and it increases. Tingling in back started at the same time. At the time it was like itchiness on the back, at that point he wasn't able to scratch but it was fine, then it became tingling that he was not able to get rid of. Inflammation in stomach started with the second dose. The first dose was no issue, he was feeling the same, second dose he had those symptoms. It increases when he drinks milk and stuff so he would say it's getting worse. Blood pressure rises sometimes: He had felt his blood pressure rise since the second vaccine, but it's normal during the day, it was tested and normal, he gets to exercise, that's fine, he has no issues with blood pressure before the second, but for example, early this morning, 12 in the morning to 6 this morning, he felt it was increasing, and he was tired and stuff. outcome normal, his blood pressure fine during day, he exercises, but he felt it early this morning, felt discomfort, he was uncomfortable and tired and now, normally it's fine, regular pressure. reported. The patient describes the experience as something similar to an allergy to some food that holds up for a long time and feels that its symptoms have increased, the symptoms diminish when performing his normal activities, today he was unable to work because he woke up with inflammation in his fingers and toes. After receiving the second dose of vaccination patient felt all these symptoms, took some medication, Acetaminophen because he was not feeling well, yesterday he couldn't sleep with the symptoms. He would visit his doctor after making the report. Patient was working for a pharmacy for 3.5 years. When asked for consent to contact, the interpreter was no longer on the line. Primary care doctor's declined, caller states he doesn't have a PCP, states he is a tourist now. Card has on the back the date, where vaccine was done, states he didn't take any medication; he is very healthy. He took Acetaminophen, clarifies as he took Tylenol (UPC unknown. Lot: SPA084, expiry is Oct2024; strength is 500mg), verified, and he just appreciates the help. Details for Vaccine Supplemental Form not provided by caller. Patient was working in supermarket with friends, they said they would vaccinate people, so he took advantage. The outcome of the events, numbness localized, feel tingling in his back, stomach inflammation, abdominal pain was not recovered, the event blood pressure increases was recovered on unknown date in 2021, the event couldn't sleep, Feel numbness and swelling in his toes and hands, Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp not feeling well, couldn't sleep with the symptoms, inflammation in his fingers and toes, he was tired, felt discomfort was unknown. Product complaint was filled: While providing and AE for the Pfizer COVID 19 vaccine, the caller states he had numbness on fingers of hand and feet: He takes Acetaminophen, later clarified as Tylenol, and it decreased, when the medication is active, then he goes back to normal and it increases. Follow up (26May2021): This is a follow up spontaneous report from contactable consumer. This 53-Year-old female consumer (patient) reported for herself new information included event detail, Batch/lot number was updated
53 2021-06-07 anaemia At 5:30 am the day following vaccination woke up with severe new unset right flank pain. Went to ED... Read more
At 5:30 am the day following vaccination woke up with severe new unset right flank pain. Went to ED and was found to have a kidney stone on CT scan. Was treated with hydration and Toradol. However, spiked a fever (possibly due to vaccine) and was pan-cultured (blood x2 and urine) and given IV antibiotics for possible UTI/pyelo. Blood and urine cultures were negative and was discharged after overnight observation. Did not have a history of kidney stones before this event.
53 2021-06-07 chest pain THREE DAYS AFTER SHOT, HAVE TINGLING FINGERTIPS ON LEFT HAND, SENSATION ON AND OF FOR COUPLE OF DAYS... Read more
THREE DAYS AFTER SHOT, HAVE TINGLING FINGERTIPS ON LEFT HAND, SENSATION ON AND OF FOR COUPLE OF DAYS. WEEK AFTER THE SHOT, STABBING PAIN UNDER LEFT ARMPIT ACROSS MIDDLE OF LEFT CHEST. LEFT HAND FEELING NUMB
53 2021-06-07 hypotension, loss of consciousness, fainting Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
53 2021-06-11 fibrin d dimer increased, pulmonary embolism, oxygen saturation decreased Started experiencing shortness of breath and coughing on May 27, 2021. Noticed shortness of breath ... Read more
Started experiencing shortness of breath and coughing on May 27, 2021. Noticed shortness of breath as walking up hill. Breathing issues continues to get worse over time. Went to urgent care doctor on June 4th. They said my oxygen level was low and could hear wheezing in chest. They did a chest x-ray and thought I might have pneumonia. Gave me antibiotics. Recommended to see primary care doctor. Went to HCF on 6/7/2021. Saw FNP. She did blood work. Scheduled me for a cat scan on 6/8. Blood tests indicated d-dimer level was high. Cat scan showed pulmonary embolisms in both lungs. Went to hospital.
53 2021-06-11 blood clot Seriousness: Does not really know what it is, it could be thrombosis; Caller has experienced redness... Read more
Seriousness: Does not really know what it is, it could be thrombosis; Caller has experienced redness/redness in thumb and finger tips; tingling/tingling in left hand; decrease sensation in his finger tips/numbness and decreased sensation in left hand; He is still experiencing all of these and has gotten worse; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 (Batch/Lot Number: EW0183) in the morning between 10:00 and 11:00 am as single dose for covid-19 immunisation at the age of 53-year-old. Medical history included an open reduction internal fixation, surgery on his right clavicle 5 years ago, which is what made him want to get the vaccine. Concomitant drugs included Multivitamin, Vitamin A and Vitamin D. The patient had an exam in December and all of the test results were normal. On 16May or 17May2021, the patient has experienced redness in thumb and fingertips, numbness, and decreased sensation in left hand, tingling in left hand. Symptoms have been ongoing for 10 days; it has progressively gotten worse. It was reported that the symptoms started 2 days after getting the vaccine on 13May2021, was 16May2021 or 17May2021. He takes multi vitamins and minerals and thought it may be related to that. He takes high doses of Vitamin A and Vitamin D. He actually thought it was due to the Vitamin A and Vitamin D. He stopped the vitamins for a few days. Treatment included: Thought maybe, apart from the vitamins, it may be because he was washing his hands so much that it may be from that. He used Aveno lotion to try and lubricate them. The outcome of event Thrombosis was unknown, outcome of other events was not recovered. The reported considered the events were related to the vaccine as it was the left finger tips, especially the thumb, compared to the right. That's why he thinks it is related to the vaccine. The clinical course was reported as: The redness was first, then the tingling. He doesn't remember the exact day. The numbness and decreased sensation were afterward. He is still experiencing all of these and has gotten worse. The thumb on the left hand looks pink and wrinkled. When comparing the right see the difference tell they are different. Seriousness: Does not really know what it is, it could be thrombosis. The redness in the thumb and finger tips is in the right as well but is not as bad as in the left. Follow attempts needed. Further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported event of thrombosis. The impact of this report on the benefit/risk profile of the Pfizer product 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
53 2021-06-13 chest pain Pain in left shoulder blade and left chest pain increased with beep breath
53 2021-06-16 inflammation of the pericardium Paracarditis
53 2021-06-17 fainting patient passed out after receiving the vaccine
53 2021-06-21 heart attack Heart attack on May 18, 2021.
53 2021-06-28 palpitations, palpitations, chest discomfort I noticed Heart skipping beats and chest discomfort 8 days after the Vaccine. It has remained an is... Read more
I noticed Heart skipping beats and chest discomfort 8 days after the Vaccine. It has remained an issue for 7+ weeks now and continues to skip many times each hour.
53 2021-06-28 inflammation of the pericardium Pericarditis
53 2021-06-29 palpitations Slight palpitations and a little dizziness and tiredness.; Little dizziness; Tiredness; This is a sp... Read more
Slight palpitations and a little dizziness and tiredness.; Little dizziness; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 20Mar2021 at 13:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient medical history included high blood pressure and high cholesterol. Concomitant medications were not reported. The patient was allergic to Gluten. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within for weeks prior to the COVID-19 vaccine. The patient had received medications within 2 weeks of vaccination, the details of which were not given. The patient experienced slight palpitations and a little dizziness and tiredness on 20Mar2021 at 02:45. The patient did not receive any treatment for palpitations, dizziness and tiredness. The clinical outcome of the events slight palpitations, little dizziness and tiredness were not recovered. Information about lot number cannot be obtained. No further information expected.
53 2021-06-29 pulmonary embolism Pulmonary Embolism
53 2021-07-01 chest discomfort, hypertension Shortness of breath; Tightness in the chest; Loss of taste; Elevated blood pressure; Back pain; diff... Read more
Shortness of breath; Tightness in the chest; Loss of taste; Elevated blood pressure; Back pain; difficulty sleeping; Extreme fatigue; headaches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG6208), via an unspecified route in left arm on 11Mar2021 at 12:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypertension. The patient had past drug allergy with ibuprofen. The patient received other medications (unspecified) within two weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021, the patient experienced extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure. No treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent nasal swab test on 22Mar2021 and test the result was negative. The clinical outcome of extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure was not resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
53 2021-07-01 bleeding on surface of brain Subarachnoid hemorrhagic stroke 3 days after second dose
53 2021-07-04 palpitations, ischemic chest pain, loss of consciousness unable to breathe, bed ridden with bouts of unconsciousness and severe chronic fatigue for over two ... Read more
unable to breathe, bed ridden with bouts of unconsciousness and severe chronic fatigue for over two weeks along with heart pains and heart palpitations. The inability to breathe and bouts of unconsciousness have subsided with chronic fatigue and heart palpitations still present. I haven't sought medical treatment because I have no insurance and I can't afford it.
53 2021-07-07 cardiac arrhythmia, palpitations 2 week after 2nd shot I started having heart palpitations, headaches, shortness of breath, dizzyness... Read more
2 week after 2nd shot I started having heart palpitations, headaches, shortness of breath, dizzyness. I did not associated these symtoms with the vaccine. These symptoms have continued for 2.5 months. Some days they are stronger, somedays less, but have not gone away. Monitoring show PVCs, but stress test and echocardiagram were unremarkable I have not discussed the vaccine as possible cause with any healthcare provider but did not on V-Safe responses.
53 2021-07-09 heart rate irregular Dizziness, difficulty breathing, body aches and pains, fluctuating heartbeat ,anxiety, loss of taste... Read more
Dizziness, difficulty breathing, body aches and pains, fluctuating heartbeat ,anxiety, loss of taste and appetite, confusion, Symptoms have been lasting almost a month,
53 2021-07-11 heart rate increased, hypertension Within 12 hours, I felt tiredness, fatigue, body was weak. I had loss of appetite. Ran a low grade f... Read more
Within 12 hours, I felt tiredness, fatigue, body was weak. I had loss of appetite. Ran a low grade fever. The cough started 2 days after the vaccine was given. With each day, I felt worse, finally on 5/28/2021, I went to the walk in clinic. They took my vitals and wheeled me to the ER. I had a fever of 101.38, elevated heart rate, high BP. nausea with an upset stomach. Several test were run on me at this time. The ER Dr. said I would feel bad for a week or so, and was put off work for 1 week and a half. My cough got worse each day and I kept that cough for about 4 weeks. The ER Dr. said I should follow up with my regular Dr. I seen Dr. 2 different times during the next few weeks.
53 2021-07-12 ischemic chest pain After the 1st shot I noticed sporadic heart pains throughout the 2week period between shots; This is... Read more
After the 1st shot I noticed sporadic heart pains throughout the 2week period between shots; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14May2021 11:30 (Lot Number: EW0167) at age of 53-year-old as single dose for covid-19 immunisation. Medical history included allergies (Pollen, Mt Ceder) not 100% sure on what causes them. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. After the 1st shot, the patient noticed sporadic heart pains throughout the 2 week period between shots on 14May2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment received. The outcome of event was unknown. Since the vaccination, it was unknown if the patient tested for COVID-19.
53 2021-07-12 ischemic chest pain I received the 2nd shot and heart pains progressively got worse; I received the 2nd shot and heart p... Read more
I received the 2nd shot and heart pains progressively got worse; I received the 2nd shot and heart pains progressively got worse; but this time it was accompanied by dizziness; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Jun2021 13:30 (Lot Number: EW0168) at age of 53 years old as a single dose for covid-19 immunisation. Medical history included allergies(Pollen, Mt Ceder) not 100% sure on what causes them. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 11:30 (Lot Number: EW0167) at age of 53 years old as a single dose for covid-19 immunisation and experienced After the 1st shot I noticed sporadic heart pains throughout the 2week period between shots. The patient received the 2nd shot and heart pains progressively got worse, but this time it was accompanied by dizziness, both in Jun2021. No treatment received. The outcome of the events was unknown. The events were reported as non-serious. Clinical course: After the 1st shot he noticed sporadic heart pains throughout the 2 week period between shots. At the 2nd shot he asked the nurse at the hospital if anyone else had experienced similar issues. They asked if he wanted the 2nd shot and he stated he was already committed at that point. He received the 2nd shot and heart pains progressively got worse, but this time it was accompanied by dizziness. He went to the ER on Wednesday 09Jun2021 where they ran a battery of tests and immediately referred me to a cardiologist. The events were resulting in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not COVID prior vaccination. It was unknown that covid tested post vaccination.
53 2021-07-12 blood clot I can feel a clot in arm making it very painful; My left arm has been in pain; I cannot use my left ... Read more
I can feel a clot in arm making it very painful; My left arm has been in pain; I cannot use my left arm.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 23Apr2021 11:00 (Lot Number: EW0172) as single dose for covid-19 immunisation at 53 years old. The patient medical history was not reported. Concomitant medication(s) included lisinopril (unknown manufacturer, 5 mg) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955) on 27Mar2021 at 10:00 in left arm when 53 years old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced can feel a clot in arm making it very painful (thrombosis) (medically significant), his left arm has been in pain (pain in extremity) (non-serious) and cannot use his left arm (mobility decreased) (non-serious) on 23Apr2021 with outcome of not recovered. The patient reported that his left arm has been in pain since the time of injection and now he can feel a clot in arm making it very painful and he cannot use his left arm. The patient was not treated for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-07-16 heart rate irregular Spots on my calves that come and go. (I have pictures) sudden irregular heartbeat. I am being evalua... Read more
Spots on my calves that come and go. (I have pictures) sudden irregular heartbeat. I am being evaluated by my doctor.
53 2021-07-18 palpitations i am 5'10" and weigh 145#. Cross country coach. Descent shape. I am having Heart palpitations since... Read more
i am 5'10" and weigh 145#. Cross country coach. Descent shape. I am having Heart palpitations since getting shots. Never issue, ever before.
53 2021-07-19 chest pain A week or two after the second shot I started filling pain in middle of the chest. It was getting be... Read more
A week or two after the second shot I started filling pain in middle of the chest. It was getting better if I was taking an Aspirin. The pain disappeared two weeks later. The pain appeared again three days ago after I swam for 5-10 minutes at the moment I got tired. Now I have the pain occurring from time to time...
53 2021-07-25 palpitations, loss of consciousness Within several weeks, I started noticing what felt like heart palpitations that caused me to lose my... Read more
Within several weeks, I started noticing what felt like heart palpitations that caused me to lose my breath and wheeze/cough. I had called my primary care physician and saw them and said I wanted a visit with a cardiologist. Just one week later, during a work call, it the event happened so severely that I started passing out. Thus, I went immediately to the ER and checked myself in. It was not until mid-July that I got to see a cardiologist, and my symptoms were much less frequent or severe by that time. For several weeks though, it was very uncomfortable and unnerving.
53 2021-07-26 chest discomfort HE SAID HIS CHEST FELT TIGHT. HE SAT FOR 5 MORE MINUTES AND WE WATCHED HIM. HIS WIFE WAS WITH HIM.... Read more
HE SAID HIS CHEST FELT TIGHT. HE SAT FOR 5 MORE MINUTES AND WE WATCHED HIM. HIS WIFE WAS WITH HIM. HE DECIDED HE FELT BETTER AND WANTED TO LEAVE.
53 2021-07-27 palpitations fast heart beat; difficulty in breathing; dizziness; confusion; This is a spontaneous report from a ... Read more
fast heart beat; difficulty in breathing; dizziness; confusion; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:00 the patient had experienced fast heartbeat, difficulty in breathing, dizziness and confusion after one hour of vaccine administration which was lasted for about 3 minutes or less. The reaction repeated again after 30 hours and lasted for about 2 minutes. But he reported only the effect that happened after 30 hours and not the initial experience. The clinical outcome of the events fast heartbeat, difficulty in breathing, dizziness and confusion was resolved on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.
54 2021-01-03 chest discomfort Patient received the vaccine and had slight chest tightness, had a slight headache and has mild naus... Read more
Patient received the vaccine and had slight chest tightness, had a slight headache and has mild nausea. He worked the day and still has the symptoms at 1:30 pm
54 2021-01-03 hypotension Patient experienced hypotension (systolic 88mmHg), diaphoresis
54 2021-01-06 lightheadedness Patient developed dyspnea on exertion noted 7 days after his vaccine; Note that he had fully recover... Read more
Patient developed dyspnea on exertion noted 7 days after his vaccine; Note that he had fully recovered from COVID infection one month prior with cardio on bicycle without drop off of performance metrics. DOE was noticeable on bike rides - almost had a syncopal episode on a bike hill climb at post injection day 10; medrol dose pack started - symptoms resolved in one week. No sign of desaturation noted on pulse oximetry; patient elected NOT to pursue the second vaccination shot given the side effects.
54 2021-01-10 pallor he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless;... Read more
he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer (brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well, ate a bit but not much, kind of pale, vomiting, trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021, after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not responsive, and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome of all of the events was unknown; not responsive was not recovered, the patient died on 06Jan2021. The cause of death was unknown (reported as: not known by reporter). An autopsy was not performed. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away
54 2021-01-12 cardiac arrest, chest pain 54 y/o M with PMH of HTN, HLD, Alcoholic Cirrhosis, Aortic Valve Stenosis, and angina BIBA as a Medi... Read more
54 y/o M with PMH of HTN, HLD, Alcoholic Cirrhosis, Aortic Valve Stenosis, and angina BIBA as a Medical Alert for cardiac arrest noted PTA. Per EMS, the patient called because he was having constant, diffuse abdominal pain x 1 day that radiated to his chest. On scene, the patient had a witnessed arrest with EMS starting CPR. He was given 3 rounds of epi without ROSC. Pt had no associated shockable rhythm. Of note, pt's wife, had noted pt had received covid vaccine the prior day.
54 2021-01-13 loss of consciousness When i woke up in morning to go for pee, I start feeling dizziness, so I set on the toilet seat for ... Read more
When i woke up in morning to go for pee, I start feeling dizziness, so I set on the toilet seat for pee. I don't know what happen and I was lying on the floor with my front head hitting the floor, My wife was trying to revive me . I tried to get up but could not walk to my room and laid down back again on carpet floor, one minute later I tried again but could not gather the courage to laid on the bed and again laid on the bed room floor carpet. My wife gave me water and sprite to drink. I start feeling better and after 10 minutes later i could go to bed for rest. I called my doctor at 9:00AM for the appointment and visited doctor at 2:00PM. he checked and took tests and EKG but all the results came out to be fine.
54 2021-01-18 cardio-respiratory arrest Resident received 1st on 1/11/21 at 12:10am (1/12/21) resident was found unresponsive. Code Blue, 91... Read more
Resident received 1st on 1/11/21 at 12:10am (1/12/21) resident was found unresponsive. Code Blue, 911 called at 12:11am. FD and EMS arrived, resident pronounced at 12:51am.
54 2021-01-21 chest pain At time of injection slight chest pain under the arm pit, side of chest, hot flushed feeling shortne... Read more
At time of injection slight chest pain under the arm pit, side of chest, hot flushed feeling shortness of breath. Hours after injection moderate pain at injection site. Days after injection growing pain at injection site. Weeks after injection a blob of pain and discomfort rising up my left arm into my left shoulder joint and lower neck.
54 2021-01-26 chest pain, inflammation of the pericardium Pt seen in ED on 1/20 with increasing chest pain - pain in the mid chest, worse with breathing and l... Read more
Pt seen in ED on 1/20 with increasing chest pain - pain in the mid chest, worse with breathing and limited ability to bend over and lay flat.. Troponin negative x2, ProBNP 42.4. Slightly elevated WBC at 11.96 and PTT at 36.7. PT/INR ok at 11 and 1. CT of the chest demonstrates no PE or pericardial effusion. ECG with no significant changes. Pt given ASA 324 mg and Norco 7.25/325 x1 in ED. D/C with Ibuprofen 800 mg TID for pericarditis. Covid test on 1/21 was negative. Pain improved as of 1/26. Per cardiologist review on 1/22 patient with elevated CRP (1.522) suggestive of pericarditis as cause.
54 2021-01-26 hypertension sig elevation in previously controlled HTN; chills without fever; extreme fatigue; upset stomach wit... Read more
sig elevation in previously controlled HTN; chills without fever; extreme fatigue; upset stomach without true nausea and loss of appetite; upset stomach without true nausea and loss of appetite; This is a spontaneous report from a contactable physician (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), via an unspecified route of administration on 11Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included hypertension, environmental allergies, and COVID-19. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), cetirizine hydrochloride (ZYRTEC), and esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]). The patient experienced sig elevation in previously controlled HTN, chills without fever, extreme fatigue, upset stomach without true nausea and loss of appetite on 11Jan2021. No treatment received for adverse events. The outcome of the events was recovering. Facility type Vaccine was Hospital. No other vaccine in four weeks. The patient was not COVID tested post vaccination.
54 2021-01-26 fast heart rate, hypertension Onset of SVT, resolving after 10 day; worsening of hypertension; first occurrence of shingles (herpe... Read more
Onset of SVT, resolving after 10 day; worsening of hypertension; first occurrence of shingles (herpes zoster recurrence)
54 2021-01-31 heart rate increased An immediate increase in heart rate, followed by a tingling in the back of the throat and tingling o... Read more
An immediate increase in heart rate, followed by a tingling in the back of the throat and tingling of the lips. Adverse reaction resolved after one hour and 30 minutes.
54 2021-02-01 fast heart rate drenching sweated for another 5 hours; diarrhea; rigors; fever to 102.7; tachycardia to 140 which al... Read more
drenching sweated for another 5 hours; diarrhea; rigors; fever to 102.7; tachycardia to 140 which all lasted for 30 minutes; This is a spontaneous report from a contactable physician reporting for self. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 14Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included asthma, covid-19 from an unknown date. Patient received first dose of bnt162b2 on 17Dec2020. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), fluticasone propionate (FLOVENT). On 15Jan2021 22:00, 36 hours after second vaccine patient had diarrhea, then rigors, fever to 102.7, tachycardia to 140 which all lasted for 30 minutes. After it stopped had drenching sweated for another 5 hours and more diarrhea. Fever lasted for 1 hour after taking Tylenol and Alleve. Felt back to normal next morning and fine since. No symptoms now. Outcome of events was recovered.
54 2021-02-02 blood pressure increased Patient is noticed to have generalized weakness, holding his head towards right side, mild right fac... Read more
Patient is noticed to have generalized weakness, holding his head towards right side, mild right facial puffiness with mild left facial droop, and sent to ER, on 1/22/21. Patient also had mild fever for the last two days and was on Tylenol, blood pressure also remained elevated moderately than the usual readings. Patient was admitted through ER for 2 days and was discharged on 1/24/21, with a diagnosis of possible TIA, Todd's paresis post seizure. Patient's CT head and MRI of brain was negative for acute stroke. Patient's left facial droop and right side facial puffiness resolved over a week but noticed to have right sided pronounced weakness with moderate swelling on right arm. Patient used to eat by himself,but now not able to do so and not able to hold cup in the right hand. Patient was again sent to ER for repeat CAT scan of head, further evaluation and management. Not sure if patient had an adverse reaction to Covid-19 vaccination, but definitely these symptoms were developed after 2 weeks of receiving Pfizer vaccination, which may be coincidental. Patient was followed up by the neurologist a week after the discharge from hospital who couldn't rule out adverse reaction of vaccination. Patient is awaiting for an EEG, carotid ultrasound and Echo as an out patient.
54 2021-02-05 loss of consciousness Body aches, fatigue, chills, blacked out
54 2021-02-09 nosebleed 1st incident: Uncontrollable nose bleed for 40 minutes. Went to ER. This occurred four days after t... Read more
1st incident: Uncontrollable nose bleed for 40 minutes. Went to ER. This occurred four days after the first shot. 2nd incident: After the second shot, the same thing happened three days later, uncontrollable nose bleed.
54 2021-02-10 cerebrovascular accident 24 hours post vaccine develoved T 100.1, headache, light sensitivity, reports headache worsened, blu... Read more
24 hours post vaccine develoved T 100.1, headache, light sensitivity, reports headache worsened, blurred vision - went to Emergency Services at Hospital, admitted. Reports diagnosis of CVA. Reports headache has improved, continues with blurred vision
54 2021-02-13 fainting Fainted at 9am with little warning, fainted again at 2:30pm with little warning.
54 2021-02-26 chest discomfort Tightness in throat/chest; difficulty breathing; hoarse voice.
54 2021-02-28 palpitations heart palpitations; shortness of breath; This is a spontaneous report from a contactable consumer (p... Read more
heart palpitations; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration at the left arm on 14Jan2021 at a single dose for COVID-19 immunization. The vaccine was administered in a Nursing Home/Senior Living Facility. The patient had no medical history. The patient had not received other vaccine in four weeks. Concomitant medication included erythromycin eye ointment. On the 17Jan2021 4PM, 3 days after being vaccinated the patient got heart palpitations and shortness of breath. This continued until the 23Jan2021 when he stopped having the heart palpitations. However, the shortness of breath has continued. It started out as light shortness of breath and has evolved into moderate. He was not gasping for air but it was uncomfortable enough where he has had to take time off of work. He was seen by a doctor on 27Jan2021. The patient did not receive any treatment for the event. The patient had Nasal swab/ SARs CoV-2 RNA Real time RT PCR on 25Jan2021, and the result was negative. The outcome of the event heart palpitations was recovered on 23Jan2021 and shortness of breath was not recovered. Information on lot number/batch number has been requested.
54 2021-03-01 heart rate increased tunnel vision; warm sensation travel from the left shoulder area to my chest/upper stomach; eyes bur... Read more
tunnel vision; warm sensation travel from the left shoulder area to my chest/upper stomach; eyes burned; could taste something; heart rate became rapid at a steadily increase amount (113 bpm)/pulse stayed at 92-94 BPM for approximately two hours; felt dizzy; lost speed sensation in the car I was driving; This is a spontaneous report from a contactable consumer (patient himself). A 54-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201), via an unknown route, on 12Feb2021 (at 12:45) at a single dose in the left arm for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included atrial fibrillation from Jun2020, ablation surgery for atrial fibrillation on unknown date, ongoing atrial tachycardia, and ongoing premature ventricular contractions (PVCs). Past drug history included allergy to penicillin. Relevant concomitant medications included vitamin NOS, mineral NOS (MEGA MEN) and amino acids NOS, carotenoids NOS, herbal NOS, hyaluronic acid, methylsulfonylmethane, minerals NOS, vitamins NOS (GNC MEGA MEN SPORT). Within approximately two minutes of receiving the shot, he felt a warm sensation travel from the left shoulder area to his chest/upper stomach, his eyes burned, he could taste something, and his heart rate became rapid at a steadily increase amount. He watched his heart rate tick up on her watch to approximately 113 BPM. His normal resting heart rate was upper 60s. He felt dizzy and out of it for about 30 minutes. He felt like he had tunnel vision and lost speed sensation in the car he was driving. His pulse stayed at 92-94 BPM for approximately two hours. He wasn't anxious about getting the shot and had actually been looking forward to it. The patient was not treated for the events. The patient had recovered from 'felt dizzy' on 12Feb2021 while the remaining events resolved in Feb2021.
54 2021-03-05 palpitations Heart started to race, face flushed, sweaty forehead and palms, felt hot. lasted approx 1 min, and... Read more
Heart started to race, face flushed, sweaty forehead and palms, felt hot. lasted approx 1 min, and slowly went away after 5min or so.... I did not notify anyone.
54 2021-03-10 fainting Patient experienced a syncopal episode two minutes after receiving Pfizer vaccine. While paramedics ... Read more
Patient experienced a syncopal episode two minutes after receiving Pfizer vaccine. While paramedics were assessing him he had another syncopal episode. He was transported to Northridge hospital for evaluation.
54 2021-03-17 heart rate increased Throat swelling ,rapid heart rate
54 2021-03-18 fainting Received Vaccination @1030Am. PT felt faint and Clammy, 1037AM. Staff lied PT down. Pt was transf... Read more
Received Vaccination @1030Am. PT felt faint and Clammy, 1037AM. Staff lied PT down. Pt was transferred to wheelchair, given water. PT began to feel better. Left @ 1105AM.
54 2021-03-20 nosebleed Epistaxis at 1320 following a fifteen minute observation of Pfizer vaccine at 1305. Patient denied a... Read more
Epistaxis at 1320 following a fifteen minute observation of Pfizer vaccine at 1305. Patient denied any HX of epistaxis. Patient observed for an additional 20 minutes. Cold pack was applied and bleeding stopped and was released home.
54 2021-03-21 atrial fibrillation Rapid Atrial Fibrillation occured 12 hours after first injection of Pfizer vaccine. I had no prior ... Read more
Rapid Atrial Fibrillation occured 12 hours after first injection of Pfizer vaccine. I had no prior history of any cardiac events.
54 2021-03-21 heart rate increased Difficulty bre-athing; Swelling of face and throat; A fast heartbeat. Pt went to the ED where he wa... Read more
Difficulty bre-athing; Swelling of face and throat; A fast heartbeat. Pt went to the ED where he was treated with solu-medrol, pepcid & benadryl and monitored over 2 hrs. He continued to report fever, chills, sore throat, mild to moderate difficulty breathing over the next 2-3 days. He refused further recommendations to return to ED and on 3/20/21 admitted to feeling better
54 2021-03-23 pallor Within minutes of patient receiving vaccine, patient began to feel lightheaded and skin color began ... Read more
Within minutes of patient receiving vaccine, patient began to feel lightheaded and skin color began to turn white. Patient parked by EMS in observation parking and became unresponsive. EMS began vital signs and tried to get him to wake up. Patient stayed unresponsive and vital signs continued to decline. EMS transported patient to hospital. Upon arrival to hospital, staff conducted EKG, chest x-ray, and blood work. All tests came back normal. Patient began to become coherent, and staff began to try and feed him and get him up. After patient was able to get self up and eat food, he was sent home. Patient is now at home recovering. He states he only feels a sore arm and is fatigued.
54 2021-03-24 platelet count decreased 2/28/2021 patient noted bleeding while brushing teeth. Over next week patient developed petechiae ... Read more
2/28/2021 patient noted bleeding while brushing teeth. Over next week patient developed petechiae and bruises. Required treatment with glucocorticoids and intravenous immunoglobulin. Potential triggers include nifedipime (started 12/20) and COVID vaccine (1/21).
54 2021-03-25 loss of consciousness Light headed and dizzy, sweating, passed out briefly. 15 seconds. This was 45 minutes after getting ... Read more
Light headed and dizzy, sweating, passed out briefly. 15 seconds. This was 45 minutes after getting injection. I did not have trouble breathing or swallowing. Very similar to what has happened to me sometimes getting blood drawn but happens at time of appointment not after. Reclined, deep breaths and started to feel better within 10 minutes. An hour later feeling much better.
54 2021-03-28 deep vein blood clot, pulmonary embolism DVT of left lower extremity 2 weeks after first shot PE
54 2021-03-29 loss of consciousness Client received vaccination and then became dizzy and lightheaded. Passed out was sent to ER via EMS
54 2021-03-29 palpitations Pain on the side of the injection, chills, difficulty breathing, palpitations and severe dizziness a... Read more
Pain on the side of the injection, chills, difficulty breathing, palpitations and severe dizziness almost like fainting. Tremors in the hands and arms, these lasted approximately one hour and thirty minutes.
54 2021-03-30 heart rate increased pt. reports feeling like his heart rate is elevated. radial pulse in 70s. pt. reports a hx of val... Read more
pt. reports feeling like his heart rate is elevated. radial pulse in 70s. pt. reports a hx of valovagal syncope. Medics present. Symptom beginning to resolve with comfort / calming measures. Will cont. to monitor for an additional 15 mins. pt. denies any difficulty swallowing / breathing &/or other S/S.
54 2021-03-30 heart rate increased Body aches; Chills; Fever of 101; Nausea; Drymouth; extreme fatigue; Rapid heartbeat; mild headache/... Read more
Body aches; Chills; Fever of 101; Nausea; Drymouth; extreme fatigue; Rapid heartbeat; mild headache/severe headache; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03Feb2021, at 14:00 (at the age of 54-year-old) as a single dose for Covid-19 immunization. The patient medical history included allergies to Penicillin. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication was not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and didn't receive any other medications within 2 weeks of vaccination. On 04Feb2021, the patient had mild headache, Injection site pain. On 05Feb2021 at 11:00 the patient had severe headache, body aches, Chills, Fever of 101, Nausea, dry mouth, extreme fatigue, rapid heartbeat. It was reported that the headache subsided on 06feb2021 at 03:00 and the patient was still fatigued. The patient took Tylenol as a treatment for all the events. The seriousness of the events was reported as non- serious. The outcome of the events was reported as recovering. Information about lot/batch number requested.
54 2021-03-31 hypertension Tinnitus and high blood pressure starting 2 days after first injection and still happening 12 days a... Read more
Tinnitus and high blood pressure starting 2 days after first injection and still happening 12 days after. Second injection scheduled for April 13, 2021.
54 2021-04-01 chest pain Hypertensive Crisis, chest pain, facial flushing which is still occuring. Went to ER at 12:15 am on ... Read more
Hypertensive Crisis, chest pain, facial flushing which is still occuring. Went to ER at 12:15 am on 3/17/2021. Treated with Labetatol.
54 2021-04-01 chest pain Within approximately a couple of days from the first of two COVID19 Pfizer injections, I developed a... Read more
Within approximately a couple of days from the first of two COVID19 Pfizer injections, I developed a progressive, systemic, neuro/neuro-muscular inflammatory pain response. The inflammation and pain first manifested in my left wrist and hand, greatly worsening recent symptomology that may have been the start of a carpal tunnel syndrome. The inflammation and pain then progressed to my right wrist and hand and right shoulder. Then they progressed to my left shoulder, under my clavicles, my hips, and my upper lumbar/lower thoracic region of my spine. Muscle groups tightened and hurt, chief among them my hamstrings and upper back. All within days. The inflammation and pain were severe, especially from the early a.m. (3 or 4 in the a.m.) to waking hours. And the conditions left me nearly debilitated and incapable of sleeping well or performing many ADLs. Then, on Monday, March 29, 2021, I saw an orthopaedic for the pains in my wrists and hands, and he prescribed me a steroid for a preliminary diagnose of bilateral carpal tunnel. The inflammation and pain throughout my body decreased considerably after only two doses of the steroids. That led me to seek a consultation with the rheumatologist.
54 2021-04-04 pulmonary embolism Pulmonary Embolism
54 2021-04-07 chest discomfort started 1pm on 4/7 patient experienced dizziness, shortness of breath, tightness of chest and throat... Read more
started 1pm on 4/7 patient experienced dizziness, shortness of breath, tightness of chest and throat, lethargic, and sweat profusely. PT woke up and bed was soaked. Anxiety and confusion lingers to today 4/8 - today patient still feel lethargic but not nearly as bad - Recommended patient to keep monitoring and proceed to ER if needed
54 2021-04-09 loss of consciousness, hypotension, body temperature decreased Passed out; Blood pressure was low for him: 112/54; temp was also low: 96.6; thirsty; feel funny; Th... Read more
Passed out; Blood pressure was low for him: 112/54; temp was also low: 96.6; thirsty; feel funny; This is a spontaneous report from a contactable consumer reported for self. This 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Mar2021 14:45 PM on Arm left at single dose (Lot # ER8732) for covid-19 immunisation. Medical history included Sleep apnea, breathing issues, IBS, Hypertension; Anxiety/Depressive disorder. No known allergies. No covid prior vaccination. Concomitant medications included other medications in two weeks. No other vaccine in four weeks. On 26Mar2021 08:00 AM, he went to the bathroom around 8 a.m. this morning and started to feel funny. He stood up and passed out onto the floor. Family members heard him and came to help. Blood pressure was low for him: 112/54. Temp was also low: 96.6. He was very thirsty. No treatments received. No covid tested post vaccination. Outcome of the events was recovering.
54 2021-04-09 palpitations Within an hour started feeling weird. over the course of the next 36 hours, my reaction to the vacc... Read more
Within an hour started feeling weird. over the course of the next 36 hours, my reaction to the vaccine is awful. Worse than my covid. At least I know my body is doing what it is supposed to be doing. But it is just miserable. Massive headache, soreness, weird shooting pains in my leg, sweats and chills and nausea, and now the racing heart and shortness of breath.
54 2021-04-10 fainting, blood pressure decreased Patient fell off chair within 15 minutes of vaccination. Patient fainted; BP dropped to 64/39. IV ... Read more
Patient fell off chair within 15 minutes of vaccination. Patient fainted; BP dropped to 64/39. IV started and transported to ER by EMS.
54 2021-04-11 fast heart rate Supraventricular Tachycardia
54 2021-04-11 fainting Reported an episode of syncope. Transferred to the ED and will follow up with PCP.
54 2021-04-13 heart rate increased, palpitations Roughly six (6) hours after I received my second dose I became extremely agitated and angered what I... Read more
Roughly six (6) hours after I received my second dose I became extremely agitated and angered what I would call a homicidal rage that lasted for about an hour which then morphed into a visual hallucinations those lasted for about an hour and those turned into racing heart with heart palpitations and bilateral involuntary hand movements tremors
54 2021-04-15 cerebrovascular accident 14 hours after vaccination patient experienced signs and symptoms of a stroke: aphasia, left arm wea... Read more
14 hours after vaccination patient experienced signs and symptoms of a stroke: aphasia, left arm weakness, clumsy, could not text. Called 911
54 2021-04-17 blood clot This is a spontaneous report received from a contactable consumer (patient). A 54-year-old male pati... Read more
This is a spontaneous report received from a contactable consumer (patient). A 54-year-old male patient (height: 193cm, weight: 99.79kg) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6207) via an unspecified route of administration at right upper arm on 18Mar2021 18:00 (54-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included blood pressure, teeth cleaned (Shortly before the shot, went to the dentist to have teeth cleaned. Directly from Dentist went to pharmacy. Went to pharmacy's Drive Thru to pick up a little antibiotic from the dentist. It was 4 capsules of Amoxicillin. He was supposed to take the Amoxicillin before the dentist office visit, but he forgot to do that. Therefore, soon as he left the dentist office he went to pharmacy to pick it up so he could take it. While he was there, was offered the COVID 19 vaccine and that it was the last shot). Concomitant medications included atenolol tablet from 2016 (been taking for 5 years) and ongoing for blood pressure, and ascorbic acid/ cyanocobalamin/ ergocalciferol/ nicotinamide/ pyridoxine hydrochloride/ retinol/ riboflavin/ thiamine mononitrate (ONE-A-DAY). No additional vaccines administered on same date. No history of all previously immunizations. No prior vaccincations wtihin 4 weeks. He got the shot Thursday and by Sunday, many different side effects were coming in. He has had side effects from the COVID VACCINE, but initially he does not want to file report, just thinks that everyone needs to get the shot. He does not have complaints. He is wondering how long the side effects will last, and when they go away. States that he is being treated as he has gone to the doctor's. Also states that he made an appointment with the doctor and almost went to the emergency room a couple of times. Right after the shot, he was getting in the car and his right leg started hurting (on 18Mar2021). It didn't go away for a couple of days. It went away but then noticed his shoes started feeling funny. He wasn't looking at his feet, put his shoes on they felt tight. Then he started to look at feet more. Below his knees, his legs are swollen. Swelling started within 2 to 3 days after the vaccine. The swelling is really severe when standing. Everybody at work has seen how sick he is and his legs. Swelling in the legs has him concerned, thinking maybe it's a blood clot. He was given medicine and would like to see it go away. He keeps his legs up. He has other side effects (all in Mar2021) and is having flu like symptoms. He basically has the flu. He has never had the flu shot. This is the first flu shot (He referred to the COVID vaccine as the flu shot as documented. However, confirmed suspect product as Pfizer covid vaccine) he has had that he knows of. He is questioning if he should get the second shot. He feels a little dizzy. Quick questions get him confused and that it comes and goes. Lungs felt full, gasping for air: not now but, since the doctor gave him antibiotics (unspecified injections, he was given 2 shots at the doctor's office, one in each arm), his lungs felt full. At times he was gasping for air. It went away but thought he was going to die. Now when he gets winded, it feels like he has a dry cough. Gets winded easily. The doctor ordered him an inhaler, Symbicort, but it was very expensive, so he did not get it at that time. He never picked it up because it was too much money. The fluid is not there anymore and he does not feel like he needs this as does not feel like it needs to be cleared. He is having wheezing. He can now take deeper breaths. Fatigue: initially, that he was feeling tired within 1 or 2 days, but he did not recall the next day feeling that way (later stated it was within 2-3 days he started to feel tired). He is still tired. Unable to clarify time frame of fatigue further. He feels bloated and full. Hasn't really eaten but feels real full and bloated. Hot and cold flashes started occurring about the same time as the other symptoms. He had these last evening. He does not get the flu very often and doesn't take the Flu shot. This is the closest thing he can remember having a pretty good episode with the flu. He was also given prescriptions for 2 new medications: Triamterene 37.5mg daily, for leg swelling; Clindamycin, 300mg, twice a day, an antibiotic. The odd thing is that it seems like his eyes are big, like really, really big, like they are really open. It is like big eye balls. States that he is just sick and his body is reacting to getting better. He has not been to work in the last 3 days. States that he is fine, just worried about work. Patient asked for personal advice about going back to work. The outcome of "his right leg started hurting" was recovered; outcome of "below his knees, his legs are swollen/ swelling in the legs/ put his shoes on they felt tight" and Fatigue/feeling tired was not recovered; outcome of other events was unknown.
54 2021-04-18 chest pain chills, night sweats, chest pain, body aches, nausea, anorexia, back pain now, 16 lb weight loss, co... Read more
chills, night sweats, chest pain, body aches, nausea, anorexia, back pain now, 16 lb weight loss, cough when sitting up and moving, peripheral neuropathy, - chest pain resolved but other issues are persistently bad, adv some of the initial symptoms could have been related to the shot, such as initial body aches and chills, but persistent and worsening issues are NOT expected this far out. I adv HCF eval given likely unrelated persistent symptoms, consider ED if effects are severe and worsening. He will likely go in tonight but he isn't sure where he will go. I adv try not to drive yourself call back if issues. PCC will FU tomorrow with patient at home. 4/11-Patient positive for Covid per MD at hospital Follow up call - Patient feeling better today, went to ED at hospital , was prescribed Flexeril, Ibuprofen and ondestron. Second vaccination is next week.
54 2021-04-18 heart rate increased Persistent Increased heart 110-114bpm started 8-10 hours after the injection and continued roughly 3... Read more
Persistent Increased heart 110-114bpm started 8-10 hours after the injection and continued roughly 30-36 hours. My heart rate while sleeping was over 95+ bpm and 110-114bpm while awake In addition, I had severe joint aches, fatigue, night sweats, fever for 48-72 hours.
54 2021-04-20 pulmonary embolism, fibrin d dimer increased Bilateral pulmonary Embolisms with pulmonary infarcts
54 2021-04-20 pulmonary embolism I went to the ER on 4/17/21. Had Pulmonary Embolism in both lungs. I was in the hospital 3 days. I... Read more
I went to the ER on 4/17/21. Had Pulmonary Embolism in both lungs. I was in the hospital 3 days. I have no personal history of blood clots and no family history of blood clots. Now I must be on blood thinners the rest of my life, because the science does not know? I understand from the doctors that 4 out of 1,000,000 cases are happening with the Pfizer vaccine. Why is this information not being released to the public? I almost died from the Pfizer vaccine and am not permanently disabled by it.
54 2021-04-21 blood clot 15 days after the 2nd shot i developed a blood clot in my left leg.
54 2021-04-24 loss of consciousness, hypotension, chest discomfort passed out/continued to drift in and out of conscientiousness; BP was very low; chest tightness; Thi... Read more
passed out/continued to drift in and out of conscientiousness; BP was very low; chest tightness; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via intramuscular route of administration on 09Apr2021 at 17:45 (at the age of 54 years) at a single dose in the left arm for COVID-19 immunization. Medical history included stroke/heart attack from 2014 to an unknown date. Concomitant medications included omeprazole (PROTONIX [OMEPRAZOLE]); atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]); levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]); amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL); citalopram; and clopidogrel. The patient previously took the first dose of BNT162B2 (lot number: EP6955) on 19Mar2021 (age: 54 years) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. Patient had no known allergies. On 09Apr2021 at 18:00, after second vaccine was given, patient passed out. His wife was with him. He came to but continued to drift in and out of conscientiousness. His BP was very low, pulse ox 99. He also had chest tightness. Ambulance was called. He was stable till ambulance came and took him to hospital. The events resulted in emergency room/department or urgent care and hospitalization. Therapeutic measures were taken as a result of the events which included IV fluids, Tylenol and something was placed under his tongue for chest tightness. The patient had COVID test on an unspecified date with unknown results. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
54 2021-04-24 blood clot, lightheadedness Felt something in my leg like a cramp / did a scan of my leg and found the clot; dizzy; nearly passe... Read more
Felt something in my leg like a cramp / did a scan of my leg and found the clot; dizzy; nearly passed out; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 at 16:30 at single dose in right arm for COVID-19 immunisation at the age of 54-year-old. Lot number was ER8732. Medical history included Human papilloma virus (HPV) positive tonsil cancer, ankylosing spondylitis, tinnitus, neuropathy, decreased memory from chemo and radiation. The patient did not have Covid prior to vaccination. Concomitant medications were unknown. The patient felt something in leg like a cramp for a week since 06Apr2021 before ER visit. On 06Apr2021, the patient got dizzy at home nearly passed out, and he went to ER. On 14Apr2021, Doctor did a scan of leg and found the clot. The patient was hospitalized due to the events and they were considered life-threatening. The patient was treated with heparin and ELIQUIS. On 14Apr2021, Rapid Covid test was negative. The patient was recovering from the events.
54 2021-04-26 hypertension, blood glucose increased soreness in arm and elbow within 30 minutes, soreness and sharp pain on the whole upper body after 2... Read more
soreness in arm and elbow within 30 minutes, soreness and sharp pain on the whole upper body after 2hrs. severe pain in all joints and never seen before crippling arthritis within 4 days. numbness in my hands, severe neck, back, elbow and wrist joint pain. sores and infections all over my legs after 5 days. migraines. blood pressure and severe glucose spikes without substantial change in diet. now no feeling in hands other than ice-cold fingers that never warm and constant pain.
54 2021-04-27 deep vein blood clot, pulmonary embolism Patient is a lovely 54 year old- year old male initially seen 4/5/2021, kindly referred by Dr. Histo... Read more
Patient is a lovely 54 year old- year old male initially seen 4/5/2021, kindly referred by Dr. History of COVID pneumonia in 4/2020 which was complicated by ARF and shingles, Ramsay Hunt Syndrome, with subsequent post-herpetic pain on right side of scalp.He recently received his COVID-19 Pfizer vaccine 3/20/2021 11 days prior to presentation to the hospital with shortness of breath, worsening dypnea on exertion which started 2 days after vaccine. Before this he was biking twice a week, and swimming nearly daily. He did report any medical problems before COVID, was on no meds. 3/31/2021-CT PE protocol showed multiple bilateral PEs without right heart strain. Pulmonary Vasculature: Bilateral filling defects consistent with pulmonary emboli are visualized involving the following: Distal right main pulmonary artery extending to the right lower lobar, segmental, and subsegmental branches, right middle lobar, segmental, and subsegmental branches and proximal right upper lobe artery. Left lower lobar, segmental, and subsegmental arteries. The right heart is not dilated.COVID/flu swab neg, trop x2 neg, BNP wnl. - Started on therapeutic lovenox then plan to transition on discharge to PO xarelto 15 mg bid x21 days then continue with xarelto 20 mg daily. He was seen by Dr. and referred to me for follow up. He had US 4/5/2021- which showed Right Lower Extremity: There is acute thrombus of the femoral proximal vein.Right Lower Extremity: There is no evidence of deep or superficial venous thrombosis in the common femoral, popliteal, posterior tibial, peroneal, GSV and SSV veins. Left Lower Extremity: There is no evidence of deep or superficial venous thrombosis.' 4/5/2021: Initial hematology visit Currently does not have any pain in legs, swelling. Reports that he still is not back to 100%, he got on peloton yesterday and was only able to go 5-6 miles at a slower pace. Denies fevers, chills, sweats. He has some intermittent pain where his previous zoster scalp lesions were. He has been undergoing facial PT. Thrombophilia workup sent which was grossly negative.
54 2021-04-27 loss of consciousness Patient received the vaccine then reported to the observation area. After a few minutes in the obser... Read more
Patient received the vaccine then reported to the observation area. After a few minutes in the observation area the patient stated he was light headed and dizzy and might pass out. A few moments later the patient passed out. He passed out from his chair to the floor where he was assessed by pharmacists and a nurse. He was sweating and was coming in and out of responsiveness. Patient never stopped breathing. 911 was called and patient was taken away by EMS. Patient was still in and out of responsiveness when EMS arrived.
54 2021-04-29 low blood platelet count, nosebleed, platelet count decreased Pt with H/O long-standing ITP, APLABs, VTEs, admitted with exacerbation of ITP and immune neutropen... Read more
Pt with H/O long-standing ITP, APLABs, VTEs, admitted with exacerbation of ITP and immune neutropenia after first dose of Pfizer COVID-19 vaccine.
54 2021-04-29 ischaemic stroke approximately 1 weeks post vaccine patient suffered vision loss and was diagnosed with ischemic stro... Read more
approximately 1 weeks post vaccine patient suffered vision loss and was diagnosed with ischemic stroke
54 2021-04-30 anaemia Patient developed GI bleed few days after vaccination. Unclear if it is related. His platelet coun... Read more
Patient developed GI bleed few days after vaccination. Unclear if it is related. His platelet count is normal. developed acute anemia due to GI bleed. Also has remote history of GI bleed 9 years ago with negative workup. did not have any recurrent bleeding since then until this episode and have been getting routine GI screening.
54 2021-04-30 inflammation of the pericardium I went to ER with extreme chest pain and difficulty in breathing. I was diagnosed with pericarditis... Read more
I went to ER with extreme chest pain and difficulty in breathing. I was diagnosed with pericarditis.
54 2021-05-02 chest pain Patient received first Pfizer COVID vaccination 3 days ago at an outside facility and has presented ... Read more
Patient received first Pfizer COVID vaccination 3 days ago at an outside facility and has presented today to our facility with chest pain found to be acute coronary syndrome. Patient is daily smoker, BMI of 35.5, and drinks 5-6 drinks daily.
54 2021-05-03 fainting Vaccinated Weds 4/28/21. Started shortly thereafter with fever Tm 102 F, chills, headache. Startin... Read more
Vaccinated Weds 4/28/21. Started shortly thereafter with fever Tm 102 F, chills, headache. Starting Thursday with fatigue and metallic taste in his mouth. He has no appetite and reports not eating x 4 days. He has had fever and headache persistent since vaccination. He has not slept x 4 days since vaccination, he reports his mind is racing. He had a syncopal episode x3 night of 5/2/21 back to back. Right before syncope he did not feel lightheaded or dizzy, chest pain, palpitations. He had LOC lasting less than a minute in total.
54 2021-05-03 blood clot Received first dose on 1/4/21 and second dose on 1/25/21. 4/28/21 reported having leg pain and was ... Read more
Received first dose on 1/4/21 and second dose on 1/25/21. 4/28/21 reported having leg pain and was seen by primary care where it was determined he had a blood clot and was placed on blood thinners.
54 2021-05-04 haemoglobin decreased Acute respiratory failure with hypoxia Pneumonia due to COVID-19 virus Patient was treated with Cov... Read more
Acute respiratory failure with hypoxia Pneumonia due to COVID-19 virus Patient was treated with Covid medications including convalescent plasma, remdesivir and dexamethasone. Patient is able to wean off oxygen, currently requiring a minimal amount of oxygen support with exertion. Patient will complete antibiotic course
54 2021-05-04 loss of consciousness 15 minutes after patient left the clinic and was driving home, he developed a metallic taste in his ... Read more
15 minutes after patient left the clinic and was driving home, he developed a metallic taste in his mouth. He called his wife who told him he might pass out and should pull over. He stopped and put on his hazard lights. His vision started to tunnel and he did pass out for about 5 minutes. After coming to, he continued the drive home, about 2 more miles. He did feel shaky for several more hours but no further symptoms. He did not contact his provider.
54 2021-05-05 cerebrovascular accident Left sided visual issues. Went to ER, Advised that I had a stroke. No issues or problems prior
54 2021-05-05 ventricular tachycardia, chest discomfort, ejection fraction decreased, heart attack Patient presented to ED with chest tightness on 4/20/21 54YO male with PMH significant for CAD s/p ... Read more
Patient presented to ED with chest tightness on 4/20/21 54YO male with PMH significant for CAD s/p PCI to RCA x2 (2003, 2005), chronic HBV, GI bleed, H. pylori gastritis presented to the hospital with chest tightness. Patient had just finished working out for about 45 minutes when he noted tightness across his lower chest/epigastric region. Found to be in V tach upon arrival and underwent electrical cardioversion with relief of symptoms. Patient was aspirin loaded and started on heparin and lidocaine drips. He underwent cardiac cath which did not show any hemodynamically significant stenosis. Also underwent cardiac MRI which demonstrated a non-viable transmural infarct of the inferior wall. Etiology of VT was thought to be scar mediated from prior MI. Patient underwent uncomplicated ICD placement and was started on metoprolol. ICD interrogation POD 1 was unremarkable. Patient discharged in stable condition with close follow up with PCP, Cardiology, and EP. Patient with unchanged coronaries and unchanged ejection fraction. Patient received Covid-19 Pfizer vaccine IM on 3/27 (left deltioid - LOT ER8733) and 4/17 (left deltioid - LOT EW0170).
54 2021-05-06 chest pain, heart attack Started developing Chest pain and eventual heart attack.
54 2021-05-09 cerebrovascular accident The expected side effects on the day after the second shot of headache, muscle aches, chills, fever.... Read more
The expected side effects on the day after the second shot of headache, muscle aches, chills, fever. On May 5, 2021, patient suffered a stroke. Could not control right arm, could not speak. Called 911, taken to ER, and checked into hospital.
54 2021-05-09 heart rate increased, blood glucose increased, hypertension The following are descriptions is a synopsis of information provided over the phone by the patient's... Read more
The following are descriptions is a synopsis of information provided over the phone by the patient's wife on 5/10: At time of second dose patient was fatigued, lethargic, hyperglycemic, and experiencing brain fog. She states some of the symptoms started some time after his first dose but couldn't provide a time frame. On 5/6 he answered the Vaccine Questionnaire question of "are you sick today?" as "unsure" and further discussion was had with a pharmacist to verify he was eligible to receive vaccine. Neither the pharmacist or patient remember the details of this discussion. Patient and wife have belief that his ethnicity contributed to dismissing of possible illness during the vaccine screening process, but due to the patient's lethargy and brain fog at the time, he could not provide specifics of the conversation. His wife was not with him during the screening process with the pharmacist or during vaccine administration. The appointment time was 4:55pm. The wife states the patient was so fatigued after the shot was administered on 5/6 that he was asleep in his chair in the observation area. Later that day fever of 100.5 was noted and controlled by OTC ibuprofen 2 hours after the ibuprofen was administered. The wife states that he rapidly declined over the 3 days after second Pfizer vaccine and she called an ambulance on Sunday 5/9. From the ER he was admitted to the ICU with the primary reason for admission listed as hyperglycemia but a COVID was listed as a contributing factor. The COVID test administered Sunday was positive. He had high blood pressure, heart rate, blood sugar, and sodium. Patients vitals have since stabilized other than the sodium is still high. He is in ICU at hospital still very lethargic as of today 5/10.
54 2021-05-11 atrial fibrillation Patient began to feel short of breath on May 7th. May 10th seen by doctor and diagnosed with new ons... Read more
Patient began to feel short of breath on May 7th. May 10th seen by doctor and diagnosed with new onset atrial fibrillation.
54 2021-05-11 blood clot I felt tired the evening of the shot. The next morning I had fever and chills, body aches everywher... Read more
I felt tired the evening of the shot. The next morning I had fever and chills, body aches everywhere, severe headache, extreme fatigue, and very upset stomach. By the second day following the vaccination I have a very bloated stomach and extreme pain. These symptoms continued with the stomach and headache becoming worse. Entered the Emergency Room the evening of May 7th and admitted into the Hospital.
54 2021-05-12 chest pain, atrial fibrillation Aches, fluish symptoms, muscle aches, fever (100ish), significant brain fog (confusion, no concentra... Read more
Aches, fluish symptoms, muscle aches, fever (100ish), significant brain fog (confusion, no concentration-still continues), regional shoulder pain, massive headache-several days, significant heart/chest pain upper left quadrant both first and second shot. Went into Atrial fibrillation 4-5 days after first shot. Massive emotional swings from ecstasy to rage and depression starting day after shot and continuing.
54 2021-05-13 hypertension, fast heart rate Had tachycardia and high blood pressure, headaches and some nausea yesterday. Tachycardia hasnt r... Read more
Had tachycardia and high blood pressure, headaches and some nausea yesterday. Tachycardia hasnt repeated but headaches and queasiness continue intermittently along with possible high BP Never had this before was wondering if possible side effect? EKG came back same as normal for me and bloodwork fine. Still feeling poorly.
54 2021-05-14 cerebrovascular accident I awoke with distorted vision in my Left eye.; a stroke; visual impairment; This is a spontaneous re... Read more
I awoke with distorted vision in my Left eye.; a stroke; visual impairment; This is a spontaneous report from a contactable Other Health Professional (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), via an unspecified route of administration, administered in arm left on 19 Jan 2021 at 19:00 (Batch/Lot Number: EL3302) as 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included omeprazole (PRILOSEC [OMEPRAZOLE]), rosuvastatin, metoprolol, and ezetimibe (ZETIA), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (lot number: EL1284) in the left arm on 29Dec2020 07:00 PM for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to COVID-19 vaccine. He was not diagnosed with COVID-19 prior vaccination. It was reported that the patient awoke with distorted vision in his left eye. He went to the emergency room and was diagnosed with a stroke. He was subsequently transferred to the (hospital name) Level 1 Stroke Center. He continued to have visual impairment. The events started on 30Apr2021 07:00 AM. The patient was hospitalized for 5 days. The events was reported serious life-threatening, hospitalization and disabling/incapacitating. Therapeutic measures were taken as a result of the events with TPA. He had been tested for COVID-19 since the vaccination through rapid test (nasal swab) on 01May2021 with negative result. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
54 2021-05-16 fainting Son came into Health Dept this morning to report that his father began throwing up and having diarrh... Read more
Son came into Health Dept this morning to report that his father began throwing up and having diarrhea Saturday morning(05/15/2021) which progressed through the day. States did not want to go to the Hospital but wanted to wait to see his MD at the Dialysis center on Monday (05/17/2021). On Sunday(05/16/2021) nausea and vomiting and diarrhea was worse and now with cough noted. States was washing his hands and fainted, EMS was called and he died that morning.
54 2021-05-19 fibrin d dimer increased Fever and chills Myalgia Viral syndrome ED to Hosp-Admission Discharged 4/18/2021 - 4/22/2021 (4... Read more
Fever and chills Myalgia Viral syndrome ED to Hosp-Admission Discharged 4/18/2021 - 4/22/2021 (4 days) Hospital MD Last attending ? Treatment team Acute respiratory failure with hypoxia (CMS/HCC) Principal problem Presenting Problem/History of Present Illness/Reason for Admission Acute respiratory failure with hypoxia (CMS/HCC) [J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82] Hospital Course This pleasant 54-year-old gentleman with history of hypertension came in with increasing shortness of breath and hypoxia secondary to Covid pneumonia resulting in hypoxic respiratory failure and diffuse pulmonary infiltrates. Patient was hospitalized for management of severe sepsis secondary to Covid pneumonia resulting in acute hypoxic respiratory failure. Patient was also treated for possible secondary bacterial pneumonia given duration of Covid symptoms prior to coming into hospital. Patient made nice recovery and was able to wean off from high flow oxygen down to 2 L with exertion. Patient overall made nice recovery hence he was discharged home. Patient was noted to have rising D-dimers despite clinical improvement in Covid infection. He is at high risk for developing DVTs hence he was recommended to use Xarelto 10 mg daily for 1 month to prevent any risk of DVTs. Patient voiced understanding of this. In he was discharged home with home health care. His readmission potential is low to moderate.
54 2021-05-19 heart rate decreased After the 15 minute post shot waiting period patient said he felt "confused" with clammy hands. H... Read more
After the 15 minute post shot waiting period patient said he felt "confused" with clammy hands. He sat in the chair and was slow to talk. I asked him if he was diabetic, and he responded that he was, but he never feels this way and had eaten before coming in. After talking a while longer, I was going to ask him if he'd like us to check his sugar, he asked me if we had a blood pressure cuff. I said we did, but he wanted to use the machine in front of the store because he felt well enough to get up and wanted to walk. I walked to the machine with him. He sat and answered the many questions tapping on screen with no issues at all. The confusion was not evident. The maching reported 111/68 or very close, with a pulse of 48. He said, "that's the issue, my pulse is down. I need to walk around." I said he could stay back at the pharmacy where we could see him, or we could call someone for him. He said staying back here would not help his pulse. I told him there was no hurry, he'd been here for his 15 minutes, but we could keep an eye on him or help him and call whatever he needed. He said no, he'd be fine, he just needed to walk around. He now had pressure in his head, not really a headache just pressure, he said it was all related to his pulse. He said if he needed help later he could always go to an Urgent Care, I offered again to call anywhere for him or call for assistance, he was not interested.
54 2021-05-19 fainting Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Mild, Additional Details: 5 minutes following second dose of pfizer pt with syncopal episode. LOC for 10 seconds, came to spontaneously without intervention. Pt placed in trendelenburg, regained consciousness. vital signs stable, blood sugar stable, no injury.
54 2021-05-19 transient ischaemic attack Date 04/30/2021 Onset of symptom at approximately 1:30pm: developed slurred speech. Lost of strengt... Read more
Date 04/30/2021 Onset of symptom at approximately 1:30pm: developed slurred speech. Lost of strength started to left lower extremity and weakness and followed up to left upper extremity with lost of strength and weakness. Symptoms lasted approximately 3 minutes, and was taken to Hospital with an admitting diagnosis of Transit Ischemic Attack.
54 2021-05-22 fainting, hypotension Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypotension-Severe,... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypotension-Severe, Additional Details: patient fainted 7-10 minutes after vaccination. He felt when tried to stand up so he layed down until the help arrives. Patient mentioned about having history of fainting whne he had blood draw years back. Never received any vaccinations. EMS took him to hospital for check up. No allergic reactons noted no breathing issues as well.
54 2021-05-22 fast heart rate Fever to T max 105.3, tachycardia to HR 135, altered mental status (lethargic, nonsensical speech)
54 2021-05-24 lightheadedness The vasovagal episode almost immediately after vaccination. The patient reports that this happens w... Read more
The vasovagal episode almost immediately after vaccination. The patient reports that this happens with most needles and anytime blood is drawn. At the time of my arrival, he is drinking juice and reports he is feeling at his baseline. No further intervention required.
54 2021-05-25 blood clot in the brain, cerebrovascular accident Major blood clot in the brain that caused a stroke He is still in hospital
54 2021-05-25 chest discomfort Headache; dizziness; foggy; heavy feeling in chest; heavy feeling in shoulders, and arm; This is a s... Read more
Headache; dizziness; foggy; heavy feeling in chest; heavy feeling in shoulders, and arm; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 54 years old, in left arm on 06May2021 15:30 at single dose for covid-19 immunisation. The patient medical history was reported as none. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks and any other medications within 2 weeks prior to vaccination. The patient experienced headache, dizziness, foggy, heavy feeling in chest, shoulders, and arm on 14May2021 05:00. The patient had not been tested for covid-19 since the vaccination. No treatment was received. The outcome of events was not recovered. Information on the lot/batch number has been requested.
54 2021-05-25 fast heart rate ED Discharged 5/5/2021 - 5/6/2021 (3 hours) Last attending ? Treatment team Acute nonintractable h... Read more
ED Discharged 5/5/2021 - 5/6/2021 (3 hours) Last attending ? Treatment team Acute nonintractable headache, unspecified headache type Clinical impression Headache Chief complaint Triage Note: To ED c/o severe HA behind R ear since being dx w COVID 4/30. Denies cough, dyspnea, fevers. Reporting he has had 1 round of COVID vaccines. Has taken "alieve, tylenol, and advil" w/o relief. Last doses all "early this morning." pt awake and alert in triage. History of Present Illness Patient is a 54 y.o. yo male presenting to the ED with severe headache behind the right ear since 4/30. Patient was diagnosed with Covid at that time and has taken 1 round of the Covid vaccine. He has tried Aleve, Tylenol and Advil without relief. He states that his last dose were all early this morning. Denies any numbness or tingling, visual disturbances, ataxia, photophobia. He has no history of strokes, MI or blood clots. He states that prior to his Covid diagnosis he is otherwise healthy. ED Discharged 5/8/2021 (4 hours) Last attending ? Treatment team COVID-19 Clinical impression Fever Chief complaint Medical Decision Making 54-year-old male who presents today due to uncontrolled fever, diagnosed with Covid on April 30. Symptomatic for about 2 weeks now. On exam appears to be uncomfortable, is febrile and tachycardic, however remaining vitals are stable. Physical exam is also reassuring. Patient not complaining of any chest pain, shortness of breath, lightheadedness. Will provide patient with symptomatic relief including fluids and ibuprofen, if able to improve patient's symptomatology will have him discharged home. His labs also show some slight hyponatremia, he will likely improve from fluids as I believe this is secondary to his diarrhea that he has been having over the last few days. CK also slightly elevated, would likely benefit from fluids. After a single liter of fluids, patient symptoms improved, fever and tachycardia also improved, continues to endorse some generalized weakness, will give second liter of fluid and Tylenol at this time as he is due for this. After receiving a second liter, the patient states that his symptoms have greatly improved at this time, comfortable returning home. I advised the patient that she should take ibuprofen and Tylenol on 6-hour cycles very regularly, he can take it in a pattern where he takes Tylenol followed by ibuprofen 3 hours later followed by Tylenol again 3 hours later, as long as he keeps 6 hours in between doses, explained to him that he should not take this any sooner than this however he should be sure to take these regularly as these will help control his fever. Also encouraged him to hydrate appropriately as this will likely prevent him from feeling poorly. He is agreeable with this plan, I provided him with appropriate return precautions.
54 2021-05-27 blood pressure increased, platelet count decreased Pfizer-BioNTech COVID-19 Vaccine EUA: patient admitted for another diagnosis and found to have COVID... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient admitted for another diagnosis and found to have COVID-19 infection two days after vaccination. Vital signs on admission stable except blood pressure slightly elevated. Patient reported shortness of breath with exertion, dry cough, and mild dyspnea at rest. Received cough suppressants and supportive care. Patient discharged medically stable two days later.
54 2021-05-27 chest pain, inflammation of the pericardium Acute pericarditis.
54 2021-05-28 chest pain, inflammation of the pericardium Presented with acute onset chest pain, worse with leaning forward, EKG showed PR depression and ST s... Read more
Presented with acute onset chest pain, worse with leaning forward, EKG showed PR depression and ST segment elevation - strongly suspected to have pericarditis based on story and EKG findings. Symptoms improved after initiation of NSAIDs. Discharged home with prescription for ibuprofen.
54 2021-05-29 palpitations, chest pain Fever, Chills, Heart Palpitations - Heart rate was 126 Joint Pain Pain in Chest when taking Breaths ... Read more
Fever, Chills, Heart Palpitations - Heart rate was 126 Joint Pain Pain in Chest when taking Breaths More Pain when lying down, cant turn on the side Eye Pain with Headaches
54 2021-06-01 arrhythmia Patient went swimming at a fitness center the day after he had his 2nd COVID-19 vaccine and was foun... Read more
Patient went swimming at a fitness center the day after he had his 2nd COVID-19 vaccine and was found unresponsive at the bottom of the shallow 4.5 deep pool while exercising. He was not able to be revived. The death certificate says that the immediate cause of death was Arrhythmia resulting from Hypertensive Atherosclerotic Cardiovascular Disease.
54 2021-06-01 loss of consciousness 2 weeks after the first dose Awful pain and stiffness in both hands. went to DR on 4/12 did blood w... Read more
2 weeks after the first dose Awful pain and stiffness in both hands. went to DR on 4/12 did blood work diagnosed with RA. Did not think about the vaccine until two weeks after the second dose I struggle to walk with severe pain in my legs, arms, and hands. Life since has been pretty rough passed out from the pain on May 16th had to have 9 staples in my head. Now my life is trying to balance medication so I can sleep at night. And get through the days at work. I have had to miss days.
54 2021-06-02 heart rate increased Approximately 24 hours after second Pfizer vaccine dose, patient reported having severe vision and b... Read more
Approximately 24 hours after second Pfizer vaccine dose, patient reported having severe vision and balance problems, headache and severe fatigue and memory loss. Vision symptoms included hallucinations, tunnel vision and blurred. Unable to stand up without staggering. Confusion. Difficulty verbalizing thoughts. Treated with ivermectin, D3, Z, quercitin, aspirin and other supplements on advice of doctor. Symptoms persisted in severe form for 48 hours, then began to improve. At 6/3/2021, blurred vision while reading, higher than normal heart rate during exercise, fatigue and intermittent memory loss. Being treated by doctor and kinesiologist for brain injury from vaccine
54 2021-06-02 fainting On the 2nd day after 2nd Pfizer vaccination I experienced dizziness then fainted, with fatigue and n... Read more
On the 2nd day after 2nd Pfizer vaccination I experienced dizziness then fainted, with fatigue and nausea
54 2021-06-13 palpitations Heart palpatations started roughly 1 week after second dose, followed by shortness of breath and swe... Read more
Heart palpatations started roughly 1 week after second dose, followed by shortness of breath and sweating. Overall lethargic until 2 weeks after second dosage.
54 2021-06-16 chest pain severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and ... Read more
severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; chest pain radiating into neck; chest pain radiating into neck/ left side of neck swelling and aching; both armpits swelling and itching extreme/ left side of neck swelling and aching; inside of right elbow were itching, swelling and medium pain; inside of right elbow were itching, swelling and medium pain/ severe pain in both shoulders which radiated down to hips; both wrists were itching and both hands were swelling with severe pain; wrist itching/ both heels were itching/ inside of right elbow were itching, swelling and medium pain/ both armpits swelling and itching extreme; hand swelling/ toes were swollen; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in left arm on 26Apr2021 08:45 (Batch/Lot Number: ER8736) (at the age of 54-years-old) as 2nd dose, single for COVID-19 immunization. Medical history was none. The patient had no known allergies. Concomitant medication included methylphenidate hydrochloride (RITALIN) 20mg ER. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in left arm on 29Mar2021 08:45 (Batch/Lot Number: EN6204) (at the age of 54-years-old) as 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 at 09:00 (day after injection) on the same arm, the patient experienced wrist itching and hand swelling (left). On the next evening on 28Apr2021, both wrists were itching and both hands were swelling with severe pain, lasted 3 hours then they went away completely. The next day on 29Apr2021 at 03:00, both heels were itching, toes were swollen mildly with almost no pain. The next day on 30Apr2021, inside of right elbow was itching, swelling and medium pain. The next day on 01May2021, there was nothing. The next day on 02May2021, both armpits swelling and itching extreme with severe pain in both shoulders which radiated down to hips after 1 hour started to go to emergency room (ER) but it all vanished completely. Sometimes the patient got a day break but otherwise, since 27Apr2021 this had happened to some part of his body (most commonly in hands) up to Friday 28May2021. The patient was put on second round of steroids and now antihistamines and he hadn't had any symptoms for 2 days. The severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching. The patient had never had similar symptoms before. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment medications to lessen swelling and pain. The outcome of events was unknown.
54 2021-06-20 blood clot Blood clot R upper leg. 4/24 left lower leg deep tissue pain x 1 week. R lower leg pain 5/10 or 12... Read more
Blood clot R upper leg. 4/24 left lower leg deep tissue pain x 1 week. R lower leg pain 5/10 or 12 x 1 week. Then redness started 5/31 saw Urgent care 6/1 started abx Bactrim DS 6/2 though was lymph node 6/4 increased swelling saw doctor. Clinic sent for US + for blood clot started blood thinners on 6/5
54 2021-06-20 troponin increased, chest pain Came to ED due to progressively worsening intermittent pleuritic chest pain, fatigue, subjective fev... Read more
Came to ED due to progressively worsening intermittent pleuritic chest pain, fatigue, subjective fevers and chills of x6 days duration. At ED patient found to have elevated troponins and non-specific ST and T wave changes on ECG. cardiology consulted who recommended continuing colchicine + ibuprofen therapy.
54 2021-06-21 arrhythmia, chest pain About two weeks after the second Pfizer covid shot I started to develop chest pains, shortness of br... Read more
About two weeks after the second Pfizer covid shot I started to develop chest pains, shortness of breath and arrhythmia. I didn't connect the dots to the shot until i read about the cases in another cou ntry. I am an avid cyclist who rides over 100 miles a month and I noticed my athletic performance was suffering greatly and I would wake up most nights from a sound sleep with chest pain.
54 2021-06-21 chest pain Chest pain, shortness of breath, wheezing, fatigue. Sx severe for several days, then waned, complete... Read more
Chest pain, shortness of breath, wheezing, fatigue. Sx severe for several days, then waned, completely recovered as of 6/22/2021
54 2021-06-22 chest pain Chest pains, exhaustion after minor physical activity, dizzyness
54 2021-06-23 inflammation of the pericardium Pleuritic chest pain & dyspnea onset 6/19/2021 (approx 2 months post vaccination). Negative troponin... Read more
Pleuritic chest pain & dyspnea onset 6/19/2021 (approx 2 months post vaccination). Negative troponins, negative chest CTA. Diagnosed as pericarditis and improved with colchicine + aspirin.
54 2021-06-25 chest pain, chest discomfort Extreme fatigue, brain fog, constricted chest, chest pain for 4 days after my second dose. Now, I've... Read more
Extreme fatigue, brain fog, constricted chest, chest pain for 4 days after my second dose. Now, I've been experiencing continued ongoing fatigue for 6 weeks. My legs grow heavy each day. I pass out from exhaustion early each night. I have trouble concentrating. I'm experiencing ankle and wrist pain with a feeling of low circulation as my feet and hands fall asleep if I sit too long. I'm also having vivid nightmares on an ongoing basis. Other than a back injury, I was healthy and normal before this vaccine. I have not been to a doctor. I have been resting, focused on eating well and taking 3000mg of Vit C a day.
54 2021-06-25 pallor Wife present with pt and she stated before he received his vaccine that he has been known to pass ou... Read more
Wife present with pt and she stated before he received his vaccine that he has been known to pass out during a vaccine or after getting a vaccine. Pt's wife came and got me from exam room around 2:50p (about 10 mins after receiving vaccine and while pt was sitting in waiting room) stating that he didn't feel well. Pt's face was pale and skin was cool and clammy but alert when I asked him if he'd like to return to an exam room to lay down. He stated that he wanted to stay in waiting room sitting with his wife. I gave pt 2 small bottles of water but he declined them at that time. I started to check his BP and he became unreponsive but eyes still open. This episode last approximately 20-30 seconds and then color return to pt's face and he became responsive and answer questions appropriately. I asked pt again if he wanted to come into an exam room and lay down but he decline again. I advised pt and wife to stay in waiting room and asked his wife to watch for any other symptoms and advised them to stay an additional 15-20 mins. Both verbalized agreement and understanding. Pt's wife said he was feeling better at 3:15pm and after drinking the water I gave him and they left. Pt was alert and ambulatory upon leaving, steady gait.
54 2021-07-05 blood clot thought was lymph; redness; L leg pain x 1 week. r lower leg pain x 1 week; Blood Clot R upper leg; ... Read more
thought was lymph; redness; L leg pain x 1 week. r lower leg pain x 1 week; Blood Clot R upper leg; This is a spontaneous report from a contactable nurse. A 54-year-old male patient received bnt162b2 (brand: Pfizer), dose 2 intramuscular, administered in arm left on 27Mar2021 14:00 (Batch/Lot Number: EP6955) as dose 2, single at the age of 54-year-old for covid-19 immunisation. Patient received first dose (lot number: EN6199) intramuscular in left arm on 05Mar2021, 10:00 am for COVID-19 immunization. No known allergies or other medical history. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced blood clot R (right) upper leg on 24Apr2021 17:00. L (left) leg pain x 1 week. R lower leg pain x 1 week about 10May2021 or 12May2021. Then redness started 31May2021 saw urgent care 01Jun2021 thought was lymph started abx bactrim then on 04Jun2021 to PMD (Withheld) clinic had us + blood clot r upper leg. The adverse event result in Doctor or other healthcare professional office/clinic visit. Event treatment included blood thinners. The outcome of event was recovering.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate .
54 2021-07-10 chest discomfort Lethargy; Body aches; Fever; Dry cough; Congestion in chest; loss of smell last night; This is a spo... Read more
Lethargy; Body aches; Fever; Dry cough; Congestion in chest; loss of smell last night; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old adult male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, DM type 2. Concomitant medications included, fish oil (MANUFACTURER UNKNOWN), metformin hydrochloride (METFORMIN XR), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN); used for unknown indication, from an unspecified date. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. On 24Mar2021 at 18:00, the patient experienced lethargy, body aches, fever, dry cough, congestion in chest and loss of smell last night. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lethargy, body aches, fever, dry cough, congestion in chest and loss of smell was not recovered at the time this report. No follow-up attempts possible. No further information expected.
54 2021-07-10 heart attack Heart attack. 2 stents installed.
54 2021-07-12 chest pain Context: Patient is a 54-year-old male who presents with right-sided flank pain, low back pain and r... Read more
Context: Patient is a 54-year-old male who presents with right-sided flank pain, low back pain and right upper chest pain. Patient has had the discomfort in the right flank radiating up into the right chest for about 2 weeks. He states the pain in his chest is right upper chest, worse with breathing in and out. He also has right flank pain and right lower lateral chest pain worse with breathing in and out. Patient just developed dysuria with urinary frequency over the past 1 to 2 days. He has had subjective fever, chills and significant diaphoresis at night. He does have a history of multiple myeloma. This was treated with a stem cell transplant in February of this year. Patient and his wife report that recent laboratory data was concerning for possible recurrence and he had a bone marrow biopsy done about a month and 1/2-2 ago. He is to have a repeat bone marrow biopsy tomorrow Patient denies any midsternal chest pain. No shortness of breath. No cough or congestion. Patient denies a history of blood clots. Does have a history of heart disease, hypertension, hyperlipidemia. Patient is morbidly obese. Patient sees Dr. - oncology
54 2021-07-12 chest pain For the first week, he had fever, body aches, and chills. After that, he had chest pain on both side... Read more
For the first week, he had fever, body aches, and chills. After that, he had chest pain on both sides. The pain was also between shoulder blades, stabbing in the chest in the middle of night. He had severe shortness of breath. His feet were cold and he could not sleep most of the nights. Today he said his breathing is okay, slowly getting back to normal.
54 2021-07-12 loss of consciousness Patient passed out at store several hours (2.5) after vaccine administration. He was transported via... Read more
Patient passed out at store several hours (2.5) after vaccine administration. He was transported via EMS to hospital and given fluids and told he was dehydrated. He still complains of headache 4 days later. He did not hit his head when he passed out.
54 2021-07-13 ischaemic stroke ischemic stroke 6/13/21
54 2021-07-14 inflammation of the heart muscle, fluid around the heart No immediate adverse reaction, however, began developing nightly fevers/profuse sweating on June 11.... Read more
No immediate adverse reaction, however, began developing nightly fevers/profuse sweating on June 11. This continued for two weeks with increasing symptoms of loss of appetite, nausea, abdominal pain, tingling sensation on scalp before going to ER. Visited urgent care on June 16 and bloodwork results indicated elevated white blood cell count and eosinophil count. There was a question as to whether patient had been subjected to a tick bite, so doxycycline was prescribed. After several days, patient returned to urgent care for follow-up bloodwork (June 20th). Results showed WBC and eosinophil count continued to escalate. He went to ER on June 25th and was admitted to the hospital for 5 days. During his visit at Hospital, he was seen by a team of specialists: cardiologist, pulmonologist, hematologist, infectious disease doctor. Multiple tests were run, as the doctors started broad to eliminate certain diagnoses - i.e., bone marrow biopsy, heart cath, CT scans, x-rays, thoracentesis, etc. Patient had fluid around his heart and lungs and was diagnosed with myocarditis. He had no previous heart issues nor family history of heart issues. Test results indicated no abnormal blockage or other issues, other than inflammation and his heart strength was at 27%. I am unable to access his account, as it was disabled after his death. An autopsy is being performed and results are pending; however, the question(s) at large: what was the condition of his heart at the time of his death and was this vaccine-related? Did his myocarditis get worse? Did his heart muscle weaken further and rupture? Please let me know if the autopsy results are needed and where to send them.
54 2021-07-15 chest discomfort, palpitations, heart rate increased Within two minutes of receiving the injection, my heart rate increased and my chest became tight. T... Read more
Within two minutes of receiving the injection, my heart rate increased and my chest became tight. The heart rate lowered, but the chest remained tight for multiple days, though lessening. Because there was no pain associated with it, I continued my normal activities and assumed it would return to normal. On the night of 04/26/21, I had palpitations the prevented sleep, needing to sit up to lessen them. This continued on subsequent nights and not having a primary care doctor, I went to the emergency room on 04/30/21. I was able to have an appointment with a primary care doctor on 06/10/21 and a cardiologist appointment on 06/17/21.
54 2021-07-18 hypertension, hypotension Systemic: Hypertension-Medium, Systemic: Hypotension-Medium, Additional Details: Patient states he h... Read more
Systemic: Hypertension-Medium, Systemic: Hypotension-Medium, Additional Details: Patient states he has had an erratic blood pressure ever since he received his 1st COVID vaccine - his dr told him to report to us
54 2021-07-22 loss of consciousness Systemic: Joint Pain-Severe, Additional Details: Patient's wife reports that pt experienced muscle p... Read more
Systemic: Joint Pain-Severe, Additional Details: Patient's wife reports that pt experienced muscle pain in shoulders, chest, back, and arm after 30 mins of administration. Later that evening, pt was unconscious and went to the emergency room where he was transferred to the ICU. He has since progressed positively and currently in rehab.
54 2021-07-24 cardiac failure congestive, cerebrovascular accident Acute CHF with LV thrombus, multiple strokes involving MCA and left cerebellar stroke, aphasia, left... Read more
Acute CHF with LV thrombus, multiple strokes involving MCA and left cerebellar stroke, aphasia, left-sided paralysis, immobility. Patient was given tPA, clinical symptoms still progressed. In rehab facility now.
54 2021-07-24 chest pain, heart rate abnormal shortness of breath, chest pain, erratic heart rate. Lasted for one month. I am an endurance amateur... Read more
shortness of breath, chest pain, erratic heart rate. Lasted for one month. I am an endurance amateur athlete so have data in cycling tracker showing the impact this had on my cycling...
54 2021-07-25 fainting, loss of consciousness Passed Out, Fainted in my waiting room chair.
54 2021-07-27 cerebrovascular accident Two mild strokes. First on 6/15/21 the second on 7/14/21. Treated consisted of heart monitoring, CT ... Read more
Two mild strokes. First on 6/15/21 the second on 7/14/21. Treated consisted of heart monitoring, CT scan, MRI on brain. Prescribed medication, blood pressure meds, and baby Aspirin.
54 2021-07-27 fainting pt developed fever later the day after getting his covid vax so he took ibuprofen and went to bed. ... Read more
pt developed fever later the day after getting his covid vax so he took ibuprofen and went to bed. Next day he went back to work. Pt showed no symptoms until the month of June when he started complaining about pain in both arms. He was using a heating pad on his shoulders to help with the pain. He was taking Aleve for the pain but it was not helping so he no longer wanted to take it. He had a vomiting episode on the afternoon of June 16th stating he thought he has eaten a bad lemon. He wasn't feeling well the morning of June 18th, 2021 but continued working. He only wanted something light to eat since he didn't feel well and was headed to bed. When his wife went to go to bed she found him collapsed on the bedroom floor with face forward in the bed. She turned him around and found him unresponsive. She contacted 911 and he was taken to Medical Center ER. They were not able to revive him. County conducted an autopsy where they found a blood clot in left artery.
54 2021-07-28 platelet count decreased drop in platelets
55 2021-01-05 chest discomfort Woke up very fatigued 12/25 only minimal activity performed creating additional fatigue. Was sleepi... Read more
Woke up very fatigued 12/25 only minimal activity performed creating additional fatigue. Was sleeping 12 plus hours a day without feeling rested in the least. No problems with sleep. Also had heaviness of chest - felt like rib cage made of iron- this dissipated by the 28-29th. No excessive cough or fever, did have dyspnea with any exertion and this continues but seems to be lessening. Was not able to work due to fatigue. Yesterday remained tired but felt noticeably different-felt lighter-and today seems promising.
55 2021-01-08 fast heart rate Headache, Tachycardia, Fatigue, dizziness Narrative:
55 2021-01-18 blood pressure increased Systemic: heavy leg and elevated bp-Medium
55 2021-01-19 cerebrovascular accident Headache and stoke
55 2021-01-25 fibrin d dimer increased Diffuse abdominal pain onset approximately 10-12 hr post dose. I was initially awoken that first ni... Read more
Diffuse abdominal pain onset approximately 10-12 hr post dose. I was initially awoken that first night with nausea and abdominal pain. This continued through 1/22/21. My nausea had subsided and I was able to eat in small quantities. My abdomen felt bloat with mild distention. The AM of 1/23/21, I awoke and the diffuse abdominal pain had abated. I was left with RLQ abdominal pinpoint pain. This became progressively worse throughout the day. I presented to the ER on 1/23/21. Chem panel was normal. CBC also normal. I received an abdominal CT scan with IV contrast for R/O appy. My appendix was normal. The scan revealed a serosal venous thrombophlebitis wth inflammation in the mesentery and transverse colitis. The pain continued to progress, so I presented to the ER again on 1/25/21. I received another abdominal CT along with additional lab work. Lactate normal. D-Dimer mildly elevated at 0.7 and CRP was 9.7. Again CBC was normal. This CT did not reveal the micro-emboli or colits but rather omental inflammation. At this point, surgery was consulted along with hematology for opinion regarding anticoagulation. The decision to anti coagulate was deferred. The diagnosis I received was omental infarct. I remain on pain medications and continue to monitor for changes in my pain and a fever.
55 2021-01-26 chest pain This individual received Pfizer COVID vaccine dose #1 on 1-26-21. About an later he complained of ch... Read more
This individual received Pfizer COVID vaccine dose #1 on 1-26-21. About an later he complained of chest pain and EMS called.
55 2021-01-26 palpitations, blood pressure increased First episode 01-15-21, started 10am, i was at work, started feeling weak and brain fog so i sat dow... Read more
First episode 01-15-21, started 10am, i was at work, started feeling weak and brain fog so i sat down and another therapist came into the office and told her how i was feeling, they checked my BP 148/92, went to the ER. They took some blood work, CBC panel were negative, thyroid test, normal, anaiongap, normal, glucose reading, normal and an EKG normal. 2nd episode 01-21-2021 started 11;45am, that morning when i woke up i felt really strong feelings of sadness and despair. At 11;45a i was about to eat and i started to feel again brain fog, total body weakness, elevated BP, they took my BP again and it was 144/88 so i went to the ER again. I could not keep my eyes open. They did a EKG again with a CTA and a CT with perfusion both were normal. They gave me fluids, sodium fluids. Agian it was transient my BP slowly went down and went home. Third episode 01-25-2021 started about 9am, i was at home did not have access to a BP cup, symptoms were same but less intense, i could feel my heart pounding, brain fog and body aches and this lingered throughout the day. It felt like I had the flu. No elevated temperature on all three of my episodes.
55 2021-01-26 palpitations It started abruptly, i experienced brain frog and super weak, globally with al muscles and was very ... Read more
It started abruptly, i experienced brain frog and super weak, globally with al muscles and was very fatigues and malaise. I had access to a blood pressure cup the reading was 148/92, usually my BP is 100/60. Once they took my BP, then i went to the ER. As time went on, I got more sleepy and tired. The first ER visit they did lab work, CBC panel which was normal, thyroid test which was normal, EKG and aniongap which were negative. They gave me no medications to take and was probably there in the ER for about 6 hours. which was on 01-15-2021. The second time, it was around 11:45am on 01-21-2021. While sitting at the edge of my bed, I felt a total sadness and despair and feeling of being alone. I then went to work felt normal in the morning and as i went to type some notes after a minute i felt the same symptoms happening again, my BP 140/88 and went to the ER. I was really tired and could of fallen asleep, felt oriented but took me a while to process things. I also had trouble moving my entire body. They placed an IV, gave me fluids, did an EKG again which was normal. They did a CT scan, CTA to my chest and neck and CT perfusion, had to inject contrast, exams were both normal. The doctor came in and told me if I was okay to drive home and I drove home. On the third episode. 01-25-2021 it occurred around 9am, the symptoms came back but with less intense. I lied down and rested., could feel my heart racing just like the other two episodes. This symptom lasted for about two hours and kind of lingered all day but i could still function. i felt like I had the flu, moderate malaise with brain fog.
55 2021-01-27 atrial fibrillation Patient received his second Pfizer vaccination on 1/14 and had no immediate adverse reaction. He sta... Read more
Patient received his second Pfizer vaccination on 1/14 and had no immediate adverse reaction. He states he developed cardiac symptoms and was seen in the ER on 1/16. He was diagnosed with new onset atrial fibrillation. No previous history of atrial fibrillation.
55 2021-01-30 nosebleed Heavy nose bleeding, swollen lymphnodes lower left neck
55 2021-02-01 heart attack Pt received vaccine on 7 jan. 2021 Twelve days later, on 19 January 2021, Pt developed symptoms of... Read more
Pt received vaccine on 7 jan. 2021 Twelve days later, on 19 January 2021, Pt developed symptoms of COVID (cough, sore throat, fever, myalgias), on 20 Jan, pt admitted to hospital for worsening symptoms. Pt tested positive for COVID 19. Pt admitted to ICU where pt had complicated hospital course to include ARDS secondary to COVID pneumonia, nonSTEMI, with biventricular heart failure, on multiple pressor, rhabdomyolysis with acute kidney injury, requiring CRRT. Pt was in hospital for 10 days; he passed away on 31 Jan 2021.
55 2021-02-09 oxygen saturation decreased, blood glucose increased, cardiac arrest, haemoglobin decreased, hypotension 2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose. Redness to bilateral upper ext... Read more
2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose. Redness to bilateral upper extremities, c/o some pain with urination, weak. V/S stable, afebrile in ED. Assess for infection. No significant abnormal labs (see below), hydrated and discharged. 2/4/2021- arrived in ED with c/o vomiting, seen earlier by PCP that day labs drawn. Shortly after arriving in the ED copious amouts of emesis noted, the patient went into full cardiac arrest and CPR was started. -Please see HPI above, in addition after intubation the patient coded again. More epinephrine and lidocaine were given. CPR was resumed. We did obtain ROSC and targeted temperature management was pursued. He is placed on a lidocaine drip and a right femoral central line was placed by myself. At this time, norepinephrine drip was initiated given his continued hypotension. Post intubation chest x-ray suggests possible abdominal pathology and once the patient was stabilized further, he was sent to the CT scanner where CT head without IV contrast and CT chest, abdomen and pelvis with IV contrast was obtained. He did lose pulses once in the radiology suite. This was brief. IV fluids were initiated and he received over 2 L of crystalloid therapy. He continued to be hypotensive in the emergency department and vasopressin was added. He also had a single dose of Neo-Synephrine and IV push fashion to help bring his blood pressure up. CT scan reveals probable bilateral aspiration pneumonia/pneumonitis and dilated loops of small bowel without a transition point and pneumatosis involving loops in the left upper quadrant. I did try to initiate consult with critical care and possible transfer, however he continued to be unstable and coded requiring CPR multiple times. He was given IV bicarbonate given his prolonged CPR state and pH. Ultimately, the family decided to make the patient comfort measures only given his critical illness. Shortly after making this decision he did pass away in the emergency department. RADIOLOGY DIAGNOSTIC - CHEST PORTABLE 02/04 2051 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2059 IMPRESSION: 1. Findings highly suspicious for portal venous gas which can be seen in the setting of bowel ischemia. Consider CT for further evaluation and/or surgical consultation. 2. Endotracheal tube 3.7 cm above the carina. 3. Low lung volumes with mild patchy perihilar opacities. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 8:55 PM Impression By: MD CT SCAN - CT HEAD WO 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2200 IMPRESSION: Negative for acute intracranial process. No evidence of mass effect, acute hemorrhage or definite acute cortical infarct. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 9:57 PM Impression By: - MD CT SCAN - CT CHEST/ABD/PELVIS W 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2214 IMPRESSION: 1. Ill-defined patchy opacities within the bilateral upper lobes, right middle lobe, in consolidative opacities within bilateral lower lobes which could represent aspiration, and/or multifocal pneumonia. 2. Small right trace left pleural effusions. 3. Diffusely dilated small bowel without a transition point and mucosal hyperenhancement involving the colon with areas of pneumatosis involving loops of small bowel within the left upper quadrant and portal venous air consistent with hypoperfusion complex. There is a small caliber appearance of the aorta and a flattened appearance of the IVC is well. 4. Intravascular air within the IVC and bilateral iliac veins could be secondary to right femoral central lying injection. 5. Somewhat abnormal enhancement pattern of the kidneys with hypoenhancement of the medullary pyramids which may suggest hypoperfusion injury as well. 6. Probable nondisplaced rib fractures on the right at ribs 2 through
55 2021-02-11 blood glucose increased, loss of consciousness Ct felt dizzy, fell forward out of his chair, was unconscious for approximately 2-3 seconds, was not... Read more
Ct felt dizzy, fell forward out of his chair, was unconscious for approximately 2-3 seconds, was not in respiratory distress, was able to answer questions. Ct was transfer to his back, then to sitting position, c/o nausea, paramedics arrived. B/P was 220/113, Blood sugar was 215.
55 2021-02-16 blood pressure increased vitals: 15:27 patient complained of dizziness, slight head ache, sweaty, light headed. Dr was made a... Read more
vitals: 15:27 patient complained of dizziness, slight head ache, sweaty, light headed. Dr was made aware, checked BP. 162/114, HR 108, 02 99%. Advised patient lay down and 15:35 bp went down to 156/103, HR 79, 02 100%. at 15:40 while laying BP 144/87, HR 70, O2 100%. 15:45 laying BP 123/75, HR 77, O2 100%. 15:50 while sitting BP is 134/82, HR 82, O2 98%. at 16:00 BP is 129/84, HR78, O2 99%. Patient stated dizziness was gone. Dr charted: dizzy and lightheaded after 1st shot, bp elevated over baseline. Monitored and transfered to stretcher. BP improved and symptoms resolved with rest. No itching, rash, shortness of breath or chest pain. Patient was able to walk around asymptomatic prior release.
55 2021-02-18 fainting vision skewed, balance off, speech slurred, syncope,
55 2021-02-18 fainting syncope, headache, slurred speech 2 days
55 2021-02-19 hypertension high blood pressure: 188/110; patient felt flushed , unwell and experienced vertigo
55 2021-02-21 low blood oxigenation, fibrin d dimer increased, troponin increased Patient was tested for covid on 2/2/21 with positive resulted. Presented to Hospital ER on 2/10/21 w... Read more
Patient was tested for covid on 2/2/21 with positive resulted. Presented to Hospital ER on 2/10/21 with c/o of abdominal pain. Diagnosed with gastritis, prescribed metoclopromide and famotidine and dc home. Returned to ER on 2/13/21 with c/o of weakness, diarrhea, foot ulcer, and loss of appetite. Diagnosed: 1) Dyspnea and hypoxia secondary to Covid-19 2) Extensive bilateral lung infiltrates secondary to Covid-19 3) Increased Cr 4) Increased LFTs, ferritin, d-dimer, troponin secondary to Covid-19 5) Elevated procalcitonin placing the patient at high risk for sepsis 6) Chronic appearing Right foot wound without signs of secondary infection Patient transferred to a different hospital in another city.
55 2021-02-22 hypotension Per H&P and physician notes, patient was admitted to hospital on 2/7/21 with status epilepticus from... Read more
Per H&P and physician notes, patient was admitted to hospital on 2/7/21 with status epilepticus from home. He had received his second dose of COVID19 vaccine on 2/6/21 per Emergency Department note. Patient was febrile on admission (40.7 Celsius) and was intubated. Patient had issues with hypotension, neurologic impairment, and metabolic issues. Received pressors, IV fluids, Keppra, IV antibiotics to cover for possible CNS infection. Lumbar puncture performed. Abnormal EEG on 2/9/21. Recurrent seizure on 2/10/21. Pt extubated on 2/12/21. Blood cultures, urine culture, and CSF culture all no growth. Sputum culture mixed oral flora. As of 2/22/2021, patient tolerating tube feeds, shakes head yes and no responding to questions.
55 2021-02-28 deep vein blood clot, pulmonary embolism Patient had the first dose of the Pfizer COVID vaccine (LOT# EL9264) on 1/29/21 at the vaccination ... Read more
Patient had the first dose of the Pfizer COVID vaccine (LOT# EL9264) on 1/29/21 at the vaccination center at Medical Center (set up in Hotel). He had the second dose on 2/19/21 (LOT# EN6201) at 12:30pm, and reported leg pain and difficulty breathing on 2/26/21 as he was going to bed. He presented to the ER at Hospital that day, and was diagnosed with a deep venous thrombosis and pulmonary embolism. He is currently taking Xarelto, and will schedule an appointment with Hematology, as he has no family or personal history of clotting disorder.
55 2021-03-02 platelet count decreased, fainting had a feeling of impending death and thought he was gonna die.; Syncopal episode; My platelets count... Read more
had a feeling of impending death and thought he was gonna die.; Syncopal episode; My platelets counts drop; metallic taste; Potassium level went down; This is a spontaneous report from a contactable nurse (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) first dose on 12Feb2021 on Deltoid Left at single dose for covid-19 immunisation. Medical history included Covid-19 and High cholesterol. Concomitant medications were not reported. He said that he was 60 days post COVID and his doctor advised him to get vaccinated. He was feeling fine, but after 10 minutes into the shot, he had a metallic taste in the mouth. After 12-13 minutes, he had a feeling of impending death and thought he was gonna die. It freaked him out. He was rushed to the ER and had a complete blood count (CBC) and Basic Metabolic Panel (BMP) test run on him. It was that his Potassium level went down to 3.3 and his platelets dropped to 141. He had tests on 28Jan2021 and mentioned that his Potassium levels were normal and had a platelet count of 181. He mentioned that there was no other way but the vaccine that could have caused this. He is if he would already have passed away from the shot from his opinion. Patient had a Syncopal episode of some type. He had an intended feeling like he was going to die after the shot, he was 60 days post Covid when he get that shot, he was getting over Covid and he was 60 days and he didn't wait the 90 days his primary doctor care told me that he can get it too because he was feeling better which he was feeling better but since then he have gotten that shot, he went to the doctor on the 28Jan2021 and he had CBC drawn on him and he went for his regular physical and Covid follow-up at his doctor, his platelets counts drop since he have had shot struck at 40 points, feels concerning. The outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "feeling of impending death and Syncopal episode " and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product 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.
55 2021-03-03 chest pain Dry Mouth, Chest Pain, SOB. Transported to Emergency room/department or urgent care.
55 2021-03-10 palpitations 2:40 p.m. - Client had shortness of breath and palpitations.
55 2021-03-13 fainting Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: note: pt stated no allergies on form and when asked verbally by immunizer. at the 7 minute mark he began to exhibit weakness and started falling off his chair. seemed like he was going to pass out. his breathing seemed labored. we position pt on floor, rph admin epipen to left outer thigh. 911 called. ems responded. pt felt better after epipen. bp, hr normal. pt taken to er by ems
55 2021-03-14 loss of consciousness Within 30 seconds of getting the shot, I passed out. EMTS immediately administered first aid to me, ... Read more
Within 30 seconds of getting the shot, I passed out. EMTS immediately administered first aid to me, and had me wait quite a while before letting me leave. They insisted that just because I passed out,please come back for 2nd dose April 5 at 7:30am.
55 2021-03-14 palpitations STARTING AROUND 12:00pPM I EXPERIANCED TWO TIMES WHERE MY HEART STARTED TO RACE FOR ROUGHLY 5 SECOND... Read more
STARTING AROUND 12:00pPM I EXPERIANCED TWO TIMES WHERE MY HEART STARTED TO RACE FOR ROUGHLY 5 SECONDS. AFTERWARDS I EXPERIANCED SHOCK LIKE SENSATIONS AROUND CHEST, AND BACK. NOT SURE IF RELATED TO THE INJECTION BUT NEVER HAD PRIOR AND DIDN'T HAVE THE DAY AFTER OF SINCE
55 2021-03-20 heart rate increased, fainting syncopal episode, elevated HR, tingling in fingers, daughter states he's "afraid of needles," EMS ev... Read more
syncopal episode, elevated HR, tingling in fingers, daughter states he's "afraid of needles," EMS evaluated, patient refused transport.
55 2021-03-21 atrial fibrillation, heart flutter, fast heart rate, palpitations 5pm 03/18/21 Heart palpitation, pulse rate 180, checked fitness watch ECG, showed SVT, Valsalva mane... Read more
5pm 03/18/21 Heart palpitation, pulse rate 180, checked fitness watch ECG, showed SVT, Valsalva maneuver, converted to A-FIB/Flutter. 5:30pm ER visit and admission to ICU for Cardioversion. Preload of Amiodarone converted back to Normal Sinus Rhythm prior to cardioversion procedure. Home 03/20/21 Follow-up in 2 weeks with cardiologist.
55 2021-03-22 pallor, blood pressure increased, heart rate increased, loss of consciousness Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared dia... Read more
Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared diaphoretic with mask down. He flagged down nurse and reported feeling hot/lightheaded. NP asked for BP machine, instructed patient to take slow deep breaths. Pt. reported he felt like he may lose consciousness. His eyes rolled and he became white/pale and appeared to stop breathing. Code assist called; didn't respond to sternal rub, but raspy breathing, weak/rapid pulse palpated; immediately transferred to the ground level without falling, 2 person assist. 9-1-1 called, BP machine didn't immediately work. As soon as his head was low, his face became bright red and he regained consciousness. He was disoriented briefly but then able to answer questions/oriented. BP elevated, HR 80s. BS 257. No s/s anaphylaxis. Hx of syncope r/t blood draw. Wife present and report hx of DM, HTN, Palpitations. He denied CP/SOB or palpitations. He had eaten and took regular medicine the morning. Paramedic arrived and patient was transported to the nearest ER. Pt. was later discharged.
55 2021-03-23 chest pain 11:10 PT STARTED TO FEEL TIGHTENING IN THROAT, PT BROUGHT OVE TO VACCINATION STATION FOR FURTHER ASS... Read more
11:10 PT STARTED TO FEEL TIGHTENING IN THROAT, PT BROUGHT OVE TO VACCINATION STATION FOR FURTHER ASSESSMENT. AIRWAY PATENT, NO STRIDOR OR S/S OF RESPIRATORYDISTRES NOTED AT THIS TIME. VSS B/P 152/90, HR 90, RR 18, SPO2 99%. BENADRYL 50 MG PO GIVEN X 1. PA OVER TO ASSESS PATIENT. PT STATES HE HAD A SIMILAR MORE MILD EXPRERIENCE WITH FIRST PFIZER DOSE. 11:30: PT STATES EVERYTHING STILL FEELS THE SAME, NO CHANGE OR WORSENING OF SYMPTOMS AT THIS TIME. 11:45 PT STATS LEFT SIDED CHEST PAIN 7/10 STABBING. MEDICAL PROVIDER NOTIFIED. PT BROUGHT BACK TO OBSERVATION ROOM. ASSESSED BY EMTS. 12 LEAD EKG PERFORMED. PT SR WITH 1ST DEGREE BLOCK. HR 70. B/P 149/94, SPO2 99% 11:50 PROVIDER IN TO SEE PT. PT TO BE TRANSFERED TO FACILITY FOR FURTHER TESTING AND TREATMENT.
55 2021-03-23 hypertension Patient received first dose of Pfizer vaccine 3/24/21. Patient became unsteady and was directed to s... Read more
Patient received first dose of Pfizer vaccine 3/24/21. Patient became unsteady and was directed to stretcher. Patient has a hx of HTN and reports not taking his BP medication for "a while." Patient was unsure what BP medication he was on. Reports potentially taking Lasix and Vit K. Patient reports not eating or drinking prior to receiving the vaccination. Alert and oriented. Denies SOB/chest pain. Vitals taken at 10:45AM: BP 197/11 HR 75 SPO2 98% RA ED rapid response called. Pt unable to stand up from stretcher. Patient was taken to ED and neurology was consulted. Neurology noted: 55-year-old man past medical history of hypertension coming with uncontrolled hypertension systolic over 220. Concern for gait instability, no evidence of strength weakness on any extremity with confrontational testing. No evidence of change in altered mental status, no evidence of cranial nerve palsy, and no evidence of sensory loss. No evidence of coordination problems with finger-to-nose testing and heel-to-shin testing bilaterally. He exhibits 5 out of 5 confrontational testing to all extremities muscles as above albeit with giveaway weakness. NIHSS 0. Although patient presents within TPA window he has had no disabling symptoms and therefore is not a candidate for TPA. Although the patient presents with a mechanical thrombectomy window he has no disabling symptoms and no evidence of LVO either on exam or my preliminary read of his CTA head and neck. As such he is not a candidate for mechanical thrombectomy. Symptoms do not localize well although patient presents with clear hypertensive urgency versus hypertensive emergency. Would recommend full medical work-up for this condition as we rule out signs of acute ischemic stroke. Patient passes dysphagia screen in the ED. Recommendation: 1. Admit to Observation. 2. MRI brain without contrast 3. Obtain stroke labs A1c, TSH, lipid profile 4. PT OT consult evaluation and treat 5. Social worker and case management consult for stroke work-up
55 2021-03-24 blood glucose increased, hypertension, oxygen saturation decreased, transient ischaemic attack, lightheadedness Within 5-minutes of vaccination, the patient reported weakness and confusion. EMS evaluated the pati... Read more
Within 5-minutes of vaccination, the patient reported weakness and confusion. EMS evaluated the patient on-site. No signs of stroke. EKG demonstrated NSR, rate 77bpm, no ST elevation. FSBG was 290mg/dl. EMS transported the patient to Hospital Emergency Department. Enroute, the patient became increasingly confused, forgetting their birthday and location. Patient was hypertensive (178/104) and reported a "crushing headache". EMS crew became concerned for stroke. In ED, the patient remained hypertensive (178/93). ED Physician had high suspicion of TIA versus acute reaction to COVID-19 vaccine. Administerd 650mg acetaminophen and 1mg Lorazepam. Admitted patient to critical care unit where patient stated they had developed a sudden-onset diffuse banding-like headache with associated nausea, diaphoresis, blurry vision, and confusion. MRI was negative and patient was transferred from ICU to hospital. Hospital physician believed the symptoms were likely a vagal mediated response or reaction to his COVID vaccination. Patient was discharged on 3/20 with diagnoses of TIA, Acute encephalopathy, Insulin-dependent type 2 diabetes, Essential hypertension, CAD, Unspecified mood disorder, Dyslipidemia, Obesity, and Mild neuro cognitive disorder
55 2021-03-27 blood pressure increased Blood Pressure spiked to 213/114 - I feel fine, but this is as high a reading as I have ever had. Re... Read more
Blood Pressure spiked to 213/114 - I feel fine, but this is as high a reading as I have ever had. Recent range between 151/98 and 184/118. I am not taking medication for blood pressure. My doctor and I are trying dient and exercise, though obviously I do have a monitor.
55 2021-03-31 chest pain chest pain
55 2021-04-03 blood pressure fluctuation No issues at/during injection, didn't even feel needle surprisingly. 1st 24 hrs, arm soreness as ty... Read more
No issues at/during injection, didn't even feel needle surprisingly. 1st 24 hrs, arm soreness as typical vax reaction 4 me. But that 2nd day after, G.I. issues began middle of nite. So fatigued & short-of-breath, barely made it to dialysis, where they put me on oxygen. All during treatment, BP fluctuated 90-170, temp 96-101, chills (shivering!), continued fatigue & weakness, even after leaving - they wanted to give me antibiotics & send me to e.r.!!! Staff did collect blood sample for culture (result in 24 hrs + neg). I refused antibiotics and e.r., convinced it was vax reaction, and I was right, all normal another day later. Anxious bout 2nd shot ??
55 2021-04-07 blood pressure increased I received the vaccine about two - three inches from the center of the muscle and in back of center ... Read more
I received the vaccine about two - three inches from the center of the muscle and in back of center - it was more in back of deltoid than the front of my deltoid. When I first got the shot, I had a burning sensation from the site of needle to back of neck to behind my ear area. It felt like a burning aching feeling. My ear felt like it was clogged up and aching. I told the medical site about it and the doctor on site said that more likely they hit a nerve. My blood pressure was very elevated. They had me stay to be observed for 45 minutes. I went back to work. I still felt it at night. The next day, I started feeling up my neck and my collarbone and my left side of my face and my head - my face felt tight and my lip felt numb on the left side and I had a slight confusion too. I went to Emergency room. They did CAT Scan and exam. After that, I noticed it was going all the way down my arm, all the left side of my body to toes. It felt like numbness - like neuropathy type feeling. It felt like constant pain. I went to the Urgent Care and they gave me Prednisone steroid (5 days of it) 5 mg to help with inflammation. I took that for the five days. I started noticing a little black bruising on my body. After that, I went to the Urgent Care again and they gave me Naproxen and and Dr gave me more Naproxen to take. He took bloodwork, too. I went to the ER and I was still feeling sick and hot. They said it was anxiety. I am still going through it - I feel it on the spot where I got the shot - and on my neck and on my head and on my left eye and down on my legs a lot - some days are worse than others but not as bad as when I had the first symptoms.
55 2021-04-08 blood pressure increased nausea, fever, elevated blood pressure, fatigue all currently resolved. This caused to worsen his an... Read more
nausea, fever, elevated blood pressure, fatigue all currently resolved. This caused to worsen his anxiety which is still presenting effects
55 2021-04-08 cerebrovascular accident, ventricular tachycardia, cardiac arrest 55-year-old male with no diagnosed past medical history presents emergency department after cardiac ... Read more
55-year-old male with no diagnosed past medical history presents emergency department after cardiac arrest. Per patient's daughter, patient was feeling at baseline today. He got his COVID vaccine at 5 PM this evening. He was running some errands and called his daughter at 8:40 PM. He told his daughter he was not feeling well. She reports he sounded out of breath and sounded as if he was slurring his words. Daughter told him to pull over and she called 911. She met him on the side of the road and he was gasping for air. She arrived at the same time as EMS. Upon arrival of EMS patient was in ventricular fibrillation. He was defibrillated 3 times. He also had one episode of ventricular tachycardia. He was given 300 mg of amiodarone and 3 rounds of epinephrine with had return of spontaneous circulation. King airway was placed and patient was brought to the emergency department.
55 2021-04-08 loss of consciousness passed out; busted head; bruised/broke elbow/dont know if it chipped elbow or just bruised; about 1 ... Read more
passed out; busted head; bruised/broke elbow/dont know if it chipped elbow or just bruised; about 1 hr after shot my stomach started feeling upset; had diarrheas' and gas; had diarrheas' and gas; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old male patient received bnt162b2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 23Mar2021, 12:30 (Lot Number: EP7534) as single dose for Covid-19 immunisation (age at vaccination was 55 years). Medical history included high blood pressure (controlled with RX). There were no known allergies. No other vaccine was received in four weeks. Patient received other medications in two weeks. Historical vaccine included bnt162b2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 02Mar2021, (Lot Number: el9266) as single dose for Covid-19 immunisation (age at vaccination was 55 years). On 23Mar2021, the patient about 1 hour after shot her stomach started feeling upset and she stopped at a rest area, had diarrhea and gas. This continued some through the evening. On 24Mar2021 (The next day), while outside with her friend, she passed out, ended up with a busted head and bruised/broke elbow/don't know if it chipped elbow or just bruised. She could feel it was coming on but then it started to pass, and the next thing was that she woke up in her driveway. No treatment received for events. No covid prior vaccination and no covid tested post vaccination was reported. The outcome for all the event(s) was recovering. No follow-up attempts are possible. No further information is expected.
55 2021-04-09 chest pain Terrible congestion, runny nose that did not stop from Sunday 4/4/21-Saturday 4/10/21 8:00 am, chest... Read more
Terrible congestion, runny nose that did not stop from Sunday 4/4/21-Saturday 4/10/21 8:00 am, chest, lungs hurt, body aches earlier in week, had to stay in bed on and off all week, no energy, forced myself to eat, severe coughing by Wednesday 4/7/21 which has only stopped on 4/10/21. was most severe Thursday 4/8-Firday 4/9 Could not concentrate all week, even watching tv.
55 2021-04-09 blood clot they had a ultrasound done and found out I had a number of clots in that position; a sore Leg, Upper... Read more
they had a ultrasound done and found out I had a number of clots in that position; a sore Leg, Upper part of the left calf 2 inches below the knee on the backside; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 15:00 (Batch/Lot Number: En6207) as SINGLE DOSE for covid-19 immunisation. Medical history included Treatable Acid reflex, anxiety and mild depression. Concomitant medications included omeprazole, buspirone and alprazolam for unspecified indication. Patient had the Covid shot on 18Mar2021 at about 3 PM the next morning (on 19Mar2021 06:00) patient woke up with a sore Leg, Upper part of the left calf 2 inches below the knee on the backside. After it did not go away, he went to the doctor then they had a ultrasound done and found out he had a number of clots in that position. Treatment received for the adverse event includes they put patient on a blood thinner. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, the patient has been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021. Covid test post vaccination done via nasal Swab, They had the results in 15 minutes, covid test result Negative, ultrasound scan: clots in that position on 19Mar2021 found out, had a number of clots in that position. Outcome of the events was recovering.
55 2021-04-12 stroke On 4/8/21 patient reported increased difficulty speaking, increased dizziness, and vision changes. ... Read more
On 4/8/21 patient reported increased difficulty speaking, increased dizziness, and vision changes. Reports new headache rated 8/10 that started at 11am 4/8. Hx of stroke 2018 with residual right side symptoms. BP 162/104, HR 80, O2 sat 97% room air at 1740. Sent to a Medical Center ER and admitted with stroke symptoms and new onset diabetes.
55 2021-04-12 cerebrovascular accident Starting slurring speech, right arm went numb and right side of face was not responding. Went to ER... Read more
Starting slurring speech, right arm went numb and right side of face was not responding. Went to ER and they confirmed he was having a stroke. Continued to have multiple strokes at ER from 8:40pm last one was 1:30am (4 hours after clot buster given). Cause of stroke is still undetermined no clots found, no high blood pressure and no high chlorestrol.
55 2021-04-12 blood clot blood clot formed in left leg in surface vein, at intersection with deep vein.
55 2021-04-13 deep vein blood clot Deep Vein Thrombosis of Right Leg
55 2021-04-13 haemoglobin decreased Low H/H, Low Iron, Low Ferritin, high TIBC, low iron sat %
55 2021-04-14 pulmonary embolism fatigue mild headache shortness of breath chills low grade fever diagnosed with ACUTE PULMONARY ... Read more
fatigue mild headache shortness of breath chills low grade fever diagnosed with ACUTE PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONATE had two hospital doctors two hematologist two pa-c specialist all suspect pfizer shot . taking eloquis for 90 days
55 2021-04-16 chest pain Swollen left testicle, and on 04/16/2021 headache and sinus pain and slight breathing issues and che... Read more
Swollen left testicle, and on 04/16/2021 headache and sinus pain and slight breathing issues and chest pain
55 2021-04-16 lightheadedness About five minutes after administering vaccine, patient's spouse reported that patient is not feelin... Read more
About five minutes after administering vaccine, patient's spouse reported that patient is not feeling good and about to faint. Pharmacist on duty immediately attended the patient. Patient was sitting on a chair, started fainting, didn't completely faint though. Patient responded to pharmacist and reported he felt like he was going to sleep and all sudden woke up. Called for emergency help, EMT team checked patient, all the vitals were ok, patient decided not to go to hospital. Patient waited in the store for additional 15 minutes and left the store around 12:45pm
55 2021-04-17 loss of consciousness actually passed out slightly; Really dizzy; can't move and stand by; This is a spontaneous report fr... Read more
actually passed out slightly; Really dizzy; can't move and stand by; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration on 27Mar2021 (batch/lot number: ER8730) at 55 years old at a SINGLE DOSE for COVID-19 immunization. The patient's medical history included Type II diabetes, Thyroid inactive, and blood pressure management, all from an unknown date. Concomitant therapy included unspecified blood pressure medication. On 27Mar2021, the patient actually passed out slightly (loss of consciousness), got really dizzy (dizziness), and can't move and stand by (movement disorder). It was reported that about 5 minutes after vaccination, patient got really dizzy and actually passed out slightly and was dizzy for about that day; he was dizzy all day, he can't move and stand by. Patient stated that he actually got better but took five days. Patient further stated, "I just determine, because of the reaction, people say, second is worse and I don't know if its allergic reaction or is that normal. If they consider." Outcome of the events was recovering.
55 2021-04-22 cerebrovascular accident, pulse abnormal Pfizer-BioNTech COVID-19 Vaccine EUA: two days after vaccination patient presented to the emergency ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: two days after vaccination patient presented to the emergency department with impaired vertical gaze and dizziness. Vital signs within normal ranges except pulse 49 beats per minute. Diagnosed with CVA, administered tPA, admitted to the hospital. Discharged two days later to home in good condition.
55 2021-04-23 chest pain Chest pain, back pain on meddle and left side.
55 2021-04-25 heart attack, troponin increased Patient received Covid-19 vaccination, admitted with massive STEMI 6 days later
55 2021-04-27 loss of consciousness Pt called call center on 4/23/21. Pt got second dose Pfizer vaccine on 4/22/21 and first on 3/30/21... Read more
Pt called call center on 4/23/21. Pt got second dose Pfizer vaccine on 4/22/21 and first on 3/30/21. Pt complains of fever 99.5 F and states when he went for a walk outside 4 hours ago and as he was talking to his neighbor he felt dizzy, blacked out for a few seconds, had weakness in his legs and fell and bruised his knees. Advised pt this is an emergency symptom and need to go to emergency room immediately. Pt states he will think about it but verbalized understanding that this an emergency symptom and need immediate attention.
55 2021-04-28 sinus rhythm LEFT LOWER EXTREMITY ISCHEMIC LIMB; ARTERIAL THROMBOSIS A week after the first dose, patient develop... Read more
LEFT LOWER EXTREMITY ISCHEMIC LIMB; ARTERIAL THROMBOSIS A week after the first dose, patient develop acute onset of left 3rd toe tip pain and tenderness.This gradually progressed to pain under his metatarsal head in the left foot. Gradually over the last 2 weeks, he has also noted increasing hip and buttock muscle fatigue with walking. Two nights ago, he developed increasing pain in his left forefoot. Yesterday, his left foot became numb and he went to Medical Center for evaluation. While there, he was found to have an ischemic left leg with lack of Doppler signals in his left foot and subsequently underwent CT angiography. This CT scan demonstrated left internal iliac occlusion, partially occlusive thrombus within the left external iliac artery with widely patent femoral popliteal system bilaterally. However, his left peroneal and anterior tibial arteries were occluded for segments, while the distal left posterior tibial artery appears occluded, although this may represent contrast bolus timing issues He has no known prior history of thrombotic issues. He has no family history of clotting abnormalities. He denies any palpitations or history of cardiac arrhythmia. He has been in sinus rhythm since his initial presentation.
55 2021-04-30 hypertension Sever distress, no food, water, sleep four days; Sever distress, no food, water, sleep four days; BP... Read more
Sever distress, no food, water, sleep four days; Sever distress, no food, water, sleep four days; BP 180/120; fever; sweats; body pain; headache; 24 lbs lost 7 days; chills; smell/taste; smell/taste; still sick; This is a spontaneous report from a contactable consumer reporting for himself. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 08Apr2021 at 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. Medical history included chronic pain from an unknown date and unknown if ongoing, and liver issues from an unknown date and unknown if ongoing. Concomitant medication(s) included morphine taken for an unspecified indication, start and stop date were not reported; fluoxetine taken for an unspecified indication, start and stop date were not reported; gabapentin taken for an unspecified indication, start and stop date were not reported; tamsulosin taken for an unspecified indication, start and stop date were not reported; and naproxen (NAPRO) taken for an unspecified indication, start and stop date were not reported. Past vaccination history included the first dose of BNT162B2 on 18Mar2021 as a single dose in the left arm for covid-19 immunization. The patient experienced sever distress, no food, water, sleep four days on 09Apr2021 at 20:00 with outcome of not recovered, blood pressure 180/120 on 09Apr2021 at 20:00 with outcome of not recovered, fever on 09Apr2021 at 20:00 with outcome of not recovered, sweats on 09Apr2021 at 20:00 with outcome of not recovered, body pain on 09Apr2021 at 20:00 with outcome of not recovered, headache on 09Apr2021 at 20:00 with outcome of not recovered, 24 lbs lost 7 days on 09Apr2021 at 20:00 with outcome of not recovered, chills on 09Apr2021 at 20:00 with outcome of not recovered, smell/taste on 09Apr2021 at 20:00 with outcome of not recovered, and still sick on 09Apr2021 at 20:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood pressure measurement: 180/120 on 09Apr2021, sars-cov-2 test nasal swab: negative on 11Apr2021. Therapeutic measures were taken as a result of sever distress, no food, water, sleep four days, blood pressure 180/120, fever, sweats, body pain, headache, 24 lbs lost 7 days, chills, smell/taste, and still sick and included migraine medications, pain control, fluids, and supportive care. It was reported that he was hospitalization in ER twice for supportive care and also reported that Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
55 2021-04-30 loss of consciousness Blacked out; This is a spontaneous report from a contactable consumer (who is also the patient). A 5... Read more
Blacked out; This is a spontaneous report from a contactable consumer (who is also the patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 26Mar2021 10:30 (lot number: ER8730); then the second dose via an unspecified route of administration, administered in the right arm, on 16Apr2021 10:30, both as single dose, for COVID-19 immunisation. Medical history included colon cancer from 2016 (5 years ago). The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient has no known allergies. There were no concomitant medications (no other medications in two weeks. The patient did not receive other vaccines in four weeks. On 26Mar2021 at 10:30, almost immediately after the first vaccination, the patient blacked out twice. On 16Apr2021, after the second vaccination, the patient blacked out four or more times. The event resulted to emergency room visit. The patient underwent EKG and blood work on an unspecified date with unknown results. The patient recovered from the event on an unspecified date.
55 2021-05-02 heart rate increased c/o muscle aches, bruise on chest, high heart rate and no appetite. On 5/3/21 see a Primary Care in ... Read more
c/o muscle aches, bruise on chest, high heart rate and no appetite. On 5/3/21 see a Primary Care in and had a heartrate of 145.
55 2021-05-02 pulmonary embolism, chest pain Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/2. He had expected post-vaccine side effec... Read more
Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/2. He had expected post-vaccine side effects including headaches, muscle aches, fever/chills, which lasted 2 days. On 4/19, he presented to the ED with 2 days of R sided pleuritic chest pain, dyspnea, and was diagnosed with PE based on CTA. He was started on treatment with apixaban and his symptoms of pleuritic pain and dyspnea have resolved.
55 2021-05-03 atrial fibrillation Afib; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-cal... Read more
Afib; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: EN6198) (age at vaccination: 55-year-old) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included nebivolol nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication from 2013 and ongoing; doxycycline (ORACEA) taken for an unspecified indication from Jul2020 and ongoing. Historical vaccine included first dose of bnt162b2 (Batch/Lot number: EC9269) on 02Feb2021 as single dose in Left arm for covid-19 immunisation. The patient had been experiencing pains on and off for about5-6 days after his first slot. Then he read an article (he swear, he was not researching anything online) about a 56 year old man who developed ITP days after receiving Pfizer vaccine. since he had Afib this article worried him. He had no idea what blood clots felt like, but he was having sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach. The doppal came back negative. The doctor suggested symptoms finally disappeared for good about two days after his second dose. The outcome of the events was unknown.
55 2021-05-03 cerebrovascular accident Admitted to hospital for stroke
55 2021-05-05 heart attack NSTEMI, treated with PCI, DES evidence of multivessel coronary artery disease PCX 100% occluded subm... Read more
NSTEMI, treated with PCI, DES evidence of multivessel coronary artery disease PCX 100% occluded submitting out of abundance of caution in case vaccine poses risk of clots in coronary artery disease patients
55 2021-05-05 cerebral haemorrhage Five days post vaccine patient had a massive cerebral hemorrhage resulting in death.
55 2021-05-06 coughing up blood Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with ... Read more
Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with Cold; Night Sweats, states it is like he took a shower; Diarrhea, states when he goes to the bathroom, it is water; Lost 14 Pounds; felt really bad; This is a spontaneous report from a contactable consumer reported for himself. A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at 55 years old on 06Apr2021 08:45 (Lot Number: ER8733; Expiration Date: 31Jul2021) at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, diagnosed 20 years prior to the report. The patient's concomitant medications were none. There were no other vaccines Administered on Same Date of the Pfizer Suspect or within 4 weeks. The patient experienced coughing, headache, fever, body shakes a lot with cold, night sweats, states it is like he took a shower; diarrhea, stated when he went to the bathroom, it was water, coughing blood, trouble breathing, lungs damaged, lost 14 pounds, all on 06Apr2021. Patient stated he was calling because his doctor told him to call. Stated he got his first injection on 06Apr2021. Told to sit for 15 minutes, and he felt fine and went to work and felt really bad after 1 hour; 09:45-10:00. Since then he had been super sick and at the hospital 3 times, later confirmed ER, not hospitalized. Patient stated the doctor also told him his lungs are damaged and they were sending him to see a specialist. Patient was asking what was going on with his body, is this a normal reaction? Stated his doctor said to call because it had been too long, stated usually it lasted 2-3 days and with Tylenol, it was gone, then it should be clear, but it had been almost 16 days for him. Stated one hour after his injection, he started feeling really bad. Stated he was coughing up blood from coughing so much. Stated he was 154 pounds, but he has lost 14 pounds. Patient stated his first injection was on 06Apr2021. Stated his second vaccine is supposed to be on 28Apr2021 but he was not going because he was afraid to go back in case it got worse. Treatment received for the events included 3 Different Antibiotics; Tylenol and Drinking Hot Tea. Patient clarified that he has had 3 Emergency Room Visits (10Apr2021, 19Apr2021, and 20Apr2021), Physician Office on 21Apr2021, but he was never admitted to hospital. Patient stated one time they kept him in the ER for 20 hours. Patient stated once he went to Hospital and then yesterday and the other day, he went to Hospital because he was having trouble breathing. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.
55 2021-05-07 blood pressure increased, palpitations Patient recieved 2nd dose and reported immediately feeling dizzy and like his heart was racing. He... Read more
Patient recieved 2nd dose and reported immediately feeling dizzy and like his heart was racing. He stated he had a history of hypertension and an hypertensive episode a few days after his first dose. pt was taken to Med Obs for assessment. His initial BP was 192/106, HR 74. He reported "shaky" vision. Pt rested on the stretcher and tried to relax. His BP remained elevated. He eventually denied feeling bad and wanted to go home. We told him it was highly advised that he go to the ER via ambulance. Pt refused and walked out of clinic on his own accord.
55 2021-05-07 heart rate increased, fainting, chest pain, cerebrovascular accident Extreme fatigue; Back of knees were cramping; Small bruise marks; Upper right arm inside he could se... Read more
Extreme fatigue; Back of knees were cramping; Small bruise marks; Upper right arm inside he could see all of his veins; Head rush; Felt like he was going to spazz out; Sweating; Diarrhea; Headache and pressure at his temples; His ears were ringing; Left arm pain from injection site; Drop foot; Legs went to sleep; Arms were roided out or supercharged/Forearms did not feel like his blood was right; Difficulty/pain breathing in the upper chest; Difficulty/pain breathing in the upper chest; Pretty big at the base of his left index finger, red spot; Pain in the right thumb base/Pain in base of right foot; He felt like he was going to die 5 times; Thought he was having a stroke; Heart rate would go up or be faint; Lost four pounds during this, and gained one back; Stiff right arm/Left thigh was stiff; Thrashing event; Heart rate went up; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, expiration date: 28Mar2021) via an unspecified route of administration on left arm 24Mar2021 10:00 at single dose for covid-19 immunization. Medical history included cytomegalovirus from on an unspecified date 2010 and Palpitations. The concomitant medications were not reported. The patient reported, he has gained back a pound and that he is starting on the road to recovery in the last week. Stiff right arm lasted the first and second week. It started the first day of when he got the shot. The next morning, he calls a thrashing event where he felt like his limbs would not work. They did work, but it felt like he needed to move them around. He was thrashing in bed and making the motion with his big joints, then getting into the small joints. It was his arms and legs. Over the course of like an hour, his heart rate went up to like 120. He does not qualify this as racing, but his heartrate is normally 60. This was several times over the course of the first week so it would have been around 04Apr2021 or 03Apr2021. Events occurred 9 days later, which is what he is considering this first week. His left arm was where he got the vaccine, but his right arm was stiff. He felt like he was going to die 5 times. He also had extreme fatigue. He never went to the emergency room. At this time, his glucose was high and his zinc was low. The doctor thinks the extreme fatigue was the antibodies reacted to the cytomegalovirus. He adds that the back of his knees was cramping in the first and second week. In the right arm, he had some small very small bruises. His forearms did not feel like his blood was right. He does not know how to describe it, but he has had metal slivers in his arm in the past and it felt like that, like an infection. He does not know how to describe it. He adds that in his upper right arm inside, he could see all of his veins, like a roadmap. He also had some other things, like his left side of his head rush, like it felt like blood was rushing from the top to left side of his brain. At dinner and meals he had several instances he could barely sit there, he felt like he was going to pass out or spazz out. His limbs felt like they were going to spazz out. In second week, he had several nights where he sweated a lot overnight. The second week into the third week, he did not have the thrashing stuff anymore but for pretty long his heart would go up a notch and/or the heart would be faint. He had diarrhea when he got up. It did not go up to 120, but maybe 80, Headache and pressure at his temples, ears ringing. Left arm pain from injection site. It started with a bang and really hurt. It was really sore and kind of spread into cramping. It was stiff and the source was the injection site. At work, he thought he was having a stroke. His left leg and thigh were stiff and spreading feeling. About 20 minutes after sitting, his legs did not work, and he collapsed. He had Drop foot when his legs got stiff. It took like a week to retrain his arm and leg, like he had a mini stroke. He did therapy for himself and retrained his arm to play guitar. He had a little bit of stiffness in his left arm that comes and goes, stiffness in his left thigh that comes and goes, and his ears are ringing a little bit and it comes and goes. He is not getting second vaccine. He took zinc per his doctor recommendation, but it did not go well. He felt like his arms were roided out or supercharged. He had difficulty/pain breathing in the upper chest, a pretty big at the base of his left index finger red spot like blood collection, and pain in the right thumb base. He had pain in the base of his right foot. Blood tests were in the second week. Glucose was high and he is hypoglycemic. Glucose 117 mg/dl (79-115 normal range), zinc 54 mcg/dl (60-120 normal range), CMV IGG AB >10 u/mL (positive is > or = 0.7 range). The outcome of the events was unknown.
55 2021-05-10 chest pain chest pain and low fever. chest pain for 5 day (increase day to day). low fever for 1 day.
55 2021-05-10 palpitations Patient reported palpitation and rash on the opposite arm after receiving the shot. Blood pressure w... Read more
Patient reported palpitation and rash on the opposite arm after receiving the shot. Blood pressure was 164/89 and he was alert and able to communicate. He took 50 mg of Benadryl and 911 was called. Patent then reported shortness of breath but he was able to talk. 911 operator advised against epipen shot and recommended to wait for paramedics. Patient was asked by paramedics if he wants to be taken to hospital and he said yes and was taken to hospital
55 2021-05-12 blood clot 2/4/2021 - Vaccine 2/26/2021 - Left Ankle surgery 4/9/2021 - Left leg swelling 4/22/2021 - Ultrasoun... Read more
2/4/2021 - Vaccine 2/26/2021 - Left Ankle surgery 4/9/2021 - Left leg swelling 4/22/2021 - Ultrasound found clots in left leg from groin to ankle
55 2021-05-13 ischemic chest pain the pain was shooting down to his heart; severe pain in his left shoulder after that second dose; in... Read more
the pain was shooting down to his heart; severe pain in his left shoulder after that second dose; injection site pain; pain is around his arms/going on the top of his legs; back and wraps down to the heart; major pain up around his shoulders and around the back of neck; I have stomach problems, I am collapsed stomach; This is a spontaneous report from a contactable consumer (patient). This 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in his left arm on 05Apr2021 at single dose for COVID-19 immunisation. Medical history included Arthritis, Sinus problem, Asthma, Bipolar disorder. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date at age of 55 years old for COVID-19 immunisation. The patient experienced injection site pain, severe pain in his left shoulder after that second dose. Some major pain up around his shoulders and around the back of neck, his left side was worst. He said that the pain was shooting down to his heart. So he went to the hospital because he thought it was something to the heart. They tested him, they evaluated him but they ruled out anything that has to do with the heart. They checked his heart, he had a cardiac catheterization, and was ruled out, everything came out negative. So, he just got out of hospital and was still developing the pain and it's on his left side, it's on his right side (as reported). He called all his doctors, they had no answers for him, now he was still in a lot of pain in both of shoulders like he was saying his left side was still the worst, and it has not gone away and the pain is still shooting down around his heart and shooting down around the back of neck and now it's going on the top of his legs. He went to the bone doctor and he was getting an MRI done, because the doctors said nothing was torn in his arms or tissues. He stated the pain was around his arms, back and wraps down to the heart. He was in dire pain, 8.5/10 and had a feeling of it was related to the vaccine. He clarified the pain was in both shoulders and the left side was worse and that was the side he had his shot on. Patient stated he had stomach problems, he was collapsed stomach. The outcome of events was unknown. Information on the lot/batch number has been requested.
55 2021-05-13 pulmonary embolism Pulmonary embolism in his left lung; Chills; Hard to breathe; shaking a lot; This is a spontaneous r... Read more
Pulmonary embolism in his left lung; Chills; Hard to breathe; shaking a lot; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0164) via an unspecified route of administration on 19Apr2021 at 12:00 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unspecified date and ongoing and urinary tract infection (UTI) from an unspecified date and unspecified if ongoing. Concomitant medications were reported as none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: first letter is either a G or O but he thought it was OE8732) via an unspecified route of administration on 29Mar2021 at 11:45 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Illness at vaccination was UTI. On 20Apr2021 the patient experienced pulmonary embolism in his left lung, chills, hard to breathe and shaking a lot. The patient was hospitalized for pulmonary embolism in his left lung (blood clot) from 20Apr2021 to 26Apr2021. The clinical course was reported as follows: The patient stated that he had the second Pfizer shot on 19Apr2021 and on the 20Apr2021 he had a really bad reaction to it. He had chills, it was hard to breath, he was shaking a lot and had a UTI and COPD and had to call an ambulance to come get him. When he went to the emergency room, they did a CT (computerized tomography) scan of his chest and found a pulmonary embolism in his left lung and he was put on a Heparin drip for 7 days and stayed in the hospital for 7 days. The event hard to breathe ended shortly after he got to the emergency room since he was on oxygen. The patient had a history of COPD, so sometimes he had trouble breathing, but right now he did not. The event shaking a lot ended a little after he got to the emergency room. The patient also stated that he had a history of UTI in the past and had a UTI during the vaccine but was not treated for the UTI until he was at the hospital. The clinical outcomes of the event pulmonary embolism in his left lung was unknown; chills, hard to breathe and shaking a lot were all recovered/resolved on 20Apr2021.
55 2021-05-15 oxygen saturation decreased, increased heart rate pain in arm, within 5 days-very tired and no apatite, fever/chills/cold sweats. within 30 days, sin... Read more
pain in arm, within 5 days-very tired and no apatite, fever/chills/cold sweats. within 30 days, sinus tachycardia, low Sp02, started having a cough. Sepsis secondary to severe right lung necrotizing pneumonia with empyema, hospitalized for 5 days. Discharged with a right chest tube with Pleur-evac. Will require at least 6 weeks of antibiotics.
55 2021-05-15 pallor, loss of consciousness, pulse abnormal vomiting, passing out; 5-10 min post vaccination, pt became diaphoretic, pale, thready -palpable pul... Read more
vomiting, passing out; 5-10 min post vaccination, pt became diaphoretic, pale, thready -palpable pulse, began to lose consciousness, ems called to eval. pt. RN/EMS lowered to the floor-pt put on side and he vomited. regained consciousness after vomiting- EMS transported hospital
55 2021-05-16 loss of consciousness Shortly after patient received his 2nd dose of Pfizer, the patient's wife reported that he passed ou... Read more
Shortly after patient received his 2nd dose of Pfizer, the patient's wife reported that he passed out in the car at the waiting area. The wife started blowing the horn and yelling for help around 12:20PM. Paramedic on duty in waiting area reported to finding patient unconscious and then reported patient regaining consciousness and began vomiting. Patient was transported to hospital for further evaluation at 12:38pm.
55 2021-05-17 blood pressure increased Headache followed by Tinnitus. Increased blood pressure at onset of each. Headache remains at lower ... Read more
Headache followed by Tinnitus. Increased blood pressure at onset of each. Headache remains at lower pain level. Tinnitus continues with no change, in both ears and has not improved.
55 2021-05-19 oxygen saturation decreased ED to Hosp-Admission Current 5/8/2021 - present (12 days) Treatment team Sepsis due to severe acu... Read more
ED to Hosp-Admission Current 5/8/2021 - present (12 days) Treatment team Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Principal problem Date: 5/8/2021 PCP: DC Hospitalist: MD Assessments Chief Complaint Patient presents with o Dizziness o Cough Principal Problem: Acute respiratory failure (CMS/HCC) Active Problems: COVID-19 Plan #Acute hypoxic respiratory failure requiring 50 L of oxygen support to maintain his oxygen saturations, patient came in with a saturations of 58% on room air. This is secondary to Covid pneumonia -Patient will be started on convalescent plasma, remdesivir and dexamethasone. -Reviewed entire plan of care with with him his interpreter at bedside and patient gave consent to receive convalescent plasma. -We will obtain acute inflammatory markers. -I will also obtain a CT scan of chest to rule out pulmonary embolism given severe hypoxia. -Anticipate hospitalization for 5 days given severe acute hypoxic respiratory failure requiring high flow oxygen. #Acute anion gap metabolic acidosis secondary to lactic acidosis secondary to Covid pneumonia resulting in severe hypoxic respiratory failure. -Check procalcitonin to see if patient is developing secondary bacterial infection. -If procalcitonin is elevated will start patient on antibiotics as well. -Use guaifenesin for mucolytic purposes. -Recheck lactic acid with the current management. #Mild hyponatremia: -Secondary to pulmonary infection with a Covid pneumonia. -No acute intervention needed, will continue to monitor. #GERD: -Continue PPI. Critical care time today is 38 minutes. Patient was educated regarding prone positioning and will prescribe a cough medication gave given intractable cough as well. # VTE Prophylaxis: heparin Full Code Diet: Active Orders No diet order for this patient
55 2021-05-21 inflammation of the pericardium Diagnosed Pericarditis; This is a spontaneous report from a contactable other healthcare professiona... Read more
Diagnosed Pericarditis; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, at age of 55-year-old), via an unspecified route of administration, administered in right arm on 13Apr2021 at 13:15 as single dose for covid-19 immunization. Medical history was none. No known allergies. Concomitant medications included atorvastatin, carvedilol and telmisartan. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, at age of 55-year-old), via an unspecified route of administration, administered in left arm on 21Mar2021 at 13:15 as single dose for covid-19 immunization. The patient experienced diagnosed pericarditis on 05May2021 at 12:00 PM, resulted in emergency room/department or urgent care, and treatment included 800 mg Ibuprofen. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had covid test post vaccination on 09May2021 and type was nasal swab, result was negative. The outcome of the event was recovered with sequelae on an unspecified date in 2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine to the reported event pericarditis cannot be completely excluded based on temporal association and known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product 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.
55 2021-05-22 chest pain Shortness of breath, chest pain, dizziness after the slightest of exertion.
55 2021-05-23 fibrin d dimer increased Swelling, redness and warmth to right lower leg noticed on April 2nd 2021.
55 2021-05-23 heart rate increased I received the vaccine in the right arm and within about 20 seconds I felt like I was going to faint... Read more
I received the vaccine in the right arm and within about 20 seconds I felt like I was going to faint and had rapid heart rate (pulse of 155) measured by EMT. I needed to remove the mask as I was having difficulty with the rapid heart rate and feeling of fainting. I also felt pins and needles type feeling in my legs and my face felt slightly swelled. I felt tired and that tired feeling lasted for the entire day. I stayed at the vaccination site for approximately 30 minutes at the advice of the EMT and went home. Later I had a slight headache but heart rate became more normal.
55 2021-05-23 heart rate increased Rapid heartbeat, fatigue
55 2021-05-25 palpitations anxiety attack; heart racing; intense feeling of heat in body; tired; shortness of breath; This is a... Read more
anxiety attack; heart racing; intense feeling of heat in body; tired; shortness of breath; This is a spontaneous report from a contactable other HCP (patient). A 55-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Apr2021 16:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergy. There were no concomitant medications and the patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient previously took levofloxacin and experienced allergy. The patient reported that approximately three minutes after taking the vaccine 24Apr2021 16:33 (also reported as 17:15), still waiting for the recommended 15 minutes to be released, he started to feel his heart racing and a very intense feeling of heat in body. After reporting to the nurse at the location, she listened to his heart asking him to take a deep breath several times. According to the nurse, he had an anxiety attack, as she did not show any signs of anaphylaxis. However, he felt very tired and the night with a little shortness of breath. He would like to know if he go for the second dose or look for another vaccine. the patient did not receive treatment for the events and the outcome of the events was resolved in 2021. Information on the lot/batch number has been requested.
55 2021-05-25 fainting, loss of consciousness first day: fever 100.7, fatigue, extreme thirsty second day: fever 100.8, very disoriented, extreme ... Read more
first day: fever 100.7, fatigue, extreme thirsty second day: fever 100.8, very disoriented, extreme fatigue, I passed out and was unconscious for atleast 2-3 minutes 911 was called.
55 2021-05-26 platelet count decreased Low Platelet count discovered after second shot.
55 2021-05-27 inflammation of the heart muscle My first vaccine was Feb 14, 2021, my second Mar 7, 2021. Following both I had <24 hours of headache... Read more
My first vaccine was Feb 14, 2021, my second Mar 7, 2021. Following both I had <24 hours of headache and lethargy before returning to normal. Symptoms were noted during hikes with cub scouts, so not particularly difficult terrain On March 27 I was very short of breath during an uphill hike and almost gasping at the top. I did no more uphill hiking until the next event May 1, at where I experienced shortness of breath and dizziness on an uphill hike. After resting a few minutes I continued for a brief period before it returned requiring me to back. May 7, short of breath and dizzy while doing yard work requiring ladder climbing May 10, short of breath and dizzy on a quick 1/2 mile walk May 10, visited GP and was admitted to hospital with abnormal ECG
55 2021-05-28 blood pressure increased Blood pressure skyrocketed by next morning, still high, despite increased medication. Diastolic rema... Read more
Blood pressure skyrocketed by next morning, still high, despite increased medication. Diastolic remains high no matter what. This began the morning after the first dose.
55 2021-06-01 deep vein blood clot Developed DVT of right leg five days after vaccine, recognized 5 days later, hospitalized two days,... Read more
Developed DVT of right leg five days after vaccine, recognized 5 days later, hospitalized two days, home on Eliquis
55 2021-06-02 atrial fibrillation Within 24 hours of receiving the second dose of the Pfizer vaccine I went into persistent atrial fi... Read more
Within 24 hours of receiving the second dose of the Pfizer vaccine I went into persistent atrial fibrillation for the first time ever despite having the condition for almost 10 years.
55 2021-06-03 hypertension Markedly elevated blood pressure, anxiety, severe body aches, chills
55 2021-06-03 heart attack, heart attack STEMI heart attack, clot in right coronary artery, 3 days in hospital 4/10/21 to 4/13/21
55 2021-06-07 cerebrovascular accident He had a stroke- sudden onset of weakness,- facial drooping, speech impairment, lethargy, and confus... Read more
He had a stroke- sudden onset of weakness,- facial drooping, speech impairment, lethargy, and confusion obvious symptoms did resolve over 24 hour- he has some residual fatigue and questionable changes post stroke
55 2021-06-07 chest discomfort Headache; Chills; Feeling unwell; Tightness in chest; Wheezing; A lot of coughing; Lungs hurt and ar... Read more
Headache; Chills; Feeling unwell; Tightness in chest; Wheezing; A lot of coughing; Lungs hurt and are kind of sore; It makes breathing difficult; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 19may2021 (at the age of 55-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 28apr2021. The patient medical history includes type 2 diabetes and patient is not a smoker. Concomitant medications were not reported. On 22may2021, 3 days after the second vaccination, the patient experienced headache, chills, feeling unwell, tightness in the chest, a lot of coughing, wheezing, lungs hurt and kind of sore and breathing difficulty. The coughing is usually dry with something coming up occasionally, but it's not much. It's been a lot of coughing and he was feeling rundown. He wants to know if this was normal after having the shot a week ago. The patient stated that his lungs begin to hurt after coughing a lot and it makes breathing difficult. He is a non-smoker, so it has nothing to do with smoking. He has tightness in the chest from coughing and his lungs are kind of sore. It just comes on and he feels fine for a while. But it just comes on and sticks with him for a while. Patient stated headache started on Saturday afternoon and it kept with him till Wednesday. After ibuprofen it stayed down but, occasionally it is off and on. It has gotten better. He had it for 3 days straight and it will come back and then it is gone away again. Patient also stated that chills happened once or twice and not sure on the day the chills stopped. Patient stated that he was at work and for a while and started feeling unwell on 22may2021 morning. And he starts with the coughing, it just comes and goes. His blood sugar has been okay. Patient received ibuprofen as treatment option for the events (headache). The seriousness of the events was unspecified. The outcome of the events headache was recovering and outcome of all other events was mentioned as unknown. No follow-up attempts possible. No further information expected.
55 2021-06-09 low blood oxigenation, fast heart rate Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to emergency department (ED) reporting fatig... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to emergency department (ED) reporting fatigue, malaise, and anorexia. Patient was hypoxemic (oxygen saturation 90%) and tachycardic (pulse 108 beats per minute). Diagnosed with COVID-19 and acute hypoxemic respiratory failure, admitted to hospital, received remdesivir, steroids, anticoagulation, and oxygen. Patient improved and was discharged two days later medically stable.
55 2021-06-09 blood clot Blood clot in the leg
55 2021-06-09 blood clot Pt called pharmacy on 06/10/2021 to report he suffered a blood clot of unknown etiology on 05/16/202... Read more
Pt called pharmacy on 06/10/2021 to report he suffered a blood clot of unknown etiology on 05/16/2021.
55 2021-06-10 heart attack NSTEMI monitored and improved on his own; no surgical intervention needed started on imdur and losar... Read more
NSTEMI monitored and improved on his own; no surgical intervention needed started on imdur and losartan and discharged home
55 2021-06-10 arrhythmia Began experiencing heart arrhythmia the Sunday adn Monday after my second shot. (Never experienced p... Read more
Began experiencing heart arrhythmia the Sunday adn Monday after my second shot. (Never experienced previously) I had another two day episode on Thursday and Friday of that same week. Went to cardiologist, got an ekg which showed the abnormal heartbeat. I am currently scheduled for stress test on the 28th of June. Dr. said it is not too worrisome but I am still experiencing the arrythmia occasionally.
55 2021-06-11 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
55 2021-06-13 atrial fibrillation I had two: First I had swollen glands in the left armpit. Second: My Atrial Fibrillation became ve... Read more
I had two: First I had swollen glands in the left armpit. Second: My Atrial Fibrillation became very active. Although i have had 3 ablations, I had several episodes of Afib spanning the last few months since my injection of the Covid vaccine.
55 2021-06-14 atrial fibrillation Patient developed intermittent afib after first dose but was not seen by a physician at that time, t... Read more
Patient developed intermittent afib after first dose but was not seen by a physician at that time, the events were recorded on his smart watch. After second dose, patient went into continuous afib with a blood pressure of 200/120 and a pulse around 200. Went to the local emergency room and was put on cardiac meds, had an ecg that confirmed the diagnosis. Was seen by the primary the next morning and put on a different cardiac med. Still no change to the afib.
55 2021-06-14 bleeding on surface of brain I suffered a Subarchnoid brain hemorrhage. The was bleed in the subarachnoid space surrounding the b... Read more
I suffered a Subarchnoid brain hemorrhage. The was bleed in the subarachnoid space surrounding the brain. I went to emergency at hospital with worst headache of my life. After a brain hemorrhage was confirmed by CT-scan, I was rush to hospital were I was treated in the Cerebral critical unit. I suffered through the worst pain of my life for 10 days as the blood from the hemorrhage drained. It 2.5 months later and I am still dealing with the effects of the hemmorhage (headaches, exhaustion, light sensitivity, short term memory loss and speech issues,
55 2021-06-15 chest pain, palpitations Heart palpitations and mild chest pain developed 3-5 days after 1st shot. Palpitations
55 2021-06-16 chest discomfort Brain fog; Nausea; weakness; Weird sensation on [his] tongue 5-10 mins; Weird taste in [his] mouth s... Read more
Brain fog; Nausea; weakness; Weird sensation on [his] tongue 5-10 mins; Weird taste in [his] mouth soon after that/funny taste in mouth; Shortness of breath/difficulty in breathing; Dizziness/Light headedness; Weakness in his upper chest and in both arms; Weakness in his upper chest and in both arms; Diarrhoea; Headache; felt like my throat is gonna close, I won't say I had any difficulty in swallowing, but it was not normal; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on 06Jun2021 at 11:30 hours as 1st dose, single dose (at the age of 55-years-old) for COVID-19 immunisation. Regarding lot number patient stated that it looks like EW, patient thought he was not sure if it was 6185 or 0185, not sure it looks like 0 but it looks like 6 too but patient think it was 0. The patient medical history included shortness of breath, sleep apnea and kidney disease (from an unknown date and unknown if ongoing). Patient sees a doctor for lot of conditions one was for shortness of breath and sleep apnea and sees a neurologist for Bph. The patient concomitant medications were not reported. Patient explained he was reluctant from getting vaccinated and nervous before the shot. On 06Jun2021, after patient took the shot, probably around 11:30 in the morning, patient was same, soon after 5 min maybe more, patient got a sensation on the left side of his tongue 5-10 mins, then kind of a weird taste came to his mouth, patient started to get a little dizzy, a little light headedness, weakness in his chest and both his arms, got shortness of breath but had been seeing a doctor for shortness of breath prior taking the Covid shot and had kind of reluctant of taking the shot but some other issues going on side, patient decided to take it, a couple of hours after the shot, patient had a headache, had the diarrhea. Patient described the weird taste like having a penny in his mouth. Patient explained he consulted a doctor on that Monday (07Jun2021), who said she encountered patients who also had the sensation on their tongues following vaccination, and that it was normal. Today (08Jun2021) patient had feeling just a little bit of nausea and patient kind a feel like a little brain fog, it was just his head doesn't feel right, the major concern was says some things risks factors and some of them had severe reactions, patient had a reaction difficulty in breathing, dizziness and feel little bit weakness, patient kind of a felt like his throat was going to close and he won't say he had any difficulty in swallowing, but it was not normal. Patient developed symptoms which spooked and scared him. Patient did not have his lab test but was constantly going to patient had just had right heart catheter right two weeks ago, you know last for him, patient was supposed to take another lab test to conduct at the end of the month for cholesterol, but patient saw neurologist for kidney disease. Events did not improve, patient just had this brain fog you know. Patient had to call a doctor after he got home, they did not prescribe him anything, patient mean he did bunch of appointment with doctor with the phone as soon as he got home from taken a Covid shot he was little worried. Patient stated he was concerned about getting the second dose of vaccine scheduled on 27Jun2021. Patient stated he will not be able to consult his doctor before the vaccination appointment and was not able to get further assistance from a pharmacist. Patient repeated he does not know what to do about the second dose. Patient was kind of reluctant taking the next shot, if he was going to feel the something like this again, he don't want to, as he already had uneasy you know just had and patient did not had difficulty in breathing all of time this comes and go, from the sentence he described it says on pamphlet that there was severe reaction to the shot and don't want to take the second shot and then end up in hospital because patient had more from it so his question was he was afraid to take the second shot. Patient don't had answer to that he means he would like to talk to somebody who can give him information kind of help me to relax little bit if it was normal and in in response it was responded that decision to receive the second dose for any other reason cannot be made by the company. Patient was referred to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection, as healthcare provider knows his health situation and had access to information that can better help inform this decision. The outcome of brain fog was not recovered and outcome for other events was unknown. Information about lot/batch number is requested.
55 2021-06-17 ischemic chest pain Having stabbing pain in his heart; This is a spontaneous report from a contactable consumer. A 55-... Read more
Having stabbing pain in his heart; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE ), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EW0170) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Sleep apnea which he had surgery for sleep apnea a long time ago, arthritis in his hand.The patient's concomitant medications were not reported. The patient previously took lisinopril for blood pressure, and has been on it for 2 years or so and has never had that experience with it. He received flu vaccine vii. A week after, he started having stabbing pain in his heart. He said it was not real bad, but enough to know it was there. He added that it was periodically on and off, and in the last 2 days, he did not feel it anymore. Outcome of event was unknown.
55 2021-06-18 cardiac arrest, fainting On April 27, after my husband took a 2 mile run. He returned and collapse outside of our home. My... Read more
On April 27, after my husband took a 2 mile run. He returned and collapse outside of our home. My son and I immediately perform CPR on him. Three week later my husband did from respiratory heart failure - cardiac arrest. He had no complaints about any chest pain ever. We had just visited his doctor that afternoon and gave no report of heart problems or any immediate health issues.
55 2021-06-18 inflammation of the pericardium Pericarditis
55 2021-06-18 blood clot blood clots in right leg; This is a spontaneous report from a Non-contactable consumer (patient). A ... Read more
blood clots in right leg; This is a spontaneous report from a Non-contactable consumer (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 03Apr2021 (Batch/Lot number was not reported) at the age of 55-year-old as single dose for covid-19 immunisation. Medical history included covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medication included etodolac taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood clots in right leg on 23Apr2021 with outcome of recovered with sequelae on an unknow date. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included apixaban (ELIQUIS). Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
55 2021-06-21 blood glucose increased Starting on 5/16/2021, I was very weak, I was headed to work the following Monday, I was urinating a... Read more
Starting on 5/16/2021, I was very weak, I was headed to work the following Monday, I was urinating a lot, sic, feeling better until the next day I experienced the same symptoms again, this went on for 5 days, The following Monday I wasn't feeling better so I called Doctor. I decided to go to urgent Care and they said I was Jaundiced, they wanted me to go to the hospital, I spent 4 days in hospital, they said I was having an auto immune response to something, did scan on liver and it looked fine, however liver biopsy did not look good, they won't tell me what I have to go in for more testing. My doctor consulted with a specialist and they concluded it may be an auto immune reaction and I was told my gallbladder is also inflamed, but it looks fine , my bilirubin numbers were off the chart. I am going to see a liver specialist at medical center at the end of July. My blood sugar has since raised into diabetic range due to steroids. I had no reaction to my first dose of covid vaccine.
55 2021-06-23 blood clot blood clots in greater saphenous vein; This is a spontaneous report from a contactable consumer (pat... Read more
blood clots in greater saphenous vein; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 08:00 at single dose in left arm (at the age of 55-year-old) for COVID-19 immunization. Medical history included covid-19. Concomitant medication included iodine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 15Apr2021, the patient experienced blood clots in greater saphenous vein. The event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included Eliquis. The outcome of the event was unknown. Information about batch/lot number has been requested.
55 2021-06-27 chest pain I don?t know the lot number. I guess my vaccination. Card might have that info. I started having sev... Read more
I don?t know the lot number. I guess my vaccination. Card might have that info. I started having severe chest pain & into my neck & L arm. All the symptoms of Pericarditis.
55 2021-06-28 pulmonary embolism On June 17 I went to the ER. Based on the symptoms I had a CT scan. I had a Bi-lateral Pulmonary ... Read more
On June 17 I went to the ER. Based on the symptoms I had a CT scan. I had a Bi-lateral Pulmonary Embolism with a Saddle Embolism. I was put on Heprin. Based on my Troponin numbers there was damage done to the right side of heart. I spend 4 days in the Hospital. I was released on the 21st of June. I have many doctor appointments scheduled including: cardiologist, phlebotomist, and Primary Physician. I have been sent home with Eliquis and will be on it for the foreseeable future. Days in Hospital: 4
55 2021-06-29 inflammation of the heart muscle Developed Myocarditis that lasted 12 hours. Went to hospital in for treatment.
55 2021-07-02 heart rate increased, chest discomfort, palpitations scratchy throat; ear ache; mild headache; Heart racing; dizziness; heart flip flopped and sped up, t... Read more
scratchy throat; ear ache; mild headache; Heart racing; dizziness; heart flip flopped and sped up, that lasted 10 minutes; gassy and reflux type chest pressure with feeling trouble breathing/Difficulty breathing; gassy and reflux type chest pressure with feeling trouble breathing; allergic reaction; This is a spontaneous report from a Pfizer sponsored program. via contactable consumer or other non hcp. A 55-year-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EW0158 and expiry date was not reported) via intramuscular route of administration, administered in Arm Left on 26Apr2021 at 10:00 as dose 1 single, for covid-19 immunisation, (received the first dose of the Pfizer vaccine a week ago today, I had some reactions to the first shot, and am trying to determine whether or not to get the second shot). Patient medical history allergy to Penicillin diagnosed 2 years ago. He was advised as a child he was allergic to it, but the local medical provider wanted to actually prove if he was actually allergic and he was tested to verify. He was also allergic to the carrier that they give it to you in. Concomitant medication included cetirizine hydrochloride (ZIRTEC, Batch/Lot number and expiry date was not reported), 1 tablet daily for allergies (Started within the last year). There was no prior Vaccinations (within 4 weeks) and no AE following prior vaccinations. There was no history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There was no family history. There was no relevant test. He did not take prior vaccination. The patient experienced within 5 minutes had dizziness on 26Apr2021 at 10:05, and my heart flip flopped and sped up, that lasted 10 minutes. I went home and later in the day I had mild headache on 26Apr2021 at 12:00 that came and went away after about 5 minutes, then on26Apr2021 at 12:05, ear ache lasted about the same amount of time and then on 26Apr2021 at 12:10 a scratchy throat and that went away, on Apr2021 gassy and reflux type chest pressure with feeling trouble breathing on 26Apr2021 that was later in the day and carried into the majority of the next day and Within 5 minutes of getting shot, he had the dizziness and heart racing. Difficult breathing was at 14:00. It was worse the following morning at 10:00. That is when he took Tums and Benadryl and by 14:00, they resolved. Headache was at 12:00 This would go away and then earache and then scratchy throat and then difficulty breathing. Ear Ache at 12:05, Scratchy throat at 12:10. There was no ER or physician's office required. Dizziness at 10:05, Heart racing at 10:05. The reporter states, He received the first dose of the Pfizer vaccine a week ago today, had some reactions to the first shot, and trying to determine whether or not to get the second shot. He had the shot at 10am, within 5 minutes had dizziness, and my heart flip flopped and sped up, that lasted 10 minutes. He went home and later in the day he had mild headache that came and went away after about 5 minutes, then he had an ear ache lasted about the same amount of time and then a scratchy throat and that went away, had gassy and reflux type chest pressure with feeling trouble breathing that was later in the day and carried into the majority of the next day. He saw in an article that a man who was hospitalized, they gave him Pepcid, and epinephrine, and Benadryl. So he took 3 tums, and two Benadryl and within a few hours symptoms decreased and felt fine. Looking at the vaccination facility where we got the vaccine, it states, there was a remote chance of severe allergic reaction. He wasn't hospitalized, etc. He did reach out, because he have tested for Penicillin reaction, he spoke to his allergy doctor, so they aren't very helpful. they said to front load with an antihistamine. They consider a severe allergic reaction if he were hospitalized and intubated. Reporter wanted to know if there was anything that has to go on the vaccination card, as to why he may not have received the 2nd dose, like if it was due to an allergic reaction. Within 5 minutes of getting shot, he had the dizziness and heart racing. It lasted 5-10 minutes. It felt like his heart flip flopped and it could have just been an increase in heart rate. The difficulty breathing happened after he came home and it was about 2 hours after the shot. Before that, he had a headache that only lasted a few minutes and it went away. Then an ear ache, which was 5 minutes after that. Then he had a scratchy throat and that went away, then the breathing portion of it kind of started that day and it continued and got worse until the next morning. It felt like he had gas and/or reflux type feeling and it was harder to take a deep breath. He saw online where someone had been treated for the same thing and was given Epinephrine, Pepcid and Benadryl. He does not know the person and read about this individual that was treated for it. He does not have any information to report for this person. Patient stated he took 3 Tums and 2 Benadryl and it resolved within a couple of hours the following morning from having taken the shot. He was allergic to penicillin diagnosed previously and was concerned about getting the shot but they said he would be fine. He had dizziness, and heart racing that lasted 10 minutes. He also was having difficulty breathing and had reflux for 8 hours for which he took a Benadryl. He would like to know if he can get second dose after experiencing side these effects. On the factsheet, it said this would be considered a severe reaction. He does not have a date, manufacturer, lot or expiration for the penicillin he was allergic to. He got tested in the last 2 years at University and tested that he was actually allergic. He later stated it was suggested in childhood that he was allergic, but never properly diagnosed until a couple of years ago. The outcome of event (dyspnoea, dizziness , ear pain, throat irritation, palpitations and Headache) was recovering and rest of events were unknown. Follow-up attempts completed. No further information expected.
55 2021-07-05 fast heart rate Tachycardia; tinnitus in both ears; This is a spontaneous report from a contactable consumer (patien... Read more
Tachycardia; tinnitus in both ears; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 23Mar2021 (reported Age at Vaccination was 55 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: EN6202) on 02Mar2021 (at 55 years old) as single dose for COVID-19 immunisation, No reaction on previous exposure to vaccine. Caller states he is experiencing since 10May2021, tinnitus in both ears, states he found out that it is being reported that people are experiencing this side effect after the Pfizer Covid vaccine so he wants to report it. States he got the first dose of the Pfizer vaccine on 02Mar2021 and second dose on 23Mar2021. States the tinnitus started on 10May2021, states it first got a little better but over the last couple of days it has gotten worse. States when he had the second vaccine, 9 minutes after the second dose he had tachycardia they rushed him to the ED (emergency department) and they kept him there for 2 hours, did an EKG and he seemed to be doing okay, states the next evening it happened again, ambulance came to his home the next evening, had a rapid heart beat again, took him to the same hospital, the ED and they let him go in a few hours later and it completely resolved and has not happened again. States he got injections in both his left and right arms, does not clarify which injection went in which arm. The patient was hospitalized for Tachycardia on unknown date. Emergency room visit for Tachycardia. The outcome of the event Tachycardia was recovered on 24Mar2021, for other event was not recovered. information on the lot/batch number has been requested.
55 2021-07-11 low blood oxigenation Patient is a 55 y.o. yo male presenting to the ED with fatigue, shortness of breath, difficulty brea... Read more
Patient is a 55 y.o. yo male presenting to the ED with fatigue, shortness of breath, difficulty breathing and poor appetite per patient's son-in-law. Patient received Covid vaccine on April 25, 2021 and about 3 days later, started to have symptoms that they thought were just postvaccination symptoms. Patient was having decreased appetite, fatigue and generally did not look well. The following week, patient was tested for work and resulted as positive for COVID-19 at that time. He then presented to the ED on May 8th, was admitted initially to the floor but had progressive decompensation of his hypoxemia and was transferred to the ICU on May 12th. He was intubated and subsequently cannulated for VV ECMO due to hypoxia. He remained on the circuit until 6/26/21 when he was successfully decannulated. He was still ventilator dependent and transferred to LTAC on 7/6. I was just asked by one of his care team members yesterday to submit this case to VAERS as he had no risk factors for such severe COVID disease other then his age of 55. He had normal BMI and no PMH. The concern from staff is that his vaccination may have not only failed to protect the patient, but could have boosted the virus's ability to infect cells; this concern is based on original vaccine and spike protein trials published back in 2005.
55 2021-07-11 palpitations Arm soreness only for 36 hours. Occasional heart palpitations noticed approximately three weeks lat... Read more
Arm soreness only for 36 hours. Occasional heart palpitations noticed approximately three weeks laters. Second dose 6/15/2021. Arm soreness and mild fever, aches, fatigue for 48 hours. Occasional palpitations continued. ER for treatment. Diagnosis: sinus arrhythmia with occasional premature ventricular complexes. Patient had normal ECG pre-vaccine (5/5/2021) based on annual wellness exam.
55 2021-07-13 pulmonary embolism Patient was admitted for seizures on 5/5/2021 with plan to discharge to a post acute facility. He wa... Read more
Patient was admitted for seizures on 5/5/2021 with plan to discharge to a post acute facility. He was negative for COVID-19 at admission. During discharge screening for facility, he was found to be COVID-19 positive. He was asymptomatic for COVID-19 and was discharged to facility on 5/22/2021. On 5/26/2021 he presented to the hospital again and was found to have a pulmonary embolism. He remained admitted until 6/6/2021.
55 2021-07-14 heart rate irregular, atrial fibrillation On April 17, 2021, I woke up with an irregular heartbeat that did not go away after taking my as-nee... Read more
On April 17, 2021, I woke up with an irregular heartbeat that did not go away after taking my as-needed dose of metoprolol 25 mg orally. I experienced feeling like I would pass out and my heart not feeling right. I called 911 which their EKG machine showed I was in atrial fibrillation (I have never had before). I was taken to hospital via ambulance. I converted back to normal sinus rhythm at arrival to the hospital in the ambulance. The cardiac workup did not show anything significant. Followed-up with my cardiologist's office.
55 2021-07-14 palpitations, heart rate increased The event shortness of breath, rapid heart beat/pounding, dizziness, and palpitations. Currently wea... Read more
The event shortness of breath, rapid heart beat/pounding, dizziness, and palpitations. Currently wearing a heart etc monitor for 7 days. F/U appointment July 27, 2021
55 2021-07-15 chest discomfort Pt. states that after receiving the 2nd dose of Phizer vaccine started to experience 04/27/2021 feel... Read more
Pt. states that after receiving the 2nd dose of Phizer vaccine started to experience 04/27/2021 feels Asthma has worsened with tightening in the chest with shortness of breath. Everyday occurrence, continuing.
55 2021-07-18 heart attack I experienced a massive heart attack on 05/07/2020. I was admitted to the ER next door to my office ... Read more
I experienced a massive heart attack on 05/07/2020. I was admitted to the ER next door to my office and two stents were placed in an artery that was clogged 60% along with one that had 100% blockage. I stayed in the hospital from Friday to Sunday and was in the ICU for 2 days.
55 2021-07-19 blood pressure increased just started feeling naeous my blood pressure jumped up, i was right down the road from the hospital... Read more
just started feeling naeous my blood pressure jumped up, i was right down the road from the hospital so i went there, i took baby aspirin to try and get it to go down i had to take another med to get my pressure down, ct scan, 2 mri, mra, blood work
55 2021-07-19 blood clot 10 after i got my vaccine , i got pneumonia had a temperature of 104 and had blood clots in both my ... Read more
10 after i got my vaccine , i got pneumonia had a temperature of 104 and had blood clots in both my arms and in my lungs. I went to the emergency room i was kept there for a week. they tested me for covid, ct scan and pvc panal. I had an infection in my lungs. took about a month to recover
55 2021-07-22 chest pain, chest discomfort After the second dose, I had a high fever/chills/body aches/soreness at the site of injection for th... Read more
After the second dose, I had a high fever/chills/body aches/soreness at the site of injection for three days. After three days of the second dose, started feeling pain/pulling of chest muscles on the left side. After continued feeling of chest pain/muscle pulling for two days, I contact a doctor on the third day, who advised me to go to ER and have examined by a physician. I went to the ER where a lot of blood tests were done and an x-ray of the chest was taken. But the ER doctor ruled out any heart-related problem. This pain started gradually reducing and reappearing every few days along with the injection site becoming sore. I started reappearing every week, then every 10 days and now it appears every two weeks. After about two weeks had the first gout attack. The doctor did not advise taking any medicine(s) to reduce uric acid before - had annual physical in Jan. Now taking Febuxostat 40 mg once daily. Also, blood work showed giant/big platelets suggesting BSS (to be investigated by a specialist on August 9)
55 2021-07-25 chest discomfort, chest pain July 27, 2021 12:45 PM. Started getting weak with exhaustion, Started getting shortness of breath, s... Read more
July 27, 2021 12:45 PM. Started getting weak with exhaustion, Started getting shortness of breath, shortness of breath while exerting myself just walking across room or doing basic kitchen chores, pressure and heaviness in chest, shortness breathing trying to sleep even with a c-pap machine, and every night for the first two weeks major chest pains so much so had to hold two pillows against my chest trying to sleep, and was able to feel heart in my chest. After two weeks of this, my mother talked me into seeing my doctor 7/7/2021. Had an x-ray of my chest. 7/22/2021 had a stress test and the results were no blockages. Now waiting for a referral from my doctor to see a heart specialist and waiting for cat scan appointment. Note: I was walking 3 to 5 miles a week before this.
55 2021-07-25 fluid around the heart, chest pain, inflammation of the pericardium Covid symptoms with 1st shot. Extreem fatigue and chest pain, shortness of breath with 2nd shot. A... Read more
Covid symptoms with 1st shot. Extreem fatigue and chest pain, shortness of breath with 2nd shot. After two trips to the Emergency room I was admitted to the hospital and diagnosed with Pericarditis and a Pericardial effusion. Traeted with steroids, Colchicine and high dose NSAIDS
55 2021-07-27 hypertension Pain in arm first week that migrated to my neck and then back. Second week my blood pressure went to... Read more
Pain in arm first week that migrated to my neck and then back. Second week my blood pressure went to 200/100 and took three months to get under control. To this day my joints still hurt, especially my back. I have gone to the doctors to discuss all these isuues and I am currently under diagnoses/treatment.
55 2021-07-28 hypertension, fibrin d dimer increased Patient hospitalized from 7/17- 7/21/21 due to breakthrough infection. Patient fully vaccinated with... Read more
Patient hospitalized from 7/17- 7/21/21 due to breakthrough infection. Patient fully vaccinated with Pfizer: received dose #1 on 12/21 /20 and dose #2 on 1/11/21. The following is copied from the discharge summary: Hospital Course: a 56 y.o. male with PMHx of HTN who is being admitted for evaluation of COVID. Patient reports that his first started having symptoms about a week ago after returning from vacation. He is vaccinated with pfizer, 2nd dose completed back in 1/2021. COVID 19 infection/ Acute Hypoxemic Respiratory failure - Continue Dexamethasone 6 mg Po daily to complete 5 more days - Completed Remdesivir 5 days - Supplemental oxygen for target saturaion >90% - CRP 6.7, ESR 30, Ferritin 817, D-dimer 494, procalcitonin 0.18 - Telemetry, no arythmias - PRN albuterol as needed - Ambulation oxygenation test done, originally qualified for oxygen but today repeat doing ok at room air. - Cm consulted for home oxygen, awaiting delivery for discharge Elevated Cr - resolved - Cr 0.89 HTN: stable - Continue home lisinopril HLD - Atorvastatin Vitals and labs personally reviewed. Dispo: Discharge Home today with above.
55 2021-07-28 heart attack Sniffles, body aches and pains, nausea, diarrhea, light headed, profuse sweating, headache and inc... Read more
Sniffles, body aches and pains, nausea, diarrhea, light headed, profuse sweating, headache and increased BP for 7+ days
55 2021-07-29 deep vein blood clot, superficial blood clot superficial thrombophlebitis; This is a spontaneous report from a contactable nurse on behalf of a d... Read more
superficial thrombophlebitis; This is a spontaneous report from a contactable nurse on behalf of a doctor and other health care professional via medical information team. A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in arm on 25Apr2021 (at the age of 55-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for asthma, start and stop date were not reported. It was reported that he has a patient, male with no medical history. The patient got his second Pfizer COVID vaccine on 25Apr2021. The patient came in "yesterday" (03Jul2021) with superficial thrombophlebitis. He has a blood clot in his varicose vein. They did a doppler to rule out a DVT, and it was negative. The doctor was wondering if the patient was supposed to be treated with an anticoagulant. The doctor thought it was related to the vaccine. The patient noticed it "yesterday" and came into the office. The doppler was negative, but he has a positive superficial clot. The patient did come back "today" for follow up. They did not know the seriousness. The patient got the first vaccine on 30Mar2021 (at the age of 55-year-old). She does not know which arms the patient got the vaccine in. The outcome of superficial thrombophlebitis was reported as resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-01-03 hypertension flushing, HTN, HA
56 2021-01-03 hypertension HA, flushing, HTN
56 2021-01-07 chest pain body ache arm sore chest pain
56 2021-01-13 cardiac arrest Cardiac arrest within 1 hour Patient had the second vaccine approximately 2 pm on Tuesday Jan 12t... Read more
Cardiac arrest within 1 hour Patient had the second vaccine approximately 2 pm on Tuesday Jan 12th He works at the extended care community and was in good health that morning with no complaints. He waited 10-15 minutes at the vaccine admin site and then told them he felt fine and was ready to get back to work. He then was found unresponsive at 3 pm within an hour of the 2nd vaccine. EMS called immediately worked on him 30 minutes in field then 30 minutes at ER was able to put him on life support yet deemed Brain dead 1-14-21 and pronounced dead an hour or so later
56 2021-01-17 heart rate increased After 4
56 2021-01-20 arrhythmia Felt brain fatigue; Felt very hungry before dinner; On 07Jan, after breakfast I suddenly felt tired,... Read more
Felt brain fatigue; Felt very hungry before dinner; On 07Jan, after breakfast I suddenly felt tired, so took a nap; During the whole day I took three naps; Had sore arm; Between 15-30 min after injection, I felt light arrhythmia twice and I tried to do deeper breath to control it. About 1.5 hours after injection, in between my pull-up exercises I felt light arrhythmia; his legs were shaking which had never happened before; This is a spontaneous report from a contactable consumer reporting for himself. A 56-years-old male patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , in the right arm on 05Jan2021 16:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced light arrhythmia on 05Jan2021 16:30 with outcome of recovered , his legs were shaking which had never happened before on 05Jan2021 with outcome of unknown, had sore arm on 06Jan2021 with outcome of recovered; felt brain fatigue on 07Jan2021 with outcome of recovered , , felt very hungry before dinner on 07Jan2021 with outcome of recovered , on 07Jan, after breakfast felt tired, so took a nap on 07Jan2021 with outcome of recovered , during the whole day i took three naps on 07Jan2021 with outcome of recovered. Course of the event: Between 15-30 min after injection, the patient felt light arrhythmia twice and tried to do deeper breath to control it. About 1.5 hours after injection, in between his pull-up exercises he felt light arrhythmia 2-3 times, and after doing the third set of pull-ups his legs were shaking which had never happened before. Next morning the patient woke up a couple hours later than his normal time. Noting that the night before he went to bed one hour earlier for no reason. When semi-waking up, he had a strong arrhythmia, followed by a couple more light ones. In the past arrhythmia did occur to him when he was very stressed or very tired, but had not have it for a few years. The patient had sore arm but tolerable. On 07Jan2021, after breakfast the patient suddenly felt tired, so took a nap. During the whole day he took three naps, which he had never done before. No arrhythmia though. The patient felt brain fatigue, but physically no problem. He felt very hungry before dinner, same as the day before, but not in other days.
56 2021-01-26 chest pain, chest discomfort Patient was hospitalized on 1/24/2021 with COVID-19. He reports symptoms started on 1/18/21, 7 days ... Read more
Patient was hospitalized on 1/24/2021 with COVID-19. He reports symptoms started on 1/18/21, 7 days prior to admission, and 11 days after receiving his first dose of the Pfizer/BioNTech COVID19 Vaccine. During this time he experienced shortness of breath and non-radiating, pressure-like chest pain, the latter prompting him to go to the Emergency Department. Upon admission his oxygen saturation was 90% and was put on 2 L nasal cannula with oxygen saturation, increasing oxygen saturation to 95%. On 1/26/2021 oxygen was increased to 4 L nasal cannula with oxygen saturation at 94%. On 1/27/21 oxygen requirements improved and pt is now on 2 L nasal cannula with oxygen saturation at 99%.
56 2021-01-28 chest discomfort nausea and vomiting, chills, body aches, chest discomfort
56 2021-01-30 chest pain, inflammation of the pericardium Severe chest pain, difficulty breathing Hospitalized for 24 hours EKG, troponin, ddimer, stress test... Read more
Severe chest pain, difficulty breathing Hospitalized for 24 hours EKG, troponin, ddimer, stress test, CT scan
56 2021-02-01 palpitations, fast heart rate FOLLOWING THE Pfizer BioNTech COVID-19 Vaccine EUA, EVENTS: DIAPHORESIS AND SHAKINESS STARTED BY 095... Read more
FOLLOWING THE Pfizer BioNTech COVID-19 Vaccine EUA, EVENTS: DIAPHORESIS AND SHAKINESS STARTED BY 0953 AM ON 02/02/2021 AND LASTED 15 MINUTES. HEART PALPITATION AND TACHICARDIA STARTED BY 0953 AM ON 02/02/21 AND ENDED AROUND 1025 AM INTERVENTIONS: RELAXATION OUTCOMES: DIAPHORESIS AND SHAKINESS ENDED BY 10:18 HEART PALPITATION AND TACHICARDIA ENDED AROUND 1025 AM PT NOTIFIED TO FOLLOW-UP WITH PCP IF NEW SYMPTOMS OR SYMPTOMS WORSEN
56 2021-02-06 chest pain, blood pressure increased, blood glucose increased Pain on left arm and chest, increase in arterial blood pressure and sugar. The employee clinic docto... Read more
Pain on left arm and chest, increase in arterial blood pressure and sugar. The employee clinic doctor told me it was not related to the vaccine and it could be inflammation and suggested to make an appointment with my cardiologist, I wanted to let you know what I experienced, I respect my health professional's opinion.
56 2021-02-07 hypertension Blood pressure sky high; Severe vertigo; Nausea; Vomiting; Cold sweats; This is a spontaneous report... Read more
Blood pressure sky high; Severe vertigo; Nausea; Vomiting; Cold sweats; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO3249; Expiration date was not reported) on 20Jan2021 (12:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included watermelon allergy. Concomitant medications included celecoxib (CELEBREX), metoprolol tartrate, simvastatin and lisinopril. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Expiration date was not reported) on the right arm on 30Dec2020 (when the patient was 56 years old) for COVID-19 immunization. On 21Jan2021 (03:45), in the morning, the patient's blood pressure was sky high; had severe vertigo; nausea; vomiting; and cold sweats. The patient had resulted in the emergency room/department or urgent case for the reported events. The patient had received unspecified medications as treatment for the nausea and vertigo. The outcome of the events, 'blood pressure was sky high', 'severe vertigo', 'nausea', 'vomiting' and 'cold sweats', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 (nasal swab) post-vaccination which was negative on 21Jan2021.
56 2021-02-08 heart rate irregular Patient described feeling an irregular heart beat that began 2 hours after the vaccination was admin... Read more
Patient described feeling an irregular heart beat that began 2 hours after the vaccination was administered. It lasted for 2 hours and was treated with metoprolol. The sensation returned the next day at 10:00am and lasted about 5 hours. It was again alleviated with metoprolol. The sensation returned 1 week later and lasted the majority of the day and was then treated with metoprolol. The irregular heart beat was confirmed by the patient's cardiologist.
56 2021-02-08 loss of consciousness Patient received vaccine then passed out a few minutes later. Patient was sitting so did not fall a... Read more
Patient received vaccine then passed out a few minutes later. Patient was sitting so did not fall and was observed by multiple people. Patient came too shortly after in a matter of 5-10 seconds. Patient sat for another 15 minutes and was being constantly observed and was fine. BP was monitored and was 115/76 pulse was 52. I followed up with at 2:43 pm and he reports to be fine. Patient thinks he suffered from a panic attack. Note at the beginning of the incident we called 911, but subsequently cancelled it.
56 2021-02-11 blood glucose increased DATE: 02/07/2021 This nurse received a call from CLA/CMT at 0823 stating client is grunting and whee... Read more
DATE: 02/07/2021 This nurse received a call from CLA/CMT at 0823 stating client is grunting and wheezing while breathing with a SpO2 of 86. This nurse instructed CLA/CMT to call 911 and get complete vitals. CLA/CMT called back with CVS: 149/106, 130, 97.7, 86. Residental support director was notified at 0828, Executive Director was notified @ 0843. Parents were notified via telephone call by this nurse @ 0922. 1109: Residential Support Director states via text ?. (name) called. (name) will need to wait for ambulance. Labs and lungs are good. Probably side effect from vaccine.? This nurse updated the parents and the ED. 1205: Ordered cvs every 4 hours and through the night with cvs reported to RN x 24 hours. 1230: returned from the ED with order for albuterol MDI 2 puffs every 4 hours as needed for coughing and wheezing. This nurse spoke to (name) at PCI. Requested chamber at cash price. Staff aware to call nurse when delivered.
56 2021-02-14 palpitations had to close my eyes due to the faint feeling; palpitation; Fatigue; chills in the back of the head;... Read more
had to close my eyes due to the faint feeling; palpitation; Fatigue; chills in the back of the head; Arm soreness; felt a mild palpitation but not as strong as the strong one I experienced after the first injection/Arm soreness was much less than after the first dose/Fatigue was comparable; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246), via an unspecified route of administration in right arm on 26Jan2021 12:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration in right arm on 05Jan2021 at single dose for COVID-19 immunization and experienced palpitation, Arm soreness and Fatigue. 30 min after injection, the patient felt a mild palpitation-stronger than any previous mild ones but not as strong as the strong one he experienced after the first injection, and he had to close his eyes due to the faint feeling. This was followed by a mild one 3 min later. In the next few days he had several additional mild to weak palpitations. The strong one that he experienced 12-14 hours after receiving the first dose did not show. Arm soreness was much less than after the first dose. Fatigue was comparable, and in third day still had to take a nap immediately after the breakfast. Additional nap was taken during the day-needed more but did not have time. The patient felt some chills in the back of the head some days but did not get "sick" at all. All events occurred on 26Jan2021 13:00. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient had no COVID prior vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Jan2021.
56 2021-02-17 blood glucose increased Death within thirty days of vaccine. Multiple co-morbidities and placed on hospice 12/28/20.
56 2021-02-18 blood pressure increased Patient complained of headache after receiving first dose; blood pressure monitored and was elevate... Read more
Patient complained of headache after receiving first dose; blood pressure monitored and was elevated. Patient was evaluated in the urgent care department and later discharged.
56 2021-02-22 hypotension Light headache, dizziness, low blood pressure (100/64 mmHg)
56 2021-02-23 blood glucose increased pt is a type 1 diabetic- increase in blood glucose above the norm despite insulin for a period of ~ ... Read more
pt is a type 1 diabetic- increase in blood glucose above the norm despite insulin for a period of ~ 6hours; This is a spontaneous report from a non-contactable consumer. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 56 years on 26Jan2021 at a SINGLE DOSE for covid-19 immunisation . Medical history included diabetes mellitus from an unknown date and unknown if ongoing type 1 diabetic. The patient's concomitant medications were not reported. The patient has a history of type 1 diabetes and had increase in blood glucose above the norm despite insulin for a period of 6hours on Jan2021. The patient underwent lab tests and procedures which included blood glucose: increase on Jan2021. No treatment was received for the event. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
56 2021-02-24 palpitations, fast heart rate Around 0530 on 2/25/2021 reported heart started to race. Received second dose of vaccine on 2/24/20... Read more
Around 0530 on 2/25/2021 reported heart started to race. Received second dose of vaccine on 2/24/2021. Stated he did not feel good but the heart racing started the next morning. Came into medical for BP check. HR 159, ECG done, SVT at 153. Dr. able to convert to normal HR with vagal maneuver.
56 2021-02-25 chest discomfort Fever of 102.3, body aches, pressure on chest, sore throat
56 2021-03-02 palpitations Mild palpitation; faint feeling; Arm soreness; This is a spontaneous report from a contactable consu... Read more
Mild palpitation; faint feeling; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first single dose of BNT162B2 (Pfizer, lot number: EL0140, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 05Jan2021 for COVID-19 immunization. Facility type vaccine: Hospital. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior to vaccination. On 05Jan2021, 30 min after injection, felt a mild palpitation-stronger than any previous mild ones but not as strong as the strong one he experienced after the first injection, and he had to close his eyes due to the faint feeling. This was followed by a mild one 3 min later. In the next few days, he had several additional mild to weak palpitations. The strong one that he experienced was 12-14 hours after receiving the first dose, did not show. The patient also experienced arm soreness after the first dose (Jan2021). The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Jan2021.
56 2021-03-03 chest discomfort I was symptom free when I went to bed four hours after vaccination. In the middle of that first nig... Read more
I was symptom free when I went to bed four hours after vaccination. In the middle of that first night (03/02/21), I awoke with an overall body ache, which persisted through the next day. In the morning of the next day (03/03/21), I awoke with soreness at the vaccination site, tightness in my chest, and a swollen, red left ankle. The overall achiness and sore arm were understandable, but the chest tightness made we wonder if inflammation in the region persisted from my cardiac ablation in May 2020 and was aggravated by the covid vaccine. I have a Kardia home-test ECG monitor, and the results of the test continue to be "normal." As far as the ankle, an MRI in August 2020 determined that I had torn my peroneal brevis tendon. After six weeks in a walking boot, I began physical therapy and noticed that if I exerted myself too much that I would get swelling and soreness. Everything in my ankle was healed by October 2020, and I have been hiking / running four times a week since without incident. I did not injure myself before the vaccination, so it seems to much of a coincidence that inflammation returned to my previously injured ankle just hours after receiving the covid vaccine.
56 2021-03-04 chest pain, fast heart rate On the night of vaccine I had a fever up to 101 degrees, aches and fatigue into the next day. Two d... Read more
On the night of vaccine I had a fever up to 101 degrees, aches and fatigue into the next day. Two days later I started having diffuse sporadic and intermittent tingling on various parts of my body. That lasted about 2 days in its greatest severity. On day 6 post vaccine, I was walking in an airport and developed chest pain, tachycardia, and shortness of breath out of proportion to my level of exertion. This chest pain, shortness of breath and tachycardia with minimal exertion (a flight of stairs. A walk to the end of driveway.) has persisted since then. A cardiac w/u with Echo and treadmill stress ECHO were negative. I also have intermittent fatigue, headaches, and a mild "brain fog."
56 2021-03-05 lightheadedness Vasovagal syncope - lightheaded, did not faint
56 2021-03-10 chest discomfort Uncontrollable chills that night starting at 3am lasted for about an hour and a half; fever and shor... Read more
Uncontrollable chills that night starting at 3am lasted for about an hour and a half; fever and shortness of breath and tightness in the chest the next day; tightness in the chest on Saturday. Patient had previously recovered from Covid in August 2020. First positive test for Covid was at the end of July 2020. Out of work, sick with Covid for over a month.
56 2021-03-10 palpitations . 24 hours after the Covid Vaccine. first dose given on 3/2/21. Pt Reports." I was driving and ha... Read more
. 24 hours after the Covid Vaccine. first dose given on 3/2/21. Pt Reports." I was driving and had to pull over experienced. SOB and suddenly my heart felt like it was jumping out of my chest" Clarified. rapid HR."Lasted about 25 minutes. with tightness of my throat'. I did not go to the doctor at the time.becuase it was such a short time and went away. " I have had no problems since".
56 2021-03-12 fainting Syncope. Evaluated by EMS-Cleared
56 2021-03-14 fainting, pallor Pt felt lightheaded once in parking lot after receiving vaccine around noon. Beeped horn at 12:10pm.... Read more
Pt felt lightheaded once in parking lot after receiving vaccine around noon. Beeped horn at 12:10pm. Fainted and reports possible stiffening of limbs/seizure activity. Hx of fainting with needles. Pt was pale and lightheaded when nurse arrived to car at 12:11pm. 911 called immediately due to possible seizure. BP 90/50, unable to obtain pulse and O2 sats. Ambulance on scene at 12:17pm and patient transported to hospital via ambulance at 12:30pm. Pt was feeling better and responsive when he left scene.
56 2021-03-14 fast heart rate Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
56 2021-03-16 blood pressure decreased Patient states he "felt weird", tingly all over and extremely anxious. Patient was brought to observ... Read more
Patient states he "felt weird", tingly all over and extremely anxious. Patient was brought to observation for continued care. vs: P-92 r-16 b/p 174/92. Repeat b/p after 15 minutes was 124/90. Patient feeling much better. Now states he had been very anxious about receiving vaccine. B/P cuff recycled it did not measure correctly- air in cuff. Repeated and up to 170/90, patient states it went up because he was worried about the cuff. Refused to have any more vital signs. Ambulated in unit, did well. Discharged home after 30 minutes.
56 2021-03-16 heart rate increased, blood pressure increased, fast heart rate Spiking heart rate up to 180 bpm while at rest, elevated heart rate at rest, elevated blood pressure... Read more
Spiking heart rate up to 180 bpm while at rest, elevated heart rate at rest, elevated blood pressure over norm. Three events of PSVT like symptoms since vaccination - 3/11 7:00am, 3/13 8:40pm, and 3/14 5:00pm. Symptoms have appeared to lessen/resolve 6 days after vaccination without intevention. Blood pressure was significantly elevated during this period. Don't know if blood pressure was elevated immediately after injection. Did not start monitoring until elevated HR symptoms appeared 38 hrs. after injection. Treatment - visit with cardiologist 3/16 and wearing a heart montitor for 14 days Do not know if the symptoms are related to the vaccine but started within 38 hrs. of vaccination.
56 2021-03-17 heart rate increased, blood pressure increased discomfort; did not sleep a wink last night; Nauseous; blood pressure elevated/139/94; heart rate el... Read more
discomfort; did not sleep a wink last night; Nauseous; blood pressure elevated/139/94; heart rate elevated/His heart rate is currently 139; This is a spontaneous report from a contactable consumer (patient). A 56 -year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9264), intramuscular (on left arm) on 28Jan2021 12:30 (at the age of 56 -years-old), single dose for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. Patient is calling about the first dose of the Pfizer covid19 vaccine which he received on Thursday. Yesterday, he started getting nauseous, it is terrible and very strong. The nausea has been continuous since yesterday. His blood pressure and heart rate is pretty elevated. Declines any treatment. The nausea was bad yesterday and stayed bad, he did not sleep a wink last night. His last blood pressure taken about 10 minutes ago was 139/94. His blood pressure is normally 125 over 65 or 70. His heart rate is currently 139. His heart rate and blood pressure became elevated yesterday. States it might have to do with how much discomfort he is in. When querying other medications and medical conditions, he reports nothing out of the ordinary. The outcome of the events sleep disorder and discomfort was unknown, other events was not recovered. No Prior Vaccinations (within 4 weeks).No AE(s) following prior vaccinations.
56 2021-03-18 blood clot amaurosis fugax. Temporarily lost vision in top half of right eye - lasted about 15-20 seconds - bl... Read more
amaurosis fugax. Temporarily lost vision in top half of right eye - lasted about 15-20 seconds - blood clot in right eye. No past history of blood clots
56 2021-03-21 cerebrovascular accident patient admitted with pontine Stroke
56 2021-03-21 hypertension High blood pressure with lower number 90 and above at times. Ringing on right side of head, high pi... Read more
High blood pressure with lower number 90 and above at times. Ringing on right side of head, high pitch hissing that various in level from low to moderate to high
56 2021-03-21 pulmonary embolism Acute unprovoked pulmanary embolism 3 days after 2nd dose
56 2021-03-22 heart rate irregular I developed an irregular heartbeat a few days after receiving the first dose. It subsequently went a... Read more
I developed an irregular heartbeat a few days after receiving the first dose. It subsequently went away in about 10 days. After the second dose, I developed the same symptom which also went away about 7-10 days later.
56 2021-03-23 chest discomfort, palpitations Pfizer-BioNTech COVID-19 Vaccine EUA On 3/11/21, ran fever 103 to 104.5, coughing, some fluid in lun... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA On 3/11/21, ran fever 103 to 104.5, coughing, some fluid in lungs, around evening time started heart palpitations and tightness pain in chest. As of 3/24/21 still have heart palpitations when doing yard work or light exercise. Tightness pain in chest area has gone away.
56 2021-03-25 loss of consciousness Patient here for COVID 19 vaccine Arrived to drive through as passenger in car. He did let RN know... Read more
Patient here for COVID 19 vaccine Arrived to drive through as passenger in car. He did let RN know before vaccine he has felt faint and has had syncopal episodes after injections or blood draws. Immediately after injection he had a loss of conciseness. Lasting approximately 1min. Partner states this was a normal reaction. He then had a second episode lasting longer than first. Partner states this is not a normal reaction for him. He was not responding to voice or touch after approximately 1-2 mins he was alert and responsesive to person, place and situation. RN stayed with Patient as he remained in car. 911 called to evaluate RN gave report and hand of to EMS. per RN
56 2021-03-26 hypotension Dizziness, fatigue. BP 84/58 (pulse 64), final BP 110/70. Orange juice, crackers, and water given. L... Read more
Dizziness, fatigue. BP 84/58 (pulse 64), final BP 110/70. Orange juice, crackers, and water given. Low BP observed for past few days.
56 2021-03-28 cardiac arrest Patient was admitted to our hospital after cardiac arrest at home
56 2021-03-29 chest pain, heart attack My father woke up 16 days after Pfizer medication was injected. According to his story, he briefly ... Read more
My father woke up 16 days after Pfizer medication was injected. According to his story, he briefly exercised, developed extreme chest pain. His significant other was present and took him to the ER and Medical Center. After obtaining EKG, the ER determined he was having an MI. Appropriate medication were initiated, he was stabalized, and transferred by ambulance to hospital. He received 2 stents in the LAD and an angioplasty for a blockage "further down".
56 2021-03-30 atrial fibrillation second instance of afib; This is a spontaneous report from a contactable consumer (patient). A 56-ye... Read more
second instance of afib; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), at vaccination age of 56-year-old via an unspecified route of administration in the left arm on 06Mar2021 09:00 (Batch/Lot Number: EN6199) as a single dose for covid-19 immunization. Medical history included afib explained (no other issues) from Sep2020 (reported as 6 months prior) to an unspecified date and post first encounter was diagnosed with obstructive sleep apnea (began cpap treatment nightly). The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient has no known allergies. Concomitant medications included metoprolol and omeprazole magnesium (PRILOSEC). The patient reported that this was only his second instance of afib. The patient reported that the second episode came 11 hours (also reported as 22:00) post vaccine (06Mar2021) and lasted for 10 hours (07Mar2021). The patient did not received treatment. The patient has not been tested post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room visit. The outcome of the event was recovered on 07Mar2021 (reported as 10 hours after onset).
56 2021-03-30 superficial blood clot Reports that 2 days after vaccine, patient noticed L neck pain and warmth with possible rash. Says t... Read more
Reports that 2 days after vaccine, patient noticed L neck pain and warmth with possible rash. Says that while the rash/warmth improved, he noted that a vein was very prominent on that side and he came to my office (I'm his PC doctor) to show me it. I felt a cord, and suspected a superficial neck vein thrombosis L side, which was confirmed on US.
56 2021-04-02 chest discomfort Flushing/sweating, dizziness, chest tightness. BP 162/110 (pulse 76). Final BP 153/104 (pulse 80). O... Read more
Flushing/sweating, dizziness, chest tightness. BP 162/110 (pulse 76). Final BP 153/104 (pulse 80). O2 sats 99%-100%. Apple juice and water given.
56 2021-04-02 chest pain About 14 hours after getting the shot, I was awoken to slight pain in my chest at what seemed to be ... Read more
About 14 hours after getting the shot, I was awoken to slight pain in my chest at what seemed to be rib #3. This would be the end of the rib at the center of my chest. I didn?t think much of it at that time. When I woke up around 0600, the pain was throughout the center of my chest. The more I exerted myself, the greater the pain. I also had a headache and neck pain. After 36 hours, I was fine. I didn?t go to the ER as I felt that the problem was muscular. My heart felt fine.
56 2021-04-04 chest pain I got home at 5 am from getting the shot, and laid down, I woke up at 9 am for a 10 am meeting with ... Read more
I got home at 5 am from getting the shot, and laid down, I woke up at 9 am for a 10 am meeting with left arm soreness at the site of the injection. I then developed body chills, ackey sore muscles Back, chest, arms and a really nagging headache. I was very groggy. Saturday, I was a mess, I bundled up with an electric blanket to stay warm. I slept most of the day. The symptoms lasted until Sunday (Easter) around noon, when I started to feel normal again
56 2021-04-04 loss of consciousness Woke up with severe shortness of breath and a fever of 103.8 - got up to get something to drink and ... Read more
Woke up with severe shortness of breath and a fever of 103.8 - got up to get something to drink and then woke wife to take me to the hospital as difficulty breathing rapidly increased - wife was getting ready to take me to the hospital when I blacked out and landed on bedroom floor - wife called 911 - I was awake again a couple of minutes later and managed to get to a chair - before ambulance arrived started to feel better - ambulance staff took my vitals and questioned me in regard to overall health, my previous day's activities, and the timing of Covid vaccination - after 30 minutes all my vitals were normal except for fever which had decreased - went back to bed after the first responders left and woke up at 11:00 with no fever, soreness, or difficulty breathing - felt like I did before the shot
56 2021-04-05 heart rate increased minor injection site pain (started during the day of vaccination), chills, fever, faster than normal... Read more
minor injection site pain (started during the day of vaccination), chills, fever, faster than normal heartbeat (started that night, about 16 hours later, and lasted until morning)
56 2021-04-06 heart flutter full body rash, worse on hands. itching, feeling of tingling and numbness. fluttering feeling in che... Read more
full body rash, worse on hands. itching, feeling of tingling and numbness. fluttering feeling in chest.
56 2021-04-07 atrial fibrillation, heart rate increased Blood in my urine, kidney pain, shortness of breath. Fast heart beat that went into atrial fib. 14... Read more
Blood in my urine, kidney pain, shortness of breath. Fast heart beat that went into atrial fib. 145 BEats a minute for 4 hours. Difficulty breathing for 2 weeks following vaccine.
56 2021-04-07 loss of consciousness Passed out in chair after vaccination, then muscles contracted for 5 seconds
56 2021-04-07 lightheadedness, chest pain Pt had a syncopal or near syncopal episode after vaccine, which he stated was normal after any need... Read more
Pt had a syncopal or near syncopal episode after vaccine, which he stated was normal after any needle. But this time he had chest pain with the syncopal episode which he stated has never happened. Pt was assessed by ems cew and transport via ambulance
56 2021-04-08 loss of consciousness, fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: pt w/ needle-phobia and hx of vasovagal ... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt w/ needle-phobia and hx of vasovagal response following injections, blood draws in past. fainted 1 min following vax (1st dose). was still in immunizing chair, and was unresponsive x 10 sec. pt then awoke and was able to move to observation area x 15 min w/o issue. provided water, and pt's daughter was present w/ him the entire time. pt was educated and to alert future immunizers of potential for reaction.
56 2021-04-08 fainting Vasovagal Syncope that resolved
56 2021-04-10 palpitations, chest discomfort, chest pain Site: Swelling at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional... Read more
Site: Swelling at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Roughly 10 minute after receiving Pfizer covid vaccine patient was feeling palpitations and throat tightness. Patient was given 2 Benadryls and waited an extra 30mins. Patient said he was feeling fine and went home after. Will followup on 4/11/2021
56 2021-04-11 chest discomfort 1015: Pt in 15-waiting lot after 1st dose of Pfizer vaccine. C/O lightheadedness. RN and NG medic re... Read more
1015: Pt in 15-waiting lot after 1st dose of Pfizer vaccine. C/O lightheadedness. RN and NG medic responded to vehicle. Vital signs WNL. Had not eaten breakfast but does not typically eat in a.m. RN provided snack and water. Advised MD by phone. 1030: Pt reports chest discomfort to L chest area. Denies tightening or sharpness-- just discomfort. No other symptoms reported. Lightheaded feeling improving. VS remain stable. MD again contacted. Advised family member to come and transport to ED if chest discomfort persists but is not urgent. 1107:Pt reports sensation improving and feels ok to drive home (10-15 minute drive.) RN instructed to pull over and call 911 if symptoms worsen. MD advised pt leaving.
56 2021-04-12 cerebrovascular accident STROKE. ACCORDING TO PATIENT'S WIFE, HE IS DOING OK. ONLY WAS HOSPITALIZED FOR A FEW DAYS AND WENT... Read more
STROKE. ACCORDING TO PATIENT'S WIFE, HE IS DOING OK. ONLY WAS HOSPITALIZED FOR A FEW DAYS AND WENT HOME. NO RECORDS OF HIS HOSPITALIZATION ARE AT ; HE WENT TO MEDICAL CENTER.
56 2021-04-12 pulmonary embolism Two weeks after receiving my second dose I began having difficulty breathing. I was diagnosed with b... Read more
Two weeks after receiving my second dose I began having difficulty breathing. I was diagnosed with bilateral pulmonary embolism. I have no family history of clotting disorders and was perfectly healthy prior to vaccine
56 2021-04-13 cerebrovascular accident The adverse event was a small stroke which occurred after/during a severe headache . There was numbi... Read more
The adverse event was a small stroke which occurred after/during a severe headache . There was numbing/tingling and muscle contractions in my left hand followed my face drooping and slurred speech. It was never said that the stroke was caused by the vaccine. It may have been a factor though.
56 2021-04-14 deep vein blood clot Swelling in left leg around calf and ankle. After a blood test and sonogram a Deep Vein Thrombosis w... Read more
Swelling in left leg around calf and ankle. After a blood test and sonogram a Deep Vein Thrombosis was found in my left leg. Determined "unprovoked" by Dr. after subsequent blood test results came back negative.
56 2021-04-14 loss of consciousness passed out while using the rest room at 11:30 p.m. family member found me and woke me up. went back ... Read more
passed out while using the rest room at 11:30 p.m. family member found me and woke me up. went back to bed.
56 2021-04-15 blood pressure increased Patient complained of feeling weak and sweaty. No chest pain or shortness of breath or rash. Treatme... Read more
Patient complained of feeling weak and sweaty. No chest pain or shortness of breath or rash. Treatment- NO po water or juice given as patient is muslim and was fasting VS 203/138, HR 69, RR 12, Pulse Ox 99% EMS called for elevated BP and symptoms EMS arrived and repeated BP with manual cuff and BP was 137/86, accucheck normal and was released to go home Patient was obsed for one hour and DCed home
56 2021-04-15 chest pain Fever, chills, body aches, chest pain
56 2021-04-16 lightheadedness, fainting Patient had a vasovagal reaction. 30 seconds after his vaccine he fainted. He was sitting and told h... Read more
Patient had a vasovagal reaction. 30 seconds after his vaccine he fainted. He was sitting and told his wife he was going to faint. According to him and his wife he has a history of that with injuries or pain. He did not have it on his first vaccine but it has happened to him several times in his life. He regained consciousness quickly and we had him sitting and gave him water. He was fine within 3 minutes. Rested for his 15 minutes and he and his wife left.
56 2021-04-16 fainting, pallor, lightheadedness Pt received initial Pfizer covid vaccine. About 8 minutes after the injection, his wife stated he w... Read more
Pt received initial Pfizer covid vaccine. About 8 minutes after the injection, his wife stated he was not feeling well. Upon assessment, pt was pale in color, a&Ox3, but sluggish to response. Pt was immediately placed from chair to floor and legs were placed in trendelenberg after initial bp was 90/60. Pt was weak but remained responsive. Pt was diaphoretic. Cold compress to forehead. No noted rash or hives, no difficulty speaking or respiratory distress. 0940- 90/60 0945 100/70 legs up on chair as he was supine on floor- pulse ox 93% 0955 110/70 97% sat; skin color returning to pink. 1000- 112/64 96% pulse 73 1010- 115/70 93% sat pulse 83 sitting up on floor 1012 bp 88/inaudible In chair 1012- bp 90/64 on floor 95% sat 78 pulse Pt remained A&O throughout assessment and to point of transfer to ER 911 ems arrived at 10:25 and began assessment. 10:35 EMS elevated pt to sitting position , and placed on cart and escorted pt to ER with security also. Pt stating he is feeling better, color pink/yellow tone.
56 2021-04-17 cardiac arrest Patient arrived to Hospital in cardiac arrest 48 hours after administration of the Pfizer Vaccine.
56 2021-04-17 hypotension PT DIAPHORETIC, HYPOTENSIVE BP 90/40 HR 60-70 O2SATS 99% ROOMS AIR PT PLACED IN STRETCHER, VITALS A... Read more
PT DIAPHORETIC, HYPOTENSIVE BP 90/40 HR 60-70 O2SATS 99% ROOMS AIR PT PLACED IN STRETCHER, VITALS AND LOC CONTINUOSLY MONITORED-AT 2:33PM PT STATED "FELT BETTER, PT NO LONGER DIAPHORETIC, VITALS BP 114/60 HR 70, O2 SATS 99% RA
56 2021-04-17 heart attack, chest pain 04/01/2021 around 5:00 PM: 1. Sore Arm, Shortness of Breath, Chest Pains, Fatigue. | Thought was He... Read more
04/01/2021 around 5:00 PM: 1. Sore Arm, Shortness of Breath, Chest Pains, Fatigue. | Thought was Heartburn, took tums and had a little relief 04/02 to 04/05/2021: Same Symptoms throughout those day, had No appetite, increased fatigue. and Tums No longer gave relief. 04/06/2021 6:00 AM: Went to emergency room and had to receive emergency heart surgery as I was diagnosed with blood clogged arteries and had been having a heart attack for the past several days
56 2021-04-19 blood pressure decreased A few days after my first dose I started feeling mild light headed when standing that would not go a... Read more
A few days after my first dose I started feeling mild light headed when standing that would not go away. I checked my standing blood pressures and notices that it was very low 83/56 with a heart rate of 110. This went on for several weeks with standing blood pressures in the 80-90's/50-60's . I was having difficulty with daily activities where I would get tired just going up and down steps. I was very concerned and made an appt with my Dr. He did not think it was related to the vaccine. I was treated with chemo and radiation in 1984 for Hodgkins disease (MOPP and ABVD) were the chemo agents. This treatment as left me with mild orthostatic hypotension which I have been dealing with for over 10yrs however I have
56 2021-04-19 deep vein blood clot Right soleal vein DVT; patient developed signs of right lower extremity swelling, erythema, pain app... Read more
Right soleal vein DVT; patient developed signs of right lower extremity swelling, erythema, pain approximately 3 days after vaccination; patient presented to hospital approximately 3 weeks after these symptoms started. Was started on Xarelto in the hospital.
56 2021-04-19 loss of consciousness, fainting THE PATIENT WAS SEATED IN THE LOBBY AFTER HIS IMMUNIZATION. HE THEN SAW A PATIENT FAINTED AND IMME... Read more
THE PATIENT WAS SEATED IN THE LOBBY AFTER HIS IMMUNIZATION. HE THEN SAW A PATIENT FAINTED AND IMMEDIATELY PASSED OUT ALSO. PARAMEDICAS WERE CALLED AND AFTER EXAMINATION THEY TOOK HIM TO THE HOSPITAL
56 2021-04-20 pulmonary embolism Bilateral Pulmonary Embolism; This is a spontaneous report from a contactable consumer (patient). A ... Read more
Bilateral Pulmonary Embolism; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EH9899), via an unspecified route of administration on 02Feb2021 (at 56-years-old) as single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EH9899), on 12Jan2021 (at 56-years-old) for COVID-19 immunization. The patient experienced Bilateral Pulmonary Embolism on 16Feb2021. Facility where the most recent COVID-19 vaccine was administered was at the Workplace clinic. The adverse event resulted Emergency room/department or urgent care. Treatment received for the adverse event was Xarelto 20 mg. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering.
56 2021-04-20 blood clot Pain in bilateral lower extremities that started after 1st dose of COVID vaccine. US completed on 4/... Read more
Pain in bilateral lower extremities that started after 1st dose of COVID vaccine. US completed on 4/16/21 showed superficial blood clot in right leg. Treatment included: warm compresses, taking ibuprofen 600 mg with food three times daily, and elevation of your right lower extremity. Outcome: unknown.
56 2021-04-21 chest discomfort Patient is a 56 y.o. year old male with PMH of COPD, CAD, DM, HTN, HLD presenting to the ED for coug... Read more
Patient is a 56 y.o. year old male with PMH of COPD, CAD, DM, HTN, HLD presenting to the ED for cough and shortness of breath. Symptoms started one week prior to arrival. Patient states cough more frequently and productive of clear-yellow sputum. Dyspnea worse with exertion. Symptoms noticeable shortly after receiving first dose of pfizer COVID19 immunization today. Chest tightness though denies chest pain. No leg pain/swelling. Patient has been compliant with previously prescribed trilogy.
56 2021-04-22 chest discomfort Systemic: throat thigtness, warmness in chest, no difficulty building but\"funny feeling\" when swal... Read more
Systemic: throat thigtness, warmness in chest, no difficulty building but\"funny feeling\" when swallowing, patient is alert, able to answer questions, able to complete sentences-Mild, Additional Details: patient describes tightening of throat, warmness of chest, no difficulty breathing but \"funny feeling\" (cottony feel according to patient) when swallowing. patient is alert, able to answer questions and able to complete sentences. pharmacist on duty immediately called 911, have epipen ready. per 911 dispatcher, rph must answer some questions first, but paramedics arrived immediately to the scene and took over. patient interviewed by paramedics and patient walked with paramedics out of building.
56 2021-04-22 chest pain 4/22/21 at 5:00am: started feeling fatigue and chills 4/22/21 at 8:00pm: started noticing chest pain... Read more
4/22/21 at 5:00am: started feeling fatigue and chills 4/22/21 at 8:00pm: started noticing chest pains on left side 4/23/21 at 2:00am: continued chest pain, noticed a bulge on left armpit 4/23/21 at 7:50am: started noticing back pain
56 2021-04-22 coughing up blood, pulmonary embolism, chest pain The day after receiving his 2nd dose of the pfizer vaccine, he developed hemoptysis and R sided ches... Read more
The day after receiving his 2nd dose of the pfizer vaccine, he developed hemoptysis and R sided chest pain. He came to the ER on 4/21/21 and was found to have extensive bilateral pulmonary embolism with hemorrhage to likely the RML/RLL. He remained hemodynamically stable and did not require supplemental oxygen. He was started on heparin gtt with stable hemoglobin.
56 2021-04-24 skin turning blue Patient was find during 30-minute post dose observation but upon getting home he was experiencing di... Read more
Patient was find during 30-minute post dose observation but upon getting home he was experiencing difficulty breathing, lips were blue, chills, pains in lower back and fever. Patient called EMT and was taking to Hospital and treated then released same day.
56 2021-04-25 blood glucose increased, blood pressure increased, skin turning blue, heart rate increased Pt. received first Pfizer covid vaccine at 5:45pm. He was brought to the observation area for 30 min... Read more
Pt. received first Pfizer covid vaccine at 5:45pm. He was brought to the observation area for 30 minutes of observation due to hx of anaphylaxis to penicillin. At approximately 5:55pm, RNs noticed that Pt had his head in his hands. When questioned, he stated he didn?t feel well. He was helped to the ground and his legs were elevated. His vitals were 190/90, P 88, Resp 34. The nurses helped him to a sitting position as he was feeling better and he answered some medical history questions. He shared that he was Type I Diabetic. He stated he checked his blood sugar last yesterday. He ate breakfast today and took insulin. No food since this morning. Patient had no symptoms of anaphylaxis and no chest pain or other complaints. Patient denied SOB or ?throat tightening?. No hives. Patient became diaphoretic and stated he was overheated. RNs helped to remove his shirt. Observation RN alerted Nurse practitioner of the ongoing incident. Nurse Practitioner went to seek sugar sources, suspecting the patient was severely hypoglycemic. Patient, still conscious and responsive and sitting up, took 10 oz. orange juice and frosting was massaged by APRN, in buccal area with patient consent. Patient initially seemed to be improving per APRN and RNs caring for patient. BP was 170/90 at next check. P 80. Regular respirations. Still no anaphylaxis symptoms (no hives, no angioedema, no throat tightening or wheezing). A few minutes later, Pt started shaking and said he was chilled. Patient was returned to supine position with legs elevated. He continued to shake and patient lips blue ? sweatshirt placed over him. RN noted that Pts? eyes rolled back in his head. RN went to alert the Clinical Team Manager/RN of the situation and stated that 911 should be called as patient not improving. Clinic Team Manager/RN concurred. While RNs stayed with patient and informed patient?s friend about what would occur, Clinic Site Manager called 911. BP 140/80 at next check. Patient continued to sweat and have chills. Rescue squad arrived ? blood sugar was 116. After emergency services assessment of patient, emergency services checked blood sugar again and it had dropped to 88 within those ~5 minutes. Patient was taken by Emergency Services at 6:36pm. RN noted that the patient remained with emergency services in parking lot for several minutes and then pt was transported to the hospital by the emergency services. His wallet, glasses and hat were given to his friend who had accompanied patient to the vaccination clinic. His friend stated that she would call patient?s wife to inform her that patient was taken to ED by emergency services.
56 2021-04-27 chest pain, heart rate increased 185/100 blood pressure (usually 130/75) high heart rate; cheeks feeling numb; airplane ear; lasted a... Read more
185/100 blood pressure (usually 130/75) high heart rate; cheeks feeling numb; airplane ear; lasted about an hour and a half; felt week for three days after with slight chest pain. very similar symptoms but lasting much longer occurred again 04/27/2021
56 2021-04-28 fibrin d dimer increased 2 days after second COVID vaccine patient began to have purple spots on his legs and erythematous sp... Read more
2 days after second COVID vaccine patient began to have purple spots on his legs and erythematous spots on the rest of his body. lower extremity rash become bullous purpura with eventually necrotic tissue in the center of the larger lesions that became up to 3 inches in diameter and many 1/2 inch to inch size lesions as well. swelling of ankles and feet all causing severe pain. seen over several weeks and had biopsy and placed on Norco for pain control and prednsione for inflammation.
56 2021-04-28 lightheadedness 4/16/21- very dizzy, pre-syncope for about 5 seconds 4/21, 22, 29- dizzy spells, few seconds each
56 2021-04-28 fainting, hypotension Within 10-minutes of vaccination, the patient experienced dizziness and a syncopal episode. EMS eval... Read more
Within 10-minutes of vaccination, the patient experienced dizziness and a syncopal episode. EMS evaluated the patient on-site. The patient was hypotensive (86/53) with a FSBG of 98mg/dL. EMS administered 700mL IV normal saline. EKG was normal. EMS transported to Hospital Emergency Department. En-route to ED, the patient's blood pressure improved (146/97) with fluids. In the ED, the patient stated that their syncope was preceeded by "feeling very warm" and nausea, but now feels improved with fluids. Labs and tests were unremarkable. Physician discharged the patient with diagnosis of vasovagal like syncope.
56 2021-04-29 chest pain On Sunday morning, April 18, as I was walking home, I experienced an intense pain in my chest, abdom... Read more
On Sunday morning, April 18, as I was walking home, I experienced an intense pain in my chest, abdomen, back and all my teeth. This did not subside until I returned home and sat down.
56 2021-05-01 fainting Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, S... Read more
Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
56 2021-05-02 palpitations 20-30 minutes after Pfizer vaccine patient became light headed, felt dizzy with blurred vision and s... Read more
20-30 minutes after Pfizer vaccine patient became light headed, felt dizzy with blurred vision and some heart palpitations
56 2021-05-03 blood glucose increased PATIENT HAD A NORMAL HGBA1C OF 5.6 ON 3/3/2021 (PRIOR TO RECEIVING ANY VACCINE). HE WAS ADMITTED ON ... Read more
PATIENT HAD A NORMAL HGBA1C OF 5.6 ON 3/3/2021 (PRIOR TO RECEIVING ANY VACCINE). HE WAS ADMITTED ON 5/3/2021 FOR DKA AND NEW ONSET DIABETES MELLITUS WITH A HGBA1C OF >14 AND SERUM GLUCOSE OF 561.
56 2021-05-03 blood clot ON 4/28 felt intense pain in legs and blurry eyes, slowly went away after taking advil, came back at... Read more
ON 4/28 felt intense pain in legs and blurry eyes, slowly went away after taking advil, came back at night, on thursday 4/29 pain continued and had shortness of breath decided to go to urgent care made appt for 4/30 813AM, at Urgent Care symptoms pointed to blood clots was told to go to local imaging company to get sonogram, sonogram showed blood clots in leg told to go to emergency room, went to Hospital and was admitted, confirmed blood clots and put on blood thinner neprin IV, released 5/2 at 1PM, at home now on blood thinner pills 10mg Eliquis
56 2021-05-04 chest pain tunnel vision; blurry; vision impairment; Vein was bulging out (about 8mm long, 3mm wide, 2mm thick.... Read more
tunnel vision; blurry; vision impairment; Vein was bulging out (about 8mm long, 3mm wide, 2mm thick. upper cheek-bone very tender to touch; Area below eye remained puffy; cute pain in area of sternum; 3/12/21 Acute pain in vicinity of left shoulder blade; pain in right lower-outer eye area at cheek-bone; This is a spontaneous report from a contactable consumer. A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 12:30 (Batch/Lot Number: EN6199) as single dose, dose 2 via an unspecified route of administration, administered in Arm Right on 29Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation . Medical history included none. There were no concomitant medications. Patient did not have Covid prior to vaccination. The patient experienced "acute pain in area of sternum. Felt like heart attack. Pain dissipated in 6 hours. Minor pain for a couple more days" on 14Mar2021 with outcome of unknown , tunnel vision on 01Apr2021 with outcome of recovered , blurry on 01Apr2021 with outcome of recovered , vision impairment on 01Apr2021 with outcome of recovered , acute pain in vicinity of left shoulder blade on 12Mar2021 22:00 with outcome of unknown , pain in right lower-outer eye area at cheek-bone on 12Mar2021 22:00 with outcome of unknown, vein was bulging out (about 8mm long, 3mm wide, 2mm thick, upper cheek-bone very tender to touch on 01Apr2021 with outcome of unknown, area below eye remained puffy on 01Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included 02Apr2021 eye exam: all was normal; 05Apr2021 Full blood work was done: normal; 15Apr2021 Partial Physical Examination, EKG and Chest x-ray: All normal; 20Apr2021 Carotid Artery Ultrasound: normal. No treatment was received. The outcome of events tunnel vision, vision impairment and blurry was recovered while outcome for other events was unknown. Patient was not tested positive for Covid post vaccination.
56 2021-05-07 heart rate increased Elevated heart rate; Lightheadedness; Lymphadenopathy; This is a spontaneous report from a contactab... Read more
Elevated heart rate; Lightheadedness; Lymphadenopathy; This is a spontaneous report from a contactable consumer. A 56-years old male consumer (patient) reported for himself who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6201) via an unspecified route of administration on 11Feb2021 at 15:15 in left arm as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per the report no other vaccine was administered in four weeks. Covid tested prior vaccination or post vaccination was reported as no. On 11Feb2021 at 15:30, the patient experienced elevated heart rate, lightheadedness and lymphadenopathy. The patient underwent lab tests and procedures on 11Feb2021 which included heart rate as elevated. The outcome of all events was unknown. No follow-up attempts are possible. No further information was provided.
56 2021-05-09 cerebrovascular accident SUFFERED STROKE
56 2021-05-10 cardio-respiratory arrest Patient death certificate lists "natural" causes, with the Immediate Cause of Death of Cardiopulmona... Read more
Patient death certificate lists "natural" causes, with the Immediate Cause of Death of Cardiopulmonary Arrest.
56 2021-05-10 chest pain, fainting, hypotension WEAKNESS AND COUGH COVID-19 pneumonia and urinary retention
56 2021-05-12 blood vessels inflammation Vasculitis involving hands and feet
56 2021-05-14 cerebral haemorrhage Brain hemorrhage; This is a spontaneous report from a contactable consumer (patient). This 56-year-o... Read more
Brain hemorrhage; This is a spontaneous report from a contactable consumer (patient). This 56-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number En6200) at single dose on 06Apr2021 13:00 via an unknown route in left arm for Covid-19 immunization. Medical history included hospitalization and vaccine received during existing hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. Concomitant drug was not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced brain hemorrhage on an unknown date in Apr2021. The event resulted in emergency room/department or urgent care, prolongation of existing hospitalization, disability or permanent damage. The report was reported as serious with seriousness criteria of prolonged hospitalization (hospitalization days were 37 days) and disabling. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
56 2021-05-15 loss of consciousness, pallor, fainting Person experienced syncope after 1st Pfizer vaccine. Person was experiencing diaphoretic, nauseous ... Read more
Person experienced syncope after 1st Pfizer vaccine. Person was experiencing diaphoretic, nauseous and was pale. Shortly after receiving first Pfizer vaccine the person lost consciousness for about 2 minutes.
56 2021-05-17 cerebrovascular accident Stroke approximately 3 Weeks after 2 dose; This is a spontaneous report from a contactable consumer(... Read more
Stroke approximately 3 Weeks after 2 dose; This is a spontaneous report from a contactable consumer(patient). A 56-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration in APR-2021 at the 56 years old at single dose for COVID-19 immunisation. The medical history included previous heart attack 4 years ago. The concomitant medications included Other medications in two weeks. There was no other vaccine in four weeks. The Historical Vaccine was first dose BNT162B2 in Mar2021 12:00 PM at 56 years old for Covid-19 immunisation. The patient experienced Stroke approximately 3 Weeks after 2 dose on 09May2021 14:30. The patient was Hospitalized due to it from May2021 to May2021(duration 2 days). There was Emergency Room Visit, department or urgent care. There was treatment for this event. The event was assessed as Life-threatening. There was no covid prior vaccination. The patient underwent lab tests and procedures, which included Nasal Swab on 09May2021: unknown. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.
56 2021-05-23 chest pain Patient admitted to the hospital on 5/11/21 with nonrheumatic aortic valve stenosis and had heart ca... Read more
Patient admitted to the hospital on 5/11/21 with nonrheumatic aortic valve stenosis and had heart catheterization. Then on 5/17/21 patient presented to the ED and was subsequently hospitalized with chest pain.
56 2021-05-23 inflammation of the pericardium Diagnosed with pericarditis approximately 2 weeks following 2nd dose
56 2021-05-25 chest pain Note Does the patient have current symptoms of illness? Yes Date symptoms started: 5/16/21 1... Read more
Note Does the patient have current symptoms of illness? Yes Date symptoms started: 5/16/21 1. Does the patient have a fever (subjective or confirmed)? No 2. Does the patient have a new onset of cough? Yes 3. Does the patient have a new onset of shortness of breath? Yes, slightly with exertion. NAD. ? If Yes: Is the patient having difficultly breathing or in distress? No 4. Additional symptoms: Congestion, runny nose, nausea and vomiting. Bronchitis Suspected COVID-19 virus infection Chest pain, unspecified type Progress Notes Encounter Date: 5/25/2021 ? ? Signed Patient is here for MAB Infusion Consent for infusion prior to this visit reviewed and verified. O2 sats > or = 90% Signs of potential reaction reviewed with patient. Tolerated IV start and MAB infusion without complication. Pt has access to pulse oximeter and thermometer for home monitoring Provided fact sheet for patients, parents and caregivers- Emergency Use Authorization of BAM for Coronovirus Disease 2019 for pt to review. Discharge instructions reviewed. Patient denies any questions Instructions COVID 19 Monoclonal Antibody (MAB) Infusion Patient Reference Guide MAB Infusion Treatment Team:
56 2021-05-26 chest discomfort Patient received vaccine without incident. About 5 minutes into the observation period, the patient ... Read more
Patient received vaccine without incident. About 5 minutes into the observation period, the patient began complaining of tightness in the chest that felt like allergic reactions he had experienced in the past. Patient had a history of severe ASCVD. He appeared calm without any trouble breathing, BP 140/80, pulse 84. Patient did not appear in distress, no clammy skin, no change in outward appearance of any kind. Patient denied chest pain. He stated that is was nothing like what happens when he has ASCVD-related chest pain. He was administered 50mg of oral diphenhydramine. Within 60 seconds of taking the oral diphenhydramine, he stated that he could feel it working and was starting to feel much better. Patient was advised to remain at the pharmacy for further observation but refused (documented). He left with his caregiver.
56 2021-05-26 heart rate increased, chest pain, loss of consciousness couple pains in the left chest area behind the breast; his stomach was feeling sick and his body was... Read more
couple pains in the left chest area behind the breast; his stomach was feeling sick and his body was hurting; His whole torso hurt and his stomach; The pain now is not like where it hit him with the back. He has back pain every day but more than he used to. the back pain was just the one day.; his arm was a little sore; He was lethargic and had no energy; He was lethargic and had no energy/weakness; diarrhea; Responding strangely to people/but is still there and is so weird; dizzy; getting really irritable; Slept all day for several days; Arm started hurting where he got the shot; been sick pretty much everyday; not feeling good in his stomach; he passed out for 2 days; breathing hard; wouldn't feel good; a fast heartbeat; chills; nausea; headache; he gets really short and impatient; forget a little something still, but just once in a while; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:30 (Lot Number: WR8783) as 1ST DOSE SINGLE for covid-19 immunisation. Medical history included ongoing sciatica, back problems, stomach was sensitive, lower back pain, bone spurs down his spine. He was a medical marijuana patient, he had Shigella when he was a baby. He was 2 or 3 and almost died but came out of it; His mom had cancer from smoking, he got the worse flu sick of his life. His stomach was sensitive all of the time. If he was too happy or too nervous get upset. He can eat spicy food, not super hot, but he can eat anything and it doesn't go crazy. He has a little bit of a sensitive stomach sometimes. He can't take a multivitamin or supplements because he would get sick to his stomach, this was before the vaccine. He was getting that same sick feeling now that he would get if he was taking a multivitamin. He had his blood drawn a week before he had the vaccine to check his kidneys with the pills he is on. It was perfect and normal, and he has had nothing since then. In his 20s he had the flu vaccine, and he had never had the flu in his life. That year he got the worse flu sick of his life. He never got the flu vaccine or other vaccines after that. That was probably between 1987 to 1990. His folks passed away. He had been in the hospital when he was little.Concomitant medications included acetaminophen taken for back pain, sciatica from an unspecified start date and ongoing; nabumetone taken for sciatica, back pain from an unspecified start date and ongoing. The patient experienced he passed out for 2 days (medically significant) on Apr2021 with outcome of unknown, been sick pretty much everyday (non-serious) on 07Apr2021 22:00 with outcome of not recovered, not feeling good in his stomach (non-serious) on 07Apr2021 with outcome of not recovered, slept all day for several days (non-serious) on 08Apr2021 with outcome of unknown, responding strangely to people/but is still there and is so weird (non-serious) on 12Apr2021 with outcome of not recovered, his stomach was feeling sick and his body was hurting (non-serious) on 15Apr2021 with outcome of not recovered, his whole torso hurt and his stomach (non-serious) on 15Apr2021 with outcome of unknown, diarrhea (non-serious) on 12Apr2021 with outcome of not recovered, getting really irritable (non-serious) on 09Apr2021 with outcome of not recovered, he had no energy (non-serious) on 12Apr2021 with outcome of recovering, he was lethargic/weakness (asthenia) (non-serious) on 12Apr2021 with outcome of not recovered, dizzy (non-serious) on 10Apr2021 with outcome of not recovered, couple pains in the left chest area behind the breast (non-serious) on 17Apr2021 with outcome of not recovered, breathing hard (non-serious) on Apr2021 with outcome of not recovered, wouldn't feel good (non-serious) on Apr2021 with outcome of not recovered, arm started hurting where he got the shot (non-serious) on 08Apr2021 with outcome of not recovered, headache (non-serious) on Apr2021 with outcome of unknown, his arm was a little sore (non-serious) on 13Apr2021 with outcome of unknown, a fast heartbeat (non-serious) on Apr2021 with outcome of unknown, chills (non-serious) on Apr2021 with outcome of unknown. Patient got sick around 10:00 at night. He was supposed to get his second dose but he was so sick and they said lets give it a week. Then he talked to his doctor and he said to wait 2-3 weeks to make sure he is back to normal. So he is scheduled for the second dose next week at 6 weeks. He asked if it was okay that the shot was given in the sunlight. He stated that he saw that it was in an ice chest but the person had to walk it over to him 20 feet and deal with his sleeve for a second or two so it was in the sun. He said all that walking it was 100% in the sun and he has read that it should not be in the sun. He asked if this could have caused bacteria and caused his symptoms. He stated his doctor was only concerned about giving him antibiotics for bacteria if it was in the sun and if that was a problem. He just read from CDC, once mixed the vaccine can be left at room temp for 6 hours and mixed vaccine does not need to be protected from light. So it sounds like his first shot was good. He had gotten the shot at about 1430 in the afternoon. He was like he is going to get the shot and everything will be great. He didn't think there would be an effect. Then strangely enough at about 2200 he was about to eat dinner and he got to not feeling good in his stomach. It had been close to 8 hours. The next day he slept all day, got up and had coffee, and Saturday he was in the chair in the living room. He is never in the chair during the day because he works. He slept all day and all night and the next day. He was responding strangely to people, and he was in and out of it. He had the shot on Wednesday and then his stomach was feeling sick and his body was hurting. He has back pain anyway and bone spurs on his spine. He was telling his wife whatever pain he is normally in was enhanced. His whole torso hurt and his stomach. The following Monday he had diarrhea. Then he started getting really irritable and didn't want to talk and was impatient. He was lethargic and had no energy. That was the second week. By the end of the second week he had a couple pains in the left chest area behind the breast. He thought it was a heart attack, then thought it was just pain not a heart attack. Every time he wouldn't feel good he would start breathing hard. Once in a while he gets pain through his chest area. His stomach would start and he would breath hard every time he didn't feel good. The third week he was supposed to get the second shot. He called the department of health for New Mexico. The nurse called back and said not to do the shot that week but to wait a week. He rescheduled for a week later. By the third week he was still not feeling good and called the doctor. He asked about the pain in his chest 3 times and he said it seemed to be okay. His arm started hurting where he got the shot in the second week. He still had no energy and he told the doctor this. Patient started taking 2 extra Tylenol during the day for pain. Lately he has been good until one little thing and then all of a sudden his stomach is hurting and he is holding his stomach. He was good today, all he did was eat a cookie and he didn't get sick. He was worse for a little while in the first or second week, he was really bad. It came and went over the next 2 weeks and now it is coming and going less frequently. He slept through 2 or 3 days. Thursday, Friday, and then Saturday he was in and out. He woke up to take the garbage out on Friday then saw he already took it out and forgot it was out there. And it was Saturday. He was kind of out of it. When he would respond strangely he would respond with a question he just asked and someone answered. It is like brain fog or like he is on something. It started after the weekend, more on 12Apr2021. Once in a while he will forget a little something still, but just once in a while. He would walk and hold his rib cage with both arms when he was hurting. He wrote down that it felt like somebody had hit him in the back with a bat in the lower back. One day it was that bad. His back pain was on Thursday 15Apr2021. The pain now is not like where it hit him with the back. He has back pain every day but more than he used to. The sore like he was hit in the back pain was just the one day. He had diarrhea 12Apr2021, 13Apr2021, and 14Apr2021 then it left for probably a week. Then it came back last week one day. Instead of every day it was every 3 or 4 days. He has not had it in the last 4 days. He hopes it is done. He noticed any time he has salad or lettuce he feels bad in the morning so he stopped eating those. He felt irritable more when he started not feeling good. The last 5 days or so more towards the evening at 1800 or 1900 he starts not feeling good and gets irritated. His wife will ask him something and he gets really short and impatient. He felt irritable more when he started not feeling good. The last 5 days or so more towards the evening at 1800 or 1900 he starts not feeling good and gets irritated. His wife will ask him something and he gets really short and impatient. The irritable feeling started right away the Friday of the week he got the shot. He is still struggling some, it will come and go. Yesterday he was zonked. With having no energy it is a big thing. He has to do something instead of what he would be doing. He works all day and takes long orders and stuff. Now he does like one order when normally he did 10. One for him is a huge little sore so he will lay on his right side. His left arm still hurts like a pulling hurt from his neck to his arm. It has been every day from 13Apr2021. It is much better and he will move and it will relax a little bit. It was really weird. The whole time he held the phone with his left hand up until one second he moved his phone and it was the same pain. At night the left side where he had the injection pulls on his neck muscle coming from his arm. He was actually taking two Tylenol in the morning and two at night when he went to bed. With the pain he takes 2 during the day, 650mg each. He was just taking 500mg and then his wife said take these. It seems to have gotten a little better. He always took them 2 times a day and now he takes them 3 times a day. After the first dose he experienced difficulty breathing dizziness, weakness, a fast heartbeat, chills, nausea, headache, he passed out for 2 days and has been sick for 5 weeks. He started having some dizziness a couple of days later and reports, it's like I would stand up too quickly and get a head rush, that kind of dizzy feeling. He confirmed that his dizziness did not start until a couple of days after he received his first dose.
56 2021-05-26 fluid around the heart, chest pain, inflammation of the pericardium Pericarditis: presented to the ED on 5.26.2021 with chest pain x2 days. Has generally felt unwell si... Read more
Pericarditis: presented to the ED on 5.26.2021 with chest pain x2 days. Has generally felt unwell since his 2nd COVID vaccination on 5.13.2021.
56 2021-05-27 heart flutter, loss of consciousness Heart arrhythmia (fluttering); I lost consciousness; This is a spontaneous report from a non-contact... Read more
Heart arrhythmia (fluttering); I lost consciousness; This is a spontaneous report from a non-contactable consumer reporting for himself A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8731) on 17Apr2021 at single dose via an unspecified route of administration for COVID-19 immunization. The patient did not have relevant medical history. Concomitant medications were not reported. The patient received first dose of BNT162B2 (lot number: ER8730) on 27Mar2021 on arm left. On an unspecified date after vaccination the patient reported he had lost consciousness in the morning right after exercise while experiencing arrhythmia. No treatment received for the events. At the time of the reporting the patient had not yet recovered from the events. No follow-up attempts are possible. No further information is expected.
56 2021-05-28 cerebrovascular accident since 2nd shot I have been extremely tried and on 4/28/21 i had a stroke.
56 2021-05-28 chest pain, pulmonary embolism Within a week after first vaccine dose, burning in legs from above the knee to feet. Numbness and ti... Read more
Within a week after first vaccine dose, burning in legs from above the knee to feet. Numbness and tingling in fingers and feet. Symptoms continue. Within a week after second vaccine, onset of bilateral upper quadrant pain, thoracic and flank pain that worsened over time. Unable to lie down due to sharp pain. Reached out to Oncology and PCP offices after symptoms of both vaccines for awareness and guidance. 5/4/21 - Emergency and inpatient visit - diagnosed with bilateral pulmonary emboli.
56 2021-05-30 cerebrovascular accident Pain in my jaw and temple to start then my words started to slur then created a stroke and confirmed... Read more
Pain in my jaw and temple to start then my words started to slur then created a stroke and confirmed my the hospital. I have had a CT scan them MRI. I am in ICU. Who is going to pay for my bills since I have no insurance.
56 2021-05-31 deep vein blood clot Patient received 2nd COVID (Pfizer) vaccine on 5/21/21, with sweats and chills but otherwise no othe... Read more
Patient received 2nd COVID (Pfizer) vaccine on 5/21/21, with sweats and chills but otherwise no other issues. On 5/26/21, he note left lower extremity edema. This did not resolve with compression hose and went to hospital for a venous doppler revealing a nonocclusive DVT in the left lower extremity politeal and calf veins. He does not smoke, no change in activity, no recent travel by car or air. He is on lenalidomide and takes aspirin 81mg PO QD.
56 2021-06-01 ischemic chest pain sharp pulsing heart pains unfamiliar to me and lasting 30 seconds
56 2021-06-02 blood pressure increased Nausea, heavy vomiting back to back, severe stomach pain, sweating, chills, severely elevated bloo... Read more
Nausea, heavy vomiting back to back, severe stomach pain, sweating, chills, severely elevated blood pressure above 200. Sickness lasted from 3/18 -3/25. No solid food until 3/25.
56 2021-06-05 blood pressure increased 5 minutes after vaccine stomach and sides felt heat, upset stomach, lightheaded and blood pressure e... Read more
5 minutes after vaccine stomach and sides felt heat, upset stomach, lightheaded and blood pressure elevated way up. felt very sick, went thru 3 extended observations that lasted about 1 hour and things started to calmed down except light headed and anxious. Finally felt like I could drive home then while driving home my temple and side face started tingling and went numb, pain in the back of my right eye this lasted about 20 minutes and the numbness went away however I had a sensation for a week in my temple and forehead. Could not go to work the next day, felt bad on and off for 8 days. Triggered anxiety for several days, did not get second dose..
56 2021-06-05 hypotension, fainting, loss of consciousness Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-M... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: Patient fainted after 15-20 minutes of getting vaccination. He said he felt overheated and exhausted before passing out. Gave him ice pack and water and had him lie down for several minutes. His bloodpressure was low then rose after a few minutes. Patient declined to be checked out by EMTs and stated was fine to go home and lay down. Figured he was probably anxious about getting the shot
56 2021-06-07 chest discomfort, pulmonary embolism This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient rece... Read more
This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 25Feb2021 13:00 (Batch/Lot number was not reported) as single dose at the age of 56-year-old for COVID-19 immunisation, administered at hospital. Medical history included known allergies to nut, ongoing hospitalisation Vaccine received during existing Hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) at 112mcg, and isosorbide mononitrate (ISOSORBIDE MONONITRATE) at 60mg, both taken for an unspecified indication, start and stop date were not reported. The patient had not received other vaccines within 4 weeks prior to BNT162B2. The patient experienced tightens of chest, difficult breathing, light headed, pulmonary embolism on 26Feb2021. The outcome of events was not recovered. The patient was hospitalized for events in 2021 for 21 days. Seriousness criteria for the evens were Life threatening and prolonged hospitalization. The patient underwent lab tests and procedures which included Sars-cov-2 test (nasal swab): negative in Sep2020. Therapeutic measures were taken as a result of tightens of events. Information on the lot/batch number has been requested.
56 2021-06-07 blood clot, palpitations feel a constant and migrating thrombosis/palpitations on the right side of my head; palpations; mild... Read more
feel a constant and migrating thrombosis/palpitations on the right side of my head; palpations; mildly painful -not quite a headache; painful sensations in the lower left leg; a slight discomfort of the arm where the shot was administered; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 11May2021 10:30 (at the age of 56 years old) (Lot Number: EW0182) as 1st dose, single for COVID-19 immunization. Medical history included high blood pressure, allergies: contrast dye. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient reported that there was a slight discomfort of the arm where the shot was administered (11May2021) - not enough to worry about & expected. The next morning (12May2021) he felt painful sensations in the lower left leg - sensations similar to stress fractures and palpations. It subsided and has not returned. About three/four days later (reported as 14May2021 18:00) continuing two weeks leading to the second dose - he felt a constant and migrating thrombosis/palpitations on the right side of his head. It was mildly painful - not quite a headache yet persistent and localized to the RT temporal lobe above the temple & slightly above that region. It became exacerbated by critical thinking when it occurred & persisted for long periods of time. The cognitive effect has become slightly debilitating & stressful. No treatment received. The outcome of the event 'a slight discomfort of the arm where the shot was administered' was unknown, of the event 'painful sensations in the lower left leg' was recovered, of the other events was not recovered.
56 2021-06-08 cerebral haemorrhage brain bleed; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sp... Read more
brain bleed; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sponsored program support. This is the first report of 2 reports, for the first dose. A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 56-years, administered in left upper bicep on 26Mar2021 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included ongoing diabetes and the patient had it for 10 years or so and was diet controlled, his blood sugars was good. And ongoing supraventricular tachycardia (SVT) for about 4 years and was medication control. And patient was an amputee from an accident many years ago. Concomitant medications included ongoing carvedilol (COREG) taken for SVT. It was reported that the patient had a brain bleed after the first dose that might be but probably wasn't related to the vaccine. Event outcomes was unknown. No follow-up attempts needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021596614 same reporter/patient/drug, different event/dose.
56 2021-06-08 inflammation of the pericardium, hypotension, heart rate increased Pericarditis; Pulmonary effusions; blood pressure was really low; heart rate was really high; starte... Read more
Pericarditis; Pulmonary effusions; blood pressure was really low; heart rate was really high; started feeling ill/not feeling well; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer sponsored program. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 22Apr2021 as 2nd dose, single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus has had it about 10 years or so, blood sugars have been good, ongoing supraventricular tachycardia had this diagnoses for about 4 years and is medication control, and amputee from an accident many years ago from an unknown date. Concomitant medication included carvedilol (COREG) taken for supraventricular tachycardia from an unspecified start date and ongoing. The patient previously received the first dose of bnt162b2 on 26Mar2021 (Lot number: EN6208) at 56 years old for COVID-19 immunization in the left upper bicep and experienced brain bleed. No history of Pfizer vaccine other than the first dose. No additional vaccine administered on the same date or 4 weeks prior. No family history. On 08May2021, it was reported that the patient started feeling ill and was not feeling well. On 12May2021, the patient walked into a clinic since he was not feeling well. They found his blood pressure was really low and heart rate was really high so he sent to the emergency room and they admitted him. When at the emergency room they did a CTA which is a CT angiography. The patient was diagnosed with the pericarditis. The patient was admitted on 12May2021 for the pericarditis and pulmonary effusions. The pericarditis is what they were concerned about though. The reporter explains before this he was fairly healthy. The patient was discharged on Friday 14May2021. He was doing pretty well for a couple days but now he is not feeling well again. He was good on 18May2021 but then was not felt well since the 20May2021. He went to doctor on 21May2021. The patient underwent lab tests and procedures on an unspecified date which included CT angiography: pericarditis, CBC: normal, Blood culture: negative, Flu test: negative, COVID-19 test: negative, RSV test: negative, Echocardiogram: normal. On 12May2021 blood pressure: really low and heart rate: really high. The events required physician's office and emergency room visit. The outcome of the events was unknown.
56 2021-06-09 atrial fibrillation, nosebleed, chest pain Fever, shortness of breath, chest pain, bloody nose, heart AFIB, lack of sleep, Diarrhea, and nausea... Read more
Fever, shortness of breath, chest pain, bloody nose, heart AFIB, lack of sleep, Diarrhea, and nausea.
56 2021-06-09 blood pressure decreased Pfizer 2nd dose.. stared with tinging in eyelids, 30 seconds of tingling in arms, tingling in lower ... Read more
Pfizer 2nd dose.. stared with tinging in eyelids, 30 seconds of tingling in arms, tingling in lower legs, blood pressure was low100/61(took blood pressure twice). After calling paramedics, discoloration in face, also felt like he was going to pass out.
56 2021-06-10 chest discomfort discomfort in chest heart, shortness of breath for about 3 days
56 2021-06-13 coughing up blood, blood clot Hemoptysis. On 06/05, a one-time event (old, dark clots) occurred. On 06/06, there were several in... Read more
Hemoptysis. On 06/05, a one-time event (old, dark clots) occurred. On 06/06, there were several instances, some older clots, some lighter/fresher blood. Then 4 days of no blood, but "normal" (usual) infected sputum colors (preexisting lung infection; see continuation page). Then on 06/11 beginning @ 7:57am, fresh (light) blood streaks/tinged sputum, which occurred a number of times over the span of approximately 5 hours, until "normal" pale yellow infected sputum was expectorated. Then on 06/12 beginning @ 9:30am, fresh blood again, which again occurred a number of times over the span of about 5 hours until the usual infected colors of sputum were expectorated. Additional information for Item 18: I have a history of MAI/MAC infection and resultant hemoptysis since 2006. However, until the first Pfizer dose, it had been 2 years since the last incident of hemoptysis, which was due, at least in large part, to malnutrition spanning a couple of months, for reasons unrelated to the lungs. I believe my most recent hemoptysis episodes are a result of my immune system being distracted by the Covid-19 vaccine, thus allowing the Mycobacterium avium (and/or other) to more effectively attack my lung tissue. There was no hemoptysis yesterday (06/13), but this has me concerned about the second dose causing additional, possibly worse, problems for my immune system, as it needs to be concentrating on my lung infection full-time; it has been keeping the MAC (and/or other) generally under control, assuming hemoptysis is a good indicator, which my X-rays over the years of monotherapy with Ethambutol suggest is the case. I discontinued Ethambutol on 06/15/2012, with no further hemoptysis until 04/26/2019, and then no hemoptysis until 11 days after the first Pfizer Covid-19 dose. It seems reasonable to conclude that the vaccine led to these latest hemoptysis events and perhaps allowed the preexisting bacterial infection to cause additional lung damage.The physician noted above is my current pulmonologist. I was to have follow-up lung CT scan and lung function tests, but did not do so in 2020 because of Covid-19 concerns. I had planned to see Dr. and my other doctors after being fully-vaccinated, but since lung function tests cannot be performed on patients with active/recent hemoptysis, this may cause an even further delay in my obtaining appropriate diagnostics and treatment.
56 2021-06-13 fluid around the heart, inflammation of the pericardium, chest pain (Small Pericardial effusion). Acute pain in the chest, esophagus and throat, pain when breathing, fe... Read more
(Small Pericardial effusion). Acute pain in the chest, esophagus and throat, pain when breathing, fever, severe headache, diarrhea, fatigue. 12 hrs admitted and 3 days later admitted to hospital. Where a pericardiocentesis was performed.
56 2021-06-15 chest pain Patient presented to the ED on 5/4/2021 with chest pain. Patient hospitalized for cholecystitis and ... Read more
Patient presented to the ED on 5/4/2021 with chest pain. Patient hospitalized for cholecystitis and s/p cholecystectomy. These visits are within 6 weeks of receiving COVID vaccination.
56 2021-06-15 coughing up blood, pulmonary embolism, chest pain Patient received his second Pfizer COVID vaccine on 6/4/21. Notes afterward he started with symptoms... Read more
Patient received his second Pfizer COVID vaccine on 6/4/21. Notes afterward he started with symptoms of a 'chest cold' and was having pain in left rib/lung/chest area. One morning walking at work and was noticing increased phlegm and chest congestion, spit up a wad of blood. Sharp left lung pain with taking a deep breath. Notes after episode, coughed up darker blood a few more times. Went to ER on 6/14/21 - imaging found with pulmonary embolism/blood clot in left lung. Discharged with Eliquis started pack 2 tab BID for 7 days, then 1 tab BID. New patient consult on 6/16/21 with myself, APRN - continuation of blood thinners initiated, referred for hematology consult, and echocardiogram ordered.
56 2021-06-15 fast heart rate, palpitations Heart palpitation; Tachycardia; Diaphoresis; Shakiness; This is a spontaneous report from a contacta... Read more
Heart palpitation; Tachycardia; Diaphoresis; Shakiness; This is a spontaneous report from a contactable Other HCP. A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3302) intramuscularly, administered in Arm Left on 02Feb2021 at 09:25 AM (at an age of 56-years, 7 months during vaccination) as single dose for COVID-19 immunisation. The patient's medical history included enlarged prostate, urinary frequency with no infection, hypertension. The patient previously took Doxycycline. The patient was allergic to medication, food, or other products including Doxycycline. The patient's concomitant medications included amlodipine, tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]). The patient had not experienced adverse event following any previous vaccine. On 02Feb2021 at 09:53 AM, the patient experienced diaphoresis, shakiness, heart palpitation and tachycardia. Diaphoresis and shakiness ended by 10:18 AM and Heart palpitation and tachycardia ended around 10:25 AM. On an unknown date, the patient underwent lab test and procedure which included: Blood glucose: 126 mg/dl. The patient was advised for relaxation. On the 02Feb2021, the outcome of the events was recovered for Diaphoresis and shakiness at 10:18 AM and Heart palpitation and tachycardia ended around 10:25 AM. Follow-up attempts are completed. No further information is expected.
56 2021-06-16 chest pain Chest pain
56 2021-06-17 pulmonary embolism, deep vein blood clot Patient reported to hospital with worsening shortness of breath and vertigo, 88% on RA. Sent for x-... Read more
Patient reported to hospital with worsening shortness of breath and vertigo, 88% on RA. Sent for x-ray, CT and US. Extensive DVT and sub-massive pulmonary embolism. Initiated on heparin drip. Currently getting consent for TPA administration.
56 2021-06-18 platelet count decreased Chills; his platelets were down; This is a spontaneous report from a contactable consumer or other n... Read more
Chills; his platelets were down; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, in Arm Right on an unspecified date in Mar2021 (at the age of 56 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included cancer from Mar2020 to Oct2020, ongoing lymphoedema from an unspecified date in 2020, ongoing High blood pressure diagnosed 2-3 years ago, ongoing Allergies, white Coat syndrome. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 in right arm on an unspecified date in Mar2021 (at the age of 56 years old) as single dose for COVID-19 immunisation and experienced no reactions, Pneumonial vaccine and FLU Shot for an unknown indication and experienced no reaction on previous exposure to Vaccine. Caller reported that his dad passed away when he was 83 and after they found cancer on his bladder. Caller reported that no one in his family has immune problems, other than his daughter who has type I diabetes. Concomitant medications included Loratidine (CLARITINE) taken for hypersensitivity from 20May2021 and ongoing, potassium chloride taken for lymphoedema from an unspecified date in 2020, lisinopril for hypertension, Terbinafine for toenail fungus for the last month and a half. On an unspecified date in Mar2021, the patient experienced some chills on the second day following his second dose of the Covid-19 vaccine. Caller reported that he was not running a fever or anything, just felt chills and that was about it. Caller reported that then everything was fine, he just experienced chills for one day. The patient received both doses of the Pfizer BioNTech COVID-19 Vaccine in Mar2021. Last year he had cancer. He is now part of a study with (withheld). As part of the study, they have been doing blood work (three times now). His antibody test for COVID-19 came negative. Caller mentioned his platelets were at 118, he had no sign of cancer on scan at end of Oct2020 (he is in remission) and reported lymphedema in one leg. Caller stated that he is aware that Pfizer conducted a study with healthy individuals. Caller wants to know if Pfizer is conducting a study with patients who have received both doses of the Pfizer BioNTech COVID-19 vaccine and who have comorbidities such as transplant patients, or patients with cancer to see how the antibodies of the vaccine are affecting them because he would be interested to participate. Caller reported that his platelets and white blood cells are still low, and his physicians did biopsies to make sure there was no bone marrow cancer. Caller reported that his physician did notice that the bone marrow that makes platelets was really taking its time getting back. Caller reported that his last report showed 118 on platelets. Caller reported that his physician informed him that he developed lymphedema from the cancer medication that he was taking. Caller reported that his physician informed him that the cancer medication can kill cancer but can attack other parts of the body. Caller did not provide details for the medication he was taking for his cancer. Caller reported that they had checked his legs to make sure that he didn't have any blood clots. Caller stated that he needs to know if Pfizer is having something that determines if someone has antibodies for Covid-19. Caller stated that Pfizer put out that the Covid-19 vaccine is 80 something percent effective after having the vaccine. Caller reported that they were looking into people that have had immune diseases and immunity disorders. Caller reported that he is out of the cancer and doesn't have anything showing that his body has cancer, whether bloodwork or all that. Caller stated that he would really like to know if he has antibodies from the Covid-19 vaccine or if he doesn't. Caller reported that he is worried that there is no way of checking to see if he has antibodies from the Covid-19 vaccine. Caller inquired how he can find out if he has antibodies to Covid-19 besides a little kip that you put a few drops of blood on and put a solution on it. Caller reported that his weight was higher and that after he found out he had cancer, it started to go down. Caller reported that he has no other symptoms, he is not diabetic, and doesn't have any kind of immunity or other symptoms. Caller reported that the only thing stopping him from going back to work was going through cancer, his doctor didn't let him go back. Caller reported that he was at risk because his platelets were down, meaning that he could be susceptible to even the common cold. Caller reported that his physician let him go back to work a week after the first dose of the Covid-19 vaccine. Caller reported that his physician informed him that more than likely the caller had a little in one of his legs that didn't show up as there wasn't swelling or doing enough to cause it. Caller reported that he just wears compression socks now and there was no damage. Caller reported that the lymphedema started during his cancer. Caller reported that while he was getting chemo, his ankles were starting to get swollen and it was determined towards the end of his cancer that it was lymphedema. Caller reported that he heard someone saying something about the possibility that people may need to take boosters of the Covid-19 vaccine. Caller reported that he heard about delta versions of the Covid-19 virus. Caller reported that they say that if you had both doses of the Covid-19 vaccine, you're covered whereas if you only had one, you're not as covered. Caller reported that he has had several Covid-19 antibody tests performed since he received the first and second dose of the Covid-19 vaccine and they have all come back negative. Caller reported that the most recent result was from today, 15Jun2021. No additional Vaccines were administered on Same Date of the Pfizer Suspect. No adverse events following prior vaccinations. The reporter considered the events as non-serious. The patient underwent lab tests and procedures which included platelet count: 118 on an unspecified date (his platelets are still low), sars-cov-2 antibody test negative: negative on 15Jun2021, white blood cell count: low on an unspecified date (white blood cells are still low). The outcome of chills was recovered on an unspecified date in Mar2021 and platelet count decreased was unknown. Information about batch/Lot number has been requested.
56 2021-06-20 heart rate abnormal Headaches, fever, rash, throwing up, heart rate uncontrollable until seen by medical specialists. It... Read more
Headaches, fever, rash, throwing up, heart rate uncontrollable until seen by medical specialists. It?s been 3 months, I haven?t felt better since the day I took the vaccine
56 2021-06-21 chest discomfort, palpitations Chills, left ventricle tightened, severe headache, heart palpitations.
56 2021-06-21 palpitations approximately 5pm my heart started RACING. similar to when I have one of my irregular heartbeat epi... Read more
approximately 5pm my heart started RACING. similar to when I have one of my irregular heartbeat episodes. i laid down and relaxed. usually they will stop within 1 hour. this was different, it continued all night, weakening me as the night progressed. i stayed in bed hoping i wasn't having a heart attack, ready to call an ambulance if necessary. after quite a few hours, it subsided and my heartbeat went back to normal. it was a very scary event.
56 2021-06-22 cerebrovascular accident Two days after the shot I was very ill with nausea, bad headache and was very lethargic. Four day l... Read more
Two days after the shot I was very ill with nausea, bad headache and was very lethargic. Four day later I went to an urgent care for treatment for nausea and the headache. Two days later I was in the emergency room in the Medical Center for treatment of the same symptoms. Eventually the headache got better so I could function but I was very lethargic and had a constant cough for the next 6-7 weeks.
56 2021-06-24 palpitations, heart flutter, heart rate increased Pt states 04/08/2021 awaken by a rapid heartbeat, irregular (skipping beats/fluttering). 04/09/2021 ... Read more
Pt states 04/08/2021 awaken by a rapid heartbeat, irregular (skipping beats/fluttering). 04/09/2021 Contact with Physician 14th Heart monitor no irregular signs seen, self checks continue per (Cardiologist) Reports since then once a month, couple days irregular palpations reporting (May, June) Continues to monitor.
56 2021-06-27 chest pain, enlargement of the heart Chest pains and Diagnosed with mild enlarged heart after vaccine
56 2021-06-29 heart rate abnormal Swelling; Bruising and hardness; Tingling; Numbness sensations; Achy and uneasy feeling through the ... Read more
Swelling; Bruising and hardness; Tingling; Numbness sensations; Achy and uneasy feeling through the forearm to date; Rapid heart rate; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 09Mar2021 at 00:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The medical history included allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient was not taking any concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 11Mar2021, the patient experienced left hand ring finger, swelling, bruising, hardness, tingling/numbness sensations. The patient also experienced achy and uneasy feeling through the forearm to-date. The patient had continued swelling and hardness in the area and experienced rapid heart rate. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling, bruising and hardness, tingling, numbness sensations, achy and uneasy feeling through the forearm to-date and rapid heart rate was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
56 2021-06-30 chest pain, troponin increased Patient was hospitalized for complicated UTI/pyelonephritis, developed epigastric and chest pain whi... Read more
Patient was hospitalized for complicated UTI/pyelonephritis, developed epigastric and chest pain while in hospital.
56 2021-07-01 heart rate increased On Sunday June 20th I was feeling sick, Fever, body aches, head ache, fatigue. I also had an infecti... Read more
On Sunday June 20th I was feeling sick, Fever, body aches, head ache, fatigue. I also had an infection in my gums around my teeth that was burning as if someone poured hot coffee in my mouth non-stop. especially the roof of my mouth and right behind my upper front teeth. After 4 days of trying to sweat it out the night sweats stopped. But my heart rate was at 161 beats per minute but I could not feel my heart beating at all. We went to an urgent care that immediately sent me by ambulance to the hospital. Right away they got my heart rate under control but they spent 4 more days trying fight the infection. Finally on June 29th I was well enough to go home.
56 2021-07-06 pulmonary embolism Pt developed DOE one week after first shot. Symptoms worsened gradually. He presented to Hospital ... Read more
Pt developed DOE one week after first shot. Symptoms worsened gradually. He presented to Hospital 01/23/2021 with Saddle Pulmonary Embolus.
56 2021-07-10 blood pressure increased blood pressure became elevated; This is a spontaneous report from a contactable consumer or other no... Read more
blood pressure became elevated; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Mar2021 (at the age of 56-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date (at the age of 56-years-old) for covid-19 immunisation. The patient experienced blood pressure became elevated on 20Mar2021. The reporter stated that he have never had a high blood pressure and he did not have high blood pressure before the vaccine after he receive the vaccine he monitor him blood pressure on a regular basis and his blood pressure became elevated he went to him doctor and confirms that indeed his blood pressure was elevated and a there was nothing that had changed in his lifestyle that would have caused that other than the taking of the vaccine mmm this lasted for about a month and a half and he went back to his doctor after the vaccine the second dose of the vaccine and his blood pressure had come down to normal levels so he believe that the vaccine created some type of reaction the cause me to have high Blood pressure. perhaps information of the heart. His cardiologist who he went to him doctor believes that it is the vaccine that is the reason that his blood pressure was elevated after the backs vaccine and then about a month and a half later it was it came back down. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 20Mar2021 he receive the vaccine he monitor him blood pressure on a regular basis and his blood pressure became elevated, blood pressure measurement: came back down on 05May2021. The outcome of the event was reported as resolved on 05May2021. Information about lot/batch number has been requested.
56 2021-07-11 cerebrovascular accident Peripheral vision loss the morning after the first covid vaccine, confusion over the weekend (approx... Read more
Peripheral vision loss the morning after the first covid vaccine, confusion over the weekend (approximately 4/2/21-4/6/21), Went to hospital Tuesday 4/6/21. Did MRI and determined patient had a stroke. Doctor said event was "fairly new." Patient was hospitalized almost 3 weeks. Doctors called it "embolic shower," said he may have had more than one stroke. They are calling in a stroke of "unknown origin" Patient currently still has short-term memory problems, blindness in right eye, and had to start dialysis treatments when in hospital, is still on dialysis.
56 2021-07-11 loss of consciousness Approximately 15 minutes after patient received a Pfizer Covid-19 and Shingrix vaccine, he lost cons... Read more
Approximately 15 minutes after patient received a Pfizer Covid-19 and Shingrix vaccine, he lost consciousness, but was visibly breathing. I called 911, then patient stopped breathing . He regained consciousness before I could begin CPR. While waiting for EMS, we took 2 BP readings (142/128 & 96/68) and I questioned patient's wife about medical history... she said that he had passed out 3-4 times in the past year. (Pt had not disclosed this on his vaccination Questionnaire)
56 2021-07-12 ischemic chest pain, heart rate abnormal, heart rate increased heartache jumped even during short walking; significantly elevated resting heart rate of 100bpm and ... Read more
heartache jumped even during short walking; significantly elevated resting heart rate of 100bpm and slow walking heart rate of 125bpm and evening parking above 140bpm; shortness of breath; a bit of dizziness; heart rate during light activity feels strained; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 09:00 at age of 56-year-old (Lot Number: EW0153) as dose 2, single for covid-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Pfizer, Lot number EP7534) on 17Mar2021 08:00 PM at age of 56-year-old in Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient had no other medical history. There were no concomitant medications. It was reported his normal resting heartrate was 65bpm. Within 6 hours of the second injection, he experienced significantly elevated resting heart rate of 100bpm and slow walking heart rate of 125bpm and evening parking above 140bpm just walking to the bathroom. This condition lasted for three days, lessening day to day. However, his resting heart rate remained higher than to the average with periods of rapid and sometimes uneven feeling heartbeat for a couple weeks. He also experienced shortness of breath and a bit of dizziness when his heartache jumped even during short walking. Currently, resting heart rate is back to his normal zone but his heart rate during light activity feels strained, with shortness of breath. The event onset date was 09Apr2021 09:00, no treatment was received, the outcome of the events was recovered with Sequel. No follow-up attempts are possible. No further information is expected.
56 2021-07-12 blood clot BLOOD CLOT IN THE LOWER EYELID OF THE RIGHT EYE.
56 2021-07-15 hypertension Patient is describing that he had to go urgent care 3 day following vaccine due to gout flare attack... Read more
Patient is describing that he had to go urgent care 3 day following vaccine due to gout flare attack. he ended up in emergency room a week later. He is telling he has severe hypertension after getting covid short.
56 2021-07-15 superficial blood clot Thrombophlebitis superficial lower limb right (blood clot in right foot). Warm compresses and time. ... Read more
Thrombophlebitis superficial lower limb right (blood clot in right foot). Warm compresses and time. Subsided.
56 2021-07-17 nosebleed Pemphigus; Nose bleeds; Globus sensation; Swelling left breast; Blood blisters in my mouth; Mouth ul... Read more
Pemphigus; Nose bleeds; Globus sensation; Swelling left breast; Blood blisters in my mouth; Mouth ulcers; Skin ulcers; This is a spontaneous report from a contactable physician (Patient himself). A 56-year-old male patient received bnt162b2 (Manufacturer: Pfizer, Formulation: Solution for injection), dose 2 single via an unknown route of administration, administered in left arm on 08Jan2021 09:00 (Batch/Lot Number: Ek9231) as dose 2, single for covid-19 immunisation in the hospital. Medical history included reflux from an unknown date and known allergies were none. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Manufacturer: Pfizer Formulation: Solution for injection), dose 2 single via an unknown route of administration, administered in left arm on 20Dec2020 10:45 (Batch/Lot Number: Ek5730) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not since vaccination. The patient reported that he started with some nose bleeds which he assumed was dry winter then developed shotgun 2to 3 weeks globus sensation. Then developed swelling left breast then started with blood blisters in his mouth. Then mouth ulcers. Then started with skin ulcers. All this was due to pemphigus on 15Jan2021. The patient underwent lab test which included biopsy proven with IF on 04Jun2021. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested. Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal association between the event pemphigus and the suspect vaccine BNT162B2 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.
56 2021-07-17 heart attack, chest pain, blood clot hard time breathing; heart attack; minor chest pain which he thought was indigestion and heart burn;... Read more
hard time breathing; heart attack; minor chest pain which he thought was indigestion and heart burn; had clot arteries based in blood clots; 1 artery was 99% blocked; cold sweats; afraid to eat because he was so bloated/acid reflux; could not hold food down; out of energy; fatigued, totally out of energy; minor chest pain which he thought was indigestion and heart burn; This is a spontaneous report form a contactable consumer (patient). A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ) on 30Mar2021 for covid-19 immunisation at the age of 56-year-old. Lot number was EP7533. Medical history included diabetes in 2018. Concomitant medications were unknown. Patient received first dose of BNT162B2 on 09Mar2021 for covid-19 immunisation (Lot Number: EN6198 Anatomical Location: Left Arm). On unknown date, electrocardiogram showed shows heart attack. The patient experienced heart attack on 06Apr2021 (treated with surgery, and received 2 stents in his heart), hard time breathing on 11Apr2021, minor chest pain on 02Apr2021 which he thought was indigestion and heart burn on 06Apr2021, had clot arteries based in blood clots, 1 artery was 99% blocked, cold sweats, fatigued and totally out of energy on 06Apr2021, afraid to eat because he was so bloated/acid reflux, vomit on 06Apr2021. The patient was hospitalized for myocardial infarction, dyspnea and chest pain. The outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.
56 2021-07-21 blood clot I experienced a blood clot in my right leg, had surgeries to remove the blood clot and put a stent i... Read more
I experienced a blood clot in my right leg, had surgeries to remove the blood clot and put a stent in. I had excruciating pain in my right leg. I went to the Hospital. I am in recovery from the adverse event.
56 2021-07-22 chest pain Pericarditits, mild chest pain, positional, pleurtic chest pain reviewed ECG with cardiology who re... Read more
Pericarditits, mild chest pain, positional, pleurtic chest pain reviewed ECG with cardiology who recommended treatment for mild pericarditis with ibuprofen tapered dosing had abnormal ECG
56 2021-07-22 fast heart rate, palpitations Tachycardia and heart palpitations that continue to this day
56 2021-07-24 heart rate increased After the first shot I felt like I had Covid again. Fever, body aches, rapid heart rate, generally j... Read more
After the first shot I felt like I had Covid again. Fever, body aches, rapid heart rate, generally just miserable.
57 2021-01-06 fibrin d dimer increased, heart rate increased, blood pressure increased After receiving the vaccine within 15 mins I had a metallic taste in my mouth. I exp fatigue and cou... Read more
After receiving the vaccine within 15 mins I had a metallic taste in my mouth. I exp fatigue and couldn't sleep I went to ER HR 180/10, elevated HR/BP, muscle joint pain and tremendous back pain. After I followed up with my PCP still elevated BP 140/70 as a result I'm on blood pressure medication. I was advised to stay on this new medicine until I receive the second dose of the vaccine. Also was told to take Benadryl and Tylenol before taking 2nd Covid vaccine.
57 2021-01-07 hypertension Chills, low-grade fever, body aches, muscle and Joint and bone pain, sore throat
57 2021-01-08 chest pain HEADACHE, SEVERE JOINT PAIN, RIGHT UPPER CHEST PAIN, LETHARGY, FEVER, CHILLS
57 2021-01-11 haemoglobin decreased, fluid around the heart, enlargement of the heart, chest discomfort, fibrin d dimer increased this 57yo Male ret. He received his first Pfizer covid vaccine on Jan 7th to left arm at hospital (n... Read more
this 57yo Male ret. He received his first Pfizer covid vaccine on Jan 7th to left arm at hospital (not where he works). He went home and reported was fine, but tired. Stated his fatigue and onset of shortness of breath began day 1 post vaccine kept him from working. As his symptoms worsened, on day 4 (1/11/2021) he obtained a pulse ox and O2 sats were in the "80's" with normal heart rate. He went to ER on 1/11 1507 with body aches, fatigue, chest discomfort and SOB where he was ultimately admitted with diagnosis of COVID-19 pneumonia. Is on O2 support via NC.
57 2021-01-15 chest discomfort 24 hours after the second vaccine I had crushing, tightness in my chest. It felt like a myocardial i... Read more
24 hours after the second vaccine I had crushing, tightness in my chest. It felt like a myocardial infarction. It lasted 24 hours. I had difficulty doing my job. I considered going to the ER to rule out a myocardial infarction not related to the vaccine. I also had bone pain in right forearm and hand which lasted 24 hours. In addition, I had muscle pain in my entire upper body but not lower body. On day 2 I had right axillary swelling and pain.
57 2021-01-21 chest discomfort HPI from ED: 57-year-old male with history of reactive airway disease, T2DM, OSA presenting with sho... Read more
HPI from ED: 57-year-old male with history of reactive airway disease, T2DM, OSA presenting with shortness of breath. Patient states 2 days ago, he had to take his dog to the vet, and they accidentally ran away; he had to run "full tilt" to catch it, which caused him to become acutely short of breath. Since then, he has had worsening difficulty breathing with any type of exertion, progressing today to dyspnea at rest. He has been using albuterol several times per day (3-4 times today), as well as his BiPAP machine that he uses for OSA, during the day without relief. Denies chest pain, though he has chest tightness associated with difficulty breathing. History of similar difficulty breathing with exertion during the winter, but never this bad; has not been hospitalized or intubated for RAD. Got his second COVID vaccine 3 days ago, after which he had fevers, now resolved. Denies recent antibiotics; no history of COPD, slight cough today, not productive of sputum, no hemoptysis. Reports a month of right leg swelling; has a history of prior right knee surgeries; no posterior calf pain, no acute changes; no history of VTE, no history of cancer, no hemoptysis, no recent procedures/surgeries/immobilizations.
57 2021-01-25 chest discomfort Approx 26 hours after receiving the vaccine client started c/o "chest didn't feel right, and it coul... Read more
Approx 26 hours after receiving the vaccine client started c/o "chest didn't feel right, and it could be my stomach. I also noticed a swollen lymph gland under my left armpit. It is 2inches wide by 4 inches long. I called my oncologist and they just said to watch it, take ibuprofen. I have a similar thing happen usually right before I take my chemotherapy." He denies fever, red streaks.
57 2021-01-26 blood pressure increased Elevated Blood Pressure 137/97 Fever temp 101 Body aches
57 2021-01-26 loss of consciousness, lightheadedness Systemic: Exhaustion, Systemic: described by the EMT as a vasovegal reaction. patient passed out and... Read more
Systemic: Exhaustion, Systemic: described by the EMT as a vasovegal reaction. patient passed out and had seizure like reactions. was unresposive and given epi pen. after EMT arrived, patient was monitored and allowed to leave; symptoms lasted 1 day
57 2021-01-27 hypotension Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but we... Read more
Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but went away after half hour. At 12 am on 1/27/21, I felt extremely dizzy, very low blood pressure (80/50), sweating, disoriented and lightheaded which lasted approximately an hour.
57 2021-01-27 hypotension Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but we... Read more
Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but went away after half hour. At 12 am on 1/27/21, I felt extremely dizzy, very low blood pressure (80/50), sweating, disoriented and lightheaded which lasted approximately an hour. Also developed a large swelling/lump on the lower part underneath my right armpit. (soft to the touch but noticeable.)
57 2021-01-30 fainting On 12/31/20, patient started to develop nausea and vomiting. Progressed to recurrent nausea/retchin... Read more
On 12/31/20, patient started to develop nausea and vomiting. Progressed to recurrent nausea/retching/intractable hiccups on 1/1/20. Presented for evaluation/iv rehydration on 1/3/21, 1/5/21 and 1/6/21. Multiple vasovagally-mediated syncopal spells on 1/5/21 - 1/6/21. Suspected to have gastroparesis on 1/8/21. Symptoms improved with Reglan 10 mg po qid by 1/15/21. Received dose 2 of COVID-19 vaccine on 1/18/21. Symptoms of gastroparesis redeveloped a few hours later, symptoms improved with domperidone 10 mg po qid by 1/23/21.
57 2021-02-01 lightheadedness Near-syncope - lightheaded, generalized weakness, thigh cramps beginning around 15' post vaccination... Read more
Near-syncope - lightheaded, generalized weakness, thigh cramps beginning around 15' post vaccination Was placed supine, BP transiently elevated Pt transported to emergency dept. where he felt better, vitals normalized, observed In ED pt denied any focal weakness
57 2021-02-04 chest discomfort Shortly after vaccine receipt client complained of general not feeling well, progressing quickly to ... Read more
Shortly after vaccine receipt client complained of general not feeling well, progressing quickly to c/o nausea, headache, cough, chest tightness. B/P initially 174/88, P=64, subsequent B/P 188/110 and c/o "severe" headache. EMS called and client transported to emergency room
57 2021-02-09 blood pressure fluctuation COVID-19 virus test positive; COVID-19 virus test positive; Blood pressure fluctuation; This is a sp... Read more
COVID-19 virus test positive; COVID-19 virus test positive; Blood pressure fluctuation; This is a spontaneous report from a contactable consumer reporting for himself and from another consumer. A 57-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK4176), via an unspecified route of administration in the right arm, on 05Jan2021 at 14:10, at single dose, for COVID-19 immunisation. Medical history included ongoing gout and ongoing blood pressure high. Concomitant medications included allopurinol (unknown manufacturer) from 2008 to an unknown date and from an unknown date to ongoing for gout, lisinopril (unknown manufacturer) from an unspecified date and ongoing for blood pressure high at 40 mg daily, an unspecified drug for blood pressure high from Dec2020 at 5 mg and an unspecified anti-inflammatory. The patient previously took allopurinol from 2008 for gout and experienced abdominal pain upper so the drug was stopped on unknown date but his uric acid levels get high and he had to go back on it again. The patient experienced COVID-19 virus test positive (medically significant) on 16Jan2021 with outcome of unknown and blood pressure fluctuation in Jan2021 with outcome of unknown. It was reported that the only symptom he had on 13Jan2021 at first was a crash in his blood pressure. It was in the 80's over 50's. After that he had a fever of 102.2 F on 13Jan2021 for which he took two Tylenol. On 13Jan2021 at 09:30 PM his temperature was back down to 98.8 F. He has not had anymore fever. He has not had any other symptoms since. His blood pressure fluctuated but they have made some changes with his medication. The patient underwent lab tests and procedures which included blood pressure: in the 80's over 50's on 13Jan2021, blood pressure: fluctuated in Jan2021, uric acid levels: high on unspecified date, body temperature: 102.2 F on 13Jan2021, body temperature: 98.8 F on 13Jan2021, COVID-19 virus test: positive on 16Jan2021. Therapeutic measures were taken as a result of the events.
57 2021-02-10 pulmonary embolism, deep vein blood clot On January 8, I started having a cramping feeling in my right calf. It went on throughout the day ... Read more
On January 8, I started having a cramping feeling in my right calf. It went on throughout the day without a event. I woke up the next morning, and the crap was worse. I ran some errands and came home and then looked at my calf of my leg and it was twice the size as my other leg. I had four spots of bruising from ankle to knee. I immediately went to the emergency room. I was hospitalized and had bloodwork and an MRI done which showed that I had a DVT and a pulmonary embolus in my right lung. I was hospitalized for two days on blood thinners. I had no shortness of breath or heart problems during this time. I was then released from the hospital on blood thinners which I have to take for the next six months.
57 2021-02-15 fast heart rate, palpitations, increased heart rate Patient presented to ED with palpitations after receiving the second dose of the Pfizer vaccine. Ove... Read more
Patient presented to ED with palpitations after receiving the second dose of the Pfizer vaccine. Overnight he reported chills and aches (unknown if febrile) with palpitations. Since then, patient felt some improvement but went to ED for further evaluation. Patient was observed overnight for persistent tachycardia with ID and cardiology evaluations. The following day, tachycardia improved and patient was discharged.
57 2021-02-25 chest pain shortness of breath; bad headaches; chest pain; rash on his neck and behind his ears; This is a spon... Read more
shortness of breath; bad headaches; chest pain; rash on his neck and behind his ears; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number N5318), via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shortness of breath, bad headaches, chest pain and rash on his neck and behind his ears, all on an unspecified date in 2021. The events were all serious as they involved hospitalization from 02Feb2021 to 03Feb2021. Details were as follows: patient received the first dose of the vaccine on 27Jan2021; he had a lot of bad side effects and went to the hospital: shortness of breath, bad headaches, chest pain, rash on his neck and behind his ears. All this happened a few days after receiving the vaccine. He had an appointment with his cardiologist and he will have a cardiac catheter placed on 19Feb2021. The second dose of the vaccine was scheduled for 18Feb2021. The outcome of the events were unknown.
57 2021-02-28 loss of consciousness, blood pressure increased 7 PM developed muscle pain and could barley pick up the right arm, chills and fever, blood pressure... Read more
7 PM developed muscle pain and could barley pick up the right arm, chills and fever, blood pressure was elevated, passed out
57 2021-03-02 very slow heart rate, hypotension Patient became hypotensive and bradycardic in the 40s. Patient passed out 4 times. EMS called over.... Read more
Patient became hypotensive and bradycardic in the 40s. Patient passed out 4 times. EMS called over. Patient refused IV or further medical treatment. 30 min with EMS. Then observed for an additional 30 mins in the observation area of the POD.
57 2021-03-02 troponin increased, chest pain Patient endorsed chest pain one hour following administration of the vaccine.
57 2021-03-04 hypertension, lightheadedness - 57 year old M experiencing dizziness following receipt of PFIZER COVID19 vaccine #1. Likely vasova... Read more
- 57 year old M experiencing dizziness following receipt of PFIZER COVID19 vaccine #1. Likely vasovagal symptoms. Symptoms resolved with Trendelenburg positioning and juice. Noted to be quite hypertensive though denies experiencing symptoms of hypertensive urgency or emergency therefore discharged to follow up with his PCM as already scheduled.
57 2021-03-09 hypertension Chills, body ache, swelling at injection site. Prolonged side effects that included several visits ... Read more
Chills, body ache, swelling at injection site. Prolonged side effects that included several visits to Primary care physician's office: Chronic headache over left temple, forehead and left eye socket , pressure on left eye, blurred and double vision, continued soreness upper body, arm, neck and head., high blood pressure lasting now 11 days but as of today (Mar. 10, 2021) getting better but still existing. Seeing Ophthalmologist Thursday Mar. 11, 2021.
57 2021-03-09 blood clot, chest discomfort I had my first shot of Pfizer vaccine last Friday morning (March 5). In the evening, I felt fatigued... Read more
I had my first shot of Pfizer vaccine last Friday morning (March 5). In the evening, I felt fatigued. So I went to sleep early. When I got up Saturday morning, I felt dizzy. The dizziness went away in a few minutes. In the next 36 hours, I had the angina feelings - tightness in the left chest and I felt heart be squeezed occasionally. When I stand up and walk, I felt better. Finally Sunday evening (March 7), I took a walk outside and felt symptom free. Maybe the walk helped, maybe the "thrombosis" had run its course before my walk. I have not had the severe angina symptoms since my PCI procedure in Feb 2018. I am sure the recent occurrence is related to the vaccine. Besides reporting the adverse event, I want to get advices whether I should receive the second shot. Thank you!
57 2021-03-11 heart rate increased, blood pressure increased tingling of tongue and feet, high spike in blood pressure (208/127), red flushed face and neck, dizz... Read more
tingling of tongue and feet, high spike in blood pressure (208/127), red flushed face and neck, dizziness and light headedness, increase in heart rate.
57 2021-03-11 fainting dizziness w. syncopal episode. Evaluated by EMS-Cleared
57 2021-03-11 fainting 5 minutes after receiving immunization he became confused and foggy, complained of being faint, fogg... Read more
5 minutes after receiving immunization he became confused and foggy, complained of being faint, foggy, and having issues with his cognitive processing, he was also cool and clammy. He stated that he was feeling light headed and dizzy. He was monitored for about 5 more minutes in the pod and his symptoms continued . He brought back to the observation area, vital signs 119/78, oxygen 92% on room air and heart rate 63. He was given apple juice and applesauce and his mask removed, he was also placed on a liter. He was continued to be observed and follow up vital signs were 125/85, heart rate 66 @ 0849. Patient skin was less clammy and patient reporting symptoms improved. patient was able to move to sitting and standing position without any issues he was escorted to the site exit without incident.
57 2021-03-14 arrhythmia Patient presented to ED for shortness of breath and dyspnea on exertion. He was attributing it to ge... Read more
Patient presented to ED for shortness of breath and dyspnea on exertion. He was attributing it to getting the COVID vaccine. Patient had gotten the 2nd dose of the Pfizer vaccine on 3/11/21. He reported that shortness of breath started about 3 weeks prior after receiving the first vaccine dose. Patient reported that he received the COVID vaccine at his place of residence and thought it was a CVS that provided the vaccinations. Patient has a PMH of cardiomyopathy and was found to be in atrial flutter in the ED. Cardiology service was consulted and plan currently is to try to cardiovert the patient. History of obesity, ETOH abuse, known RBBB, dilated NICM with HFrEF (has been out of meds) hx of c
57 2021-03-14 fainting, lightheadedness, chest discomfort PRESENTING PROBLEM: Syncope and collapse [R55] HOSPITAL COURSE: History of Present Illness: 57-ye... Read more
PRESENTING PROBLEM: Syncope and collapse [R55] HOSPITAL COURSE: History of Present Illness: 57-year-old man known to me for bilateral lung transplant for bronchoalveolar cell carcinoma complicated by bilateral pleural effusions of unknown etiology and mild decrease in pulmonary mechanics, DVT on Eliquis who came to the Emergency Room 3/12/21 with a chief complaint of near syncope. Patient and woke up in the early morning hours of 3/12/21 to use the restroom. While urinating, he became very dizzy and nauseated and had a sense like he needed to lay down to rest. Other than nausea he did not have any other symptoms. He returned to his bed and fell upon his wife and had decreased level of consciousness but without total loss of consciousness (he was able to hear his wife talking to him but was unable to respond). This lasted about a minute and slowly he came back to his senses. After this he felt quite cold and did have some shaking but is not clear whether these were true rigors. He did not have any preceding fevers nor did he have any fevers in the emergency room. After about 5-10 minutes he was feeling back to his normal self but want to come into the hospital to get checked out. He has never had anything like this before.The patient has had chest pressure since his COVID vaccine which he had on Wednesday. This is been intermittent, mostly positional and better with laying on his side and leaning forward, worse with recumbency. It is not pleuritic in nature. No associated shortness of breath. No other fevers chills sweats. No sick contacts. Evaluation in the emergency room was done and a CT scan was done and no pulmonary embolus was found. No parenchymal abnormalities. The patient's pleural effusions remain, and her mildly worsened, personally reviewed. Baseline labs were unremarkable for anemia, kidney injury.EKG personally reviewed, normal sinus rhythm. High sensitivity troponin was done and negative. Family otherwise feels well, no sick contacts, eating well no nausea vomiting diarrhea blood in his stool. Pt admitted for observation. Continued to feel well VSS, ekg stable, ECHO without acute findings (see below), UA neg, cardiac monitoring uneventful, orthostatics negative, walking in halls and eating well. Appears to have had vaso vagal episode. Will be getting routine head imaging in the coming month with cancer history See below testing Care plan upon discharge > To call if any return of symptoms > To hold metformin until Monday due to recent dye load > Blood cultures Pending, low clinical suspicion > To change H2 blocker to PPI due to GERD on 3 month esophagram > Follow up in clinic when return from break > Dr discussing with pulmonary team most recent CT (see below) and treatment plan moving forward Brief exam: awake, alert, oriented, not in any distress. PERRL, EMOI, tongue midline. Upper and lower extremities at full strength 5/5 in the arms, hands, dorsi flex and flexion at the ankles, knees and legs. Sensation not tested. Brief history and medical decision making: s/p bilateral lung transplant for bronchoalveolar cell carcinoma complicated by bilateral loculated pleural effusion, DVT on eliquis presenting post syncopal event. Syncopal event without evidence of seizure like activity, fast recovery, and no sudden changes consistent with an acute cardiac event. Thus symptoms were likely due to vasovagal event possibly post COVID_19 related side effect (headache, achy muscles, not feeling well overall). He has no neurologic deficit, CTA thorax without PE, negative EKG, troponin and echocardiogram. He is not on antihypertensives and blood pressures have been normal. Given his initial diagnosis of BAC, there may be concern for metastatic disease, though symptoms have not persisted and he has no focal deficit. He also received contrast for his CTA today, thus will defer further imaging for now. Syncope: - defer 2nd dose of COVID-19 vaccine as its effectiveness in transplant patient is not established and patient potentially had an adverse event. - oral hydration encouraged - monitor for additional ongoing neurologic symptoms such as headaches, vision changes, neck stiffness, fevers, night sweats, weight loss, weakness or paraesthesias - patient advised to avoid driving until further evaluation - consider MRI brain with and without contrast if any symptoms persist or reoccur Complex loculated pleural effusion
57 2021-03-15 cardiac arrest Patient died of cardiac arrest at hospital 3/12/2021
57 2021-03-15 hypertension We had to call 911 at 2:00am. He \woke up from sleep with Uvulitis and sore throat with swelling in ... Read more
We had to call 911 at 2:00am. He \woke up from sleep with Uvulitis and sore throat with swelling in his throat. He felt like his throat was closing. His wife gave him 2 Benedryl while waiting for the paramedics to arrive. They arrived quickly, within 10 minutes. The medical team monitored him at home for about 30 minutes. During this time had high Blood Pressure. They offered to take him to the hospital but he declined. He wanted to monitor himself at home to see if it would resolve itself. He spent the rest of the night in a recliner to help him breath, with his wife by his side. He did not follow up with any medical professional. He did NOT get the 2nd vaccination and will NOT.
57 2021-03-18 cardiac arrest Patient passed away unrelated to covid vaccine Narrative: The patient had with a history of ischemic... Read more
Patient passed away unrelated to covid vaccine Narrative: The patient had with a history of ischemic cardiomyopathy and multiple PCI's, CABG history of acute renal failure and hypokalemia and decompensated heart failure. Patient received his first dose of Pfizer dose on 2/18. Patient passed away on 3/8 due to cardiac arrest upon arrival to ER. Cause of death is not related to COVID-19 vaccination.
57 2021-03-21 blood glucose increased The patients blood sugars shot up from 130 to 450 over a period of one week, went into DKA,was admi... Read more
The patients blood sugars shot up from 130 to 450 over a period of one week, went into DKA,was admitted to ICU. Patient recovered home and he has been on Insulin Lantus.
57 2021-03-21 pulmonary embolism, chest pain Pt admitted with acute pleuritic CP and dyspnea that started the day after vaccination. Found to hav... Read more
Pt admitted with acute pleuritic CP and dyspnea that started the day after vaccination. Found to have bilateral PE
57 2021-03-22 very slow heart rate Roof of mouth swelling, soft pallet swelling (@10 minutes),right side of upper scalp went numb (@20 ... Read more
Roof of mouth swelling, soft pallet swelling (@10 minutes),right side of upper scalp went numb (@20 mins) spreading to brow ridge -right side then spreading to left upper lip swelling (@30 mins). tongue and throat @40mins. Epipen given, swelling improved within a minute observed for 4 hours then released
57 2021-03-22 fainting After receiving his vaccine, patient had a slight syncopal episode. Patient reported that he was go... Read more
After receiving his vaccine, patient had a slight syncopal episode. Patient reported that he was going to get lightheaded as he normally gets this way with vaccines or blood draw. Patient never passed out; however, he almost fell when getting up from the vaccine chair, he reports lightheadedness and requested to lay down on the ground and have his feet elevated. Oxygen was brought to patient by post observation and 2 Liters delivered maintaining 99% saturation. After approximately six minutes, patient decided to get up from the ground. Two staff including patient?s wife assisted him to stand however, patient requested to be seated for a while. Patient was then moved to post observation where he was conscious, speaking clearly and monitored for an additional 30 minutes with no further incident.
57 2021-03-24 chest pain Patient started feeling dizzy and like his lips were tingling after dose. Given oral Benadryl and s... Read more
Patient started feeling dizzy and like his lips were tingling after dose. Given oral Benadryl and symptoms resolved. Presented to the ED the next day with a rash and intermittent chest pain and dizziness.
57 2021-03-25 pallor Patient reported nausea and lightheadedness and was vomiting in the bathroom 2-3 later. He ambulated... Read more
Patient reported nausea and lightheadedness and was vomiting in the bathroom 2-3 later. He ambulated standby assist to the bathroom, turned pallor, diaphoretic. Accompanied to the bathroom with an LVN and RN. Patient had 1 episode of emesis. Patient has a history of hypertension and takes meds for it.
57 2021-03-26 blood pressure increased Dizziness. Severe at times, especially when moving. Nausea. Weakness, very shaky. Onsite nurses an... Read more
Dizziness. Severe at times, especially when moving. Nausea. Weakness, very shaky. Onsite nurses and doctor gave me water, peanut butter crackers, and a juice box. No change. BP elevated, 157/109 p:98 O2s: 99 on site. Transferred to the Hospital via ambulance. After 2-3 hours, dizziness began to resolve. Doctor ordered blood tests and IV fluids, 1L.
57 2021-03-27 loss of consciousness, blood pressure decreased about 5 minutes after the vaccine pt sarted to get lightheaded and sat on the floor. He started to p... Read more
about 5 minutes after the vaccine pt sarted to get lightheaded and sat on the floor. He started to pass out and I laid him down and had someone call 9111. He woke up pretty quickly. His BP dropped again when the ambulance was here so he went with them
57 2021-03-29 fainting, cardiac arrest Per ED Provider Report, the patient collapsed while outside on 3/25/21. Ambulance was called to the ... Read more
Per ED Provider Report, the patient collapsed while outside on 3/25/21. Ambulance was called to the scene where patient was found unresponsive. Patient was transferred to Hospital. Patient was in full cardiac arrest upon arrival. CPR was initiated. Patient deceased. Patient's mother stated the patient had been feeling badly for 2-days, but refused to seek medical treatment.
57 2021-03-31 hypertension Blood Pressure went very high. 192/91 Monday, 189/127 Tuesday. Back to normal (121/83) by Thursday... Read more
Blood Pressure went very high. 192/91 Monday, 189/127 Tuesday. Back to normal (121/83) by Thursday.
57 2021-03-31 blood clot Blood clot/very large blood clot from his thigh to his calf; Joint pain; chills; he can't even walk ... Read more
Blood clot/very large blood clot from his thigh to his calf; Joint pain; chills; he can't even walk now; leg pain; This is a spontaneous report received from a contactable consumer (patient's wife). A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, on 25Feb2021 (at the age of 57-years-old), at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The consumer stated she's asking on behalf of her husband. He received his first dose of Pfizer-BioNTech COVID-19 Vaccine on 25Feb2021 and had Joint pain and chills after that (on unspecified date in 2021) he was diagnosed with Blood clot (unspecified date in 2021); she stated he had no history of similar health issues and wanted to know if it could be directly linked to this vaccine. The wife further reported that it's dramatically changing his life, he can't even walk now. He had the Covid vaccine on 25Feb2021 and he has no history of blood clots. He developed a leg pain (on unspecified date in 2021) which was odd and they thought that maybe it was some arthritis or something like that. They went to the orthopedist and he was being treated for what the orthopedist thought was a bakers cyst. But then they discovered it was a very large blood clot from his thigh to his calf. They would like to know about this. They have been looking into what he had experienced, and it seems very unusual. It just seems too coincidental that this happened after the Covid vaccine. The emergency room doctor of course shut them down immediately and said that the Covid vaccine never would have done this. But the patient's doctor yesterday said that there are too many unknowns to say for sure that the Covid vaccine didn't cause this. She is not saying that they are against the Covid vaccine, but they are concerned. The patient is on blood thinners now and they just need to know if there is a possible correlation. She had heard on the world news that there is a connection after receiving the (company name) Covid vaccine and now they are shutting this vaccine down in (region name). She saw on the news last night they were asking if there is a correlation with the Pfizer and (company name) Covid vaccines and this. It is very concerning. They have been trying to do research and there is nothing that you can find. The only thing that they did see online was about the doctor that died of a blood disorder in (state name), he had thrombocytopenia. The patient is going to be sent to see a vein doctor. She stated that he has a lot of things ahead of him and he is too young to be dealing with all of this. They are going to be following up with the vein doctor and she would like to have this information when the vein doctor calls later today. The reported adverse events resulted to an emergency room and physician office visit (went to the orthopedist). The patient received corrective treatment as response to the reported events. Outcome of the events was unknown.
57 2021-04-01 cerebrovascular accident Stroke; BNT162B2 (First dose: 28-DEC-2020; second dose: 14Jan2021); BNT162B2 (First dose: 28-DEC-20... Read more
Stroke; BNT162B2 (First dose: 28-DEC-2020; second dose: 14Jan2021); BNT162B2 (First dose: 28-DEC-2020; second dose: 14Jan2021); This is a spontaneous report from a contactable other health professional (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 14Jan2021 (at the age of 57 years; as reported) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 28Dec2020 in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had a stroke on 01Feb2021 at 15:00. The event resulted to emergency room/department visit and physician office visit but was not given any treatment (as reported). The patient was hospitalized for stroke for 27 days. The event was considered serious, life threatening, and disabling/incapacitating. Patient's nasal swab test on an unspecified date was negative. The outcome of stroke was not recovered.; Sender's Comments: Based on know n drug profile it is unlikely that the reported cerebrovascular accident was causally related to BNT162B2. This is probably an intercurrent medical condition. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the product and on the conduct of the study are 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.
57 2021-04-01 heart rate increased High Fever, fast hart rate, shills and disturbed vision (vision got double)
57 2021-04-02 arrhythmia, fast heart rate Approximately 48 hours after vaccination, I experienced sudden onset of tachycardia (heart rate ~130... Read more
Approximately 48 hours after vaccination, I experienced sudden onset of tachycardia (heart rate ~130-150) which continued into the morning (April 1st 2021). The tachycardia transitioned into atrial flutter (confirmed by an EKG in the cardiologists office that afternoon) with associated shortness of breath (secondary to the cardiac arrhythmia). I had a cardio version that afternoon (4/1/2021, 4:00pm) and converted to normal sinus rhythm. I was given a rhythm and rate modifier medication and anticoagulant. Prior to the COVID vaccination, I had been symptom free for 3 years from my atrial fibrillation and atrial flutter.
57 2021-04-06 blood pressure increased About 7 - 8 days after the vaccination, the patient began experiencing numbness in his chin that cam... Read more
About 7 - 8 days after the vaccination, the patient began experiencing numbness in his chin that came and went. By Friday, April 2, the patient began experiencing left side numbness and droopiness in his face, had slurred speech and increased blood pressure. Patient thought he was having a stroke, so wife took him to the ER. All lab work and medical tests came back normal. The patient has an appointment with their family doctor on 4/8 and an appointment with a neurologist next month.
57 2021-04-06 deep vein blood clot Pain, swelling, and redness right calf for 2 days. Diagnosed with acute DVT.
57 2021-04-06 inflammation of the pericardium, fluid around the heart Pericarditis leading to pericardial effusion; Pericarditis leading to pericardial effusion; This is ... Read more
Pericarditis leading to pericardial effusion; Pericarditis leading to pericardial effusion; This is a spontaneous report from a contactable other hcp (Patient). A 57-year-old male patient received bnt162b2, dose 1 via an unspecified route of administration, administered in arm right on 01Mar2021 (Lot Number: EN6201) as single dose for COVID-19 immunisation. Age at vaccination was 57-year-old. Medical history included chronic pancreatitis, gastritis from an unknown date. No Known allergies. No covid prior vaccination. Concomitant medications in two weeks included amlodipine; losartan; trazodone; ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nicotinic acid, pantothenic acid, phosphorus, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, zinc (CENTRUM MEN 50+), all taken for an unspecified indication, start and stop date were not reported. The patient experienced pericarditis leading to pericardial effusion on 05Mar2021 20:30. AE treatment included Pericardiocentesis. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The serious criteria for the event was hospitalization, medically significant, life threatening. The patient was hospitalized for 4 days. The patient received bnt162b2, dose 2 Intramuscularly, administered in arm right on 23Mar2021 07:00 AM (Lot Number: EP6955) as single dose for COVID-19 immunisation. Covid tested post vaccination included Nasal Swab Covid19 PCR on 07Mar2021: Negative. The outcome of the event was not recovered.
57 2021-04-08 pallor, fainting syncopal event, patient felt dizzy and was pale, patient was laid back and encouraged to drink water... Read more
syncopal event, patient felt dizzy and was pale, patient was laid back and encouraged to drink water, vital signs stable and resolved by end of 30 minute observation period.
57 2021-04-09 deep vein blood clot, pulmonary embolism pain in left leg calf, left side of chest DVT and PE 2 visits to Urgent Care Lovenox and Pradaxa
57 2021-04-09 nosebleed Severe bloody nose and light headed
57 2021-04-10 chest pain 24 hours after receiving first dose, developed pleurisy. 48 hours after receiving first dose, Er v... Read more
24 hours after receiving first dose, developed pleurisy. 48 hours after receiving first dose, Er visit sharp pains right side chest upon every breath. Slept sitting up for 2 weeks.
57 2021-04-11 deep vein blood clot DVT Left leg, headache, myalgias
57 2021-04-11 hypotension 24 hours vomiting diarrhea. Light headed lower BP from normal for week after.
57 2021-04-11 blood clot Blood Clot On Friday, April 9th I started with a pain in my ankle around 4PM. It was getting worst ... Read more
Blood Clot On Friday, April 9th I started with a pain in my ankle around 4PM. It was getting worst and worst. It got red, swollen and I was unable to walk normal, I started limping. Around 2PM on Saturday, April 10th, I went to the ER and I had my ultrasound done. I have a blood clot. They prescribe me Eliquis; 10 mg twice a day for one week and 5 mg twice a day for two to six months...
57 2021-04-12 heart flutter Developed a Heart Flutter roughly 40 hours after second dose of Pfizer. Unclear whether the vaccine... Read more
Developed a Heart Flutter roughly 40 hours after second dose of Pfizer. Unclear whether the vaccine caused the event, but patient has never had this condition in the past. Treatment put on metoprolol and eliquis. Conditions have subsided but still a mild heart flutter two days post incident
57 2021-04-12 deep vein blood clot Adverse event #1: Flu-like symptoms, severe headache, vision blurriness, lasting roughly 10 days. ... Read more
Adverse event #1: Flu-like symptoms, severe headache, vision blurriness, lasting roughly 10 days. Adverse event #2: Deep Vein Thrombosis in the left Popliteal vein with moderate associated edema and pain. Required Emergency Room visit, diagnosis, and treatment with Eliquis. This event prevented normal daily work activities for 5 days, after which edema and pain has mostly subsided.
57 2021-04-13 platelet count decreased 3/29/2021 Pfizer COVID vaccine #1. Reports feeling poorly since that day. 4/3/2021 ED visit for com... Read more
3/29/2021 Pfizer COVID vaccine #1. Reports feeling poorly since that day. 4/3/2021 ED visit for complaint of SOB, fever, body aches. Admitted for sepsis. 4/4 intubated. 4/12 extubated. 4/14 remains hospitalized. Workup negative for infectious cause. Oncologist consulted, does not appear cancer related. MD suspects reaction to vaccine.
57 2021-04-13 blood clot Blood Clot-Bad swelling in right arm. Arm tingling, numbness and discolored. Arm is swollen from top... Read more
Blood Clot-Bad swelling in right arm. Arm tingling, numbness and discolored. Arm is swollen from top of arm to fingers. Notice first sign on Monday morning (04/12/2021) when i awoke from bed around 7:00am.
57 2021-04-14 deep vein blood clot, superficial blood clot, pulmonary embolism 1. Acute left deep venous thrombosis in the popliteal, posterior tibial, peroneal, one branch of gas... Read more
1. Acute left deep venous thrombosis in the popliteal, posterior tibial, peroneal, one branch of gastrocnemius veins. 2. Acute left superficial venous thrombosis in the great saphenous prox thigh to knee extending tinto a varicose vein at the proximal calf. 1. Pulmonary embolism with large thrombus burden bilaterally, right greater than left ASA/heparin gtt started
57 2021-04-15 fast heart rate, palpitations Patient reports feeling fine 4/7/2021. He did have a shot of whiskey on 4/8/2021 around 8pm. Reports... Read more
Patient reports feeling fine 4/7/2021. He did have a shot of whiskey on 4/8/2021 around 8pm. Reports fever, nausea and fatigue starting at 6pm on 4/8/2021. He then woke up every hour on the hour starting around 1200 midnight and reported having racing heart and having to use the restroom every hour (abnormal for him this frequent). The adverse event was tachycardia (160-180bpm) starting shortly before midnight and this was persistent until 4am. He has not had any tachycardia since. He did not seek medical attention and this has only happened to him once before (>20 years ago when he was dehydrated).
57 2021-04-17 nosebleed nose bleed, it's adverse because I have never had one
57 2021-04-17 hypertension I had the same symptoms that lead to my March 19, 2020 (13 months ago) ER admission to hospital, whe... Read more
I had the same symptoms that lead to my March 19, 2020 (13 months ago) ER admission to hospital, where I presented with left flank pain, diarrhea, cold sweat, nausea, dizziness, very high blood pressure, and feeling of malaise. Symptoms started within 7 days after the 2nd injection. Went to doctor on Apr. 16, 2021 with the same symptoms described above, except cold sweat. Had left flank pain that made walking difficult, diarrhea, nausea, dizziness, and BP 189/88. Normal BP is 140/88. Urinalysis showed blood in urine. Other results of blood test were not provided as of this date.
57 2021-04-17 pulmonary embolism small peripheral right lower lobe pulmonary embolism; anaphylaxis; whole body rash and erythema; who... Read more
small peripheral right lower lobe pulmonary embolism; anaphylaxis; whole body rash and erythema; whole body rash and erythema; This is a spontaneous report received from a contactable physician. A 57-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 01Mar2021 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included joint pain and ongoing 45-packs per year smoker. The patient did not have any allergies to medications, food, or other products. Concomitant medications included salbutamol (ALBUTEROL), hydroxyzine (manufacturer unknown) and diclofenac sodium (manufacturer unknown). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The physician reported, "patient had anaphylaxis and whole-body rash and erythema on separate hospitalization (I was not involved for this but reviewed photos and this was reportedly attributed to the vaccine; I'm uncertain if that event was reported). On hospitalization, the patient was with small peripheral right lower lobe pulmonary embolism on a CT PE (CT scan for Pulmonary Embolus). Patient is an active smoker. No other obvious cause." As a result of the adverse events (unspecified), the patient was hospitalized for one day. The start date of the events was on 29Mar2021. The patient was treated with apixaban (for pulmonary embolism). The clinical outcome of "anaphylaxis and whole-body rash and erythema" and "small peripheral right lower lobe pulmonary embolism" was resolving. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events pulmonary embolism, anaphylactic reaction and associated generalized rash and generalized erythema. The impact of this report on the benefit/risk profile of the Pfizer product 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.
57 2021-04-17 fainting, loss of consciousness, pallor 49yr patient with hx of Hashimoto who had received second dose at 10:58M, was observed to pass out w... Read more
49yr patient with hx of Hashimoto who had received second dose at 10:58M, was observed to pass out while sitting on the observation area, as per paramedic patient (who was sitting right in front of him) pass out for 30 seconds while sitting on his chair. On my arrival patient awake, alert and oriented x3, seem a little pale, he was sitting up drinking water, he was taken to the examination room, laying flat on the stretcher, initial vital signs were BP 93/58 HR 48 RR 20, Sat 100% on room air, EKG long strip was done with showed sinus bradicardia, subsequent BP after 18 mins were 104/70 and then 114/69 HR 60. Patient denies shortness of breath, itchining or rash. fingerstick was 102mg/dL. (see below)
57 2021-04-18 cerebrovascular accident, blood clot Had a blood clot and a stroke and blind in right eye, and some paralysis in face. Happened day after... Read more
Had a blood clot and a stroke and blind in right eye, and some paralysis in face. Happened day after first vaccine.
57 2021-04-18 chest pain, skin turning blue, fast heart rate Immediately upon being vaccinated, the patient felt weak, tachycardic, and had chills and nausea. He... Read more
Immediately upon being vaccinated, the patient felt weak, tachycardic, and had chills and nausea. He was observed for 20 minutes, at which time his symptoms abated and he left the vaccination facility. However, his symptoms returned later in the day. He presented to our office 15 days after vaccination. At that point, he was suffering coldness in his extremities with peripheral cyanosis of hands, feet, and nose. He reported chest pain and had an abnormal EKG with ST depressions in several leads. He stated that over the past two weeks, his symptoms would come and go, lasting for hours at a time and constituting weakness, extreme fatigue, cold extremities, and body aches.
57 2021-04-19 loss of consciousness After 8 minutes I broke out in a cold sweat and immediately passed out for 30-45 seconds. I woke up ... Read more
After 8 minutes I broke out in a cold sweat and immediately passed out for 30-45 seconds. I woke up laying on my back not knowing how I got there.
57 2021-04-20 chest pain, heart attack Pfizer vaccine , 2 doses. Second dose on Friday 4/16. On Saturday had a strong chest pain, spend all... Read more
Pfizer vaccine , 2 doses. Second dose on Friday 4/16. On Saturday had a strong chest pain, spend all day Sunday with upper back pain and chest pain. Monday pain got stronger, Tuesday on and off chest and upper back pain. Went to the hospital and he had suffered a heart attack. No primo medical conditions of anything cardiovascular related. Only medical hx he has is kidney stones. He is currently at the hospital pending catheterization.
57 2021-04-20 hypotension, atrial fibrillation patient received Pfizer covid vaccine on 4/12. On 4/13 patient presented to ER with purple fingers ... Read more
patient received Pfizer covid vaccine on 4/12. On 4/13 patient presented to ER with purple fingers and toes. bilateral feet numb and tingling. patient admitted to hospital. by morning 4/14 patien resp status declined, ciwa score 15, afib rvr, ams, low bp. septic shock. source unclear.
57 2021-04-21 heart rate increased, hypertension, fast heart rate patient waited about 15 minutes after his vaccine. Upon leaving patient began to feel light headed. ... Read more
patient waited about 15 minutes after his vaccine. Upon leaving patient began to feel light headed. patient was then asked to take a seat and vitals were check. patient showed hypertension (which he states was due to not taking his blood pressure medications x 3 days) and patient also showed mild tachycardia (102BPM), patient states increased heart rate is due to his anxiety. Other vitals stable. patient was then monitored for an additional 10 minutes and states he is no longer light headed. patient is given advice to follow up with his doctor about his high blood pressure and encouraged to call 911 if he experiences any symptoms after leaving.
57 2021-04-22 palpitations Patient complained of heart palpitations while waiting for 15 minutes. EMS was called and attended t... Read more
Patient complained of heart palpitations while waiting for 15 minutes. EMS was called and attended to patient at store.
57 2021-04-23 heart rate increased, hypertension Uncontrolled hypertension, injection site pain, increased myalgia pain, headache, sinus congestion, ... Read more
Uncontrolled hypertension, injection site pain, increased myalgia pain, headache, sinus congestion, nervous, tiredness, back pain, hip pain, increased heart rate, shortness of breath, shoulder pain, muscle soreness, sleeplessness. All ongoing.
57 2021-04-24 deep vein blood clot DVT's in right calf; This is a spontaneous report from a contactable consumer (patient). A 57-year-o... Read more
DVT's in right calf; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, in left arm on 16Mar2021 02:00 (at 57-years age) as single dose for covid-19 immunisation. Medical history included ongoing high blood pressure diagnosed in 2002 and it is under control with medications, ongoing diabetes diagnosed in 2000, neuropathy, allergies. The patient previously took first dose of BNT162B2 for Covid-19 immunization as Covid-19 vaccine first dose. Concomitant medications included metformin taken for diabetes mellitus from 2010 and ongoing at 1000 mg, twice a day; hydroxyzine (HYDROXYZINE) taken for allergies and ongoing at 25 mg, once a day; omeprazole (OMEPRAZOLE) taken for high blood pressure and ongoing at 40 mg, once a day; losartan (LOSARTAN) taken for hypertension and ongoing at 100 mg, once a day; carvedilol (CARVEDILOL) taken for high blood pressure and ongoing at 6.25 mg, twice a day; gabapentin (GABAPENTIN) taken for neuropathy and ongoing at 800 mg, twice a day; trazodone (TRAZODONE) taken for sleep and ongoing at 100 mg, once a day; simvastatin (SIMVASTATIN) at 20 mg, once a day taken for blood cholesterol and ongoing; insulin detemir (LEVEMIR) taken for diabetes mellitus and ongoing at 30 uL, once a day. Patient hopes he was not going to die. States on Saturday 3Apr2021 he went to the ER because he had DVT's in his right calf and they gave him the pneumonia vaccine there and he was under the influence because he was on pain medications. Patient received the pneumonia vaccine on Sunday 04Apr2021. NDC, lot number, or expiry date unknown. Caller states he got the second dose of the Pfizer vaccine today 6Apr2021. patient hopes he was not going to die because he took the two vaccines so close to each other. Patient has had DVT's since 2014 but flared up this Saturday 03Apr2021. States it was under control and it is recovering slowly, blood is flowing, INR is flowing, and it is therapeutic. they gave him a heparin drip to dissolve it in the ER. Patient was admitted to hospital at 12 midnight on 04Apr2021 and got out on 05Apr2021. The outcome of the event was resolving. Information on the lot/batch number has been requested.
57 2021-04-24 hypertension This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiration date not provided), via an unspecified route of administration, on 06Apr2021 10:30 (at the age of 57-year-old), at single dose, for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) from 2018 and ongoing, and had a shot, a steroid for COPD; high blood pressure from 2016 and ongoing, and patient took medication for it; 7 heart attacks; 8 stents in his heart; patient was a smoker (ongoing, had been smoking for a long time. He was a walking post card for don't smoke. He stated that he can only walk twenty feet before he was out of breath); and patient was allergic to penicillin and Lortab. Family history included patient had a family member die of cancer and lupus. Patient had two biopsies for skin cancer (unknown date) within 4 weeks prior vaccinations. Concomitant medications were not reported. On 07Apr2021, the patient experienced extremely high blood pressure, arm aching, body aches, night sweats, and headaches. The patient stated since receiving the vaccine, that his blood pressure was very high and his medications were not bring it down. He stated that one of his blood pressures was 197/121 and this morning it was 181/130, which was extremely high for him. He stated that he went through the aches and his arm was hurting. He even had sweats last night. Patient stated that his blood pressure still hadn't come down and he could feel headache from the pressure. He stated he already called the doctor, and the doctor told him that if it persisted to go to the emergency room. He stated that he took a couple of medications for his blood pressure and he declined giving medication information. He said that one started with an R and he took another one twice a day. He said that all the names of them, remembering them at his age was hard. He stated that he could read that small writing he had to get a magnifying glasses. Patient was scheduled for next vaccine on 04May2021. He stated that his blood pressure was not so unbearable but it was pretty high, he checked his blood pressure twice a day for everyday. He stated whatever he was lucky if he remembers if he had breakfast in the morning, until he remembered that he hadn't had breakfast. He stated that his arm started aching on 07Apr2021, it had improved but was still ongoing. He stated that it felt pretty good. Patient's blood pressure had been constant since today was the 8th it's only been a little over 24 hours now. On 07Apr2021 he had night sweats. He woke up pillow was soaking wet. He stated that his body aches still ongoing started about the same time. His headache started at the same time and was still going on. Patient stated he had a heart attack in 2016 and he hadn't had a normal blood pressure since. He hadn't been able to keep it all in check since the vaccine. His blood pressure medicine had been changed from 20 mgs to 40 mgs. He was under constant doctor care. The patient underwent lab tests and procedures, which included blood pressure was 197/121 (unknown date), 181/130 (08Apr2021), and 165/116 (08Apr2021). Patient's heart rate was 85 (unknown date). Patient stated his normal blood pressure was 135/85, his normal heart rate was 75. The outcome of the events "extremely high blood pressure", "body aches", "headaches" was not recovered; of event "arm aching" was recovering; of other events was unknown. No follow-up attempts are needed. No further information is expected.
57 2021-04-24 blood clot Blood clots, Hospitalization, Blood thinners
57 2021-04-27 pulmonary embolism, deep vein blood clot Left leg pain and swelling a couple weeks after shot one of Pfizer vaccine. After a few more days of... Read more
Left leg pain and swelling a couple weeks after shot one of Pfizer vaccine. After a few more days of leg not getting any better, saw Doctor who ordered Ultra sound of left leg and CT scan of lungs. Extensive DVT clot found in left leg, low density bi lateral pulmonary embolism in both lower lobes of lungs found from CT scan. Hospital stay for 2 days, Heparin given in hospital and now I'm on eliquis blood thinner. Had gotten my second Pfizer shot 3 days before admittance to hospital.
57 2021-04-28 pallor Patient stated he was sensitive to the smell of alcohol and needed to turn away after the administra... Read more
Patient stated he was sensitive to the smell of alcohol and needed to turn away after the administration of the vaccine. He stated like he was feeling like he might pass out. He removed mask, stated he was getting warm, hat removed. He asked to be lowered to the floor. Never lost consciousness. Color pale. Skin diaphoretic. BP 137/84 pulse 80, SpO2 96%. Cold washcloth applied. Rapid response team called. Vital signs monitored. Patient assisted to chair for observation. 10:02 am patient recovered and left the facility in stable condition.
57 2021-04-29 pulmonary embolism Pulmonary Embolism. Survived.
57 2021-04-29 fainting Fever/chills, low temperature (up to 100.2F), feeling faint (fainting one time); symptoms lasted for... Read more
Fever/chills, low temperature (up to 100.2F), feeling faint (fainting one time); symptoms lasted for 3 days
57 2021-04-29 cardiac arrhythmia Severe premature ventricular beats began to occur on the second day after the first injection. At pr... Read more
Severe premature ventricular beats began to occur on the second day after the first injection. At present, I have been taking metoprololhe to control premature beats.
57 2021-04-30 chest pain Patient woke today, 5/1/21, with severe pain in left shoulder and chest to the point of being nausea... Read more
Patient woke today, 5/1/21, with severe pain in left shoulder and chest to the point of being nauseated. No known cause.
57 2021-04-30 hypertension Muscle aches; head aches; injection site soreness; hypertension; tiredness; increased back and shoul... Read more
Muscle aches; head aches; injection site soreness; hypertension; tiredness; increased back and shoulder pain; increased back and shoulder pain/ hip pain; sleepless; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in right arm on 07Apr2021 at 13:45 (lot number: ER8737; expiry date: unknown) at a single dose, for COVID-19 immunisation. Medical history included non-Hodgkin's lymphoma, fibromyalgia, and hypertension. Concomitant medications included meloxicam, rosuvastatin and lisinopril. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient had no known allergies. On 08Apr2021 at 12:00 AM, the patient experienced muscle aches, headaches, injection site soreness, hypertension, tiredness, increased back and shoulder pain, sleepless, and hip pain. The events resulted in emergency room visit, physician's office visit, and one day hospitalization on unspecified date. The patient received unspecified treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 15Apr2021. Outcome of the events was not recovered.
57 2021-04-30 fainting Syncope; This is a spontaneous report from a contactable nurse (patient). A 57-year-old male patient... Read more
Syncope; This is a spontaneous report from a contactable nurse (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 11:30 (Batch/Lot Number: ER8735) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced syncope on 17Apr2021 11:45. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of syncope. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available and the close temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported 'syncope' cannot be completely excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product 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.
57 2021-04-30 blood clot two blood clots in his leg; This is a spontaneous report from a contactable consumer reporting on be... Read more
two blood clots in his leg; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 08Feb2021 (Lot Number: EM9810, unknown expiration) and second dose on 02Mar2021 (Lot Number: ENU202, unknown expiration; pending clarification), both received at the age of 57 years old via unspecified route of administration as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter called to report that the patient had a Pfizer vaccine, received second COVID vaccine on 02Mar2021, and couples of weeks ago, a week longer that the patient was diagnosed with two blood clots in his leg. The patient got both of COVID-19 vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested.
57 2021-05-01 heart rate increased elevated heart rate. My heart rate went from high 70s to low 80 to low 100s. It stayed at that level... Read more
elevated heart rate. My heart rate went from high 70s to low 80 to low 100s. It stayed at that level for 12 hours before falling below 100 into the 90s. The next morning it was back to its regular rate.
57 2021-05-03 cardio-respiratory arrest Pfizer COVID-19 Vaccine EUA Patient received dose #1 of Pfizer COVID-19 vaccine on 3/6/2021 and Dose... Read more
Pfizer COVID-19 Vaccine EUA Patient received dose #1 of Pfizer COVID-19 vaccine on 3/6/2021 and Dose #2 on 4/24/2021. Patient was found down on 4/25/2021 for an unknown amount of time and EMS was called. Patient noted to be seizing on EMS arrival. Blood glucose was noted to be 32 and an amp of D50 was administered. Patient arrested, received CPR (approximately 1 round) and was intubated in the field. His second glucose reading was undetectable and he received a second amp of D50. Patient also received sodium bicarb, calcium, and epinephrine and transported to ED. Patient subsequently transferred to Medical Center. He was treated for septic shock. His mentation remained very poor after pressors weaned off and sedation stopped. He likely had severe brain injury from hypoglycemia and anoxia - poor brainstem reflexed but did have spontaneous breathing - very poor prognosis - patient was extubated for comfort measures and all interventions stopped after family discussion and per their plan.
57 2021-05-03 palpitations, cardiac arrhythmia approx 20 minutes post vaccine administration - pt felt lightheaded and c/o palpitations. initial BP... Read more
approx 20 minutes post vaccine administration - pt felt lightheaded and c/o palpitations. initial BP 220/100, pulse 65, pulse ox normal. given water and allowed to rest. 15 minutes later BP 195/96, HR 56. his lungs were clear, no SOB or wheezing. on tongue/facial swelling or tingling/itching. pt's heart was sinus regular to brady with frequent PVCs. denies chest pain. pt then noted blurry vision in addition to lightheadedness and feeling shaky. continued palpitations. he was escorted to ER. in ER, his BP is 145/84. EKG shows SB w/ PACs. he felt better and was dc'd home. no medications administered. to f/u with PCP.
57 2021-05-03 transient ischaemic attack Six days after receiving the Pfizer vaccine, patients developed transient ischemic attacks. Had a f... Read more
Six days after receiving the Pfizer vaccine, patients developed transient ischemic attacks. Had a full evaluation at Medicine Center. Work up negative and symptoms resolved; atorvastin dose was doubled. He has had some short term memory loss and decrease in neurocognitive function. He had the second dose of the vaccine as scheduled, following which he had a severe unilateral headache but he did not seek care/evaluation.
57 2021-05-04 chest discomfort Pressure in chest, light-headedness, tingling in arms continuing for two weeks after initial symptom... Read more
Pressure in chest, light-headedness, tingling in arms continuing for two weeks after initial symptoms.
57 2021-05-04 loss of consciousness Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few mi... Read more
Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few minutes.I experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time; Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few minutes.I experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time; Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few minutes.I experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time; Was unable to sleep for longer than an hour at a time for 5 days; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at school or student health clinic on 15Mar2021 16:45 (at the age of 57-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient had no medical history. The patient had no allergies to medication, food, or products. Concomitant medications included finasteride and morniflumate (FLOMAX [MORNIFLUMATE]). On 15Mar2021 at 19:15, approximately 3 hours after injection, the patient became very dizzy, lightheaded, and passed out for a few minutes. The patient also experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time. There was no treatment for the events. On an unspecified date, the patient recovered from all events. Information about batch/lot number has been requested.
57 2021-05-04 palpitations, atrial fibrillation Soreness to the injection site for 2-3 days. Sudden onset of palpitations 5 days after the vaccine,... Read more
Soreness to the injection site for 2-3 days. Sudden onset of palpitations 5 days after the vaccine, which lasted 3 days. Diagnosed as Atrial Fibrillation of unknown origin. No previous history or known risk factors.
57 2021-05-06 pallor Pale, some slurred speech. Vitals wnl.
57 2021-05-07 hypotension, cerebrovascular accident stroke like symptoms; on his left side he had face droop; he had a speech slur; he couldn't move his... Read more
stroke like symptoms; on his left side he had face droop; he had a speech slur; he couldn't move his left arm/couldn't lift his left arm; low blood pressure; his face was numb; his lip was twitching; bad headache; brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 21Apr2021 14:00 (Batch/Lot Number: EW0169) as single dose (at the age of 57-years-old) for COVID-19 immunisation. Medical history included stroke from 02Feb2020 to 02May2020 (not ongoing). The patient had 3 stroked last year and he was put on ELIQUIS and baby aspirin and a regimen for his strokes. The last one he had was 02May2020 and he has had no problems since then. Last year when he had strokes it wasn't because of his heart it was because of an artery in his brain that went 90 degrees. In Jun2020 they found out that the problem was an artery and that's when the doctor to do the double dose baby aspirin and then everything was fine and he had no episodes at all. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), lot number: P116218, expiration date: Jan2022 taken for stroke from 02Feb2020 to an unspecified stop date; and apixaban (ELIQUIS), lot number: 1796050, expiration date: Sep2023 taken for stroke from 02Feb2020 to an unspecified stop date. The patient had no additional vaccines on the same date as Pfizer vaccine and had no prior vaccine within 4 weeks. The patient had his first shot of the Pfizer COVID vaccine on 21Apr2021 at 14:00 and stated that they made him go wait for 15 minutes in his car. 10 minutes into waiting after the COVID vaccine, he had to call over the EMT because he had stroke like symptoms. On his left side he had face droop, he had a speech slur and he couldn't move his left arm. The patient was transferred to the hospital and was hospitalized. His CT scan was fine, the CT scan with dye was fine, his MRI was fine, and his heart was fine. The patient wanted to know if he should get the second COVID vaccine because of the reaction that he had from the first COVID vaccine. The patient got the COVID vaccine on 21Apr2021 and on 23Apr2021 he was still having a bad headache, brain fog and there was a deficit on his left side. He can't grab and hold something in his left hand and he has a slight deficit on the left side corner of his mouth. The patient was planning on seeing the provider in the first week of May2021. The patient added that he was told to wait 15 minutes and then 10 minutes in he could feel his face was numb and his lip was twitching and he couldn't lift his left arm. He laid on the horn and the EMS came over and they said that he had stroke like symptoms so they transferred him out of his car and into an ambulance where he had vitals taken and he had another episode of stroke like symptoms. They took him into a different ambulance and had another episode in that ambulance when they were on the way to the hospital. He didn't have anything after that except a bad headache and a slight deficit on his left side, according to them, and just a brain fog like when he was trying to figure out how to put things together and he was still having those at the time of the report. The patient was discharged from the hospital on 22Apr2021. The patient stated that his last stroke was on 02May2020 and he has had no headaches since until he had the COVID vaccine on 21Apr2021. According to the doctors and the neurologist at the hospital he could've had a stroke, he could've had low blood pressure from the vaccine or he could've had a multitude of other things but they recommended him to call Pfizer and CDC for the report. While in the hospital, he had a CT scan without contrast, a CT with contrast on 21Apr2021; an MRI without contrast on 21Apr2021; an echocardiogram without dye and with dye on 22Apr2021 and they did another MRI but of his neck on 22Apr2021; all were normal. The patient was hospitalized for stroke like symptoms, on his left side he had face droop, he had a speech slur and he couldn't move his left arm from 21Apr2021. The event stroke like symptoms resolved with sequel on 22Apr2021. The patient recovered from on his left side he had face droop, he had a speech slur, and he couldn't move his left arm on 22Apr2021. The patient has not recovered from bad headache, brain fog. The outcome of his face was numb was unknown, his lip was twitching and low blood pressure was unknown.
57 2021-05-07 palpitations, heart rate increased (2) episodes of racing heart beat 110 and 139 with High Blood Pressure; (2) episodes of racing heart... Read more
(2) episodes of racing heart beat 110 and 139 with High Blood Pressure; (2) episodes of racing heart beat 110 and 139 with High Blood Pressure; This is a spontaneous report from a contactable consumer. A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration, administered in right arm on 10Apr2021 12:00 (Lot Number: EW0161) as SINGLE DOSE (at the age of 57 years old) for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Prior to COVID Vaccine on 07Apr2021 he entered in AFib and needed to be Cardioverted. The patient did not have any known allergies. The patient's concomitant medications was none. The patient did receive any other vaccine within 4 weeks prior to the vaccine. The patient received the BNT162B2 vaccine at Public Health Clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient called his primary care physician and asked should he take the shot scheduled for 10Apr2021 and she told him he was ok to take the shot. On 16Apr2021 22:00 and 18Apr2021 he had (2) episodes of racing heart beat 110 and 139 with high blood pressure. On unknown date, he was admitted to the hospital on the second and had a Cardiac CT Scan and Echocardiogram both came back negative for coronary heart disease or any heart issues. He was on a patch for 2 week electrical study. On beta blockers and antianxiety. He had no prior heart or anxiety issues ever in his life. The events resulted in Emergency room/department or urgent care, and Hospitalization. Number of days of hospitalization was 1. The patient underwent lab tests and procedures which included blood pressure: high on 16Apr2021, Cardiac CT Scan: negative on unknown date, echocardiogram: negative on unknown date, heart beat: 110 on 16Apr2021, heart beat: 139 on 18Apr2021 , Covid test: Negative on 01Feb2021. Outcome of the events was not recovered.
57 2021-05-07 pulmonary embolism, deep vein blood clot DVT and PE, 2 weeks after first vaccine; DVT and PE, 2 weeks after first vaccine; This is a spontane... Read more
DVT and PE, 2 weeks after first vaccine; DVT and PE, 2 weeks after first vaccine; This is a spontaneous report from a contactable physician. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) at the age of 57-years-old as single dose for covid-19 immunisation. Medical history included hypertension and hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included lisinopril; levothyroxine; amlodipine all taken for an unspecified indication, start and stop date were not reported. The patient experienced DVT (deep vein thrombosis) and PE (pulmonary embolism), 2 weeks after first vaccine on 08Apr2021. The patient was hospitalized due to the events for 1 day. Therapeutic measures were taken as a result of the events. The patient recovered from the events on an unspecified date in Apr2021. Information on lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between events DVT (deep vein thrombosis) and PE (pulmonary embolism) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
57 2021-05-07 blood clot, heart attack Heart Attack due to blood clot in RCA. Occurred on 4/27/2021 at 11 pm; Heart Attack due to blood clo... Read more
Heart Attack due to blood clot in RCA. Occurred on 4/27/2021 at 11 pm; Heart Attack due to blood clot in RCA. Occurred on 4/27/2021 at 11 pm; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 29Mar2021 03:00 (Batch/Lot Number: ER8733) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included pitavastatin calcium taken for an unspecified indication, start and stop date were not reported. The patient experienced heart attack due to blood clot in rca. occurred on 27Apr2021 at 11 pm. The patient was hospitalized for the reported events and was Life threatening (immediate risk of death from the event). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Apr2021 Nasal Swab. Therapeutic measures were taken as a result of the events which includes Emergency Heart Cath and Stent. The outcome of the events was recovered with sequel. No follow-up attempts are needed. No further information is expected.
57 2021-05-08 pallor Pale, some slurred speech. Vitals wnl.
57 2021-05-09 chest pain within an hour headache. For two days following the vaccine aches and pains accompanied by chills, ... Read more
within an hour headache. For two days following the vaccine aches and pains accompanied by chills, much like a flu. After that cleared, I noticed a pain in my upper chest on the left side. To this day it is still tender to the touch.
57 2021-05-11 chest discomfort Within just a couple minutes, I felt tightness in my chest. A few minutes later I felt tightness in... Read more
Within just a couple minutes, I felt tightness in my chest. A few minutes later I felt tightness in my throat. This is the same affect I have when I breath in cooked, steaming mushrooms on pizza or other cooked foods. I informed a nurse nearby about it and she had another nurse come over and talk to me. They asked me if I wanted to go to the Emergency Room at the hospital and I declined, thinking it would subside, and because I was there with a woman whom I am one of her home care providers.. I did relaxation exercises and drank water to relax and it helped a little but after leaving, I went to a pharmacy and purchased Benadryl and took a 20ml dose. Within about 30 minutes I was feeling better and the next day my chest felt fine but my throat still bothered me; I assumed my throat muscles were still sore from the swelling.
57 2021-05-11 heart attack Patient was feeling fatigue, unwell the night after getting the vaccine. The next day he stayed home... Read more
Patient was feeling fatigue, unwell the night after getting the vaccine. The next day he stayed home, did not go to work as he was not feeling well. Two days after getting the vaccine, he had trouble breathing, an ambulance was called and he was pronounced deceased hours later. He had a heart attack.
57 2021-05-12 heart attack I21.3 - STEMI (ST elevation myocardial infarction) (CMS/HCC)
57 2021-05-12 transient ischaemic attack slurred speech; Right arm and right leg weakness; TIA; Fever; Weakness; This is a spontaneous report... Read more
slurred speech; Right arm and right leg weakness; TIA; Fever; Weakness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8737), via an unspecified route of administration in right arm on 16Apr2021 16:00 as 2nd dose, single for COVID-19 immunization. Medical history included hypertension (Htn) and non-insulin dependent diabetes mellitus (Niddm). Concomitant medications included amlodipine and vitamins nos (MULTIVITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8730) in the left arm on 26Mar2021. The patient experienced slurred speech, right arm and right leg weakness, transient ischaemic attack (TIA), fever, and weakness, all on 18Apr2021 08:00. The events resulted to ER visit (Emergency room/department or urgent care) and patient was hospitalized for 2 days. Therapeutic measures were taken as a result of the events and reportedly included treatment with blood thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered with sequel. Events seriousness was hospitalization and disability. Information on lot/batch number was available. Additional information has been requested.
57 2021-05-13 cerebrovascular accident Person suffer a stroke and started having seizures and continuously having Seizures
57 2021-05-16 ischaemic stroke Ischemic stroke Patient received tPA and has had significant improvement in symptoms.
57 2021-05-17 heart rate decreased, chest pain, very slow heart rate 24hrs post 2nd Dose Pfizer. Bradycardia, chest pain, fever, skin patches heat sensation, swollen te... Read more
24hrs post 2nd Dose Pfizer. Bradycardia, chest pain, fever, skin patches heat sensation, swollen testicals, lymph nodes swollen, entire body joint pain, severe headache, foggy, extremely tired. At 9:25am (24hrs after 2nd dose) I was able to muster enough energy to text. 15 minutes later my heart was beating so slow I was unable to move my hand to grab my phone. It was like I was paralyzed for a couple hours other than my heart beat hurt and below 30 bpm for a couple hours. In and out of being awake. After a couple hrs I was able to move and my heart was beating faster. My chest hurt significantly for 12 days. May 13th, (9days post) I went to Emergency Room in evening. Fear of blood clots with chest hurting and extreme fatigue. ER preformed an XRAY for heart size and lungs, Blood work for blood clots and markets for heart attach. All came in negative to a heart related event causing pain.
57 2021-05-18 chest pain, oxygen saturation decreased ED to Hosp-Admission Discharged 3/28/2021 - 3/29/2021 (30 hours) Last attending ? Treatment team... Read more
ED to Hosp-Admission Discharged 3/28/2021 - 3/29/2021 (30 hours) Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Discharge Diagnosis Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Unknown Type 2 diabetes mellitus without complication, without long-term current use of insulin (CMS/HCC) Yes Obstructive sleep apnea syndrome Yes Restrictive lung disease Yes Morbid obesity due to excess calories (CMS/HCC) Yes Prostate cancer (CMS/HCC) Yes Status post radiation therapy Not Applicable COVID-19 virus detected Yes Hospital Course COVID-19 Pneumonia Patient presented with headache, chills, diarrhea, dry cough and rash. Patient was maintaining saturation of 91-92% at rest and was desaturating down to 88-89% on slightest exertion. Patient was started on oral dexamethasone 6 mg daily and remdesivir therapy. Patient left AMA on Day 2 admission. Patient was provided 10 days of dexamethasone therapy. Atopic Rash Likely secondary to COVID-19 infection or allergic reaction. Rash responded well to Benadryl therapy initially. Patient reported reappearance of rash the next day. Patient was continued on Benadryl PRN. Chest Pain, Resolved Heart score of 3. EKG unremarkable for ischemic changes. Clinical suspicion for angina was low. Type 2 Diabetes Most recent HbA1c of 7.8 on 11/2020. Patient is on home glipizide therapy. Patient started on 8 units of Lantus nightly and low-dose sliding scale. Essential Hypertension Patient is on lisinopril 20 mg therapy at home. Home dose of lisinopril resumed Possible obesity hypoventilation syndrome Possible COPD Previous note by pulmonologist reflects that patient's disease might be restrictive instead of obstructive however as he had responded to inhalers, inhalers were continued. Patient's home Incruse Ellipta was resumed. DuoNebs as needed were given. Obstructive Sleep Apnea Patient uses CPAP at night. CPAP ordered to be used nightly during hospital stay Major depressive disorder Symptoms are well controlled on Prozac therapy. Home dose of Prozac resumed Hypercholesterolemia Home dose of atorvastatin 40 mg resumed Morbid Obesity
57 2021-05-18 hypertension ear infection; hypertension 168/98; Branch Retinal Vein Occlusion; blurry vision in my left eye; Thi... Read more
ear infection; hypertension 168/98; Branch Retinal Vein Occlusion; blurry vision in my left eye; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 24Mar2021 10:00 as 1st dose, single for COVID-19 immunization. There were no medical history and concomitant medications. No other vaccines in four weeks and no other medications in two weeks. No known allergies. No COVID-19 prior to vaccination and not tested post vaccination. On 25Mar2021 08:00, the patient had blurry vision in my left eye and was referred to a Retina Specialist. The patient was diagnosed with Branch Retinal Vein Occlusion and is receiving AVASTIN shots in the eye monthly in the hopes of getting the vision back to normal. On 02May2021, the patient visited a walk-in clinic for an ear infection and was diagnosed with hypertension. BP 168/98. Patient had several reading in this range after the visit. The patient visited his general practitioner (GP) and was started a regimen of Lisinopril 2.5 mg to help bring down the BP. The outcome of the events was reported as not recovered.
57 2021-05-19 heart rate increased difficulty breathing; face was flushed; heart rate went up; Wheezing; This is a spontaneous report f... Read more
difficulty breathing; face was flushed; heart rate went up; Wheezing; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 57 years, on 26Apr2021 (Batch/Lot Number: EW0170) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included autoimmune thyroiditis, allergies, hay fever, allergies to grasses, cheese and weeds; all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for autoimmune thyroiditis, start and stop date were not reported and an unspecified Antihistamine. The patient stated that 45 minutes later (26Apr2021) he stated that his face was flushed, his heart was beating fast, he was wheezing and had difficulty breathing but, not severe. He states that these conditions were not serious enough to seek medical attention and reports that they were gone by the end of the next day. The patient reported 5 hours after shot at his symptoms were at about 50 percent of what they were, By the next morning, they were down to about 10 percent and by the end of the day, on 27Apr2021, they were gone. The patient would like to know if this will keep him from getting his second dose of the vaccine. The patient underwent lab tests and procedures which included heart rate: increase on 26Apr2021. The outcome of the events was recovered on 27Apr2021.
57 2021-05-21 palpitations Patient is feeling dizzy and having trouble breathing. I asked the patient how he was feeling. Patie... Read more
Patient is feeling dizzy and having trouble breathing. I asked the patient how he was feeling. Patient states that he is feeling like his heart is racing and still feeling dizzy . Took the patients vitals at 12:05 pm heart rate 126, o2 99, blood pressure 191/125, at 12:10 pm heart rate 123, o2 100, blood pressure 170/113, at 12:13 am heart rate 107, o2 99, blood pressure 161/111, at 12:18 pm heart rate 96, o2 99, blood pressure 152/99, and again at 12:23 pm blood pressure was 156/99. I asked how patient was feeling and he stated that the dizziness was a little better but still felt weak.. I asked the patient how he was feeling. The patient stated that he still feels dizzy and weak.
57 2021-05-23 chest pain, chest discomfort Patient came in for second COVID-19 Pfizer Biontech vaccine on 5/21/21. Patient stated 5 days after ... Read more
Patient came in for second COVID-19 Pfizer Biontech vaccine on 5/21/21. Patient stated 5 days after receiving the first dose, he experienced severe chest pain for 2.5 days and experienced chest tightness and was in pain. Patient did not seek any medical attention and the pain went away after 2.5 days. We have not seen reports of this adverse event, therefore, did not provide the second dose of the vaccine and recommended the patient to follow-up with their PCP before receiving the second dose.
57 2021-05-24 heart attack My father in law suffered a heart attacked on the day he received his second shot. at the time of th... Read more
My father in law suffered a heart attacked on the day he received his second shot. at the time of this he was staying in our house where he wasn't found until two days later when we received a call from his work saying he never showed up or called in to work. The medical examiner told us that prior to the second vaccine in the last few weeks he had suffered some sort of heart issue that damaged his heart, but wasn't big enough for him to notice or think anything of it. The timeline the medical examiner gave us would have been after receiving the first vaccine. He then received his second Vaccine on a Thursday which was the last time anyone heard from him and he didn't show up to work Friday and was found Saturday after we were notified he didn't show up to work and we called 911. The medical examiner said he suffered a heart attack. The medical examiner said they had to write the death date on Saturday because that was when he was found, but the last anyone heard of him was prior to getting the vaccine and then he missed work the very next day(which was Friday).
57 2021-05-24 fluid around the heart, chest pain, chest discomfort Patient received a 2nd dose of Pfizer vaccine on 5/3/2021. Patient presents to the ED on 5/23/2021 w... Read more
Patient received a 2nd dose of Pfizer vaccine on 5/3/2021. Patient presents to the ED on 5/23/2021 with chief complaint of fatigue, chest pain, shortness of breath on exertion. Patient reports fatigue of 2 week duration associated with right-sided chest discomfort, dyspnea, and night sweats. He reports approximately 1 week ago onset of pleuritic R-sided, nonradiating chest pain, with provocative factor of cough and palliative factor of lying supine. He additionally reports dyspnea on exertion and at rest and night sweats of 1 wk duration. CT chest angio showed Large Pericardial effusion, moderate Left pleural effusion, mild right pleural effusion, ascites. On 5/24/2021, patient underwent pericardiocentesis with 800cc of reddish fluid drainage, and left thoracocentesis with transudative fluid. Cytology is pending.
57 2021-05-25 fluid around the heart, fibrin d dimer increased Patient presented with SOB for 2 weeks post vaccination along with headache, fatigue/nausea. He was ... Read more
Patient presented with SOB for 2 weeks post vaccination along with headache, fatigue/nausea. He was found to have pericardial effusion and bilateral pleural effusions. He had pericardiocentesis with 975ml drained. He had bilateral thoracentesis with 820 ml drained from R lung and 800 ml drained from L lung.
57 2021-05-26 atrial fibrillation Pt became diaphoretic following1st dose of Pfizer vaccine. Medics placed pt on cardiac monitor. Ca... Read more
Pt became diaphoretic following1st dose of Pfizer vaccine. Medics placed pt on cardiac monitor. Cardiac rhythm was ST, then pt went into A-fib. VS: BP=184/100, HR= 128, RR= 22, 02 sat= 98% RA. Pt stated he had not taken his BP med today. 911 called and pt transported to hospital. VS at transport: BP= 165/122, HR= 130, RR= 22, 02 Sat= 99%. Cardiac rhythm: A-fibrillation Medics placed an 18G L AC prior to departure.
57 2021-05-27 loss of consciousness, hypotension passed out; blood pressure is low/blood pressure was 80 something over 50 something; white blood cou... Read more
passed out; blood pressure is low/blood pressure was 80 something over 50 something; white blood count is high; dehydrated; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received bnt162b2 (PFIZER COVID 19 VACCINE, Batch/Lot Number: EW0169), via an unspecified route of administration, administered in Arm Left on 22Apr2021 08:00 (57-years-old) as 1st dose, single for COVID-19 immunization (his cardiologist recommended him to get it and signed him up for it). Medical history included ongoing coronary stents (Has 18 coronary stents in total. The last three stents were put in 2018), burning of nerves in the back from Apr2021 (The burning of nerves was done through injection), underlying heart issue, neuropathy, diabetes, blood pressure, Cholesterol. Concomitant medications included metformin taken for diabetes from an unspecified start date and ongoing; pantoprazole from an unspecified start date and ongoing; lorazepam from an unspecified start date and ongoing; gabapentin like a nerve block for neuropathy and diabetes from an unspecified start date and ongoing; isosorbide taken for slow release nitro for heart from an unspecified start date and ongoing; carvedilol taken as beta blocker and helps blood pressure and stuff from an unspecified start date to 10May2021; rosuvastatin taken for cholesterol from an unspecified start date and ongoing; ticagrelor (BRILINTA) taken as blood thinner; losartan taken for blood pressure from an unspecified date and unspecified date; acetylsalicylic acid (ASPRIN, Bayer) from an unspecified start date and ongoing; magnesium from an unspecified start date and ongoing; furosemide taken as water pill from an unspecified date and unspecified date; metoprolol from 10May2021 to an unspecified stop date; amlodipine from an unspecified date and from May2021; chlorthalid tabniva taken as water pill (25mg at night at the time of the shot, couple of days ago he had to start cutting it in half, now he is only taking 12.5mg at night). The patient previously took Plavix (Brilinta replaced Plavix to keep his stents open. He was on Plavix over 6 years ago), Fentanyl, and Versed. The patient experienced passed out (hospitalization) on 04May2021, blood pressure is low/blood pressure was 80 something over 50 something (hospitalization) on 01May2021, not feeling well on Apr2021, white blood count is high on an unspecified date, dehydrated on an unspecified date. The patient was hospitalized for passed out and blood pressure is low/blood pressure was 80 something over 50 something from 04May2021 to 05May2021. The patient underwent lab tests and procedures which included blood count: 13 on 12May2021. The patient received Pfizer COVID vaccine and reported after 1st dose received on 22Apr2021 he is not feeling well, he has an underlying heart issue and a history of stents placed, white blood cells are high and has a low blood pressure. His Dr. asked him to call Pfizer to ask if this could have been reported as side effects from vaccination. He was asking if he should get the second dose. He had Pfizer shot and has got to get the second one on Saturday. He doesn't know if it is related or not. He has been going to the doctor. He has underlying conditions and takes heart medications and has stents. He has not been feeling good since getting the shot. He is not sure if it is affiliated. His white blood count is high and he has to go to the doctor. His doctor is advising him to hold off on getting the second one and told him to call and ask if anyone else has had side effects like that. He clarified shot as COVID19 Vaccine. He saw his cardiologist yesterday and they thought it was interesting that he started having problems. They wanted him to call the phone number and see if he can postpone the second one. He is not sure if it is related to the shot. His blood pressure has been really low (01May2021) since taking the shot. He takes a ton of medications and they are having to adjust his medications since. Not been feeling good is ongoing. It started 3 to 4 days after getting shot. White blood count is high information reported as he was in the hospital and they didn't say anything about his white count. They did his blood count yesterday and they said it was 13 and want him to see his primary care. He just found out about that yesterday. He is going to see his primary care today. He was in the hospital from 04May2021 to 05May2021 because he passed out because his blood pressure was 80 something over 50 something. Blood pressure is low has improved but they have adjusted his medications to help it improve. COVID19 Vaccination Card: it says first dose COVID19. It doesn't have how much was administered. There is a number 42221 on the vaccination card, but he is not sure what it is. At first caller had said he got the vaccine on 24Apr2021, but then clarified that he got the vaccine on 22Apr2021. The patient went to Emergency Room. His wife had to call the ambulance because his wife thought it was his heart. They took him to the ER. They were treating him for his heart and then realized it was his blood pressure was extremely low. Prior Vaccinations (within 4 weeks): No vaccine, but he did have burning of nerves in the back at Pain Clinic done in Apr2021. The burning of nerves was done through injection. He has had it done many times. They give him a local anesthetic when they do it and also Fentanyl and Versed. He has had Fentanyl and Versed many times, due to having stents. Family Medical History Relevant to AE: No. His sisters have gotten it and they are fine. His brother has gotten it and he is fine. Patient did not wish to do a report about his siblings experience with the vaccine. His brother has issues like caller and takes medications, but he hasn't had any side effects from the vaccine. The outcome of the event blood pressure is low/blood pressure was 80 something over 50 something was recovering, not feeling well was not recovered, while for other events was unknown.
57 2021-05-27 loss of consciousness body aches; chills; headache; dizziness; goes from being cold and hot; passing out a few times; shak... Read more
body aches; chills; headache; dizziness; goes from being cold and hot; passing out a few times; shaking similar to seizure/eyes kind of glazed; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EW0182), via an unspecified route of administration, administered in arm left on 11May2021 08:00 (at the age of 57-years-old) as 2nd dose, single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drugstore. The patient medical history included covid before, he had a bad case of it from Nov2020. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number was not reported) on 20Apr2021 (at the age of 57-years-old) as 1st dose, single dose for covid-19 immunisation, and experienced all of the same symptoms (body aches, chills, goes from being cold and hot, headache and dizziness) but he did not pass out. The patient always gets the flu vaccine. The patient's concomitant medications were not reported. On 11May2021 15:15, the patient experienced passing out a few times, eyes kind of glazed, and shaking similar to seizure; and at 19:00, the patient body pain, chills, headache, dizziness and goes from being cold and hot. The outcome of the events was unknown.
57 2021-05-28 pulmonary embolism, fast heart rate, coughing up blood, deep vein blood clot, chest pain Presented to ED with complaint of chest pain onset 0800 this morning. He endorse shortness of breath... Read more
Presented to ED with complaint of chest pain onset 0800 this morning. He endorse shortness of breath and a cough that has been ongoing for three weeks.Patient even at rest has significant tachypnea usually in the 40s and sometimes even into the 50s breaths per minute. Sepsis present on admission. COVID-19 infection was diagnosed on the eighth of this month, now is negative. Has been on a ceftriaxone and azithromycin. Could be due to multifocal pneumonia and PE. Changed to cefuroxime,7-day course. Leukocytosis could be due to steroids, recommend to repeat CBC in about a week. Multifocal pneumonia: With underlying COVID-19 diagnosed on the eighth, now is negative. Completed azithromycin for 3 days and was on a ceftriaxone, changed to p.o. cefuroxime on antibiotic for suspicion for secondary bacterial infection, will complete the course. Acute bilateral pulmonary emboli: on Xarelto. Echo reviewed. Mild hemoptysis: Could be due to pulmonary emboli, infarcts, remains on anticoagulation. No recurrence. Left lower extremity DVT/SVT: Anticoagulation as above. Transaminitis: Denies use of alcohol, he has some nonspecific complaint on the right sided abdomen but negative Murphy and ultrasound shows normal gallbladder, normal liver, stable.
57 2021-05-29 blood pressure increased After Vaccination client was waiting in observation area when he complained of ?feeling dizzy? appro... Read more
After Vaccination client was waiting in observation area when he complained of ?feeling dizzy? approximately 15 mins into his observation. Client was placed in anti-gravity chair by EMT. Vital Signs were taken at 1115am BP 132/86 HR 61 RR 14 02 96%. Client stated he has a history of syncope and anxiety prior to shots. Client has a history of high blood pressure. Client reported not having breakfast in the morning and was given a snack at 1115am. He was recommended to stay an additional 30mins for observation, client complied. Vital Signs 1120: BP 186 HR 66 RR14 02 96% at same time client stated he ?felt better.? Client continued to be in anti-gravity chair in no apparent distress. He was able to answer all questions with no issues. Vitals 1125: BP 132/J80 HR 62 RR 14 02 95% 1130: BP 129/ HR 62 RR14 02 95%. Client was alert and oriented throughout the entire observation. No further interventions were necessary, and client was ready to head home. Emergency Precautions were given by EMT, if his symptoms worsened to seek emergency care. He was also recommended to follow with his Primary Care Provider.
57 2021-05-30 platelet count decreased, fibrin d dimer increased, blood glucose increased Skin hurting/sensitivity (Day 1 forward), severe chills (day 2 forward), headache (day 1 forward), f... Read more
Skin hurting/sensitivity (Day 1 forward), severe chills (day 2 forward), headache (day 1 forward), fatigue (day 1 forward), mild cough on/off, eye pain (? day 4 forward), achey (day 1 forward), chest rash (? day 3 forward), fever (? day 5 forward 101.9 day 5), back pain (? day 5 forward), labored breathing (? day 5 forward), diarrhea (? day 5 forward), sore throat (? day 5 forward) vomit (day 7). Symptoms of chills and miserable feeling increased day 4 on. Tylenol, Albuterol on day 6, Day 8 hospitalized, antibiotics and oxygen, Sepsis and shock, less than one day in hospital - passed on 3/2/21 am.
57 2021-06-01 chest pain Severe pain in chest above my heart.
57 2021-06-01 hypertension high blood pressure; blockage / two cardiac stents placed; This is a spontaneous report from a non-c... Read more
high blood pressure; blockage / two cardiac stents placed; This is a spontaneous report from a non-contactable consumer (patient). This 57 years old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 at 05:00 (at 57 years of age) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced high blood pressure on 11Feb2021. The event required ER visit on 11Feb2021, physician office visit and was reported as serious per hospitalization for 3 days and as life-threatening. Cardiac cath lab was performed on 12Feb2021 and blockage was found, resulting in two cardiac stents placed. Device date: 25May2021. High blood pressure resolved with sequel on an unspecified date in 2021. Blockage outcome was unknown. On 25Feb2021 at 05:30 the patient received the second vaccination. On 15Apr2021, the patient had another emergency trip to ER, another blockage in the left anterior descending artery. This blockage was only 40% blocked in Feb2021 and suddenly in Apr2021 became 99% blocked. Dr suspected a blook clot when symptoms of shortness of breath appeared suddenly. Since the vaccination, the patient had been tested for COVID-19 (on an unknown date in 2021, with unknown results). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021601862 same patient, different vaccine dose/events
57 2021-06-03 blood clot a blook clot; blockage in the Left Anterior Descending artery; symptoms of shortness of breath; This... Read more
a blook clot; blockage in the Left Anterior Descending artery; symptoms of shortness of breath; This is a spontaneous report from a non-contactable consumer or other non hcp. A 58-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Feb2021 17:30 (at the age of 57-years-old) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 02Feb2021and experienced cardiac blockage. The patient did not take any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021 the patient experienced a blook clot, blockage in the left anterior descending artery and symptoms of shortness of breath. The events were reported as serious (life threatening). It was reported that 15Apr2021, emergency trip to ER, blockage in the Left Anterior Descending artery. This blockage was only 40% blocked in Feb2021, and suddenly in April became 99% blocked. Dr suspected a blook clot when symptoms of shortness of breath appeared suddenly. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Blockage in the Left Anterior Descending artery was treated with cardiac stents. The patient underwent lab tests and procedures which included COVID-19 test tested performed on an unspecified date (result not reported). The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021600543 same patient, different vaccine dose/events
57 2021-06-09 chest pain Patient presented to the ED with atypical chest pain on 3/20/2021. Patient presented to the ED with ... Read more
Patient presented to the ED with atypical chest pain on 3/20/2021. Patient presented to the ED with lumbar back pain and was subsequently hospitalized on 4/27/2021. These visits are within 6 weeks of receiving COVID vaccination.
57 2021-06-10 chest pain Patient called health system call center on 5/10/21. Per pt, he had received dose 2 of pfizer vaccin... Read more
Patient called health system call center on 5/10/21. Per pt, he had received dose 2 of pfizer vaccine on 4/20/21. Pt said about 5/6/21, he started to feel pain in arm, back and chest. Pt said, he feels congestion, lost appetite, have difficulty when swallowing, itchy and numbness in hands and fingers sometimes. Per pt, heTakes 2tablets of 500mg tylenol twice daily since pain began 5/6/21 . URgent care visit made for patient for 5/10/21
57 2021-06-11 platelet count decreased Her husband passed away; Sepsis; Shock due to bilateral pulmonary acute disease syndrome; Shock due ... Read more
Her husband passed away; Sepsis; Shock due to bilateral pulmonary acute disease syndrome; Shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage; misery and feeling horrible; Severe chills; Headache; Shortness of breath; Fever; Fatigue; Diarrhea; Muscle aches; Skin sensitivity and rash; Skin sensitivity and rash; Sore throat; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm on 22Feb2021 at 10:00 (Lot Number: EN6202) (at the age of 57-year-old) as single dose for COVID-19 immunisation. Medical history included high cholesterol from 2017 to an unknown date, seasonal allergy from an unknown date and unknown if ongoing and arteriosclerosis from 2017 to an unknown date. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Feb2021 (Lot Number: EL9264) (at the age of 57-year-old) as single dose for COVID-19 immunisation; the patient previously received ZYRTEC (10mg almost daily) for seasonal allergy, ibuprofen (ADVIL, 200 mg) and TYLENOL both for pain. Caller stated that the patient passed away on 02Mar2021 which was 8 days after the 2nd dose of the Pfizer COVID Vaccine. On 26Feb2021 the patient went to urgent care and then on 01Mar2021 he went to the hospital emergency room (ER). It was reported that an autopsy was performed on 06Mar2021 and the cause of death listed sepsis and complications from sepsis and shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage. The manner of death was natural and the lung presentation is highly suggestive of diffuse alveolar damage due to COVID-19 although the patient had several negative tests for COVID. The patient tested negative for influenza AB, negative for valley fever, negative for Legionnaire's disease and was in the hospital for less than 24 hours. The patient went back to urgent care on 28Feb2021 and was feeling miserable and asking for blood tests and urine tests, stated at that time his platelets were low at 122, glucose was high at 105, sodium was low at 134, calcium was low at 8.3, urine was negative and the patient did not get these labs til Monday when he was on the way to the emergency room and it was all different when he got to the hospital. The test for strep was negative, the oxygen was low at 86 percent when he got to the hospital on Monday and they just had to keep increasing his oxygen, stated a culture, no further details provided about the culture. A CTA done on the chest on Monday which was bad and stated the patient was symptomatic and they did not treat him for COVID but had a clinical suspicion for COVID. Adenovirus was not detected, metapneumonia virus was not detected, respiratory syncytial virus was not detected, parainfluenza was not detected, his platelets kept dropping and he had two tests for valley fever which is Cocci IGG and IGM and those were negative, the sodium level on 02Mar2021 was 126, all of these things were low: chloride 92, CO2 18, calcium 7.8, glucose was high at 222, bun was high at 21, creatinine was high at 1.4, EGFR was low at 52, WBC was high at 18.6, RBC was high at 7.39, HGB was 22.6, HCT was 66.4, RDW was high at 15, RDWFD was 45.5, and platelets were low at 61. The patient came into the emergency room those labs were when he was failing completely and on 01Mar2021 was when he arrived in the ER; at that time his WBC were normal, RBC was high at 6.16, HGB was high at 18.5, HCT was high at 54.9, platelets were low at 73, monocytes absolute were high at 0.96, sodium was low at 129, chloride was low at 95, calcium was low at 8.3, glucose was high at 150 and this was 7 days past the Pfizer COVID Vaccine. The patient was negative for strep pneumonia antigen and negative for Legionnaires Urinary antigen. The chest X-ray was done on 26Feb2021 and the patient was in misery and feeling horrible and they sent him home with albuterol and possible antibiotic to start that Monday and he had severe chills, headache, shortness of breath, fever, fatigue, diarrhea, muscle aches, skin sensitivity and rash, sore throat. Chest X-ray says normal; states the albuterol was PROAIR HFA 90mcg and he tested negative for influenza AB and he never got to the antibiotic because they said to wait til Monday and by that time this was an emergency. The patient outcome of sepsis and shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage was fatal and unknown for the other events. The patient died on 02Mar2021. An autopsy was performed that revealed the cause of death was sepsis and complications from sepsis and shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage.; Reported Cause(s) of Death: Sepsis; Autopsy-determined Cause(s) of Death: Shock due to bilateral pulmonary acute disease syndrome; Diffuse alveolar damage
57 2021-06-13 hypertension, inflammation of the pericardium 1st dose Pfizer 12/26/2020 Lot# EL0140, 2nd dose 01/20/2021 Lot# EL3247 Sever coughing, pericarditis... Read more
1st dose Pfizer 12/26/2020 Lot# EL0140, 2nd dose 01/20/2021 Lot# EL3247 Sever coughing, pericarditis, high blood pressure medication on now 50mg Metoprolol twice daily
57 2021-06-15 heart attack NSTEMI went to cardiac cath and received stent in LAD. Started on prasugrel 10 mg daily, lisinopril ... Read more
NSTEMI went to cardiac cath and received stent in LAD. Started on prasugrel 10 mg daily, lisinopril 2.5 mg daily, and aspirin 81 mg daily discharged home
57 2021-06-15 blood pressure increased Starting on the day of the vaccine 1st dose- I felt a little dizzy in the waiting area. A day later... Read more
Starting on the day of the vaccine 1st dose- I felt a little dizzy in the waiting area. A day later, I felt tired and fatigued. About 6 days post vaccine, I woke up with flushing and both ears started to ring, more signficantly in the left ear. I took my blood pressure and it was elevated at 160/90. I went to the doctor the next day and had an MRI (came back normal). I was prescribed blood medication (amlodipine). I went to an audiologist and was found to have hearing loss. I went back to my PCP and my BP was still elevated and was prescribed atenolol in addition to amlodipine. Currently, I am still having flushing, fatigue, and tinnitus.
57 2021-06-15 palpitations Heart palpitations at night. I went to the ER two straight nights. After numerous heart tests, not... Read more
Heart palpitations at night. I went to the ER two straight nights. After numerous heart tests, nothing has been found. My doctor has suggested stress could be the cause; however, this is the first time such issues have ever occurred. Given recent news, I felt I needed to report it as a potential side effect.
57 2021-06-16 chest pain, fainting Patient because dizzy, developed chest pains, and collapsed. EMS was called to the scene and patient... Read more
Patient because dizzy, developed chest pains, and collapsed. EMS was called to the scene and patient transported to nearest hospital.
57 2021-06-21 heart rate increased When I was resting my pulse rate would shoot up really high. Then go back to normal fast. An episode... Read more
When I was resting my pulse rate would shoot up really high. Then go back to normal fast. An episode could go for a few minutes up to 15 minutes periodically throughout the day.
57 2021-06-21 fast heart rate, heart rate increased I had an elevated pulse for 4 hours straight. I have a SVT which I am being treated for currently. I... Read more
I had an elevated pulse for 4 hours straight. I have a SVT which I am being treated for currently. In a holding pattern to find out what my next step in treatment would be.
57 2021-06-22 heart rate irregular This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of BNT162B2 at 57-year-old, via an unspecified route of administration in arm left on 31Mar2021 at single dose, and the second dose at 57-year-old via an unspecified route of administration on 21Apr2021 at single dose for COVID-19 immunisation, and testosterone, via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020, and left arm bothered him. There were no concomitant medications. Patient reported his tongue and taste buds were "screwed up" and it had been painful to eat which had resulted in weight loss of 50 pounds in the last 5 months and this had gotten worse since being vaccinated. He was fatigued and his whole body hurt and sports injuries from past were very painful. He had previous Covid infection in Dec2020. He had seen many doctors and had an appointment with neurologist coming up. He didn't have much hope. He felt like he had 75% Covid all the time and his body felt like he had been hit by a truck. Not really that bad but like his taste buds were screwed up and it kind of progressed since he received the vaccine. Ever since the patient got the vaccine, the arm that he got the vaccine in it killed him, every joint in his body hurt, and he had seen lots of doctors about this and no one could figure it out. The patient was 250 pounds before this started. Patient was having something wrong with his tongue and taste buds, it was hard to explain. It was painful to eat, the patient had been to an ENT and they were sending the patient to neurology to figure it out. The tongue thing went away they thought it was thrush, then talked to another ENT and thought it was something neurological. The patient's whole body hurt. The patient was unsure when all of this started but he stated that it had worsened over the last couple of months. The patient's mouth was in pain. The patient was fatigued. The patient's left arm bothered him before the vaccine but it had progressively gotten worse over time. All of the symptoms that the patient had from COVID got progressively worse after the vaccine. The patient's arms were really lose and it felt like the arms wanted to come out of the socket. The pain could be a 9/10 and nothing touched it. The day after the first shot, the patient got testosterone shots, they found and erratic heartbeat which freaked out the patient. They did and EKG and said it was okay but couldn't determine what it was. Patient was tested and it showed hypothyroid and they did an intake test. The doctors thought it was thyroiditis but that got better but then it snowballed into what it was. Investigations: The patient was tested for cancer, rheumatoid arthritis and all sorts of different things which were all negative. The patient was a healthy guy otherwise, besides these symptoms. Action taken in response to the events for testosterone was unknown. Outcome of events his tongue and taste buds were "screwed up", the arm that he got the vaccine in it kills him/left arm bothered him before the vaccine but it had progressively gotten worse over time, every joint in his body hurt, and erratic heartbeat was not resolved, and of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-06-22 troponin increased, chest pain, inflammation of the heart muscle 1st day after the shot - I had a strong reaction to the 2nd dose of the Pfizer vaccine - usual sympt... Read more
1st day after the shot - I had a strong reaction to the 2nd dose of the Pfizer vaccine - usual symptoms, muscle aches, headache. 2nd day after the shot - mild achiness, getting better. 3rd day after the shot - significant chest pains in the left chest. Went to hospital. Blood test showed elevated levels of troponin. I was admitted, stayed overnight, and the next day underwent an angiogram (no blockages), a sonogram (no markers for pulmonary embolism). My last test was a cardiac MRI which definitively showed that I had MYOCARDITIS. Symptoms subsided and I was discharged from the hospital that same day on April 2nd. I've since resumed my normal workout regimen with no lasting symptoms, only a large hospital bill.
57 2021-06-23 arrhythmia I have developed arrythmia for the first time in my life. On some days, the arrythmia has prevented... Read more
I have developed arrythmia for the first time in my life. On some days, the arrythmia has prevented me from sleeping overnight. I have visited a cardiologist for the first time in my life, though i have had annual normal EKGs each year for my annual physical. Dr. currently has me wearing a Zio Patch heart monitor to help determine what is happening.
57 2021-06-23 inflammation of the pericardium, chest pain Approximately one week after vaccination patient experienced a flare up of RA. Rheumatologist increa... Read more
Approximately one week after vaccination patient experienced a flare up of RA. Rheumatologist increased Prednisone with only minor improvement. On 6/3/21 patient started experiencing radiating chest pain. Presented to ED and was later admitted. He was diagnosed with pericarditis and treated accordingly.
57 2021-06-25 chest pain, heart rate increased First shot: 102 fever for first 3 days after vaccination. Then chest pain day 4-6. Shortness of b... Read more
First shot: 102 fever for first 3 days after vaccination. Then chest pain day 4-6. Shortness of breath, fatigue for 7 days. Resting heart rate elevated from 60 to 90 for 13 days. 2nd Shot: Same response & duration. Not as severe. Fever was 100. My heart rate monitor measured high Heart Rate Variation during both shots. 2-1/2 months after first shot, resting heart rate & heart variation returned to almost normal.
57 2021-06-28 sinus rhythm, arrhythmia Pt. has hysterical of atrial fibrillation, which had been successfully controlled for 1yr+3weeks pri... Read more
Pt. has hysterical of atrial fibrillation, which had been successfully controlled for 1yr+3weeks prior to second dose. Pt experienced episode of atrial fibrillation ~2days subsequent to second dose of vaccine. Pt. spontainiously converted to sinus rhythm ~ 2 weeks later. Pt. Continued to have episodes of a-fib at increasing intervals and decreasing duration through March (approx 3 mos. after 2nd dose.) About 4mos. subsequent to 2nd vaccine dose, pt experienced a persistent episode of atrial flutter, which was terminated via electrocardioversion after 4 weeks.
57 2021-06-29 chest pain Patient presents to the hospital with constant left sided chest pain, intermittent left arm tingling... Read more
Patient presents to the hospital with constant left sided chest pain, intermittent left arm tingling, nausea, vomiting, confusion and shortness of breath. Chest pain is worse with deep inspiration. Tests ran include EKG/CXR, chest CT, and labs. Admitted to hospital for observation work up. Serial EKG, serial troponin, CT head Patient was discharged AMA with cardiology and pulmonary consults. Medications on discharge: Aspirin 81, Spiriva, and albuterol HFA. Symptoms likely a result of exacerbation of other disease processed, but cannot rule out contributory effects of the vaccine
57 2021-06-29 blood clot, chest discomfort After the second dose my chest started to feel very tight at first. Yet, it progressed to my right c... Read more
After the second dose my chest started to feel very tight at first. Yet, it progressed to my right calf. I was experiencing very severe pain in my right calf. I thought the pain will eventually go away yet it still continued. About three weeks after my second dose, May 24th, I drove myself to a local clinic, and they directed me to the emergency room to get a X-Ray of my right calf. They found a blood clot. The doctors bandaged my calf and prescribed me Xarelto to treat the pain. In addition to the prescription, they directed me to a Vascular doctor to documented the recovery. As of now it is unclear if the blood clot is completely gone, however, my calf is still swollen. In addition to that, my little toe and the heel of my right foot is numb to any sensations.
57 2021-06-30 blood clot blood clotted; had persistent synovitis in all knuckles; This is a spontaneous report from a non-con... Read more
blood clotted; had persistent synovitis in all knuckles; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: ew0186 and Expiration date: unknown), via an unspecified route of administration, in arm left on 26May2021 (at the age of 57-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included amitriptyline hydrochloride (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at 10 mg and frequency for unknown indication; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took flu shot on an unspecified date in 2017 and experienced synovitis. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 28May2021, since his first Pfizer shot have had persistent synovitis in all knuckles. On an unspecified date in Jun2021, 12 days after first Pfizer shot donated blood and blood clotted in tubes before completion. He had donated about 40 times and that was the first time his blood has clotted. The case was assessed as non-serious. No treatment was received for events. The clinical outcome of had persistent synovitis in all knuckles, blood clotted were not recovered.
57 2021-07-01 nosebleed Lightheaded; Fatigued/ very tired; Nosebleed; Sweaty feet; intense dreams; This is a spontaneous rep... Read more
Lightheaded; Fatigued/ very tired; Nosebleed; Sweaty feet; intense dreams; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 08:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient was allergic to unspecified medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 22Mar2021 at 08:00, after the injection the patient felt lightheaded and fatigued. The patient waited and monitored for 45 minutes before leaving. The patient had breakfast afterwards but very tired, went home and slept solid for 3 hours with intense dreams. The patient slept well the night before. The patient felt better as the day progressed. On 22Mar2021, at night, the patient went to bed early and woke up with a nosebleed, blood pooled in mouth from the nose bleed and sweaty feet. The patient underwent lab test which included blood test on an unknown date in Feb2021 and the result showed negative. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. Therapeutic measures taken for the adverse events included water and blood pressure check (result not provided). The clinical outcome of events lightheaded, fatigue, nosebleed, intense dreams and sweaty feet was recovering. No follow-up attempts are needed. No further information is expected.
57 2021-07-01 inflammation of the heart muscle, chest pain Background: Exposed to Granddaughter who began experiencing fever, nausea and vomiting the evening o... Read more
Background: Exposed to Granddaughter who began experiencing fever, nausea and vomiting the evening of 3/19. Ten of twelve of the children in her preschool class (and many of their parents also) experienced the same symptoms beginning that evening or the following day. Granddaughters mother (my daughter) and father (son-n-law) also began experiencing the same symptoms on 3/21 and 3/22, respectively. I was also exposed to them on those dates. Their symptoms all resolved within two-three days. My adverse experiences: I was vaccinated at noon on 3/23. Shortly after midnight, 3/24, I began experiencing the same symptoms (see background) as my family members. The symptoms persisted throughout the days of 3/24 and 3/25. On 3/25 I visited my internist, Dr., who prescribed ciprofloxacin and ondansetron. He also ordered a COVID-19 test, for which I was negative. Shortly after midnight, 3/26 I awoke diaphoretic, noting my nausea had resolved. Also at that time, I began experiencing joint pain and a dull ache in my chest. By around 4 am the joint pain had subsided, but the chest pain had increased, to the point that I went to the Hospital ER. Although my ECG was inconclusive, troponin levels drawn were indicative for a possible NSTEMI. A cardiac catheterization was performed showing no coronary artery disease and normal cardiac function. After an echocardiogram was performed and further troponin levels decreased over the day, I was diagnosed with MYOCARDITIS, and told it was likely a result of a suspected virus that was presumed to be the cause of my previous GI illness. I was released from the hospital on 3/27. I have experienced no further symptoms since my hospitalization.
57 2021-07-02 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 10-15 mins after vaccine, pt stated he was feeling dizzy. RPh went to take pt's BP, but pt fainted. called 911. pt woke up after 5 mins, no trouble breathing, but sweating. BP was 167/93 & pulse 78. First responders came and took BP and blood sugar. pt fainted again for 5-10 mins, stopped beathing few mins and decided to transport him to nearest ER. RPh called next day 6/29 & 7/1 but no response and left message.
57 2021-07-04 chest discomfort I've been experiencing intermittent sensations in my upper and lower chest [lung and heart] area sin... Read more
I've been experiencing intermittent sensations in my upper and lower chest [lung and heart] area since I received my 2nd Pfizer vaccination shot on June 22, 2021. It?s been happening for two weeks, today but I?m only now reporting it because I?m getting concerned. Each time it?s happened, it lasts for a couple of hours and it's scaring me. I feel pressure in there like something?s not right. I?m not paranoid but I am concerned and want to report it.
57 2021-07-06 chest discomfort Dry skin; swollen feet, hands and face; hives; peeling skin; itchiness; pressure on chest; sinus hea... Read more
Dry skin; swollen feet, hands and face; hives; peeling skin; itchiness; pressure on chest; sinus headaches; and bleeding skin
57 2021-07-10 chest discomfort Woke up at 3:36 am on May 27th. I was feeling lightheaded when I got up to pee. Laid down and the fe... Read more
Woke up at 3:36 am on May 27th. I was feeling lightheaded when I got up to pee. Laid down and the feeling didn?t go away. Went into another room to put my head between my legs and the feeling did not go away. And then began to feel a pressure sensation in my chest and feeling clammy. Woke up my family and I went to the ER. When I arrived at the ER my heart rate was 32 bpm.
57 2021-07-12 palpitations heart palpitations
57 2021-07-13 cerebrovascular accident suffered a stroke
57 2021-07-13 cerebrovascular accident Stroke - CVA (cerebral vascular accident) (HCC) on 05/21/2021; 6:00am 10 day Hospital stay, ongoing ... Read more
Stroke - CVA (cerebral vascular accident) (HCC) on 05/21/2021; 6:00am 10 day Hospital stay, ongoing Rehabilitation / Physical and Occupational Therapy
57 2021-07-13 deep vein blood clot Confirmed DVT in right calf behind the knee that started on 7/9/21, 2 days after the 2nd vaccine inj... Read more
Confirmed DVT in right calf behind the knee that started on 7/9/21, 2 days after the 2nd vaccine injection.
57 2021-07-17 heart rate decreased, hypotension shortness of breath; Low heart rate at 38 to 45; facial swelling; cough; low blood pressure 98/52 - ... Read more
shortness of breath; Low heart rate at 38 to 45; facial swelling; cough; low blood pressure 98/52 - 98/50; generalized weakness; This is a spontaneous report from a contactable other Healthcare professional (patient) reported for himself. A 57-years-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was 57 years) as dose number unknown, single for COVID-19 immunization. The patient did not have any relevant medical history, concurrent conditions, relevant past drug history and known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jun2021 at 15:00 pm, the patient experienced low heart rate at 38 to 45, low blood pressure 98/52 - 98/50, generalized weakness, facial swelling, cough, shortness of breath. The patient was not hospitalized for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included blood pressure measurement: low (98/52 - 98/50) and heart rate: low (38 to 45) on 06Jun2021. The patient received treatment with Amoxicillin, Benadryl, bedrest and oral hydration. The device date was reported as 27Jun2021. The outcome of the events at the time of last observation was resolving. Information about lot/batch number has been requested.
57 2021-07-23 anaemia I woke up the morning of the 15th of May with severe back pain, went to the DR on the 17th of May a... Read more
I woke up the morning of the 15th of May with severe back pain, went to the DR on the 17th of May and got prescription for pain killer steroid, and muscle relaxer as well. I managed the back pain okay after that but all of my core muscles were hurting as well, and I had intestinal issues which all lasted until late June as well. They also did some blood work on May 17th as well. Then on June 7th, I got blood work done again at a hematologist and got the results on the 21st of June. June 7th I had also started on an iron supplement and June 21st I started on antibiotics. On June 17th I had started to feel better, but felt a whole lot better by the end of June overall.
57 2021-07-27 blood pressure increased brain fog; Tiredness; Spike in blood pressure/High very high Blood pressure, needed treatment to bri... Read more
brain fog; Tiredness; Spike in blood pressure/High very high Blood pressure, needed treatment to bring down 210 over 109.; immediately ringing in ears; Facial stiffness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm (reported as left shoulder) on 29Mar2021 09:30 (Batch/Lot Number: ER8730) (at the age of 57-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient had no relevant medical history and no known allergies. There were no concomitant medications. On 30Mar2021, the patient experienced spike in blood pressure, immediately ringing in ears, and facial stiffness. On 31Mar2021, the patient experienced brain fog and tiredness. It was further reported that after tracking O2, blood pressure, heart rate and exercise for one and half years with all being under normal, the patient almost immediately had ringing in ear, facial stiffness, high very high blood pressure, needed treatment to bring down 210 over 109 (blood pressure medicine). The events spike in blood pressure, had ringing in ear, and facial stiffness were considered as serious important medical event. The events spike in blood pressure, brain fog and tiredness resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: normal in 2020, blood pressure measurement: needed treatment to bring down 210 over 109 in 2021, heart rate: normal in 2020, oxygen saturation: normal in 2020, and physical examination: good (released for sports) on 30Sep2020. Therapeutic measures were taken as a result of all events. The patient received the second dose of bnt162b2 administered in left shoulder on 19Apr2021 09:30 (Batch/Lot number: EW0153). The patient was recovering from spike in blood pressure, immediately ringing in ears, and facial stiffness while outcome of brain fog and tiredness was not yet recovered. Follow-up attempts are completed. No further information is expected.
57 2021-07-27 chest pain Severe difficulty in breathing/shortness of breath; chest pains; This is a spontaneous report from a... Read more
Severe difficulty in breathing/shortness of breath; chest pains; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ew0151), via an unspecified route of administration, administered in the left arm on 03Apr2021 14:00 (at the age of 57 years old) as dose 1, single for COVID-19 immunization. Medical history included angina, asthma, sleep apnea and carotid artery spasm, all from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously took codeine and ace inhibitors and experienced drug allergies for both. The patient experienced severe difficulty in breathing/shortness of breath and chest pains on 03Apr2021 14:15. It was reported that the patient experienced severe difficulty in breathing chest pains shortness of breath. He was taken from site to hospital via ambulance and they gave him a hundred percent oxygen and they gave him shots to counteract the severe side effects from the vaccine. The adverse event result in emergency room/department or urgent care. Treatment received included oxygen IVs and four shots. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
57 2021-07-27 heart rate increased This is a spontaneous report from a contactable consumer (patient). A 57 years old male patient rece... Read more
This is a spontaneous report from a contactable consumer (patient). A 57 years old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 31Mar2021 12:00 (at the age of 57 years)(Batch/Lot Number: ER8732) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from 27Nov2020 to an unknown date. There were no concomitant medications. The patient previously took allegra and experienced allergies. Patient historical vaccine included Shingrix (he got Shringrix closer to 2 months ago). It was reported that, caller would like to know why he got sicker from the covid vaccine than from the natural infection itself which he had 27Nov2020. DSU: E-transmitting possible duplicate AE as caller stated they already reported AE to previous agent. Report# #. Caller states 'how do I have more symptoms than when I actually caught the virus?' after receiving the 1st dose of the covid vaccine. It was not anaphylaxis or an allergic reaction as his shortness of breath happened 1-2 days after receiving the dose and today was the 5th day and he was starting to feel better. Caller used the term (Withheld) information referring to information he has received so far. Unclear from who exactly. Additional Context: States he was calling about the Pfizer covid vaccine and was calling to report severe side effects he experienced last week and for some questions he had. States he had COVID four months ago on 27Nov2020 for about 2 weeks it took to shake it and he was no worse for wear but had 103 degree Fahrenheit temperature, lost 13 pounds, had a cough that drug on and he figured he was building immunities. States he does not know how long the immunity would last from having covid so he got the Pfizer COVID Vaccine and took the 1st dose on 31Mar2021; states the vaccine made him sicker with more symptoms and he was worse with the vaccine than he was with the actual disease covid. HCP information: Caller declined to provide HCP information and states he feels that is not necessary. Reporter details: Caller declined to provide email address. States by the evening on 31Mar2021, he had a headache, a very sore arm and never had a vaccine or shot that hurt as much as the Pfizer COVID Vaccine did; no further details provided. States what he experienced was listed as potential side effects and by that evening, he was feeling shivers, had a temperature, it made him really tired, pounding headache and elevated pulse; states his fever got up to 102.2 degrees Fahrenheit and he has probably hotter than that when he checked his temperature. Caller states these symptoms lasted through about 2 days; states the fever resolved with Tylenol and has not taken it this morning and kind of had leftovers and was trying to shake it; states he had 3-4 days of Tylenol and last night it seems to take the fever out. States the elevated pulse was up by 30 and he clarified to state his pulse usually runs normally by his wrist 55-75 resting heart beat and his pulse was 87 for about three days and the Pfizer vaccine jacked him up. States he had muscle joints, aches and pains and chills and doesn't know if the vaccine caused the fever or how severe but he had to get in bed and the 2nd day he did not get up. States the injection site was swelling and had pain and he had swollen lymph nodes. States if he had not felt better on Saturday morning he would have gone to the urgent care or to his HCP but he started to feel a little better. States the Pfizer vaccine caused a cough and shortness of breath for about 2 of the three days after he got the vaccine. States the elevated pulse struck him as strange and he did not experience this with the covid he had last fall and he did have the cough last fall with covid after Thanksgiving but was not short of breath and was able to keep exercising at that time and going through that hit him harder with the vaccine. Caller states he slept in his chair which cleared his lungs and it really surprised him that this occurred. States he takes vitamins and an allergy pill Allegra and takes Tamsulosin in the morning for his prostate deal and has taken all of these for years and started the Allegra probably last month since it was spring and he has allergies. States he got the 1st dose of Shingrix weeks earlier than the Pfizer vaccine but does not know the date; states he got Shringrix closer to 2 months ago when he had his annual physical and follow up and checked before scheduling the Shingrix and was told as long as it was two weeks apart from the Pfizer vaccine he was good and thought it might be around 6 weeks that he had the Shingrix and the HCP is his primary doctor and it was Dr. (Withheld). States he tried to do the online filing with the CDC website from the sheet they gave him but the website did not work and when the channels and numbers don't work it wastes everyone's time. States he got the Pfizer vaccine and the Shingrix vaccine in different arms on purpose. States his questions are if he can't get the disease from the Pfizer vaccine, why did he get additional symptoms that were more severe than when he had the disease covid; what is the level of effects with one dose of the Pfizer Vaccine and he would not have taken it if he knew how severe he would react and is not planning on getting the 2nd dose; if this is normal and was it expected and Pfizer is keeping quiet to coax everyone to get the vaccine right now he is not taking the 2nd dose, so what is good for the 1st and he feels like he had a booster with his 1st dose and feels like he had 2 doses since he actually had covid prior to the vaccine; people his age are older and have more severe side effects with the 2nd dose he has read and maybe this is the 2nd dose so why would he get the 2nd dose. Caller states he will take his chances on getting the disease. States he thinks it had been more than a month since he had the Shringrix vaccine and states he has no lot number, expiry date or NDC to provide. The patient underwent lab tests and procedures which included on an unspecified date, shake: 103 fahrenheit, shake 102.2 fahrenheit, heart rate: up by 30, heart rate: 87. Therapeutic measures were taken as a r Therapeutic measures were taken as a result of event fever got up to 102.2 degrees Fahrenheit. The outcome of the events fever got up to 102.2 degrees Fahrenheit was recovered on 02Apr2021, shortness of breath was recovering, for other events outcome was unknown. No follow-up attempts are possible. No further information is expected.
58 2021-01-01 chest pain Injection site pain and tiredeness day after injection. Severe left sided low back pain centered in ... Read more
Injection site pain and tiredeness day after injection. Severe left sided low back pain centered in sacroiliac joint, next day radiating into left leg and left thorax on Sunday, five days after injection. Severe disruption in all ADLs necessitating narcotic pain medication and an emergent visit with chiropracter. This pain is somewhat better but still persists today 14 days after onset!! This is absolutely miserable. I think I'd rather have COVID
58 2021-01-01 lightheadedness, blood pressure decreased, heart rate increased I received the *Pfizer-BioNTech Covid-19 Vaccine EUA*. I was already not feeling my best that mornin... Read more
I received the *Pfizer-BioNTech Covid-19 Vaccine EUA*. I was already not feeling my best that morning symptoms of warmness at home no fever , I checked. No issues with vaccine given approximately 0715, until 1005 am after a very busy morning with nothing but coffee to drink. As I sat down to assist in order entry in our chemo clinic I suddenly became aware of a very rapid heart rate. I realized that I was having a vaso-vagal response and started perspiring lightly and realizing I was having drop in blood pressure. I composed myself removed my mask and breathed slowly and drank cold water while sitting. After a few minutes I was able to slow my heart rate and felt secure enough to leave the pharmacy. I slowly walked and controlled my breathing and continued to drink water. I was able to return to work and continued until the end of the day. I felt somewhat fatigued until bedtime that evening. Slept reasonably well that night and had no other symptoms to my memory the following day.
58 2021-01-05 heart rate increased Aches, Dizzy, Chills, high pulse rate, cant sleep
58 2021-01-07 enlargement of the heart Intermittently productive cough, dyspnea, body aches, HA, neck pain 3 days after dose. CXR in ED fo... Read more
Intermittently productive cough, dyspnea, body aches, HA, neck pain 3 days after dose. CXR in ED found LLL pneumonia and enlarged heart; given ABX and isolation.
58 2021-01-07 heart rate increased Heart rate increased; Swelling arm; Arm soreness; soreness at the vaccine injection site; This is a ... Read more
Heart rate increased; Swelling arm; Arm soreness; soreness at the vaccine injection site; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686, expiration date unknown) via an unspecified route of administration on 28Dec2020 at 13:00 (at the age of 58-years-old) at an unspecified dose in the upper left arm for COVID-19 vaccination. Medical history was reported as "no pre-existing conditions." He mentioned that he reviewed his allergies with a pharmacist prior to vaccination but did not specify what his allergies were. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was a tobacco user from an unknown date. The patient also reported a history of pneumonia which was reported to have occurred on seven different occasions following each of seven different vaccinations with the flu vaccine (manufacturers unknown) prior to 2013. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. He stated that after receiving the COVID 19 Vaccine he had side effects. He said the side effects went away at twenty four hours later, but he is still having one side effect, and has a concern. He clarified that he has an elevated heart rate since getting the COVID 19 Vaccine. He said he has never had an elevated heart rate before getting the COVID 19 Vaccine. He reported his heart rate is normally low, between 62-65. He said when he was at work on 28Dec2020 his heart rate was OK, but prior to going to bed that night his heart rate was 93 - 95. He said he thought at first he was just stressed. He also reported the COVID 19 Vaccine is the only thing he has taken. He mentioned that his heart rate has been down to 93, but then up to 105, and higher. He specified that he first presented with an elevated heart rate between 4:00 5:00PM on Tuesday, 29Dec2020. He said the elevated heart rate subsided enough for him to sleep later that day. He said he then started work around 10:00AM today, 30Dec2020, and felt the elevated heart rate in himself, and didn't say anything to anyone at work. He said when his heart rate got bad, it was about 12:30PM today and that today (30Dec2020) at work he didn't feel right at lunch, so he took his oxygen level and heart rate. He said his heart rate was 141. He said he called his primary care doctor, but didn't go to the emergency room. He said he doesn't have chest pain. He said he said something about his heart rate to a staff member at work, and the staff member tested his heart rate, and told him it was 141. He said he spoke to the nurse at his doctor's office, and the nurse said the doctor couldn't do much, and that he could go to emergency room or their practice's urgent care that is open until 7:00PM. He said he tried to go to the hospital emergency room, but ended up driving by because the hospital was so busy they were triaging patient's in the parking lot. The patient also experienced arm swelling and arm soreness following the vaccination on 28Dec2020. He said he could feel the soreness at the vaccine injection site when he moved his left arm. He stated that the swelling was down to his biceps and it resolved within 12- to 14 hours after the vaccination. As treatment, the patient took a generic 81 mg Baby Aspirin (UPC Number: 050428323922, Lot Number: P110657 Expiration Date: May2020) on 30Dec2020 between 3:00 and 3:30. The patient stated that the generic 81mg baby aspirin was an expired product. The clinical outcome of heart rate increased was not recovered and the clinical outcome of arm swelling, arm soreness and vaccination site soreness was recovered on 28Dec2020.
58 2021-01-12 ischemic chest pain Less than 2 days after having the 1st shot of the COVID-19 vaccine, I woke up at 2am and experienced... Read more
Less than 2 days after having the 1st shot of the COVID-19 vaccine, I woke up at 2am and experienced Bell's palsy on the left side of my face...and had minor heart pain...was dizzy...had loss of balance...slurred speech, I had all of the symptoms of a stroke. Later in that same morning the swelling starting going down, so I waited to go to the emergency room...did not want to spend the money for all of the tests. I woke up the next morning and still had heart pain, so I decided to go to emergency room .
58 2021-01-13 chest pain Tingling sensation, flu like symptoms, chest pain, sore throat, tiredness. ER visit for chest pains... Read more
Tingling sensation, flu like symptoms, chest pain, sore throat, tiredness. ER visit for chest pains, labs and testing done, heart attack ruled out. Patient reported that symptoms were result of Covid Vaccine side effects. Onset of symptoms began on 1/11/21, ER visit on 1/13/21 for chest pains, returned home on 1/13/21 after tests were completed. Patient reports feeling better.
58 2021-01-13 platelet count decreased, fainting, blood pressure increased, cerebrovascular accident He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effe... Read more
He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered. Unknown if any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension. Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product 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.
58 2021-01-19 blood glucose increased initial symptoms 1 hour post vaccine: joint pain left arm (shoulder/elbow/wrist), joint pain bilater... Read more
initial symptoms 1 hour post vaccine: joint pain left arm (shoulder/elbow/wrist), joint pain bilateral ankles and joint pain to right foot specifically 2nd and 3rd MTP, back pain and headache. Left arm pain, back pain and headache resolved within 48 hours. Patient has continued with moderate pain into right foot (2-3rd MTP joints), now with forefoot edema and erythema and continued bilateral ankle pain.
58 2021-01-21 blood pressure increased, blood glucose increased Tempeture of 101, Spike in blood pressure, Spike in sugar of 310, Pains in Joints weakness, Dizzines... Read more
Tempeture of 101, Spike in blood pressure, Spike in sugar of 310, Pains in Joints weakness, Dizziness
58 2021-01-22 chest pain Chest pain and cramping with difficulty breathing.
58 2021-01-27 heart rate increased, hypertension tingling and tongue thickness, increase HR and BP Claritin given-symptoms subsides after few minutes... Read more
tingling and tongue thickness, increase HR and BP Claritin given-symptoms subsides after few minutes Benadryl 25 mg x 2 po given as a home meds per MD
58 2021-01-28 chest pain Pt reported to Covid-19 vaccination clinic for Pfizer lot #EL3302 first dose.Reported allergy to sul... Read more
Pt reported to Covid-19 vaccination clinic for Pfizer lot #EL3302 first dose.Reported allergy to sulfa drugs and was in observation for 30 minutes. At approximately 25 minutes post vaccination at 10:15am, Pt signaled that he wanted to leave & was instructed to stay 5 more minutes. Pt anxious and began to shake, saying he could not breathe. Vitals were 147/88, HR 86, O2 98% on RA. Pt was reclined on floor and reported being cold and was striking his head on the blanket; head stabilized. Patient was alert and oriented x3, but complained of chest pain. EMS called, arrived at 10:25, Vitals: 144/92, HR83 O2 99% on 2L. Pt stable & transported to hospital by EMS at 10:35am
58 2021-01-29 loss of consciousness Severe pain in injection arm, profuse sweating on second day. A lot of vomiting causing me pass out... Read more
Severe pain in injection arm, profuse sweating on second day. A lot of vomiting causing me pass out out and be taken to the hospital via ambulance.
58 2021-01-31 fainting 24 hours after second dose. No interruption of current medications. Patient had a syncopal episode a... Read more
24 hours after second dose. No interruption of current medications. Patient had a syncopal episode after experiencing fatigue, fevers, and chills.
58 2021-02-02 enlargement of the heart, fibrin d dimer increased, oxygen saturation decreased Wheezing, Decrease in O2 saturation, Increase in RR, SOB, Temp of 99.3.Hospitalized.
58 2021-02-03 chest pain Employee reports that he awoke on Sunday morning 1/31 with "burning in the chest" that was not respo... Read more
Employee reports that he awoke on Sunday morning 1/31 with "burning in the chest" that was not responsive to his normal medication (pantoprazole). Employee is reporting that pain is still present on 2/4 but is not severe and feels "like a bruise." No other symptoms reported
58 2021-02-03 palpitations, fainting After about 15 minutes s/p injection, patient verbalized feeling his heart racing. Vital signs at 14... Read more
After about 15 minutes s/p injection, patient verbalized feeling his heart racing. Vital signs at 14:32 BP 143/83, spo2 98% on room air, HR 102. No acute distress noted. Patient stated he felt his heart racing after his first dose but it resolved without intervention. We waited about 15 minutes more for continued observation. Patient ambulated to restroom and collapsed, diaphoretic and verbalized his heart was racing. Rapid response called and patient assisted to the ED via wheelchair.
58 2021-02-04 oxygen saturation decreased, heart rate increased extreme chills; awful headache; body aches; severe sweating; low oxygen; 102 degree temperature; 120... Read more
extreme chills; awful headache; body aches; severe sweating; low oxygen; 102 degree temperature; 120 pulse rate(abnormal for me); my arm felt like it was broken (9/10), but no other problems. Twelve hours later, the pain was still 9/10".; shoulder still sore; This is a spontaneous report from a contactable 58-year-old female consumer reporting for herself A 58 years old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249) on 16Jan2021 at 23:30 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. The patient did not have medical history. Concomitant medications were not reported. The patient reported at inoculation, the injection was high on right arm, and his arm felt like it was broken (9/10), but no other problems. On 17Jan2021 twelve hours later, the pain was still 9/10 so the patient put two heating pads on the site of injection. On the same day (17Jan2021) shortly thereafter, patient also experienced extreme chills, low oxygen (94), 102 degree temperature, 120 pulse rate (abnormal for him), awful headache, body aches, then severe sweating. This peaked 8 hours later and it was gone within 24 hours. No Treatment was given for the events. At the time of rh reporting the patient informed his shoulder was much better, but still sore. Patient also informed he was positive for SARS-Cov-2 from 07Dec2020 to 28Dec2020.He had mild symptoms. The patient recovered with sequel from the events on an unspecified date.
58 2021-02-12 chest pain pain and rash at injection site, bodyaches, chest pain, fatigue, joint pain.
58 2021-02-14 dilation of blood vessels, deep vein blood clot Developed upper extremity Deep Vein Thrombosis (DVT) with complete occlusion of the Axillary and Sub... Read more
Developed upper extremity Deep Vein Thrombosis (DVT) with complete occlusion of the Axillary and SubClavian veins of the right arm. Swelling, redness of the right arm and hand. Pain in the right axilla. Visibly distended veins near the right clavicle, upper arm, forearm and hand. This occurred 2 weeks following 2nd dose of COVID vaccine. Patient has no risk factors or other known causes of DVT.
58 2021-02-16 oxygen saturation decreased, heart rate increased Immediately experienced chills; elevated pulse/heart rate and low oxygen; elevated fever; pulse/hea... Read more
Immediately experienced chills; elevated pulse/heart rate and low oxygen; elevated fever; pulse/heart rate went to 120; fever went to 102.5; and oxygen at 94. After 4 hours, metrics returned to within normal range. Weak and tired the rest of evening and into the next day.
58 2021-02-18 palpitations Flu like symptoms starting about 12 hours after vaccination that last for 2 days. Since then he has... Read more
Flu like symptoms starting about 12 hours after vaccination that last for 2 days. Since then he has noted an vague "lightheaded" sensation that is slowly improving. He has also noticed some heart palpitations.
58 2021-02-20 excessive bleeding Immediate local reaction at the injection site. Bleeding of less than 1 cc and raised 2x2 cm bump.... Read more
Immediate local reaction at the injection site. Bleeding of less than 1 cc and raised 2x2 cm bump. Benadryl and symptoms resolved.
58 2021-02-20 hypertension Onset of sweating, lightheadedness, dizziness, shakiness, about 5 minutes after vaccination. Taken t... Read more
Onset of sweating, lightheadedness, dizziness, shakiness, about 5 minutes after vaccination. Taken to medical area, BP 180/100s, HR 90, Temp normal. Exam normal except for hand tremors. Minimal liquid and no food intake in last 24 hours. POC glucose 96 a minute or two after eating crackers. Given more food and water. Initial symptoms improved but continued hand tremors and persistent hypertension to high 170s/high90s for over 1 hour, HR 70s. One BP 160s/90s HR 60 but then back to BP systolic 170s. Transferred patient to local emergency room for further evaluation. Patient reported that he was discharged from ED after several hours that evening.
58 2021-02-25 chest pain pain and rash at injection site; pain and rash at injection site; body aches; joint pain; chest pain... Read more
pain and rash at injection site; pain and rash at injection site; body aches; joint pain; chest pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 58-year-old male nurse received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Feb2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 58-year-old. Lot number was el1283. Medical history included allergy to penicillin, diabetes, Hypertension, Covid-19 (covid long haulers). Concomitant medications were unknown. On 12Feb2021, the patient experienced pain and rash at injection site, body aches, joint pain, chest pain, fatigue. The patient was not treated for the events. The patient did not recover from the events. Prior to vaccination, the patient was diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
58 2021-02-27 chest pain, chest discomfort, fast heart rate Pt developed acute onset chest tightness and difficulty swallowing about 1.5 hours after his vaccina... Read more
Pt developed acute onset chest tightness and difficulty swallowing about 1.5 hours after his vaccination, and about 10 minutes after the completion of a test dose of iron dextran. He was acutely distressed. He was treated with IV benadryl and IM epinephrine. The difficulty swallowing resolved, but chest tightness persisted. Trial of nitroglycerin did not improve his pain so pt was given IV hydromorphone. After approximately 10 minutes he was relaxed and breathing comfortably, but still endorsing chest pain.
58 2021-03-01 chest pain Pt began feeling short of breath and feverish the night after receiving vaccine, which worsened to r... Read more
Pt began feeling short of breath and feverish the night after receiving vaccine, which worsened to right-sided chest pain w/ inspiration that radiated to his back. Pt returned to work 03/01/2021 then checked into urgent care the following day d/t worsening symptoms. Patient Plan written by PAC: "At this time the nature of your pain is not clear. Your cardiac enzymes are within normal limits except for myoglobin which often goes up with skeletal muscle pain. Your BNP test which can come up with congestive heart failure is elevated slightly from your normal. We will want to recheck this in a week or so. Differential diagnoses could be skeletal muscle pain/injury, herpes zoster or shingles. (This can sometimes have sharp nerve type pain that will develop into a rash within the first 7 days.) Your rapid COVID test was negative. We are sending a PCR test out just to confirm. While awaiting test results please isolate at home. We will call you soon as results are back. Refer to Mendocino County's packet/isolation order. Your potassium level is low at 3.2. It should be 3.6. We gave you some potassium to take in the clinic. I am going to give you some to take for an additional few days. When you follow-up next week plan to have your labs redrawn." Plan Orders: SARS-CoV-2 RNA (COVID-19), QUALITATIVE NAAT to be performed. URIC ACID to be performed. The patient had the following medication order(s) completed today: Potassium Chloride 40meq PO; Toradol 15mg IVP.
58 2021-03-01 fainting Client had a full syncopal episode while getting up after his advised post vaccination observation t... Read more
Client had a full syncopal episode while getting up after his advised post vaccination observation time @0842. Client had an unassisted fall and witness said incident occurred for 45 seconds. Client was then assisted to his seat by our medical staff and evaluated. Client advised for complete medical evaluation at the ER in which he was hesitant at first, but then cooperated. Client verbalized no head trauma or hx of syncopal episodes. EMS arrived to transport client to Emergency care @ 0852.
58 2021-03-06 atrial fibrillation Within a minute of receiving vaccine I felt a very cold lump/ feeling in my throat that got worse ov... Read more
Within a minute of receiving vaccine I felt a very cold lump/ feeling in my throat that got worse over the next few minutes making it difficult to swallow. At the same time I felt very fuzzy and numb all over my face and body and very light headed. My arms and legs felt very heavy. The EMT took my blood pressure and told me it was 174/125. My normal BP is 110/60. I have had my BP taken once a month over last 20 years at my monthly pain center appointments. They hooked me up to a 4 lead cardiac monitor and said I had A -Fib. They then hooked me up to a 12 lead ekg monitor and said I didn?t have A-Fib. I have had 3 EKG?s in last year because I was scheduled to have total knee replacement surgery which was rescheduled 2 times and all 3 EKG?s were completely normal. After about 1 hour my symptoms improved to the point where I could go home. I Have had between 20-30 knee procedures over the last 40 years and my reaction to the vaccine felt exactly like I was being put to sleep by sodium pentothal or a very high dose of Versed.
58 2021-03-10 cardiac arrhythmia High level of fatigue. Fatigue and extreme tiredness seems to have triggered PVCs.
58 2021-03-12 atrial fibrillation went into AFIB 3/6/21 ....ER and inpatient from 3/6 to 3/9 No previous heart events whatsoever Ho... Read more
went into AFIB 3/6/21 ....ER and inpatient from 3/6 to 3/9 No previous heart events whatsoever Hospital cardiac nurse said she had recently been made aware of several cases of Pfizer shot leading to AFIB....said she was on a committee
58 2021-03-13 blood pressure decreased Ihave high blood pressure. I became light headed after 10 minutes of receiving vaccine. Doctor told ... Read more
Ihave high blood pressure. I became light headed after 10 minutes of receiving vaccine. Doctor told me it lowers blood pressure. My blood pressure was low all day. The next day my blood pressure was still not right and I was cold and could not warm up and it was 75 degrees in the house.I had mild spasms and twitches.
58 2021-03-14 loss of consciousness, pallor He received the vaccine at 1055. At 1108 am the patient became light headed, dizzy, and diaphoretic... Read more
He received the vaccine at 1055. At 1108 am the patient became light headed, dizzy, and diaphoretic. The patient experienced LOC for a few seconds. He did not fall during the episode. After a few minutes he was able to stand and walk to the observation area with assistance. Vitals were taken at 1110 BP was 104/57, HR 53, sat 97%. The patient's hands were clammy and he was pale at the time. He denied SOB, chest pain, or difficulty breathing. At 1122 am vitals were 134/73, HR 59, and sat 97%. He reported he felt better at that time. He called his wife to take him home so he would not have to drive. His wife arrived at 1210. The patient left in a stable condition, vitals normal, and walking without assistance.
58 2021-03-15 palpitations Pt came back into clinic on 3/16/2021 to ask if we would submit an adverse event request. Pt waited ... Read more
Pt came back into clinic on 3/16/2021 to ask if we would submit an adverse event request. Pt waited 15 minutes and had no reaction in clinic and then on drive back home pt states that his face became flush, he began having shortness of breath, and palpitations. Pt states that he pulled of onto side of road and waited approximately 15 minutes and then symptoms began to dissipate. Pt has had no further symptoms and the symptoms he states that he had were unwitnessed by medical staff at clinic. Once again pt waited till 3/16/2021 to report this to the clinic.
58 2021-03-17 blood pressure increased pt. experiencing dizziness, following the vaccination. pt. denies any other s/s. medics present. ... Read more
pt. experiencing dizziness, following the vaccination. pt. denies any other s/s. medics present. resolved with calming / comfort measures. BP 153/89. HR: 70. SP02: 96%. BG: 112; RR: 18
58 2021-03-17 cardiac arrest Respiratory and cardiac arrest about 9 hours post injection.
58 2021-03-18 fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
58 2021-03-20 arrhythmia, fast heart rate 1. Supra-ventricular tachycardia arrhythmia with cough. 3/06/21 11pm and lasted 15 days. Still somew... Read more
1. Supra-ventricular tachycardia arrhythmia with cough. 3/06/21 11pm and lasted 15 days. Still somewhat present but much less the last 2 days. 2. 102.1 fever and severe myalgia and mod-severe nausea. 03/06/21 6pm to 03/09/21 6pm about 72 hours.
58 2021-03-21 heart rate increased Clearing throat, scratchy throat, headache.
58 2021-03-22 loss of consciousness pt passed out about 2 minutes after receiving vaccine. Pt was seated when he lost consciousness, pt ... Read more
pt passed out about 2 minutes after receiving vaccine. Pt was seated when he lost consciousness, pt was initially disoriented but was fully conscious and lucid within seconds. Pt stated that he did not hit head when falling from chair, blood pressure was normal at two separate readings minutes after the incident, pt was sweaty with loss of color but was more embarrassed than anything, wife and son returned from shopping, pt felt much better and left with his wife approximately 30 minutes after receiving the vaccine. A follow-up call 4 hours after the event was made. Pt stated he was at work and felt fine.
58 2021-03-23 chest pain Pt reported having chest pain and labored breathing 10mins after the vaccine. PT was nauseous and al... Read more
Pt reported having chest pain and labored breathing 10mins after the vaccine. PT was nauseous and also felt faint. PT was also very sweaty. EMS to scene. Pt BP was 189/99. Pt was advised he needs to go to the ER. Pt refused transport and signed documents by ems. No Epi pen was given. Pt had a coworker take him to ED where he had an ACS workup. No findings. Discharged from ED
58 2021-03-27 chest pain Dizziness, chest pain, cough, subjective fever, body aches
58 2021-03-27 palpitations Dizziness, shortness of breath, cold sweats, fatigue, unsteady on feet, feeling of heart racing, sev... Read more
Dizziness, shortness of breath, cold sweats, fatigue, unsteady on feet, feeling of heart racing, severe vomiting, total exhaustion. These symptoms were severe, much worse than when I had the virus in December. I thought I was having a stroke and was minutes away from dialing 911.
58 2021-03-27 fainting, pallor, loss of consciousness Vaccinated at 12:20pm. At approx 12:34 pt told wife he felt faint, was sitting in observation area i... Read more
Vaccinated at 12:20pm. At approx 12:34 pt told wife he felt faint, was sitting in observation area in drivers seat of his own vehicle. Had brief syncopal episode witnessed by his wife with jerky motions of legs and arms lasting a few seconds. Patient awoke immediately with memory of event, was oriented and remember events leading up to being vaccinated. No incontinence. Car seat reclined. Reports no pain, pt appeared pal but no diaphoretic. BP 140/82, P 64 regular RR 14 unlabored. Oxygen sat 98%. EMS called, patient refused transport to hospital but agreed to follow up with primary care provider. Wife sis he was very anxious about his vaccine.
58 2021-03-28 fast heart rate Cold sweat, dizziness, tachycardia, headache, persists after 24 hours but not as much
58 2021-03-28 low platelet count Thrombocytopenia (CMS/HCC) Prostate cancer (CMS/HCC) Pain VOMITING DEATH
58 2021-03-29 heart attack My husband died on Feb 5. 2021. I do not know if the vaccination had any effect but he died of hear... Read more
My husband died on Feb 5. 2021. I do not know if the vaccination had any effect but he died of heart attack from Coronary Artery Disease which was unknown.
58 2021-03-29 fainting, troponin increased Syncope, sent to ER for workup and was monitored obs over night.
58 2021-04-01 blood glucose increased Blood sugar spiked to 440
58 2021-04-01 chest pain, chest discomfort Sporadic pain & tightness in chest
58 2021-04-01 chest pain 1st dose Pfizer administered at 0940 at clinic. patient experienced no reactions or symptoms during ... Read more
1st dose Pfizer administered at 0940 at clinic. patient experienced no reactions or symptoms during observation period at the clinic. Patient had been home for approximately 2 hours when he started experiencing some chest pain prior to his seizures around 1210. He does have a history of seizures which are uncontrolled ranging from having them twice a week to twice a month. patient reports the seizures were no worse than any other seizure he has had in the past. The seizures lasted periodically for approximately 20 minutes. patient reports he didn't consult with his PCP or neurologist prior to the vaccine. The patient was encouraged to seek medical treatment if symptoms persist or worsen over the next hours. He was also encouraged to reach out to his neurologists prior to the second dose.
58 2021-04-01 deep vein blood clot DVT Lower Right Leg; This is a spontaneous report from a non-contactable consumer (patient). A 58-ye... Read more
DVT Lower Right Leg; This is a spontaneous report from a non-contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), via an unspecified route of administration in the left arm on 04Mar2021 16:15 (lot number: EN6199) as a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient was not diagnosed with covid prior vaccination. On 13Mar2021, the patient had DVT lower right leg which resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event which included Warfarin/Enoxaparin. The patient has not been covid tested post vaccination. The outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.
58 2021-04-02 hypotension, hypertension, fainting Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Syste... Read more
Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild
58 2021-04-02 fainting Syncope episode; Lightheaded; This is a spontaneous report from a non-contactable nurse. A 58-year-o... Read more
Syncope episode; Lightheaded; This is a spontaneous report from a non-contactable nurse. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscularly on 19Mar2021 at 13:00 (01:00 PM) (Batch/Lot Number: ep6955) at the age of 58-years-old as single dose for COVID-19 immunization. The patient was vaccinated at a hospital. There was no other vaccine in four weeks. The patient's medical history and patient's concomitant medications were not reported. The patient experienced lightheaded/syncope episode on 19Mar2021 at 13:15 (01:15 PM). The events resulted in emergency room/department or urgent care. It was unknown if the patient received treatment for the events. The patient had no COVID prior to vaccination and has not been tested for COVID post vaccination. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event syncope episode cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
58 2021-04-04 blood pressure decreased Approximately 5 minutes after injection, patient developed CP 4/10 no SOB, no diaphoresis. Patient ... Read more
Approximately 5 minutes after injection, patient developed CP 4/10 no SOB, no diaphoresis. Patient brought to medical obs tent. VS 95% O2 Sat RA, HR 80, BP 168/102. Patient has not taken morning medications including for HTN. Pain decreased to 1/10 with no intervention during assessment. No numbness, no tingling, no dizziness, no distress. BP decreased to 148/82. Patient wishes to follow up with his PCP. Medical director consulted. Patient advised to seek 12 lead ECG assessment at local ED or with PCP. Patient will be going to PCP office at present and will go to local ED if CP returns en route. No distress noted at time of DC.
58 2021-04-04 cardio-respiratory arrest Cardiopulmonary arrest; This is a spontaneous report from a contactable physician. A 58-year-old mal... Read more
Cardiopulmonary arrest; This is a spontaneous report from a contactable physician. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscular on 14Mar2021 (12:00) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hepatitis B. The patient's concomitant medications were not reported. The patient previously took tenofovir. On 14Mar2021 (21:00), the patient had cardiopulmonary arrest. The reported event had resulted into emergency room/department or urgent care visit. The patient was hospitalized from Mar2021 to an unspecified date due to the reported event, and was reported to be life-threatening. The patient was intubated in response to the event. The patient had a negative SARS CoV-2 test both on 14Mar2021 and 15Mar2021. The outcome of the event, cardiopulmonary arrest, was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information provided and a temporal association, a causal relationship between the event cardiopulmonary arrest and BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
58 2021-04-04 hypotension, very slow heart rate Immediately following injection pt felt dizzy and became diaphoretic. Pt monitored in emergency tent... Read more
Immediately following injection pt felt dizzy and became diaphoretic. Pt monitored in emergency tent and found to have bradycardia and hypotension. With continued observation pt continued to be dizzy, diaphoretic, hypotensive and bradycardic. EMS called and found glucose to be within normal range.
58 2021-04-06 chest discomfort Fatigue, minor chest tightness, minor chest congestion, nighttime cough.
58 2021-04-06 palpitations Within 15 minutes, felt extremely tired. This was the same response when taking the 1st shot, howe... Read more
Within 15 minutes, felt extremely tired. This was the same response when taking the 1st shot, however, it didn?t seem as bad. After waiting 30 minutes, began driving home, but within 10 minutes, began to feel like heart was racing, and whole body was kind of numb feeling. I did check heart with my watch which only showed 89bpm. After another 10 minutes, I arrived home, and I was shaking uncontrollably and my hands and feet were cold. Temp was only 97.4. After another 20 minutes, the symptoms all went away.
58 2021-04-06 fainting I woke at 6:30am on 04/07/2021 in a state of complete confusion and disorientation. It was a level ... Read more
I woke at 6:30am on 04/07/2021 in a state of complete confusion and disorientation. It was a level of disorientation I have never experienced before in my lifetime. I fainted one time and was having extreme difficulty getting my bearings and walking and was simply in total "mental disarray". I was having difficulty producing words, a prolonged stutter, you might say. I was shaking. The local paramedics came and I was taken to the local ER. Because I was having difficulty speaking, the paramedics (and later the physicians) thought I might have had a TIA. An MRI on 04/07/2021 at 5pm produced a negative result. So i can only attribute my reaction to the vaccine. It was very significant, and i thought it made sense to report it.
58 2021-04-07 pulmonary embolism, blood clot Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each... Read more
Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 21Feb2021 14:00 (at the age of 58-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and it was unknown if the patient has been tested for COVID-19 since the vaccination. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient had no concomitant medications received within 2 weeks of vaccination. On 10Mar2021 at 11:30 AM, the patient experienced massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung). The patient was hospitalized for the events for 4 days. The events were also considered as life-threatening. Therapeutic measures were taken as a result of massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung) which included intravenous anticoagulants and injected anticoagulant. The patient was recovering from the events. Information about the lot/batch number has been requested.
58 2021-04-09 hypertension, cerebrovascular accident I hadn't been feeling well. Called my Doctor the day after receiving the shot and made an appointmen... Read more
I hadn't been feeling well. Called my Doctor the day after receiving the shot and made an appointment for the first available time (Friday April 2). On Thursday morning I was having vision problems, high blood pressure, weakness on left side. I was rushed to the hospital administered tPA and was diagnosed with a stroke.
58 2021-04-09 loss of consciousness passed out/unconscious; feel weak; dizzy; not normal; This is a spontaneous report from a contactabl... Read more
passed out/unconscious; feel weak; dizzy; not normal; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 26Mar2021 09:45AM (Lot Number: ER8730) as single dose for COVID-19 immunisation. The patient had COVID prior vaccination. The patient had no other medical history or known allergies. The patient's concomitant medications were reported as none. The patient did not have COVID test post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking the vaccine the patient waited for 15 minutes prior to departing the facility in order to make sure there was no adverse reactions. At approximately 10:15 10:30 AM the patient drove back home. After driving for about five minutes while stopped at a traffic light the patient completely passed out at 10:45, he was unconscious for approximately 2 to 3 minutes, almost crashed his car and EMT support had to be called. The patient regained his conscience but it took him over a half hour to feel 50% better. Until 8:30 PM 26Mar2021, the patient still felt weak and dizzy and not normal. No treatment was received for events. The outcome of events was recovering.
58 2021-04-11 chest pain Pt reports beginning to feel ill on 4/5/21 with flu-like symptoms (body aches, muscle pain, fatigue,... Read more
Pt reports beginning to feel ill on 4/5/21 with flu-like symptoms (body aches, muscle pain, fatigue, and chest pain when deep breathing). Saw PCP on 4/6/21 and was sent to hospital for chest X-ray. Pt states that X-ray was normal but PCP treated for pneumonia with antibiotics based on symptoms.
58 2021-04-11 excessive bleeding COUMADIN LEVEL 8.0 PLUS. STOPPED TAKING COUMADIN FOR THREE DAYS. TOOK 1 VITAMIN K TAB 400MCG ON 4/9 ... Read more
COUMADIN LEVEL 8.0 PLUS. STOPPED TAKING COUMADIN FOR THREE DAYS. TOOK 1 VITAMIN K TAB 400MCG ON 4/9 AND 4/11. ATE LEAFY GREENS FOR 3 DAYS. INR VALUE 4/12 2.4. RED MARKS AND BRUISING AT INJECTION SITE AND ON BOTH FORE-ARMS. NICKED MYSELF SHAVING, TOOK 48 HOURS FOR BLEEDING TO STOP. NO BLOOD IN URINE OR STOOL. JOINTS ACHE REALLY BAD, TAKING 1000MG TYLENOL EVERY 8 HRS, MUSCLES ACHE REALLY BAD, BESIDES TYLENOL, MASSAGING AFFECTED MUSCLES. LOTS AND LOTS OF PAIN
58 2021-04-12 blood clot 58 year old white male with history of blood clots developed symptoms of leg pain during 4/11 early... Read more
58 year old white male with history of blood clots developed symptoms of leg pain during 4/11 early am . pt received COVID vaccine on 4/8 developed leg pain on 4/11 early am and went to er and was advised he was clotting in leg at point of previous procedure. he was given eliquis and was told to follow up with specialist
58 2021-04-13 deep vein blood clot Acute DVT of right lower extremity, diagnosed via venous duplex of lower extremity. Presented to Eme... Read more
Acute DVT of right lower extremity, diagnosed via venous duplex of lower extremity. Presented to Emergency Room on 4/5/21 with right leg swelling.
58 2021-04-13 hypotension, loss of consciousness Patient received pfizer vaccine, sitting for observation for 15min and observed by next patient, who... Read more
Patient received pfizer vaccine, sitting for observation for 15min and observed by next patient, who alerted pharmacist, that he passed out, dropped phone/papers, and shakes. Pharmacist about to administer epipen but he regained consciousness in seconds, alert and stated dizzy, drank water given to him. 911 called and paramedic came to check him. BP is low, he's brought out in strecher to hospital(?) for evaluation. Wife came to pharmacy later to inquire since she got call from him being in hospital for observation. Wife stated that he is nervous about needles, vaccination
58 2021-04-13 heart attack Blood clotting resulting in blockage of LAD artery, precipitating an Myocardial Infarction.
58 2021-04-13 bleeding on surface of brain Pfizer-BioNTech COVID-19 Vaccine EUA Intense pain behind left eye then left side of head while runni... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Intense pain behind left eye then left side of head while running/exercising. Went to emergency room within an hour had CT scan verifying acute subatachnoid hemorrhage. MRI, Angiogram and Ultrasounds of the head and neck were also performed.
58 2021-04-14 chest discomfort, palpitations Anaphylaxis x- scratchy throat at +10 mins x- swollen tonsils at +15 mins x- difficulty swallowing a... Read more
Anaphylaxis x- scratchy throat at +10 mins x- swollen tonsils at +15 mins x- difficulty swallowing at +20 mins x- voice changed noticably at +30 mins, subsequently lost x- Some heart palpitations and chest tension at +45 mins x- Angiodema of right eye +90 mins
58 2021-04-14 deep vein blood clot, palpitations, pulmonary embolism, very slow heart rate, troponin increased DVT behind the right knee that developed 3-4 days after the vaccination. I then developed a pulmona... Read more
DVT behind the right knee that developed 3-4 days after the vaccination. I then developed a pulmonary embolism on 01/01/2021.
58 2021-04-15 chest pain Became like a case of pleurisy with debilitating pain & chest pain -many labs taken, X-rays , CAT S... Read more
Became like a case of pleurisy with debilitating pain & chest pain -many labs taken, X-rays , CAT SCAN, for lungs, In ER.... over $7.000 with more expenses for 5 dr. Appt. post vaccine Difficulty with breathing - unable to sleep - continued pain-dr. Called today - 4/16/21 Begin antibiotic
58 2021-04-16 hypertension Had bad headache one week after taking Pfizer covid vaccine. 3 days later went to ER due to severe h... Read more
Had bad headache one week after taking Pfizer covid vaccine. 3 days later went to ER due to severe headache and high blood pressure. was diagnosed with Shingles in ER.
58 2021-04-16 ischaemic stroke, hypertension confusion reported by family since the covid vaccine was administered - came to hospital ED 7 days l... Read more
confusion reported by family since the covid vaccine was administered - came to hospital ED 7 days later and multiple acute ischemic strokes were identified. also noted to be hypertensive and diabetic, previously undiagnosed.
58 2021-04-17 cardiac arrhythmia, heart rate irregular, chest discomfort, chest discomfort, heart rate irregular, cardiac arrhythmia Cardiac symptoms, iirregular heartbeat, chest tightness, nausea. Urgent Care, Emergency room and car... Read more
Cardiac symptoms, iirregular heartbeat, chest tightness, nausea. Urgent Care, Emergency room and cardiologist. Various Tests and medication.
58 2021-04-18 fainting, pulmonary embolism The patient had previously been diagnosed with COVID-19 in November 2020, but did no require hospita... Read more
The patient had previously been diagnosed with COVID-19 in November 2020, but did no require hospitalization and had recovered. He received his first dose of the Pfizer COVID vaccine on 2/25/2021, and on 3/15/2021, collapsed suddenly at home and was unable to be resuscitated. An autopsy was performed at the request of the family, and a massive pulmonary embolus was found in the main pulmonary artery and extending far into the segmental pulmonary arteries of both lungs.
58 2021-04-19 haemoglobin decreased Day after first vaccine (Tuesday March 30) was administered, developed severe headache, chills, neck... Read more
Day after first vaccine (Tuesday March 30) was administered, developed severe headache, chills, neck pain, and slight abdominal cramp. By Friday April 2, severe abdominal cramp, headaches, nausea, slight high temperature. Persisted throughout the whole weekend. Called in sick Tuesday April 6 for abdominal cramp, temperature, confusion - admitted to ER.
58 2021-04-19 hypertension Vaccine 4/5/21. Fever and fatigue 4/6/21. Better 2 days later. Started feeling ill Wednesday 4/14... Read more
Vaccine 4/5/21. Fever and fatigue 4/6/21. Better 2 days later. Started feeling ill Wednesday 4/14/21. Went to the Doctors 4/16. They treated as sinus infection. Sunday 4/18 started rash - Clinic gave shingles medication. Went to Optomologist and Medical MD on Monday 4/19/21. Shingles on face left side, eye, eyelid, head, swelling. Cornea 3 lesions. Scrip for eye medication also. First shot on 3/13 no reaction, only a little tired the next day, fully functional.
58 2021-04-20 hypertension, platelet count decreased, cerebrovascular accident Patient presented to ED with complaint of right sided facial droop accompanied by numbness and tingl... Read more
Patient presented to ED with complaint of right sided facial droop accompanied by numbness and tingling. The patient went to bed at 0700 after working third shift with no symptoms and awoke at 1400 with these complaints. Patient was hypertensive at ED presentation. Patient was diagnosed with stroke and admitted to the hospital. Patient received clopidogrel (loaded with aspirin per self at home PTA).
58 2021-04-21 chest pain After vaccination approximately 10min, client was noted to have reddened face and stressed appearanc... Read more
After vaccination approximately 10min, client was noted to have reddened face and stressed appearance and then post administration monitor called for health care assistance. Nurses responded with O2 and emergency cart. Client reported unable to swallow. Client status changed deeper reddened/dusky skin and assisted to the floor. At 3:27pm administered epipen and O2 also applied via simple mask at 10L/min. VS continuously monitored. At 3:32pm administered 2nd epipen due to client status continuing to decline. Client reported yes to question of chest pain with deep breaths, unable to speak. 911 was called at 3:26pm. EMT arrived at 3:35 and assumed care. Client transferred to facility. Spouse present throughout event and Additional information for Item 18: ambulated off floor with EMT.
58 2021-04-22 blood glucose increased He got the vaccine, had no reaction at all. After 4 days he noticed it was messing with his blood s... Read more
He got the vaccine, had no reaction at all. After 4 days he noticed it was messing with his blood sugar. He had a lot of sweats, itching, high levels up to 396 and lows to 48 within the last 2 days. Today so far he seems to be okay other than blood sugar of 340. He did call his doctor who told him to take an extra pill and then to reread it at noon and call him back.
58 2021-04-22 cerebrovascular accident Aschemia. Stroke. Paralysis on the left side of the body.
58 2021-04-22 pulmonary embolism Patient presented with pleuritic chest pain on 4/12/21 and was diagnosed with multiple pulmonary emb... Read more
Patient presented with pleuritic chest pain on 4/12/21 and was diagnosed with multiple pulmonary embolisms. He was treated with heparin drip and discharged on Eliquis.
58 2021-04-23 chest pain Intense tingling on palms and bottom; chills; weakness; stomach pain; chest pain; low grade fever; n... Read more
Intense tingling on palms and bottom; chills; weakness; stomach pain; chest pain; low grade fever; needed bed rest; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received first dose of BNT162B2 (BNT162B2), Via an unspecified route of administration, administered in Arm Right on 09Jan2021 08:30 (Batch/Lot Number: EK9231) as single, dose 2 via an unspecified route of administration, administered in Arm Right on 30Jan2021 (Batch/Lot Number: EL9262) as single for covid-19 immunisation. The patient Medical history included glaucoma, asthma, hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications included simvastatin (SIMVASTATIN); atropine (ATROPINE); dorzolamide (DORZOLAMIDE); escitalopram oxalate (LATA) taken for an unspecified indication, start and stop date were not reported. The patient experienced intense tingling on palms and bottom (paraesthesia), chills (chills), weakness (asthenia), stomach pain (abdominal pain upper), chest pain (chest pain), low grade fever (pyrexia), needed bed rest (bed rest) on 09Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Feb2021. Therapeutic measures were taken as a result of intense tingling on palms and bottom (paraesthesia), chills (chills), weakness (asthenia), stomach pain (abdominal pain upper), chest pain (chest pain), low grade fever (pyrexia), needed bed rest (bed rest). The outcome of events was recovering.
58 2021-04-23 hypertension Initial symptom was swollen lymph nodes in left armpit--where I got the shot. I am informed enough t... Read more
Initial symptom was swollen lymph nodes in left armpit--where I got the shot. I am informed enough to know this means I had active antibodies that recognized the virus and attacked it. This lasted approximately 4 days. After day 2, this began where I am today; occasional vertigo/loss of balance with persistent high blood pressure/headaches consistent with when I contracted Covid 11/2020. I have been to my primary doctor twice. The possibility of this being a vaccine reaction has never come up. It is as if I have the headache/blood pressure portion of Covid infection all over again. There is no outcome yet. Having read other people's comments, it is a waste of time and money to get diagnostic tests, and physicians are guessing. No thank you, I learned of these symptoms and this website from the many internet forums (one is listed above) where people are discussing their vaccine reactions. I never wanted this vaccine, but there is considerable pressure to get vaccinated, even when you contracted the virus. I feel vaccine passports are going to be forced on people. I regret the decision to do this. My second shot is scheduled for 4/30, but I am cancelling it, I am certain this is Covid vaccine related. I am a very healthy and physically fit 58 year old that eats well. Don't drink, don't smoke, mainly vegetarian diet.
58 2021-04-24 blood pressure decreased Full blown seizure; Fatigue; Confusion; Breathing was off; breath was heavier; patient's blood press... Read more
Full blown seizure; Fatigue; Confusion; Breathing was off; breath was heavier; patient's blood pressure was very low; Real sluggish/get slow; Speech started to get slow; This is spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734) via an unspecified route of administration in left arm on 04Apr2021 12:00 at age of 58-year-old at single dose for COVID-19 immunization. It also stated the patient was one of the most vulnerable against virus so he took the Covid-19 Vaccine. Medical history included ongoing cardiac failure congestive diagnosed probably 10 years ago, ongoing diabetes mellitus diagnosed probably 20 years ago, ongoing dialysis for 3.5 years. Concomitant medication included ongoing unspecified blood thinner. Caller reported that the patient didn't take any blood pressure medications and that she knew the patient took a blood thinner. Caller unable to provide further detail for the patient's medications as she doesn't have the patient's list of medications with her. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7534) injected in left arm in Mar2021 at age of 58-year-old for COVID-19 immunization and experienced fatigue after the first dose of the Covid-19 vaccine. Caller reported that it was hard to determine the cause of the fatigue because the patient was on dialysis, but that the patient has been more fatigued since he received the first dose of the Covid-19 vaccine. The patient was a compromised fellow with a host of pre-existing conditions as far as heart disease, diabetes, and dialysis. Caller was calling in regard to the Pfizer Covid-19 vaccine. Caller reported that she was calling to report a bad reaction that her husband, the patient, received on Sunday, 04Apr2021, following his second dose of the Covid-19 vaccine. Approximately 3 hours after receiving the Covid-19 vaccine, the patient had a full blown seizure at 15:00 on Sunday, 04Apr2021. Caller reported that she had to call emergency responders following the patient's seizure. The patient was doing better but the experience with his seizure was quite traumatic. Caller stated that if it was going to happen, it was going to happen to us. About 3 hours after receiving his Covid-19 vaccine on 04Apr2021, the patient became real sluggish and his speech started getting slow before the seizure occurred. Caller reported that the patient made a gradual descent downwards. Caller reported that she swears the patient has not been the same as far as fatigue goes since the patient received his first dose of the Covid-19 vaccine 3 weeks prior. Caller reported that she thought the fatigue was maybe from dialysis. The patient started to get slow just before the seizure, about 2.5 hours after he received the second dose of the Covid-19 vaccine. The patient was laying down following the second dose of the Covid-19 vaccine. Caller reported that the patient's breathing was off. The patient's breath was heavier. Caller reported that after she noticed the patient's breathing was off, she asked the patient if he was ok. Caller reported that this is when she noticed that the patient's speech was really slow and that he was experiencing confusion. The patient has had no more seizure activity. The patient was still being monitored in the hospital. Caller reported that the patient didn't remember any of it. It's hard to say if the patient's sluggishness and fatigue were ongoing. Caller reported that she couldn't go see the patient while he was in the hospital but that the patient's voice sounds much stronger. For Confusion and Speech: Caller reported that the patient seems to be back/ returned to normal. Caller reported that she knew that the patient's cardiologist went to see the patient. The patient's cardiologist said that there was nothing that happened to the patient's heart, that what the patient experienced was not a heart issue, and that the event had no effect on the patient's heart. The medical staff stated that the seizure the patient experienced was related to a blood pressure drop. Caller reported that the patient's blood pressure was very low on 04Apr2021. The patient required a visit to Emergency Room for event seizure, no visit of physician office. Admitted on Sunday, 04Apr2021 for seizure, and still hospitalized. For investigations: Caller reported that the medical staff at the hospital definitely did lab work but she was not sure if any imaging was performed. Caller reported that she has no results available for tests that were performed. The outcome of events confusion and "speech started to get slow" was recovered in Apr2021, the outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021380129 same patient, different product(dose)/event
58 2021-04-24 chest pain, heart rate irregular Felt like all my nerve endings were being electrified while on Fire; I could not keep down food for ... Read more
Felt like all my nerve endings were being electrified while on Fire; I could not keep down food for 10 days. Then, could not keep down liquids for 3 days then went to the E/R; High Clotting Factor; dehydration; chest pains/Had pains in my heart also; Heart was not beating correctly; body cramps all over; High temperature along with sudden chills; High temperature along with sudden chills; frequent sweats; Extreme pain; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left arm on 06Apr2021 at 07:00 PM, at single dose for COVID-19 immunisation. The patient had medical history of fibromyalgi, anxiety and allergy to all anti-depressants. The concomitant medication included clonidine once a day for anxiety. It reported that, on 07Apr2021 at 8:00 AM, patient experienced extreme pain felt like all nerve endings were being electrified while on fire such extreme pain ever since the vaccine. After 10 days he could not take it anymore. Patient could not keep down food for 10 days. Then, could not keep down liquids for 3 days then went to the E/R. Had a high clotting factor along with dehydration and chest pains. Heart was not beating correctly, and they were worried his blood would clot, heart attack, aneurism and death. He had pains in heart also, body cramps all over. High temperature along with sudden chills and frequent sweat. Contact the ICU ward at for all the details on the problem vaccine caused. The all adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Patient hospitalized for the 2 days and treated with the morphine for pain, 5 bags of Saline and blood Thinner. Vaccination facility: Pharmacy or Drug Store. Patient did not take any other vaccine in four weeks. There was no COVID prior vaccination and COVID tested post vaccination (Nasal Swab, result negative) on 16Apr2021. Information about lot/batch number has been requested.
58 2021-04-24 loss of consciousness Four hours later he passed out/ Four hours after getting vaccine he was on the floor and out like a ... Read more
Four hours later he passed out/ Four hours after getting vaccine he was on the floor and out like a light; Sore right arm; goofy; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 58-years-old intramuscular, administered in Arm Right on 04Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation and prophylaxis. Medical history included high cholesterol, allergy (When pollen is heavy, it is worse) from an unknown date and unknown if ongoing, fractured his shoulder in 05Feb2021, sinus jacked up from an unknown date and unknown if ongoing, covid-19 from Nov2020 to an unknown date, anemic from Dec2020 to an unknown date, nasal surgery on an unknown date, fever blisters from an unknown date and unknown if ongoing, immune system disorder from an unknown date and unknown if ongoing. Concomitant medications included zolpidem tartrate (AMBIEN) taken to help sleep; atorvastatin (LIPITOR) taken for high cholesterol; loratadine taken for allergy; cetirizine hydrochloride (ZYRTEC) taken for allergy; mometasone furoate (FLONASE) taken for allergy; start and stop date were not reported for all; fish oil (OMEGA 3) and selenium (SELENIUM) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D3 1000) taken for immune system disorder; iron (IRON) taken for anaemia; lysine taken for fever blisters ; zinc taken for immune system disorder, start and stop date were not reported for all and multivitamin. It was reported that four hours after getting vaccine on 04Mar2021, he was on the floor and out like a light. This is the first one he received and his doctor said not to get second one. He had the first one and about 4 hours later, he was on the kitchen floor and out like a light. He doesn't know if it was connected to shot or not. He never had problems before. He got the vaccine around 09:30 and around 13:30, his friend came in for lunch and found him on the floor. She freaked out. She said she liked to never got him awake and said he was goofy for a good half hour. He does not know how long he was on the floor. His arm was sore on 04Mar2021 09:30 for about 4 days. The patient underwent lab tests and procedures which included blood iron: so low on an unspecified date. The patient was recovering from passed out and sore arm while recovered from goofy on 04Mar2021.
58 2021-04-28 cerebrovascular accident On or about April 14, 2021 patient yelled out to a friend to come help him. Patient stated that he "... Read more
On or about April 14, 2021 patient yelled out to a friend to come help him. Patient stated that he "could not see or move". The friend called the ambulance and patient was taken to hospital. One of the doctors tending to patient told me patient had several strokes (over 5). These strokes have left him blind and incapacitated. He is still currently at hospital.
58 2021-04-28 deep vein blood clot DVT in right leg; Swelling in right leg; Discomfort in right leg while walking; This is a spontaneou... Read more
DVT in right leg; Swelling in right leg; Discomfort in right leg while walking; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 10Mar2021 at 16:30 (batch/lot number: EN6208) as a single dose for COVID-19 immunisation (wanted the protection). Medical history included deep vein thrombosis (DVT) from Jul2018 and ongoing. No family medical history relevant to the adverse events. Concomitant medication included warfarin taken for maintenance level for history of DVT from Aug2020 and ongoing. The patient experienced DVT in right leg on 02Apr2021, swelling in right leg on 15Mar2021 and discomfort in right leg while walking on 15Mar2021. The patient reported that he had a reaction to the COVID-19 vaccine and he believes that it was directly related to the COVID-19 vaccine. He reported that he has a history of blood clots in his right leg going back to 2018. He reported that his most recent DVT was in Aug2020 and he was cleared in Nov2020. He reported that he received the COVID-19 vaccine on 10Mar2021. He reported that on 15Mar2021, he started to notice his right leg swelling. He reported that he called his physician on 29Mar2021 and that his physician ordered an ultrasound. He reported that he had the ultrasound on 02Apr2021 and a deep vein thrombosis was found again. Swelling in right leg: he reported that the swelling has gone down. He reported that the reason that he mentioned that he has a history of blood clots was because of his warfarin dosage. He reported that he was first diagnosed with a deep vein thrombosis in Jul2018. He reported that he went through that cycle and that his maintenance level of warfarin was maybe 10 or 12 mg of warfarin per day. He reported that he had another deep vein thrombosis in Aug2020, and since Aug2020 he has been on 17 mg of warfarin daily. He reported that the blood level on warfarin maintenance was supposed to be between 2 and 2.5. He reported that now because of the deep vein thrombosis he experienced in Aug2020, his doctor wanted his level to be at 2.5 to 3.5. He stated that he doesn't think that at that blood level for his warfarin that he should have gotten a blood clot. He reported that something compromised or interfered with the warfarin, resulting in a deep vein thrombosis. Discomfort when walking: he reported that it feels like his leg was compressing. He reported that the discomfort seems to have gotten better. He was queried for details of warfarin prescription. He reported that the 10 or 12 mg warfarin tablets that he had been taking when the blood clot was diagnosed in Aug2020 have been consumed and he no longer has the bottle. He reported that he did not have the bottle with him for his current warfarin prescription. He reported that the warfarin was not auto-refilled by the pharmacy. He reported that the warfarin was only prescribed a week or two at a time. Investigations: he reported that since Aug2020 when the deep vein thrombosis returned, he started doing self INR tests at home. He reported that he constantly self-monitors his INR at home and his levels were consistently at 3.0 to 3.1. He reported that he monitors his INR at least once a week, sometimes twice a week depending on how he feels. He reported that sometimes his INR goes over 4 and he can feel it. He reported that his system was a little off when it feels too high so he knows how to adjust. He reported that he last checked his INR today, 15Apr2021, and that it was 4.0. He reported that he typically checks his INR on Wednesday. He reported that he keeps a log of his INR levels. He reported that he did not see his physician on 29Mar2021, but that he called his physician and his physician wrote a prescription for the caller to get an ultrasound. Vaccination facility type was pharmacy. Vaccine was not administered at military facility. The adverse events did not require a visit to the emergency room and physician office. No prior vaccinations (within 4 weeks). He reported that he doesn't usually get vaccines. BNT162B2 second dose (lot number: ER5729) was administered on an unspecified date; anatomical location: left arm. The outcome of the events was recovering.
58 2021-04-28 low blood oxigenation, blood glucose increased 57 y/o male, with past medical history of Liver Transplant, damage to the Left Base of the Lung, Ast... Read more
57 y/o male, with past medical history of Liver Transplant, damage to the Left Base of the Lung, Asthma, HTN, DM, Pneumonia (currently), Psych history (undisclosed), Induced Coma, Kidney and Liver Failure, who presents with dizziness and shortness of breath onset post vaccination. Patient states that this is his second dose in the two-dose series, received to the left arm. Patient states that after the first Pfizer vaccination he had some discomfort to the site, but no other reaction. NP and Paramedics at patient side. Patient legs were elevated and initial vital obtained. Patient was noted to be Hypoxic, oxygen saturation was 88-89% on RA. When asked if patient uses oxygen, he stated that yes but didn?t bring it here to the facility. Patient all other vitals within normal limits (132/73 BP, 85 P, 14 Resp). Patient noted to be Hyperglycemic at 242, patient states that he did not take his diabetes medication this am. At this time, patient was placed on 2 L of O2 by NC. Patient saturations did not improve (91%), so O2 increased to 4 L by NC with no improvement. Patient now discloses that he currently has a lung infection and is being treated with antibiotics, which he has started today. Patient states that he has pneumonia but that he was recently tested for Covid with a negative result (no documentation provided). It was determined by the NP that patient needed to be transported to the ER. Patient is unstable, hypoxic, hyperglycemic, currently being treated for lung infection and has an extensive medical history. Fire rescue arrived to site and also explained to patient that its in his best interest to be transported, patient refusing. Patient signed Against Medical Advice and patient was transported to his personal vehicle via stretcher. Due to patient refusing to be transported by Fire Rescue, the NP also had patient sign an AMA form for site. CNO and PM aware.
58 2021-04-28 transient ischaemic attack Suspected TIA; Experienced a numbness in right hand, arm, drooping right side of face; Experienced a... Read more
Suspected TIA; Experienced a numbness in right hand, arm, drooping right side of face; Experienced a numbness in right hand, arm, drooping right side of face; slurred speech; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose in right arm on 05Mar2021 14:30 (Lot: EN6199) and second dose in left arm on 26Mar2021 14:30 (Lot: ER8732); both via an unspecified route of administration (at the age of 58-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included allergy induced asthma and seasonal allergies. The patient's concomitant medications were not reported. The patient experienced a numbness in right hand, arm, drooping right side of face and slurred speech, it lasted for 1-2 minutes. The patient went to the ER. Suspected TIA. These events started on 11Apr2021 at 10:00. The events resulted in emergency room/department or urgent care. The patient received unspecified treatment for the events. On 10Apr2021, nasal swab was negative. On 11Apr2021, Covid test type post vaccination with unknown results, rapid and nasal swab was negative. It was reported that the patient had MRI, CT, EKG with unknown results on unspecified dates. The outcome of the events was recovering.
58 2021-04-29 pallor Nausea, sweating, pale. Given water and crackers. BPs 142/78 (pulse 75), 144/76 (pulse 74), O2 sat 1... Read more
Nausea, sweating, pale. Given water and crackers. BPs 142/78 (pulse 75), 144/76 (pulse 74), O2 sat 100%.
58 2021-04-30 chest pain chest pain/a little worse; It feel sore every time I move from one side to another/Sore/Hurts when h... Read more
chest pain/a little worse; It feel sore every time I move from one side to another/Sore/Hurts when he coughs; It hurts when I cough; Short of breath; This is a spontaneous report from a contactable consumer (Patient). A 57-year-old male patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solu-tion for injection, lot number: Solution for injection, lot number: EW0164, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration in left arm on 19Apr2021 18:00 (at the age of 58-year-old) as single dose for COVID-19 immunisation (for Covid-19). The patient had no medical history. There was no family history. The patient did not take concomitant medications. There was no previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on the same date as the Pfizer vaccine. Patient did not receive prior vaccinations (within 4 weeks). Patient experienced chest pain/a little worse on 19Apr2021, It feel sore every time I move from one side to another/Sore/Hurts when he coughs, It hurts when I cough, short of breath on an unspecified date in Apr2021. Patient stated he have received the first Pfizer shot and experienced chest pain. It feel sore every time he move from one side to another. It hurts when he cough." It was informed to patient that chest pain has not been reported with the vaccine. However, muscle and joint pain has been associated with the vaccine. Please seek medical advice if your symptoms persists or get worst. Chest pain is a symptoms that should not be ignored. Chest pain started late last night and its still sore, it hurts, the same, it was a little worse this morning, but he's laying down not moving around, so it still feels the same, verified as persisting. He did not treat the symptoms in any way. States he said he is going to take some Advil. Any adverse event did not require a visit to emergency room or physician's office. There were no relevant tests. The outcome of event for chest pain/a little worse was not recovered and for other event it was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
58 2021-05-01 chest pain Patient received his first dose of COVID vaccine on 4/16/21, and he developed nausea, occasional che... Read more
Patient received his first dose of COVID vaccine on 4/16/21, and he developed nausea, occasional chest pains, dyspnea, and fever ~ 4/21/21. Patient tested positive for COVID on 4/23/21 and his symptoms progressively worsened until he presented to the ED on 5/1/21. Patient was admitted to the hospital for COVID treatment, but was discharged on 5/2/21 since his symptoms rapidly improved.
58 2021-05-01 pulmonary embolism, deep vein blood clot dvt, pulmonary embolism
58 2021-05-01 pulmonary embolism Diagnosed with pulmonary embolism on 4/28/21, 11 days after receiving the 2nd dose of the vaccine.
58 2021-05-02 blood pressure increased, palpitations PERNICIOUS PALPITATIONS (RACING HEARTBEAT, 130/MIN?), ABOUT 5 EPISODES IN 5 HOURS. THE SECOND EPISOD... Read more
PERNICIOUS PALPITATIONS (RACING HEARTBEAT, 130/MIN?), ABOUT 5 EPISODES IN 5 HOURS. THE SECOND EPISODE WAS THE WORST. ELEVATED BLOOD PRESSURE (180/110?) DURING PALPITATIONS. OVERALL DISCOMFORT IN WHOLE BODY. STAYED IN EMERGENCY ROOM FOR ABOUT 5+ HOURS. EVEN AFTER DISCHARGE, MUCH MILDER EPISODES LASTED THROUGHOUT THE NIGHT. EMERGENCY ROOM TREATMENT WAS ONLY SALINE. PATIENT TOOK 160 MG MAGNESIUM AFTER SECOND EPISODE. AT HOME PATIENT TOOK SOME MORE MAGNESIUM (~50 MG) AND VERAPAMIL (~60MG). 30 HOURS AFTER THE INCIDENT, MOSTLY RECOVERED BUT FEELING WEAK.
58 2021-05-02 cerebrovascular accident stroke on 3/8/2021. 2nd dose was 1/4/2021
58 2021-05-02 palpitations, fast heart rate, hypertension Systemic: Hypertension-Severe, Systemic: Tachycardia-Severe, Additional Details: Patient has history... Read more
Systemic: Hypertension-Severe, Systemic: Tachycardia-Severe, Additional Details: Patient has history of PAT (tachycardia) and heart palpitations and is history of Verapamil per patient. He was not feeling well after the shot and we observed him and had the minute clinic nurses come to take his blood pressure and heart rate. He was feeling heart palpitations after the shot. After the nurse took the blood pressure he felt better and his palpitations slowed down so we had him sit again. He had palpitations again nurse call 911 paramedics took pt to hospital
58 2021-05-03 chest discomfort Chills; fever; body aches; painful lump in armpit; chest fullness/discomfort; hard to take a deep br... Read more
Chills; fever; body aches; painful lump in armpit; chest fullness/discomfort; hard to take a deep breath; fatigue.
58 2021-05-04 blood pressure increased, blood glucose increased Onset of moderate to severe dizziness, immediately followed by tingling sensation, then severe numbn... Read more
Onset of moderate to severe dizziness, immediately followed by tingling sensation, then severe numbness on entire left side of face (left lips) and entire outside left side body, from head to toes. Face, neck shoulder, arm, torso, leg, foot and toes
58 2021-05-04 blood clot Blood Clot discovered in my leg my Wednesday April 27. Incredible amounts of pain. By May 5 pain cau... Read more
Blood Clot discovered in my leg my Wednesday April 27. Incredible amounts of pain. By May 5 pain caused by unknown bruise on foot on same leg.
58 2021-05-05 atrial fibrillation Atrial fibrillation at 11:45pm on 4/14 resulting in carioverson at 2:00am in 4/15
58 2021-05-07 cerebrovascular accident, chest pain, heart attack I don't know it is stroke or something; heart burn something; its like I am having a heart attack; f... Read more
I don't know it is stroke or something; heart burn something; its like I am having a heart attack; feeling crappy/ feeling funny/ I can feel like the drug was inside me like something was changing/ something happening with my body; Headache/ slight headache; Chest pain/ I can feel a pain where my heart is; arm was sore; heart burn; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 09Apr2021 at a single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 18Mar2021 for COVID-19 immunisation (left arm). Patient stated, "the second was really bad my arm was sore for like over a week I mean it was sore. I don't know I have not felt the same since. I can feel like the drug was inside me like something was changing and I never had no problem for anything but now its been like at the last when I got the shot was 9th of April of this month, its been like 2 weeks now almost and it is like I feel crappy. I have headache I have like a chest pain u know in my chest. I have like my heart is I don't know its like I am having a heart attack or something I don't know it is stroke or something. I do not know it is feeling funny. I have no problem I do, may be I have may be heart burn something. I don't know because on every single day everyday I have chest pain my heart, headache I have slight headache now. I don't know why I can feel a pain where my heart is on left side now I got the pain on right side you know I have the pain there and I wondering what's going on so I don't know". Consumer stated, "First its both side that is what I am saying now right now so as I am talking to I have pain in my heart and like it feels the heart u know I don't know there is a weird thing in my heart. I feel like you have a heart attack or so, I you feel like a chest pain or you had a heart burn or something and then on my right side has started it is like something happening with my body you know now its the right side. I don't really know, I can feel me liver, my kidneys are like something is like I can feel something is going I don't know what's going on with my body. You know after getting the shot right now I have the slight headache. I took a quite couple of Tylenol as stuff but that seems like no. This every single day you know that you I thought it will go away but it did not go away". Consumer stated, "Yes, it is the first time. Like I said I thought it will go away but it is not getting any better. I am getting concerned. I do not know I have to be admitted to hospital. I do not have no insurance or anything. I am really worried." The patient hasn't been to the doctor, he was calling first for help. He has no insurance so he cannot just go to the doctor. Consumer stated, "It never improved no. Persisting." Outcome of the events was not recovered. Information on the lot/batch number has been requested.
58 2021-05-07 palpitations Patient received vaccine around 5:15 pm on 4/13/21 and later that night he experienced small tremors... Read more
Patient received vaccine around 5:15 pm on 4/13/21 and later that night he experienced small tremors in both arms, shortness of breath, and a pounding heart. All symptoms lasted about 3 days. He did not notify pharmacy or doctor until he was ready for the second dose which he did not receive. He will follow up with his doctor. Patient mentioned he thinks he was Covid 19 positive in January 2020 but was never tested to confirm.
58 2021-05-08 deep vein blood clot Left upper extremity deep vein thrombosis. Left arm swelling started 5/3/21. Swelling and pain wors... Read more
Left upper extremity deep vein thrombosis. Left arm swelling started 5/3/21. Swelling and pain worsened. LUEDVT of the axillary vein confirmed by ultrasound at ER on 5/8/21. Xarelto 15 mg PO BID initiated.
58 2021-05-09 blood pressure fluctuation I continue to struggle with these re-awakened symptoms from my Covid infection 11/2020 * Headaches ... Read more
I continue to struggle with these re-awakened symptoms from my Covid infection 11/2020 * Headaches * Spiking blood pressure * Brain fog/light headedness * I often smell a campfire, i.e. wood burning smell
58 2021-05-10 blood glucose increased This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient rece... Read more
This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 (Batch/Lot Number: EW0161) as single dose for COVID-19 immunization. Medical history included ongoing type 2 diabetes mellitus (Diagnosed 1 year and a half or 2 years ago), ongoing hypertension (Diagnosed 1 year and a half or 2 years ago Blood pressure was 130/90 and it used to be a lot higher), ongoing blood cholesterol (Diagnosed 1 year and a half or 2 years ago), He threw his back out (He threw his back out when he worked at a nursery in the 1980s), back pain (He has not missed work due to back pain in 15 years) ongoing Herniated disc, His A1c was 9.3, now it is down to 6.1. Concomitant medication included metformin taken for type 2 diabetes mellitus, chlorthalidone taken for hypertension, rosuvastatin taken for blood cholesterol, hydrocodone taken for an unspecified indication. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17 Mar 2021 (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization and tetracycline and Got knots in his stomach. On Apr 2021, the patient experienced back ache/couple or three days after the vaccine he had pain. it was a gradual pain that got worse/he has to pick up his left leg; if he lifts it on his own it hurts his left lower back, his back was totally wrenched. he feels the vaccine aggravated an old back injury on an unspecified date, his arm was sore for one or two days on Apr 2021, his blood sugar yesterday was 144 on 29Apr2021. Patient visited physician for back pain. Patient stated he has not missed work due to back pain in 15 years. a couple or three days after the vaccine he had pain. It was a gradual pain that got worse until he had to miss work for a couple of days. States this was after the second dose of the vaccine. Says it was back pain. States it took him 10 minutes to get out of bed, his back was totally wrenched. He feels the vaccine aggravated an old back injury. States it wasn't like when he threw his back out because that pain was immediate. States this was a gradual pain that got the point he couldn't work with it. Patient believes the vaccine caused 2 weeks of back ache. The patient underwent lab tests and procedures which included blood glucose: 144 on 29Apr2021. The action taken in response to the event for BNT162B2 was not applicable. Outcome of event His back was totally wrenched. He feels the vaccine aggravated an old back injury, His blood sugar yesterday was 144 was unknown, His arm was sore for one or two days was recovered and for Back ache/Couple or three days after the vaccine he had pain. It was a gradual pain that got worse/He has to pick up his left leg; if he lifts it on his own it hurts his left lower back, His back was totally wrenched. He feels the vaccine aggravated an old back injury it was recovering. No Follow-up attempts are needed. No further information is expected.
58 2021-05-10 heart failure Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vacc... Read more
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was heart failure.
58 2021-05-11 fainting After receiving his 1st dose of Pfizer Vaccine. Our pt was waiting in the observation area when he s... Read more
After receiving his 1st dose of Pfizer Vaccine. Our pt was waiting in the observation area when he slumped to the ground. He was unresponsive for about 20 seconds. When he came to he was awake and oriented. He reported that he has a history of seizures. He is not on medication and has not had a seizure in 9 years. 911 was called and the paramedics took the pt to the hospital for further evaluation.
58 2021-05-13 low blood oxigenation, chest discomfort, chest pain "Pfizer-BioNTech COVID-19 Vaccine EUA" -- pt admitted for covid-19 after 1 dose of covid-19 vaccine ... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA" -- pt admitted for covid-19 after 1 dose of covid-19 vaccine Pt received covid-19 vaccine on 3/18/2021. Admitted to hosp on 4/2/2021 with c/o SOBx6dyas, with intermittent chest tightness+pleuritic chest pain+ productive cought with yellow sputum + chills, loss of taste and smell, myalgia, sore throat, headache. Spouse was tested positive one week PTA. Hypoxia on RA at home with 88% readings. Received Remdesivir x5days and Dexamethasone; 4/2/2021 89% O2sat on RA, put on 2-3L NC and O2 sat improved to 95-98% 4/3/2021 on 3L NC, O2 sat 97-98% 4/4/2021 on 2L NC, O2 sat 94-95% 4/5-4/6 on 2L NC, O2 sat 97-99% 4/7/2021 O2 sat 96-99% on RA
58 2021-05-14 pallor, fainting patient turned pael and fainted for a minute , he said he felt he slept for a minute
58 2021-05-14 blood clot There is nonocclusive thrombus in the proximal left femoral vein. There is occlusive thrombus from t... Read more
There is nonocclusive thrombus in the proximal left femoral vein. There is occlusive thrombus from the mid femur vein to the popliteal and calf veins; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 26Mar2021 at 12:00 PM (at age of 58 years old, Lot Number: ER8733) as a single dose for covid-19 immunization. Medical history included hypertension from an unknown date. Concomitant medications included amlodipine, zolpidem, lisinopril. The patient previous took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 05Mar2021 at 01:00 PM (at age of 58 years old, Lot Number: EN6206) as a single dose for covid-19 immunization. It was reported the patient the left common femoral and great saphenous veins are patent. There was nonocclusive thrombus in the proximal left femoral vein. There was occlusive thrombus from the mid femur vein to the popliteal and calf veins on 22Apr2021 12:00. The patient was hospitalized for 3 days, it was life threatening illness. Treatment received IV heparin. The event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on 29Apr2021. The outcome of event was not recovered.
58 2021-05-15 hypertension Hypertension. Severe swelling of hands feet. Nausea diarrhea headache cognitive impairment
58 2021-05-17 stroke Patient presented to the ED and was subsequently hospitalized for cerebral infarction within 6 weeks... Read more
Patient presented to the ED and was subsequently hospitalized for cerebral infarction within 6 weeks of receiving COVID vaccination.
58 2021-05-18 fluid around the heart large pericardial effusion with early signs of tamponade physiology; large pericardial effusion with... Read more
large pericardial effusion with early signs of tamponade physiology; large pericardial effusion with early signs of tamponade physiology; dose 1, 04Mar2021/dose 2, 04Mar2021; dose 1, 04Mar2021/dose 2, 04Mar2021; This is a spontaneous report from a contactable other health care professional. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 04Mar2021 (Lot Number: EN6203) as 1ST DOSE, SINGLE, dose 2, administered in Arm Left on 04Mar2021 (Lot Number: EP6955) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included Stage IV colorectal adenocarcinoma, Shellfish (rash), Peanuts (rash) and rash. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included cetuximab; acetylsalicylic acid (ASPIRIN); atorvastatin; cholecalciferol; levothyroxine. The patient experienced large pericardial effusion with early signs of tamponade physiology on 01Apr2021. Malignancy and infection were ruled out by cytology which showed only mesothelial cells; cultures were negative. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Pericardiocentesis treatment received. The patient hospitalized for 6 days. The patient underwent nasal swab COVID test negative on 08May2021. The outcome was recovered.; Sender's Comments: Reported 'large pericardial effusion with early signs of tamponade physiology', occurred 28 days after bnt162b2 vaccination, is considered unrelated to bnt162b2 but more likely an intercurrent medical condition. Patient's underlying malignancy, concurrent medical condition for which levothyroxine was administered, concomitant medication cetuximab may have contributed to reported event. The impact of this report on the benefit/risk profile of the Pfizer product 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.
58 2021-05-19 atrial fibrillation Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 58-years-... Read more
Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 58-years-old-male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733) at single dose via an unknown route in left arm on 27Mar2021 10:00 for Covid-19 immunization. Medical history included hypertension, hairy cell leukemia, and high cholesterol. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included simvastatin, lisinopril, doxazosin, and acetylsalicylic acid (ASPIRIN 81mg). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced atrial fibrillation on 14Apr2021 23:45 requiring cardioversion. The event was assessed as non-serious. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was unknown.
58 2021-05-19 chest pain Pt received first Pfizer COVID-19 vaccine on 5/7/2021. Pt started to experience severe chest pain an... Read more
Pt received first Pfizer COVID-19 vaccine on 5/7/2021. Pt started to experience severe chest pain and went to the ED on 5/9. PMH of CAD, with coronary stents in 2011. Pt admitted to the hospital.
58 2021-05-19 fainting 1 minute after vaccine administration, patient acutely experienced dizziness and vocalized light he... Read more
1 minute after vaccine administration, patient acutely experienced dizziness and vocalized light headedness resulting in syncope. Syncope witnessed by staff lasting 15-20 seconds. Patient was provided with water and gatorade and no additional issues noted. VITALS: T 97, HR 80, BP 122./84 Lungs CTAB
58 2021-05-21 hypertension Patient exhibits cough, severe HTN, fatigue, and development of Bell's palsy. Treatment: Patient sta... Read more
Patient exhibits cough, severe HTN, fatigue, and development of Bell's palsy. Treatment: Patient started Ivermectin
58 2021-05-21 platelet count decreased, nosebleed Sun, 5-2-21, Petechiae appears on my lower feet, ankles, and lower legs/shins. Random bruises appea... Read more
Sun, 5-2-21, Petechiae appears on my lower feet, ankles, and lower legs/shins. Random bruises appearing without contact/bump. Mon, 5-3-21, Petechiae now appearing on my hands, forearms. Petechiae spots beginning to appear on my face. Nose and mouth bleeding. Went to hospital ER on 5-3-21. Rec'd IGIV (2 days), and Decadron (Steroid) 40mg daily (5 days). Discharged from Hospital after 5 days on 5-7-21, with platelet count at 58 (58,000). - Follow-up blood draw post-discharge on 5-13-21 showed platelet level back down to 1 (1,000). Directed to hospital by hematologist office, re-admitted on 5-13-21. Rec'd IGIV (3 days) and IV Solumedrol (Steroid), and Oral Steroid (2 days). Discharged again from Hospital after 2nd 5-day hospital stay.
58 2021-05-22 heart rate increased 2021.05.20, 11:30PM felt unusually tired after my daily evening 3-mile walk. Muscles all over my bod... Read more
2021.05.20, 11:30PM felt unusually tired after my daily evening 3-mile walk. Muscles all over my body ached. 2021.05.20 12 midnight - 2021.05.21 8:00AM - slept very poorly with several interruptions, lots of sweating, mattress and bedding damp by the morning. I did not feel hot like when I have a fever. 2021.05.21 - 8:00AM - 9:00PM - Felt weak and lethargic. Muscle pain all over body continued. I needed to nap for two hours during the day. My heart rate was elevated about 15 percent above normal. After the nap I still felt tired. Food helped a little, but I went to be early, at 9PM. 2021.05.21 - 9:00PM - 2021.05. 22 - 8:00AM - Slept poorly with several interruptions, chills, and night sweats. Again awoke with damp mattress and bedding. For the first 10 minutes after rising I felt a little better, but then the muscle pain intensified and the lethargy too. I spent several hours of the day lying down in bed. Ate normally, which improved my overall feeling and energy level. Also consumed electrolytes and water. In the evening I started to feel not fully recovered, but a lot better than 24 hours prior. I went to bed at 11PM. 2021.05.22 - 11PM - 2021.05.23 - 10AM - I had some chills on preparing my bed, but overall slept better. Some sweating still. 2021.05.23 10AM - present 8PM - Felt much better. 95 percent of normal.
58 2021-05-24 fainting Patient had syncopal episode within 15 minutes of vaccination. Patient had not eaten that morning. ... Read more
Patient had syncopal episode within 15 minutes of vaccination. Patient had not eaten that morning. Felt better after resting and was released to home.
58 2021-05-25 loss of consciousness Patient received the vaccine on 3-31-21. Then at 4:00 am on 4-1-2021, he became lightheaded and rep... Read more
Patient received the vaccine on 3-31-21. Then at 4:00 am on 4-1-2021, he became lightheaded and reports passing out. He had several weeks of general malaise and mild headache. He does not recall head trauma and had no bruising, "goose egg", etc. He felt generally unwell with a mild headache since then. Then on May 16th, 2021, while traveling with his wife, his left hand and arm and left side of tongue became numb and week. He was mildly confused. His wife took him to the ER and he was transferred to hospital for neurosurgery admission. Hospital records note that they presume the subdural bleed was triggered from the fall the morning of May 5th.
58 2021-05-25 inflammation of the pericardium Pericarditis. Inflamation of the heart muscle.
58 2021-05-26 loss of consciousness, fainting Approx 5 min after receiving the 2nd Pfizer COVID vaccine the patient fainted hitting head against w... Read more
Approx 5 min after receiving the 2nd Pfizer COVID vaccine the patient fainted hitting head against wall, scraping knee from falling and biting his lip. Pt was unconscious for approx 45 secs to 1 min. Vitals remained within normal limits during entire encounter except for increase in respiration rate of about 26-28. After regaining consciousness the pt was confused, nauseas, vomiting, diaphoretic and clammy to the touch. EMS arrived un scene approx 5-10 minutes after pt hitting his head and was transported to Hospital
58 2021-05-26 loss of consciousness Patient received their 2nd Pfizer COVID vaccine and about 5 minutes afterwards in the observation ar... Read more
Patient received their 2nd Pfizer COVID vaccine and about 5 minutes afterwards in the observation area the patient became lightheaded and collapsed hitting his head against the wall, EMS was called. While collapsing the patient bit his tongue, scraped his knee, and developed a visible bump on his head. Patient was unconscious while collapsed lasting approximately 45 seconds to 1 minute. When he regained consciousness he was confused and unaware where he was or what happened. Vitals were taken throughout being unconscious every 5 minutes until EMS arrived which was about 5-10 minutes after the patient collapsed. After regaining consciousness patient was cold, diaphoretic, nauseas, and emesis x 2. Report was given to EMS and transported to Hospital.
58 2021-05-27 inflammation of the pericardium Pericarditis by ECG criteria requiring hospitalization.
58 2021-05-28 anaemia Presented to ED 3 days after covid vaccine. Patient has history of Cancer of Ampulla of Vater/HTN/As... Read more
Presented to ED 3 days after covid vaccine. Patient has history of Cancer of Ampulla of Vater/HTN/Asthma who presents with anemia. Patient with metastatic ampulla of Vater cancer--+ carcinomatosis. Patient was to have a Whipple procedure as treatment liver at time of procedure patient was found to have carcinomatosis and Whipple was canceled. Patient states that he last had chemo approximately 2 weeks ago. In the past 2 weeks patient has had paracenteses performed--most recent paracentesis was today. Patient with "bloody taps" on both occasions. Patient has also had anemia. Patient had transfusion last Friday. Today, patient with worsening anemia. Patient with abd pain prior to paracentesis today-improved after procedure. Patient denies GI bleeding-no hematemesis/no coffee-ground emesis/no melena/no hematochezia. States that the only time he has seen blood is during paracenteses. Patient is admitted for further evaluation of anemia. It was felt that the bleeding is from masses in his abdomen. He was treated with supportive care, transfusions prn and paracentesis via his catheter. When he felt improved he discharged.
58 2021-05-28 atrial fibrillation Sent heart into A-fibrillation
58 2021-05-28 oxygen saturation decreased shortness of breath and my oxygen levels dropped
58 2021-05-31 chest pain Saying he could not breath; anxious; reported being cold; complained of Chest pain; began to shake; ... Read more
Saying he could not breath; anxious; reported being cold; complained of Chest pain; began to shake; This is a spontaneous report from a contactable other hcp reported that a 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3302 and expiration date: unknown), via intramuscularly in Arm Left on 29Jan2021 at 09:45 (at the age of 58 years old) as a single dose for COVID-19 immunisation. Medical history included allergies to Sulfa drugs from an unknown date and unknown if ongoing, Cardiac stents from 2004 to an unknown date. Concomitant medications included Lipitor, Aspirin, Plavix, Nitroglycerine for an unspecified indication from an unspecified date. No other illness reported at the time of vaccination and up to one month prior. The patient was in observation for 30 minutes. At approximately 25 minutes post vaccination at 10:15am, Patient signaled that he wanted to leave and was instructed to stay 5 minutes. Patient anxious and began to shake, saying he could not breathe. Vitals were 147/88, HR 86, O2 98% on RA. Pt was reclined on floor and reported being cold and was striking his head on the blanket; head stabilized. Patient was alert and oriented X3 but complained of Chest pain. EMS called, arrived at 10:25, vitals: 144/92, HR83 O2 99% on 2L. Pt stable & transported by EMS at 10:35am. The patient underwent lab tests and procedures which included heart rate: 86, 83, investigation: 147/88, 144/92, oxygen saturation: O2 98% on RA , oxygen saturation: 99 % on 29Jan2021. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
58 2021-06-01 lightheadedness Vasovagal, diaphoretic.
58 2021-06-02 blood pressure increased Left arm was only sore for 36 hours; Within 1 minute throat got ice cold; Difficult to swallow; Fuzz... Read more
Left arm was only sore for 36 hours; Within 1 minute throat got ice cold; Difficult to swallow; Fuzzy feeling over entire body; Numb face; Tingly feeling; Heavy arms and legs; Light headed, felt very woozy; Blood Pressure went up to 170/120; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple (20 to 30) bilateral knee surgeries and total right knee joint replacement on 02May2020. Concomitant medications included oxycodone 5mg (MANUFACTURER UNKNOWN) as needed, aspirin 88mg/day (MANUFACTURER UNKNOWN) for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 05Mar2021 (within 1 minute of vaccination), the patients throat got ice cold and more difficult to swallow, fuzzy feeling over entire body, numb face, tingly feeling, heavy arms and legs. Light headed, felt very woozy. It felt exactly like patient had been administered general anaesthesia right before surgery. The patient blood pressure (BP) went up to 170/120 (unspecified unit). As symptoms started getting better after 1 hour, BP went down to 140/70. On an unknown date, the left arm was only sore for 36 hours. It was reported that, emergency medical technician (EMT) did multiple blood pressure checks and electrocardiogram (EKG) at the vaccine site. The patient did not received treatment for adverse events. The clinical outcome of events throat discomforts, swallowing difficult, fuzzy, numbness in face, tingling, heavy feeling in arms and legs, light headed and blood pressure increased was recovered on 05Mar2021 (symptoms were gone after 3 to 4 hours from onset of reaction) and the event pain in arm was recovered on an unknown date (left arm was sore for 36 hours). No follow-up attempts are needed. No further information is expected.
58 2021-06-04 coughing up blood, chest pain Large Amount of Histamine; he still did not feel well/ felt terrible this morning; Earache and Ear D... Read more
Large Amount of Histamine; he still did not feel well/ felt terrible this morning; Earache and Ear Drainage; Dizziness; Chills; Fever; Soreness; Spitting up Blood; Problems Breathing; Shaking worse than usual; Headache; Nausea; Chest Pains; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 21May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 doses. This is the second of two reports for dose 2. This 58-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 05May2021 11:30 (Lot Number: EW0179) at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies and ear trouble. The patient's family medical history was none. The patient's concomitant medication was none. The patient no adverse effect following prior vaccinations. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 14Apr2021 (Lot Number: EW0164) at single dose for COVID-19 immunization and experienced events including earache and ear drainage from 17Apr2021 to 20Apr2021; dizziness from 15Apr2021 to Apr2021; chills and fever from 15Apr2021 to Apr2021; soreness from 15Apr2021 to Apr2021; spitting up blood from 15Apr2021 to Apr2021; problems breathing from 15Apr2021 to Apr2021; shaking worse than usual from 15Apr2021 to Apr2021; headache from 15Apr2021 to Apr2021; nausea from 15Apr2021 to Apr2021; chest pains from 15Apr2021 to Apr2021. The patient stated all of the symptoms from the first dose started on 15Apr2021 and recovered by 18Apr2021 or 19Apr2021. The patient stated he almost called the ER after the first shot because it was new to him and he did not know what he was dealing with. The patient had no other vaccine within 4 weeks. The patient received the second dose on 05May2021. The patient experienced earache and ear drainage from 08May2021 to 11May2021; dizziness from May2021 to 18May2021; chills and fever from May2021 to 18May2021; soreness from May2021 to 18May2021; spitting up blood from May2021 to 18May2021; problems breathing from May2021 to 18May2021; shaking worse than usual from May2021 to 18May2021; headache from May2021; nausea from May2021; chest pains from May2021. The patient stated he had the same side effects with both the first and second doses, but with the second shot they were worse and longer. The patient stated he still did not feel well. The patient stated the side effects from the second vaccine started either the 06May2021 or 07May2021 and recovered 18May2021, except the headache, nausea, and chest pain were persisting. The patient stated he felt terrible this morning (21May2021) and he realized this could be from something else. The patient also experienced large amount of histamine; more than usual after the second dose. The events did not require a visit to emergency room neither physician office. All the events except earache did not require treatment. The patient stated he got both vaccines at the beginning of allergy season, but he had no reason to believe it was all from his allergies, it was seemingly related to the vaccine. The outcome of event large amount of histamine; more than usual was resolving. The outcome of event headache, nausea, chest pains, did not feel well/ felt terrible was not resolved. The outcome of other events was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021582540 same drug/ patient, different dose number/ event
58 2021-06-04 coughing up blood, chest pain Earache and Ear Drainage; Dizziness; Chills; Fever; Problems Breathing; Shaking worse than usual; He... Read more
Earache and Ear Drainage; Dizziness; Chills; Fever; Problems Breathing; Shaking worse than usual; Headache; Nausea; Chest Pains; Soreness; Spitting up Blood; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 21May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 doses. This is the first of two reports for dose 1. This 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 14Apr2021 (Lot Number: EW0164) at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies and ear trouble. The patient's family medical history was none. The patient's concomitant medication was none. The patient no adverse effect following prior vaccinations. The patient had no other vaccine within 4 weeks. The patient experienced events including earache and ear drainage from 17Apr2021 to 20Apr2021; dizziness from 15Apr2021 to Apr2021; chills and fever from 15Apr2021 to Apr2021; soreness from 15Apr2021 to Apr2021; spitting up blood from 15Apr2021 to Apr2021; problems breathing from 15Apr2021 to Apr2021; shaking worse than usual from 15Apr2021 to Apr2021; headache from 15Apr2021 to Apr2021; nausea from 15Apr2021 to Apr2021; chest pains from 15Apr2021 to Apr2021. The patient stated the symptoms from the first dose started on 15Apr2021 and recovered by 18Apr2021 or 19Apr2021. The patient stated he almost called the ER after the first shot because it was new to him and he did not know what he was dealing with. The events did not require a visit to emergency room neither physician office. All the events except earache did not require treatment. The patient stated he got both vaccines at the beginning of allergy season, but he had no reason to believe it was all from his allergies, it was seemingly related to the vaccine. The outcome of events was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021580978 same drug/ patient, different dose number/ event
58 2021-06-06 low blood oxigenation Facial swelling, Mild hypoxia, body aches. Anaphylaxis
58 2021-06-06 troponin increased fevers, cough, elevated trop 1.45, low voltage EKG, possible myocarditis 10 days post vaccination wi... Read more
fevers, cough, elevated trop 1.45, low voltage EKG, possible myocarditis 10 days post vaccination with the 2nd dose. Also tested positive for COVID 19 with CT of 35 (had COVID in April) - unclear if this is reinfection vs vaccine effect
58 2021-06-07 chest pain sore arm; chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs; chest pain... Read more
sore arm; chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs; chest pain/muscle pain in the rib in the chest ribs; teeth pain; teeth sensitivity; anxiety; When I take a death breathe it hurts and sometimes it doesn't; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 58-year) on 07Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Advil 12 hours back for arthralgia. The patient stated, she received the first dose of her Pfizer vaccine that morning at 9:45am or 10am. she was fine. she just had a sore arm. About 2 and 1/2 hours later experienced: chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs. Minor issue: teeth pain/sensitivity there. she talked to her PCP and he said she had anxiety, so took CBD oil. She stated "When I lie down the pain wakes me up because of the pain. When I take a death breathe it hurts and sometimes it doesn't. It's been almost 8 hours, there's no gas that I'm passing. I'm eating very light food (it's not due to the food I'm eating). It's a unique experience. Something new. not very severe. Question asked whether to take Advil or pain medicine. I was taking Advil for my joint pain, yesterday last night around 10:30 I took the last dose. Today I didn't take anything. Question asked if I should monitor for anything else." On 07Mar2021 the patient experienced sore arm, chest area feels like gas, chest pain/muscle pain in the rib in the chest ribs, teeth pain, teeth sensitivity, anxiety and when I take a death breathe it hurts and sometimes it doesn't. Therapeutic measures were taken as a result of anxiety. The clinical outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
58 2021-06-08 deep vein blood clot Deep vein thrombosis from groin to knee; This is a spontaneous report from a contactable consumer (p... Read more
Deep vein thrombosis from groin to knee; This is a spontaneous report from a contactable consumer (patient). This 58-years-old male patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm, on 04May2021 at 14:00 (lot EW0171), at the age of 58 years, for COVID-19 immunization. The first dose of BNT162B2 vaccine was administered on 09Apr2021 at 15:00 (at 58 years of age), lot: EP7533, in left arm. Medical history included COVID-19. Past drug history included allergy to lamotrigine (LAMITRIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 21May2021 the patient deep vein thrombosis from groin to knee. The event required ER visit, Doctor or other healthcare professional office/clinic visit, hospitalization for 6 days and was reported as serious also as life-threatening condition. Treatment received included removed blood clot and blood thinners administration. The event was resolving at the time of report. Since the vaccination, the patient had not been tested for COVID-19.
58 2021-06-08 pulmonary embolism found to have bilateral pulmonary embolism. No other provoking event on history
58 2021-06-10 low platelet count D69.6 - Thrombocytopenia, unspecified
58 2021-06-11 heart rate increased, fast heart rate Systemic: Tachycardia-Severe, Additional Details: HR was about 190. happened on different days up to... Read more
Systemic: Tachycardia-Severe, Additional Details: HR was about 190. happened on different days up to 5 days after vaccine lasting anywhere from 15min-3 hours. no issues observed during post- vaccination period
58 2021-06-12 inflammation of the pericardium, chest pain, chest discomfort Pericarditis Chest discomfort/pain and left shoulder pain began on 5/3/21. Went to emergency room o... Read more
Pericarditis Chest discomfort/pain and left shoulder pain began on 5/3/21. Went to emergency room on 5/5/21 and EKG showed that this was thought to be Pericarditis. I was admitted for one night.
58 2021-06-13 chest pain, cardiac arrest 4/27/2021 nausea, on 4/28/2021 nausea, vomiting, diarrhea, 4/30/2021 chest pain, 5/1/2021 cardiac ar... Read more
4/27/2021 nausea, on 4/28/2021 nausea, vomiting, diarrhea, 4/30/2021 chest pain, 5/1/2021 cardiac arrest
58 2021-06-15 deep vein blood clot Started pain in the left leg after 3 weeks, Found DVT in left leg after ultrasound
58 2021-06-16 blood clot Had a large boil at the shot site, developed blood clots in arm which caused alot of pain.
58 2021-06-23 atrial fibrillation Within 90 days of receiving vaccine, (April 02,2021) I experienced Atrial Fibrillation. Heart rate ... Read more
Within 90 days of receiving vaccine, (April 02,2021) I experienced Atrial Fibrillation. Heart rate approached 160bpm, and was admitted to the ER. I did get lucky and cardioverted on my own, but now I'm on new heart medications (metoprolol) and have had to adjust my lifestyle.
58 2021-06-24 heart rate increased DOSE 1 12/20/2021, began to feel sick. 12/24/2021 I had a high fever, called the CDC, a physician sp... Read more
DOSE 1 12/20/2021, began to feel sick. 12/24/2021 I had a high fever, called the CDC, a physician spoke with me, then on Christmas day I called into work sick, I went to ER, and I tested positive for COVID. DOSE 2 01/07/2021, I had shortness of breath, high heart rate, fatigue, brain fog, body aches, some coughing, some nasal congestion. Testing on Feb 1st, 2021 visited ER.
58 2021-06-26 cardiac failure congestive, heart attack, chest pain, ejection fraction decreased, stroke, transient ischaemic attack, fibrin d dimer increased On April 30, 2021, I received the 2nd dose of the COVID-19 (Pfizer-BioNTech) vaccine which was 3 wee... Read more
On April 30, 2021, I received the 2nd dose of the COVID-19 (Pfizer-BioNTech) vaccine which was 3 weeks after receiving the 1st dose. Then on May 3rd, I experienced pronounced shortness-of-breath while at work lifting objects up to 20 lbs and walking short distances of 20 to 40 m on flat ground. Then on May 4th, 2021, I went into a nearby Urgent Care Clinic (UCC) with shortness-of-breath and exertional dyspnea as the main symptoms. At the UCC blood tests were done along with EKG and chest x-ray. Blood tests revealed several results that were not within standard ranges: troponin (1.25 ng/mL), BNP (5130 pg/mL), D-dimer (1320 ng/mL FEU), and C-reactive protein (75.5 mg/L). I was told that I had congestive heart failure and NSTEMI. UCC then directed me to go to the Emergency Department (ED) at a nearby hospital. In the ED, more tests were done: EKG, CT scan chest (no blood clots were found in the lungs), and cardiac ultrasound (estimated ejection fraction 40-45%). That evening I was transferred to the main hospital for further observation and tests. Not much happened on May 5th and I was not seen by a doctor until 5pm. Then early in the morning of May 6th, I experienced chest pain which lasted between 5 and 10 minutes. I was given oral nitroglycerine. My primary care physician (PCP) and a cardiologist elected to move forward with an angiogram. On May 6th, I underwent cardiac catheterization (CC). The CC report states: (a) 2nd Diag lesion is 50% stenosed (b) Mid RCA to Dist RCA lesion is 80% stenosed,(c) RV branch lesion is 80% stenosed, (d) RPDA lesion is 80% stenosed. Likely spontaneous coronary artery dissection of the mid to distal RCA and postal to mid PDA status post PCI with 2 Xience drug-eluting stents. Post-angiogram+angioplasty tests were done, including carotid artery ultrasound (results within normal limits. No hemodynamically significant stenoses) and MRI brain (punctate foci of restricted diffusion in both cerebral hemispheres. Multiple vascular distributions w/o larger territorial infarct suggest emboli). Other blood test results were: antinuclear antibody (ANA) IFA screen (positive), BNP (8631 pg/mL). I was released from the hospital on May 8, 2021. Follow-up care included cardiac rehab therapy and consultations with the cardiologist, PCP, a neurologist and rheumatologist. Incidentally, 12 days after the angiogram and angioplasty, I experienced temporary numbness and loss of movement in my right arm which lasted no more than a minute, indicative of a transient ischemic attack (TIA). Root cause investigations focusing on SCAD and TIA are on-going.
58 2021-06-27 hypertension I started having a headache on 04/03/2021 that wouldn't go away. I checked my blood pressure on 04/... Read more
I started having a headache on 04/03/2021 that wouldn't go away. I checked my blood pressure on 04/06/2021 and it was elevated at 190/100. It stayed elevated for the next few days. I went to a care center on 04/09/2021 and started on Amlodipine 5mg until I could see my primary Dr. a couple days later. He added Losartan 25mg which I am still taking both. I have never had an elevated blood pressure.
58 2021-07-01 atrial fibrillation, heart rate increased Woke up with anxious feeling, heart was beating faster than normal, hands/fingers cold. Tested ecg ... Read more
Woke up with anxious feeling, heart was beating faster than normal, hands/fingers cold. Tested ecg with Watch and it indicated Atrial Fibrillation. I didn?t believe it and retried several times over the next hours and finally went to ER.
58 2021-07-01 blood pressure increased increased blood pressure; profound tinnitus; This is a spontaneous report from a contactable nurse (... Read more
increased blood pressure; profound tinnitus; This is a spontaneous report from a contactable nurse (patient). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Feb2021 (Age at vaccination was 58 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. No known allergies reported. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: el4236), via intramuscular in right arm on an unspecified date in Jan2021 at 08:00 AM. The patient was not received other vaccine in four weeks and other medications in two weeks. The patient not had Covid prior vaccination and not Covid tested post vaccination. On 11Feb2021 at 12:00 AM, the patient experienced increased blood pressure and profound tinnitus. The report was assessed as non serious. Outcome of the events was not recovered. Information about lot/batch number has been requested.
58 2021-07-01 chest pain Dizzyness for days after vaccine, then weakness, nausea, cramps, shortness of breath, trembling. and... Read more
Dizzyness for days after vaccine, then weakness, nausea, cramps, shortness of breath, trembling. and chest pain a few times a week
58 2021-07-02 pallor Person got really pale and dizzi. Wife was with the person and the Pharmacy team tried to help the p... Read more
Person got really pale and dizzi. Wife was with the person and the Pharmacy team tried to help the person. We offered to drink juice, put Ice pack and keep cheking him. BP was okay 112/104. Called 911. Pulse was above 100.
58 2021-07-08 chest discomfort Fatigue, Chest pangs (not significant enough to call them pains), sensitive spleen / liver, upper bo... Read more
Fatigue, Chest pangs (not significant enough to call them pains), sensitive spleen / liver, upper body aches, swollen feet, inner thigh pain. Fatigue started day after 2nd shot and has continued. Additional systems started ~ 2 weeks post second shot and continued. Intensity of additional symptoms have reduced over the past 3 weeks.
58 2021-07-10 chest pain, atrial fibrillation I had major chest pain, and was gasping for air to; I had major chest pain, and was gasping for air ... Read more
I had major chest pain, and was gasping for air to; I had major chest pain, and was gasping for air to; was in Afib; i struggle getting out of bed to feed myself; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old male patient received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0612), via an unspecified route of administration, administered in arm right on 17Apr2021 (at the age of 58-year-old) at dose number unknown as a single dose for COVID-19 immunisation. Medical history included high blood pressure (other medications the patient received within 2 weeks of vaccination: High blood pressure medication). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 17Apr2021 the patient experienced major chest pain, and was gasping for air to, was in afib, the patient struggled to get out of bed to feed himself. Re-ported Event: patient received the vaccine early morning of 17Apr, and carried on his day, that night is when the symptoms came. The 2 symptoms that later sent patient to the hospital a few days later as patient explained. Patient had major chest pain and was gasping for air to breath. It was getting worse then out of nowhere, it stopped. And about 10 minutes later it hit patient again. This was a never-ending cycle all night long back and forth symptoms of intense chest pain and gasping for any air at all. By morning the symptoms had faded away. Carried on patient day when night came, they symptoms where back, not near intense as the night before, but still severe. This happened for a few more days and then patient went to his Dr, because the breathing was a major problem. Patient went to the Dr and she sent patient to the ER instantly. They ER said patient was in Afib and never had this or any history in the family. This has changed patient life, patient carrier. To this day patient struggle getting out of bed to feed himself. Adverse event result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was hospitalised for one day. The clinical outcome of the events was not resolved. Follow up attempts are possible. Further information is expected.
58 2021-07-11 cardiac arrest, heart attack Pt. states received Phizer vaccine 06/02/2021 experiencing fatigue, nauseous. 06/10/2021 adverse ev... Read more
Pt. states received Phizer vaccine 06/02/2021 experiencing fatigue, nauseous. 06/10/2021 adverse event of vomiting, aspiration, heart attack, cardiac arrest, coma 4 days, ICU reporting slight brain damage. Discharged 06/18/2021 to Rehabilitation Facility discharged 07/07/2021.
58 2021-07-15 haemoglobin decreased, palpitations, hypertension Strong Hissing in both ears (still present), high blood pressure (147/92 pulse 98). Pressure in my ... Read more
Strong Hissing in both ears (still present), high blood pressure (147/92 pulse 98). Pressure in my head and 'feeling my heart pounding'. Normally I do not have high blood pressure, nor pulse nor headaches. Mild chills that went away Hissing still present but at lower levels. Blood pressure is back to normal. Taking Metroprolol in addition to the hives medication mentioned in the beginning. It is helpful. Also took Iboprufen and Tylenol the first two days after vaccination. Have been given Singulair for anti-inflammatory action re. my ears that show congestion. Will follow up in a week and if it does not help might switch to cortizone. Will follow up with a dr. appointment at the end of the month. Blood test next week Feeling better slowly and hopefully surely.
58 2021-07-16 heart rate increased Heart rate increase. Short of breath. Tingling in hands and arms. Light headed. Bad taste in mouth.
58 2021-07-17 heart attack acute STEMI , underwent coronary artery bypass x3 vessels
58 2021-07-17 cardiac failure congestive Right lower extremity cellulitis in clinic, admitted again on 6/14 for acute CHF and GI bleed.
58 2021-07-27 nosebleed Two episodes of uncharacteristic nose bleeds; Two episodes of uncharacteristic nose bleeds; This is ... Read more
Two episodes of uncharacteristic nose bleeds; Two episodes of uncharacteristic nose bleeds; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 01Apr2021 at 14:00 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient did not receive any other medication within two weeks of vaccination. The patient did not have a history of allergies to any food products or medications or others. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 21:00 and on 04Apr2021, the patient experienced two episodes of uncharacteristic nose bleeds. The patient did not receive any treatment for the event. The clinical outcome of the event two episodes of uncharacteristic nose bleeds was unknown at the time of this report. No follow-up attempts are needed. No further information is expected
59 2021-01-06 chest pain, hypertension Left Chest Pain that was sharp for about 5 minutes. Blood pressure initially was 196/96. Blood pre... Read more
Left Chest Pain that was sharp for about 5 minutes. Blood pressure initially was 196/96. Blood pressure came down, and I completed a full day of seeing patients. I then reported in the evening to the ER for testing. No Heart Attack or Blood Clot was diagnosed. So, this was musculoskeletal pain at the left costochondral region.
59 2021-01-07 blood pressure increased, fast heart rate Tachycardia/HR going up to 140 /minute; Blood pressure went up to 157/94; This is a spontaneous repo... Read more
Tachycardia/HR going up to 140 /minute; Blood pressure went up to 157/94; This is a spontaneous report from a contactable physician (patient himself). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (left arm), on 21Dec2020 at 16:30, at a single dose, for COVID-19 immunization. Relevant medical history included coronary artery disease (CAD) prior percutaneous coronary intervention (PCI) in 2004. The patient has no known allergies. Concomitant medications in two weeks included aspirin, ramipril, ezetimibe, simvastatin (VYTORIN), vitamin D3, and diclofenac. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The vaccine was administered in the hospital. On 21Dec2020, within 3 minutes of receiving the vaccine (at 16:45), the patient developed tachycardia with heart rate (HR) going up to 140 /minute and blood pressure went up to 157/94. Heart rate returned to 90s within few minutes while his blood pressure slowly returned to baseline 134/84 after 2 hours. The patient did not receive treatment for the events. The patient recovered from the events on the same day (21Dec2020). Since vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
59 2021-01-09 chest pain All That you describe. What are the risk of the PFIZER Vaccine. injection site pain tiredness, Se... Read more
All That you describe. What are the risk of the PFIZER Vaccine. injection site pain tiredness, Severe headache, muscle pain, severe chills, slight fever, injection site swelling, nausea, pain in crest area and lung pain. When taking deep breaths the lung issue would diminish.
59 2021-01-09 hypertension, heart rate abnormal, atrial fibrillation Severe hypertension with BP 185/105 and new onset atrial fibrillation
59 2021-01-12 palpitations Chills; nausea; dizziness; fatigue; Epi-gastric pain; racing heart; depression; This is a spontaneou... Read more
Chills; nausea; dizziness; fatigue; Epi-gastric pain; racing heart; depression; This is a spontaneous report from a contactable healthcare profession (HCP) (patient). A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly on 23Dec2020 11:00 at a single dose in left arm for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), COVID-prior-vaccination: Yes. No allergies to medications, food, or other products. Concomitant medication included ibuprofen in two weeks. On 24Dec2020, the patient experienced chills, nausea, dizziness, fatigue, epi-gastric pain, racing heart, and depression. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for adverse event. The outcome of events was recovered on 24Dec2020. This is a non-serious report. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
59 2021-01-13 chest pain, chest discomfort During post-vaccination monitoring, the employee verbalized complaints of a "heavy chest" and "chest... Read more
During post-vaccination monitoring, the employee verbalized complaints of a "heavy chest" and "chest tightening." Vital signs were taken at 7:15 AM: BP 169/96 mmHg, HR 78 bpm, 99% O2. Employee reports this feeling has "happened in the past" and that he takes medication. Employee monitoring continued, was offered PO fluids. Vital signs at 7:35: 171/96 mmHg, HR 74, 98% O2. At time of second vital signs (7:35) employee reported resolution of chest tightness. He believes it was stress-induced (on the job stress). He reports chest pain occasionally a which he manages with "distraction." Saw his PCP 2 months ago for hypertension.
59 2021-01-13 low blood oxigenation, haemoglobin decreased altered mental status, hypoxic, fever 39.3, agitated
59 2021-01-16 chest pain Diffuse body and joint aches, pleuritic chest pain, malaise, insomnia due to pain- started ~12 hrs a... Read more
Diffuse body and joint aches, pleuritic chest pain, malaise, insomnia due to pain- started ~12 hrs after vaccine and got worse over next 1-1/2 days then plateaued. Body aches and chest pain lessened 3rd day but rheumatoid arthritis flared up in hands and feet especially on 4th day
59 2021-01-17 hypotension high grade fever 34 hrs post vaccine up to 104 for next 3 days , followed by diarrhea -on day 3 re... Read more
high grade fever 34 hrs post vaccine up to 104 for next 3 days , followed by diarrhea -on day 3 requiring ivf ( 3 liters)due to hypotension( I did not take this day my antihypertensives ) On day 4 low grade fever followed by resolution and loose stools continued through day 6.
59 2021-01-25 hypertension, skin turning blue, oxygen saturation decreased On 1/4/21 Client had what appeared to be a seizure and went unresponsive. He foamed from the mouth a... Read more
On 1/4/21 Client had what appeared to be a seizure and went unresponsive. He foamed from the mouth and turned blue. O2 Sat was in the 60's, O2 was applied previous to paramedics arrival. BP was high. Unresponsive for 30 minutes. When he woke he did not recognize anyone, did not know where he was at or what day of the week it was. He was transported to the Hospital. Multiple tests were ran and nothing out of the ordinary was found. Started seizure medication.
59 2021-01-26 fast heart rate ?Pfizer-BioNTech COVID-19 Vaccine EUA 2 days after 2nd dose of pfizer in ED for possible unrelated ... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA 2 days after 2nd dose of pfizer in ED for possible unrelated issue, had R scrotal/testicular pain, negative ultrasound. also with tachycardia.
59 2021-01-28 palpitations Pt developed palpitations, tingling of left sided face, vomiting
59 2021-01-29 fainting, pallor, blood pressure increased Approximately 60 seconds prior to emergency, patient felt a sense of panic (first time ever). State... Read more
Approximately 60 seconds prior to emergency, patient felt a sense of panic (first time ever). Stated to me (wife) "I feel like I am having a panic attack" as we walked on to a parking garage elevator at 12:30 pm on 1.22.21. As I turned to push the button to go down, leaned against the wall of the elevator. His eyes fluttered and back, he was a little pale. When I turned around, again, he fainted and fell face down on the elevator floor. He never stopped breathing and had no convulsions. He was out for less than 30 seconds. When he came to, he got up by himself with minimal assist from me (911 was already on their way). He did not remember saying that he felt like he was having a panic attack; but he remember the fear/panic he felt just prior to. He was oriented x3. I had him smile, stick his tongue out and speak to make sure it was not a TIA or stroke and there were no symptoms of that. His bladder did release. He went by ambulance to the ER (we were on a mini vacation to celebrate his birthday). They did a CAT scan, checked his blood sugar twice, EKG twice, complete blood work panels and urinalysis All tests were either normal or negative. They found nothing. His BP was normal for the first 30 minutes at the hospital, then increased. But has been normal ever since (he checks it daily). Absolutely no other symptoms since that episode. He met with our PCP on 1.29.21 as a follow-up and she directed us to complete this form. She has ordered a consult with a Neurologist and that is scheduled for 3.10.21. His second shot for the vaccine is due on 2.9.21.
59 2021-01-29 blood clot, oxygen saturation decreased, pulmonary embolism, deep vein blood clot On day 04 After receiving the 2nd Covid 19 Pfizer vaccine, I experienced a deep pain in my upper inn... Read more
On day 04 After receiving the 2nd Covid 19 Pfizer vaccine, I experienced a deep pain in my upper inner right thigh around 0600 am of the 16th of January. At the same time my calf muscle of that same right leg was in pain. I thought it to be muscular pain as I was told by the reading material regarding symptoms of the covid 19 vaccine there could be aches an pains attributed to the 2nd shot. I used a deep heating rub on both areas of my right leg and put heat on them to treat the soreness. This occured over the next few days feeling this pain in my right leg and treated the same way applying heat. Within about 24 hours of the pain in my legs I started experiencing a shortness of breath while walking up and down st. On day 04 After receiving the 2nd Covid 19 Pfizer vaccine, I experienced a deep pain in my upper inner right thigh around 0600 am of the 16th of January. At the same time my calf muscle of that same right leg was in pain. I thought it to be muscular pain as I was told by the reading material regarding symptoms of the covid 19 vaccine there could be aches an pains attributed to the 2nd shot. I used a deep heating rub on both areas of my right leg and put heat on them to treat the soreness. This occured over the next few days feeling this pain in my right leg and treated the same way applying heat. Within about 24 hours of the pain in my legs I started experiencing a shortness of breath while walking up and down stairs as part of my daily activities. The symptoms of shortness of breath only seemed to appear when I was on any form of extended walking activity or physical movements or exercise this would of have been starting around the 17th of January. The right leg pain was masked by the heating rub while the shortness of breath continued for the next few days. On the 19th of January, I went to an Urgent Care Facility at 0800 am to see a Medical professional to discuss my symptoms I was previously experiencing and to figure out why I was having a shortness of breath and the pain in my right leg. The on staff Physician's Assistant had a Nurse conduct a Covid 19 Rapids test (negative) and a second swab was administered and sent to the Lab. Which produced a (negative for Covid 19) on the 20th of January. An Xray was not taken to determine my shortness of breath. The Dr listened to my lungs and heart, though I did let the PA know I had received both Pfizer shots and when they were administered. I was carrying My Shot record for the vaccine with the dates and lot number. He didnt appear to be interested in further diagnosis and made sure I had the paperwork to track the results of my Covid swab sent to the lab. The visit was completed and I was released to go back to work/home. I carried on the symptoms of the shortness of breath from the 19th of January to the 22nd of January monitoring my O2 (oxygen levels) with a pulse oximeter. They ranged from 90-93. On the evening of the 22nd of January I was becoming very uncomfortable with my breathing climbing the stairs in my home and monitored my O2 readings with the oximeter on my finger when walking upstairs and they dropped down to 60-65. My wife drove me to the emergency room at Hospital. I walked into the ER and checked myself in for shortness of breath and leg pain in my right leg. I was admitted into the emergency room and put on 15 litres of oxygen. The emergency room Dr ordered a chest Xray, Cat Scan of my chest and heart and a sonogram of my right leg. The testing results came back with a noted large pulmonary emboli on my lungs/heart area and blood clots throughout my right leg (right lower extremity DVT). Surgery was performed to remove the pulmonary emboli and I was put on a Heprin Drip to thin out my blood for the remaining clots in my chest and my right leg. The attending physician ordered a T.E.E. (transesophageal Echocardiogram) to observe my heart functions. I was told the TEE did not demonstrate any further recommend surgeries. I was administered a test for my cardio and heart functions prior to my discharge on 27 January 2021. I was prescribed Eloquis for maintenance medication to be monitored by followup visits to my cardiologist and Hemotologist within the next few weeks. I have not family or personal history of Blood Clots. I do perform administrative duties as part of my job, which requires sitting and working on a computer. Note however I move around very often during a work day and operate a farm tractor and have an active life style. I have not recently had any extended trips more than 2 hours nor have I flown within the past year or so.
59 2021-01-31 deep vein blood clot, superficial blood clot Superficial and deep vein thrombosis was diagnosed on 27th of January. Symptoms had been going on ... Read more
Superficial and deep vein thrombosis was diagnosed on 27th of January. Symptoms had been going on for around 2 weeks.
59 2021-01-31 heart rate increased Sudden light headedness, room spinning, increased heart rate, slight ringing in the ears. Weakness.... Read more
Sudden light headedness, room spinning, increased heart rate, slight ringing in the ears. Weakness. Lasted about 15 minutes. Felt mildly lightheaded, and had loss of energy symptoms for about 12 hours. Felt good for about 1hour after that then a second episode happened about 10pm. The second episode was about half as severe as the first and only lasted about a minute or two. Woke up this morning 02/01/2021 feeling fairly normal.
59 2021-02-03 heart rate increased, loss of consciousness I have had a weekly routine of fasting one day a week for the last 20 years. Sometimes I would exten... Read more
I have had a weekly routine of fasting one day a week for the last 20 years. Sometimes I would extend this to 3 days, water only. I am healthy, 6'1" weight 170-180 all of my adult life. Resting HR <56. 9 days after having my first vaccination, I did a 24 hour fast. I woke at 2 am to go to the bathroom. I became lightheaded and passed out while standing over the toilet. I layed on the floor for over 5 minutes with my head spinning. I then realized I was hypoglycemic. I have never had this issue. I took some orange juice and recovered my strength. I hit my head on the top of the toilet which required my to have 5 sutures in my chin at the ER that night. Today I was working out for 30 minutes on an elliptical. I work out 4 to 5 times weekly. 10 minutes after returning to my room I noticed I was dizzy and checked my pulse from my watch. My HR was 210. this lasted for over 10 minutes. I have never had this issue. I believe it would not be in my best interest to take the second vaccination.
59 2021-02-05 heart rate increased Elevated heart rate from approximately 1pm to 5pm and again 5:45pm to 5:50pm. As monitored by my Wa... Read more
Elevated heart rate from approximately 1pm to 5pm and again 5:45pm to 5:50pm. As monitored by my Watch, resting heart rate earlier in the day ranged from 58 to 64 bpm. During the times of elevation, resting heart rate increased to 87 to 93 bpm. As of 6:25pm, resting heart rate returned to below 65 bpm and no further action taken.
59 2021-02-07 hypertension swollen face and hands rash on face and hands light-headed inability to walk at normal rate shortnes... Read more
swollen face and hands rash on face and hands light-headed inability to walk at normal rate shortness of breath dryness in throat higher than normal blood pressure
59 2021-02-08 blood pressure increased 2:45pm less than ten minutes post vaccination c/o severe headache. BP elevated above normal greate... Read more
2:45pm less than ten minutes post vaccination c/o severe headache. BP elevated above normal greater than 180/ denies dizziness. Hx of DM currently on holter monitor. Hx of MS 2:50pm BP 179/81HR 69 SPO2 99% 2:55pm BP 180/81 HR 66 SPO2 99% 3:08pm BP 171/76 HR 64 SPO2 99% 3:25pm BP 185/79 HR 62 SPO2 100% 3:30pm EE verbalized feeling much better able to ambulate per self went home.
59 2021-02-08 coughing up blood Around 1:00 pm started coughing blood,hour later had fever 104 had to be rushed to ER. I was hospita... Read more
Around 1:00 pm started coughing blood,hour later had fever 104 had to be rushed to ER. I was hospitalized for 8 days. The physician diagnosed me with bacterial pneumonia. After being discharged from hospital had another CT scan found 3 in undefinable mass on right lung and nodules left lung. I have a appt scheduled to follow up with a Pulmonary specialist on 3/9.
59 2021-02-09 cerebrovascular accident, loss of consciousness On Saturday 2/6 unwitnessed fall without loss of consciousness. Gait was unstable, weakness on righ... Read more
On Saturday 2/6 unwitnessed fall without loss of consciousness. Gait was unstable, weakness on right side (RUE, RLE) slurred speech, difficulty with finding words. Transported by POV to ED for evaluation of stroke - same sx with onset of parasthesia in right upper arm. Stroke protocol done - received tPA with resolution of symptoms during infusion. Stayed in hospital until protocol completed. Symptoms resolved over the course of the hopsitalization.
59 2021-02-10 pallor Lightheaded; Skin color pale; Dry mouth; This is a spontaneous report from a contactable consumer (p... Read more
Lightheaded; Skin color pale; Dry mouth; This is a spontaneous report from a contactable consumer (patient himself). This 59-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 27Jan2021 (at 09:30) at a single dose on the left arm for COVID-19 immunisation. The vaccine was administered at Clinic. No relevant medical history was provided. No known allergies. Relevant concomitant medications included atorvastatin and tamsulosin. On 27Jan2021 (at 09:45), the patient was lightheaded, she had skin color pale and dry mouth. The events were assessed as non-serious and lasted approximately 1.5 hours. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. No treatments were given for the events. The events resolved on 27Jan2021.
59 2021-02-17 chest pain Chest pain; shortness of breath; pain radiating down left arm; This is a spontaneous report from a c... Read more
Chest pain; shortness of breath; pain radiating down left arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 06Feb2021 12:00 at single dose in left arm for COVID-19 immunisation. Medical history included allergies to iodinated contrast, chronic lymphocytic leukaemia (CLL), herniated discs. The patient didn't have COVID prior vaccination. Concomitant medications included tamsulosin hydrochloride (FLOMAX), sertraline hydrochloride (ZOLOFT), valacyclovir, ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER). The patient previously received the first dose of bnt162b2 on 16Jan2021 02:00 PM in left arm for COVID-19 immunisation. There were no other vaccine in four weeks. The patient experienced chest pain, shortness of breath, pain radiating down left arm. Adverse events start from 07Feb2021 05:45 AM. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and hospitalization for 1 day. Treatment was received for the events. The patient underwent lab test which included Blood tests, EKG on unknown date. The outcome of the events was recovering. COVID was not tested post vaccination. Information on Lot/Batch has been requested.
59 2021-02-19 nosebleed Received vaccine at 1:00pm. Waited 15 minutes in waiting area. No adverse effects. Returned to work... Read more
Received vaccine at 1:00pm. Waited 15 minutes in waiting area. No adverse effects. Returned to work. At 10:00 pm while sleeping on my back, felt liquid dripping in the back of throat. Rolled over to side and felt liquid dripping from nose onto pillow. Woke up to blow nose and realized that sheets,blanket, and pillow were covered with bright red blood. Went to breakfast table to sit upright to attempt to stop bleeding. Bleeding continued for one hour until stopped. Note: The relative humidity in home was at 49%. This was a posterior nosebleed; not anterior from dry air.
59 2021-02-22 hypertension, chest discomfort 2 days later developed chest tightness, left arm pain, weakness, HTN
59 2021-02-26 nosebleed Alergic reaction in the left arm after two weeks due to vaccine. Skin redness, no inflammation and n... Read more
Alergic reaction in the left arm after two weeks due to vaccine. Skin redness, no inflammation and no pain and little hot in the area and occasionally nose bleeding.
59 2021-03-10 blood glucose increased patient woke up filling faint and dizzy. temperature went to 102 and his blood glucose level was 160... Read more
patient woke up filling faint and dizzy. temperature went to 102 and his blood glucose level was 160.
59 2021-03-12 chest discomfort Immediate after the shot i had a weird taste and slight feeling of nausea which soon went away. Ar... Read more
Immediate after the shot i had a weird taste and slight feeling of nausea which soon went away. Around 6 pm on the day of the injection I noticed that my taste buds were more sensitive. Following that I became very sluggish. So I went to bed shortly afterwards. The following morning I was still sluggish and there was a feeling of openness in my upper chest area. The feeling of tiredness an no energy started and continued until Wednesday the 3rd of March. That morning I awaken feeling better. I still have a feeling of openness in my upper chest area. But overall I feel great.
59 2021-03-14 chest pain 2 weeks post vaccine developed thoracic pain, now 6 weeks later (8 weeks post vaccine) treating for... Read more
2 weeks post vaccine developed thoracic pain, now 6 weeks later (8 weeks post vaccine) treating for post herpetic neuralgia (zoster sine herpete)
59 2021-03-17 blood clot Pfizer-BioNTech COVID-19 Vaccine EUA Approximately three weeks after this injection, I began to fee... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately three weeks after this injection, I began to feel a pain in my left leg. I assumed it was a cramp. I then received a second dose (Lot # EN6206) on 3/13/21. Over that weekend the pain in my leg grew worse and the leg began to swell. on 3/15, I went to my primary care physician who said it looked like a blood clot. He sent me to a radiologist for an ultrasound (?) of the leg. After confirming the clot, I went to a local ER. They started me on Eliquis to treat the clot
59 2021-03-18 blood glucose increased my blood sugar spiked. had just had blood work done prior to first dose no sign of diabetes 2 days a... Read more
my blood sugar spiked. had just had blood work done prior to first dose no sign of diabetes 2 days after 2nd shot started feel fatigue headache and urine increase went to doctor today i have type 2 diabetes.
59 2021-03-22 palpitations 11:38am Patient states "I feel palpitation and shortness of breath". Pt. stated "I feel better". ... Read more
11:38am Patient states "I feel palpitation and shortness of breath". Pt. stated "I feel better". Vital signs 11:38am 152/80 92 18 O2 99%; 11:43am 122/78 64 16 O2 98%; 11:48am 118/72 67 16 O2 98%; Patient in the passenger seat, went home calm and cooperative. Disposition: Patient left the parking lot by car, calm and cooperative.
59 2021-03-24 hypotension, fainting Pt with witnessed ground level fall from chair due to syncopal event after receiving vaccine. Pt sus... Read more
Pt with witnessed ground level fall from chair due to syncopal event after receiving vaccine. Pt sustained blunt trauma to his head that included a contusion over his right forehead and laceration to posterior right ear. Pt was AOx2, not oriented to time, confused and repeating himself. Pt was also diaphoretic and hypotensive after the event. Due to altered mental status pt was transported by EMS to a local hospital for further evaluation.
59 2021-03-25 chest pain Chest pain and extremely bad heartburn. Symptoms have subsided since then.
59 2021-03-25 loss of consciousness, pallor Pt at chair, received vaccination and proceeded to pass out, Placed in wheel chair and elevated feet... Read more
Pt at chair, received vaccination and proceeded to pass out, Placed in wheel chair and elevated feet. ammonia spirits under nose. groggy but able to answer questions. very pale and sweaty. knew where he was and his name. Strong pulse noted. Pt moved to stretcher to Observation room @11:45 BP 105/58, Pulse 58, RR 24 Pulse Ox 100. 11:31 BP 111/66, Pulse 58, RR 28 Pulse Ox 100. Vital signs remain stable for next 15 minutes. started to take sips of apple juice and water. Head of bed raised bits at a time. Felt dizzy at drastic head of bed elevations. 11:55 BP 110/65 Pulse 51, RR 20, Pulse Ox 100. Pulse dipping to high 40s but pt states that this is his normal. Wife at bedside. reports feeling nausea and did eventually vomit. feels better after emesis. 1230 BP 126/74 pulse 53 RR 20 PO 99. eventually sitting and standing up. 12:50 BP 134/79 pulse 64 RR 20 po 96. felt good. walked with pt and wife out to exit. Discharged to home with wife.
59 2021-03-27 palpitations Heart Palpitations (appear to be premature ventricular contractions), foggy head. on and off for tw... Read more
Heart Palpitations (appear to be premature ventricular contractions), foggy head. on and off for two weeks. Anxious feelings and foggy brain accompany palpitations. Feel normal part of the time.
59 2021-03-31 blood pressure decreased, heart rate decreased Blood pressure dropped from 107/72 to 103/67. HR dropped from 73 to 60. O2 sat from 96 to 97%
59 2021-04-01 loss of consciousness At 11:39am, patient & wife mention that patient has history of passing out. Then suddenly, patient s... Read more
At 11:39am, patient & wife mention that patient has history of passing out. Then suddenly, patient started to feel lightheaded & dizziness. Patient loss of conciousness and was lay down to the floor assisted. Patient was diaphoretic, loss of conciousness for about 1 to 2 mins, VS#1 130/90, 68 & 98%. Patient regain conciousness, alert & oriented. At 11:46am, VS#2 132/100, 96% & 71 sitting down. Transfer to wheelchair & monitored for 30mins, 11:54 VS#3 130/70, 97% & 66. At 1209, VS#4 140/90, 97% & 67 on standing position, denies dizziness, lightheadedness, SOB & with steady gait. Patient able to go home with wife. No s/sx of distress.
59 2021-04-02 pallor, fainting PATIENT HAD SYNCOPAL EPISODE, UNAROUSABLE TO STERNAL RUB, PALE, CLAMMY, DIAPHORETIC. VITAL SIGNS OBT... Read more
PATIENT HAD SYNCOPAL EPISODE, UNAROUSABLE TO STERNAL RUB, PALE, CLAMMY, DIAPHORETIC. VITAL SIGNS OBTAINED. 911 WAS CALLED FOR TRANSPORT.
59 2021-04-05 palpitations Fever, Dizziness, Weakness, confusion for 3 day. racing heart and sore throat. Ladder brought patien... Read more
Fever, Dizziness, Weakness, confusion for 3 day. racing heart and sore throat. Ladder brought patient to Doctor office for treatment. Antibiotics treatment for sore throat to no effect. 2nd dose started and to date same effect. Patient is in pain.
59 2021-04-06 loss of consciousness, transient ischaemic attack passed out; i may have had a TIA; This is a spontaneous report from a contactable consumer (patient)... Read more
passed out; i may have had a TIA; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of bnt162b2 (BNT162B2, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 11:15 (at the age of 59-year-old) at single dose for COVID-19 immunization. Medical history included high blood pressure. The patient had no known allergies. Concomitant medication included losartan. No other vaccine in four weeks. No COVID prior vaccination. On 19Mar2021 11:15 AM, the patient immediately passed out and was taken by ambulance to hospital. They said that he may have had a TIA (even though the CT scan and MRI were clean). The patient will not get the 2nd vaccine because of his reaction. The adverse events resulted in Emergency room/department or urgent care, Hospitalization. He was hospitalized on 19Mar2021. The patient had nasal swab test on 19Mar2021 with negative result. The patient received treatment for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
59 2021-04-07 blood pressure increased Feelings of sickness and elevated blood pressure as well as dizziness.
59 2021-04-08 chest discomfort, chest pain Began feeling a little warm and flushed and tired. I felt off overall. On the 8th around 12pm. I cam... Read more
Began feeling a little warm and flushed and tired. I felt off overall. On the 8th around 12pm. I cam e home from work around 4:30 and laid down til 5:30 and I woke up feeling a little better but around 6:15 I felt the same as earlier that day and then it got worse. My ears were ringing loudly and I had shortness of breath, I had difficulty breathing, and my chest was tight and I had pain in the center of my chest and I was nauseous and hungry but really couldn't eat anything. I checked my BP at home and it was 189/127 and then 192/122. I was well hydrated but I drank 2 16 ounce glasses of water and sat down to try and relax. An hour later the ringing stopped and I was feeling much better. I took my BP again and it was up to 202/126. I decided to go to the ER at this time. around 11pm it was 143/89. Ringing and flushed still present with some stomach issues (4/9)
59 2021-04-08 palpitations pt says his heart started racing, he was dizzy, had SOB, and hands were shaking. Pt called PCP whic... Read more
pt says his heart started racing, he was dizzy, had SOB, and hands were shaking. Pt called PCP which told him to get to an ER. He went to ER. They did several test. His heart was miss-firing. They gave him some medication which brought heart rate down but needed to had have an electrical shock. This brought his heart rate down to 85. He has been referred to a Cardiologist which he will schedule appt today.
59 2021-04-09 heart failure Reported cause(s) of patient death: Heart failure; chills; fever; This is a spontaneous report from ... Read more
Reported cause(s) of patient death: Heart failure; chills; fever; This is a spontaneous report from a contactable consumer (patient's spouse). A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) at the age of 59-years-old, via an unspecified route of administration in left arm on 17Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included congestive heart failure, diabetes, and high blood pressure. He has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included olmesartan medoxomil, furosemide, repaglinide, metformin, amlodipine, atorvastatin, carvedilol, hydrochlorothiazide, and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was reported as other. The patient experienced chills, fever, and heart failure on 18Mar2021. The events resulted in emergency room/department or urgent care, doctor or other healthcare professional office/clinic visit, and hospitalization for 8 days from Mar2021 to Mar2021. He eventually passed away on 31Mar2021. Treatment received for the events was reported as unknown. The patient underwent lab test and procedure which included nasal swab for COVID which was negative on 20Mar2021. The outcome of the events chills and fever were unknown. The patient died on 31Mar2021. The cause of death was heart failure. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Heart failure
59 2021-04-09 deep vein blood clot Developed Left lower extremity DVT 24 hours after vaccine; This is a spontaneous report from a non-c... Read more
Developed Left lower extremity DVT 24 hours after vaccine; This is a spontaneous report from a non-contactable Physician. A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, on 24Mar2021 (at the age of 59-year-old) at a single dose for COVID-19 immunisation. Relevant medical history included hypertension (HTN), diabetes mellitus (DM) and hyperlipidemia (HLD). The patient did not have history of deep vein thrombosis (DVT) and no other risk factors. The patient was not diagnosed with COVID-19 before vaccination. No relevant concomitant medications were provided. She developed left lower extremity DVT 24 hours after vaccine, on 25Mar2021. The event required emergency room visit. The patient was treated with an anticoagulation therapy. Post vaccination COVID-19 test was not done. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, the event deep vein thrombosis was most likely due to the patient's underlying hypertension, diabetes mellitus and hyperlipidemia. However a possible contributory role of vaccine BNT162B2 to the event can not be totally excluded. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product 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.
59 2021-04-12 chest pain, heart rate increased On the 4th day after the injection I start feeling the extreme weakness and extensive heartbeat whic... Read more
On the 4th day after the injection I start feeling the extreme weakness and extensive heartbeat which forced me to spend a few days in the bed. Right after that, even if the condition in general got improved, I?m still experiencing extensive heartbeat and occasional pain within the heart area. Also, I got new symptoms for the sciatic nerve related pain.
59 2021-04-12 blood clot Blood Clot detected liver vein. Dr. placed me on Xarelto
59 2021-04-13 cerebrovascular accident, transient ischaemic attack Stoke (TIA)
59 2021-04-13 pallor, chest pain Pt, approximately after 20 minutes post first dose vaccine, developed dizziness, nausea, and sub-ste... Read more
Pt, approximately after 20 minutes post first dose vaccine, developed dizziness, nausea, and sub-sternal 8/10 chest pain. Pt airway patent, breathing, tachpemic and non-labored. Pulse strong and tachycardic with adequate perfusion. Pt pale, warm, dry skin. Pt transported by emergency services to Hospital.
59 2021-04-13 pulmonary embolism PE in both lungs. Needed an ER visit 5 days after vaccination
59 2021-04-14 fainting Pt fainted after getting vaccinated and afterwords told us that he had not had food that morning due... Read more
Pt fainted after getting vaccinated and afterwords told us that he had not had food that morning due to being nervous.
59 2021-04-15 pallor, lightheadedness, loss of consciousness Pt has hx of vasovagal reaction when getting any sort of immunization/injection. Pt found in Vaccina... Read more
Pt has hx of vasovagal reaction when getting any sort of immunization/injection. Pt found in Vaccination boot number 1 with healthcare provider. PT had just received his Pfizer immunization. PT stated he wasn't feeling well and needed a moment. Pt then became diaphoretic, pale, cool skins. Paramedic asked patient if we could take him to cot for observation. PT agreed and stood up turned and sat in wheel chair. PT taken to cot and as we arrived pt became unconscious. Pt was unresponsive to verbal and painful stimuli. Pt remained unconscious for approximately 20 seconds. Once patient regained consciousness he was immediately Alert and Oriented x4, skins were pale, moist, cool. pt was carried to cot during his unconscious episode. pt layed down for a while, vitals were assessed at 1556: BP-128/88, HR 64, RR 22, SPO2- 94%. Pt immediately feeling much better and taken to observation for an additional 30 minutes. Pt advised to let us know if he was feeling faint again.
59 2021-04-16 chest pain, fast heart rate Within minutes after receiving 2nd dose of Pfizer COVID vaccine (at approximately 1200) patient pres... Read more
Within minutes after receiving 2nd dose of Pfizer COVID vaccine (at approximately 1200) patient presented to this RN due to complaints of feeling like she would pass out. She was holding her head in a wheelchair and appeared quite uncomfortable. She was safely transported to a recliner to elevate legs. She was lying in a flat position. Mask taken off due to complaints of "having a hard time breathing." Patient complained of LEFT sided chest pain; unable to determine if this pain is acute or chronic. Patients slow to respond and unable to describe symptoms well. Patients slow to respond to questioning. Patient with mildly stuttered speech. Eventually patient admitted to dizziness. Given the nature of presentation, first responder called and arrived quickly. Vitals at 1200: 135/112, semi-Fowler's position, right arm. 84 bpm, apical, regular, 95%, room air. Patient denied swelling, throat tightness. No rash. Patient sat up in chair to help with breathing. Vitals at 1212: Heart rate 101 bpm. No apparent respiratory distress. NP briefly auscultated prior to immediate transport to Emergency Department. Patient transported to Emergency Department via wheelchair with First Responder.
59 2021-04-17 loss of consciousness Pfizer-BioNTech COVID-19 Vaccine EUA 4/14/21 12:45 pm - vaccination - no issues 11:00 pm - Chills, c... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 4/14/21 12:45 pm - vaccination - no issues 11:00 pm - Chills, chattering teeth, nausea 4/15/21 1:00 am - loose bowels, minor headache 8:30 am - Vertigo, unable to stand, collapse on floor, major nausea, dizziness - go straight to bed 8:30 am - 8:30 pm - Sleep off/on entire period, arm pain, drink water, take tylenol, chills, nausea, lethargy 8:30 pm - Midnight - profuse sweating soaking clothes, major headaches, nausea - continue to sleep 4/16/21 Midnight - 6:00 am - Restless sleep, loose bowels at times All day - Awake, tired, occasional nausea. limited appetite 4/17/21 Limited appetite - occasional nausea
59 2021-04-18 atrial fibrillation, heart attack Aortic valve endocarditis with MSSA, NSTEMI, Atrial fibrillation. Patient will likely require valve ... Read more
Aortic valve endocarditis with MSSA, NSTEMI, Atrial fibrillation. Patient will likely require valve replacement
59 2021-04-18 nosebleed since the second shot have had six nose bleeds. It has happened daily and sometimes it take long tim... Read more
since the second shot have had six nose bleeds. It has happened daily and sometimes it take long time to stop
59 2021-04-18 nosebleed nose bleeds every day after 2nd shot. contacted my doctor awaiting call back
59 2021-04-19 loss of consciousness Patient received vaccination at 10:15am, waited 15 minutes, then went to work. Patient reported blur... Read more
Patient received vaccination at 10:15am, waited 15 minutes, then went to work. Patient reported blurry vision, cold chills, dizziness and stomach cramping beginning 12:30pm. Patient sat down and began experiencing a new onset headache. Patient tried to get up once, sat down, then tried to get up again and reportedly blacked out. Patient was aroused by coworkers at which time was taken to his residence. Patient did not seek treatment. Roughly 24 hours after the event the patient reported still feeling weak and light headed. Patient was urged to seek medical treatment.
59 2021-04-20 chest discomfort Worsening anxiety with chest tightness and feeling of trouble swallowing
59 2021-04-21 deep vein blood clot pt had right leg swelling and pain starting on 03-22-21 and presented for medical care on 03-29-21 ... Read more
pt had right leg swelling and pain starting on 03-22-21 and presented for medical care on 03-29-21 was found to have elevated d-Dimers and Doppler RLE showed occlusive clot in right peroneal vein and non-occlusive clot in right popliteal vein
59 2021-04-21 haemoglobin decreased, fast heart rate developed initially right knee pain which then a few days later was the left knee and significant pa... Read more
developed initially right knee pain which then a few days later was the left knee and significant pain in the MCP joints of both hands. Taking a fair amount of Naprosyn for pain relief and presented with tachycardia and hemoglobin of 6.3 from likely GI bleed.
59 2021-04-22 stroke Patient experience CVA type symptoms and was found to have a subacute right corona radiata infarct.
59 2021-04-22 transient ischaemic attack On 7 April, approx 9AM, pt. experienced a TIA (Transient Ischemic Attack or Mini-stroke). Siblings ... Read more
On 7 April, approx 9AM, pt. experienced a TIA (Transient Ischemic Attack or Mini-stroke). Siblings became aware by 10:30, and by 11:45 he was at the ER. His speech was extremely restricted and he was barely able to speak a few words. Face was partially asymmetric, but gross and fine motor skills basically unaffected. He could walk and write his name, follow commands to move arm and legs. Underwent multiple tests including CAT scan, when no sign of bleed stroke confirmed. At admittance, Stroke Scale score = 4. By 3PM, speech started to return, and continued to return. Continued tests with EEG, EKG, and TTE, but no source for TIA could be pinpointed. Unable to perform MRI due to embedded medical device. By next morning speech had almost returned to normal. No physical restrictions noted on following day. Discharged 6PM on 8 April. Doctors unable to explain cause and could not comment on whether related to receiving vaccine a week prior. Recovery seems to be complete with no negative lasting effects as of 22 April, 2021.
59 2021-04-23 blood clot Blood clot in left lower extremity, requiring TpA
59 2021-04-24 blood glucose increased sight problems; double vision issue; eyelid was drooping; high blood sugar; This is a spontaneous re... Read more
sight problems; double vision issue; eyelid was drooping; high blood sugar; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. On Sunday, 21Feb2021, he got the second dose of Pfizer's COVID-19 vaccine, at night he started experiencing a reaction, he began having sight problems. He thought it would be temporary, so he went to bed (used slang), but on Monday he still had the double vision issue, he had problems in his vision, his eyelid was drooping, so he went to the emergency room at (Name). They determined he has double vision and right now his eyelid is completely drooped. He is very surprised after receiving the vaccine, he has low cholesterol and high blood sugar at 126, his blood pressure was 133-135. The patient underwent lab tests and procedures which included blood cholesterol: low on an unspecified date, blood glucose: 126 on an unspecified date, blood pressure measurement: 133-135 on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.
59 2021-04-24 blood glucose increased Became very ill..Extreme fatigue..Nausea, fever bodyaches leg cramps..Threw up from nausea..Could on... Read more
Became very ill..Extreme fatigue..Nausea, fever bodyaches leg cramps..Threw up from nausea..Could only lay down..Extreme headache and huge reaction from injection site..Blood sugars would not come down..Remained stubbornly high..Sleep...Wake up..have extreme leg cramps and body aches..Made way to bathroom brvause of nausea..Nearly threw up..Ended up just lying on the floor and going to sleep again...Got up ..Went into bedroom. Sip of diet soda..Back to sleep...Finally got up at 3pm...Signs of being able to come through..Was very close to going to Urgent Care but physically would have been too challenging to go...Had food at 10pm ...Slept through 5am...Soreness in arm has become much less..Signs of survival...Seriously have second thoughts about ever having another vaccine in future unless they improve the process...
59 2021-04-24 blood clot 3 days after the first dose I developed a blood clot in my right calf, never had one before, no trau... Read more
3 days after the first dose I developed a blood clot in my right calf, never had one before, no trauma, i am very active; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first received first dose of bnt162b2 (Pfizer, Formulation: Solution for injection, Lot Number: EP 7534b) via an unspecified route of administration, administered in left arm on 13Mar2021 11:00 at a single dose for covid-19 immunization. Medical history and known allergies were none. Concomitant medication included rivaroxaban (XARELTO). The patient developed a blood clot in his right calf 3 days after the first dose, never had one before, no trauma, he was very active on 16Mar2021 07:00. No covid vaccination was taken prior. No covid tested post vaccination. Blood thinner for the clot was given as the treatment. The outcome of the event was not recovered.
59 2021-04-25 arrhythmia, hypertension 1-5 days swelling and rash, pain in arm at injection side Day 3-4 Throbbing leg - felt artery flutte... Read more
1-5 days swelling and rash, pain in arm at injection side Day 3-4 Throbbing leg - felt artery flutter. 1-12 days recurring headache 3-18 days pain in shoulder and armpit near injection site Day 12-18 swelling in hand Day 2-18 - extreme fatigue, lack of energy Day 2-18 - higher blood pressure Day 4-18 ? Nausea and forgetfulness
59 2021-04-26 cerebrovascular accident This is a spontaneous report from two contactable consumers (one of them is the patient) from a Pfiz... Read more
This is a spontaneous report from two contactable consumers (one of them is the patient) from a Pfizer sponsored program. A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EP534) via an unspecified route of administration, administered in Arm Left, at the age of 59-year-old, on 22Mar2021 08:30, as SINGLE DOSE for covid-19 immunization. Medical history included three strokes, hypertension, diabetes mellitus. The patient had no additional Vaccines Administered on Same Date of the Pfizer Suspect and had no prior vaccinations within the last 4 weeks. Concomitant medications included metformin taken for diabetes mellitus (has been taking for many years) and losartan taken for hypertension since 2018 (has been taking for about 3 years). On 09Apr2021, the patient was feeling bad and went to the hospital. There he was told that he has had three strokes in the past. The patient was told that one of the strokes was about a month ago (Mar2021). He went to the hospital three days ago. He was not admitted and was sent home. He went back again and was sent home. He was started on Plavix two days ago for stroke. The events required emergency room visit. The patient right now is working and travelling and he supposed to have the 2nd dose of the vaccine on 12Apr2021. He wants to know if he can take it late or what possible that he can do. Outcome of was feeling bad was unknown while the event stroke recovered in 2021 with sequelae.
59 2021-04-26 fainting, cardiac arrest I was notified that patient passed away at Hospital 10:37 am today. Per message to medical office fr... Read more
I was notified that patient passed away at Hospital 10:37 am today. Per message to medical office from Coroner, it was reported that patient collapsed this morning while walking his dog. Patient was brought in by ALS complaint of FULL ARREST to Hospital 10:10 am and pronounced at 10:37 am 4/24/2021 by Dr. at Hospital.
59 2021-04-27 loss of consciousness loss of consciousness; slumped on the floor/going down; nausea; This is a spontaneous report from a ... Read more
loss of consciousness; slumped on the floor/going down; nausea; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (COVID 19 Pfizer), dose 2 via an unspecified route of administration, administered in right arm on 10Apr2021 13:00 (Lot Number: ER8729) as single dose for COVID-19 immunisation; and trazodone, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 50 mg for insomnia. Medical history included high blood pressure and low thyroid from an unknown date and unknown if ongoing. The patient had unspecified medication for high blood pressure and low thyroid. The patient previously received codeine and experienced allergies. The patient previously received 1st dose of BNT162B2 COVID19 Pfizer, lot = EN6207, on 16Mar2021, 06:30 pm, in the left arm for covid-19 immunization. About 36 hours after injection of 2nd dose and about six hours after taking 50mg of Trazodone for insomnia, awoke to get a drink of water. Experienced sudden onset of nausea so he didn't take the drink but went to the bathroom to urinate instead. Came to (regained consciousness) finding self slumped on the floor. No advance feeling of lightheadedness. No memory of going down. Out for an unknown period of time. Hadn't had a lot to drink after receiving the injection. No prior occurrences of loss of consciousness. Onset of events was 12Apr2021 01:00 am. Outcome of events recovered with no treatment. The patient was not diagnosed of COVID prior vaccination and has not been tested for COVID post vaccination. The action taken in response to the events for trazodone was unknown.
59 2021-05-01 cardiac arrest, blood glucose increased Because patient had a severe adverse reaction to the first injection, he stated to me that he would ... Read more
Because patient had a severe adverse reaction to the first injection, he stated to me that he would not be getting the second injection. Two workers (from the mental health day program, he went to before the covid lockdown) both advised him to get the second injection, however, and he complied. After injection he had episodes of difficulty breathing and vomiting for several nights. Soon after that, he started having to go to the emergency room for blood sugars over 500 (prior to injection his diabetes had been controllable at care home). When he went to ER (for high blood sugar) March 18th, his heart stopped and could not be re-started. He died.
59 2021-05-02 heart failure Pt had progressive shortness of breath 4-5 days prior to vaccine administration that resulted in hos... Read more
Pt had progressive shortness of breath 4-5 days prior to vaccine administration that resulted in hospital admission and ICU transfer for hypoxic respiratory failure (possible secondary to pneumonia, acute HF exacerbation with fluid overload, etc.). Unclear if related to vaccine given patient's underlying comorbidities and progressive nature of the respiratory failure starting even prior to vaccine administration.
59 2021-05-03 heart attack E87.6 - Hypokalemia I24.9 - ACS (acute coronary syndrome) (CMS/HCC) I21.4 - NSTEMI (non-ST elevated ... Read more
E87.6 - Hypokalemia I24.9 - ACS (acute coronary syndrome) (CMS/HCC) I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)
59 2021-05-03 chest discomfort Shortly after receiving the covid vaccination, he began to complain of visual disturbance, nausea an... Read more
Shortly after receiving the covid vaccination, he began to complain of visual disturbance, nausea and vomiting. He had dry heaves and had biohazard container. He complained of chest tightness at 1:20 pm with BP=140/80-97% pulse ox and 74 pulse. At 1:25 pm, he was 112/70, 97% and 66 heart . After sitting total of 30 minutes, he left the recovery to go home and his dizziness had dissipated.
59 2021-05-03 chest discomfort 8:30 am the day after the vaccine my lower right lip and lower right face swelled. For 14 days ever... Read more
8:30 am the day after the vaccine my lower right lip and lower right face swelled. For 14 days every day I had a headache and cramps. Daily fatigue. One day it felt like a giant hand was squeezing me around the chest and back. Random periods of nausea. One day I had overwhelming fatigue, it took every ounce of my strength to lift myself. It felt like something was laying on me pushing me down. Another day my upper right lip and upper right face swelled. Arm hurt at vaccine site. All this went on over a period of 2 weeks. To this day my upper right lip randomly swells.
59 2021-05-04 heart rate increased rapid heartbeat; mild dizziness; This is a spontaneous report from a contactable consumer. A 59-year... Read more
rapid heartbeat; mild dizziness; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 13Apr2021 (Batch/Lot Number: ER8737) as single dose for covid-19 immunisation. Patient received the first dose on 23Mar2021. Medical history included lymphoma, blood pressure measurement, and cardiovascular disorder. Concomitant medication included sotalol taken for blood pressure measurement, start and stop date were not reported. The patient experienced rapid heartbeat and mild dizziness on 13Apr2021. Outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
59 2021-05-04 loss of consciousness Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot... Read more
Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot; Threw up; This is a spontaneous report from a contactable consumer (the patient) and then from a contactable consumer (the patient's wife). A 59-year-old male patient received the first dose of BNT162B2 (lot number not provided), via an unspecified route of administration in the left arm on 31Mar2021 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included: fish oil (OMEGA 3 FISH OIL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient felt ill shortly after receiving the shot. Told to sit down. Passed out. Awoke on the floor. Told possible seizure. Sat up. Threw up. Told to lie back down. Ambulance came and took him to the hospital. He spent 90 minutes in the Emergency Room. He was unable to work for a couple of days. He had extreme fatigue and brain fog. He was not back to relatively normal for at least 10 days. Treatment received was reported as yes: ran tests including 3 EKGs, on an unspecified date. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
59 2021-05-04 blood clot This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732) at the age of 59-years-old, via an unspecified route of administration in left arm on 22Mar2021 at 15:00 at single dose for COVID-19 immunisation. The patient's medical history was reported as none. He has no known allergies and has COVID prior to vaccination. Concomitant medications included metoprolol, rosuvastatin, oxybutynin, and tamsulosin. There were no other vaccines in four weeks and no additional vaccines administered on the same date of the COVID-19 vaccine. The patient reported that he was having some wild effects from the vaccine and did not know what to do. On 26Mar2021 at 15:00, he was having neuropathy like effects. His hands, arms, legs, and feet were experiencing pain and burning sensations, they were burning like nerve damage; he also has a little burning sensation in his nose and cheeks. He has never had this before. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. He was also having some weird sensations in his calf muscles, these sensations started within the past week and a half (Apr2021) which prompted physician office visit. The physician placed him on gabapentin 100 mg to start from 12Apr2021, but it was not enough, it was titrated up to 300 mg, three times a day and he is scheduled to see specialist soon. The patient mentioned that this vaccine has ruined his health. He also went to an urgent care center because his leg was bothering him, it was swelling on an unspecified date in 2021; he thought he had a blood clot; they did some kind of test where they looked at the leg and did not find anything. He didn't have a particular question. He would just like to talk to someone to see if this was going on with anyone else, if it will go away, or if this was permanent problem he will have. The patient was not tested for COVID post vaccination. He received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration in left arm on 13Apr2021 at 15:00 at single dose for COVID-19 immunisation. The outcome of the events was not recovered.
59 2021-05-05 fainting I had the vaccination (my second) and waited the required 15 minutes after the injection. I felt fi... Read more
I had the vaccination (my second) and waited the required 15 minutes after the injection. I felt fine and got on my bike and road home. I took a longer route (10 miles), and I remember things up to almost the end. The bike ride ended with a bad fall, I presumably had a syncopal event and crashed my bicycle. Bad hit on helmet, and I was unconscious for probably five minutes. I was found and woken up by a passerby (I have no memory of this) and then the EMTs arrived. Checked into Emergency Room. They suspected a cardiac event, but I have so far passed all the tests (exercise stress test, echocardiogram, normal QT). I have *never* had an event like this, the bike ride, while a little long, was quite normal for me. I also note that I had possibly not had enough to eat or drink that morning. So, based on the curious timing of this event, I personally believe it's related to the shot. I also don't really believe this is an anxiety related syncopal event (it was more than an hour after the shot), but rather I suspect an immune response, perhaps aggravated by dehydration/lack of enough food. But who knows? I was out cold, and don't remember the minute or so up to the crash. I did go back to inspect the bikeway that I was on to see if there was anything there that could have caused a crash (tree branches, rough surface) and I found nothing. It was a pretty flat easy bike path at that point.
59 2021-05-06 arrhythmia, pallor, chest pain Note 01/18/2021 Wife called patient has been ill all weekend. He is pale, passing out, Arhythmia, n... Read more
Note 01/18/2021 Wife called patient has been ill all weekend. He is pale, passing out, Arhythmia, no fever, no cough, no SOB (but hasn't been doing much either). Was going to have pt seen this am, but spoke with healthcare and wants Pt to go to ER for emergent testing. Called wife back and she was notified. CHEST PAIN, PALPITATIONS, NAUSEA, SOB
59 2021-05-06 blood clot 4/28/2021-Lower left leg hurting; 4/29/2021-can't put weight on leg; ER visit with doppler to confir... Read more
4/28/2021-Lower left leg hurting; 4/29/2021-can't put weight on leg; ER visit with doppler to confirm blot clot in calf; ER gave Norco 5-325 mg for pain; fever of 101; 4/30/2021-still can't put weight on leg and fever of 101.8; 5/1/2021-woke up with no pain; clot still there; 5/3/2021-saw primary doctor for ER follow-up on clot; primary doctor confirmed there is a small clot in deep vein and could take up to 6 months for it to dissolve on its own.
59 2021-05-07 chest pain chest pain; This is a spontaneous report from a contactable consumer (patient) reported that a 59-ye... Read more
chest pain; This is a spontaneous report from a contactable consumer (patient) reported that a 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 01May2021 10:30 (at the age of 59-years-old) as a single dose for covid-19 immunization. The vaccine was administered at the Pharmacy/drug store. The patient's medical history and concomitant medications were not reported. The next day morning on 02May2021 05:00, the patient experienced chest pain. The event was considered as life-threatening. It was unknown if the patient received treatment for the event. The outcome of the event was unknown. Information on the lot/batch number has been requested.
59 2021-05-07 heart rate decreased, hypotension, cerebrovascular accident stroke on 5/2 8:45 am hospitalized 5 days no physiologiical explanation. 3/4 of right cerebellum is ... Read more
stroke on 5/2 8:45 am hospitalized 5 days no physiologiical explanation. 3/4 of right cerebellum is dead. at onset nausea vomiting vision loss, loss of balance and coordination BP bottomed out low heartrate while sleepiing
59 2021-05-13 chest pain February 7, 2021 to March 20, 2021: Same evening burning sensation in forehead, muscle aches in legs... Read more
February 7, 2021 to March 20, 2021: Same evening burning sensation in forehead, muscle aches in legs. Following three weeks: sore throat, 3 weeks laryngitis, shortness of breath, chest and upper respiratory pain, overall lethargy, late February and March: 3 weeks abdominal pains and continuous diarrhea .
59 2021-05-18 chest discomfort, heart attack Received first vaccine 4/21/21. Within two days started having tightness in chest, but no other adve... Read more
Received first vaccine 4/21/21. Within two days started having tightness in chest, but no other adverse reactions, happened a couple times a day. 5/13/21 received second vaccine....had tightness two more times, then 5/14:22 evening had a heart attack....ambulance to Hospital. 99% blockage in LAD. Hospital inserted stent. Spoke with all of the Cardiologists about my concerns as Heart problems ?Do not? run in my family. I have always had excellent blood pressure and low cholesterol....my father is 86 and was a smoker, and never been on blood pressure medication, same with my late Grandfather. I?ve ?never? had any type of chest pains in my life. Also, I am retired military and have had numerous vaccines, with no issues. The hospital cardiologists said that I could report this, but they believe the Heart attack is due to the fact that I smoke....I just don?t believe that....the Heart Attack occurred 36 hours after my second vaccine!!!
59 2021-05-18 chest pain Patient developed renal infarct May 4, 2021. No previous history of thromboembolic disease. He sub... Read more
Patient developed renal infarct May 4, 2021. No previous history of thromboembolic disease. He subsequently developed severe upper chest pain and fatigue with an elevated high-sensitivity troponin I greater than 1000. He had cardiac catheterization on May 17,2021 which revealed nonobstructive coronary artery disease. His inflammatory markers are elevated (CRP, sed rate). He is scheduled for cardiac MRI to look for inflammatory disease of the heart. The patient himself is wondering if these events could be triggered by the COVID-19 vaccine he received.
59 2021-05-18 blood clot, pulmonary embolism pulmonary embolism; Blood Clot; This is a spontaneous report from a contactable consumer (patient). ... Read more
pulmonary embolism; Blood Clot; This is a spontaneous report from a contactable consumer (patient). A 59-yearold male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 (Batch/Lot Number: ew0153) as 1st dose, single (at the age of 59 years) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has not had covid-19 prior to vaccination. The patient experienced pulmonary embolism on an unspecified date and blood clot on 22Apr2021 with outcome of not recovered. The patient was hospitalized for blood clot for 2 days. The patient underwent lab tests and procedures which included blood test: negative on 26Apr2021. Therapeutic measures were taken as a result of the events incudes blood thinner. The outcome of the event blood clot was not recovered and unknown outcome for the event pulmonary embolism. The patient was tested negative for Covid-19 on 23Apr2021 (post vaccination). No follow-up attempts are possible; information about batch number already obtained.
59 2021-05-19 atrial fibrillation, cardiac failure congestive Congestive heart failure, in AFIB; Congestive heart failure, in AFIB; This is a spontaneous report f... Read more
Congestive heart failure, in AFIB; Congestive heart failure, in AFIB; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 21Apr2021 (at the age of 59-years-old) as 1 st dose, single for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The reported Events were congestive heart failure, in AFib on 03May2021, hospitalization not prolonged. The events resulted to emergency room/department or urgent care. Received unspecified treatment for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
59 2021-05-21 loss of consciousness, lightheadedness Passed out; Vertigo; Nausea; felt like he was going to pass out; Lost 12 pounds since getting the se... Read more
Passed out; Vertigo; Nausea; felt like he was going to pass out; Lost 12 pounds since getting the second shot; 103 fever; Severe chills/Shivering uncontrollably; Every inch of body ached; Headache; Low back pain; could barely walk; Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729), via an unspecified route of administration, administered in left arm on 09Apr2021 at 17:00 (at 59-year-old) at single dose for COVID-19 immunization. Patient medical history was reported as none. He had a family history of ulcers but he has never had any ulcers but that could maybe be related to the blood in stool. The patient's concomitant medications were not reported. No additional administered vaccines. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), via an unspecified route of administration, administered in right arm on 20Mar2021 at 18:00 (at 59-year-old) at single dose for COVID-19 Immunization, and experienced soreness in the arms. On 10Apr2021 03:00 (reported as 10 hours after receiving the second dose of the vaccine), the patient had a 103 fever, severe chills, every inch of his body ached, headache, shivering uncontrollably and most of this was just for 2 or 3 days. Patient stated then in Apr2021 (reported as a week ago) he had severe low back pain where he could barely walk. Patient stated then last weekend in Apr2021 he had noticed blood in his stool, this started either on last Thursday (29Apr2021) or Friday (30Apr2021). Patient stated and on Tuesday (04May2021) he started getting vertigo, nausea, and passed out. Caller asked was that common side effects or was this an unrelated virus. For event headache, patient stated for 1 day it was a severe headache and then it was a bad headache for 2 or 3 days but he was still experiencing a headache currently. Patient stated the worst part of the headache he has recovered from but he still had a headache and it has gotten much better. For event low back pain, patient stated the back pain got really severe for a week then it got better then came back and right now it was minor but the severe pain was only for about a week. Patient stated that nausea comes and goes. That was another symptom he has lost 12 pounds since getting the second shot. He still felt like he was going to pass out but only passed out that one time. He still had symptoms that he could pass out at any minute. Patient clarified that he went to the emergency room the day after the second dose of the vaccine when his first set of symptoms started. He had also taken ondansetron hydrochloride (ZOFRAN), dimenhydrinate (DRAMAMINE), and paracetamol (TYLENOL). Patient did not visit physician office but he let the physician know. No relevant tests. The outcome of the event severe chills/shivering uncontrollably was recovered on 11Apr2021, events 103 fever and every inch of body ached were recovered on 12Apr2021, event passed out was recovered on 04May2021; outcome of events headache, low back pain, could barely walk, nausea was recovering; outcome of events blood in stool, vertigo, lost 12 pounds since getting the second shot, felt like he was going to pass out was not recovered.
59 2021-05-22 atrial fibrillation, heart attack After 2nd shot I went into AFib about 5/6 days later. This lead to a heart attack about 17 days afte... Read more
After 2nd shot I went into AFib about 5/6 days later. This lead to a heart attack about 17 days after 2nd covid shot.
59 2021-05-23 heart rate increased, blood pressure increased Three minutes following receiving the vaccination I experienced rapid heart beat, confusion, burning... Read more
Three minutes following receiving the vaccination I experienced rapid heart beat, confusion, burning in lungs, blood pressure increase. Wheeled down to emergency room. Given anti nausea medication, exrays on heart and lungs, saline IV, heart monitored
59 2021-05-23 low blood oxigenation, oxygen saturation decreased Vaccine 3/15, 4/8. Admit 5/1. Admit for hypoxia d/t COVID PNA. H/O RA w/interstitial lung disease. I... Read more
Vaccine 3/15, 4/8. Admit 5/1. Admit for hypoxia d/t COVID PNA. H/O RA w/interstitial lung disease. In ER temp 100.1, SpO2 94%. WBC WNL, later elevated. CXR shows interstitial lung disease. Treated w/steroid, dose of convalescent plasma, supportive care, oxygen. Brief History: Patient who presented with the above complaints. Patient with a history of longstanding rheumatoid arthritis who presents to the ER with above-stated symptoms. Patient reports history of chronic dry cough which she attributes to having lung disease related to rheumatoid arthritis. Patient has received both doses of Pfizer COVID-19 vaccine, 2nd dose on April 8th. About 2 weeks ago he started having low-grade fevers with worsening of cough and shortness of breath. Patient was tested at an urgent care center and tested negative for COVID-19. Denies any known sick contacts. No recent travel history. Symptoms worsened about a week ago with persistent fevers, increasing cough and shortness of breath. Patient went to see his rheumatologist and diagnosed with interstitial lung disease this week and referred to see pulmonology. He was monitoring his oxygen saturations at home which have been dropping down to 88-89% on room air that made him come to the ER. Patient tested positive for COVID-19 in the emergency room. CT angiogram of the chest showed no evidence of any pulmonary emboli but evidence of interstitial lung disease bilaterally. He is currently being admitted for hypoxia secondary to COVID-19 pneumonia. Patient denies any chest pain Hospital Course: Patient was admitted. Kept on steroids and oxygen. Seen by Infectious Disease. Got a dose of convalescent plasma This morning he is on room air. Past the walk study. Feeling lot better. Seems to be stable for discharge on oral steroids to finish up the course.
59 2021-05-24 arrhythmia Heart Arrythmia
59 2021-05-24 coughing up blood Patient developed hemoptysis requiring two hospitalizations with acute hypoxic respiratory failure r... Read more
Patient developed hemoptysis requiring two hospitalizations with acute hypoxic respiratory failure requiring intubation during his second admission. Hospital stay was complicated by HAP and PIV infiltration while infusing levophed (for hypotension attributed to sedation) resulting in a right forearm scar.
59 2021-05-26 heart attack, chest pain night of 5/18 into early morning of 5/19: Pain in right arm, and upper right back, shoulder, and che... Read more
night of 5/18 into early morning of 5/19: Pain in right arm, and upper right back, shoulder, and chest. Ultimately Vomiting violently. Could not lie down without the pain returning. 5/19 Day: Had light breakfast and dinner. No vomiting, but could not lie down without same pain. Morning of 5/20: Breakfast of cereal and fruit at 9am. And noon, I experienced pain again, vomiting at noon. Then to Urgent care, then, Emergency Room, then Hospital.
59 2021-05-27 inflammation of the heart muscle, troponin increased Likely myocarditis. Elevated troponin, clean cath. Started on colchicine.
59 2021-05-27 pulmonary embolism My husband died May 1st, 3 weeks after his last vaccine April 10 . He had a saddle pulmonary emboli... Read more
My husband died May 1st, 3 weeks after his last vaccine April 10 . He had a saddle pulmonary emboli. He did not have any symptoms that I knew of prior to May 1st. Entering info for research data.
59 2021-05-27 pulmonary embolism Unprovoked bilateral pulmonary embolism Impression: multiple bilateral pulmonary emboli and proxim... Read more
Unprovoked bilateral pulmonary embolism Impression: multiple bilateral pulmonary emboli and proximol of which are in the right interlobar right middle lobar, right lower lobar and left lobar arteries. there is also multiple bilateral segmental pulmonary emboli. there is no CT evidence of pulmonary arterial hypertension or right sided heart strain however recommend echocardiogram
59 2021-05-28 atrial fibrillation, heart attack, nosebleed s/p 2 doses of Covid-19 vaccine. Pt presented for weakness, SOB, fatigue progressive over the past ... Read more
s/p 2 doses of Covid-19 vaccine. Pt presented for weakness, SOB, fatigue progressive over the past month prior to admission. Found to be pancytopenic with bone marrow biopsy consistent with MDS. He was started on chemo but stay was complicated by neutropenic fevers, epistaxis, retinal hemorrhage, AKI, fluid overload, hypoxic respiratory failure, atrial fibrillation with RVR, and shock. He ultimately had a heart attack while admitted and was transitioned to comfort care after medical interventions could not stabilize hemodynamics.
59 2021-05-28 fast heart rate, chest pain Injection pain, chest pain, tachycardia, fatigue,. nausea and vomitting
59 2021-05-31 chest pain 3/26/21 Chest pain 1 day after vaccine then shortness of breath with exertion and fatigue. Symptoms... Read more
3/26/21 Chest pain 1 day after vaccine then shortness of breath with exertion and fatigue. Symptoms worsened when at work 3/29/21 so went to ER. Saw PCP 3/30/21 and tests ordered. No change in symptoms. Saw Cardiologist next week 4/6/21 and admitted to hospital for heart catheterization 4/7/21. Cath was negative so was discharged from hospital. Symptoms continued so saw Cardiologist NP 4/28/21 and tests ordered EGD done 5/10/21 and was negative Echocardiogram and AAA sonogram done 5/13/21 and were negative as well Was released to go back to work 5/18/21 Continue to have rare chest pain with exertion that is not as severe now. Shortness of breath and fatigue daily with moderate exertion now
59 2021-06-01 cerebrovascular accident, ischaemic stroke I63.9 - CVA (cerebral vascular accident) I63.9 - Acute ischemic stroke R29.810 - Facial weakness R... Read more
I63.9 - CVA (cerebral vascular accident) I63.9 - Acute ischemic stroke R29.810 - Facial weakness R56.9 - Unspecified convulsions
59 2021-06-02 haemoglobin decreased, anaemia Developed muscle aches, fatigue, cough, congestion, and mild headache on 5/26/2021. Tested positive ... Read more
Developed muscle aches, fatigue, cough, congestion, and mild headache on 5/26/2021. Tested positive for COVID on 5/28/2021, with SARS CoV2 RNA NP swab. Advised to go to the ED, with regard to history of Asthma with respiratory manifestation of COVID. Went to the ED, and administered Decadron IV, vitals monitored, EKG and CXR performed, and labs drawn. Labs showed mild anemia, a low WBC, and Lymphcytopenia. Normal EKG and CXR. Given Prednisone orally for 5 days, Zithromax Z-Pack, and Ivermectin 5 day oral course. Returned to the ED on 5/31/2021 for administration of IV monoclonal antibody infusion and repeat Labs/Vital sign evaluation. Remain on 10 quarantine up to today, with ongoing mild SOB and cough unremitting.
59 2021-06-02 heart attack Received vaccine on 3/26/21 by 3/27/21 in the afternoon, arm became real sore. On 3/28/21 started ... Read more
Received vaccine on 3/26/21 by 3/27/21 in the afternoon, arm became real sore. On 3/28/21 started running a 102 temp with body aches, by 3/29/21 whole arm was sore and that night moved into the chest area. In the middle of the night pain was unbearable and took him to hospital where we were told he was having a heart attack. Transferred him by ambulance to Regional hospital.
59 2021-06-03 pulmonary embolism I26.99 - Subacute massive pulmonary embolism (CMS/HCC) I26.99 - Other pulmonary embolism without acu... Read more
I26.99 - Subacute massive pulmonary embolism (CMS/HCC) I26.99 - Other pulmonary embolism without acute cor pulmonale
59 2021-06-06 ventricular tachycardia, atrial fibrillation, hypotension Ventricular tachycardia with a pulse. Cardioversion x 3, Amiodarone 300mg IVP, Lidocaine 100mg IVP,... Read more
Ventricular tachycardia with a pulse. Cardioversion x 3, Amiodarone 300mg IVP, Lidocaine 100mg IVP, Amiodarone drip & Levophed drip started.
59 2021-06-08 palpitations Starting on the day of the vaccine (2nd dose)- I felt "a warm, chemical and electrical sensation" in... Read more
Starting on the day of the vaccine (2nd dose)- I felt "a warm, chemical and electrical sensation" in my chest a few hours after the vaccine. The next morning, I was unable to have a bowel movement, when usually I am very regular. I was not able to have a bowel movement for a couple of days. I felt very constipated and would try to force myself to have a bowel movement. I ate more fiber and fiber pills and drink more water, which was uneffective. I was finally able to have a bowel movement but it took a lot of force and would push the point of exhaustion and almost passing out. On 2/19/2021, I decided to seek medical care for my constipation, stomach cramps, fatigue, difficulty concentrating and shortness of breath. The doctor diagnosed me with Covid long hauler (I had a previous covid infection in 11/2020). I was prescribe probotics (for constipation) and rest for 2 months. I am still feeling fatigue and having heart palpitations. They order ECG(normal) and blood work (normal).
59 2021-06-09 blood pressure increased blood pressure was elevated; a migraine like headache; persistent severe headache; This is a spontan... Read more
blood pressure was elevated; a migraine like headache; persistent severe headache; This is a spontaneous report from a contactable consumer (patient's wife). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 20Apr2021 (Lot number and Expiry date was not reported) as 2nd dose, single dose for COVID-19 immunisation. Medical history included ongoing body mass index increased. The patient's concomitant medications were not reported. The patient received first dose of vaccine on an unspecified date for COVID-19 immunisation. History included he does not really take anything. He has had some injuries lately but that is not a medical condition. On 20Apr2021 the patient experienced a migraine like headache, on an unspecified date the patient experienced blood pressure was elevated. He has had a persistent severe headache which sometimes feels like a migraine since receiving the vaccine. She was concerned because his MD has never heard of a headache lasting this long (approximately 3 weeks) after the vaccine. She wants to know if this has been reported before. The migraine like headache from what caller's husband said was it started in the evening. He had the vaccine in the morning, but caller was a little fuzzy on that because they did not go together. By evening, he had a dull headache that got worse. He has headache ever since. He went to the doctors a week ago and they checked his blood pressure and did all kinds of things. They did say they thought there was a chance it was the vaccine even thought they had not heard of it lasting that long. This week, yesterday, they took him to the ER to get an evaluation and it just will not stop. The family doctor did full blood workup and everything was in normal ranges. They took his sugar and protein that tells you hydration. His blood pressure was elevated. When he went to the ER, caller things they repeated the screenings. They did carbon monoxide testing, CAT Scan, and Chest x-ray. Everything came out good or, well, it was negative. They want him to see a neurologist. They hooked him up to an IV and they tried to relieve the pain with a headache cocktail and it did not take the edge off of it. So, they are a little baffled by that. Caller does not know specific dates, times, or results. Caller states she does not know what the medications were, maybe it was Toradol was one thing she heard, and they also gave him Benadryl with it. They said it was something they give to people with migraines and it takes it out and helps them sleep. He usually does not take anything but she got him to try allergy medicine, a couple days of Excedrin, and a couple of days of other things. None of them seem to work. He told the ER and they said if it does not work, do not take it. Also, he took Aleve a couple of days. Caller does not have any of this information as she is at work, and she states she did buy all of them. He tried name brand Aleve, Allegra for about 3 days, generic Excedrin which she thinks was Ibuprofen, and Tylenol. Caller confirms her husband was not admitted to the hospital, they sent him home with a referral to follow up with neuro and not the family doctor, and to come back if it gets worse. Today he was supposed to call them. Caller's husband was at the ER yesterday, 09May2021. A CAT Scan showed no mass or anything. They gave him several different things to relieve the headache and nothing worked. The outcome of the events was unknown. Information on the lot/batch number has been requested.
59 2021-06-11 heart attack Vaccine at about 4pm Heart attack 7pm Stent placed Full body hives, still persistent 2 months later
59 2021-06-15 hypertension, heart rate increased bad chills; shaking; Fatigue for 2 days; higher than normal sleeping heart rate; higher blood pressu... Read more
bad chills; shaking; Fatigue for 2 days; higher than normal sleeping heart rate; higher blood pressure; workouts much more difficult.; This is a spontaneous report from a contactable consumer (patient). This 59-year-old male consumer reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 03Feb2021 at 14:00 (at the age of 59-years-old) at single dose for COVID-19 immunization. No other medications in two weeks. Medical history included high blood pressure. After receiving the second shot, bad chills and shaking that night. Fatigue for 2 days. For the next month, higher than normal sleeping heart rate, higher blood pressure, workouts much more difficult. No treatment received. Outcome was Recovering. No Covid prior vaccination and no Covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-06-17 loss of consciousness lost so much weight; there it inflamed the places where you have bumps; dry skin; had fungus things ... Read more
lost so much weight; there it inflamed the places where you have bumps; dry skin; had fungus things push under the nail; fever, says 98.6 is about a half point to a point high; passed out; dead for a while; Itching; Stomach a little bit bad/Sick to his stomach; Really, really tired; Brain is scrambled a little bit/Brain things get a little not right/Brain things get a little not right/Fogged up a little bit more lately/ Feeling kind of crummy/ Feeling a little bit bad; Dry mouth; Judgement is off; Falling a bunch of times; Slept and slept and slept; This is a spontaneous report from a contactable consumer reported for himself. This 59-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Deltoid on 13May2021 (Lot Number: EW0167; Expiration Date: Aug2021) at single dose for COVID-19 immunisation. Medical history included ongoing cardiac failure, ongoing hypoxia (Hypoxia, brain injury), Kidney problems , ongoing myoclonus (he has several different things, says stuff comes from the brain injury, and from medicines they gave him), hepatitis C (he had treatment for Hepatitis C when it first came out, says it's cleared up and has never had bad liver function. States he was diagnosed 15 years ago), ongoing attention deficit hyperactivity disorder (ADHD, combined type), ongoing ventricular fibrillation, ongoing gastrooesophageal reflux disease (GERD, he has had GERD all his adult life), ongoing back pain (chronic back pain, he has had chronic back pain since he was about 15). Handicapped/ disabled, depression, heartburn and acid reflux, cardiomyopathy, pain, urine flow decreased. Concomitant medications included ongoing acetylsalicylic acid (ASPIRIN (E.C.)) taken for cardiac failure, he has been taking this medication for years; ongoing atorvastatin (LIPITOR [ATORVASTATIN]) as heart medicine, he has been taking this medication for years; ongoing clonazepam (CLONAZEPAM) taken for brain injury; ongoing escitalopram oxalate (LEXAPRO) taken for depression, he has been taking this for 25 years; ongoing esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for heartburn and acid reflux; ongoing furosemide (FUROSEMIDE) taken for heart failure and fluid, he has been taking this somewhere between 5-10 yrs; ongoing isosorbide mononitrate (ISOSORBIDE MONONITRATE), he doesn't know what he takes these for, something for added heart; ongoing levothyroxine sodium (SYNTHROID) taken for thyroid disorder; ongoing losartan (LOSARTAN) taken for cardiomyopathy; nystatin (NYSTATIN), he doesn't know why he takes this, says it's probably for his heart; ongoing primidone (PRIMIDONE); ongoing promethazine (PROMETHAZINE); ongoing spironolactone (SPIRONOLACTONE); ongoing trazodone (TRAZODONE) taken for sleep disorder, he uses it as a tranquilizer, uses it for pain, they say he's a drug seeker and won't give pain medicine.; ongoing morniflumate (FLOMAX [MORNIFLUMATE]) taken for urine flow decreased. The patient experienced passed out on May2021 with outcome of unknown , dead for a while on May2021 with outcome of unknown, itching on May2021 with outcome of recovered in 2021, stomach a little bit bad/sick to his stomach on May2021 with outcome of recovered on May2021, really tired on May2021 with outcome of unknown, brain is scrambled a little bit/brain things get a little not right/brain things get a little not right/fogged up a little bit more lately/ feeling kind of crummy/ feeling a little bit bad on May2021 with outcome of recovering , dry mouth on May2021 with outcome of recovered in 2021, judgement is off on May2021 with outcome of recovered in 2021, falling a bunch of times on May2021 with outcome of recovering , slept and slept on May2021 with outcome of unknown, lost so much weight on unspecified date with outcome of unknown, there it inflamed the places where you have bumps and dry skin on unspecified date with outcome of unknown, had fungus things push under the nail on unspecified date with outcome of unknown, fever on unspecified date with outcome of unknown. The clinical course was reported as follows: This past week he has been feeling kind of crummy, says he's disabled, and can lose track. He says his brain is scrambled a little bit since he got hit, says he passed out, was dead for a while, states that affects him quite a bit, and he says he loses track. He says when he tells about that, he didn't know he got the first shot and it had a little place that hopes it didn't mess up. He states he put on small wounds, corcetin. States when they did the shot, says usually they'll make you hold, ask you to hold the cotton ball in place, says they get a Band-Aid on tight and push down, says they put compression so it doesn't leak. He states this was loose when he got home, it was leaking like a little bubble, a little fluid. When he washed it, he washed it off. Right close to it, there were two other places. He states when they gave him some steroid cream, he put that on there it inflamed the places where you have bumps and dry skin and a cut and looks like a little cut. Says when he put cream, it got inflamed and angry. He stated he was watching Dr, and when she calls it a cyst or something is infected, she calls it angry. He says there was a bunch where they put the Band-Aid, and he put just a dab of corcetin, believe that's what he had when he put, took it off the first time, and it had two bigger places that were a scab. He says once he put 2 by 3 Band-Aids and left it on for a couple of days, says he did this several times since last year or two, says to try to clear some of this stuff up, don't scratch, says he did get an itch in that location when he got the shot. He didn't scratch, said he wanted to pull Band-Aid off and scratch but didn't do it. He says it cleared up but he's been feeling a little funny, just maybe a little sick to his stomach, dry mouth, stuff like that. He says he didn't think it's a problem, says he had that problem like after 3, 4, or 5 weeks and all of a sudden he has a little episode where he gets to feeling funny, says his judgement is off and the brain things get a little not right. He stated he then fell a lot, says he's been falling a bunch of times in the last week, he'll feel better and it won't bother him. He says it's a cycle he's gone through since he lost oxygen. He doesn't think it's anything, it's confusing, says it has so many symptoms, and when he read this it has so many symptoms. Confirmed patient was referring to COVID vaccine. He states he hasn't had eczema then most of it, sometimes he'll scratch, it will build up like a scab and he'll scrape it off, put some of the ointment on there. but a band aid on top, leave it down for a couple of days, after a shower, a couple of showers, it comes off. He says it clears it up, says if it doesn't, just wash, wash it hard, it scrubs the scab off. He states the worst thing he had was his toenails, he had to work on them, had fungus things push under the nail, under the side, and he cut it. He used cortisone 10 on it, says they always quit making something that works well, states you know how you get a yellow toenail. He says he's been putting Neosporin on it. Clarified corcetin is Cortizone 10, it is pretty strong stuff. He says he puts it on these places on his arm using Neosporin. Attempted to clarify that itching began after use of Cortizone 10, states nothing like that, says it did itch a few days after still a little bit, there were three little places under that Band-Aid where they put the shot. He ended up putting Neosporin right when he took that band aid off it was itching, says he washed it good, then put Neosporin on it, says it's cleared back up to its normal roughness. For event itching, he states at first it was almost a scab, but it was not quite a scab, it was wet like a little bubble. After the scab, when he got ready to take, it was itchy after the band aid was on there a couple of days, he took a shower, washed it, and put more ointment on it. Each time he took the Band-Aid off, he washed it, washed his arm, and put the Band-Aid back on. He did the same again and it's gone away. He states he is feeling a little bit bad, his stomach is a little bit bad. He hadn't checked it lately, when he gets a fever, says 98.6 is about a half point to a point high. He was really, really tired, says he slept and slept and slept. Says this is similar to the cycle that he goes through with his brain injury, says it's the same cycle he goes through. He also stated he lost so much weight laying in bed.
59 2021-06-18 chest pain, fluid around the heart, inflammation of the pericardium Symptoms: Chest pain radiating to neck starting on June 4, 2021 with fatigue and slight shortness of... Read more
Symptoms: Chest pain radiating to neck starting on June 4, 2021 with fatigue and slight shortness of breath Seen at Urgent Care and sent to Hospital and found to have PERICARDITIS and PERICARDIAL EFFUSION. Given medications and hospitalized for 24 hours.
59 2021-06-18 pulmonary embolism, ejection fraction decreased, oxygen saturation decreased Pt complained of right flank pain starting 5/25/2021 and though he had kidney stone. Pt presented to... Read more
Pt complained of right flank pain starting 5/25/2021 and though he had kidney stone. Pt presented to office 5/27/2021 and pain on exam appeared to be more pleuritic. Pt denied shortness of breath an d pulse ox was 94%. Pt declined ER evaluation. Pt was started on xarelto 15 mg bid and STAT CT of chest was done morning of 5/28/2021 which confirmed bilateral pulmonary emboli directed toward lower lobes, moderate clot burden. Given clot burden patient was admitted for IV heparin therapy. Venous duplex of lower extremties showed no evidence of acute DVT in visualized segments though there was a possible venous valve, vessel wall scarring o a small amount of non occlusive thrombus of the left profunda vein.
59 2021-06-18 cardiac arrhythmia, heart rate decreased, very slow heart rate, palpitations, arrhythmia Pfizer-BioNTech COVID-19 Vaccine EUA: Heart Arrhythmia, causing very low Bradycardia (as low as 31),... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Heart Arrhythmia, causing very low Bradycardia (as low as 31), as well as some palpitations, usually after the very low heart rate, like heart was trying to make up missed beats; 4 times felt after 1st dose, 12+ times felt after 2nd dose; called cardiologist office and told to go to emergency room, which I did on 4/16, admitted for observation on 4/17, discharged 4/17 after cardiologist visit and agreement to get nuclear stress test as outpatient. Nothing felt after 4/17; stress test on 5/6; only some usual PVCs and a couple PACs during successful stress test. Cleared by cardiologist for normal activities 5/24/21.
59 2021-06-21 chest pain, troponin increased, inflammation of the pericardium Severe chest pain, elevated troponins, and Pericarditis diagnosis on 5/26/2021, Hospital.
59 2021-06-22 ischemic chest pain Five days after receiving his second dose of the Pfizer Vaccine, my husband began to occasionally e... Read more
Five days after receiving his second dose of the Pfizer Vaccine, my husband began to occasionally experience mild jabs of pain in his heart. At the time, he thought little of it. Two days later, Pt developed an irritating skin rash in the lower region of his left shoulder blade. A day later, the rash had spread to include the left side of his torso, beneath his left arm. Now, 7 days since the onset of symptoms, Pt jabs of heart pain are sharper and more frequent and the rash has intensified in its appearance and irritation. Additionally, my usually super-active, mountain-bike-riding husband has become quite fatigued. In other words, Pt has what appears to be a classic case of SHINGLES. And, since Pt overall health has been excellent throughout his 59 years of life, we wondered if the vaccine might be responsible for having triggered his shingles outbreak. We thought it important to report this possible correlation, just in case.
59 2021-06-22 chest discomfort I experienced extreme body aches, that lead to pressure in my chest. That lead to me going to the ER... Read more
I experienced extreme body aches, that lead to pressure in my chest. That lead to me going to the ER on 04/15/2021 was diagnosed with inflammation of the chest. I had to be on crutches for a little bit because the inflammation traveled to my feet and legs. Also developed tendinitis.
59 2021-06-23 fainting Syncope; Psychosis; Encephalopathy; This is a spontaneous report from a contactable physician. A 59-... Read more
Syncope; Psychosis; Encephalopathy; This is a spontaneous report from a contactable physician. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 18May2021 12:00 at the age of 59-years-old (Batch/Lot Number: EW0176) as single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included hypertension (HTN), overactive bladder, benign prostatic hyperplasia (BPH). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered on 22Apr2021 at the age of 59-years-old (Batch/Lot Number: ew0164) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included amlodipine, lisinopril, oxybutynin, tamsulosin, hydroxyzine. The patient experienced syncope, psychosis/encephalopathy within 2 hours at 18May2021 14:00. Duration of hospitalization was 2. AE treatment included antipsychotics. The patient underwent lab tests and procedures which included Nasal Swab: negative on 20May2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and investigators, as appropriate.
59 2021-06-27 blood pressure increased Stroke like symptoms, severe headaches, elevate blood pressure, tingling and numbness around mouth, ... Read more
Stroke like symptoms, severe headaches, elevate blood pressure, tingling and numbness around mouth, right side of body was sore and numb, right side of neck was sore
59 2021-06-29 chest pain The morning after the vaccine, sudden onset of severe left-side chest pains, left arm, and back. Per... Read more
The morning after the vaccine, sudden onset of severe left-side chest pains, left arm, and back. Persisted till the next day but gradually got better. No pain after 3rd day.; sudden onset of severe left-side chest pains, left arm,; severe left-side chest pains, left arm, and back.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6202) via an unspecified route of administration (age at vaccination 59-year) in Right Arm on 05Mar2021 15:00 as dose 1, single for COVID-19 immunization. Medical history included Stroke history; early Alzheimers and Diverticulosis from an unknown date and unknown if ongoing. Concomitant medications included Atorvastatin (ATORVASTATIN); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); Gabapentin (GABAPENTIN); famotidine (PEPCID AC) and Tamsulosin (TAMSULOSIN) taken for an unspecified indication, start and stop date were not reported. The patient was having no known allergies. The patient was not tested COVID prior and post vaccination. It was reported that the patient did not received any other vaccine in four weeks. Facility type vaccine was school or student health clinic. On 06Mar2021 08:30 AM in the morning after the vaccine the patient experienced sudden onset of severe left-side chest pains, left arm, and back. persisted till the next day but gradually got better. no pain after 3rd day. The seriousness of the events was serious (medically significant) and AE resulted in visit emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse events; AE treatment included: Nitroglycerin, 4 aspirin, lab tests, EKG, X-ray. The clinical outcome of the events was recovered on an unspecified date of Mar2021 No follow-up attempts are possible. No further information is expected.
59 2021-06-30 blood clot Feet and legs swollen, left worse than right; Started walking around that it was doing the damage it... Read more
Feet and legs swollen, left worse than right; Started walking around that it was doing the damage it was doing until he figured out he couldn't walk; Sick; Throwing up; Diarrhea/Diarrhea was reported as worsened; Headache; Got out of bed one day and fell to the floor; Blood clots in both legs; This is a spontaneous report from a contactable consumer (the patient). A 59-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0153), via an unspecified route of administration, administered in right arm on 14Apr2021 (at the age of 59-years-old) at hospital as a single dose for COVID-19 immunisation. The patient's medical history and his family history were reported as none. There were no concomitant medications. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration, administered in right arm on 24Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation and experienced sick, headache, throwing up, diarrhea, fell, feet and legs swollen, left worse than right and he couldn't walk. No other vaccinations. On an unspecified date in Jun 2021, the patient experienced blood clots in both legs and on unspecified date the patient experienced sick, throwing up, diarrhea/diarrhea was reported as worsened, headache, started walking around that it was doing the damage it was doing until he figured out, he couldn't walk, got out of bed one day and fell to the floor and feet and legs swollen, left worse than right. The consumer stated that "he has been sick with both shots. Stated after the last shot he got blood clots in both legs and just got back from the doctor, stated the doctor said that the blood clots were caused by the vaccine. Consumer stated he went to see the doctor yesterday, 15Jun2021 at 09:00. Caller stated that after the first and second dose he has been throwing up, had diarrhea, a headache, and did not realize that when he started walking around that it was doing the damage it was doing until he figured out he couldn't walk, states one of the days, exact date not provided, he got out of bed one day and fell to the floor, stated then he realized what happened, stated it has been going on for a good while, stated his feet and legs swollen, started about 4 weeks ago, exact start dates of all events unknown. Stated he can hardly walk due to the swelling. Stated they gave him a medication for the diarrhea, exact name unknown. Stated they are treating the blood clots with Eliquis, two pills in the morning and two in the evening." Event Blood clots in both legs was required physician office visit. Therapeutic measures were taken as a result of blood clots in both legs, diarrhea/diarrhea was reported as worsened. The outcome of events blood clots in both legs, diarrhea/diarrhea was reported as worsened, headache, started walking around that it was doing the damage it was doing until he figured out, he couldn't walk and feet and legs swollen, left worse than right was not recovered whereas the outcome of sick and got out of bed one day and fell to the floor was unknown, throwing up was recovering.
59 2021-07-01 chest discomfort I got sick for 3 days and I still have tightness in the chest and difficulty breathing with exertion
59 2021-07-01 heart attack, blood clot Patient states that he has had 2 heart attacks and 4 blood clots since second dose of covid vaccine.... Read more
Patient states that he has had 2 heart attacks and 4 blood clots since second dose of covid vaccine. He was treated at the Hospital for the first Heart attack and at another hospital for his second heart attack. He does not have a PCP and was seen by a Physician at the Hospital for his first heart attack and is being seen by a doctor at the other hospital. I tried to contact the doctor's office and have not been able to get any more information. I talked to a representative at VAERS on 7/2 to see what to do. She stated to just send what I had and you would contact the patient if you need more information.
59 2021-07-06 palpitations Chills, headache and fatigue lasted about 12 hours. Heart racing, feeling of heart pounding, not bei... Read more
Chills, headache and fatigue lasted about 12 hours. Heart racing, feeling of heart pounding, not being able to relax and extreme fatigue started on 3rd day after vaccine and lasted about 2-3 weeks.
59 2021-07-06 cardiac arrhythmia Increased heart PVC's within a week after second shot 4/8/21 and still continuing. Taking Metoprolo... Read more
Increased heart PVC's within a week after second shot 4/8/21 and still continuing. Taking Metoprolol to manage but still ongoing. Not resolving. Sudden Sensoneural hearing loss 6/2/21 went to ENT and he prescribed high dose prednisone for 5 weeks, hearing returning to as it was but still have constant ringing in both ears (tinnitus)
59 2021-07-08 chest discomfort, heart rate irregular, heart flutter Within a couple hours of the vaccine, in addition to expected arm soreness, I felt tingling up and d... Read more
Within a couple hours of the vaccine, in addition to expected arm soreness, I felt tingling up and down arm, then odd feeling throughout my body and head by the afternoon (just very odd, not pain). I did not have any cold fever or flu-like symptoms. But, within the next day or two, more concerning symptoms appeared: I felt, for lack of a better way to describe it, very "twitchy" from my chest, like a flutter. I've felt restless and fatigued at the same time nearly all the time, like excess energy and exhaustion both at once. I feel an uncomfortable feeling, like irregular heartbeat or arrhythmia in chest especially at night lying down, which as been interfering with sleep. I have felt the restlessness and fatigue off and on night and day, interfering with focus and work. This has gone on for over two months now since the first vaccine dose. My overall health and how I felt were excellent the day prior to the vaccine. There is definitely something off with my metabolism, in particular my cardiovascular and aerobic function, since the vaccine that has not yet resolved itself. I can still exercise and feel better by doing so, but, it always feels at a lower performance level than before the vaccine. The feeling in my chest, like a harder heartbeat than normal, and sometimes what fits some of the symptoms of congestive heart failure or possibly myocarditis, is most concerning. I experience some periods where it feels like almost a wheezing in the back of my throat when I breathe. This was persistent for awhile and now seems to be more off and on, becoming less often. I am slender, exercise regularly and eat fairly healthy, am fit, and have never had any major health problems. There definitely seems some kind of cardiovascular, aerobic and/or respiratory effect from the vaccine.
59 2021-07-08 pulmonary embolism, deep vein blood clot I was hosp 4/16/2021 after I developed right calf discomfort and was found to have a progressive rig... Read more
I was hosp 4/16/2021 after I developed right calf discomfort and was found to have a progressive right poplital DVT on ultrasound imaging 4/16/21 and 4/18/21. Also found was a lower lobe subsegmental pulminary emboli noted on CTA 4/16/21. No history of blood clots, ever or in family history, none, cause of this clot is not yet fully understood.
59 2021-07-09 atrial fibrillation The day after my second immunization, I began feeling extremely fatigued. The extreme fatigue conti... Read more
The day after my second immunization, I began feeling extremely fatigued. The extreme fatigue continued until June 14, 2021, when I went to my doctor. The VA doctor indicated that it could be related to a heart issue. Testing confirmed an abnormal ECG with atrial fibrillation with rapid ventricular response. I was given a prescription for blood pressure medication and sent a heart monitor to wear for two weeks. I have never had any issue prior to the second immunization with my heart. I had an EKG last year as part of a routine examination and my heart was deemed at that time to be absolutely normal. I am still having issues with extreme fatigue that has not improved with time.
59 2021-07-11 chest discomfort Real tightness in chest, nervousness, not able to breath ,deep breath. could not go up stairs. after... Read more
Real tightness in chest, nervousness, not able to breath ,deep breath. could not go up stairs. after 2nd day went to urgent care.
59 2021-07-11 palpitations Heart palpitations Shortness of breath Light headed
59 2021-07-14 pulmonary embolism, deep vein blood clot DVT/PE
59 2021-07-18 heart attack, arrhythmia arrhythmia, presumed MI, death
59 2021-07-20 hypertension Vision loss; Severe Vertigo; Headaches; insomnia; High blood pressure; Tinnitis; Sleep issues; Anxie... Read more
Vision loss; Severe Vertigo; Headaches; insomnia; High blood pressure; Tinnitis; Sleep issues; Anxiety; Absolutely feel horrible/Had not feel himself in 90 days; Possible diagnosis of post vaccine psychosis.; Migraine; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received bnt162b2 (BNT162B2) at the age of 59-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:30 (Batch/Lot Number: ew0162) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The COVID-19 vaccine was administered in Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination included Trilogy, Flownase Sensimist. Historical Vaccine included BNT162B2 for COVID-19 immunization on 18Mar2021 at the age of 59-year-old (dose 1, product=COVID 19, brand=Pfizer, lot number=ER2613, administration time=16:30, vaccine location=Left arm). The patient experienced vision loss, severe vertigo, headaches, insomnia, high blood pressure, tinnitis, sleep issues, anxiety, absolutely feel horrible, possible diagnosis of post vaccine psychosis on 11Apr2021 07:30, migraine in 2021, with outcome of not recovered. Detail information was as following reported Event: Severe Vertigo, headaches, insomnia, high blood pressure, vision loss, Tinnitis. Vertigo just about 3 days after 2 nd vaccine. Had not feel himself in 90 days. Still experiencing headaches, sleep issues, anxiety. Absolutely feel horrible. Blood pressure up significantly over historical levels. Being treated for high blood pressure, sleep, anxiety, headaches. Currently seeing a neurologist. Possible diagnosis of post vaccine psychosis. The report was reported as non-serious. The events resulted in Doctor or other healthcare professional office clinic visit Emergency room department or urgent care. Treatment received included Vertigo treatment, Migraine treatment, Ongoing. Since the vaccination, the patient has not been tested for COVID-19.
59 2021-07-25 heart rate irregular, chest pain Pt. states that after receiving the 2nd dose of Phizer 02/23/2021, started experiencing fluid in the... Read more
Pt. states that after receiving the 2nd dose of Phizer 02/23/2021, started experiencing fluid in the ears (both), ENT visit prescribed steroids. (Previous condition "Holiday Heart") out of rhythm heart pain continues but reduced after steroid use. Hearing loss noted in both ears.