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From the 9/10/2021 release of VAERS data:

Found 14,925 cases where Vaccine is COVID19 and Patient Died



Case Details

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VAERS ID: 1029891 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Alanine aminotransferase, Altered state of consciousness, Aspartate aminotransferase, Benign breast neoplasm, Bilirubin conjugated, Blood bilirubin, Blood creatinine, Blood pressure measurement, Body temperature, Breast swelling, Cardiac failure, Cardiac output, Coma, Haemoglobin, Hallucinations, mixed, Heart rate, Hepatic function abnormal, Hypotension, Melaena, Metastases to peritoneum, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Peau d'orange, Physical examination, SARS-CoV-2 test, Somnolence, Swelling, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; NEOMERCAZOLE; DIGOXINE; FLUOXETINE; FUROSEMIDE; SOTALOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety reaction; Attempted suicide; Decompensation cardiac (hospitalization in Nov2020); Hypertension arterial; Hyperthyroidism; Monoclonal gammopathy of unknown significance; Paroxysmal atrial fibrillation (treated with amiodarone (replaced by sotalol since 2011 following hyperthyroidism))
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: Bilirubine conjugated; Result Unstructured Data: Test Result:34 umol/l; Test Date: 20210125; Test Name: Bilirubine total; Result Unstructured Data: Test Result:44 umol/l; Test Date: 20201123; Test Name: Creatinine; Result Unstructured Data: Test Result:52 umol/l; Test Date: 20210125; Test Name: Creatinine; Result Unstructured Data: Test Result:119 umol/l; Test Date: 20210127; Test Name: Creatinine; Result Unstructured Data: Test Result:212 umol/l; Test Date: 20210125; Test Name: Blood pressure; Result Unstructured Data: Test Result:impregnable mmHg; Test Date: 20210125; Test Name: Blood pressure; Result Unstructured Data: Test Result:80/40 mmHg; Test Date: 20210128; Test Name: Blood pressure; Result Unstructured Data: Test Result:80/50 mmHg; Test Date: 20210125; Test Name: Temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210125; Test Name: Cardiac output; Result Unstructured Data: Test Result:148; Test Date: 20210125; Test Name: Haemoglobin; Result Unstructured Data: Test Result:12.4 g/dl; Test Date: 20210127; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.8 g/dl; Test Date: 20210125; Test Name: Heart rate; Result Unstructured Data: Test Result:24; Comments: 24 bpm; Test Date: 20210125; Test Name: Heart rate; Result Unstructured Data: Test Result:118; Comments: 118 bpm; Test Date: 20210128; Test Name: Heart rate; Result Unstructured Data: Test Result:107; Comments: 107 bpm; Test Date: 20210125; Test Name: NT-ProBNP; Result Unstructured Data: Test Result:14756 ng/L; Test Date: 20210127; Test Name: NT-ProBNP; Result Unstructured Data: Test Result:21581 ng/L; Test Date: 20210125; Test Name: Oxygen saturation; Test Result: 48 %; Test Date: 20210125; Test Name: physical examination; Result Unstructured Data: Test Result:drowsy, reaction to pain, heart rate 24, saturatio; Comments: drowsy, reaction to pain, impregnable blood pressure, no radial pulse, cold extremities; Test Date: 20210125; Test Name: physical examination; Result Unstructured Data: Test Result:marbled appearance, cold extremities. muted heartb; Comments: marbled appearance,cold extr.muted heartbeat,no pulse,soft calves w/out odema of the low limbs.Low-pitched wheezing sounds (rhonchis); Test Date: 20210125; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210125; Test Name: Leucocytes; Result Unstructured Data: Test Result:18.4 g/l; Test Date: 20210127; Test Name: Leucocytes; Result Unstructured Data: Test Result:19.4 g/l; Test Date: 20210125; Test Name: AlAT; Result Unstructured Data: Test Result:277; Test Date: 20210125; Test Name: ASPAT; Result Unstructured Data: Test Result:775
CDC Split Type: FRPFIZER INC2021127076

Write-up: Melaena; swelling with skin change (orange peel) left breast, left flank swelling with skin infiltration; swelling with skin change (orange peel) left breast, left flank swelling with skin infiltration; swelling with skin change (orange peel) left breast, left flank swelling with skin infiltration; drowsiness; blood pressure 80/40 mmHg; Decompensation cardiac; altered either consciousness or coma; altered either consciousness or coma; auditory and visual hallucinations; Probable neoplasia of the left breast and/or left colon with peritoneal carcinomatosis and other locations; Acute renal failure and associated hepatic function; Probable neoplasia of the left breast and/or left colon with peritoneal carcinomatosis and other locations; Acute renal failure and associated hepatic function; This is a spontaneous report from a contactable physician via Regulatory Authority downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-AN20210183. An 89-years-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot EJ6795), intramuscular in the left arm on 21Jan2021 at single dose for covid-19 immunisation. Medical history included hypergammaglobulinaemia benign monoclonal, hypertension, anxiety, paroxysmal atrial fibrillation from 2002 with cardiac decompensation treated with amiodarone (replaced by sotalol since 2011 following hyperthyroidism), suicide attempt. The patient was hospitalized in Nov2020 for cardiac decompensation. The patient was living in a nursery home. The patient was at risk of developing a severe form of COVID-19 disease: yes (heart failure, age, unstable general condition). The patient did not have previous COVID-19 and PCR/serology COVID-19 test was not taken. Concomitant habitual treatment included apixaban (ELIQUIS), carbimazole (NEOMERCAZOLE), digoxin, fluoxetine, furosemide and sotalol since 2011. The patient experienced decompensation cardiac on 25Jan2021. The patient died on 31Jan2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included alanine aminotransferase (0-35 UI/l): 277 on 25Jan2021, aspartate aminotransferase (0-35 UI/l): 775 on 25Jan2021, blood creatinine: 52 umol/l on 23Nov2020, 119 umol/l on 25Jan2021, 212 umol/l on 27Jan2021, blood pressure measurement: 80/50 mmhg on 28Jan2021, body temperature: 36. 4 centigrade on 25Jan2021, cardiac output: 148 on 25Jan2021, haemoglobin: 12. 4 g/dl on 25Jan2021, 11. 8 g/dl on 27Jan2021, heart rate: 24 then 118 bpm on 25Jan2021 marbled appearance, cold extremities, muted heartbeat, no pulse, soft calves without oedema of the lower limbs; low-pitched wheezing sounds (rhonchis), heart rate: 107 bpm on 28Jan2021, bilirubine conjugated (0-5 umol/l): 34 umol/l on 25Jan2021, bilirubine total (0-15 umol/l): 44 on 25Jan2021, n-terminal prohormone brain natriuretic peptide: 14756 ng/l on 25Jan2021, 21581 on 27Jan2021. Leucocytes: 18,4 g/l on 25Jan2021, 19,4 g/l on 27Jan2021. Clinical course was as follows. On 25Jan2021 drowsiness without initial hemodynamic disorder or desaturation, altered either consciousness or coma, auditory and visual hallucinations for a few days. No signs of cranial trauma or fever. No case of COVID-19 in this patients nursery home. COVID-19 PCR test - negative on 25Jan2021. When taken in charge of firefighters on 25Jan2021 physical examination showed drowsy, reaction to pain, heart rate 24, saturation 48%, cardiac output 148, impregnable blood pressure, no radial pulse, cold extremities, temperature 36,4C. On arrival Glasgow 10 (Y3V2M5), Heart rate 118, blood pressure 80/40 mmHg, marbled appearance, cold extremities, muted heartbeat, no pulse, soft calves without oedema of the lower limbs. Low-pitched wheezing sounds (rhonchis). On 28Jan2021 blood pressure 80/50 mmHg, heart rate 107/min, significant swelling with skin change (orange peel) left breast, left flank swelling with skin infiltration. Melaena. Additional examinations: Treatment and progression: Limitation of active therapeutics raised on 25Jan2021, initiation of antibiotic therapy with ceftriaxone 1g/day and intravenously metronidazole. Morphine if pain or dyspnea, Midazolam if anxiety, Scopolamine if congestion. Probable neoplasia of the left breast and/or left colon with peritoneal carcinomatosis and other locations. On 28Jan2021 start of treatment with morphine + midazolam. On 31Jan2021: patient''s death noted at 14:21. Conclusion: Global cardiac decompensation in a patient with a significant cardiac history 4 days after a first injection of Comirnaty, probable discovery of associated neoplasia, and hallucinations. Acute renal failure and associated hepatic function. Death of the patient following this episode. Accountability made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Official bulletin of the Ministry of Health n 84/50, January 24, 1984; published in Therapy 1985: 40: 111-8. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1029893 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, C-reactive protein, C-reactive protein increased, Dehydration, Pneumonia aspiration, Pneumonia bacterial, Respiratory distress, Seizure, Transient ischaemic attack
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; COVID-19; COVID-19 respiratory infection; Epilepsy; Hypoxemia; Sebaceous cyst; Tibia fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: C-reactive protein; Result Unstructured Data: Test Result:329
CDC Split Type: FRPFIZER INC2021126231

Write-up: INCREASED CRP at 329; transient ischemic (TI) shock; aspiration pneumonia; convulsive crisis; ACUTE RENAL FAILURE; BACTERIAL PNEUMONIA; DEHYDRATION; RESPIRATORY DISTRESS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-LL20210270 This is a report received from the Regulatory Authority. An elderly male patient received bnt162b2 (COMIRNATY, Lot#: EJ6796), via Intramuscular on 14Jan2021 at single dose for covid-19 immunization. Medical history included covid-19 infections from Oct2020, Deficiency encephalopathy on epilepsy in childhood and unknown if ongoing, Hypoxemic lung disease from 2013, covid-19 from Oct2020, Sebaceous cyst abscess in the back and unknown if ongoing , cholecystectomy from 1989, Tibial and mandibular fracture and unknown if ongoing. The profile was that of a person with cerebral palsy care home resident patient. The patient''s concomitant medications were not reported. Onset of unresponsive respiratory distress O2 high concentration mask (oxygen therapy mask) (14Jan2021). On 18Jan2021 he presents clinically observed bacterial pneumonia, dehydration, acute end-stage renal failure. Death by transient ischemic (TI) shock with a C-reactive protein at 329 on 19Jan2021 in connection with aspiration pneumonia in the context of a convulsive crisis. The outcome of the events was fatal. It was unknown if autopsy was performed.; Reported Cause(s) of Death: transient ischemic (TI) shock; aspiration pneumonia; convulsive crisis; INCREASED CRP


VAERS ID: 1029898 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adult failure to thrive, Investigation, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arnold neuralgia; Arterial hypertension; Dementia; Malnutrition; Osteoarthritis of neck; Palliative care; Pneumonia aspiration; Rectal bleeding; Sigmoid diverticulitis; Starvation; Transient ischaemic attack; Ulcer
Allergies:
Diagnostic Lab Data: Test Date: 2020; Test Name: examinations; Result Unstructured Data: Test Result:suspected colonic lesions consistent with a tumor; Test Date: 20200727; Test Name: COVID-19 test; Test Result: Negative ; Test Date: 20200820; Test Name: COVID-19 test; Test Result: Negative ; Test Date: 20201109; Test Name: COVID-19 test; Test Result: Negative ; Test Date: 20201116; Test Name: COVID-19 test; Test Result: Negative ; Test Date: 20201123; Test Name: COVID-19 test; Test Result: Negative ; Test Date: 20201207; Test Name: COVID-19 test; Test Result: Negative ; Test Date: 20201214; Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021127177

Write-up: Adult failure to thrive; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. This is a report received from the Regulatory Authority. Regulatory Authority report number was FR-AFSSAPS-NT20210140. An 81-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EM0477), intramuscular in the arm on 15Jan2021 as a single dose for COVID-19 vaccination. Medical history included rectal bleeding, sigmoid diverticulitis, dementia, osteoarthritis of neck, aspiration pneumonia, Arnold''s neuralgia, undernutrition, starvation, arterial hypertension, transient ischaemic attack, and ulcer; all from unknown dates and unknown if ongoing. The patient''s concomitant medications included unspecified nutritional supplements. In Jan2021, the patient experienced adult failure to thrive; which was serious for being fatal. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had COVID-19 tests on 27Jul2020, 20Aug2020, 09Nov2020, 16Nov2020, 23Nov2020, 07Dec2020, and 14Dec2020; all of which were negative. The clinical course was as follows: He lived at home but with a substantial plan of assistance. He was hospitalized last summer for a deterioration in his general condition. The examinations performed suspected colonic lesions consistent with a tumor. The patient presented with nausea and vomiting. It was decided, given the comorbidities, not to perform a biopsy in search of cancer and no surgical management. He was therefore hospitalized for palliative care with nutritional supplements mainly during the last month of life. The patient was vaccinated on 15Jan2021 with family agreement and no adverse effects described after vaccination. On 22Jan2021 at 05:00, the patient died due to slip syndrome (as reported). The clinical outcome of adult failure to thrive was fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: adult failure to thrive


VAERS ID: 1029899 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pneumonia aspiration, Pyrexia, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUROGESIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fracture of clavicle; Hyperalgesia; Osteoporosis; Weakness of arms
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: febrile
CDC Split Type: FRPFIZER INC2021127175

Write-up: Pyrexia; Distress respiratory; aspiration pneumonia; This is a spontaneous report from a contactable Physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NT20210141. This is a report received from the Regulatory Authority. A 92-year-old female patient received the first dose of bnt162b2 (COMIRNATY) Batch/lot number: EJ6795, intramuscularly on 21Jan2021 at single dose in right arm for covid-19 vaccination. Medical history included osteoporosis, clavicular fracture in 2014, impotence of the left arm post-traumatic and hyperalgesic. The patient''s concomitant medications included fentanyl (DUROGESIC) 12ug / hour for hyperalgesic. The patient showed no signs of ongoing infection on the day of vaccination, 21Jan2021 (normal constants, RAS clinical examinations). The monitoring of the constants at 15 min, 30 min then every 3 hours for 24 hours then once / d (anti-Covid post-vaccination surveillance protocol within the care home where the vaccination took place), was normal. Day 0 to Day 6. On 26Jan2021, the patient was febrile (38.5 Celsius degrees, Pyrexia), and presented with respiratory distress. The patient did not want hospitalization or relentlessness, palliative care was supervised by the doctor on 15 (in the absence of a doctor who could travel), who prescribed SC morphine. In the absence of auscultation by a doctor, knowing that the patient was on the wrong track, it can be assumed that she had aspiration pneumonia. The death was declared on 27Jan2021. It was not reported if an autopsy was performed. The outcome of the events was fatal.; Reported Cause(s) of Death: Pyrexia; Distress respiratory; aspiration pneumonia


VAERS ID: 1029901 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Nausea
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021126105

Write-up: Infarct myocardial; nausea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-PO20210157. This is a report received from the Regulatory Authority. An 85-year-old female patient received first injection of bnt162b2 (COMIRNATY, unknown lot number), intramuscularly on 25Jan2021 at 0.3 ml, single at unknown injection arm for COVID-19 vaccination. The patient medical history was not reported. There were no concomitant medications. The patient experienced infarct myocardial on 30Jan2021, which led to death. The patient does not present, according to her husband, of notable antecedents (medical history), in particular cardiac. On 30Jan2021 in the morning, she declared a feeling of chest tightness to her husband. The husband reported that the patient presented retro-sternal pain radiating between the shoulder blades accompanied by nausea for 45 minutes. She wanted to go to the bathroom to throw up. The husband heard a crashing noise in the toilet and found his wife unconscious on the floor. The death was quickly noted at 11:00 am. The cause mentioned by the doctor on the spot is the occurrence of a heart attack. She did not have a priori COVID 19, no information on a possible COVID-19 test. The patient had no usual treatment. The action taken in response to the event for bnt162b2 was not applicable. The patient died on 30Jan2021. It was not reported if an autopsy was performed. The outcome of nausea was known. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1029904 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Creatinine renal clearance, Death, Echocardiogram, SARS-CoV-2 test, Ultrasound Doppler
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]; RAMIPRIL; LOXAPAC [LOXAPINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome (without a clearly established diagnosis of bipolarity; usual normalization in a few days or weeks, rapidly improved by transient increases in Urbanyl.); Behavior disorder (Moderate behavioral disorders, progressively increasing over the years, attributed to an dementia disease); Carcinoma excision (infiltrating epidermoid carcinoma, cutaneous, at temporal level, having benefited from a resection); Corneal lesion (Corneal lesions, corneal transplant refusal 2011.); Deep vein thrombosis (Right femoropopliteal DVT in 2010, left popliteal iliofemoral in May2017); Dementia (no objective tests, validated by daily observation; managed best by behavioral method and sometimes a small dose of benzodiaepines); Hallux Valgus correction (Hallux valgus operated in 1996); Hypertension arterial; Mood altered (Alternation of anxiodepressive / euphoric periods without a clearly established diagnosis of bipolarity, usual normalization in a few days or weeks, rapidly improved by transient increases in Urbanyl.); Renal insufficiency (Moderate; Clearance 50 ml/min in Feb2020); Squamous cell carcinoma of skin (infiltrating epidermoid carcinoma, cutaneous, at temporal level, having benefited from a resection); TIA (brutal lack of word isolated in Jan2012, brain CT Supra-aortic trunks echodoppler cardio echo Normal)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Brain CT; Result Unstructured Data: Test Result:normal; Test Date: 202002; Test Name: clearance; Result Unstructured Data: Test Result:50 ml/min; Test Date: 202101; Test Name: cardio echo; Result Unstructured Data: Test Result:normal; Test Date: 20210121; Test Name: PCR SARScov-2; Test Result: Negative ; Test Date: 202101; Test Name: Supra-aortic trunks echodoppler; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021125894

Write-up: Death unexplained; This is as spontaneous report received from a contactable physician, downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-RS20210112. A 100-year-old female patient received BNT162B2 (COMIRNATY) (lot number EM0477, expiry date unknown) on 19Jan2021 16:00 at a single dose intramuscularly in the right arm for sars-cov2-vaccination. The patient''s medical history included transient Ischeamic attack (TIA) (brutal lack of word isolated in Jan2012, brain CT, Supra-aortic trunks echodoppler, cardio echo were normal); moderate renal failure (clearance 50 ml/min in Feb2020); arterial hypertension; right femoropopliteal deep vein thrombosis (DVT) in 2010, left popliteal iliofemoral in May2017; alternation of anxiodepressive / euphoric periods without a clearly established diagnosis of bipolarity, usual normalization in a few days or weeks, rapidly improved by transient increases in Urbanyl; moderate behavioral disorders, progressively increasing over the years, attributed to an demential disease (no objective tests) validated by daily observation, and which the healthcare team managed best by behavioral method and sometimes a small dose of benzodiaepines; infiltrating epidermoid carcinoma, cutaneous, at temporal level, having benefited from a resection; Hallux valgus operated in 1996; corneal lesions, corneal transplant refusal 2011. Concomitant medications included amlodipine, acetylsalicylic acid/ascorbic acid (ASPIRIN), ramipril, loxapine hydrochloride (LOXAPAC). No particular health event in recent weeks (general condition fragile but stable). No loxapine (LOXAPAC) given in the week before death. Vaccination against COVID-19 on 01Jan2021 at 4 p.m. by BNT162B2 in the right arm. No adverse effects during post-vaccination monitoring, or subsequently (nothing noticeable at the injection site, no sign of discomfort observed afterwards). The patient was found deceased on the morning of Thursday 21Jan2021, without any sign of orientation towards a particular cause of death. Postmortem nasopharyngeal swab PCR SarsCov2 negative. The event was reported as death unexplained. No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1029905 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210123; Test Name: ECG; Result Unstructured Data: Test Result:extensive anterior transmural; Comments: extensive anterior transmural myocardial infarction. Thrombolysis
CDC Split Type: FRPFIZER INC2021126232

Write-up: Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB regulatory authority FR-AFSSAPS-TS20210136. An 86-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscularly on 19Jan2021 at single dose for covid-19 vaccination. The patient''s medical history and concomitant medications were not reported. There was no information on cardiovascular history or current treatments. Declaration made by the establishment that received the patient for chest pain. On 23Jan2021 at night, onset of lasting intense chest pain. On ECG: extensive anterior transmural myocardial infarction. The patient had thrombolysis. The patient had death during transfer from hospital to hospital. In total, death complicating an extensive transmural infarction in a patient vaccinated 4 days previously with Comirnaty. The patient died on 23Jan2021. An autopsy was not performed. The outcome of the event was fatal. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1029906 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021136012

Write-up: death; This is a spontaneous report from a contactable physician. This report was received via a sales representative. This physician reported similar events for 16 patients. This is the first of 16 reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. It was not reported if an autopsy was performed. According physician event was not related to vaccine. Patient should have been ill before vaccination. The information on the batch number has been requested.; Sender''s Comments: The causal association cannot be excluded between the reported event of death and BNT162B2 vaccine. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.,Linked Report(s) : FR-PFIZER INC-2021136132 same reporter, drug, different event;FR-PFIZER INC-2021136128 same reporter, drug, different event;FR-PFIZER INC-2021136133 same reporter, drug, different event;FR-PFIZER INC-2021136124 same reporter, drug, different event;FR-PFIZER INC-2021136131 same reporter, drug, different event;FR-PFIZER INC-2021136125 same reporter, drug, different event;FR-PFIZER INC-2021136126 same reporter, drug, different event;FR-PFIZER INC-2021136127 same reporter, drug, different event;FR-PFIZER INC-2021136130 same reporter, drug, different event;FR-PFIZER INC-2021136129 same reporter, drug, different event;FR-PFIZER INC-2021136123 same reporter, drug, different event;FR-PFIZER INC-2021136122 same reporter, drug, different event;FR-PFIZER INC-2021136121 same reporter, drug, different event;FR-PFIZER INC-2021136120 same reporter, drug, different event;FR-PFIZER INC-2021136119 same reporter, drug, same event, different patient; Reported Cause(s) of Death: death


VAERS ID: 1029907 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021136119

Write-up: patient died; This is a spontaneous report from a contactable physician via a sales representative. This physician reported similar events for 16 patients. This is the 2nd of 16 reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. According physician event was not related to vaccine. The patient should have been ill before vaccination. The information on the batch number has been requested.; Sender''s Comments: Lacking information on the cause of patient''s demise, the Company cannot completely exclude a causal relationship between the recent administrated COVID 19 vaccine, BNT162B2, and patient''s death of unknown cause, as a cautionary measure and for reporting purposes. More information on the patient''s underlying medical conditions, relevant lab tests, autopsy result would be helpful for the Company to make a more meaningful causality 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 RA, IEC, as appropriate.,Linked Report(s) : FR-PFIZER INC-2021136012 same reporter, drug, same event, different patient; Reported Cause(s) of Death: died


VAERS ID: 1029915 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm, Decreased appetite, Fatigue, Illness, SARS-CoV-2 test, Scan
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; ISOSORBIDE MONONITRATE; LORAZEPAM; NITROLINGUAL; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Anxiety; Fainting (In last 10 years had episodes of passing out, cause unknown but presented with low blood pressure.); Heart attack (Mild heart attack approx 50yrs); High cholesterol; Low blood pressure; Stroke (Mini-stroke in mid 50yrs); Swallowing difficult (possibly due to narrowed oesophagus but not diagnosed)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: scan; Result Unstructured Data: Test Result:abdominal aortic aneuryism; Test Name: COVID test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021080631

Write-up: collapsed with CT revealed abdominal aortic aneurysm; Tiredness; Sickness; Appetite lost; This is a spontaneous report from a contactable consumer. This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202101261310362580, Safety Report Unique Identifier GB-MHRA-ADR 24649051. An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK4243, expiry date unknown) via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient''s medical history included mild heart attack at approximately 50 years old, mini-stroke in mid 50 years old, difficulty with swallowing - possibly due to narrowed oesophagus but not diagnosed, angina pectoris, high cholesterol, anxiety. In last 10 years the patient had had episodes of passing out, cause unknown, but presented with low blood pressure. He was not enrolled in clinical trial. COVID test on an unspecified date confirmed negative. Concomitant medication included aspirin (ASPIRIN) for ministroke, isosorbide mononitrate (ISOSORBIDE MONONITRATE) for angina pectoris, lorazepam (LORAZEPAM) for anxiety, glyceryl trinitrate (NITROLINGUAL) for anginal pain, simvastatin (SIMVASTATIN) for high cholesterol. The patient experienced sickness, tiredness and loss of appetite on 22Jan2021. The sickness occurred on the first day after the vaccination. The extreme tiredness and loss of appetite continued for 2 days then suddenly he collapsed on day 3 after the vaccination. Ambulance called and admitted to hospital for tests. A scan found an abdominal aortic aneurysm which required emergency surgery and the patient didn''t survive the operation. The patient had not had symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine. Suspect Reactions. The outcome of sickness, tiredness and loss of appetite was unknown; the outcome of abdominal aortic aneurysm was death. Follow-up attempts are completed. No further information is expected. ; Reported Cause(s) of Death: Abdominal aortic aneurysm


VAERS ID: 1029937 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dementia, Drug ineffective, Encephalitis, Pneumonia, SARS-CoV-2 test, Seizure
SMQs:, Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Dementia (narrow), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; BISOPROLOL; LANSOPRAZOL; RANOLAZINE; TEMAZEPAM; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Myocardial infarction; Prostate cancer; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021133041

Write-up: Pneumonia; SARS-CoV-2 infection; SARS-CoV-2 infection; Dementia; Shaking; Encephalitis; 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-202102041702516100, Safety Report Unique Identifier GB-MHRA-ADR 24701055. An 83-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EJ1688), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. Medical history included prostate cancer, dementia, myocardial infarction. Concomitant medication included atorvastatin, bisoprolol, lansoprazol, ranolazine, temazepam, warfarin for myocardial infarction. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced pneumonia (death) on an unspecified date, sars-cov-2 infection (medically significant) on 15Jan2021 with outcome of not recovered, dementia (medically significant) on 07Jan2021 with outcome of not recovered, shaking (medically significant) on 07Jan2021 with outcome of not recovered, encephalitis (medically significant) on 07Jan2021 with outcome of not recovered. Event description: Massive and immediate increase in dementia symptoms, hospitalized with suspected stroke but tests ruled out this. Violent whole body convulsions developed and became uncontrollable. Treated for potential encephalitis / bacterial meningitis but again ruled out following test. Treated with antibiotics for undetermined infection but ongoing deterioration in condition. Developed pneumonia and contracted corona virus whilst still in hospital and ultimately died 2 week after admission to hospital with COD listed as pneumonia. No coronavirus symptoms shown despite positive test. The patient underwent lab tests and procedures which included sars-cov-2 test: yes - positive covid-19 test on 15Jan2021. The patient died on 22Jan2021, cause of death was pneumonia. 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: Pneumonia


VAERS ID: 1029941 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0379 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; FLUOXETINE; OMEPRAZOLE; RAMIPRIL; SIMVASTATIN
Current Illness:
Preexisting Conditions: Comments: . Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not pregnant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021133235

Write-up: Death; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202102061030262760, Safety Report Unique Identifier GB-MHRA-ADR 24712372. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT EL0379), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not pregnant. Concomitant medication included amlodipine for blood pressure abnormal, fluoxetine, omeprazole, ramipril, simvastatin. The patient experienced death on 13Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unknown date. The patient died on 13Jan2021. 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


VAERS ID: 1029943 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN3924 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Cough, Death, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID; ATORVASTATIN; CLOPIDOGREL; DULOXETINE; EPOETIN ZETA; FOSTAIR; FUROSEMIDE; GLICLAZIDE; LANTHANUM CARBONATE; LINAGLIPTIN; OMEPRAZOLE; PREGABALIN; RENAGEL [SEVELAMER HYDROCHLORIDE]; VENOFER; VENTOLIN [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Asthma; COPD; Depression; Discectomy (L4/5 discectomy for disc prolapse); Diuresis; Diverticulitis; Ejection fraction (ejection factor 30-35%); Hypercholesterolaemia; Hyperphosphatemia; Iron deficiency; Myocardial infarction (Non St elevation myocardial infarction); Neuropathic pain; SARS-CoV-2 sepsis; Smoker; Type 2 diabetes mellitus; Comments: ejection factor 30-35% Type 2 diabetes Smoker COPD Diverticulitis L4/5 discectomy for disc prolapse Non St elevation myocardial infarction, Right coronary artery stenosis - drug eluting stent for 12 months dual antiplatelet agents Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021132644

Write-up: Death; aspirated; coughing; This is a spontaneous report from a contactable healthcare professional. This is a report received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202102061730379880, Safety Report Unique Identifier GB-MHRA-ADR 24714372. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# en3924) via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunization. Medical history included SARS-CoV-2 sepsis, Non St elevation myocardial infarction, right coronary artery stenosis - drug eluting stent for 12 months dual antiplatelet agents, L4/5 discectomy for disc prolapse, ejection factor 30-35%, type 2 diabetes, smoker, chronic obstructive pulmonary disease (COPD), diverticulitis, hypercholesterolaemia, depression, anaemia, asthma, diuresis, Hyperphosphatemia, neuropathic pain, Iron deficiency. Concomitant medication included acetylsalicylic acid as anticoagulant therapy, atorvastatin for hypercholesterolaemia, clopidogrel as anticoagulant therapy, duloxetine for depression, epoetin zeta for anaemia, beclometasone dipropionate/formoterol fumarate (FOSTAIR) for asthma, furosemide for polyuria, gliclazide for diabetes mellitus, lanthanum carbonate for hyperphosphataemia, linagliptin for diabetes mellitus, omeprazole, pregabalin for neuralgia, sevelamer hydrochloride (RENAGEL) for hyperphosphataemia, saccharated iron oxide (VENOFER) for iron deficiency, salbutamol sulfate (VENTOLIN) for asthma. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The patient was well after vaccination, left dialysis 2 hours after vaccination, had a coughing fit at home, aspirated and died on 02Feb2021. He had coughing fits in the past and vomited on dialysis whilst on his back and aspirated which required suctioning and resuscitation a few times. The patient''s brother informed he had had a coughing fit at home and his wife had found him unconscious/dead. It was unknown if autopsy was performed. It was probably not caused by vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The outcome of events cough and aspirated was unknown. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1029946 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-07
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021131543

Write-up: Death; 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-202102071716314990, Safety Report Unique Identifier GB-MHRA-ADR 24716555. A 76-year-old male patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number not known) via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunisation. The patient has not had symptoms associated with COVID-19 and the patient is not enrolled in clinical trial. The patient concomitant medications were not reported. The patient died on 07Feb2021. The patient has not tested positive for COVID-19 since having the vaccine on 04Feb2021. It was unknown whether autopsy was done. No follow-up attempts possible; information regarding batch/lot cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1029950 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Malaise, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negative (postmortem)
CDC Split Type: GRPFIZER INC2021147990

Write-up: The patient died; Feeling unwell; This is a spontaneous report from a contactable consumer (relative). An 85-year-old male patient received the first dose of the bnt162b2 (COMIRNATY), intramuscularly on an unknown date in Feb2021 at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unknown date in Feb2021, the patient was feeling unwell; "on the following date of the vaccination." The patient died (death, medically significant) on an unknown date in Feb2021; five days after the vaccination. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (postmortem) on an unknown date in Feb2021. The patient died on an unknown date in Feb2021 due to an unknown cause of death. An autopsy was performed, and the results were not provided. The batch/lot numbers for the vaccine, COMIRNATY, were not provided and will be requested during follow up.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1029951 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Circulatory collapse, Death, Electrocardiogram, Metabolic acidosis, Pulseless electrical activity
SMQs:, Anaphylactic reaction (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NOACID [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; COVEREX; ADEXOR; ASA; NEBILET; ROSUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Coronary artery occlusion; Hypertension; Hypertrophic cardiomyopathy; Ischemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: EKG; Result Unstructured Data: Test Result:anterior STEMI
CDC Split Type: HUPFIZER INC2021134250

Write-up: died; anterior STEMI; metabolic acidosis; pulseless electrical activity; circulatory arrest; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB HU-OGYI-035821. A 64-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, batch/lot number: EJ6134), intramuscularly on 27Jan2021 at 0.3 mL, single in left arm for covid-19 immunization. Medical history included Ischemic heart disease, Hypertrophic cardiomyopathy, previous acute myocardial infarction, all from an unknown date and unknown if ongoing; hypertension; left anterior descending and circumflex artery occlusion. Concomitant medications included pantoprazole sodium sesquihydrate (NOACID [PANTOPRAZOLE SODIUM SESQUIHYDRATE]); perindopril erbumine (COVEREX); trimetazidine hydrochloride (ADEXOR); acetylsalicylic acid (ASA); nebivolol hydrochloride (NEBILET); rosuvastatin. On 29Jan2021 at 7:46 am, the patient was taken to the emergency by the ambulance after 1-hour long resuscitation, where pulseless electrical activity and metabolic acidosis was observed. There was no reversible cause behind circulatory arrest, it was considered to be related to his known underlying cardiact and metabolic diseases. Resuscitation was continued and thrombolysis was initiated. No return of spontaneous circulation was detected during prolonged resuscitation. Despite the therapeutic efforts (40 mEq HCO3, 7 mg Tonogen (epinephrine), 50 mg Actilyse powder and solvent for solution for injection or infusion (alteplase, Boehringer Ingelheim International GmbH), Isolyte solution for infusion (electrolits,: Fresenius Kabi Kft.)), the patient died at 8:35 am on 29Jan2021. The patient died on 29Jan2021. It was unknown if an autopsy was performed. Test results included EKG: anterior STEMI on 29Jan2021. The outcome of anterior STEMI and died was fatal, of the other events was unknown. Sender Comment: According to the medical records, the patient''s death was related to his severe cardiac diseases. There is an unlikely causal relationship between the event and Comirnaty. The case is serious due to the patient''s death as reported. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: anterior STEMI; died


VAERS ID: 1029973 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Respiratory crisis; A regulatory report was received from a physician concerning a 92-years-old, female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced respiratory crisis. The patient''s medical history was not provided. Concomitant product use was not provided by the reporter. On 22 Jan 2021, approximately five days prior to death, the patient received their first of two planned doses of mRNA-1273 [Lot number 300042698] intramuscularly for prophylaxis of COVID-19 infection. The reporter reports that the patient was already on home O2 therapy for global respiratory failure in COPD, the diagnosis is suspected acute pulmonary edema. On 27 Jan 2021, the patient experienced a respiratory arrest which lead to death. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 27 Jan 2021. The cause of death was respiratory crisis. Plans for an autopsy were unknown.; Reporter''s Comments: Very limited information regarding the event has been provided at this time. The cause of death was respiratory crisis. Plans for an autopsy were unknown. However, the patient''s history of being on home O2 therapy for global respiratory failure in COPD is risk factors and confounds causality assessment.; Reported Cause(s) of Death: Arrest Respiratory


VAERS ID: 1029975 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPALGOS; COUMADIN; FUROSEMIDE; BISOPROLOL FUMARATE; LANSOX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210114; Test Name: sudden rise temp; Result Unstructured Data: Test Result:sudden rise temp$g 39 ?C
CDC Split Type: ITPFIZER INC2021126227

Write-up: Sudden rise temp$g 39 ? C, gasping, death.; Sudden rise temp$g 39 ? C, gasping, death.; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB IT-MINISAL02-668518. A 91-years-old female patient received the first dose of bnt162b2 (COMIRNATY, LOT number: EL 1484), intramuscular at arm left (reported as left shoulder) on 08Jan2021 at single dose for COVID-19 vaccination. The patient medical history was not reported. Concomitant medication included oxycodone hydrochloride, paracetamol (DEPALGOS), warfarin sodium (COUMADIN), furosemide, bisoprolol fumarate, lansoprazole (LANSOX). The patient experienced sudden rise temp$g 39 ?C, gasping and death on 14Jan2021. It was not reported if an autopsy was performed. Center of Pharmacovigilance Comment on 03Feb21 included required clinical report and on hold.; Reported Cause(s) of Death: sudden rise temp$g 39 ? c; gasping and death


VAERS ID: 1029979 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Chills, Fatigue, Malaise, Pyrexia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TEMAZEPAM; PREGABALINE; MACROGOL 400; BUMETANIDE; FUROSEMIDE; ASCAL CARDIO; BISACODYL; OXYCODON; OMEPRAZOL
Current Illness: Angina pectoris; Atrial fibrillation; Axonal neuropathy; Cauda equina syndrome; Coronary artery disease; Heart failure; Hypertension; Mitral stenosis; Spinal cord injury; Vascular parkinsonism
Preexisting Conditions: Medical History/Concurrent Conditions: Spondylodiscitis
Allergies:
Diagnostic Lab Data: Test Date: 20210130; Test Name: body temperature; Result Unstructured Data: Test Result:Fever: 37.5 to 38 degrees Celsius Centigrade
CDC Split Type: NLPFIZER INC2021126265

Write-up: Fatigue; Not feeling well; Fever: 37.5 to 38 degrees Celsius; Chills; acute decompensatie; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB and received via Regulatory Authority NL-LRB-00436526 .Safety Report Unique Identifier NL-LRB-00437560. A 96-year-old male patient received bnt162b2 (COMIRNATY, Lot#: EM0477), via Intramuscular on 29Jan2021 at single dose for covid-19 immunization. Medical history included heart failure, spinal cord injury, cauda equina syndrome, vascular parkinsonism, mitral stenosis, atrial fibrillation, hypertension, coronary artery disease, axonal neuropathy, spondylodiscitis, angina pectoris. Concomitant medications included omeprazol tablet msr 20mg bisacodyl tablet msr 5mg macrogol 400 carbasalaatcalcium poeder 100mg furosemide injectievlst 10mg/ml bumetanide tablet 5mg pregabaline temazepam oxycodon tablet 10mg. The patient with chills (death), malaise (death), fatigue (death), body temperature increased (death) following administration of covid-19 vaccin pfizer injvlst for covid 19 immunisation. The patient was known with heart failure which was increasing during the weeks before vaccination. According to the reporter, increased body temperature might have contributed to the heart failure what might have resulted in decompensation cordis. The patient was not hospitalized and deceased 1,5 day after vaccination. The outcome of body temperature increased is fatal, the outcome of chills is fatal, the outcome of fatigue is fatal and the outcome of malaise is fatal. Drugs and latency: 1. covid-19 vaccin pfizer injvlstchills: 1 days after start, malaise: 1 days after start, fatigue: 1 days after start, body temperature increased: 1 days after start. No autopsy was done. Case Summary and Reporter''s Comments Text: Pfizer vaccin (Comirnaty). Past drug therapy Pfizer vaccin (Comirnaty): no. Confounding factors: severe heart failure. Previous COVID-19 infection: No. Other diagnostic procedures: pt was familiar with heart failure, complaints have been increasing in recent weeks. I have not opted for a hospitalization because of mr and family. Furthermore, pt is very old. Follow-up 03Feb2021 Follow-up received: 1.pt died 31Jan in the night, so 1, 5th day after vaccination 2. Medical history Transverse lesion sensory right L2, left L1, motor right L2, left L21994 fibroslcerosis bladder neck wv bladder neck incision1987 TURP related to BPH2006 cauda equina syndrome2006 canal stenosis2006 lower body parkinson based on vascular white matter abnormalities2013 Heart failure with mitral stenosis and AF2013 Vascular stenosis and AF2013 Vascular stenosis with AF2013 2006 Chron, idiopathic axonal polyneuropathy 2016 Spondylodisciitis: antibiotics i.v.Atrial fibrillation Neurogenic bladder after partial spinal cord injury Angina pectoris 3. medication: omeprazole 20mg bisacodyl 5mg macrogolascalfurosemide 40mg im + bumetanide 8mg oral pregabaline temazepamoxycodone zn for breathlessness 4. No autopsy was done. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Pfizer vaccin (Comirnaty). Past drug therapy Pfizer vaccin (Comirnaty): no. Confounding factors: severe heart failure. Previous COVID-19 infection: No. Other diagnostic procedures: pt was familiar with heart failure, complaints have been increasing in recent weeks. I have not opted for a hospitalization because of mr and family. Furthermore, pt is very old.; Reported Cause(s) of Death: acute decompensatie; Fatigue; Not feeling well; Fever: 37.5 to 38 degrees Celsius; Chills


VAERS ID: 1029980 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Oxygen saturation decreased, SARS-CoV-2 test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210130; Test Name: pcr test; Result Unstructured Data: Test Result:Positive; Comments: PCR test
CDC Split Type: NLPFIZER INC2021126255

Write-up: Requirement for oxygen; Confused; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority-WEB. Regulatory authority or other manufacturer number NL-LRB-00436580. A 96-year-old male patient received bnt162b2 (COMIRNATY) at single dose on 27Jan2021 for covid-19 immunisation. Medical history included suspected covid-19 from 25Jan2021 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced requirement for oxygen and confused on 30Jan2021 following administration of covid-19 vaccine. A PCR SARS Cov 2 test was performed and was found positive on 30Jan2021. The first symptoms of a Covid 19 infection were present 2 days before the vaccination. 3 days after vaccination the patient became confused and had need for oxygen. The patient deceased within 5 days after vaccination in 2021. The outcome of confused and of outcome of oxygen saturation decreased were considered fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain.; Reported Cause(s) of Death: Requirement for oxygen; Confused


VAERS ID: 1029981 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021126266

Write-up: 27 Jan vaccination. 31 Jan CVA. 01Feb Death; This is a spontaneous report from a contactable physician. This is a report received from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority or other manufacturer number NL-LRB-00437578. A 91 years old female patient received BNT162B2 (Comirnaty, Batch/Lot number: EM0477) at single dose for COVID-19 immunisation on 27Jan2021. Relevant history included the patient had dementia at an advanced stage and ongoing. The patient was not sent to the hospital but was treated with comfort policy. The patient was not known with allergies. Relevant concomitant drugs were unknown. 4 days after vaccination (on 31Jan2021), the patient experienced a cerebro vascular accident (CVA) and one day later (On 01Feb2021), the patient deceased. The patient did not experience adverse reactions during the vacciantion. The outcome of cerebrovascular accident was fatal. It was unknown if autopsy was performed or not. Case Summary and Reporter''s Comments Text: Pfizer vaccine (Comirnaty); Past drug therapy Pfizer vaccine (Comirnaty): no; 27Jan vaccination. 31Jan CVA. 01Feb Death; Additional information ADR: 3-4 days after vaccination stroke; in view of extensive VG with advanced dementia in connection with family not submitted. Quickly deployed on comfort policy. No side effects during or after administration. No known allergy. Unknown connection; but for completeness mention. COVID19; Previous COVID-19 infection: No; Other diagnostic procedures: due to death I cannot view medication data for now; if desired, this can be requested later at the pharmacy. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: CVA


VAERS ID: 1029982 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-11
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary imaging procedure, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Advanced lung cancer; Costal cartilage fracture; Living in nursing home (Short-term stay due to thoracic spine compression fracture.); Thoracic spine compression fracture (Upper thoracic column.)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Pulmonary imaging procedure; Result Unstructured Data: Test Result:pleural effusion (known, previously established); Comments: and atelectasis.
CDC Split Type: NOPFIZER INC2021127220

Write-up: RESPIRATORY FAILURE; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [NO-NOMAADVRE-FHI-2021-U3p9g], Safety Report Unique Identifier is NO-NOMAADVRE-E2B_00014435. A 73 years old female patient received the first dose of BNT162B2 (COMIRNATY, Lot#: EJ6795) via intramuscular at single dose in left arm on 06Jan2021 at 14:00 for COVID-19 immunisation. Medical history included advanced lung cancer; patient was currently living in nursing home (short-term stay) due to thoracic spine compression fracture (upper thoracic column) and costal cartilage fracture. Concomitant medication was not reported. On 11Jan2021, the patient developed respiratory failure, for which the patient was hospitalised (in Jan2021) for further examination. Pulmonary imaging procedure in Jan2021 showed pleural effusion (known, previously established) and atelectasis. Probably due to mechanical respiratory restriction. No other pathological findings. The patient was discharged to the nursing home and died within few days on 19Jan2021. It was unknown if an autopsy was performed or not. The outcome of event was fatal. The case was considered to be serious. Sender Comment: The report concerns a patient in his 70s, who experienced respiratory failure a few days after the first dose of the Covid-19 vaccine Comirnaty. The patient was admitted to hospital for clarification, but was discharged without specific pathological findings in addition to increasing pleural fluid (which was known from before) and some atelectasis, most likely due to mechanical ventilation restriction. Discharged back to the nursing home''s short-term ward and died after a few days. The patient was admitted to a short-term ward in a nursing home due to a compression fracture and had advanced lung cancer. The reporter states that the patient was stable and in good shape in the days before vaccination. The vaccine is non-living and therefore can not cause diseases that are vaccinated against or any other infections. Non-specific disease symptoms may nevertheless occur in the first days after vaccination with all vaccines. A large proportion of those vaccinated in the Comirnaty studies reported fatigue, joint and muscle pain, and a small proportion developed fever and chills after this vaccine. Such symptoms are usually short-lived and transient. However, we cannot rule out that such relatively mild side effects as mentioned above may become more pronounced and / or lead to a more serious course in severely debilitated patients. In each case, it is difficult to know whether the symptoms are due to a vaccine, exacerbation of the patient''s underlying disease or another, random concurrent cause that has nothing to do with the vaccine in question. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. On the basis of the information in the report and in accordance with international criteria, the causal relationship 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, the report is also classified as serious, even though a causal link between the vaccine and the death has not been established. ; Reported Cause(s) of Death: RESPIRATORY FAILURE


VAERS ID: 1029983 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Fall, General physical health deterioration
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home (For at least half a year.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021127222

Write-up: DEATH FROM NATURAL CAUSES; fell in the bathroom two days after the vaccination, and her general condition deteriorated significantly after this; fell in the bathroom two days after the vaccination, and her general condition deteriorated significantly after this; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is NO-NOMAADVRE-FHI-2021-U4rd3. Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014430. A 94-year-old female patient received BNT162B2 (COMIRNATY; Lot number EM0477), intramuscular on 20Jan2021, at 10:30 as single dose for covid-19 immunization. Medical history included Living in nursing home from an unknown date for at least half a year. The patient''s concomitant medications were not reported. The patient experienced death from natural causes on 25Jan2021. The patient died on 25Jan2021. It was not reported if an autopsy was performed. Event assessment for BNT162B2 for death was reported as unlikely. Sender Comment: A 94-year-old woman died five days after the second dose of covid-19 vaccine (Cominarty). She fell in the bathroom two days after the vaccination, and her general condition deteriorated significantly after this. The reporter considers that the death is a natural death due to a fall and consequent reduced general condition. An adverse reaction report was submitted due to the fact that the death occurred shortly after the vaccination. 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. However, 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 something else incidental, at the same time a cause that has nothing to do with the vaccination in question. On the basis of the information in the report, only the reporter''s causality assessment is registered. The reporter has stated that there is no suspicion of a connection with vaccination, and therefore a causal connection with vaccination is considered unlikely. An unlikely causal relationship is defined as a reaction, including pathological laboratory tests, that occurs in such a temporal relationship to the use of a drug that a causal relationship is unlikely (but not impossible), and where underlying disease, other drugs or chemicals may explain the reaction. Since the patient died, the message is classified as serious, even though a causal link between the vaccine and the death has not been established. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: 29Jan2021 RELIS: additional information collected (phone). This is a final report.; Reported Cause(s) of Death: DEATH FROM NATURAL CAUSES


VAERS ID: 1029984 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Productive cough, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ROBINUL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Frailty; Living in nursing home; Pelvic fracture
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021126256

Write-up: DYSPNEA; PRODUCTIVE COUGH; FEVER; This is a spontaneous report from contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB regulatory authority or other manufacturer number NO-NOMAADVRE-FHI-2021-U5x8d, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014499. A 97-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on left arm on 04Jan2021 at single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), pelvic fracture, Frailty and Living in nursing home. Concomitant medication included glycopyrronium bromide (ROBINUL) for dyspnea and a pain pump. The patient experienced dyspnea, productive cough and fever on 06Jan2021. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Event Assessment: all 3 events: comirnaty: Regional Pharmacovigilance Center: possible Sender Comment: Background: Woman in her late 90s with underlying COPD. Gradually increasing frailty in recent months. Pelvic fracture six months ago, and has not recovered after this. Vaccinated with the covid-19 vaccine Comirnaty and two days after vaccination, she developed a fever, heavy breathing and itchy cough after vaccination. Fell quickly during the following weeks, died approx. 3 weeks after vaccination and onset of symptoms. In the last few days she had a pain pump and received Robinul (glycopyrronium bromide). The notifier indicates that the event is to be regarded as an adverse event after vaccination, and not necessarily a side effect of the vaccine. Comment: Fever is a known side effect of this vaccine. Sore throat and wheezing, on the other hand, are not a known side effect of this vaccine. Another cause of the symptoms must therefore also be considered. There is no information on whether the woman has been tested for covid-19 infection, or other infectious disease. None of the vaccine components are live and the vaccine can not cause infectious disease. The patient developed symptoms two days after vaccination, and it is considered that there is a temporal connection between the onset of symptoms and vaccination. Symptoms due to inactivated vaccines usually begin within a day or two after vaccination, and will usually return within a few days. When vaccinating patients with frailty who have underlying diseases, some serious events, including death, may occur relatively soon after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccination, with a subsequent immune response, may in itself have contributed to a physiological stress / strain, which may further have affected the patient''s basic condition / disease. In each case, it is difficult to know whether the symptoms and subsequent deaths are due to the vaccine, the patient''s underlying disease or other accidental, concurrent cause that has nothing to do with the vaccination in question. Based on the information in the report and in accordance with international criteria, the causal link with vaccination in this case is considered 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''s death, the report is classified as serious, even though no causal link between the vaccine and the death has been established.; Reported Cause(s) of Death: DYSPNEA; PRODUCTIVE COUGH; fever


VAERS ID: 1029985 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Cerebrovascular accident, Confusional state, Hemiplegia, Pneumonia, Somnolence
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MEDOX [MINERALS NOS;VITAMINS NOS]; HIPREX [METHENAMINE HIPPURATE]; EBIXA; VISCOTEARS; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; DONEPEZIL ACCORD
Current Illness: Dementia (increasing need for assistance); Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Balance difficulty; Performance status decreased; Speech disorder; Walking difficulty; Weight loss
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021127223

Write-up: LUNG INFECTION NOS; Increasing confusion; suspected stroke; impaired consciousness; impaired power left side; somnolent; This is a spontaneous report from contactable other Health Professional downloaded from the Medicines Agency (EMA) EudraVigilance-WEB regulatory authority or other manufacturer number NO-NOMAADVRE-FHI-2021-U9xdj, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014597. A 75 years old male patient received the first dose of BNT162B2 (COMIRNATY) on 13Jan2020 intramuscular in arm left at single dose for COVID-19 vaccination. The medical history included ongoing dementia, weight loss, ongoing living in nursing home. Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), carbomer (VISCOTEARS), minerals NOS, vitamins NOS (MEDOX), memantine hydrochloride (EBIXA), methenamine hippurate (HIPREX), donepezil hydrochloride (Donepezil Accord). On 17Jan2021, the patient developed lung infection NOS. The patient''s outcome was Fatal, at the time of the report. The case was considered to be serious. Event assessment for Comirnaty and Donepezil Accord from reporter was reported as unlikely. The patient died on 27Jan2021, it was unknown if autopsy done. Event outcome of impaired consciousness was not recovered, while for other events was unknown. Reporter''s comment: A patient with reduced function in recent years due to advanced dementia, with increasing weight loss, loss of language, difficulties with balance and walking, and increasing need for assistance. Received vaccine Comirnaty on 13Jan2021; no immediate reactions. Increasing confusion has been reported from 17Jan2021. The patient was admitted to hospital on 21Jan2021; with suspected stroke; impaired consciousness, impaired power left side, somnolent (all on Jan2021). No sign of cerebral event; but no improvement in condition. Suspected lung infection; and AB IV was initiated. The patient did not regain full consciousness; and died at the hospital on 27Jan2021. No suspicion of association between vaccination with Comirnaty and development of infection; but reported for assessment because it is a new vaccine. Sender''s Comment: When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or some other incidental cause happening at the same time which has nothing to do with the vaccination in question. On the basis of the information in the report, the reporter''s causal assessment is registered. Reporter has stated that there is no suspicion of a connection with vaccination. NIPH agrees with this assessment as none of the vaccine components are alive, and the vaccine can therefore not cause infectious disease. Therefore, a causal relationship with vaccination is considered unlikely. An unlikely causal relationship is defined as a reaction, including pathological laboratory tests, that occurs in such a temporal relationship to the use of a drug that a causal relationship is unlikely (but not impossible), and where underlying disease, other drugs or chemicals may explain the reaction. Since the patient died, the message is classified as serious. No follow-up attempts possible. No further information expected. Batch/Lot numbers can not be obtained.; Reporter''s Comments: A patient with reduced function in recent years due to advanced dementia, with increasing weight loss, loss of language, difficulties with balance and walking, and increasing need for assistance. Received vaccine Comirnaty on 13Jan2021; no immediate reactions. Increasing confusion has been reported from 17Jan2021. The patient was admitted to hospital on 21Jan2021; with suspected stroke; impaired consciousness, impaired power left side, somnolent. No sign of celebral event; but no improvement in condition. Suspected lung infection; and ab iv was initiated. The patient did not regain full consciousness; and died at the hospital on 27Jan2021. No suspicion of association between vaccination with Comirnaty and development of infection; but reported for assessment because it is a new vaccine.; Reported Cause(s) of Death: Lung infection NOS


VAERS ID: 1029986 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chronic kidney disease, Confusional state, General physical health deterioration, Rash, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Kidney failure chronic; Living in nursing home; Markedly reduced food intake; Reduced general condition
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021127302

Write-up: URTICARIA; rash; CONFUSION STATE; REDUCED GENERAL CONDITION; CHRONIC RENAL FAILURE WORSENED; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [NO-NOMAADVRE-FHI-2021-Un9nw], Safety Report Unique Identifier is NO-NOMAADVRE-E2B_00014423. A 92-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular at single dose in left arm on 05Jan2021 at 10:35 for Covid-19 vaccination; amoxicillin orally at 500 mg thrice a day (every 8 hours) from 31Dec2020 for an unspecified indication. Ongoing medical history included living in nursing home, reduced general condition, markedly reduced food intake, dementia, kidney failure chronic. Concomitant medication was not reported. On 09Jan2021, the patient developed urticaria and rash; then confusion state, chronic renal failure worsened and reduced general condition in Jan2021. Patient died on 25Jan2021 due to urticaria, confusion state, chronic renal failure worsened and reduced general condition. It was unknown if an autopsy was performed or not. The action taken with amoxicillin was unknown. The outcome of event rash was resolved in Jan2021. The outcome of rest events was fatal. The case was considered to be serious. Reporter''s comment: Elderly patient, nursing home resident. Downward arrow with impaired general condition, reduced food intake in the weeks before Pfizer''s covid 19 vaccine was given. Known dementia and chronic kidney failure. Using antibiotics from 31Dec2020 - amoxicillin 500 mg three times daily. Despite being on antibiotics, the vaccine was given 05Jan2021. Developed rash 4 days later. Possible reaction to vaccine. Developed a pronounced bodily drug-induced rash 9Jan2021 (urticarial character), with subsequent confusion, worsening of chronic renal failure due to dehydration. The rash was successfully treated with antihistamines and prednisolone. The general condition was not marked better and she was weakened. Hospitalization was not considered due to old age and significant comorbidity. Died peacefully after short sick leave with palliative care for 3 days. Died 25Jan2021. Batch / LOT number has been registered in SYSVAK, but the nursing home was unable to find this in its journal, for information. Sender Comment: 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. However, 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 some other coincidental event which has nothing to do with the vaccination in question. Urticaria is an immediate type of allergic reaction and only rarely begins later than 24 hours after contact with the triggering allergen. The longer the time interval between vaccination and symptom onset, the greater the likelihood that urticaria is due to something other than the vaccine. It is unlikely that urticaria that breaks out more than 1 day after vaccination is due to the vaccine, although a causal relationship can not be ruled out with certainty. Symptoms such as fever, headache and general malaise occur in the first days after vaccination with all vaccines. It can therefore not be ruled out that the vaccine has contributed to the other symptoms. The report states that the patient was also using amoxicillin with an unknown duration of treatment. Amoxicillin is known to have a number of skin side effects, both less severe such as skin rash, urticaria and itching, and in rare cases severe drug-induced skin reactions (erythema multiforme, Stevens-Johnson syndrome, TEN, bullous and exfoliative dermatitis, AGEP, DRESS). The amoxicillin may therefore also be a possible cause of the patient''s symptoms. Based on the information in the report and in accordance with international criteria, the causal relationship with vaccination and urticaria is considered unlikely, and the other symptoms 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, the message is classified as serious, even though no causal link between the vaccine and the death has been established.; Reporter''s Comments: Summary of Reporter Comment Elderly patient, nursing home resident. Downward arrow with impaired general condition, reduced food intake in the weeks before Pfizer''s covid 19 vaccine was given. Despite being on antibiotics, the vaccine was given 05Jan2021. Developed rash 4 days later. Possible reaction to vaccine. Developed a pronounced bodily drug-induced rash 9Jan2021 (urticarial character), with subsequent confusion, worsening of chronic renal failure due to dehydration.; Reported Cause(s) of Death: URTICARIA; REDUCED GENERAL CONDITION; CONFUSION STATE; CHRONIC RENAL FAILURE WORSENED


VAERS ID: 1029987 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cerebrovascular accident, Computerised tomogram head, Dysphagia, Heart rate, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE]; SINGULAIR; AMLODIPIN ACCORD; PARACET [PARACETAMOL]; INCRUSE; SOBRIL; ALBYL-E
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dementia; Hypertension; Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: Blood pressure; Result Unstructured Data: Test Result:195/113; Comments: Systolic: 195 Diastolic: 113; Test Date: 20210120; Test Name: CT brain scan; Result Unstructured Data: Test Result:did not show relevant pathology; Comments: (No signs of hemorrhage); Test Date: 20210120; Test Name: Pulse rate; Result Unstructured Data: Test Result:83; Comments: Units:/min
CDC Split Type: NOPFIZER INC2021126246

Write-up: STROKE; nauseous and unwell; nauseous and unwell; she could not swallow; This is as spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is NO-NOMAADVRE-FHI-2021-Uq7jw, Safety report unique identifier NO-NOMAADVRE-E2B_00014481. An 85-year-old female patient received bnt162b2 (COMIRNATY) Intramuscular at left arm on 12Jan2021 13:05 at single dose for vaccination. Medical history included Hypertension, advanced dementia, Living in nursing home and chronic obstructive pulmonary disease (COPD). Concomitant medication included fluticasone furoate, vilanterol trifenatate (RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE]), montelukast sodium (SINGULAIR), amlodipine besilate (AMLODIPIN ACCORD), paracetamol (PARACET [PARACETAMOL]), umeclidinium bromide (INCRUSE), oxazepam (SOBRIL) and acetylsalicylic acid, magnesium oxide (ALBYL-E). Woman in her 80s, a nursing home resident, with advanced dementia, hypertension and COPD. CPR (cardio-pulmonary resuscitation) minus. Eight days after vaccination with Comirnaty; found in her own bed with symptoms compatible with stroke (20Jan2021). Blood pressure 195/113, pulse 83 (Units:/min), nauseous and unwell. CT brain scan did not show relevant pathology (No signs of hemorrhage). Some improvement in symptoms (speech problems and strength), but she could not swallow. Intravenous fluids were given, the condition worsened and the patient died six days after the onset of symptoms. Patient was died because of stroke on 26Jan2021 and outcome of other events was not recovered. It was unknown if an autopsy was done. Sender comment: Background: Woman in her 80s with advanced dementia, hypertension and COPD. CPR minus. Lives in a housing association for people with severe dementia. Vaccinated with the covid-19 vaccine Comirnaty, was in its normal form at vaccination. Eight days after vaccination found in own bed in the morning with reduced strength left side, somewhat drooping mouth on one side and language difficulties / aphasia. Was in her habitual state when she went to bed the night before, and should have been calm through the night. Blood pressure 195/113, pulse 83. Seemed nauseous and unwell. CT caput did not show anything relevant and the patient was sent back to the housing association. Got speech back and some movement in the left lower extremity. Failed to swallow. Intravenous fluids were tried, but the condition worsened and the patient died six days after the onset of symptoms. Comment: We consider it more likely that the underlying disease / risk factors for stroke (including hypertension, age) are the cause of the event in question. On the basis of the information in the report and in accordance with international criteria, the causal connection with vaccination is nevertheless considered 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''s death, the message is classified as serious, even though no causal link between the vaccine and the death has been established. When vaccinating marginal patients with several underlying diseases and risk factors for disease, some serious events, including death, may occur shortly after vaccination, without any connection to vaccination. Relatedness of drug to reaction(s)/event: Source of assessment was Regional Pharmacovigilance Center. Result of Assessment was Possible. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Stroke


VAERS ID: 1029995 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary oedema, Pyrexia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021129542

Write-up: Pulmonary oedema; Fever; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, regulatory authority number is SE-MPA-2021-001271. Other case identifier number is SE-MPA-1611305446859. A 97-year-old male patient received BNT162B2 (COMIRNATY, lot number unknown), via an unspecified route of administration in Jan2021 at single dose (reported as "1 DF") for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pulmonary oedema and fever in Jan2021. Report was assessed as serious, death. It was reported that consumer report regarding a patient living in a special home care living. The reported adverse reactions are fever and pulmonary oedema. Two days after the vaccination, the man fell ill and was rushed to hospital. He was treated there with Furix against the fluid in the lungs and with morphine. Two days later, the man died. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary oedema; fever


VAERS ID: 1029998 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENLAFAXINE; MIRTAZAPINE; ALVEDON; RISPERDAL; MEMANTINE; OXASCAND; TEGRETOL; FOLACIN [FOLIC ACID]; BETOLVIDON; EXELON [RIVASTIGMINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021127839

Write-up: DVT-Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from Regulatory Authority, regulatory authority SE-MPA-2021-001934. Other case identifier number SE-MPA-1611843754339. A 71-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, lot EJ6795), intramuscularly in Jan2021 at 0.3 mL, single for covid-19 immunisation. Medical history included dementia. Concomitant medication included venlafaxine, mirtazapine, paracetamol (ALVEDON), risperidone (RISPERDAL), memantine, oxazepam (OXASCAND), carbamazepine (TEGRETOL), folic acid (FOLACIN), cyanocobalamin (BETOLVIDON), rivastigmine (EXELON). The patient experienced DVT-pulmonary embolism in Jan2021. Ten days after the woman was vaccinated with Comirnaty she collapses dead. An autopsy was performed which shows pulmonary embolism. Report assessed as serious, death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: pulmonary embolism; Autopsy-determined Cause(s) of Death: pulmonary embolism


VAERS ID: 1030000 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-28
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, COVID-19 pneumonia, Drug ineffective, Malaise, Miosis, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test, Unresponsive to stimuli
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immobile
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: Body temperature; Result Unstructured Data: Test Result:increased; Test Date: 20210128; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:88-91 %; Test Date: 20210129; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: SIPFIZER INC2021135359

Write-up: unresponsive to pain stimuli; narrowed pupils; increased body temperature (38 degree celsius); low SpO2 (88-91%); became unwell; Covid pneumonia i.o.; Covid pneumonia i.o.; This is a spontaneous case report received from a physician. The report was downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [regulatory authority SI-JAZMP-NCPHV-2021SI0091_0091]. A 90-year-old male patient received first dose of BNT162B2 (COMIRNATY) Lot number EJ6134, Intramuscular on 22Jan2021 at single dose for COVID-19 vaccination. Medical history included Immobile. Concomitant mediation was not reported. The patient was vaccinated with a first dose of BNT162B2, on 22Jan2021. On 28Jan2021 the patient became unwell, with increased body temperature (38 degree celsius), oxygen saturation was 88-91%, he did not drink any water and thus infusion was inserted. The patient had Covid pneumonia i.o. on 28Jan2021. On 29Jan2021 the patient became unresponsive to pain stimuli, with narrowed pupils. Clinical status: above the lungs sporadic expiratory crackles were heard, heart action was rhythmical with mild systolic murmur. Lower legs without evident oedema, skin on legs changed. The reporting physician did not decide to hospitalise the patient as no difference in the outcome was expected. Lab data included COVID-19 PCR test positive on 29Jan2021. Outcome: the patient died on an unknow date in 2021 due to Covid pneumonia i.o.. Other events are considered as life-threatening. No data on autopsy was included in the initial case report. The outcome of unresponsive to pain stimuli, low SpO2 (88-91%), became unwell, narrowed pupils, increased body temperature (38 degree celsius) was not resolved. Sender Comment: Serious and unexpected case report with fatal outcome. Further follow up on the case will be searched in order to fully assess the case. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Covid pneumonia i.o.; Covid pneumonia i.o.


VAERS ID: 1033175 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROLIA; CANDESARTAN ORION; SIMVASTATIN; BISOPROLOL SANDOZ; TROMBYL; Kalcipos-D forte
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidaemia; Hypertension; Osteoporosis; Shellfish allergy; Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1611646034519

Write-up: Death; A regulatory authority report was received from a healthcare professional concerning a 77-year-old female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and the patient died. The patient''s medical history included a shellfish allergy, hyperlipidemia, osteoporosis, hypertension, and type I diabetes. Concomitant medications included Prolia, candesartan orion, Simvastatin, bisoprolol Sandoz, trombyl, and kalcipos-D forte all for an unknown indications. In Jan 2021, the patient received their first dose of two planned doses of mRNA-1273 (lot number 300042698) intramuscularly for the COVID-19 vaccination. On an unknown date, the patient died. No treatment medication was reported. The patient died due to the unknown cause. Autopsy details were not provided.; Reporter''s Comments: This case concerns a 77 year-old, female patient with history of shellfish allergy, hyperlipidemia, osteoporosis, hypertension, and type I diabetes, who experienced event of death. The event occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. Cause of death was not reported. Based on the current available limited information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the event is assessed as possibly related. However, the patient''s comorbidities are risk factors and confounds causality assessment.; Reported Cause(s) of Death: Death


VAERS ID: 1033467 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-03-23
Onset:2021-01-29
   Days after vaccination:312
Submitted: 0000-00-00
Entered: 2021-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, Cyanosis, Dyspnoea, Hyperhidrosis, Hypertension, Hypoxia, Pallor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Speech loss; Stroke
Allergies:
Diagnostic Lab Data: Test Name: covid 19; Test Result: Positive ; Result Unstructured Data: results and units were unknown
CDC Split Type: BRSA2021SA051803

Write-up: acute respiratory failure; cyanosis of extremities; dyspnoea; show profuse sweating; desaturation; pallor; covid 19; arterial hypertension; Initial information regarding this valid serious unsolicited case downloaded from regulatory authority database without narrative (level 2A), was received on 09-Feb-2021 from consumer/ non-health care professional via Health Authorities (Health Authority Reference Number BR-SA-SAC20210212001254). The following narrative is based on the information retrieved from all other accessible data. This case involves a 73-year old elderly female patient who experienced respiratory failure, cyanosis of extremities (cyanosis), dyspnoea, show profuse sweating (hyperhidrosis), desaturation (hypoxia), pallor, arterial hypertension (hypertension) and covid 19 (covid-19), while she received vaccine INFLUENZA VACCINE and COVID-19 VACCINE. Medical history included Stroke, Speech loss and was Bedridden. Past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing arterial hypertension. Concomitant medications were not reported. On 23-Mar-2020, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination. On an unknown date, the patient received COVID-19 VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination. On 29-Jan-2021, patient experienced acute respiratory failure, cyanosis of extremities (cyanosis), dyspnoea, show profuse sweating (hyperhidrosis), desaturation (hypoxia), pallor, arterial hypertension (hypertension) and covid 19 (covid-19), 10 months 6 days following the administration of suspect vaccine. The patient was hospitalized for these events (seriousness). Seriousness criteria was assessed as medically significant as per important medical event (IME) list for the event acute respiratory failure and Hypoxia, and COVID-19 as per reporter. It was not reported if the patient received a corrective treatment. Outcome of the events was fatal on 30-Jan-2021 for acute respiratory failure. There will be no information available regarding batch number in this case.; Sender''s Comments: This case concerns a 73-year-old female patient who experienced acute respiratory failure, cyanosis, dyspnoea, hyperhidrosis, hypoxia, pallor, hypertension and covid-19 after vaccination with company suspect INFLUENZA VACCINE and non-company suspect COVID-19 VACCINE. The time to onset was compatible with the events. Relevant laboratory test results included: COVID-19 - Positive [results and units were unknown] and Medical history included Stroke, Speech loss and was Bedridden. At the time of the event, the patient had ongoing arterial hypertension. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: severe acute respiratory failure; cyanosis of extremities; dyspnoea; show profuse sweating; desaturation; pallor; arterial hypertension; COVID-19


VAERS ID: 1034500 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood albumin, Depressed level of consciousness, Hypoglycaemia, SARS-CoV-2 test
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Klebsiella infection; Malnutrition; Starvation; Urinary infection (Klebsellia pneumoniae)
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: albumin; Result Unstructured Data: Test Result:21 g/l; Test Date: 20210113; Test Name: SARS-CoV-2 PCR test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021104018

Write-up: Hypoglycaemia; Consciousness clouding; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-LM20210068. A 96-year-old female patient received the first dose of bnt162b2 (COMIRNATY) lot no: EM0477, intramuscular on 14Jan2021 at a single dose for covid-19 immunisation. Medical history included urinary infection (Klebsellia pneumoniae) from 30Dec2020 to an unknown date, treated with AUGMENTIN from an unknown date until 06Jan2021; starvation; very undernourished (albumin 21g / L in Dec2020), refusing treatment and food; severe dementia such as Alzheimer''s. The patient had no history of hypoglycemia. The patient''s concomitant medications were not reported. The patient previously received flu vaccination on 22Oct2020 for immunization. The patient experienced consciousness clouding on 14Jan2021 and hypoglycaemia on 14Jan2021 18:00. Clinical course was reported as follows. On 14Jan2021 at 18:00, the patient had hypoglycemia at 0.62 symptomatic with disturbances of consciousness. Normalization after administration of half an ampoule of G30% and infusion of G5%. Degradation of the general condition and death on 15Jan2021 at 21:00. The patient underwent SARS-CoV-2 PCR test negative on 13Jan2021. The patient died on 15Jan2021 and cause of death was general physical health deterioration. Autopsy was not done. Outcome of the events hypoglycemia and consciousness clouding was recovering; No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1035017 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure immeasurable, Blood pressure measurement, Breath sounds, Choking, Death, Electrocardiogram, Fatigue, Heart rate, Oxygen saturation, Oxygen saturation immeasurable, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORANO
Current Illness: Atrial fibrillation (Atrial fibrillation); COPD (COPD); Dementia (Dementia); GERD (GERD)
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperthyroidism (treated hyperthyroidism); Hypokalaemia (State after hypokalemia); Kidney failure (Condition after renal failure)
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: Blood pressure; Result Unstructured Data: Test Result:could not be measured as before; Test Date: 20210124; Test Name: ECG; Result Unstructured Data: Test Result:unremarkable; Comments: ECG (emergency physician) was unremarkable.; Test Date: 20210124; Test Name: heartbeat; Result Unstructured Data: Test Result:regular; Test Date: 20210124; Test Name: O2 saturation; Test Result: 97 %; Comments: O2 administration. Saturation increased to 97; Test Date: 20210124; Test Name: O2 saturation; Result Unstructured Data: Test Result:impossible to measure %
CDC Split Type: ATPFIZER INC2021135307

Write-up: Found in bed without vital signs/ Death NOS; Ate soup and drank little. Swallowed more than once. Still bubbling.; Breath sounds; currently seems very tired; Oxygen saturation immeasurable; Pale; Blood pressure immeasurable; during personal hygiene collapses/syncope; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB AT-BASGAGES-2021-00992. An 89-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot EJ6797) via an unspecified route of administration at single dose 12:00 on 21Jan2021 for COVID-19 immunisation. The patient had a medical history of kidney failure, ongoing atrial fibrillation, ongoing dementia, hyperthyroidism, ongoing chronic obstructive pulmonary disease (COPD), hypokalaemia, ongoing gastrooesophageal reflux disease (GERD). The patient had allergy to metagelan (ongoing). Concomitant medications included loratadine (LORANO) for drug allergy (metagelan). On 24Jan2021 10:45 the patient experienced syncope. On 24Jan2021 10:46 the patient experienced pale, blood pressure immeasurable, oxygen saturation immeasurable. On 24Jan2021 11:34 the patient experienced tiredness. On 24Jan2021 13:45 the patient experienced choked on food, breath sounds. On 24Jan2021 17:40 the patient experienced death NOS. The clinical course as follows: 21Jan2021 05:30: patient visibly asleep during all rounds. Vaccination on 21Jan2021 11:00: prophylaxis for allergy 1 melting tablet loratadine 10 mg (active time 30 minutes before vaccination). 12:00 COVID vaccinated Biontech-Pfizer EJ6797 and patient was unremarkable. The patient was discharged to inpatient area for observation. 22Jan2021 06:28: patient was awake - bed and IKV contaminated with stool- changed. 23Jan2021 06:23: patient visibly asleep on all RG. 24Jan2021 06:09: patient visibly asleep at all ventilators. Crisis situation: 24Jan2021 10:45/10:46: Patient collapsed during personal care, ashen, no RR available, saturation impossible to measure. Patient was breathing deeply again after transfer to bed - O2 administration. Saturation increased to 97%, facial color less ashy, heartbeat regular. Her son was informed. 11:22: Blood pressure could not be measured as before, emergency physician was notified. While the emergency physician arrived, the general condition improved, the resident regained more color and also opened her eyes. ECG (emergency physician) was unremarkable. After consultation between the emergency physician and her son, the patient was not taken to the hospital. 11:33: Brothers alternated briefly with their mother in the room. 11:34: Patient seemed very tired at the moment. Son said goodbye. 11:36: According to the physician, O2 administration continues at 2L/min for the time being, possibly add NaCl 0.9% if the drinking quantity was less than 500 ml. 12:01: Rounds: As a result of syncope over the weekend, O2 administration, NaCl 0.9% as a single case medication. 13:45: Patient was smiling again, had eaten soup and drunk little, had swallowed several times. She was still bubbling. 17:58 (also reported as 17:40): Patient was found in bed without vital signs. 18:04: Doctor''s visit: Physician was notified for necropsy. The patient''s outcome was: unknown for choked on food and breath sounds, recovered/resolved for syncope on 24Jan2021, recovered/resolved for pale, recovered/resolved for Blood pressure immeasurable, recovered/resolved for oxygen saturation immeasurable, recovered/resolved for Tiredness, fatal for Death NOS. No autopsy had been performed or was planned. The events "syncope, pale, blood pressure immeasurable, oxygen saturation immeasurable" were reported as medically significant, and "tiredness, choked on food, breath sounds" were reported as non-serious by HA. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1035023 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Anaphylactic reaction, COVID-19 pneumonia, Cardio-respiratory arrest, Computerised tomogram, Dyspnoea, Hypotension, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CLEXANE; MELATONINE; PROLOPA; PANTOMED [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; AACIFEMINE; FEROGRAD; DONEPEZIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendicitis; Benign paroxysmal positional vertigo; Cholecystectomy; Dementia with Lewy bodies; Recurrent urinary tract infection; Urinary incontinence
Allergies:
Diagnostic Lab Data: Test Date: 20210122; Test Name: CT scan; Result Unstructured Data: Test Result:covid pneumonia of moderate to severe attack; Comments: multiple frosted glass areas disseminated in the different lobes with a predominance of the middle and lower lobes where there are areas of densification without signs of pulmonary embolism
CDC Split Type: BEPFIZER INC2021134698

Write-up: Dyspnea; hypotensive discomfort; Malaise; Anaphylactic reaction; covid pneumonia of moderate to severe attack; Acute hypoxemic respiratory failure; Cardio-respiratory arrest; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority BE-FAMHP-DHH-N2021-76010. A 69-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot number EM0477) via an unspecified route of administration on 22Jan2021 around 15:00 at a single dose for covid-19 vaccination. The patient medical history included lewy body dementia, appendicitis and did cholecystectomy, benign paroxysmal positional vertigo, urinary incontinence and repeated urinary tract infections. Concomitant medications included enoxaparin sodium (CLEXANE, Strength: 40mg) at 1 DF, daily; melatonine at 2mg, daily; benserazide hydrochloride, levodopa (PROLOPA 250) at 1.5 DF, daily; pantoprazole sodium sesquihydrate (PANTOMED, Strength: 40mg) at 1 DF, daily; estriol (AACIFEMINE, Strength: 2mg) at 1DF, daily; ascorbic acid, ferrous sulfate (FEROGRAD, Strength: 500mg) at 1DF, daily; donepezil (Strength: 10mg) at 1DF, daily. Degradation 1 hour later with hypotensive discomfort and dyspnea. The patient felt malaise. Call from the home doctor and considered as impression of anaphylactic reaction, without erythema or pruritus. The patient was received 0.3 mg sc of adrenaline. Then, the patient was admitted to the emergency department which concluded with a covid pneumonia of moderate to severe attack on the CT scan (multiple frosted glass areas disseminated in the different lobes with a predominance of the middle and lower lobes where there are areas of densification) without signs of pulmonary embolism. Acute hypoxemic respiratory failure with moderate oxygen needs (4L / min DTM). A few hours later, the patient presented with cardio-respiratory arrest, probably in the context of massive inhalation of gastric contents. Resuscitation maneuvers were started and the patient was transferred to intensive care. The patient was died on 24Jan2021 in intensive care. It was unknown whether autopsy was done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardio-respiratory arrest; Anaphylactic reaction; Dyspnea; Malaise; hypotensive discomfort; covid pneumonia of moderate to severe attack; Acute hypoxemic respiratory failure


VAERS ID: 1035029 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood pressure measurement, Body temperature, C-reactive protein, Cardiac failure, Dementia, Diarrhoea, Headache, Heart rate, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Pain, Physical examination, Respiratory tract infection, SARS-CoV-2 test, Swelling face, White blood cell count
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Dementia (narrow), Pseudomembranous colitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO; AMLODIPINE; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm enlargement (Thoracic aortic aneurysm with a diameter of 62mm without treatment / surgery on patient''s request); Atrial fibrillation (Paroxysmal atrial fibrillation); Hypertensive heart disease (NYHA2 and EF maintained. Hypertensive Heart Disease with preserved EF 2019)
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: Blood creatinine; Result Unstructured Data: Test Result:84 umol/l; Test Date: 20210119; Test Name: Plasma potassium; Result Unstructured Data: Test Result:4.8 mmol/L; Test Date: 20210118; Test Name: Blood pressure; Result Unstructured Data: Test Result:135/80 mmHg; Test Date: 20210119; Test Name: Blood pressure; Result Unstructured Data: Test Result:normotensive mmHg; Test Date: 20210118; Test Name: Body temperature; Result Unstructured Data: Test Result:no fiever; Test Date: 20210119; Test Name: Body temperature; Result Unstructured Data: Test Result:afebrile; Test Date: 20210119; Test Name: C-reactive protein; Result Unstructured Data: Test Result:165 mg/l; Test Date: 20210118; Test Name: Heart rate; Result Unstructured Data: Test Result:120; Test Date: 20210119; Test Name: Heart rate; Result Unstructured Data: Test Result:120; Comments: tachycardic; Test Date: 20210119; Test Name: N-terminal prohormone brain natriuretic peptide; Result Unstructured Data: Test Result:5''255 pg/mL; Test Date: 202012; Test Name: SpO2; Test Result: 95 %; Test Date: 20210119; Test Name: SpO2; Test Result: 93 %; Test Date: 20210119; Test Name: Auscoltatory; Result Unstructured Data: Test Result:moist rales basal on both sides,emphasized left; Comments: moist rales basal on both sides but emphasized on the left; slight leg edema.; Test Date: 20210119; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210119; Test Name: Leucocyte count; Result Unstructured Data: Test Result:10.2 x10 9/l
CDC Split Type: CHPFIZER INC2021136425

Write-up: moderately oriented in the development of dementia; no assured ADR. Clinical infection + cardiac decompensation with exitus letalis 1 week after vaccination; no assured ADR. Clinical infection + cardiac decompensation with exitus letalis 1 week after vaccination/Respiratory infection; headache; slight diarrhea; body aches; swelling of the right side of the face; This is a spontaneous report received from a contactable physician via Agency, the regulatory authority. Regulatory authority report number CH-SM-2021-10496. An 86-year-old female patient received bnt162b2 (COMIRNATY), intramuscularly on 11Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertensive heart disease with preserved EF 2019, paroxysmal atrial fibrillation and thoracic aortic aneurysm with a diameter of 62mm (incidental finding in CT Jun2019) without treatment / surgery at the patient''s request. Concomitant medication included rivaroxaban (XARELTO) orally at 20mg once a day since 01Jul2019, amlodipine orally at 5mg once a day since 01Jan2013, pantoprazole orally at 20mg once a day since 01Jan2013. The patient previously received penicillin and experienced allergy and exanthema, Alendron and experienced allergy and exanthema, Lisinopril and experienced allergy and dry cough. As a resident at a home (assisted living in an apartment), the patient was vaccinated with the COVID vaccine from Pfizer / Biontech on 11Jan2021. Apparently from 14Jan2021 then headache, slight diarrhea and body aches without fever as well as a not quantifiable swelling of the right side of the face. This all improved significantly after 3 days. The family doctor was not informed of these complaints at this time. The family doctor was only contacted on the evening of 18Jan2021 because of "chills" without fever and somewhat shallow breathing. Blood pressure is 135 / 80 mmHg and the heart rate is 120. No fever. The family doctor ordered a COVID-19 smear over the phone and symptomatic therapy with Dafalgan or Novalgin from the reserve medication. A home visit the next noon (19Jan2021) was promised and then carried out. The patient presented in a slightly reduced general condition, moderately oriented in the development of dementia. Normotensive but still tachycardic 120 and arrhythmic with known paroxysmal atrial fibrillation. SpO2 93% for indoor air (previous value in Dec2020: 95%). Auscultatory, moist rales basal on both sides but emphasized on the left; slight leg edema. No pain but exertional dyspnea NYHA2. afebrile. Laboratory: CRP (C-reactive protein) 165mg / l, Lc (Leucocyte count) 10.2 G / l, Crea (Blood creatinine) 84umol / l, potassium 4.8mmol / l, ProNT BNP (N-terminal prohormone brain natriuretic peptide) 5255 pg / ml. SarsCov2 PCR smear pending at this time. The patient refused hospitalization. With the daughter present, it was decided that COVID would continue to be possible and that antibiotics would not be given for the time being. Joint decision to wait for the next morning to give antibiotics in the case of negative PCR and to aim for frequency control with B-blockers. In the morning, however, the home phone called that the patient died that night. COVID-19 smear finally negative. At inspection of the corpse the patient sitting on the sofa in daytime clothes (nightgown laid out by daughter not used the night before). Nothing special. Pronounced rigor mortis. The time of death by the family doctor set to 19Jan2021 at 10 p.m. For death, no assured ADR, clinical infection and cardiac decompensation with exitus letalis 1 week after vaccination. An autopsy was not performed. Sender''s diagnosis/syndrome and/or reclassification of reaction/event: Respiratory infection. The outcome of events cardiac decompensation and respiratory infection was fatal, and outcome of headache, slight diarrhea, body aches and swelling of the right side of the face was recovered in Jan2021. The outcome of dementia was unknown. This case was reported by Agency as serious with seriousness criterion Results in death. A causal relationship between Comirnaty and the event death was assessed by Agency as being Unlikely. Reporter comment: Death in temporal correlation with the administration of Comirnaty. Sender''s comment of Agency as reported: Death occurred 8 days after administration of the COVID-19 Comirnaty vaccine, of an elderly woman already heart-compromised, with NYHA2 heart insufficiency, atrial fibrillation and 62mm thoracic aortic aneurysm. Immediately after vaccination, the patient did not experience adverse reactions. Only 3 days later the patient had mild symptoms with headache, arthralgia and light diarrhea but without fever, which at the time was not considered to be such as to be reported to the doctor and which resolved in 3 days. Subsequently, 7 days after vaccination, chills with no fever and weak breathing arose, bilateral basal crackles on auscultation. In consideration of the laboratory value of pro-NT BNP, of the CRP, of the persistent tachycardic condition, given that the patient was negative by PCR for COVID-19, the evaluation of the treating physician is likely, which profiles a situation compatible with a state lower respiratory tract infectious and left heart failure. In the current state of knowledge, despite the temporal link, given the critical clinical and laboratory conditions and the advanced age of the patient, we believe a direct causal correlation between vaccination with Comirnaty and the patient''s death is unlikely. We do not have imaging diagnostic elements to support this hypothesis nor an autopsy. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reporter''s Comments: Death in temporal correlation with the administration of Comirnaty.; Reported Cause(s) of Death: no assured ADR. Clinical infection + cardiac decompensation with exitus letalis 1 week after vaccination; no assured ADR. Clinical infection + cardiac decompensation with exitus letalis 1 week after vaccination/Respiratory infection


VAERS ID: 1035034 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Muscle disorder, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-COV-2; Result Unstructured Data: Test Result:negative
CDC Split Type: CHPFIZER INC2021136287

Write-up: general condition deterioration; fever; muscle complaints; This is a spontaneous report received from a contactable physician via regulatory authority. Regulatory authority report number CH-SM-2021-10839. An 85-year-old male patient received bnt162b2 (BNT162B2) first dose, via an unspecified route of administration on 08Jan2021 at single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The male patient was a nursing home resident where some residents were positive for COVID-19. An outbreak test was carried out on all staff and residents, and the negatively tested, asymptomatic residents were vaccinated on 08Jan2021. On 10Jan2021, the patient had fever, muscle complaints and general condition deterioration, which led to death after 7 days (17Jan2021). In other residents, the course was practically identical, they were then tested again for COVID during the illness phase, both were positive (and died within 7 days). The patient''s course was practically identical but he was not tested for COVID. The family doctor suspected a vaccination adverse reaction. In addition, the victim''s relatives requested a report from Regulatory Authority. Based on consultations and the medical infectious diseases service of the hospital ("no indications of a vaccination adverse reaction"), the medical service decided that the course of events corresponded to natural death (no unusual death) and was not to be interpreted as a adverse reaction to the vaccination. The general practitioner nevertheless requested that the Regulatory Authority be notified by the physician. A causality between BNT162B2 and death was reported as being unlikely by the Regulatory Authority. This case was assessed as serious with seriousness criterion results in death. Sender''s comment verbatim: Elderly nursing home resident tested negative for SARS-CoV-2 before receiving Comirnaty vaccine on 08Jan2021. On 10Jan2021 the patient developed fever muscle pain and general condition deterioration resulting in death 7 days later. In view of similar cases of other residents with confirmation of COVID-19, in the case of the patient in question we cannot rule out the possibility that he too was infected with SARS-CoV-2 (which he was carrying at the time of the swab or falsely negative swab), a virus that was definitely present in the facility, and that this infection, like similar cases in other residents, led to his death. However, we have no proof of this because we do not have the result of the swab, which was not taken after the patient became symptomatic on 10Jan2021. However, in view of the position taken by the doctor, supported by an infectivological evaluation (Infectiology Service of the Hospital ) that indicates "no hints for vaccination adverse reaction" and that was judged to be natural death (and not an "unusual death case"), we assessed the causal correlation between the death and Comirnaty vaccine to be unlikely.; Reported Cause(s) of Death: general condition deterioration; muscle complaints; fever


VAERS ID: 1035040 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Psoriasis, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021126646

Write-up: Death; Respiratory distress; Psoriasis flare-up; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority. The regulatory authority report number is DE-PEI-PEI2021002086. A female patient of an unspecified age received BNT162B2 (COMIRNATY; Lot number EM0477), intramuscular from 14Jan2021 to an unspecified date at SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. The patient''s concomitant medications were not reported. After vaccination, the patient experienced psoriasis flare-up on 15Jan2021; respiratory distress on 20Jan2021, and death on 21Jan2021. The patient died on 21Jan2021. An autopsy was not performed. Causality was reported as follows: Comirnaty/ Psoriasis flare-up, Respiratory distress, Death/ PEI/ A. Consistent causal association to No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1035041 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-28
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; Depression; Hypertension arterial; Restrictive respiratory insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021134715

Write-up: Cardiogenic shock; Respiratory insufficiency; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority DE-PEI-PEI2021002116. A 90-year-old female patient received the first dose of bnt162b2 (COMIRNATY) (lot number unknown), intramuscular on 13Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing, respiratory failure from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, cardiac failure from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 28Jan2021 after vaccination the patient developed Cardiogenic shock and Respiratory insufficiency, lasting for unknown. The patient is dead. Death cause was reported as Cardiogenic shock. The patient died on 28Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiogenic shock


VAERS ID: 1035042 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain damage (early childhood); Epilepsy; Palliative care
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: autopsy; Result Unstructured Data: Test Result:No adverse drug reaction
CDC Split Type: DEPFIZER INC2021134722

Write-up: Unclear death 5 hours after vaccination; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021002127, received from regulatory authority. A 66-year-old female patient received the second dose of bnt162b2 (COMIRNATY, lot number unknown), intramuscular on 02Feb2021 at single dose for COVID-19 immunisation. Medical history included Palliative care, Epilepsy, Brain damage (early childhood), all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. 5 hours after vaccination the patient developed Sudden death unexplained, lasting for unknown. The patient was dead on 02Feb2021. Death cause was reported as Sudden death unexplained. An autopsy was performed in Feb2021 that revealed no adverse drug reaction. Reporter''s comment: The deceased patient the physician reported was autopsied. There was no evidence of a vaccination reaction. Therefore physician would like to withdraw his/her suspected reaction report. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender''s Comments: The reported events are likely due to the underlying medical conditions and are unrelated to suspect drug BNT162B2.; Reported Cause(s) of Death: Sudden death unexplained; Autopsy-determined Cause(s) of Death: No adverse drug reaction


VAERS ID: 1035043 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronavirus test positive, Drug ineffective, SARS-CoV-2 test, Upper respiratory tract infection
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary heart disease; Dementia Alzheimer''s type; Nephropathy; Palliative care; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: Corona test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021134724

Write-up: Coronatest positive; Coronatest positive; Upper respiratory tract infection; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-PEI2021002143. A 98-years-old female patient received the first dose bnt162b2 (COMIRNATY, lot number EJ6796), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included palliative care, coronary artery disease, nephropathy, dementia alzheimer''s type, type 2 diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced upper respiratory tract infection on 05Jan2021, coronatest positive on 07Jan2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of event coronatest positive was unknown. The outcome of event upper respiratory tract infection was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Upper respiratory infection


VAERS ID: 1035044 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haematemesis, Upper gastrointestinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Hemiparesis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021134729

Write-up: Upper gastrointestinal bleeding; Hematemesis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory authority number: DE-PEI-PEI2021002145. A 82-years-old male patient received the first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included apoplexy and hemiparesis both from 2018 to an unknown date. The patient''s concomitant medications were not reported. On 06Jan2021 after vaccination the patient developed upper gastrointestinal haemorrhage and hematemesis, lasting for unknown and result in death. The patient dead on an unknown date. It was not reported if an autopsy was performed. Outcome of the event was fatal. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: upper gastrointestinal haemorrhage; hematemesis


VAERS ID: 1035045 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical condition abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary heart disease; Dementia; Multimorbidity; Prostate cancer metastatic; Renal insufficiency; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021134663

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


VAERS ID: 1035046 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210114; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 20210127; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: DEPFIZER INC2021134659

Write-up: Exitus letalis/ Sudden death unexplained; sars-cov-2 test: positive on 14Jan2021; sars-cov-2 test: positive on 14Jan2021; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, number DE-PEI-PEI2021002162. This report was forwarded via RA, however no RA number was provided. A 89-years old female patient received the first dose of bnt162b2 (COMIRNATY), lot number unknown, via an unspecified route of administration on 13Jan2021 (at the age of 89-years old) as a single dose for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. The patient experienced exitus letalis on 31Jan2021. Death cause was reported as Sudden death unexplained. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Jan2021, sars-cov-2 test: negative on 27Jan2021. An autopsy was performed and results were not provided. Outcome of the sars-cov-2 test: positive on 14Jan2021 was unknown. Reporter comment: Patient in stable general condition. Sender comment: According to the nursing staff in the home, this is the 12th death in temporal connection with the Corona vaccination. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Exitus letalis/ Sudden death unexplained


VAERS ID: 1035047 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19 pneumonia, Chest X-ray, Drug ineffective, SARS-CoV-2 sepsis, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral microangiopathy; Dementia; Epilepsy; Hypertension arterial; Ischemic cerebral infarction; Polyneuropathy
Allergies:
Diagnostic Lab Data: Test Date: 20210116; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Lung infiltrate; Test Date: 20210116; Test Name: COVID-19 rapid POC test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021134666

Write-up: Covid-19 Pneumonia/ COVID-19 rapid POC test: positive on 16Jan2021; Hyperinflammation syndrome; ARDS; Covid-19 Pneumonia; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority DE-PEI-PEI2021002163. A 68-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EM0477), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. Medical history included dementia, hypertension, cerebral microangiopathy, epilepsy, polyneuropathy, ischaemic cerebral infarction all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced hyperinflammation syndrome (SARS-CoV-2 sepsis), covid-19 pneumonia, ARDS (acute respiratory distress syndrome) all on 16Jan2021, the events were reported as serious per fatal. The patient underwent lab tests and procedures which included chest x-ray: lung infiltrate on 16Jan2021, COVID-19 rapid POC test: positive on 16Jan2021. The patient died on 16Jan2021. An autopsy was performed, and results were not provided.; Reported Cause(s) of Death: COVID-19 pneumonia; SARS-CoV-2 sepsis; ARDS; Covid-19 Pneumonia/ COVID-19 rapid POC test: positive on 16Jan2021


VAERS ID: 1035048 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2021-01-05
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arterial occlusive disease, COVID-19 pneumonia, Circulatory collapse, Drug ineffective, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Hypersensitivity (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder carcinoma; Cardiac insufficiency; Degeneration macular; Glaucoma; Goitre excision; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021134665

Write-up: Failure circulatory; Arterial occlusion; COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority- WEB [DE-PEI-PEI2021002175] received via Regulatory Authority. A female 94-year(s)-old patient was vaccinated with the first dose of bnt162b2 (COMIRNATY), (batch no.: was not reported) via an unknown route of administration on 27Dec2020 at single dose for COVID-19 immunization. Medical history included: glaucoma, hypertension arterial, cardiac insufficiency, degeneration macular, bladder carcinoma, goitre excision. Concomitant medication was not reported. 10 days after vaccination the patient developed COVID-19 pneumonia on 05Jan2021 (lasting for 8 days), arterial occlusion on 11Jan2021 and failure circulatory on 12Jan2021. Thrombectomy performed on 11Jan2021. Resuscitation required after general anesthesia. The patient died on 12Jan2021. Diagnosis was confirmed by COVID-19 virus test on 05Jan2021 (result: positive). Death cause was reported as circulatory collapse. All events were reported as serious with fatal seriousness criterion. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Failure circulatory; COVID-19 pneumonia; COVID-19 pneumonia; Arterial occlusion


VAERS ID: 1035050 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-10
Onset:2021-01-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Fibrin D dimer, Pneumonia, Procalcitonin, SARS-CoV-2 test, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Diabetes mellitus; Myocardial infarction; Comments: DD: ADE Antibody dependent Enhancement
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Creatinine; Test Result: 4 mg/dl; Test Date: 2021; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:Increased; Test Date: 2021; Test Name: Procalcitonin; Result Unstructured Data: Test Result:3; Comments: 3 u/ml; Test Date: 2021; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative
CDC Split Type: DEPFIZER INC2021146128

Write-up: Pneumonie; Schock; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, DE-PEI-PEI2021002331. An 85 years old male patient received the first dose of BNT162B2 (COMIRNATY, Lot. EJ6796) intramuscularly, at single dose, on 10Jan2021, for COVID-19 immunization. Relevant medical history included myocardial infarction, diabetes mellitus, and dementia, all from an unspecified date and unknown if ongoing. Concomitant medications were unknown. The patient experienced pneumonia on 20Jan2021 and shock on an unspecified date, in 2021. Clinical outcome of the events was reported as fatal. Relevant laboratory tests included COVID-19 virus test negative, Fibrin D dimer increased, procalcitonin 3 u/ml and creatinine 4 mg/dl. The patient died on an unspecified date, in 2021. No autopsy was done.; Reported Cause(s) of Death: Shock; Pneumonia


VAERS ID: 1035057 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-06
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Valvular heart disease NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021137578

Write-up: death; This is a spontaneous report from a contactable nurse. A 52-years-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Medical history included valvular heart disease and diabetes mellitus. The patient''s concomitant medications were not reported. The patient received the first dose on 27Jan2021, he had no side effects. On 06Feb2021 he died. The cause of death was not reported. It was not reported if an autopsy was performed. Lot/batch number has been requested.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The unknown cause of death is assessed as related to suspected vaccine BNT162B2 per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: died


VAERS ID: 1035058 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021150946

Write-up: died; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB, regulatory authority report number is DE-DCGMA-21187794. The physician reported on three patients with similar events. This is the first of three reports. An elderly patient of unspecified gender received BNT162B2 (COMIRNATY) (lot number/expiration date: not provided), via an unspecified route of administration on an unknown date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient died in the nursing home after receiving vaccination. The cause of death was not provided. It was unknown if an autopsy was performed. No Follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021151226 the same product, the same event, a different patient;DE-PFIZER INC-2021151227 the same product, the same event, a different patient;DE-PFIZER INC-2021126603 the same product, the same event, a different patient; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1035059 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021151226

Write-up: Died; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority is DE-DCGMA-21187794. The physician reported on three patients with similar events. This is the second of three reports. An elderly patient of unspecified gender received BNT162B2 (COMIRNATY) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date, 1 dosage form as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient died in the nursing home after receiving vaccination. The cause of death was not provided. It was unknown if an autopsy was performed. No Follow-Up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021126603 the same product, the same event, a different patient;DE-PFIZER INC-2021150946 the same product, the same event, a different patient;DE-PFIZER INC-2021151227 the same product, the same event, a different patient; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1035060 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021151227

Write-up: Death; This is a spontaneous report from a physician created as a split case from the case downloaded from the regulatory authority-WEB, regulatory authority is DE-DCGMA-21187794. The Physician reported information on three patients (as a "Comment") . This is the third of the three cases. A patient of unspecified age and gender received BNT162B2 (COMIRNATY, Lot number unknown), via an unspecified route of administration on an unknown date (at an unknown age) as a single dose (reported as "1 DF") for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported. The reporter commented that "another three patients have died in the nursing home after the corona vaccination." The patient died on an unspecified date. It was unknown if an autopsy was performed. No further information was reported. No Follow-Up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021126603 the same product, the same event, a dofferent patient;DE-PFIZER INC-2021150946 the same product, the same event, a dofferent patient;DE-PFIZER INC-2021151226 the same product, the same event, a different patient; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1035091 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Arterial hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021139723

Write-up: unknown cause of death; This is a spontaneous report from contactable physicians. This report was received via a sales representative. A 52-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number and exp. date unknown), via an unspecified route of administration on 05Feb2021, at single dose covid-19 immunization. Medical history included arterial hypertension, allergic rhinitis. The patient''s concomitant medications were not reported. The patient died on the early morning of 06Feb2021 after receiving the second dose of Comirnaty 12h before the event. Her son had recently debuted with an autoimmune disease. The patient died on 06Feb2021. It was not reported if an autopsy was performed. Information about lot/batch number has been requested.; Sender''s Comments: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. The case will be re-assessed when relevant information, particularly the cause of death, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1035098 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, Death, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Diabetes; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: Hyperkalemia; Result Unstructured Data: Test Result:5.8 mEq/l
CDC Split Type: FRPFIZER INC2021134703

Write-up: Death NOS; Emesis; Headache; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory-WEB FR-AFSSAPS-BX20210382 This is a report received from the Regulatory Authority. An 89-years-old female patient received bnt162b2 (COMIRNATY, lot number EJ6134), intramuscular on 15Jan2021 at single dose for covid-19 immunisation. Medical history included anaemia, hypertension, diabetes. The patient''s concomitant medications were not reported. The patient experienced death NOS on 17Jan2021, emesis and headache on 16Jan2021. Pre-vaccination context where the patient had refused to eat for two days. Blood test requested but vaccination performed before obtaining the results. On the balance sheet, dehydration objectified with hyperkalaemia at 5.8 mEq / L treated 5 hours after vaccination with Kayexalate. The patient died on 17Jan2021. An autopsy was not performed. The outcome of events emesis and headache was not recovered. Cause of death mentioned by the doctor: intracranial hypertension or ischemic stroke with dehydration (pending clarification). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1035099 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Oxygen saturation abnormal
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Fracture femur
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: desaturation; Result Unstructured Data: Test Result:desaturation
CDC Split Type: FRPFIZER INC2021141042

Write-up: Acute circulatory failure; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-BX20210445. This is a report received from the Regulatory Authority. A 90-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY, lot # EJ6795) intramuscular at single dose on 28Jan2021 for covid-19 immunisation. Medical history included femur fracture, dementia. The patient''s concomitant medications were not reported. The patient experienced acute circulatory failure with hypotension, bradycardia, desaturation on 02Feb2021. The patient died on 02Feb2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Acute circulatory failure


VAERS ID: 1035102 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Asthenia, Blood glucose, Blood pressure measurement, C-reactive protein, Coma scale, Erythema, Face oedema, Generalised oedema, Glomerular filtration rate, Laboratory test, N-terminal prohormone brain natriuretic peptide, Oedema peripheral, Oxygen saturation, Protein albumin ratio, Somnolence
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; KAYEXALATE; CALCIDOSE [CALCIUM CARBONATE;COLECALCIFEROL]; DOLIPRANE; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; NOVORAPID; SODIUM CHLORIDE; IMOVANE; BISOCE; OXYGEN; MICROPAKINE
Current Illness: Hospitalization
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Carcinoma basal cell (nodular infiltrator nodular type in a fibroepithelial tumor of Pinkus in the dorso-lumbar region); Cardiac failure (decompensation ischemic heart disease in November 2016 (apical hypokinesia)); Failure respiratory; Morbid obesity; Myocardial ischaemia (decompensation ischemic heart disease in November 2016 (apical hypokinesia)); Poliomyelitis (paraplegic); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: Glucose; Result Unstructured Data: Test Result:0.40 g/l; Test Date: 20210121; Test Name: BP; Result Unstructured Data: Test Result:130/60; Test Date: 20210121; Test Name: Glasgow; Result Unstructured Data: Test Result:7; Test Date: 20210118; Test Name: CRPV; Result Unstructured Data: Test Result:20; Test Date: 20210118; Test Name: MDRD; Result Unstructured Data: Test Result:41 mL/Min; Test Date: 20210121; Test Name: flumazenil test; Test Result: Negative ; Test Date: 20210118; Test Name: pro-BNP; Result Unstructured Data: Test Result:467; Test Date: 20210121; Test Name: Oxygen saturation; Test Result: 81 %; Comments: desaturation at 81% in 1 l / min. Oxygen increase to 3 l / min; Test Date: 20210118; Test Name: total proteins; Result Unstructured Data: Test Result:68
CDC Split Type: FRPFIZER INC2021134734

Write-up: Acute respiratory failure; The patient presents drowsiness and asthenia; The patient presents drowsiness and asthenia; redness in the right arm/redness in both arms with pigmentation of the stomach and thighs/ redness of the face; edema on the face; Generalized edema; edemas located mainly in the upper limbs, and predominant on the right; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) regulatory authority-WEB FR-AFSSAPS-LM20210110. An 84-year-old female patient received first dose of bnt162b2 (COMIRNATY) via intramuscular at left arm on 08Jan2021 at single dose for COVID-19 vaccination. Co-suspect drug included vildagliptin (GALVUS) orally from 04Jan2021 to 21Jan2021 at 50 mg once a day for Type 2 diabetes mellitus. Medical history included Cardiac failure from Nov2016 and unknown if ongoing (decompensation ischemic heart disease in November 2016 (apical hypokinesia)); Carcinoma basal cell from Jul2020 and unknown if ongoing (nodular infiltrator; Invasive basal cell carcinoma of nodular type in a fibroepithelial tumor of Pinkus in the dorso-lumbar region); Poliomyelitis (paraplegic), Type 2 diabetes mellitus, Chronic Failure respiratory, all from unknown date and unknown if going; bedridden; morbid obesity; hospitalized since Aug2017 and ongoing. No history of allergies (erythema on contact with certain dressings only). Concomitant medication included furosemide, sodium polystyrene sulfonate (KAYEXALATE), calcium carbonate, colecalciferol (CALCIDOSE [CALCIUM CARBONATE;COLECALCIFEROL]), paracetamol (DOLIPRANE), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]), insulin aspart (NOVORAPID), sodium chloride, zopiclone (IMOVANE), bisoprolol fumarate (BISOCE), oxygen, valproate sodium, valproic acid (MICROPAKINE). Patient was experienced Acute respiratory failure on 21Jan2021 and Generalized edema on 12Jan2021. On 12Jan2021 the patient presents edemas located mainly in the upper limbs, and predominant on the right. It is prescribed the local application of mannitol 10%. Then extension of this edema on the face from 15Jan2021, without burning sensation. On 17Jan2021, this edema becomes more important in the arms, neck and face with redness in the right arm (arm opposite to the vaccination). From 18Jan2021, diuretic therapy is reinforced: 40 mg of SC furosemide at 3 p.m. then 125 mg in the morning and 80 mg at noon orally (compared to 60 mg in the morning usually) + corticosteroid treatment started: 120 mg of methylprednisolone in SC at 3 p.m. then 40 mg in the morning. The patient presents drowsiness and asthenia. 18Jan2021, MDRD: 41 mL/Min, Total proteins: 68, Pro-BNP = 467, CRPV = 20, no fever. The patient''s clinical condition improved on 19Jan2021: she was able to eat and take her oral treatments, with logorrhea. Edemas in the upper limbs are still present. The corticosteroids are therefore maintained with a change to 80 mg of methylprednisolone in the morning. On 20Jan2021 morning, the patient presented redness in both arms with pigmentation of the stomach and thighs. At 11:45 am, these disappeared. She is wide awake, not in pain, has taken her oral treatments. The topical application of mannitol and the corticosteroid treatment are maintained. On 21Jan2021 at 9 a.m., the patient was drowsy and still presented with generalized edema (arms and legs) with redness of the face. She is not dyspneic but remains oxygen dependent. Vildagliptin is stopped and furosemide treatment is increased to 250 mg / 24h in PSE-SC after a bolus of 60 mg. Around 9.45 a.m., the patient presented rolled-up eyes and foamy saliva, she was reactive without desaturation. No pulmonary signs observed. BP = 130/60. Good saturation. The facial redness observed transiently disappears after administration of corticosteroid therapy. At 4 p.m., increase with the appearance of edema of the tongue in particular and desaturation at 81% in 1 l / min. Oxygen increase to 3 l / min. She received 80 mg of Furosemide SC, 150 mg methylprednisolone and one ampoule of Polaramine* 5 mg SC. The patient is transferred to the emergency: Glasgow 7, pendular movement of the eyes, hypoglycemia at 0.40 g/l, intermediate and reactive pupils, bilateral edema +++ leg and arm. Sounds of the heart regularly perceived without breath, hypoventilation. Venous line placed by the resuscitator. Treatment received at emergency: G30%: 2 IV ampoules, Furosemide: 80 mg IV, Oxygen: 6 l / min, Epinephrine and budesonide aerosol, Negative flumazenil test. Faced with the suspicion of angioneurotic edema under vildagliptin, an injection of Firazyr* is also given: 30 mg SC.On 22Jan2021, the patient was still hospitalized in the intensive care without noticeable improvement. Sedation is started with midazolam at 10 a.m. and oxygen flow is reduced to 3 l / min from 4 p.m. She was sent back to long-term care unit at 5:00 p.m. The patient is placed on furosemide at 500 mg / 24h, the edemas are still present, in slight regression, with continued sedation associated with analgesia (oxycodone electric syringe pump) and under 2 l / min of oxygen. Palliative care, persistence of edema. Action taken of vildagliptin was unknown. Patient was died because of Acute respiratory failure and Generalized edema on 26Jan2021. The last outcome of other events was unknown. The autopsy was not done.; Reported Cause(s) of Death: Acute respiratory failure; Generalized edema


VAERS ID: 1035103 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Lip oedema, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Dementia; Functional bowel syndrome; Hypertension arterial; Hypothyroidism; Intestinal polyp; Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: fever; Result Unstructured Data: Test Result:38.8 Centigrade
CDC Split Type: FRPFIZER INC2021134736

Write-up: Death unexplained; fever of 38.8 Celsius degrees in the axilla; Oedema lip; This is a spontaneous report from a contactable Physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-LY20210363 This is a report received from the Regulatory Authority. A 102-year-old female patient received first dose of BNT162B2 (COMIRNATY) Lot number EJ6788, Intramuscular in left arm on 26Jan2021 at single dose for COVID-19 vaccination. Medical history included Functional bowel syndrome, Hypothyroidism, Dementia, Hypertension arterial, Intestinal polyp, Renal failure, Anxiodepressive syndrome. No allergic attack. Concomitant medication was not reported. On 28Jan2021, the patient had deterioration of the general condition with significant labial edema, fever of 38.8 Celsius degrees in the axilla. The patient has no rash, no dyspnea. Supported by Solumedrol, subcutaneous hydration, paracetamol. Then, in palliative care, addition of morphine and clonazepam subcutaneous injection in the face of agitation. The patient had Death unexplained on 31Jan2021. The patient died on 31Jan2021 11:40 p.m. No cause identified. The outcome of labial edema was resolved. The outcome of fever of 38.8 Celsius degrees in the axilla was unknown.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1035105 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-02
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchopneumopathy, Cardiac failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis rheumatoid; Failure respiratory; Heart failure; Kidney failure; Scoliosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021134706

Write-up: Decompensation cardiac; Acute bronchopneumopathy; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB FR-AFSSAPS-NT20210142. An 86-year-old female patient received bnt162b2 (COMIRNATY), intramuscularly on 21Jan2021 at single dose for covid-19 prophylaxis. Medical history included scoliosis from an unknown date and unknown if ongoing, Arthritis rheumatoid from an unknown date and unknown if ongoing, Failure respiratory from an unknown date and unknown if ongoing, heart failure from an unknown date and unknown if ongoing, Kidney failure from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced decompensation cardiac on 02Feb2021, acute bronchopneumopathy on 02Feb2021. The events were serious as death. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch numbers cannot be obtained. ; Reported Cause(s) of Death: Acute bronchopneumopathy; Decompensation cardiac


VAERS ID: 1035106 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive disturbance; Diabetes; Ischaemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021134713

Write-up: Emesis; Cardiogenic shock; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-NT20210150. An 86-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number EJ6795) via intramuscular in right arm on 12Jan2021 at single dose for covid-19 prophylaxis. Medical history included ischaemic heart disease, cognitive disturbance, diabetes all unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced emesis and cardiogenic shock result in death on 18Jan2021. The events were fatal. The patient died on 18Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Emesis; Cardiogenic shock


VAERS ID: 1035109 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Blood pressure measurement, Heart rate, Oxygen saturation, Tachycardia
SMQs:, Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; CITALOPRAM; LEVETIRACETAM; AMLOR; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; FENTANYL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal hernia (abdominal wall eventration cure); Anxiety; Bowel obstruction; Chondrocalcinosis; Cognitive disorder; Epilepsy; Hernia hiatal; Hypertension arterial; Neurocognitive deficit; Patella fracture (left patella fracture); Wrist fracture (left wrist fracture)
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: Blood pressure; Result Unstructured Data: Test Result:107/70 mmHg; Test Date: 20210126; Test Name: Blood pressure; Result Unstructured Data: Test Result:no drop in blood pressure mmHg; Test Date: 20210126; Test Name: Heart rate; Result Unstructured Data: Test Result:94/min; Test Date: 20210126; Test Name: Heart rate; Result Unstructured Data: Test Result:130/min; Test Date: 20210126; Test Name: Saturation; Test Result: 93 %; Test Date: 20210126; Test Name: Saturation; Test Result: 78 %
CDC Split Type: FRPFIZER INC2021134720

Write-up: Acute respiratory distress syndrome; Tachycardia; This is a spontaneous report from a contactable physician (geriatrician) downloaded from the Agency Regulatory Authority, Regulatory Authority Report Number: FR-AFSSAPS-PA20210200. A 91-years-old female patient received second dose of bnt162b2 (COMIRNATY, Lot#: EM0477), via intramuscular, on 26Jan2021 at 0.3 mL single for COVID-19 vaccination. Co-suspect included fentanyl, via cutaneous from 26Jan2021 to an unspecified date at unknown dose for pain. Medical history included epilepsy, hypertension arterial, chondrocalcinosis, bowel obstruction, anxiety, hernia hiatal, neurocognitive deficit, neurocognitive disorders, left patella fracture/ left wrist fracture, abdominal wall eventration cure, no signs of allergy. The historical vaccine included Comirnaty 1st intramuscular injection on 05Jan2021 lot# EJ6795 (post-first injection tolerance was very good without observable effects). Concomitant medication included Furosemide 20 mg/day started on 14Sep2020 for hypertension, Citalopram 20 mg/day started on 07Feb2020 for neurocognitive disorders, Levetiracetam 6 mg/day started on 14Sep2020 for epilepsy, amlodipine besilate (AMLOR) at 5 mg/day introduced on 18Sep2020 for hypertension, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) 2 sachets/day introduced on 14Sep2020 for intestinal disorders. Noted administration of fentanyl 12 ug/h for 3 days on 26Jan2021 for pain (patient intolerant to opioids). Bedridden patient having had difficulty eating for several days. Family was informed on 26Jan2021 about the transport of the patient to comfort care with management adapted to the loss of autonomy (anti-decubitus care, pain assessment, full-scale help with toilet, diet and hydration). Clinically: asthenic patient at risk of aspiration, examined on the morning of 26Jan2021, no dyspnea, constant normal with blood pressure at 107/70, saturation at 93%, heart rate at 94/min, afebrile. Normal conditions of use of the comirnaty vaccine concerning the 2nd injection booster. Shortly after the injection of the vaccine, appearance of a discreet supraclavicular indrawing followed by rapid decompensation with acute respiratory distress, desaturation with saturation at 78%, no drop in blood pressure but tachycardia at 130/min. Despite the first aid: oxygen therapy and injection of adrenaline, death quickly occurred after the injection of comirnaty without carrying out additional investigations or resuscitation (patient in comfort care). Chronology of events: Application of the fentanyl patch was done on 26Jan2021 at 10 a.m. (schedule validated on the nursing software). The 2nd injection reminder of the comirnaty vaccine took place on 26Jan2021 at 1:58 p.m. (traced in real time on the vaccination certificate: Data sent to health insurance). Death was declared at 2:50 p.m.. The patient experienced acute respiratory distress syndrome and tachycardia on 26Jan2021. The seriousness criteria of the events were reported as death. The patient died on 26Jan2021. An autopsy was not performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute respiratory distress syndrome; Tachycardia


VAERS ID: 1035112 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Atrial fibrillation; Permanent cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021134726

Write-up: Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-PC20210125. A 93-year-old female patient received first dose of bnt162b2 (COMIRNATY) Lot # EJ6795, intramuscular on 21Jan2021 at single dose in the left arm for covid-19 immunisation. Medical history included atrial fibrillation and Alzheimer''s disease both from an unknown date and unknown if ongoing, and permanent cardiac pacemaker insertion. Concomitant medication included rivaroxaban (XARELTO) for atrial fibrillation. The patient experienced death unexplained in the afternoon, without prodrome on 24Jan2021. It was unknown if an autopsy was performed. The patient is considered to be at risk of developing a severe form of COVID-19 disease due to her age.She has not had COVID-19 and has not been tested. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1035117 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dysphonia, International normalised ratio, International normalised ratio abnormal, Productive cough, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALDACTONE [SPIRONOLACTONE]; BISOCE; FORLAX; LASILIX [FUROSEMIDE]; LOSARTAN; PANTOPRAZOLE; RISPERDAL; SINTROM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac arrhythmia; Cardiac pacemaker replacement; Hospitalization (Discharged with stopping anticoagulation for 7 days (resumption scheduled for 29Jan2021).); Hypertension arterial; Ischaemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210130; Test Name: INR; Result Unstructured Data: Test Result:1.14
CDC Split Type: FRPFIZER INC2021141162

Write-up: Sudden death unexplained; INR abnormal 1.14; Productive cough; Hoarseness; This is a spontaneous report downloaded from the Medicines Agency (MA) regulatory authority-WEB [Regulatory Authority number FR-AFSSAPS-PV20210161] from a contactable physician. An 88-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY) (lot# EJ6788), intramuscular in left arm, on 28Jan2021, at 0.3 ml single, for COVID-19 immunisation. Medical history included myocardial ischaemia (unknown if ongoing), hypertension (unknown if ongoing), arrhythmia (unknown if ongoing), cardiac pacemaker replacement on 20Jan2021 (not ongoing), hospitalisation from an unknown date to 22Jan2021 (discharged with stopping anticoagulation for 7 days (resumption scheduled for 29Jan2021)). Concomitant medications included spironolactone (ALDACTONE), bisoprolol fumarate (BISOCE), macrogol 4000 (FORLAX), furosemide (LASILIX), losartan (unknown manufacturer), pantoprazole (unknown manufacturer), risperidone (RISPERDAL), acenocoumarol (SINTROM). The patient experienced hoarseness on 28Jan2021 with outcome of unknown, productive cough on 29Jan2021 with outcome of unknown, international normalised ratio (INR) abnormal 1.14 on 30Jan2021 with outcome of unknown and sudden death unexplained on 01Feb2021. On 28Jan2021: takeover of SINTROM by a registered nurse in advance (he noted an hematoma at the pacemaker, same day stop). On 29Jan2021: unknown intake of SINTROM (productive cough without fever). On 30Jan2021: dosage of the International Normalized Ratio (INR) at 1.14 (resumption of Vitamin K antagonists (VKA)). On 01Feb2021: patient was found dead in her chair, at her home around 09:00 AM after having had breakfast that morning. Cause of death not known. The patient underwent lab tests and procedures which included international normalised ratio (INR): 1.14 on 30Jan2021. The patient died on 01Feb2021 due to sudden death unexplained. An autopsy was not performed. General case description: death occurred 4 days after a 1st vaccination with COMIRNATY in an 88-year-old patient with a cardiovascular history, in the context of a change in pacemaker and International Normalized Ratio (INR) imbalance following an interruption of the anticoagulant treatment.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1035118 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM; ASPIRIN (E.C.); VITAMIN D NOS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Chronic obstructive pulmonary disease; Cognitive disturbance; Ischaemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021134664

Write-up: Cardiac arrest; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory authority WEB. The Regulatory Authority Report Number is FR-AFSSAPS-RE20210184. A contactable physician reported an 83-year-old male patient received BNT162B2 (COMIRNATY, Batch number: EJ6788), intramuscularly in the right arm on 19Jan2021 as a single dose form for Covid-19 immunization. The patient''s medical history included cognitive disorder from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, myocardial ischaemia from an unknown date and unknown if ongoing and chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. The patient had not contracted Covid-19. Concomitant medication included escitalopram (ESCITALOPRAM), acetylsalicylic acid (ASPIRIN (E.C.) and vitamin d nos (VITAMIN D NOS). On 22Jan2021, the patient experienced cardiac arrest during breakfast with no prodromes. The caregivers immediately rescued and performed a chest massage. A defibrillator was used which sent several shocks without success. Oxygen was also used via a high concentration mask. Death was noted on the spot by the Emergency Medical Aid Service that arrived in the meantime. The patient died on 22Jan2021. 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: Cardiac arrest


VAERS ID: 1035119 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-26
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Body temperature, COVID-19, Computerised tomogram, Drug ineffective, Heart rate, Motor dysfunction, Neurological examination, Oxygen saturation, Polymerase chain reaction
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Supraventricular tachyarrhythmias (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anterior cruciate ligament tear (Ligamentoplasty of the right anterior cruciate ligament); Appendicectomy; Blindness, one eye (blindness of the right eye); Calcific pancreatitis; Cataract (right) (probable cataract of the right eye); Chronic alcoholism (chronic alcoholism, currently weaned); Diabetes; Humerus fracture (Right humeral fracture with braces); Hypertension arterial; Hyperthyroidism; Peripheral obliterative arteriopathy; Tetraparesis (Appearance of a motor deficit in the 2 upper limbs); Transmetatarsal amputation (trans metatarsal amputation of the right foot); Ulcerative gastritis
Allergies:
Diagnostic Lab Data: Test Date: 20210114; Test Name: TA; Result Unstructured Data: Test Result:128/73; Test Date: 20210114; Test Name: TA; Result Unstructured Data: Test Result:12/7; Test Date: 20210114; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Test Date: 20210114; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Test Date: 20180827; Test Name: CT SCAN; Result Unstructured Data: Test Result:found diffuse encephalic atrophy with old left fro; Comments: found diffuse encephalic atrophy with old left frontal ischemic sequelae + per-ventricular leucoaraiosis.; Test Date: 20210114; Test Name: pulse rate; Result Unstructured Data: Test Result:60; Test Date: 20210114; Test Name: pulse rate; Result Unstructured Data: Test Result:78; Test Date: 20180827; Test Name: MOTOR DEFICIT; Result Unstructured Data: Test Result:Appearance of a motor deficit in the 2 upper limbs; Comments: Appearance of a motor deficit in the 2 upper limbs making it difficult to take meals alone from the summer of 2018; Test Date: 20180827; Test Name: Neurological exam; Result Unstructured Data: Test Result:had highlighted a tetraparesis around 4/5 greater; Comments: had highlighted a tetraparesis around 4/5 greater with a more marked deficit in the upper right limb, probably related to humeral surgery in 2013, associated with advanced peripheral neuropathy, related to diabetes and cognitive impairment with notable dysexecutive syndrome; Test Date: 20210114; Test Name: oxygen saturation; Result Unstructured Data: Test Result:95; Test Date: 20210114; Test Name: oxygen saturation; Result Unstructured Data: Test Result:97; Test Date: 20210114; Test Name: PCR; Result Unstructured Data: Test Result:COVID +
CDC Split Type: FRPFIZER INC2021134701

Write-up: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable other health professional downloaded from the regulatory authority FR-AFSSAPS-SE20210154. This reporter reported similar events for two patients. This is the second of two reports. A 68-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot no. EJ6796), intramuscularly in left arm on 14Jan2021 at single dose for covid-19 immunization. Medical history included cataract (probable cataract of the right eye), Anterior cruciate ligament tear (Ligamentoplasty of the right anterior cruciate ligament), ulcerative gastritis, peripheral arterial occlusive disease, Transmetatarsal amputation (trans metatarsal amputation of the right foot), pancreatitis chronic, hyperthyroidism, Hypertension arterial, diabetes mellitus, appendicectomy, Humerus fracture, Blindness, one eye, Tetraparesis all from an unknown date and unknown if ongoing; Chronic alcoholism from an unknown date not ongoing. Background included: diabetes complicated by transmetatarsal amputation of the right foot under insulin; AOMI; HTA (hypertension); probable cataract of the right eye with blindness of the right eye; Right humeral fracture with braces; Ligamentoplasty of the right anterior cruciate ligament, appendectomy; Calcifying pancreatitis; Biological hyperthyroidism; Ulcerated gastritis; Insane syndrome: CT scan of 27Aug18 which found diffuse encephalic atrophy with old left frontal ischemic sequelae + per-ventricular leucoaraiosis. Appearance of a motor deficit in the 2 upper limbs making it difficult to take meals alone from the summer of 2018. The neurological examination had highlighted a tetraparesis around 4/5 greater with a more marked deficit in the upper right limb, probably related to humeral surgery in 2013, associated with advanced peripheral neuropathy, related to diabetes and cognitive impairment with notable dysexecutive syndrome. Patient institutionalized around the age of 60 in a context of chronic alcoholism, currently weaned. Treatment in 2019 included: insulin glargine (ABASAGLAR) 100: 10-0-0; alprazolam 0.5: 0.5-0.5-1; amlodipine 5: 1-0-0; rosuvastatin 5: 0-0-1; boric acid; sodium borate (DACRYOSERUM) 1-0-1; betamethasone dipropionate; calcipotriol (DAIVOBET) 50: 1-0-1; econazole 1-0-1; latanoprost (MONOPROST) 0-0-1; clopidogrel 0-1-0; retinol;tocopherol (VITAMIN A) 0-0-1. The patient''s concomitant medications were not reported. The patient experienced covid-19 (death) on 26Jan2021, Symptoms: dyspnea, fever, asthenia =$g put on O2. The patient underwent lab tests and procedures which included computerised tomogram: found diffuse encephalic atrophy with old left frontal ischemic sequelae + per-ventricular leucoaraiosis on 27Aug2018, motor dysfunction: Appearance of a motor deficit in the 2 upper limbs making it difficult to take meals alone from the summer of 2018 on 27Aug2018, neurological examination: had highlighted a tetraparesis around 4/5 greater with a more marked deficit in the upper right limb, probably related to humeral surgery in 2013, associated with advanced peripheral neuropathy, related to diabetes and cognitive impairment with notable dysexecutive syndrome on 27Aug2018, Constant monitoring before injection on 14Jan2021: pulse: 60; TA (Atrial fibrillation): 128/73; Saturation: 95; Temperature: 36.7. Constant monitoring 15 minutes after injection on 14Jan2021: pulse: 78; TA: 12/7; Saturation: 97; Temperature: 36.1. PCR (polymerase chain reaction): COVID positive on 14Jan2021. The patient died on 28Jan2021. It was not reported if an autopsy was performed.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021134697 different patient, same cluster of reports; Reported Cause(s) of Death: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms


VAERS ID: 1035120 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, COVID-19, Drug ineffective, Heart rate, Oxygen saturation, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Anxiodepressive syndrome; Carotid endarterectomy (1988 Internal carotid endariectomy); Cataract; Cataract operation; Hypothyroidism; Senile macular degeneration
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:115/10; Comments: Constant monitoring before injection; Test Name: Blood pressure; Result Unstructured Data: Test Result:11/8; Comments: Constant monitoring 15 minutes after injection; Test Name: temperature; Result Unstructured Data: Test Result:36.5; Comments: Constant monitoring before injection; Test Name: temperature; Result Unstructured Data: Test Result:36.2; Comments: Constant monitoring 15 minutes after injection; Test Name: Pulse rate; Result Unstructured Data: Test Result:80; Comments: Constant monitoring before injection; Test Name: Pulse rate; Result Unstructured Data: Test Result:84; Comments: Constant monitoring 15 minutes after injection; Test Name: saturation; Result Unstructured Data: Test Result:91; Comments: Constant monitoring before injection; Test Name: saturation; Result Unstructured Data: Test Result:93; Comments: Constant monitoring 15 minutes after injection; Test Date: 20210118; Test Name: PCR SARS-COV 2; Test Result: Positive
CDC Split Type: FRPFIZER INC2021134697

Write-up: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable other HCP from the Medicines Agency (MA) Regulatory authority WEB FR-AFSSAPS-SE20210161. This other HCP reported similar events for 2 patients. This is the first of two reports. A 78-year-old female patient received first dose of bnt162b2 (COMIRNATY, Lot#EJ6796), intramuscularly on 14Jan2021 at single dose, left arm for covid-19 immunisation. Medical history included cataract surgery, senile macular degeneration, Internal carotid endarterectomy from 1988, Alzheimer''s disease from 2015, hypothyroidism, Anxiodepressive syndrome, Catarct surgery. The patient''s concomitant medications were not reported. Treatment in Dec2020 included acetylsalicylate lysine (KARDEGIC) 75mg 1 sachet at noon; paroxetine 20 mg 1 + 0.5 in the morning; mianserine 10mg 2 tablets if needed; diazepam 10 drops at bedtime; olanzapine 5mg 0.5 -0 -0.5; zopiclone 7.5mg 0-0-1; levothyroxine sodium (LEVOTHYROX) 100?g 1-0-0; calcium D3: 500mg 1 sachet in the morning. The patient experienced covid-19 (PCR COVID +) on 18Jan2021. The event was serious as death. Symptoms reported as dyspnea, fever, fatigue. The patient was put on O2. The patient underwent lab tests and procedures which included blood pressure (Constant monitoring before injection): 115/10, blood pressure (Constant monitoring 15 minutes after injection): 11/8, body temperature(Constant monitoring before injection): 36.5, body temperature (Constant monitoring 15 minutes after injection): 36.2, pulse rate(Constant monitoring before injection): 80, pulse rate(Constant monitoring 15 minutes after injection): 84, oxygen saturation(Constant monitoring before injection): 91, oxygen saturation(Constant monitoring 15 minutes after injection): 93, PCR covid + on 18Jan2021. The patient died on 23Jan2021. It was not reported if an autopsy was performed. ; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021134701 different patient, same cluster of reports; Reported Cause(s) of Death: COVID-19 infection


VAERS ID: 1035122 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMINE [METFORMIN]; ACIDE FOLIQUE ARROW; KARDEGIC; PAROXETINE ARROW; TOUJEO; PRAVASTATINE ARROW; RAMIPRIL MYLAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Arterial hypertension; Blood glucose abnormal; Cognitive disturbance (progressive cognitive impairment and possible underlying psychiatric disorders); Dyslipidaemia; Hospitalization (due to dysglycemia, weight loss and anemia); Non-insulin-dependent diabetes mellitus; Stroke; Weight loss
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021141210

Write-up: Sudden death, cause unknown; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-TO20210272. A 77-year-old male patient received first dose of BNT162B2 (COMIRNATY, lot number: EJ6788), intramuscular on 26Jan2021 at single dose for COVID-19 immunization. The patient medical history included stroke in 2009, non-insulin-dependent diabetes mellitus, arterial hypertension, dyslipidemia, cognitive disturbance (progressive cognitive impairment and possible underlying psychiatric disorders), anemia, weight loss, dysglycemia, all from an unknown date and unknown if ongoing, the patient was hospitalized from 28Nov2020 to 03Dec2020 due to dysglycemia, weight loss and anemia. The patient''s concomitant medication included metformin oral from 01Dec2020 at 1700 mg once a day for non-insulin-dependent diabetes mellitus, folic acid (ACIDE FOLIQUE ARROW, formulation: tablet, strength: 5 mg) oral from 30Nov2020 at 5 mg once a day, acetylsalicylate lysine (KARDEGIC, formulation: powder for oral solution, strength: 75 mg) oral from 29Nov2020 at 1 dose form once a day, paroxetine hydrochloride (PAROXETINE ARROW, formulation: film-coated tablet, strength: 20 mg) oral from 29Ded2020 at 20 mg once a day, insulin glargine (TOUJEO, formulation: solution for injection in pre-filled pen, strength: 300 iU/mL) subcutaneous from 02Dec2020 at 20 iU once a day (evening) , pravastatin sodium (PRAVASTATINE ARROW, formulation: tablet, strength: 20 mg) oral from 29Nov2020 at 20 mg once a day and ramipril (RAMIPRIL MYLAN, formulation: tablet, strength: 5 mg) oral from 29Nov2020 at 5 mg once a day. The patient experienced sudden death (cause unknown) on 27Jan2021. An autopsy was not performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1035123 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-30
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021141212

Write-up: Death NOS; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority FR-AFSSAPS-TO20210392. A 93-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot EM0477) intramuscular at single dose on20Jan2021 for covid-19 immunisation. Medical history included terminal hypertrophic cardiac and cardiac failure. The patient''s concomitant medications were not reported. The patient died on 30Jan2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: End stage cardiac failure


VAERS ID: 1035124 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-04
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischaemic heart disease (2 stents in Oct2017); Stent placement
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021141213

Write-up: Infarct myocardial; Death NOS; This is a spontaneous report from a contactable physician received from the Medicines Agency (MA) Regulatory authority-WEB (Regulatory Authority number FR-AFSSAPS-TO20210394). An 87 years old female patient received BNT162B2 (COMIRNATY; lot EM0477) intramuscular, on 21Jan2021, at single dose, for COVID-19 immunisation. Medical history included ischemic heart disease (2 stents in Oct2017). Concomitant medications were not reported. The patient died on 04Feb2021 following an extensive myocardial infarction occurring on an old ischemic heart disease (2 stents in Oct2017). Cause of death was reported as infarct myocardial. No autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death NOS; Infarct myocardial


VAERS ID: 1035125 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021141199

Write-up: Death NOS; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-TO20210397. A 90-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, batch/lot # EM0477) intramuscular at single dose on 07Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on 09Jan2021. An autopsy was not performed. Patient was noted at the end of her life. No follow-up attempts are possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1035126 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-17
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Eyelid ptosis, Haematemesis, Heart rate, Oxygen saturation, Pneumonia aspiration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOLIPRANE; FORLAX; KARDEGIC; LEVETIRACETAM; PANTOPRAZOLE; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Haemorrhagic stroke; Hernia hiatal
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: blood pressure; Result Unstructured Data: Test Result:nothing to report mmHg; Test Date: 20210117; Test Name: blood pressure; Result Unstructured Data: Test Result:140/50 mmHg; Test Date: 202101; Test Name: temperature; Result Unstructured Data: Test Result:nothing to report Centigrade; Test Date: 20210117; Test Name: temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Test Date: 202101; Test Name: pulse; Result Unstructured Data: Test Result:nothing to report; Test Date: 20210117; Test Name: pulse; Result Unstructured Data: Test Result:120 BPM; Test Date: 20210117; Test Name: saturation; Test Result: 74 %; Comments: in open air; Test Date: 20210117; Test Name: saturation; Test Result: 95 %; Comments: Put under O2 4 l/min with saturation at 95 %
CDC Split Type: FRPFIZER INC2021141172

Write-up: left eye tending to droop; Hematemesis; Pneumonia aspiration; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority number FR-AFSSAPS-TS20210151). A 79 years old patient of unspecified gender received the first single dose of BNT162B2 (COMIRNATY; lot EM0477) intramuscular, on 08Jan2021, for COVID-19 vaccination. Medical history included haemorrhagic stroke and hernia hiatal (both not ongoing). Concomitant medications included paracetamol (DOLIPRANE), macrogol 4000 (FORLAX), acetylsalicylate lysine (KARDEGIC) as long-term treatment, levetiracetam, pantoprazole, tamsulosin. After vaccination, monitoring over 3 days (blood pressure, pulse, pain, skin reaction and temperature): nothing to report. Nothing abnormal since then. On 16Jan2021 in the evening onset of nausea. On 17Jan2021 at 4:30 A.M. gray vomiting. One hour later, traces of vomiting in the nose, the left eye tending to droop, no pain, blood pressure at 140/50 mmHg, pulse at 120 BPM, desaturation at 74 % in open air, temperature at 37.1 ?C. Put under O2 4 l/min with saturation at 95 %. Antibiotic therapy with amoxicillin/clavulanic acid (AUGMENTIN). On 17Jan2021 at 7:10 A.M. the patient was found dead with the presence of black vomiting in large quantities. Probable aspiration pneumonia on vomiting. Cause of death was reported as pneumonia aspiration. No autopsy was done. In total, inhalation pneumonia on severe black vomiting in a patient with a history of hiatus hernia and treated with Kardegic vaccinated 9 days previously with 1st Comirnaty dose. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia aspiration; Hematemesis


VAERS ID: 1035136 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Basophil count, Basophil percentage, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood creatinine, Blood potassium, Blood sodium, COVID-19, Death, Drug ineffective, Eosinophil count, Eosinophil percentage, Full blood count, Glomerular filtration rate, Haematocrit, Haemoglobin, Investigation, Liver function test, Lymphocyte count, Lymphocyte percentage, Mean cell haemoglobin, Mean cell volume, Mean platelet volume, Medical observation, Monocyte count, Monocyte percentage, Neutrophil count, Neutrophil percentage, Ophthalmological examination, Platelet count, Red blood cell analysis, Red blood cell count, Red cell distribution width, Renal function test, SARS-CoV-2 test, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOXYCYCLINE; SALBUTAMOL
Current Illness: Cough; Ex-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Cough
Allergies:
Diagnostic Lab Data: Test Date: 20201125; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Basophil count; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: basophils percentage; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Blood albumin; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Blood alkaline phosphatase; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Blood bilirubin; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Blood creatinine; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Blood potassium; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Blood sodium; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Eosinophil count; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: percentage eosinophils; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Full blood count; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Haematocrit; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Haemoglobin; Result Unstructured Data: Test Result:unknown results; Test Date: 20200710; Test Name: Investigation; Result Unstructured Data: Test Result:Diabetes Year of Care annual review; Test Date: 20201125; Test Name: Liver function test; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Lymphocyte count; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: percentage lymphocytes; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Mean cell haemoglobin; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Mean cell volume; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: mean platelet volume; Result Unstructured Data: Test Result:unknown results; Test Date: 20200326; Test Name: Medical observation; Result Unstructured Data: Test Result:Seen in respiratory clinic; Test Date: 20201125; Test Name: Monocyte count; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: percentage monocytes; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Neutrophil count; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: percentage neutrophils; Result Unstructured Data: Test Result:unknown results; Test Date: 20201211; Test Name: Ophthalmological examination; Result Unstructured Data: Test Result:Left/right eye no maculopathy, left/right eye; Comments: Left/right eye no maculopathy, left/right eye background diabetic retinopathy (disorder); Test Date: 20201125; Test Name: Platelet count; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Red blood cell analysis; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Red blood cell count; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: red blood cell distribution; Result Unstructured Data: Test Result:unknown results; Test Date: 20201125; Test Name: Renal function test; Result Unstructured Data: Test Result:unknown results; Comments: renal profile; Test Date: 20210122; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 20201125; Test Name: White blood cell count; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC2021137332

Write-up: Death; COVID-19 confirmed by laboratory test; COVID-19 confirmed by laboratory test; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-EMIS-8379-9a7f5014-3aa5-4bba-81ac-291254a2ed39. Safety unique identifier GB-MHRA-ADR 24706554. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 12Jan2021 at single dose for COVID-19 immunization. Medical history included cough from 04Jan2021 to 02Feb2021, ex-tobacco user from 16Jun2020 and ongoing, cough from 12Mar2020 and ongoing. Concomitant medication included doxycycline from 04Jan2021 for cough, salbutamol from 04Jan2021 for cough. The patient previously received influenza vaccine (INFLUENZA VIRUS) on 25Sep2020. The patient experienced death (medically significant) on an unspecified date, got COVID $g 10 days post dose (medically significant) on 22Jan2021. Event details: COVID-19 confirmed by laboratory test. Got COVID $g 10 days post dose. 29/01/2021: Death notification from hospital. 02/02/2021: Patient died in hospital (pending clarification). The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 22Jan2021, alanine aminotransferase/ basophil count/ basophil percentage/ blood albumin/ blood alkaline phosphatase/ blood bilirubin/ blood creatinine/ blood potassium/blood sodium/ eosinophil count/ eosinophil percentage/ full blood count/ glomerular filtration rate/ haematocrit/ haemoglobin/ Liver function test/Lymphocyte count/ percentage lymphocytes/ Mean cell haemoglobin/ Mean cell volume/ mean platelet volume/ Monocyte count/percentage monocytes/ Neutrophil count/ percentage neutrophils/ Platelet count/ Red blood cell analysis/ Red blood cell count/ red blood cell distribution/ Renal function test (renal profile)/ White blood cell count, all on 25Nov2020 with unknown result, investigation: Diabetes Year of Care annual review on 10Jul2020, Medical observation: Seen in respiratory clinic on 26Mar2020, Ophthalmological examination: Left/right eye no maculopathy, left/right eye background diabetic retinopathy (disorder) on 11Dec2020. The patient died on an unspecified date (pending clarification). It was not reported if an autopsy was performed. The outcome of the event death was fatal, of the other event was not recovered. No follow-up attempts possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1035144 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN3924 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Apparent death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; BENDROFLUMETHIAZIDE; BISOPROLOL; BUMETANIDE; COLCHICINE; DERMOL [BENZALKONIUM CHLORIDE;CHLORHEXIDINE HYDROCHLORIDE;ISOPROPYL MYRISTATE;PARAFFIN, LIQUID]; EDOXABAN; FLUCLOXACILLIN; MIRTAZAPINE; MOMETASONE; OMEPRAZOLE; RAMIPRIL;
Current Illness: Mental status changes
Preexisting Conditions: Medical History/Concurrent Conditions: Gout; Morbid obesity; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021143984

Write-up: Apparent death; This is a spontaneous report received from a contactable physician via the regulatory authority. The Regulatory Authority report number is GB-MHRA-TPP14859110C947848YC1612535730736. Safety Report Unique Identifier GB-MHRA-ADR 24707694. A 61-year-old male patient received bnt162b2 (BNT162b2, Manufacturer Pfizer-BioNTech, lot# EN3924), via an unspecified route of administration, on 03Feb2021, at single dose, for COVID-19 immunisation. Medical history included gout, type 2 diabetes mellitus and morbid obesity. Concomitant medications included allopurinol (unknown manufacturer) at 1 dosage form (DF) 1x/day for gout from 29May2020 to unknown date, bendroflumethiazide (unknown manufacturer) from 29May2020 at 1 DF 1x/day (in the morning), bisoprolol (unknown manufacturer) from 29May2020 at 1 DF 1x/day, bumetanide (unknown manufacturer) from 29May2020 at 4 DF 1x/day, colchicine (unknown manufacturer) from 29May2020 to 19Jan2021 at 3x/day for 4 days (or until gout resolves) for gout, benzalkonium chloride, benzalkonium chloride solution, chlorhexidine dihydrochloride, isopropyl myristate, liquid paraffin (DERMOL) from 29May2020 as substitute of soap, edoxaban (unknown manufacturer) from 29May2020 at 1 DF 1x/day, flucloxacillin (unknown manufacturer) from 02Feb2021 at 1 DF 4x/day, mirtazapine (unknown manufacturer) from 29May2020 at 1 DF 1x/day, mometasone (unknown manufacturer) from 29May2020 at 1 DF 1x/day topical for skin inflammation, omeprazole (unknown manufacturer) from 29May2020 at 1 DF 1x/day, ramipril (unknown manufacturer) from 29May2020 at 1 DF 1x/day, sertraline (unknown manufacturer) from 29May2020 at 1 DF 1x/day, spironolactone (unknown manufacturer) from 29May2020 at 1 DF 1x/day, zinc (unknown manufacturer) from 14Dec2020 to 15Dec2020 used as directed. The patient experienced apparent death on 03Feb2021 with fatal outcome on 03Feb2021. An autopsy was not performed. It was reported that patient was in midst of mental health issue when vaccinated. After was found 3 hours later unexpected death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Apparent death; Death unexplained


VAERS ID: 1035310 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Lower respiratory tract infection, SARS-CoV-2 test, Seizure
SMQs:, Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chest infection; CVA; Hypertension; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021137102

Write-up: Seizure; SARS-CoV-2 infection; SARS-CoV-2 infection; Chest infection; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the RA. Regulatory authority report number: GB-MHRA-WEBCOVID-202102062019418600, Safety Report Unique Identifier GB-MHRA-ADR 24714675. An 85-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. Medical history included lower respiratory tract infection, hypertension, cerebrovascular accident and atrial fibrillation unknown if ongoing. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included prednisolone. The patient experienced SARS-CoV-2 infection on 20Jan2021, chest infection on 10Jan2021, seizure on 02Feb2021. SARS-CoV-2 infection, chest infection and seizure. Length of being unwell after the vaccination, not to put finger on. Then chest infection treated with antibiotics and prednisolone. Had seizure like episode before completing those medications. Passed away the day after the episode. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive covid-19 test on 20Jan2021. The patient died on 03Feb2021 with SARS-CoV-2 infection as cause of death. The outcome of rest events was unknown. It was unknown if an autopsy was performed. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; SARS-CoV-2 infection


VAERS ID: 1035311 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, C-reactive protein, COVID-19, Delusion, Drug ineffective, Gastric haemorrhage, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Gastrointestinal haemorrhage (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATENOLOL; FUROSEMIDE; ISOSORBIDE; LANSOPRAZOLE; PREDNISONE; SPIRONOLACTONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Function kidney decreased; Giant cell arteritis; Heart disease, unspecified; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: C-reactive protein; Result Unstructured Data: Test Result:over 400; Test Date: 20210114; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive
CDC Split Type: GBPFIZER INC2021143624

Write-up: Gastric bleeding; joint pain; Myalgia; Delusion; Whilst in hospital he caught Covid; SARS-CoV-2 infection; This is a spontaneous report received from a contactable consumer by Pfizer from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202102080904506790. Safety unique identifier GB-MHRA-ADR 24718838. An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 30Dec2020 for covid-19 immunisation. Medical history included giant cell arteritis, cardiac disorder, renal impairment. Concomitant medication included atenolol, furosemide, isosorbide, lansoprazole. The patient experienced gastric bleeding on 02Jan2021 with fatal outcome on 21Jan2021, whilst in hospital he caught Covid on 15Jan2021 (as reported) with outcome of not recovered, joint pain on an unspecified date with outcome of unknown, myalgia on an unspecified date with outcome of unknown, delusion on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included c-reactive protein: over 400 on an unspecified date, sars-cov-2 test: positive on 14Jan2021 (as reported). The patient died on 21Jan2021. It was not reported if an autopsy was performed. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. The reporter stated that "My father got very unwell 3 days after he had the vaccine, he became bed bound, his symptoms got so bad he had a gastric bleed that they could not control, so he was hospitalised, his C-reactive protein inflammatory markers went up to over 400 (should be below 8) he became delusional and was screaming in pain from muscle and joint pain. Whilst in hospital he caught Covid and we lost him NOT from Covid but from the effects of the vaccine, He died with covid and not of Covid. His symptoms were devastating from the Jab and then it was a domino effect from there on". No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Gastric haemorrhage


VAERS ID: 1035312 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac arrest; Resuscitation; Comments: Patient received vaccine during preceding day - attended the following morning by ambulance service staff in cardiac arrest. Presenting rhythm. Died at scene despite advanced life support resuscitation. Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021137211

Write-up: Cardiac arrest; This is a spontaneous report received from a contactable pharmacist by Pfizer from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202102080941138480. Safety unique identifier GB-MHRA-ADR 24718909. An 85-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 01Feb2021 at first dose, single dose for COVID-19 immunization. Medical history included cardiac arrest, and resuscitation. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest on 02Feb2021, which assessed life threatening and led to death. Patient received vaccine during preceding day - attended the following morning by Ambulance Service staff in cardiac arrest. Presenting rhythm asystole. The patient died at scene despite advanced life support resuscitation. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Unsure if patient is enrolled in clinical trial. The patient died on 02Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1035315 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-10
Onset:2021-01-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Look this is my Grandma who had the vaccine who i didnt get to talk to for a year. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021143738

Write-up: Death of grandmother; Suspected COVID-19; This is a spontaneous report from a contactable consumer (reporting on behalf of the grandmother) received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202102081831554880, Safety Report Unique Identifier GB-MHRA-ADR 24724594. An 83 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Jan2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not enrolled in clinical trial. The patient had suspected COVID-19 on 17Jan2021. A positive COVID-19 virus test was reported on an unknown date. The reporter reported death of grandmother on 24Jan2021. Cause of death was not specified. It was unknown if an autopsy was done. The reporter added that the patient got coronavirus from the vaccine. The patient told the reporter on the phone that she had no other interactions and had been at home the whole time as her food was delivered by the reporter''s uncle. So, the reporter considered that either the place where the elderly was taken to be vaccinated was not safe or the vaccine did not work. It was also reported that the patient had not tested positive for COVID-19 since having the vaccine. Suspected COVID-19 outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death of grandmother


VAERS ID: 1035316 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-01-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Myocardial infarction, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: COVID-19 test; Result Unstructured Data: Test Result:has not tested positive for COVID-19 (negative)
CDC Split Type: GBPFIZER INC2021143654

Write-up: Heart failure; Heart attack; This is a spontaneous report received from a contactable consumer by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202102090912104590, Safety Report Unique Identifier GB-MHRA-ADR 24726340. A 76 years old male patient (height 175 cm) received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 23Jan2021, for COVID-19 immunisation. Relevant medical history was unknown. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included atorvastatin. On 24Jan2021, the patient experienced heart attack. The patient had 2nd heart attack on 27Jan2021 and heart failure on 28Jan2021. The patient died on 29Jan2021. It was unknown if autopsy was done. The patient has been tested for COVID-19 on 27Jan2021 and resulted negative (has not tested positive for COVID-19). No follow-up attempts are possible, information about lot number cannot be obtained.; Reported Cause(s) of Death: Heart attack; Heart failure


VAERS ID: 1035317 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-02-08
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma scale, Computerised tomogram, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACICLOVIR; AMLODIPINE; AMOXICILLIN; CEFTRIAXONE; FERROUS FUMARATE; HYOSCINE BUTYLBROMIDE; LEVETIRACETAM; METARAMINOL; PERINDOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Iron deficiency anaemia; Comments: Hypertension Iron deficiency anaemia Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: GCS; Result Unstructured Data: Test Result:3; Test Name: GCS; Result Unstructured Data: Test Result:8; Test Name: CT; Result Unstructured Data: Test Result:normal
CDC Split Type: GBPFIZER INC2021143936

Write-up: Seizure; This is a spontaneous report from a contactable physician. This is a report received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202102090949475210 , Safety Report Unique Identifier GB-MHRA-ADR 24726836. An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 14Jan2021 for Covid-19 immunisation. Medical history included hypertension, iron deficiency anaemia. Concomitant medication included aciclovir, amlodipine, amoxicillin, ceftriaxone, ferrous fumarate, hyoscine butylbromide, levetiracetam, metaraminol, perindopril. The patient experienced seizure on 08Feb2021 with fatal outcome. Clinical course as follows: Patient was confused over phone and son found at patient collapsed on the floor at home, confused. Admitted to A&E with GCS 3 which improved later to GCS 8. At least 3 seizures since admission. Likely to be secondary hypoxic brian injury. CT normal. LP results awaited. Post-mortem awaited. The patient underwent lab tests and procedures which included on unknown date coma scale: 3; coma scale: 8; computerised tomogram: normal. The patient died on 08Feb2021. It was not reported if an autopsy was performed. The patient had not been tested for COVID-19 since the vaccination. Unsure if the patient had had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected; Reported Cause(s) of Death: SEIZURE


VAERS ID: 1035318 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Vaccinated 19/1/21 Died 24/1/21 Unsure if patient has had symptoms associated with COVID-19 Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021143954

Write-up: Death; This is a spontaneous report from a contactable other health professional via the MHRA. The Regulatory Authority report number is GB-MHRA-WEBCOVID-202102091305302930. Safety Report Unique Identifier GB-MHRA-ADR 24728147. A 36-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 19Jan2021, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was unsure if patient had symptoms associated with COVID-19 and if patient was enrolled in clinical trial. The patient experienced death (death, life threatening) on 24Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unknown date. An autopsy was not performed. Patient did not test positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: DEATH


VAERS ID: 1035319 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unsure if patient has had symptoms associated with COVID-19 Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021143781

Write-up: Death; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202102091331040050, Safety Report Unique Identifier GB-MHRA-ADR 24728268. A 77-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was unsure if patient had had symptoms associated with COVID-19 and it was unsure if patient was enrolled in clinical trial. The patient underwent lab tests and procedures which included negative covid-19 test on unspecified date. The patient died on 02Feb2021. It was not reported if an autopsy was performed. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1035320 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021143776

Write-up: Death; This is a spontaneous report received from a contactable Health Care Professional by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202102091335437340, Safety Report Unique Identifier GB-MHRA-ADR 24728307. A 74 years old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 03Feb2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. It was unsure if patient has had symptoms associated with COVID-19. COVID-19 test was not performed. Unsure if patient was enrolled in clinical trial. On 03Feb2021, the patient died. It was unknown if autopsy was done. No follow-up attempts are possible, information about lot number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1035322 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Death, Neuropsychiatric symptoms, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Behavioral and psychiatric symptoms of dementia; Dementia; Comments: Dementia (End of life medication prescribed but not commenced) Unsure if patient has had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021144183

Write-up: stage dementia; agitated; Death; This is a spontaneous report from a contactable consumer. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102091537110060 , Safety Report Unique Identifier GB-MHRA-ADR 24729689. A 87-years-old female patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation . Medical history included dementia, neuropsychiatric symptoms. The patient''s concomitant medications were not reported. On the 09Jan21 patient''s condition deteriorated and she became very agitated. The patient died on 13Jan2021. The patient was tested positive to Sars-cov-2 test: on an unknown date. 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


VAERS ID: 1035324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Diarrhoea, Dyspnoea, Faeces discoloured, Fatigue, Nausea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency; Liver cirrhosis; Oesophageal varices NOS; Comments: Liver cirrhosis Oesophageal varices Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021147086

Write-up: Laboured breathing; Diarrhea; Black stools; Nausea; Weakness; Tiredness; Loss of balance; This is a spontaneous report received by Pfizer from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202102101534529310 and Safety Report Unique Identifier GB-MHRA-ADR 24736232. A 77-years-old female patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 22Jan2021 at single dose for covid-19 immunisation . Medical history included hepatic cirrhosis, immunodeficiency and varices oesophageal. The patient''s concomitant medications were not reported. The patient experienced dyspnea on 22Jan2021 , diarrhea on 22Jan2021 with outcome of not recovered , black stools on 22Jan2021 with outcome of not recovered , nausea on 22Jan2021 with outcome of not recovered , weakness on 22Jan2021 with outcome of not recovered , tiredness on 22Jan2021 with outcome of not recovered , loss of balance on 22Jan2021 with outcome of not recovered. The patient died on 26Jan2021 from dyspnea. The patient underwent lab tests and procedures which included sars-cov-2 test: negative covid-19 test on 26Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Laboured breathing


VAERS ID: 1035342 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus (Under treatment); Hypertension (Under treatment)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021161491

Write-up: sudden death; The initial case was missing the following minimum criteria: (no first-hand knowledge). Upon receipt of follow-up information on (16Feb2021), this case now contains all required information to be considered valid. An 87-year-old male patient received BNT162B2 (COMIRNATY), intramuscular on 15Feb2021 as single dose for covid-19 immunisation. Medical history included hypertension and diabetes mellitus from unknown dates , both under treatment. The patient''s concomitant medications were not reported. The patient experienced sudden death on an unspecified date. Details were as follows patient experienced sudden death on an unspecified date eight minutes after vaccination. According to the first evaluation, death was neither due to the vaccination nor due an anaphylactic shock but it was a sudden death which occurred after vaccination. An autopsy would be performed was initially noted. The pneumologist who was present in the event, reported to the medical advisor that the patient after vaccination, was waiting for 20 minutes as per protocol. However, after about 10 mins, he collapsed. Resuscitation was performed, but the patient expired. Samples were collected in order to check if it was an anaphylactic reaction and an autopsy was also performed at the time of this report. Results would be available on 17Feb2021. According to the autopsy, the patients death was shortly after his vaccination at the hospital due to coronary artery stenosis and hypertrophic heart disease. An announcement signed by the Manager of the hospital stated that according to the findings of the autopsy, in relation to the loss of the 87 year old, shortly after his vaccination; his loss was due to coronary artery stenosis and hypertrophic heart disease, while no finding was found to support an anaphylactic reaction or other, vaccine-related. The manager pointed out that the vaccination had nothing to do with the event, and referred to the vaccine literature where such a side effect is not described. He stressed that there was no justification for the vaccine to cause such a complication in humans, in just a few minutes. The patient died on an unspecified date. An autopsy was performed.; Sender''s Comments: Based on the current available information, the event Sudden death is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. Coronary artery stenosis and hypertrophic heart disease may provide plausible explanations for the event. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: sudden death; coronary artery stenosis and hypertrophic heart disease; coronary artery stenosis and hypertrophic heart disease


VAERS ID: 1035353 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021142239

Write-up: Death; This is a spontaneous report from downloaded from the regulatory authority-WEB (IE-HPRA-2021-064671). A contactable physician reported that a 91-year-old male patient received the first dose of BNT162B2 (COMIRNATY) at single dose, on 19Jan2021, for COVID-19 immunisation. Relevant medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. Concomitant medications were unknown. On 21Jan2021, the patient died. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about lot number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1035354 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-30
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH AM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ABILIFY; BISOPROLOL; ELIQUIS; HALCION
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Blood transfusion (transfused 2 units); BPSD; Deafness; Dementia (Advanced); Fall; Insomnia; Macular degeneration; Osteoarthrosis; Pubis fracture; Stroke; Total knee replacement; Urinary tract infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021141068

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory -WEB IE-HPRA-2021-064759. A 91-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot number: AM0477), via an unspecified route of administration on 22Jan2021 at 0.3 mL single dose for COVID-19 immunization. The patient medical history included blood transfusion (transfused 2 units) and pubis fracture on Aug2018, fall on an unspecified date, stroke on 2014, total knee replacement on an unspecified date, osteoarthritis, atrial fibrillation (AFib), neuropsychiatric symptoms (BPSD), urinary tract infection, macular degeneration, dementia (advanced), deafness and insomnia, each from an unknown date and unknown if ongoing. The patient''s concomitant medication included aripiprazole (ABILIFY, formulation: tablet) for BPSD, bisoprolol at 2.5 mg once a day for AFib, apixaban (ELIQUIS, strength: 2.5 mg, formulation: film-coated tablet) at 2.5 mg twice a day for AFib and triazolam (HALCION, formulation: tablet) at 0.25 mg once a day for insomnia, all from 11Sep2018 to 30Jan2021. The patient experienced death on 30Jan2021. An autopsy was performed on 30Jan2021 and the results were not provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1035361 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain injury, Cardiac arrest, Death, Pneumonia, Pulmonary oedema, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension; Ischemic heart disease; Paget''s disease
Allergies:
Diagnostic Lab Data: Test Name: PCR for COVID 19; Result Unstructured Data: Test Result:negative
CDC Split Type: ILPFIZER INC2021144699

Write-up: pneumonia; pulmonary edema; asystole; brain damage after CPR; The patient passed away; This is a spontaneous report from a contactable consumer or other non hcp received via the Health Authority. The regulatory authority report number is Portal_22142 ( Health Authority internal reference number 73107). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 25Jan2021 for Covid-19 immunisation. Medical history included ischemic heart disease, hypertension, diabetes, paget''s disease. Concomitant medications were not reported. On 28Jan2021, the patient was brought to the emergency medical center after an event of asystole at home, she underwent CPR by MDA. She was hospitalized in the cardiac intensive care, the patient was with brain damage after CPR, anesthetized and resuscitated. Diagnosis of pneumonia and pulmonary edema. The patient passed away on 02Feb2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included PCR for COVID 19: negative on unknown date. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: The patient passed away


VAERS ID: 1035414 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PURSENNID [SENNA ALEXANDRINA LEAF]; HUMALOG; FUROSEMIDE; OMEPRAZOLE; COUMADIN; LANTUS; ALMARYTM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021141151

Write-up: Sudden death; This is as spontaneous report received from a contactable other HCP downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-670854 A 96-year-old female patient received the second dose of bnt162b2 (COMIRNATY) (Lot # EL1484), intramuscular at single dose in the left arm on 02Feb2021 for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included senna alexandrina leaf (PURSENNID [SENNA ALEXANDRINA LEAF]), insulin lispro (HUMALOG), furosemide, omeprazole, warfarin sodium (COUMADIN), insulin glargine (LANTUS), flecainide acetate (ALMARYTM). The patient experienced sudden death on 03Feb2021. The patient died on 03Feb2021. It was not reported if an autopsy was performed. Reporter''s comment: In therapy with lantus, humalog, coumadin, almarytm 100mg, furosemide 25mg, omeprazole 20mg, pursennid 12, g Sender''s comment: 05Feb2021 local pharmacovigilance responsible Informed doctor of vaccination service who provided vaccine name and batch. Clinical report with host history requested. On hold. No follow-up attempts possible. No further information expected.; Reporter''s Comments: In therapy with lantus, humalog, coumadin, almarytm 100mg, furosemide 25mg, omeprazole 20mg, pursennid 12, g; Reported Cause(s) of Death: Sudden death


VAERS ID: 1035415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6163 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Coagulopathy, Fibrin D dimer, Platelet count
SMQs:, Haemorrhage laboratory terms (broad), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity
Allergies:
Diagnostic Lab Data: Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:more than 80; Comments: D-dimer increase; Test Name: Platelet count; Result Unstructured Data: Test Result:59 000; Comments: Thrombocytopenia
CDC Split Type: ITPFIZER INC2021141118

Write-up: Sinus cerebral thrombosis. Discoagulopathy.; Sinus cerebral thrombosis. Discoagulopathy.; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Agency MINISAL02-670914. A 55-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot number: EL1484), on 07Jan2021 and second dose of BNT162B2 (COMIRNATY, lot number: EJ6163) on 28Jan2021, both intramuscular at single dose for COVID-19 immunization. The patient medical history included obesity from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 30Jan2021, the patient experienced sinus cerebral thrombosis and dis-coagulopathy. The events were serious (fatal). The patient underwent lab tests and procedures which included fibrin D dimer: more than 80 (D-dimer increased), platelet count: 59 000 (thrombocytopenia). Therapeutic measures were taken as a result of the events and included heparin. The patient died on 02Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Coagulopathy; Cerebral venous sinus thrombosis


VAERS ID: 1035417 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Inflammatory marker test, International normalised ratio, Off label use, Product use issue
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SACUBITRIL;VALSARTAN; WARFARIN; BISOPROLOL; TORASEMIDE; METHYLPREDNISOLONE; CICLOSPORIN; CELLCEPT [MYCOPHENOLATE MOFETIL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aorta coarctation repair; Cardiovascular disease, unspecified; Chronic heart failure; Coronary artery disease; Hypertension; Insertion of implantable cardioverter device; Kidney transplant; Myocardial infarct; Radiofrequency ablation
Allergies:
Diagnostic Lab Data: Test Name: inflammatory marker; Result Unstructured Data: Test Result:In norm; Test Name: INR; Result Unstructured Data: Test Result:2.4 (on warfarin)
CDC Split Type: LTPFIZER INC2021134898

Write-up: Death; the patient received long-term immunosuppressive treatment from 18Jan2008 to 20Jan2021; the patient received long-term immunosuppressive treatment from 18Jan2008 to 20Jan2021; This is a spontaneous report from a contactable physician (nephrologist) was received from Regulatory Authority LT-SMCA-3939. A 67-year-old male patient received bnt162b2 (COMIRNATY), Intramuscularly on 13Jan2021 at single dose for Covid-19 immunisation. Medical history included Radiofrequency ablation of AV node, Insertion of implantable cardioverter device (insertion of permanent pacemaker), Myocardial infarct, Hypertension, Aorta coarctation repair (prosthetic replacement of aorta) from 2010 to an unknown date, Coronary artery disease (coronary arteries bypass), Cardiovascular disease, unspecified, Chronic heart failure, Kidney transplant from 2008 to an unknown date. Concomitant medication included sacubitril; valsartan (sacubitril/valsartan 97/103 mg) from Nov2020 for hypertension, warfarin (strength 5 MG) from 23Apr2010 for Aorta coarctation repair, bisoprolol (strength 5 MG) from an unspecified date to 20Jan2021 for Hypertension, torasemide (10 mg) for Heart failure, methylprednisolone (2 mg) 2 mg x 1, ciclosporin (75 mg) 75 mg x 1 and mycophenolate mofetil (CELLCEPT, 1 g) 1000 mg x 2, all from 18Jan2008 to 20Jan2021 for long-term immunosuppressive treatment. The patient experienced death on 20Jan2021. The patient underwent lab tests and procedures which included inflammatory marker: In norm, INR: 2.4 (on warfarin). Blood tests performed prior to vaccination demonstrated normal function of transplanted kidney and normal ranges of inflammatory markers. INR was 2,4 (on warfarin). Nephrologist contacted the patient by telephone call on 19Jan2021. The patient was feeling well and had no any adverse reaction to vaccine. Patient was found dead at home on 20Jan2021. The rapporteur considered that patient experienced sudden cardiac death not related to vaccination. It not known whether the autopsy was performed. No follow-up attempts are possible, Information on batch number cannot be obtained.; Sender''s Comments: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. The case will be re-assessed when relevant information, particularly the cause of death, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1035424 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Nausea, Oxygen saturation, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Elderly; Heart failure; Oedema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: PCR test; Test Result: Negative ; Test Date: 20210129; Test Name: PCR test; Test Result: Negative ; Test Date: 20210128; Test Name: body temperature; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Test Date: 20210128; Test Name: saturation; Test Result: 80 %
CDC Split Type: NLPFIZER INC2021135245

Write-up: Fever 38 to 40.5 Centigrade; Dyspnoea; Nausea; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (NL-LRB-00437238. A 92-year-old female patient received bnt162b2 (COMIRNATY, lot number EM0477), via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing elderly, ongoing Heart failure, ongoing oedema. The patient''s concomitant medications were not reported. The patient experienced fever 38 to 40.5 centigrade on 28Jan2021, nausea on 27Jan2021, dyspnoea on 28Jan2021. The events were serious as fatal. The patient underwent lab tests and procedures which included PCR test: negative on 24Jan2021 and 29Jan2021. According to the physician, the cause of death was a cardiac arrest due to heart failure. Pyrexia was treated with paracetamol and dyspnoe with oxygen therapy (saturation 80%). The patient died on 29Jan2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Fever 38 to 40.5 Centigrade; Nausea; Dyspnoea; cardiac arrest due to heart failure; cardiac arrest due to heart failure


VAERS ID: 1035425 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-01-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Cardiac disorder, Condition aggravated, Decreased appetite, Fatigue, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIGOXINE; ACENOCOUMAROL; XALACOM; COLECALCIFEROL; SPIRONOLACTON; OMEPRAZOL; DUTASTERIDE; FUROSEMIDE
Current Illness: Cardiovascular disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210131; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 to 38 Centigrade
CDC Split Type: NLPFIZER INC2021135242

Write-up: Decreased appetite; death, probably death as a result of acute heart death/ cardiac cause; death, probably death as a result of acute heart death/ cardiac cause; Nausea; malaise/ did not feel well. general malaise; Fatigue; Fever, 37.5 to 38 Centigrade; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB NL-LRB-00437276. A 90 years old male patient received the first dose of bnt162b2 (COMIRNATY) on 30Jan2021 at single dose (Lot EM0477) for covid-19 immunisation. Medical history included ongoing cardiovascular disease, unspecified. No Previous COVID-19 infection. No diagnostic procedures. Concomitant medication included digoxine (0.0625mg tablet) at 0.06 mg, acenocoumarol (1mg tablet) at 1mg, latanoprost, timolol maleate (XALACOM), colecalciferol (5600 iU Capsule) at 5600 iU/kg, spironolacton (25mg tablet) at 25mg, omeprazol (40mg Gastro-resistant capsule) at 40 mg, dutasteride (0.5mg capsule) at 0.5mg, and furosemide (40mg tablet) at 40mg. The patient experienced death, probably death as a result of acute heart death/ cardiac cause, 3 days after start (02Feb2021); nausea, 2 days after start (01Feb2021); malaise/ did not feel well. general malaise: 1 days after start (31Jan2021); fatigue: 1 days after start (31Jan2021); body temperature increased, Fever, 37.5 to 38 Centigrade: 1 days after start (31Jan2021); decreased appetite: latency unknown. Unexpectedly, the patient deceased 3 days after vaccination on 02Feb2021 in his sleep with no apparent cause. The cause of death is unclear, but a cardiac cause was suspected considering the cardiovascular disease in his medical history. Unclear if there is a causal relation between the vaccination and the death. Iom forensic doctor issued as natural death. Presumed death due to acute cardiac death because of history of cardiovascular disease. Confounding factors: History of cardiovascular disease. Death probably due to cardiac cause. It is unknown if autopsy done. Outcome of the event death, probably death as a result of acute heart death/ cardiac cause was fatal. Outcome of other events was unknown.; Reported Cause(s) of Death: death, probably death as a result of acute heart death/ cardiac cause; death, probably death as a result of acute heart death/ cardiac cause


VAERS ID: 1035426 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-02-02
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Heart rate, Oxygen saturation, Physical examination
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aspiration pneumonia; Ileus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Test Date: 20210124; Test Name: Heart rate; Result Unstructured Data: Test Result:115x/min; Test Date: 20210124; Test Name: oxygen saturation; Test Result: 90 %; Test Date: 20210124; Test Name: physical examination; Result Unstructured Data: Test Result:pulmonary crepitations (both sides), swollen abdom; Comments: pulmonary crepitations (both sides), swollen abdomen
CDC Split Type: NLPFIZER INC2021135251

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number: NL-LRB-00437294. A 90-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot# EM0477), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 vaccination, midazolam (injection fluid 5 mg/ml), via an unspecified route of administration from 27Jan2021 at 10 mg, cyclic (Freq: 4 h; 6x daily 10mg) for Discomfort and anxiety during death phase, morphine (injection fluid 10 mg/ml), via an unspecified route of administration from 25Jan2021 to an unspecified date at 1 DF (Injection liquid, 10 mg / ml (milligrams per milliliter)) for Pain due to ileus and pneumonia with dyspnoea, paracetamol (1000 mg suppository), via an unspecified route of administration from 25Jan2021 at 1000 mg, cyclic (Freq: 6 h; 1000mg 4x daily) for Abdominal pain with ileus. The patient''s concomitant medications were not reported. Three days before vaccination, the patient had pyrexia (38.7 degrees Celsius), a decreased oxygen saturation (90%), tachycardia (115/min), swollen abdomen and pulmonary crepitation (both sides). An ileus was suspected with possible aspiration pneumonia. Pain medication was started, morphine and paracetamol, two days before vaccination and a palliative setting was initiated. Since the patient was recovering on 27Jan2021, she was vaccinated with a covid-19 vaccine (Pfizer/BioNTech). But that same day, the patient health deteriorated again. A palliative setting was initiated again and midazolam was started. The patient deceased on 02Feb2021, 6 days after vaccination. According to the reporter, the cause of death was dedicated to the pre-existing disease, which already existed before vaccination. The patient underwent lab tests and procedures which included temperature: 38.7 centigrade on 24Jan2021, heart rate: 115x/min on 24Jan2021, oxygen saturation: 90 % on 24Jan2021, physical examination: pulmonary crepitations (both sides), swollen abdomen on 24Jan2021. The action taken in response to the event for midazolam and paracetamol was Not Applicable, for morphine was dose increased. The patient died on 02Feb2021. It was not reported if an autopsy was performed. Case summary and reporter''s comments: Pfizer vaccine (Comirnaty). Past drug therapy Pfizer vaccine (Comirnaty): no. Patient died on 02Feb2021. Additional information ADR: Patient presented on 24Jan2021 with fever T 38.7C, O2 sat 90% and tachycardia 115x / min, with vomiting and noticeable bulging and painful stomach. Pulmonary crepitus on both sides. Thought of ileus with possible aspiration pneumonia, diaphragm stimulation. On 25Jan dying path route was used aimed at comfort. Patient barely ate and drank. Because patient 27Jan2021 suddenly recovered, started eating and drinking again, recovery was considered. Given recovery, it was not possible to determine a death prognosis of less than 3 months. It was decided to vaccinate with the Pfizer Comirnaty round of vaccination on 27Jan. However, the same evening of 27Jan still deteriorated and dying path route was restarted with midazolam added due to unrest. The patient died on 02Feb2021. Consultation took place with forensic doctor who issued a natural death in view of pre-existing suffering before vaccination. The vaccination contribution to the death is considered none. confounding factors: ileus. Previous COVID-19 infection: No. Other diagnostic procedures: No. No follow-up attempts possible. No further information expected.; Sender''s Comments: The 90-year-old patient had pre-existing ileus and pneumonia, and already accepted palliative setting prior to vaccination. The cause of death was reported as underlying ileus and pneumonia, and unrelated to the first dose of bnt162b2 (COMIRNATY).; Reported Cause(s) of Death: possibly aspiration pneumonia; ileus


VAERS ID: 1035429 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Cardiac asthma, Electrocardiogram
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; FLIXOTIDE; MELATONIN; SIMVASTATIN
Current Illness: Asthma; COPD; Intellectual disability
Preexisting Conditions: Medical History/Concurrent Conditions: Exposure to COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210131; Test Name: ECG; Result Unstructured Data: Test Result:ST-elevations within normal range; Comments: Acute Myocardial Infarction cannot be realiable determined.
CDC Split Type: NLPFIZER INC2021135261

Write-up: exacerbation of asthma; Cardiac asthma; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency[NL-LRB-00437887], received via Regulatory Authority. A 70-years-old male patient received bnt162b2 (COMIRNATY, Strength 0.3 ml, LOT# EM0477), via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease, ongoing intellectual disability, ongoing asthma, contact with someone who tested positive for SARS-CoV-2 virus. Concomitant medication included metformin, fluticasone propionate (FLIXOTIDE), melatonin, simvastatin. On 31Jan2021, the patient experienced asthma aggravated (exacerbation), cardiac asthma. Seriousness criteria for both events was fatal. Event description: Four days after vaccination, the patient became dyspnoeic, restless, had a low oxygen saturation, low blood pressure and tachycardia. An ECG was performed on 31Jan2021 which showed ST-elevations within a normal range. An acute myocardial infarction could not be reliable determined. The patient was treated with prednisone, salbutamol/ipratropium, amoxicillin/clavulanic acid and oxygen. Unfortunately, the patient deceased due to the asthma exacerbation/cardiac asthma, between 4-7 days after vaccination. The reporter described that the day before vaccination, the patient had contact with someone who tested positive for SARS-CoV-2 virus. An attempt to test the patient for a COVID-19 infection failed, due to a moderate intellectual disability. The patient died on an unspecified date. It was not reported if an autopsy was performed. Case Summary and Reporter''s Comments: Pfizer vaccine (Comirnaty). Past drug therapy Pfizer vaccine (Comirnaty): no. Exacerbation of asthma / cardiac asthma (cause of death reported by the attending GP). Additional information ADR: 4th day after vaccination sudden breathlessness, agitation, low saturation, low blood pressure, fast pulse, ECG: seen tachycardia and fluctuating baseline: AMI cannot be reliably determined, ST elev within the norms. The day before vaccination I was in contact with a companion who tested positive for corona. Corona test tried, but not successful (with moderate intellectual disability). confounding factors; confounding factors: asthma / COPD, possible corona infection? COVID19: Previous COVID-19 infection: No. Other diagnostic procedures: ECG: seen tachycardia and variable baseline: AMI cannot be reliably determined, ST-elev within the norms.; Reporter''s Comments: Pfizer vaccine (Comirnaty). Past drug therapy Pfizer vaccine (Comirnaty): no. Exacerbation of asthma / cardiac asthma (cause of death reported by the attending GP). Additional information ADR: 4th day after vaccination sudden breathlessness, agitation, low saturation, low blood pressure, fast pulse, ECG: seen tachycardia and fluctuating baseline: AMI cannot be reliably determined, ST elev within the norms. The day before vaccination I was in contact with a companion who tested positive for corona. Corona test tried, but not successful (with moderate intellectual disability). confounding factors; confounding factors: asthma / COPD, possible corona infection? COVID19: Previous COVID-19 infection: No. Other diagnostic procedures: ECG: seen tachycardia and variable baseline: AMI cannot be reliably determined, ST-elev within the norms.; Reported Cause(s) of Death: Cardiac asthma; exacerbation of asthma


VAERS ID: 1035430 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Lung disorder, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021135256

Write-up: 2 days after vaccination lung function impairment; with saturation decrease; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority NL-LRB-00437942. An 86 years male patient received BNT162B2 (COMIRNATY, lot# unknown) on 28Jan2021 at single dose for covid-19 immunisation. The reporter described that the patient had no respiratoire complaints in his medical history, no lung complaints and lung medication. No Previous COVID-19 infection. Concomitant medication was amlodipine capsule. Patient experienced pulmonary function impairment on 30Jan2021 (death), oxygen saturation decreased on 30Jan2021 (death) following administration of covid-19 vaccine. 2 days after vaccination lung function attenuation with saturation decrease. The patient deceased 2-6 days after vaccination. The patient was treated with oxygen and salbutamol/ipratropium. The outcome of oxygen saturation decreased is fatal and the outcome of pulmonary function impairment is fatal. Autopsy was done, results not available. No follow-up attempts are possible, lot/batch number cannot be obtained.; Reported Cause(s) of Death: saturation drop; lung function damping


VAERS ID: 1035431 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Choking, Fatigue, Malaise, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; OMEPRAZOLE; LACTULOSESTROOP; OXYCODONE; CITALOPRAM
Current Illness: Demented
Preexisting Conditions: Medical History/Concurrent Conditions: Infection NOS (frequent infections)
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: body temperature increased; Result Unstructured Data: Test Result:37.5 to 38 Centigrade; Test Date: 20200201; Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: NLPFIZER INC2021141429

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority NL-LRB-00438556 and safety report unique identifier [ NL-LRB-00439092]. A 94-year-old female patient received bnt162b2 (COMIRNATY, Lot # EM0477) at single dose on 29Jan2021 for covid-19 immunisation. Medical history included ongoing demented with declining life expectancy, frequent infections. No previous COVID-19 infection. Concomitant medication included paracetamol (PARACETAMOL, tablet 500mg) at 500mg unknown, omeprazole (OMEPRAZOLE, capsule msr 40mg) at 40mg unknown, lactulose (LACTULOSE STROOP) at 670mg/ml (500mg/g), oxycodone (OXYCODONE, tablet 5mg) at 5mg unknown, citalopram (CITALOPRAM, coated tablet) at 10mg unknown. The patient experienced fatigue and not feeling well on 01Feb2021, fever/body temperature increased: 37.5 to 38 degrees celsius on 03Feb2021, choking due to malaise in Feb2021. The patient underwent lab tests and procedures which included body temperature increased: 37.5 to 38 centigrade on 03Feb2021, Sars-cov-2 test: negative on 01Feb2020. The patient died 6 days after vaccination on 04Feb2021. The outcome of all events was fatal. It was not reported if an autopsy was performed. The primary cause of death of the patient was respiratory tract infection in advanced dementia with descending lifeline The reporter mentioned that the adverse events following immunisation (choking due to malaise and fatigue) may have accelerated death, could have contributed to the patient''s death. The reporter suspected fatigue / drowsiness, causing choking as influencing specific side effect. The patient''s health status before and at the time of vaccination very vulnerable and fragile for years. Estimated life expectancy was more than 4 weeks.; Reporter''s comments:BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no confounding factors confounding factors: dementia with declining lifeline and frequent infections COVID19 Previous COVID-19 infection: No 05Feb2021 Follow up received by email; changes in the notification: Summary, Patient death date, cause of death1a. What was the primary cause of death of the patient? 1b. On what date did your patient die? 2. What is your estimate of the contribution that the side effects of the vaccine may have made to the death? - none / - very unlikely / side effects from the vaccine may have accelerated death / - side effects from the vaccine have very likely accelerated death / - it is extremely unlikely that this patient would be without these side effects in the short term deceased 3. If you suspect an influence of the side effects, what specific side effect do you suspect? 4. What was the patient''s health status before and at the time of vaccination? Was there an infection? 5. Around the time of the vaccination, did your patient have another corona test or was there a suspicion of corona? 1a respiratory tract infection in advanced dementia with descending lifeline1b 04Feb20211a2 side effects of the vaccine may have accelerated death3 fatigue / drowsiness, causing choking4 . very vulnerable, but life expectancy still longer than 4 weeks, but vulnerable for years. 5. yes, this one was negative. 01Feb2020; Reported Cause(s) of Death: respiratory infection


VAERS ID: 1035432 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cough, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CINNARIZINE; PRAVASTATIN; KETOCONAZOL; OXYCODON; PARACETAMOL; VITAMINE B COMPLEX; CALCIUM CARBONATE; CLOPIDOGREL; UREA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210201; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever rose to 40 Centigrade; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Test Date: 2021; Test Name: COVID 19 rapid test; Result Unstructured Data: Test Result:Negative; Test Date: 2021; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Negative
CDC Split Type: NLPFIZER INC2021142718

Write-up: Cough; Fever 38 to 40.5 degrees Celsius; This is a spontaneous report downloaded from the Regulatory Authority-WEB, NL-LRB-00438893, safety report unique identifier NL-LRB-00439102. A contactable physician reported that an 81 years old female patient (weight 93.7 kgs) received the second dose of BNT162B2 (COMIRNATY, Lot. EM0477) at 0.3 mL, single dose, on 27Jan2021, for COVID-19 immunisation. Relevant medical history was unknown. Concomitant medications included oral cinnarizine, tablet 25 mg, from an unspecified date, for an unknown indication; oral pravastatin tablet 20 mg, from an unspecified date, for an unknown indication; ketoconazol shampoo 20 mg/g, from an unspecified date, for an unknown indication; oral oxycodone hydrochloride capsule 5 mg, from an unspecified date, for an unknown indication; oral paracetamol tablet, 1000 mg, from an unspecified date, for an unknown indication; oral vitamine B complex, tablet, from an unspecified date, for an unknown indication; oral calcium carbonate chewable tablet, 1.25 g, from an unspecified date, for an unknown indication; oral clopidogrel, tablet 75 mg, from an unspecified date, for an unknown indication and urea cream 100 mg/g, from an unspecified date, for an unknown indication. On 31Jan2021, the patient experienced cough and pyrexia (38 to 40.5 degrees Celsius). The adverse events were assessed as serious: cough (death, life threatening) and pyrexia (death). It was unknown if autopsy was done. Reporter''s comments: BioNTech / Pfizer vaccine (COMIRNATY). Past drug therapy BioNTech / Pfizer vaccine (COMIRNATY): no cough and fever. On 31Jan2021 patient developed fever and cough, PCR COVID 19 negative. At 01Feb2021 the fever rose to 40.0 Centigrade. Previous COVID-19 infection: No. Other diagnostic procedures: COVID 19 PCR negative; COVID 19 rapid test negative.; Reporter''s Comments: BioNTech / Pfizer vaccine (COMIRNATY). Past drug therapy BioNTech / Pfizer vaccine (COMIRNATY): no cough and fever. On 31Jan2021 patient developed fever and cough, PCR COVID 19 negative. At 01Feb2021 the fever rose to 40.0 Centigrade. Previous COVID-19 infection: No. Other diagnostic procedures: COVID 19 PCR negative; COVID 19 rapid test negative.; Reported Cause(s) of Death: Cough; Pyrexia


VAERS ID: 1035433 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-18
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Kidney failure (Moderate); Living in nursing home; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021146133

Write-up: FOUND DEAD; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority NO-NOMAADVRE-FHI-2021-00042. An 89-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot number: EJ6796), intramuscular at arm left on 05Jan2021 at 0.3 mL single dose for COVID-19 immunization. The patient medical history included kidney failure (moderate), type II diabetes mellitus, dementia and living in nursing home, each from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient had an unknown cause of death on 18Jan2021, which was reported as fatal. It was not reported if an autopsy was performed. The reporter did not suspect a relationship between the vaccination and the death. Sender''s Comment: an 89-year-old woman died 13 days after vaccination with COVID-19 vaccine (COMIRNATY). No symptoms between the time of vaccination and the day she was found dead in bed in the morning. She was in good shape during this period. The reporter does not suspect a link between vaccination and death. When vaccinating patients with frailty who are ill with many underlying diseases, some serious incidents, including death, may occur shortly after vaccination without any connection to vaccination. However, 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 some other simultaneous, random cause that has nothing to do with the vaccination in question. On the basis of the information in the message, only the reporter''s cause assessment is registered. Reporter has stated that there is no suspicion of a connection with vaccination, and therefore a causal connection with vaccination is considered unlikely. Since the patient died, the message is classified as serious. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1035434 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-21
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Depressed level of consciousness, General physical health deterioration, Heart rate, Investigation, Oxygen saturation
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Frailty (Reporter stated that the patient for some time have become increasingly frail, but it is unclear whether this started before or after vaccination.); Reduced general condition (Reporter stated that the patient for some time have become increasingly frail, but it is unclear whether this started before or after vaccination.)
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: Pulse rate; Result Unstructured Data: Test Result:Markedly increased,; Test Date: 20210121; Test Name: Investigation NOS; Result Unstructured Data: Test Result:No parameters indicative of infection.; Test Date: 20210125; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:Decreased.
CDC Split Type: NOPFIZER INC2021146124

Write-up: This is a spontaneous report from a contactable other healthcare downloaded from the Agency. The regulatory authority report number is NO-NOMAADVRE-FHI-2021-U2rp1. Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014469. An 84-year-old female patient received BNT162B2 (COMIRNATY; Lot number EJ6795), intramuscular on 08Jan2021, at 12:00 as first single dose for covid-19 immunisation. Medical history included reduced general condition from an unknown date (reporter stated that the patient for some time have become increasingly frail, but it is unclear whether this started before or after vaccination). The patient''s concomitant medications were not reported. The patient experienced reduced general condition, anorexia and consciousness decreased on 21Jan2021, which were all serious as they lead to death. The patient underwent lab tests and procedures which included pulse rate: markedly increased, on 25Jan2021, investigation: no parameters indicative of infection on 21Jan2021, oxygen saturation: decreased on 25Jan2021. The patient died on 25Jan2021. It was not reported if an autopsy was performed. Sender Comment: The report concerns a patient in his 80s, who two weeks after the first dose of the Covid-19 vaccine Comirnaty had a significantly reduced general condition, where the patient did not take in nutrition and was then not contactable. The patient had no signs of infection. In the following days, the patient became increasingly weaker and died 17 days after vaccination. The notifier states that the patient has had a reduced general condition for a long time and has become weaker, but it does not appear from the notification whether this fallout had started before or after vaccination. The notification does not contain sufficient information to be able to assess whether the matter in question is related to vaccination. Since the message describes a suspected side effect that led to the patient''s death, it is classified as serious, and we ask that you submit more details about the incident (the patient''s condition before and after vaccination, concomitant illness and medication, any test results and the course). This is important in order to be able to assess the incident as best as possible. In this dialogue, you can submit journal notes / epicrisis / laboratory answers and / or other reports. In addition, you can provide your birth number, name or other info that is relevant to the event. The information is processed securely in this dialog, and is automatically deleted after 4 months. Processing and storage of personal data takes place in accordance with the Health Register Act. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: ANOREXIA; CONSCIOUSNESS DECREASED; REDUCED GENERAL CONDITION


VAERS ID: 1035435 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-12
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Condition aggravated, General physical health deterioration, Hyperventilation, Infection, Oxygen saturation, Pyrexia, Rales
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; FLUTIDE [FLUTICASONE PROPIONATE]
Current Illness: Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Airway secretion excessive (Increased mucus production in the respiratory tract); Asthma; Atrial fibrillation; Breathing abnormally deep (Severe difficulties with heavy breathing in periods.); Laboured breathing (Severe difficulties with heavy breathing in periods.); Neurodegenerative disorder (Probable atypical ALS, but not finally established (evaluation in process).); Somatic dysfunction (Severe loss of function in recent months.); Urethral catheterisation
Allergies:
Diagnostic Lab Data: Test Date: 20210112; Test Name: C-reactive protein; Result Unstructured Data: Test Result:68 mg/l; Test Date: 20210114; Test Name: C-reactive protein; Result Unstructured Data: Test Result:153 mg/l; Comments: increased; Test Date: 20210116; Test Name: C-reactive protein; Result Unstructured Data: Test Result:decreased (value not reported) mg/l; Test Date: 20210116; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:decreased; Comments: despite O2 treatment
CDC Split Type: NOPFIZER INC2021146138

Write-up: This is a spontaneous report from contactable physician downloaded from the Regulatory Authority (Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014524, Worldwide unique case identification number NO-NOMAADVRE-FHI-2021-U7x31). An 87 years old male patient received the first single dose of BNT162B2 (COMIRNATY; lot EJ6795) intramuscular, on 07Jan2021, for Covid-19 vaccination. Medical history included airway secretion excessive (increased mucus production in the respiratory tract), living in nursing home since 07Jan2021, urethral catheterization, neurodegenerative disorder (probable atypical ALS, but not finally established (evaluation in process)), somatic dysfunction (severe loss of function in recent months), laboured breathing (severe difficulties with heavy breathing in periods), atrial fibrillation and asthma. Concomitant medications included oral apixaban (ELIQUIS) from an unknown date to 16Jan2021, at 2.5 mg, 2x/day, for atrial fibrillation and fluticasone propionate (FLUTIDE) via respiratory inhalation, from an unknown date to 16Jan2021, at 125 ug, 2x/day, for asthma. The patient was admitted as a nursing home resident on 07Jan2021 and received the first dose of Covid-19 vaccination the same day. On 12Jan2021 the patient experienced reduced general condition and fever. On 12Jan2021 C-reactive protein was 68 mg/L. No clear infection focus was found, but probably respiratory. The patient started treatment with sulfamethoxazole and trimethoprim (BACTRIM). No improvement after two days and C-reactive protein increased to 153 mg/L. On 14Jan2021, treatment was changed to ceftriaxone iv, in addition fluid iv. On 15Jan2021 the patient showed clinical improvement and treatment was continued. On 16Jan2021 C-reactive protein had decreased (value not reported), but the resident was very tired and oxygen saturation decreased despite O2 treatment. The patient developed further heavy breathing and moist rales. Furosemide (FURIX) was administered in case of hypervolemia, but with no effect. Active treatment was discontinued and palliative treatment was initiated on 16Jan2021. Rapid deterioration in the evening and the patient died on 16Jan2021. Cause of death was reported as infection NOS. It was unknown if an autopsy was performed. The outcome of further heavy breathing and moist rales was unknown. The other events outcome was reported as fatal. Relatedness of drug to reactions/events: possible by reporter who stated that the patient''s symptoms and subsequent death could be related to immunization, due to a reasonable time relation to administration of Comirnaty. However, the reporter considered it more likely that poor health due to a severe underlying disorder (probably neurodegenerative), contracted an infection of which he died (most probable cause of death). Sender Comment: The report concerned a patient in his 80s, who developed a fever and reduced general condition a few days after the first dose of Comirnaty vaccine. The patient had elevated CRP, but not sure focus. The patient experienced short-term improvement after switching from oral antibiotic treatment to more broad-spectrum intravenous antibiotics. Due to the patient''s condition in general, it was decided to discontinue active treatment and initiate palliative treatment. The patient died 9 days after vaccination. The patient had a serious underlying illness and had recently arrived at the nursing home. Reporter considered that the person in question was most likely to be related to general impaired health, with consequent infection resulting in death. Reporter did not exclude, however, that the matter in question may be linked to vaccination, due to a temporal relationship. The most common adverse reactions 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. However, they cannot rule out that relatively mild side effects may become more pronounced and / or lead to a more serious course in severely debilitated patients. Data from use in frail patients with comorbidity were limited, and such lack of information will be obtained in post-marketing studies, among other things. In the individual case, however, it was difficult to know whether the symptoms prior to the death were due to a vaccine or another, random simultaneous cause that had nothing to do with the vaccine in question. When vaccinating vulnerable / frail, multi-diseased elderly patients, some serious events, including death, may occur shortly after vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. Normally, between 300 and 400 people die per week in nursing homes and similar institutions in Norway. A report from 2015 found that 7% of patients in Norwegian nursing homes (including long-term place, short-term place and rehabilitation) died within the first three months after admission. In a later Norwegian study of patients on long-term stays, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and find, among other things, that the risk of death is increased in the first four months after hospitalization, and that patients who have recently been admitted to hospital have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In general, the cause of death in nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death was usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio- and cerebro-vascular disease accounted for 1 in 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (20%), respiratory and infectious diseases (including pneumonia and sepsis) (15%), and cancer (10%). Based on the information in the report, the causal connection with vaccination is considered as possible. A possible causal relationship was defined as a reaction, including pathological laboratory tests, which occured 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''s death, the message was also classified as serious, even though no causal link between the vaccine and the death had been established. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infection NOS; Reduced general condition; Fever


VAERS ID: 1035436 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bedridden, C-reactive protein, Death, Hypophagia, Weight
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ARICEPT; LASIX [FUROSEMIDE]; ZOLOFT; LEVAXIN; REMERON; VITAMIN B12 [HYDROXOCOBALAMIN]; XARELTO; KALEORID; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; PANODIL; DUROFERON; ENTOCORT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Colitis microscopic; Depressive disorder (Periodic depression where the patient became bedridden and had reduced dietary intake.); General nutrition disorder (had reduced dietary intake); Living in residential institution
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:30 mg/l; Comments: Around 30 mg/L. Probably due to residual activity of microscopic colitis, according to reporter.; Test Date: 20210121; Test Name: Weight; Test Result: 35 kg
CDC Split Type: NOPFIZER INC2021146127

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority NO-NOMAADVRE-FHI-2021-U7xjz. A 91-year-old female patient received first dose of BNT162B2 (COMIRNATY), intramuscular at arm left on 12-Jan-2021 at single dose for COVID-19 immunization. The patient medical history included colitis microscopic from 2020 to an unknown date, Alzheimer''s disease, depressive disorder (periodic depression where the patient became bedridden and had reduced dietary intake), general nutrition disorder (had reduced dietary intake) and living in residential institution, all from an unknown date and unknown if ongoing. The patient''s concomitant medication included ARICEPT strength: 5 mg, LASIX strength: 30 mg, ZOLOFT, strength: 50 mg, LEVAXIN, strength: 100 ug, REMERON, strength: 15 mg) , VITAMIN B12, strength: 1 mg/mL, XARELTO, strength: 20 mg, KALEORID, strength: 750 mg, MOVICOL, strength: 13.125 g/46.6 mg/350.7 mg/178.5 mg, PANODIL, strength: 1 g, DUROFERON, strength: 100 mg, ENTOCORT, strength: 3 mg. In Jan-2021, the patient experienced markedly reduced dietary intake and bedridden, the patient death occurred on 21-Jan-2021. The events were serious, the outcome was fatal. The patient underwent lab tests and procedures which included C-reactive protein: 30 mg/l (probably due to residual activity of microscopic colitis, according to reporter) in Jan-2021 and body weight: 35 kg on 21-Jan-2021. It was not reported if an autopsy was performed. The reporter stated that marasmus (marasmus senilis) was stated as cause of death on the death certificate, with Alzheimer''s disease indicated as the ground disease precipitating death. Sender''s comment: the report concerns a patient in her 90s, who just over a week after the first dose of the COVID-19 vaccine COMIRNATY became bedridden and could take only a little nutrition. The patient died 9 days after vaccination. The patient was generally frail, partly due to low weight, malnutrition and advanced dementia. The patient had had similar episodes with similar symptoms before but was in a good period when the vaccine was administered. The reporter states that the death is perceived as natural but reports due to the close time relationship between vaccination and death. Normally, between 300 and 400 people die per week in nursing homes and similar institutions. In a study of patients on long-term stays, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and find, among other things, that the risk of death is increased in the first four months after nursing home admission, and that patients who have recently been hospitalized have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In general, the cause of death in nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio- and cerebrovascular diseases were accounted for 1 in 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (about 20%), respiratory and infectious diseases (including pneumonia and sepsis) (about 15%), and cancer (about 10%). When vaccinating vulnerable / frail, multi-diseased elderly patients, some serious events, including death, may occur shortly after vaccination. Reporter has stated that there is no suspicion that the death is related to vaccination, and therefore the causal connection with vaccination is set as unlikely. An improbable causal relationship is defined as a reaction, including pathological laboratory tests, that occurs in such a temporal relationship to the use of a drug that a causal relationship is unlikely (but not impossible), and where underlying disease, other drugs or chemicals may explain the reaction. In the individual case, however, it is difficult to know whether the symptoms prior to the death are due to a vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. Based on the information in the report, the facts that the patient became bedridden and ingested little nutrition were also registered as side effects, and for these symptoms the causal relationship with vaccination is considered 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 later died, 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, information about batch number cannot be obtained. Reported Cause(s) of Death: MARASMUS; ALZHEIMER''S DISEASE.


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