Pfizer

Cardiovascular symptom reports

Female, 76 - 89 years

Age Reported Symptoms Notes
76 2021-01-19 body temperature decreased, fainting Lowered body temperature 30 min after dose, left hand began to itch approx. 45 minutes, both hands i... Read more
Lowered body temperature 30 min after dose, left hand began to itch approx. 45 minutes, both hands itching & swelling, then feet within hour. Total lose of vision within 90 min followed by fainting approx 10 minutes later. Fainted at check-in desk of emergency room
76 2021-01-21 heart rate increased Within minutes I felt dizzy and then my heart started beating rapidly. Nurse took my blood pressure,... Read more
Within minutes I felt dizzy and then my heart started beating rapidly. Nurse took my blood pressure, pulse, respirations. I was held at clinic for 30 minutes. Symptoms subsided gradually and were gone in 15 minutes.
76 2021-01-21 heart rate irregular DEVELOPED HEADACHE, MOIST, PRODUCTIVE COUGH, ELEVATED IRREGULAR HEARTRATE. FOLLOWING UP WITH PCP
76 2021-01-22 heart attack, troponin increased fever up to 103, chills, aches, malaise, abd pain, vomiting, went to the ER had IVF abnormal labs, +... Read more
fever up to 103, chills, aches, malaise, abd pain, vomiting, went to the ER had IVF abnormal labs, + non st elevation MI
76 2021-01-25 low blood oxigenation, cardiac arrest decedent had shortness of breath and hypoxia, cardiac arrested in front of the EMS crew, ACLS initia... Read more
decedent had shortness of breath and hypoxia, cardiac arrested in front of the EMS crew, ACLS initiated, arrived in the Hospital ED asystole and pronounced dead
76 2021-01-27 chest discomfort Patient with known CAD. Per member, has had NTG 5x in last 6 months. Patient states unable to do any... Read more
Patient with known CAD. Per member, has had NTG 5x in last 6 months. Patient states unable to do anything but medical therapy " all 6 grafts clogged". c/o precordial and right sided chest pressure, took ntg with improvement , recurrent pain and member took second dose of ntg .Pain started to return and 911 called.
76 2021-01-27 heart rate irregular, heart rate increased Patient described fast heart rate and irregular. Stated she gets it with all allergies and frequentl... Read more
Patient described fast heart rate and irregular. Stated she gets it with all allergies and frequently Given requested benadryl 25 mg po with resolution of symptoms
76 2021-01-28 blood pressure increased Within 5 minutes I became nauseated, then l began growing weak, alerted staff and they started monit... Read more
Within 5 minutes I became nauseated, then l began growing weak, alerted staff and they started monitoring my blood pressure which had gone up to 159 (usual is around 120), began uncontrollable shaking. After about 1 1/2 hours my blood pressure lowered to 136 and I was transported by wheel chair to car to return home.
76 2021-01-28 heart rate increased believed the heart rate might be a result of being nervous; Tightness of throat/throat tightness; La... Read more
believed the heart rate might be a result of being nervous; Tightness of throat/throat tightness; Laboured breathing; Fast HR/high heart rate; This is a spontaneous report from a contactable nurse, reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 03Jan2021 at a single dose for COVID-19 immunization. Medical history included sensitivity to pollen, sensitivity to narcotics and allergic reactions to perfume, all from unknown dates and unknown if ongoing. There were no concomitant medications. The patient previously received pneumonia vaccine and flu vaccine, both for immunization and experienced pain on the side. The patient also previously took cortisone to lower her immune system. It was reported that on 03Jan2021, the patient developed a slight reaction immediately after first dose of Pfizer Covid vaccine which included tightness of throat along with laboured breathing with fast HR/heart rate was high (she believed it was greater than 80 BPM; her heart rate is usually in the 60's) which resolved after a few minutes. The nurse was going to give her Benadryl but did not as her signs and symptoms were resolving. She was asking for recommendations/clarifications on whether she should get the second dose given her reactions. She never had that type of reaction before. She had had sensitivity to pollen and narcotics. She read that she should not receive the second dose given her reactions but was asking for clarification. She would like to get the second dose and bought an Epi pen. Throat tightness and high heart rate didn't last for more than two minutes maximum. She visited websites and was directed not to get the second dose. She wanted to be 100% certain in regards to whether or not she should receive the second dose. Stated tightness in throat wasn't really that bad. She felt throat tightness previously when smelling perfume. Stated it wasn't anything to be frightened about. She also stated some websites said it does not matter and some websites said not to get the second dose. Also wanted to know if having the Epi Pen would help. She added that she explained reaction to the physician who advised her to get an Epi Pen for the second COVID Vaccine dose. She only had allergic reactions to pollen and perfume. Got the vaccine for Pneumonia and Flu. Did not get adverse reactions, but stated she only had pain on the side. Confirmed she has no NDC/Lot/Exp for the Pneumonia vaccine and Flu vaccine. She also got Coronavirus three months prior to receiving the COVID vaccine. She clarified that she diagnosed herself and it was the weirdest thing. She took cortisone to lower her immune system. Received first dose of COVID Vaccine on 03Jan2021. She wa due for second COVID Vaccine on 26Jan2021. She stated she is a psychologist with specialty in mental health. She believed the heart rate might be a result of being nervous. When she is nervous her heart rate goes up. Tightness of throat made her concerned. When asked about the indication, she stated that her husband works and the right thing to do was to be protected. She read she should have stopped taking Ibuprofen 10 days prior to the COVID Vaccine. She was not taking Ibuprofen any longer. Has no NDC/Lot/Exp for Ibuprofen at time of call. Confirmed she did not use the Epi Pen after the first dose of COVID Vaccine. She bought it for the second dose. The nurse who administered COVID Vaccine to the patient suggested she take Benadryl. By that time, she was feeling better. She stated it was questionable for half an hour. The outcome of the event Tightness of throat/throat tightness and fast HR/high heart rate was recovered on 03Jan2021 while the outcome of all other events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: The patient had medical history included sensitivity to pollen, sensitivity to narcotics and allergic reactions to perfume. The reported events were likely related to first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and clinical course. 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.
76 2021-01-28 heart rate increased Rapid heart beat, went from normal 60 BPM to 110 up to 135 BPM went to ER as instructed in handout s... Read more
Rapid heart beat, went from normal 60 BPM to 110 up to 135 BPM went to ER as instructed in handout sheet
76 2021-01-29 atrial fibrillation, heart rate increased AFib / rapid heartbeat an hour after receiving first dose. AFib again two days later around 11a on 1... Read more
AFib / rapid heartbeat an hour after receiving first dose. AFib again two days later around 11a on 1/30. Lasts for about 45 minutes
76 2021-01-31 chest discomfort, blood pressure decreased Patient experienced chest heaviness and warmth from her chest to her arm. Her blood pressure was 220... Read more
Patient experienced chest heaviness and warmth from her chest to her arm. Her blood pressure was 220/120s. We monitored her and her blood pressure decreased to 170s/110s over 30 minutes. EMS was called to evaluate her but she refused to go to the hospital.
76 2021-01-31 chest discomfort Chest tightness; hives on the side of her neck; scratchiness in throat; gums were throbbing; This is... Read more
Chest tightness; hives on the side of her neck; scratchiness in throat; gums were throbbing; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EJ1686, Expire Date: 30Mar2021), intramuscular at Deltoid Left on 15Jan2021 11:08 at the 76 years old at 0.3 mL, single for COVID-19 immunization. The patient medical history included allergies issues with shellfish (allergic reactions), hyperlipidemia and hypertension. The concomitant medications were none. There was no additional vaccines administered on same date of the suspect. The patient was experienced for over 20 minutes with no side effects. After she left on an hour after administration (15Jan2021 12:08), she started feeling scratchiness in throat, her gums were throbbing and chest tightness. She did say she didn't take any Benadryl. She didn't have airway issues, but she did have hives on the side of her neck on 15Jan2021 12:08. She got the shot on 15Jan2021. The side effects started shortly after she left on an hour after administration. Her symptoms were relieved by 15Jan2021 21:30, and she got the shot at 11:08 am. The patient had allergic reactions in the past. She knew what to expect. She got the shot in her Left Deltoid. The reporter had a gut feeling she didn't need to get the second dose. The reporter assessed all the events were not serious. She did not require medical intervention. She did not go to the Emergency room or Physician Office. The patient was not hospitalized, or in the ICU. The Causality was not provided by the reporter. The outcome of the events was recovered on 15Jan2021 21:30.
76 2021-01-31 hypertension, chest pain Shortness of breath, slight chest pain, shakiness, hypertension above normal BP
76 2021-01-31 lightheadedness Patient was observed for 15 minutes after the vaccination administration, felt fine, and left the fa... Read more
Patient was observed for 15 minutes after the vaccination administration, felt fine, and left the facility with her husband. The 2 of them drove 2 blocks away to a restaurant to eat. Midway through her meal, she reported that she started to feel "funny" like she was "drunk" or something, and felt nausea and hot/sweaty. Her husband got her in the vehicle and drove to the vaccination facility, When he arrived, she was obtunded and "out of it." No respiratory distress, No noted rash, but some clamminess/diaphoresis. She was initially examined by FNP and cursory limited neuro exam while patient was seated did not reveal any gross motor deficits. FNP called 911 and staff called for me. When I arrived, patient was groggy, but responsive. She was A&O x3 and in no distress. Pulse 54, strong and regular (normal rate for her per patient--on a Beta blocker). BP 120/74. O2 sat 97% on outdoor cold air. Patient was able to move all extremities equally and with equal strength. Lungs CTA, Heart regular no murmur, abdomen soft. Patient complained of continued malaise/grogginess and nausea, no vomiting. EMS arrived, checked glucose, which was "normal" (I didn't hear the result) and patient declined transport. I discussed ER evaluation vs. continued monitoring by me. Patient and husband requested monitoring. Patient stayed in the vehicle with her husband, I gave the husband my phone number to call if any worsening. I checked on her 5 minutes later, then 10 minutes after that. By that time, her adult daughter had arrived. We again discussed continue family monitoring vs. ER. The family wanted to take the patient home to monitor. Patient stated "If I could just go to bed, I think I will be fine." I called to check on the patient at 6p. She had rested well and was improved. She still felt a bit groggy, but otherwise was feeling better. I called to check on the patient 1/29 at noon. At that point, husband stated that she was "back to normal. Symptoms and signs appeared to be consistent with a vasovagal response. I suspected symptoms may have been prolonged by her Beta blocker
76 2021-02-01 loss of consciousness 24 hours after receiving the vaccine, I passed out while walking. I do not have any other new medic... Read more
24 hours after receiving the vaccine, I passed out while walking. I do not have any other new medications; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Arm Left on 13Jan2021 at 08:00 AM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included bronchiectasis. Patient had no known allergies. Concomitant medications in two weeks prior to the vaccination included olodaterol hydrochloride, tiotropium bromide monohydrate (STIOLTO RESPIMAT), salbutamol (ALBUTEROL HFA) and multi vitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 10:00 AM patient passed out while walking, 24 hours after receiving the vaccine, patient did not have any other new medications. Event resulted in emergency room/department or urgent care and hospitalization for one day. Treatments received included cast on hand, computerised tomogram (Ct) scans, electrocardiogram (EKG) and echocardiogram on unknown date with unknown results. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the event, at the time of the report.
76 2021-02-01 lightheadedness, pallor 76 yo female with PMHx of CAD s/p CABG 2016, abdominal aortic aneurym, HTN, HLD, Asthma, Diverticulo... Read more
76 yo female with PMHx of CAD s/p CABG 2016, abdominal aortic aneurym, HTN, HLD, Asthma, Diverticulosis, Osteopenia. Presenting to the ED after having Pre-syncope. She reported that today morning she felt nauseated with episode of vomiting, burping and abdominal discomfort after having her lunch meal, headed out to receive her vaccine, she felt well till 10 minutes after the vaccine where a nurse noticed she is pale and less responsive, BP was measured back then and was ~70 ?, the patient reported that she was sitting when that happened, she felt lightheaded, sweating, blurry vision, nauseated. But denies any chest pain, sob, palpitation, weakness or numbness. She was out of balance and feeling weak till she came to the ED where she felt better after IV fluids.
76 2021-02-02 hypertension Anaphylaxis symptoms started three day after the shot I started having chills, trembles, sore throat... Read more
Anaphylaxis symptoms started three day after the shot I started having chills, trembles, sore throat, very high BP, Swelling and numbness on tongue and lips, pain and burning of feet, tingling all over, joint pain,
76 2021-02-02 oxygen saturation decreased SHORTNESS OF BREATH, LOW O2 STATS
76 2021-02-04 heart rate increased Rapid heartbeat, shaky, clammy skin, heavy perspiration, nausea, stomach cramps, pain throughout bod... Read more
Rapid heartbeat, shaky, clammy skin, heavy perspiration, nausea, stomach cramps, pain throughout body along with pin and needle feeling mostly on the left side from my foot to the top on my head. Lips felt swollen. Itch in chest, neck with a rash, back legs, mostly all over.
76 2021-02-04 heart rate irregular Rash, increased irregular heartbeat, feeling off-have not contacted anyone yet
76 2021-02-07 palpitations, chest pain Pt developed nausea, dizziness, and chest pain during her 15 min observation period. Pt was clutchin... Read more
Pt developed nausea, dizziness, and chest pain during her 15 min observation period. Pt was clutching her chest and stated that she felt her heart racing. 911 called and pt transported to ED.
76 2021-02-07 fainting Pt received injection, then collapsed, with no memory of event. Pt was unresponsive approximately 1... Read more
Pt received injection, then collapsed, with no memory of event. Pt was unresponsive approximately 15 seconds. HR 52 & irregular, BP 110/80
76 2021-02-08 blood pressure increased "Pfizer-Bio-Tech COVID-19 Vaccine EUA" After receiving the Covid-19 vaccine at 12:15 pm client comp... Read more
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" After receiving the Covid-19 vaccine at 12:15 pm client compliant of having tingling lip and tongue symptoms. She stated that she has anxiety and had the same symptoms with the 1st vaccine and received liquid Benadryl. He brought in a note from the allergist that the benefit outweighs the risk and individual should be given vaccine in a controlled environment. 12:15 patient received 25 mg po of Benadryl elixir by mouth 99% Sat's, 156/90,79,20; 12:20 pm v/s 158/92, 56, 20, 99%, 12:25 PM, v/s, 150/90, 56, 18, 99%. Individual was monitor for 30 minutes and stated her can barely felt the tingling in her lips and tongue. Discharge vitals at 12:43 pm 146/92, 58, 18, 98 %.
76 2021-02-09 hypotension Pt with acute resp failure, COVID PNA, that developed symptoms 9 days prior to admit and ultimately ... Read more
Pt with acute resp failure, COVID PNA, that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior toa admit, then shortly after progressed with other covid symptoms and was admitted. She decompensated while intp and was transferred to ICU for rising O2 needs, ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed, hemodynamics deteriorated. Pt passed soon after(2/2).
76 2021-02-10 hypertension BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back... Read more
BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back; Back getting hot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 76-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date not reported) , via an unspecified route of administration on the left arm on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included anaphylaxis with contrast media (Biaxin and eucalyptus), allergies: latex, antihistamines, sulfa, olive trees; allergic reactions to iodine, asthma, cardiac arrest, has a pacemaker; all from unknown dates. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), vitamin D3, levocabastine hydrochloride (ZYRTEC), iron, diltiazem, salbutamol sulfate (ALBUTEROL). The patient previously took Biaxin, eucalyptus and tiger balm and experienced anaphylaxis, Cipro, sucralfate, adrenaline (EPIPEN), corticosteroid and experienced allergies. The patient previously received Shingles vaccine on Nov2020 for immunization and experienced intermittent itchy back sensation. The patient reported that after vaccine reaction today (27Jan2021) - back rash, burning sensation, swollen face. It was further reported that the patient experienced potential anaphylactic reaction; 15 minutes after the administration she got her back getting hot and Itchy and a rash breakout. It was also reported that the patient's BP was a bit high for her on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: a bit high for her on an unspecified date. Therapeutic measures were taken as a result of anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot which included treatment with Benadryl (Took one 25 mg Benadryl. Then she took another 25 mg Benadryl); it was reported that 30 minutes later symptoms started to subside. The patient recovered from anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot on 27Jan2021, while the outcome of BP was a bit high for her was unknown.
76 2021-02-11 atrial fibrillation Patient received the vaccine at an outside healthcare facility on 2/11/21. At approximately 1 pm she... Read more
Patient received the vaccine at an outside healthcare facility on 2/11/21. At approximately 1 pm she screamed out and fell out of her chair. EMS was called and patient was found to be in Vfib. ACLS was performed for approximately 42 minutes prior to arrival at ED. At that time the patient had been pulseless for 25 minutes. Patient received 450 mg of amiodarone, epinephrine x7, sodium bicarbonate x2, and 7 AED shocks. In the ED 3 more doses of epinephrine were given, one more dose of sodium bicarbonate, and 5 additional shocks. ROSC was not achieved and time of death was called at 1416.
76 2021-02-12 blood pressure increased Immediately, within 2 hours of the vaccination, I developed a severe headache, join pain (knees, elb... Read more
Immediately, within 2 hours of the vaccination, I developed a severe headache, join pain (knees, elbows, mostly legs and lower extremities) which evolved into intense, burning abdominal pain. My blood pressure rose to 160; however, there was no fever, cough or shortness of breath. This condition lasted until the 7am on the morning of February 8th, but pains returned that evening (Monday 2/8) through Tuesday morning. Symptoms subsided during the day on Tuesday, yet on Tuesday evening (2/9, approximately 48 hours after the injection), severe symptoms returned, similar to the initial evening. I visited my Primary Physician on Wednesday afternoon (2/10) for a consult.
76 2021-02-13 pulmonary embolism Bilateral lung emboli Acute cor pulmonary
76 2021-02-14 chest discomfort, platelet count decreased She had emesis within 30 minutes of 2nd dose of vaccine. Her nausea continued for 1 hour with abdom... Read more
She had emesis within 30 minutes of 2nd dose of vaccine. Her nausea continued for 1 hour with abdominal and chest discomfort. She was taken to ED. Her vital signs remained stable. All work-up for cardiac event was negative. This was determined to be a vaccine reaction leading to nausea with 1 episode of emesis.
76 2021-02-15 oxygen saturation decreased Lethargy, confusion, unsteady gait. Decreased O2 saturation, difficulty swallowing.
76 2021-02-15 platelet count decreased, chest discomfort, low platelet count, heart attack Started having fever chills nausea and diarrhea and felt short of breath on 2/13. SOB and diarrhe... Read more
Started having fever chills nausea and diarrhea and felt short of breath on 2/13. SOB and diarrhea was better on 2/14 bug then on 2/15 pt started to feel chest pressure. pt admitted to hospital on 2/15 noted to have NSTEMI and plt=68. Thrombocytopenia is new for pt. on 2/16 plt=79. pt has been on ibrance for years for hx of breast ca- has never had thrombocytopenia related to the ibrance.
76 2021-02-16 hypertension Within 15-minutes of vaccination, the patient reported dizziness, lightheadedness, and nausea. EMS e... Read more
Within 15-minutes of vaccination, the patient reported dizziness, lightheadedness, and nausea. EMS evaluated patient on-site and administered 4mg Ondansetron PO. Patient was hypertensive (156/84) in transport to Emergency Department. Patient remained hypertensive in ED. Discharged from ED with diagnoses of dizziness, nausea, resolved, secondary to vaccination.
76 2021-02-16 hypotension Pt passed soon after; shortly after progressed with other covid symptoms and was admitted / acute re... Read more
Pt passed soon after; shortly after progressed with other covid symptoms and was admitted / acute resp failure, COVID pneumonia; acute resp failure, COVID pneumonia; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; This is a spontaneous report from a non-contactable Pharmacist. A 76-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EL3247), intramuscular on 19Jan2021 at single dose for COVID-19 immunisation. The patient medical history included COVID symptoms from 16Jan2021 and ongoing. Concomitant medications were not reported. The patient with acute resp failure, COVID pneumonia, that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior to a admit, then shortly after progressed with other covid symptoms and was admitted on 25Jan2021. She decompensated while intp and was transferred to ICU for rising O2 needs, ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed, hemodynamics deteriorated. The patient died on 02Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events death, COVID-19 pneumonia, acute respiratory failure, hypotension, abdominal wall haematoma and abdominal wall haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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.; Reported Cause(s) of Death: Pt passed soon after
76 2021-02-17 chest pain The first night after the vaccine had a headache and woke up with pain near her mouth. The 2nd nigh... Read more
The first night after the vaccine had a headache and woke up with pain near her mouth. The 2nd night, Tuesday, 2/16/21 it got bad, woke up around the same time early morning, had pain on the right quadrant of her upper body, from her ear, eye, throat and down to right under her throat. When she swallows the pain is very severe with difficulty swallowing and that pain radiates to the upper part of her chest. Then on the third night, last night, all the same pain but the headache had disappeared. Today, 2/18/21 she is still having the same symptoms. The hardest thing to deal with is the ear pain in the right ear, and the pain under her right throat area. She has taken one Benadryl at 8:00 AM, and will take another at 8:00 PM. The Benadryl triggers her tinnitus so is limited with that. Her daughter is trying to find OTC medicine for the ear. She has not called her doctor as they are trying to treat it with OTC medicines. For additional information call her daughter: who takes care of all her medical information.
76 2021-02-17 fainting Felt tiredfrom after vaccine, may have had a fever. Had a syncopal event 34 hours after vaccination
76 2021-02-18 blood pressure increased After receiving the vaccine, my daughter took me to my Cardiologist appointment (this was scheduled ... Read more
After receiving the vaccine, my daughter took me to my Cardiologist appointment (this was scheduled before I received the vaccine). When I got to my doctor my blood pressure was elevated, it was about 180/88. My blood pressure is never that high. It did go down before I left to 140/84. When we were walking in the elevator after leaving the appointment my gait was unsteady. I felt very weak. I also light headed, and dizzy. It felt like the feeling of the sedation you have receive before having surgery. When we made it home I couldn't even see straight. This lasted about 2 hours. I feel much better today.
76 2021-02-18 cerebrovascular accident Patient on 02/09/21 starting having slow thought process and weakness in left arm and hand and had l... Read more
Patient on 02/09/21 starting having slow thought process and weakness in left arm and hand and had little strength in left hand and was dropping things. patient was scheduled for ct scan for headaches later that week. Called and got ct scan to be done state. Patient had a CT scan on 02/09/21 which was negative and saw the doctor on 02/12/21 and he ordered an MRI which showed patient had a CVA, cerebrovascular accident-stroke, MRI results revealed the CVA.
76 2021-02-21 cerebrovascular accident CLIENT STATES 9:15AM ON 2-5-21 SHE WAS PASSENGER IN CAR AND HUSBAND NOTICED THAT SHE HAD STOPPED TAL... Read more
CLIENT STATES 9:15AM ON 2-5-21 SHE WAS PASSENGER IN CAR AND HUSBAND NOTICED THAT SHE HAD STOPPED TALKING AND WAS JUST STARRING X 2 MIN, THEN BECAME RESPONSIVE AND TALKATIVE AGAIN. SHE WAS 'NOT QUITE HERSELF FOR ABOUT 3 DAYS'. MRI, MRA, CT OF BRAIN & U.S. OF CAROTIDS DONE. DX WITH RT TEMPORAL/PARIETAL CVA. NOW ON PLAVIX & ASA 81MG. HAS APPT WITH NEUROLOGIST 2-17-21. REMAINS 'NOT QUITE HERSELF AND OFF BALANCE'.
76 2021-02-21 loss of consciousness I received my 2nd vaccine at 12:15 at the facility on Tuesday, Feb. 16. At about 10:30 that night I... Read more
I received my 2nd vaccine at 12:15 at the facility on Tuesday, Feb. 16. At about 10:30 that night I began to feel a bit light headed. I went to bed around 11:30 and didn't sleep very well. On Wed. am after going to the bathroom, I felt woozy while washing my hands. When I thought I felt better, I made my way back to the bedroom and passed out. I fell on my right side, bruising the right side of my face, my right hip and my right thigh. I apparently had my left hand under me when I fell because I broke the knuckle under the pinkie of my left hand.
76 2021-02-22 blood pressure increased Patient received 2 doses of COVID-19 vaccination in same arm on same day (several minutes apart). No... Read more
Patient received 2 doses of COVID-19 vaccination in same arm on same day (several minutes apart). No symptoms reported, aside from anxiety-induced blood pressure elevation
76 2021-02-22 chest discomfort post injection, c/o pain and tingling bilateral arms, chest tightness, and tongue "feels strange", d... Read more
post injection, c/o pain and tingling bilateral arms, chest tightness, and tongue "feels strange", difficulty breathing
76 2021-02-22 loss of consciousness, nosebleed passed out / fell; passed out / fell; developed a nose bleed that would not stop; This is a spontane... Read more
passed out / fell; passed out / fell; developed a nose bleed that would not stop; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. Medical history included high blood pressure, diabetic, stage 3 kidney disease, known allergies to penicillin. The patient's concomitant medications were not reported. It was reported that patient got the shot on Thursday morning (04Feb2021) and later that evening reported as at 10:00pm, the patient developed a nose bleed that would not stop. By 10:30pm she passed out/fell, site car management was called and she was sent to the ER where she stayed for evaluations for 2 days. The reporter does not think the Covid shot was connected to the event. No treatment was given to the patient. The patient had no covid prior to vaccination and was not tested for covid post vaccination. The patient was recovering from the events at the time of the report. Information about lot/batch number has been requested.
76 2021-02-23 nosebleed, coughing up blood, chest pain Day after vaccine she felt tired, today she woke up coughed up blood then noticed that her nose was... Read more
Day after vaccine she felt tired, today she woke up coughed up blood then noticed that her nose was bleeding; bleeding lasted about 1.5 hours, now stopped #1 Pfizer 1/31/21 1115 #2 Pfizer 2/20/21 1300 #1 Pfizer lot EL9265 #2 Pfizer lot EN6200
76 2021-02-23 heart rate increased fast heartbeat, first experienced 2or 3days after injection, during early morning hours, 2 n... Read more
fast heartbeat, first experienced 2or 3days after injection, during early morning hours, 2 nights then the next night no fast heartbeat, the fourth night again the fast heartbeat two times during the same night. I originally thought it was possibly what I had eaten, or maybe my medication. After reading side effects of vaccine I decided to report this thinking it could possibly be the vaccine.
76 2021-02-24 palpitations Patient complained of racing pulse, anxiety, dizziness during 15 min observation time. BP elevated ... Read more
Patient complained of racing pulse, anxiety, dizziness during 15 min observation time. BP elevated 175/91, HR 120-130. pOx 99% RA. talked patient through deep breathing, anxiety reducing exercises. Vitals started to come down (153/71, HR 96). Patient then complained that she was feeling unwell again, very dizzy, HR increased as well as BP again. 911 called to patient to go to ER for evaluation.
76 2021-02-24 sinus rhythm, hypertension patient reported feeling faint, got lightheaded, dizzy, nauseated
76 2021-02-25 hypertension DIPLOPIA, CONTINUING TO TODAY HYPERTENSION, IMPROVING ON ADDITION OF AMLODIPINE
76 2021-02-25 superficial blood clot Patient developed extensive superficial thrombophlebitis of left leg within 36 hours of receiving t... Read more
Patient developed extensive superficial thrombophlebitis of left leg within 36 hours of receiving the vaccine with no other provocative factor
76 2021-02-26 chest discomfort Patient presented with tightness in chest. HR 70 sinus rhythm BP 171/81 and then 171/89 She refus... Read more
Patient presented with tightness in chest. HR 70 sinus rhythm BP 171/81 and then 171/89 She refused transport to hospital.
76 2021-02-26 low blood platelet count, platelet count decreased immunothrombocytopenia refractory to platelet transfusions, starting steroids and IVIG
76 2021-02-27 heart failure, atrial fibrillation Received the vaccine & the next day became very weak and ill with throwing up. Her sister came to vi... Read more
Received the vaccine & the next day became very weak and ill with throwing up. Her sister came to visit and noticed her right face was drooping & her balance was off so she called ambulance. Subsequently has been hospitalized for a month with a heart failure exacerbation that has led to ICU care, sepsis with Klebsiella pneumonia, acute kidney injury now with long term dialysis, hyponatremia, & elevated liver enzymes
76 2021-02-27 loss of consciousness Patient began feeling tired 1 hour post dose. At 3 hours post dose, patient began feeling woozy, di... Read more
Patient began feeling tired 1 hour post dose. At 3 hours post dose, patient began feeling woozy, dizzy and disoriented. Patient got dizzy and passed out while walking to bathroom. She fell and sustained a significant laceration to her arm. She continued to feel dizzy and "just not right" several times over the hour until she finally called 911. When paramedics arrived, she continued to lose consciousness and required full assistance to be placed onto the stretcher. Her BP was all over the place for the better part of 6 hours, with highs as high as 145/95 and lows as low as 81/42. This reaction lasted for a total of 8 hours.
76 2021-03-01 heart rate abnormal . Following Covid-19 vaccine, patient complained of rapid heart rate @ 16:15. Vital signs were taken... Read more
. Following Covid-19 vaccine, patient complained of rapid heart rate @ 16:15. Vital signs were taken at 16:16: o2 Sat: 99%, Pulse: 76, BP: 200/99. Patient stated that she did not drink enough because she had a long commute home, and did not want to use the bathroom. RN recommended the patient to drink water, and handed her a bottle of water, which she drank completely. Vital signs were retaken at 16:21: o2 Sat: 100%, HR: 70, BP: 192/91. Patient was advised that she will be taken to the ER for continuous monitoring, but the patient insisted to decline, and stated that she did not want to go to the ER.
76 2021-03-02 heart rate increased rapid heartbeat/went up, the highest was 135/went to 110, 96, 105; This is a spontaneous report from... Read more
rapid heartbeat/went up, the highest was 135/went to 110, 96, 105; This is a spontaneous report from a contactable consumer (patient) reported that a 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on the left arm on 27Jan2021 13:30 at a single dose to protect against Covid. The patient's medical history was not reported. Concomitant medication included as heart medication (unspecified). The patient previously received FLU VACCINE on an unspecified date for immunization. The patient reported that she had the first Pfizer Covid-19 shot last Wednesday (27Jan2021) and got an adverse event, rapid heartbeat. She ended up going to the emergency room and had an EKG, chest x-ray, and bloodwork (complete blood work) to see for heart problems, they checked her heart. Normally her heart rate was about 50-60, but hers went up, the highest was 135. She was monitored, and her heart rate went to 110, 96, 105, and it kept going up and down and then she was later released. It didn't actually go back down to normal until about 8:30-8:45 that night as mentioned once the heart rate went down that night, it's been normal since then. The outcome of the event was recovered on 27Jan2021. She wanted to know if she should get the second one. She was to get the second dose on 17Feb2021 and not sure if she should get it or not, wanted to know what Pfizer recommends.
76 2021-03-02 low blood oxigenation Patient was admitted with impression of COPD exacerbation and hypoxia. She was treated with antibiot... Read more
Patient was admitted with impression of COPD exacerbation and hypoxia. She was treated with antibiotic and bronchodilators. Her symptoms gradually improved and she was discharged. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
76 2021-03-02 pulmonary embolism shortness of breath, dyspnea on exertion that started after 2nd vaccine, found to have pulmonary emb... Read more
shortness of breath, dyspnea on exertion that started after 2nd vaccine, found to have pulmonary embolism 2 weeks later
76 2021-03-03 chest discomfort Reported not feeling well, sent to ED. Per Ed note: Patient here from covid vaccine clinic. c/o thro... Read more
Reported not feeling well, sent to ED. Per Ed note: Patient here from covid vaccine clinic. c/o throat tightness w/ small amount of dyspnea. states throat feeling better now, still having some tightness in chest. Patient received IV benadryl and IV famotidine and felt fine. No need for treatment with epinephrine IM. Was discharged home.
76 2021-03-06 palpitations, atrial fibrillation Pfizer-BioNTech COVID-19 Vaccine EUA Patient had just received her 1st COVID vaccine and was sitting... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Patient had just received her 1st COVID vaccine and was sitting down monitoring symptoms when she suddenly flipped into a different heart rhythm and felt palpitations like her heart was racing. Her heart rate was checked and found to be 130 beats per minute. Transferred to the emergency department On arrival to ED, patient is well-appearing in no distress. Heart rate 134 on arrival. EKG performed and confirmed atrial fibrillation. IV was established, fluids and additional IV metoprolol administered. Labs with mild hypokalemia at 3.2 which was replenished in the ED. Heart rate flipped to normal sinus rhythm and repeat EKG showed her baseline right bundle-branch block with left axis deviation, T-wave inversions in lead V2, V3, III consistent with previous EKGs. She reports she has improved symptoms, no increased dyspnea and no chest pain. Patient discharged home
76 2021-03-08 heart failure SOB a few days after vaccination; one week later, new onset of acute exacerbation of HFrEF with subs... Read more
SOB a few days after vaccination; one week later, new onset of acute exacerbation of HFrEF with subsequent respiratory failure and hospitalization
76 2021-03-09 chest pain, hypertension, low blood pressure, lightheadedness Within 15-minutes of vaccination, the patient reported dizziness, nausea, and chest pain. EMS evalua... Read more
Within 15-minutes of vaccination, the patient reported dizziness, nausea, and chest pain. EMS evaluated the patient on-site. Patient was found to have orthostatic hypotension, hypoglycemia, and was near-syncopal. EMS administered 400mL of normal saline and 15g oral glucose. EMS transported the patient to Emergency Department. In the ED, the patient was hypertensive (163/73). EKG demonstrated NSR, rate 67 bpm, no ST-T changes, no ectopy, normal PR & QRS intervals. CBC/CMP was unremarkable. Patient noted improvement and was discharged with a diagnosis of a probable vasovagal event.
76 2021-03-09 loss of consciousness Lost consciousness; palms began to itch, then soles of feet; This is a spontaneous report from a con... Read more
Lost consciousness; palms began to itch, then soles of feet; This is a spontaneous report from a consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (lot number was EL8982 and expiration date was unknown) via an unspecified route of administration at left arm 18Jan2021 14:30 at single dose for COVID-19 immunisation, amoxicillin via an unspecified route of administration from 18Jan2021 at 14:50 at 4 DF for dental apt, procaine hydrochloride (NOVOCAIN) via an unspecified route of administration from 18Jan2021 at unknown dosing regimen for an unspecified indication. Medical history included 3 joint replacements and known allergies to raw celery, clover honey and ragweed. Concomitant medication included atorvastatin calcium (ATORVASTIN), brimonidine tartrate, timolol maleate (COMBIGAN), levothyroxine, tolterodine. There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. The patient had no reaction in first 15 minutes. Within 20 minutes of shot, patient took 4 amoxicillin for dental apt (as reported), then received procaine hydrochloride (Novocain). 45 min after shot, her palms began to itch, then soles of feet. Then she total loss of sight on 18Jan2021 at 15:30. Patient lost consciousness at emergency room check-in. Patient visited emergency room/department or urgent care. Patient received epinephrine injection as treatment. She also had CT scan of head and chest in Jan2021. She did not have COVID tested post vaccination. The outcome of events was recovered in 2021. The action taken in response to the events for amoxicillin and procaine hydrochloride was unknown.
76 2021-03-09 blood vessels inflammation Developed N/V ~2 weeks after 2nd covid vaccine. Presented to PCP, labwork revealed AKI and hyperkale... Read more
Developed N/V ~2 weeks after 2nd covid vaccine. Presented to PCP, labwork revealed AKI and hyperkalemia. Sent to ED. Admission lab included SCr 8.55 mg/dL and K+ 5.7 mmol/L. Repeat K+ level 7.0 mmol/L (6 hours later). Pt admitted, vascath placed, emergently dialyzed. Further work up revealed positive anti-nuclear antibody, positive anti-nuclear antibody titer, and elevated glomerular basement membrane antibody. High dose steroids (methylprednisone 1g iv qday x 3 days) started for presumed vasculitis. Renal biopsy performed, results c/w severe crescentic acute glomerulonephritis. Treated with rituximab 375mg/m2, subsequently transferred to another facility for plamapheresis.
76 2021-03-11 blood pressure increased Patient complained of "Whooshing" in her ears and nervousness. Blood pressure taken. BP elevated. ... Read more
Patient complained of "Whooshing" in her ears and nervousness. Blood pressure taken. BP elevated. Patient's husband states that this "whooshing" has been going on for about a year. No trouble breathing, no itching, no rash, no swelling of mouth our throat. Patient advised to consult a physician related to elevated blood pressure. Patient declined EMS.
76 2021-03-11 transient ischaemic attack, cerebrovascular accident stroke, tia in left eye
76 2021-03-13 ischaemic stroke Stroke (ischemic - isolated) occurred 6 days after vaccine administration
76 2021-03-14 nosebleed Pain, headache, tiredness, loss of appetite for the 2 days after the injection (February 20th and 2... Read more
Pain, headache, tiredness, loss of appetite for the 2 days after the injection (February 20th and 21st. ON THE 22nd I WOKE UP TO A SEVERE NOSE BLEED THAT I COULD NOT STOP! I NEVER RECALL HAVING A NOSE BLEED IN MY LIFE! I HAD MY SECOND SHOT ON FRIDAY, MARCH 12, AND WHILE SITTING WATCHING TV MY NOSE STARTED BLEEDING AGAIN EXCEPT, NOT SO PROFUSELY! It seem very strange to me that this would happen days after having the Covid vaccine
76 2021-03-15 palpitations Headache first and 2nd day. A week later woke me up 2 nights in a row but only lasted 12-15 minutes.... Read more
Headache first and 2nd day. A week later woke me up 2 nights in a row but only lasted 12-15 minutes. Skipped heart beats day after and the next am, none since. Rash of red irregular dots about the size of a pencil eraser with bumpy raised flesh directly on veins. started 2 weeks after, lasted 4 days, loss of appetite, much more intense joint pain and sleeplessness which comes and goes.
76 2021-03-15 pallor seizure like activity of upper extremities. slumped over in chair vomited pale in color
76 2021-03-15 fainting Fainted & throat tightened up
76 2021-03-17 cerebrovascular accident stroke; Extensive FLAIR hyperintense signal signal in the cerebral white matter/ Mild hyperintense s... Read more
stroke; Extensive FLAIR hyperintense signal signal in the cerebral white matter/ Mild hyperintense signal in the brain stem and medial cerebellum; This is a spontaneous report from a contactable consumer. This consumer reported for a 76-year-old female patient (reporter's mother) who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302) first dose via unspecified route of administration on 21Jan2021 at 12:00 PM in left arm at single dose for COVID-19 Immunization in the hospital. There was no other vaccine administered in four weeks. Medical history included COPD (Chronic obstructive pulmonary disease), Small Cell Lung Carcinoma with metastases to brain s/p surgery, chemotherapy and radiation in 2014, dementia. Concomitant medications included citalopram at 40mg, levothyroxine at 0.05 mg, salbutamol (ALBUTEROL). The patient previously took Codeine and experienced allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient had what appeared to be a stroke on Saturday, 23Jan2021 at 12:00 PM. A CT, MRI and an Echocardiogram were all performed on 23Jan2021 and there was no acute intracranial hemorrhage, mass effect, midline shift, or extra-axial fluid collection. Extensive FLAIR hyperintense signal signal in the cerebral white matter. Mild hyperintense signal in the brain stem and medial cerebellum. Following contrast administration there is no abnormal CNS enhancement. The adverse events resulted in Emergency room/department or urgent care and hospitalization for seven days from Jan2021. Treatment given was TPA to reverse adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was recovered/resolved with sequel. No follow-up attempts possible. No further information expected.
76 2021-03-18 excessive bleeding diarrhea; color of the diarrhea looked red and looked like it had blood on it; she sat down in a cha... Read more
diarrhea; color of the diarrhea looked red and looked like it had blood on it; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; shaking/trembling out of control; hurting from her neck down to her toes; joints were achy, hurt, and stiff; joints were achy, hurt, and stiff; her teeth were chattering and cant stop, and when she tried to stop that it made it worse; she had hard time walking/Her gait was off and she was kind of jerking; fell in the bathroom; she was too weak; hard time rolling and trying to get out of bed; Her gait was off and she was kind of jerking; little nausea; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea; she was kind of wiped out for a couple of days (in 2021) and it was all over now; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6203), via an unspecified route of administration in left arm on 27Feb2021 (at the age of 76years) as single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia diagnosed in 1999; Covid-19 from 23Nov2020 to Dec2020 (went to the hospital because of pain in her side at night. Was told she had pneumonia and pleurisy, she got it 2 days after her husband did, but hers was a mild case); her husband had Covid in Nov2020 and died in Dec2020 and hemorrhoids (from having babies years ago). Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN). The patient had no investigation assessment. The patient scheduled her first dose for 27Dec2021. The patient had questions about it, but the person administering it did not speak English and she said that initially she did not have any reactions while she was there. The patient received the first dose of the vaccine on 27Feb2021 and has a lot of adverse events. After the getting the shot, she woke up at 0400 and experienced shaking (whole body was shaking), trembling out of control, hurting from her neck down to her toes, her joints were achy, hurt, and stiff, her teeth were chattering and couldn't stop, and when she tried to stop that it made it worse, when she got up she had hard time walking, so much that when she had diarrhea, she had diarrhea on the floor, she also noticed that the color of the diarrhea looked red and looked like it had blood on it but she was not sure. After that, she sat down in a chair and noticed that it had blood when she got up and suspected that she had hemorrhoids and bleeding because of the diarrhea. She thought it was a result of the reaction to the shot. She noted that that she had COVID on 23Nov2020 and that she heard that people who had COVID might not need to get the second shot but it was only speculation so she was asking if this was true. She mentioned that she waited 90 days before getting the vaccine as per CDC guidelines and knew that the 2nd dose can be given for 42 days after the first dose. The patient's daughter in law who was an occupational therapist volunteered to fly in and take care of her after the second shot on 27Mar2021 but her 2nd shot was due on 20Mar2021 so she wouldn't be there until then. The patient was having a hard time rescheduling her appointment so asked if there was anything can be done. The patient would prefer not to take the second dose due to the side effects. The patient also reported that it looked like someone who had a stroke trying to walk again, her gait was off and she was kind of jerking. As she would take a step her foot would go down on a slant like it was skidding. She said that this happened one other time to her. It was like she was leaning forward and could not stop herself. When she was able to get up, she went into the living room and sat in her husband's chair and fell asleep until 15:00. When she got up, she noticed a lot of blood in the chair. The patient asked if this was allowed. She went home and took a couple of acetylsalicylic acid, caffeine, paracetamol because she did not have paracetamol (Tylenol), and she went to sleep. She had a hard time rolling and trying to get out of bed. She turned on her electric blankety and her heat. She said that by 0600 most of the shaking had gone away. She felt a little nausea, but got some dry toast. She said that she wanted to take a shower, but she started getting diarrhea from the injection. She fell in the bathroom and could not get herself up for over an hour because she was too weak. When she fell on the floor, she tried to get on a rug because she was still having the diarrhea on the floor. She said that it was everywhere. The next day she called her son and his wife they said that she could be alone for her second shot. She was scheduled for 20Mar2021 for her second dose. The patient had a hard time changing the appointment and her son could not come to stay with her until 27Mar2021. A friend told the patient that on the news it said that a second shot may not be necessary for people who have had Covid-19 already and she wanted to know if Pfizer has heard of this. The patient said that she was kind of wiped out for a couple of days (in 2021) and it was all over now. The doctor's office was aware of what happened and she was told to take extra strength Tylenol before and after the second injection to address these symptoms. The consumer considered the case as non-serious. The outcome of the event fatigue was recovered in 2021 while for the remaining events was unknown.
76 2021-03-18 hypertension Felt dizzy as we were leaving the facility where I received the shot. Extremely dizzy and light head... Read more
Felt dizzy as we were leaving the facility where I received the shot. Extremely dizzy and light headed for 5 days after that. Called to report the dizzyiness and they sent me to Urgent Care
76 2021-03-19 oxygen saturation decreased Low oxygen noticed at doctors office, was rushed to the ER. Is now on oxygen 24/7. Drops extremely... Read more
Low oxygen noticed at doctors office, was rushed to the ER. Is now on oxygen 24/7. Drops extremely low with any movement.
76 2021-03-20 heart rate increased she is not thinking straight; she is able to hear her heartbeat in her ears; having a ringing in her... Read more
she is not thinking straight; she is able to hear her heartbeat in her ears; having a ringing in her ears; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; She feels fuzzy in her head; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection lot no: EN5318), intramuscular injection in left arm on 01 Feb 2021 for covid-19 immunisation. the patients' medical history included ongoing high blood pressure and High cholesterol. The patient's historic vaccine included Shingrix for shingles on unspecified date in 2020. The patients Concomitant medication included Amlodipine 5mg tablet once a day orally, Hydrochlorothiazide 12.5mg tablet once a orally, Olmesartan 40mg tablet once a day orally, Meloxicam 7.5mg small tablet orally, three times a week, Preservision Eye Vitamin one soft gel capsule by orally, probiotic two gummies once a day orally, apple cider vinegar gummy two gummies once a day orally for Cholesterol, Citracal + D, calcium and vitamin d supplementation two tablets twice a day orally. on 01 Feb 2021, the patient experienced tingling/ numbness on tongue, lips, and roof of her mouth, felt fuzzy in her head. On 03Feb2021, she experienced Ringing in ears. The outcome of events was not recovered.
76 2021-03-20 loss of consciousness Fine after shot and evening; went to bed approximately at 9pm and got so cold, put 3 blankets on an... Read more
Fine after shot and evening; went to bed approximately at 9pm and got so cold, put 3 blankets on and was fine. Got up about 2AM to go to the bathroom; started back to bed; had a bad taste in mouth, so decided to brush my teeth. Started brushing and all of a sudden, felt faint; before I could get the toothbrush back, I fell and my husband rushed over. Said I was out completely; got me awake and back up and went to bed and slept. until 11am. At 3pm when taking a shower, noticed my left shoulder blade was real sore and looked and there were 3 red strips below should blade - no bleeding tho. top R. side of head kinda sore, so must have hit when falling. Went back to bed and slept good. Didn't need to go to the Dr. and am feeling good now. Just rested for a couple days. Had been feeling really good and don't take any prescriptions, so could only think it had to have something to do with the shot. Today is the 4th day and feel good.
76 2021-03-22 cardio-respiratory arrest, cardiac arrest Cardiopulmonary arrest at home @ 1 hour after vaccine administration. CPR by EMS to today hospital f... Read more
Cardiopulmonary arrest at home @ 1 hour after vaccine administration. CPR by EMS to today hospital for asystolic cardiac arrest. Pt. Intubated then terminally extubated
76 2021-03-22 chest pain, ischemic chest pain heart pain; Shoulder pain; Neck ache; Stiff neck; severe chest pain; This is a spontaneous report fr... Read more
heart pain; Shoulder pain; Neck ache; Stiff neck; severe chest pain; This is a spontaneous report from a contactable consumer (patient). This 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 23Feb2021 15:15 (batch/lot number: EN6198) as a single dose for COVID-19 immunization. Medical history included heart attack approximately 20 years ago). Family history included heart problems. Patient received unspecified concomitant medications. No additional vaccines administered on the same date of the Pfizer suspect. Patient experienced some side effects after receiving the first dose of the Pfizer-BioNtech Covid-19 vaccine. About 3-4 hour after she received the vaccine, on 03Feb2021 19:00, she had heart pain for around 5 hours, she also experienced shoulder and neck ache. These symptoms have resolved. She would like to know if she should receive the second dose of the vaccine, if these symptoms would be worse. Treatment for side effects: she put Spikenard, an oil, on the chest for the heart. At 15:10, she was fine, went home, had dinner, and then she first got shoulder pain/shoulder blade pain and then a stiff neck. Then she thought, she will go to bed and then had severe chest pain most of the night. Patient has never had flu or any vaccines. AEs did not require a visit to emergency room/physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event shoulder pain was recovering, of the event neck pain was recovered in 2021, and of the events heart pain, stiff neck, and chest pain was recovered on 23Feb2021.
76 2021-03-23 chest pain, low blood oxigenation, hypotension, atrial fibrillation 1st vaccine on 2/20 and reported feeling "lousy" afterwards. On the evening of 2/23 felt like she wa... Read more
1st vaccine on 2/20 and reported feeling "lousy" afterwards. On the evening of 2/23 felt like she was going to pass out. Felt worse when she woke the next morning. Presented to the ER on 2/24 with chest pain and "indigestion". Found to be in A.Fib with RVR. Vomited in ER triage. On 2/25 developed altered mental status, hypotension, hypoxemia. She was intubated and transferred to the ICU with severe lactic acidosis/shock/multiorgan failure. Had Right lower lobe infiltrate and right pleural effusion. Diagnosed with pneumonia and possible ischemic bowel. Died on 2/26. Family requested autopsy.
76 2021-03-24 cardio-respiratory arrest, fainting Patient got 2nd vaccine, waited 15 minutes for observation and collapsed when getting into car
76 2021-03-24 chest pain chest, back underarm pain; chest, back underarm pain; back pain; adhesions; Inflammation numbers wer... Read more
chest, back underarm pain; chest, back underarm pain; back pain; adhesions; Inflammation numbers were high; Clotting numbers were way high over 2000; pneumonia; This is a spontaneous report received from a contactable consumer. A 76-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 01Jan2021 11:45 at single dose for COVID-19 immunisation. Medical history included thyroid, pancreas, and known allergies: Sulfa, k-flex, macrobid, statins, and pork. Concomitant medications included levothyroxine sodium (L-THYROXINE CAMPUS), vitamin B3, magnesium sulfate, and unspecified blood thinners. The patient experienced chest, back underarm pain two week later and did not get better. Patient had some adhesions and thought maybe from that. Patient had surgery and did not help. Pain kept getting worse. ED visit. On 04Mar2021, patient was diagnosed with pneumonia and sent home. After antibiotic, patient was no better. Another ED visit on 08Mar2021, clotting numbers were way high over 2000. Inflammation numbers were high. Patient was admitted every test available. 3 days in hospital. Patient was no better. Pain was terrible. Chest underarms and upper back. Patient was in serious pain and afraid to get second shot. Patient had cancelled. These adverse events were result in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. This case was reported as serious with seriousness criteria-caused/prolonged hospitalization. The patient underwent lab tests and procedures which included several computerised tomogram (CT scan): unknown results on an unspecified date, COVID test (nasal swab): negative on 08Mar2021, and X-ray: unknown results on an unspecified date. Patient was treatment for the adverse events. Outcome of the events was not resolved. Information on the lot/batch number has been requested.
76 2021-03-24 heart rate increased, hypotension, anaemia fever, low blood pressure, high heart rate, anemia, fluid on lungs. hospitalized 2/19-2/23, 2/26-3/... Read more
fever, low blood pressure, high heart rate, anemia, fluid on lungs. hospitalized 2/19-2/23, 2/26-3/1, and 3/15-current
76 2021-03-24 heart rate increased 3/5 Anxiety attack with increased heart rate ...lasted about 20 minutes after taking one half of a ... Read more
3/5 Anxiety attack with increased heart rate ...lasted about 20 minutes after taking one half of a cyclobenzaprine and full glass of waterand deep breathing; had another evening of March 10. much shorter duration.. After second shot, day after slight headache and bone tired...tiredness continues to present and my head feels like is has a vise or a helmet on it. Also have developed a kind of dermatitus but don't know for sure if I had it before and didn't realize it. I just want to sit down or lie down...My leg/butt muscles feel not up to the job...and in general thru today I just feel "off". Some days better than others.
76 2021-03-24 heart attack Back hurt a tremendous amount; Lower back, hips, knees, neck pain; Lower back, hips, knees, neck pai... Read more
Back hurt a tremendous amount; Lower back, hips, knees, neck pain; Lower back, hips, knees, neck pain; When she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes.; Very sore, uncomfortable stomach; Exhausted; Chills; Felt like she was having a heart attack; a bit congested; Aches; jaw pain; facial pain; Quite a bit of saliva in her mouth, it filled up quite a lot; sore on the injection site; Bit of a sore arm/left arm pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Right Arm on 02Mar2021 14:26 (Batch/Lot Number: EN619G) as single dose for vaccination. Medical history included joint replacements (specified as 1 hip done in 2007; right knee done in Jan2013; another knee was done in Feb2017; another knee was done in 1986); and in 2011, neck fracture. There were no concomitant medications. The patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 02Mar2021, she had sore on the injection site, experienced excess saliva production. On 05Mar2021, she experienced chills, feeling of heart attack: left arm pain, jaw pain, facial pain. She is worried to take the 2nd shot as she might have more symptoms on the 2nd dose. On an unspecified date, the patient had lower back, hips, knees, neck pain, eye socket hurts when rolling her eyes, sore stomach, and exhausted. It was also reported as follows: on 02Mar2021 after she got home from being administered the Pfizer-BioNTech COVID-19 Vaccine she had quite a bit of saliva in her mouth, it filled up quite a lot; and a bit of a sore arm for a couple of days but that was about it at that point. On Friday, 05Mar2021 she started getting chills and aches; and felt like she was having a heart attack: her left arm hurt and her left side of face hurt down in her jaw. She was afraid and considered going to the hospital but thought she was going to wait it out see what it is and it passed. She then once again got a lot of saliva in her mouth again. Over the next few days she developed aches that were primarily located in her joint replacements, it seemed like the aches attacked those areas of joint replacements in her hips, knees and where she had a neck fracture. She had a lot of pain and a lot of chills. She was never bedridden, but would lay down because she was exhausted. Her back hurt a tremendous amount. Another thing that happened is her eyes, when she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes; she did not have a headache; this whole indentation there with her eyes hurt to move them from one side to another. She also had a very sore, uncomfortable stomach; it was not an upset stomach; just seemed very sore, uncomfortable. At first that first part of 05Mar2021 she seemed a bit congested. She is very worried about second dose of Pfizer-BioNTech COVID-19 Vaccine because of the first dose creating all of these difficulties. She does not know what she should be doing. She is scheduled to get her second dose of the Pfizer-BioNTech COVID-19 Vaccine on 24Mar2021 because she is leaving by plane on 29Mar2021. That only gives her like 4-5 days before she leaves and she knows that the other symptoms after the first dose of the Pfizer-BioNTech COVID-19 Vaccine did not start until 3 days later. She is concerned about that, because she is flying to take care of her sister; she is worried about the second dose because she does not like what she experienced with the first dose because she heard that the second dose will be terrible; she is worried about leaving and experiencing those horrible things. She reported that there are no tests/investigations relative to this report to provide. The only thing recently done was having X-rays of her neck on 24Feb2021 because of her neck issues with the fractured neck she had in 2011. Outcome of the events was unknown.
76 2021-03-30 blood glucose increased has been experiencing high sugar level; having pain at tip of radius- sore to touch. Very sore; join... Read more
has been experiencing high sugar level; having pain at tip of radius- sore to touch. Very sore; joint pain; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and via sponsored program . A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. The patient previously took steroid shots that cause blood sugars to sky rocket, but that was expected. The patient stated, "about the time I got the shot, started having pain at tip of radius- sore to touch. Very sore. No trauma there. It doesn't comes and goes. I'm aware of it" on 23Feb2021. The patient also said she has had increased blood sugars since the vaccine (readings of 197, 147, 154) on 23Feb2021. The patient further stated that she was looking at book and has had higher numbers of 197,147 and 154. Stated that she was usually 120 or below. Stated that she does not know if it had anything to do with it. Stated that the tip of her radius was terribly sore to the touch. Stated that it said that joint pain was a side effect on an unspecified date in 2021. Patient wanted to know if it was a side effect or just her own aches and pains. The outcome of all events was unknown. Information on the lot/batch number has been requested.
76 2021-03-30 heart rate decreased, palpitations Diarrhea; Heart palpitation; occasional low pulse rate; sore joints; low grade fever; This is a spon... Read more
Diarrhea; Heart palpitation; occasional low pulse rate; sore joints; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection), first dose on 14Jan2021 at 12:45 (lot number: EL0140 and expiration date was unknown) and second dose on 04Feb2021 at 12:45 (Lot Number: EL3302 and expiration date was unknown) both administered in Left Arm via an unspecified route of administration at a single dose for COVID-19 immunization. Medical history included diabetes, CAD (coronary artery disease), aortic stenosis, COPD (chronic obstructive pulmonary disease), arthritis. Concomitant medication was not reported. The patient was not received other vaccines within four weeks of vaccination. The patient received unspecified medications within two weeks of vaccination. On 05Feb2021, the patient experienced diarrhea, heart palpitation, occasional low pulse rate, sore joints, and low-grade fever. The patient not received treatment for the events. The patient not had covid prior to vaccination. The patient not tested for covid post vaccination. The outcome of all events was reported as not recovered.
76 2021-04-02 chest discomfort Chest tightness shortly after vaccination, sent to EC and admitted to observation and seen by cardio... Read more
Chest tightness shortly after vaccination, sent to EC and admitted to observation and seen by cardiology, ruled out ACS and discharged in less than 48 hours
76 2021-04-05 blood pressure increased Patient was hospitalized from 3/11-3/15 for mental status changes. No obvious etiology found. On adm... Read more
Patient was hospitalized from 3/11-3/15 for mental status changes. No obvious etiology found. On admission she was found to be + for SARS-Co-V2. She had no respiratory symptoms and was not treated. She was discharged to
76 2021-04-05 blood pressure increased Pfizer-BioN Tech COVID-19 Vaccine EUA: Swelling in mouth/lips, severe itching (all over, especially... Read more
Pfizer-BioN Tech COVID-19 Vaccine EUA: Swelling in mouth/lips, severe itching (all over, especially legs, thighs, back, arms, scalp, eyebrows and in nostrils, sensitivity to sound, elevated blood pressure, swelling in ankles, nausea
76 2021-04-05 low blood oxigenation, atrial fibrillation Received dose and tolerated it well. Over last week increasingly SOB, diarrhea and weakness. Of note... Read more
Received dose and tolerated it well. Over last week increasingly SOB, diarrhea and weakness. Of note family contact tested positive for She was admitted to the hospital - c Patient admitted to COVID unit as PUI, tested positive for COVID on 3/7. Required O2 and intubated with ICU admission. She remained intubated for 12 days. Her ICU course was complicated ARDS with severe hypoxemia, A.fib with RVR, mod-severe PFO with R to L shunt, spontaneous intraperitoneal bleed, septic shock, renal failure and ultimately multi-organ failure. Family made decision to transition to comfort measures only. She died shortly after extubation.
76 2021-04-06 fainting Faint; Fever; Dizzy; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A... Read more
Faint; Fever; Dizzy; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in right arm on 20Mar2021 12:00 (Lot Number: EP7534) as single dose for covid-19 immunization at age 76 years old. Not pregnant at the time of vaccination. The patient medical history was not reported. No allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included lisinopril; amlodipine besylate; and carvedilol; all taken for product used for unknown indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 administered in right arm on 26Feb2021 12:00 PM (lot no: EN6202) for COVID-19 immunization at age 76 years old. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 21Mar2021, the patient experienced faint, fever, dizzy, and diarrhea. The events were reported as non-serious. No treatment received for the adverse events. The patient had not recovered from the events.
76 2021-04-09 arrhythmia impacted stool; Impacted bowel movement; She actually tore and was bleeding really bad; exhausted; s... Read more
impacted stool; Impacted bowel movement; She actually tore and was bleeding really bad; exhausted; she had arrhythmia episode; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 76-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date: 30Jun2021), via an unspecified route of administration, in Arm Left, on 09Mar2021 at 01:30 PM, as a single dose for COVID-19 immunization, at hospital and administered by a Nurse. Patient's medical history was not reported. Concomitant medications included rosuvastatin calcium, at 10 mg, 3x/day, (three days a week) and then at 5 mg, 4x/day, (5 mg four days a week); levothyroxine (50 ug) for Thyroid disorder and amlodipine besylate (2.5 mg) and had been taking fiber and probiotics. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Lot number; EN5318, expiry date; 31May2021, Received in right arm) for COVID-19 immunization; Had no problem with first COVID-19 Vaccine. No pain at site, nothing. Patient stated that she had arrhythmia episode and that was unusual for me; Since then I have had four more episodes in Mar2021. Patient stated that her second dose of the vaccine at 1:30 pm. The same day at 10 pm, she experienced an impacted stool. She stated that she was on the toilet from 10 pm-12:15. She wanted to know if this is a reported side effect of the vaccine. After receiving second dose, patient stayed 30 minutes and felt fine. At 10 PM felt that need to go to the bathroom, which she thought was odd. More than two hours she tried to pass a BM. It was so impacted she could feel it all around her anus. Was ready to go to the hospital. Didn't know what to do. Waited and waited sitting on the toilet. Was trying to see if she could dig anything out and it was non-productive. At 12:15 AM bowel movement finally left. It was 13 inches long and 3 inches around. She actually tore and was bleeding really bad. She usually drinks a lot of water, but was not able to the day of the second COVID-19 Vaccine. It was stated that total time of bowel movement impaction was two hours and 15minutes (Began 10PM on 09Mar2021 and passed at 12:15AM on 10Mar2021). She was not supposed to push with bowel movement impactions. Patient was told by Doctor, patient could get a heart attack or stroke from pushing impacted bowel movements. Patient was so exhausted and a very bad experience. No further details provided. Had a lot of vaccinations over the time due to living in Honduras for 2 years and traveling in Brazil. No further details provided. Scheduled mammogram fourth months from second dose. Patient did not receive other vaccines within 4 weeks or prior vaccination. She had a colonoscopy 6-8 months before the vaccine and had been taking fiber and probiotics. Outcome of the events impacted stool and Impacted bowel movement was recovered on 10Mar2021; for all other events it was unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
76 2021-04-09 atrial fibrillation A fib; This is a spontaneous report from a contactable healthcare professional. A 76-year-old femal... Read more
A fib; This is a spontaneous report from a contactable healthcare professional. A 76-year-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered on right arm on 26Mar2021 14:30 (Batch/Lot Number: EP6955) at single dose (at the age of 76 years old) for COVID-19 immunisation. Medical history included have not been in Afib for 4 months prior. Concomitant medication included metoprolol, lisinopril and rivaroxaban (XARELTO), all taken for an unspecified indication, start and stop date were not reported. The patient received BTN162B2, dose 1 for COVID-19 immunisation. 1 hour and 5 minutes after injection (26-MAR-2021 15:35) of second dose, the patient went into a fib. Have not been in Afib for 4 months prior. The patient received no treatment. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of atrial fibrillation due to temporal relationship. Case will be re-assessed upon the additional information provided.
76 2021-04-09 blood pressure increased After receiving the 2nd dose of the Pfizer immunization, the pts blood pressure began to increase. I... Read more
After receiving the 2nd dose of the Pfizer immunization, the pts blood pressure began to increase. It got to 210/120. Paramedics were called and responded promptly. Pt was left in their care.
76 2021-04-10 heart rate abnormal, atrial fibrillation For 3 days after I was so tired it was hard to get off couch. My Afib has been controlled but the a... Read more
For 3 days after I was so tired it was hard to get off couch. My Afib has been controlled but the afternoon of shot heart rate started to fluxuate. had appt with heart Dr. took EKG was ok but stated that there were several patients with same systems. by Thursday April 1st, heart rate was up to 143, called 911, by the time I got to ER it was going down. Had another EKG with in range and all other blood work was OK. Right ankle that swells because of arthritis swelling is now worse.
76 2021-04-10 hypertension 09:11 - 76 y.o. female with h/o Graves disease brought in by EMS presenting with altered mental stat... Read more
09:11 - 76 y.o. female with h/o Graves disease brought in by EMS presenting with altered mental status after COVID vaccine. The pt reports that she received the first COVID vaccine several weeks ago and immediately afterwards she felt warm and had some difficulty focusing and walking. This resolved and she has since felt well. Today at 0800 she had her second dose of the COVID vaccine. About 15 minutes later she had an acute change in her mental status. She became disoriented and slow to answer questions. She also started having difficulty walking. She was also noted to be hypertensive with systolic BP in the 200s. She was subsequently sent here by the doctor at the vaccine clinic via EMS. Currently the pt is feeling somewhat improved and more back to her baseline. She notes that she still does not feel quite herself. Notes that her symptoms feel similar to her reaction after the first vaccine except much worse. Sates she takes Levothyroxine but no other medications. She last had her thyroid numbers checked in January and they were somewhat "off."
76 2021-04-11 chest pain Presented to emergency department with chest pain, report symptoms a few days prior to presentation.... Read more
Presented to emergency department with chest pain, report symptoms a few days prior to presentation. Reported mild shortness of breath, chills, and hot flashes. Was found to be COVID-19 positive upon admission to hospital floor. Symptoms are believed to not be related to COVID-19 infection and was not treated for infection.
76 2021-04-12 atrial fibrillation is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no sid... Read more
is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no side effects from her first COVID-19 vaccine. After the 2nd one she had muscle aches, headache, freezing cold, and "weird", and felt really badly then at 9:30 PM, 32 hrs after the 2nd vaccine dose she felt the a-fib started. She had not been in a-fib in many years. Cardiology had already recommended eliquis but she was holding off. She had diltiazem from 2017 that she tried but with out relief. They rate controlled her but she remained in a-fib, started eliquis, and she went home. For 2.5 weeks she had headache and chest pain, other muscle pain, felt horrible, until she stopped the Eliquis. Since stopping the Eliquis, she still has occasional mild chest pain, and headache, and flushing. Her current chest pain is left chest, not radiating. The quality varies, stabbing pain in a very small location at times, may be associated with eating. She did have a stress test years ago and was "fine". She had a dental appointment planned that she had to cancel, she has moved it to May 4th.
76 2021-04-12 blood pressure increased Patient is here today for her second Pfizer vaccination. She reports that after the first vaccine, ... Read more
Patient is here today for her second Pfizer vaccination. She reports that after the first vaccine, she felt very cold and had a sore arm for about 4 days. States that she took a 3-4 hour nap after she got home and the chills improved/resolved. Reports that she received the vaccine at around 10:00 AM. Was in the waiting area and was having some blurring of vision that was "coming in and out" and dizziness. She was taken to the personal observation area to lie down at 10:36 AM. Vital signs monitored. Blood pressure elevated, even though symptoms of blurring vision resolved. At around 10:55 AM, patient sat up on edge of cot. Continues to reports symptoms have resolved. No return of symptoms with standing. Patient walked well without the need of assistance. Husband accompanied her out of facility. Advised that, should blurring of vision reoccur, she should be seen in ED. Advised to schedule a blood pressure recheck with her PCP before the weekend. Patient acknowledged understanding of above information.
76 2021-04-13 heart attack, cardiac arrest Death Cardiac arrest Hyperkalemia NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) ESRD need... Read more
Death Cardiac arrest Hyperkalemia NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) ESRD needing dialysis (CMS/HCC)
76 2021-04-14 heart rate increased FEELING VERY SICK. Pain is unbearable. arm is sore. Fast pulse. when I get up I feel like I am goin... Read more
FEELING VERY SICK. Pain is unbearable. arm is sore. Fast pulse. when I get up I feel like I am going to faint. Chills low fever, Pain in joints and muscles severe headache.
76 2021-04-15 deep vein blood clot, pulmonary embolism On 02/26/2021, 10 days after given the vaccine I was admitted to the hospital with a blood clot in m... Read more
On 02/26/2021, 10 days after given the vaccine I was admitted to the hospital with a blood clot in my left leg and in both lungs. I was given Heparin, admitted, started on Xarelto, released on 02/28/2021. I will be on blood thinners for a at least 90 days.
76 2021-04-20 fibrin d dimer increased, stroke Patient dreamt she was having a stroke around midnight (estimated) the night of her vaccine. Woke wi... Read more
Patient dreamt she was having a stroke around midnight (estimated) the night of her vaccine. Woke with LUE/LLE weakness and facial droop. Did not immediately report, but after persistent symptoms presented to ED 3/10 for evaluation. MRI showed early infarct right frontal lobe in setting of extensive chronic ischemic small vessel disease throughout the periventricular and subcortical white matter. MRA head/neck negative. EKG: NSR
76 2021-04-21 chest discomfort, atrial fibrillation, inflammation of the pericardium Increased shortness of breath for a few weeks and then acute worsening of this along with new chest ... Read more
Increased shortness of breath for a few weeks and then acute worsening of this along with new chest tightness on 4/30 which led to hospitalization and ultimately diagnosis of pericarditis. Atrial fibrillation also developed during the course of the 4 day, 3 night hospitalization.
76 2021-04-21 chest pain, pulmonary embolism, blood clot 03/17: Got 2nd dose of Pfizer vaccine 03/23: Pain started in chest and leg 03/24: Pain forced her to... Read more
03/17: Got 2nd dose of Pfizer vaccine 03/23: Pain started in chest and leg 03/24: Pain forced her to go to ER where it was discovered that she had a clot in her lungs and leg. Now on Xarelto
76 2021-04-21 chest pain Two weeks after receiving vaccine, experiencing severe pain in under left breast, radiating around ... Read more
Two weeks after receiving vaccine, experiencing severe pain in under left breast, radiating around to the back. Chest pain and some breathlessness. I took her to the ER , on March 27, 2021, thinking it might be her heart. She was admitted for observation. She broke out with a severe case of shingles the next day, 3/28/21. She had been fully vaccinated for Shingles two years before (Shingrix).
76 2021-04-23 chest pain Chest pain/stabbing pain on her chest wall at the right side; This is a spontaneous report from a co... Read more
Chest pain/stabbing pain on her chest wall at the right side; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EL9269; Expiration Date: unknown), via an unspecified route of administration, administered in arm Left on 30Jan2021 at 11:00 (at the age of 76-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included Lupus from 1976 to an unknown date. There were no concomitant medications. Prior Vaccinations (within 4 weeks) reported as none. History of all previous immunization and additional vaccines administered on same date with the Pfizer vaccine reported as none. Consumer reported that she had a side effect that she had never seen listed. She had no pain or redness at the vaccine site; but about 18:00 on Sunday night she had stabbing pain on her chest wall at the right side with no other symptoms. She took an aspirin and laid down because she couldn't move with the pain. The next morning she took another aspirin and laid in bed that day. It was bad for three days. The last time she noticed that the pain was on Monday. She was thinking that she had dodged a bullet because she was not having any pain at the site. Patient stated that she had friends, (name provided) and (name provided), in their 80s, who had pain from the elbow to shoulder, she spoke with them the day after they received their shots and they got there shot at the same time and place as the patient. Patient was scheduled to receive the second dose of the vaccine on 20Feb2021. She wanted to know that the chest pain a side effect and mentioned that she was concerned about getting the next dose. On 31Jan2021, the patient experienced Chest pain/stabbing pain on her chest wall at the right side. Therapeutic measures were taken as a result of chest pain and included treatment with aspirin. Patient did not required a visit to physician or Emergency room. Relevant test reported as none. The outcome of the event was recovered on 08Feb2021. No follow-up attempts are possible. No further information is expected.
76 2021-04-24 heart rate increased Only has a little pain on my arm where I was given the shot; This is a spontaneous report from a con... Read more
Only has a little pain on my arm where I was given the shot; This is a spontaneous report from a contactable consumer reported for herself in response to Non-HCP letter sent in cross reference case. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included heart rate increased, blood cholesterol increased, hypertension from an unknown date and unknown if ongoing. Concomitant medications included ongoing metoprolol 25mg, twice daily, lisinopril 5mg once daily from Jun2020 for hypertension, ongoing atorvastatin (LIPITOR (ATORVASTATIN) 20 mg once daily from Jun2020 for blood cholesterol increased, ongoing levothyroxine, diphenhydramine hydrochloride (BENADRYL) from an unknown date to unknown date for unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration (Lot number: EL9261) as SINGLE DOSE for covid-19 immunisation causes rapid heartbeat was monitored, it keep going up and down/went to the emergency room. The patient only has a little pain on my arm where i was given the shot on an unspecified date. Drank a lot of water before after shot, Nurse suggested taking Benadryl after the shot which I did and had no reaction. The patient underwent lab tests and procedures which included heart rate increased: 135-120-110 bpm (Normal BPM 55-65 was up to 135-120-110 etc after vaccine (1st shot)), heart rate normal: 55-65 bpm (Normal BPM 55-65). The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown. Information about batch/lot number has been requested.
76 2021-04-24 heart rate irregular Irregular heartbeat. Lasted 12 hours. Had no adverse symptoms from this. Felt fine. Home BP machine ... Read more
Irregular heartbeat. Lasted 12 hours. Had no adverse symptoms from this. Felt fine. Home BP machine registered 124/82. Pulse in the 80s.
76 2021-04-25 heart rate increased, troponin increased This 76 year old female received the Covid shot on 2/27/2021 and went to the ED on 4/13/202... Read more
This 76 year old female received the Covid shot on 2/27/2021 and went to the ED on 4/13/2021 and was admitted on 4/13/2021 with hortness of breath, abnormal lab, and returned to ED on 4/16/2021 and admitted on 4/17/2021 with vomiting, elevated troponin, dehydration and returned on 4/23/2021 and admitted on 4/24/2021 with rapid heart rate and acute respiratory failure and died on 4/24/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
76 2021-04-26 palpitations Reported heart palpitations
76 2021-04-27 blood pressure increased Her legs got weak; she lost coordination; anxiety was exacerbated by her terrible fatigue; depressio... Read more
Her legs got weak; she lost coordination; anxiety was exacerbated by her terrible fatigue; depression was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; She noticed that her blood pressure raised after receiving the first dose of the covid vaccine.; Total exhaustion/she is so tired; could not sleep; She experienced pain at the injection site./Her pain got worse and worse; left or right toe will get stuck; hysterical; she is stressed; did not have complete energy; She states that her illness is too much; This is a spontaneous report from a Pfizer sponsored program received from a contactable healthcare professional (patient). A 76-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscularly administered in the right deltoid on 30Mar2021 10:00 (Lot number: GR8732 or 6R8732 [as reported]; Expiration Date: 31Jul2021) as a single dose for covid-19 immunisation. Medical history included blood pressure/hypertension; had breast cancer twice with the last time was in 2010 to unknown date which was 23 years later than the first time she had it (1987). She had infiltrating ductal cancer, stage one, that was HER-2 positive. She states that this is the most malignant breast cancer. She had to have extensive chemotherapy and also took Herceptin every 3 weeks for a year. The overriding symptom from her cancer was extreme fatigue; has been in chronic fatigue syndrome and in bed for 7 years, she was getting over chemo and she can barely walk. She has trouble walking long distances; had a mastectomy from 2010 to an unknown date without lymph node dissection; had a central node dissection; took a wheelchair to the hospital whenever she received the first dose of the covid vaccine; ongoing anxiety, depression and nervousness which is not new to her. She has had this on and off for the past year; and antihistamine that raises her blood pressure dangerously, it does not matter which kind of antihistamine whether it is Benadryl or over the counter. The only antihistamine that does not raise her blood pressure was a children's allergy medication. She took half of a children's dose. It did not raise her blood pressure, but it did not stop her itching. Family history included her mother's sister and she are very sensitive to medications. She has the same type of problems. As her mother's sister has aged, her problems have gotten better. As caller gets older, her problems are getting worse. Concomitant medication included carvedilol taken for blood pressure on unknown therapy dates. The patient previously took dupilumab (DUPIXENT) for skin conditions that having itching which she had side effects (Lot number: 0LU23A; Expiration date: Feb2023). Dupixent is a medication used for skin conditions that having itching, not cirrhosis, she cannot remember the name of the skin condition. Her skin started itching around Jun2020 or Jul2020. She saw eight different dermatologists. She found a doctor who was an itch specialist. Dupixent is the only thing that is going to work for her because antihistamines raise her blood pressure dangerously; and one time her doctor made a mistake, he ordered her hydroxyzine 25mg PO (Per oral). The doctor did not look on her chart to see her allergy list. She cut the pill in half and took half a dose. By the time she realized what she took, she was having so much itching. She woke up and felt like her head was going to explode and her blood pressure was 220/112. She took three tablets of her antihypertensive medication. She taken carvedilol 3.125mg. She did not even bother going to the hospital because by the time they would have saw her, and treated her, she could have had a stroke. The hospital is slow to treat people. Because she is a nurse practitioner, she knew that 3 tablets would be the correct dose for how high (Apr2021) her blood pressure was. She also previously took Benadryl but that raises her blood pressure dangerously. The patient reported that she received her first dose of the covid vaccine on 30Mar2021 and she had many side effects. She reported that the most predominant symptom is total exhaustion. For the first seven days after receiving the first dose of the covid vaccine, she was in bed for seven days nonstop. She placed a large grocery shopping order. She was able to get up and use the bathroom and cook small meals. She had someone come in to help her with the dishes, and to clean up the house. She talked to her internist of 20 years, and he told her to take the vaccine. Within five minutes, she started getting side effects. She inquired if it was safe to take the second dose of the covid vaccine. She has been so fatigued that she has been in bed for a 3 weeks-time frame and then her Blood pressure went up, it was 200 something, like 223/103. She went to the ER, and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room, and because she waited so long, she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She added that the second week after receiving the first dose of the covid vaccine, she was able to get up every other day and go somewhere but the next day after she went somewhere, she was in bed all day and did not have complete energy (2021). She added that her refrigerator was going out, so someone drove her to department store 30 minutes away. She walked from the car, to the refrigerator section in department store, walked into the mall to get ice cream and then walked back to the car. By the time she got home, she immediately got back in her bed because she was so worn out. That was on Saturday. She was in bed all day yesterday. This morning, she feels better than yesterday. She thought about going to the store yesterday, but she knew she did not have the energy to go. Someone is coming later today to help her, and they will have to go to the store for her since she does not have any family nearby. She mentioned that the total exhaustion began on 31Mar2021. She took a wheelchair to the hospital whenever she received the first dose of the covid vaccine. She has trouble walking long distances. She called the hospital before she went, and the hospital did not have any wheelchairs she could use. The hospital cleared everything out of the way so they could fit the most patients as possible in the building. She had trouble walking the day that she received her first dose of the covid vaccine. Someone wheeled her in and out using her own wheelchair. She cannot go to the grocery store. Using a wheelchair is the only way she could have in and out. She could walk from her wheelchair into the examination room, and then after she went right back into her wheelchair. She is glad that she called because she does not know what she would have done without a wheelchair. It is hard for her to go on, sometimes she just feels like crying. Her trouble walking does not feel 100 percent, but it has gotten better. She is anxious, depressed and nervous also. Before her breast cancer, she had chronic fatigue. She could volunteer at a clinic for a few hours a week. She had radiation, and that caused exacerbation of her chronic fatigue. Her doctor told her that for some people, chemotherapy will make chronic fatigue better and that chemotherapy could help her chronic fatigue. Before she got chronic fatigue syndrome, she had a lot of energy. She used to work in an ICU that had 15 patients, with ambulatory patients on the outside. She worked six days a week then she transferred to a hospital where she took care of patients after they had open heart surgery. She used to be a very high energy person. Her exhaustion has gotten better, because she can get up every other day and leave the house. She cannot stop doing life. It is difficult for her that she cannot go to the grocery store. After seven days, she could go out every other day. Whenever she went to a certain company, she almost fell. Her legs got weak and she lost coordination on Tuesday (06Apr2021). Since then, it has happened a little bit here and there. It is almost like she is not sure when it will happen. In an instance, she can be working in the house, and her left or right toe will get stuck. This happens to her occasionally after chemotherapy. She noticed that her blood pressure raised after receiving the first dose of the covid vaccine (Apr2021) and she takes medication (small dose of carvedilol) for hypertension. She takes her blood pressure medication every other day. Out of the past four days, her blood pressure has been elevated twice (Apr2021). If her blood pressure is elevated more than normal, her doctor prescribed for her to take an extra dose. Her blood pressure has not been elevated dramatically. She did take an extra dose of carvedilol because her blood pressure was within the scope of her blood pressure expertise. She went to the ER and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room and because she waited so long she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She also stated that her blood pressure went up yesterday last night (18Apr2021), not right after getting the first dose. Last night at 6:00 PM, she took a nap and after she woke up took her blood pressure, she didn't feel anything in specific, she always takes her blood Pressure pill twice a day anyway. When she checked her pressure, it was 223/120 (Apr2021) and immediately took 2 Carvedilol 3.125mg and went to the ER, by the time she got there it was down significantly (Apr2021), but she is anxious and sat there and waited. They said they were going to do some blood work and an EKG but they left her there, so she decided to take a company home. Her Blood pressure has been up, she then went to sleep and after (Apr2021), it was 189/105, 183/105, and 165/95, she is a nervous wreck. She was ill for a long time, she had cancer twice, now she lives alone, she has been alone for all these weeks, her friends are here and there and come over. The Last 3 weeks she has been alone. She hired someone, but it was expensive. Now she feels hysterical (2021), after she saw her blood pressure, last night she was crying, and called the neighbor and they drove her right to the hospital then she was waiting in the ER for so long. She got her first shot on 30Mar2021 and she couldn't do anything in bed for 7 days, she is supposed to get the second shot tomorrow (20Apr2021) but doesn't want to be in bed again like that. She is anxious, depressed and nervous that began on 03Apr2021. During the week, she is distracted by the market. She has not been able to trade, because she does not trust her judgment right now. She did buy one this morning. Anxiety, depression and nervousness is not new to her which she has had this on and off for the past year. She has a lot going on. She needed to sell her two-story house and move to a one-story house that is easily assessable to healthcare and meals. She thinks this is disabling in face that she does not feel strong enough to make a decision. She cannot make a decision and she does not feel good enough too. Her anxiety, depression and nervousness was exacerbated by her terrible fatigue. She is experiencing awful symptoms. She went to the grocery store, and the stumbled and went into a company. She had to carry her milk and other items in slowly, and little by little. She thought this is awful, and she got into bed. She could not do anything. She mentioned that her illness is too much (2021). She was crying and she lives alone. The patient mentioned that the pain at the injection site began four hours after receiving the first dose of the covid vaccine. She received the vaccine at 10:00 AM then started getting really bad pain about 6:00 PM and then about 10:00PM or 11:00PM, it started to get unbearable. By 12:00AM (31Mar2021), the pain was so bad that she could not sleep because of the pain. She was in agony. She took took Tylenol and it did not touch her pain, but her pain got worse and worse, so she took three Tylenol tablets then they worked. She her friend and asked him to come over since she is afraid to take narcotics. She just laid there in bed and spent all night in agony. She tried a thing she put in the freezer and tried heat. She does not remember if either of those worked. The pain resolved about 2 days after. The patient declined safety report, saying that she is stressed and anxious (2021), she just wants to be transferred for her question. The reporter considered the events fatigue aggravated serious and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as medically significant. The outcome of the events fatigue aggravated recovering; as for the events blood pressure raised, 'anxiety, depression and nervousness was exacerbated by her terrible fatigue', lower extremities weakness of and coordination impaired were not recovered; while the event vaccination site pain was recovered on 01Apr2021 (reported as 2 days after). The outcome of the other events was unknown.; Sender's Comments: Based on the information provided, the events fatigue aggravated and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as serious (IME).Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information.
76 2021-04-27 blood clot Blood clot in her lower abdominal area; had the worst pain through her side that ran down her left l... Read more
Blood clot in her lower abdominal area; had the worst pain through her side that ran down her left leg and to her ankle; had the worst pain through her side that ran down her left leg and to her ankle; nerves are all tangled up; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Arm Right on 17Mar2021 13:50 (at 76-years-old) as single dose for COVID-19 immunisation. The vaccine was administered at a hospital. It was not administered at a military facility. Medical history included hip replacement four years ago in 2017 (First right then 2 months later left) and knee replacement six years ago in 2015 (both 2 months apart). There were no concomitant medications. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6203), administered in Left Arm on 25Feb2021 (at 76-years-old) for COVID-19 immunisation and experienced bad headaches. The patient received the second dose of vaccine on 17Mar2021. On 29Mar2021, she was not hurting and went to brunch with friends. Afterwards (on the same date, 29Mar2021), she was sitting and got the worst pain through her side that ran down her left leg and to her ankle. She drove herself home but was in such misery. She went to the emergency room the next day, on 30Mar2021, wherein she had a CT (computerized tomography) scan that showed a blood clot in her lower abdominal area. She was taking pain medication every 6 hours, or she could hardly stand it. On 08Apr2021, she went back to the emergency room because she could hardly stand it. She was kept in observation status but was not admitted. She was scheduled to have another CT scan on 06May2021. She is not sure what they will do because the nerves are wrapped around it. She also mentioned that her doctor wants to do a biopsy. The pain was also running down to her ankle. She stated that she has had both of her hips replaced in the past. She added that her doctor will do an MRI (magnetic resonance imaging). He will put in a drain if it has not shrunk. The doctor can't do anything because the nerves are all tangled up (2021). As corrective treatment, the patient was taking pain medication for the blood clot and pain through her side that ran down her left leg and to her ankle. Outcome of nerves are all tangled up was unknown, while outcome of the other events was not recovered.
76 2021-05-02 atrial fibrillation, palpitations, chest pain, chest discomfort, blood glucose increased 03/09: presents to the ED with palpitations that began 90 minutes prior to arrival. The patient has... Read more
03/09: presents to the ED with palpitations that began 90 minutes prior to arrival. The patient has a history of paroxysmal atrial fibrillation but has not had an event for many years. She had her second Covid vaccination yesterday and did have flulike symptoms including headache, myalgias, and shakiness through the last night. She wonders if this triggered her symptoms. No chest pain, dyspnea, or lightheadedness. 23: 18. Cardizem 17.5 mg IV. 03/10 still in ER 00: 17. The patient is discussed with hospitalist. would not recommend admitting the patient given her stability. The patient's atrial fibrillation responded very well to the IV Cardizem. Her atrial fibrillation is now in the 80s. She is asymptomatic. CHA2DS2-VASc score of 2. 00: 18. Cardizem 30 mg p.o. The patient is quite concerned about stroke. Her mother died of CVA. We will start anticoagulation today pending cardiology follow-up. Eliquis 5 mg po. Recommended follow up with cardiology 03/16 visit with cardiology Paroxysmal atrial fibrillation Established Recently symptomatic with RVR after Covid vaccination Rhythm controlled with flecainide 100 mg twice daily Rate controlled with diltiazem 120 mg daily ? CHA2DS2-VASc Risk Factors/Score: AGE(>=75), Female Gender and 3 points: "moderate-high" risk - Stroke risk as 3.2% per year and 4.6% risk of stroke/TIA/systemic embolism. o HAS-BLED Risk Factors/Score: Age > 65 years and 1 Points - "Low Risk" - 3.4% annual risk of major bleeding in one validation study and 1.02 bleeds per 100 patient-years in another validation study. Continue Eliquis 5 mg twice daily for embolic prophylaxis (creatinine 0.76 on 3/9/2021) 04/02 appt with PCP for ER follow up Patient is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no side effects from her first COVID-19 vaccine. After the 2nd one she had muscle aches, headache, freezing cold, and "weird", and felt really badly then at 9:30 PM, 32 hrs after the 2nd vaccine dose she felt the a-fib started. She had not been in a-fib in many years. Cardiology had already recommended eliquis but she was holding off. She had diltiazem from 2017 that she tried but with out relief. They rate controlled her but she remained in a-fib, started eliquis, and she went home. For 2.5 weeks she had headache and chest pain, other muscle pain, felt horrible, until she stopped the Eliquis. Since stopping the Eliquis, she still has occasional mild chest pain, and headache, and flushing. Her current chest pain is left chest, not radiating. The quality varies, stabbing pain in a very small location at times, may be associated with eating. 04/20 ER visit: Patient is a 76 y.o. female who presents with palpitations that started this evening, sudden onset, has a history of paroxysmal atrial fibrillation, and is maintained on 100 g of flecainide twice daily and diltiazem daily. She also has short acting diltiazem 60 mg tablets to take for episodes of breakthrough arrhythmia. She took a 60 mg short acting diltiazem prior to arrival She endorses some chest pressure with this though not severe, denies any dyspnea diaphoresis or nausea Not anticoagulated 04/29 Follow up with PCP For years she has been well controlled on low dose methimazole. Recently she has had 2 bouts of a-fib, when trying eliquis prescription and again following her 2nd COVID-19 vaccine. Upon recheck her TSH remains suppressed and FT4 elevated. Increasing from 5 to 10 mg methimazole now. Left side of thyroid is palpably thickened with no nodules noted. Recommended Ultrasound. Explained that if nodules are seen, a follow up image may be indicated to assess nodule activity. Not in a-fib today. C/o general malaise, shakiness, chest tightness, & flushing. Graves since 2006 She is feeling out of sorts, shaky, flushing, chest tightness, recurring headache. She has to stop and rest when trying to do activities as she will feel weak. Not sleeping well. Systolic BP labile, from 105, to 155, to 135.
76 2021-05-02 cerebrovascular accident, atrial fibrillation CVA/afib on April 4, alive
76 2021-05-04 chest discomfort, chest pain Dizziness and left side pain/discomfort around chest area (5/10). Pt received 2 L of O2 via NC and 3... Read more
Dizziness and left side pain/discomfort around chest area (5/10). Pt received 2 L of O2 via NC and 325 mg of ASA. Vitals stable. Pt did not take BP med today, pt agreed to take her Benicar 20mg when escorted to her car (med in car).
76 2021-05-06 fibrin d dimer increased Patient completed 2-dose Pfizer series on 1/31/21 and passed away on 2/13/21. Pt presented to ER on... Read more
Patient completed 2-dose Pfizer series on 1/31/21 and passed away on 2/13/21. Pt presented to ER on 2/11/21 with SOB, weakness, diffuse abdominal pain and diarrhea that started that day. Pt tested positive for COVID and was transferred out to a higher level of care. 1st dose: 1/5/21, 2nd dose: 1/31/21
76 2021-05-07 cerebrovascular accident, stroke This 76 year old female received the Pfizer Covid shot on 2/27 /21 and went to the ED on 4/3/21... Read more
This 76 year old female received the Pfizer Covid shot on 2/27 /21 and went to the ED on 4/3/21 and was admitted on 4/3/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) I63.9 - Cerebral infarction, unspecified
76 2021-05-07 heart rate abnormal, atrial fibrillation, heart attack, heart rate irregular, chest discomfort Butterflies in the chest that went to quivering; quivering; A-Fib/Arterial fibrillation with rapid v... Read more
Butterflies in the chest that went to quivering; quivering; A-Fib/Arterial fibrillation with rapid ventricular response; Arterial fibrillation with rapid ventricular response; cannot rule out anterior infarct and abnormal EKG; cannot rule out anterior infarct and abnormal EKG; trouble breathing; Her heart rate is screwed up; she feels so weak; irregular heart beat; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Mar2021 (lot number: EP7534) as SINGLE DOSE for COVID-19 immunization. Medical history included asthma, chronic obstructive pulmonary disease (COPD), irritable bowel syndrome described as a condition where you're in the bathroom a lot, fibromyalgia, little depression, heartburn, upset stomach, heart fluttering issues, congestion spray (nasal congestion), and had part of a lung taken out. Family medical history included heart issues (dad and uncle). Concomitant medications included salbutamol (VENTOLINE [SALBUTAMOL]) for asthma; venlafaxine hydrochloride (EFFEXOR) for little depression; pantoprazole for heartburn and upset stomach; fluticasone propionate (lot number: AA47468, expiration date: Aug2020) for congestion spray (nasal congestion); fluticasone propionate, salmeterol xinafoate (ADVAIR) for heart fluttering issues. The patient previously took SHINGRIX (also reported as shingles vaccine, for clarification) for immunization and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) on 25Feb2021 (age: 76 years) in the left shoulder for COVID-19 immunization. On 18Mar2021, right after taking the vaccine, patient started to experience quivering inside. Initially it felt like butterflies in the chest and then to quivering, it was then quivering the whole week. She knew she was going in for a test , an endoscopy, where they go down the throat. So she waited, the quivering did not go away for a whole week. It lasted until Friday before her endoscopy. When they found out, they sent her to ER at the hospital. They did not do the endoscopy. They said they might have to shock her heart or something. They wanted her to see the cardiologist right away. From the ER, she had 2 IVs, 1 in each arm. They were also taking blood every 4 hours (unknown results). The provided diagnosis was arterial fibrillation with rapid ventricular response and cannot rule out anterior infarct and abnormal EKG (Mar2021). The events cannot rule out anterior infarct and abnormal EKG, butterflies in the chest that went to quivering, A-Fib/Arterial fibrillation with rapid ventricular response resulted in emergency room visit and physician office visit and let to hospitalization. The patient was hospitalized from 2021 to an unknown date (also reported for 2 days, for clarification). It also gave her A-Fib, trouble breathing and now her heart rate is screwed up (Mar2021). On an unspecified date in 2021, she feels so weak and has irregular heartbeat. Therapeutic measures were taken as a result of the events which included Eliquis, Atorvastatin, Diltiazem, and other unspecified medications. The outcome of cannot rule out anterior infarct and abnormal EKG, butterflies in the chest that went to quivering, arterial fibrillation with rapid ventricular response, she feels so weak was not recovered; while the other events was unknown.
76 2021-05-07 low platelet count This 76 year old female received the Pfizer Covid shot on 2/15/21 and went to the ED on 4/6 /21 ... Read more
This 76 year old female received the Pfizer Covid shot on 2/15/21 and went to the ED on 4/6 /21 and was admitted on 4/6/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified GI Bleed
76 2021-05-09 chest pain Diziness, chest pain. Given Oxygen 2L via nasal cannula and ASA 325 mg PO. Patient saw cardiologist ... Read more
Diziness, chest pain. Given Oxygen 2L via nasal cannula and ASA 325 mg PO. Patient saw cardiologist 2 months ago for valvular disease, not a candidate for surgery, does not have any NTG Rx, does not take her ASA or Benicar regularly (did not take them today). Symptoms resolved, patient stable & released from vaccination site.
76 2021-05-09 nosebleed, heart attack This 76 year old black female received the Covid shot on 2/27/21 and went to the ED and was adm... Read more
This 76 year old black female received the Covid shot on 2/27/21 and went to the ED and was admitted on 3/17/21 and again to the ED and admitted on 4/7/21 with the diagnoses listed below. Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction Non-ST elevation (NSTEMI) myocardial infarction Epistaxis
76 2021-05-10 heart attack NSTEMI (non-ST elevated myocardial infarction)
76 2021-05-11 heart attack I21.4 - Non-ST elevation (NSTEMI) myocardial infarction
76 2021-05-11 blood glucose increased bumps under skin , extra dry skin.
76 2021-05-11 pulmonary embolism, deep vein blood clot Unprovoked Dvt/pe
76 2021-05-11 pulmonary embolism, fibrin d dimer increased, deep vein blood clot DVT and PE, pt p/w progresssive SOB 2nd dose recieved on 3/12/21
76 2021-05-14 heart attack Pt presented with coffee ground emesis and acute st elevation myocardia infarction. She was DNR. She... Read more
Pt presented with coffee ground emesis and acute st elevation myocardia infarction. She was DNR. She was admitted and expired in a few hours.
76 2021-05-16 palpitations Systolic pressure for five days up to 220 - Added extra blood pressure medicine in the middle of th... Read more
Systolic pressure for five days up to 220 - Added extra blood pressure medicine in the middle of the day. That kept the systolic pressure slightly under 160. Diastolic pressure was never over 75. Symptoms were sweating, heart pounding, headache, and fatigue.. Resolved itself on May 16, 2021 at approximately 6 p.m. when blood pressure again registered 125/74.
76 2021-05-17 cerebrovascular accident, transient ischaemic attack After vaccine on Wednesday three fingers on my right hand went numb and my mouth felt like I had a s... Read more
After vaccine on Wednesday three fingers on my right hand went numb and my mouth felt like I had a shot of Novocain, then my tongue had a little tingling. I texted my doctor and he said to go to the ER and they checked me out did EKG, blood work, CAT scan, covid test that was negative and I was admitted. I got an MRI and did other urine test, I was being checked every hour. I was given Plavix and other meds and was told that I had a stroke/TIA.
76 2021-05-17 loss of consciousness Dizzy,Fever, Disoriented, (expected: arm soreness, heat, swelling administered frozen pea bag) ras... Read more
Dizzy,Fever, Disoriented, (expected: arm soreness, heat, swelling administered frozen pea bag) rash on forearms,, not hives, passed out for 9 hours I thought I would just relax with my frozen peas and watch tv. 9 hours later, I was slumped on the couch, tv had not been turned on , I was fully dressed including shoes, no blanket or pillow, very cold all the lights that I had turned on were still on and it was 5:10 in the am I had not brushed my teeth or taken evening medication. I had warmed left overs in the oven thinking I might just be hungry. Oven was off but oven door was open food was uneaten except for a couple of bites. I live alone. I still work and manage everything on my own.
76 2021-05-21 atrial fibrillation, palpitations Pt recivied her 2nd covid 19 vaccine on 3/26. Patient is a 76-year-old female with a past medical hi... Read more
Pt recivied her 2nd covid 19 vaccine on 3/26. Patient is a 76-year-old female with a past medical history significant for hypertension, depression, hypothyroidism 2nd covid 19 vaccine on 3/26 who presented on 5/18 to the ER with complaints of lightheadedness and nausea that occurred over the weekend and was diagnosed with new onset rapid atrial fibrillation. She denied chest pain or shortness of breath but noticed intermittent bouts of palpitations. She went to see her PCP who referred her to the emergency room. EKG and telemetry in the emergency room were significant for new onset rapid atrial fib. She was given diltiazem and admitted to the hospitalist service. CT of the chest was negative for pulmonary emboli or focal consolidation. She had no electrolyte derangements she has no history of sleep apnea and no history of obesity. Her troponin and delta were unremarkable. She was subsequently admitted to the hospitalist service. She was treated with metoprolol and amiodarone along with Eliquis. She was seen by her cardiologist. Her recent echocardiogram was normal. Her TSH was actually elevated at 11.0 so her levothyroxine dose was increased to 175 mcg daily with a TSH in 6 weeks. At this time patient's rate is much better controlled but she remains in atrial fib. She will be following up with her cardiologist closely post discharge. She is also complaining of persistent R shoulder pain and weakness since her vaccine. Her shoulder x ray showed arthritic changes. She also c/o the worst headache of her life that lasted a week starting on May 4th. CT head was neg.
76 2021-05-22 heart rate increased, fast heart rate, blood pressure increased Rapid heart beat at 138-144 bpm with both doses, with blood pressure spikes, that lasted for hours, ... Read more
Rapid heart beat at 138-144 bpm with both doses, with blood pressure spikes, that lasted for hours, resulting in hospitalization, continued medial monitoring, medication, continued medical follow up and testing.
76 2021-05-24 ejection fraction decreased, chest pain, low blood oxigenation, haemoglobin decreased, blood glucose increased Hypoxia & Shortness of breath Chief Complaint Patient presents with ? Shortness of Breath x 3 da... Read more
Hypoxia & Shortness of breath Chief Complaint Patient presents with ? Shortness of Breath x 3 days, denies any cough, congestion, or fever. daughter is with her. Oxygen very low 74, provider notified right away and he came into room. ED to Hosp-Admission Discharged 4/15/2021 - 4/17/2021 (2 days) Last attending ? Treatment team Aspiration pneumonia of left lower lobe, unspecified aspiration pneumonia type (CMS/HCC) Principal problem Hospital Course HPI: a 76 y.o. female presenting to the ED with chief complaint of chest pain and shortness of breath. Patient is being seen in the emergency department for evaluation of the above, here with her daughter. Patient was seen and evaluated by local urgent care and referred here for evaluation. Is reported that patient was hypoxic. Patient's daughter also states that they have been monitoring her oxygen saturation at home and it has been in the 60s and 80%. Patient does report a cough. She has been using her inhaler more frequently. Received her Covid vaccination 2 days ago. Hospital Course: Patient was admitted and placed on supplemental O2. Chest x-ray 4/15/2021 showed some opacity at the left costophrenic angle effusion with some areas of atelectasis possible. Chest CT performed on 4/16/2021 revealed small areas of consolidation/infiltrate in the right upper and left lower lobes of the lungs, emphysema, and a 3 mm pulmonary nodule in the left upper lobe. Small bilateral pleural effusions have decreased since CT of12/11/2020. Initial CBC revealed white blood cell count of 9.3. Hemoglobin and hematocrit were stable at 8.8 and 29.4. Renal function was stable as well. Glucose on 4/16/2021 fasting was 222. Magnesium was at goal at 2.5. Procalcitonin levels were performed and were 0.19. She was initially started on IV vancomycin and cefepime as well as Flagyl due to possible aspiration pneumonia. On 4/17/2021, patient was adamant on being discharged. She did discuss possibly signing out AMA. I did explain to her the ramifications of that. She voiced understanding. I also discussed this with her daughter, as well. She required 4 L of supplemental O2 and achieved an O2 sat of 93%. On room air patient was 78%. Therefore, home O2 was ordered. IV antibiotics were changed to oral Levaquin 250 mg to take 1 by mouth daily (based on renal function) for 7 days and generic Flagyl 500 mg to take 1 3 times a day for 7 days. She was instructed to take antibiotics as prescribed as well as use supplemental O2. She was also advised that if symptoms worsened she was to return to the emergency room. At time of discharge she was stable with supplemental O2 in place. ED to Hosp-Admission Discharged 4/28/2021 - 5/4/2021 (6 days) Last attending ? Treatment team Hospital Course HPI: a 76 y.o. female with a past medical history of systolic and diastolic heart failure, diabetes mellitus type 2, above-the-knee amputation of left lower extremity, who comes from home where her oxygen saturation as per the daughter was 25%. She was recently discharged from here on 4/17/2021 for left lower lobe pneumonia. She does not want to be in the hospital. She states that she felt fine when she came in this time. She was evaluated by the ICU who stated she is a DNR/DNI and felt that with BiPAP modification she was satting better. She was adamant that she wanted to leave the last time she was here and went home with oral Levaquin and Flagyl. When she arrived, nursing states that there was dried stool on her bottom. The patient denies any current shortness of breath. She wants her BiPAP mask removed as it is uncomfortable to her. After explaining it as needed she agreed to have it on. She denies any abdominal pain, she denies any chest pain. She denies any fevers or chills. Hospital Course: Patient was admitted for acute on chronic diastolic CHF, acute on chronic hypoxic respiratory failure secondary to CHF and COVID-19. Patient was also treated for elevated blood pressures. Cardiology was consulted, patient was placed on Lasix twice daily and was started on hydralazine for blood pressure. From pneumonia standpoint, patient started on Zosyn, for COVID-19 patient was started on Decadron and remdesivir. Patient finished a course of remdesivir in the hospital. Patient went from using 5 L oxygen to only 1 L, meanwhile chronically she has been using 3 L at home prior to coming into the hospital. Patient has not been requiring any further BiPAP. She has been afebrile for more than 48 hours. Today nephrology recommended to lower Lasix down to once daily instead of twice daily to avoid kidney injury. Patient is medically stable for discharging home today to finish her course of Augmentin and Decadron. Patient appears to be very hesitant about having to continue self isolating. Family understands the need for further isolation. Patient will receive a remote monitoring kit upon discharge. ED to Hosp-Admission Discharged 5/10/2021 - 5/17/2021 (7 days) Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Hospital Course HPI: Patient was admitted with hypoxia and pneumonia due to COVID-19 virus. For details please see the history and physical. Hospital Course: Patient had previously been diagnosed with COVID-19 pneumonia about 3 weeks ago and had been treated with remdesivir Decadron and antibiotics. She was now admitted with pneumonia and hypoxemia. Her oxygen requirement went up and she was at 1 point requiring high flow oxygen up to 15 L/min. Subsequently her oxygen requirement was able to be tapered. She was treated with steroids during this hospitalization. Her oxygen requirement is now down to 4 L/min. She is feeling better. She is now felt stable for discharge with outpatient follow-up with her PCP. Steroids have been stopped on discharge. Her daughter was regularly updated during this hospitalization. I called and left a message at the time of discharge today.
76 2021-05-26 chest pain, heart attack, inflammation of the heart muscle, troponin increased Acute Myocarditis
76 2021-05-26 pallor Large oval patch (plaque?) rough around the border, smooth and paler color inside. 1" long. Center... Read more
Large oval patch (plaque?) rough around the border, smooth and paler color inside. 1" long. Center of my back (I have a photo) I just noticed it yesterday. No treatments.
76 2021-06-01 blood pressure increased, heart rate increased blood pressure was 174/106/blood pressure shot up to 198/116/blood pressure shot up to 175/106; 93 p... Read more
blood pressure was 174/106/blood pressure shot up to 198/116/blood pressure shot up to 175/106; 93 pulse/99 pulse/109 pulse; This is a spontaneous report from a contactable consumer, the patient. A 76-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration, administered in right arm on 21Feb2021 16:00 (at the age of 76-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration, administered in right arm on 31Jan2021 16:00 (at the age of 76-years-old) as a single dose for covid-19 immunization. Medical history included, blood pressure abnormal, blood cholesterol abnormal (was on blood pressure medication for many years; after losing 20 pounds did not need it anymore; take Crestor 10mg for cholesterol (total around 160)) and had allergy with rubber (latex band aids). Concomitant medication(s) included vitamin d3; rosuvastatin calcium (CRESTOR). On 21Feb2021 16:30, the patient reported about 1-2 minutes after receiving 2nd shot on 21Feb2021 "I could feel a reaction. I waited 30 minutes before leaving to make sure it wasn't anaphylaxis. When I got home my blood pressure was 174/106/93 pulse. The patient had no other vaccine within four weeks. 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 24Feb2021 blood pressure shot up to 198/116/99 pulse. On 01Mar2021 blood pressure shot up to 175/106/109 pulse. After the first shot, the patient had slight rise in blood pressure and pulse after about 5 days but otherwise just felt tired". The patient recevied treatment with benicar 40 mg and lorazepam 5 mg, zicam. Outcome of the event was recovered with sequelae (recovered with lasting effects). No follow-up attempts are possible. No further information is expected.
76 2021-06-01 stroke I63.9 - Cerebral infarction, unspecified N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmo... Read more
I63.9 - Cerebral infarction, unspecified N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia R56.9 - Unspecified convulsions
76 2021-06-03 cardiac arrhythmia, chest discomfort Medic responded emergency reference allergic reaction at vaccine clinic Medic to find 76/f seated in... Read more
Medic responded emergency reference allergic reaction at vaccine clinic Medic to find 76/f seated in drivers seat, c/o nausea immediately after receiving vaccine. EMS standby staff on scene. Pt stated she had received vaccine approx 30 minutes prior to EMS arrival and began to feel ill <15 minutes later at which time standby EMS crew were alerted and in turn alerted transport. Pt has extensive list of allergies, including many antibiotics. Pt was A&OX4, pink warm and dry w/ good ABCs/PMS upon EMS arrival. Pt had no apparent life threats/injuries, was PEARL, equal lung sounds. Upon being placed in ambulance pt began to complain of dull ex pressure 2/10. 3 lead displayed sinus rhythm w/ PVCs which pt stated was her normal per pt cardiologist and that she was medicated for same with herbal medication.12 lead obtained, no elevation or depression noted, PVCs still noted, otherwise unremarkable. R-IV access attempted x2, good flash vein blew. 3 and 12 lead obtained to rule out cardiac involvement and monitor for changes. Given reference pt statement of positive ex pressure. Zofran considered, Medic was already at hospital when last IV was unsuccessful, PO zofran not given. No further interventions. Pt moved to stairchair via stand and pivot with assistance, secured via straps and moved to stretcher, pt placed in stretcher via stand and pivot with assitance, covered for comfort, secured via straps/siderails and moved to ambulance without incident. Pt and pt vitals monitored for duration of routine transport. Pt report called for prior to arrival. Upon arrival pt offloaded and moved to bed in ER via sheet draw without assistance. Pt care report given and pt care transferred to ER RN. Medic checked back in service. 76-year-old presenting with nausea and general malaise. Symptoms started about 15 minutes after receiving her COVID-19 vaccine around 2:30 PM. She has been nauseous but had no vomiting. Slight central chest discomfort with palpitations. Also feeling somewhat dizzy. She did not receive any medications. EMS was called and brought her to the ED. Denies any itchy skin, abdominal discomfort, sensation of throat swelling or pain. No wheezing or difficulty breathing. She has had anaphylaxis to medications in the past but she is unsure exactly which ones except for codeine. 76-year-old presenting with possible reaction to the Pfizer COVID-19 vaccine. Constellation of symptoms are not consistent with anaphylaxis but may represent a different type of allergic reaction. Will give Zofran for nausea, Benadryl, and observe. Basic labs and EKG. KG My interpretation of EKG Normal sinus rhythm. Normal axis and intervals. No acute ST elevations or depressions. Reexamination/Reevaluation Patient was observed for over an hour without any progression of symptoms. Her nausea improved with Zofran. No episodes of vomiting in the ED. Discharged with plan to follow-up with her PCP, continue symptom management at home. Diagnosis/Disposition Nausea without vomiting atient Instructions Continue your regular medications as prescribed. Use Zofran 4 mg every 8 hours as needed for nausea. Follow-up with your doctor within the next 1 to 2 days for recheck. Return to the ED if you develop severe difficulty breathing, severe chest pain, intractable nausea and vomiting or have other concerns. RX Given ondansetron: 1 tab, PO/SL, TID, nausea/vomiting, # 10 tab, 0 Refil(s)
76 2021-06-03 ventricular tachycardia Patient was found to have NSVT on recent pacemaker check. This occurred 4 days after receiving her ... Read more
Patient was found to have NSVT on recent pacemaker check. This occurred 4 days after receiving her 2nd Pfizer COVID-19 vaccination. Patient states it was a 'blip' on her device. She had no further other symptoms noted. Patient is unsure if is related to the vaccine or if this was something else related to cardiac history. Her primary care provider did ask that she report this.
76 2021-06-07 hypertension She had high Blood pressure yesterday; Second dose administered on the Left Arm, her arm did hurt a ... Read more
She had high Blood pressure yesterday; Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose; started getting hungry; she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs; swelling under her eyes/eyes started getting swollen; face was swollen; Eye infection; face felt tight; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EM9810; NDC number: Not Provided Expiry Date: Unknown) via an unspecified route of administration on the left arm on 06Feb2021 at 8:31AM (at the age of 76 years), as a 2nd dose, single dose for COVID-19 immunization. The patient medical history included disc protruding (diagnosed before the covid vaccine in Jun2020 or around that, she recalls having several months of MRI's in 2020) and high blood pressure. The patient's concomitant medications included Epidural Shot (Verbatim) for Protruding Disc Patient on 27Jan2021 (she had to go to the doctor in the clinic and get epidural shot in the back at the disc thats protruding). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EL3249; NDC number: Not Provided, Expiry Date: Unknown) via an unspecified route of administration on the left arm on 16Jan2021 at 12 PM (noon) as 1st dose, single dose (at the age of 76 years) for COVID-19 immunization. Clinical course: She took second dose of Pfizer Covid Vaccine on 06Feb2021, though she had no reaction initially. A week later from vaccination on Feb2021, she then began to notice her eyes started getting swollen couple days after, she then felt like her eyes felt like they were closing, then she saw her whole face was swelling, it looks like she had Chipmunk cheeks. She went to the doctor hoping it would go away, she was prescribed Benadryl and a decongestant as treatment. She takes Benadryl three times a day and the decongestant in the morning and her face is still swollen. It started with the eyes and the bag under the eyes, that was the first thing she noticed. She laughs and though she initially had an eye infection. She just wants to know if there is any other reports of this happening, or how to get rid of it, this has been there since she got her second dose on the 06Feb2021 since like 10Feb2021. After the second vaccine on 06Feb2021 around that time an hour later, she was on the way home and started getting hungry, she thought that was a symptom as well as her arm hurt a bit. She was starving till Monday got up 2AM, 6AM ate all day Sunday and Monday ate all day, as reported "all she knows is she was craving a crab sandwich." Her Eyes swelling started a couple days later and the Face swelling was either the second week or same time, she just recalls looking at the eyes. She recalls telling her son her face felt tight in Feb2021. At the doctors appointment she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs, she is a small girl. The Appointment with the doctor was yesterday (15Mar2021), they prescribed Benadryl. Patient clarified that she was not Prescribed Zyrtec, it was a decongestant but she does not know the name of it. The Druggist however told her she could take another medication also. As reported "The eye swelling and face swelling, at the moment she look like she been drunk, her face is plentiful, she is still swollen, her lids are not bad, but it is ongoing, it has gotten worse because prior she didnt even know it was there and its showing more now. She asked son if he thought she was swollen because she feels tight, over the weekend her face being swollen was noticeable, she is noticing people are pointing it out now." She adds her arm did not hurt with first dose. Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose and the next day (07Feb2021). She thought initially that she didn't have any side effects. She had High blood pressure yesterday (15Mar2021), but that usually goes up and down for her and nothing new. It was reported that, a week later, patient experienced swelling under her eyes, face was swollen, eye infection and face felt tight on Feb2021; hunger and vaccination site pain on 06Feb2021 (reported as the day she got this dose); hypertension on 15Mar2021 (reported as yesterday). Patient would like to know if swelling of the face is a reported side effect from the covid vaccine, how long her side effects from the covid vaccine will last and asking for suggestions on how to get rid of the side effects from the covid vaccine. The outcome of event vaccination site pain was recovered in Feb2021 (duration of event was 2 days), swelling under her eyes, face was swollen was not recovered while outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.
76 2021-06-09 cerebrovascular accident, blood clot Blood clot caused stroke on right side of the body 4 weeks after the 2nd dose of vaccination; Blood ... Read more
Blood clot caused stroke on right side of the body 4 weeks after the 2nd dose of vaccination; Blood clot caused stroke on right side of the body 4 weeks after the 2nd dose of vaccination; The patient also received the first dose of other vaccine on 18Apr2021.; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 76 years old, in left arm on 18Apr2021 14:30 at single dose for covid-19 immunisation. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. The patient received high blood pressure medicine within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 76 years old, in left arm on 28Mar2021 14:30 at single dose for covid-19 immunisation. The patient also received the first dose of other vaccine on 18Apr2021. The patient experienced blood clot caused stroke on right side of the body 4 weeks after the second dose of vaccination on 15May2021 20:00. The patient was hospitalized for the events blood clot caused stroke on right side of the body for 14 days. The events blood clot caused stroke on right side of the body caused disability. The patient had not been tested for covid-19 since the vaccination. Therapeutic measures were taken as a result of blood clot caused stroke on right side of the body 4 weeks and included treatment with tissue plasminogen activator (TPA) shot, magnetic resonance imaging (MRI) and therapy. The outcome of events blood clot caused stroke was recovering. The outcome of event received other vaccine on 18Apr2021 was unknown. Information on the batch/lot number has been requested.
76 2021-06-09 fluid around the heart, fast heart rate, chest discomfort, chest pain, palpitations, atrial fibrillation, sinus rhythm, inflammation of the pericardium, cardiac failure congestive Acute idiopathic Pericarditis with recent hx of new onset rapid atrial fib admitted from 5/18-5/21 t... Read more
Acute idiopathic Pericarditis with recent hx of new onset rapid atrial fib admitted from 5/18-5/21 thought to be a possible immune mediated side effect from her covid 19 vaccine .. since 5/9 she has been experiencing daily severe headaches, malaise, intermittent palpitations. Ct brain at that time neg for bleed but showed small/old b/l lacunar infarcts. cta was neg for pe/acute pathology. She was discharged out on amiodarone, metoprolol and eliquiss to follow up with cardiology.on follow up with him her amiodarone was dc'd and the plan was to see EP for possible cardioversion but She then was readmitted from 6/5 -6/8 with new pericardititis with new b/l pleural effusions, new chf and new cardiomyopathy. She c/o 2 days of sob, b/l shoulder pain, chest heaviness and pain, worsened while lying flat along with continued intermittent racing heart. cxr showed new Basilar predominant opacities in both lungs suggesting pulmonary edema and was admitted with new chf with bnp of 993. She was then noted to have an elevated wbc with left shift and a fever and her CRP was markedly elevated at 67. CT chest showing Nonspecific abnormalities including 1cm thick pericardial effusion, bilateral pleural effusions and mild right-sided ground-glass lung opacification. . She has had no recent infections, travel, cont meds, does not drink alcohol, smoke or use drugs or supplements covid 19 neg. She was started on colchicine 0.6mg bid and ibuprofen 600mg q8h on 6/6 and was discharged home to follow up again with cardiology. she has improvement in herwbc to normal, resolution of L shift, resolution of fever and only slight increased crp. She has also converted to sinus rhythm although still tachycardic around 110bpm. Her headache is gone and she is no longer vomiting. State echo done this am showing ef 55% and new hypokinesis of the basal inferior wall and a Small amount of pericardial effusion with out any doppler evidence of Tamponade She had an echo last month which was normal She was also started on antibiotics due to b/l effusions which were eventually stopped before discharge
76 2021-06-14 palpitations Heart pounding, palpitations day 3-4. Decreased hearing after shot #2 given on 03/29/2021. Incre... Read more
Heart pounding, palpitations day 3-4. Decreased hearing after shot #2 given on 03/29/2021. Increased joint pain in right hip after second shot. Noticed pain increase about first week of May, 2021.
76 2021-06-14 blood vessels inflammation, fluid around the heart A few days after I got the shot I started having night sweats, nausea. The night sweats went away un... Read more
A few days after I got the shot I started having night sweats, nausea. The night sweats went away until I got my second vaccine. Now I have them every night. They are not as bad. My doctor put me on medicine. I have fluid around my heart. Pericardial effusion is what I was diagnosed with. I also have small cell vasculitis. My red blood cell dropped.
76 2021-06-15 heart attack, chest pain 5 days later went to ER with severe chest pain. Determined it was a heart attack due to blood clot. ... Read more
5 days later went to ER with severe chest pain. Determined it was a heart attack due to blood clot. Was in the hospital for 2 days. EKG, catheter to heart, cat scan, blood tests
76 2021-06-18 nosebleed Major nosebleed; Headache; This is a spontaneous report received from a contactable consumer or othe... Read more
Major nosebleed; Headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient reported for herself). A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown, Expiration Date: unknown), via an unspecified route of administered in Arm Left on 03Jun2021 08:00 (at the age of 46-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus Verbatim: Diabetic (She takes medication.Caller stated she probably was diagnosed 25 years ago. It's been a while), allergy (she took the shot because of her allergies), peripheral swelling (Her arm swelled up 3 times), compromised immune status, respiratory illness, genetic, chromosomal abnormalities, Endocrine abnormalities (endocrine abnormalities, including diabetes and obesity) from an unknown date and unknown if ongoing verbatim. The patient concomitant medications were not reported. The patient previously took epinephrine and experienced drug hypersensitivity. smallpox vaccine, vaccination Date: 1969. Her daughter was getting her smallpox vaccination at the same time. The caller had never had a smallpox vaccination. They decided to give it to her and her daughter at the same time. Her arm swelled all up again to the point her daughter took her to the emergency room. patient took Tetanus vaccine in 1996 and experienced allergy to vaccine, they told the caller she was allergic to the tetanus. She now wears a bracelet. Hopefully no one will give her a tetanus shot. Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Caller stated she probably was diagnosed 25 years ago. Caller stated she does take diabetic medication. Vaccination Facility Type caller stated the clinic is connected to the hospital. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reporter stated, She had her first shot. She was advised to be near a hospital when she took the shot because of her allergic to the Epinephrine. she took the shot there. On 03Jun2021, patient experienced headache. she didn't had a headache before the shot. By noon, she was felt this headache. Caller stated she still has a little bit of it right above her left eye. the headache didn't go away with the Tylenol. The Tylenol doesn't seem to help much. She had to go buy some Tylenol. She had a major nosebleed on 05Jun2021 14:35 Saturday. Her headache kept getting worse. Reporter stated she did go to the physician office to get the packing removed from her nose. She went to the Emergency Room on Saturday. They had to cauterize her nose and packed it. She had no idea if it was from the shot or if the shot contributed to it. She hasn't had a nosebleed like that in years. It has been a long time since she had a bad nosebleed. She just wanted to let Pfizer know what's going on with her because it may help someone else. Her daughter was in healthcare and said caller should call and let Pfizer know. What good was it going to do to continue with the report. Reporter stated she still has a little bit headache on right above her left eye. It's not quite as bad as it was. It's there. She can tell it's there. Reporter stated she has no idea about dose. Caller stated she was not hospitalized. The outcome of the event major nosebleed was reported as recovered on 08Jun2021 and the headache was recovering. Description of complaint: Caller was reporting an AE to the Pfizer Covid Shot. Caller reports taking Tylenol for a headache and the headache did not go away. Caller reports the Tylenol doesn't seem to help much. Product strength and count size dispensed: Caller confirmed that it is 500 mg of Acetaminophen. She only took 2 like the instructions tell you. Count size is 60 tablets in the bottle. Packaging sealed and intact: absolutely. Information on the lot/batch number has been requested.
76 2021-06-20 heart failure Patient presented to the ED and was subsequently hospitalized for heart failure within 6 weeks of re... Read more
Patient presented to the ED and was subsequently hospitalized for heart failure within 6 weeks of receiving COVID vaccination.
76 2021-06-28 arrhythmia Developed arrhythmia after second vaccine
76 2021-06-29 blood clot in the brain, cerebrovascular accident Stroke. MRI shows small blood clot. in lower back of brain leaving a small blank spot in my vision... Read more
Stroke. MRI shows small blood clot. in lower back of brain leaving a small blank spot in my vision in upper right
76 2021-06-30 skin turning blue, pallor secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse ... Read more
secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse 46 , cyanotic lips, limp, resps 11. pt passed at 2:30
76 2021-07-01 arrhythmia, fluid around the heart, chest discomfort, atrial fibrillation About a week after the vaccine, I started to notice a subtle difference in my heart beat. At night,... Read more
About a week after the vaccine, I started to notice a subtle difference in my heart beat. At night, I could feel my heart beat was a little off. I went to the doctor for something unrelated and was place on EKG that's how the doctor detected my arrythmia. He said I had A-fib and sent me to the ER. The ER confirmed my A-fib with an EKG and prescribed Eliquis, furosemide and potassium. A few days after discharge, I had chest heaviness and couldn't breath. I went to the ER. They did an EKG, CAT scan, blood work which also confirmed A-fib and build up of fluid around my heart, lungs and abdomen. I followed up with a cardiologist office and was to continue with the medications at discharge. I am being followed with a cardiolgist. Since then, my heart rythm is back to normal from what I can tell.
76 2021-07-06 hypotension Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a bi... Read more
Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a big chip in her hip; Chipped the acetabulum on her pelvis, there is a big chip on that, but it did stay in place, so no surgery is needed; Precipitous drop in energy level; Fuzzy mentally; Acute lethargy; A little arm soreness; Low blood pressure; She wasn't feeling well; In a lot of pain with the chip in her hip; Fell on her right side and it was in her house, of course, on her tile floor; Low cholesterol; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206; Expiration date was not reported) on the right deltoid on 11Mar2021 (09:45) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization at the clinic (not in a military facility). Medical history included ongoing hypothyroidism diagnosed probably 10 years ago. Concomitant medication included levothyroxine for hypothyroidism. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on 17Feb2021 on the left deltoid for COVID-19 immunization. On 12Mar2021, the patient had a little arm soreness. On 13Mar2021, the patient had precipitous drop in energy level (50% drop in energy her level; then 30% down at the time of reporting); was fuzzy mentally enough that her friends event noticed it; and had acute lethargy. On 20Mar2021, the patient had stumbled, and right arm x-ray AC and lateral showed she broke her right arm in three places; got a big chip in her hip; and right hip x-ray showed she had chipped the acetabulum on her pelvis (there was a big chip on that), but it did stay in place, so no surgery was needed. The patient had a surgery on the right arm, and had to have a 4-hour surgery to replace the Olecranon where it should have been, and a plate and a couple of screws. The events, 'stumbled and broke her right arm in three places', 'got a big chip in her hip' and 'chipped the acetabulum on her pelvis', were assessed as serious (medically significant). On an unspecified date in 2021, the patient had low blood pressure (110/60); was not feeling well due to the second dose of vaccination; was in a lot of pain with the chip in her hip; fell on her right side and it was in her house, of course, on her tile floor; and had low cholesterol. The reported events had resulted into an emergency room visit and physician's office visit (orthopedics). The outcome of the events was recovering for 'stumbled and broke her right arm in three places', 'precipitous drop in energy level', 'fuzzy mentally' and 'acute lethargy'; was not recovered for 'got a big chip in her hip'; was recovered on 14Mar2021 for 'arm soreness'; and was unknown for all the other events. No follow-up attempts are possible. No further information is expected.
76 2021-07-07 palpitations Pt call hospital call center on 5/26/21 c/o Shortness of breath, rapid heartbeat and weakness start... Read more
Pt call hospital call center on 5/26/21 c/o Shortness of breath, rapid heartbeat and weakness started 2 days ago. Patient stated received covid vaccine 2nd dose 5/22/2021 which she received at outside pharmacy. Pt advised to go to ED but she declined. ED education were reiterated to patient.
76 2021-07-08 heart rate increased, blood pressure increased I had slight rise in blood pressure and pulse; I had slight rise in blood pressure and pulse; felt t... Read more
I had slight rise in blood pressure and pulse; I had slight rise in blood pressure and pulse; felt tired; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Right on 31Jan2021 16:00 as (At the age of 76-years) DOSE 1, SINGLE for COVID-19 immunisation. Medical history included blood pressure abnormal, patient Was on blood pressure medication for many years. After losing 20 pounds did not need it anymore, blood cholesterol abnormal from an unknown date and unknown if ongoing Take Crestor 10 mg for cholesterol (total around160). Patient had no Known allergies except latex band aids. Concomitant medication included vitamin d3 and rosuvastatin calcium (CRESTOR). Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination and post vaccination. It was reported that After the first shot patient had slight rise in blood pressure and pulse after about 5 days but otherwise just felt tired. As treatment patient received Benicar 40 mg and Lorazapam.5 mg, Zicam. The patient underwent lab tests and procedures which included blood pressure measurement: rise on Feb2021 slight rise in blood pressure and pulse, heart rate: rise on Feb2021 slight rise in blood pressure and pulse. On an unspecified date in 2021, the events was resolved with sequelae. No follow-up attempts are possible. No further information is expected.
76 2021-07-09 pulmonary embolism SADDLE PE IN BOTH LUNGS ELIQUIS-HEPARIN-TPA SURGERY TO BUST UP CLOTS
76 2021-07-13 fainting syncope 24 hours after vaccine
76 2021-07-14 transient ischaemic attack, nosebleed Seems to be described closest to a TIA, then several days later a severe bloody nose,
76 2021-07-16 blood clot RIGHT LEG SWELLING, PURPLE IN COLOR, ER VISIT REQUIRING DUPLEX SCAN WITH RESULT OF EXTENSIVE BLOOD C... Read more
RIGHT LEG SWELLING, PURPLE IN COLOR, ER VISIT REQUIRING DUPLEX SCAN WITH RESULT OF EXTENSIVE BLOOD CLOT DOWN ENTIRE LEG, 80 % BLOCKAGE. THREE DAY HOSPITAL STAY, INTERVENES TREATMENT OF HEPRIN
76 2021-07-17 heart attack admitted with STEMI and acute hypoxic respiratory failure and severe cardiogenic shock requiring ICU... Read more
admitted with STEMI and acute hypoxic respiratory failure and severe cardiogenic shock requiring ICU vasopressor support.
76 2021-07-17 heart rate increased, lightheadedness Second dose: lymph nodes under jaw still swollen; Second dose: dizzy; Second dose: rapid heartbeat; ... Read more
Second dose: lymph nodes under jaw still swollen; Second dose: dizzy; Second dose: rapid heartbeat; Second dose: almost passed out; Second dose: throat tightened; Second dose: jaw was tender; Second dose: lymph nodes under jaw were tender; Second dose: jaw was tender/Second dose: lymph nodes under jaw were tender; Second dose: tired; Second dose: nauseous; Second dose: diarrhea; Second dose: muscle pain; Second dose: joint pain; Second dose: chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 30Jan2021 (76-years-old at the time of vaccination), (Batch/Lot Number: EL9265, Expiry date May2021) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection dose 1 via an unspecified route of administration, administered in Arm Right on 09Jan2021 12:30(76-years-old at the time of vaccination), (Batch/Lot Number: EL3248; Expiration Date: Apr2021) as DOSE 1, SINGLE for covid-19 immunisation and experienced throat started tightening, Lymph nodes under her jaw were sensitive to the touch, feeling more and more tired, entire body was leaden with lethargy, couldn't do anything, all her joints were aflame, nauseous, pain in muscles, pain in joints, couldn't raise either of her arms, chills, low grade fever of 99.2 degrees Fahrenheit, Fatigue. Patient was dreading getting the second Covid 19 vaccine. One of the questions on the questionnaire she filled out prior to getting her second dose was if she had a severe reaction to any vaccine. She answered yes but no one at the facility asked her about it. She put that she may have had a severe reaction with the first Covid 19 vaccine but no one at the facility questioned it. She put question marks on the questionnaire on that question to indicate she didn't know if she had a severe reaction for sure or not. She did want to have protection against the Covid 19 virus, so she did get the second Covid 19 vaccine. After getting the second Covid 19 vaccine she experienced the same thing going home. Her throat tightened. Her jaw and lymph nodes under her jaw were tender. She was tired but didn't feel the leaden feeling she had with the first Covid 19 vaccine. She was nauseous and had diarrhea. She had muscle pain and joint pain and chills. These symptoms went on for 5 days. She thought she would be ok after the 5 days like she was after her first Covid 19 vaccine dose. On the sixth day she almost passed out in the grocery store. She had to sit on the floor of the grocery store and put her head between her knees. She was dizzy. She was still having the diarrhea, nausea, and chills. It was like having influenza symptoms. She went home that day and got into bed. Then gradually she got better. Maybe around the 9th day after the vaccine she was able to do some things around her house and on the 10th day she was better. Her lymph nodes under her jaw were still swollen. She doesn't know if what she experienced were normal side effects. She found the Pfizer reporting website obtuse. The website indicates there was a time limit to finish a report. She did not file online because she wasn't sure she'd be able to finish in the time limit. She was grateful for protection against the Covid 19 virus and would get the Covid 19 vaccines all over again, but she was not looking forward to getting a Covid 19 vaccine booster. She reported she was very healthy and active. When probed if she had seen her primary care doctor or gone to the emergency department, she reports the hospital was far away. She was living in a rural area in the mountains and did not trust the closest hospital to her. Her doctor friend who was an ophthalmologist told her that her antibodies were really kicking in and that's why she had the reaction to the Covid 19 vaccine like she did. When probing adverse events following any other vaccines, she reports she hasn't had a vaccine since childhood and doesn't remember having any adverse events from her childhood vaccinations. The last vaccine she had prior to the Covid 19 vaccine was the cold vaccine she received in 1992. She'd like to add she also had a rapid heartbeat with the dizziness on the day she almost passed out in the grocery store. That was the sixth day after the second Covid 19 vaccine on 05Feb2021. Her heartbeat was rapid for about a week after starting on 05Feb2021. The clinical outcome of the events lymph nodes under jaw still swollen was not recovered, remaining all events was unknown. No Follow up attempts are possible: No Further information is excepted.
76 2021-07-19 arrhythmia Atrium flutter Blurry right eye Shortness of breath July 4 2021 onset. Still in vestigating. Rule... Read more
Atrium flutter Blurry right eye Shortness of breath July 4 2021 onset. Still in vestigating. Ruled out stroke, glaucoma, no retina damage. At ER on 5th
76 2021-07-21 blood pressure increased, heart rate increased anxiety attack on Feb 5 and again on Feb 17...did not seek medical attention...took a baby aspirin a... Read more
anxiety attack on Feb 5 and again on Feb 17...did not seek medical attention...took a baby aspirin and a half a muscle relaxer. both dissapated on their own. Had another much more serious attack June 15 with heart rate at 126...visited ER...they did ECG but after waiting in receiption for over an hour my heart rate and bp were back down within normal range. Have also been having "flushes" through my system like warm water is being put into my system...lasts seconds..sometimes increased heart rate other times not. June10-11 major spike in blood pressure. with 3 day hospital vist as a result. Now on BP meds.
76 2021-07-21 oxygen saturation decreased PFIZER-BIONTECH COVID-19 EUA. PATIENT FULLY VACCINATED WITH PFIZER COVID-19 VACCINE. 7/19/21 4:19... Read more
PFIZER-BIONTECH COVID-19 EUA. PATIENT FULLY VACCINATED WITH PFIZER COVID-19 VACCINE. 7/19/21 4:19PM: TESTED POSTIVE FOR COVID-19. COUGH WITH CONGESTION NOTED. 02 SAT 97%. 7/20/21 10:57AM: O2 SAT 98%, AFEBRILE. NO COMPLAINTS. 7/20/21 8:30PM: PATIENT 02 sat 77% RA, SOB, non-prod cough, wheezes/crackles TO LUNG FIELDS. PLACED ON O2 @4L, O2 CAME UP TO 82%. PATIENT VERY LETHARGIC. AFEBRILE AT 98.4. NURSING FACILITY SENT TO ER.
76 2021-07-28 cerebrovascular accident I63.9 - Stroke (cerebrum) (CMS/HCC) R29.810 - Facial weakness
77 2021-01-04 fibrin d dimer increased, troponin increased Pt vaccinated on 12/23. PCP notified that SOB and fatigue getting worse on 1/4. Unable to keep pre-o... Read more
Pt vaccinated on 12/23. PCP notified that SOB and fatigue getting worse on 1/4. Unable to keep pre-op Dental work planned prior to mitral valve surgery on 1/14/2021. PCP referred her to our ED where she was diagnosed with COVID-19 and transferred to facility, which is where her surgery was planned.
77 2021-01-07 transient ischaemic attack, cerebral haemorrhage Facial drooping on 1/4/2021 6 days after the vaccine suffered a mild TIA or bells palsy event. appo... Read more
Facial drooping on 1/4/2021 6 days after the vaccine suffered a mild TIA or bells palsy event. appointments for a CT scan. Has mild facial drooping on the side that is already affected by TIA / cerebral hemorrhage. The long-term or permanent outcome is unknown.
77 2021-01-12 heart rate increased, blood pressure increased dizzy, progressing to high heart rate, high than baseline BP, about 1 hour to return to baseline
77 2021-01-12 fast heart rate light headed then tachycardia
77 2021-01-19 heart rate increased, low blood oxigenation, hypotension Complaints of dizziness and weakness resulting in a fall with injury, hypoxia (resulting in initiat... Read more
Complaints of dizziness and weakness resulting in a fall with injury, hypoxia (resulting in initiation of supplemental oxygen continuous since 1-16-2021),acute hypotension, elevated heart rate, complaints of feeling unwell, increased confusion.
77 2021-01-20 blood pressure increased Weakness Disorientation
77 2021-01-22 heart rate increased 10:00am done with shot, 1/2 hour observation, 10 to 15 minutes later driving home felt need to have ... Read more
10:00am done with shot, 1/2 hour observation, 10 to 15 minutes later driving home felt need to have a BM, arriving home had diarrhea then tremors of both hands, fast heart, and extreme tiredness
77 2021-01-24 chest discomfort Some chest tightness. Sent patient to ER for evaluation.
77 2021-01-25 blood pressure increased, blood pressure increased Headache / Pruritus / erythema/flushed / elevated B/P
77 2021-01-25 blood pressure increased Headache / rash / pruritus / erythema / elevated B/P
77 2021-01-25 blood pressure increased epigastric pain 4/10 with elevated blood pressure 170/72, HR 75
77 2021-01-25 fainting admitted to hospital on 21 Jan 21 with Acute cystitis without hematuria; Cardiovascular disease; Dia... Read more
admitted to hospital on 21 Jan 21 with Acute cystitis without hematuria; Cardiovascular disease; Diarrhea; ST segment depression; Syncope, unspecified syncope type Discharged on 26 Jan 21
77 2021-01-26 blood glucose increased High blood sugars for 24 hours even with two additional doses foyr hours apart by injection of 10 un... Read more
High blood sugars for 24 hours even with two additional doses foyr hours apart by injection of 10 units of Novolog Aspart insulin
77 2021-01-26 blood pressure increased Very Soar Arm and tired first day. Second day, Soar Throat when swallowing, Swollen Eyes in the mor... Read more
Very Soar Arm and tired first day. Second day, Soar Throat when swallowing, Swollen Eyes in the morning when I woke up, increased blood pressure at times and not as stable when walking. Very Tired. Took Benedryl on second day, one in morning and one at night. Seemed to calm symptoms. Soar Throat lasted two days and much better today (day 3). Left Arm also less soar today and stability when walking seems better...
77 2021-01-26 chest discomfort tightness in throat, chest discomfort, felt throat was closing off, difficulty swallowing
77 2021-01-27 palpitations, increased heart rate Palpitation, shaking, weakness, sudden onset on 1/27/21 at 8:00am. Was seen in the ED and found to ... Read more
Palpitation, shaking, weakness, sudden onset on 1/27/21 at 8:00am. Was seen in the ED and found to be in sinus tachycardia; resolved without intervention.
77 2021-01-28 cardiac failure congestive, low blood oxigenation Hypertensive urgency and acute CHF exacerbation with hypoxia. Hospitalized for diuresis with furosem... Read more
Hypertensive urgency and acute CHF exacerbation with hypoxia. Hospitalized for diuresis with furosemide. Currently much improved and discharged home. Symptoms started night of 1/22/2021. Worsened 1/25. Went to urgent care 1/26 and sent to hospital where she was admitted 1/26-28. Patient diagnosed with COVID-19 and was hospitalized for acute respiratory failure not requiring intubation in Jun 2020.
77 2021-01-31 atrial fibrillation Patient arrived in ED with new onset A-fib w/RVR
77 2021-01-31 heart rate irregular 10:55 "I feel a little woozy" HR - irregular; dry; "feelin' a little nauseated" Neuro - intact; moni... Read more
10:55 "I feel a little woozy" HR - irregular; dry; "feelin' a little nauseated" Neuro - intact; monitoring sats & b/p. 1103 - Nausea - gone! good V/S. Stayed with patient, V/S equalized and pt slowly got better.
77 2021-02-01 chest pain Chest pain; Fever; Hypokalemia; Pyelonephritis
77 2021-02-03 blood pressure increased Persistent headache followed 12 hrs later by mild dizziness, nausea, feeling vaguely ?off, now in 4t... Read more
Persistent headache followed 12 hrs later by mild dizziness, nausea, feeling vaguely ?off, now in 4th day. BP slightly elevated this morning 138/80.
77 2021-02-03 chest pain Itching/She was itching on her knee, leg, arm, neck, and ears.; She had hives on the knee; The two t... Read more
Itching/She was itching on her knee, leg, arm, neck, and ears.; She had hives on the knee; The two that had her most worried was the memory loss and chest pain; Chest pain; It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street; Spasms/spasms were like in her back where her shoulders were and it was bulging; It hurt from her neck and up into her head.; It hurt from her neck and up into her head.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3246, expiration date unspecified), via an unspecified route of administration on 10Jan2021 (around noon) at single dose (left arm) for COVID-19 immunization. Medical history included ongoing diabetes, ongoing blood pressure high/blood pressure, ongoing heart problems; heart disease, kidney disease, history of itching, fluid (imbalance), stroke so taking for clotting, history of neck issues and she was allergic to a lot of medications. Ongoing concomitant medications included ubidecarenone (COQ-10), zinc, torsemide for fluid, clopidogrel for had a stroke so taking for clotting, insulin glargine (LANTUS) for diabetes and isosorbide mononitrate, carvedilol, irbesartan and amlodipine, all for blood pressure. Patient reported that she got the injection on Sunday and then later she started to get spasms on 12Jan2021. These spasms were like in her back where her shoulders were and it was bulging and it hurt from her neck and up into her head. She mentioned she was 77 years old and sometimes she has to think about a word before she gets it out, but yesterday (14Jan2021) it was different. It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street on and this lasted 15 minutes and then it went away. She confirmed she does not have it right now. It did not last a long time, but it scared her so bad. Then yesterday evening (14Jan2021), she started to have funny chest pain. She told her husband if it did not go away she would go to the ER. However, after an 1 hour it went away. It was like a sticking pain. The chest pain lasted for an hour and started around 18:00. On an unspecified date, she started itching at night. She has a history of itching, but this was out the box. She had hives on the knee. It was crazy. She itched all over. She had to get out of bed and sit in a chair until 1:30AM. She was still itching, but it was not as bad. Patient reported that due to the kidney disease she has itching, but the itching she was having after this COVID Vaccine was different and more. It was out of the box. She confirmed this was the first injection and now she was scared to get the second injection. Patient reported that the itching started when she went to bed. She went to bed around 21:00 and around 21:30, she got out of bed because she was itching so bad. She stated there was not anything different on the bed. It was the same thing that was up there the night before. She did not change the sheets or anything. She had to get up and sit in a chair and she could not believe how bad her knee was itching. She was itching on her knee, leg, arm, neck, and ears. She stated she takes a lot of medications. She was very funny with medications and they have to work with her to get the right one for her. Due to having these other conditions was why she wanted to get the COVID Vaccine. She reported she will have her blood drawn next week. The two that had her most worried was the memory loss and chest pain. However, these passed and she did not go the ER or physician office. She was afraid if she gets the second injection this will happen again and she may not come out as well form it. Prior vaccinations within 4 weeks was none. Outcome of events spasms/spasms were like in her back where her shoulders were and it was bulging and itching/itching on her knee, leg, arm, neck, and ears was recovering; chest pain was recovered on 14Jan2021 at 19:00; and outcome of the rest of events was unknown.
77 2021-02-04 chest discomfort Flu like symptoms, chest heaviness, anorexia, cough...symptoms have resolved as of 1/29/21
77 2021-02-04 hypertension, heart rate irregular she did not feel totally right; some high blood pressure; she has an irregular heart beat; This is a... Read more
she did not feel totally right; some high blood pressure; she has an irregular heart beat; This is a spontaneous report from a contactable consumer (patient). The 77-years-old female patient received first dose of BNT162b2 (BNT162B2, lot number: EL3248), via an unspecified route of administration on 18Jan2021at SINGLE DOSE for covid-19 immunisation. Medical history included diagnosis of irregular heart rate prior to the vaccine, about 4-5 years ago, allergy, Cholesterol. The patient experienced some high blood pressure on Jan2021, she has an irregular heart beat on Jan2021. "I developed some high blood pressure after getting the vaccine." she has developed a very high blood pressure reading and that is unusual for her, states she went to a walk in clinic on Tuesday and then to the doctor today. Caller states that it really concerns her that someone who is medically savvy as she could have a serious problem. stated that she did not feel totally right while she was waiting afterwards, states that she came home and laid around and the next morning, she can tell when it is high because she is chronically low. Caller states the next morning the top number of her blood pressure was 166, states bottom number is never out of sync (AS REPORTED). Caller states she could feel it really bad yesterday, really bad states she took the pressure once and it was 182/94 and a little later it was 192/84 and that is when she went to the walk in clinic. Caller states she has an irregular heart beat and she takes a blood pressure medication to treat that, takes 25mg once a day at night time. Yesterday morning she took another one before she went to the walk in clinic to help treat the high blood pressure, so she had 50 mg in 12 hours; when she got there they checked it and it was 178/72. She also takes an allergy medication and something for cholesterol that she has been taking for years. She called on 21Jan2021 around 5pm regarding the Pfizer covid vaccine. She called because she was having blood pressure issues and two different doctors thought it was covid vaccine related. It has taken since then till today to get a reasonable blood pressure. Her thoughts are not to get the second dose. She is asking if she will have any protection if she does not get the vaccine and if there will be any adverse effects if she goes not get the second vaccine. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.
77 2021-02-04 hypertension Within 15-minutes of vaccination, the patient reported feeling short of breath and lightheaded. Pati... Read more
Within 15-minutes of vaccination, the patient reported feeling short of breath and lightheaded. Patient stated this was a regular occurrence and that it happens multiple times a week. Patient also attributed it to her anxiety. Patient was hypertensive (180/88), A&Ox4 with GCS15. Patient sat down to catch her breath and stated improvement. Patient refused transport.
77 2021-02-05 pallor Patient complained of dizziness and said she was going to pass out. Observation nurse called site cl... Read more
Patient complained of dizziness and said she was going to pass out. Observation nurse called site clinical lead over, at that time the patient was responding to verbal cues. Mask was taken down and she was guided to take slow deep breaths, continued to report feeling as though she was going to pass out. Site clinical lead then noted patient with fixed gaze to the size, clenching hands and rigid posture. Observation nurse called for EMS assistance. Patient breathing slowed, mouth open, eyes remain fixed to the size with rigid posture for 5-10 seconds. Patient did not respond to any verbal cues. Site clinical lead and observation nurse lowered patient to the floor, at which point patient became responsive. Responded correctly to reason for visit to site, location and how she was feeling. Denied history of seizures or stroke. Reported feeling anxious and needing to use the bathroom. Did not appear to lose bowel control at any point. Patient was very diaphoretic and pale, but alert overall. Cold compresses applied to forehead and back of neck while patient remained supine. EMS arrived and had patient sit up, at which point she again became very pale and reported feeling as through she was going to pass out. EMS transported to hospital for further evaluation.
77 2021-02-06 arrhythmia, atrial fibrillation, heart rate increased Increase in cardiac arrhythmia - a-fib and rapid pulse, up to 135bpm while asleep Muscle and joint p... Read more
Increase in cardiac arrhythmia - a-fib and rapid pulse, up to 135bpm while asleep Muscle and joint pain Fatigue
77 2021-02-06 transient ischaemic attack Transiet Ischemic Attack
77 2021-02-07 chest pain Pt reported that she had a Pfizer vaccine on 2/7 at 10am and went home and experienced chest pain at... Read more
Pt reported that she had a Pfizer vaccine on 2/7 at 10am and went home and experienced chest pain at 1pm that lasted for only a few seconds. Pt also experienced a mild SOB while walking in the hallway. Mild SOB was only lasted for a few secs (prior to chest pain). Pt stopped and rested and Pt felt fine afterwards. Chest pain Hx: Upon assessment, Pt also reported that pt experienced chest pain x1 (6 months ago) which also lasted for a few seconds. But, pt never reported this to pt's physician. Other Sxs: Symptoms: Headache. Onset: 2/8 AM. Pt took Tylenol 1000mg this 9am. Pt states she usually takes QAM for her arthritis. Effect: "It did not help." Pt denies any change in vision, blurry vision, double vision. Denies NV. Pt denies any chest pain or SOB today. Pt was able to speak clearly in full sentences. Pt was able to do ADLs without this morning. Pt stated, " I am able to carry on all my chores without difficulties. Other than headache I feel completely fine." No distress noted that needed an emergent care. Recommendation -Pt denies any significant related symptoms such as ?worst headache of life? or changes in vision, speech, or coordination, or nausea/vomiting. -Instructed to take analgesics such as Acetaminophen after 4-6 hrs (Adult dose: DO NOT EXCEED 4,000mg per day unless directed by the doctor) according to package instructions provided there are no contraindications. -Advised to rest and increase water intake. Education: -If pt experiences any chest pain, SOB, visual changes, change in mental status, N/V or ?worst headache of life?, pt was advised to go the nearest ED. -If headache is severe, focal, progressive or persists > 1 day: Pt was advised to reach out to PCP same day.???If PCP is not available should seek care at Urgent Care. Pt verbalized understanding and agreed with the plan.
77 2021-02-08 blood glucose increased diabetic; sugar level went to 66; shaking; dizziness; fatigue; This is a spontaneous report from a c... Read more
diabetic; sugar level went to 66; shaking; dizziness; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), via an unspecified route of administration, on 23Jan2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history included drug allergy (to epinephrine), diabetes, chronic obstructive pulmonary disease (COPD), arthritis. Patient did not have COVID-19 prior to vaccination. Concomitant medications included glipizide (unknown manufacturer), losartan (unknown manufacturer), lovastatin (unknown manufacturer), metformin hydrochloride (MEDFORMIN), meloxicam (unknown manufacturer). The patient experienced diabetic, sugar level went to 66, shaking, dizziness and fatigue all on 24Jan2021 at 11:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood glucose: 66 on 24Jan2021, 88 on 24Jan2021, 360 on 24Jan2021, 186 on 25Jan2021. On 24Jan2021 it was reported that sugar level went to 66. She ate sugar, level went to 88, ate more sugar level went to 360. Therapeutic measures were taken as a result of diabetic and sugar level went to 66 and included sugar. No therapeutic measures were taken as a result of the other events. Patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.
77 2021-02-09 hypertension "I started to feel strange". "Funny taste in mouth, dizziness, difficulty swallowing, and not thinki... Read more
"I started to feel strange". "Funny taste in mouth, dizziness, difficulty swallowing, and not thinking clearly, history of reaction to high dose flu shot, HTN
77 2021-02-10 blood pressure increased My blood pressure was a little elevated, high for me / elevated blood pressure; Arm sore; This is a ... Read more
My blood pressure was a little elevated, high for me / elevated blood pressure; Arm sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FL3246, expiry date not reported), via an unspecified route of administration in the left arm on 23Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing thyroid disorder. Concomitant medication included hctz. The patient experienced that her blood pressure was a little elevated, high for her/elevated blood pressure on an unspecified date. On 25Jan2021, the patient experienced arm sore. The patient underwent lab tests and procedures which included blood pressure measurement: 160/88 on an unspecified date, blood pressure measurement: normal (reported as normally around 130, 135, 138, normally runs 140/35-38), heart rate: 85 on an unspecified date, laboratory test: unknown result on an unspecified date. Clinical outcome of arm sore was recovering, while for blood pressure increased was unknown.
77 2021-02-10 heart rate increased HR at 11:30 and it was 104; This is a spontaneous report from a contactable consumer (reported for h... Read more
HR at 11:30 and it was 104; This is a spontaneous report from a contactable consumer (reported for herself). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 26Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included Afib (atrial fibrillation) from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination and reporting. Concomitant medications included apixaban (5 mg tab) at 5 mg, and atorvastatin calcium (10 mg tab) at 10 mg; both reported as other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient checked her HR (heart rate) at 11:30 and it was 104, and at 12:30 it had come down to 90. No treatments received in response to the event reported. The event was 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). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event "HR at 11:30 and it was 104" was recovering. Information on the lot/batch number has been requested.
77 2021-02-10 heart rate increased dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection... Read more
dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection site swelling; redness; nauseated; swollen lymph nodes on throat; face swelling; fast heartbeat; body didn't feel well; chills; didn't feel like herself; light headed; felt weak; tired/slept all day; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 15:30 at a single dose on right arm for COVID-19 immunization. Medical history included breast cancer 16 years ago, patient on defibrillator from Oct2016 (it was reported that this past October2020 would have been 4 years since she had the defibrillator put in), ongoing congestive heart failure, ongoing (COPD) chronic obstructive pulmonary disease, sinuses problems, back and hip problems, positive for COVID-19 from 11Jan2021, and hurting. The patient's concomitant medications were not reported. The patient previously received flu shot for immunization on unspecified date. On Saturday (23Jan2021), the patient reported that she "slept all day, felt weak, light-headed, and tired". The patient stated, "I have problems breathing anyways". The patient stated she "doesn't want to eat anything". On Sunday (24Jan2021), the patient "felt good", then Monday (25Jan2021), "didn't feel too bad". On unspecified date, patient experienced hot and cold chills, body didn't feel well, and breathing problems. She has breathing problems because she has COPD. Other things in the list of the adverse events (from the paperwork she was given) that the patient experienced include tiredness, headaches, muscle pain, chills, fever, joint pain, injection site swelling, redness, nauseated, feeling unwell, swollen lymph nodes on throat, face swelling, a fast heartbeat, dizziness, and weakness. Right now (26Jan2021), the patient did not even feel like going to her doctor's appointment (on Thursday). She just didn't feel like doing anything. She didn't feel like herself on 26Jan2021. She clarified on 11Jan2021 (prior to vaccination), she went to hospital because she was hurting. She clarified it was in and out of the Emergency Room. She was never admitted into the hospital. They ran some tests urine, blood, EKG tests. All the tests came back good. The patient underwent COVID test on 11Jan2021: positive; and same test on 22Jan2021: negative. Outcome of the events was unknown. Information about lot/batch number has been requested.
77 2021-02-10 heart rate increased During being observed patient stated to medic that her heart was beating fast and is having body fl... Read more
During being observed patient stated to medic that her heart was beating fast and is having body flashes. Patient taken to medic station. EKG and vital signs were done which showed within normal range. Patient observed and released in 30 minutes.
77 2021-02-12 excessive bleeding Bleeding on the toe of foot. Complete sock from ball of foot to end of ties was soaked with blo... Read more
Bleeding on the toe of foot. Complete sock from ball of foot to end of ties was soaked with blood. This was a spot that Would bleed when I had IV chemo therapy in 2012. Called Dr. And HHT. Clinic at Hospital
77 2021-02-13 hypertension RECEIVED BOTH DOSES OF PFIZER VACCINE. (01/23/21 & 02/13/21) AFTER 1 DAY (02/14/21) WENT TO ICC REPO... Read more
RECEIVED BOTH DOSES OF PFIZER VACCINE. (01/23/21 & 02/13/21) AFTER 1 DAY (02/14/21) WENT TO ICC REPORTING SUDDEN HEARING LOSS IN RT EAR, LIGHT-HEADEDNESS, AND FEELING UNBALANCED. DIAGNOSED WITH HEARING LOSS OF RT EAR AND HYPERTENSION AND INSTRUCTED TO GO TO ER. WENT ER ON 02/14/21 AND WAS DIAGNOSED WITH ACUTE HEARING LOSS OF RT EAR.
77 2021-02-14 pallor Covid dose #2 (Lot EN6201) given at 1:19pm. Pt began feeling flushed, hot, and weak at approximatel... Read more
Covid dose #2 (Lot EN6201) given at 1:19pm. Pt began feeling flushed, hot, and weak at approximately 1:30pm. She was able to walk into Triage under her own power. BP was 190s/90s upon arrival to traige. Pt pale and complained of feeling lightheaded and that she felt like she was going to pass out. 400ml of orange juice given since patient stated that she had not eaten since 8am. Blood sugar taken 15 minutes after resulted at 116. Multiple blood pressures taken resulted in consistent 190s/90s. 911 called by provider at 2:07pm. Fire Department arrived on scene at 2:13pm. EMS arrived on scene at 2:16pm. Vitals taken by EMS and it was determined that since her blood pressure continued to be elevated similar as prior and she felt unable to stand under her own power to take her to Emergency Department. EMS left the clinic at 2:30pm. Pt had all belonging with her and her family had been notified. She remained conscious and able to answer questions throughout the event.
77 2021-02-18 very slow heart rate, troponin increased, fainting, chest pain Pt. recieved COVID vaccine on 4 Feb and came to hospital on 5 Feb with Chest pain; Elevated troponin... Read more
Pt. recieved COVID vaccine on 4 Feb and came to hospital on 5 Feb with Chest pain; Elevated troponin; Exertional chest pain; Symptomatic bradycardia. Admitted for ACS and being treated with heparin. syncopal eisode. she was discharged on 9 Feb. Home course unknown
77 2021-02-19 hypertension Patient face was flush. Noticed by family after the 15 min observation. Pt had no DIB or other com... Read more
Patient face was flush. Noticed by family after the 15 min observation. Pt had no DIB or other complaints. Pts BP was high and has a history of hypertension. Unknown if this was caused by the vaccine or the patients preexisting health conditions. Pt was transported to hospital by ambulance.
77 2021-02-20 chest pain RECEIVED PFIZER COVID-19 VACCINE 1ST DOSE ON 02/20/21. REPORTED TO ER ON 02/21/21 WITH COMPLAINTS OF... Read more
RECEIVED PFIZER COVID-19 VACCINE 1ST DOSE ON 02/20/21. REPORTED TO ER ON 02/21/21 WITH COMPLAINTS OF ABDOMINAL PAIN AND NAUSEA AND VOMITING. DAIGNOSED WITH EPIGASTRIC ABDOMINAL PAIN, ATYPICAL CHEST PAIN, URINARY TRACT INFECTION WITH OUT HEMATURIA, AND HIATAL HERNIA. DISCHARGED HOME WITH INSTRUCTIONS FOR FOLLOW UP APPOINTMNET WITH PCP, GI, GENERAL SURGERY, AND CARDIOLOGY.
77 2021-02-21 chest pain patient c/o lightheadness at 11:55am. Blood pressure was 142/90. Consulted with Doctor. observed ... Read more
patient c/o lightheadness at 11:55am. Blood pressure was 142/90. Consulted with Doctor. observed for 10 more minutes. Patient started c/o numbness in face, shortness of breath and chest pain around 12:05pm. 02 was 99%. Consulted with Doctor and paramedics called. Patient was confused and had difficulty with balance while being transferred to ambulance. Transported to medical Center at 12:18pm
77 2021-02-22 body temperature decreased Experienced bad taste in my mouth right away, lips felt weird, breathing very raspy, chills, itching... Read more
Experienced bad taste in my mouth right away, lips felt weird, breathing very raspy, chills, itching on head, ears, arms, headache, swallowing issues, stuffy nose, sinus pressure, extreme fatigue, dry mouth (felt like cotton in my mouth), temperature dropped. Took about five days to feel okay. Took Benadryl (took twice with six hours between doses, took antihistmine, Levocetiriine, used pro air quite often, 20 mg of Prednisone at 2:30 am on the 22 and finally felt relief. Dr.. was informed after I got better.
77 2021-02-23 arrhythmia, fast heart rate Tachycardia; strong arrhythmia.
77 2021-02-23 cardiac arrest, low blood oxigenation the patient had hypoxemia the evening of the shot, and then was found unresponsive the next morning,... Read more
the patient had hypoxemia the evening of the shot, and then was found unresponsive the next morning, in cardiac arrest at home. Temperature on arrival to ED was 91 degrees. found to have severe anoxic brain injury after 60+ minutes of CPR. may already be brain dead.
77 2021-02-23 chest discomfort 2/19/21 12:30 AM- slight headache, followed by chills and body ache-especially lower bac. Last unti... Read more
2/19/21 12:30 AM- slight headache, followed by chills and body ache-especially lower bac. Last until about 4 PM 2/19/21 2/19/21 2:00 AM - discomfort chest/heart- Thought maybe I should mention it to doc if continued. Lasted 20 min. max. 2/19/21 12:30 AM-lower abdominal discomfort, bowel movement did not relieve discomfort - intermittent for several days until 2/23/21. Did not interfere with activities. Since symptoms were mild, I "toughed" it out. No medication
77 2021-02-23 hypertension, palpitations At 15 Minutes: Dizzy, felt like head exploded, heart pounding, BP over 200 for a short time, taken t... Read more
At 15 Minutes: Dizzy, felt like head exploded, heart pounding, BP over 200 for a short time, taken to a room for observation, after about 30 minutes taken to Prompt Care Facility on premesis. Had slight nausea, shakiness, weakness, little dizzy, headache. Treatment: observation, asking questions, checking vital signs, checked Glucose: Normal. Stayed at Clinic approx. 1 Hour. Considered going to ER but continued to feel better as time passed and went home. BP was at 167/66 when leaving. Later same evening 10:30 p.m. at home: BP at 136/72/66, Next day 2/21/2021 BP at 128/70/63. 2/22/2021 BP 123/66/61. Continue to have headaches.
77 2021-02-23 troponin increased Cardiogenic shock occurred on 2/10/2021, approximately 12 hours after patient received her 12th dos... Read more
Cardiogenic shock occurred on 2/10/2021, approximately 12 hours after patient received her 12th dose of pemetrexed/pembrolizumab and 4 days after COVID vaccine. Coronary angiography was done on 2/10/2021 and no significant coronary narrowing or blockage were noted. Baseline troponin on 2/10/21 was 0.02 and later on 2/10/21, troponins were 9.99 & 25.27. Creatinine increase from 1.2 to 3.4 within 24hours, and AST/ALT increased from 23 & 31 to 4,220 & 4,786 respectively on 2/11. Patient expired on 02/11/2021.
77 2021-02-24 fainting Fever, syncope. Pt has small rash to administration site.
77 2021-02-25 palpitations Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a m... Read more
Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a muscle twitch; Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a muscle twitch; Arm is sore; Heart is pounding; I'm a little jittery. I am very nervous; I'm a little jittery. I am very nervous; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the right arm on 27Jan2021 (10:00) at a single dose for COVID-19 immunization at the school/student health clinic. Medical history included diabetes diagnosed about 12 years ago; high blood pressure diagnosed about 30 or 40 years ago; and weight loss. Concomitant medication included insulin (INSULIN) for diabetes. The patient previously took influenza vaccine, sitagliptin phosphate (JANUVIA) and tramadol (ZALDIAR); and had rash on both medications. The patient had previously received a flu shot around the 6th or 7th of Dec2020. On 27Jan2021, at "about 4PM", the patient had felt jumpy on the injection site/right arm started jumping; it had "been jumping, jumpin jumpin jumpin, a muscle twitch". Also on 27Jan2021, at "about 4PM", the patient's arm was sore; heart was pounding; was a little jittery; and was very nervous. The outcome of the events, 'felt jumpy on the injection site/right arm started jumping', 'had "been jumping, jumpin jumpin jumpin, a muscle twitch"', 'arm was sore', 'heart was pounding', 'little jittery' and 'very nervous', was unknown.
77 2021-02-28 blood pressure increased, chest pain Client report having COVID in November 10, 2020. Client received first dose on 02/09/21 at 2 pm, re... Read more
Client report having COVID in November 10, 2020. Client received first dose on 02/09/21 at 2 pm, reaction of SOB began two hours later. SOB progressed to chest pain and fatigue. She sat at kitchen table to relax and rest, fell asleep for 2 hours. When she woke up she continued to have trouble breathing, drank some warm tea, went to bed and slept for 12 hours. This is not usual for her sleep schedule. The next day she felt better for a couple of hours then had some difficulty breathing again. She went to Urgent Care. EKG and chest X-ray preformed came back normal. Blood pressure was elevated. Client given 4 puffs of an inhaler. Discharged to home.
77 2021-02-28 heart rate irregular patient c/o cotton mouth, felling like a tight airway. Breath sounds diminished bilaterally, expira... Read more
patient c/o cotton mouth, felling like a tight airway. Breath sounds diminished bilaterally, expiratory wheezes. Vital signs 136/88-108 (irregular) O2 Sat 95% History of anaphylaxis . O2 sate decreased to 88% Epinephrine 0.3mg IM administered at 3:09pm. Pt states that feeling of tightness EMS notified and patient transported to hospital at 3:25pm
77 2021-03-01 low blood pressure Back pain, bilateral lower extremity neuropathy, paresthesias, lower extremity weakness, urinary ret... Read more
Back pain, bilateral lower extremity neuropathy, paresthesias, lower extremity weakness, urinary retention, orthostatic hypotension
77 2021-03-02 chest pain, chest discomfort Vaccinated with Pfizer COVID vaccine on 1/21/21 and 2/12/21. Unknown facility, lot number Hospital ... Read more
Vaccinated with Pfizer COVID vaccine on 1/21/21 and 2/12/21. Unknown facility, lot number Hospital course 2/24 ? 2/26/21 2/24 Chief complaint: Chest Pain. Per EMS - CP and SOB started 1220. Mid CP radiating to left arm. semi-relief with nitro x 2. Reports N. Denies V and no other symptoms. Hx cardiac stents, MI. HPI: Patient is a 77-year-old female who presents to the ER for evaluation of chest pain. Patient states that her chest pain started this afternoon around 1230 when she was cooking lunch. She says it lasted for about 10 minutes and was a intense substernal chest pressure sensation with radiation down her left arm. She had associated shortness of breath and diaphoresis and also endorsed nausea without vomiting. Patient also states she is had some occasional dizziness which she described as a room spinning sensation is made worse when she is in positions and standing or moves her head. She has a history of 2 heart attacks and 2 stents placed which were done. She has no local cardiology follow-up and she lives at an apartment and follows with pace. EMS gave her 4 aspirin prior to arrival she takes no blood thinners but she does take Plavix. Patient has a history of COPD and also endorses some wheezing, she says they took her nebulizer away from her for fear of spreading coronavirus and she is oxygen dependent at nighttime. COVID positive 2/24/21 (this assay amplifies and detects The target rna using real-time pcr. Testing performed on cepheid genexpert) Patient states she tested negative for COVID 19 last week at her PCP and got her 2nd COVID 19 vaccine on 2/11/2021. She reports having dinner with a friend 3 weeks ago who just passed away from COVID 19. EKG shows normal sinus rhythm with incomplete right bundle branch block and no obvious ST segment elevations or acute ischemic intervals Troponin negative Patient admitted to the COVID unit. Home (baseline) O2 requirement 2.5L at night 2/25: 3L O2 nasal cannula continuously, reduced to 2L within 12 hours No fever COPD with acute exacerbation: Diffusely wheezing bilaterally and in tripod position on exam. Start IV Solu-Medrol COVID-19 viral infection: Start IV Remdesivir as she is now requiring supplemental oxygen. IV steroids as above. Chest pain, history of CAD with previous stenting --Denies any chest pain on exam. EKG negative for ischemic changes. Troponin negative x1. Continue to trend troponin x2 more occurrences. --Continue Aspirin, Plavix, statin, Imdur. Anxiety disorder: Continue Prozac. Add Xanax 0.25 mg 3 times daily as needed. 2/26: medically ready for discharge to SNF COVID unit. Augmentin 875/125 x 7 days dexamethasone 6mg daily x 8 days
77 2021-03-02 heart attack, ischemic chest pain, blood clot she was hospitalized 2.5 days after having symptoms of a "massive heart attack" 2 days after the vac... Read more
she was hospitalized 2.5 days after having symptoms of a "massive heart attack" 2 days after the vaccine; blood clot; pain on the left side/pain so bad/ pain was so severe couldn't bent over and couldn't get up; pain was in the heart and underneath the rib; pain was in the heart and underneath the rib; had a little trouble breathing; broke out in a sweat; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date in Feb2021 at a single dose for COVID-19 immunization. Medical history included asthmatic, had double pneumonia years ago, has ongoing atrial fibrillation and a pacemaker to control it as the only problem she has in her heart. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient was hospitalized for 2.5 days after having symptoms of a massive heart attack two days after the vaccine. It was reported that two days post vaccination, the patient was rushed to the hospital by ambulance as they thought she was having a massive heart attack. She added her symptoms lasted for hours, she had pain so bad that she was bent over and had a little trouble breathing. She said the pain was in the heart and underneath the rib, on the left side. She later mentioned she did not feel like it was AFib. She said they did every test possible and listed the following ones: ultrasound, stress test, x-ray (unknown results), and blood work in Feb2021. She specified that her blood work indicated a blood clot. She mentioned she was told by her personal friend, who was a doctor, that by having the shot sometimes it indicated you have blood clots when you really don't. The patient also specified that she broke out in a sweat, the pain was so severe that she could not bend over and could not get up; therefore, they treated her as if she was having a massive heart attack for 12 hours at the hospital. It was reported that they kept giving her stuff to stop the effect with her heart. She mentioned her second dose was scheduled on 25Feb2021. She asked if her experience was reported as a side effect to the vaccine and should she get the second dose of the vaccine. She explained the doctors did not know what she had, and she needed to determine if she can receive the second dose. She also asked if we could notify her if a similar reaction is reported. The outcome of the events was unknown. Information on lot/batch number has been requested.
77 2021-03-03 hypertension they gave her some IV because she was dehydrated; high blood pressure; felt like she was getting a m... Read more
they gave her some IV because she was dehydrated; high blood pressure; felt like she was getting a migraine; she started getting dizzy; she has never had a hangover but it felt like she had a hangover; she didn't feel good; she was sick on her stomach; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. Patient received the first dose of the COVID vaccine and was experiencing high blood pressure on an unspecified date in Jan2021. Patient went to the ER and they told her something in the vaccine made it go up. Patient would like to know what in the vaccine would cause her blood pressure to go up and if any has experienced high blood pressure as a side effect of the vaccine. Patient reported that she didn't feel good, felt like she was getting a migraine and after that she started getting dizzy and she thought she was going to help herself and lay down on the bed for about 45 minutes and then she got up after that and walked around on Jan2021. She felt like, she has never had a hangover but it felt like she had a hangover, that was what it felt like, and she thought she hopes that doesn't last and she got up Wednesday morning (Jan2021) and went to her podiatrist appointment. She didn't feel good but she was okay so she went to the podiatrist and then later she was fixing supper and she had some grease in a pan that she fried something in and she thought she wanted to get some water in it so she went to go with the pan and she got to the door and took 3 steps back and she thought good Lord, there is something is wrong here. She did empty the water and the grease and she thought well it is going to have to stay there, it was right at the back door so anyway. Her son came home from work and she got him get the blood pressure cuff and take her pressure and it was 158/98 and she thought, this was not good. She said she will just go lay down for a while and she went on to bed. The patient was taken into the hospital via an ambulance. She sat there until about 4-5 hours and later they got to take her blood pressure and result was 189/92 on Jan2021. They gave her some IV because she was dehydrated and she got home, she lives about 30 miles form the hospital so they got home about 3 o'clock and next day she didn't feel good but she felt better. She confirmed she was not admitted to the hospital it was an ER visit and they sent her home. She felt Thursday was not a good day she came down off of what had her up. She was going to say no to the second dose because she was sick on her stomach and drunk as a dog, she was really dizzy, very dizzy and she just had to sit down quiet her self. She was supposed to have surgery but because of COVID it has been cancelled 3 times. The outcome of the events were unknown.
77 2021-03-03 cardiac arrhythmia Have had benign PVCs in the past usually maybe 3 episodes a month. Four days after 2nd vaccine injec... Read more
Have had benign PVCs in the past usually maybe 3 episodes a month. Four days after 2nd vaccine injection, I started to experience daily episodes 4 or 5 times per day in most cases; Have had benign PVCs in the past usually maybe 3 episodes a month. Four days after 2nd vaccine injection, I started to experience daily episodes 4 or 5 times per day in most cases; This is a spontaneous report from a contactable consumer who reported for herself, a 77-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 9262), via an unspecified route of administration in the left arm, on 09Feb2021 at 07:30, at the age of 77 years, at a single dose for COVID-19 immunization. Medical history included diabetes, spinal stenosis, and ongoing PVCs. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Concomitant medications included metformin, statin, and hydrochlorothiazide. The patient previously took codeine and had allergy; and received the first dose of BNT162B2 (Pfizer, Lot number: EL1284) on 19Jan2021 at 03:00 PM, at the age of 76 years, in the right arm, for COVID-19 immunization. It was reported that patient have had benign PVCs in the past - usually maybe 3 episodes a month. On 13Feb2021, reported as "four days after 2nd vaccine injection", patient started to experience daily episodes - 4 or 5 times per day in most cases. From day 4 to day 11, experiencing these episodes. On day 11 they started to subside. Patient was taking essential electrolytes and extra magnesium to help. The events were reported as non-serious. The outcome of the events was recovering.
77 2021-03-04 blood pressure increased Patient states she reacted immediately after receiving the vaccine. States that she felt dizzy & lig... Read more
Patient states she reacted immediately after receiving the vaccine. States that she felt dizzy & light headed, her BP went up to 163/90 and she had tingling in her feet "as if I were wearing tight compression socks". Medical record indicates that she called 911 the day after her vaccine & reported dizziness & slurred speech. She was told to go to the ER, but did not go. She reported to her PCP's office that she had arm itching, she was anxious & fatigued as well. She also reported that she "felt funny in the back of her throat" & seemed to be coughing more. Headache also reported.
77 2021-03-04 heart flutter, troponin increased Patient presented to ED with chief complaint of sudden onset dizziness, epigastric pain and generali... Read more
Patient presented to ED with chief complaint of sudden onset dizziness, epigastric pain and generalized weakness, symptoms happened the day before yesterday, resolved, she noticed when she is trying to do any activities she gets heart fluttering. Epigastric pain noted in ED. Troponin Elevated, heparin IV started for possible NSTEMI. Patient is currently admitted.
77 2021-03-04 lightheadedness It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; It... Read more
It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; Felt like I was going to pass out; Felt unwell; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration (at the age of 77-years-old) on 15Feb2021 at a single dose for COVID-19 immunization. Medical history included Diabetes, asthma, High blood pressure, fibromyalgia, cane user, Neuropathy. Concomitant medication included pregabalin (LYRICA) and unspecified medications ("No, I am not because it's a very long list and I don't feel good, I am jerking and I just don't feel like doing that I am sorry."). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Patient stated, "My experience with the COVID-19, I had the injection on 15Feb, the second one and I went back and sat in my chair and I was okay. And then I got up to leave and I felt like I was going to pass out (15Feb2021). So, I sat down in the chair, my husband asked for the nurse and she came and she thought it was my diabetes which I also sort of felt that, but anyway I came home and I felt unwell (15Feb2021), that afternoon and then the next day, I would feel like that and then the next day I had improved but I started with this jerking and that has been going now since then but today it's more like (incomplete sentence). At first, it was like small and now they are getting big like a jerk. I called my family doctor yesterday and I talked with the nurse and she told me that I needed to be checked within 4 hours. So, I went to one of the in and out you know places, emergency places that you can go to and she took a lot of blood, and ones that came back were okay but the other results, she is not going to get until tomorrow, I have to go back. But have you have anybody else that has had this experience?" The date when adverse event started was reported as "Started out, it was like a little twitch on Wednesday night that would have been from Monday to Wednesday and then today it's just like a jerk, it's big. My whole body is just jerking. I did not feel well the afternoon I had it. But the next day, I thought I was better and that is when the twitch started." The patient was experiencing event worse than ever. It's like a bigger jerk now. No treatment was received for the events. Lab test: "They took 5 vials of blood yesterday when I went to that doctor, and I heard for some of it, but for the rest, I will have the results tomorrow and I just had my blood drawn on Thursday from my kidney doctor. So, I have blood drawn all the time." The outcome of the event "felt like I was going to pass out" and felt unwell was recovering, and "it was like a little twitch and then today it's like a jerk, it's big/whole body is just jerking" was not recovered.
77 2021-03-07 chest discomfort Progress Notes (Nurse Practitioner) ? ? Infusion Center Cosigned by: MD at 3/4/2021 8:28 AM Expan... Read more
Progress Notes (Nurse Practitioner) ? ? Infusion Center Cosigned by: MD at 3/4/2021 8:28 AM Expand AllCollapse All COVID VACCINE CLINIC 3/2/2021 Subjective Patient is a 77 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience chest tightness and lightheadedness. She denied rash, glossal tightness or increased work of breathing This provider was notified of patient reaction and I was then assessed in the emergency bay area. PMH HTN, obesity and NIDDM. Cardiac cath 2 years ago: normal per report. Pt has NIDDM, ate eggs/baco this AM with AM FBS: 150 mg/mL. Pt has re-applied her long sleeve sweater and heavy coat as she began her observation period. She was alert, mild pallor with normal VS on arrival. Blood sugar: 80 mg/dL. Oxygen applied. BP138/62, HR76. Sat 100 % Granola bar/water provided with complete resolution of symptoms Monitored patient for severe reaction symptoms, including but not limited to any need for additional diagnostics. Recommendation for 30" observation period at Dose #2 of 2 . APRN-C Previous Reactions: none Objective Vitals There were no vitals filed for this visit. Blood Sugar 82 collected at 0953 Arrives in wheelchair, awake, alert HEENT: No glossal issues, no stridor LS CTA S1S2 Skin pale. No rash Anxious Assessment/Plan Treatment included: oxygen, blood glucose, VS monitoring, snack Follow up response to treatment: complete resolution of symptoms Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: hypoglycemic event APRN Electronically Signed 3/2/2021 9:52 AM
77 2021-03-08 atrial fibrillation, blood pressure increased, heart rate increased, heart rate irregular has not smell or taste a lot of the time; has not smell or taste a lot of the time; sight is not cle... Read more
has not smell or taste a lot of the time; has not smell or taste a lot of the time; sight is not clear; flipped out; her blood pressure went up while she was in the Emergency room; panicked; Lightheadedness; Weakness; felt a little tired at that time; atrial fibrillation/started racing/Heartbeats irregular; anxiety; couldn't breathe/shortness of breath/hard time breathing; it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated; her heart rate was flying; scared; she said it was not a migraine headache like she is used to, but more of a mild headache; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EM9801), via an unspecified route of administration on the left arm, first dose on 04Feb2021 (Administered between 9:30-10:00AM) at single dose for COVID-19 immunisation. Medical history included chronic migraines all her life. She said her migraines have let up as she has gotten older. She also had an irregular heart rate before, saying her irregular heart rate started in her adult life. She said she considered herself more of a "carrier" for an irregular heart rate because her irregular heart rate doesn't happen enough for her to think about it. She said she doesn't have an irregular heart rate now. She said her father had a pacemaker & her 2 brothers had heart problems; her oldest brother passed away from his heart problems & her other brother has blood pressure issues. Patient also had mild asthma as an adult. She said she worked at (name) in a dusty environment, and lived near a landfill, where a lot of her neighbors have gotten sick. She said she needs an inhaler for her asthma. She said when she needs the inhaler, she takes 3-4 puffs at a time. She said she doesn't use the inhaler every day and also mentioned that her grandfather had died of a bad asthma attack. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on the same date of vaccine. No prior vaccinations within 4 weeks. There were no concomitant medications. On 13Feb2021, the patient experienced an atrial fibrillation in which she started racing and couldn't breathe. She mentioned that she recently attended a funeral but attributed the symptoms as side effects of the vaccine. She was taken to the Emergency room where she was given cortisone and resolved her symptoms. Patient also further reported she had side effects with the Pfizer COVID-19 Vaccine. She clarified she had her first COVID-19 Vaccine dose on 04Feb2021. She said her side effects happened less than 14 days after getting the COVID-19 Vaccine. Patient thought her side effects from the COVID-19 Vaccine may have been anxiety within. She said her nephew had died of COVID-19, and when she was at his funeral at the graveside, she flipped out while she was at her nephew's funeral, she was not doing good. She said she has a history of chronic migraines, and mild asthma. She said she had to lean against a gravestone because she couldn't breath. She said it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated. She said her heart rate was flying, and she had an irregular heart beat. She said she left her nephew's graveside and went to an urgent care. She said the doctor at the urgent care had done an EKG result abnormal, and told her she needed to go to the Emergency Room right away. She said the doctor had called the paramedics to transport her from the urgent care to the Emergency Room at (Institute name). She said she did not have any pain, but had a hard time breathing. She said she may have been scared because her grandfather had died of a bad asthma attack. She said she has chronic migraines, but what she had at the time was a mild headache, and not a migraine. She said she has not smell or taste a lot of the time. She clarified she has had no smell or taste for a while, saying she would not be able to tell if she got the COVID-19 Virus because of her loss of taste and smell. She said she was tested the Friday before her nephew's funeral and was negative for the COVID-19 Virus. She said she has had a total of four COVID-19 Virus tests before, and all her COVID-19 Virus tests have been negative. She clarified she did not have a COVID-19 Virus test while she was at the ER on Saturday, 13Feb2021. With her nephew's death, getting her COVID-19 Vaccine had left her mind. She said it didn't dawn on her until she settled down, and she thought her high heart rate and irregular heart beat were side effects of the COVID-19 Vaccine. She said she read the paperwork that was given to her at the time she got the COVID-19 Vaccine. She said the side effects listed for the COVID-19 Vaccine is what she had, a very fast heart beat, and it was very hard for her to breath. She said the Emergency Room doctor didn't think to ask her about the COVID-19 Vaccine. She said she panicked when she got to the hospital. She said she didn't even know that someone had drew blood from her. She said someone put a label on her, and told her the label was to show blood was drawn from her. She said when she looked down at the label, she saw an IV access was put in her arm. Additional treatment reported when she was in the Emergency Room, she was given an injection (clarified as IVPB on 13Feb2021) of Diltiazem 120mg at 12:13:50 PM, she said she was given another Diltiazem 5mg injection at the same time. She clarified she was diagnosed in the Emergency Room with Atrial Fibrillation. Patient stated that her blood pressure went up while she was in the Emergency room. She said she was kept in the Emergency Room so she could be monitored up until that evening. She said after the Diltiazem injections were given, her heart rate went down. She said the Emergency Room doctor gave her a prescription for Diltiazem 120mg white capsules, and told her to take the Diltiazem 120mg every day. She said the emergency room doctor told her she could go home, and that she needed to follow-up with her regular doctor. Reported she no longer has the shortness of breath, lightheadedness, or weakness. She said had felt a little tired at that time, as well. Patient also reported that on 22Feb2021 was her first day outside of her house since last Sunday (14Feb2021) and reported she has a slight headache, and her sight is not clear. She said she now feels she has "name" back, clarifying she has recovered completely. She has a follow up with her doctor on 24Feb2021. She is scheduled to take her 2nd dose on 04Mar2021 and is asking if she should take anything before the shot. Vaccination Facility Type was a pharmacy/drug store. Vaccine was not administered at Facility. The outcome of the events was recovered on an unspecified date.
77 2021-03-08 palpitations ct reports having fever, body aches, stomach pain with nausea and diarrhea, palpations, rash on her ... Read more
ct reports having fever, body aches, stomach pain with nausea and diarrhea, palpations, rash on her face, vision problems
77 2021-03-12 loss of consciousness Was monitored for 30 mins and felt lightheaded and weak at the exit table. I was put in wheelchair, ... Read more
Was monitored for 30 mins and felt lightheaded and weak at the exit table. I was put in wheelchair, moved to a cot, and Paramedics were called. I was weak, couldn't stand without help and I felt drugged. I was taken to ER for monitoring and testing for reasons why this occurred. Continued to feel passed out for 2 hours. Tests for heart attack, diabetes and anemia were negative Diagnoses was Vasovagal attack - sent home after 8 hours monitoring
77 2021-03-14 atrial fibrillation, chest discomfort Have WPW with no complications until 03/12/2012 . I was taken to hospital after experiencing heavy c... Read more
Have WPW with no complications until 03/12/2012 . I was taken to hospital after experiencing heavy chest and hard to breathe. I was released on 03/13/2021 after heart settled down. Only thing I can say is this episode came on quite differently than other episodes of WPW.
77 2021-03-14 cerebrovascular accident Approximately 2.5 days following my mothers fist covid-19 vaccine dose, she had a stroke and was adm... Read more
Approximately 2.5 days following my mothers fist covid-19 vaccine dose, she had a stroke and was admitted to the emergency room. She survived the stroke and following a brief stay at a skilled nursing facility, is still undergoing physical, occupational, and speech therapy.
77 2021-03-14 heart rate increased weak feeling; heartbeat climb up and up; unnerving; This is a spontaneous report from a contactable ... Read more
weak feeling; heartbeat climb up and up; unnerving; This is a spontaneous report from a contactable consumer (patient). This 77-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318; expiration date 31May2021) via an unspecified route of administration on 05Feb2021 at 11:30 (at the age of 77-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included losartan, escitalopram, and atorvastatin from unknown dates for unspecified indications. The patient received dose 1 of BNT162B2 (lot number EL1284; left arm) on 15Jan2021 at 11:00. The patient previously received codeine on an unknown date for an unknown indication and experienced allergy. On 06Feb2021 at 13:00 the patient experienced a weak feeling and heartbeat climb up. The patient had a weak feeling, had to sit down and took her pulse with oximeter and her Apple watch. She watched her heartbeat climb up and up. She tried yoga breathing but could not slow it down. She was not sure how long this went on because it was very unnerving, but it reached as high as 105 before it started to go down. The beats went up, then down, finally started to keep going down. Once more there was a wave of the weakness through her before she stayed in the 73+ range. The patient was usually in the 60's. Since then the patient's heartbeats have been what is usual for her. During the episode the patient's husband found "rapid heartbeat" on the paper they received. The patient was concerned this happened a day after the vaccine, not within an hour. The events were reported as non-serious. The patient was not hospitalized and did not receive any treatment for the events. The outcomes of weak feeling and rapid heartbeat were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
77 2021-03-14 palpitations dizziness; nausea; heart palpitations; fatigue 13 days; This is a spontaneous report received from a... Read more
dizziness; nausea; heart palpitations; fatigue 13 days; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (herself) reported that a 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EL9269) via an unspecified route of administration in left arm on 11Feb2021 14:00 at single dose for Covid-19 immunization. Medical history included Cholesterol, high blood pressure and history of ovarian and breast cancer. Concomitant medications included Pregabalin, rosuvastatin calcium (CRESTOR), fluoxetine hydrochloride (PROZAC) and amolodipine. Patient is good health had a bad reaction to the 1st COVID dose vaccine. Ended up in hospital emergency room on Friday 18Feb2021 with extreme dizziness and nausea and heart palpitations. Fatigue which had been going on since Friday 12Feb2021 14:30. Having had these reactions patient need to know from Pfizer is it safe for me to have second dose which is scheduled 04Mar2021. Seriousness was reported as non-serious. Patient did not receive treatment for events. No follow-up attempts are possible. No further information was provided.
77 2021-03-15 atrial fibrillation 6 hours of AFIB/taking a medication for AFIB and have not had AFIB for 3 years; 6 hours of AFIB/taki... Read more
6 hours of AFIB/taking a medication for AFIB and have not had AFIB for 3 years; 6 hours of AFIB/taking a medication for AFIB and have not had AFIB for 3 years; This is a spontaneous report from a non-contactable consumer (patient herself). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), via an unspecified route of administration on the left arm, on 26Feb2021 10:15, at a single dose, for covid-19 immunization. Medical history included allergies: bee stings and sulfa drugs, AFIB (not had AFIB for 3 years) and, had a confirmed case of COVID on Jan2021 (reported as 1 month before vaccination). Concomitant medication included unspecified medication for AFIB. The patient experienced 6 hours of AFIB on 27Feb2021 10:15, 24 hours after first dose. The patient was taking a medication for AFIB (concomitant medication) and have not had AFIB for 3 years. The patient recovered from the adverse event on 27Feb2021 16:15 with no treatment received for it. The patient was not covid-tested post-vaccination. No follow-up attempts are possible. No further information is expected.
77 2021-03-15 chest discomfort sore at vaccination point; tightness and heaviness in chest about two hours following injection, las... Read more
sore at vaccination point; tightness and heaviness in chest about two hours following injection, lasted about two minutes.
77 2021-03-15 low blood oxigenation 3/11/2021 Patient presented with severe upper back muscle spasms and shortness of breath for the las... Read more
3/11/2021 Patient presented with severe upper back muscle spasms and shortness of breath for the last 2 days. Diagnosed with pneumonia and hypoxia, confirmed by imaging. Covid test negative on admission.
77 2021-03-15 palpitations 1. I feel like I am going to fall, unstable gait with head pressure. 2. Generalized dizziness. 3. Sc... Read more
1. I feel like I am going to fall, unstable gait with head pressure. 2. Generalized dizziness. 3. Scared and my heart races.
77 2021-03-15 blood clot Lymph gland under left arm size of golf ball, smaller glands swollen underarm, (soft), neck swollen... Read more
Lymph gland under left arm size of golf ball, smaller glands swollen underarm, (soft), neck swollen, left foot swollen, weakness, small blood clot in myopic of middle finger, small modules in upper thigh, sore on lower lip right side
77 2021-03-17 blood pressure decreased, cardiac arrest One week post vaccine, caller's mother started to feel "phlegm-y", coughing up clear phlegm. The ne... Read more
One week post vaccine, caller's mother started to feel "phlegm-y", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14.
77 2021-03-17 hypertension, blood pressure increased Within 30-minutes of vaccination, the patient reported feeling nauseous. The patient was reportedly ... Read more
Within 30-minutes of vaccination, the patient reported feeling nauseous. The patient was reportedly hypertensive. No EMS report was filed. The patient did proceed to Emergency Department for follow-up. In the ED, the patient was hypertensive (153/69) and stated they continued to be nauseous. The physician administered 4mg IV Odansetron and 1L IV saline. Labs were unremarkable. The patient reported feeling improved after treatment and was discharged with a diagnosis of Side effect of vaccination.
77 2021-03-17 heart attack Chills; aches and pains; chest spasms; a fever a little shy of 101; hard to breathe; feel ill; activ... Read more
Chills; aches and pains; chest spasms; a fever a little shy of 101; hard to breathe; feel ill; activated all that discomfort; she thought she was having a heart attack; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 20Jan2021 12:30 at single dose in right arm to prevent covid. Vaccination Facility Type was Health department. Medical history included rotator cuff challenge. There were no concomitant medications. No other vaccine was administered on the same date. There were no prior vaccinations within 4 weeks and no adverse events were following prior vaccinations. Patient was calling about Pfizer Covid vaccine. She had the first shot on 20Jan2021. She did not have a reaction. She went to go get her monthly massage on Saturday (23Jan2021). On Sunday morning (24Jan2021) she started to feel ill and she had to go the hospital. She confirmed she was not admitted to the hospital. She had chills, aches and pains, it felt like an elephant was on her chest, she had chest spasms, a fever a little shy of 101. She went to hospital and the doctor there told her she had covid since she had all the symptoms. She confirmed she did not have covid and had a negative covid test. She had chest x-ray and an EKG since she thought she was having a heart attack. Reported her massage was primarily on her left shoulder, it was a deep massage on that area since she had a rotator cuff challenge, massage was focused on that shoulder. She was thinking that the vaccine activated all that discomfort since she felt it from the left part of shoulder, went down to her chest like a v, and back up to her right shoulder. Every time she took a breath she had a chest spasm and it was hard to breathe. The events required a visit to emergency room. For treatment, they gave her medication to take called robaxin, it was an anti-spasm, and 800mg of ibuprofen. She took robaxin Sunday night, Monday, and she took one on Tuesday since she was feeling better. She was sensitive to medication. She felt dizzy and nausea from Robaxin. The patient had recovered from the events completely by Wednesday on 27Jan2021. She had a reminder to return for the second dose on 10Feb2021. She was asking if she should get the second dose. Information about Batch/Lot number has been requested.
77 2021-03-17 fast heart rate, ventricular tachycardia On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body... Read more
On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body aches dry cough shortness of breath and subjective fevers as aggressive worsening since Friday. Patient received a 2nd dose of the pfizer COVID-19 vaccine on Friday 3/12/21 and states her symptoms worsened since then. Chest x-ray showed patchy bilateral infiltrates with concern for COVID pneumonia, also questionable vascular congestion as patient does have significant history of heart failure with pacemaker. EKG revealed paced rhythm 87 beats per minute. Emergency room patient was placed on BiPAP and responded well, patient was given vancomycin and cefepime for sepsis protocol.
77 2021-03-18 blood pressure increased Pt received the second dose of the Pfizer vaccine. The patient waited 15 minutes in the observation... Read more
Pt received the second dose of the Pfizer vaccine. The patient waited 15 minutes in the observation area. Once the patient left the building, her husband returned with her within 5 minutes of leaving bc, he noticed her having swelling of her left lower lip and itching in the throat with some difficulty breathing. She was attended to immediately by EMS, PA& physician at the site. Vitals were obtained: blood pressure was elevated at 220/110, PO2 96% pulse 115 BPM. A dose of 50 mg of benadryl was given to the patient orally. Within 10 minutes she felt improvement in her breathing and the swelling in her lip was not as prominent. BP remained elevated 200/100 , transported to hospital for further Tx & observation.
77 2021-03-18 fainting Fainted; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 77-year-... Read more
Fainted; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Feb2021 10:00 (lot number: EN6201) at the age of 77 years old, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously took codeine and experienced allergies. The patient previously received first dose of bnt162b2 on 04Feb2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, lot number: EL9264, administration time: 09:45 AM, vaccine location: left arm). Next morning after vaccination (occurred on 24Feb2021 08:00), the patient felt lightheaded while bending over to empty dishwasher. The patient sat down on chair; and the patient's husband found the patient on floor, as she had fainted. The patient had no recall of fainting. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. The patient did not receive other vaccines four weeks prior to COVID vaccine. The patient recovered from the events on unspecified date.
77 2021-03-18 fainting Within 5 minutes I became very light headed and weak. Also very hot and shaky. They had to put me i... Read more
Within 5 minutes I became very light headed and weak. Also very hot and shaky. They had to put me into another room that was much cooler and put me into a recliner with feet up, ice behind my neck and on my forehead. I was pushing water so it was not dehydration, and I had eaten my normal healty breakfast also so not low blood sugar. This was my second shot and I had the same reaction with the first shot. It took about an hour before I could stand and walk again, but was still a bit shaky and faintly light headed for about another hour.
77 2021-03-19 blood pressure increased March 12, 2021 - On Friday about 2pm, I started with a runny nose ? by Sunday afternoon it was like ... Read more
March 12, 2021 - On Friday about 2pm, I started with a runny nose ? by Sunday afternoon it was like a faucet turned on ? running down my face. March 13 - Saturday morning, I started coughing c chest congestion, and had Phlegm rattling in my chest, started sneezing very frequently/ some diarrhea. Otherwise, I felt fine. March 14 - Sunday morning, I started wheezing slightly, coughing more and sneezing frequently. Felt fine. Went shopping. Nose ran so much in store, had to run to the store to get paper towels to catch it. Later, when I carried a heavy bag of groceries from one car 12 feet to another, noticed I was very exhausted and had to rest about 15 minutes before driving home. Wheezing more. Monday, March 15, I took my B/P meds at 1:00am and my blood pressure was way up x 4 (160?s/ 70?s) p58-64, at 2:08am ? B/P was 183/92) so I took my PRN Clonidine and ate all the high Potassium foods I had in the house. By 3:40am my B/P was 120/66 but went back up later with coughing. I felt fine but tired. A little after 4am, I carried a bag of apples and a bag of oranges up my stairs and was totally exhausted ? I felt the energy draining out of me, and so was out of breath I dropped the bags on the floor and sat hyperventilating to get enough air in my lungs until I could breathe normally ? for 40 minutes - it felt like fluid building in my lungs. I started massaging my abdomen like crazy and coughing until it subsided ? considering whether I should go to E.R. My breathing did get some better But I sure did not exert myself. Just picking up my computer was taking my energy. Still coughing and getting rid of some phlegm. This was very scary and I was on the verge of going to the E.R. at 4:45am - I called the E.R. who said I probably could wait for a urgent care to open or talk to Dr.?s office. My breathing was some better. By 6:10am I was so tired I fell asleep. At 10am my B/P was 138/77 p53. Still very weak, coughing, wheezing, and trying to get rid of phlegm. I had no other symptoms. I called my Dr. who got me in a urgent care in her building at 3pm. That evening I started Postural Drainage which helped in getting rid of the phlegm. I have continued that still. March 16 ? I ?chatted? my doctor to let her know all that was going on. She scheduled me to see the Respiratory office in her building on the next day. I was feeling much better ? little nasal dripping, lungs felt better, March 17 ? Wednesday ? went to Respiratory appt but declined treatment because I felt so much better. More energy, better lungs than Tuesday, wheezing gone, less phlegm, still some coughing ? which is okay with me. I think this is a severe enough reaction that I should not have the second dose ? which is known to be more severe than the first.
77 2021-03-19 hypertension, pallor Patient experienced high blood pressure, paleness, numbness and unawareness
77 2021-03-21 pallor, low blood oxigenation "Pt presented to Clinic for her vaccine. Post vaccine, pt was feeling faint/weak and was pale. Pt st... Read more
"Pt presented to Clinic for her vaccine. Post vaccine, pt was feeling faint/weak and was pale. Pt sts feeling short of breath prior to arrival. Pt has hx of lung cancer. Pt was drained last at home on 3/14 per pt husband. EMS performed 12 lead and checked vitals. Pt color improved upon lying on stretcher for a few minutes. Pt's pulmonologist was contacted to see if they want her to go to her appointment scheduled at 1330 or to be transported to ED. Pt. was then transported via EMS to ED." Pt was inpt from 3/18/21 - 3/21/21 with diagnosis of E. Coli bacteremia, recurrent left pleural effusion with drain in place, resolved hypoxia on oxygen, follicular non Hodgkin's lymphoma, pancytopenia, poor appetite, insomnia. Patient was started on cefepime and then Rocephin per Infectious Disease team but she continued to the duration of this admission until ultimately transitioning her to oral antibiotics with Cipro twice daily to complete 7 day course from 03/19; this prescription was sent to her pharmacy upon discharge. Discharged home with hospice services (per pt /family preference) for comfort care
77 2021-03-23 chest discomfort After patient left vaccination site (25 min later) she had tightness on her chest,and difficulty bre... Read more
After patient left vaccination site (25 min later) she had tightness on her chest,and difficulty breathing for over 10 min. Pt drove home, and she felt better like 1 hour later. Three days later, on 03/07/2021 she was seen by her provider who ordered her: 1.Stress test, 2.Eco-cardio Doppler, 3. PFT (Pulmonary Functional Test). Provider didn't tell patient not to take the second dose of Pfizer vaccine, but to wait until patient completes these tests. Patient understood she must wait for her provider to indicate if she is allow to get Pfizer Anti-covid vaccine second dose, or not.
77 2021-03-24 cardiac arrest, blood glucose increased, troponin increased, ejection fraction decreased, atrial fibrillation, oxygen saturation decreased, platelet count decreased, skin turning blue She had been in her usual state of health until tonight. Assisted living facility staff called. He m... Read more
She had been in her usual state of health until tonight. Assisted living facility staff called. He mentioned that the facility staff had earlier noticed that she was dragging her right foot and and has been needing more assistance with activities. The patient was walking and did not feel well. She was lowered to the ground and had a witnessed cardiac arrest. The ambulance was called and she was reportedly found to have pulseless electrical activity. She was given Epinephrine and Amiodarone with return of pulse. The patient was brought to the Emergency Room and was evaluated by ER physician. EKG showed atrial fibrillation, ventricular rate = 66, RBBB with Brugada pattern. She was emergently brought to the Cath Lab. Cardiac catheterization showed normal coronary arteries but EF 35-40%. Repeat EKG showed atrial fibrillation with rapid ventricular response = 110, RBBB. Therapeutic hypothermia was initiated. The patient was admitted to the ICU on mechanical ventilation with TV 350 RR 14 PEEP 5. She is sedated with Propofol and Fentanyl IV. She is on Levophed IV. ABG showed pH = 7.22, pCO2 = 53, pO2 = 66, O2 sat = 88%. Lactate level = 9.5. WBC 8.8, Hgb 13.4, Hct 46, Platelets 138. Na 138, K 3.2, Cl 102, bicarb 20, BUN 16, Crea 1.19, estimated GFR = 44 mL/minute. Magnesium 2.7. Glucose levels have ranged from 273-312. Pro-Calcitonin = 0.26. Albumin 3.7. SGOT 262, SGPT 294. Troponin elevated at 47. Pro-BNP = 600. Urinalysis showed large blood. Chest x-ray showed vague peripheral pneumonitis. Endotracheal tube is in place. COVID-19 test by PCR is negative (2/5/21). COURSE IN HOSPITAL The patient was admitted to the ICU and was followed by Pulmonary/Critical Care. Patient was maintained on mechanical ventilation, sedated with propofol and fentanyl IV. Vasopressors were administered (Levophed IV). She was managed with therapeutic hypothermia. She was followed by Cardiology. Foley catheter was inserted for close input/output monitoring. Neuro checks, vital signs, daily weights, pulse oximetry, cardiac telemetry and fingersticks were monitored. She was given sodium bicarbonate IV due to metabolic acidosis. She was also given insulin IV drip. Potassium chloride IV was administered due to hypokalemia. The patient was given amiodarone IV. Platelet count was noted to be low but stable. Glucose levels were within acceptable range. Metabolic acidosis resolved. Hypokalemia resolved. Hypomagnesemia resolved. There were elevated LFTs which improved. Elevated CPK also improved. She was taken off hypothermia protocol. Sedation was decreased and she was able to open her eyes with verbal stimulus but unable to follow commands. Ammonia level was normal. Neurology evaluated the patient. EEG showed left periodic epileptiform discharges consistent with severe diffuse encephalopathy. Chest x-ray revealed right upper lung and left mid lung increasing opacity for which meropenem IV was started. Levophed was discontinued. Initially she had peripheral cyanosis, but this resolved upon discontinuation of vasopressors. Brain MRI was done demonstrating diffuse bilateral small and moderate-sized ischemic foci throughout the cerebellum and cerebellar region suggestive of embolism. There also was chronic marked atrophy and moderate small-vessel gliosis. CIRCUMSTANCES SURROUNDING DEMISE Based on neurologic evaluation, her prognosis for meaningful neurologic recovery was thought to be extremely poor. The patient was evaluated and followed by Palliative Care. She does not have family members and had designated her neighbor friends as her power of attorney. They have known the patient for a ling time and they know that she does not want to live like this. A decision was therefore made for comfort care measures only. Compassionate extubation was performed on February 12, 2021. The patient passed away on February 12, 2021, at 6:39 p.m.
77 2021-03-24 chest pain severe pain emanating from injection site; traveled upward over shoulder; continued up right side of... Read more
severe pain emanating from injection site; traveled upward over shoulder; continued up right side of neck; heavy right earache; sore throat; headache forehead and across top of my head; dry heaves; feverish/chills/shivering; feverish/chills/shivering; words mixed up; Felt pain in center chest; congestion across bronchial area and developed upper respiratory congestion temporarily; congestion across bronchial area and developed upper respiratory congestion temporarily; fatigued; had severe coughing spell which included choking and further nausea; had severe coughing spell which included choking and further nausea; severe nausea; Ripple effect across bridge of nose; strong metallic odor and taste within mouth; moving from back of throat and nostrils; it is both painful and difficult to raise my right arm very high; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6060, first dose) solution for injection intramuscular in the right arm on 09Mar2021 at 16:00 (at the age of 77-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: yes. Concomitant medication included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Mar2021 16:15, the patient had severe coughing spell which included choking and further nausea, ripple effect across bridge of nose, strong metallic odor and taste within mouth moving from back of throat and nostrils, it is both painful and difficult to raise my right arm very high. On 10Mar2021, the patient experienced dry heaves, feverish/chills/shivering, words mixed up, felt pain in center chest, congestion across bronchial area and developed upper respiratory congestion temporarily, fatigued. On 10Mar2021 03:00 the patient had severe pain emanating from injection site traveled upward over shoulder continued up right side of neck heavy right earache, sore throat, headache forehead and across top of my head. Unspecified treatment was provided for the events. The outcome of the events choking, coughing, nausea, ripple effect across bridge of nose, strong metallic odor and taste and smell, severe pain emanating from injection site upward over shoulder continued up right side of neck heavy right earache, sore throat, headache, dry heaves, feverish, chills/shivering, words mixed up, Felt pain in center chest, painful and difficult to raise my right arm very high, fatigued was not recovered. The outcome of the event congestion across bronchial area and developed upper respiratory congestion temporarily was recovering. Since the vaccination, the patient has not been tested for COVID-19.
77 2021-03-24 hypertension, heart rate increased She has constant spiking of her blood pressure (BP) and lack of sleep/She has been in and out of the... Read more
She has constant spiking of her blood pressure (BP) and lack of sleep/She has been in and out of the hospital for her high BP/admitted to Hospital with 200/103 Bl; she has constant spiking of her blood pressure (BP) and lack of sleep; Racing Pulse; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; This is a spontaneous report from a contactable consumer. A 77-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EL9262), via an unspecified route of administration in left arm on 25Jan2021 (vaccination age 77 years) at single dose for COVID-19 immunization. Medical history included: cholesterol, spinal fusion L4/5, stenosis, allergies to medications, food, or other products: kefex, Zithromax, levofloxacin, oxycontin, methylprednisolone, Lisinopril, ezetimibe, Amlodipine. She reported she has constant spiking of her blood pressure (BP) and lack of sleep for 37 days (average 1-3 hours daily), since the vaccination. She described the following: She has experienced "dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function". When she "lays down", her "heart is racing so fast and [her] BP gets so high that it won't let [her] sleep". She feels like her "body is going crazy". She "cannot get more than 2-3 hours of sleep other than 1-2 exceptions". Also, her "BP wakes her from a dead sleep". When she wakes up, she usually "takes a rice [pad] and applies hot and cold to her neck, and she sometimes takes some Tylenol". "Every time [she] wakes up, her BP [readings] are around 152/101 and 160/97. She has been in and out of the hospital for her high BP. After the hospital, she called (Number) because her BP "was off the chart". Her cardiologist ruled out heart issues. She did an "echo, a stress test and EKG". On 01Feb2021 she was admitted to hospital with 200/103 blood pressure. Ruled out cardiovascular & placed on Amlodipine. Now 37 Days later with many visits to doctors, blood pressure remains high. Cardiologist ran stress test & echo with no heart issues. Placed on many Blood Pressure Medications that also created side-affects (urination, flushing, dizziness, extreme headaches); Amlodipine 5 mg, Metoprolol 25 mg, Alprazolam 0.25 mg as needed, Propranol 20 mg. Today, picking up yet another (Hydralazine?) as last-ditch effort. BP daily spikes remain high (160/99 and 175/100). Racing Pulse & BP wakes me out of a dead sleep within 1-2 hours. So weak & constant neck pain that feels like someone is placing pressure around my neck. The blood pressure medication received are the following: Amlodipine from 1Feb2021 until 9Feb2021. She explained it work well to manage her BP but she "could not urinate and had red flashes in [her] face"; therefore, it was stopped by her cardiologist. She was off the BP medication from 9Feb2021 until 17Feb2021. Metoprolol from 18Feb2021 until 25Feb2021, but it didn't work. She explained it was stopped by her doctor because of side effects. Propranolol in combination with Alprazolam as needed for anxiety. She explained she "took 3" of the tablets for anxiety. Hydralazine 25mg which she started yesterday, after seeing her cardiologist. She explained she only got 3 hours of sleep last night. She woke up around 1:30am/2am" her heartrate was at "93" and she put heat and cold on her neck to settle the pain. She specified the headache and pain were so bad it lasted for 1.5 hours, and her BP was 150/93 at 3 am .She added she had a "red and flushed face" and therefore took a "Benadryl at 4am". She explained her BP was down to "125/78", after taking the Benadryl, but got up to "147/90" at 7 am when she attempted to call Pfizer. She explained she has "done [her] due diligence: she consulted HCP, did all the test, she attempted to go for walks and do activities she can tolerate, but her symptoms persist. She added she use to golf and cannot anymore. She explained her symptoms are persisting until this day and her body won't handle it further. She mentioned she knows she is COVID-19 free because when helping take care of her quadriplegic son in the summer, she tested negative. Outcome of events was not recovered.; Sender's Comments: Linked Report(s) : PFIZER INC-2021277006 same patient, different vaccine dose/AE.
77 2021-03-25 chest discomfort chills, headache, fatigue, shortness of breath, heaviness on chest for 2-3 days and shortness of bre... Read more
chills, headache, fatigue, shortness of breath, heaviness on chest for 2-3 days and shortness of breath and heaviness on chest is ongoing
77 2021-03-26 heart rate increased, dilation of blood vessels Pain in left left behind Calf also behind Thigh Swollen vein in left arm from wrist to high way up m... Read more
Pain in left left behind Calf also behind Thigh Swollen vein in left arm from wrist to high way up my arm . Some pain and lumps. Fast heart rate
77 2021-03-28 chest discomfort Presented to emergency department with complaint of shortness of breath and chest discomfort. She r... Read more
Presented to emergency department with complaint of shortness of breath and chest discomfort. She reports shortness of breath began last night. States shortness of breath is exacerbated with exertion. She also reports generalized chest discomfort with shortness of breath. Recently placed on an antibiotic on the 22nd for a bilateral lower leg skin rash. States dermatologist was unsure what kind of rash or what the rash is, so biopsies were obtained and patient is to return next Wednesday for results. Otherwise respiratory history has had asthma as a child but has not had any exacerbation or symptoms as an adult. She recently received her second COVID-19 vaccine. Denies palpitations, fever, chills, congestion or cough.
77 2021-03-29 fast heart rate Patient admitted to hospital with altered mental status and fever. Found to meet SIRS criteria by re... Read more
Patient admitted to hospital with altered mental status and fever. Found to meet SIRS criteria by recurrent fever and tachycardia, but no white count and otherwise hemodynamically stable. Urine cultures and blood cultures were drawn and did not demonstrate growth. Body imaging was done without e/o of infection. Patient started improving 1 day after admission (2 days after the second Pfizer COVID vaccine) without much intervention save for supportive care (antipyretics, antiemetics, etc.)
77 2021-03-30 cardiac arrest Cardiac arrest resulting in death. I actually do not know the name of the vaccine or which type it ... Read more
Cardiac arrest resulting in death. I actually do not know the name of the vaccine or which type it was it was her 2nd one and it occurred today at 1:30 pm
77 2021-03-30 heart rate irregular, heart rate increased 1:30 pm after shot at 11:30 heart started to beat rapidly and erratic. Wouldn?t stop after an hour.... Read more
1:30 pm after shot at 11:30 heart started to beat rapidly and erratic. Wouldn?t stop after an hour. Went to emergency part of hospital. Took ekg, drew blood to see if anything was not correct, had chest X-ray. All came out fine except ekg. Did not settle down. ER doctor called my doctor and he said other AFib patients have had this happen also. Er doctor agreed with my doctor. Also had no chest pains or shortness of breath or dizziness. Told to take Tylenol for a couple days and was released. The erratic and fast pace of my heart has eased some but still persists.
77 2021-03-31 chest pain Chest pains
77 2021-04-01 heart rate increased Community member, Dose #2 During post vaccination observation, lightheaded & elevated HR to ED with ... Read more
Community member, Dose #2 During post vaccination observation, lightheaded & elevated HR to ED with headache & anxiety, improved & discharged to home
77 2021-04-06 chest discomfort 04/07/2021 5:25 am woke up with tight chest and shallow breathing. Immediately took asthma medicati... Read more
04/07/2021 5:25 am woke up with tight chest and shallow breathing. Immediately took asthma medication. I usually take 2 puffs of Advair and 2 puffs Xopenex an hour or two after waking (daily treatment. I don't wake up with a tight chest. 6:30 a.m. breathing has normalized. Have headache, earache and some nasal drainage.
77 2021-04-06 hypertension Couldn't breathe/shortness of breath; Back pain; blood pressure was high; was just sick; This is a s... Read more
Couldn't breathe/shortness of breath; Back pain; blood pressure was high; was just sick; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 (at the age of 77-years-old) (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood pressure abnormal, cancer in her left lung, ongoing blood cholesterol abnormal, ongoing gastric disorder, ongoing diverticulitis Verbatim: Virticulitis. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) taken for blood pressure abnormal; atorvastatin (ATORVASTATIN) taken for blood cholesterol; hydralazine taken for blood pressure abnormal; lisinopril (LISINOPRIL) taken for blood pressure abnormal from Feb2021 and ongoing; pantoprazole taken for gastric disorder from 2020 and ongoing. The patient had her first shot and after that, a week after she experienced some adverse events like back pain and sickness. After the patient started experiencing back pain, and got progressively worse, she was having problem breathing/Shortness of breath was reported. The patient was ambulanced and mentioned she was brought to the hospital/stayed with her doctors overnight due to the experiences she had. She had blood work done and based on the results, they suspected a blood clot on her lung and her CT scan did show that she did not have a clot in her lung. It was also reported that they did blood test and urine test and that all that EKG because the patient had her blood pressure gone considerably high and in the blood test. She was prescribed to take Tylenol every 8 hours and a to put a back patch on the left side of her back where she is experiencing pain. Caller did not provide if she was admitted to the hospital, or if she just stayed in the ER overnight for observation. Now, she wants to know if she will still proceed with her 2nd shot on 29Mar2021. The patient underwent lab tests and procedures which included abdomen scan: normal, no indication of blood clot on 17Mar2021, angiogram: normal, no indication of blood clot on 17Mar2021, blood pressure measurement: high, blood test: a blood clot on her lung on Mar2021, computerised tomogram: normal, no indication of blood clot on 17Mar2021, covid-19: negative on 17Mar2021, x-ray of pelvis and hip: normal, no indication of blood clot on 17Mar2021. Therapeutic measures were taken as a result of back pain (back pain). The seriousness of the events back pain and Couldn't breathe/shortness of breath was hospitalization. The outcome of the events back pain was recovering. The outcome of the other events was unknown.
77 2021-04-07 ischaemic stroke SEVERE HA , DOCTORS SAYS SE HAD ISCHEMIC STROKE , NOT SURE IF RELATED TO THE VACCINE What happened ... Read more
SEVERE HA , DOCTORS SAYS SE HAD ISCHEMIC STROKE , NOT SURE IF RELATED TO THE VACCINE What happened as a result of the adverse event? SAW DOCTOR
77 2021-04-08 blood glucose increased Reports dizziness immediately following vaccine inject. She reports same symptom with first vaccine,... Read more
Reports dizziness immediately following vaccine inject. She reports same symptom with first vaccine, and was transported to Rush ER. VS 130/78, 68, O2 sat 99 %
77 2021-04-11 palpitations Pt self-reported heart palpitations and dizziness 1 day post-vaccine. Resolved on its own with no tr... Read more
Pt self-reported heart palpitations and dizziness 1 day post-vaccine. Resolved on its own with no treatment.
77 2021-04-12 nosebleed Extreme headache rot. Side of head, extreme back pain in left wing one , Runny nose, Chills to... Read more
Extreme headache rot. Side of head, extreme back pain in left wing one , Runny nose, Chills took Tylenol and napped for hrs for two days. 2 heavynosebleeds right nostril one wk later. 2nd shot on 2-21-2021, Hot, 4 nights of night sweats, Two more bloody noses right nostril. Tired
77 2021-04-13 platelet count decreased, low blood oxigenation Pt received her 2nd covid 19 vaccine on 4/7/2021 and was admitted severe sob, respiratory failure an... Read more
Pt received her 2nd covid 19 vaccine on 4/7/2021 and was admitted severe sob, respiratory failure and hypoxia on 4/10/2021/ she remains hospitalized as of 4/14/2021. she is being treated with oxygen, antibiotics, steroids and nebulizers.
77 2021-04-14 pulmonary embolism Developed sudden pulmonary embolism on 4/5/21. No DVT. Very active pt. Unprovoked
77 2021-04-17 chest pain, heart attack, loss of consciousness, heart rate increased she and they thought she was having a heart attack; she must have passed out because she didn't reme... Read more
she and they thought she was having a heart attack; she must have passed out because she didn't remember all the tests; she got a sharp pain underneath her left rib cage/pain was number10/still had pain off and on, periodically; broke out in sweat, real bad, number 10, she broke out in a clammy sweat; hard to breath, she got a sharp pain underneath her left rib cage; the muscle that goes around her heart, it was having like a charley horse; heart rate, She says 102, 103, it went up to 200 in the ambulance.; chest pain; Nausea; hard to breath, she got a sharp pain underneath her left rib cage; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as single dose for COVID-19 immunization. Medical history included ongoing atrial fibrillation for a about 6 years , ongoing anemic for the last 20 years, glaucoma from 1998, had both eyes operated on and in 2016 she was operated on again, cataract had this 4 years ago in she says, in 1918, 1919, she clarifies 2018, Cardiac pacemaker insertion which pacemaker that controls her heart so the pulse does not drop below 65. She says that pacemaker was implanted, she thinks, 2014 maybe, blood pressure, arthritis throughout her body and had 30 operations, body doesn't absorb what she eats, anxiety, asthma, muscle spasms; she reported she has had a lot of surgeries, both of her ankles have had triple fusions, these were in 2005, 2010, 2014, 2018, both her ankles were fused, she had 5 surgeries on her feet; she has had both of her knees replaced because of arthritis, 2012 and 2015 she believes, had numerous other surgeries and she doesn't want to go through all of them, a right shoulder reverse rotator cuff repair, she had a rotator cuff put in, she doesn't have a rotator cuff, this happened in 2019, her left shoulder, because of an automobile accident, rotator cuff was so damaged that they couldn't repair it, she has minimum use of her left arm and has had operations on her left shoulder in 2005; had a pacemaker put in about 6 years ago, the next morning they kept her overnight, they came in, they took an Xray, she had to go back 2 days later because the lead had come of the heart, they had to go back in an reattach the lead to the heart; 2 years ago her pacemaker was going all over her chest, the doctor did not believe her and it landed under her armpit, it was the size of an orange, the doctor thought it was a lump, she went to the hospital, her pacemaker started falling apart, they took it out and put a new one in, it was about 4 years ago; a lump in her breast, she has been put under 30 times, they were all necessary, nothing for glamorizing; had surgeries in her left arm and some fingers than were numb. There was no prior vaccinations within 4 weeks, no events prior vaccinations and no family history. Ongoing concomitant medication included baclofen taken for muscle spasms for about 2 years, calcium for arthritis and her bones degenerate for 30 years, ergocalciferol (CALCIFEROL VIT D) taken for gets anemic real easy for 20 years, duloxetine taken for anxiety, taking this about 3 years ago; ferrous sulfate taken for anemic real easy for about 20 years; folic acid taken to rebuild cells taking this she thinks in 2015, furosemide taken for a diuretic to get rid of fluid for 2 years, metoprolol tartrate taken for atrial fibrillation, and blood pressure, taking this since she had her pacemaker put in; montelukast for asthma for 20 years; hydrocodone bitartrate, paracetamol (NORCO) taken for arthritis for 20 years, and warfarin taken for blood thinner/thin the blood out so she doesn't get blood clots; and adults vitamins for bone supplement and metabolism for 20 years as her body doesn't absorb what she eats. She says she takes a lot of medications and when she does blood bloodwork she was low so they make her take them. The patient previously took rivaroxaban (XARELTO). On 06Feb2021, the patient experienced she thought she was having a heart attack. The patient reported that she had to call an ambulance at 11:30 at night, she thought she had a massive heart attack. She had chest pain, nausea, it was hard to breath, she got a sharp pain underneath her left rib cage. She stated that when the ambulance got here they thought she was having a heart attack, they did nitroglycerin, when they got to the house, when in the ambulance on the way to the hospital they did another pill of nitroglycerin when they got to the hospital. The pain was a number 10. She stated she broke out in sweat, once they got her all hooked up they got to the hospital 6 miles away to the hospital. She was there for 2 full days, they did Xrays, dye in her, checked her hears, and did bloodwork. When she had chest pain, she reported they gave the morphine, it lasted about 6 hours; she still had problems breathing, they took her, she must have passed out because she didn't remember all the tests, she was in and out of it, the severe pain stopped after 6 hours, still had pain off and on, periodically. When she got pain in the ambulance then the nausea went away. After the hospital nitro and another shot for the pain, the nausea stopped. After the hospital after this they gave morphine and the pain subsided a little but didn't totally go away until 6 o'clock in the evening, she still had problems breathing because every time she breathed she got pain under her left rib cage. She says the sweat was at home, real bad, number 10, she broke out in a clammy sweat, on the 6th when she was having pain. She says that after the hospital, a couple days after that, she saw her cardiologists, he told her what happened, it was related to vaccine, it was the muscle that goes around her heart, it was having like a charley horse, he says it felt like you're having a heart attack, her tests said her heart was good. She talks about her blood pressure and heart rate, and says 102, 103, it went up to 200 in the ambulance. She says they thought it was a heart attack, her blood pressure was usually low blood pressure and all the symptoms she was having was because of her muscle having a charley horse that felt like it was coming from the heart, if they had contacted him, he said she would have just needed a massive amount of anti-inflammatory and it would have stopped the pain. The events required an emergency room visit. She wanted to know if anybody else has been hospitalized for massive heart attacks and says that's what she was having. The patient had her second shot on 22Feb2021. Outcome of event nausea was recovered on an unspecified date; and outcome of the rest of events was unknown.
77 2021-04-17 chest pain acute chest pain, sent private vehicle to closest ED, family with member
77 2021-04-17 excessive bleeding Bleeding; Blood in her stools; Volumes of regular stool/went to the bathroom 20 times; Did not have ... Read more
Bleeding; Blood in her stools; Volumes of regular stool/went to the bathroom 20 times; Did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool/there may be something in the vaccine that could help her Irritable Bowel Syndrome; Aching arm; This is a spontaneous report. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9267; Expiration date was not reported) on the left arm on 28Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the Health Department. Medical history included ongoing irritable bowel syndrome for over 50 years; high level of hormones; was losing hair; and had rectal bleeding from Jan2021 to an unspecified date. Concomitant medication included ongoing spironolactone from Jan2021. On 01Mar2021, the patient did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool, and mentioned that there may be something in the vaccine that helped her irritable bowel syndrome; and had aching arm. On 02Mar2021, the patient was bleeding; had blood in her stools; and had volumes of regular stool, and went to the bathroom 20 times. The patient did not receive any treatment for the reported events. The outcome of the events was unknown. The patient had received the second dose of vaccination on 28Mar2021.
77 2021-04-18 deep vein blood clot Pt admitted to hospital on 3/4/2021 with Extensive DVT to the LLE. No history of cancer or thrombos... Read more
Pt admitted to hospital on 3/4/2021 with Extensive DVT to the LLE. No history of cancer or thromboses. History of redness and swelling to entire left leg starting on 3/1/2021. Received Heparin infusion in hospital. Currently receiving Eliquis p.o. Pt also underwent trombectomy with iliac stent placement by IR.
77 2021-04-18 platelet count decreased, haemoglobin decreased Severe fatigue after first dose. 1 week after 2nd dose 3/18/21, developed worsening fatigue with 43... Read more
Severe fatigue after first dose. 1 week after 2nd dose 3/18/21, developed worsening fatigue with 43% blasts on peripheral CBC indicating a transformation from CMML to AML.
77 2021-04-19 fibrin d dimer increased Pfizer COVID Vaccine EUA Patient received Pfizer vaccine 3/3/21. COVID Positive 3/20/21 3/20/21: Pa... Read more
Pfizer COVID Vaccine EUA Patient received Pfizer vaccine 3/3/21. COVID Positive 3/20/21 3/20/21: Patient is a 77-year-old female with past medical history of bilateral breast cancer (post bilateral mastectomy), CHF, CAD, CKD stage II/III, HTN, obesity, obstructive sleep apnea (not on CPAP), and spinal stenosis presenting today. Patient presented via ambulance her daughter. Patient was unable to cooperate, HPI obtained from patient's daughter. Patient's daughter stated approximately 1 week ago patient started to be "unresponsive" and was not talking/responding often. Mostly answered "yes/no" questions. She seemed the be "acting different". When asked, pt denied any pain over the last week. Her daughter denies any infectious process such as fever/chills or cough cough. Her daughter notes approximately 2 years ago patient has similar event, was seen in the ED, but nothing remarkable was found. Reviewed today, patient's daughter stated the patient had a "shaking "episode in had "on responses ". It was described as "shivering" and a blank stare during this unresponsive state. Episode lasted approximately 1 minute. The daughter denied any history of strokes or seizures. Pt usually lives with another daughter and so the daughter present was unable to verify if pt takes her prescribed medications daily. Her daughter denies knowing any Advance Directives or POA set up. Smoking, alcohol, and illicit drug use were denied. Pt was seen 9/2019 for a similar event with concern of stroke vs syncope vs TIA that resolved on its own. 3/25/21: 77-year-old F presented on admission that began approximately 6 days prior. HPI obtained from patient's daughter on admission. Patient's daughter stated approximately 1 week ago patient started to become "unresponsive" and was not talking/responding often. Mostly answered "yes/no" questions. Patient's daughter stated the patient had a period of unresponsives and was shaking her left arm on the day of admission. It was described as "shivering" and a blank stare during this unresponsive state. Left sided weakness was noted. In the ED, vitals signs significant for 88% on room air. CXR showed bilateral infiltrates in lower lobes, CT of head was unremarkable, EKG normal sinus with sinus arrhythmia, CT of chest completed due to elevated D-Dimer showed no PE but showed ground-glass airspace disease and stable 14mm nodule at lower pole of right thyroid. Pt was admitted for Acute Encephalopathy with unknown etiology. COVID testing came back positive. Patient started on Routine COVID management protocol which included IV dexamethasone, remdesivir, vitamin D, vitamin C, zinc, with daily labs (d-dimer, CPK, CRP, CMP, LDH until stable/not upward trending). Patient to continue vitamin D, vitamin C, and zinc upon discharge to rehab. Patient had MRI obtained which showed scattered foci of acute infarcts right posterior parietal lobe/multiple foci of acute microhemorrhages likely hypertensive. Neurology consulted, stated infarct could be due to COVID so continued on lovenox and stopped aspirin. Recommended to keep blood pressures 110-140/80-90. Last documented note from neurology was 03/22/2021 - contacted multiple times but unable to reach afterwards. Discharging patient on xarelto for 30 days and recommending to follow-up outpatient to transition to aspirin and plavix. With this management on board, patient's symptoms improved significantly since admission. Patient discharged in stable condition to rehab.
77 2021-04-22 low blood oxigenation NA Hospitalization for Acute Resp Failure with Hypoxia secondary to acute and chronic CAD
77 2021-04-24 blood pressure increased Headache; Tiredness; Difficulty breathing; Dizziness; Weakness; Nauseated; blood pressure was up; Te... Read more
Headache; Tiredness; Difficulty breathing; Dizziness; Weakness; Nauseated; blood pressure was up; Teeth chattering/chills; couldn't hardly stand up; This is a spontaneous report from a contactable consumer (patient reported herself). A 77-year-old female patient received first dose of BNT162B2 (COVID shot, Solution for injection, NDC number: Unknown) via an unspecified route of administration to her right arm on 24Feb2021 3 PM (Batch number: EN6201) as single dose for Covid-19 immunization. Vaccination Facility Type: Hospital. The patient's medical history included bladder issue (she had just been to see her doctor for bladder issues, this was prior to taking the COVID shot). Concomitant medications was reported as none. On 24Feb2021, the patient experienced blood pressure was up, teeth chattering and could not hardly stand up. On 24Feb2021 3 PM, she experienced nauseated. On 25Feb2021, she experienced headache, chills, tiredness, difficulty breathing, dizziness and weakness. Caller, reporting on the COVID shot, said that she had a reaction and had to go to the hospital. She was calling to report. It was explained that she was sick all over which she clarified as being nauseated. At first she said it started an hour to hour and a half after the shot but then clarified she got the shot at 3 PM and the event started that night. The caller was treated and released. She went to the hospital about 6 PM and was sent her home about 9 PM. She was given a steroid shot, Benadryl, her teeth were chattering and was given a pill for that. It was noted while at the hospital she could not hardly stand up. Also, her blood pressure was up and they had to get that down before she left; she was given a pill to get that down. Her blood pressure was 225 but she did not know the bottom number. She was taking the medication given and taking it easy. She was having headache, chills, tiredness, difficulty breathing, dizziness, and weakness. This all started today. The nausea was ongoing from yesterday. The caller explained that she did not think that she should take the second dose if this was what she experienced after the first dose. It was reported that the patient went to emergency room. Relevant tests were none. Outcome of the events nauseated, headache, chills, tiredness, dizziness, weakness was not recovered; blood pressure was up was recovered on 24Feb2021; and other events was unknown. No follow-up attempts are possible; No further information is expected.
77 2021-04-24 low platelet count, platelet count decreased, troponin increased, enlargement of the heart 3/8/21 ED: c/c of SOB x 2 days. Pt c/o diarrhea. Pt states that she received the 2nd pfizer vaccine ... Read more
3/8/21 ED: c/c of SOB x 2 days. Pt c/o diarrhea. Pt states that she received the 2nd pfizer vaccine 2 days ago. O2 at triage was 96% on RA. She was seen in this facility Saturday 3/6/21 for HA. CTA and labs unremarkable. She reports persistent HA, though improved when compared to Saturday. Reports multiple episodes of NB diarrhea. No other medications or treatments tried. In the ER she was seen to have a significant leukocytosis with wbc in 26, AKi with SCr in 2.7, thombocytopenia. Ordered CT scan which showed congestion and LLL pna and trace effusion. ID, Cardiology and Nephrology consulted. Treated for acute kidney injury with hyposmolar hyponatremia, on tolvactam, Sodium 133, trending up. Treated for sepsis with gram negative bacteremia d/t e.coli, completed ceftriaxone course. Treated for essential hypertension, elevated troponin, BP now controlled. Discharged home on 3/17/21
77 2021-04-25 anaemia gi bleed, anemia, bilateral interstitial pneumonia with scars
77 2021-04-27 blood pressure increased Very Elevated blood pressure. The same for my husband who got shot at the same time. Also a friend... Read more
Very Elevated blood pressure. The same for my husband who got shot at the same time. Also a friend.
77 2021-04-27 chest discomfort Mild sensation in left chest area and along left side neck, along with mild shortness of breath star... Read more
Mild sensation in left chest area and along left side neck, along with mild shortness of breath starting about 3/20/21 Has since disappeared. On or about 3/25/21 a hard, painful rash appeared on buttocks and has since healed. A second larger painful rash appeared in a different area on or about 4/5/21 and lasted about 2 weeks. Along with rash is tenderness of skin in surrendering area of rash, there is pain under breast area which extends to back and persists.
77 2021-04-27 transient ischaemic attack affected her balance and walking/out of balance; affected her balance and walking; TIA; This is a sp... Read more
affected her balance and walking/out of balance; affected her balance and walking; TIA; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 25Mar2021 10:00 (batch/lot number EP6955 and expiry date not reported) at 77 years of age as single dose for covid-19 immunization in a clinic facility and not in military facility. Medical history included Stroke from 2014 and another in Dec2018; the patient had MRI to confirm, ongoing blood thinner (therapy). Concomitant medications included rivaroxaban (XARELTO) taken for blood thinner from Jan2019 and ongoing. The patient previously took first dose of bnt162b2 on 04Mar2021 at 77 year of age for covid-19 immunization and experienced arm soreness, Eliquis for 2.5 years after the first stroke for blood thinner and couldn't deal with Eliquis very well and made her feel like she was dying. The patient had no prior vaccinations (within 4 weeks). On 30Mar2021, the patient experienced TIA (transient ischaemic attack). The patient informed that at first she had nothing then five days after the second dose (30Mar2021), she had a TIA. The TIA that she experienced was so sudden and so alarming. It affected her balance and walking (unspecified date). The patient informed that when she was walking to pick up a stick she felt out of balance. The patient was walking like she was a drunken sailor and was staggering. It was the oddest thing. The patient has not talked to her doctor. The TIA was quick then it was gone. It was scary. The patient did not seek treatment (no treatment received). The outcome of the event TIA was recovered on 30Mar2021, while unknown for the rest of the events. The patient considered that the TIA may have had nothing to do with the shot, it happened 5 days later.
77 2021-04-29 stroke This 77 year old white female received the Covid shot on 03/13/21 and went to the ED on 4/10/... Read more
This 77 year old white female received the Covid shot on 03/13/21 and went to the ED on 4/10/21 and was admitted on 4/10/21 with hyponatremia with excess fluid volume, acute respiratory failure with hypercapnia, transient confusion, acute heart failure, shortness of breath and went to the ED again on 4/18/21 with cerebral infarction and died on 4/29/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
77 2021-04-29 palpitations Uncontrollable body shaking, high fever, cold and hot sweats, was not aware at times of where I was ... Read more
Uncontrollable body shaking, high fever, cold and hot sweats, was not aware at times of where I was or what day it was, my husband had to hold me to help stop the shaking.....NOT CHILLS, could not walk, diarrhea. This happened also on March 31st, my FIRST injection.....My heart was beating out of my chest.... very scary. Please don't tell me this is NORMAL!!! I've lost at least 5 lbs. I am petrified to get the booster, if there is one, I WILL NOT GET IT... ANY SUGGESTIONS.
77 2021-04-30 blood clot, cerebrovascular accident stroke caused by a blood clot; stroke caused by a blood clot; right arm went completely numb; She is... Read more
stroke caused by a blood clot; stroke caused by a blood clot; right arm went completely numb; She is tired; shortness of breath; her eyes were blurry; her head felt like somebody put a spike in it on the right side; sore arm; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06Feb2021 13:15 (Lot Number: EM9809) (at age of 77-year-old) as single dose for COVID-19 immunisation. Medical history included colitis ulcerative from Oct2020 (dropped weight, she dropped from 127 pounds to 109 pounds) , cardiac disorder, atrial fibrillation, and osteoporosis, all were ongoing. Concomitant medications included carvedilol taken for cardiac disorder, atrial fibrillation from an unspecified start date and ongoing; cyanocobalamin (VITAMIN B12) taken for cardiac disorder from 2018 (reported as has taking it close to 3 years) and ongoing; denosumab (PROLIA) taken for osteoporosis from an unspecified start date and ongoing; ubidecarenone (Q10) taken for cardiac disorder from unknown start date and ongoing; calcium, colecalciferol (CALCIUM + D3) taken for osteoporosis from 2020 (reported as a year ago) and ongoing; influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported, and vitamins NOS (MULTIVITAMIN) from an unspecified start date and ongoing, the patient started taking it when she was a senior in high school and stated because she is not the best eater in the world. There was no prior vaccinations (within 4 weeks). AE(s) following prior vaccinations: The patient stated arm is sore with flu shot and probably did when she was little when she got the loaded shot, the mumps one. She wouldn't remember that because she was little. The patient experienced stroke caused by a blood clot on 20Feb202114:30 with seriousness criteria hospitalization, sore arm on 07Feb2021, and right arm went completely numb, tired, shortness of breath, her eyes were blurry, her head felt like somebody put a spike in it on the right side on an unspecified date. The event stroke caused by a blood clot result in emergency room visit.The patient was hospitalized for stroke caused by a blood clot from 23Feb2021 to 24Feb2021. The patient reported that she received the first dose and she is thankful she got it on 06Feb2021 and the only side effect she had was a sore arm. Stated on 20Feb2021 she had a stroke caused by a blood clot obviously, she ended up in the hospital. She didn't think at the time, doesn't fault the physicians that took care of her. She didn't think it was related and her eldest son thought it was related. The patient stated they thought it was a mild stroke and after they did the C scan the neurosurgeon, while she was lying in the hospital bed, looked at her assistant and said he couldn't believe that she was talking and walking. The patient stated part of it was ignorance on her part, everyone thought it was the left side that numbs, but hers was the right side. Stated she didn't fall, she dropped something and went down to get it and her right arm went completely numb and she couldn't get back up and she tried to push with legs and couldn't get up. Stated all of a sudden her eyes were blurry and then she never gets headaches and her head felt like somebody put a spike in it on the right side, stated it is supposed to affect the left side. stated she has a heart problem. The patient stated she had a sore arm for about a week, lasted for a few days. stated she gets a sore arm with the flu shot. stated when she would roll over to lay on her left side and roll over on that arm it was enough to wake her up. stated it lasted about 5 days. She couldn't figure out why it was lasting so long. Stated the second thing that happened was that she went to her son's home that night for dinner, hadn't told him about it and while she was eating dinner she asked am if she leaning to the left and he said yes, she was and that her words were being slurred and only lasted for about 10 mins. Stated she didn't call and ignorance is unreal with this stuff. She went to urgent care the next day and they didn't call the ambulance. When she went to the doctor on 23 Feb2021 she was sent immediately to Hospital so she could go through the ER and that's when the neurosurgeon became involved. Stated right now her balance isn't quite right but she is driving and she was taking care of herself and they didn't send anyone home to help her. She was not having any problem talking. Stated she was not going to get into this and will beat it and get back to normal. She was tired a lot, which they said it's normal. Stated she was a real dynamite. Stated it is improving slowly, she was extremely tired and not taking her long walk like she was used to and has shortness of breath, she was not trying to over do it. Stated she always gets a sore arm with the flu shot. Stated her pain level is lower than most people. The patient stated the sore arm started late evening but the next day was really hurting and the main thing was rolling over. The patient stated she didn't take anything for her sore arm, she won't even take an aspirin because some of these Advil medications will mix with the heart medications. Stated in the hospital they were giving her medications she had through an IV in her arm but doesn't know what was going through that. Stated they put her on a blood thinner and they were testing the blood thinner through the IV. She was so miserable, she just wanted to go home and get a good nights sleep. Stated they took all kinds of test, checked her oxygen and had to have a certain number before she could go home. The patient received treatment for event stroke caused by a blood clot and not received treatment for sore arm . The outcome of events stroke caused by a blood clot was resolving, of event sore arm was resolved on 12Feb2021, of other events was unknown.
77 2021-05-07 low platelet count This 77 year old white female received the Pfizer Covid shot on 4/22/21 and went to the ED on4/2... Read more
This 77 year old white female received the Pfizer Covid shot on 4/22/21 and went to the ED on4/24/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified
77 2021-05-10 atrial fibrillation, fast heart rate afib and tachycardia for 3-4 days; afib and tachycardia for 3-4 days; chills; lethargy; kind a brain... Read more
afib and tachycardia for 3-4 days; afib and tachycardia for 3-4 days; chills; lethargy; kind a brain fog; felt like I had a cold spent 2 days feeling like that; She has as temperamental immune system. She is extremely sensitive. She reacts to everything; This is a spontaneous report from a contactable consumer (patient) via Medical Information. A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 72-year-old for COVID-19 immunisation. The patient medical history included temperamental immune system (she is extremely sensitive. She reacts to everything). The concomitant medications were not reported. on an unspecified the patient experienced atrial fibrillation (AFIB), tachycardia, chills, lethargy, brain fog, felt like i had a cold spent 2 days feeling like that, hypersensitivity. Therapeutic measures were taken as a result of AFIB, tachycardia. The outcome of events was unknown. The course of events was as follows: On an unspecified she had reacted to the first vaccine: the first day she was fine. The next day she had chills, lethargy, kind a brain fog, felt like she had a cold and spent 2 days feeling like that. On Day 3 she had AFIB and tachycardia for 3-4 days saw the heart doctor and got medicine for that. She had a temperamental immune system. The stress test was super important. She was wandering if she had the Pfizer vaccine a week after the stress test. She got it at the university, and she wandered if they were restricted to give it to her a few days after my scheduled date: They wanted to rule out blockage in her heart. She was having a test done around the same time as the 2nd Pfizer vaccine. She wanted to know if she could get the 2nd dose of the Pfizer vaccine later/ a week after the stress test. She wanted the vaccine, it was important. On 04May21 she was going to have a dye based test checking your heart, a stress test. The stress test was scheduled the same morning as her 2nd dose of the Pfizer COVID vaccine. She was advised to consult with your doctor or pharmacist for further guidance.
77 2021-05-10 cerebral haemorrhage I61.9 - ICH (intracerebral hemorrhage)
77 2021-05-12 oxygen saturation decreased Fatigue extreme; Not want to eat breakfast, did not have energy just wanted to sleep/ feel very wea... Read more
Fatigue extreme; Not want to eat breakfast, did not have energy just wanted to sleep/ feel very weak; Dizzy; Spinning around like in a tunnel/ Vertigo; Had like 4 attacks a day and I did not hold down laying in bed and looking up ceiling and ceiling starts spinning; Frightening; little warm in the arm; Resting heart rate but the oxygen was running low it was like 84-80; I don't feel good;; Hit me like a rocket; This is a spontaneous report received from a contactable consumer (Patient) via a Pfizer Sponsored program. A 77-year-old female patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not Reported), via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunisation. edical history included ongoing hypertension, ongoing COPD (chronic obstructive pulmonary disease) and ongoing acid reflux. Concomitant medication included metoprolol succinate at 50 mg, once a day for hypertension, alprazolam (XANAX) at 2.5 DF, twice a day for anxiety, albuterol at Every 3 to 4 hours as needed for chronic obstructive pulmonary disease, budesonide at 5 mL, twice a day for chronic obstructive pulmonary disease, arformoterol tartrate (BROVANA) at twice a day morning and night for chronic obstructive pulmonary disease, tiotropium bromide (SPIRIVA) Inhaled through the mouth, once a day as a bronchodilator, aspirin, omeprazole (PROTONIX) at 40 mg, once a day for Acid reflux, diltiazem at 300 mg, once a day for hypertension and unspecified vitamins. Patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization received on 26Jan2021 and experienced warm arm. It was reported that, the patient had a very bad experience with the shot. On Tuesday in this rehabilitation, they were giving out the shot, this was her second shot in this place. The first shot she had no reaction, just a little warm arm. On an unspecified date in Feb2021, the second hit her like a rocket, the day after the shot or the day over the shot just a little warm in the arm nothing really, the next day woke up extremely fatigued did not even want to eat breakfast did not have the energy just wanted to sleep and she said what was going on with her and then she got up very fatigued. Then the physical therapist came in to give physical and they "supposed to" (not clarified) her. It showed a good blood pressure everything was good resting heart rate, but the oxygen was running low it was like 84-80 and she knew she was because she could feel it while she was walking and patient told them she does not feel good, she felt very weak and thought it must be from the shot. So that went on then and go on to this same thing very dizzy on the next day of second shot on 17Feb2021, spinning. That day spinning around in like a tunnel. She had like 4 attacks a day and she did not hold down that she was laying in her bed and she was looking up in the ceiling and this ceiling starts spinning with the whole room. That was 4th of those on Thursday, Wednesday she was just tired, Friday she had less of them but the same thing spinning around, never fell down but again it was not while she was standing up. The physical therapist said to her sit up do not lay down in the bed. Now she was taking pulmonology medication through a nebulizer. Patient also taking bronchodilator and she take a prednisone pill 20 mg, albuterol and she take other medication. Patient did the Covid test when he had blood work up. They do a blood work up every 2 weeks here. But everything was good. The outcome for events was reported as unknown. Information about lot/batch number has been requested.
77 2021-05-13 chest pain, heart attack Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified SHORTNESS OF BREAT... Read more
Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified SHORTNESS OF BREATH CHEST PAIN RESPIRATORY DISTRESS
77 2021-05-13 pulmonary embolism was diagnosed with pulmonary emboli 4/26/21
77 2021-05-17 lightheadedness, heart rate increased, hypertension feeling a little weird; Nauseous; Headaches; blood pressure went up over 220; pulse rate went way up... Read more
feeling a little weird; Nauseous; Headaches; blood pressure went up over 220; pulse rate went way up; really ill; memory is a little off right now; felt like I am going to faint; ringing in the ears; dizzy/light headed; a really really sore arm for two days after the vaccine; allergic reaction; This is a spontaneous report from a contactable consumer, the patient. This 77-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171), via an unspecified route of administration on 29Apr2021 (at the age of 77-year-old) as a single dose for COVID-19 immunization. Medical history included allergies and sinus headaches which she takes (Excedrin) off and on for years in the past, and high blood pressure. Concomitant medications included atenolol (manufacturer unknown) taken for hypertension, start and stop date were not reported. Past drug history included the patient received a flu shot (unspecified Flu shot) with a mega reaction she was sick for weeks which was at least probably 15-20 years ago So, she never got a flu shot after that and she has never had the flu. On 29Apr2021, the patient had a really really sore arm for two days after the vaccine, dizzy/light headed, felt like I am going to faint, and ringing in the ears. On an unspecified date in 2021, she experienced allergic reaction. On 01May2021, she was really ill, and her blood pressure went up over 220 and pulse rate went way up. On 02May2021, she experienced headaches. On 06May2021, she was feeling a little weird and nauseous. On an unspecified date in May2021, her memory is a little off right now. The clinical course was as follows: the patient reported, "I had a really really sore arm for two days after the vaccine, it's okay now, I couldn't really move it. I feel I may be having a severe allergic reaction to the Pfizer vaccine (Pfizer Covid-19 Vaccine) got on Thursday (29Apr2021) of this past week. I am very light headed, dizzy and felt like I am going to faint, has ringing in the ears, and all that has been going on about a week, since last Thursday (29Apr2021). Then I was really ill last night (01May2021). It started last night when we went to bed around 11 O'clock. I have never had anything like this in my life. My blood pressure was through the roof. With a blood pressure cuff and a stethoscope, her blood pressure went up over 220 which was so high that had never happened before, so I took an extra pill (atenolol 25 mg tablet) last night (01May2021) which helped a little bit but not enough, and I really thought that I was going to pass out and be really sick. Because I thought that it was either having a stroke or a heart attack, my husband had to call ambulance to take me to the hospital last night. The systolic and diastolic and pulse rate went way up. They did chest x-ray, blood work, and urinalysis, and everything came back fine and they could not find anything. They just felt that I was just having a major reaction to the shot so they sent me home. I just got home this morning (02May2021) from having to go to the emergency room. But as soon as we got home, I started with a humongous headache and so I had Excedrin/Tylenol for headaches because I used to get sinus headaches. So, I took that, and it helped a little bit, my headache got a little better. Anyhow, I am much better right now and I am sleeping. But tomorrow it will be the same." Later the patient also reported, "Today (06May2021) I am feeling a little weird with ringing of ears and is light headed sometimes. Because of the light headedness, I feels a little nauseous. But I am a still very nauseous. I feel like I am going to faint again and my blood pressure I think has gone back up. I am trying to keep calm and trying to figure out what is going on. But I am really afraid if I am having a reaction to the vaccine unfortunately. I am dizzy and I do not want to start getting worst again. I guess I will feel better if you tell me that this happens sometimes and what can I do to decrease somehow?" She also stated that she did contact her doctor about this event but she didn't get very far. Her memory is a little off right now because she really has not felt well. She stated that her biggest thing is her blood pressure. She also stated, "The only thing that I am really concerned now is about getting the second shot because I already had the reactions by the first shot. Am I going to face the same thing or even the worse with the second shot?" Treatments were received for her blood pressure went up over 220 and headaches. The clinical outcomes of the event "a really really sore arm for two days after the vaccine" resolved on 01May2021, the event nauseous was not resolved, while the events, allergic reaction, really ill, felt like I am going to faint, pulse rate went way up, ringing in the ears, dizzy/light headed, Headaches, feeling a little weird and memory is a little off right now were unknown.
77 2021-05-19 loss of consciousness became extremely dizzy; when I came home and passed out.; Hit my head on floor; received a concussio... Read more
became extremely dizzy; when I came home and passed out.; Hit my head on floor; received a concussion; cut on scalp; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 15Mar2021 13:45 (at the age of 77-year-old) (Batch/Lot Number: en6205) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included atorvastatin; furosemide; and calcium. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: el9265), administered in left arm on 22Feb2021 at 02:30 PM (at the age of 77-year-old) for COVID-19 immunisation. On 15Mar2021, the patient became extremely dizzy when she came home and passed out. She hit her head on floor and received a concussion and cut on scalp. The events caused hospitalization for 2 days. The patient was tested for COVID post vaccination via nasal swab on 22Apr2021 which was negative. Therapeutic measures were taken as a result of all events which includes computed tomography (CAT) scan and electrocardiogram (EKG) with unknown results. The patient recovered from the events on an unspecified date.
77 2021-05-26 atrial fibrillation Vaccine on Wednesday 4/28/21. Started to have mild headache, nausea, generalized malaise and chills... Read more
Vaccine on Wednesday 4/28/21. Started to have mild headache, nausea, generalized malaise and chills on Thursday 4/29/21. Seemed to then improve but then became lightheaded and dizzy. Came to emergency room 5/2/21 at 1000. BP stable at 136/69, O2 sat 99% on room air. No significant findings on blood work (CMP, CBC, Troponin, BNP, TSH all within normal limits). Chest Xray was normal. EKG showed atrial fibrillation with rapid ventricular rate in the 150s. She was given IV diltiazem and her heart rate was controlled. She was admitted to the hospital for observation and conversion from IV to PO diltiazem. She declined oral anticoagulation. She was discharged home on 5/3/21 and instructed to follow up with her PCP and was to see cardiology.
77 2021-05-26 heart rate increased, palpitations Jaw pain up into eye; lymph nodes in the neck that made her hard to move her head; leg cramps; sleep... Read more
Jaw pain up into eye; lymph nodes in the neck that made her hard to move her head; leg cramps; sleepy; palpitations; My chest has been beating like a 107 and it is normally like in the 70/Fast heart beat; lymph nodes in the neck that made her hard to move her head; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; she was sneezing; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205, Expiry Date; UPC and NDC number: Unknown), via an unspecified route of administration on 26Feb2021 01:00 PM in the right arm at 1ST DOSE, SINGLE for COVID-19 immunisation. Patient's age at vaccination was 77 Years. Medical history reported as, the patient first states that she was medication free, but then clarifies that she does takes a vitamin D that is prescribed by her doctor. She had a lot of allergies when she was very young, she was tested for allergies. Two years ago she didn't think she was sick but her calcium was high, she had 2 parathyroid glands removed and she was stronger than she was before. She takes no pills for it, she has nothing wrong with her, outside of the cancer she had when she was 55 years old. Caller reported that the injection did not hurt for either herself or her husband, and it was wonderful. The patient states that she had no fever or chills from the vaccine, but both the caller and her husband were tired after receiving the vaccine, but caller thought it was from stress. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included an unknown vaccine and patient states as, that back a long time, when she was a youngster, when she was given whatever vaccination is needed to go to school, her arm swelled past her elbow, and she was sick for a few days. Caller does not remember which injection it was, it was whatever injection she had to have to go to school, she was 5 years old. Caller doesn't recall the name of the injection. No prior vaccinations (within 4 weeks). The patient states that she does not take the flu shot or anything like that, ever. Vaccination facility was reported as outside the distribution center in the parking lot. On an unspecified date in Feb2021, the patient experienced My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose, lymph nodes in the neck that made her hard to move her head, I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help and she was sneezing; On 26Feb2021, experienced my chest has been beating like a 107 and it is normally like in the 70/Fast heartbeat, sleepy, palpitations; On 01Mar2021, experienced leg cramps; On 03Mar2021, experienced lymph nodes in the neck that made her hard to move her head; On 04Mar2021, experienced Jaw pain up into eye. The report received as, the patient was pleased where she had the injection it didn't have swelling or get red and she does have a history of allergies and her doctor said it was ok to get the shot. The doctor told her, that if she had any eye tearing, nasal drip, or other things like that, to take a Benadryl. Caller waited 12 hours, because her eyes did start to tear, and she was sneezing and so she took a non-drowsy Benadryl, but she waited 12 hours to take the Benadryl, because she didn't want it to interfere. The patient experienced fast heartbeat started in the evening on the same day. Patient also had fast heartbeat yesterday. She reports she had a fast heartbeat; it was in the low 90s, she knows that's not fast for some people, but it was fast for her, and it would come and go like palpitations. Patient does have a machine, her heartbeat was in the 90s, and her chest has been beating like a 107 and it was normally like in the 70s. Caller was in the kitchen when she felt it, so she sat down. The patient reports that she has not experienced the palpitations today. The patient states that she was doing something in the kitchen, she's very active. She normally gets up in the morning and does the breast stroke for 1.5 hours, and patient states that she only got up to the pool once this week, and she didn't stay at the pool long because of the leg cramps. The patient reports she did have a fast heartbeat yesterday. The patient reports that she also started to have a lot of cramps in her legs, which she has never had before in her life. The patient states that 2 days ago, the lymph nodes in her neck must have been swollen, and it hurt so bad last night, she didn't know what to do, she took regular over the counter Tylenol and it did help. The patient states that it's not bothering her today. it's right down the sides of her neck. She looked on the internet for lymph nodes in neck, she knew she had lymph nodes in her neck and it was really, really tight. It was both sides of her neck. It's not as bad today because she couldn't stand it anymore last night so she could take Tylenol. She was to a point sitting in a chair, how could she stretch her neck because it hurt so bad. But this morning she can move it pretty good. She told her husband if it continued that she would go to hospital. She was concerned with if she should get the second shot or not. She was wondering did the first Covid shot cause this. She did take Tylenol this morning, she also reports jaw pain and up into her eyes, that started yesterday, and it has been relieved. She's concerned if she got this with the first shot, could she get it with the second which was scheduled on 19Mar2021, and she was a little doubtful about getting that second shot. The patient states that she was very seriously thinking of not getting the second shot, because she had an awful lot of discomfort with this first shot. The patient states that it wasn't that she was tired, she was just sleepy, she was sleepy on the day she got the vaccine, and then on Saturday, 27Feb2021 she had 3 naps, then on Sunday, 28Feb2021 she had 2-3 naps. Then on Monday, 01Mar2021 she was back to normal. The only things caller was concerned about was if she should get the second shot. She read about not getting the second shot if you had a fast heartbeat. She would call her doctor, but all the doctors are telling people to get the shot. The only reason she got it was because of her husband and his underlying conditions. No specify Antipyretic used around the dates of Vaccination. No relevant tests. The patient underwent lab tests and procedures which included Heartbeat: 107, 90s on 26Feb2021. Outcome of the event lymph nodes in the neck that made her hard to move her head was recovering; events palpitations, jaw pain up into eye recovered on an unknown date; event leg cramps recovered on 03Mar2021 and outcome for remaining events was unknown. No follow-up attempts are possible. No further information was expected.
77 2021-05-26 hypertension getting lightheaded; Excessive hypertension/ 180/88 to 94; This is spontaneous report from a contact... Read more
getting lightheaded; Excessive hypertension/ 180/88 to 94; This is spontaneous report from a contactable nurse reported for herself. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 21Mar2021 (Batch/Lot Number: ER8727) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included hypertension, paroxysmal atrial tachycardia, stroke when she was 40, had COVID in Mar2020 (Her cardiologist believes she had COVID too but never did a test) and broke her ankle. Concomitant medication included warfarin sodium (COUMADIN) because she had a stroke and broke her ankle and got a clot from her ankle to her groin; ongoing diltiazem hydrochloride (DILTIAZEM HYDROCHLORIDE) taken for paroxysmal atrial tachycardia and hypertension; Chlorthalidone taken for polyuria and hypertension; verapamil hydrochloride (VERAPAMIL) taken for paroxysmal atrial tachycardia for years. Patient received first dose of bnt162b2 on 28Feb2021 in left upper arm. Patient was a retired nurse and stated about a month after the second dose of the vaccine she started getting lightheaded, she went to Urgent Care because her daughter who is a nurse insisted. Her blood pressure at Urgent Care was really, really high, she was having excessive hypertension. Before the vaccine she was on a blood pressure medication for several years and had no issues. She went to see her cardiologist and they moved her from one medication to 3 medications (then add Losartan, Diltiazem) to get this controlled. In the morning she was lightheaded and her blood pressure is high before her morning medication. Diltiazem is 24 hours. She gets up at 3AM and once she takes the medication it seems to be ok. Her blood pressure is reasonable now. It is not like it was initially when elevated. Initially it was 180/88 to 94 when she first went to see the cardiologist after second COVID19 Vaccine. Currently her blood pressure in the morning is usually 154/ 77. That was when she first takes it when she gets up. Later in the morning it is running 110/77. The event outcome was unknown. She was feeling that it had to do with the second injection. Patient considered it was medically significant for high blood pressure and lightheaded, and considered both events related to COVID19 Vaccine.; Sender's Comments: Based on the known drug profile, there is a reasonable possibility of casual relationship between the drug BNT162b2 and the events Dizziness and Hypertension. 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.
77 2021-05-31 excessive bleeding major bleed; GI bleed; This is a spontaneous report from a contactable consumer. A 77-years-old fema... Read more
major bleed; GI bleed; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 25Feb2021 (at the age of 77-year-old) (Lot Number: EN6200) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Medical history included first time she experienced bleeding was in 2013 because of aspirin. Stated that she decided it was a good idea to take baby aspirin so she took it on her own. She was told don't ever take aspirin ever again and she didn't have any problem until Nov2020. That was the first incident, in 2013, that told her she should not take blood thinner. They took her off the blood thinner in Nov2020. She had been taking aspirin. She lost half her blood; she lost it two settings. She sat down to take a bowel movement and was told she lost half of her blood. Not sure when she started Aspirin but she stopped it in 2013. It was mentioned that she could take aspirin. She was on a low dose of Eliquis for atrial fibrillation for prevention of a blood clots or heart attack. she had bleeding in the last year. The one that was the most was back in Nov2020; it was more pronounced. Mentioned that she went in on 12Nov2020 for the bleeding and then had to go back in because her legs were swelling. She stopped taking Eliquis in Nov2020 and from then until Apr2021 she had no bleeding. It was several years ago when she was diagnosed. She was riding her bike in the neighborhood, and felt too tired so she stopped at the doctor and went in and told them she felt weird, they couldn't get her BP and took her to the hospital and her heart rate was sky high like 250. They said she might had to have electric. She didn't have any pain but states she was psychologically freaked out by everyone running around. Mentioned that, she was first placed on dronedarone (MULTAQ) 400mg twice daily to treat her atrial fibrillation; she can't remember the year. After taking it as prescribed for some time she got atrial fibrillation again. She was told by the doctor it had lost its efficacy. Concomitant medications included Fenofibrate taken for blood cholesterol, Metoprolol succinate taken for blood pressure, Vitamins NOS, Ferrous Sulfate taken for anemia, Vitamin D3 all are ongoing. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EL3246) on 06Feb2021 in arm left for covid-19 immunization. It was reported that, On 25Feb2021 she received her second dose of the Pfizer-BioNtech Covid-19 vaccine, on 19Apr2021 she had a major bleed and GI bleed (Hospitalization) on 19Apr2021. The patient was hospitalized for major bleed and GI bleed from 19Apr2021 to 21Apr2021. Outcome of the events was unknown. No further information expected.
77 2021-06-01 cerebrovascular accident I63.9 - CVA (cerebral vascular accident) (CMS/HCC) R29.810 - Facial weakness
77 2021-06-01 low platelet count death D69.6 - Thrombocytopenia, unspecified Respiratory failure Intercranial mass
77 2021-06-03 hypertension Horrible feeling; Blood pressure goes high; Joint hurt; Fever/ very low temperature; This is a spont... Read more
Horrible feeling; Blood pressure goes high; Joint hurt; Fever/ very low temperature; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A 77-years-old female consumer (patient) reported for herself that she 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 an unspecified date as a single dose for covid-19 immunization. The patient previously took tylenol as per her common sense and epipens (double dose) for swollen mouth and lips (due to a cleaner) two months ago. Concomitant medications were not reported. As per the description, it was reported that the patient was scared because she didn't had anyone. She was hesitated to get a vaccine. She experienced some reactions after her 2nd dose of the Pfizer vaccine. Her joint hurt and she was in a bad situation. She had a very low temperature than the normal temperature, blood pressure was high when she got upset. She was very angry that she had fever and had nobody to ask a question. She reported that no one told her about a high fever (100.4) or to go to the hospital. She said it was not worth it for her to get a fever. She reported the information on the paper was very vague and not clear, she felt horrible as she suffered and wanted to let know. She wanted to complain that the temperature of fever was not written and none of those were approved. She was asked to contact her local doctor. That was the most horrible experience for her. The patient underwent lab tests and procedures which included blood pressure measurement as high, body temperature as and 100.4. The outcome of all the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
77 2021-06-09 cerebral haemorrhage Nontraumatic intracerebral hemorrhage, unspecified
77 2021-06-16 oxygen saturation decreased 2/22/2021 - Tested positive for Covid 3/9/2021 - found down at her SNF, taken to ER. complains of lo... Read more
2/22/2021 - Tested positive for Covid 3/9/2021 - found down at her SNF, taken to ER. complains of lower back pain, left hip pain, bilateral knee pain, low O2 sat Dx: Aspiration pneumonia of both lower lobes (HCC), *Left lower lobe pneumonia, History of COVID-19, Urinary retention, Diarrhea C diff negative. 3/22: placed on palliative care after speaking with family 3/23: Expired
77 2021-06-17 cerebrovascular accident Started with left hand being useless, then shaking. Shaking moved up to elbow. She tried to take o... Read more
Started with left hand being useless, then shaking. Shaking moved up to elbow. She tried to take off her sweatshirt and her arm froze--this is the last thing she remembers. Husband called 911 and she went to the ER. She had had a seizure and they found 2 brain lesions. She had a CT scan and an MRI in the ER. There was memory loss in the beginning and slurring of words. She felt a weighty fatigue. Was put on Keppra for seizures. Had consults with neurology, a neurosurgeon, a neuro-oncologist--all unsure of what exactly these brain lesions were. Back left lower part of brain: a small lesion, which was basically ignored Right side, towards front, part of brain, on top of and/or intertwined with motor strip: not sure what this is, a stroke or tumor (the neurosurgeon and neurologist had differing opinions) 2/22--1st MRI--shows 2 spots between these 2 MRIs the bloodwork, CT scan, and ultrasound are done--results normal 3/23--2nd MRI--larger lesion is bigger. Was not thought to be a cancerous tumor 4/23--3rd MRI--Looks like larger lesion is improving. A scheduled brain biopsy is postponed 5/20--4th MRI--the small spot is almost gone and the larger spot is much smaller, about 1/8th the size of the February MRI. According to the neuro-oncologist, this was an atypical stroke.
77 2021-06-23 deep vein blood clot Deep vein thrombosis
77 2021-06-28 heart attack I21.4 - Non-ST elevation (NSTEMI) myocardial infarction J18.9 - Pneumonia, unspecified organism
77 2021-06-29 pulmonary embolism Pulmonary embolism (CMS/HCC)
77 2021-07-06 haemoglobin decreased, oxygen saturation decreased, low blood oxigenation Pfizer COVID Vaccine EUA Pfizer Dose 1 2/6/21 (lot # not listed) Pfizer Dose 2 3/6/21 (lot # not li... Read more
Pfizer COVID Vaccine EUA Pfizer Dose 1 2/6/21 (lot # not listed) Pfizer Dose 2 3/6/21 (lot # not listed) COVID Positive 5/25/21 at PCP office (but negative upon repeat testing 5/25/21) 5/25/21: The patient is a 78-year-old female presents emergency department today after testing positive for COVID-19 at her PCP office, they recommended she present to ED to rule out pulmonary embolism. Patient has a past medical history significant for ESRD on HD Monday Wednesday Friday, hypertension, diabetes mellitus type 2, anemia of CKD, and osteoarthritis. Of note, the patient had her COVID-19 Pfizer vaccination series completed in February of this year. On arrival to the ED, the patient's temperature is 98.4° F, heart rate 68, respiratory rate 26, saturating 90% on room air with blood pressure 163/63. The patient did desaturate to 87% on room air when ambulating in the room. The patient's laboratory studies were significant for HGB 11.3, ESR 44, CRP 1.7, BUN 17, CR 4.80, UA: Proteinuria, trace hematuria, small leukoesterase, many bacteria, 11-30 pyuria, 1-3 RBCs and moderate squamous epithelial cells sent for culture. Blood cultures x2 obtained. Chest x-ray shows no acute cardiopulmonary findings. V/Q scan showed normal exam. EKG showed normal sinus rhythm. The patient was seen emergency department laying in bed. She reports worsening shortness of breath over the weekend and COVID like symptoms for the past week. She reports some dyspnea on exertion. She states she has been weak, fatigued, had some chills, and was seen by her PCP, who tested her for COVID-19 and she tested positive. This COVID-19 test is not and are records. The patient has had some desaturations less than 90% when she falls asleep. She wishes to be a full code. 6/1/21: She is admitted to the hospital, as mentioned above 0 repeat COVID test is negative. V/Q scan is reported as normal. She is started on dexamethasone 6 mg IV daily, along with IV antibiotics ceftriaxone Zithromax and Acapella. Pulse ox is monitored, oxygen is weaned off patient has been stable on room air and has been afebrile. Nephrology consult is requested, patient had hemodialysis as per Nephrology recommendations on Monday, Wednesday and Friday. Her blood pressures were uncontrolled, her home medications Coreg dose was increased to 37.5 mg p.o. b.i.d. and Procardia XL increased to 60 mg p.o. daily and blood pressures have been stable now. Patient did complain of weakness to ambulate, had physical therapy and occupational therapy evaluation. She is being discharged home today in stable condition for skilled nursing. She is off steroids now. Discharge plan is discussed with the patient.
77 2021-07-11 cerebrovascular accident Stroke
77 2021-07-12 blood pressure increased, chest discomfort, chest pain I first lost my nail. It was unusual because there was no trauma to the nail. I was reaching for som... Read more
I first lost my nail. It was unusual because there was no trauma to the nail. I was reaching for something across my bed, and I started experiencing radiating pain across my chest as well as pressure. I stayed very still and then it spread through my left arm and up into my shoulder, neck ear and jaw. I remained still and tried breathing the best I could. This lasted a minute or two and then it released and was over. About a month later, I was diagnosed with RSV which ran down into my lungs and soon my blood pressure was going up because my heart was working so hard to breathe. It was over 200/175 which is abnormal for me. I had to end up calling an ambulance because I was having trouble breathing. I was prescribed blood pressure medication, steroids, antibiotics, prednisone and oxygen. I was not allowed to get out of bed, I couldn't walk. They told me it would take baby steps.
77 2021-07-12 cerebrovascular accident, blood clot in the brain My mother has had her share of health problems predominantly relating to her Afib diagnosis,however ... Read more
My mother has had her share of health problems predominantly relating to her Afib diagnosis,however after every dose she experienced side effects that have set her back in ways that were completely new,loss of memory Sluring her words, really bad head aches leading up to the first and second stroke.She was able to drive live on her own had sweet and kind,funny personality now that is all gone. She is a shell of who she was and our family just simply misses her,I truly just wish that we would have had been warned of the possible risks to patients like her prior to getting the vaccine.No matter how small the possibility of adverse reaction.We would have chosen to keep her longer.
77 2021-07-15 blood pressure increased RIGHT ARM HURT THE NEXT MORNING. LEFT ARM HURT THE 2nd MORNING. A WEEK LATER MY BLOOD PRESSURE WEN... Read more
RIGHT ARM HURT THE NEXT MORNING. LEFT ARM HURT THE 2nd MORNING. A WEEK LATER MY BLOOD PRESSURE WENT UP ABOUT 40 POINTS AND I WENT TO DR AND HE RAISED MY BLOOD PRESSURE DOSE. THEN BOTH MY KNEE JOINTS SWELLED FOR A WEEK. THE SWELLING LEFT MY KNEES AND WENT DOWN TO MY ANKLE BONES. IT HAS BEENOVER A MONTH AND I CAN BARELY WALK.
77 2021-07-21 heart attack, troponin increased, atrial fibrillation, chest discomfort, chest pain, fibrin d dimer increased, inflammation of the pericardium Pericarditis S/S: actue chest pain or pressure, Chest pain made worse bu lying down, deep inspiratio... Read more
Pericarditis S/S: actue chest pain or pressure, Chest pain made worse bu lying down, deep inspiration or cough, Pain Hx from 3 providers Patient presents for CP that started on Sunday night. Worse with inspiration states she feels like she has to breath shallow. Reports at 3:30 this morning pain was worse. Developed this retrosternal pleuritic chest pain late Sunday that has worsened over the course of the day yesterday and early this morning. She describes it as radiating up into her neck at times. No shortness of breath or cough. The pain encompasses a large area of her central chest which can radiate up the center of her neck. It is worse with deep breaths but not worse with walking. Initial Admit for Chest pain, developed A Fib during ED admission. Seen by Cardiology. Admitted 2/16-2/18. Neg CT pulm angiogram. Disch Diag including Cardiology 1. Pleuritic chest pain, 02/17/2021 2. Atrial fibrillation, 02/18/2021 3. NSTEMI (non-ST elevated myocardial infarction), 02/17/2021 4. Pleural effusion, bilateral, 02/18/2021 Pt readmitted 2/19/21. Troponin neg at that admit. D Dimer, Quantitative: 2.62 mcg/mL FEU Troponin I: <0.030 ng/mL BNP: 227 pg/mL Cardiology consult 2/20/21 called it pericarditis On 3/10/21 admitted for salicylate toxicity (on ASA for AFib) and ED provider stated that 2/16/21 admit for chest pain states that cardiology note at 3/10/21 stated the prior admit included diagnosis of pericarditis
77 2021-07-21 low blood oxigenation Patient presented to the ED and was subsequently hospitalized for acute respiratory failure with hyp... Read more
Patient presented to the ED and was subsequently hospitalized for acute respiratory failure with hypoxia and pneumonia within 6 weeks of receiving first dose of covid vaccination.
77 2021-07-21 palpitations Feeling tired. After about six weeks, rapid decline with COPD - trouble breathing and heart palpit... Read more
Feeling tired. After about six weeks, rapid decline with COPD - trouble breathing and heart palpitations.
77 2021-07-22 fluid around the heart, chest pain, enlargement of the heart, inflammation of the pericardium, chest discomfort DX: Pericarditis onset 05/07/2021 Clinician description of chest pain: She now has some constant dul... Read more
DX: Pericarditis onset 05/07/2021 Clinician description of chest pain: She now has some constant dull central chest pain and vague shortness of breath similar to her symptoms she had with her pericarditis. She is concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis and concern for rheumatologic etiology. CT Chest showed Cardiomegaly and small pericardial effusion, similar to 1/4/2021. Mild abnormality of CXR may be baseline. Mild abnormality in ECG. Elevated inflammatory markers and normal troponin. As above this easily could be a flare of a prior diagnosis of pericarditis due to being on a prednisone taper. She is under the care of a Rheumatologist. Concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis on a steroid taper and concern for rheumatologic etiology. S/S: Dyspnea pn exertion, acute chest pain or pressure onset 05/03/2021
77 2021-07-23 blood pressure increased Blood pressure spikes for 3 days starting on day 3 after the vaccine. Top number spiked to 180 for 3... Read more
Blood pressure spikes for 3 days starting on day 3 after the vaccine. Top number spiked to 180 for 3 days in a row.
77 2021-07-23 chest pain PT C/O CHEST PAIN AND SOB POSITIVE COVID TEST ON 7/22/21
77 2021-07-26 fainting fever, syncope, fatigue
77 2021-07-27 low blood oxigenation, troponin increased Was exposed to a positive COVID person. On 4/4 pt. reported to the emergency department with cough, ... Read more
Was exposed to a positive COVID person. On 4/4 pt. reported to the emergency department with cough, sore throat, fatigue, sinus congestion. Tested positive for COVID on 4/4. Chest x-ray done, diagnosed with pneumonia on oral azithromycin. On 4/7 pt. returned to the Emergency department via ambulance - she was hypoxic, weaker and more short of breath - O2 sats in the 70s. Received blood on 4/5 as well as monoclonal antibodies. Troponin elevated at 0.409, EKG showed inverted T-waves.. Patient transfered to hospital.
77 2021-07-27 palpitations she couldn't breathe very good and her heart started racing; she couldn't breathe very good and her ... Read more
she couldn't breathe very good and her heart started racing; she couldn't breathe very good and her heart started racing; Just didn't feel good; Tired; Felt queasy; Dizziness; blood sugar was low; Sore Left Arm; This is the spontaneous report from a contactable consumer. This 77-year-old female consumer reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6201 and expiry date: 31-May-2021) via an unspecified route of administration on 24-Feb-2021 at 08:15 in left arm (77-year-old), as dose 2, single for COVID-19 immunization. Medical history included of the patient included a dental surgery. When she got up in the morning her face was real puffy and she thought she looked like the Pillsbury dough boy. Both cheeks were swollen. This surgery was to remove a tooth. She stated that she took her premedication before her oral surgeon appointment. She previously had a kidney replacement and a shoulder replacement. She always takes pain meds before she does any dental work. She had blood pressure measurement, depression, knee arthroplasty, shoulder arthroplasty, thyroid atrophy, renal failure, coronary arterial stent insertion, hypothyroidism and steroid therapy. Concomitant medications of the patient included sertraline taken for antidepressant therapy, levothyroxine taken for hypothyroidism, potassium citrate taken for renal failure, atorvastatin taken for coronary arterial stent insertion, hydrochlorothiazide taken for blood pressure measurement, prednisone taken for steroid therapy from 27Jan2021 to an unspecified stop date; amoxicillin taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9265 and expiry date 31May2021) via an unspecified route of administration on 02Feb2021 in left arm (77-year-old), as dose 1, single for COVID-19 immunization and had no problems. It was mentioned that additional vaccines administered on same date of the pfizer suspect were reported as none. On 25Feb2021 the patient experienced sore left arm. On 28Feb2021 the patient did not feel good, tiredness, felt queasy, dizziness and blood sugar was low. So she had some orange juice and went about her day to grocery shop, so she laid down to take a nap and then felt okay. On 01Mar2021 she could not breathe very good and her heart started racing. Caller reported that she did not get clammy and that was why she did not feel it was hypoglycemia. She has not had that for years as she watched and made sure she does not eat too many carbs. She was tired and took a 3 hours nap. Caller states the whole time she just did not feel herself, but she just went on and pushed things aside as she had a life to live. She did not relate it to the vaccine at first. She got out her information paper and she had all of the symptoms that were on the paper besides the rash. The patient did not require emergency room and physician office visit. On an unknown date in 2021 breathing difficult, Heart racing, Feeling unwell, Tired, Felt queasy, Dizziness, blood sugar was low recovered. On 27Feb2021 sore left arm recovered. Caller would like to know if it is typical to experience side effects four days after receiving a dose of the Pfizer vaccine. Caller stated that she was home when she experienced the side effects and felt like a wet noodle and just wanted to lay down and did not seek medical attention. Caller did not clarify what the other number was that she had called and was directed to Pfizer DSU, but stated she had not made any reports previously. Caller does not have an email for her doctor at this time. She said she has not called him. She felt sick yesterday. Her cousin wanted her to go to the hospital but she said she can not do it as she could not breath good and just wanted to lie down. She was so weak. Caller mentioned that she was a little chubby, but she exercises and moves around a lot. Caller stated that she was not feeling good but went on because she has a life to live and go on with things. Caller stated she was taking Prednisone when she received her second Covid vaccination and she wondered if that had anything to do with her reaction. The patient took Excedrin Migraine for headache took Saturday, caller was unaware of dose she took. She stated that it was just over the counter. The Excedrin Migraine expiration date 21Dec and Lot SP2W, but she stated that she usually just takes Tylenol. Caller Mentioned taking normal vitamins daily and I Caps, she stated she feels like she does well for her age, and then restated that she does Damn well for her age. Caller states her family has heart disease issues during Vaccine supplemental form but continued to stated that she does not feel that was relevant to this report. Follow-up attempts were completed. No further information was expected.
77 2021-07-27 troponin increased, low blood oxigenation Was exposed to a positive COVID person. On 4/4 PT reported to the emergency department with cough, s... Read more
Was exposed to a positive COVID person. On 4/4 PT reported to the emergency department with cough, sore throat, fatigue, sinus congestion. Tested positive for COVID on 4/4. Chest x-ray done, diagnosed with pneumonia on oral azithromycin. On 4/7 PT returned to the Emergency department via ambulance - she was hypoxic, weaker and more short of breath - O2 sats in the 70s. Received blood on 4/5 as well as monoclonal antibodies. Troponin elevated at 0.409, EKG showed inverted T-waves.. Patient transfered to Hospital.
77 2021-07-28 blood pressure increased Elevated blood pressure; swelling in mouth/lips; Nausea; Sensitivity to sound; Severe itching (all o... Read more
Elevated blood pressure; swelling in mouth/lips; Nausea; Sensitivity to sound; Severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils); This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0140), via an unspecified route of administration in the left arm on 20Jan2021 at 10:00 (at the age of 77-years-old), as a single dose for COVID-19 immunisation. Medical history included spinal stenosis, degenerative disc disease, arthritis, sciatica, high blood pressure, diabetes, high cholesterol, pollen allergy, dust allergy, ragweed allergy, carageenan allergy and fruit allergy (tomatoes). Concomitant medications included morphine sulfate (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and metoprolol succinate (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously took simvastatin on unknown date for an unspecified indication and experienced drug allergy. 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 20Jan2021 at 22:00, the patient experienced swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure. It was unknown if therapeutic measures were taken as a result of 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 swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
78 2021-01-08 chest pain, heart rate increased Rapid heart rate and pain in upper chest for about 15-20 minutes. Called 911, they gave two EKGs wh... Read more
Rapid heart rate and pain in upper chest for about 15-20 minutes. Called 911, they gave two EKGs which appeared to be normal.
78 2021-01-08 loss of consciousness Patient was unresponsive in her room during the night, had gotten the vaccine this morning, 911 call... Read more
Patient was unresponsive in her room during the night, had gotten the vaccine this morning, 911 called. Had right arm pain and loss of consciousness. EMS got 180/104 BP and blood glucose was 122. Was transported to hospital. Returned to the facility the next day with no complications, was just fatigued.
78 2021-01-18 chest discomfort Patient stated she has had anaphylactic reaction to a flu vaccine a couple months ago. Patient state... Read more
Patient stated she has had anaphylactic reaction to a flu vaccine a couple months ago. Patient stated she spoke with her physician and he still recommend her to receive the COVID-19 vaccine today. Discussed premedication; however, patient stated that doesn't work. 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. , RN took patient, via wheelchair, to ED. Husband was with patient. ED triage took patient back and husband checked in patient.
78 2021-01-18 chest discomfort Patient stated she has had anaphylactic reaction to a flu vaccine a couple of months ago. Patient s... Read more
Patient stated she has had anaphylactic reaction to a flu vaccine a couple of months ago. Patient stated she spoke with her physician and he still recommend her to receive the COVID-19 vaccine today. Discussed pre-medication; however, patient stated that doesn't work. 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. RN , took patient, via wheelchair, to ED. Husband was with patient. ED triage took patient back and husband checked in patient.
78 2021-01-18 heart rate increased Symptoms: "fast heart beat" HR around 100-108. BP normal. No intervention. Resolved on its own.
78 2021-01-20 heart rate increased, blood pressure increased Increase pulse; increase B/P; headache; light headed; unsteady lasting from 1/11/21-1/20/21.
78 2021-01-20 low blood oxigenation Admitted to hospital 1/14/2021 with acute mental status changes, hypoxia, pneumonia (previous positi... Read more
Admitted to hospital 1/14/2021 with acute mental status changes, hypoxia, pneumonia (previous positive COVID 12/18/2020) ICU 1/14/2021-1/16/2021, currently hospitalized PCU level of care
78 2021-01-26 hypotension Progress Notes (Physician Assistant) ? ? Family Medicine Cosign Needed Expand All Collapse All ... Read more
Progress Notes (Physician Assistant) ? ? Family Medicine Cosign Needed Expand All Collapse All Date: 1/25/2021 Subjective 78 y.o. male who was seen today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience dizziness. He denied difficulty breathing and difficulty swallowing. 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 hypotension and rapid progression of symptoms. Patient ate a bowl of oatmeal this morning prior to receiving his vaccine. He has only drank a small amount of diet coke today, no water. He became dizzy when standing up and some while walking. He notes the dizziness resolved on his walk to the medical evaluation bay. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness Patient denies chills, fever, facial swelling, chest tightness, shortness of breath, wheezing and headaches Previous Reactions: Denies Objective Vitals Vitals: 01/25/21 1150 BP: 133/86 Pulse: 84 SpO2: 97% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Assessment/Plan Treatment included: water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Patients symptoms of dizziness completely resolved prior to discharge. He denied dizziness when standing up and walking to leave the medical evaluation bay. Electronically Signed 1/25/2021 12:02 PM
78 2021-01-26 platelet count decreased Low plts at 6. Admitted to hospital.
78 2021-01-28 blood pressure increased, heart rate increased This is a spontaneous report from a contactable consumer who reported for herself. A 78-year-old fem... Read more
This is a spontaneous report from a contactable consumer who reported for herself. A 78-year-old female patient received her single first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3246), at right arm, 17:00 on 08Jan2021 for Covid-19 immunization. The patient's medical history included hyperlipidemia, hypothyroidism, osteopenia, skin cancer, osteoarthritis right hip and had known allergies to zocor, lipitor, latex, fluorouracil, imiquimod, travis. The patient normally had low blood pressure and pulse. Patient had no Covid-19 prior to vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and pravastatin sodium (PRAVASTATINE SODIUM ACCORD). Patient had no other vaccines within four weeks. 08:00 on 10Jan2021, the patient had increase in B/P, pulse, and developed headache and light headed. The patient had healthcare professional office/clinic visit. No treatment was received. The patient had not tested Covid-19 prior to or post vaccination. The outcome of the events was not resolved at the time of reporting.
78 2021-01-28 heart rate increased, fluid around the heart felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fas... Read more
felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fast heart rate (100 bpm); low grade fever; felt very weak; pleuralpericardial effusion; pleuralpericardial effusion; This is a spontaneous report from a contactable consumer. A non-pregnant 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 16Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included allergic to opioids, allergy to fish, cirrhosis with portal hypertension, parkinsonism, heart blockage, type 2 diabetes, depression, early dementia. The patient previously took morphine and experienced drug hypersensitivity. There was unspecified concomitant medication. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced allergic to morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced felt tired, nausea, headache, short of breath, rapid/shallow breathing, fast heart rate (100 bpm), low grade fever, felt very weak, pleuralpericardial effusion on 16Jan2021. All the events were reported with the seriousness criteria of disability, hospitalization and being life-threatening. The patient was hospitalized for the events for 4 days. After the injection, from 0 to 24 hours the patient felt tired, had nausea, a headache, short of breath then at about 24 hours post injection developed rapid/shallow breathing, fast heart rate (100 bpm) low grade fever and felt very weak. The patent was taken to the emergency room (ER) at 30 hours post injection and it was determined (Xray, CTA & EKG) that she had a pleuralpericardial effusion. She was flown by air life to another ER for treatment. The patient underwent lab tests and procedures on 16Jan2021 which included angiogram (CTA): had a pleuralpericardial effusion; body temperature: low grade fever; electrocardiogram (EKG): had a pleuralpericardial effusion; heart rate: 100 beats per minute (bpm); X-ray: had a pleuralpericardial effusion. The patient had a rapid nasal swab on 17Jan2021 which was negative. Therapeutic measures were taken as a result of the events and included unspecified medications & oxygen therapy. The outcome of the events was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
78 2021-01-30 hypotension Patient reported that after a couple of hours of receiving the covid vaccine, she became dizzy, naus... Read more
Patient reported that after a couple of hours of receiving the covid vaccine, she became dizzy, nauseated, and lightheaded. She reported her blood pressure was low 80/60 and her heart rate about 100. She rested and her pressure came up. Then she reported a couple hours later she felt that way again while walking around house. She sat down and felt better. Then around 6p symptoms came back and she also had a headache and a little shortness of breath. She then decided to go to the ER.
78 2021-01-31 chest pain dizziness, mild chest pain for a few hours Resolved by that evening
78 2021-02-01 chest discomfort, blood pressure increased she had a wave that started at the top of her head and felt like she was losing consciousness and th... Read more
she had a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest; Chest tightness; like she was going to faint or go to sleep; like she was going to faint or go to sleep; she barely had a little pain at the COVID-19 Vaccine injection site that went away quickly; This is a spontaneous report from a contactable consumer, the patient. This 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), dose 1 , single dose via an unspecified route of administration in the left upper arm on 08Jan2021 at 09:15 AM (at the age of 78 years-old) for COVID-19 vaccination. Relevant medical history included ongoing high blood pressure in Dec2020. Concomitant medications included valsartan (DIOVAN) 160mg tablet, once a day from 10Dec2020 and ongoing for high blood pressure and clobazem (CALM) from Jan2021, lot: 1115941, expiration: Mar2022. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 08Jan2021 at 09:15 AM, the patient barely had a little pain at the COVID-19 vaccine injection site that went away quickly. On 18Jan2021, the patient had chest tightness and a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest. She said it was like she was going to faint or go to sleep. She said the wave went down to her chest area and stayed for a big portion of the day. She said she had a heaviness in her chest, clarified as a chest tightness. She said she has no heart issues. The patient still had some tightness in her chest and it may be just from worry. She said she was normally calm, so she was not sure about what was causing her current chest tightness. The patient did not think what she experienced on 18Jan2021 was serious enough to contact her primary care doctor. There were no relevant laboratory tests done. The patient did not require a visit to the emergency room or physician's office. The clinical outcome of event, barely had a little pain at the COVID-19 vaccine injection site was recovered on an unknown date in Jan2021. The clinical outcome of event, wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head was recovered on 18Jan2021 after treatment was given. The clinical outcome of chest tightness was recovering after treatment was given. The clinical outcome of like she was going to faint or go to sleep was unknown.
78 2021-02-03 heart rate irregular, palpitations About 7-10 minutes after receiving the shot, patient started to feel extremely shaky and warm. Her f... Read more
About 7-10 minutes after receiving the shot, patient started to feel extremely shaky and warm. Her face turned red and hands were shaking. Patient felt her heart skipping with irregular heart beats. The nurse measured the patient's blood pressure and it was 183/95 with a pulse of 104. The patient was observed for an hour.
78 2021-02-03 pallor Approximately 10 minutes after receiving the COVID- 19 vaccine resident displayed seizure activity, ... Read more
Approximately 10 minutes after receiving the COVID- 19 vaccine resident displayed seizure activity, staring straight ahead and strong allover muscle jerking of both the up and lower extremities, color became gray, activity lasted approximately 3 minutes, resident then became relaxed, color returned to normal, BP-140/80, 97.8, 60, 16, sleeping the remainder of the shift,. Resident continued to decline until resident CTB on 1/19/21
78 2021-02-04 chest pain chest pain with throat irritation 1 day after receiving vaccine. no anaphylaxis. symptoms resolved.
78 2021-02-04 palpitations Immediately after receiving the vaccine had heart palpitations while sitting down for the 15 minute ... Read more
Immediately after receiving the vaccine had heart palpitations while sitting down for the 15 minute wait time. She thought it would be temporary and go away, but did not. She came home, and it was still happening, still having them. She talked to her daughter and went to the ER. They did an EKG and blood work for fear of having a heart attack, all was negative. Didn't do anything more for her. After 3 hours and moved to a chair and then it suddenly stopped. She did have this reaction for about 5 hours. Still feeling tired but not sure if it was from weather or stress itself.
78 2021-02-05 troponin increased, fast heart rate, low blood oxigenation, haemoglobin decreased AMS-Fever-UTI-myoclonic jerks-unresponsive <6hrs post 1st covid vaccine. AMS-UTI- post 2nd covid vac... Read more
AMS-Fever-UTI-myoclonic jerks-unresponsive <6hrs post 1st covid vaccine. AMS-UTI- post 2nd covid vaccine
78 2021-02-07 blood pressure increased, hypertension double vision, little dizzy, headache - yesterday had her 2nd vaccine SYMPTOMS DURATION: 2 days. Pa... Read more
double vision, little dizzy, headache - yesterday had her 2nd vaccine SYMPTOMS DURATION: 2 days. Patient states she got her first COVID vaccine on 2/5/21 and had a slight headache but no other symptoms. Today, she was sitting the car when she started to have double vision. She reports dizziness/lightheadedness that is moderate. Patient states the double vision isn't everything but random things and at random times today. Denies dehydration, fever, or injection site abnormalities. No headache today. Reports that last week at her PCP's office her BP was slightly elevated and she thinks her BP may be elevated right now but does not have a cuff with her to check. Went to the Emergency Department on 2.6.21 - admitted overnight until the 7th. DETAILS OF HOSPITAL STAY: DX: Diplopia [H53.2] Blurred vision, bilateral [H53.8] HOSPITAL COURSE: 1. Double vision post COVID vaccine. Unclear etiology or if related to vaccine reaction. Resolved. CVA ruled out. Could be migraine associated. Advised patient to talk to PCP about migraine prophylaxis and see ophthalmology as outpatient. 2. HTN 3. HLD Advised patient not to drive till cleared by ophthalmology Inpatient workup included myasthenia gravis panel which is still pending The patient is a 78-year-old right-handed woman who received her first Pfizer COVID vaccination February 5. This morning she developed double vision. Images were horizontal she does not know if they were binocular or monocular. She saw couple with 1 child and it appeared that they had 2 children. She looked at her son and saw 2 heads on 1 body. She saw 2 traffic lights. Each time she saw diplopia, it lasted for maybe 1 minute, and after blinking it went away. The double vision was not associated with headache, facial numbness or weakness, numbness or weakness in her extremities, speech change or imbalance. She recovered from each episode. She has had torn retina twice in each eye. Those were each associated with flashes of light in floaters. She did not have a fever today. She has never had double vision before. Review of systems: She admits to a history of headaches. She said she had catamenial headaches and sinus headaches.
78 2021-02-07 chest pain Symptoms: c/o chest pain, lightheadedness, vitals WNL. Intervention: rest, reassurance - symptoms re... Read more
Symptoms: c/o chest pain, lightheadedness, vitals WNL. Intervention: rest, reassurance - symptoms resolved.
78 2021-02-07 heart rate increased, chest discomfort I began feeling weak around 3:15 and was worse by 4 PM. Then I began having shivers but no temp. I f... Read more
I began feeling weak around 3:15 and was worse by 4 PM. Then I began having shivers but no temp. I felt weak and pulse raced as soon as I got up and walked around. Some aches and pains and malaise but I slept all night. Next day still felt poorly but no chills. Got a cold spell towards evening bu lasted about 1 hr. Some slight congestions that was relieved with a good cough maybe twice a day for another couple of days. That is all.
78 2021-02-07 palpitations, fast heart rate Around 3:50pm patient had complaint of heart jumping. Heart rate was initially 104, after 30 minutes... Read more
Around 3:50pm patient had complaint of heart jumping. Heart rate was initially 104, after 30 minutes rest, coached deep breathing, heart rate 90 regular. Patient was persistently uncomfortable and tachycardic and requested EMS evaluation. Responding EMS checked EKG, glucose, BP (etc) and released. Patient seemed to have moderate reaction to vaccine.
78 2021-02-09 chest discomfort c/o chest "felt a little tight", denies pain, SOB ,. Feels better after 10 min.
78 2021-02-10 hypertension, heart rate increased severe headache lasted almost 3 days High blood pressure with a racing heart on the third day I re... Read more
severe headache lasted almost 3 days High blood pressure with a racing heart on the third day I received a prescription from my cardioligist the next I lost my sense of taste as of 02/02/2021 (11 days) my taste has not returned
78 2021-02-10 hypotension Felt faint and lightheaded thirteen minutes after receiving shot. Hypotension down to Systolic Blood... Read more
Felt faint and lightheaded thirteen minutes after receiving shot. Hypotension down to Systolic Blood pressure of 72. Became unresponsive; EpiPen used. Patient improved. Taken by paramedics to emergency department
78 2021-02-10 palpitations Pt reported Heart palpitations apprx 3 days following 1st dose. Pt reports the episode last for ap... Read more
Pt reported Heart palpitations apprx 3 days following 1st dose. Pt reports the episode last for apprx 2hrs
78 2021-02-11 chest discomfort, chest discomfort 10 minutes after receiving injection patient c/o check pressure.
78 2021-02-11 loss of consciousness, cardio-respiratory arrest Few minutes post vaccination, after moving to observation area via wheelchair, the patient complaine... Read more
Few minutes post vaccination, after moving to observation area via wheelchair, the patient complained of dizziness. She took glucose tabs she had brought with her. Staff wheeled her to Triage # 1. Her eyes rolled back in her head and she lost consciousness. Staff (paramedics on site) transferred her to gurney and started compressions. AED placed, V- Fib was rhythm, Shock # 1 given, CPR resumed. Shocked again. Fire truck and additional EMT arrived on site and took over care. Epinephrine was given 3 times via intra-osseous route, Amiodarone given intra-osseous route. Additional defibrillation with on site AED for a total of 6-7 times. Patient had good chest rise with ambu-bag, no airway obstruction or peri-oral edema noted. Code called at 12:40 PM.
78 2021-02-14 cardiac arrest, loss of consciousness unconscious; no heart rate/heart was not beating; all of the sudden she stopped breathing and her he... Read more
unconscious; no heart rate/heart was not beating; all of the sudden she stopped breathing and her heart stopped beating; COVID 19 test positive; act funny, kind of quiet and not talking which was unusual for her; pressure was 60 over 4; This is a spontaneous report from a contactable consumer (patient husband). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), via an unspecified route of administration on 28Jan2021 16:00 at single dose at left arm for covid-19 immunization. Medical history included kidney ablation (ablation on the kidney cancer 5 years ago), kidney cancer, blood pressure, neuropathy, pain, had a urinary tract infection 19Dec2020 and they saw the cancer came back, radiologist read the CAT Scan and said the size of the tumor 1.5 to 2.4. Concomitant medications included acebutolol for blood pressure taking for years, diclofenac for neuropathy using for 10 years, oxycodone for pain taking 19 years; all ongoing, and oxycodone hydrochloride (OXYCONTIN) for pain. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Family Medical History was none. The caller stated that he was not sure if the Pfizer COVID-19 vaccine could have given patient (his wife) COVID-19 or not. He also stated that when they received their vaccines the facility was very crowded as was the hospital when the wife was getting her blood work done so he was not sure when or where she contracted COVID-19. On 29Jan2021, patient was very busy running several errands including going to the hospital for bloodwork and a nuclear medicine injection as part of a work up for kidney ablation that the patient was supposed to have completed, patient was in the process of getting ready to have an ablation on her kidney and had the nuclear scan for her kidneys and then went to get a COVID test. After they got home, patient sat down at the computer and she started to act funny, kind of quiet and not talking which was unusual for her. So at about 1700PM the husband went in to ask her what kind of music she would like and he found her unconscious in the chair. He took her blood pressure and it was 60 over 4; with no heart rate; she was just barely breathing, he could tell by the way her mouth moved. He tried to breath for her, all of the sudden she stopped breathing and her heart stopped beating. He called (phone number provided) and they rushed her to the hospital, and the paramedics verified her heart was not beating and they started to do resuscitation. Then they finally pulled her out of the chair and put her on the floor and she started to breath. When they took her to the ambulance she was still not quite coherent; she didn't know what was happening. She was taken to the hospital emergency room and stayed there for 12 hours and they monitored her with an EKG and only saw one spike for 6 seconds. They discharged her on 30Jan2021 afternoon and she has been totally normal 100 percent since then. Since she had been home she had been doing well and has had no other events. Added patient had never had a heart problem before. Caller stated that he was not sure if this event was related to her receiving the vaccine or not. Now they had to stay in quarantine 10 days until 08Feb2021 since the COVID test given at the hospital on 29Jan2021 night when she went in was positive. Patient was scheduled to received the second shot 18Feb2021. Outcome of events unconscious, no heart rate, pressure was 60 over 4 was recovered on 29Jan2021, events started to act funny and stopped breathing was recovered on 30Jan2021, outcome of other events was unknown. The adverse events resulted in emergency room/department or urgent care, patient was taken to the ER and monitored for 12 hours but no admission. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect.
78 2021-02-14 palpitations, atrial fibrillation I was in A Fib; feel strange; felt like my heart was racing; I felt shaky; This is a spontaneous rep... Read more
I was in A Fib; feel strange; felt like my heart was racing; I felt shaky; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL963), via an unspecified route of administration on 26Jan2021 12:00 at single dose in the left arm for COVID-19 immunization. The patient medical history included borderline high blood pressure, high cholesterol, Hashimoto's, hypothyroid. The patient's concomitant medications included rosuvastatin, levothyroxine sodium (LEVOXYL), hydrochlorothiazide and lisinpro received within 2 weeks of vaccination. The patient previously took ezetimibe (ZETIA) and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. After sitting in recovery room for about 10 minutes following injection patient began to feel strange. Patient called the nurse on duty and said she felt like her heart was racing. The nurse took her BP and pulseox and administered a mini EKG. Then the nurse called the EMT on duty who gave patient a six leader EKG and said patient was in A Fib. Asked if patient had ever had A fib before, patient said no. Then asked if patient wanted to go to the hospital, patient said no. After sitting with the EMT for five minutes or so another EKG showed patient was no longer in A Fib. Patient felt shaky for the rest of the day, but is normal now. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Outcome of the events was recovering.
78 2021-02-14 fast heart rate, cardiac arrhythmia Premature Ventricular Contractions, Tachycardia. Has lasted 4 weeks.
78 2021-02-15 chest pain, chest discomfort chest feels like pt has croup, chest pain, body aches, headache
78 2021-02-15 hypertension Received Pfizer 1/22/2021. RNA+ 2/4/2021. S/S SOB, cough, confusion. COVID assoc. resp. failure, sta... Read more
Received Pfizer 1/22/2021. RNA+ 2/4/2021. S/S SOB, cough, confusion. COVID assoc. resp. failure, stage 4 lung cancer, COPD, HTN, former smoker. patient in hospice and died 2/10/2021.
78 2021-02-15 palpitations, blood pressure increased After vaccine a feeling of something going thru my body. Got very hot and dizzy. Sat in chair and ... Read more
After vaccine a feeling of something going thru my body. Got very hot and dizzy. Sat in chair and nurse took my blood pressure which spiked to 208. I was shaking and my heart was pounding. I was rushed to the emergency room. Put on IV, Heart monitor, lung x-ray and blood test. Blood pressure was still at 188 at 2:00 PM. Asked to leave at 3:00 PM, I still did not feel good but I needed to get home, because my husband was home my himself and very upset. I am his caretaker. My pressure dropped to 158 at 10:00PM I had bad headaches for 4 days and I still get them once in a while. I do not have high blood pressure, my blood pressure is usually between 120 - 130.
78 2021-02-16 chest pain, chest discomfort, hypertension Very High Blood Presser---Concerned about a Heart Attach--Teeth Aching--Back Pain--Chest Pain--Feeli... Read more
Very High Blood Presser---Concerned about a Heart Attach--Teeth Aching--Back Pain--Chest Pain--Feeling like a heavy object was on her chest or stomach--Pain from back moved to her sides.
78 2021-02-16 hypertension Pt felt flushed, had a HA and was dizzy. Was taken to first aid and medic reported pt BP 200/99 seve... Read more
Pt felt flushed, had a HA and was dizzy. Was taken to first aid and medic reported pt BP 200/99 several times. Pt transported to ER for high BP and dizziness
78 2021-02-16 heart attack Patient received her vaccine on 2/2/2021 in the morning. She was observed for over 15 minutes and ha... Read more
Patient received her vaccine on 2/2/2021 in the morning. She was observed for over 15 minutes and had no history of any anaphylactic reaction of any sort. She felt fine and went home. 2/15/2021 we were notified by her family that she had passed away on 2/7/2021 at home. The cause of death was stated as myocardial infarct secondary to coronary artery disease. We do not think it had to do with the vaccine administration. The patient had many comorbidities.
78 2021-02-17 blood pressure increased, palpitations 10 minutes after vaccination, patient noted onset of dizziness, feeling "strange", tingling in her l... Read more
10 minutes after vaccination, patient noted onset of dizziness, feeling "strange", tingling in her left hand, and palpitations. At 15 minutes after vaccination, her blood pressure was found to be 200/84 LA and HR90 . O2 sat 98% on RA. T 98.2 F. Pt remained alert and in no distress, but continued to feel dizzy and unwell. Her repeat blood pressure was 184/84. EMS was notified and patient was transported to the emergency room.
78 2021-02-21 hypertension On 2/19/2021, 78yr old female with history of asthma, diverticulitis, GERD, hiatal hernia, HTN, and ... Read more
On 2/19/2021, 78yr old female with history of asthma, diverticulitis, GERD, hiatal hernia, HTN, and hyperlipidemia was administered second dose of COVID-19 Pfizer vaccine 0.3mL in left deltoid (LOT # EN6201). Patient has several documented allergies including dextromethorphan (anaphylaxis), guaifenesin (anaphylaxis), olmesartan (itching), erythromycin (unknown), hydrocodone (unknown), atorvastatin/pravastatin/rosuvastatin (muscle pain), codeine (throat swelling), shrimp (hives, itching). Patient received first dose of COVID-19 Pfizer vaccine on 1/27/21 without any documented issues. Patient initially tolerated injection without incident and was sent for post-injection 15min observation. During 15min observation period, patient became dizzy, diaphoretic, nauseated, and unable to walk with steady gait, hypertensive and endorsed hives. EMS called and patient sent to ED. During initial presentation to ED, BP 180/80, HR 85, and 97% on RA. Patient given Benadryl 25mg PO and ondansetron 4mg IVP at 2055. 1L LR bolus given at 2059. BP lowered during ED observation (BP 160/80 on 2/20 at 0442). Acetaminophen 650mg PO given at 0442 prior to discharge. Patient discharged home in stable condition ~ 0500 on 2/20 with plan for patient to follow up with outpatient provider. EpiPen was not prescribed at discharge. No update to EPIC allergies noted at this time. Of note, reporter notes unable to check POC BG at clinic (glucometer unavailable). Patient has no history of diabetes, but noted that has similar "episodes" with low BG. EMS checked BG (POC = 144).
78 2021-02-21 low blood pressure, fainting Patient admitted following a syncopal episode which was found to be likely due to dehydration, ortho... Read more
Patient admitted following a syncopal episode which was found to be likely due to dehydration, orthostatic hypotension, and post-operative pain after ORIF.
78 2021-02-22 chest pain patient stated she had chest pain while in observation area, patient was alert and oriented, patient... Read more
patient stated she had chest pain while in observation area, patient was alert and oriented, patient stated that she was nervous, emergency services were called and patient was taken to ED
78 2021-02-22 ischaemic stroke Acute ischemic stroke on 02Jan2021; This is a spontaneous report from a contactable Healthcare Profe... Read more
Acute ischemic stroke on 02Jan2021; This is a spontaneous report from a contactable Healthcare Professional. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at single dose for COVID-19 immunisation at the age of 78-year-old. Medical history and concomitant medications were unknown. The patient was not pregnant at the time of vaccination. Patient had Acute ischemic stroke on 02Jan2021; the patient was hospitalized, and she was treated for the event. On 01Feb2021, nasal swab resulted negative. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was recovering from the event. Patient has not tested positive for COVID-19 since having the vaccine. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information there is no evidence or argument to suggest a causal relationship between the reported event of ischemic stroke and BNT162B2 administration. Event occurred prior to vaccination.
78 2021-02-22 pulmonary embolism At location, she felt fine during 15min wait At 3:30-4:30 Zoom call, she looked good, but said she w... Read more
At location, she felt fine during 15min wait At 3:30-4:30 Zoom call, she looked good, but said she wasn?t feeling great & was concerned due to chills & 4days headaches after 1st dose At 8:30pm she called with chills, 3 layers of clothes & bedwarmer on... said her teeth chattered & was trying to drink warm water to heat from the inside (hydration w/o cold water; said no more coffee) At 11:00pm she texted chills were over, she was expecting aches ?but would be asleep during them?... good attitude at the time At 2:19am she called, had fallen & couldn?t get up, said she called a friend to come help her ... said she?d tried to get up, but legs were numb... said she was dizzy when she fell, total dry mouth & had reached for water, but it spilled when she knocked into things when she fell. She wondered if she should call Fire Dept (but wasn?t making total sense). Her friend came, tried to help, but I think she decided to call 911 for help getting her up & wants EMTs to check her out. **She had fallen during Covid, went to ER & they gave fluids & she was ?good? for a week, but then dizzy & severe lethargy, same friend took her to ER & she was admitted (negative covid test at that point), but very large PE, thus heparin & then Eliquis (Dec 2020).
78 2021-02-23 cardiac failure congestive Patient passed away on 2/1/21 at the Health System. She was there for congestive heart failure (CHF)... Read more
Patient passed away on 2/1/21 at the Health System. She was there for congestive heart failure (CHF) which had been a problem for her since contracting COVID-19 (symptoms began 10/29/20 and tested positive 10/30/20). She had been to see her medical provider several times after her isolation period as well as a few trips to the hospital for, what they called "CHF flare-ups". Her last hospitalization began on January 30, 2021. Her social worker reported on t1/31/21 that "she would likely be returning in another day or two".
78 2021-02-28 arrhythmia In addition to the expected response such as fever, chilling, fatigue , for 24 hours, I had cardiac ... Read more
In addition to the expected response such as fever, chilling, fatigue , for 24 hours, I had cardiac arrhythmias (PACs) lasting 1-2 hours on February 24, 25 and 26, 2021. No atrial fib but very frequent PACs which was highly unusual for me. No atrial fib since July, 2020. Also I think the expected response was for around 24 hours. I was in the bed for 36 hours and felt fatigued from February 21, 2021 through February 26, 2021.
78 2021-02-28 chest pain Severe headache; Feeling unwell; Joint pains; Muscle pains; Difficulty breathing; Chest pain; Tiredn... Read more
Severe headache; Feeling unwell; Joint pains; Muscle pains; Difficulty breathing; Chest pain; Tiredness; She felt a "little bit of nausea, very slight"; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL3302), via an unspecified route of administration in the left arm on 23Jan2021 11:00 at single dose for Covid-19 immunisation. Medical history included blood pressure abnormal, thyroid disorder and high cholesterol. Concomitant medications included levothyroxine, lisinopril and rosuvastatin. The patient experienced severe headache, feeling unwell, joint pains, muscle pains, difficulty breathing, chest pain, tiredness on 24Jan2021 and little bit of nausea, very slight on unspecified date in Jan2021. The outcome of headache was recovered on 24Jan2021; for difficulty breathing was recovered; for chest pain and fatigue was recovering; for other events was unknown.
78 2021-03-02 blood glucose increased, hypertension I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stom... Read more
I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; Blood sugar was very high; Blood pressure was very high; I had shingles on it; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 29Jan2021 (at 78-year-old) at single dose for COVID-19 immunization (Because she was of that age and she wanted to travel again). Medical history included ongoing Diabetic. There were no concomitant medications. Reason for no lot number of COVID 19 Vaccine, consumer stated, "It says Pfizer, EL9267, no 62, I am not sure now. Maybe I think it says 2, it's a 2." She woke up at 1 in the morning and started really scratching (31Jan2021) and it's really is pink red pumps (31Jan2021) on her stomach. It started to spread in the whole stomach, then over the breast and under the arm, around her back. She had the reactions. It was a total rash (31Jan2021) and red. She took her blood sugar, she was diabetic, her blood sugar was very high (Jan2021), then she took her blood pressure, her blood pressure was very high (Jan2021). She was all ready to go to the hospital because when you have a rash that's not good. But now 3 hours later her rash disappeared and she felt much better again. When confirmed if the consumer wanted to report the same or have some questions, consumer stated, that she have question, why did she get the rash after she had the COVID vaccine, she had her shot on Friday, Pfizer shot vaccine on Friday. She stated that she felt better, she only have a little bit in her back itching. But everything else it was so red, she meant she had shingles (Jan2021) on it. It's the hospital who gave her the shot. Due date for the next shot was on 19Feb2021. It was stated that she is Diabetic, she don't take any medication, she did it on her own and she is border lined. On lab work, consumer stated that every half a year she had a blood test. Regarding treatment, the consumer stated that she didn't take anything, she was wondering if she was allowed to take anti-histamine. The outcome of the event Itching and Redness was recovering, rash was recovered, while other events was unknown. Information on the lot/batch number has been requested.
78 2021-03-02 nosebleed Nose bleed on March 3, 2021. Rested all day after with pressure on nose. Unusual event for me.
78 2021-03-02 palpitations felt fairly decent/feel bad; she "came down with covid"/test positive for COVID; she is kind of weak... Read more
felt fairly decent/feel bad; she "came down with covid"/test positive for COVID; she is kind of weak; her heart was racing; aching/aches; she ran a fever that got up to 101; cough; her arm got sore; allergies; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) on 15Jan2021 at single dose in left arm for COVID Prevention. Medical history included ongoing High Blood Pressure, she was diagnosed approximately 5 years prior to starting blood pressure medications in 1998. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN AND HYDROCHLOROTHIAZIDE) at 320mg/12.5mg, once daily, by mouth from 1998 and ongoing, amlodipine besylate at 5mg, once daily, by mouth at night from 1998, both for High blood pressure. The patient stated that she did not realize, but she must have been exposed to the COVID Virus, prior to getting her shot. She stated that on 15Jan2021, she went and got her Pfizer COVID shot, and that same day, by the time she got home, she was starting to feel bad and it went downhill from there. She mentioned that on the same day on 15Jan2021, she "came down with covid". She finally went in on 22Jan2021, and got tested, and she did test positive for COVID. The patient was tested Positive for COVID-19 on 22Jan2021. She did believe she was getting better. On 29Jan2021, she felt fairly decent, and today, she is kind of weak but she is assuming that will happen. She was scheduled to go back for her second dose on 08Feb2021, and she is wondering if there are recommendations about the second dose, for people who tested positive for COVID after having gotten the first dose. When queried for her PCP contact information, she stated that her head is not working really great and she feels stupid she did not have this information handy to provide. She states that the first week with her symptoms, she just figured she did have the virus. She had a cough but it never got down to where she had trouble breathing, and she just figured that her body had to go through, whatever it was going to go through, and as long as the patient felt like she was okay, there was not anything anyone could do, she just had to play it out. When she did finally go get tested, the doctor told her to get on Nyquil and Ibuprofen, so that is what the patient has been taking, and she feels like it has helped a lot. Before she saw the doctor, she was taking Acetaminophen, but the doctor told her to do the Nyquil and Ibuprofen, so that is what she has been doing. By the time she got home from getting her vaccine, her heart was racing. She took her blood pressure and it was okay at 125/73, and her heart rate was 72. She has high blood pressure and she takes two medications for that, so she took her night time blood pressure pill and the fast beating of her heart went away. The next day, she got to aching. She has had all different aches, and she ran a fever that got up to 101, and the rest of the time it was 100 or 99, but the fevers were not all day long, they would just come and go. Now she has had no fever in four or more days, and she is doing better. She does still have the cough, but she also has allergies so she does not know what is causing the cough. As far as the reaction to the vaccine, just her arm got sore. But she thinks she was exposed prior to getting the vaccine and just did not know it. she stated that the people took her temperature the day of the shot and she didn't have a temperature. She did not receive any other vaccines on the same day as the COVID vaccine. The outcome of fever was recovering, of cough and allergies was not recovered, of her heart was racing was recovered.
78 2021-03-03 arrhythmia Patient's heart went out of rhythm and began to beat very rapidly; This is a spontaneous report from... Read more
Patient's heart went out of rhythm and began to beat very rapidly; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient (weight: 71.21 kg, height: 168 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) on the left arm, at single dose, on 17Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder and acid reflux (oesophageal), both from an unspecified date. Concomitant medication included levothyroxine, from an unspecified date, at an unknown dose, for thyroid disorder. On an unspecified date, in Feb2021, the patient's heart went out of rhythm and began to beat very rapidly. No treatment received. Blood test was performed on an unspecified date, in Feb2021 to check vitamin D level, B12 level and thyroid (unknown result). Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the adverse event was unknown at time of this report.
78 2021-03-03 hypertension PT received 2nd dose of Pfizer at 1730. PT presented with hives down her arms in the observation ro... Read more
PT received 2nd dose of Pfizer at 1730. PT presented with hives down her arms in the observation room and EMS was alerted at 1735. EMS took vitals, and PT refused Benadryl. PT presented with hypertension (NIBP 227/116) and hospital contacted by EMS. PT agreed to be transported to the Hospital. Medic arrived at 1805 and transported PT to ER.
78 2021-03-04 heart rate increased Excessive shivering/shaking; weakening of lower legs; spiked high temp during the night into the n... Read more
Excessive shivering/shaking; weakening of lower legs; spiked high temp during the night into the next day. 102, finally lowered 48 hours later. Nausea; massive headache; complete body pain in muscles and joints, including jaws and eye sockets. exhaustion, fast hearbeat; no injection site swelling or pain. Reecovery within 72 hours, fatigue and nausea for another 12 hours more or less. I do feel it was worth it.
78 2021-03-10 fainting LTC Pharmacy was notified of a potential vaccine related hospital admission on 3/8/2021. The followi... Read more
LTC Pharmacy was notified of a potential vaccine related hospital admission on 3/8/2021. The following information was gathered from discussion with RPH at Hospital. The patient received second dose of Pfizer COVID vaccine on 2/26/2021. The patient then had nausea, vomiting, and poor oral intake. On 2/27/2021, the patient went to the bathroom and while on the toilet, had a vasovagal event which led to her hitting the side of the face while falling. Patient was then taken to the hospital for evaluation. The patient does have a pacemaker but the cause of the event was determined to likely be due to dehydration. Lab work was performed and pertinent lab values include: potassium of 3.1, SCr of 0.8, and BUN of 13. The patient received potassium supplementation and IV hydration in the hospital. Patient was discharged on 2/28/2021. Of note, the patient does have a pacemaker and a follow-up appointment with cardiology to evaluate the pacemaker was scheduled upon discharge.
78 2021-03-11 anaemia Patient presented to the ED on 3/9/2021 with symptomatic anemia. The patient has a history of this. ... Read more
Patient presented to the ED on 3/9/2021 with symptomatic anemia. The patient has a history of this. The patient received PRBC and platelets.
78 2021-03-12 nosebleed frequent gushing bloody nose, 1 lasting 8 hours
78 2021-03-14 blood clot, deep vein blood clot Pain in left leg - outside 2/7/21 went to clinic 2/8/21 Given an ultrasound Diagnosis: Blood Clot (D... Read more
Pain in left leg - outside 2/7/21 went to clinic 2/8/21 Given an ultrasound Diagnosis: Blood Clot (Dvt) Given immediate shot in belly And prescription for Eliquis Followed up with Dr. (internist) 2/11/21
78 2021-03-18 cerebrovascular accident Cerebrovascular Hemorrhage (Stroke), left occipital zone; This is a spontaneous report from a contac... Read more
Cerebrovascular Hemorrhage (Stroke), left occipital zone; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK4176) at single dose, in the left arm, on 13Jan2021, at 15:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Relevant medical history included Sulfa allergy (Sulfonamide allergy) and drug hypersensitivity due to pethidine hydrochloride (DEMEROL) was reported as past drug event. On 03Feb2021, received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN5318) at single dose, in the left arm, for COVID-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID) and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). On 18Jan2021, at 12:30 PM, the patient experienced cerebrovascular hemorrhage (stroke), left occipital zone. Hospitalization and treatment (stroke Center ICU care) were required (duration of hospitalization 4 days). Clinical outcome of the adverse event was recovering at time of this report. Post the vaccination, the patient has been tested for COVID-19 (Nasal Swab) on 18Jan2021 and resulted negative.
78 2021-03-21 heart attack heart attack one week after 2nd dose of pfizer vaccine. mild. 3 days in hospital, now on long list... Read more
heart attack one week after 2nd dose of pfizer vaccine. mild. 3 days in hospital, now on long list of heart medications. She already is suffering from demensia and these heart medications cause her more confusion.
78 2021-03-22 chest pain vaccinated 1/13. presented for COVID screening on 1/14 due to a + exposure. Test was +. Patient c... Read more
vaccinated 1/13. presented for COVID screening on 1/14 due to a + exposure. Test was +. Patient came to ED on 1/16 with weakness, congestion, poor appetite, coughing. Previous headache and sweating had resolved by the time she presented. Discharged with isolation instructions. Returned to ED late on 1/22 with " right-sided chest pain described as sharp constant 6/10 nonradiating pain localized to the right side of upper chest, shortness of breath with exertion since this afternoon. She does endorse subjective fevers, with associated increased coughing which is productive in nature, shortness of breath." Admitted to ICU early 1/23, transferred to Medical Center on 2/4/21.
78 2021-03-22 hypertension On 02/22/2021 received Pfizer 2nd shot of Covid 19 Vaccine. Next morning, 02/23/2021 around 6am coul... Read more
On 02/22/2021 received Pfizer 2nd shot of Covid 19 Vaccine. Next morning, 02/23/2021 around 6am could not lift my head off pillow, the room and everything was spinning around. I called my husband and he tried to get me to sit up but i could not. He took my blood pressure and it was in the high 165+ so he called our neighbor who is a registered nurse, she took the blood pressure and now 179+ and kept going up and at 190+ she called 911 and they took me to the ER at the hospital, they took the blood pressure and it was 212. At the hospital it reached 237 but the dizziness was going away. I came home around 3:14pm. Follow up visit with my doctor on 2/26 and 3/15 by phone call going over testresults. Some of the tests given on 03/02 Electrocardiographics & Vascular lab. Then on 03/15 more test MRI and MRIA. Than on the last Dr. office visit on 03/15 all tests were clean. Before the last visit we did a lot of checking around with people we know (doctors and nurses) about what was going on and mentioned about the Covid-19 vaccine shot given the day before and they mentioned that people were getting dizziness and some vertigo also one we talked with was a nurse, who missed two days of work because she as dizzy the day after the vaccine. So I mentioned this to the Doctor who said he has heard the same thing. He said that this could have caused what happened to me
78 2021-03-23 hypertension, palpitations my heart started pounding, rate was 130-140; BP went to about 180/110; nauseated; This is a spontane... Read more
my heart started pounding, rate was 130-140; BP went to about 180/110; nauseated; This is a spontaneous report received from a contactable consumer reported (patient herself). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6205), via an unspecified route of administration on 28Feb2021 11:30 in left arm at single dose for covid-19 immunization. Medical history included IBS (irritable bowel syndrome), migraine, and allergies: codeine, mushrooms, shrimp. Pregnant at the time of vaccination was no. Concomitant medication within 2 weeks of vaccination included atenolol; ergocalciferol (CALCIFEROL VIT D); esomeprazole magnesium (NEXIUM 24HR); methylcellulose (CITRUCEL); paracetamol (TYLENOL); atorvastatin (LIPITOR). The patient previously took the first dose of bnt162b2 (lot number: EL9264) on 07Feb2021 at 09:00 AM in right arm for covid-19 immunization. About ten hours after injection (28Feb2021 21:30), her started pounding, rate was 130-140, BP (blood pressure) went to about 180/110 and she became nauseated. This happened as she was sitting quietly watching TV. After about 15 minutes she called 911 and was taken to hospital. All events were reported as serious and resulted in emergency room/department or urgent care, hospitalization on 28Feb2021. The patient underwent lab tests and procedures which included nasal swab: negative on 01Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment for events included Telemetry, ondansetron hydrochloride (ZOFRAN), prochlorperazine edisylate (COMPAZINE). Outcome of events were recovered in 2021.
78 2021-03-23 fast heart rate Tachycardia, hypertensive urgency, paresthesia of the lips about 3 hours following vaccination
78 2021-03-25 hypertension she woke up dizzy; it was like everything was moving or shaking just a little bit, and it would driv... Read more
she woke up dizzy; it was like everything was moving or shaking just a little bit, and it would drive someone crazy; her eyes felt like they were burning out of the sockets; she was tired the next morning; she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet; she was nauseated; temperature of 103; she broke out in a terrible sweat; she was weak as water; light headedness; high blood pressure; This is a spontaneous report from a contactable consumer via Medical information centre. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 27Jan2021 14:00 as single dose for covid-19 immunisation. Medical history and concomitant medications was not reported. On 27Jan2021 20:00 the patient experienced light headedness, she broke out in a terrible sweat, she was weak as water. On 27Jan2021 the patient experienced high blood pressure. On 28Jan2021 her eyes felt like they were burning out of the sockets, she was tired the next morning, she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet, she was nauseated, temperature of 103 (pyrexia). On 05Feb2021 she woke up dizzy and it was like everything was moving or shaking just a little bit, and it would drive someone crazy. The event high blood pressure was considered as serious (Medical significant). It was reported that she had the Pfizer COVID shot 2 weeks ago today. She had severe reaction to the shot, she didn't have it immediately she got the shot on 27Jan2021 and at 2 pm and at about 8 pm she was sweeping the floor and she broke out in a terrible sweat and after that she was weak as water and then started feeling lightheaded and her blood pressure was going up, she put cold rags on her head. She did not take temperature but she did take her blood pressure and it was like 198/something, she said she noted at 8:30 she took it again and it was 180/98 she started drinking water she thought she might be dehydrated and finally by 9:45 she got it down 148/58, she slept that night felt pretty good but she was tired the next morning, about 4 o'clock that afternoon the second day she felt wonderful she went to sleep at about 10 o'clock, but when the clock was striking midnight it woke her up and she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet she was lightheaded her eyes felt like they were burning out of the sockets, she was nauseated when she stood up so she took Tums and that took care of the nausea. She came in and took her blood pressure and that is when it was 194/90 the second time, she has a Rely On arm band and it said 205/98 and then she took it again and it said 235/117. She called the medic and he told her he thought she had a false reading but her temperature was 103 and before he left her blood pressure come down 180/70. Her heart rate was 86 the medic got ready to go her temperature came down to 102.2. On 05Feb2021 which was last Friday she woke up dizzy and light headed and but it was like everything was moving or shaking just a little bit, and it would drive someone crazy .On Saturday she took 3 Motrin that morning and Amlodipine 5 mg and 20 gm Omeprazole and she also takes 1 24 HR Allegra with Fexafenadine and her temperature was normal that day, all day it has been normal. On Sunday at lunch time she got light headed and was floating again and she checked her blood pressure and it was 183/77.She stated that her doctor recommended to get the second dose if she have no more side effects She plan on getting the second dose next Wednesday. Therapeutic measures were taken as a result of high blood pressure, she was nauseated and temperature of 103. The outcome of the events was unknown.
78 2021-03-28 fainting 1st dose: Syncope 2nd dose: rash (Chest and injection site, lip edema)
78 2021-03-28 blood clot 2/2/2021 red scaly skin rash dorsum right hand. Next day pinpoint hemorrhagic 2-4 mm sized lesions ... Read more
2/2/2021 red scaly skin rash dorsum right hand. Next day pinpoint hemorrhagic 2-4 mm sized lesions on palmar surface of fingertips and sides of fingers, 21 in all. Diagnosed as clots by cardiologist and dermatologist on 2/25.Gradual resolution and healing by 3/14/2021.
78 2021-03-30 cerebrovascular accident, blood pressure increased blood pressure sky high; blood pressure sky high; couldn't walk; almost having a stroke; little dizz... Read more
blood pressure sky high; blood pressure sky high; couldn't walk; almost having a stroke; little dizzy; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation, blood pressure high, asthma. There were no concomitant medications. No other products. They have not had any other recent vaccinations or started any new medications. Caller said she had her first dose of the Pfizer COVID-19 vaccine shot 25Feb2021, then two weeks later her blood pressure was sky high and she couldn't walk and she went to the emergency room and they said that she was almost having a stroke. She said she was admitted 11Mar2021 and stayed until this past Sunday which was 14Mar2021. She hadn't seen her primary care provider (PCP) yet she only saw the doctor at the hospital. She was supposed to go back on 18Mar to get her second shot, so she wanted to know if it was gonna be safe. Caller said that she has recovered, and when she came home, she was a little dizzy, but they gave her a medication for vertigo and right now she was ok. Outcome of the events was recovered in Mar2021.
78 2021-03-30 heart rate increased her immune system since has not been the same and has been very deprived; her immune system since ha... Read more
her immune system since has not been the same and has been very deprived; her immune system since has not been the same and has been very deprived; wasn't feeling right; Dizzy; weak and very disoriented; weak and very disoriented; did not feel good; terrible headache and laid down right away; things started spinning/head spinning; Nauseous; Flu like symptoms; Flushed; very cold; chills; very cold; chills; Pain in arm; rapid heart beat; anxious; like something was going to happen; bathroom a couple times and felt week with the flu like symptoms, they were very bad; did eat something later yesterday, but food was flat tasting; didn't taste right; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262, Expiration date: Unknown) via intramuscular route of administration in left arm on 28Jan2021 10:00 as SINGLE DOSE for COVID-19 immunization in the clinic. Medical history included neoplasm malignant, chemotherapy, radiotherapy, immune system disorder (her immune system since has not been the same and has been very deprived) from an unknown date and unknown if ongoing. Concomitant medications included bee venom for arthropod sting. The patient experienced wasn't feeling right , dizzy, weak and very disoriented, did not feel good, terrible headache and laid down right away, things started spinning/head spinning, nauseous, flu like symptoms, flushed, very cold, chills, pain in arm, rapid heart beat, anxious, like something was going to happen, bathroom a couple times and felt week with the flu like symptoms, they were very bad, did eat something later yesterday, but food was flat tasting, didn't taste right on 28Jan2021 and her immune system since has not been the same and has been very deprived on an unspecified date. the first Covid shot yesterday at 10:00. They had her to sit for 15 minutes to make sure she was okay to walk. About 7-8 minutes she noticed she wasn't feeling right, dizzy, weak and very disoriented. She got up and didn't want to create a scene and started walking through the clinic and stopped to ask the receptionist to call her husband in the car. There was so many people so she just kept walking and luckily was able to get to car and told her husband she did not feel good. By then she had a terrible headache and when she got home she laid down right away. Then things started spinning and she was very nauseous and is aware that these things can happen with the vaccine. Had flu like symptoms like she never had before, but this was worse. She did not have a fever, but was flushed and very cold, chills. Her arm was not hurting until about 9pm and during the night she had a rapid heart beat, but not really. Was very anxious like something was going to happen and she tried to calm herself by taking deep breaths but does not know if that worked. Finally, after 3 hours she was able to go to sleep and did go to the bathroom a couple times and felt week with the flu like symptoms, they were very bad. When she got up today she was 60-65% better. She did eat something later yesterday and had thought the nausea was because she hadn't eaten all day long. The food was flat tasting and she know she has that whenever she has the flu where nothing tastes right. She clarifies she has that anyway since 16 years ago she had cancer and a strong dose of chemotherapy and radiation and her immune system since has not been the same and has been very deprived. Whenever she gets sick she gets deathly sick and has to be watched or she may have to get hospitalized due to weakened immune system. States some people say that the second dose is worse, is that true or is it the same feeling. If she feels like that with the second dose she may not get it. No further details provided. Mentions as the day goes on she comes around more. Has to get her glasses to see card given. No other vaccines given that day or 4 weeks prior. No problems with vaccines in past. The outcome of event her immune system since has not been the same and has been very deprived was unknown and other events were not recovered. No follow-up attempts are possible. No further information is expected.
78 2021-03-30 loss of consciousness, arrhythmia I lost consciousness; hitting my head; bruising body; when I had my blood pressure taken it was over... Read more
I lost consciousness; hitting my head; bruising body; when I had my blood pressure taken it was over 200 landing me in ER overnight to try to get my BP down; suffering with Arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Feb2021 (lot number: EN6201) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), administered in the right arm on 01Feb2021 12:00 AM for COVID-19 immunisation and experienced achy body, tiredness, fever and chills. After the second vaccine early in the next morning (23Feb2021) around 3 am, the patient lost consciousness when retuning from the bathroom hitting her head and bruising body. She lay on the floor for approximately 15-20 minutes. She was ordered by her primary care physician to have a brain scan but when she had her blood pressure taken it was over 200 landing her in emergency room (ER) overnight to try to get her BP down. She was now on beta blockers and was still suffering with arrhythmia awaiting an appointment with her new cardiologist. She was hospitalized for 2 days due to the events. She had no COVID prior vaccination and has not tested COVID post vaccination. She has no other vaccine in four weeks. Therapeutic measures were taken as a result of the events. The outcome of the events were not recovered.
78 2021-03-30 palpitations Trembling; muscle weakness; palpitations; light headed, dizziness; slight headache; This is a sponta... Read more
Trembling; muscle weakness; palpitations; light headed, dizziness; slight headache; This is a spontaneous report from a contactable other HCP. This 78-year-old female other HCP (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN6201) via an unspecified route of administration from 08Feb2021 at 1:00 pm to 08Feb2021 at 1:00 pm at single dose on right arm for covid-19 immunisation. Vaccine facility type vaccine was doctor's office/urgent care. The patient was 78 years old and not pregnant at the time of vaccination. Patient's medical history included hypothyroid, hypertension, elevated cholesterol, possible heart condition, obesity, known allergies: shellfish, MSG (dates unspecified). Concomitant medications included Losartan, hydrochlorothiazide, triamterene (Dyazide), Levothyroxine, Pravastatin via an unspecified route of administration from unspecified date to an unspecified date at unknown dose and frequency for an unknown indication. If other vaccine in four weeks: No. Patient experienced trembling, muscle weakness, palpitations. light-headed, dizziness, slight headache on 08Feb2021 at 01:15 pm. AE resulted in: Doctor or other healthcare professional office/clinic visit. If treatment AE: no, If covid prior vaccination: no, If covid tested post vaccination: no. The outcome of events was recovered on an unknown date.
78 2021-03-31 chest discomfort Pt has allergic reaction w/ her 1st dose. She was in the middle of her graded COVID-19 Challenge (... Read more
Pt has allergic reaction w/ her 1st dose. She was in the middle of her graded COVID-19 Challenge (dose 2) under a physician's supervision. Pt just received 0.03ml (10% ) of full dose. Pt then started experiencing increased mucus in her throat, clearing of throat, and states that her ears feel weird about 11 minutes later. Her Vitals at this time were 168/78, 85 HR, 14Resp, 100% Spo2. 5 minutes later another set of vital signs were taken at 152/84, 86 HR, 16 resp, 95% Spo2. EPi 0.3 mg was administered immediately. Pt states that her throat feels better about 3 minutes later, but her chest still feels irritated. Her Spo2 was up to 100% at this time. Pt then stated that she is starting to feel shortness breath after using the bathroom. Pt is then transferred directly to the ER .
78 2021-03-31 chest pain, hypertension Patient complained of dizziness and presented with substernal chest pain and mild shortness of breat... Read more
Patient complained of dizziness and presented with substernal chest pain and mild shortness of breath within 15-20 minutes after receiving COVID-19 vaccine. History of hypertension and non-compliance with antihypertensive medications. Relative reports patient also with possible history of stroke with no anticoagulation. Patient hypertensive initially with Systolic in 180s and diastolic in the 80s, upon onset of symptoms. Chest pain minimized within 10 minutes after blood pressure came down to the systolic level in the 170s. Ground ambulance called to transport to Emergency Department, but patient declined ambulance transport and was taken to ED by car with son-in -law.
78 2021-03-31 heart rate decreased, palpitations, blood pressure increased Pt developed palpitations, headache, dizziness and nausea after receiving vaccine. BP 192/81, repeat... Read more
Pt developed palpitations, headache, dizziness and nausea after receiving vaccine. BP 192/81, repeat 206/86. HR decreased from 106 to 90; regular rhythm and rate. O2sat 99 RA. Lungs CTA. Denies chest pressure, tightness, sob. Also reported throat discomfort; benadryl 25 mg po x1 given. Sent to ER.
78 2021-03-31 low platelet count rise in Cr; Developed decreased PO intake; mild acute kidney injury; pancytopenia; lymphopenia; thro... Read more
rise in Cr; Developed decreased PO intake; mild acute kidney injury; pancytopenia; lymphopenia; thrombocytopenia; This is a spontaneous report from a contactable Physician. A 78-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 10Mar2021, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient had unspecified concomitant medications. The patient had the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 Immunisation. On 13Mar2021, the patient developed decreased PO intake, then mild acute kidney injury with rise in Cr and pancytopenia/lymphopenia/thrombocy topenia. The events caused hospitalization. Treatment for the events were IV fluids, Hematology consult. The outcome of the events was recovered. The patient had negative covid swab test on 12Mar2021.; Sender's Comments: Based on the narrative information provided, a causal association between the reported events and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA 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.
78 2021-04-04 fast heart rate, hypertension ER HPI: 78 y.o. female who presents with respiratory distress. Patient is transported to the emerge... Read more
ER HPI: 78 y.o. female who presents with respiratory distress. Patient is transported to the emergency room via emergency medical services from local long-term care facility. Patient is unable to give any history due to acuity and severity of current condition. On arrival to the emergency room patient is in obvious distress she is hypertensive with a blood pressure of 74/51 she is tachycardic with a rate of about 140 she is tachypneic with a rate of the 29th at 30 her oxygen saturation on a non-rebreather are 82% and her temperature is 102.9°. FINAL IMPRESSION ICD-10-CM ICD-9-CM 1. Septic shock (HCC) A41.9 038.9 R65.21 785.52 995.92 2. Aspiration pneumonia of right lower lobe due to gastric secretions (HCC) J69.0 507.0 3. Acute hypoxemic respiratory failure (HCC) J96.01 518.81
78 2021-04-06 oxygen saturation decreased, deep vein blood clot, low blood oxigenation, troponin increased, pulmonary embolism symptoms, signs, time course, etc.) 78 yo female patient with PMHx of paroxysmal atrial fib / COPD /... Read more
symptoms, signs, time course, etc.) 78 yo female patient with PMHx of paroxysmal atrial fib / COPD / smoking / anxiety-depression / obesity / arthritis and prior bil PE in 2018 after knee surgery (anticoagulated with Xarelto) who presented to FH on 03/30/2021 with SOB x2 weeks. Of note she received her 2nd COVID vaccine dose on 03/05/2021 and since she has worsening SOB. Pt reported cough w/ yellow sputum prior to her admission. At urgent care, she was hypoxic with Sat 82%, therefore she was transferred to ED for further w/u. Lab w/u showed BNP of 1,074 and trop of 32. She was found to have a negative POC COVID-19 and PCR is pending. Bil venous Dopplers show acute occlusive DVT in the R popliteal vein above and below the knee w/ slow flow in the R fem vein and no DV IN the LLE. TTE on 03/31/2021 showed EF 65-70% w/ G2DD, mod-severe RV failure and severe pulmonary HTN, mod TR, and dilated IVC. Decision was made to CT chest w/ contrast despite renal function given high suspicion for PE. CT chest w/ contrast showed large clot burden PE w/ findings c/w R heart strain, a 12x9 mm lobulated nodule in the RUL concerning for neoplasm, increasing patchy infiltrates, and increasing R pleural effusion and new trace L pleural effusion. Patient required 12L O2 via NC. IR was contacted at but felt that patient was not a candidate for CDT or for IVC filter. Patient was transferred to ICU for further care. Patient received IV heparin per the PE Protocol from, Alteplase 40mg on 4/1, and was started on treatment dose of Eliquis.
78 2021-04-07 haemoglobin decreased Pt admitted on 4/5/2021 c/o roughly 4 weeks of just general dyspepsia and feeling like she had aci... Read more
Pt admitted on 4/5/2021 c/o roughly 4 weeks of just general dyspepsia and feeling like she had acid reflux. She reports that then progressed to some nausea and then vomiting and then some generalized right upper quadrant midepigastric abdominal pain. She also noticed that her skin was becoming yellow. She reports no changes in any of her medications recently she had her second COVID-19 vaccination on 2/14 and blood work on 2/ 8 consisting of liver enzymes/CMP was normal. she arrived severely jaundiced with severe transaminitis, hyperbilirubinemia and acute renal failure. ERCP revealed no gross obstruction and free flowing bile and sphincterotomy was done with no improvement in her blood work. she remains hospitalized and is being transferred for HLOC due to worsening condition REVIEW OF SYSTEMS:
78 2021-04-07 heart rate increased Presented to ED with persistent cough X 1 week, some SOB. No obvious fever. ROS + for cough, shortne... Read more
Presented to ED with persistent cough X 1 week, some SOB. No obvious fever. ROS + for cough, shortness of breath and wheezing. BP 131/84 HR 107 RR 22. Admitted to general medicine floor on 2L O2 via NC, Rx with remdesivir + Dexamethasone.
78 2021-04-08 chest discomfort Patient received her first Pfizer COVID-19 vaccine and began feeling throat tightness, SOB, chest ti... Read more
Patient received her first Pfizer COVID-19 vaccine and began feeling throat tightness, SOB, chest tightness and itching about 15 minutes after vaccine. Patient was going to be observed for 30 minute due to history of anaphylaxis. Patient was given 0.3 mg epinephrine in left thigh and 50 mg benadryl IM in right deltoid at 17:06. VS before medications 174/73 HR 73 and after medications was 187/64 HR 78. Nitro patch was removed by Dr. prior to medication administration.
78 2021-04-09 blood pressure increased, chest pain it began working up her arm with arm pain and chest pain which persisted and she went to the hospita... Read more
it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours; it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours; blood pressure went up to 198/203; still has tiredness; difficulty swallowing like her throat is still tight; difficulty swallowing like her throat is still tight; short of breath; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), first dose via an unspecified route of administration, administered in Arm Right on 11Mar2021 11:00, single dose for covid-19 immunisation. Medical history included silent heart attack, ongoing Barrett's oesophagus from 2008, fall she had over two months (2021), eye surgery on an unknown date. She does not get any shots and can't have shots even for the flu shot because she had problems with two flu shots she had; states she had a problem with each one of the flu shots and does not know the names of the flu shots and has no lot numbers to provide for them; states she had the flu shots in the early 1990's and worked in healthcare and had to have them and they told her back then if she wanted to work she had to have the flu shots and then she got sick with both of the flu shots and they said they guessed they would not force her to have the flu shots. The patient's concomitant medications were not reported. Patient had the first dose administered and then about 14 hours after (12Mar2021) that she had no problems until it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours. She does not know what to do about getting the 2nd dose of the vaccine and was at her cardiologist's this week and he said he is not familiar with the Pfizer vaccine causing chest pain; caller states she has a history of silent heart attacks. She still has tiredness and difficulty swallowing like her throat is still tight and they told her to mention if she does go for the second dose of the vaccine to mention that she had this situation.The chest pain and arm pain began 12Mar2021 and the arm pain is in her right arm where the vaccine was administered and the arm pain and chest pain have resolved; states the arm pain and chest pain stopped and she thinks that lasted about an hour and a half and she called a family member to take her to the hospital; states about 2:30am that same day she was admitted the morning of 12Mar2021 and was discharged on 13Mar2021. They ran every test known to the patient and for a while her blood pressure went up to 198/203 in the emergency room (12Mar2021) and she is not on any medication; caller states she does have Crestor but has not started on it and has not taken it yet. The tiredness and difficulty swallowing like her throat is still tight began the same time she was having the chest pain and she is not having any chest pain or anything like that right now but the tiredness and difficulty swallowing like her throat is still tight is still ongoing; states she did go get cardiac clearance to make sure which was this past week and she does not feel well and like for her the tiredness is bugging her. The tiredness and difficulty swallowing are better but she knows they are there and she tries to swallow something and is like boy her throat is still tight. They did an ultrasound in her left leg because she was limping from a fall she had over two months ago but still has a sore ankle from that and they sent her down for the ultrasound and a CT looking for blood clots in her lungs because she was short of breath (12Mar2021); caller states she thinks they were running everything they could to rule out things; states everything was negative for the CT and ultrasound and she believes the CT and ultrasound were done on 12Mar2021. She has no idea when she was diagnosed with silent heart attacks but they kept asking her about this when she went in for eye surgery and asked her when she had a heart attack and she said she had never had one and they said yes she had and she never knew. She just set up a HCP appointment after the reported events with a gastroenterologist because she has Barrett's and because of the esophagus she did not know if it flared up by the Pfizer vaccine and that caused the pain because the two pains of the heart and esophagus mimic each other with pain going up into the jaw so they were ruling out which one it was; states she went out as an atypical chest pain and called the cardiologist and went in and went over her records from the hospital with the cardiologist. She does not know what caused what in terms of the pain. The outcome of the event blood pressure increased was unknown, chest pain and pain in arm was recovered, other events was recovering.
78 2021-04-10 chest pain Pt reported sharp, pinching 2/10 pain in chest. Patient reported nervousness and a history of simil... Read more
Pt reported sharp, pinching 2/10 pain in chest. Patient reported nervousness and a history of similar episode when stressed. Pt vitals assessed. BP 164/78, HR 56, 98% SpO2. Patient denied itchiness, rashes, hives, and difficulty breathing. Pt given water. Pt advised to stay for further observation. Pt reassessed at 1625. BP 162/78, HR 59, 97% SpO2. Pt denied difficulty breathing, itchiness, rashes, and hives. Patient offered transportation. Patient declined transportation. Patient left facility at approx. 1630 with steady gait and unlabored respirations.
78 2021-04-12 cerebrovascular accident 3/17: dizzyness attributed to hunger, ate, went to bed. 3/18: unsteadiness walking, difficulty eati... Read more
3/17: dizzyness attributed to hunger, ate, went to bed. 3/18: unsteadiness walking, difficulty eating and speaking. Did not call 911/alert family. 3/19: symptoms continued. Daughter observed symptoms, including facial droop, and transported to local hospital ED. 3/20: discharged without seeing neurologist. CT scan and other tests failed to show stroke. However, MRI not performed. 3/22: outpatient visit to neurologist who, based on symptoms, concluded stroke had occured on left side of brain due to COVID 19 vaccine. 3/24: MRI performed and shows stroke. 3/30: MD orders additional tests. 4/1: admitted to Rehab. Hospital for 9 days.
78 2021-04-12 loss of consciousness passed out for a very short period of time; was awakened by total body shaking and it was not just ... Read more
passed out for a very short period of time; was awakened by total body shaking and it was not just shivers but was uncontrollable shaking; her body felt warm but then she was freezing; her body felt warm but then she was freezing; was sick and was different and very weak; muscles were sore; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)), via an unspecified route of administration, administered in the left arm on 17Mar2021 12:10 (Batch/Lot Number: EN6207; Expiration Date: 31May2021) as a single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of the Pfizer BioNTech COVID19 vaccine on 23Feb2021 (lot number: EN6198 with expiry date 31May2021) for Covid-19 immunization. The patient experienced passed out for a very short period of time and awakened by total body shaking and it was not just shivers but was uncontrollable shaking on 18Mar2021; her body felt warm but then she was freezing, she was sick and was different and very weak, and muscles were sore in Mar2021. It was further reported that the patient got the 2nd dose of the Pfizer BioNTech vaccine that day on 17Mar2021 and about 12:45am or 1:30am the next morning she was awakened by total body shaking and it was not just shivers but was uncontrollable shaking; the shaking has resolved completely but she is not sure when it resolved but she was shaking for a good while because she can remember being so uncomfortable with her body moving so much which went on for maybe 20 minutes or so when her husband woke up.Patient's husband then woke up and got Ibuprofen and gave it to her and that stopped the shaking which surprised her and she did not know the Ibuprofen would work to stop the shaking that well and the Ibuprofen did work in stopping the shaking. The Ibuprofen stopped the shaking and she can remember to touch her body felt warm but then she was freezing and she does not know what this means but this was not ongoing and resolved when her husband gave her the ibuprofen and she stopped shaking right away which always amazed her that the Ibuprofen worked. She stated fortunately the Ibuprofen stopped her from shaking and she was able to sleep until early morning when she woke up and knew she was sick and was different and very weak; states the weakness was not ongoing and the approximate time the weakness resolved was unknown but she was down the rest of the day and after that she passed out for a very short period of time and held her head up and stood up and thought wow something was going on and asked where was this coming from and it was not nausea but she was just weak. She has not passed out for a huge amount of time but fortunately she had some towels laying close by and was able to use a towel; states after that she stopped for the rest of the day and only got up to go to the potty and was just so weak and heard that from many people that they just slept afterwards.Caller states her muscles were sore and she realized that was just normal and after the 2nd dose of the vaccine she knew her muscles would probably be sore and this was resolved. She came downstairs and was sitting on a chair and then stood and no longer sat in the chair and her husband knew things were not right with her and her eyes looked funny and she passed out and that never happened to her before and she was passed out for a few moments. Other than the Ibuprofen she did not have treatment and did not go to the emergency room or the HCP office. Patient only took one Ibuprofen and she has a very small body and her husband sometimes takes 2-3 Ibuprofen and she thinks wow that is so many but she herself does not have any medication and she just took one Ibuprofen and it worked; She took the Ibuprofen on 18Mar2021 in the early morning. Fortunately she was in good health. Outcome of the event passed out for a very short period of time, was awakened by total body shaking and it was not just shivers but was uncontrollable shaking and muscles were sore was recovered in Mar2021, and unknown outcome for the remaining events.
78 2021-04-14 cerebrovascular accident Patient had a stroke within a few weeks of having her second shot.
78 2021-04-14 deep vein blood clot Patient had ED visit with leg swelling and pain that resulted in right mid femoral DVT discharged ho... Read more
Patient had ED visit with leg swelling and pain that resulted in right mid femoral DVT discharged home from ED with apixaban.
78 2021-04-14 heart rate increased Shortness of breath, and rapid heart beat
78 2021-04-14 palpitations After 5 minutes of receiving vaccine, patient became nauseous. Once home, she complained of dizzines... Read more
After 5 minutes of receiving vaccine, patient became nauseous. Once home, she complained of dizziness. Around 4am, patient was awakened with strong heart palpitations. She noticed ankle and foot swelling after about a day. She also noticed a rash on the vaccine arm, neck and under chin. She experienced severe nausea and vomiting over the next 3 days and could not eat food. She did not seek medical attention and chose to stay in bed to recover. As of today, the patient says she is almost recovered from these events.
78 2021-04-19 transient ischaemic attack Altered mental state, memory loss, confusion, diagnosed as transient ischemic attack, most symptoms ... Read more
Altered mental state, memory loss, confusion, diagnosed as transient ischemic attack, most symptoms resolved in 24 hours
78 2021-04-20 hypertension, blood pressure increased Acute headache radiating to neck and right shoulder and right eye. Acute hypertension with hypertens... Read more
Acute headache radiating to neck and right shoulder and right eye. Acute hypertension with hypertensive crisis BP 223/113 needing Emergency department admission. Following this ED visit the the BP had been uncontrolled with ongoing headaches and right sided neck pain radiating to the right eye/head through March and in April have improved. During this time had #2 Pfizer vaccine 2/12/21 and had experienced arm pain and headache as well as a spike in her BPs as well as right sided neck pain radiating to her right eye
78 2021-04-21 cerebrovascular accident Patient received her first dose of Pfizer vaccine on 4/1/21. Patient has a stroke 4/6/21 and passed... Read more
Patient received her first dose of Pfizer vaccine on 4/1/21. Patient has a stroke 4/6/21 and passed away on 4/10/21.
78 2021-04-21 pulmonary embolism, blood clot On 2/18/21, 10 days after receiving the vaccine, I donated blood as usual. About 30 minutes later I... Read more
On 2/18/21, 10 days after receiving the vaccine, I donated blood as usual. About 30 minutes later I was light headed, had abdominal cramping pain, bowel emptying and possibly fainted. I was transported by EMTs to the ER and was later diagnosed with inflamitory bowel by a CT scan. I took antibiotics and was feeling fine. My gastroenterologist performed a colonoscopy on 3/24/21 and the findings were that I was healed and tissue samples were normal. 3/25/21 I had an annual physical and was told I was in good health. Later that afternoon I began feeling light headed upon standing. In the night I called my health insurance hotline because my blood oxygen meter was beeping continuously. The Dr. on call told me to go by ambulance to the ER. When sitting or lying down, I felt fine and all the tests at the ER for my heart and my vital signs were good. A few hours later, they did a hest Xray and then a CT scan of my lungs which showed a saddle embulism. I had also thought I had bruised my knee if and when I fainted on 2/18 and 1o hours later a blood lot was found by ultrasound of my left knee. I was given blood thinners in the ER and then in ICU where I spent the next night. I am now taking Eleris. I was also given pantoprozole for GERD coughing the next day. I continue to have periods of abdominal ramping/pain, light headedness in waves and pressure in my head. I have disontinued the stomach medication with some feeling better with the lightheadedness.
78 2021-04-22 heart rate increased Post vaccine patient reports feeling raised heart rate. Pt was transported to med obs via wheel chai... Read more
Post vaccine patient reports feeling raised heart rate. Pt was transported to med obs via wheel chair. Pt remained in wheelchair. Pt reports not feeling this way after her first vaccine . Per patient her BP is higher then usual . Pt didn't want anything to drink . Pt reported feeling better and was released at 11:30 with her grandson . Vitals as follow: 1114 BP 168/81 HR 67 RR 18 SpO2 96 1119 BP 157/80 HR 66 RR 20 SpO2 96 1124 BP 168/76 HR 67 RR 18 SpO2 98 1129 BP 158/75 HR 67 RR 18 SpO2 98
78 2021-04-23 chest discomfort severe pain; joint pain; headache; fever; nausea plus heavy chest feeling; Have persistent cough; He... Read more
severe pain; joint pain; headache; fever; nausea plus heavy chest feeling; Have persistent cough; Heavy chest feeling; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 13:15 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation. Medical history included gastrooesophageal reflux disease. Concomitant medication(s) included vitamin d3 (VITAMIN D3) taken for an unspecified indication, vitamin b complex (B COMPLEX [vitamin b complex]) taken for an unspecified indication, fish oil (fish oil) taken for an unspecified indication, biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID [FAMOTIDINE]) taken for an unspecified indication. The patient previously took covid-19 vaccine for covid-19 immunisation. On 15feb2021, at 18:30 the patient experienced severe pain, joint pain, headache, fever, nausea plus heavy chest feeling and have persistent cough. The patient was recovering from the events. The action taken in response to the event(s) for bnt162b2 was not applicable. No follow-up attempts are possible. No further information is expected.
78 2021-04-24 arrhythmia, chest discomfort nauseous; feeling unwell; Chest heaviness; Chills; Fatigue; her quality of life was low and getting ... Read more
nauseous; feeling unwell; Chest heaviness; Chills; Fatigue; her quality of life was low and getting worse everyday; Weakness; swollen lymph nodes in neck and groin; irregular fast heartbeats; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 01Mar2021 (Batch/Lot Number: EN6200), at single dose, for COVID-19 immunisation. Medical history included lymphadenectomy, thyroidectomy (in 2014 or 2017), COVID-19 from Feb2020 to an unknown date (not ongoing). Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation (lot# EL9269) intramuscular in left arm and experienced vaccination site swelling and azithromycin (ZITHROMAX) and experienced drug intolerance and illness. The patient experienced weakness (disability) in 2021 with outcome of not recovered, swollen lymph nodes in neck and groin (disability) in 2021 with outcome of not recovered, chest heaviness (disability) on 07Apr2021 with outcome of not recovered, fatigue (disability) in 2021 with outcome of not recovered, her quality of life was low and getting worse everyday(disability) in 2021 with outcome of unknown, chills (disability) on 07Apr2021 with outcome of unknown, nauseous (disability) on 08Apr2021 with outcome of unknown, dizziness (disability) in 2021 with outcome of not recovered, feeling unwell (disability) on 08Apr2021 with outcome of unknown, irregular fast heartbeats (disability, medically significant) in 2021 with outcome of recovered in 2021. Therapeutic measures were taken as a result of the events and included treatment with 1 Baby Aspirin. The reporter (patient) considered all these symptoms she was reporting were disabling because she had no quality of life. No follow-up attempts are needed. No further information is expected.
78 2021-04-24 body temperature decreased Sundowning/sundowners; feel tired/Tiredness; headache on right side of head/not terrible, not like a... Read more
Sundowning/sundowners; feel tired/Tiredness; headache on right side of head/not terrible, not like a hangover; Muscle pain/all over her body; chills; low temperature/was just a couple digits off; Joint pain/all over her body; during these days that she felt so awful she couldn't work her way through it; had a bad spell; felt bad; restless legs; felt unwell; tossing and turning, trouble sleeping; tossing and turning, trouble sleeping/did not sleep except for a couple of times; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199 and expiration date: Jun2021, via an unspecified route of administration, administered in right arm on 15Mar2021 as single dose for Covid-19 immunisation. Medical history included arthritis, diabetes, hypertension, rotator cuff repair, cancer (mom and dad both have passed from it. two uncles and grandparents have had cancer. cancer is pretty relevant in the family), alcoholism (mom and dad both have passed from it). Concomitant medication(s) included metformin taken for diabetes mellitus, metoprolol tartrate taken for hypertension, losartan potassium and lovastatin, ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). The patient stated that she was fine until a few days ago, 4 or 5 days ago she started to feel tired, headache on one side of her head, muscle pain and chills, low temperature, joint pain and just felt unwell. By the weekend the patient stated that she was down on the couch and her son was worried about her and suggested that she go to the hospital, which she refused. The patient described the headache as 'just there', states not terrible, not like a hangover. Since waking up today, she has not had a headache. She also added that she had trouble sleeping on Saturday night (03Apr2021). She stated she did not sleep except for a couple of times and she was just tossing and turning and took ibuprofen and it didn't help. The patient stated that the muscle pain and joint pain was all over her body. She had rotator cuff surgery on her right-side years ago and during this time she was carrying groceries on her own and her left shoulder started throbbing like the rotator cuff pain that she had in the past and she recognized it right away. She stated that she is not real sure if the muscle pain in her shoulder is a result of the vaccine or not. She has full of arthritis and was not sure if the pain is caused by the vaccine or not, but with her regular arthritis, if she has been sitting and gets up and walks around she is able to work her way through it, but during these days that she felt so awful she couldn't work her way through it. The patient stated that she feels like she has been suffering from sundowners but states she feels it's not related to COVID vaccine. She writes herself notes and forgets what notes mean. The patient was on hold so long with the first one. The patient had her first vaccination on March 15th and she am supposed to go back Wednesday April 7th for the second one. She had a bad spell for about 4 days last week. Today, she feel fine and have no temperature. She didn't have a temperature when she felt bad. The patient was having chills, restless legs, couldn't sleep. Now, the patient was feeling better. The patient recovered from the event headache unilateral, muscle pain, chills, body temperature decreased, generalized joint pain and feeling unwell on 05Apr2021, for events difficulty sleeping and restless was recovered on 04Apr2021. The outcome of other events was unknown.
78 2021-04-24 loss of consciousness Blood clots in Lungs; No longer able to do activities of daily living; Almost fell to floor from sit... Read more
Blood clots in Lungs; No longer able to do activities of daily living; Almost fell to floor from sitting position; short of breath; total body exhaustion/fatigue; sleepy throughout the day; unstable, weak; debilitating symptoms bedridden/unstable, weak; debilitating symptoms bedridden; passed out completely while sitting; Unable to complete daily 1 mile walk at park/Unable to take stairs; Lightheaded/dizzy; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 26Mar2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included patient had COVID-19 Dec2021 and recovered completely in 2 weeks. Symptoms: fever, sleepy. Went back to daily walk after 2 weeks. No loss of smell, no loss of taste, no mental changes- was very happy with my complete recovery. Took vaccine 26Mar2021 at recommendation of doctor to be safe from variants. Regret deeply, still hospitalized as of this writing. Concomitant medications included ramipril; rosuvastatin calcium 40mg; levothyroxine, all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulphur and experienced allergies. The patient experienced unable to complete daily 1 mile walk at park/unable to take stairs on 27Mar2021, lightheaded/dizzy on 27Mar2021, passed out completely while sitting on 28Mar2021, unstable, weak on 30Mar2021, short of breath on 31Mar2021, total body exhaustion/fatigue on 31Mar2021, sleepy throughout the day on 31Mar2021, almost fell to floor from sitting position on 09Apr2021, debilitating symptoms bedridden/unstable, weak on 26Mar2021, debilitating symptoms bedridden on 26Mar2021, no longer able to do activities of daily living on 13Apr2021, blood clots in lungs on 14Apr2021, all with outcome of not recovered. Reported adverse event: 27Mar2021 - Unable to complete daily 1 mile walk at park. Lightheaded, dizzy 28Mar2021 Dizzy, passed out completely while sitting. Revived and taken to hospital by ambulance 28Mar2021 Admitted to (hospital name withheld) 30Mar2021 Discharge from hospital - unstable, weak 31Mar- 08Apr2021 - short of breath easily. Unable to take stairs. Discontinued daily walk, weak, total body exhaustion, sleepy throughout the day 09Apr2021 - Almost fell to floor from sitting position. Patient's daughter lowered patient gently to the floor. Revived shortly 13Apr2021 Saw primary doctor Dr (name withheld). Shared her debilitating symptoms bedridden since Covid-19 vaccine on 26Mar. BP taken from lying down, sitting and standing was markedly different and explained caused passing out and lightheaded. No longer able to do activities of daily living 14Apr2021 - Exhaustion and fatigue, her daughter to her back to the hospital 14Apr2021 - Passed out in Emergency Room @ (hospital name withheld). Admitted. Blood clots in LUNGS. The events 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. The patient was hospitalized for unable to complete daily 1 mile walk at park/unable to take stairs, lightheaded/dizzy, passed out completely while sitting, all from 28Mar2021 to 30Mar2021. The patient underwent lab tests which included blood pressure measurement: markedly different on unknown date. Patient was not pregnant. No other vaccine in four weeks.Patient had covid prior vaccination. No covid tested post vaccination. The treatment received for events included Heparin administered, still hospitalized as of now. Information about Lot/ Batch number has been requested.
78 2021-04-25 atrial fibrillation, fainting Patient became faint after her waiting period and had to be moved by wheelchair to the medic suite. ... Read more
Patient became faint after her waiting period and had to be moved by wheelchair to the medic suite. She was fairly unresponsive but did respond to verbal commands. She was assessed by the medic. Her respirations and blood pressure and pulse ox were normal, but she showed atrial fibrillation on the monitor. Called 911, and patient was transported to the Hospital by ambulance at 3:30 PM.
78 2021-04-25 hypertension Tingling in arm, slight hypertension. EMS called and evaluated patient. Pt. refused transport, sx ... Read more
Tingling in arm, slight hypertension. EMS called and evaluated patient. Pt. refused transport, sx resolved
78 2021-04-26 loss of consciousness she just felt dizzy so fast and passed out; passed out; She hurt her ankle from it; This is a sponta... Read more
she just felt dizzy so fast and passed out; passed out; She hurt her ankle from it; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 08:45 (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, atrial fibrillation from Aug2020 and ongoing , cystitis. Concomitant medications included sulfamethoxazole, trimethoprim taken for cystitis from 27Mar2021 to 02Apr2021; apixaban (ELIQUIS) taken for atrial fibrillation from an unspecified start date and ongoing; atenolol (ATENOLOL) taken for Blood pressure from an unspecified start date and ongoing. The patient received first dose of bnt162b2 for COVID-19 immunization on 15Mar2021 lot number: EN6202, Expiry date: 30Jun2021. The patient received the second dose of the Covid vaccine around 8:45 a.m. and states that she "felt fabulous." On 06Apr2021 she felt fabulous. She said that she had a doctors appointment at 1200 06Apr2021 and her blood pressure was good. She said that she was also taking an antibiotic prior to that week. She asked the doctors about taking vaccines after taking the antibiotic since the medication said that you should avoid vaccines while taking the antibiotic, and they all said that it was fine. She came home about 1330 06Apr2021 and she passed out while making her lunch. She hurt her ankle from it and she is not a happy camper. She said that all her vitals were good and her blood was good. That was all taken 2 hours before she passed out. The weird thing was she never felt better that day after she passed out. She said that she had no reaction after the first shot. Prior to this she felt good and there was no warning, she just felt dizzy so fast and passed out. Caller said that her ankle is getting better and she hurt her toe too, but it is getting better. She treated the ankle with ice. She said that it could have been worse. She said that she did not understand this and had no side effects previously. The event passed out was assessed as serious (medically significant). The patient underwent lab tests and procedures which included blood test: good on an unspecified date her blood was good. Therapeutic measures were taken as a result of she hurt her ankle from it (arthralgia). The outcome of the event passed out was recovered with sequel on 06Apr2021, unknown for the other events.
78 2021-04-27 cerebrovascular accident Approximately 5 minutes after vaccine patient had a suspected stroke. Patient was in observation ar... Read more
Approximately 5 minutes after vaccine patient had a suspected stroke. Patient was in observation area and reported right side weakness, facial droop and slurred speech. Patient was attended to by EMS service and transported to a local hospital.
78 2021-04-27 hypotension urgent continuous diarrhea, abdominal cramps, weight loss (5 lbs) in 3 days, dehydration, low blood ... Read more
urgent continuous diarrhea, abdominal cramps, weight loss (5 lbs) in 3 days, dehydration, low blood pressure. clear liquid diet, blood pressure medications adjustment
78 2021-04-28 troponin increased Elevated troponin Essential Hypertension Abmulatory dysfunction Generalized weakness COVID-19 infect... Read more
Elevated troponin Essential Hypertension Abmulatory dysfunction Generalized weakness COVID-19 infection Hypomagnesemia
78 2021-04-29 atrial fibrillation, arrhythmia Diarrhea; several episodes of heart arrhythmia on two different days starting 10 days after second ... Read more
Diarrhea; several episodes of heart arrhythmia on two different days starting 10 days after second COVID-19 vaccine injection. Although I am predisposed to heart arrhythmia having been diagnosed with super ventricular tachycardia in late teen years, then atrial fibrillation starting at age 60, I was getting an episode of a-fib only once every 3-4 months following an ablation procedure. This was different as I had several episodes in a day on two different days. They subsided only following the taking of propafenone.
78 2021-04-29 pulmonary embolism, blood pressure increased, enlargement of the heart "Pfizer-BioNTech COVID-19 Vaccine" - received first dose 2/26/2021 and second dose 3/19/2021, admitt... Read more
"Pfizer-BioNTech COVID-19 Vaccine" - received first dose 2/26/2021 and second dose 3/19/2021, admitted for acute segmental LLL PE. Pt endorsed subacute progressive DOE x6 months. Admitted to hospital with elevated BP and 2 weeks of progressively worsening SOB (after 3/19/2021, at which time pt received the second dose of vaccine.) EMS reported SaO2 79%. CXR - moderate diffuse edema or pneumonitis in both lungs, small pleural effusions, cardiomegaly CTA of chest - acute PE involving segmental pulmonary arteries to L lower lobe, moderate diffuse ground-glass opacities in both lungs (R>L) -- > possible drug-induced pneumonitis (lower suspicion because pt had been on palbociclib x2 years) or volume overload.
78 2021-04-30 loss of consciousness 78 year old female client received her 1st dose of Pfizer Covid 19 Vaccine on her left arm at 11:20 ... Read more
78 year old female client received her 1st dose of Pfizer Covid 19 Vaccine on her left arm at 11:20 AM Around 11:25 AM client reported seeing black. EMT and MD arrive to check on the client at 11:28 AM. Her vitals were 108/104 BP, 16 HR, 98% O2, 0/10 pain. MD gave patient water and gatorade she laid her down and elevated her feet. MD also instructed client to deep breath. At 11:36 AM client BP was 160/96. MD adviced patient to consult with her primary MD regarding of getting prescription for BP medications since patient is currently not on one. Client left on a wheelchair accompanied by grandaughter. Client reported of feeling better and not seeing black anymore
78 2021-05-01 blood pressure decreased Sore at injection sight (mild) next day. Nothing noticeable until 24 Apr 21 Pounding headache... Read more
Sore at injection sight (mild) next day. Nothing noticeable until 24 Apr 21 Pounding headache, fatigue, sleepy long periods , mild sore throat, blood pressure lower than usual . Temperature with in normal limits . I have been resting a lot , waiting for conditions to improve, however, as of this writing nothing has changed. Thus I decided to file this report. my I have not seen my healthcare provider yet but will make contact tomorrow
78 2021-05-02 platelet count decreased, haemoglobin decreased Patient experienced an arthritis flare after the 1st dose, and this became much more intense after t... Read more
Patient experienced an arthritis flare after the 1st dose, and this became much more intense after the 2nd dose. She had increased weakness, abdominal pain, loss of appetite (not eating/drinking much), falls, and failure to thrive x3 weeks after the second dose which all ultimately got her admitted to the hospital (4/6/21). Upon admission, her blood counts were found to be dangerously low.
78 2021-05-03 fainting, chest pain after vaccination, patient began to feel lightheaded and dizzy, experienced syncope. after waiting ... Read more
after vaccination, patient began to feel lightheaded and dizzy, experienced syncope. after waiting for about 15 minutes she began to complain about chest pain. We decided to call 911 as she was extremely agitated and tremors
78 2021-05-07 low platelet count This 78 year old patient received the Covid shot on 2/27/21 and went to the ED on 3/1/21 with ... Read more
This 78 year old patient received the Covid shot on 2/27/21 and went to the ED on 3/1/21 with the following diagnoses listed below. Thrombocytopenia, unspecified
78 2021-05-09 pulmonary embolism I26.99 - Pulmonary embolism on right I26.99 - Other pulmonary embolism without acute cor pulmonale
78 2021-05-10 heart attack, chest pain, cerebrovascular accident Non-ST elevation (NSTEMI) myocardial infarction Facial weakness NSTEMI (non-ST elevated myocardial i... Read more
Non-ST elevation (NSTEMI) myocardial infarction Facial weakness NSTEMI (non-ST elevated myocardial infarction) CHEST PAIN CEREBROVASCULAR ACCIDENT
78 2021-05-10 fibrin d dimer increased, heart rate increased high D-dimer test result (485); rapid heart rate; This is a spontaneous report from a contactable co... Read more
high D-dimer test result (485); rapid heart rate; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via unspecified route of administration on 11Feb2021 08:30 AM in left arm as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no known allergies. Concomitant medication included (other medications in two weeks) lisinopril, simvastatin, fluticasone propionate, salmeterol xinafoate (ADVAIR), 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any COVID prior vaccination. Since the vaccination the patient was not tested for COVID-19. The patient experienced rapid heart rate on 14Feb2021, high D-dimer test result (485) on 15Feb2021 at 7.00 PM. The patient did not receive any treatment for the events. The AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered on an unknown date in 2021. Information on the lot/batch number has been requested.
78 2021-05-11 blood pressure decreased harder to breathe; smell of food made me sick later that day; blood pressure went down; cold chills;... Read more
harder to breathe; smell of food made me sick later that day; blood pressure went down; cold chills; Shaking; This is a spontaneous report from a contactable consumer (patient reported for herself). A 78-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982) administered in left arm via an unspecified route of administration on 27Feb2021 at 10:00AM as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, known allergies to sulfa and Tetanus shots. The patient's concomitant medications were not reported. The patient previously took first dose of historical vaccine of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported) via an unspecified route of administration on 06Feb2021 at 10:00 am as SINGLE DOSE for covid-19 immunization and experienced no adverse event. Other historical vaccine in 4 weeks included Prolia on 21Jan2021 in doctor office. On 28Feb2021 at 12:30 am, the patient was harder to breathe, smell of food made me sick later that day, blood pressure went down, cold chills and shaking. The patient reported as Shaking was so hard as she could not hold glass of water or get the pills out of the bottle because they flew all over the place. This lasted for 2 hours. Then smell of food made the patient sick later that day and then with the cold chills. It took heating pad and other heating products to stop from shaking. patient blood pressure went down to 98/60 and harder to breathe for just a short time. Treatment received for the event shaking and no treatment received for other events. The outcome of the events was recovering. No follow up attempts were possible. No further information was expected.
78 2021-05-11 cerebrovascular accident I63.9 - Cerebrovascular accident (CVA) determined by clinical assessment
78 2021-05-11 lightheadedness VS 141/83 mmHg, 98 bpm, 95% RA Around 15 mins after receiving vaccine, pt stood up and felt dizzy/ne... Read more
VS 141/83 mmHg, 98 bpm, 95% RA Around 15 mins after receiving vaccine, pt stood up and felt dizzy/near syncopal, no hives, itching, swelling, SOB, HA, CP or numbness Heart rhythm, swelling, SOB, HA, CP or numbness Heart rhythm regular, no murmurs, lungs clear to auscultation. No cyanosis. Resting tumor history Pt says history of breaking out in hives after getting a shot of "something" Despite rest, giving water and putting pt in Trendelenburg position still felt unstable gait/station with standing
78 2021-05-12 blood clot, chest pain Patient stated she developed clots during hospital admission with the complaint of chest pain. Patie... Read more
Patient stated she developed clots during hospital admission with the complaint of chest pain. Patient stated at hospital admission, they discovered blood clot in her right leg and right lung. Patient was treated with oxygen and medication. Patient was inpatient for two nights and sent home lovenox injections for one week and continuing with Eliquis. Patient is currently on Eliquis for unknown duration. Patient will see cardiologist in three weeks and reevaluate.
78 2021-05-18 blood clot numerous blood clots below the knee; left leg swelling/ It got so swollen/left foot swelling; pain w... Read more
numerous blood clots below the knee; left leg swelling/ It got so swollen/left foot swelling; pain with walking left leg; This is a spontaneous report from a contactable nurse reporting for herself. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Right Arm on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for covid-19 immunisation (Age at vaccination 78 years). The patient medical history was not reported. On 04Feb2021 the patient received the first dose of BNT162B2 and experienced sore arm. The patient's concomitant medications were not reported. The patient experienced pain with walking left leg on 28Feb2021 with outcome of recovering , left leg swelling/ it got so swollen/left foot swelling on 03Mar2021 with outcome of not recovered , numerous blood clots below the knee on 04Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included blood test: unknown results, ultrasound joint: numerous blood clots below the knee on 04Apr2021 , vital signs measurement: unknown results. Course of the event: The patient waited for the timeframe after the second dose and had no problems. 4 days after, she experienced pain with walking in her left leg. She took Aleve for a few days. It got so swollen, she should have gone then to her Primary Medical Doctor, but she did not go until 25Mar2021. She was sent to Hospital for an Ultrasound of her leg on 04Apr2021. After the Ultrasound, she was taken to the Emergency Department at the hospital. The doctor told her she had numerous blood clots below the knee. Was prescribed Eliquis 5mg. She was instructed to take 2 tablets or 10mg twice a day, 8hrs apart for 1 week and then 1 tablet twice a day for the remainder of the 74 tablets. She completed that. She was out of them and got a refill of Eliquis 5mg on 26Apr2021. She received 60 tablets and can refill for 5 times. She is really concerned. The swelling is still so bad and so that could that mean blood clots are still in there. The ER doctor told her that the medication is dangerous. It thins the blood and can cause bleeding and the blood clot can go to her heart. Follow up information has been requested.; Sender's Comments: The causality has been assessed as related to bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Right Arm on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for covid-19 immunization, based on temporal association and profile of the product.,Linked Report(s) : 2021499984 same patient/drug, diff dose/event
78 2021-05-20 atrial fibrillation 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. Diagnoses were pneumonia, A-fib and hyponatremia. Patient died on 4/21/2021
78 2021-05-22 chest discomfort About 45 minutes after 2nd shot I had very odd feeling of lightheaded and dizzy. Also felt like a t... Read more
About 45 minutes after 2nd shot I had very odd feeling of lightheaded and dizzy. Also felt like a tight band around chest and difficulty in a deep breath. This lasted about 20 minutes. Since then a lot of joint pain and fatigue
78 2021-05-24 heart rate increased feeling a click right before her fast heartbeat then drink water and slows it down/something clicks ... Read more
feeling a click right before her fast heartbeat then drink water and slows it down/something clicks in body, heart beats really fast; really bad pain in her right knee; muscles really tight; didn't feel so good; she was scared to death, her nerves; anxiety; very frightened; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right on 21Jan2021 (at the age of 78-year-old) (Batch/Lot Number: EL1283) as 1st dose, single for covid-19 immunisation. Medical history included hypo thyroiditis (does not have it anymore, it was 30 years ago when she was a teacher), knee that was broken twice and allergic to antibiotics from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced feeling a click right before her fast heartbeat then drink water and slows it down/something clicks in body, heart beats really fast, really bad pain in her right knee, muscles really tight, didn't feel so good, she was scared to death, her nerves, anxiety and very frightened. The reporter stated that feeling a click right before her fast heartbeat then drink water and slows it down, was happened after she got her first covid shot. The patient asked to know if it was safe for her to get the second dose of the vaccine. The patient wondered if anyone else, she had the first Pfizer vaccine, later clarified as the COVID vaccine, a week ago last day before the time of this report, and she used to have a really fast heartbeat, but it slowed down, and once in a while, it was fast and stuff, now she had this happened twice, where she felt something click in her body, her heart beats really fast, and she drank water immediately, it slows down, has anyone said this after getting the vaccine. She has been on the phone for two hours. She never had a little click, she had thyroid hypo thyroiditis and every evening she would have a fast heartbeat, her blood pressure would go, but she never had when she would feel this little click, like a little, and her heart was really fast in morning of the report, it was really fast, and the minute she drinks water, it slows it down, it does not make sense. Also, her muscles are really tight, she was 78 and having a hard time with this pandemic, her nerves not good, she was nervous about the vaccine. She stated she was a teacher, and her weight was 106-107 pounds. About the event feeling a click right before her fast heartbeat then drink water and slows it down/something clicks in body, heart beats really fast, the patient stated, unknown when this started, exact date unknown, this has happened twice, this morning was the second one, and the minute she drank water, it slows it down, but it was very very fast, and she did not feel so good after, she was scared to death, her nerves are shot, she has trouble with anxiety, she was feeling ok now. She was nervous about what was going on and would feel better if someone else said they experienced the same. About the event muscles being really tight, the patient stated she has knots, her muscles are tight in her shoulders and neck lots, last night she was writing recipes, she does recipes boxes for her grandkids, and she was using her right arm a lot, she does not get to go to spa since the pandemic, she has not gotten to go to her for over a year. Her husband rubbed it out, and she did heat. Her muscles were tight right after she did it, so it could be something, it said if you think you had a symptom and also the second night after, she had a really bad pain in her right knee, it lasted one night, it was a knee that was broken twice, which may be why it was that leg. She was very very frightened to take it, she reacts to things strangely, when she has any procedure, they always say they never had that happen to anyone, she was allergic to antibiotics, different things happen when she takes different things, she was nervous about the whole thing, which may have to do with it. The second dose is on 12Feb2021. The outcome of the event muscles really tight was recovering and unknown for other events. Follow-up attempts are completed. No further information is expected.
78 2021-05-24 palpitations, hypertension feeling palpitations; blood in her urine; pain in her right kidney; While she was there they took he... Read more
feeling palpitations; blood in her urine; pain in her right kidney; While she was there they took her BP and it was 190/90 and she takes BP pills then last night it was a little high but it came down by itself.; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 25Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included anticoagulant therapy (blood thinner) from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid taken for anticoagulant therapy, start and stop date were not reported. The only medicine that is relevant is the Baby Aspirin, it is 84 mg. She confirms 84 mg baby Aspirin. Her cardiologist gave it to her for a blood thinner. On Jan2021 patient experienced feeling palpitations, blood in her urine, pain in her right kidney and while she was there, they took her BP and it was 190/90 and she takes BP pills then last night it was a little high, but it came down by itself. The patient underwent lab tests and procedures which included blood pressure measurement as 190/90 on Jan2021 she was there they took her BP and it was elevated to 190/90, sars-cov-2 test as unknown results on 28Jan2021 she went to get a COVID test yesterday, urine analysis as blood on Jan2021. Caller is calling about the Pfizer COVID-19 vaccine. She received the first dose 25Jan2021, last Monday and then she began feeling palpitations. She also had blood in her urine and pain in her right kidney. Today her urine was clear but the palpitations are still there and she wanted to call and report and ask does she need to do something about it. Also she went to get a COVID test yesterday. No further information provided. While she was there they took her BP and it was 190/90 and she takes BP pills then last night it was a little high but it came down by itself. No further information provided. She has a flight, should she not fly or is there no problem. She also is set to get the second dose 15Feb2021 and she wants to know what will happen should she not take her baby Aspirin. She takes a Baby Aspiring every 2 days, she took one last night but she does not know if maybe the baby Aspirin is the reason she got the blood in her urine. She wants to know if she should suspend the vaccine or get it. She sees the date she is to get the second vaccine 15Feb2021. She does not see any expiration date. Trying to prevent COVID she is at risk with other issues, she gets pneumonia easy. She has had the vaccine for pneumonia and flu because she is elderly (78) and that is an At risk age. She confirms she wants to know if she should still get the second dose after this experience and also if she does take the second dose should she stop the Baby Aspirin a few days before. The outcome of the events was not recovered for palpitations and recovered for blood in urine, whereas unknown for the other events. Follow-up (29Jan2021): This is a follow-up spontaneous report from a contactable consumer. No new significant information was found. Follow-up attempts are completed. No further information is expected.
78 2021-05-25 blood clot Patient has a blood clot; Pain sent patient to the emergency room; Patient was tired, and was having... Read more
Patient has a blood clot; Pain sent patient to the emergency room; Patient was tired, and was having a hard time breathing. Patient was thinking it was something else; Patient was tired, and was having a hard time breathing. Patient was thinking it was something else; This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported for a 79-year-old female patient (reporter's mother) that: Submitted by Call Centre Selected Report Type: Initial Is report related to a study or programme? No Patient Ethnicity: Unknown Is the patient also the reporter? No Reporter type: Consumer or other non-health professional Specify Consumer or other non-health professional: Reporter is patient's daughter Primary / Prescribing Healthcare Professional Info Adverse events: Dates for Patient has a blood clot: (From: Apr2021 To: Ongoing) Reporter seriousness for Patient has a blood clot: Hospitalization Dates when patient was in hospital for Patient has a blood clot: 29Apr2021 to 02May2021 Dates for Pain sent patient to the emergency room: (From: 26Apr2021 To: Ongoing) Reporter seriousness for Pain sent patient to the emergency room: Unspecified Dates for Patient was tired and was having a hard time breathing. Patient was thinking it was something else: (From: Apr2021 To: Ongoing) Reporter seriousness for Patient was tired and was having a hard time breathing. Patient was thinking it was something else: Unspecified Is Pfizer covid vaccine a Pfizer product? Yes Pfizer covid vaccine manufacturer: Unspecified Dates for Pfizer covid vaccine: (Start: 20Feb2021 Stop: Unspecified) NDC number of Pfizer covid vaccine: Unknown Expiry Date of Pfizer covid vaccine: Unknown Why was the patient taking Pfizer covid vaccine (Verbatim): Because of patient's age Other Products: No Patient History: No Investigation Assessment: No Additional Context: Reporter is calling on behalf of someone else. Reporter is calling about the Pfizer covid vaccine. Reporter is hoping for some guidance. It is reporters understanding, that if there is complications after the covid vaccine, there is compensation available. She is asking does she need to go somewhere for that. Reporter is calling about her mother. Reporter's mother is the patient. Reporter's address: Reporter was asked for her mailing address. Reporter stated that she will provide patient's mailing address, that it would be easier to provide patient's address. Primary / Prescribing Healthcare Professional Info: Declined. Patient has a blood clot: Patient is now out of the hospital, but she is on a blood thinner for the next six months. She was diagnosed with a blood clot and hospitalized on 29Apr2021. Patient began having adverse reactions two weeks prior, but patient did not realize they were related to her blood clot. Reporter does not know an exact start date. Patient is getting better with the blood thinner, but the blood clot is still there. Pain sent patient to the emergency room: Pain began on 26Apr2021. Patient is still in pain, but it is not as severe. Patient was tired and was having a hard time breathing. Patient was thinking it was something else: Began about two weeks prior to being diagnosed with a blood clot. The problem is, it is a large blood clots, and has done damage to patient's lungs. Reporter states because of the blood thinners that patient is having to take, patient is having complications. The blood thinners are very expensive. The blood thinners are interfering with other medications that patient is on. No further information provided. First dose administered on 20Feb2021 about 12:00PM in left arm. Lot number: EL9266 NDC: Unknown Expiry date: Unknown Second dose administered on 13Mar2021 at 1:30PM in left arm. Lot number: Unknown NDC: Unknown Expiry date: Unknown Patient Age at Time of Vaccination in Years: 79 Vaccination Facility Type: Other, Pop up clinic. Vaccine Administered at Military Facility? Not provided. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Did any AE(s) require a visit to: Emergency Room? Yes. If the patient was hospitalized, how many days was the hospital stay? Four days. Physician Office? Yes. Patient has saw an oncologist, primary care physician, neurologist and pneumologist. Prior Vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: Not provided. Patient's Medical History: None. Family Medical History Relevant to AE(s): None. Relevant Tests: None. Reporter is asking what all she needs to submit to Pfizer Legal. Reporter is asking if she needs a lawyer to handle this. PSCC Communication: Caller notified that all requests for compensation will need to be made in writing to Pfizer Legal. Caller was provided with Pfizer Legal Department's address of Pfizer, Inc. Legal Department Follow-up attempts are needed. Additional information is requested
78 2021-05-31 palpitations Flu like symptoms; Weakness; Headache; Tiredness; just sleeping /. She slept it off for a couple of ... Read more
Flu like symptoms; Weakness; Headache; Tiredness; just sleeping /. She slept it off for a couple of days./felt very sleepy; she could feel her heart racing; had a heavy feeling on her head; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date were unknown), via an unspecified route of administration on 26Jan2021 10:00 (at the age of 78-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included asthma and chronic obstructive pulmonary disease from an unspecified date, diagnosed many years ago. Broken collarbone and Broken wrist on 28Dec2020. It was reported that she had three broken bones in her wrist, she can't lay in bed anyway, so she sleeps on the sofa, getting constipated on an unspecified date, The patient was allergic to Benadryl. It was also reported that she doesn't sleep too well, due to the sitting up in the chair business. concomitant medications were not reported. On 26Jan2021, 2-3 hours after, she felt very sleepy, had a heavy feeling on her head that was almost flu-ish but had no fever nor chills, and she felt that her heart was racing Influenza like illness, weakness, headache, and tiredness. She slept it off for a couple of days. She was enquired if she can still take the 2nd dose of the vaccine given these side effects. It was reported that she had her first dose of the shot on the 26th of Jan and thinks she had a reaction, though it was not enough to go to her doctor or anything, she was too weak. She said she didn't have chills, was not nauseous, had no fever, she feels like she had the flu, and. She said that she gets up and eats then goes back to sleep or does whatever else she had to do. she can't lay in bed anyway so she sleeps on the sofa. she did get up the next day and all the time had a headache. She says she doesn't take the flu shot because her older brother had a terrible reaction to that, none of her siblings take that shot, but she knows what it feels like to have a bad cold with your head heavy, that kind of feeling, she imagines that is what the flu feels like. The patient received treatment with Tylenol for headache. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): 110/70 mmHg on an unspecified date, blood test: unknown on an unspecified date, Pulse (heart rate): pulse was ok on an unspecified date. Caller said that she was so surprised when she went to her doctor's appointment that her heart was racing, and she thought her blood pressure would be sky high, but the bottom number was 70 something, which is low for her, and the top number was 110, so it was perfect, which she doesn't usually have. She said that her pulse was ok and everything else was ok, and she had blood work taken that day but they didn't get those results back yet, so she doesn't know what they are. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (13May2021): Follow-up attempts completed. No further information expected.
78 2021-06-02 palpitations Patient has one episode of Palpitation for about an hour, got better on its own. Patient had palpita... Read more
Patient has one episode of Palpitation for about an hour, got better on its own. Patient had palpitation, long time ago and got better with ablation.
78 2021-06-03 atrial fibrillation because of blood pressure and AFIB issues and had a pacemaker implanted and missed her 2nd shot.; be... Read more
because of blood pressure and AFIB issues and had a pacemaker implanted and missed her 2nd shot.; because of blood pressure and AFIB issues and had a pacemaker implanted and missed her 2nd shot.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 06Apr2021 (age at vaccination 78 years) as single dose for COVID-19 immunization. Medical history included previously had a stroke 3 months ago. Been in Anaphylactic shock in the past due to severe allergic reactions to medication. Concomitant medications included was not reported. she was on Eliquis which a blood thinner and taking other heart medication. On 27Apr2021 the patient was admitted to the hospital, she had previously a stroke 3 month ago and she was admitted to the hospital for implant of a pacemaker on Apr27. she was recently released from the hospital and patient was in the rehab for about 2 weeks. she wants to know it safe for her to get the second shot under these circumstances. Patient on Eliquis used as a blood thinner and taking other heart medications. She going to be 79 next months and patient just wanted to know if there's a risk for patient. and she also had been in anaphylactic shock in the past due to severe allergic reactions to medication. she wants to confirm that the weather needs to reschedule for 1 dose if patient missed the 42 days window. Consumer was provided Pfizer Medical Information website. On 27Apr2021 the patient experienced because of blood pressure and AFIB issues and had a pacemaker implanted and missed her 2nd shot. The outcome of events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
78 2021-06-03 hypertension, heart rate irregular Shaky; Warm; My face turned red; My hands were shaking; I felt my heart skipping with irregular hear... Read more
Shaky; Warm; My face turned red; My hands were shaking; I felt my heart skipping with irregular heart beats; The nurse measured my blood pressure and it was 183/95 with a pulse of 104; This is a Spontaneous report from a Contactable Consumer (patient, self-reported). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Feb2021 at 08:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included hypertension, chronic lymphocytic leukemia, osteoporosis, glaucoma and known allergies: reaction to epinephrine (cannot have Novocain with epinephrine), reaction to histamines and tyramine. Concomitant medications included metoprolol succinate (TOPROL XL), Amlodipine, Levothyroxine, and Atorvastatin. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 03Feb2021, about 7-10 minutes after receiving the shot, she started to feel extremely shaky and warm. Her face turned red, and her hands were shaking. She felt her heart skipping with irregular heartbeats. The nurse measured her blood pressure, and it was 183/95 with a pulse of 104. She was observed for an hour. The patient did not receive treatment for the events. Outcome of the events was recovered on an unknown date in Feb2021. Follow-up attempts completed. No further information expected.
78 2021-06-03 bleeding on surface of brain, fainting syncope; Acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural h... Read more
syncope; Acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; hemorrhagic contusion with edema; hemorrhagic contusion with edema; fatigue; malaise; HA; This is a spontaneous report from a contactable physician. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 21Feb2021 (Lot Number: EN6200) (at the age of 78-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hyperlipidemia (HDL) and hypothyroidism, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. 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 SSRI, PNC (unknown), sulfa and oxycodone; the patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 31Jan2021 (Batch/Lot Number: EL9265) as single dose for COVID-19 immunisation. Within 12 hours of vaccine (on 22Feb2021) the patient developed symptoms of fatigue, malaise, headache (HA) and severe and near syncope. She visited the emergency department (ED) the following day. Work up at that time including blood work and no imaging. She was treated with IVFs and discharged. Symptoms of malaise, fatigue and HA persisted for > 1 week. A computerized tomogram (CT) of the head was performed on 05Mar2021, this CT showed the following: acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; 2X3 left front hemorrhagic contusion with edema. The events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the events and includes conservative measures (as reported). The patient outcome of the event was recovered with sequel.; 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 reported events 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.
78 2021-06-07 heart rate increased Feeling unwell; fast heart beat; nauseous; unbalanced when walking; This is a spontaneous report fro... Read more
Feeling unwell; fast heart beat; nauseous; unbalanced when walking; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9810 and Expiration date not reported) via an unspecified route of administration, administered in Arm Left on 04Feb2021 14:35 as 1st dose single dose for COVID-19 immunisation. The patient medical history included anxiety from Unspecified to Unspecified date. The patient concomitant medication included alprazolam (XANAX) taken for anxiety from Unspecified to Unspecified date. The patient received no other vaccines in the past 4 weeks period. On 05Feb2021, morning, she noticed she is feeling unwell and had a fast heart beat. After eating it got a little better. It says on the paperwork normal side effects to expect like feeling unwell and fast heartbeat which has calm down for her, but she was wondering how long this was expected to last and have the side effect. She was not feeling good this morning. She doesn't want this to last a long time. The patient reported that after the vaccine she felt nothing, no pain, no pain even at the arm. The patient reported that, she was not completely sure how she was feeling because she was sitting now, she felt nauseous and unbalanced, she was feeling unwell. As she was sitting down, she thinks it was better, but she still feels unbalanced when walking. The patient took half a Xanax when her heartbeat was fast, that was usually the trick that slows it. It was reported that, she takes Xanax for anxiety and maybe that was it was. She took the Xanax because she had to wait on the phone for so long to speak to someone. The second dose was schedule date on 02Mar2021. The patient had so many medications, but had not taken them before this started, she took them later. The patient received list of what she could expect, on the list what she had was a common reaction, but the Fast heart rate was in the call section, but it was not that bad for her to call 911 as she knows a fast heartbeat can happen with her anxiety. She usually gets the flu vaccine and pneumonia vaccine, she does not remember when she had it last, she usually gets them when it comes out or when pharmacy announces it and asks her. The patient noticed that people who usually get the COVID virus die of Pneumonia, so she thought she would get the pneumonia vaccine. The patient had some exam 2 weeks ago, and yesterday the Physician left a message about the results and did state on the phone that she has nothing to worry about. The outcome of Feeling unwell was not resolved and fast heart beat was resolving. Follow-up attempts are completed. No further information is expected.
78 2021-06-08 hypertension Blood pressure high; her doctor could see that she had some pneumonia showing; Coughing; soreness in... Read more
Blood pressure high; her doctor could see that she had some pneumonia showing; Coughing; soreness in her arm; slept all day long; started running a 99.9 temperature; could not catch her breath, her breathing was down in the danger zone at 220; This is a spontaneous report from a contactable consumer (Patient). A 79-year-old elderly female patient received bnt162b2 (COMIRANTY; Solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration on 11Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date the patient experienced, the patient could not catch her breath, her breathing was down in the danger zone at 220 reported dyspnoea and hospitalization on an unspecified date, had high blood pressure, her doctor could see that she had some pneumonia showing, coughing, soreness in her arm, slept all day long. Additional Context: Consumer states that her doctor wanted her to call and report this, because she has asthma and allergies that are chronic. Consumer states that she took her first Pfizer injection in April. She saw her allergy specialist on the 1st, and she tested the Consumer before she took the vaccine. She states that her breathing was at 113% breathing capacity (good) and the allergy specialist wanted her to go ahead and get the injection, which the Consumer did. Consumer clarifies that she received the first Pfizer COVID vaccine on 11Apr2021 and that she did really good with that one. Consumer then received the second COVID vaccine on 13May2021. She came home and slept almost all night long and thought she was okay. The Consumer explains she was not feeling real good before she went to receive her second dose. It was kind of like she was having some coughing and stuff, but she thought it was not bad and that she could still go ahead and get it. She went ahead on 13May2021 and had the second dose. Consumer states that on the first day, she slept all day long- the whole entire day, she didn't even wake up. On the second day, the Consumer states that she had soreness in her arm. Then, she noticed she was getting really sick and started running a 99.9 temperature. It was getting worse day by day, and she kept coughing and getting worse. Then, on 18May2021, her husband took her to the emergency room and they just automatically treated her for asthma and allergy and sent her home. This was on Tuesday night. On Thursday night, she got so bad that her breathing was down in the danger zone at 220. She couldn't breathe. Her husband rushed her back to the ER and this time, they kept the Consumer and hospitalized her for a week. Her blood pressure was high. She clarifies normally her breathing on her peak flow meter, she can always do from 350-400. Well on Thursday night, her peak flow was all the way down to 220 and she could not catch her breath. Consumer states that she was admitted to the hospital and they had her on oxygen and blood pressure medication. She states that they did a bronch on her and still did not really come to a conclusion of what was happening. She was told it looked like it could be an infection in her lungs. Consumer states that she is having to see three doctors this week because of this since she got out of the hospital. She saw her medical doctor, Dr., yesterday who was very concerned because she had a recent patient that was about the same age as the Consumer- he was 75 years old. This patient had done the same thing, only he ended up taking pneumonia and dying with it. The doctor told the Consumer in her x-ray, her doctor could see that she had some pneumonia showing. The Consumer asked her doctor while she was in the hospital about the pneumonia and they refused to listen to anything the Consumer said, so Dr. told her that the Consumer needed to report this because she is still so sick. Consumer clarifies that she was hospitalized for a week and that she just got out on Saturday, 29May2021. While reporting the event details, the Consumer stated that she had and emergency call coming through and that she had to take it. Consumer had to end the call, stating she had to go and requested this call handler call her back. The patient was hospitalized due to events. The patient underwent lab tests and procedures which included blood pressure measurement, body temperature: 99.9, peak expiratory flow rate: 220 Units: x-ray: had pneumonia showing. The outcome of the events was unknown.
78 2021-06-11 chest pain, pulmonary embolism Patient stated she had the Pfizer #2 vaccination end of April (unsure of date) and 1 week later beca... Read more
Patient stated she had the Pfizer #2 vaccination end of April (unsure of date) and 1 week later became symptomatic with SOB. For 3 weeks she felt SOB with CP. She presented to hospital and found to have bilateral pulmonary embolisms. Please contact patient for further details. She states she is very healthy and does not have risk factors for clots. She requested I fill out this form for her. I spoke to our pharmacy and they directed me here. I do not know all of the details therefore more investigation should be performed.
78 2021-06-13 atrial fibrillation Within 2 weeks of shot, AFIB episodes increased in number, going from one ocassionally, to 2 within ... Read more
Within 2 weeks of shot, AFIB episodes increased in number, going from one ocassionally, to 2 within 2 weeks and then on April 2, 2021, they began to occur daily and last for 6-8 hours. This continued for approximately 5 weeks after which they began to subside and now happen weekly at much shorter intervals
78 2021-06-16 hypertension, heart rate increased Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy... Read more
Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; BP was high; high heart rate & MAP; high heart rate & MAP; tired; left side of throat felt swollen; feelings of being "out of sorts"; Small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins; Mild nausea; Arm soreness at vaccination site; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 14Mar2021 13:15 (at the age of 78 years old) as 2nd dose, 0.3 mL single for covid-19 immunization. Medical history included thyroid nodules, mild macular degeneration, postmenopausal syndrome, high blood pressure (HBP), total hysterectomy w/oophorectomy, gallbladder removal, appendectomy, allergy to penicillin, allergy to contrast dye, allergy to adhesives, and hard of hearing (HOH). Concomitant medications included valsartan (DIOVAN); famotidine (FAMO); pravastatin; estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); and vitamin D3, all taken for an unspecified indication, start and stop date were not reported. The patient previously took nitrofurantoin (MACRODANTIN), clarithromycin (CLARITIN) and experienced drug drug allergy from both; also previously received the first dose of BNT162B2 (Lot number: EN6201), on 14Feb2021, 13:00, administered in left arm, for COVID-19 immunization. On 14Mar2021 late same day, the patient experienced mild nausea which lasted less than an hour, arm soreness vaccination site. On evening of 15Mar2021, a small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins. Upon waking on 16Mar2021 the patient was still itching spots plus left eye was itchy, dry and red; with a bit of nausea, BP was high, no fever, high heart rate and mean arterial pressure (MAP), was tired, left side of throat felt swollen, feelings of being "out of sorts", and her arm no longer hurts at all. The patient took Benadryl and Aleve and all seem better at the moment. She stated she would describe her symptoms as mild although somewhat scary especially the increase in blood pressure and MAP. Her oxygen was normal at 95-97. The patient was recovering from the events.
78 2021-06-20 blood pressure increased I went to have a minor surgery on my hand and they took my blood pressure and my pressure was elevat... Read more
I went to have a minor surgery on my hand and they took my blood pressure and my pressure was elevated. I contacted my doctor because my pressure stayed high. I increased my blood pressure meds and it was able to stabilize.
78 2021-06-22 heart flutter, palpitations, cardiac arrhythmia Five weeks after the second dose of the vaccine I noticed my heart was fluttering. I was having palp... Read more
Five weeks after the second dose of the vaccine I noticed my heart was fluttering. I was having palpitations. I visited my doctor and the EKG did not show any problems. I then wore a heart monitor for 48 Monitor and it showed that I was having PVCs. I have never had any heart rhythm problems before. I am a Marathon Athlete and in good health normally. I still have the PVCs which seem to be OK when I am running but get worse with stress.
78 2021-06-23 body temperature decreased day after getting the 1st dose she got a headache/chills/low temp/couldn't more left arm/arm, neck a... Read more
day after getting the 1st dose she got a headache/chills/low temp/couldn't more left arm/arm, neck and shoulder pain
78 2021-06-24 excessive bleeding Arm swelled and became inflamed and had some bleeding. 6 weeks of therapy
78 2021-06-24 palpitations This is a spontaneous report received from a contactable consumer or other non hcp. A 78-years-old f... Read more
This is a spontaneous report received from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9809) via intramuscular route of administration in left arm on 05Feb2021 at 09:45 (age at vaccination 78 years old) as single dose for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing Mother had heart issues, but she is passed away, ongoing panic attack the caller said that she has only had like 2 panic attacks in her life. She said that on 30Dec2021 she had a panic attack on the day of the vaccine, she had a light one on the way to get the injection, she said that she had COVID-19 previously and was diagnosed 05Jan2021 and was cleared so she took the vaccine, ongoing fatigue She said that her tiredness started during when she had COVID-19, but stated that she understands it was a symptom post COVID-19, ongoing gait disturbance She said that she may have been wobbly on her feet since she had COVID-19, but has gotten worse since the injection. There were no concomitant medications. On 05Feb2021 the patient experienced panic attack, her heart was racing/heart was racing to 132, unstable and wobbly on her feet, extremely tired and on unspecified date in February 2021 she said she feels like her eyesight has gotten worse, unstable and wobbly on her feet was reported as worsened/extremely tired was reported as worsened/she said she feels like her eyesight has gotten worse/and got very worse after vaccination. with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram fine in 2021. The clinical outcome of the event panic attack, her heart was racing/heart was racing to 132 were recovered and unstable and wobbly on her feet, extremely tired were not recovered other events were unknown. Follow-up attempts are completed. No further information is expected.
78 2021-06-27 heart rate abnormal, arrhythmia, atrial fibrillation I experienced shortness of breath and inability to draw a deep breath. I thought I was experiencing... Read more
I experienced shortness of breath and inability to draw a deep breath. I thought I was experiencing allergies. I went to see my primary care physician's assistant. She became alarmed when my heart rate was 141 and insisted I go to the hospital via ambulance right then (May 11, 2021 approximated 10:30 a.m.) I spent the first day in the Emergency Room at Hospital then was admitted to a private room. I was discharged on May 14th with prescriptions for Eliquis, digoxin, lasix, metoprolol, and lisinipril with the hope that m heart would return to normal pulse on its own, I had a echocardiogram, confirming Atrial Flutter. had an angiogram and was told there were no blockages. I had a transesophageal echocardiogram. It determined the doctor could not safely shock my heart back into rhythm. I have another scheduled for July 1, 2021.
78 2021-06-28 cardiac failure congestive acute congestive heart failure, dilatation of thoracic aortic aneurysm to 4.4 cm
78 2021-06-29 cardiac failure congestive Death 5/25/2021 Causes of death listed on death certififcate: 1. Acute Hypoxic Respiratory Failure ... Read more
Death 5/25/2021 Causes of death listed on death certififcate: 1. Acute Hypoxic Respiratory Failure due to Bilateral COVID-19 pneumonia 2. Bilateral Covid-19 Pneumonia 3. Covid-19 disease 4. Acute Renal failure, Metabolic Acidosis, Hyperkalemia, Acute Congestive cardiac failure
78 2021-06-29 fast heart rate One day after first dose of Pfizer vaccine, patient was admitted for fever, weakness and altered men... Read more
One day after first dose of Pfizer vaccine, patient was admitted for fever, weakness and altered mental status. At admission exhibited SIRS (fever, tachycardia), ultimately no infection was identified on work up.
78 2021-06-30 blood pressure increased dizzy; cramping in stomach; hard to swallow solid food; body shook; chills/teeth chattered; BP rose ... Read more
dizzy; cramping in stomach; hard to swallow solid food; body shook; chills/teeth chattered; BP rose to 170/89; felt jittery; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported that a 78-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing high BP Onset date: 5+ years Stop date: Ongoing Pertinent details: Controlled; ongoing acid reflux disease Onset date: 10+ years Stop date: Ongoing Pertinent details: Controlled. There were no concomitant medications. On 20Feb2021, the patient experienced BP rose to 170/89; felt jittery; chills/teeth chattered; body shook; On 21Feb2021, dizzy; cramping in stomach; hard to swallow solid food. The patient underwent lab tests and procedures which included blood pressure measurement: 217/105 mmhg on 28Jan2021, blood pressure measurement: 170/89 mmhg on 20Feb2021, pyrexia: 103 on 28Jan2021. It was reported that patient took 2nd shot on Wednesday 17Feb. On Saturday 20Feb BP rose to 170/89 felt jittery. On Sunday 21Feb become jittery, dizzy, BP high and had cramping in stomach. Hard to swallow solid food. Went on until doctor ordered Dicyclomine. It helps. On Saturday 20Feb had chills for 2and half hours. Teeth chattered and body shook. Stomach was still cramping after 2and half weeks and solid food is hard to swallow. I have an appointment with a gastrologist. The clinical outcome of all events were unknown. No follow-up attempts are possible. No further information is expected.
78 2021-07-01 chest pain chest pain that went around to my upper back also; chest pain that went around to my upper back also... Read more
chest pain that went around to my upper back also; chest pain that went around to my upper back also; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269, expiration date: not reported), via an unspecified route of administration, administered in arm right on 06Feb2021 09:00 (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. Medical history included heart attack in 2019 and 5 stents put in, known allergies (unspecified), known allergies: yes. Historical vaccine patient received included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL2283, expiration date: not reported), via an unspecified route of administration, administered in arm right on 13Jan2021 08:00 (at the age of 78-years-old) as dose 1, single for covid-19 immunisation. Concomitant medications were not reported. other medications in two weeks. No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination. On 08Feb2021 08:00, the patient experienced 'chest pain that went around to my upper back also'. The patient underwent lab tests and procedures which included bloodwork, chest x-ray, electrocardiogram (EKG) and ultrasound scan, all with unknown results in 2021. Chest pain that went around to my upper back also lead to emergency room/department or urgent care. Unspecified treatment was given for chest pain that went around to her upper back also. The outcome for both events was resolved in 2021. No follow-up attempts are possible. No further information is expected.
78 2021-07-05 cerebral haemorrhage death I61.9 - Nontraumatic intracerebral hemorrhage, unspecified
78 2021-07-12 hypertension went right back to sleep after her call and didn't wake up till next morning,; dull headache; head w... Read more
went right back to sleep after her call and didn't wake up till next morning,; dull headache; head was swimming; blood pressure went to 220/blood pressure was really high; black spots across my face; swimmy headed; legs didn't feel like they would hold her up/felt like my legs weren't going to hold me up; weak; very fatigued; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8731), via an unspecified route of administration, administered in left arm on 15Apr2021 13:15 (at the age of 78-years-old) as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She had her shot and just had a bad reaction to her very first shot. She came home, states sometimes she may doze off for 15 minutes or so but she fell asleep until at 16:00 she was woken up by a call from a friend. On 15Apr2021, she felt very fatigued and weak on Friday; later adds she was tired the day of shot as well. She laid around all day sleeping on Friday. On 17Apr2021 Saturday her legs didn't feel like they would hold her up and so she laid around again all day. On 18Apr2021 Sunday she knows had gotten up to go to bathroom a couple of times in the night; but then in the morning she was going to get up and felt faint; later adds she felt dizzy; states her head was swimming and she saw black spots and it scared her to death. Adds she thought she should go and sit up in the living room. But even after she sat down, sitting straight up, she kept seeing black spots. A friend took her to the emergency room (ER) for the dizziness and seeing spots. At the ER they found her blood pressure was really high; she thinks it was 220 over something, she forgot the bottom figure. They put an IV in to give her medication; did an electrocardiogram; a chest xray; blood work; a urinalysis and all of those tests everything was fine. The ER staff helped her to bathroom and her head was still swimming but they said that was because her blood pressure was still high. Adds her blood pressure went down on it's own and she had no medication for the blood pressure. They told her you are remarkable at your age to not to be on medication. She saw her doctor yesterday. Reports at the doctor's office her blood pressure was about 128/63. The doctor told her it was kind a low and that she basically runs low. She was not dizzy anymore on Sunday after her blood pressure went down. Adds she got a dull headache yesterday but she thinks it might of been a caffeine headache because she has had a caffeine headache in the past when she had to stop caffeine for a test or something. She has to take the second dose on 06May2021, and her doctor told her to take it; but she is scared to death. She asking for a recommendation as to whether she should get the second dose. The adverse event resulted the patient to visit emergency room and was not admitted and also visited to physician office. Outcome of the event hypertension was resolved on 18Apr2021, while for events- black spots across my face, dull headache, swimmy headed, feeling abnormal, head was swimming was resolved on 19Apr2021 and that for fatigue, weak was not recovered and sleep disorder was unknown. No follow-up attempts are possible. No further information was expected.
78 2021-07-13 transient ischaemic attack TIA, right side of body weakened to point of not being able to stand, left side of face numb, emerge... Read more
TIA, right side of body weakened to point of not being able to stand, left side of face numb, emergency hospital 24 hours for monitoring and tests.
78 2021-07-14 very slow heart rate, fainting Two days after COVID vaccine, patient suddenly lost a tooth, despite having no prior dental issues. ... Read more
Two days after COVID vaccine, patient suddenly lost a tooth, despite having no prior dental issues. Then her face ended up developing a long last swelling and rash episode that lasted for 1.5-2 months. Patient thinks it was a reaction to the amoxicillin she was given, but it persisted despite not being on the medicine, being given steroids, and antihistamines. Patient was in the ED twice for the facial swelling. Also saw Dermatology. Pt later saw an allergist and she is not allergic to amoxicillin, only other new thing had been the vaccine when it all started. Then the patient suddenly develops severe bradycardia to the point of syncope and episodes of sinus arrest. Patient then ended up requiring a pacemaker to be placed.
78 2021-07-14 platelet count decreased hospitalized with SIRS the next day, 2/20/2021, thought to be due to the immunization. discharged 3/... Read more
hospitalized with SIRS the next day, 2/20/2021, thought to be due to the immunization. discharged 3/4/2021
78 2021-07-26 blood glucose increased, platelet count decreased Prior to March 21, 2021 patient was able to walk on her own (although pace was slow), get in and out... Read more
Prior to March 21, 2021 patient was able to walk on her own (although pace was slow), get in and out of bed or chairs, able to dress herself, use the toilet and shower and communicate verbally (although voice was not very loud. She received the second Pfizer/BioNTech COVID-19 vaccine 2:30 PM on March 18, 2021; on March 21, 2021 she had gotten up at 4:00 AM and was walking through the kitchen when she found herself on her back on the floor and was unable to get up. She required help in getting up and has not been able to walk on her own ever since. She requires help in getting in and out of bed, in and out of chairs, cannot use toilet and shower on her own, is unable to dress herself and her voice has become a whis
78 2021-07-27 loss of consciousness, cerebrovascular accident Nine days after the first dose of the vaccine on 02/01/2021 during the night I had a severe headache... Read more
Nine days after the first dose of the vaccine on 02/01/2021 during the night I had a severe headache and I lost consciousness. I was taken to the hospital and I had had a stroke. I was hospitalized for four days and transferred to rehab on 02/05/2021 where I remained for 21 days. I was discharged from rehab on 02/26/2021. I also had in home therapy and continued to receive physical therapy until recently. I received the second dose of the vaccine in the hospital on 02/11/2021.
79 2021-01-04 chest pain pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, ... Read more
pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, chest and back; pains radiating down right arm, chest and back; nausea; Vomiting; severe chest and back pains on right; severe chest and back pains on right; This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient medical history was not reported. Concomitant medication in two weeks included citalopram, levothyroxine, atorvastatin, anastrozol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 3rd day (21Dec2020), the patient experienced severe chest and back pains on right at time of 12:30 AM. On 4th day (22Dec2020) pains radiating down right arm, chest and back, nausea and vomiting. On 5th day (23Dec2020) pain under right arm pit, very stiff neck, pain radiating into ear. Temperature was normal. On 6th day (24Dec2020) most symptoms dissipated. On 7th day (25Dec2020) almost back to normal. No treatment received for the events. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
79 2021-01-08 palpitations, fast heart rate Dizziness, Diarrhea, Palpitations & Tachycardia Narrative: Patient remained in facility for 15 minu... Read more
Dizziness, Diarrhea, Palpitations & Tachycardia Narrative: Patient remained in facility for 15 minutes after receiving vaccination. Upon ambulating to depart facility, patient returned to area complaining of dizziness and fast heart beat. Patient was immediately seated and vital signs were obtained. 0954- BP 150/82, pulse 80, Oxygen saturation 95%, and temp 97.8. Patient drank 8 ounces water. Patient reported feeling better after 10 minutes. Repeat vital signs at 1007 BP 127/74, pulse 80, oxygen saturation 95%. Patient with no further complaints of dizziness or fast heart beat. Patient did not verbalize any other complaints. Patient denied escalation to emergency department. Condition was resolved prior to leaving facility. Patient left facility ambulatory without any difficultly, and was accompanied by family member. Patient instructed to call 911 and report to nearest emergency room for any further issues or complaints. Patient verbalized understanding of instructions in her own words.
79 2021-01-10 lightheadedness, heart rate increased, blood clot, oxygen saturation decreased Resident had seizure like activity followed by a vagel response with large bowel movement. Resident ... Read more
Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low oxygen levels. Resident not responding to stimuli.
79 2021-01-18 fainting Pt ambulated w/ assistance into observation area, upon sitting down in observation, Pt appeared fai... Read more
Pt ambulated w/ assistance into observation area, upon sitting down in observation, Pt appeared faint, almost losing consciousness, Pt never lost consciousness, Dr. called, Dr. and more staff arrived, Pt was assisted to the floor, O2 began @ 8L, then lowered to 4 L, vitals taken BP 145/80, HR 76, O2 98%, O2 sat flucuated btw 84%-98%, AXOX4, EMS arrived within minutes and took over, Pt observed by EMS for 30mins. stable and released to go home per Pt request.
79 2021-01-19 palpitations Pt reports symptom onset 2:04 of palpitations and throat "slightly tight". States she has a pacemake... Read more
Pt reports symptom onset 2:04 of palpitations and throat "slightly tight". States she has a pacemaker and "just wanted to make sure everything is OK" Observed drinking ice water without difficulty. VS 163/81, pults 64, respirations 16. Observed x 20 minutes, VS remained stable. Pt states "sensation" has resolved. Advised to call 911 if symptoms worsen. Released to husband's care.
79 2021-01-21 palpitations, blood pressure increased Within 5 minutes of receiving the vaccine, my heart started racing, my blood pressure shot up to 190... Read more
Within 5 minutes of receiving the vaccine, my heart started racing, my blood pressure shot up to 190 over ? (Usually my BP is low normal), my face was very flushed.
79 2021-01-22 hypertension right arm unusable for 48 hours following injection, high blood pressure (200)4th day, TMJ 4th and ... Read more
right arm unusable for 48 hours following injection, high blood pressure (200)4th day, TMJ 4th and 5th days, joint pain in both shoulders 3rd day
79 2021-01-25 chest discomfort Fleeting headache after vaccination. Chest tightness last night which is a little more than usual. F... Read more
Fleeting headache after vaccination. Chest tightness last night which is a little more than usual. Feels fine today.
79 2021-01-25 deep vein blood clot patient presented to her primary care for evaluation of leg pain. Noted on US that patient had a DVT... Read more
patient presented to her primary care for evaluation of leg pain. Noted on US that patient had a DVT in Left distal superficial femoral and popliteal veins. patient was hospitalized for treatment as patient had recent diagnosis of GI bleed and would need close monitoring of blood thinning medications. Of note- patient is 1/3 hospitalized with cardiac/blood issues currently in this facility who received a vaccine from this pharmacy in the last month and all three patients have the same COVID vaccine lot number. Physician elected to have a VAERS put in on all patients to ensure investigation was properly handled.
79 2021-01-25 heart rate irregular Irregular heart rate pretty severe for a couple of hours then I had chills and enough to make my tee... Read more
Irregular heart rate pretty severe for a couple of hours then I had chills and enough to make my teeth clatter and also dry heave for some hours until I took the medicine under the tongue and it got better. I still have shaking in my hands and feet as well.
79 2021-01-26 atrial fibrillation New onset Afib
79 2021-01-26 hypertension Numbness and tingling sensation on right side of the body (leg, arm, back) Flushing in the face High... Read more
Numbness and tingling sensation on right side of the body (leg, arm, back) Flushing in the face Higher than normal blood pressure Sensations started earlier in the day on Saturday. On Sunday at 1pm, she went to the hospital and the symptoms stayed until 6pm. She was sent home from the hospital with diagnoses of parasthesia and numbness. Sensations started again earlier today, Wednesday the 27th. Called the doctor and said there isn't much they can do because they don't know much about the vaccine.
79 2021-01-26 hypertension Shortly after vaccination, patient developed dizziness and tingling sensation along jawline. Patien... Read more
Shortly after vaccination, patient developed dizziness and tingling sensation along jawline. Patient mildly hypertensive. Approximately 15 minutes later, dizziness developed but tingling sensation also experienced in bilateral feet. Evaluated in ER and ultimately sent home without further complication.
79 2021-01-27 platelet count decreased Started on 1/25/2021. Patient developed palpable purpura and petichia to bilateral lower legs. Plate... Read more
Started on 1/25/2021. Patient developed palpable purpura and petichia to bilateral lower legs. Platelet count transient drop to 126k, then back up to 150k.
79 2021-01-28 blood pressure increased, pallor 1300 - After vaccine administration pt c/o dizziness/lightheadedness. Skin was pale & diaphoretic. A... Read more
1300 - After vaccine administration pt c/o dizziness/lightheadedness. Skin was pale & diaphoretic. Assisted to supine position on floor. Feet elevated. BP 190/80, Pulse 96, RR 28 Axox3. 1305 pt remained on floor confusion noted, Axox1, repetative questions BP 189/80, states "Why am I here?" 1310 Pt. remained in supine position, continues to ask repetitive questions even after re-orienting to person/place/time. Husband states "I think she's just nervous." 1320 Pt. continues to show signs of confusion, states "What happened, who are you? Why did I get a covid vaccine? who gave it tome?" 1320 911 called 1345 Pt. transported to Hospital via Medic
79 2021-01-30 loss of consciousness Seated playing cards. Sudden onset extreme dizziness, short seizure, blacked out X 1-2 seconds Other... Read more
Seated playing cards. Sudden onset extreme dizziness, short seizure, blacked out X 1-2 seconds Other player called 911. One fire truck followed shortly by one ambulance both with two very cute EMTs. All vital signs normal. Very similar to dehydration attacks but worse and that always followed rising and walking. This attack worse and was not set off ambulating. Worried about a worse effect after second vaccine.
79 2021-01-31 blood pressure increased Dizzy and light headed, mild nausea, weak and tired with occasional shortness of breath. Elevated bl... Read more
Dizzy and light headed, mild nausea, weak and tired with occasional shortness of breath. Elevated blood pressure causing headaches. I have been unable to send this via the phone/text. I am exhausted from this continued distress. Normally very active and healthy.
79 2021-02-01 cardiac arrest Cardiac arrest; Patient transported by EMS to hospital 11:00pm on 01/29/2021. Patient received vacci... Read more
Cardiac arrest; Patient transported by EMS to hospital 11:00pm on 01/29/2021. Patient received vaccine on 01/25/2021. Patient expired 01/30/2021 within the hour into the new day after midnight on 01/30/2021. Patient was feeling well prior to and any chronic health conditions were well controlled. Sudden cardiac arrest 4 days after receiving the vaccine. Details given by patients husband/POA.
79 2021-02-01 chest discomfort Pt received COVID 19 vaccine at 1400. While in 30 minute observations area patient had c/o chest pre... Read more
Pt received COVID 19 vaccine at 1400. While in 30 minute observations area patient had c/o chest pressure, SOB, lightheadedness, Patient appears in NAD, skin PWD, patient is restless. Patient requesting b/p to be checked. Patient taken to first area where EMS on duty assessed patient. B/P 190/8-0 HR 90, RR 18, SaO2 96% on RA, CBG 144. Patient sitting in wheelchair and did state that she had a history of HTN and did not take prescribed medications, Lisinopril, Norvasc, today. Pt also take venlafaxine for anxiety. Pt observed by EMS, given snack, and water. Patient reports improvement of symptoms. VSS: b/p 156/70, HR 88, RR 18. Patient cleared by EMS and discharged home at approximately 1445.
79 2021-02-01 palpitations Chest palpitations, thickness of tongue. Medic administered epinephrine injection and benadryl thoug... Read more
Chest palpitations, thickness of tongue. Medic administered epinephrine injection and benadryl though IV in arm in tent on site. Taken by ambulance to hospital and observed for over 4 hours.
79 2021-02-02 blood pressure increased Patient complained of feeling feverish. Vital signs taken and patient temp was initially 99.4 then ... Read more
Patient complained of feeling feverish. Vital signs taken and patient temp was initially 99.4 then went down to 98.5 after 30 minutes. BP was elevated and ranged from 181/113 - 175/109. BP remained high, therefore, patient taken to ED for medical clearance.
79 2021-02-03 low platelet count, platelet count decreased 79 yo female with past medical history only significant for endovascular coiling of cerebral aneurys... Read more
79 yo female with past medical history only significant for endovascular coiling of cerebral aneurysms over 30 years ago presenting with fevers, fatigue, weakness, noise sensitivity, myalgias,and tremors. She exercises regularly and has become so weak that she cannot climb stairs. Neurological exam revealed hyperreflexia, subtle proximal muscle weakness, the presence of a startle reflex and rooting reflex, clonus, and a positive Babinski. Infectious work up has been negative, autoimmune evaluation is underway. Inpatient neurology consultation has been obtained, she was given a trial of diazepam for stiff person syndrome and started on daily IVIG on 2/3/2021 for a 5 day course. She continues to have an elevated CRP, a mild transaminitis, and mild thrombocytopenia. The ESR dropped from 44 to 20 with hydration. She has had no cognitive changes. No headache, visual changes, jaw pain. We are unable to obtain MRI given the presence of these coils which are not MRI compatible. Encephalitis immune antibodies are pending, myositis panel, MOG antibodies ADEM are pending, GAD65 antibody pending.
79 2021-02-07 blood pressure increased, hypertension hypertension/Blood pressure high; Really tired; some stuff with her kidneys; This is a spontaneous r... Read more
hypertension/Blood pressure high; Really tired; some stuff with her kidneys; This is a spontaneous report a Pfizer Sponsored Program from a contactable consumer (patient). A 79-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL8982) on 16Jan2021 14:30 at single dose in right arm for to prevent Covid-19. Medical history included ongoing sjogren's syndrome, hypertension. Prior vaccinations, the patient maybe tired and unwell from the flu vaccine and shingles vaccine (SHINGRIX) for immunization. There were no concomitant medications. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient got her first vaccine on 16Jan2021. About 3 days later, on 19Jan2021, she was really tired but it only lasted for that one day. States that on 19Jan2021, 20Jan2021, and 21Jan2021, her blood pressure shot way up and she went to the ER on 21Jan2021 because it had been so high for a few days. States that at home it was 172/104, 172/107, and 200/103. When she got to the ER it was 200/110. States that her blood pressure has improved on it's own today. While she was in the ER, they checked her Troponin's which were low, her EKG was normal, and the doctor said everything looked okay, except some stuff with her kidneys but that doesn't have anything to do with her blood pressure. Before she got the first dose she had a history of hypertension but it was already managed by medication and her BP was on normal range prior to vaccination. The AEs High blood pressure and Really tired require a visit to Emergency room on 21Jan2021. The patient was on BP medications. The patient was hospitalized for hypertension and Really tired. The outcome of hypertension was recovering, of Really tired was recovered on 19Jan2021, of other events were unknown. Second dose was scheduled on 06Feb2021.
79 2021-02-10 blood glucose increased, hypertension Within 15-minutes of vaccination, the patient reported dizziness and feeling lightheaded. EMS manage... Read more
Within 15-minutes of vaccination, the patient reported dizziness and feeling lightheaded. EMS managed patient's care on-site. Patient was hypertensive (178/96), SPO2 96%, and HR 90bpm. EKG was unremarkable. FSBG was 137 mg/dl. During EMS evaluation, patient stated they were feeling better and refused transport to hospital.
79 2021-02-10 blood glucose increased At 1207, resident was noted having facial twitching and seizures and crackles , Vitals: BP 199/95, O... Read more
At 1207, resident was noted having facial twitching and seizures and crackles , Vitals: BP 199/95, O2 Sats 89% on RA, PR 88, Temp 97.3, RR was hardly counted because of body movement. Blood sugar was 172 mg/dL. Hooked on O2 at 4L per NC. Informed MD and ordered to send to ER. Family - were updated. Ambulance was called. Family clarified resident's status is DNR. Report was given to ER nurse. Updated ER that INR today is 5.5 and MD ordered to HOLD Coumadin till 02-11-21.
79 2021-02-10 blood pressure increased 45 minutes after injection the left side of my face became numb to half of my tongue BP was higher ... Read more
45 minutes after injection the left side of my face became numb to half of my tongue BP was higher than normal 177/97! Numbness lasted about 45 minutes! BP was back to normal the next morning! 2/9/2021
79 2021-02-10 palpitations, chest pain, chest discomfort Vaccinated at 12:45. No reaction until 7:45 pm. Racing heart, labored breathing, pressure and sligh... Read more
Vaccinated at 12:45. No reaction until 7:45 pm. Racing heart, labored breathing, pressure and slight pain in chest. Called 911 and to Hospital ER. Aspirin given in ambulance. All back to normal by 10 pm and went home.
79 2021-02-10 fainting fainting day after vaccination chills and flu=like symptoms
79 2021-02-12 heart attack, loss of consciousness, heart failure She started having breathing problems/heart attack appearance. on 1/22/21 and went to the ER. Upon a... Read more
She started having breathing problems/heart attack appearance. on 1/22/21 and went to the ER. Upon admittance was told it was an anaphylactic shock from the Covid shot. They kept her in ICU and released her 1/23/21. At 12:45 am on 1/24/21 she passed out and we called the ambulance. Hospital admitted her and worked through multiple organ failure issues and thought her numbers were under control. She was released on 1/27/21 and was driving on 1/28/21 around 4:15 pm and appears to have had heart failure and had a wreck. She passed away that day.
79 2021-02-13 hypertension, chest discomfort Patient started to experience chest tightness and then hypertension
79 2021-02-15 pallor 91.2kg 79 yo nonsmoking/nonEtOH drinking M with PMH significant for Parkinson's disease, postural hy... Read more
91.2kg 79 yo nonsmoking/nonEtOH drinking M with PMH significant for Parkinson's disease, postural hypotension, recent hip surgery and eye problems was at the vaccine clinic for his 2nd Covid-19 vaccine with the product. Allergy history includes tree nut and MSG allergy (hives, swelling, pruritus) and Sinemet, midazolam and fentanyl causing nausea or vomiting. After IM injection of the vaccine (lot # EM9810) into his left arm, the patient felt lightheaded. Patient was diaphoretic and pale. BP was 64/49 with HR 66 and O2 sats 92% on room air which is near baseline. Patient was moved to a recliner chair with feet elevated and given something to drink and monitored
79 2021-02-17 blood pressure increased Drooping of left cheek; Elevated blood pressure; nodes in neck enlarged; sore to touch; headache; Th... Read more
Drooping of left cheek; Elevated blood pressure; nodes in neck enlarged; sore to touch; headache; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiration date was not reported), via an unspecified route of administration on 28Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included allergies and known allergies to sulfa drugs. Patient was not pregnant at the time of vaccination. Concomitant medication included ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), iron, colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN). The patient previously took first dose of bnt162b2 on 07Jan2021 09:45 on the left arm for COVID-19 immunization. The patient experienced elevated blood pressure, all nodes in neck enlarged and sore to touch, drooping of left cheek and headache on 29Jan2021 22:00. Condition persisted for 4 days. The patient received an unspecified treatment. The patient had a visit to the doctor and emergency room. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events at the time of the report.
79 2021-02-17 cerebrovascular accident may have had a mini stroke; Bell's Palsy/developed facial drooping/her eye was drooping; fell; This ... Read more
may have had a mini stroke; Bell's Palsy/developed facial drooping/her eye was drooping; fell; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (BNT162B2, Pfizer COVID-19 Vaccine; Batch/lot number: EL9262), via an unspecified route of administration injection to right upper arm on 22Jan2021 14:00 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing she was a fainter (She was a fainter, she just faints so she has a hard time getting shots. Pfizer COVID-19 Vaccine administered to her by nurse while she was in her car seat. She just asked the nurse to let her lay down in the car seat when injection was administered so that if she fainted she would not fall far; she was still getting the wash cloth on her head preparing when the Nurse had already finished administering the injection.); ongoing depressed sometimes (she was depressed sometimes, was stressed. She was the primary caregiver for her 96 year old mother. She had seen something about stress and COVID and shots and everything); ongoing Very tired (She was almost 80 years old so she was very tired often. She was the primary caregiver for her 96 year old mother. By the time she comes home at night around 21:30 she was just wiped.); Obesity (She was really overweight but she did not like the term obesity.); thyroid disorder; hypertension; Cataract and glaucoma in left eye; family history of ongoing facial paralysis (Dad had Bell's palsy that might have been 30 years ago. He died at age 87 years.); diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes). Concomitant medication included Levothyroxine at 100mcg taken once daily in the morning early before she eats with Start date unknown, but at least 10-15 years ago for Thyroid. Enalapril at 10mg taken once daily (Caller initially reported product name as Vasotec, but clarified it is not Vasotec, it is drop for eye cataract and glaucoma) for High blood pressure. Brimonidine with Strength unknown, 1 drop in both eyes twice daily, started maybe 1 year ago. Specified cataract and glaucoma in left eye; but drop was administered to both eyes; and left eye was eye affected by Bell's palsy for Cataract and glaucoma in left eye. The patient previously took codeine and experienced allergy with onset maybe about 50 years ago, she was not sure; occurred during dental procedure; had bad headaches but no lasting effects so they assumed allergy to codeine; she did not know if still has allergy but says she does if asked. The patient experienced bell's palsy/developed facial drooping/her eye was drooping on 29Jan2021 with outcome of recovering, may have had a mini stroke on an unspecified date with outcome of unknown , fell on 27Jan2021 with outcome of unknown (reported date of end of reaction was 27Jan2021), she could not blink that eye on 29Jan2021 with outcome of not recovered. Five days later she fell and developed facial drooping. HCP suggested she may have had a mini stroke causing facial drooping and the fall. She went to the ER on 29Jan2021 and the ER believed it was Bell's Palsy. She was still experiencing facial symptoms but they are improving. This consumer was administered her first dose if Pfizer COVID-19 Vaccine 22Jan2021. She reported having fell 27Jan2021. She was diagnosed with Bell's palsy in 29Jan2021 after having been seen in the emergency room. She is supposed to have the second dose/booster of Pfizer COVID-19 Vaccine on 12Feb2021. She called to ask if she should or should not still get the second dose as scheduled; and if Bell's palsy could be a reaction to the Pfizer COVID-19 Vaccine. The emergency room staff did not know how she got Bell's palsy, but knew she had the Pfizer COIVD-19 Vaccine and were kind of assuming the Bell's palsy was a reaction to the vaccine. She dis not have Bell's palsy bad. The emergency room staff thought at first she had a stroke before diagnosing her with Bell's palsy. On Wednesday, 27Jan2021 she had a friend named (Name withheld) who came over for tea. Patient has an oriental rug, and around 15:00 patient fell face first on oriental rug. She was just fine after the fall initially. She wonders if her having fell has anything to do with the Bell's palsy. She thinks it was the night of 27Jan2021 or 28Jan2021 when she asked her son if her face looked funny, did she look ok, because her face felt a little funny. She was looking in the mirror and her smile was looking crooked, and her eye looked like it was drooping. When she got up Friday, 29Jan2021 she could see her eye was drooping, and she could not blink that eye. She called her Ophthalmologist who saw her the afternoon of 29Jan2021 around 13:30-13:55. The Ophthalmologist said yeah something is going on with that eye. Her friend called his friend who is a Pediatric Neurologist that advised her to go to the emergency room. She was seen in the emergency room of (Hospital name withheld) around 17:00 on 29Jan2021. She was not admitted to the hospital at that time; but was evaluated and treated. She Bell's palsy outcome: she is doing so much better. She still has a hard time blinking her left eye, she still cannot blink her bad eye: left eye, without also closing her good eye: right eye. She is not drooling, she can drink without drooling. Her smile is still just a little crooked. She was given 2 prescriptions in the emergency room which were Prednisone and Valtrex. On 29Jan2021 in the emergency room they did tests including testing her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure. There were no notable or abnormal results of any of those tests. They wanted her to go see her doctor last week but she did not have a chance to do so. She has an appointment with her primary doctor on Monday coming up. She has not yet seen her primary doctor about this. History of all 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) was None. The event Bell's palsy require a visit to Emergency Room, no to Physician Office. The patient was not hospitalized. No Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient underwent lab tests which included her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure, all with no notable or abnormal results of any of those tests on 29Jan2021.
79 2021-02-17 excessive bleeding Developed itching and redness all over body. Eyes itchy and developed hemorrhage; Jaw pain. Patient ... Read more
Developed itching and redness all over body. Eyes itchy and developed hemorrhage; Jaw pain. Patient had COVID-19 a few months ago.
79 2021-02-18 heart rate increased Rapid heart rate , hot, stinging, flushed facial skin Unsteadiness, lightheadedness
79 2021-02-18 hypotension The night of the vaccination, I experienced icy cold hands and feet throughout the night. I had to ... Read more
The night of the vaccination, I experienced icy cold hands and feet throughout the night. I had to get up twice to put additional blankets on the bed, even though the house was heated as usual. I also experienced frequent muscle spasms and cramps in both legs throughout the night. The following day, Feb 18, 2021 and today, Feb 19, 2021 I have been very low on energy, simply sat all day. Experienced lower than usual blood pressure (98/84 w/ 127 heart rate, 89/71 w/ 77 heart rate. Currently feeling normal at 4:25 pm.
79 2021-02-21 chest pain, blood pressure increased to ER on 2/19/21 breathing difficulty, hoarse voice , chest pain, skin itchy, headache, edema, body... Read more
to ER on 2/19/21 breathing difficulty, hoarse voice , chest pain, skin itchy, headache, edema, body joint pain, elevated B/P
79 2021-02-21 skin turning blue Redness on the thighs, legs, and chest. very little redness on my arm(s). I was watching tv 3 days a... Read more
Redness on the thighs, legs, and chest. very little redness on my arm(s). I was watching tv 3 days after receiving the vaccine and my palms were suddenly blue and I could see every vein in my hands and fingers. they were cold and color returned after submerging them in warm water.
79 2021-02-21 palpitations Heart Palpitations
79 2021-02-24 chest pain Patient was given the vaccine and waited the recommended time (15 minutes) after the administration ... Read more
Patient was given the vaccine and waited the recommended time (15 minutes) after the administration of the vaccine and did not report any reaction at that time. Approximately six hours after the injection, she suddenly noticed she was having trouble breathing, could not catch her breath, and a call was made to 911. She was transported via ambulance to the hospital, where she remained for a week.
79 2021-02-25 chest pain Per NP note, "...presented to vaccine cancer center to receive first dose of COVID 19 vaccination. F... Read more
Per NP note, "...presented to vaccine cancer center to receive first dose of COVID 19 vaccination. First dose of Pfizer vaccine (Lot # EN6202) administered. Immediately after administration, Pt complained of acute mid-sternal chest pain described pressure. EKG completed, Pt observed for an additional 20 minutes, reported spontaneous resolution of symptoms. Prior to discharge pain completely resolved, lungs clear to auscultation , cardiac exam with normal S1 & S2,no rubs, gallops or murmurs. Pt admitted to being anxious, has a documented history of white coat syndrome."
79 2021-02-25 fainting, cerebrovascular accident, atrial fibrillation has sporadic a-fib (at baseline); She stated she was in real bad stroke territory; she felt like she... Read more
has sporadic a-fib (at baseline); She stated she was in real bad stroke territory; she felt like she was going to faint; Her blood pressure was 220/97; tingling in her hands and feet; felt like brain sizzling like it was frying/going to faint; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, first dose) solution for injection intramuscular in the left arm on 06Feb2021 at 09:30 (at the age of 79-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing sporadic A fib (atrial fibrillation) for 6 years know about; allergy to polyethylene glycol in 1985 (she had difficulty taking birth, control pills and they found out it was the coating PEG in); cerebrovascular accident prophylaxis; in 1985 She had difficulty taking birth control pills and they found out it was the coating PEG in it. She had an allergy to this where she broke out in bumps on her fingers and mouth and had itchy eyes, a full blown allergy; and when she was 45 going through menopause. Concomitant medication included apixaban (ELIQUIS) for A fib and cerebrovascular accident prophylaxis. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021, the patient had sporadic a-fib (at baseline) then put in a medical van requiring emergency room visit. The patient stated, She stated she was in real bad stroke territory, felt like she was going to faint (6 minutes after vaccination), blood pressure was 220/97, tingling in her hands (6 minutes after vaccination) and feet and felt like brain sizzling like it was frying/going to faint (6 minutes after vaccination) on 06Feb2021. Lab tests included blood pressure on an unknown date high 150s and never lower than 187, then on 06Feb2021 was 220/97, on 09Feb2021 was systolic blood pressure 180, then on 10Feb2021 had gone down. The outcome of the events atrial fibrillation and feeling unwell was recovered on 06Feb2021, after 3 hours. The outcome of the events stroke, faint and tingling of extremity was unknown. The outcome of the event blood pressure was 220/97 was recovered on 10Feb2021.
79 2021-02-26 palpitations Pt developed a flushed feeling, numbness in hands and palpitations(heart racing) several minutes aft... Read more
Pt developed a flushed feeling, numbness in hands and palpitations(heart racing) several minutes after injection. Symptoms slowly subsided after 20-30 minutes of observation. HR: 100, SBP: 150, SP02: 99. EMS services/hospital evaluation was offered and pt declined. She elected to go home with her husband as the driver with a plan to self monitor at home.
79 2021-02-27 nosebleed After patient completed 15 minute waiting period post vaccination, she had almost left the clinic an... Read more
After patient completed 15 minute waiting period post vaccination, she had almost left the clinic and noted that her nose was "running". She proceeded to have a gushing nosebleed that lasted approximately 1 hour. When we noted that the bleeding was continuing, we called her grandson to pick her up and take her to the ER. Called the ER at 6:15 pm and pt still there being evaluated.
79 2021-03-01 hypertension shot started to hurt; blood pressure was gone up; Fever; my head feels like it is going to explode; ... Read more
shot started to hurt; blood pressure was gone up; Fever; my head feels like it is going to explode; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) solution for injection, via an unspecified route of administration on 29Jan2021 at 08:30 at single dose for COVID-19 immunization. The patient has a lot of medical conditions (unspecified). Concomitant medications included unspecified medications. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 (lot number: EL3286) at single dose for COVID-19 immunization and experienced fever. The patient reported that she had her shot this morning (29Jan2021) at about 08:30 and towards evening, the shot started to hurt and so she wanted to make sure that it didn't go against anything, and put a little ice on it or maybe it was worthless on ice on certain situations after the fact that she thought this was too late. She wanted to make sure she could do that. The patient's blood pressure also went up on 29Jan2021. She was taking several different medicines for blood pressure. She took them already tonight. She was hoping that she will be feeling a little bit better. Sometimes, she gets a little fever on Jan2021, also like maybe 99 (unspecified). She just wanted to know if any of the medications were good or not for the shot. The patient was asking whether the drugs interacted. The patient also reported that when she took her first shot, she had a little fever and asked what she could take for it. An agent stated that she could take paracetamol (TYLENOL). The patient mentioned that she took her pills, otherwise, her head felt like it was going to explode on Jan2021. She took her high blood pressure medicines. She has three medications namely clonidine, losartan and propranolol. She has a lot of medical conditions that was why she was calling because she takes other medications. The outcome of the events was unknown.
79 2021-03-02 excessive bleeding pain in her hand/ lower part of each finger hurt; joint pain in right hand; bled quite a bit; This i... Read more
pain in her hand/ lower part of each finger hurt; joint pain in right hand; bled quite a bit; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9263), intramuscular on 27Jan2021 (at the age of 79-years-old) as a single dose in the left shoulder for COVID-19 vaccination. Medical history included shoulder surgery about 10 years ago and she lost use of her thumb and index finger, the nerve comes from the shoulder; her hand might be numb and stiff, often but not every morning from an unknown date. Concomitant medications were reported as she is on medication but nothing she feels is relevant. On 03Feb2021, the patient experienced pain in her hand and all the lower part of each finger hurt for about 5-10 seconds, joint pain in her right hand lasting 10-15 seconds, it did not last very long; and she bled quite a bit stating she thinks she got it right in the vein on 27Jan2021. The pain happened about four different mornings but has not had pain "since Friday" and that was lighter sharp pain with no numbness. The clinical outcome of the event bleeding was unknown; pain in extremity and joint pain was recovered on 12Feb2021.
79 2021-03-02 palpitations Had a Herpes Simplex virus that was dormant unless I get excited; Got the vaccine; First reaction wa... Read more
Had a Herpes Simplex virus that was dormant unless I get excited; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; My heart felt like rush; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Have Covid tongue; symptoms got progressively worse; feeling just kind of bumped out; This is a spontaneous report from a consumer (the patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration on 10Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization. Medical history included cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR). The patient previously took Aspirin (e.c.) about 10-15 years ago and experienced anaphylactic reaction, Lyrica about 10-15 years ago for neuralgia and experienced hypersensitivity. The patient reported that on 10Feb2021, she got the vaccine. When she first obtained the vaccine, she was put in a holding situation in regards to having any reaction. She was sitting there about 10-15 minutes, and the first reaction was a numbing on left side of her face and her eye, her jaw and then her left arm was tingling, then she developed a taste of metal in her mouth; had a very salty taste along with the metal taste in her mouth; her mouth became dry. Her heart felt like rush. The "EMT" guy was there, he watched her. So, she sat there for a while. She went home and her symptoms got progressively worse. It was almost an immediate reaction. She started to get an ache in her left eye/pressure in her eye, and feeling just kind of bumped out. Immediately, after she got the vaccine, she had a very salty taste along with the metal taste in my mouth. When I came home, my mouth became dry. The patient reported that she still have a salty taste in her mouth and have "Covid tongue". The patient also reported that she had a herpes simplex virus that was dormant unless she get excited and it has been down for a long period of time. The patient reported that "I am afraid to take my second dose". The patient did not receive treatment for the events. She stated " I just thought it would go away". The clinical outcome of the event salty taste in her mouth was not recovered. The clinical outcome of the remaining events was unknown.
79 2021-03-02 fainting nearly fainting; Head ache; fatigue; upset stomach; vomiting; chills; new mouth sores; painful arm; ... Read more
nearly fainting; Head ache; fatigue; upset stomach; vomiting; chills; new mouth sores; painful arm; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9365) via an unspecified route of administration in the right arm on 15Feb2021 12:00 AM at single dose for covid-19 immunisation. Medical history included allergy to bees and wasps. The patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin and olmesartan medoxomil. The patient previously received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration in the right arm on 21Jan2021 12:00 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After receiving the second dose, the patient experienced headache, fatigue, upset stomach and nearly vomiting, chills, nearly fainting and new mouth sores, painful arm on 15Feb2021 13:15. No treatment was received for the adverse events. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovered in Feb2021.
79 2021-03-02 transient ischaemic attack Lost part of my vision and it only lasted for three to four minutes; mini stroke/ TIA; This is a spo... Read more
Lost part of my vision and it only lasted for three to four minutes; mini stroke/ TIA; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2(Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9284, Expiration date: 31May2021), via an unspecified route of administration at the left arm on 11Feb2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Feb2021 7pm, patient went to get something to open the can of soup but when she went into the pantry, she lost part of her vision and it only lasted for three to four minutes. The patient's daughter who is a neurologist thought it was the mini stroke or TIA (Feb2021). The doctor was setting up the sonogram for her arteries and her neck and also for her heart and said she might have to rely on a pacemaker. The outcome of the events was unknown.
79 2021-03-03 nosebleed short of breath; nose bleed/lost a lot of blood/bleeding; This is a spontaneous report from a contac... Read more
short of breath; nose bleed/lost a lot of blood/bleeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9263 and expiry date unknown, via unspecified route of administration on 26Jan2021 at single dose for Covid-19 immunization, and eicosapentaenoic acid ethyl ester (VASCEPA), acetylsalicylic acid (BABY ASPIRIN); both via unspecified route of administration from unspecified date to 31Jan2021 at unknown dose and frequency for unspecified indication. Medical history was none. Concomitant medication was not reported. The patient had taken the first shot of the Pfizer shot on 26Jan2021 (Tuesday) and the patient seemed to managing it pretty well, she got short of breath one night (unspecified date) but in general, she felt okay. But several days later, 5 days later Sunday (31Jan2021), on Sunday morning she felt okay, what happened was she leaned a little bit, she bent down to wash her hands in the sink and she had a huge nose bleed, it was nothing like she ever had before, she was just wiping, spurting a lot of blood so this was 5 days. It was the morning of the 5th day and they had to call an ambulance to take her to the hospital and then she left the hospital. The patient had lost a lot of blood in the ambulance, they said they had never seen so much blood, they could not stop it, they kept giving her towels and the same thing in the hospital, in the emergency room. The patient was just bleeding over everywhere. The patient informed that for the last several years she has been having one baby aspirin and has been taking for the last few months or two, two or four Vascepa which was a fish oil supplement that can thin the blood but she has never had anything like this and they said go to her ENT, and she went up going ENT, and first time she went she would not take out the packing. The patient informed that it was too severe for her to take out the packing and, when she went back with her following time she took some of the packing and it started to bleed again and she cauterized it in a lot of places and you know would wait and do it again. And then she end up putting some kind of bandage that was going to help the blood clotting. Now, she has been subsequently going back to her and it was still in the very end of. The patient informed that she was still passing some very small blood clots, it has not even stopped. The patient informed that she was on 19 days passed already, since she had the bleed. The patient was very concerned. The patient informed that she was supposed to get her second vaccine in 2 to 3 days, Tuesday and she thought that this was the very bad experience that she had. The patient wanted to know if the aspirin and fish oil could have contributed to this, she stopped these as of 31Jan2021. The patient was talking to her daughter and her daughter has a friend whose mother lives in the same area and had her first Pfizer vaccine and had a small nose bleed right afterwards and then when she has second vaccine, she had another, a very bad. The patient informed that her daughter and a friend of hers said that a similar reaction occurred to her mother after the first dose of the Pfizer vaccine, she had two small nasal bleeds and right afterwards, when she took the second vaccine she had a very big one, like hers, where she had to be taken to the hospital. The patient was concerned, she has been told that the response to the 2nd vaccine was stronger than the first. The patient further informed that she had no nose bleed like this before, like her husband was a physician, that she never had anything like this before, this was very serious kind of situation to happen, and this after the very first vaccine that she had. She had a very severe nosebleed, she had to go to the hospital to stop it. She was on a baby aspirin and some fish oil as well. The patient informed that she wasn't warned that this could thin her blood, that this was enough of a dose to do anything to create this deluge of bleeding. The patient informed that she was few days out from getting her second shot and she had stopped the baby aspirin and the fish oil about three weeks ago. The patient informed that she was not going to take second. The patient wanted to know how long she was going to wait, how long she was going to test her antibody and see that she don't have any more antibodies and will go take the other brand vaccine. The patient added she was reporting that she had a terrible nosebleed and wanted to file a safety report. The patient wanted to know that if she choose not to get the 2nd vaccine, because of her worry of having this reaction again, how long would it be before she could get another vaccine; how long can she wait to get the second dose, or can she get a second dose from another manufacturer. The patient was requested to contact physician. The action taken in response to the events for eicosapentaenoic acid ethyl ester (VASCEPA) and acetylsalicylic acid was permanently withdrawn. The outcome of the events was unknown.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the BNT162B2 and the event nosebleed cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021191054 same reporter, similar drug/events, different patient
79 2021-03-04 blood pressure increased Patient complained of feeling dizzy 10 minutes after receiving vaccine. Elevated blood pressure. W... Read more
Patient complained of feeling dizzy 10 minutes after receiving vaccine. Elevated blood pressure. Was seen in the Emergency Department related to her ongoing elevated blood pressure, headache, and dizziness.
79 2021-03-07 lightheadedness The patient had near-syncope and confusion about 2 minutes after receiving a vaccine. She is diabet... Read more
The patient had near-syncope and confusion about 2 minutes after receiving a vaccine. She is diabetic and hadn't eaten at all yet and thought it was more of a metabolic derangement. She was sent to the ER.
79 2021-03-08 atrial fibrillation COVID-19 vaccination that result in hospitalization or death are to be reported. This patient receiv... Read more
COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Pfizer on12/30 and 1/21 . Patient is admitted to hospital on 3/7 for atrial fibrillation with rapid ventricular rate
79 2021-03-08 fainting 15 monitoring status. Syncope episode after release from Monitoring (outside). Escorted back to moni... Read more
15 monitoring status. Syncope episode after release from Monitoring (outside). Escorted back to monitoring area in w/c. Evaluated by Paramedics. SaO2 98% P 110 BP 142/84. 2:50PM feels "normal" hold until 3 and re-evaluate. 3:05mstands w/o dizziness. W/c escort to car. Home
79 2021-03-09 chest pain Starting about middle of my chest up to my neck it started to get little bit bubbles on it and now i... Read more
Starting about middle of my chest up to my neck it started to get little bit bubbles on it and now it's just burning like crazy and it's starting around my ankles; It's like my chest is burned; This is a spontaneous report from a contactable consumer (patient). A 79-year-old Female patient (also the age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 29Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included Atrial fibrillation (AFib) and back surgery (reported as: I am recovering from very serious back surgery) both from an unknown date and unknown if ongoing. Concomitant medication included methotrexate (reported as , it's a little cancer pill (Further clarification was unknown if consumer have cancer, hence cancer was not captured in medical condition), once a week), tocilizumab (ACTEMRA) (reported as I am on IV Infusions every 4 weeks and the name of it is Actemra), apixaban (ELIQUIS) (reported as I am on Eliquis because I am AFib, heart), and then another heart medicine plus all the patient's 'vitamins' (unspecified). The patient previously took oxycodone and experienced allergy (reported as I can't take any of those drugs, I am allergic to all that stuff. Yeah I can't take any of that pain medicine (Unspecified Medications)). The patient stated that: "I was calling about the, I had my first shot for the virus and on my chest, starting about middle of my chest up to my neck it started to get little bit bubbles on it and now it's just burning like crazy and it's starting around my ankles. Does that have anything to do with that shot?" The reporter confirmed that the next shot is due on 22Feb2021. The patient added that, "Actually last week they were really light, and they just keep getting worst. I was actually going to call my doctor tomorrow because I was concerned about getting this injection anyways because of my history on having reactions to medicine. I can't take any like Oxycodone or like any of those (also reported as "I can't take any of those drugs, I am allergic to all that stuff. Yeah I can't take any of that pain medicine (Unspecified Medications). No, I don't have anything like that."). I can't take any of those drugs (Unspecified Medications). And she said she thought it would be alright but I am recovering from very serious back surgery and so I have had a hard time with that. So, I thought I should call and see if I should get my second injection or if I should just let it go." It was also reported that: "Yes, it's like my chest is burned." Consumer stated for the treatment, "The only thing I put on was Benadryl cream. To keep it from 'itching'." The patient asked "Should I get the second injection?" The outcome of the events was unknown.
79 2021-03-11 haemoglobin decreased, heart rate increased severely cold, short of breath, exhaustion, muscle pain, nausea, fast heart rate, dizzy, weak
79 2021-03-13 chest pain Unexpected chest pain along the left side, especially painful the first night. Light pain lasting 10... Read more
Unexpected chest pain along the left side, especially painful the first night. Light pain lasting 10-15 minutes randomly usually once per day on days following date of vaccination. Patient states that it did not feel like heartburn. Patient has never had a heart attack and cannot compare the two experiences. Expected right arm pain at injection site that subsided after a day or two.
79 2021-03-13 nosebleed 79 y/o F pt presents w/ fatigue and cough, onset 10 days. Pt states she received her first dose of t... Read more
79 y/o F pt presents w/ fatigue and cough, onset 10 days. Pt states she received her first dose of the COVID-19 vaccine on 3/2/2021 and reports experiencing sx of HAs, sore throat, bloody mucus, cough, fatigue, and body aches; pt states sx subsided except for the fatigue and cough. Pt reports having taken zicam and coricidin w/ slight relief but states she stopped taking those 5 days ago. Pt reports taking an antihistamine and doing nasal sprays w/ some relief as well.
79 2021-03-14 deep vein blood clot Developed an Acute nonoocclusive DVT in left leg 10 days after my first vaccine. Decided to decline...