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National Vaccine Information Center Your Health. Your Family. Your Choice. |
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| Table |
 |   | |
| Event Outcome | Count | Percent |
| Death | 58 | 100% |
| Office Visit | 1 | 1.72% |
| Emergency Doctor/Room | 4 | 6.9% |
| Hospitalized | 16 | 27.59% |
| Life Threatening | 5 | 8.62% |
| TOTAL | † 84 | † 144.83% |
| † Because some cases have multiple vaccinations and symptoms, a single case can account for multiple entries in this table. This is the reason why the Total Count is greater than 58 (the number of cases found), and the Total Percentage is greater than 100. | ||
| Case Details |
Administered by: Work Purchased by: ?
Life Threatening? No Write-up: Death by massive heart attack. Pfizer-BioNTech COVID-19 Vaccine EUA | |||||||||||||||||||
Administered by: Senior Living Purchased by: ?
Life Threatening? No Write-up: had a vaccination on 12/31/2020 late morning passed away early morning 01/01/2020. This is a 93 year old with significant heart issues. EF of 20% among other comorbidities. He died suddenly approximately 0430, it is unlikely it was related to receiving the vaccine. | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: died; tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. A 97-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 at 97-years-old at a single dose for COVID-19 immunization; administered by the nursing home. Medical history included glaucoma from an unknown date and unknown if ongoing. Concomitant medications included: "used a sav for skin tears", and "eye drops for glaucoma" from an unknown date to an unknown date. On 07Jan2021, the patient experienced: tested positive for COVID (medically significant). The patient died (death, medically significant) on 17Jan2021. The clinical course was reported as follows: The reporter stated that in regard to the patient''s height and weight: "was probably getting down to about five foot eight. Shrinking." The reporter stated that If she remembered correctly, they were trying to maintain the patient''s weight 135 to 136 pounds. The reporter stated that her father was in a nursing home. The patient received his first dose of the COVID vaccine on 30Dec2020. The patient died on 17Jan2021. The reporter stated that she "wanted Pfizer to know that the little old people in the nursing might not be strong enough for the vaccine." The reporter stated that she was "not calling to complaining." The reporter stated that there was nothing wrong with her dad. He was elderly with no health issues. "He was literally on no medications. The only reason he was in the nursing home was because he was afraid to walk." The reporter stated that she received a call about giving the patient the vaccine and she said yes because she wanted him to have the vaccine. One week after the vaccine, the patient tested positive for COVID "like all the other people" (no further details provided). The reporter stated that her dad had no symptoms of COVID. The director of nursing said the patient was doing so well. The patient ate his lunch, he laid down for nap, and at 14:30 he was gone. The patient "went peacefully in his sleep." The reporter then again stated that the patient literally had nothing wrong with him. "They were shocked. They fed him and he took a nap. He was sleeping, but it was eternally." The reporter stated that, "it might not have been the Pfizer vaccine, maybe his heart wore out." In regard to an autopsy: the reporter stated that they would get it done if needed. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 07Jan2021. History of all previous immunization with the Pfizer vaccine considered as suspect: none. It was unknown if there were additional vaccines administered on the same date of the Pfizer suspect, but the reporter doubted it. There were no prior vaccinations within 4 weeks. There were no adverse events following the prior vaccinations. The clinical outcome of the event, died, was fatal. The clinical outcome of the event, tested positive for COVID, was unknown. The patient died on 17Jan2021 due to an unknown cause of death. An autopsy was not performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: died | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: We do not believe that the patient''s death was an adverse event from the vaccine. Patient received COVID vaccine from Pfizer Dose #1 12/19/2020 (lot # EK5730) and Dose #2 1/7/2021 (lot # EL1284). No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction. Patient died 1/10/2021 from chronic respiratory failure and congestive heart failure after recent aspiration pneumonia requiring hospitalization. Death was anticipated and not sudden. We were told to report his death to VAERS even though his death was anticipated and not related to his vaccination. | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: Patient did not have any adverse reaction to the COVID vaccine, but we were asked by our health dept to submit a VAERS report since the patient died between his first and second dose. Received Pfizer Dose #1 12/17/2020. No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction. Date of death 12/23/2020 from aspiration pneumonia complicated by end-stage heart failure and ischemic cardiomyopathy. Death was anticipated and not sudden. | |||||||||||||||||||
Administered by: Senior Living Purchased by: ?
Life Threatening? No Write-up: On the evening of 10JAN2021, patient experienced a low grade fever, decreased oxygen saturation of 38%, heart rate of 124, confusion. Patient received oxygen via face mask, morphine and ativan. By 11JAN2021, patient was no longer verbal, able to eat or communicate and was kept on comfort measure only. On the morning of 17JAN2021, the patient passed away. | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: Pt. was admitted to hospital on 1/6/21 with fatigue, weakness. Pt. was Covid positive in November of 2020. Impression upon admission was fatigue may be due to her aortic stenosis and some hypertensive issues with blood pressure changes. She was anemic. WBC was elevated to 19.2, HBG 10.5, NA-131, K+ - 3.1, Rule out bacterial infection. Potential source could be her heart valve. Also noted to have acute renal failure with BUN of 47 and Creatinine of 2.2 noted. Pt. was transferred to Hospital on 1/8/2021 with dx of aortic stenosis, bacteremia, ARF, Dehydration and anemia. Discharged with dx. of sepsis. Pt. expired on 1/18/21 with dx. of severe sepsis, complete heart block, staphylococcus epidermidis bacteremia. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Died; Increased respirations (22 and labored at times); Pulse 105; 94% O2 on RA; Labored breathing at times; leukocytosis; elevated BUN; left lower lung congestion; elevated creatinine; Temperature of 102.0F; Redness on face; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced redness on face, increased respirations, labored breathing at times, temperature of 102F, pulse of 105, 94 percent O2, leukocytosis, elevated BUN, left lower lung congestion, elevated creatinine, and death. The patient''s medical history, as provided by the reporter, included dementia and reduced mobility. No relevant concomitant medications were reported. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient began to experience redness on her face, increased respirations (reported as 22 and labored at times), pulse of 105, and 94 percent oxygen saturation on room air. The patient had a fever of 102 degrees Fahrenheit. Laboratory tests revealed a negative influenza swab, elevated white blood cell count of 14.1, elevated BUN at 113, and creatinine 2.7. Chest x-ray showed mild, left lower lung infiltrate. On 31 Dec 2020, the patient went under hospice care per her family request.. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 01 Jan 2021, the cause of death was unknown.; Reporter''s Comments: This case concerns a 92-year-old, female subject with medical history of dementia and reduced mobility, who experienced the serious unexpected events of death, respiratory rate increased, heart rate increased, oxygen saturation decreased, elevated BUN, elevated creatinine, left lung congestion and dyspnoea and the non-serious events of erythema and pyrexia. The events of respiratory rate increased, heart rate increased, oxygen saturation decreased, dyspnoea, erythema and pyrexia occurred 2 days after the first dose of the study medication administration, and the event of death occurred 4 days after the first dose of the study medication administration. Very limited information regarding the events is available at this time and no definite diagnosis or autopsy report have been provided. Additional information has been requested.; Reported Cause(s) of Death: Died | |||||||||||||||||||
Administered by: Senior Living Purchased by: ?
Life Threatening? Yes Write-up: she was injected, sh stopped eating and talking, the doctor watched her for 2 days. had her transported to the hospital. i was told she had tested positive for COVID 2 times once at the home and once at the hospital. with in 2 DAYS at the hospital she wa on a ventilator 2 days later she died. i talked with the rehab center and confirmed she tested negative for COVID on Dec 27th 2020 and was given the Vaccine on the 29th Dec 202 was in the hospital 4 day later, was on a ventilator 4 days after that then died a few day later as her heart stopped beating. all the while i had POA and was not contacted by Hospital staff until after they had made the next step. | |||||||||||||||||||
Administered by: Senior Living Purchased by: ?
Life Threatening? No Write-up: HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient''s room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. ? Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and ACLS guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. ? Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and ACLS guidelines initiated. ? In reviewing patient''s chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%. | |||||||||||||||||||
Administered by: Senior Living Purchased by: ?
Life Threatening? No Write-up: Is patient deceased: Yes; Low pulse; This is a spontaneous report from two contactable nurses reporting for a patient. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140 expiration date Mar2021) intramuscular on 22Dec2020 at 10:30 at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home. Patient age at time of vaccination was 70 years. Patient''s Medical History included ongoing Type 2 Diabetes Mellitus Without Complication onset date: admission 22Oct2020, ongoing morbid obesity due to excess calories onset date: admission 22Oct2020, cardiac disorder, essential hypertension, hypertension, schizophrenia, hyperlipidemia, benign prostatic hyperplasia (BPH), Gastrooesophageal reflux disease (GERD), depression, hypothyroid, epilepsy, pain, dry eyes, anxiety, restlessness, 17Jan2020 Slid out of chair to floor, no injury, on 27Jan2020, 28Jan2020, 29Jan2020 diarrhea noted. Concomitant medications included acetylsalicylic acid (ASPIRIN EC) for Cardiac Health, atenolol (ATENOLOL) for Essential Hypertension, atorvastatin calcium (ATORVASTATIN CALCIUM) for hyperlipidemia, finasteride (FINASTERIDE) for benign prostatic hyperplasia, tamsulosin hydrochloride (FLOMAX) benign prostatic hyperplasia, insulin glargine (LANTUS) for diabetes mellitus, lithium carbonate (LITHIUM CARBONATE) for Schizophrenia, losartan potassium (LOSARTAN POTASSIUM) for hypertension, lurasidone hydrochloride (LURASIDONE HYDROCHLORIDE) for Schizophrenia, omeprazole (OMEPRAZOLE) for gastrooesophageal reflux disease, sertraline hcl (SERTRALINE HCL) for depression, levothyroxine sodium (SYNTHROID) for hypothyroid, ergocalciferol (VIT D) for supplement, haloperidol (HALOPERIDOL) for Schizophrenia, levetiracetam (KEPPRA) for epilepsy, paracetamol (TYLENOL EXTRA-STRENGTH) for pain, propylene glycol (ARTIFICIAL TEARS) for dry eyes, lorazepam (ATIVAN) for a anxiety or restlessness. As antipyretic use was reported Tylenol ES (500 mg) Tab, 2 Tabs by Mouth Routine use three times a day given at time of vaccination and after. It was reported the patient was Covid+. He was tested on 21Dec2020 and was not admitted to hospital. Event Onset Date was reported as 24Dec2020 (clarification pending). On 30Dec2020 the patient was started on O2 at 2L for low pulse. O2 was increased over time to eventually O2 at 8L on 03Jan2021. Morphine Sulfate was started on 03Jan2021 at 5 mg sl/by mouth every 2 hours as needed for pain or airhunger. The patient deceased on 03Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The AEs did not require a visit to Emergency Room or Physician Office. Outcome of Low pulse was unknown.; Sender''s Comments: Based on the information available the events Death (unknown cause) and Heart rate decreased are attributed to patient''s multiple underlying medical conditions including Type 2 Diabetes Mellitus, morbid obesity, cardiac disorder, hypertension, epilepsy etc. However, based solely on a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the above mentioned events cannot be completely excluded. The case will be reevaluated should additional information, including the cause of death, become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Is patient deceased: Yes | |||||||||||||||||||
Administered by: Senior Living Purchased by: ?
Life Threatening? No Write-up: Approximately 1800, nursing staff reported patient had facial drooping and slurred speech. Patient vitals were stable. Symptoms resolved. 2/1/2021 Resident observed in the bedroom, unresponsive. No heartbeat or lung sounds upon auscultation. Pupils mid-dilated and fixated, no reaction to light. Carotid pulses were not palpable. Pronounced dead at 1422 by nurse practitioner. | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: Heart attack and death; This is a spontaneous report from a contactable Nurse. A 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Ej1685) intramuscular in left arm on 18Dec2020 at 11:00 AM at single dose for COVID-19 immunisation. Medical history was none, no known allergies. No other concomitant medications in two weeks. No other vaccine in four weeks. The patient experienced heart attack at 05:30 pm on 06Apr2021 and the event caused patient death. No treatment for the event. Autopsy results was available. Autopsy remarks: heart attack. No COVID prior vaccination, no COVID tested post vaccination. The patient died on 06Apr2021. An autopsy was performed and the reported cause of death was heart attack.; Sender''s Comments: Myocardial infarction occurred 3 months and 19 days after BNT162B2 vaccine administration. The event is considered unrelated to suspect drug being rather an incidental occurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Heart attack and death; Autopsy-determined Cause(s) of Death: Heart attack | |||||||||||||||||||
Administered by: Public Purchased by: ?
Life Threatening? No Write-up: Heart stopped suddenly after 18 days probably due to presence of Potassium Chloride in the injection. Outcome DEATH within 2 hours thereof as medics unable to regain consciousness after CPR. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient''s past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient''s 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient''s other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function ("D" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was "4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given "soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient''s diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient''s respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender''s Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: cardiac arrest; heart failure; did not feel well, lost consciousness and died; did not feel well, lost consciousness and died; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 08:30 at single dose for covid-19 immunisation. Medical history included suffered from the past from heart attacks, active heart disease, malignant disease. The patient''s concomitant medications were not reported. A man of 75 years old, who suffers from many different background diseases, died (this morning 28Dec2020) from cardiac arrest, two hours after he received the injection. The man received the injection at 8.30am, and after he was feeling okay he was released to go home. After a while when he was home he did not feel well, lost consciousness and died, and he was pronounced dead from heart failure. The patient died on 28Dec2020. It was not reported if an autopsy was performed. The outcome of the event cardiac arrest and heart failure was fatal while the outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-2020517177 same reporter, same vaccine, reporting similar events in different patients.; Reported Cause(s) of Death: heart failure; cardiac arrest | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: Death within 24 hours after dose; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority (GB-MHRA-EYC 00236003 and GB-MHRA-ADR 24545815). A 78-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, on 20Dec2020 at 16:00 as a single dose for COVID-19 immunization. Medical history included cardiac disease and lung disease. The patient had no known allergies. Concomitant medications included an unspecified hypertensive taken for hypertension, an unspecified drug for ischaemic heart disease, and an unspecified drug for chronic obstructive pulmonary disease (COPD). The patient experienced death within 24 hours after dose on 21Dec2020. The event was reported as fatal. The clinical course was reported as follows: The patient was observed for 15 minutes after the dose was given and had no side effects. In the evening, the patient felt well. The patient received the vaccination as he was a high risk patient, elderly, and with a background of cardiac and lung disease. The clinical outcome of death within 24 hours after dose was fatal. The patient died on 21Dec2020. The cause of death was unexplained. It was unknown if an autopsy was performed. The reporter assessed the causality between the vaccination and death as unlikely. No follow-up attempts possible; information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Death unexplained | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: patient died after collapsing in his home several hours after he received the vaccine; patient died after collapsing in his home several hours after he received the vaccine; The initial case was missing the following minimum criteria: the reporter does not have first-hand knowledge of the reported events and was not identifiable. Upon receipt of follow-up information on 06Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable healthcare professional via regulatory Authority. The regulatory authority reported similar events for three patients. This is the first of three reports. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK4237), via an unspecified route of administration on 28Dec2020 as a single dose for COVID-19 immunization. Medical history included dementia, cardiac background with pacemaker, atrial fibrillation, heart failure, and penicillin allergy. The patient was not allergic to polyethylene glycol. The patient''s concomitant medications were not reported. On 29Dec2020, the patient died after collapsing in his home several hours after he received the vaccine. Outcome of collapsing was not recovered. The patient had no pulse when he arrived at the hospital. It was not reported if an autopsy was performed. The cause of death was unknown. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: The advance old patient had underlying cardiac background with pacemaker, atrial fibrillation and heart failure, therefore the pre-existing cardiovascular medical conditions more likely provide explanations for collapsing lead to the patient death. More information especially death cause and autopsy results are needed for further meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2021009752 same reporter, product, similar event, different patient;IL-PFIZER INC-2021009751 same reporter, product, similar event, different patient; Reported Cause(s) of Death: Unknown cause of death | |||||||||||||||||||
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Life Threatening? No Write-up: Death; This is a spontaneous report from a contactable consumer and a physician downloaded from the Regulatory Authority number GB-MHRA-WEBCOVID-20201222043330 and Safety Report Unique Identifier GB-MHRA-ADR 24545938. A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT: EJ0553) via an unspecified route of administration on 20Dec2020 around 15:45 at single dose in left upper arm for COVID-19 vaccination. The patient ongoing medical history included Depression, Hypertension, chronic obstructive pulmonary disease and ischaemic heart disease. Patient is not enrolled in clinical trial. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient has not had symptoms associated with COVID-19. Concomitant medication included citalopram taken for Depression. The patient was taking unspecified concomitant medications for hypertension, chronic obstructive pulmonary disease (COPD) and ischaemic heart disease. The patient experienced death in Dec2020 (reported as in the evening of the 20Dec2020 or morning of 21Dec2020). Specifically, it was reported that the patient had the first dose of the vaccine at around 15:45 on 20Dec2020 and was observed for 15 minutes after with no side effects, the patient then left the site with family member. He was well that evening, he lived alone but spoke on the phone in the evening and felt well. On the 21Dec2020, after went to check on him and he was found in his bed passed away. When seeing the body, it was assumed that he had passed away in the evening of the 20Dec2020 or morning of 21Dec2020. Although unlikely, it was less than 24 hours after taking the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. The patient was found dead in his flat the next day on 21Dec2020 by next of kin. He was dropped of home by family after the vaccination, he spoke to his family on the night after having the vaccination and told them he was feeling fine and was going to bed. He did not respond to telephone calls the next day (on Monday 21Dec2020) so the family went over to his flat and found he had passed away. The patient was registered at another surgery. Screening questions were asked, no contra indication found. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death | |||||||||||||||||||
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Life Threatening? No Write-up: sudden death; This is a spontaneous report received from a contactable physician from the. The regulatory authority report number is GB-MHRA-WEBCOVID-20210106143746. A 90 years old male patient received BNT162B2 (Batch/lot number: EJ0553) on 21Dec2020 at single dose for COVID-19 immunization. Medical history was Chronic kidney disease, heart disease. Concomitant drug was acetylsalicylic acid (ASPIRINE) for Myocardial ischaemia, atorvastatin for Myocardial ischaemia, bisoprolol for Myocardial ischaemia, levothyroxine sodium for Hypothyroidism, ramipril for Hypertension, goserelin acetate (ZOLADEX LA) for Prostate cancer. No reaction noted but sudden death 3 days after vaccination (24Dec2020), although had history of heart disease. Cause of death not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Outcome of the event was fatal. Unknown whether autopsy done or not. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death | |||||||||||||||||||
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Life Threatening? No Write-up: stroke; This is a spontaneous report from a contactable physician received by Pfizer from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 24566618 & GB-MHRA-WEBCOVID-20210107104558. An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ0553/V0001), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. Relevant medical history included: ischemic heart disease (IHD) and arteriopathy. Patient has not had symptoms associated with COVID-19 and is not enrolled in clinical trial. Concomitant medications included: clopidogrel (MANUFACTURER UNKNOWN), taken for transient ischaemic attack (TIA) from Jul2012 to an unspecified date, furosemide (MANUFACTURER UNKNOWN) taken from Jul2012 to an unspecified date, lansoprazole (MANUFACTURER UNKNOWN), taken from Nov2012 to an unspecified date, nebivolol (MANUFACTURER UNKNOWN), taken for left ventricular dysfunction from 01Jul2014 to an unspecified date, ramipril (MANUFACTURER UNKNOWN), taken from 2012 to an unspecified date and simvastatin (MANUFACTURER UNKNOWN) taken for hypercholesteremia from Nov2012 to an unspecified date. The patient experienced stroke on 19Dec2020, which caused hospitalization. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 21Dec2020. The clinical outcome of stroke was fatal. The patient died of the stroke in the hospital on an unspecified date. An autopsy was not performed. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Stroke | |||||||||||||||||||
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Life Threatening? No Write-up: Death NOS; significant ST changes in keeping with acute cardiac event; Sudden collapse; significant ST changes in keeping with acute cardiac event; This is a spontaneous report received from a contactable physician by Pfizer from the Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-20210112181704. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ0724), via an unspeciifed route of administration on 22Dec2020 at sigle dose for COVID-19 immunisation. Medical history included myocardial ischaemia, coronary artery bypass graft (CABG), abdominal aortic aneurysm (AAA) repair, micturition urgency and depression (under mental health secondary care/consultant led service). Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included acetylsalicylic acid for myocardial ischaemia, lansoprazole for unknown indication, mirabegron for micturition urgency, olanzapine for depression, pregabalin for depression, INFLUENZA VACCINE on 23Sep2020 for immunisation, simvastatin for myocardial ischaemia, tamsulosin for micturition urgency and venlafaxine for depression. The patient experienced death NOS on 12Jan2021. It was reported: patient has past history of ischaemia heart disease (IHD) - previous CABG and AAA repair. Also has significant psychiatric history and remains under consultant led service (previously was detained Agency S3). Sudden collapse this evening (12Jan2021) and Ambulance led resuscitation unsuccessful. During resuscitation regained cardiac output briefly and ECG at that time (12Jan2021) by ambulance crew showed significant ST changes in keeping with acute cardiac event. Patient has been breathless for last 1w. Received Pfizer covid vaccine 22Dec2020 so reported due to proximity of this novel treatment to event rather than definite causation or effect. the reporter noted that they were the OOH GP who has dealt with this patient and Ambulance on the evening and had no other involvement. More information will be available from patient''s registered GP. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of events sudden collapse and significant ST changes in keeping with acute cardiac event was unknown. The patient died on 12Jan2021. It was not reported if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Death NOS | |||||||||||||||||||
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Life Threatening? No Write-up: Vomiting; Increased shortness of breath; Short episodes of decreased consciousness after toilet visits; Diarrhea; felt unwell, the patient herself says that it feels like the flu; felt unwell, the patient herself says that it feels like the flu; The initial case was missing the following minimum criteria: reporter had no first hand knowledge. Upon receipt of follow-up information on 14Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report downloaded from the Regulatory Authority WEB NO-NOMAADVRE-FHI-2021-U427R, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013732. A contactable other health professional reported that an 81-year-old female patient received her first dose of bnt162b2 (COMIRNATY, batch/lot number: EJ6796), via intramuscular route on 29Dec2020, at single dose administered into left arm for covid-19 immunisation. Medical history included heart attack, cerebral ischaemia from 2017, aortic stenosis, atelectasis, osteopetrosis, antidiuretic hormone increased, urinary tract infection from 26Dec2020, dilated cardiomyopathy, palliative care, atrial fibrillation, heart failure, gastric acid increased, oedema, pain, pain back, anxiety, glaucoma secondary, obstipation, pacemaker in 2017, increased cognitive impairment and possibly dementia. Concomitant medication included bisoprolol fumarate (EMCONCOR CHF) for an unspecified indication, apixaban (ELIQUIS) for atrial fibrilation, spironolactone (SPIRIX) for heart failure, ramipril (TRIATEC) for heart failure, pantoprazole sodium sesquihydrate (SOMAC) for gastric acid increased, bumetanide (BURINEX) for heart failure and oedema, pivmecillinam hydrochloride (SELEXID) for urinary tract infection, morphine sulfate (DOLCONTIN) for pain, paracetamol (PARACET) for pain back, olanzapine (ZYPREXA) for anxiety, latanoprost (XALATAN) for glaucoma secondary, lactulose (BETULAC) for obstipation and selenium oxide (SELENIUM OXIDE) for urinary tract infection. The patient experienced vomiting, increased shortness of breath, short episodes of decreased consciousness after toilet visits, diarrhea and felt unwell, the patient herself says that it feels like the flu; all on 02Jan2021 and died on the same day. The patient underwent lab tests and procedures which included gene mutation identification test: positive - heterozygot: R 33 Q in LMNA on an unspecified date. It was not reported if an autopsy was performed. The Center assessed the causality between bnt162b2 and all events as Possible. Outcome of the events was fatal. Reporter Comment: Regulatory Authority has requested additional information. This is a preliminary report. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: NIPH has requested additional information. This is a preliminary report.; Reported Cause(s) of Death: Increased shortness of breath; Short episodes of decreased consciousness after toilet visits; Diarrhea; felt unwell, the patient herself says that it feels like the flu; felt unwell, the patient herself says that it feels like the flu; Vomiting | |||||||||||||||||||
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Life Threatening? No Write-up: ACUTE RENAL FAILURE; body temperature: 33.1 centigrade; blood pressure: 96/55 mmhg; CONFUSION; REDUCED GENERAL CONDITION; The initial case was missing the following minimum criteria: reporter had no first-hand knowledge. Upon receipt of follow-up information on 15Jan2021, this case now contains all required information to be considered valid. This is a spontaneous follow up report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-UGYJ2 Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013718. A 95-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number and expiration date unknown), intramuscular on 28Dec2020, at single dose for covid-19 immunisation. The patient also received salbutamol (VENTOLINE) at 5 mg (x 4 as needed) for dyspnea and pantoprazole sodium sesquihydrate (SOMAC, 20 mg) at 20 mg, once per day for gastric ulcer prophylaxis. Medical history included ongoing mitral valve insufficiency, pneumonia from Feb2020 to an unknown date, ongoing polymyalgia rheumatica, decompensated heart failure from Jan2019 to an unknown date, ongoing hypertension, ongoing atrial fibrillation, and oedema, obstipation, ongoing dyspnea, sleep disorder and agitation. Concomitant medication included bumetanide (BURINEX) for oedema, losartan (LOSARTAN KRKA) for hypertension, lactulose (BETULAC) for obstipation, calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (NYCOPLUS B-TOTAL), reported as "Biotin 30 ug, Folic acid 200 ug, Niacin 20 mg, Pantotensyre 5 mg, Riboflavin 1.7 mg, Tiamin 1.5 mg, Vitamin B6 1.6 mg, Vitamin B12 2 ug (Nycoplus B-kompleks)" for Vitamin supplementation, paracetamol for pain relief, ipratropium bromide (ATROVENT) for dyspnoea, zopiclone (ZOPIKLON MYLAN) for sleep disorder, metoprolol succinate (METOPROLOL SANDOZ) for atrial fibrillation, codeine phosphate, paracetamol (PARALGIN FORTE) for pain relief, melatonin (CIRCADIN) for sleep disorder, oxazepam (SOBRIL) for agitation. The patient experienced acute renal failure on 30Dec2020 and required hospitalization on an unspecified date. The patient experienced confusion and reduced general condition on 30Dec2020. The patient died on 02Jan2021 due to acute renal failure, confusion and reduced general condition. The patient underwent lab tests and procedures on 01Jan2021 which included serum albumin: 34 g/l, blood creatinine: 303 umol/l, serum potassium: 5.1 mmol/l, blood pressure: 96/55 mmHg, body temperature: 33.1 centigrade, brain natriuretic peptide: 30345 ng/l, C-reactive protein: 30 mg/l, estimated glomerular filtration rate: 11 ml/min, additional information provided for unit: {1.73_m2} (mL/min/{1.73_m2}), heart rate: irregular; 64 bpm, oxygen saturation: 90 %, physical examination: Pitting oedema legs; pulmonary sound reduced; reduced general condition; afebrile, COVID-19 virus test: negative, urine analysis: no findings, leukocyte count: 7.8 x10 9/l. The patient died on 02Jan2021 due to acute renal failure, confusion and reduced general condition. An autopsy was not performed. The outcome of the rest events was unknown. Event assessment for COMIRNATY, VENTOLINE and SOMAC to Confusion, Acute renal failure, and Reduced general condition: possible (Regional Pharmacovigilance Center). Reported case narrative from Regional Pharmacovigilance Center: 95 year old female with numerous co-morbidities. Post-vaccination reduced general condition. Hospitalized 4 days after immunisation with Comirnaty with acute renal failure, serum creatinine levels $g 300. History of low-grade renal impairment, with habitual creatinine approx 70. No signs of infection. General condition deteriorated quickly, died the following day, 5 days after immunisation. Sender comment: The patient was a female in her 90''s with comorbidity in the form of amongst other hypertension, atrial fibrillation and heart failure. From previously, known reduced kidney function (creatinine around 70). Was admitted to the hospital with acute kidney failure, 4 days after vaccination with Comirnaty. No sign of infection. Rapid deterioation of the condition and the patient died the day after admittance to the hospital. The patient is assessed as having a high risk of developing kidney failure in the first place. When vaccinating marginal, older patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccination could have contributed to worsening of the patients underlying disease. In the individual case it is hard to know if the death was caused by the vaccination, the patient''s underlying disease or some other, coincidential, concurrent cause which does not have any relationship to the vaccination. The causality is assessed as possible - due to the concurrence in timing, and a causal relationship to the vaccination cannot be ruled out. No follow-up attempts are possible, information about batch number cannot be obtained.; Reporter''s Comments: 08Jan2021: Agency: this is a preliminary report; Reported Cause(s) of Death: Acute renal failure; confusion; reduced general condition | |||||||||||||||||||
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Life Threatening? No Write-up: Cardiac arrest; Respiratory arrest; Unresponsive to stimuli; did not feel well; cyanosed; right bundle branch block; collapsed; Pulseless electrical activity; Hypothermic; Bradycardia; This is a spontaneous report received from a contactable pharmacist by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-ADR 24547306 and GB-MHRA-WEBCOVID-20201224141239. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EJ0553), via an unspecified route of administration on 16Dec2020 17:22 at single dose for COVID-19 vaccination. Medical history included chronic kidney disease, myocardial ischaemia, neuropathy peripheral, osteoarthritis, angina pectoris, cardiac failure, chronic obstructive pulmonary disease, diabetes mellitus and benign prostatic hyperplasia, all from an unspecified date and unknown if ongoing; gout, dyspepsia, constipation, hypercholesteremia, dry eye, pulmonary embolism, analgesic therapy, diabetic neuropathy and hypercholesterolaemia. Patient had not had symptoms associated with COVID-19. Patient had not been tested/or has had an inconclusive test for COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included allopurinol for gout, amoxicillin for chronic obstructive pulmonary disease, umeclidinium bromide, vilanterol trifenatate (ANORO) for chronic obstructive pulmonary disease, apixaban for pulmonary embolism, bisoprolol for cardiac failure, carbocisteine for chronic obstructive pulmonary disease, codeine phosphate, paracetamol (CO-CODAMOL) for analgesic therapy, duloxetine for diabetic neuropathy, furosemide for cardiac failure, insulin human injection, isophane (HUMULIN I) for diabetes mellitus, lansoprazole for dyspepsia, isosorbide mononitrate (MONOMIL XL) for angina pectoris, prednisolone for chronic obstructive pulmonary disease, salbutamol for chronic obstructive pulmonary disease, senna alexandrina for constipation, simvastatin for hypercholesterolaemia, guaraprolose (Systane eye drops) for dry eye and tamsulosin for benign prostatic hyperplasia. It was reported: Patient was vaccinated on 16Dec2020 at 17:22, he remained in the vaccination hub for 15 minutes to rule out any anaphylaxis or side effects. He felt fine after 15 minutes so went home. Within 30 minutes of going home he didn''t feel well and collapsed in the garden. An ambulance was called at 18:21 and arrived on the scene at 18:27. The ambulance documented in their notes the reason for the call was patient did not feel well 30 minutes after having the vaccine and collapsed. Patient did not complain of chest pain prior to collapse. Patient became unresponsive to stimuli at 18:50, low respiratory effort after collapse, patient went into respiratory arrest at 18:55 and went into cardiac arrest at 18:57. Advanced life support was given to the patient. Patient was pronounced dead at hospital emergency department at 20:14 on 16Dec2020. Cause of death was noted as cardiac arrest. Patient had not tested positive for COVID-19 since having the vaccine. Patient initially breathing independently with 5 liters nasal specs. Patient stated he couldn''t breathe before collapse so administered 6 liters via mask, respirations dropped to 8 per minute before respiratory arrest. Patient appeared cyanosed, assisted ventilation throughout, good rise and fall of chest, good equal air entry bilaterally. Circulation, initial radial pulse felt thread and slow HR (heart rate) 40 bpm (beats per minute), 12 lead ECG (electrocardiogram) showed bradycardia, right bundle branch block. Patient went into cardiac arrest at 18:57, witnessed by crew so immediate compressions commenced. Patient in PEA (pulseless electrical activity) rhythm throughout. Initially alert and orientated but appeared distressed. Became unresponsive at 18:50. Patient was hypothermic, so dose interval for adrenaline was doubled. Full ALS (advanced life support) protocol followed throughout. Patient died at the hospital on 16Dec2020 at 20:14. The cause of death was reported to be cardiac arrest. It was not reported if an autopsy had been performed. At the time death the outcome of the following events was reported to be not recovered: collapsed, respiratory arrest, unresponsive to stimuli, did not feel well. The outcome of the following events was unknown: pulseless electrical activity, hypothermic, right bundle branch block, cyanosed, bradycardia. No seriousness criteria were provided for the non-fatal events. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest | |||||||||||||||||||
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Life Threatening? No Write-up: Heart attack; Head injury; Circulatory problems; Fall; This is a spontaneous report from a non-contactable Consumer or other non-HCP downloaded from the Regulatory Authority WEB DE-PEI-PEI2021000493. This is a report received from the Regulatory Authority. A 91-year-old male patient received his first dose of bnt162b2 (COMIRNATY, batch number not reported) via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included duodenal ulcer, vagotomy in 1988, ulcus ventriculi, myocardial infarction, cerebellar infarction, angina pectoris, stent insertion NOS, artificial cardiac pacemaker user from 2019. Patient had previous illnesses. The patient''s concomitant medications were not reported. Two hours after vaccination, the patient developed circulatory problems/ circulatory disorder peripheral, fall, head injury. The patient experienced acute myocardial infarction. The patient was dead on 04Jan2021 and death cause was reported as Acute myocardial infarction. It was not reported if an autopsy was performed. Relatedness of drug to all reactions/events: (Source of assessment: Regulatory Authority) C. Inconsistent causal association.; Reported Cause(s) of Death: circulatory problems; Acute myocardial infarction; fall; head injury | |||||||||||||||||||
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Life Threatening? No Write-up: heavy sensation in arm following jab; Death; This is a spontaneous report from a contactable physician. Report downloaded from the Agency Regulatory Authority-WEBGB-MHRA-EYC 00236211 with Safety Report Unique Identifier of GB-MHRA-ADR 24546700. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch: EJ0553/V0003), intramuscular in arm on 18Dec2020 at 30 ug single (30micrograms/0.3ml dose) for COVID-19 immunization. Medical history included gout, hypertension, Lumbar spondylosis, Epiretinal membrane, Swelling of legs, Sciatica, Osteoarthritis (all unknown if ongoing), had ongoing high risk of heart disease and diabetes mellitus (DM). Concomitant medication included allopurinol, acetylsalicylic acid, simvastatin, amitriptyline, tramadol hydrochloride, ibuprofen (FENBID) gel, buspirone, atenolol, hyaluronate sodium (HYLO-FORTE) eye drops. Patient died of unknown cause 2 days later (on 20Dec2020). Daughter has confirmed he had heavy sensation in arm following jab, but no other symptoms, he was found dead in bed. The outcome of heavy sensation in arm was not recovered. Awaiting coroners post-mortem (PM) for medical certificate cause of death (MCCD). The reporting physician did not think that the death is likely to be related to the administration of the vaccine. It was unknown if an autopsy was performed. No follow-up attempts needed. No further information expected.; Sender''s Comments: The 85-year-old male patient had medical history included gout, hypertension, lumbar spondylosis, epiretinal membrane, swelling of legs, sciatica, osteoarthritis, ongoing high risk of heart disease and diabetes mellitus (DM), and was on multiple concomitant medications. He received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020, and died of unknown cause 2 days later. He had heavy sensation in arm following jab, but no other symptoms, and he was found dead in bed. The company concurs with the reporting physician that the death is not likely to be causally related to the administration of the vaccine.; Reported Cause(s) of Death: Death | |||||||||||||||||||
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Life Threatening? No Write-up: Cause of death was unknown but was probably due to frailty/known IHD/CCF; Cause of death was unknown but was probably due to frailty/known IHD/CCF; Cause of death was unknown but was probably due to frailty/known IHD/CCF; Cause of death was unknown but was probably due to frailty/known IHD/CCF; General physical health deterioration; falling 02 sats; subsequent arrest; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number: GB-MHRA-WEBCOVID-20210112154920, and safety report unique identifier: GB-MHRA-ADR 24584672. A 90-year-old female patient received single dose of BNT162B2 (Solution for injection), via an unspecified route of administration on 29Dec2020 for COVID-19 immunization. Medical history included frailty of old age, congestive cardiac failure, atrial fibrillation (AF), left ventricular hypertrophy (LVH), transient ischaemic attack (TIA), ischaemic heart disease, epilepsy, indigestion, pain, and constipation. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included apixaban from 31Oct2019 for persistent atrial fibrillation, atorvastatin from 10Sep2019 for ischaemic heart disease, bisoprolol from 05Dec2017 for ischaemic heart disease, carbamazepine from 21Jan2002 for epilepsy, cimetidine from 03Apr2020 for indigestion, codeine from 22May2015 for pain, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (COSMOCOL) from 16Dec2019 for constipation, digoxin from 31Oct2019 for atrial fibrillation, furosemide from 05Mar2020 for heart failure, congestive; and perindopril from 11Jul2020 for heart failure, congestive. The patient experienced general physical health deterioration on 30Dec2020 next day after vaccination. Rapid deterioration in health: falling 02 sats and subsequent arrest. The events were considered serious: medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. The outcome of general physical health deterioration, falling O2 sats, and subsequent arrest was unknown.The patient died on 30Dec2020. Cause of death was unknown but was probably due to frailty/known IHD/CCF. Cannot say if vaccination was causer of this but patient died within 24 hrs of the vaccination. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death | |||||||||||||||||||
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Life Threatening? No Write-up: Rectorrhagia; This is a spontaneous report from a contactable healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority (ES-AEMPS-712082). A 96-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6796), intramuscularly, on 27Dec2020 at a single dose (reported as 0.3 mL) for COVID-19 vaccination and acenocoumarol (SINTROM), orally, from 26Mar2012 at an unspecified dose for fibrillation atrial. Medical history included anaemia, ischaemic cardiomyopathy, type 2 diabetes mellitus, hypertension arterial, fibrillation atrial, osteoporosis, cognitive deterioration/cognitive impairment, non-ongoing cerebrovascular accident (CVA) from Jul2001 to Jul2001, arthrosis/osteoarthritis, intestinal ischemia, brain infarction, residual persistent instability, hypertensive heart disease with conserved left ventricular ejection fraction (LVEF), flutter headset, right bundle branch block, and depressive syndrome. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) from 01Dec2020, valsartan (MANUFACTURED BY: KERN PHARMA) from 26Nov2019, amlodipine besilate (AMLODIPINO; MANUFACTURED BY: MYLAN PHARMACEUTICALS) from 16Jan2020, latanoprost, timolol maleate (XALACOM) from 28Mar2012, furosemide (FUROSEMIDA; MANUFACTURED BY: KERN PHARMA) from 07Apr2012, insulin (ACTRAPID) from 14Jun2017, metformin (MANUFACTURER UNKNOWN) taken for type 2 diabetes mellitus from 27Jan2020, metamizole sodium (METAMIZOL; MANUFACTURED BY: NORMON) from 14Sep2017, and captopril (MANUFACTURER UNKNOWN). The patient experienced rectorrhagia on 29Dec2020, which caused hospitalization and was reported as fatal. The clinical course was reported as follows: On 31Dec2020, the patient was taken to a hospital because for the previous three days small clots were observed in diapers. The international normalised ratio (INR) increased at 5.5 on 31Dec2020. There was a suspicion of ischemic colitis. On 03Jan2021, the patient presented with an abundant rectorrhagia. On 04Jan2021, the patient evolved unfavorably despite unspecified serum therapy and transfusion of unspecified concentrates. Treatment with sedoanalgesia was decided, but patient passed away. The action taken in response to the event for acenocoumarol was permanently withdrawn on 31Dec2020. The clinical outcome of rectorrhagia was fatal. The patient died on 05Jan2021. The cause of death was assessed as rectorrhagia (no cause of death reported). It was not reported if an autopsy was performed. Sender''s Comment: This is AA not known for the vaccine. Given the patient''s history (anticoagulated patient) and clinical suspicion, there is an alternative explanation to the vaccine. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Rectorrhagia | |||||||||||||||||||
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Life Threatening? Yes Write-up: pneumonia; Three individuals had died after vaccination against corona/ Heart failiure; Disease progression; Cough; felt ill; Fever; The initial case was missing the following minimum criteria: (no first-hand knowledge). Upon receipt of follow-up information on (19Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer and additional reporter: physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. This is a report received from the Medicines Agency. The regulatory authority report number is IS-IMA-1502. A 94-year-old female patient received the bnt162b2 (COMIRNATY; Lot Number: EJ6796 and Expiration Date: 30Apr2021), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient''s medical history included hypertension, Alzheimer''s disease, pneumonia, Ischemic cardiomyopathy; all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced the following events and outcomes: three individuals had died after vaccination against corona/ heart failure (death, hospitalization, medically significant, life threatening) on 04Jan2021, disease progression (death, hospitalization, life threatening) on 31Dec2020, pneumonia (death, hospitalization, medically significant, life threatening) on an unspecified date, cough (death, hospitalization, life threatening) on 31Dec2020, felt ill (death, hospitalization, life threatening) on 31Dec2020, fever (death, life threatening) on 31Dec2020 (also reported :30Dec2020); all of which had a fatal outcome. Narrative as received: "This case was received via e-reporting system by IMA from a physician. A 94-year old female with Alzheimer''s disease, HTN and ischaemic cardiomyopathy was vaccinated with COMIRNATY on 29Dec2020. No concomitant medications were reported. On 31Dec2020 the patient experienced fever (37.8), coughing and felt ill. Two days later the patient experienced heart failure and passed away on 04Jan2021. The patient was also diagnosed with pneumonia but not treated for pneumonia after consultation with the patient''s family due to the patient''s condition." The patient died on 04Jan2021 due to heart failure and pneumonia. It was unknown if an autopsy was performed. Reporter''s comments: "Cause of death was declared as pneumonia and heart failure. Causal association with COVID-19 vaccine is due to time relationship, uncertain causality."; Reported Cause(s) of Death: Heart failure; Pneumonia | |||||||||||||||||||
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Life Threatening? No Write-up: Heart failure; heart attack; The initial case was missing the following minimum criteria: (no first-hand knowledge). Upon receipt of follow-up information on (19Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer or other non-health professional and a contactable healthcare professional. This is a spontaneous report downloaded from the regulatory authority IS-IMA-1500. The report was received from a contactable physician via the e-reporting system by the regulatory authority. An 88-year-old male patient received bnt162b2 (COMIRNATY; lot number EJ6796, expiration date 30Apr2021), via an unspecified route of administration on 30Dec2020 as single dose for covid-19 immunization. Medical history included kidney failure and ischemic heart disease. No concomitant medication was reported. No direct adverse events were reported after injection. The patient was transferred to the hospital and diagnosed with a heart attack and heart failure on 02Jan2021. The patient died one day later. The patient died on 03Jan2021. It was not reported if an autopsy was performed. Outcome of events were fatal. Reporter''s comment: The only indication of the relationship between the events and the injection is the timing of the vaccination. The patient''s daughter thought it was an adverse event, but the reporter considered it unlikely but theoretically possible. Sender''s comment: This case is being further investigated locally. Follow-up information will be provided if available. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The only indication of the relationship between the events and the injection is the timing of the vaccination. The patient''s daughter thought it was an adverse event, but the reporter considered it unlikely but theoretically possible; Reported Cause(s) of Death: heart attack; heart failure | |||||||||||||||||||
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Life Threatening? No Write-up: presumed/ suspected further MI; Death/ Sudden death; This is a spontaneous report from a contactable Physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-20210111153208. Safety Report Unique Identifier GB-MHRA-ADR 24580919. A 93-year-old female patient received her fist single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EJ1688) on 30Dec2020 for covid19 immunisation. The patient had a history of chronic kidney disease (CKD), ischemic heart disease (IHD), strokes and vascular dementia. The patient was in elderly mentally infirm (EMI) residential homes care and had a myocardial infarction (MI) in Oct2020. Other relevant medical history included constipation, agitation in dementia, peripheral oedema, dyspepsia, depression and asthma. Concomitant medications included aripiprazole for dementia, bisoprolol for IHD, clopidogrel for IHD, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (COSMOCOL) for constipation, diazepam for agitation in dementia, calcium carbonate, colecalciferol (EVACAL D3) for bone protection, furosemide for peripheral oedema, omeprazole for dyspepsia, senna alexandrina leaf (SENNA) for constipation, sertraline for depression, salbutamol (VENTOLINE) for asthma. The patient was feeling fine after Covid vaccination. Day 6 post immunization, on 05Jan2021, she was found dead at side of bed, sat leaning against wall with hand on chest. It was also reported as sudden death and presumed/ suspected further MI. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient had Covid-19 virus test on 01Jan2021 and result was negative. It was unknown if an autopsy was performed. It was reported that the death unlikely caused by vaccination as she was feeling well in the week leading up to death and suspected further MI, but best to report given time proximity and black triangle drug.; Reported Cause(s) of Death: presumed/ suspected further MI | |||||||||||||||||||
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Life Threatening? No Write-up: Death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB SE-MPA-2021-000089, Safety Report Unique Identifier SE-MPA-1609851420494. A 86-years-old female patient received bnt162b2 (COMIRNATY, batch/lot number: EJ6795), intramuscular on 30Dec2020 at single dose for covid-19 immunization. Medical history included cardiac failure, atrial fibrillation, stroke, ischemic heart disease, all from an unknown date and unknown if ongoing. Concomitant medications included carvedilol, paracetamol, furosemide (IMPUGAN), urea (CANODERM), calcium carbonate, colecalciferol (KALCIPOS-D), levothyroxine sodium (LEVAXIN), warfarin sodium (WARAN), citalopram. Previous drug reactions included beta-lactamase-sensitive penicillins, cefalosporiner third generation and tetracyclines, unknown what kind of reactions. The patient experienced death in Jan2021 with outcome of fatal. The woman did not have any reactions at that time for the vaccination. Four days after the vaccination the woman was found dead. It was not reported if an autopsy was performed. The cause of death was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death | |||||||||||||||||||
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Life Threatening? No Write-up: massive central pulmonary embolism of the A. pulmonaris dexter and sinister; brownish vaginal discharge; no urine; This is a spontaneous report from a contactable healthcare professional/ physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. The regulatory authority report number AT-BASGAGES-2021-00009. An 87-year-old female patient BNT162B2 (COMIRNATY; Lot number EJ6796), via an unspecified route of administration on 28Dec2020 as single dose for COVID-19 immunization. The patient''s medical history and concurrent conditions included: COVID-19 PCR test positive on 25NOV2020, diabetes mellitus (continuing; treated with medication, values were in the normal range), hypertension (continuing; hypertension values were checked once a day for the last few days, controlled, and were also in the normal range - 130/80, Heart rate 74 / min), decompensation cardiac (continuing), pneumonia (Condition after pneumonia right subfield in Jul2020 - the oxygen saturation was checked daily and was 93%), dementia (continuing), Arteriosclerosis (continuing; severe general atherosclerosis), Strumectomy (Condition after strumectomy with substitution), Deep vein thrombosis (continuing; deep vein thrombosis on both sides), Emphysema pulmonary (continuing; highly chronic obstructive pulmonary emphysema), Cholecystectomy (Status post cholecystectomy), Appendectomy (Status post appendectomy), Hysterectomy (Status post hysterectomy), Adnexectomy (Status post adnexectomy), retention cyst (continuing). Concomitant medication included candesartan (MANUFACTURER UNKNOWN) from 21JUL2020, rilmenidine (ITERIUM) for 10JUN2020, risperidone (RISPERIDON SANDOZ), metamizole sodium (NOVALGIN [METAMIZOLE SODIUM]) for musculoskeletal pain from 05APR2019 and 27JUL2020 and , macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXOGOL) from 13DEC2019, metoclopramide hydrochloride (PASPERTIN) from 15JUL2020, sodium picosulfate (DULCOLAX) from 06AUG2019, levothyroxine sodium (THYREX) from 23JUN2019, memantine (MANUFACTURER UNKNOWN) from 16JUL2020, doxazosin mesilate (DOXAZOSIN HEXAL) from 09JUN2020, esomeprazole (DUROTIV) from 03FEB2020, lactulose (LAEVOLAC), linagliptin (TRAJENTA) from 05APR2019, acetylsalicylic acid (DOMINAL) from 18NOV2019, sertraline hydrochloride (SERTRALIN BLUEFISH) from 05JUN2020, colecalciferol (OLEOVIT D3) from 15JUL2019, magnesium carbonate, magnesium oxide (MAGNOSOLV) from 05APR2019, calcium chloride, potassium chloride, sodium chloride (RINGER FRESENIUS) from 17DEC2019, ambroxol hydrochloride (AMBROBENE) for coughing from 09JUN2020, levothyroxine sodium (THYREX) for coughing from 22JUN2019. The patient experienced massive central pulmonary embolism of the a. pulmonaris dexter and sinister on 23Jan2020 which was serious as it had fatal outcome; she also experienced brownish vaginal discharge on 30Dec2020 with outcome of unknown; Patient had no urine on 29Dec2020 with outcome of recovered on 29Dec2020. The patient underwent lab tests and procedures which included history COVID-19 PCR test that was positive on 25Nov2020 and COVID-19 PCR test again on 07Dec2020 was negative. Clinical course was as follows: the patient received BNT162B2 on 28Dec2020, then on 30Dec2020, the patient experienced vaginal discharge abnormality. On 29Dec2020, the patient experienced urinary retention. On 31Dec2020, at 03:45 the patient experienced recurrent pulmonary embolism death. The patient died from recurrent pulmonary embolism. BASGAGES follow up autopsy findings from reported the cause of death as massive central pulmonary embolism of A. pulmonalis dext et sin. The patient died on 31Dec2020. Sender''s comments: BASGAGES comment from 7.1.2020: Data capture aid form of Pfizer taken into consideration for further request of FU. Cause of death and Autopsy findings requested. Confounding factors: elderly age, underlying diabetes mellitus, hypertension, decompensation cardiac, deep vein thrombosis, etc The causal relationship between the product Comirnaty and pulmonary embolism is assessed as unlikely. The information provided in this individual case does not warrant a change in the product information or other measures. The case will be closed at this time. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Recurrent pulmonary embolism | |||||||||||||||||||
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Life Threatening? No Write-up: Urinary tract infection; Acute circulatory failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from the Regulatory Authority. The regulatory authority report number is SE-Regulatory Authority-2021-000216. An 83-year-old male patient received the bnt162b2 (COMIRNATY), intramuscularly in Dec2020 at 0.3 mL, single for COVID-19 immunization. Medical history included hypertension, Parkinson''s disease, chronic obstructive pulmonary disease, diverticulosis, type 2 diabetes mellitus, arteriosclerotic heart disease, wheelchair user, catheter; all from an unknown date and unknown if ongoing. Concomitant medications included benserazide hydrochloride, levodopa (MADOPARK QUICK), sodium picosulfate (CILAXORAL), magnesium citrate; magnesium lactate (MANUFACTURER UNKNOWN), linagliptin (TRAJENTA), calcium carbonate, colecalciferol (KALCIPOS D) , paracetamol (ALVEDON), folic acid (FOLVIDON), salbutamol sulfate (BUVENTOL EASYHALER), cyanocobalamin (BETOLVIDON), lactulose (LAKTULOS MEDA) , colecalciferol (DIVIFARM), cinchocaine hydrochloride, prednisolone caproate (SCHERIPROCT [CINCHOCAINE HYDROCHLORIDE;PREDNISOLONE CAPROATE]), propylene glycol (PROPYLESS), glyceryl trinitrate (NITROLINGUAL), omeprazole (OMEPRAZOL SANDOZ [OMEPRAZOLE]) , furosemide (IMPUGAN [FUROSEMIDE]), bisoprolol fumarate (BISOPROLOL SANDOZ), budesonide, formoterol fumarate (BUFOMIX EASYHALER), ferrous sulfate (DUROFERON), tiotropium bromide (SPIRIVA RESPIMAT); all taken for an unspecified indication from an unspecified date to an unspecified date. The patient experienced: patient that died in infection 5 days after the vaccination (death, hospitalization, medically significant), urinary tract infection (death, hospitalization, medically significant), acute circulatory failure (death, hospitalization, medically significant); all in Jan2021. The patient was hospitalized for the events from Jan2021 to Jan2021. The clinical course was reported as follows: The physician reported regarding an 83-year-old male who was using a wheelchair and catheter; who was vaccinated with COMIRNATY (also reported as: TOZINAMERAN), COVID-19 mRNA Vaccine (nucleoside modified), which was given at a special housing for the elderly. The physician became somnolent the same afternoon and sent to the hospital. A urinary tract infection was diagnosed in the hospital. The patient did not have a fever; however, the patient''s C-reactive protein (CRP) was 97. The patient was treated with an intravenous antibiotic in the hospital. The patient was then sent to a special housing with the tablet amoxicillin/clavulanic acid BB. The patient slowly improved but died in his sleep five days after the vaccination. The cause of death was acute circulatory failure due to urinary tract infection in combination with the underlying diseases atherosclerotic heart disease and Parkinson''s disease. Therapeutic measures were taken as a result of urinary tract infection. The clinical outcome of the events was fatal. The patient died on an unspecified date in Jan2021 due to acute circulatory failure, urinary tract infection, atherosclerotic heart disease, and Parkinson''s disease. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: atherosclerotic heart disease; Parkinson''s disease; Acute circulatory failure; Urinary tract infection | |||||||||||||||||||
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Life Threatening? No Write-up: cardiac decompensation with tachyarrhythmia; cardiac decompensation with tachyarrhythmia; acute on chronic renal failure; COVID pneumonia; COVID pneumonia; This is a spontaneous report from a contactable physician and a other healthcare professional (HCP). An 89-year-old male patient received first dose of BNT162B2 (COMIRNATY, lot number: EJ6796), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The relevant medical history included ongoing arterial hypertension, ongoing cardiac insufficiency, ongoing atrial fibrillation, bladder cancer (underwent surgery), ongoing dementia and ongoing living in nursing home. Concomitant medications were not reported. On day of vaccination a rapid test for SARS-CoV 2 was negative, but there were already cases in the nursing home. The next day the patient developed runny nose and temperature up to 37.4 degrees, a PCR test was positive. On 31Dec2020 he had fever of 39.2 degrees and a heart rate of 140. He was hospitalized on 31Dec2020. The oxygen saturation was 87%. The patient experienced cardiac decompensation with tachyarrhythmia and acute on chronic renal failure with onset date 31Dec2020. Symptoms were reported as fever, cough, respiratory insufficiency. Diagnosis was confirmed by lab tests and chest X-ray. Despite of treatment with antibiotics, oxygen, Remdesivir and dexamethasone the patient died due to cardiac decompensation on 04Jan2021. It was unknown if vaccination complications occurred after previous vaccinations. The outcome of the event cardiac decompensation was fatal, while other events were unknown.; Sender''s Comments: The 89-year-old patient had relevant medical history included ongoing arterial hypertension, cardiac insufficiency, atrial fibrillation, bladder cancer (underwent surgery), dementia and living in nursing home. He received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020, and COVID-19 test positive on 30Dec2020. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. Diagnosis of COVID-19 pneumonia was confirmed by lab tests and chest X-ray. The fatal cardiac decompensation was likely triggered by the COVID infection, and all events including tachyarrhythmia and acute on chronic renal failure were unlikely causally related to the first dose of BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: cardiac decompensation | |||||||||||||||||||
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Life Threatening? No Write-up: Death; SARS-CoV-2 infection; SARS-CoV-2 infection; Malaise; Dyspnoea; Vomiting; This is a spontaneous report received from a contactable consumer by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202101181625023630 and Safety Report Unique Identifier GB-MHRA-ADR 24610617. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date was not provided), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 vaccination. Medical history included Parkinson''s disease, heart rate decreased, nasopharyngitis (had colds before and always got through them); all unknown if ongoing. Concomitant medication included rivastigmine (RIVASTIGMIN) from 30Dec2020 for Parkinson''s disease. It was reported that the patient had the vaccine on 30Dec2020 and within 4 days (as reported), the patient felt really unwell on 04Jan2021. He then had trouble breathing and also started vomiting 04Jan2021 . He was taken to hospital on 06Jan2021 and then informed and told to expect the worse. His vitals were giving up on an unspecified date. It was reported that the patient was quite strong for his age despite his Parkinson''s disease. It was reported that the patient tested positive for COVID-19 virus test on 05Jan2021 and 13Jan2021. The patient died on 13Jan2021 (also reported as 05Jan2021). An autopsy was not performed. It was reported that the patient was hospitalized due to the events. The outcome of the event SARS-CoV-2 infection was not recovered, while unknown for the events vomiting, dyspnoea and malaise. No follow up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death | |||||||||||||||||||
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Life Threatening? No Write-up: Posterior myocardial infarction; Nausea with vomiting; Nausea with vomiting; This is a spontaneous report from a contactable healthcare professional and physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB AT-BASGAGES-2021-00013. A 92-year-old female patient received bnt162b2 (COMIRNATY; batch/lot: EJ6796, expiration date: unknown), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 vaccination. Medical history included ongoing chronic heart failure in AF(atrial fibrillation); left ventricular hypertrophy, pacemaker insertion (cardiac) from 1998 (condition after DDDR-PM implantation 1998, change of generator), ongoing dementia aggravated (advanced dementia), ongoing hemorrhagic cystitis, hysterectomy (St. p. hysterectomy), ongoing generalized arteriosclerosis (severe general atherosclerosis), ongoing retention cyst (vascular scars and retention cysts up to 1 cm in size on both kidneys), nausea and vomiting, ongoing type II diabetes mellitus, complicated urinary tract infection, prerenal kidney failure as part of a urinary tract infection, iron deficiency anemia, ongoing struma nodosa (small nodular goiter nodosa on both sides), ongoing sigmoid diverticulitis, deep vein thrombosis (Z.N. extensive arm vein thrombosis on the right), ongoing emphysema pulmonary (highly chronic obstructive pulmonary emphysema) and pain in the musculoskeletal system. It was also reported that in the days before the vaccination, the patient had refused to eat and drink, she had nausea and nausea also on particular days (e.g. on December 14th, 2020, December 23rd, 2020). Concomitant medications included bisoprolol fumarate (BISOPROLOL SANDOZ) on 28Oct2020, calcium chloride dihydrate, potassium chloride, sodium chloride, sodium lactate (RINGERLACTAT NACH HARTMANN BAXTER VIAFLO) on 17Dec2020, risperidone (RISPERIDON SANDOZ) on 24Dec2020, mirtazapine (MIRTAZAPIN SANDOZ) on 24Dec2020, lactulose (LAEVOLAC-LAKTULOZ) on 01Dec2020, metamizole sodium (NOVALGINE) from 04Nov2020 for pain in the musculoskeletal system, pantoprazole (PANTOLOC [PANTOPRAZOLE]) from 19Oct2020 and apixaban (ELIQUIS) on 28Oct2020. There were no signs of another infection, fever. Daily health check (cough, sore throat, shortness of breath, vomiting, diarrhea, loss of smell) were OK in the days after vaccination. On 28Dec2020 at 20:22, the patient experienced nausea with vomiting. The outcome of the event nausea with vomiting was recovered on 29Dec2020. On 01Jan2021, the patient experienced nausea with vomiting again with an unknown outcome. On 03Jan2021, the patient experienced posterior myocardial infarction. The patient died on 03Jan2021 due to posterior myocardial infarction. Autopsy was performed. Autopsy findings from 05Jan2021 showed cause of death of posteroseptal myocardial infarction. Sender''s comments: BASGAGES comment from 07Jan2020: Data capture aid form of Pfizer taken into consideration for further request of FU. Cause of death and Autopsy findings requested. Confounding factors: elderly age and underlying type II diabetes mellitus, nausea, Nausea, chronic heart failure, atrial fibrillation, generalized arteriosclerosis, etc. The causal relationship between the product Comirnaty and myocardial infarction is assessed as unlikely. The information provided in this individual case does not warrant a change in the product information or other measures. The case will be closed at this time. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Posterior myocardial infarction; Autopsy-determined Cause(s) of Death: posteroseptal myocardial infarction | |||||||||||||||||||
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Life Threatening? Yes Write-up: Covid-19 Pneumonie/PCR test was now positive; Covid-19 Pneumonie/PCR test was now positive; Decompensation cardiac; acute chronic kidney disease; Tachyarrhythmia; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB regulatory authority number DE-PEI-PEI2021000834. An 89-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EJ6796), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunisation. Medical history included arterial hypertension, atrial fibrillation, dementia, bladder carcinoma, cardiac insufficiency and heart failure; all unknown if ongoing, and bladder carcinoma surgery (not ongoing). The patient''s concomitant medications were not reported. It was reported that the patient was vaccinated by the health department on 29Dec2020, a rapid test for Sars-CoV 2 was negative, but there have been cases of Covid 19 in the house. The next day (30Dec2020) he developed feeling cold and temperature up to 37.4, a PCR test was now positive (unspecified date). On 31Dec2020 he had a fever of 39.2 and a pulse of 140. The patient was admitted to the hospital and the oxygen saturation was 87%. Despite treatment with antibiotics, oxygen, remdesivir and dexamethasone the patient died due to the events decompensation cardiac, COVID-19 pneumonie/PCR test was now positive, acute chronic kidney disease and tachyarrhythmia. The patient died on 31Dec2020. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Decompensation cardiac; Covid-19 Pneumonie/PCR test was now positive; Covid-19 Pneumonie/PCR test was now positive; acute chronic kidney disease; Tachyarrhythmia | |||||||||||||||||||
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Life Threatening? Yes Write-up: COVID-19 virus test (result: positiv/positive); COVID-19 virus test (result: positiv/positive); Temperature increase; Vd. a. pneumonia; Tachycardia; Food refusal/Diet refusal; Food refusal/Diet refusal; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB. The regulatory authority report number is DE-PEI-PEI2021000840. An 83-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: EJ6796), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. Medical history included dementia, cardiac insufficiency, renal insufficiency, all from unknown dates and unknown if ongoing; and stroke from Apr2019 to an unknown date. The patient''s concomitant medications were not reported. On 30Dec2020, after vaccination, the patient developed diet refusal/food refusal; and on 06Jan2021, the patient experienced tachycardia, body temperature increased and pneumonia, lasting for unknown. The patient was dead and condition was life threatening. The reporter assessed the events diet refusal/food refusal, tachycardia, body temperature increased and pneumonia as serious (death and life threatening). It was also reported that the patient experienced COVID-19 virus test (result: positiv/positive) on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 37.9 centigrade, heart rate: 123 bpm and COVID-19 virus test: positive (ct value 31), all on unspecified dates; and oxygen saturation: 74-78 % on 07Jan2021. The outcome of the events diet refusal/food refusal, tachycardia, body temperature increased and pneumonia was fatal while the outcome of the event COVID-19 virus test (result: positiv/positive) was unknown. The patient died on 07Jan2021. Causes of death were diet refusal/food refusal, tachycardia, body temperature increased and pneumonia. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number was already obtained.; Reported Cause(s) of Death: Tachycardia; Temperature increase; Vd. a. pneumonia; Food refusal/Diet refusal; Food refusal/Diet refusal | |||||||||||||||||||
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Life Threatening? No Write-up: DEATH; breath shortness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, report number SE-MPA-2021-000419, other case identifier SE-MPA-1610636715016. An 83-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot/batch number: EJ6796) solution for injection, intramuscular in Dec2020 at a single dose for Covid-19 vaccination. Medical history included somnolence in 2016 after Imovane intake, atrial fibrillation, Peripheral vascular disease, chronic renal failure, cardiac failure, type II diabetes mellitus, ischemic heart disease, Peripheral swelling and some fluid in lung; all unknown if ongoing; admitted to hospital after fall, unknown infection, and necrotic toes. Concomitant medications included furosemide sodium (FUROSEMID ACCORD) from 18Dec2020 as needed, 2-4 ml, sodium polystyrene sulfonate (RESONIUM) from 14Dec2020 at 0.5 DF, as needed, oxazepam (SOBRIL, 5mg) from 23Dec2020 as needed, 1-2 tablets, allopurinol (ALLOPURINOL NORDIC DRUGS, 100mg) from 22Aug2020 to Dec2020 at 100 mg, daily, darbepoetin alfa (ARANESP, 30ug) from 07Dec2020 at 1 DF, every 2 weeks, glycerol (MINIDERM [GLYCEROL], 20%) from 28Nov2020 to Dec2020 at 1 DF, as needed, glyceryl trinitrate (GLYCERYLNITRAT I ESSEX, 1%) from 28Nov2020 to Dec2020 at 1 DF, as needed, max 2 DF/daily, acetylcysteine 200mg from 28Nov2020 to Dec2020, midazolam hydrochloride (MIDAZOLAM HAMELN) from Dec2020 at as needed, 0.2-0.5 ml, latanoprost (LATANOPROST STADA, 50ug/ml) from 25May2018 to Dec2020 at 1 DF, daily, 1 drop at night, desloratadine (AERIUS [DESLORATADINE, 5mg]) from 20Dec2020 at 5 mg, daily, glycopyrronium bromide (ROBINUL) from 23Dec2020 at 1 mL, as needed, morphine hydrochloride (MORFIN MEDA) from Dec2020 at as needed, 0.25-1 ml, paracetamol (ALVEDON, 500mg) from 08Dec2020 at 3000 mg, daily, carbomer (VISCOTEARS, 2mg/g) from 25May2018 to Dec2020 at 1 DF, as needed, 1 dropp, finasteride (FINASTERID SANDOZ, 5mg) from 21Nov2017 to Dec2020 at 5 mg, daily, sodium picosulfate (CILAXORAL, 7.5mg/ml) from 18Dec2020 at daily, 10-20 drops per night, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) from 19Dec2020 at 1-2 sachets per day, omeprazole 10mg from 28Nov2020 to Dec2020 at 10 mg, daily, furosemide (FURIX [FUROSEMIDE, 500mg]) from Dec2020 at 250 mg, daily, haloperidol (HALDOL, 5mg/ml) from Dec2020 at as needed, 0.1-0.2 ml, morphine hydrochloride (MORFIN ABCUR, 10mg/ml) from 23Dec2020 at as needed, 0.25-0.5 ml, budesonide, formoterol fumarate (SYMBICORT FORTE TURBUHALER) from 09Dec2020 at 2 DF, daily, dalteparin sodium (FRAGMIN, 5000 IU) from 10Dec2020 at 1 DF, daily, hypromellose (HYPROSAN, 3.2mg/ml) from 15Jan2019 to Dec2020 at 1 DF, as needed, 1 dropp. The patient previously took zopiclone (IMOVANE) in 2016 and experienced somnolence. Patient was admitted to hospital after fall with unknown infection and necrotic toes due to vascular disease. Treated with antibiotics. During the hospital visit, patient had worsened renal and heart failure despite treatment. Transferred to palliative care. Awake, eating and drinking but bedridden. Peripheral swelling and some fluid in lung. Patient was then vaccinated with Comirnaty. After an hour, patient received palliative injection with morphine for breath shortness. Patient died the same evening. According to the reporter, since the patient was in the palliative care phase, it was not sure that death was caused by the vaccine. The patient died in Dec2020. The action taken in response to the event for bnt162b2 was not applicable. It was unknown if an autopsy was performed. No follow-up activities are needed. No further information is expected.; Reported Cause(s) of Death: Uknown cause of death | |||||||||||||||||||
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Life Threatening? No Write-up: FEVER; REDUCED GENERAL CONDITION; TIREDNESS; This is a spontaneous report downloaded from the regulatory authority-WEB NO-NOMAADVRE-FHI-2021-Upj5z, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013906. A contactable physician reported that a 96-year-old female patient had received bnt162b2 (COMIRNATY, batch/lot number EJ6796), via intramuscular route on 29Dec2020, at single dose (first dose, administered into left arm) for covid-19 immunisation. Medical history included being bedridden from an unknown date and unknown if ongoing (last couple of years, able to be seated in a chair some of the time during the day), living in residential institution from 11Dec2020 to an unknown date, urosepsis from an unspecified date in Dec2020 to an unspecified date in Dec2020, ongoing cardiac failure, oral candidiasis from an unspecified date in Dec2020 to an unspecified date in Dec2020, ongoing atrial fibrillation, and rheumatic disorder from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took cefotaxime for urosepsis from an unspecified date to 23Dec2020. The patient experienced tiredness (fatigue) (death) on 01Jan2021, fever (pyrexia) (death) on 03Jan2021, and reduced general condition (general physical health deterioration) (death) on 01Jan2021. The patient underwent lab tests and procedures which included body temperature: $g38 centigrade on 03Jan2021, c-reactive protein: 82 mg/l on 23Dec2020, 50 mg/l on 28Dec2020, 52 mg/l on 03Jan2021, and red blood cell sedimentation rate: 78 mm/h on 28Dec2020. The patient died on 03Jan2021. It was not reported if an autopsy was performed. The Regional Pharmacovigilance Center has assessed the causal relationship between the suspect product and the reported event(s) as Possible. Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: A 96 Years old Female patient received Comirnaty on 29Dec2020 for VACCINATION. The patient was admitted to NURSING HOME (11Dec2020), after being treated for CARDIAC FAILURE, UROSEPSIS (Dec2020 - Dec2020), ORAL CANDIDIASIS (Dec2020 - Dec2020), for which the patient was treated with Cefotaxime until 23Dec2020. The medical history also included ATRIAL FIBRILLATION, RHEUMATIC DISORDER, and the patient has been BEDRIDDEN the last couple of years, but able to be seated in a chair some of time during the day. On 01Jan2021, the patient developed increasing TIREDNESS, REDUCED GENERAL CONDITION with reduced fluid and food intake. On 03Jan2021, the patient also developed FEVER. Relevant laboratory findings and investigations included in the report ( C-REACTIVE PROTEIN, 23Dec2020, 82 mg/L (Upon discontinuation of cefotaxime.) )( C-REACTIVE PROTEIN, 28Dec2020, 50 mg/L, Stable value since discontinuing cefotaxime.)( ERYTHROCYTE SEDIMENTATION RATE, 28Dec2020, 78 mm/h )( BODY TEMPERATURE, 03Jan2021, $g38 deg C )( C-REACTIVE PROTEIN, 03Jan2021, 52 mg/L ). The reporting physician stated that despite an increased value of C-reactive protein before vaccination, no new infection focus was found, and the patient was clinically stable and in no pain. The physician had also contacted an infectious diseases specialist for advice regarding another geriatric patient with ongoing long-term antibiotic treatment and increased C-reactive treatment, and had received a green light for vaccination with Comirnaty. The patient''s outcome was Fatal, at the time of the report. The case was considered to be Serious. This case was received from a Physician. Sender''s Comments (Health Authority comments): "The report concerns a patient in her 90s, who experienced fatigue, reduced general condition and fever a few days after the first dose of the Covid-19 vaccine Comirnaty, and the patient died. Reporter states that the patient was admitted to the institution after treatment for urosepsis, heart failure and oral candidiasis. The patient had also experienced atrial fibrillation and had been Bedridden for the past couple of years. The patient had been on long-term treatment with cefotaxime, which was discontinued approximately one week before the vaccine was given. The patient had stably elevated CRP (50 mg/L) after discontinuation of cefotaxime, but was clinically stable with no increase in pain and no new focus of infection was found. Another geriatric patient with ongoing long-term antibiotic treatment and elevated CRP had received a clear signal for vaccination from drugs for infection. The most common adverse reactions with Comirnaty in study participants were injection site pain ($g 80%), fatigue ($g 60%), headache ($g 50%), myalgia and chills ($g 30%), arthralgia ($g 20%), fever and swelling at the injection site ($g 10%). They occurred within 1-2 days after vaccination, were usually of mild or moderate intensity and passed after a few days. Adverse reactions occurred less frequently in the elderly ($g 55 years) than in younger adults. Data from use in frail patients with co-morbidity (eg cardiovascular disease) are nevertheless limited, and such lack of information will be obtained in post-marketing studies, among other things. It is stated in the report that the patient had underlying diseases before vaccination. As the incident is described, it is more likely that these diseases are behind the incident. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. It cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or other accidental, concurrent cause that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died afterwards, the report is also classified as serious, even though no causal link between the vaccine and the death has been established". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: TIREDNESS; FEVER; REDUCED GENERAL CONDITION | |||||||||||||||||||
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Life Threatening? No Write-up: Urosepsis; suspected bacterial infection, possibly pneumonia; consciousness decreased; loose stools/diarrhea; SIRS (Systemic inflammatory response syndrome) after vaccination, other infection?; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, regulatory authority report number SE-MPA-2021-000610, other case identifier number SE-MPA-1611041115055. An 82-year-old male patient received bnt162b2 (COMIRNATY), lot number: EJ6796, intramuscular on 27Dec2020 at 0.3 mL, single for COVID-19 immunisation. Medical history included long-term abdominal pain, anxiety, paroxysmal atrial fibrillation, suprapubic bladder catheter, cholelithiasis, mild cognitive disorder, gastric ulcer, glaucoma, chronic prostatitis, purple urine bag syndrome, renal failure, spinal stenosis, recurrent urinary tract infections and previously ileus on two occasions. Concomitant medications included clomethiazole edisilate (HEMINEVRIN) from 04Oct2020, calcium chloride, potassium chloride, sodium acetate, sodium chloride (RINGER ACETATO BAXTER) from 05Dec2020, mirtazapine (MIRTAZAPIN ACTAVIS) from 11Nov2020, buprenorphine from 04Oct2020, paracetamol (PARACETAMOL APOFRI) from 28Oct2020, dorzolamide hydrochloride, timolol maleate (DORZOLAMID/TIMOLOL) from 23Oct2020, bimatoprost (LUMIGAN) from 23Oct2020, zopiclone (IMOVANE) from 23Sep2020, karbamid (KARBAMID) from 28Apr2020, pregabalin (PREGABALIN SANDOZ) from 19Aug2020; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO) from 11Mar2020; oxycodone hydrochloride (OXYNORM) from 04Oct2002, and oxazepam (OXASCAND) from 01Apr2020. The patient experienced SIRS (Systemic inflammatory response syndrome) after vaccination, other infection? on 29Dec2020 with date of onset reported as 2 days after the immunization. On 31Dec2020, the patient had a fever of over 38 degrees Centigrade and had loose stools/diarrhea twice during the week, C-reactive protein (CRP) was 70. There was nothing abnormal related to the man''s suprapubic catheter, though he had finished treatment with antibiotics due to urinary tract infection the previous week. COVID-19-test was taken and came back negative the next day, CRP had decreased spontaneously to 50. On 02Jan2021, the man was somnolent but answered adequately. Respiratory rate was 34-38, oxygen saturation 88 % on air, heart rate 100, blood pressure 100/70 and CRP 92. The patient was prescribed Bricanyl for obstructive breathing and Cefatrixon 1 gram, the physician suspected bacterial infection, possibly pneumonia. The patient''s health deteriorated the following days, his consciousness decreased, he neither ate nor drank, CRP increased and there was no improvement from the intravenous antibiotic. A conversation about end-of-life care and refraining from hospitalisation had been had during previous health deterioration. The patient passed away in the beginning of Jan2021. The outcome of the events ''SIRS and Urosepsis'' was fatal, event ''suspected bacterial infection, possibly pneumonia'' was not recovered; and unknown for the other events. The cause of death according to the death certificate was urosepsis. No autopsy was planned. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Urosepsis; SIRS (Systemic inflammatory response syndrome) after vaccination, other infection? | |||||||||||||||||||
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Life Threatening? No Write-up: sudden death; This is a spontaneous report from two contactable physicians via Regulatory Authority, downloaded from Regulatory Authority-WEB (SI-JAZMP-NCPHV-2021SI0048_0048). A 79-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot number EJ6796) intramuscular on 27Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included ongoing alcoholism, ongoing hypertension arterial, ongoing type 2 diabetes mellitus on insulin with frequent hypoglycemia, hypoglycaemia, purulent conjunctivitis from 03Dec2020 and ongoing benign prostatic hyperplasia. Concomitant medications included insulin aspart/insulin aspart protamine (crystalline) (NOVOMIX) subcutaneous at 10x5 unit, 60UE+60UE+60UE fort type 2 diabetes mellitus, bromazepam (LEXAURIN) at 3 mg twice daily, solifenacin succinate/tamsulosin hydrochloride (VESOMNI) at 1 DF (6mg/0.4mg), 1x/day (1x1) for benign prostatic hyperplasia and latanoprost/timolol maleate (XALACOM) at 1 DF (0.05mg/5mg/ml), 1x/day (1x1 gtt/in the eye) for purulent conjunctivitis. The patient previously took tobramycin (TOBREX) at 1mg/3mg/ml for purulent conjunctivitis. On 08Jan2021, the patient was found without signs of life at the toilet at 20:15 PM, which was defined as sudden death as the patient was feeling good until then. The reporting physician (the one who identified death) stated that in the medical history of the patient no data on previous adverse drug reactions could be found. Autopsy was performed on 11Jan2021 - final report was still awaited, but preliminary report was nevertheless gained along with further information from the patient''s GP. The patient was independent with regard to taking medications (insulin) and all daily activities, although he moved with difficulties and used the wheelchair. The patient also took care of blood glucose tests and as stated insulin administration. On the day the patient died smell of alcohol was sensed in his room. During Dec2020 the patient had a few medical checks: on 03Dec2020 due to mucopurulent conjunctivitis (two prescriptions were issued: TOBREX 1mg/3mg/ml eye drops, XALACOM 0.05mg/5mg/ml eye drops), on 18Dec2020 (at that time VESOMNI 6mg/0.4mg tbl. prescription was issued for benign prostatic hyperplasia), on 21Dec2020 the patient received prescription for NOVOMIX 30 FlexPen 100 IU/ml with a sheme (10x5 units, 60UE+60UE+60UE), on 27Dec2020 the patient was vaccinated against COVID-19 and no adverse reaction was seen. On 31Dec2020 the patient was prescribed LEXAURIN 3 mg tbl. (it was evident from the documentation that this was a part of his regular therapy, indication was not specified). On 15Dec2020 COVID-19 PRC test was performed, the result was not marked in the provided document, but it was not stated in the report that the patient had a previously confirmed SARS-CoV-2 infection. Preliminary autopsy results: Cause of death a) Cardiorespiratory failure c) Diabetes mellitus. Hyperthrophy and dilatation of the whole heart, moderate to severe stage (550g -heart weight). Severe atherosclerosis of descendant branch of left coronary artery (LAD), focally stenosant up to 80%. Aortic stenosis, moderate. Congestion oedema of the lungs, moderate. Chronic congestion in liver and splen. Arterioarteriolonephrosclerosis. Atherosclerosis of aorta and her brunches, mild to moderate. Enlarged prostate. Lipomatosis of pancreas. Condition after cerebovascular accident parietooccipitally on the right. Terminal oedema of the brain. Sender Comment: Serious (fatal) and unexpected ADR, assessment of the case is still ongoing, confounders such as age and concurrent diseases are noted. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiorespiratory failure; Cardiorespiratory failure | |||||||||||||||||||
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Life Threatening? No Write-up: cardiorespiratory arrest; COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report a contactable pharmacist downloaded from the Agency Agency-WEB (ES-AEMPS-726724). An 82-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot number: J6796), intramuscularly in the right arm, on 28Dec2020 at a single dose for COVID-19 immunisation. Medical history included cardiovascular disorder (excluding hypertension) and nursing home resident. The patient''s concomitant medications were not reported. The patient experienced COVID-19 pneumonia on 11Jan2021 and cardiorespiratory arrest on 24Jan2021, which caused hospitalization and was reported as fatal. The clinical course was reported as follows: The patient was in a nursing home with no previous diagnosis or suspicion of COVID-19 and was vaccinated on 28Dec2020. On 11Jan2021, an COVID-19 antigen test was performed with a positive result. On 12Jan2021, the patient started to have symptoms of dyspnea, fatigue, oxygen saturation (SaO2): 88-89% without oxygen, heart rate (Fc): 90 beats per minute (bpm), temperature: 37.5 degrees, and vesicular murmur with crackling, for which he was referred to the hospital. After initial improvement and maintenance of stable SaO2 with oxygen, the patient died on 24Jan2021 due to cardiorespiratory arrest due to COVID-19 pneumonia. The patient died on 24Jan2021. The cause of death was reported as COVID-19 pneumonia and cardiorespiratory arrest. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia; cardiorespiratory arrest | |||||||||||||||||||
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Life Threatening? No Write-up: Sepsis; Pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. Regulatory Authority report number is SE-MPA-2021-001251. Other case identifier number SE-MPA-1611326316846. An 87-year-old male patient received BNT162B2 (COMIRNATY; Lot number Lot number: PAA156571-EJ6795), intramuscular in Dec2020 as single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, osteoporosis and dementia from unknown dates and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced sepsis and pneumonia in Jan2021, which were serious as it lead to death; patient was admitted to the hospital on an unspecified date. Details were as follows: The man had a scenario compatible with pneumonia and sepsis. 16 days after the vaccination with BNT162B2 the patient was wheezy in the morning and there was a suspicion of aspiration. He suddenly got worse with elevated temperature, low blood pressure and fast heart rate. The patient was admitted to a hospital on an unspecified date, and a chest X-ray was performed where they saw bilateral pneumonia. The patient died a few days later. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pneumonia; Sepsis | |||||||||||||||||||
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Life Threatening? No Write-up: Chronic obstructive pulmonary disease; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB and received via Regulatory Authority SE-MPA-2021-000707. A 85-years-old female patient received BNT162B2 (COMIRNATY, lot# EJ6795), via an unspecified route of administration in Dec2020 at single dose for COVID-19 vaccination. Medical history included earlier myopcardial infarct, chronic obstructive pulmonary disease (COPD), cardiac failure, all from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient experienced died eight days after vaccination in Jan2021. According to the report the main cause of death is COPD. Heart failure and status after myocardial infarction are contributing causes. Furthermore, expected death in COPD with heart failure as a contributing factor. Reporter does not assess patients death as a drug side effect. The patient died in Jan2021. Report assessed as serious, Death. No autopsy performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Chronic obstructive pulmonary disease | |||||||||||||||||||
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Life Threatening? No Write-up: IMAGE COMPATIBLE WITH SEPSIS; IMAGE COMPATIBLE WITH PNEUMONIA; This is a spontaneous report from a contactable physician downloaded from theRegulatory Authority-Web. The regulatory authority report number is SE-MPA-2021-001193. Other case identifier number is SE-MPA-1611325222540. A 92-year-old male patient received BNT162B2 (COMIRNATY Lot number PAA156571-EJ6795), intramuscular on 30Dec2020 as single dose for covid-19 immunization. Medical history included hypertension, dementia, venous insufficiency, enlarged prostate, hypothyroidism, claudication and cerebrovascular disorder, all from unknown dates and unknown if ongoing. No concomitant medications were noted. The patient experienced image compatible with sepsis and image compatible with pneumonia three weeks after vaccination in Jan2021, which were serious as they lead to death. The patient underwent lab tests and procedures on an unspecified date which included blood pressure: low, body temperature: high, heart rate: fast. Details were as follows: patient suddenly started to breath fast and coughed. Suspicion of aspiration pneumonia was aroused but, the patient got worse during one day and developed sepsis. Low blood pressure, fast heart rate, high temperature, blue lips, respiratory distress, poor pulse oximetry ("POX"). The patient died the day after. The cause of death was severe bacterial pneumonia. The patient was not autopsied. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pneumonia bacterial | |||||||||||||||||||
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Life Threatening? No Write-up: general condition deterioration; This is a spontaneous report from a physician. This is a report received from the regulatory authority. Regulatory authority or other manufacturer number DE-PEI-PEI2021002149. An 82-year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot# EJ6796), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. The patient medical history included multimorbidity, dementia, Type II diabetes mellitus, renal insufficiency, coronary heart disease, prostate cancer metastatic. The patient concomitant medications were not reported. After vaccination the patient developed general physical condition abnormal. The patient was dead. Death cause was reported as general physical health deterioration. Source of Assessment: Attending Physician. Result of Assessment: Inconsistent causal association. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: General physical health deterioration | |||||||||||||||||||
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Life Threatening? No Write-up: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB and received via Regulatory Authority DK-DKMA-WBS-0032128. Safety Report Unique Identifier (DK-DKMA-ADR 24692697). An 86-year-old male patient received first dose bnt162b2 (COMIRNATY) Lot # EJ6797, intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Medical history included Esophageal acid reflux, Allergy, Hyperactive bladder, Constipation, Heart rate irregular, pain,ongoing Living in nursing home (there was a covid-19 outbreak among several residents and staff), ongoing general physical health deterioration and ongoing COVID-19. Concomitant medication included calcium carbonate, colecalciferol (CALCIUM & VITAMIN D3) from 07Feb2019 as Calcium supplementation, sodium fluoride (DURAPHAT)from 20Nov2019 as Dental disorder prophylaxis, potassium chloride (KALIUMKLORID ORIFARM) from 14Jan2019 as Potassium supplementation, furosemide (FUROSEMID ORIFARM) from 14Jan2019 as diuretic therapy, mirabegron (BETMIGA) from 02Jun2020 for Hyperactive bladder, paracetamol (PAMOL) from 09Sep2019 for pain, rivaroxaban (XARELTO) from 05Dec2019 as Thrombosis prophylaxis, bisacodyl (TOILAX) from 13Mar2019 for Constipation, cetirizine hydrochloride (ALNOK) from 06Feb2019 for Allergy, pantoprazole sodium sesquihydrate (PANTOPRAZOLE TEVA) from 25-Sep2019 for Esophageal acid reflux, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (GANGIDEN) from 19Feb2019 for Constipation, metoprolol succinate (METOPROLOLSUCCINAT HEXAL) from 28Feb2019 for Heart rate irregular. The patient experienced death on 05Jan2021. it was not inconceivable that the total liability of covid-19 disease and the vaccination has been fatal for the patient. The patient underwent lab tests and procedures which included COVID-19 virus test: positive in Jan2021. The patient died on 05Jan2021. An autopsy was not performed. The ADRs were by the physician reported as Fatal. Reported cause of death: Death and of/with COVID-19. Only usual confirmation of death was performed post mortem. No findings were reported. If the Medicines Agency receives supplemental significant information regarding this case the case will be re-submitted. Sender Comment: COMMENT from MA: Version 001 has not been submitted to RA. Agency should therefore consider version 2 as the initial report. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient | |||||||||||||||||||
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Life Threatening? No Write-up: Dead 45 minutes after the vaccination; Wheeze; Phlegm; Heart insufficiency; Breathing difficult; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB , SE-MPA-1611739167214. Safety Report Unique Identifier SE-MPA-2021-001770. A 92-year-old female patient received bnt162b2 (COMIRNATY) (Lot # EJ 6795), intramuscular at 0.3 mL, single on an unspecified date in Dec2020 for Covid-19 immunisation. Medical history included hypertension, cerebrovascular accident, dementia, mixed anxiety and depressive disorder, cataract. Concomitant medication included citalopram hydrobromide (CITALOPRAM SANDOZ), morphine hydrochloride (MORFIN ABCUR), acetylsalicylic acid (TROMBYL), latanoprost (MONOPROST), midazolam hydrochloride (MIDAZOLAM ACCORD) , urea (CANODERM), furosemide (FURIX [FUROSEMIDE]), cyanocobalamin (BEHEPAN [CYANOCOBALAMIN]), gabapentin (GABAPENTIN ACCORD), folacin [folic acid] (FOLACIN [FOLIC ACID]) , metoprolol succinate (METOPROLOL ORION), brinzolamide (AZOPT), fentanyl (FENTANYL MYLAN), oxycodone hydrochloride (OXYNORM). On an unspecified date in Dec2020, the patient experienced wheeze, and dead 45 minutes after the vaccination. The patient died on an unspecified date Dec2020. An autopsy was not performed. Course of events: The patient developed thick phlegm in throat and mouth, she had difficult to swallow and wheezing which was discovered 45 minutes after the vaccination with Comirnaty. According to the reporter no signs of anaphylaxis but the patient received Jext 300 micrograms subcutaneously in her thigh and 10 tablets of Betapred dissolved in water, she also received Robinul 0,2 mg/ml injection 1 ml subcutaneously. The patient was put in prone side position with elevated head end but died within 5 minutes. According to the report was the ultimate cause of the woman''s death was probably heart insufficiency and breathing difficulties. Report assessed as serious, death.; Reported Cause(s) of Death: Heart insufficiency; Breathing difficult | |||||||||||||||||||
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Life Threatening? No Write-up: Bullous pemphigoid; This is a spontaneous report from a contactable Physician downloaded from the regulatory authority FR-AFSSAPS-TS20210610 This is a report received from the Regulatory Authority. A 77-years-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 14Jan2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for covid-19 immunization; venlafaxine hydrochloride (VENLAFAXINE HCL), oral from 11Dec2020 to 16Feb2021, at 37.5 mg, daily for depression. Medical history included cerebral amyloid microangiopathy with microbleeds (contraindicating antiaggregants and anticoagulants); partial thyroidectomy; appendectomy; 3 cesarean sections; total hip replacement (THA); right and left knee surgery; surgery for varicose veins of the lower limb; cholecystectomy; right and left carpal tunnel surgery; narrow lumbar canal surgery; amputation of the right 5th toe following ulceration. Concomitant medication included candesartan, levothyroxine (L-THYROXINE), sotalol; zopiclone; alprazolam (discontinued on 10Dec2020); atorvastatin (dose reduction on 10Dec2020); lactulose (DUPHALAC) if necessary; paracetamol (DOLIPRANE) if needed; calendula officinalis, rhamnus frangula (NORMACOL) if needed. It was reported that in total, probable bullous pemphigoid (onset date 08Feb2021) on D25 of Comirnaty (dose 1) and D59 of venlafaxine leading to death in the patient living in nursing homes. Action taken for venlafaxine was Permanently Withdrawn. The patient died on 27Feb2021. The cause of death was bullous pemphigoid. An autopsy was not performed. Clinical course reported as follow: The patient living in a care home who presented on 12Jan2021 dermatitis of the inguinal folds, the vulva, the intergluteal fold for which treatment with Econazole powder is initiated. On 18Jan2021: discontinuation of Econazole in the face of worsening skin involvement. Discontinuation of atorvastatin (benefit / risk unfavorable). On 25Jan2021 : Econazole relay by CONVEEN cream in thin layers on dermatitis. Prescription of Betadine ovule for 5 days in front of a vulvitis with greenish losses. On 08Feb2021: two identified dermatological damage 1 / dermatitis always intense, purplish at the groin and vulva, with scraping treated Conveen; 2 / appearance of erythematous and itchy plaques on the body (thorax, upper and lower limbs, but not affecting the back). Sensation of grains of sand on palpation, very probable eczema. Initiation of treatment with Flixovate 2 per day. On 16Feb2021. Continuation of eczema with the same intensity. Flixovate relay by Clarelux. Faced with the suspicion of an iatrogenic origin, discontinuation of venlafaxine. On 18Feb2021 : worsening of the skin condition. Erythematous maculopapular rash with multiple small elements, inframillimetric infracentimetric vesicles, producing inflammatory placards in the left knee, left arm (posterior face) and right arm. In the feet, rash with individualized elements, vesicles of more or less large size. On 19Feb2021 : neutrophilic hyperleukocytosis (13 G / L) (9.36 G / L) and hypereosinophilia (1.027 G / L) in the biological assessment. On 22Feb2021 : presence of bubbles in the hands, feet and neck. On 23Feb021 : at 4 p.m., malaise with desaturation cyanosis, polypnea and transient bradycardia. Absence of fever. Auscultation of the deaf heart, movements in the 2 fields. Increase in the number of skin bubbles all over the body. Rapid recovery from 100 percent saturation with high concentration mask and 5 l / min O2. ECG : sinus rhythm 100/mn, QRS ends, PR 0,16s, some shifting premature ventricular contraction (PVC), Q DIII, AQRS 10 degrees, repolarization Nle. Introduction LOVENOX 0.4ml x 1 - SOTALOL reduction. In the biological assessment: CRP increased (20.4 mg/L), hypoalbuminemia 30 g/l, hypernatremia 147 mmol/l, hypokalaemia 3,78 mmol/l, hyperleukocytosis 14,3 G/l ; hypereosinophilia 1,416 G/l ; neutrophilia 10,525 G/L . On 23Feb2021 : dermatological opinion: Bullous pemphigoid probable in front of the appearance of tense bubbles present in the hands and feet. Introduction ADAPTIC on erosive lesions + DERMOVAL 1 to 3 tubes / day as needed on all lesions. Blood assay of anti epidermal membrane antibodies. On 25Feb2021 : extension of the bubbles on the upper limbs, hives on the shoulders +/- scratching lesions. Yesterday 38 bubbles of any diameter were pierced. In the evening, drowsy patient who could not eat or drink, IV infusion impossible because elbow folds under the bandages, subcutaneous infusion not recommended due to skin problems. Still has HC mask, no cyanosis or mottling, RAS ausculation. Twilight state? On 26Feb2021 :Temperature 38 degrees. The injured areas are large, with significant water loss, edema of the right upper limb from the shoulder to the hot hand, less significant edema of the left upper limb, but localized to the hand and elbow. No edema of the lower limbs, just isolated redness and bubbles except on the feet where the lesions are important. Macerated appearance of the hands and feet. Not reactive, auscultation of heart and lungs RAS. Palate: doubt about bubbles on the palate. On 27Feb2021 : death of the patient at 10:30 am. Biology report : On 19Feb2021 : red cells 4330 G/l (normal 3960 to 5120 G/l) ; haemoglobin 12,8 g/dl (normal = 11,7 to 15 g/dl) ; haematocrit 38,5 percent (normal = 34,7 to 44,4 percent) ; mean corpuscular volume (mean cell volume (MCV)) 89 (normal = 78 to 95) ; hyperleukocytosis 13 G/l (normal = 3,9 to 11 G/l) ; neutrophilia 9,36 G/l (normal 2 to 7 G/l) ; hypereosinophilia 1,027 G/l (normal < 5 G/L)) ; basophiles 0,78 G/l (normal < 0,1 G/l) ; lymphocytes 1,85 G/l (normal = 1,5 to 4 G/l) ; monocytes 0,75 G/l (normal = 0,2 to 1 G/l) ; CRP 3,4 mg/l (normal < 5 mg/l). 23Feb2021 : red cells 4710 G/l ; haemoglobin 13,9 g/dL ; haematocrit 41,7 % ; mean corpuscular volume (mean cell volume (MCV)) 89 ; hyperleukocytosis 14,3 G/l ; hypereosinophilia 1,416 G/l ; neutrophilia 10,525 G/L ; basophiles 0,29 G/l ; lymphocytes 1,602 G/l ; monocytes 0,729 G/l ; platelets 315 G/l (normal = 180 to 440 G/l) ; vs 4 mm (normal < 20 mm) ; glycosylated hemoglobin 5,70 % (normal < 6 %) ; urea 9,96 mmol/l (normal = 3,32 to 7,14 mmol/l) ; creatinine 50 umol/l (normal = 50 to 98 umol/l) ; glomerular filtration rate (GFR) 90 ml/min ; chlorine 112 mmol/l (normal = 98 to 175 mmol/l) ; hypernatremia 147 mmol/l (normal = 137 to 145 mmol/l) hypokalaemia 3,78 mmol/l (normal = 4 to 5,30 mmol/l) ; alkaline reserve 23 mmol/l (normal = 22 to 31 mmol/l) ; proteins 60 g/l (normal = 60 to 80 g/l) calcium 2,27 mmol/l (normal = 2,10 to 2,55 mmol/l) ; hypoalbuminemia 30 g/l (normal = 34 to 48 g/l) ; corrected calcemia 2,52 mmol/l (normal = 2,6 to 2,55 mmol/l) ; vitamin B12 < 148 pmol/ml ; folic acid 9,27 nmol/l (normal $g 7,0 nmol/l) ; CRP increased 20,4 mg/l ; TSH 1,29 mU/l (normal = 0,44 mU/l) ; vitamin D2-D3 70,8 nmol/l (normal 15,5 a 124,8 nmol/l). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Bullous pemphigoid | |||||||||||||||||||
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Life Threatening? Yes Write-up: Died in sleep; breathless; lack of energy; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202103160905193470, Safety Report Unique Identifier GB-MHRA-ADR 24952876. An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection) dose 1 via an unspecified route of administration on 23Dec2020 (Batch/Lot Number: EJO553/V0006) at a single dose for covid-19 immunization. Medical history included myopathy and cardiomyopathy from an unknown date and unknown if ongoing. He suffered with Cardiomyopathy. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test and patient was not enrolled in clinical trial. Concomitant medications included bisoprolol taken for cardiomyopathy, spironolactone taken for an unspecified indication; both start and stop date were not reported. The patient had lack of energy on 24Dec2020, was breathless on 01Jan2021 and died in sleep on 02Jan2021. The clinical course was reported as: "My father had had moderate to severe cardio myopathy but it was being managed well. He was a very active man for his age. He had the Pfizer jab on 23Dec2020 and the next day and following days told us that he felt lack of energy. The day before he died, he told mum he felt breathless and that continued to the actual day he died. As it was 01Jan2021 and covid, he didn''t ring up the Dr but said he would on the Monday - sadly his heart stopped on sat 02Jan2021. We felt we should report this." The patient died on 02Jan2021. It was not reported if an autopsy was performed. Outcome of the event lack of energy and breathless was unknown. The events were considered life threatening. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Died in sleep | |||||||||||||||||||
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Life Threatening? No Write-up: micro thrombi; massive heart attack; feeling a bit ill; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104031853465280, and Sender''s Safety Report Unique Identifier GB-MHRA-ADR 25077034. An 81-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Dec2020 (Batch/Lot Number: Not known) as single dose for covid-19 immunisation. Patient medical history included ongoing high cholesterol for maybe 30 years. The patient was shielding and had no COVID symptoms. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Patient experienced feeling a bit ill on 05Jan2021 with outcome of unknown, and micro thrombi, massive heart attack on unspecified date with fatal outcome. Clinical course: patient was healthy active (had a dog) and with no health issues except for high cholesterol which had for maybe 30 years, wasn''t fat at all. Patient complained by phone of feeling a bit ill and was going to bed on 05Jan2021. Patient was found dead the next day (06Jan2021). It took 7 weeks to get an autopsy which confirmed micro thrombi gave him a massive heart attack. Reported cause of death was micro thrombi and massive heart attack. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: micro thrombi; massive heart attack; Autopsy-determined Cause(s) of Death: micro thrombi; massive heart attack | |||||||||||||||||||
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Life Threatening? No Write-up: increased cough and mucus/Respiratory tract infection; This is a spontaneous report from a contactable Other Health Professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-853210. An 88-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EJ6796), intramuscular on 30Dec2020 (at unknown age) as 0.3 mL single for COVID-19 immunisation. Medical history included Ischemic heart disease, heart failure, Complete Arrhythmia due to Atrial fibrillation, pacemaker carrier from 2002 ongoing, Diabetes Mellitus, chronic kidney failure, multiple episodes of bronchitis, low heart rate, aspiration. Diabetes Mellitus, chronic kidney failure, multiple episodes of bronchitis and aspiration treated with antibiotics and bronchodilators. The patient''s concomitant medications were not reported. The last assessment in Jun2020 due to a malfunction of the pacemaker, advises against replacement due to the patient''s situation. On 07Jan2021 new episode of increased cough and mucus/Respiratory tract infection, start of treatment with levofloxain, prednisone and bronchodilators. COVID-19 PCR test: Negative on 07Jan2021. She dies in her sleep, they realize when they go to wake her up on 08Jan2021 at 7:00 a.m. The patient died on 08Jan2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: increased cough and mucus/Respiratory tract infection | |||||||||||||||||||
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Life Threatening? No Write-up: Subarachnoid hemorrhage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-SE20211054 , Safety Report Unique Identifier FR-AFSSAPS-2021052754.Telephone declaration on 29Apr2021, medically confirmed. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 22Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation; bevacizumab (ZIRABEV), intravenous (IV) drip from 01Oct2020 (Batch/Lot number was not reported) to 08Apr2021, at 5 mg/kg, frequency as every14 days for adenocarcinoma of colon. The patient''s medical history included hypertension arterial; MALT (mucosa-associated lymphoid tissue) lymphoma; Ischaemic heart disease; Benign prostatic hyperplasia; Urinary lithiasis (2 extracorporeal lithotripsy); Epithelial carcinomas of the scalp; Hepatic metastatic colonic adenocarcinoma. Surgeries history also reported Total gastrectomy for MALT lymphoma in 1996; Cholecystectomy in 2006; Triple coronary artery bypass surgery in 2012; and TAVI with arterial resection in 2019. Patient has allergies to PENICILLIN and "EFFERALGAN ?" (Toxic: 0). COVID-19 HISTORY: patient was at risk of developing a severe form of COVID-19, patient was with no history of COVID-19, it was unknown if patient had been tested for COVID-19. ONCOLOGY HISTORY: in Jul2020, Lieberkuhnien adenocarcinoma diagnosed with synchronous hepatic and pulmonary metastases; On 07Sept2020, Multidisciplinary Oncology Digestive meeting: Indication of first chemotherapy of a bio-chemical type plus biotherapy according to the complete molecular biology, then re-evaluation of the surgical project secondarily; On 18Jan2021, Multidisciplinary Oncology Digestive meeting: Assessment after 6 treatments with FOLFOX AVASTIN, significant hypertension and AVASTIN stopped at treatment 5 despite treatment adjustments. Weight loss with poor state of health despite the adapted dosage. Drop in angiotensin-converting enzyme to 56 compared to 929. Computed tomography scan = diminution of the hepatic lesions with thoracic stability. Proposition of maintenance therapy with 5FU hormone therapy. Discussion of reintroduction of BEVACIZUMAB depending on pressure balance; Last chemotherapy treatment on 08Apr2021: Response after 6 treatments with FOLFOX AVASTIN but poor state of health and improved hypertension after dose was adapted. Currently: maintenance with 5Fu plus Bevacizumab with Treatment 1: 11Feb2021, Treatment 2: 25Feb2021, Treatment 3: 11Mar2021, Treatment 4: 25Mar2021, Treatment 5: 08Apr2021. Cure composed of: ZIRABEV (bevacizumab): 5mg/kg, Calcium Levofolinate: 200mg/m?, and Fluorouracile: 400mg/m? slow intravenous plus 2400 mg/m? via mobile diffuser. The patient''s concomitant medications included rosuvastatin 5mg: 0-0-1; acebutolol 200mg: 0.5-0-0; acetylsalicylate lysine (KARDEGIC) 75mg: 0-1-0; perindopril 8mg: 0-0-1; serenoa repens extract (PERMIXON) 160mg: 1-0-1; ferrous sulfate (TARDYFERON) 1-0-0; pantoprazole 20mg: 1-0-0; calcium levofolinate 200mg/m?; and fluorouracil (FLUOROURACILE) 400mg/m? slow intravenous + 2400 mg/m? via mobile diffuser. The patient experienced subarachnoid hemorrhage on 13Apr2021 which resulted in death. The description of the effect and detailed clinical course was follows: On 13Apr2021, treated by the Emergency medical assistance service for neurological issues in a context of metastatic rectal cancer being treated with chemotherapy. Context of balance issues since the previous day (12Apr2021). Last contact with the patient yesterday at 23:00. Patient found at home in a coma since at least this morning. No evidence of a fall or head injury. Upon arrival of the Emergency medical assistance service: Glasgow Coma Scale 7, left hemiparesis with + blood bradykinin concentration. Blood pressure: 168/77. HR: 98. Emergency cerebral computed tomography: Fisher 4 sub-arachnoid haemorrhage with damage to the left temporal horn and significant intracranial hypertension; Neurosurgeon opinion: no surgical evidence or indication selected. IMAGING: Cerebral scan on 13Apr2021: Predominantly peri-mesencephalic meningeal haemorrhage, and in the occipital cortical sulci. Tetra-ventricular hematic flooding leading to upstream hydrocephalus with early transependymal resorption disorders. No aneurism seen in the Willis polygon arteries. Mesencephalic oedema; Urgent neurosurgeon opinion. PROGRESS: patient transferred to the palliative care unit. Death on 18Apr2021. CONCLUSION: patient presented with a meningeal haemorrhage at Day 23 from Dose 1 of COMIRNATY, in a context of chemotherapy for a metastatic adenocarcinoma with treatment 5 of bevacizumab 10 days earlier. The patient died on 18Apr2021. The cause of death was reported as subarachnoid hemorrhage. It was unknown if an autopsy was performed. The outcome of the other events besides subarachnoid hemorrhage was unknown. No follow-up attempts possible. No further information expected. Batch/lot number cannot be obtained.; Reported Cause(s) of Death: Subarachnoid hemorrhage | |||||||||||||||||||
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Life Threatening? No Write-up: Urinary tract infection; urinary retention; Ischaemic heart disease; Cardiac failure; This is a spontaneous report received from a contactable Physician by Pfizer from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 25354592. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Dec2020 (Batch/Lot number was not reported) as single dose for covid-19 immunisation . Medical history included ongoing pulmonary fibrosis, ongoing chronic kidney disease, ongoing hypertension. Concomitant medications included alfacalcidol (ALFACALCIDOL) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; hydroxocobalamin (HYDROXOCOBALAMIN) taken for an unspecified indication from an unspecified start date to 03Jun2020. The patient experienced urinary tract infection (UTI) on 05Jan2021, given amoxicillin then on 13Jan2021 nitrofurantoin and was admitted 24Jan2021 with urinary retention. "Unsure of reaction but was serious sequelae of vaccine but (?) timeline" as reported. The patient died in Feb2021 due to cardiac failure and ischaemic heart disease; It was not reported if an autopsy was performed. Outcome of the other events at the time of death was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Ischaemic heart disease; Cardiac failure | |||||||||||||||||||
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Life Threatening? No Write-up: lung infection; fluid on the lung; Dehydration; not eating; diarrhoea; sickness/feels sick; Nausea; partial heart failure; Ischemic stroke; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106052132504810-KM5DX, Safety Report Unique Identifier GB-MHRA-ADR 25426521. A 87-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Dec2020 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included cardiac failure, ischaemic stroke, pneumonia. Concomitant medications included agathosma betulina leaf, aphanes arvensis herb, arctostaphylos uva-ursi leaf, taraxacum officinale root (HRI WATER BALANCE) taken for an unspecified indication, start and stop date were not reported. The patient experienced ischemic stroke on 11Feb2021, partial heart failure, lung infection, fluid on the lung, nausea, dehydration, not eating, all on an unspecified date; diarrhoea and sickness/feels sick on 28Apr2021. Events were reported as serious with hospitalization and fatal outcome. The patient was hospitalized for ischemic stroke, partial heart failure, nausea from 11Feb2021 to 23Feb2021. The patient was hospitalized for lung infection and fluid on the lung from 19Apr2021 to 23Apr2021. The patient was hospitalized for diarrhoea, dehydrated, not eating, sickness/feels sick from 03May2021 to 07May2021. Events diarrhoea and sickness caused Physician Office Visit. The patient underwent lab tests and procedures which included echocardiogram: unknown results on 23Feb2021 and on 23Apr2021, COVID-19 virus test: negative on 11Feb2021, x-ray: unknown results on 23Feb2021 and 23Apr2021. The patient died on 13May2021. An autopsy was not performed. The outcome of the all events was fatal. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. Clinical course reported as follows: 11Feb2021 Ischemic Stroke went into hospital till 23Feb2021. Had various scans and X-rays. Partial heart failure. 23Feb2021, home with carers going in but wasn''t coping. 06Mar2021 went into residential home for care had to do 2 weeks isolation. Really struggled as no family could visit. 19Apr2021, back to hospital for lung infection, fluid on the lung. Various scans X-rays and electrocardiogram (ECG) on 23Apr2021 and came out of hospital, back to residential home, on strong antibiotics and water tablets. 28Apr2021 visit by doctor, bad diarrhoea and sickness from strong antibiotics. Told she has to stay on them, not eating as feels sick. 03May2021, dehydrated, back in hospital more tests and scans. 07May2021 back to residential home. Died on 13May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Ischemic stroke; Failure heart; Lung infection; Pulmonary oedema; Nausea; Diarrhea; Dehydration; Sickness; Decreased appetite | |||||||||||||||||||
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