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From the 10/15/2021 release of VAERS data:

Found 17,128 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 1313435 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Dyspnoea, Headache, Limb discomfort, Productive cough
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20211

Write-up: Unknown cause of death; This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Unknown cause of death), PRODUCTIVE COUGH, LIMB DISCOMFORT, HEADACHE and DYSPNOEA in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001651) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and. On 16-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PRODUCTIVE COUGH (seriousness criterion medically, LIMB DISCOMFORT (seriousness criterion medically significant), HEADACHE (seriousness criterion medically significant) and DYSPNOEA (seriousness criterion medically significant). The patient died on 20-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCTIVE COUGH, LIMB DISCOMFORT, HEADACHE and DYSPNOEA had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication or treatment were provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1313720 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-04-29
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Cardiac failure acute
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   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: Acenocoumarol 1mg, vit. D3 25mcg
Current Illness: no, just very tired after the first shot on 28-01-2021 couldn''t get out of bed anymore (patient had a normal physical condition)
Preexisting Conditions: dementia
Allergies: unknown
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: 1 month between 1st and 2nd shot. 9 weeks after second shot acute heart failure (the patient had no heart problems before)


VAERS ID: 1315088 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Auscultation, Blood gases, Blood glucose, Blood lactic acid, Blood pressure measurement, Cardiopulmonary exercise test, Circulatory collapse, Coma scale, Computerised tomogram, Confusional state, Electrocardiogram, Heart rate, Hyperglycaemia, Intestinal ischaemia, Investigation, Lactic acidosis, Leukocytosis, Leukocyturia, Lipase, Liver function test, Metabolic acidosis, Multiple organ dysfunction syndrome, Nervous system disorder, Neurological examination, Neutrophil count, Oxygen saturation, PCO2 increased, Pancreatitis acute, Peritonitis, Platelet count, Pleural effusion, Portal vein phlebitis, Renal function test, Respiratory failure, SARS-CoV-2 test, Sputum test, Systemic inflammatory response syndrome, Tachycardia, Urological examination, Visual analogue scale, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), 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), Dementia (broad), Gastrointestinal perforation (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   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: Cholecystectomy; Insulin-dependent diabetes mellitus (Familial: Insulin-dependent diabetes in the mother.)
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: Auscultation; Result Unstructured Data: Test Result:BHA found on auscultation. No abdominal murmur per; Test Date: 20210422; Test Name: Auscultation; Result Unstructured Data: Test Result:Bilateral pleural effusions on auscultation; Test Date: 20210421; Test Name: blood gas; Result Unstructured Data: Test Result:shows metabolic acidosis with a PH at 7.30 with a; Test Date: 20210420; Test Name: Blood glucose; Result Unstructured Data: Test Result:2.98 g/l; Test Date: 20210422; Test Name: lactate; Result Unstructured Data: Test Result:, pH 7.28, lactates 5.3; Test Date: 20210422; Test Name: BP; Result Unstructured Data: Test Result:90 mmHg; Test Date: 20210421; Test Name: CARDIO-PULMONARY; Result Unstructured Data: Test Result:No RHJ or TJ found on inspection; Test Date: 20210422; Test Name: glasgow scale; Result Unstructured Data: Test Result:The Glasgow score is rated at 13 (Y3V4M6) without; Test Date: 20210421; Test Name: CT scan; Result Unstructured Data: Test Result:a CT scan is performed and shows an infiltration o; Test Date: 20210422; Test Name: CT scan; Result Unstructured Data: Test Result:An injected TAP CT scan is performed on 22Apr2021; Test Date: 20210421; Test Name: ECG; Result Unstructured Data: Test Result:ECG performed in principle: regular sinus tachycar; Test Date: 20210422; Test Name: heart rate; Result Unstructured Data: Test Result:120; Test Date: 20210421; Test Name: pulse rate; Result Unstructured Data: Test Result:114; Test Date: 20210420; Test Name: clinical/BISAP; Result Unstructured Data: Test Result:the patient is in pain, diffuse pain with pelvic d; Test Date: 20210422; Test Name: clinical/BISAP; Result Unstructured Data: Test Result:The seriousness of the disease is certain, BISAP 5; Test Date: 20210421; Test Name: HEPATO-ABDO; Result Unstructured Data: Test Result:Diffuse abdominal pain; Test Date: 20210420; Test Name: lipase; Result Unstructured Data: Test Result:3553 IU/l; Test Date: 20210422; Test Name: hepatic check; Result Unstructured Data: Test Result:No disturbance of BH (hepatic check) in the initia; Test Date: 20210421; Test Name: Neuro; Result Unstructured Data: Test Result:Conscious and well-oriented patient; Test Date: 20210422; Test Name: Neuro; Result Unstructured Data: Test Result:neurological failure with appearance of confusion; Test Date: 20210420; Test Name: PNN; Result Unstructured Data: Test Result:16.36 x10 9/l; Test Date: 20210421; Test Name: oxygen saturation; Test Result: 98 %; Test Date: 20210422; Test Name: oxygen saturation; Result Unstructured Data: Test Result:respiratory failure with 93% sat under 4L, FR 32. %; Test Date: 20210422; Test Name: platelet; Result Unstructured Data: Test Result:197 x10 9/l; Test Date: 20210423; Test Name: platelet; Result Unstructured Data: Test Result:88 x10 9/l; Test Date: 20210424; Test Name: platelet; Result Unstructured Data: Test Result:65 x10 9/l; Test Date: 20210420; Test Name: renal; Result Unstructured Data: Test Result:55; Test Date: 20210421; Test Name: renal; Result Unstructured Data: Test Result:71; Test Date: 20210422; Test Name: renal; Result Unstructured Data: Test Result:96; Test Date: 20210420; Test Name: COVID PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20210420; Test Name: cytobacteriological examination of sputum; Result Unstructured Data: Test Result:An ECBU (cytobacteriological examination of sputum; Test Date: 20210421; Test Name: Pancreatitis SIRS; Result Unstructured Data: Test Result:3; Test Date: 20210421; Test Name: URO; Result Unstructured Data: Test Result:No SFU (functional urinary signs); Test Date: 20210421; Test Name: EVA; Result Unstructured Data: Test Result:7/10
CDC Split Type: FRPFIZER INC2021512385

Write-up: found small ischemia, ischemic small intestine; right colic associated with peritonitis; multi failure; neurological failure with appearance of confusion; neurological failure with appearance of confusion; respiratory failure; hemodynamic failure; lactic acidosis/pH 7.28, lactates 5.3; Bilateral pleural effusions; pylephlebitis of the splenic vein; tachycardia/Tachycardium at 114; leukocytosis; high PCO2; Acute pancreatitis; vomiting; abdominal pain; Hyperglycemia; leukocyturia; metabolic acidosis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority FR-AFSSAPS-RS20211119, Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021045921. A 73-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 20Apr2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included cholecystectomy in 2015. The patient''s had a history of Insulin-dependent diabetes. The patient''s concomitant medications were not reported. On 20Apr2021, the patient experienced 1st episode of vomiting plus abdominal pain post Comirnaty injection which was resolved rapidly. Second episode of sudden vomiting about 2 hours after injection. The patient consulted on 20Apr2021 at the facility. The patient went to emergency department. On the clinical level: the patient is in pain, diffuse pain with pelvic defense: a titration of morphine at 4 mg is performed. On the biological level: PNN increased to 16.36 G / L, lipasemia to 3553 IU / L with, however, normal hepatic assessment. Hyperglycemia was reported with a blood glucose level of 2.98 g / L (treated with insulin 10 Units). An ECBU (cytobacteriological examination of sputum) was performed and showed leukocyturia. A COVID PCR comes back negative on 20Apr2021. A blood gas produced on 21Apr2021 showed metabolic acidosis with a PH at 7.30 with a PCO2 at 32.5 and a PO2 at 108 + lactate at 4.4 mmol / L + HCO3- at 16.1. On the radiological level, a CT scan was performed and showed an infiltration of the pancreatic compartment with fluid effusion from the mesentery root, the pararenal and latero-conal spaces. No picture of gallstones. No sign of perforation. The scan without IV concluded with acute pancreatitis. The patient was transferred on 21Apr2021 to another ETB (Emergency Response Course) and to an adapted service in front of this pancreatitis presenting 3 SIRS criteria. Clinical examination on entry, HEPATO-ABDO with diffuse abdominal pain, no palpable mass, abdominal defense + pain on palpation. EVA(visual analog scale): 7/10, Good hydration: normal skin folds. BHA (hydroaeric noises) found on auscultation. No abdominal murmur perceived on auscultation. Pancreatitis SIRS 3: tachycardia + leukocytosis + high PCO2. CARDIO-PULMONARY result included no RHJ (hepato-jugular reflux) or TJ (jugular turgor) found on inspection, perceived peripheral pulse, lack of OMI (edema of the lower limbs) not taking the bucket, no added hiss or noise, no hissing and wheezing on auscultation, bilateral and symmetrical vesicular murmur and no sign in favor of DVT (deep vein thrombosis). NEURO reported conscious and well-oriented patient. No deficit of the cranial pairs nor sensory and motor disorder. UROLOGY reported no SFU (functional urinary signs), absence of bladder ball found on percussion / palpation. In the evening of 21Apr2021, the patient presented tachycardium at 114. SAT at 98% under 3.5 L of O2. Patient in great pain with VAS (visual analog scale) 7/10, morphine applied. Currently, carrying an NG Probe. ECG performed in principle with regular sinus tachycardia, slightly left axis, no ST or sign of BBG (left bundle branch block). Pr at 120 ms QTC calculated at 350 ms. Reminder tomorrow of MT for history and treatment in progress. In the morning of 22Apr2021, the patient with multi-failure, hemodynamic failure, FC 120, oliguria 300cc over 14 hours. Renal failure with appearance of an ARI (created on 20Apr2021 at 55), created on the evening of 21Apr2021 at 71 and 96 today (22Apr2021). The patient also had lactic acidosis with pH 7.28, and lactates 5.3. Neurological failure with appearance of confusion (incoherent speech today, disorientation, slowing ++). Respiratory failure with 93% sat under 4L, FR 32. Bilateral pleural effusions on auscultation. Diffuse abdominal defense. Rare BHA (hydroaeric noises). Diffuse abdominal pain, not relieved by morphine PSE 1mg / h. Increase to 1.5 mg / h, bolus of 3. Specialist advice given the seriousness of the picture of hydration +++ 1L of phy in free flow. And transfer to another service. The patient has no disturbance of BH (hepatic check) in the initial phase (ASAT 21, ALAT 22, GGT 25, PAL 89, bili 10). BH finding cytolysis at 50. No cholestasis. Indication nevertheless an abdominal ultrasound in order to rule out a possible lithiasic cause (ruled out by the echo on 22Apr2021). No alcohol consumption, calcemia and normal triglycerides. The patient was transferred to another department on 22Apr2021. The Glasgow score was rated at 13 (Y3V4M6) without focal deficit. There was moderate temporo-spatial disorientation. She presented sinus tachycardia at 130 bpm with mean arterial pressure kept at 90 mmHg. There were signs of peripheral hypoperfusion with cool extremities and slight mottling of the knees. There was no sign of right or left heart failure. Hematosis was altered with superficial polypnea at 25 cycles per minute without signs of struggle, and SpO2 at 91% under 6L of oxygen per minute. Cardiopulmonary auscultation finds a muffled vesicular murmur in the bases. Pulmonary x-ray shows bilateral atelectasis and pleural blunting. The abdomen was bloated, distended, and spontaneously painful and tender on palpation. Hydroaeric noises were not perceived. The nasogastric tube was productive. The patient benefits from the placement of a central venous catheter and an arterial catheter upon entry to monitor blood volume and allow a more detailed analysis of hemodynamics. Likewise, urinary catheterization makes it possible to more precisely quantify diuresis. NIV was introduced to combat atelectasis seen on auscultation. An injected TAP CT scan was performed on 22Apr2021 for evaluation at H48 and to explore the parenchyma and pulmonary vessels. She found acute Balthazar E-10 pancreatitis complicated by pylephlebitis of the splenic vein, abundant bilateral pleural effusion and bilateral contact atelectasis. The digestive loops were well vascularized. Curative anticoagulation with UFH(unfractionated heparin) was therefore started. The seriousness of the disease was certain, BISAP 5 and Balthazar E-10. The evolution was very quickly unfavorable. Respiratory failure requires the patient''s orotracheal intubation after rapid sequence induction (Cormack 1). The pleura were drained, bringing back a sero-hematic fluid negative in bacteriology. Hypoxia remained severe despite protective ventilation, high PEP and the appearance of bi-basal condensations led to a prone position on 23Apr2021. There was no response and the hemodynamics worsened, forcing this treatment to be stopped 3 hours later. Hepatic failure appears, suggesting a shock liver. The very rapid deterioration suggests a digestive complication such as ischemia or perforation. An exploratory laparotomy was indicated, but given the intensity of the organ failures, an AV ECMO is discussed with the surgeons to allow digestive surgery under good conditions. In view of the seriousness and the expected low benefit, the indication was not retained. The exploratory laparotomy was performed on 23Apr2021 and found small ischemia and right colic associated with peritonitis. The right colon and the ischemic small intestine are resected, mounted in the stoma. Hemodynamics and ventilation are difficult, filling and amines continued. Antibiotic therapy with CEFOTAXIME and METRONIDAZOLE is introduced, supplemented by a dose of AMIKACIN. However, the situation deteriorates further, the small stoma becoming necrotic and giving rise to suspicion of total ischemia of the digestive tract despite the treatments undertaken. This then becomes a therapeutic impasse. The family is met on several occasions to inform them of the diagnosis and the development of the situation until the therapeutic impasse. The patient died of her illness on 25Apr2021. In Total: acute fulminant pancreatitis, BISAP 5 and Balthazar E-10 without clear etiology found, complicated by digestive ischemia and associated peritonitis responsible for multiple organ failure and death. Pancreatitis occurring within 2 hours of the D1 of the COMIRNARTY vaccine and death within 5 days of the D1. Evolution of the results of Pq (platelets) during hospitalization (N 150-400 G / l): 197 on 22Apr2021 in the morning, 142 on 22Apr2021 evening, 88 on 23Apr2021, 65 on 24Apr2021 (the day before death ). The outcome of the events vomiting and abdominal pain was not recovered while unknown for the other events. The patient died on 25Apr2021. Autopsy requested by the family. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: found small ischemia; right colic associated with peritonitis; multi failure; neurological failure with appearance of confusion; neurological failure with appearance of confusion; respiratory failure; hemodynamic failure; acute pancreatitis


VAERS ID: 1315282 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   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: Astrix; Tritace; Rosuvastatin; Teva
Current Illness: Hyperlipidaemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:negative
CDC Split Type: HUPFIZER INC2021506504

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number HU-OGYI-254521. A 60-year-old male patient received bnt162b2 (Pfizer vaccine, Lot Number: EW2239 and expiration date not provided), intramuscular, administered in Arm Left on 10Apr2021 as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunisation. The patient''s medical history included ongoing Hyperlipidaemia and ongoing Hypertension. The patient''s concomitant medications included acetylsalicylic acid (ASTRIX), ramipril (TRITACE), and rosuvastatin calcium (ROSUVASTATIN TEVA). On 14Apr2021, the patient experienced acute myocardial infarction and died. The patient underwent lab tests and procedures which included SARS-CoV-2 PCR test: negative on 15Apr2021. The patient died on 14Apr2021. An autopsy was performed and results were not provided. Sender Comment: According to the SmPC of Pfizer vaccine concentrate for dispersion for injection, acute myocardial infarction is not listed and not expected. TTO is 4 days. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered unlikely. The case is considered serious due to fatal outcome. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: acute myocardial infarction


VAERS ID: 1315459 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, C-reactive protein, Coma scale, Completed suicide, Dizziness postural, Heart rate, Hyperventilation, Lip haemorrhage, Lumbar puncture, Magnetic resonance imaging head, Mental disorder, Oxygen saturation, Procalcitonin, Pyrexia, Respiratory rate, SARS-CoV-2 test, Tetany, Tremor, White blood cell count
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Suicide/self-injury (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abnormal behaviour (He had pyrexia once and rampaged suddenly in childhood. It was nearly encephalitis.); Pyrexia (He had pyrexia once and rampaged suddenly in childhood. It was nearly encephalitis.)
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/98; Comments: at 10:00; Test Date: 20210423; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210425; Test Name: Body temperature; Result Unstructured Data: Test Result:38s Centigrade; Test Date: 20210426; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Test Date: 20210427; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: 36.2 in the morning; Test Date: 20210427; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: at 10:45; Test Date: 20210427; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Comments: at 12:45; Test Date: 20210427; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Comments: at 14:00; Test Date: 20210427; Test Name: JCS (coma scale); Result Unstructured Data: Test Result:300; Comments: at 18:20; Test Date: 20210427; Test Name: CRP; Result Unstructured Data: Test Result:no increase; Test Date: 20210427; Test Name: Heart rate; Result Unstructured Data: Test Result:168; Comments: at 10:00; Test Date: 20210427; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:normal in the number of cells; Test Date: 20210427; Test Name: Head MRI; Result Unstructured Data: Test Result:normal; Test Date: 20210427; Test Name: SPO2; Test Result: 98 %; Comments: at 10:00; Test Date: 20210427; Test Name: Procalcitonin; Result Unstructured Data: Test Result:no increase; Test Date: 20210427; Test Name: RR; Result Unstructured Data: Test Result:32; Test Date: 20210427; Test Name: COVID 19 PCR test; Test Result: Negative ; Test Date: 20210427; Test Name: WBC; Result Unstructured Data: Test Result:11300
CDC Split Type: JPPFIZER INC2021477191

Write-up: Mental state abnormal; committed suicide; hyperpnoea; tetany-like symptom in fingers and hands; bleeding from the lips; Shaking of hands; Pyrexia of 38s degrees centigrade/37.1 degrees centigrade/37.9 degrees centigrade; Dizziness on standing up; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 10May2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable pharmacist and a contactable physician via a Pfizer sales a regulatory authority. Regulatory authority report number is v21105444. A 25-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER7449, Expiration Date 30Jun2021) via intramuscular on 23Apr2021 at 16:00 at single dose for COVID-19 immunization. Relevant medical history included pyrexia once and rampaged suddenly in childhood, it was nearly encephalitis. The patient did not have a history of mental disease and worked normally. Concomitant medications were not reported. On 23Apr2021 the patient was vaccinated with BNT162b2 as a healthcare professional. It was unknown how the patient was on Saturday and Sunday (24Apr2021 to 25Apr2021). It seemed that the patient had pyrexia of 38 degrees centigrade then. On Sunday, 25Apr2021, the patient developed lightheadedness upon standing and tremulousness of hands when being with his friend and his friend carried him home from the apartment. Pyrexia of 38s degrees centigrade on 25Apr2021 was also reported, but no information about it was provided from the patient and his parents. The patient had pyrexia of 37.1 degrees centigrade on Monday morning (on 26Apr2021). The patient made a phone call to the physician for consultation. The physician instructed the patient to take a rest and asked about his condition later in the evening because he was living alone. The patient told the physician his condition was good. He had pyrexia of 37.9 degrees centigrade on Tuesday (on 27Apr2021). This case was reported because vaccination with BNT162b2 could not be denied triggering the event. On the morning of 27Apr2021 (4 days after the vaccination), the patient experienced mental state abnormal and committed suicide. The patient who worked as a clinical laboratory technician for the hospital was running riot as discovered taking out potassium chloride (KCL) without permission on 27Apr2021. He was finally hold down. He was diagnosed by psychiatric consultation with Paranoid state/Mental disorder. The patient was being transported to a psychiatric hospital in a passenger car by his family. But on the way, the patient jumped out of the car overcoming the family''s restraint and died. The followings were detailed incident report about the patient''s failed attempt to take out KCL from an operation room without permission on Tuesday, 27Apr2021. The course on 27Apr2021: On Tuesday, 27Apr2021, it was reported from the superior of the patient that the patient worked from the morning. His body temperature was 36.2 degrees centigrade. His task was changed considering his physical condition. At 09:00 on the same date, the patient was looking at the schedule of cardiac catheterization on PC monitor in the conference room for menstruation when the chief engineer of the clinical laboratory department was checking a memorandum of an electrocardiogram room. The patient was wearing surgical suit as he always wears it. The chief engineer of the clinical laboratory department talked to the patient for the confirmation of his condition because he had just recovered, "Are you all right?" The patient was not friendly but seemed composed as usual and his condition was likely not bad. His facial color was not bad, either. Around at 09:30, the assistant pharmacist talked to the patient because the assistant saw the patient (wearing shield mask in surgical suit) trying to open the medicine cabinet in a cold place after checking it after he came in the pharmacy. Conversation between the patient and the assistant pharmacist was as following: The patient: "I came here for cardioplegic solution." The assistant pharmacist: "Did you come here to bring cardioplegic solution back home?" The assistant pharmacist and the patient together looked into the medicine cabinet, but they could not find any cardioplegic solution. "Do you need it right now?" The assistant pharmacist asked the patient about several things such as his phone number and told him that the assistant pharmacist would call the patient when cardioplegic solution was prepared. The patient got wet-eyed though he did not reply to the question of the assistant pharmacist. The patient: "Put cardioplegic solution on there when it is prepared." pointing his finger to the designated place. The assistant pharmacist: "I will not put cardioplegic solution on there because it should be reserved in the cold place. I will call you when it is prepared." The assistant confirmed the nameplate (with a green line) on the pocket when the patient came out of the pharmacy and family name on the nameplate was confirmed to be one character, but the name could not be confirmed. The patient was a skinny young male and his height was about 160 cm. The pharmacist made a phone call to the clinical engineer (CE) and confirmed that CE had not charged the price of cardioplegic solution. Around 09:30 to 09:40, the nurse witnessed a staff (patient) in surgical suit walking into the direction of room number 8 after coming out of operation room number 7. The patient seemed not normal and he was not wearing a cap. The patient was looking into the pink cart with his hands laying down on it. In the pink cart, there were general anesthetic drugs on the tray, syringes, pumps, acetaminophen (ACELIO Bag for intravenous injection) and others. Conversation between the nurse and the patient was as following: Nurse: "What are you doing?" The patient: "Drugs." Nurse: "What for?" The patient: "potassium." The nurse thought that his answers were not related to the questions and felt that was strange. The nurse answered to the patient, "drugs are not here" and the patient walked into the direction of room number 5. The nurse escaped into operation room number 7 to distance herself from the patient because she felt the danger. When she came out of the room to report to the chief nurse after a while, she heard a shrieking voice. The circulating nurse was in charge of the operation room number 4. When she came into hallway out of the room at the time of intubation, she found an unfamiliar guy wearing shield mask in surgical suit tottering towards operation room number 5, 6 and 7. He was not wearing a cap. He seemed looking inside though the window on the door while the operation was ongoing. He came across an operating room nurse and had a conversation with her and then walked into the direction of operation room number 4 and 5. The circulating nurse reported to the chief nurse because he walked towards the aisle between operation room number 4 and 5, as follows: There was a stranger (patient). Although his nameplate had a green line, she felt strange because she did not know him. He had nothing in his hands. The chief nurse went to check him. The patient was touching something on the blue cart while crouching down around the shelf in the backside of the backyard. The patient had KCL in his hand and there was a red disposal bag for pump-oxygenator. CE talked to the patient, "what are you doing?" and then the patient kicked CE''s hip with his knee, but CE felt no pain and did not feel that the patient strongly hit CE. When the patient stayed about two meters away from CE, the nurse watching them shouted, "Suspicious man!". When the patient fell after trying to run away, the staff held him down. CE felt fear and cried. The items in the disposal bags were as follows: 2 kits of KCL, 2 or 3 bottles of tribenoside (HEMOCURON), a few blood gas syringes with no needles, several impure gauzes, 5 or 6 syringes of 2.5 ml, 5 ml and 10 ml, 5 or 6 pink 18 G needles, a infusion set for 20 drops and the one for 60 drops. Before 10:00, head of secretariat, general head nurse, and head nurse of Safety Management were informed of the incident and arrived at the operation room. The patient was held down by several persons, lying on face down with his hands bound in rope. A call to police was already made. They once stopped holding him down and turned him face up. He was found to be a hospital laboratory group staff from the name card. The patient was bleeding from the lips, and the haemostasis was performed. After promising not to behave violently, they untied the rope and made him on a wheelchair. The patient had tetany-like symptom in fingers and hands and hyperpnoea. The patient could not make conversation. Bp 150/98, HR 168, SpO2 98 %. The patient nodded to a question "Would you like to lie down?", and the patient was moved to emergency department in a condition of fixed with belt to a wheelchair. At 10:00, the patient was surrounded by a lot of people at the backyard with his hands tied. When the chief head confirmed his face, the patient had no expression on the face. The patient was vacant, and he was muttering something that could not be discriminated. The patient looked different in expression, which was so much that he could not be recognized as him with looking once. At 10:30, in emergency department, the patient was restless throughout. When the patient was asked a question, he made only an absent-minded response. The patient said "Yes, yes" in a small voice, but it could not be determined he actually understood. The patient sometimes started moving restlessly. The head of secretariat and emergency nurse confirmed the patient if it was alright that chief engineer of clinical laboratory department accompanied with him. The patient told "I am afraid to be alone" and "why am I in this situation?". The patient told it was alright that that chief engineer of clinical laboratory department accompanied with him. So, chief engineer of clinical laboratory department did. They talked to him "We are all on your side." to give consideration to his feelings. At 10:45, when head nurse of Safety Management observed him, the patient responded "Yes" to all the question when the patient was talked to. The patient did not make eye contact with anyone. The patient was absent-minded and could not make conversation. What he said including "I do not want to say that", "No, No", "What?", "Oh god", "It sucks", "Great", and "No, not like that", made no sense, and he was just muttering. The patient was asked if he was hearing someone''s voices and the patient answered "Yes". Body temperature was 37.9 degree Centigrade. A psychiatrist saw him. He was in a paranoid state. Admission to another hospital was considered, and the patient was directed to see a neurologist for the consciousness disturbed. When the psychiatrist saw him, the patient said "cardioprotective agent" and "cardiac arrest" to a question "What is KCL a drug for?". His father came to the hospital. When the father met the patient, the father said "He looks different than usual". At 12:00, the patient had pyrexia. He was directed by head of the hospital to receive COVID 19 PCR test, which showed negative. At 12:45, the patient had consultation by a neurologist. He remembered to enter Operation room with thoughts. They were unable to pursue him because the patient broke down crying. Body temperature was 38.1 degrees centigrade. Blood test showed WBC was 11300 and CRP and procalcitonin did not increase. At 13:00, head MRI was taken. The patient was so scared that a clinical laboratory technician accompanied him. No abnormalities were found. At 14:00, lumbar puncture was performed. Number of cells was normal. Body temperature was 38.1 degrees centigrade. At 14:50, respiratory rate (RR) was 32 per minute. A tendency of hyperpnoea was seen. A psychiatrist gave an explanation of admission to a psychiatry hospital. The patient''s family mentioned that he looked different after vaccinated with bnt162b2. They hoped that the patient was admitted to the hospital and returned home after he was afebrile. It seemed that they would not accept that the patient was admitted to a psychiatry hospital. The physician explained that this hospital was not a psychiatry hospital and the patient was unable to be admitted. The physician told that he/she realized the feeling that they wanted to return him home and he/she could not take responsibility. Head of secretariat mentioned to the family as follows: "the patient may steal drug again. It was unknown what he was going to do with that, though. That was a dangerous drug, lethal one. It would be rather better for him to find the behavior". Head of secretariat recommended them to go to the special hospital not to repeat the same thing. The patient''s father said "I want to take the patient home. The patient made abnormal behaviour in the past when having pyrexia". The patient''s mother said that "He had pyrexia once and rampaged suddenly in childhood. It was nearly encephalitis. I suppose this time is almost the same. He does not say a lot and tends to give the surroundings an unfriendly feeling. He had a strange symptom last Saturday (24Apr2021) and Sunday (25Apr2021). We got a phone call from him after having a meal with friends of his. He complained that he had dizziness and shaking of hands. He came and stayed at our home instead of his apartment." At 16:00, the patient''s father told that the patient wanted to apologize to the staff member he kicked. Head nurse of Safety Management talked about the situation. The staff member neither had pain nor got hurt and did not mind. The father wished to convey his son''s apology to the staff member. The patient changed clothes to those director technician and chief technician at Clinical Laboratory brought. The father asked if the patient should bring underwear. The hospital instructed them to go to the special hospital because underwear was ready there. At 16:15, the patient and his father and mother walked to the parking lot. Director of Emergency department witnessed that the father drove the car and the patient and his mother rode together. He/she called the mother to be with the patient. A little past 17:00, head of secretariat received a phone form the patient''s mother. He jumped out of the car on express way and run over by the following cars. He was going to a hospital by ambulance. The father cooperated with on-site investigation. At 18:20, an emergency physician of a tertiary emergency hospital made a phone call to the hospital. Director of Emergency department answered the phone. Emergency physician: "The mother would not talk. What has happened? How come did you take him not by ambulance? Coma Scale (JCS) is 300. He is in a very serious condition. We will take a CT right away." At 21:30, the patient died (on the following morning at 7:00, the mother made a phone call and Head of secretariat answered it). It was not if autopsy was preformed. The outcome of events mental state abnormal and committed suicide was fatal, outcome of other events was unknown. The reporting physician classified the events mental state abnormal and committed suicide as serious (death, cause of death and autopsy result was not provided) and assessed the causality between the event and BNT162b2 as un-assessable. Other possible cause of the event such as any other diseases was abnormal behavior (only a single time, developed after having fever in his childhood). The reporting physician commented as follows: There appeared a possibility that vaccination with BNT162b2 may have triggered it.; Reported Cause(s) of Death: mental state abnormal; committed suicide


VAERS ID: 1315535 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Cardiac hypertrophy, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax, Heart rate, Intestinal obstruction, Mesenteric vascular occlusion, Oxygen saturation, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypertension (narrow), Cardiomyopathy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Low back pain; Pain; Sleep deficit; Urinary incontinence
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: blood pressure; Result Unstructured Data: Test Result:121/59; Comments: 8:45; Test Date: 20210421; Test Name: blood pressure; Result Unstructured Data: Test Result:121/67; Comments: 9:08; Test Date: 20210421; Test Name: blood pressure; Result Unstructured Data: Test Result:139/48; Comments: 10:20; Test Date: 20210421; Test Name: blood pressure; Result Unstructured Data: Test Result:124/64; Comments: 11:50; Test Date: 20210424; Test Name: blood pressure; Result Unstructured Data: Test Result:152/82; Comments: 13:30; Test Date: 20210424; Test Name: blood pressure; Result Unstructured Data: Test Result:168/75; Comments: 10:30; Test Date: 20210421; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: 8:45; Test Date: 20210421; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: 9:08; Test Date: 20210421; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: 11:50; Test Date: 20210424; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: 13:30; Test Date: 20210424; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: 10:30; Test Date: 20210424; Test Name: Abdomen CT; Result Unstructured Data: Test Result:showed niveau was found in small intestine and lar; Test Date: 20210424; Test Name: Head CT; Result Unstructured Data: Test Result:showed no acute cerebral haemorrhage or cerebral i; Comments: showed no acute cerebral haemorrhage or cerebral infarction; Test Date: 20210424; Test Name: Chest CT; Result Unstructured Data: Test Result:showed no obvious pneumonia or pleural effusion; Comments: No vomit that induce asphyxia in bronchus was noted. showed no obvious pneumonia or pleural effusion Although cardiac hypertrophy was found, no sign of cardiac failure was noted.; Test Date: 20210421; Test Name: pulse rate; Result Unstructured Data: Test Result:49; Comments: 8:45; Test Date: 20210421; Test Name: pulse rate; Result Unstructured Data: Test Result:67; Comments: 9:08; Test Date: 20210421; Test Name: pulse rate; Result Unstructured Data: Test Result:61; Comments: 10:20; Test Date: 20210421; Test Name: pulse rate; Result Unstructured Data: Test Result:64; Comments: 11:50; Test Date: 20210424; Test Name: pulse rate; Result Unstructured Data: Test Result:87; Comments: 13:30; Test Date: 20210424; Test Name: pulse rate; Result Unstructured Data: Test Result:65; Comments: 10:30; Test Date: 20210421; Test Name: SpO2; Test Result: 98 %; Comments: 9:08; Test Date: 20210421; Test Name: SpO2; Test Result: 96 %; Comments: 11:50; Test Date: 20210424; Test Name: SpO2; Test Result: 99 %; Comments: 13:30; Test Date: 20210424; Test Name: SpO2; Test Result: 93 %; Comments: 10:30
CDC Split Type: JPPFIZER INC2021531047

Write-up: blood pressure 168/75; Vomiting; Cardiac hypertrophy; Intestinal obstruction (vascular mesenteric occlusion); Intestinal obstruction (vascular mesenteric occlusion); This is a spontaneous report from a contactable internist (physician) received via a Pfizer sale representative. The patient was 94 years old female with ongoing dementia. The patient concomitant medications were not provided. On 23Apr2021, the patient received BNT162b2 (COMIRNATY, Lot# and Expiration date unknown) via intramuscular as a single dose for COVID-19 immunization. The dose number was not provided. On 24Apr2021 (1 day after the vaccination), the patient experienced intestinal obstruction (vascular mesenteric occlusion). On 24Apr2021 at 18:27 (1 day after the vaccination), the patient died. The outcome was fatal. The course of the event was as follows: On 20Apr2021 at 22:45, the patient made nurse call continuously many times saying "Help! Help!" The patient lay on the bed and stated, she could not move because her body ached. Sign of intestinal obstruction was considered, or lumbar part and sacral region. At the same time, urinary incontinence was noted. No abnormality was found with vitals. (Urinary retention was considered). The patient was told, "please relax herself and sleep well. A nursing home worker will return next morning" on the timing when the patient calmed down. On 21Apr2021 in the morning, the patient came down to the office at the first floor with a nursing home worker to say thank you. When the internist went to see the patient in the hospital room at the 5th floor, the patient was found measuring body temperature in front of an office. At 8:45, body temperature 36.5 degrees Centigrade, blood pressure 121/59, pulse rate 49 and no abnormality was found. The patient seemed a little concerned. The physician went to see the patient in the hospital room at a little past 09:00. Body temperature 36.0 degrees Centigrade, blood pressure 121/67, pulse rate 67, and SpO2 98% at 9:08. By the time the nursing home worker visited her room, the patient had washed the towel used under her body, and she was hanging the laundry up with help of the nursing home worker. Her gait was unsteady, and the patient complained of feeling tired because she had insufficient sleep, for which the patient was instructed to rest in her room. At 10:20, the patient was lying on her bed. The patient complained of being unable to get herself up from the bed because she had low back pain. Blood pressure 139/48, pulse rated 61. Her body was slightly feverish. The patient tended to get lie down even the physician tried to get her up. The patient insisted that she felt better lying down turning her body to the wall side. Bathing was not performed. At 11:50, the patient made a nurse call. The patient was found lying with her arm and body fell between the wall and bed. The patient told her body was sucked into it. A nursing home worker got her body up and put a pillow into the space to prevent the patient from fall into it again. Body temperature 37.0 degrees Centigrade, blood pressure 124/64, pulse rate 64, and SpO2 96%. From 14:00 to 15:00, the patient was seen at the outpatient clinic in reclining wheelchair. Chief complaint included whole body aching, but no headache was noted when the patient moved both hip joints. No pain due to hitting or falling was noted. Because patients cared in a nursing home tended to complain whole body aching, the primary physician considered it was a kind of behavioral and psychological symptom of dementia (BPSD) accompanying dementia. Follow-up after that was unspecified. On 22Apr2021, the patient''s course of the day was unspecified. On 23Apr2021, the patient came down to the first floor in while chair for receiving COVID-19 vaccine. At history taking, no complain of body was heard in specific from the patient. The patient received intramuscular injection of BNT162b2 (COMIRNATY, Lot# and Expiration date unknown) vaccine. The patient was followed up for about 1 hour, but no abnormality was noted. The patient ate dinner as usual. On 24Apr2021 at 5:00, the patient vomited. Thereafter, 4 times of vomiting were noted. The patient could not eat breakfast. At 10:30, nursing home recoded that vomiting with brownish vomit and saliva, body temperature 36.4 degrees Centigrade, pulse rate 65, SpO2 93%, blood pressure 168/75. At 13:30, the patient was seen at the outpatient clinic in reclining wheelchair. The patient responded with smile to the questions, but her speech was not clear. Body temperature 36.5 degrees Centigrade, blood pressure 152/82, pulse rate 87, SpO2 99%. No murmur was hear at auscultation, regular. No tenderness in abdominal region, and bowel sound normal. Cause for vomiting was unspecified. Treatment was provided with glucose, potassium chloride, sodium chloride, sodium lactate (SOLDEM) 3A 1000 mL at 1 dose and metoclopramide hydrochloride (PRIMPERAN) at 1 ample. At 17:50, on room visit, the patient in her room. No respiratory abnormal was found, but the patient eyes were closed when her name was called. At 18:00, on room visit, respiratory arrest was noted. Monitor showed flat. One mouth of vomit mark was seen. At 18:27, the patient family came over. Her death was confirmed with two nieces as witnesses. Systemic CT (AI) was performed to find death cause. Head CT showed no acute cerebral haemorrhage or cerebral infarction. Chest CT showed no obvious pneumonia or pleural effusion. No vomit that induce asphyxia in bronchus was noted. Although cardiac hypertrophy was found, no sign of cardiac failure was noted. Abdominal CT showed niveau was found in small intestine and large intestine, but occluded site was unspecified. Anaphylaxis known with BNT162b2 vaccine was not found. At 19:56, after details were told to the patient''s family, pathologic autopsy was asked for further investigation for death cause. However, the family declined it because they considered that the patient made a lot of effort and died a peaceful death. The internist classified the event as serious (Death) and the causality between the event and BNT162b2 as unassessable. The internist considered the intestinal obstruction (vascular mesenteric occlusion) was the most like death cause based on the AI result although pathologic autopsy was not performed and the death cause was not identified. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the available information, the company considered that the events intestinal obstruction (vascular mesenteric occlusion) were unrelated to the vaccination with BNT162B2. Of note, sign of intestinal obstruction was suspected prior to the vaccination. The events were most likely related to the patient''s advanced age and underlying medical conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: Intestinal obstruction (vascular mesenteric occlusion); Intestinal obstruction (vascular mesenteric occlusion)


VAERS ID: 1315536 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Cardio-respiratory arrest, Computerised tomogram
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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   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; Diabetes mellitus; Renal disease (currently stable)
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210509; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210510; Test Name: CT; Result Unstructured Data: Test Result:No apparent haemorrhage intracranial and aortic; Comments: dissection with pleural effusion in bronchi
CDC Split Type: JPPFIZER INC2021531180

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency Regulator Authority. The regulatory authority report number is v21105644. A 77-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EX3617; Expiration Date: 31Aug2021), via an unspecified route of administration, on 09May2021 at 15:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included renal disease (currently stable), diabetes mellitus, and dementia. The patient''s concomitant medications were not reported. The patient experienced cardio-respiratory arrest on 10May2021 at 06:00, which was reported as fatal. The clinical course was reported as follows: On 09May2021, the patient had physical deconditioning and received the vaccination. The body temperature before vaccination was 36.4 degrees Centigrade on 09May2021. After the vaccination, the patient did not eat dinner. The last time the existence of the patient was confirmed was on 10May2021 at 01:00. On 10May2021 at 06:00 (about 15 hours after the vaccination), the patient''s wife woke him up, and he was found in a state of cardio-respiratory arrest. The patient was emergently transferred to the reporting hospital. On 10May2021 at 06:47, intubation and securing a route were done, and adrenaline (MANUFACTURER UNKNOWN) was administered twice. However, the heart did not return spontaneous circulation. On 10May2021 at 07:16, the patient was confirmed dead. A blood test was performed in May2021 with unknown results. A computerised tomogram (CT) was performed on 10May2021 with results of no apparent haemorrhage intracranial and aortic dissection with pleural effusion in bronchi and aortic dissection. The patient was suspected of having heart disorder by the physician. Therapeutic measures were taken as a result of the event as aforementioned. The patient died on 10May2021 at 07:16. The cause of death was reported as cardio-respiratory arrest. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was not provided.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1315560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-04-28
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiac failure, Disturbance in attention, Oedema, Oedema peripheral, Somnolence, Urine analysis normal
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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: FEVARIN; DIAZEPAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:no abnormalities; Test Name: urine tests; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: NLPFIZER INC2021492114

Write-up: Oedema started at legs, spreads to whole legs, hands; oedema in the legs which spread throughout the legs into the buttocks, lower back; Little concentration so she falls asleep after a page of reading and can''t follow TV programs/Concentration loss; Sleepy: She is very sleepy so she falls asleep after a page of reading and can''t follow TV programs/Somnolence; Heart failure; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from a regulatory authority-WEB NL-LRB-00513409, received from Regulatory Authority. A 90-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EP2166), via an unspecified route of administration on 03Mar2021 as 2nd dose, 0.3 ml single for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included fluvoxamine maleate (FEVARIN) and diazepam, both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of COMIRNATY on 27Jan2021 for COVID-19 immunisation and experienced no adverse reaction. The patient experienced oedema started at legs, spreads to whole legs, hands and oedema in the legs which spread throughout the legs into the buttocks, lower back on an unspecified date, little concentration so she falls asleep after a page of reading and can''t follow tv programs/concentration loss and sleepy: she is very sleepy so she falls asleep after a page of reading and can''t follow tv programs/somnolence on an unspecified date; heart failure on 28Apr2021. Treatment: Oedema is treated with diuretics; however, that treatment is stopped in consultation with the GP because it caused more harm than good. Two weeks after the second vaccination, the patient developed oedema in the legs which spread throughout the legs into the buttocks, lower back and hands. It has affected the quality of life because it used to be a healthy woman who is now no longer able to move as smoothly as before and who can no longer dress herself. She has to pant often, but her heart appears to be fine. She does not experience dyspnoea. She has been to the GP who investigated her blood and urine but was unable to find any abnormalities. The internist too was not able to find abnormalities. The GP had given her diuretics, but they caused more harm than good, so the treatment was stopped. They made the patient anxious. Up until now, the patient can barely walk. The GP does not know what to do. Latency: oedema: 2 weeks after start, somnolence and concentration loss: latency unknown. The patient was a healthy woman who is no longer herself since the oedema. She can hardly walk anymore. Must pant then (heart is okay, not stuffy). She is very sleepy, little concentration so she falls asleep after a page of reading and can''t follow TV programs. The oedema breaks her skin. She can no longer dress herself, the reporter''s father (94) has to help her, she is awake at night (while she was always a good sleeper), she then gets out of bed but is physically difficult to get back in. The doctor has done extensive blood and urine tests. All values are normal. Subsequently, her mother went to the internist for an examination, he also concluded that everything is fine. She has now been given water pills from the doctor, but they have not helped, and the remedy was worse than the disease, because she became anxious. She can barely walk now, and her parents are desperate. The patient''s mother died today (28Apr2021) in the hospital, this week the cardiologist diagnosed heart failure. They don''t know if this started with Pfizer, only that the edema started 2 weeks after the 2nd vaccine and that she gained 25 kilos of fluid in a few weeks, from 53 to 80 kilos. She was leading a healthy life. The patient underwent lab tests and procedures which included blood test: no abnormalities and urine analysis normal: no abnormalities on an unspecified date. The outcome of concentration loss and somnolence is unknown, while of the rest was fatal. The patient died on 28Apr2021. It was unknown if an autopsy was performed. Oedema and oedema peripheral were reported as fatal, medically significant and serious per hospitalization by the regulatory authority. Case Summary and Reporter''s Comments Text: 28Apr2021 Follow-up received: Dear people, my mother died today in the hospital, this week the cardiologist diagnosed heart failure. We don''t know if this started with Pfizer, only that the edema started 2 weeks after the 2nd vaccine and that she gained 25 kilos of fluid in a few weeks, from 53 to 80 kilos . She was leading a healthy life. Hopefully this will be sufficient for you Kind regards. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: 28Apr2021 Follow-up received: Dear people, my mother died today in the hospital, this week the cardiologist diagnosed heart failure. We don''t know if this started with Pfizer, only that the edema started 2 weeks after the 2nd vaccine and that she gained 25 kilos of fluid in a few weeks, from 53 to 80 kilos . She was leading a healthy life. Hopefully this will be sufficient for you Kind regards.; Reported Cause(s) of Death: Heart failure; Oedema started at legs, spreads to whole legs, hands; oedema in the legs which spread throughout the legs into the buttocks, lower back


VAERS ID: 1315568 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Fall, Head discomfort, Monoparesis, Scan brain
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 8
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: 20210326; Test Name: Brain scan; Result Unstructured Data: Test Result:showed cerebral infarction
CDC Split Type: NLPFIZER INC2021512468

Write-up: Cerebral infarction on March 26 (scan); preceded by small infarction on 22 march; on 22 March, limb disintegration (frequent falls) and very strange feeling in the head; frequent falls; on 22 March, limb disintegration (frequent falls) and very strange feeling in the head; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) -WEB, regulatory authority number NL-LRB-00528554. A 98-year-old male patient received bnt162b2 (Pfizer vaccine) at the age of 98 years, dose 2 via an unspecified route of administration on 19Mar2021 (Lot Number: Unknown) as single for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medication includes non-specified anticoagulant and non-specified stomach medications. The patient previously received 1st dose of bnt162b2 (Pfizer vaccine) on 12Feb2021 for covid-19 immunisation with no adverse reaction. The patient experienced cerebral infarction on March 26 (scan), preceded by small infarction on March 22. The patient also had limb disintegration (frequent falls) and very strange feeling in the head. The patient underwent lab tests and procedures which included brain scan: showed cerebral infarction on 26Mar2021. The patient died on 30Mar2021 due to cerebral infarction. It was unknown if an autopsy was performed. It was also reported as follows: cerebral infarction (death) and cerebral infarct with limb paresis and head discomfort following administration of COVID-19 vaccine Pfizer. The patient had a small cerebral infarction with limb paresis (patient has fallen multiple times) and a weird feeling in his head 3 days after vaccination. Seven days after vaccination he had another cerebral infarct which was confirmed on a brain scan. Outcome of non-fatal events was unknown. No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cerebral infarction on March 26 (scan)


VAERS ID: 1316341 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram, Haemorrhagic stroke, Magnetic resonance imaging head, Pyramidal tract syndrome
SMQs:, Haemorrhage terms (excl laboratory terms) (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: 2021-04-17
   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: ROSUVASTATIN; EXELON [RIVASTIGMINE]
Current Illness: Dementia vascular
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Encephalopathy
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Test Result: Inconclusive ; Result Unstructured Data: Bleeding in basal ganglia; Test Name: MRI brain; Test Result: Inconclusive ; Result Unstructured Data: Bleeding in basal ganglia
CDC Split Type: GRMODERNATX, INC.MOD20211

Write-up: Haemorrhagic stroke; Pyramidal tract syndrome; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGIC STROKE (Haemorrhagic stroke) and PYRAMIDAL TRACT SYNDROME (Pyramidal tract syndrome) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Encephalopathy and Dyslipidaemia. Concurrent medical conditions included Dementia vascular. Concomitant products included ROSUVASTATIN from 01-Apr-2015 to an unknown date and RIVASTIGMINE (EXELON [RIVASTIGMINE]) for an unknown indication. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced HAEMORRHAGIC STROKE (Haemorrhagic stroke) (seriousness criteria death, hospitalization prolonged and medically significant) and PYRAMIDAL TRACT SYNDROME (Pyramidal tract syndrome) (seriousness criterion hospitalization prolonged). The patient died on 17-Apr-2021. The reported cause of death was Pyramidal tract syndrome and Haemorrhagic stroke. It is unknown if an autopsy was performed. At the time of death, PYRAMIDAL TRACT SYNDROME (Pyramidal tract syndrome) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: bleeding in basal ganglia (Inconclusive) Bleeding in basal ganglia. On an unknown date, Magnetic resonance imaging head: bleeding in basal ganglia (Inconclusive) Bleeding in basal ganglia. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Company comment: This is a case of death in a 71-year-old female subject with a medical history of Dementia vascular, Encephalopathy and Dyslipidemia, who died 11 days after receiving the vaccine. Based on information received and patient''s risk factors from the medical history, the event/death is assessed as unlikely related to mRNA-1273.; Sender''s Comments: This is a case of death in a 71-year-old female subject with a medical history of Dementia vascular, Encephalopathy and Dyslipidemia, who died 11 days after receiving the vaccine. Based on information received and patient''s risk factors from the medical history, the event/death is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Pyramidal tract syndrome; Haemorrhagic stroke


VAERS ID: 1316387 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Diffuse alveolar damage, Organising pneumonia, Sepsis, Thrombophlebitis
SMQs:, Interstitial lung disease (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Eosinophilic pneumonia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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: UNASYN [SULTAMICILLIN]; FUROSEMID; TAZONAM; CEREBOKAN; NOVALGIN [METAMIZOLE SODIUM]; NEUROBION [CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE;THIAMINE DISULFIDE]; PANTOPRAZOLE; FENTANYL; HYDAL; VENDAL [MORPHINE SULFATE]; MUCOBENE
Current Illness: Acute renal insufficiency; Anthracosis; Dementia; Emphysema; Urinary tract infection; Urothelial carcinoma recurrent
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021521747

Write-up: chronic organizing focal florid pneumonia; Sepsis; with additional signs of diffuse alveolar damage; inflamed vascular thrombosis; This serious spontaneous report was received from a contactable Physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-25676. An 88-years-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 18Mar2021 (Lot Number: ET1831) as 2nd dose, single for covid-19 vaccination. Medical history included ongoing anthracosis, ongoing emphysema, ongoing urinary tract infection, ongoing urothelial carcinoma recurrent, ongoing acute renal insufficiency and ongoing dementia. Concomitant medication(s) included sultamicillin (UNASYN); furosemide (FUROSEMID); piperacillin sodium, tazobactam sodium (TAZONAM); ginkgo biloba extract (CEREBOKAN); metamizole sodium (NOVALGIN); cyanocobalamin, pyridoxine hydrochloride, thiamine disulfide (NEUROBION); pantoprazole; fentanyl; hydromorphone hydrochloride (HYDAL); morphine sulfate (VENDAL); acetylcysteine (MUCOBENE). Patient received first dose of bnt162b2 (COMIRNATY) on 25Feb2021 for covid-19 immunisation. On 18Mar2021 the patient experienced chronic organizing focal florid pneumonia with additional signs of diffuse alveolar damage (Life-threatening) or with an inflamed vascular thrombosis (Life-threatening). The patient experienced sepsis (Life-threatening) on 18Mar2021. The patient was fatal for organizing pneumonia, not recovered for other events. The patient died on 18Mar2021 at 6:00 p.m. The autopsy determined cause of death was reported to be organizing pneumonia. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: chronic organizing pneumonia


VAERS ID: 1316393 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, 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: 2021-05-02
   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: METFORMIN; FOLAVIT; LORMETAZEPAM; D-CURE; DUOVENT; VALIUM; EZETROL; NEXIAM [ESOMEPRAZOLE SODIUM]; TAMSULOSIN; AMLOR; QUETIAPINE; PARACETAMOL; SOTALOL; CIRCADIN; IRBESARTAN EG; MOXONIDINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Confusion; Fall ((ethyl impregnation context)); Head injury (post fall (ethyl impregnation context); Hepatoma (a post-fall intracerebral hematoma)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021522132

Write-up: Unexpected death the night of 1 to 02May21.; Unexpected death the night of 1 to 02May21.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-90650 A 76-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Batch/lot number: ET3674) on 29Apr2021 at single dose for COVID-19 immunisation. Patient hospitalized for rehabilitation following a post-fall intracerebral hematoma (ethyl impregnation context) dating from 28Mar2021. Confusion already presented before the vaccine. Concomitant drugs included amlodipine besilate (AMLOR), melatonin (CIRCADIN), colecalciferol (D-CURE), ezetimibe (EZETROL), irbesartan (IRBESARTAN Eg), folic acid (FOLAVIT), lormetazepam, metformine, moxonidine, esomeprazole sodium (NEXIAM), paracetamol, quetiapin, sotalol, diazepam (VALIUM), fenoterol hydrobromide, ipratropium bromide (DUOVENT), tamsulosin, and nutritional supplement: Befortex. The patient was found dead in the morning in his bed; died in sleep/sudden death on 02May2021. No treatment was received. No autopsy was scheduled. Reporter''s comments: Not the explanation for the death of this patient, found dead in the morning in his bed. However, he was very confused and bedridden following his head trauma and was starting a revalidation with us. Given his age and general condition, no autopsy was scheduled. Not the feeling that there was a connection to the vaccine. His condition did not worsen after the vaccine and we had no reason to worry the day before he died. Result of assessment: Comirnaty/ Events: Sudden Death, Died in sleep: unclassifiable No follow-up attempts are possible.; Reporter''s Comments: Treatment - No Evolution of the ADR - Death Not the explanation for the death of this patient, found dead in the morning in his bed. However, he was very confused and bedridden following his head trauma and was starting a revalidation with us. Given his age and general condition, no autopsy was scheduled. Not the feeling that there was a connection to the vaccine. His condition did not worsen after the vaccine and we had no reason to worry the day before he died.; Reported Cause(s) of Death: found dead in the morning in his bed


VAERS ID: 1316394 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Chest X-ray, Death, Dyspnoea, General physical health deterioration, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Pyrexia, Respiratory disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 12
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: 20210325; Test Name: Chest X-ray; Result Unstructured Data: Test Result:signs of pneumonia; Test Date: 20210325; Test Name: CRP; Result Unstructured Data: Test Result:240; Test Date: 20210325; Test Name: O2 saturation; Result Unstructured Data: Test Result:very low
CDC Split Type: BEPFIZER INC2021522157

Write-up: Death; Pneumonia; Oxygen saturation low; Difficulty breathing; General physical health deterioration; Fever; CRP increased; respiratory disorder; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is BE-FAMHP-DHH-N2021-90754. A 79-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Batch/lot number ER2659) on 24Mar2021 at single dose for COVID-19 immunisation. Medical history was reported as no particular history. Concomitant medications were not reported. It was reported adverse drug reactions (ADR''s): respiratory disorder, difficulty breathing, general physical health deterioration, pneumonia, CRP increased, oxygen saturation low on 25Mar2021, death on 06Apr2021. It was reported fever starting 1 or 2 days after Covid vaccination, continuing for 2-3 days with signs of deteriorating general condition. Call from the attending physician who orders a chest x-ray at the hospital. Suggested diagnosis: pneumonia. Rapid worsening leading to death. Reporter''s comments: Treatment given in hospital: oxygen, antibiotics. Evolution of the ADR was death. Examinations included inflammatory syndrome (CRP: 240), Chest x-ray showing signs of pneumonia; very low O2 saturation. Outcome of respiratory disorder, difficulty breathing, general physical health deterioration, pneumonia, CRP increased, oxygen saturation low, fever was unknown, for death was fatal. An autopsy was unknow and the reported cause of death was unknown. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Treatment given in hospital: oxygen, antibiotics. Examinations - inflammatory syndrome (CRP: 240), Chest x-ray showing signs of pneumonia; very low O2 saturation. Fever starting 1 or 2 days after Covid vaccination, continuing for 2-3 days with signs of deteriorating general condition. Call from the attending physician who orders a chest x-ray at the hospital. Suggested diagnosis: pneumonia. Rapid worsening leading to death in a 79-year-old man with no particular history.; Reported Cause(s) of Death: death


VAERS ID: 1316408 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-14
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: CAPFIZER INC2021523184

Write-up: died; This is a spontaneous report received from a contactable physician through a Pfizer sales representative. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that father of one of physician''s patients died within a week of taking bnt162b2. Cause of death was unknown, unknown if an autopsy was performed. Information on the batch number has been requested.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. 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: 1316410 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 RA / 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: 2021-03-03
   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: ZOPICLONE; JANUVIA [SITAGLIPTIN PHOSPHATE]; B12 [CYANOCOBALAMIN]; METFORMIN; GLICLAZIDE; ATORVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; CALCIUM [CALCIUM CARBONATE]; VITAMIN D [VITAMIN D NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm ruptured; Atherosclerotic cardiovascular disease (diffuse atherosclerotic vascular disease (subclavian and carotid)); Diabetes; Heart failure with reduced ejection fraction; Infarction; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021541037

Write-up: found dead in her bed; This is a spontaneous report received from a contactable physician. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (at the age of 58-years-old), administered in Arm Right on 25Feb2021 (Lot Number: Unknown) as 1st dose, single for COVID-19 immunization. Medical history included s / p ruptured aneurysm, vascular dementia, old MCAS infarction (as reported), Heart failure (LVEF 23%), atherosclerotic heart disease old infarction (subclavian and carotid), diffuse MVAS (subclavian and carotid, as reported), and diabetes. Concomitant medications included zopiclone, sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), cyanocobalamin, metformin, gliclazide, atorvastatin, aspirin, calcium carbonate, vitamin D: all taken for an unspecified indication, start and stop dates were not reported. The 58-year-old patient very ill (s / p ruptured aneurysm, vascular dementia, atherosclerotic heart disease old infarction, cardiac insufficiency (left ventricular Ejection Fraction LVEF 23%), diffuse atherosclerotic vascular disease (subclavian and carotid), diabetes) who received her 1st dose on February 25 and was found dead in her bed on 03Mar2021. Her body was found in her bed, semi sitting on the edge of the bed and body thrown backwards, suggesting sudden death. The family kept the reporter informed 1 week later and no autopsy was done. The patient died on 03Mar2021. An autopsy was not performed. Facility where the most recent COVID-19 vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. 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, sudden death


VAERS ID: 1316423 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Infarction, Renal disorder
SMQs:, Lack of efficacy/effect (narrow), Myocardial infarction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CRPFIZER INC2021523445

Write-up: COVID-19; COVID-19; Infarction; Renal damage; This is a spontaneous report from a non-contactable consumer. A elderly male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. The patient received the vaccine and subsequently presented Covid 19 and he was hospitalized in intensive care. The patient only received the first dose. The patient who was hospitalized in the ICU who had received the first dose of the vaccine against COVID19 passed away, apparently the patient had renal damage and an infarction. Patient died on an unspecified date, 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: Renal damage; infarction; COVID-19; COVID-19


VAERS ID: 1316428 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, COVID-19, COVID-19 pneumonia, Clostridium difficile colitis, Coma, Computerised tomogram thorax, Ear infection, Ear pain, Heart rate, Influenza like illness, Klebsiella infection, Lacrimation increased, Microbiology test, Oxygen saturation, Pain in extremity, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Sputum test, Starvation, Tachycardia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Lacrimal disorders (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 47
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:
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: Body temperature; Result Unstructured Data: Test Result:<=39 Centigrade; Test Date: 20210305; Test Name: Body temperature; Result Unstructured Data: Test Result:<=39 Centigrade; Test Date: 202103; Test Name: Chest CT; Result Unstructured Data: Test Result:unspecified finding; Comments: unspecified finding lungs; Test Date: 20210308; Test Name: C-reactive protein; Result Unstructured Data: Test Result:100 mg/l; Comments: Kept rising from then on; Test Date: 20210410; Test Name: Heart rate; Result Unstructured Data: Test Result:tachycardia; Comments: tachycardia; Test Date: 202103; Test Name: Microbiology test; Result Unstructured Data: Test Result:Clostridium difficile; Comments: Clostridium difficile; Test Date: 202103; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:decreased; Comments: decreased; Test Date: 20210308; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 202103; Test Name: Sputum test; Result Unstructured Data: Test Result:Klebsiella pneumoniae; Comments: Klebsiella pneumoniae
CDC Split Type: CZPFIZER INC2021522070

Write-up: COVID-19 pneumonia; Tachycardia; COVID-19; Fever; Inanition/gaunt; Diarrhea caused by Clostridium difficile; Klebsiella pneumoniae infection; induced coma; Headache, elevated temperature, fatigue; Ear pain; ear inflammation; Rhinorrhea; Dacryorrhea; Pain in the left upper limb; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB CZ-CZSUKL-21004773. An 81-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular in left arm on 25Feb2021 (Lot Number: Unknown, at age of 81 years old) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. In the evening after the vaccination on 25Feb2021, the patient appeared pain of the vaccinated arm (left). The next day on 26Feb2021, the patient had a headache, ear pain, rhinorrhea, and dacryorrhea, Flu-like symptoms (Headache, elevated temperature, fatigue). The headache escalated and fatigue appeared during the next two days. On the fourth day after the vaccination on 01Mar2021, elevated body temperature and dry cough appeared. On the fifth day on 02Mar2021, the cough escalated and her physician prescribed Isoprinosine to her. On the seventh and eighth day (04Mar2021 and 05Mar2021), a fever of 39?C appeared (also reported as less or equal to 39) and she had prescribed Augmentin for ear inflammation. On the tenth day (07Mar2021), an ambulance was called for the patient and she was admitted to the hospital. On the eleventh day on 08Mar2021, a COVID-19 test was done with a positive result, the level of her c-reactive protein was 100 mg/L and she still complained about ear pain (ORL examination found no pathology). After 4 days, the patient was put on an oxygen mask. She was then transferred to the Anesthesiology department because of CRP elevation, where she was set to an induced coma and she breathed using mechanical ventilation. She was administered Meropenem. After waking up from the artificial sleep, a Klebsiella pneumoniae was isolated from the patient''s sputum and she was administered Vancomycin and Solumedrol in Mar2021. After two more days in Mar2021, her O2 saturation decreased and she had diarrhea. A Clostridium difficile was confirmed microbiologically, which resulted in a change of antibiotics to Biseptol. Finding on chest CT was unspecified, the patient still had a cough, was gaunt (Inanition) and her CRP kept elevating. She was administered oxygen and after a week she was transferred to the pulmonary department (standard), where she was put on an oxygen mask. On 10Apr2021, the patient developed tachycardia and was therefore transferred to the Intensive care unit. According to the reporter, the patient''s lung was destroyed (about a 1/3 was working). Events COVID-19 & COVID-19 pneumonia were reported with event stop dates DATA 14APR2021. The outcome of events COVID-19 and COVID-19 pneumonia was fatal. The outcome of event persistent dry cough was not recovered. The outcome of rest events was unknown. On 14Apr2021, the patient died of pneumonia. The patient died on 14Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible; batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19


VAERS ID: 1316434 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-07
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 23
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; Epilepsy (Last seizure 2010)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021522133

Write-up: Tremble; General debility; This is a spontaneous report received from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100055350. A 94-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 30Mar2021 (Lot number ER7812) as 0.3 ml single dose for COVID-19 immunisation. The patient''s medical history included epilepsy (Last seizure 2010) and diabetes. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 09Mar2021 as 0.3 ml single dose for COVID-19 immunisation. On 07Apr2021, the patient experienced fatal events general debility, tremble. The patient died on 30Apr2021. Cause of death also reported as unknown cause of death. Regulatory Authority assessed the relatedness of drug to reactions/events as D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: general debility; tremble


VAERS ID: 1316435 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   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: Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021522129

Write-up: Unknown cause of death; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100055353. An 81-year-old male patient received 2nd dose of BNT162B2 (COMIRNATY, lot number ET3045) at 0.3 ml single dose on 22Apr2021 for COVID-19 immunisation. Medical history and concurrent conditions included Parkinson''s disease. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (COMIRNATY) at 0.3 ml single dose on 25Mar2021 for COVID-19 immunisation. On 27Apr2021 the patient experienced unknown cause of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1316437 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-05-04
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210504; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:death; Comments: death during resuscitation
CDC Split Type: DEPFIZER INC2021522170

Write-up: Fulminant pulmonary artery embolism; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100056276. A 66-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: Unknown) at 0.3ml single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 04May2021, the patient experienced fulminant pulmonary artery embolism and transthoracic echocardiography death during resuscitation. Patient died on 04May2021. It was not reported if an autopsy was performed. Outcome of fulminant pulmonary artery embolism was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1316438 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Dizziness, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   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: Arterial hypertension; Coronary disease; Nicotine dependence
Preexisting Conditions: Medical History/Concurrent Conditions: Infarct myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021522124

Write-up: Death sudden; Light headedness; Chills; General debility; This is a spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100056279. A 47-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 28Apr2021 (Batch/Lot number was not reported) at 0.3ml single for COVID-19 immunisation. Medical history included ongoing arterial hypertension, ongoing nicotine dependence, infarct myocardial from Jan2020 to an unknown date, ongoing coronary disease. The patient''s concomitant medications were not reported. On 29Apr2021, the patient experienced general debility, light headedness, chills. On 02May2021, the patient experienced death sudden. It was not reported if an autopsy was performed. The patient''s outcome was fatal for general debility, fatal for light headedness, fatal for chills, fatal for death sudden. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Light headedness; Chills; General debility; Death sudden


VAERS ID: 1316441 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arterial occlusive disease, Intestinal ischaemia
SMQs:, Embolic and thrombotic events, arterial (narrow), Ischaemic colitis (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021522094

Write-up: Arterial occlusion; Mesenteric ischaemia; This is a spontaneous report received from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100056377. A 78-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Apr2021 at the age of 78-years-old (Lot Number: EW8904) as 0.3 ml single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient''s weight was not reported, and height was not reported. The patient experienced mesenteric ischaemia, arterial occlusion on 11Apr2021. The patient''s outcome was fatal for mesenteric ischaemia, fatal for arterial occlusion. The patient died on an unspecified date. It was not reported if an autopsy was performed. The relatedness of drug to reactions was D. unclassifiable by Regulatory Authority. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: mesenteric ischaemia; arterial occlusion


VAERS ID: 1316442 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Influenza like illness, Pneumonia
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Osteoporosis; Renal insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Old tuberculosis (many years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021522105

Write-up: Pneumonia; Dyspnoea; Flu-like symptoms; Cough; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100056645. A 91-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Apr2021 at 91 years old (Lot Number: EW8904) as 0.3ML single for covid-19 immunisation. Medical history included ongoing osteoporosis, ongoing renal insufficiency, old tuberculosis from an unknown date, many years prior to the report. The patient''s concomitant medications were not reported. On 15Apr2021 the patient experienced Flu-like symptoms, Cough, Dyspnoea, Pneumonia. The patient''s outcome was fatal for the events. The patient died on an unknown date. It was not reported if an autopsy was performed. This report is serious - death, hospitalization. Relatedness of drug to reactions/events was unclassifiable per HA. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Flu-like symptoms; Cough; Dyspnoea; Pneumonia


VAERS ID: 1316443 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Leukopenia, Lymphopenia, Pneumonia, Pyrexia
SMQs:, Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 9
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; Atrial fibrillation; Tachyarrhythmia absoluta
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021522056

Write-up: Leucopenia; Pyrexia; Lymphopenia; Pneumonia; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100056646. An 84-year-old female patient received BNT162B2 (COMIRNATY) dose 2 via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: Unknown) as 2ND DOSE, 0.3 ML SINGLE for covid-19 immunisation. Ongoing medical history included tachyarrhythmia absoluta, atrial fibrillation, arterial hypertension. The patient''s concomitant medications were not reported. The patient previously received first dose of COMIRNATY on 26Mar2021 at 0.3 mL. On 19Apr2021, the patient experienced pyrexia, pneumonia, leucopenia, lymphopenia and resulted in hospitalization and death. The outcome of events was fatal. The patient died on 28Apr2021. An autopsy was performed and results were not provided. Report was considered as serious with death and hospitalization. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Pneumonia; Leucopenia; Lymphopenia; Pyrexia


VAERS ID: 1316444 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-04-26
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-05-14
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: 2021-04-26
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021527604

Write-up: Unknown cause of death; This is as spontaneous report from a non-contactable physician via Regulatory Authority, downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100058010. A 94-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 05Feb2021 (at the age of 94-year-old) (Batch/Lot number was not reported) at 0.3 mL single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (COMIRNATY) at 0.3 mL single on 15Jan2021. The patient experienced unknown cause of death on 26Apr2021. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s): Source of assessment: Regulatory Authority: Result of Assessment: D. Unclassifiable. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1316445 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-04-26
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-05-14
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: 2021-04-26
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021527599

Write-up: Unknown cause of death; This is as spontaneous report from a non-contactable physician via Regulatory Authority, downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100058011. A 91-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 05Feb2021 (at the age of 90-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (COMIRNATY) on 15Jan2021 at 0.3 ml single dose for COVID-19 immunisation. The patient experienced unknown cause of death on 26Apr2021. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s): Source of assessment: Regulatory Authority: Result of Assessment: D. Unclassifiable. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1316448 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis
SMQs:, 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: 2021-05-01
   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:
CDC Split Type: DEPFIZER INC2021527619

Write-up: Cerebral vein thrombosis; This is a spontaneous report from a non-contactable consumer via Regulatory Authority (RA), downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021061101. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100053266. A 28-year-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 01May2021 at 08:00 (at the age of 28-year-old) (Batch/Lot Number: EX3510) at 0.3 mL single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 01May2021, the patient experienced cerebral vein thrombosis (thrombosis of venous sinuses) with fatal outcome. The patient died on 01May2021 at 14:30. It was not reported if an autopsy was performed. Relatedness of drug to reactions/events: Comirnaty/ Thrombosis of venous sinuses/ Regulatory Authority/ D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Thrombosis of venous sinuses


VAERS ID: 1316464 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Pneumonia, Pulmonary function test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 70
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OXYGEN
Current Illness: Cardiovascular disorder; Chronic obstructive airways disease; Leg ulcer (Infected. Treated without success. Need for amputation of the leg, due to infection. Patient denied); Sclerosis multiple; Terminal state (was in terminal COPD treatment at home and received oxygen, 2 L as a permanent treatment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210201; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20210201; Test Name: Lung function; Test Result: 17 %
CDC Split Type: DKPFIZER INC2021527602

Write-up: Admitted with breathing problems related to severe COPD. She is discharged for loving care with probe (stated by physician); Pneumonia after both vaccinations (repoted by relative to patient, not confirmed by physician); This is a spontaneous report received on 26Apr2021 from the Patient Compensation Association (case number: 21-3989), with follow-up from the general practitioner from a contactable lawyer downloaded from the Medicines Agency (MA) -WEB, regulatory authority number DK-DKMA-ADR 25231875. This is the first of two reports for the second dose vaccination. A 81-year-old female patient received second dose of BNT162B2 (COMIRANTY; Solution for injection; Lot number EK9788; expiration date: 31May2021), via an unspecified route of administration on 29Jan2021 (at the age of 81-year-old) as 2nd dose, 1DF single for COVID-19 immunization. There was no information regarding past medication. There was no information regarding patient medical history. Patient concurrent conditions included Chronic obstructive airways disease (was in terminal COPD treatment at home and received oxygen, 2 L as a permanent treatment), Cardiovascular disorder, Sclerosis multiple and had infected Leg ulcer (treated without success. Need for amputation of the leg, due to infection. Patient denied that). Concomitant medication included oxygen (2 L as a permanent treatment). On 03Jan2021 the patient was vaccinated with first dose of COMIRNATY (Batch number: EJ6797; expiration date 30Apr2021). On 04Jan2021, the day after first dose the patient developed obstipation. On the 05Jan2021 the patient developed fever and on unknown date in Jan2021 the patient developed Pneumonia (Pneumonia after both vaccinations (reported by relative to patient, not confirmed by physician)). The patient was treated with non-specified antibiotics due to fever after first vaccination (Not recurrent after second vaccination (reported by physician)). On 11Jan2021 the physician followed up and she had good effect of antibiotics. The ADR Fever and obstipation were recovered. On 01Feb2021, 3 days after the second vaccination the patient developed Breathing difficult and on unknown date the patient developed Pneumonia again. The ADR Pneumonia were by the relative of the patient reported being Fatal. The patient was admitted on 01Feb2021 due to Breathing difficult. Reported causes of death: Pneumonia (reported by the relative) and Chronic obstructive airways disease (reported by the physician). Test results: On 01Feb2021: Body temperature: 38,5 C and Lung function: 17 %. Causality: According to the physician, she had no fever and was not affected by the 2nd vaccine. On 1Feb2021, the patient was admitted to the emergency room due to breathing problems, which were related to her very severe COPD. Lung function of 17%. She was discharged for loving care with probe (stated by physician). The physician could not confirm or deny whether the vaccine was related to ADRs, due to her co-morbidities. COMMENT from Regulatory Authority: RA had received a copy of the relative to the patient''s initial report to Patient Compensation Association. Please note, that no decision has yet been made by Patient Compensation Association. The patient died on 12Mar2021. Autopsy was not performed. The outcome of the ADR Pneumonia was fatal and ADR Breathing difficult was not recovered. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : DK-PFIZER INC-2021534827 same patient different dose; Reported Cause(s) of Death: Chronic obstructive airways disease; Pneumonia


VAERS ID: 1316465 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Fall, Head injury, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DONEPEZIL KRKA; LEVODOPA/CARBIDOPA/ENTACAPONE ORION; SINEMET
Current Illness: Dementia (due to Parkinson''s disease); Living in nursing home; Parkinson''s disease; Trauma NOS (Unspecified trauma to sternum. No further information. Not resulting in admission)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021527598

Write-up: Cardiac arrest, unexpected. Never woke up again; Cramping observed at nursinghome/occurrence of Seizure/patient developed seizures; patient fell over at the nursing home; hit her head; This is a spontaneous report from a contactable lawyer and physicians downloaded from a regulatory authority-WEB, regulatory authority number DK-DKMA-ADR 25232323. A 65-years-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: EK9788, Expiration Date: 31May2021) via an unspecified route of administration on 29Jan2021 as single dose for COVID-19 immunisation. On 05Jan2021, the patient was vaccinated with first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: EM0477, Expiration date was not reported) via an unspecified route of administration on 05Jan2021 as single dose for COVID-19 immunisation. There is no information regarding past medication. There is no information regarding patient medical history. Concurrent conditions included Parkinson''s disease and Dementia due to Parkinson''s disease. Living in nursing home. On 09Jan2021 the patient had an unspecified trauma to sternum (No further information. Not resulting in admission). Concomitant medications included donepezil hydrochloride (DONEPEZIL KRKA, Film-coated tablet, 10mg ) taken for dementia from 20Nov2017; carbidopa, entacapone, levodopa (LEVODOPA/CARBIDOPA/ENTACAPONE ORION, Film-coated tablet,75mg, 18.75mg, 200mg) taken for parkinson''s disease from 11Jan2021; carbidopa, levodopa (SINEMET, Tablet, 12.5mg, 50mg) taken for parkinson''s disease from 29May2018. On 31Jan2021, the patient developed seizures and had cardiac arrest. The patient hits her head while falling during cardiac arrest. She also had non-specified brain damage as a result of cardiac arrest. There was no suspicion of blood clots or bleeding. The ADRs were by the relative to the patient reported as being Fatal. The patient was admitted to the hospital emergency department. The patient was vaccination with DiTeBooster at arrival. No other information regarding treatment. It took about 3 days at emergency department to assess whether her life was worth saving. It was concluded that the patient could not be rescued due to brain damage as a result of cardiac arrest. The ADR cardiac arrest was fatal.. The patient died on 03Feb2021. Reported cause of death was cardiac arrest. Autopsy not performed. There is no information regarding test results. Causality: The patient''s general practitioner: Based on the epicrisis from the hospital, the patient''s general practitioner confirms that the patient fell over at the nursing home on 31Jan2021, where she lived with cardiac arrest and at the same time hit her head. The GP cannot rule out a possible link between vaccination and death. The GP had also noted this in the death certificate. Therefore, the case is medically confirmed. The GP had not vaccinated the patient, so she did not know if the patient experienced ADRs after the first dose of COMIRNATY. The medical record states that there was telephone contact to the emergency telephone 1813 on 09Jan21, where the deceased had trauma to the sternum. The physician did not have further information about this, but it did not look like the patient was admitted. The physician at the emergency department: The physician confirms the course of events, and adds that the patient has been observed cramping in the nursing home. The physician did not believe there was a causal link between the vaccine and the death, but believes it was an unfortunate coincidence. Therapeutic measures were taken as a result of cardiac arrest, unexpected. never woke up again, cramping observed at nursing home. The outcome for events Cardiac arrest, unexpected Never woke up again, Cramping observed at nursinghome/occurrence of Seizure/patient developed seizures was fatal and unknown for other events. Sender Comment: COMMENT from a regulatory authority: a regulatory authority has received a copy of the relatives to the patient''s initial report to an Association. Please note, that no decision has yet been made by an Association. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1316470 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-03
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Constipation, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 70
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OXYGEN
Current Illness: Cardiovascular disorder; Chronic obstructive airways disease; Leg ulcer (Infected. Treated without success. Need for amputation of the leg, due to infection. Patient denied); Sclerosis multiple; Terminal state (was in terminal COPD treatment at home and received oxygen, 2 L as a permanent treatment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade
CDC Split Type: DKPFIZER INC2021534827

Write-up: fever after first vaccination. not recurrent after second vaccination (reported by physician); obstipation after first vaccination (reported by physician); Pneumonia after both vaccinations (repoted by relative to patient, not confirmed by physician); This is a spontaneous report received from a contactable lawyer downloaded from the regulatory authority-WEB DK-DKMA-ADR 25231875. This is the second of two reports for the first dose vaccination. A 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EJ6797; Expiration Date: 30Apr2021), via an unspecified route of administration on 03Jan2021 as single dose for covid-19 immunization. Medical history included ongoing multiple sclerosis, ongoing terminal state was in terminal COPD treatment at home and received oxygen, 2 L as a permanent treatment, ongoing chronic obstructive pulmonary disease, ongoing skin ulcer Infected which was treated without success and need for amputation of the leg due to infection, ongoing cardiovascular disorder at the time of death. Patient denied. Concomitant medications included oxygen. On an unknown date in Jan2021, the patient experienced pneumonia after both vaccinations (reported by relative to patient, not confirmed by physician). On 04Jan2021, the patient experienced obstipation after first vaccination (reported by physician) and on 05Jan2021, she had fever after first vaccination which was not recurrent after second vaccination (reported by physician). On 05Jan2021, the patient body temperature was reported as 38.5 centigrade. Therapeutic measures were taken as a result of pneumonia after both vaccinations, obstipation after first vaccination, fever after first vaccination. The outcome of the events obstipation and fever were reported as recovered. On 12Mar2021, the patient died and an autopsy was not performed. The reported cause of death was pneumonia. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : DK-PFIZER INC-2021527602 same patient different dose; Reported Cause(s) of Death: Chronic obstructive airways disease; Pneumonia


VAERS ID: 1316475 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Auscultation, Blood acid phosphatase, Blood bicarbonate, Blood bilirubin, Blood creatinine, Blood glucose, Blood lactic acid, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, Chest X-ray, Chronic obstructive pulmonary disease, Coagulation test, Dyspnoea, Electrocardiogram, Gamma-glutamyltransferase, Haematocrit, Haemoglobin, Heart rate, Hypercapnic coma, Laboratory test, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, PCO2, PO2, Platelet count, Respiratory acidosis, Tachypnoea, White blood cell count, pH body fluid
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 2
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: Carpal tunnel syndrome; COPD; Dyslipidaemia; Hypertension arterial; Ischaemic heart disease; Myelopathy cervical; Obesity (BMI$g=30); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: GPT; Result Unstructured Data: Test Result:144; Test Date: 20210424; Test Name: GOT; Result Unstructured Data: Test Result:64; Test Date: 202104; Test Name: auscultation; Result Unstructured Data: Test Result:in notes; Comments: - Cardiac auscultation: Rhythmic, I do not auscultate murmurs - Lung auscultation: Generalized hypoventilation, crackles up to medium fields; Test Date: 20210424; Test Name: FA; Result Unstructured Data: Test Result:124; Test Date: 20210424; Test Name: bicarbonates; Result Unstructured Data: Test Result:29; Test Date: 20210424; Test Name: total bilirubin; Result Unstructured Data: Test Result:0.38; Test Date: 20210424; Test Name: creatinine; Result Unstructured Data: Test Result:1.04; Test Date: 20210424; Test Name: glucose; Result Unstructured Data: Test Result:232; Test Date: 20210424; Test Name: lactate; Result Unstructured Data: Test Result:2.2; Test Date: 20210424; Test Name: potassium; Result Unstructured Data: Test Result:4.2; Test Date: 202104; Test Name: blood pressure; Result Unstructured Data: Test Result:120/70 mmHg; Test Date: 20210424; Test Name: sodium; Result Unstructured Data: Test Result:145; Test Date: 20210424; Test Name: urea; Result Unstructured Data: Test Result:94; Test Date: 202104; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210424; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:in notes; Comments: Poor technique, apparently increased cardiothoracic index, bilateral interstitial infiltrates; Test Date: 20210424; Test Name: coagulation; Result Unstructured Data: Test Result:normal; Test Date: 20210424; Test Name: C-reactive protein; Result Unstructured Data: Test Result:16.4; Test Date: 20210424; Test Name: ECG; Result Unstructured Data: Test Result:in notes; Comments: Sinus rhythm 75 bpm, normal axis, normal PR, narrow QRS, non-objective alterations in repolarization.; Test Date: 20210424; Test Name: GGT; Result Unstructured Data: Test Result:60; Test Date: 20210424; Test Name: hematocrit; Result Unstructured Data: Test Result:54.3; Test Date: 20210424; Test Name: hemoglobin; Result Unstructured Data: Test Result:15.6; Test Date: 202104; Test Name: pulse; Result Unstructured Data: Test Result:99; Test Date: 20210424; Test Name: G.ART with VMK; Test Result: 50 %; Test Date: 20210424; Test Name: PROBNP; Result Unstructured Data: Test Result:6755; Test Date: 202104; Test Name: O2 saturation; Test Result: 58 %; Test Date: 20210424; Test Name: O2 saturation; Test Result: 84 %; Test Date: 20210424; Test Name: O2 saturation; Test Result: 30 %; Test Date: 20210424; Test Name: pCO2; Result Unstructured Data: Test Result:91.5; Test Date: 20210424; Test Name: pH; Result Unstructured Data: Test Result:7.12; Test Date: 20210424; Test Name: platelets; Result Unstructured Data: Test Result:24400; Test Date: 20210424; Test Name: pO2; Result Unstructured Data: Test Result:60.3; Test Date: 20210424; Test Name: leucocyte; Result Unstructured Data: Test Result:9300
CDC Split Type: ESPFIZER INC2021522110

Write-up: hypercapnic coma; respiratory acidosis; decompensed copd; Acute dyspnoea; Tachypnea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB ES-AEMPS-842817. An 84-year-old male patient received bnt162b2 (COMIRNATY, lot number: EW9127) at left arm on 20Apr2021 at second dose, single for COVID-19 immunisation. Medical history included Ischaemic heart disease from 2005, COPD, Obesity (BMI$g=30), Myelopathy cervical, Hypertension arterial, Type 2 diabetes mellitus, Dyslipidaemia, Carpal tunnel syndrome. Concomitant medications were not reported. Patient previously took the first dose of Comirnaty (batch/lot number EW2239) on 30Mar2021 for COVID-19 immunisation. Patient also took (pantoprazole sodium sesquihydrate) PANTECTA, hidroxil b12-b6-b1 film-coated tablets, spiolto respimat 2.5 micrograms / 2.5 micrograms solution for inhalation 1 cartridge of 60 puffs (30 doses), EMCONCOR COR 2,5 mg film-coated tablets, (citicoline piracetam) SOMAZINA 100 mg/ml oral solution, hypromellose (METICEL), fesoterodine fumarate (TOVIAZ) 4 mg prolonged-release tablets, furosemide (SEGURIL), empagliflozin (JARDIANCE) 10 mg film-coated tablets, beclometasone dipropionate formoterol fumarate glycopyrronium bromide (TRIMBOW) 87 micrograms / 5 micrograms / 9 micrograms solution for inhalation in pressure container, acetylsalicylic acid atorvastatin calcium ramipril (TRINOMIA) 100mg/20mg/2,5mg hard capsules, colecalciferol (VIDESIL) 25.000 UI oral solution, 1 ampoule. Patient experienced Acute dyspnoea and Tachypnea on 22Apr2021 (Hospitalization and death). It was reported as 112 notice of a male with dyspnea vaccine reaction 2 dose day 20. T 36.2, o2 saturation 58, blood pressure 120/70, hr 99, matte noise in lung fields, distal and facial cyanosis. fortecortin + ventolin + seguril iv is administered in dripper and im. patient was referred for 112 due to increased habitual dyspnea accompanied by drowsiness, tachypnea, no chest pain, no fever, no other symptoms. Regular general state, conscious and lethargic, cyanotic and regular perfections. Tachypneic at rest with abdominal breathing. chest: Cardiac auscultation: Rhythmic, do not auscultate murmurs; Lung auscultation: Generalized hypoventilation, crackles up to medium fields; abdomen: Globulous, soft, not painful on palpation. No masses or megalies. No signs of peritoneal irritation; lower limbs: Edema without fovea, or signs of deep vein thrombosis. He arrives at the Internal Medicine floor. Patient in hypercapnic coma. 30% saturation with respiratory pauses. Calm. No shortness of breath. Does not respond to stimuli. Poor clinical evolution, the patient finally dies calm. Diagnostics: hypercapnic coma, respiratory acidosis, decompensed copd, exitus letalis. 24Apr2021 Blood test: HEMOGRAM: Hemoglobin 15.6, Hematocrit 54.3, Leukocytes 9300, Platelets 244000. G.ART with VMK 50%: pH 7.12, pCO2 91.5, pO2 60.3, Bicarbonate 29, Sat 84%, Lactate 2.2. Biochemistry: Glucose 232, Urea 94, Creatine 1.04, Na 145, K 4.2, Bilirubin Total 0.38, GOT 64, GPT 144, GGT 60, Acid phosphatase 124. PROBNP 6755. CRP 16.4. Coagulation: Normal. ECG: Sinus rhythm 75 bpm, normal axis, normal PR, narrow QRS, non-objective alterations in repolarization. Patient died on 24Apr2021. It was unknown if autopsy was done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: decompensed copd; Hypercapnic coma; Acidosis respiratory


VAERS ID: 1316479 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure measurement, Cardiac monitoring, Computerised tomogram head, Embolic stroke, SARS-CoV-2 test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 15
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: NICARDIPINE; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic renal failure; Dyslipidemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Respiratory auscultation; Result Unstructured Data: Test Result:scattered wheezing, noise of secretions, abdomen n; Comments: scattered wheezing, noise of secretions, abdomen not tender to palpation, lower limbs without edema.; Test Date: 202104; Test Name: blood pressure; Result Unstructured Data: Test Result:142/89 mmHg; Test Date: 202104; Test Name: Cardiac auscultation; Result Unstructured Data: Test Result:Sinus rhythm tones at 120 pm; Test Date: 202104; Test Name: skull CT; Result Unstructured Data: Test Result:Signs of a heart attack established in the territo; Comments: Signs of a heart attack established in the territory of the left MCA.; Test Date: 20210420; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021522038

Write-up: Left anterior stroke, possibly of caridoembolic etiology due to non-anticoagulated AF; This is a spontaneous report from a contactable Other Health Professional downloaded from the regulatory authority ES-AEMPS-851060. A 91-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EW2239), intramuscular on 09Apr2021(at unknown age) as 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension, dyslipidemia, non-decoagulated atrial fibrillation, chronic renal failure. Concomitant medications included nicardipine; bisoprolol. The patient with a good previous situation was found on the floor at home with right faciobrachial hemipelgia and global aphasia. Comatose, poor reactivity to pain, anisocoria with non-measurable reactivity due to bilateral cataract, global hypotonia, extensive right Babinsky, tachypnea with high serectional noise, Cardiac auscultation: Sinus rhythm tones at 120 pm, Respiratory auscultation: scattered wheezing, noise of secretions, abdomen not tender to palpation, lower limbs without edema. Blood pressure 142/89. Emergency skull CT. Signs of a heart attack established in the territory of the left MCA, all above test on Apr2021. COVID-19 PCR test 20Apr2021: negative. Left anterior stroke on 11Apr2021, possibly of caridoembolic etiology due to non-anticoagulated AF. The patient was hospitalized on unknown date. Evolution of a non-reversible coma, comfort measures are applied and death on 26Apr2021. It was unknown if any Autopsy Done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Left anterior stroke


VAERS ID: 1316480 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-07
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Respiratory tract infection, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   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: Cardiac assistance device user
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Aspiration; Atrial fibrillation; Bronchitis; Diabetes mellitus; Heart failure; Heart rate low; Ischemic heart disease; Kidney failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021522051

Write-up: increased cough and mucus/Respiratory tract infection; This is a spontaneous report from a contactable Other Health Professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-853210. An 88-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EJ6796), intramuscular on 30Dec2020 (at unknown age) as 0.3 mL single for COVID-19 immunisation. Medical history included Ischemic heart disease, heart failure, Complete Arrhythmia due to Atrial fibrillation, pacemaker carrier from 2002 ongoing, Diabetes Mellitus, chronic kidney failure, multiple episodes of bronchitis, low heart rate, aspiration. Diabetes Mellitus, chronic kidney failure, multiple episodes of bronchitis and aspiration treated with antibiotics and bronchodilators. The patient''s concomitant medications were not reported. The last assessment in Jun2020 due to a malfunction of the pacemaker, advises against replacement due to the patient''s situation. On 07Jan2021 new episode of increased cough and mucus/Respiratory tract infection, start of treatment with levofloxain, prednisone and bronchodilators. COVID-19 PCR test: Negative on 07Jan2021. She dies in her sleep, they realize when they go to wake her up on 08Jan2021 at 7:00 a.m. The patient died on 08Jan2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: increased cough and mucus/Respiratory tract infection


VAERS ID: 1316482 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, General physical health deterioration, Hypotonia, Respiratory rate increased, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20211

Write-up: Death; Breathing rate increased; Flaccidity; General physical health deterioration; Vomiting; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), RESPIRATORY RATE INCREASED (Breathing rate increased), HYPOTONIA (Flaccidity), GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration) and VOMITING (Vomiting) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DEATH (Death) (seriousness criterion death), RESPIRATORY RATE INCREASED (Breathing rate increased) (seriousness criterion medically significant), HYPOTONIA (Flaccidity) (seriousness criterion medically significant), GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On 21-Apr-2021, RESPIRATORY RATE INCREASED (Breathing rate increased), HYPOTONIA (Flaccidity), GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration) and VOMITING (Vomiting) outcome was unknown. The patient died on 21-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Company Comment: This is a case of death in a 80-year-old male subject with unknown medical history, who died one day after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 80-year-old male subject with unknown medical history, who died one day after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1316489 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein abnormal, Confusional state, Escherichia infection, Fall, Klebsiella infection, Platelet count, Platelet count decreased, Pyelonephritis, Renal failure, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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: Impaired renal function
Preexisting Conditions: Medical History/Concurrent Conditions: Cytostatic chemotherapy; Gastric cancer; Noninvasive ductal carcinoma; Ovarian cancer (chemotherapy); Pancreatic resection; Splenectomy; Total gastrectomy
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: CRP; Result Unstructured Data: Test Result:rising; Test Date: 202104; Test Name: thrombocytes; Result Unstructured Data: Test Result:normal; Test Date: 202104; Test Name: thrombocytes; Result Unstructured Data: Test Result:72; Test Date: 202104; Test Name: urine; Result Unstructured Data: Test Result:bacteria in the urine (coli + klebsiella)
CDC Split Type: FIPFIZER INC2021521656

Write-up: urine bacteria (coli + klebsiella); urine bacteria (coli + klebsiella); pyelonephritis; renal function deteriorates, (already impaired for many years); thrombocytes decrease from normal level to 72; confused; Fall; c-reactive protein (CRP) was 187/CRP rises again after first decreasing; This is a spontaneous report downloaded from the Regulatory Authority-WEB regulatory authority number FI-FIMEA-20212348. A contactable physician reported that a 95-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: EJ6134), intramuscular on 21Apr2021 (Batch/Lot Number: EJ6134) as a single dose for COVID-19 immunisation. Medical history included ovarian cancer diagnosed in 1995 and received chemotherapy, gastric cancer in 2000, total gastrectomy, splenectomy, pancreatic resection (reported as ''resectio caput pancreatis''), cytostatics, all on an unknown date, noninvasive ductal carcinoma (reported as ''ca mammae ductale l'') on Mar2020 and ongoing impaired renal function. The patient''s concomitant medications were not reported. On 22Apr2021, the patient had a fall and was found lying on the floor of his apartment confused and attentive. The patient did not understand to use the alarm. The patient''s c-reactive protein (CRP) was 187 and there was bacteria in the urine (coli + klebsiella) which was treated as pyelonephritis. The patient''s condition gradually deteriorates despite adequate antibiotics (Zinacef), renal function deteriorates (already impaired for many years) and CRP rises again after first decreasing, thrombocytes decrease from normal level to 72, there was no visible bleeding and no paralysis symptoms. The patient went into exitus (after that active treatments have ended) due to the events on 28Apr2021. It was not reported if an autopsy was performed. It was uncertain connection with vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: urine bacteria (coli + klebsiella); renal function deteriorates, (already impaired for many years); thrombocytes decrease from normal level to 72; confused; pyelonephritis; fall; c-reactive protein (CRP) was 187/CRP rises again after first decreasing


VAERS ID: 1316494 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Dyspnoea, Fall, General physical health deterioration, Oxygen saturation decreased, Pelvic fracture, Procalcitonin, Red blood cell sedimentation rate, SARS-CoV-2 test, White blood cell count
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Osteoporosis/osteopenia (broad), Respiratory failure (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 10
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: CRP; Result Unstructured Data: Test Result:50; Test Name: PCT; Test Result: Negative ; Test Name: sedimentation rate; Result Unstructured Data: Test Result:25; Test Name: PCR COVID; Test Result: Negative ; Test Name: leuco; Result Unstructured Data: Test Result:16000
CDC Split Type: FRPFIZER INC2021521546

Write-up: fell, resulting in a fractured pelvis; fell, resulting in a fractured pelvis; dyspnea; desaturation; Reduced general condition; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number FR-AFSSAPS-DJ20211036. A 90-year-old female patient received bnt162b2 (Pfizer vaccine), intramuscular on 12Apr2021 (Batch/Lot Number: EW2246) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Apr2021, the patient experienced reduced general condition. It was further reported that on 15Apr2021, 4 days after vaccination, there was a deterioration in general condition, dyspnea and desaturation requiring oxygen therapy. Biological inflammatory syndrome: leuco: 16000, C-reactive protein (CRP): 50, sedimentation rate: 25, procalcitonin (PCT) was negative, and polymerase chain reaction (PCR) COVID was negative. Additionally, it was reported that 2 days after the onset of symptoms (17Apr2021), the patient fell, resulting in a fractured pelvis. It was decided in agreement with the family to keep the patient at home and not to persevere. Continuation of comfort care with oxygen (O2), medical bed at home with family warned of the rapid rate of degradation. On 25Apr2021, 14 days after the vaccination, the patient died. The patient had no COVID-19 disease history. In total, there was a deterioration in general condition 4 days after the injection of a second dose of bnt162b2 vaccine. Therapeutic measures were taken as a result of dyspnea and desaturation. The outcome of fell, resulting in a fractured pelvis, and dyspnea and desaturation requiring oxygen therapy was unknown while event reduced general condition resulted to fatal outcome. The patient died on 25Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: reduced general condition


VAERS ID: 1316495 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-04-21
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
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: 2021-04-29
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure; Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: O2 saturation; Test Result: 80 %; Test Date: 20210422; Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: variant
CDC Split Type: FRPFIZER INC2021521525

Write-up: Vaccination failure; Covid-19; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-DJ20211039 Safety Report Unique Identifier FR-AFSSAPS-2021047437 A 96-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 28Jan2021 (Batch/Lot Number: EK9788) as 1st dose, single and intramuscular on 18Feb2021 (Batch/Lot Number: EK9788) as 2nd dose, single for covid-19 immunization. The patient''s medical history included ongoing cardiac failure and ongoing dementia. The patient''s concomitant medications were not reported. The patient experienced vaccination failure on 21Apr2021 as the patient had covid-19. First signs on 21Apr2021 includes hoarse cough, wheezing. The patient''s PCR return positive (variant identified) on 22Apr2021. Quickly appeared a desaturation (80%) and congestion.The patient contracted COVID probably following a personal visit (no other patient in the sick nursing home at this time nor any member of the staff). Patient was placed on antibiotics, corticosteroids and O2. The outcome of the event vaccination failure and Covid-19 was fatal. The patient died on 29Apr2021. An autopsy was not performed. No follow-up attempts are possible; information about batch number already obtained.; Reported Cause(s) of Death: vaccination failure; COVID-19


VAERS ID: 1316496 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-04-22
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, COVID-19 pneumonia, Lymphocyte count, Pyrexia, SARS-CoV-2 test, Streptococcus test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MIRTAZAPINE; NOVORAPID; ATORVASTATIN; ZEFFIX; XARELTO; NATISPRAY; BACTRIM FORTE; ZELITREX; INNOVAIR; LASILIX [FUROSEMIDE]; OXYCONTIN; ARANESP; VYNDAQEL
Current Illness: AFib; Anxiodepressive syndrome; Atrioventricular block; Cardiac amyloidosis; Chronic lymphocytic leukaemia (stage C); Hypertensive heart disease NOS; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of prostate (treated by surgery and Enantone until 2014); Cessation of smoking (20 years ago); Femur fracture (post-traumatic left femoral fracture in 2003); Fracture femur (fracture of the right femur in 1960); Fracture of pelvis; Nephrolithotomy (left); Osteotomy (right tibia); Prostate transurethral resection
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:9/5; Test Date: 20210422; Test Name: body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Test Name: lymphocytes; Result Unstructured Data: Test Result:70 g/l; Comments: Lymphocytosis at 70 G / l in the context of CLL probably related to the infectious state.; Test Date: 20210422; Test Name: PCR COVID-19 test; Test Result: Positive ; Comments: Mutation profile compatible with the English variant (lineage 20I / 501Y.V1); Test Name: Alpha hemolytic Streptococcus test; Test Result: Positive ; Comments: alpha hemolytic streptococcus with favorable outcome under Tazocillin
CDC Split Type: FRPFIZER INC2021521539

Write-up: He was hospitalized from March 23 to April 6, 2021 for pneumonia/Polymerase chain reaction PCR COVID-19 positive on 22Apr2021; general condition for a few days with fever for 72 hours (38.4 on April 22); Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-DJ20211041. A 94-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 11Mar2021 (lot number: EP9598) as 2nd dose, single; dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing cardiac amyloidosis, ongoing type 2 diabetes mellitus, femur fracture from 2003 to an unknown date (post-traumatic left femoral fracture in 2003), ongoing atrial fibrillation (AFib), cessation of smoking 20 years ago, ongoing atrioventricular block, osteotomy from 1988 to an unknown date (right tibia), nephrolithotomy from 1958 to an unknown date (left), ongoing anxiodepressive syndrome, ongoing hypertensive heart disease not specified, fracture of pelvis on unknown date, ongoing stage C chronic lymphocytic leukaemia, Adenocarcinoma of prostate from 2007 to 2014 (treated by surgery and Enantone until 2014), Prostate transurethral resection on unknown date, and fracture of the right femur in 1960 and unknown if ongoing. Concomitant medications included mirtazapine; insulin aspart (NOVORAPID); atorvastatin; lamivudine (ZEFFIX); rivaroxaban (XARELTO); glyceryl trinitrate (NATISPRAY); sulfamethoxazole, trimethoprim (BACTRIM FORTE); valaciclovir hydrochloride (ZELITREX); beclometasone dipropionate, formoterol fumarate (INNOVAIR); furosemide (LASILIX); oxycodone hydrochloride (OXYCONTIN); darbepoetin alfa (ARANESP); tafamidis meglumine (VYNDAQEL); all taken for an unspecified indication, start and stop date were not reported. History of the disease: Patient having benefited from these 2 injections against COVID-19 by COMIRNATY (2nd injection on 11Mar2021 lot EP9598). He was hospitalized from 23Mar2021 to 06Apr2021 for pneumonia with ECBC positive for multiresistant maltophilia steno trophoblasts and alpha hemolytic streptococcus with favorable outcome under Tazocillin. Lymphocytosis at 70 G / l in the context of CLL probably related to the infectious state. Patient referred by the general practitioner on 22Apr2021 for significant deterioration in general condition for a few days with fever for 72 hours (38.4 centigrade on 22Apr2021). Lung congestion has been increasing for a few days. Blood pressure at 9/5, dyspnea, difficulty eating. Treatment with Augmentin was started on 20Apr2021. Polymerase chain reaction PCR COVID-19 positive on 22Apr2021. Mutation profile compatible with the variant (lineage 20I / 501Y.V1). Unfavorable evolution with passage in palliative care deceased on 30April2021. Death of the patient in this context on 02May2021. Outcome of ''general condition for a few days with fever for 72 hours (38.4 on April 22)'' was unknown. The patient died on 02May2021. An autopsy was not performed. No follow-up attempts are possible. Information on the lot/batch number of first dose cannot be obtained. No further information is expected.; Reported Cause(s) of Death: COVID pneumonia


VAERS ID: 1316536 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Asthenia, Bronchiectasis, Cardiac failure, Cough, Oedema, Oedema peripheral, Secretion discharge, Somnolence, Tachycardia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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: LYSANXIA; COLECALCIFEROL; EFFERALGAN [PARACETAMOL]; ELIQUIS; GAVISCON [ALGELDRATE;ALGINIC ACID;MAGNESIUM TRISILICATE;SODIUM BICARBONATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anorexia nervosa; Atrial fibrillation; Constipation; Embolism pulmonary; Hyperthyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021521996

Write-up: bronchial dilation; tachycardia; the edema of the lower limbs rises to the groin; acute pulmonary edema; asthenia; drowsiness; cough; mucus; Decompensation cardiac; edema of the lower limbs; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-LY20213645, Safety report unique identifier FR-AFSSAPS-2021046232. A 92-years-old female patient received the first dose of BNT162B2 (COMIRNATY), intramuscular, administered in Arm Left on 14Apr2021 (Batch/Lot Number: EW2246) as single dose for COVID-19 immunisation. Medical history included anorexia nervosa for 5 years (39kg), constipation, pulmonary embolism, atrial fibrillation, hyperthyroidism. Patient had no historical COVID-19 infection. Concomitant medications included prazepam (LYSANXIA); colecalciferol; paracetamol (EFFERALGAN); apixaban (ELIQUIS 2.5); algeldrate, alginic acid, magnesium trisilicate, sodium bicarbonate (GAVISCON). On 14Apr2021: vaccination with a first dose of vaccine batch n EW2246, in the left arm. On 15Apr2021: appearance of edema of the lower limbs. On 17Apr2021: appearance of asthenia, drowsiness, cough, mucus and acute pulmonary edema, supported by a medical consultation by doctor. Prescription of a morphine patch. On 18Apr2021: in the morning, the edema of the lower limbs rises to the groin. On 19Apr2021: bronchial dilation and tachycardia. No indrawing or dyspnea. Patient experienced decompensation cardiac on 15Apr2021. The patient died on 19Apr2021. Cause of death reported as decompensation cardiac. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1316543 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac arrest, Death, Decreased appetite, Fatigue, General physical health deterioration, Headache, Malaise, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRINITRINE MYLAN; LAMALINE [CAFFEINE;PAPAVER SOMNIFERUM LATEX;PARACETAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart attack; Stomach pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021521577

Write-up: death unexplained; cardiac arrest; Headache; Reduced general condition; Nausea; Asthenia; general ma; very severe fatigue; Appetite lost; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority FR-AFSSAPS-NC20211837, Safety Report Unique Identifier FR-AFSSAPS-2021048349. A 92-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 01Apr2021 (Batch/Lot Number: ER9470) as 1st dose, single for covid-19 immunisation. Medical history included heart attack in 1971 where patient had cardiac weakness since and stomach pain. Since then he has been living normally without unnecessary effort. Concomitant medications included glyceryl trinitrate (TRINITRINE MYLAN) and caffeine, papaver somniferum latex, paracetamol (LAMALINE) both taken for an unspecified indication, start and stop date were not reported. The patient experienced general malaise, very severe fatigue - getting worse to the point of dragging yourself around to get around, almost permanent headache while never usually a headache, nausea, asthenia and reduced general condition on 03Apr2021; appetite lost on 01Apr2021 and death unexplained on 17Apr2021. It was reported that the patient no longer ate at all since the vaccination. The patient lived alone, just had calls from time to time from his family who he said he was not well. But since he had been having pain in his stomach for a long time, no one was worried about his condition over the phone. The patient was last seen alive on 15Apr2021 and was found dead by the housekeeper on 17Apr2021 sitting on a bench. The doctor who came to see the death believes he has been dead for several days. The patient died on 17Apr2021 due to cardiac arrest. It was unknown if an autopsy was performed. The outcome of event cardiac arrest and death unexplained was fatal; all other events were not recovered. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1316585 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-04-13
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchitis, COVID-19, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 12
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: Test Date: 20210419; Test Name: PCR; Result Unstructured Data: Test Result:positive; Comments: variant
CDC Split Type: FRPFIZER INC2021521580

Write-up: Desaturation and right focus; Vaccination failure/COVID-19/Carrying out a PCR which turns out to be positive (so-called variant).; COVID-19/Carrying out a PCR which turns out to be positive (so-called variant).; fever; auscultatory bronchitis; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority-WEB regulatory authority [FR-AFSSAPS-NT20211359], Sender''s Safety Report Unique Identifier [FR-AFSSAPS-2021047756]. An 88-year-old male patient received bnt162b2 (COMIRNATY), dose 2 on 12Feb2021 (Lot Number: EJ6789) and dose 1 on 22Jan2021 (Lot Number: EJ6788); both via intramuscular at single dose for SARS-CoV-2 vaccination. Medical history included stable COPD living in a nursing home. No respiratory pathology since 2015. The patient''s concomitant medications were not reported. On 13Apr2021, the patient experienced early auscultatory bronchitis. No cough (sore throat isolated symptom). On 18Apr2021, he had fever. On 19Apr2021, carrying out a PCR which turns out to be positive (so-called variant), Covid 19. On 21Apr2021: Desaturation and right focus. Progressive worsening despite increased antibiotics, dexamethasone and oxygen therapy and right pleural puncture. Therapeutic measures were taken as a result of the events. The patient died on 25Apr2021 around 5 a.m. Cause of death was Vaccination failure and Covid 19. It was unknown if an autopsy was performed. The outcome of the events auscultatory bronchitis, fever and desaturation was unknown. The outcome of the remaining events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination failure; COVID-19


VAERS ID: 1316661 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-19
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Thromboembolic event
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021521922

Write-up: Cerebral hemorrhage; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PC20210910, Safety Report Unique Identifier: FR-AFSSAPS-2021044730. An 83-year-old male patient received first dose of BNT162B2 (COMIRNATY, lot number: ER9470) at the age of 82-years, via intramuscular on 30Mar2021 at single dose for COVID-19 immunisation. Medical history included arterial hypertension and thromboembolic event. Concomitant medications were not reported. The patient experienced cerebral hemorrhage on 19Apr2021 which caused him hospitalization and death. It was reported that on 19Apr2021, death by sudden massive cerebral hemorrhage without prodromes. It was unknown if an autopsy was done or not. The patient died on 19Apr2021. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral hemorrhage


VAERS ID: 1316702 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Coma scale, Computerised tomogram head, Dyspnoea, General physical health deterioration, Ischaemic stroke, Magnetic resonance imaging head, Malaise, Ocular discomfort, Specialist consultation
SMQs:, Anaphylactic reaction (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 4
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: L-THYROXINE [LEVOTHYROXINE]; ASPEGIC [ACETYLSALICYLIC ACID]; LANTUS; INEXIUM [ESOMEPRAZOLE SODIUM]; UVEDOSE; KARDEGIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Infarct myocardial; Insulin-dependent diabetes mellitus; Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: glasgow coma scale; Result Unstructured Data: Test Result:3; Test Date: 20210418; Test Name: brain CT; Result Unstructured Data: Test Result:no recent bleeding, no engagement; Test Date: 20210419; Test Name: MRI brain; Result Unstructured Data: Test Result:recent ischemic stroke; Comments: recent ischemic stroke constituted multi-territorial making suspect an embolic origin. No hemorrhagic transformation. Obstruction of the posterior cerebral arteries, the right vertebral artery and the M2 portion of the left middle cerebral artery.; Test Date: 20210418; Test Name: specialist consultation; Result Unstructured Data: Test Result:non-arousable, bilateral tight miosis; Comments: non-arousable, bilateral tight miosis
CDC Split Type: FRPFIZER INC2021521943

Write-up: Ischemic stroke; malaise; eye revulsion; Dyspneic; Gradual deterioration of the general condition; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB: FR-AFSSAPS-PS20210916 and Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021047263. A 92-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular administered in left arm on 16Apr2021 (Batch/Lot Number: EW4815) as single dose for covid-19 immunisation. Medical history included arterial hypertension, infarct myocardial from 1995, "allergies" to penicillin, iodine, streptomycin, intolerance to ramipril, insulin-dependent diabetes. Concomitant medications included levothyroxine (L-THYROXINE); acetylsalicylic acid (ASPEGIC); insulin glargine (LANTUS); esomeprazole sodium (INEXIUM); colecalciferol (UVEDOSE); acetylsalicylate lysine (KARDEGIC). On 18Apr2021, the patient had malaise with eye revulsion and loss of contact. Gradual deterioration of the general condition. Dyspneic patient on 15L of O2. Glasgow 3, non-arousable, bilateral tight miosis. Given the patient''s advanced age, very limited autonomy (living with her husband and daughter at home) and the gravity of the current situation, a collegial decision that the benefit / risk ratio of hospitalization in intensive care would be unfavorable. Orientation towards comfort care. Brain CT with no recent bleeding, no engagement. On 19Apr202, realization of a cerebral MRI: recent ischemic stroke constituted multi-territorial making suspect an embolic origin. No hemorrhagic transformation. Obstruction of the posterior cerebral arteries, the right vertebral artery and the M2 portion of the left middle cerebral artery. Neuro-vascular opinion was very poor prognosis, no indication to start anticoagulation, continuation of KARDEGIC 250 mg (usual treatment). No improvement in state of consciousness during hospitalization. No symptoms of discomfort. The death occurs on 22Apr2021. Cause of death was ischemic stroke. All of the events were serious per hospitalization. An autopsy was not performed. The outcome of ischemic stroke was fatal, of other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ischemic stroke


VAERS ID: 1318065 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Chills, Illness, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (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), 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: 2021-04-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke (previous stroke in May 2017)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021498435

Write-up: sick; fever; chills; vomiting; stroke; brain bleed; This is a spontaneous report from a contactable other health care professional (patient''s niece). A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 23Apr2021 13:00 (Batch/Lot number was not reported) (at the age of 91 years old) at 2nd dose, single for COVID-19 immunisation. Medical history included previous stroke in May2017. The patient was not pregnant at the time of vaccination. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Apr2021 at 03:00, the patient became extremely sick. On 24Apr2021, she had fever, chills and vomiting. Later that evening (24Apr2021), she passed away from a stroke and brain bleed. The adverse events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event sick was not recovered, and unknown outcome for fever, chills and vomiting. The patient died on 24Apr2021. It was unknown if an autopsy was performed. Information on batch/lot number has been requested.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. Medical history of previous stroke may provided a plausible alternative explanation for the events of Stroke and Cerebral bleeding. 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: Stroke; brain bleed


VAERS ID: 1318085 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 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: CRPFIZER INC2021513930

Write-up: Heart arrest; This is a spontaneous report from a non-contactable pharmacist via a Pfizer colleague. A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient received the vaccine on a Thursday and on Sunday died due to a heart arrest (unspecified date). The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: There is no sufficient evidence that the reported fatal heart arrest, although temporally related, may be related to administration of BNT162B2. Of note, medical history and concomitant medications were not provided to determine pre-existing risk factors or conditions that may have led to the event. Case will be reassess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Heart arrest


VAERS ID: 1318086 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-14
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: 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: Alzheimer''s disease; Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CRPFIZER INC2021517047

Write-up: Passed away/died; This is a spontaneous report from a non-contactable consumer. A 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as single dose, for covid-19 immunisation. Medical history included ongoing alzheimer''s and ongoing diabetes. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 Immunization. The consumer reported that his grandmother (the patient), an 84-year-old female patient, with a pathological history of Alzheimer''s and Diabetes, died a week after the placement of the second dose of the Pfizer Covid 19 vaccine. The consumer stated that both Alzheimer''s and Diabetes were under control at the time of vaccination, and that the death of the patient surprised them. She was "healthy", she went to sleep, and the next day, she woke up dead, a week after receiving the vaccine (second dose). The patient died on an unspecified date. 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: Passed away/died


VAERS ID: 1318087 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, COVID-19 pneumonia, Communication disorder, Confusional state, Disease progression, Inflammatory marker increased, Inflammatory marker test, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 10
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: Epilepsy; LBBB (LBBB - Left bundle branch block); Primary hypertension; Prostatic hyperplasia
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemic stroke
Allergies:
Diagnostic Lab Data: Test Name: inflammatory markers; Result Unstructured Data: Test Result:rose; Test Date: 20210401; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: CZPFIZER INC2021522075

Write-up: his condition progressed; inflammatory markers rose; Interstitial pneumonia due to COVID-19; Weakness; problems with communication; Confusion; COVID-19; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB CZ-CZSUKL-21004786. A 73-year-old male patient received bnt162b2 (COMIRNATY, Lot number: ET7205) intramuscular on 26Mar2021 at single dose for covid-19 immunisation. The patient''s medical history included special epileptic syndrome, primary hypertension, LBBB - Left bundle branch block, prostatic hyperplasia, all ongoing, ischaemic ictus from an unknown date and not ongoing. Concomitant medications were none. On 01Apr2021, the patient was hospitalized on the COVID-19 department for confusion, weakness, and problems with communication. The patient was found to have COVID-19. His condition slowly improved to the point when he was 07Apr2021 transferred to a standard department. Here his condition progressed, his auscultatory readings worsened, and his inflammatory markers rose. On 11Apr2021 the patient died. The patient experienced interstitial pneumonia due to COVID-19 on 07Apr2021. Time Interval between beginning of drug administration and start of reaction Covid-19 pneumonia was 12 days. The cause of death was interstitial pneumonia due to COVID-19. It was unknown if an autopsy was performed. The patient underwent lab test included COVID-19 virus test: positive on 01Apr2021, inflammatory markers: rose on an unknown date. The outcome of the event" Interstitial pneumonia due to COVID-19" was fatal, of the events "weakness", "problems with communication", "confusion" was recovered, of the other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Interstitial pneumonia due to COVID-19


VAERS ID: 1318088 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Heart rate
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   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:
Allergies:
Diagnostic Lab Data: Test Name: Initial rhythm; Result Unstructured Data: Test Result:ventricular fibrillation
CDC Split Type: DEPFIZER INC2021527597

Write-up: Death of unknown origin, two days after initial vaccination with Pfizer vaccine, according to the patient''s partner.; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (MA) -WEB. Regulatory authority number is DE-PEI-CADR2021062133. Safety report unique identifier DE-PEI-202100054490. A 47-year-old male patient received the first dose of the bnt162b2 (Pfizer vaccine), via an unspecified route of administration on 30Apr2021 at 0.3ml, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced death of unknown origin, two days after initial vaccination with bnt162b2, according to the patient''s partner on 02May2021. The patient died on 02May2021 due to unknown cause. It was not reported if an autopsy was performed. Relatedness of vaccine to reaction as per PEI was assessed as unclassifiable. Sender Comment: Patient collapsed unobserved while going to the toilet. No resuscitation. Initial rhythm was ventricular fibrillation. Subsequent resuscitation and attempt at ECMO. Patient died of yet unknown cause. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1318093 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-04-26
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
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: 2021-05-02
   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: ACIDUM FOLICUM; ATORVASTATIN; BISOCE; FUROSEMIDE; METFORMIN; NEO MERCAZOLE; OLANZAPINE; RAMIPRIL; VITABACT; XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure (Heart failure); Diabetes; Hypertension arterial (High blood pressure); Hyperthyroidism; Infarct myocardial
Allergies:
Diagnostic Lab Data: Test Date: 20210502; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210426; Test Name: PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021521574

Write-up: Vaccination failure; COVID-19 PCR test positive; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-DJ20211042, Safety Report Unique Identifier FR-AFSSAPS-2021047636. An 83-year-old male patient received BNT162B2 (COMIRNATY), intramuscular on 04Feb2021 (batch/lot number: EK9788) as 2nd dose, single, and intramuscular on 14Jan2021 (batch/lot number: EM0477) as 1st dose, single for COVID-19 vaccination. Medical history included hyperthyroidism, hypertension arterial (high blood pressure), atrial fibrillation, infarct myocardial, diabetes and cardiac failure (heart failure). Concomitant medications included acidum folicum, atorvastatin, bisoprolol fumarate (BISOCE), furosemide, metformin, carbimazole (NEO MERCAZOLE), olanzapine, ramipril, picloxydine dihydrochloride (VITABACT) and rivaroxaban (XARELTO). The patient experienced vaccination failure and COVID-19 PCR test positive on 26Apr2021 with fatal outcome. It was further reported that PCR positive on 26Apr2021. He presented flu-like symptoms on 01May2021 and died on 02May2021. On the day of death the symptoms were fever of 39 degrees, asthenia and spasms. No variant identified. Context of several cases in the same nursing home (cf DJ20211054 + other case under documentation). In total: 83-year-old patient who presented with a vaccine failure and died at the nursing home on 02May2021. A drug was substantially coded if the name of the specialty was not known. The outcome of the rest of the events was unknown. The patient died on 02May2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 PCR test positive; Vaccination failure


VAERS ID: 1318094 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-11
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, 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: 2021-04-11
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Heart failure
Allergies:
Diagnostic Lab Data: Test Name: covid-19; Test Result: Positive
CDC Split Type: FRPFIZER INC2021522030

Write-up: vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB: Worldwide unique case identification number-FR-AFSSAPS-LL20212433, Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021047048. A 96-year-old male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: EM6950) as 1st dose, single and dose 2 via intramuscular, administered in Arm Left on 12Mar2021 (Lot Number: ET3620) as 2nd dose, single for covid-19 immunisation. Medical history included heart failure and covid-19. The patient''s concomitant medications were not reported. The patient experienced vaccination failure on 11Apr2021 and hospitalized from an unspecified date. On 11Apr2021, the patient died of a COVID 19 infection despite a complete vaccination schedule. The patient underwent lab tests and procedures which included covid-19 test: positive on an unspecified date. The patient died on 11Apr2021 due to COVID-19. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: died of a COVID 19 infection despite a complete vaccination schedule; died of a COVID 19 infection despite a complete vaccination schedule


VAERS ID: 1318095 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-21
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, 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: 2021-04-23
   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: PERMIXON; TEMERIT; LERCAN; KENZEN [CANDESARTAN CILEXETIL]; EUPANTOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastrooesophageal junction cancer metastatic (chemotherapy with XELODA); Hypertension arterial; Prostatic carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: O2; Result Unstructured Data: Test Result:40; Comments: L/min; Test Date: 20210422; Test Name: O2; Result Unstructured Data: Test Result:15; Comments: L/min; Test Date: 20210422; Test Name: O2; Result Unstructured Data: Test Result:30; Comments: L/min; Test Date: 20210422; Test Name: COVID diagnosis; Test Result: Positive
CDC Split Type: FRPFIZER INC2021521572

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB FR-AFSSAPS-LL20212462 with Safety Report Unique Identifier FR-AFSSAPS-2021047805. An 85-year-old male patient received bnt162b2 (COMIRNATY lot/batch number and expiration date not reported) intramuscular on Feb2021 as 1st dose, single and on Mar2021 as 2nd dose, single for COVID-19 immunisation. Medical history included gastrooesophageal junction cancer metastatic (chemotherapy with XELODA), prostatic carcinoma and hypertension arterial. Concomitant medications included serenoa repens extract (PERMIXON), nebivolol hydrochloride (TEMERIT), lercanidipine hydrochloride (LERCAN), candesartan cilexetil (KENZEN [CANDESARTAN CILEXETIL]) and pantoprazole sodium sesquihydrate (EUPANTOL). The patient experienced vaccination failure and COVID-19 on 21Apr2021. On 21Apr2021: fall at home, inability to get up then disturbance of consciousness. Supported by the Emergency and Resuscitation Service then in the emergency room of the Hospital. On 22Apr2021: COVID diagnosis with unfavorable prognosis, maximum care in room but rejected for resuscitation. COVID disease management with oxygen therapy, roactemra 700 mg, levofloxacin 750 mg / 24h, dexamethaosone 6mg / 24h, cefotaxime 3g / 24h. On 22Apr2021: patient who desaturated under O2 15 L / min. O2 increased to 30 L / min then to 40 L / min. On 23Apr2021: death of the patient due to the events. 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: Vaccination failure; COVID-19


VAERS ID: 1318097 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-23
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory 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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   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: Medical History/Concurrent Conditions: Appendicectomy; Arthrosis; Polyradiculoneuritis; Quadruple vessel bypass graft
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021521557

Write-up: Cardiorespiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [FR-AFSSAPS-TO20213238], Safety Report Unique Identifier [FR-AFSSAPS-2021048705]. A 72-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 09Apr2021 (Batch/Lot Number: EW2239) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Arthrosis, Polyradiculoneuritis, Appendicectomy, all from an unknown date, Quadruple vessel bypass graft from 2017 to 2017, not ongoing. The patient''s concomitant medications were not reported. On 23Apr2021 occurrence of a violent malaise with cardiorespiratory arrest without resuscitation leading to death. The patient died on 23Apr2021, unknown autopsy was performed, outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: occurrence of a violent malaise with cardiorespiratory arrest without resuscitation leading to death.


VAERS ID: 1318102 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Aspartate aminotransferase, Blood lactic acid, Blood potassium, Blood pressure measurement, Brain oedema, Cardio-respiratory arrest, Computerised tomogram, Computerised tomogram abdomen, Echocardiogram, Electrocardiogram, Heart rate, Magnetic resonance imaging head, Neurological examination, Nicotinamide, Platelet count, Prothrombin time ratio, Pulmonary embolism, SARS-CoV-2 test, Troponin, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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: COVERSYL [PERINDOPRIL ERBUMINE]; ESOMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Gastroesophageal reflux; Smoker (stopped 2008, 40 packs per year)
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: Computerised tomography angiography; Result Unstructured Data: Test Result:Proximal pulmonary embolism, bilateral, truncal le; Comments: Proximal pulmonary embolism, bilateral, truncal level with signs of associated computerised tomography severity; dilation of the right cavities with an increased right ventricle to left ventricle ratio greater than 1. Thin blade of anterior pericardial effusion and left pleural effusion both with a thickness of one millimetre. No adenomegaly of the various axes. No lesion suggestive of a possible Covid 19 infection. Bilateral posterior basal condensation bands related to atelectasis phenomena. No suspicious nodule visible. On the cuts passing through the abdomen within the acquisition limit: Presence of a cyst-like lesion of approximately 3 cm visible within the hepatic segment IV. 9 mm small axis lymph node at the level of the retroportal blade with discreet infiltration of the fat around the periphery. No pejorative-type bone lesion.; Test Date: 20210426; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:900 IU/l; Test Date: 20210427; Test Name: lactate; Result Unstructured Data: Test Result:Lactate 3.2 vs. 2.3 in the morning -$g 10 pm monito; Comments: Lactate 3.2 vs. 2.3 in the morning -$g10 pm monitoring: 7,7 1 dose Amiklin +; Test Date: 20210427; Test Name: potassium; Result Unstructured Data: Test Result:6.1; Test Date: 20210428; Test Name: BP; Result Unstructured Data: Test Result:+ hypo-blood pressure (average blood pressure 35); Comments: + hypo-blood pressure (average blood pressure 35) responding poorly to the increase in nicotinamide adenine dinucleotide; Test Date: 20210427; Test Name: Cranial computerised tomography scan; Result Unstructured Data: Test Result:Triventricular hydrocephalus with ventricular junc; Comments: Triventricular hydrocephalus with ventricular junctions measured at 18 and 17 mm and 3rd ventricle at 12 mm and collapsed V4 not visible. Sign of transependymal resorption disorder, with hypodensity of the white matter viewed from the ventricular junctions. Collapse of the cerebral sulci. Dedifferentiated appearance of the parenchyma of the posterior fossa, which can give rise to the suspicion of an ischemia in the process of forming, but difficult to assert. These abnormalities are to be addressed by performing magnetic resonance imaging. Signs of tonsil involvement. No evidence of recent intra- or extra-axial bleeding. No abnormality of the cervico-occipital hinge. Free sinus structures. No suspicious bone lesion observed.; Test Date: 20210427; Test Name: CT scan; Result Unstructured Data: Test Result:scan for evidence of digestive ischemia and cerebr; Comments: scan for evidence of digestive ischemia and cerebral computerised tomography scan for ischemic lesions following cardiac arrest.; Test Date: 20210427; Test Name: Abdominal and pelvic computerised tomography scan; Result Unstructured Data: Test Result:Mild enhancement of the digestive loop wall, but n; Comments: Mild enhancement of the digestive loop wall, but noticeable, without thickening, nor parietal pneumatosis, associated with permeability of the mesenteric vessels, not making it possible to rely on a clear argument for an established mesenteric ischemia. All of the arteries present with a very small calibre, to be linked to the patient''s haemodynamic disorders. Liver of normal size and morphology, with no suspected focused parenchymal abnormality. Cysts on segments III and V of 18 and 25 mm. Permeability of the venous port and hepatic system. No dilation of the intra- and extra-hepatic bile ducts. Thin-walled gallbladder, with no detectable lithiasis on the scan. No suspicious focal lesion observed on the pancreas (unusual pancreatic calcifications), the spleen and the adrenals. Multiple bilateral renal cortical hypodensities, triangular in shape with a cortical base, suggesting areas of infarction on low flow, rather than nephritis foci, which can hardly be formally eliminated. No gaseous peritoneal effusion. Low abundance intra-abdominal effusion. No celio-mesenteric, para lumbo-aortic or iliac adenomegaly detected. Moderate hydroaeric colon content, without dilation of the small loops, nor of the colon suggestive of occlusive syndrome. Moderate abundance bilateral pleural effusion, with ventilatory disturbances on contact. Appearance of a spontaneous, non-enhanced hyperdensity of the anterior mediastinal fat, in front of the heart, measured up to 21 mm in thickness, in favour of a haematic origin (non-compressive haematoma after external cardiac massage). Homogeneous 32 mm fatty lesion of the right gluteal region. No suspicious osteolytic or osteo-condensing lesion.; Test Date: 20210426; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:Transthoracic echocardiography shows good left ven; Comments: Transthoracic echocardiography shows good left ventricular function but above all a major dilation of the right ventricle with paradoxical septum; coronary angiography not performed; Test Date: 20210427; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:moderate right ventricle dilation without acute co; Comments: moderate right ventricle dilation without acute cor pulmonale, septum less stiff than yesterday in PSPA, Tricuspid annular plane systolic excursion 29 mm, no pulmonary arterial hypertension. Left ventricle empty ++ hyperkinetic in favour of septic vasoplegia despite everything (nicotinamide adenine dinucleotide-dependence ++ and fever + procalcitonin$g90): digestive translocation?; Test Date: 20210426; Test Name: electrogram; Result Unstructured Data: Test Result:On the electrocardiogram anterior acute coronary s; Comments: On the electrocardiogram anterior acute coronary syndrome. Heparin 8,000 - Aspirin 250 mg 3 cardiac arrests after resumption of rhythm Thrombolysis 9:42 am. No cardiac arrests afterward No Flow 0 Low Flow 50 min (10 minutes external heart massage son + 40 minutes LUCAS). 7 mg of adrenaline; Test Date: 20210428; Test Name: Heart rate; Result Unstructured Data: Test Result:Heart rate 60 vs. 110, bispectral index (vs. 53); Comments: Heart rate 60 vs. 110, bispectral index (vs. 53) and anisocoria Left$gRight in favour of an outbreak of inter-cranial hypertension Improvement afterward: new pupil isocores, haemodynamic improvement (heart rate 100 at 6:30 am), resumption of spontaneous ventilation; Resumption of sedation despite not waking up; Test Date: 20210428; Test Name: Cerebral MRI; Result Unstructured Data: Test Result:Cerebral magnetic resonance imaging = Very extensi; Comments: Cerebral magnetic resonance imaging = Very extensive ischemic lesions at the supra and infra-tentorial level, secondary to cardio-respiratory arrest. Very extensive cerebellar lesions, with significant mass effect on adjacent structures, on the brainstem and effacement of the 4th ventricle, with appearance of upstream hydrocephalus; Test Date: 20210428; Test Name: Neurological; Result Unstructured Data: Test Result:Neurosurgical opinion in view of the poor neurolog; Comments: Neurosurgical opinion in view of the poor neurological prognosis with posterior fossa ischemia and involvement of the cerebellar tonsils: no indication for a ventricular bypass. At the end of the afternoon, onset of an areactive bilateral mydriasis followed by suppression of brainstem reflexes.; Test Date: 20210428; Test Name: nicotinamide adenine dinucleotide; Result Unstructured Data: Test Result:haemodynamic failure not responding to the nicotin; Comments: haemodynamic failure not responding to the nicotinamide adenine dinucleotide 38 mg/H.; Test Date: 20210426; Test Name: Platelet count; Result Unstructured Data: Test Result:240000; Comments: no thrombocytopaenia; Test Date: 20210426; Test Name: prothrombin ratio; Test Result: 65 %; Test Date: 20210427; Test Name: SARS CoV-2 PCR; Test Result: Negative ; Test Date: 20210426; Test Name: troponin; Result Unstructured Data: Test Result:1714 ng/L; Test Date: 20210426; Test Name: ventricular fibrillation; Test Result: 50 %
CDC Split Type: FRPFIZER INC2021521850

Write-up: Cardio-respiratory arrest; Acute massive pulmonary embolism; Cerebral oedema; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB regulatory authority FR-AFSSAPS-TS20211545, Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021047600. A 60-year-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 21Apr2021 as single dose for covid-19 immunisation. Medical history included high blood pressure, gastro-oesophageal reflux, and smoking (stopped 2008, 40 packs per year). The patient''s concomitant medications include chronic treatment with perindopril erbumine (COVERSYL) for high blood pressure; Esomeprazole for gastro-oesophageal reflux; and Respimat. Clinical course: On Day 5: 26Apr2021, chest pain with dyspnoea. Emergency medical services call around 9:10 am. Cardiac arrest in the presence of his wife while the dispatcher was on the phone with her. No Flow = 30 sec. Low Flow 10 min (external heart massage by wife). Upon arrival at Emergency Medical Services asystole, mechanical heart massage. Tracheal intubation. Resumption of rhythm after 2 mg of adrenaline. On the electrocardiogram anterior acute coronary syndrome. Heparin 8,000 - Aspirin 250 mg. 3 cardiac arrests after resumption of rhythm. Thrombolysis 9:42 am. No cardiac arrests afterward. Slight signs of awakening (cough on breathing) to be noted before administering sedation with midazolam. And post-adrenaline mydriasis but regressive. Summary: No Flow 0 Low Flow 50 min (10 minutes external heart massage son + 40 minutes LUCAS). 7 mg of adrenaline. Upon arrival at the medical examiner''s office: Transthoracic echocardiography shows good left ventricular function but above all a major dilation of the right ventricle with paradoxical septum; coronary angiography not performed. Computerised tomography angiography: Proximal pulmonary embolism, bilateral, truncal level with signs of associated computerised tomography severity; dilation of the right cavities with an increased right ventricle to left ventricle ratio greater than 1. Thin blade of anterior pericardial effusion and left pleural effusion both with a thickness of one millimetre. No adenomegaly of the various axes. No lesion suggestive of a possible Covid 19 infection. Bilateral posterior basal condensation bands related to atelectasis phenomena. No suspicious nodule visible. On the cuts passing through the abdomen within the acquisition limit: Presence of a cyst-like lesion of approximately 3 cm visible within the hepatic segment IV. 9 mm small axis lymph node at the level of the retroportal blade with discreet infiltration of the fat around the periphery. No pejorative-type bone lesion. Biological analysis: creatinine, urea, troponin 1714 ng/L, aspartate aminotransferase 900 UI/L, prothrombin ratio 65%, ventricular fibrillation 50%; no thrombocytopaenia (240,000 platelets). Therefore cardiorespiratory arrest (No Flow 0, Low Flow 50'') on pulmonary embolism, complicated by anuric acute kidney failure, and hypoxic hepatitis +/- sepsis/digestive translocation. Continuation nicotinamide adenine dinucleotide, right ventricle, introduce dobutamine, apparent trabecular thickness treated with ceftriaxone + Flagyl (digestive dilation + vomiting on admission). On 27Apr2021, Satisfactory evolution with respect to the haematosis. Haemodynamically unstable with great need for Noradrenaline, SARS CoV-2 PCR (Polymerase chain reaction) test: negative. Computerised tomography scan for evidence of digestive ischemia and cerebral computerised tomography scan for ischemic lesions following cardiac arrest. Cranial computerised tomography scan Triventricular hydrocephalus with ventricular junctions measured at 18 and 17 mm and 3rd ventricle at 12 mm and collapsed V4 not visible. Sign of transependymal resorption disorder, with hypodensity of the white matter viewed from the ventricular junctions. Collapse of the cerebral sulci. Dedifferentiated appearance of the parenchyma of the posterior fossa, which can give rise to the suspicion of an ischemia in the process of forming, but difficult to assert. These abnormalities are to be addressed by performing magnetic resonance imaging. Signs of tonsil involvement. No evidence of recent intra- or extra-axial bleeding. No abnormality of the cervico-occipital hinge. Free sinus structures. No suspicious bone lesion observed. Abdominal and pelvic computerised tomography scan: Mild enhancement of the digestive loop wall, but noticeable, without thickening, nor parietal pneumatosis, associated with permeability of the mesenteric vessels, not making it possible to rely on a clear argument for an established mesenteric ischemia. All of the arteries present with a very small calibre, to be linked to the patient''s haemodynamic disorders. Liver of normal size and morphology, with no suspected focused parenchymal abnormality. Cysts on segments III and V of 18 and 25 mm. Permeability of the venous port and hepatic system. No dilation of the intra- and extra-hepatic bile ducts. Thin-walled gallbladder, with no detectable lithiasis on the scan. No suspicious focal lesion observed on the pancreas (unusual pancreatic calcifications), the spleen and the adrenals. Multiple bilateral renal cortical hypodensities, triangular in shape with a cortical base, suggesting areas of infarction on low flow, rather than nephritis foci, which can hardly be formally eliminated. No gaseous peritoneal effusion. Low abundance intra-abdominal effusion. No celio-mesenteric, para lumbo-aortic or iliac adenomegaly detected. Moderate hydroaeric colon content, without dilation of the small loops, nor of the colon suggestive of occlusive syndrome. Moderate abundance bilateral pleural effusion, with ventilatory disturbances on contact. Appearance of a spontaneous, non-enhanced hyperdensity of the anterior mediastinal fat, in front of the heart, measured up to 21 mm in thickness, in favour of a haematic origin (non-compressive haematoma after external cardiac massage). Homogeneous 32 mm fatty lesion of the right gluteal region. No suspicious osteolytic or osteo-condensing lesion. Conclusions: Skull: Triventricular hydrocephalus, with collapsed V4, collapse of intracranial sulci and tonsil involvement with probable cerebral oedema, predominant in the posterior fossa of ischemic origin. Abdomen and pelvis: No argument for a developing mesenteric ischemia, nor for an occlusive syndrome. Multiple renal cortical hypodensities, in favour of ischemic lesions, without formally eliminating nephritis foci, which appear less probable. No clear focus of further abdomino-pelvic infection. Persistence of anuric acute kidney failure with potassium 6.1 at 18 hours; Persistent haemodynamic instability despite nicotinamide adenine dinucleotide 7.5 mg/hours responding (transiently) only in the right ventricle, with septic atmosphere. Lactate 3.2 vs. 2.3 in the morning -$g 10 pm monitoring: 7,7 1 dose Amiklin +. Transthoracic echocardiography: moderate right ventricle dilation without acute cor pulmonale, septum less stiff than yesterday in PSPA, Tricuspid annular plane systolic excursion 29 mm, no pulmonary arterial hypertension. Left ventricle empty ++ hyperkinetic in favour of septic vasoplegia despite everything (nicotinamide adenine dinucleotide-dependence ++ and fever + procalcitonin$g90): digestive translocation. Note: neuron specific enolase$g300 on Day 1 and computerised tomography scan and transcranial Doppler of cerebral oedema. On 28Apr2021 6 am: sudden apnoea/breathing (in modes of mechanical ventilation) + hypo-blood pressure (average blood pressure 35) responding poorly to the increase in nicotinamide adenine dinucleotide. Upon examination: Heart rate 60 vs. 110, bispectral index (vs. 53) and anisocoria Left$gRight in favour of an outbreak of inter-cranial hypertension. Improvement afterward: new pupil isocores, haemodynamic improvement (heart rate 100 at 6:30 am), resumption of spontaneous ventilation; Resumption of sedation despite not waking up. At 8:00 pm: Cerebral magnetic resonance imaging = Very extensive ischemic lesions at the supra and infra-tentorial level, secondary to cardio-respiratory arrest. Very extensive cerebellar lesions, with significant mass effect on adjacent structures, on the brainstem and effacement of the 4th ventricle, with appearance of upstream hydrocephalus. Neurosurgical opinion in view of the poor neurological prognosis with posterior fossa ischemia and involvement of the cerebellar tonsils: no indication for a ventricular bypass. At the end of the afternoon, onset of an areactive bilateral mydriasis followed by suppression of brainstem reflexes. At 12:00 am: haemodynamic failure not responding to the nicotinamide adenine dinucleotide 38 mg/H. At 12:50 am: death. Patient died on 28Apr2021, no autopsy done. In total, massive pulmonary embolism complicated by cardiorespiratory arrest on Day 5 of the 1st dose of Comirnaty in a 60 year old hypertensive patient. Resuscitation effective but secondary death from complications of anoxia (ischemic cerebral oedema). No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest; Acute massive pulmonary embolism; Cerebral oedema


VAERS ID: 1318103 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Blood pressure systolic, Cardiac arrest, Chest discomfort, Coma scale, Dyspnoea exertional, Electrocardiogram, End-tidal CO2, Haemoglobin, Oxygen saturation, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TENORDATE; CRESTOR; XATRAL
Current Illness: Prostate cancer (Remission was on the verge of being pronounced)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Deep vein thrombosis (Following a prolonged flight by plane); Hypercholesterolemia; Overweight; Radiotherapy (Last session about 1 year ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210503; Test Name: Blood pressure; Result Unstructured Data: Test Result:Low; Test Date: 20210503; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:70 mmHg; Test Date: 20210503; Test Name: Glasgow; Result Unstructured Data: Test Result:3; Test Date: 20210503; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Asystole then a few large complexes; Comments: Asystole then a few large complexes without cardiac activity; Test Date: 20210503; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Complete asystole; Test Date: 20210503; Test Name: ETCO2; Test Result: 5 %; Test Date: 20210503; Test Name: ETCO2; Test Result: 30 %; Test Date: 20210503; Test Name: ETCO2; Test Result: 40 %; Test Date: 20210503; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.3 g/dl; Test Date: 20210503; Test Name: SpO2; Test Result: 90 %
CDC Split Type: FRPFIZER INC2021521566

Write-up: Probable massive pulmonary embolism; Arrest cardiac; Chest tightness; Dyspnoea exertional; Asthenia; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority Report Numbers: FR-AFSSAPS-TS20211560 and FR-AFSSAPS-2021048322). A contactable physician reported that a 60-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: ET6956), intramuscular, on 23Apr2021, as first dose, single, for COVID-19 immunization. The patient''s medical history included arterial hypertension, old hypercholesterolemia, overweight, ongoing prostate cancer discovered in 2020 treated by radiotherapy (last session about 1 year ago in 2020, remission was on the verge of being pronounced), and deep vein thrombosis following a prolonged flight by plane and contemporaneous with the discovery of prostate cancer (medical treatment, no notion of thrombophilia assessment, favorable outcome). The patient''s concomitant medications included atenolol/ nifedipine (TENORDATE) for arterial hypertension, rosuvastatin calcium (CRESTOR) for old hypercholesterolemia, and alfuzosin hydrochloride (XATRAL). Antecedent or not of COVID-19 was not specified. The patient in good general condition. First injection of BNT162B2 vaccine was on 23Apr2021. No notion of specific manifestations of immediate course or in the days following vaccination. By the end of Apr2021 (approximately 1 week after vaccination), there was onset of dyspnea on exertion (dyspnea exertional) and asthenia, gradually increasing. On 02May2021, there was also chest tightness. 03May2021 (approximately 10 days after vaccination), distressed patient, who himself takes 1 tablet of cetirizine in the middle of the day (fearing that these manifestations are of allergic origin). No notion of other manifestations than those previously described, in particular no notion of rash, no flu-like syndrome or fever. In the afternoon (03May2021 at 4:53 PM), the patient was sitting with family, having a snack. He gets up suddenly and says he feels unwell, then fainting with low blood pressure to 70 mmHg systolic, brief contact breaks in front of his family present. Rapid recovery, patient then very dyspneic. The called for help. About 5 minutes later, recurrence of a malaise, again in front of witnesses, this time with loss of consciousness then cardio-respiratory arrest (arrest cardiac), entourage immediately began a cardiac massage (4:48 PM). Arrival of (medical service) (4:53 PM, 5 minute-massage). The patient''s Glasgow was 3 in mydriasis and asystole, livid, cyanosis of the ears and extremities, large jugular turgor. No saturation or blood pressure that can be taken from the outset, end-tidal CO2 (ETCO2) at 5%. Intubation, adrenaline (1 +1 +3 mg) but electromechanical dissociation (some complexes ineffective, without associated pulse). Hemoglobin 14.3 g/dl. Beginning of thrombolysis with alteplase (ACTILYSE) (7000 units) at 5:10 PM (after 15 minutes of medical resuscitation), followed by automated cardiac massage. Subsequently, intermittent recovery of fine complexes and increase in ETCO2 to 30% (5:15 PM) then 40% (5:20 PM). SpO2 90% at 5:20 PM. IVSE epinephrine (10/50, 4 ml/h) from 5:20 PM. (25 min of sheave), 5:38 PM: 4.2% bicarbonates 150 ml 4.2 at 5:38 PM. Asystole then a few large complexes without cardiac activity at 5:40 PM per electrocardiogram, continuation of automated external cardiac massage and increase in adrenaline at 3 mg/h, then loss of activity. At 6:10 PM, end of resuscitation in the face of complete asystole per electrocardiogram, 1 hour after thrombolysis and after 1 hour and 15 minutes of medical resuscitation. The doctor concluded that there was refractory cardiac arrest in a context of probable massive pulmonary embolism. Scientific autopsy requested. In total, refractory cardiac arrest (on pulmonary embolism on an unspecified date). Despite resuscitation in a patient who had dyspnea for 4 days, chest tightness since the day before, the dyspnea having occurred approximately 1 week after a first injection of BNT162B2 vaccine. Patient in good general condition, who had prostate cancer in remission (end of radiotherapy treatment a year earlier) and a history of deep vein thrombosis (at the time of discovery of the cancer and following an extended flight, without recurrence thereafter). The outcome of the events was fatal. The patient died on 03May2021. An autopsy was performed, and results were not provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Arrest cardiac; Probable massive pulmonary embolism; Dyspnoea exertional; Asthenia; Chest tightness


VAERS ID: 1318134 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, SARS-CoV-2 test, Sudden death
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), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: Medical History/Concurrent Conditions: Cardiac arrest
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021529877

Write-up: cardiac arrest; Death sudden; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The Regulatory Authority report number is GB-MHRA-WEBCOVID-202104191352412370. Safety Report Unique Identifier GB-MHRA-ADR 25260789. A 29-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Apr2021, as single dose, for COVID-19 immunisation. Medical history included cardiac arrest. Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. Patient was not taking any medication prior to the COVID-19 vaccination. The patient experienced cardiac arrest (death, life threatening) on 01Apr2021, death sudden (death, life threatening) on 01Apr2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unknown date. The patient died on 01Apr2021. An autopsy was performed and results were not provided. Patient has not tested 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: Cardiac arrest; Death sudden


VAERS ID: 1318143 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-19
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20211

Write-up: death; Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (death) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 19-Apr-2021 The patient died on 19-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. A patient of an unknown age and gender who received mRNA-1273 died on an unknown days after he received the first dose of vaccine. No medical conditions or concomitant products were provided. Based on the current case data, this case has been classified as invalid. Very limited information has been reported at this time. Further information is not expected.; Sender''s Comments: A patient of an unknown age and gender who received mRNA-1273 died on an unknown days after he received the first dose of vaccine. No medical conditions or concomitant products were provided. Based on the current case data, this case has been classified as invalid. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1318809 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-21
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autoimmune haemolytic anaemia, Blood count, Blood lactate dehydrogenase, Cardiac arrest, Computerised tomogram, Coombs direct test, Haemolysis, Haemolytic anaemia, Jaundice, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Cholestasis and jaundice of hepatic origin (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 3
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: FOLIC ACID; OMEPRAZOLE; PREDNISOLONE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CLL (stable and had never been treated); Fall; Hypercholesterolaemia; Hypertension (was on medication); Prostate cancer
Allergies:
Diagnostic Lab Data: Test Name: blood count; Result Unstructured Data: Test Result:no signs of haemolysis; Test Name: LDH level; Result Unstructured Data: Test Result:high; Test Name: CT Scan; Result Unstructured Data: Test Result:unknown result; Test Name: DAT; Result Unstructured Data: Test Result:positive haemolytic anaemia; Comments: strongly positive; Test Name: WBC; Result Unstructured Data: Test Result:rose from about 100 to almost 300
CDC Split Type: GBPFIZER INC2021492674

Write-up: haemolytic anaemia; jaundice; haemolysis; cardiac arrest; Autoimmune haemolytic anaemia; This is a spontaneous report received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104301412091770-KSXIK, Safety Report Unique Identifier: GB-MHRA-ADR 25225126. A contactable physician reported that a 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, via an unspecified route of administration on 31Mar2021 (lot number: not reported) at 2nd dose, single for COVID-19 immunisation. Medical history included fall; hypercholesterolaemia; prostate cancer; hypertension and was on medication; chronic lymphocytic leukaemia (CLL) which was stable and had never been treated. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications included folic acid; omeprazole; prednisolone at 80 mg; and ramipril taken for hypertension. The patient experienced jaundice, haemolytic anaemia, cardiac arrest, and haemolysis on an unspecified date; and autoimmune haemolytic anaemia on 21Apr2021. Clinical course reported as follows: he was known to have CLL and had a blood count a few weeks earlier and had been seen in clinic when he was well with no signs of haemolysis. He had never needed treatment for the CLL. He was started on 80 mg prednisolone and folic acid. Patient was admitted on 21Apr2021 with anaemia & jaundice and tests indicated DAT positive haemolytic anaemia. During those few days in hospital his WBC rose from about 100 to almost 300. His haemoglobin continued to fall and he had a cardiac arrest on 24Apr2021 and resuscitation attempts were not successful. DAT strongly positive, high LDH level, and CT scan (unknown results). Reactions were not related to possible blood clots or low platelet counts. Patient has not tested positive for COVID-19 since having the vaccine. Regulatory authority assessed the events as serious resulted to death. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Autoimmune haemolytic anaemia; haemolytic anaemia; jaundice; cardiac arrest; haemolysis


VAERS ID: 1318811 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-04-01
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN1185 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-platelet antibody, Cerebral venous sinus thrombosis, Computerised tomogram, Femoral artery embolism, Heparin-induced thrombocytopenia test, Imaging procedure, Immune thrombocytopenia, Immunology test, Magnetic resonance imaging, Mesenteric vein thrombosis, Ophthalmic vein thrombosis, Periorbital infection, Peripheral ischaemia, Platelet count, Portal vein thrombosis, SARS-CoV-2 test, Splenic vein thrombosis, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Ischaemic colitis (broad), Glaucoma (broad), Retinal disorders (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Ocular infections (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: anti-PF4 antibodies; Test Result: Positive ; Test Date: 20210426; Test Name: CT scan; Result Unstructured Data: Test Result:Portal, splenic & superior mesenteric vein thrombo; Comments: Portal, splenic & superior mesenteric vein thrombosis; Test Date: 20210420; Test Name: Heparin-induced thrombocytopenia test gel card; Test Result: Negative ; Test Date: 20210423; Test Name: Repeat imaging; Result Unstructured Data: Test Result:persistent bilateral superior opthalmic vein throm; Comments: persistent bilateral superior opthalmic vein thrombosis and cerebral venous sinus thrombosis.; Test Date: 20210420; Test Name: Heparin-induced thrombocytopenia test ELISA; Test Result: Positive ; Comments: HIT ELISA: HIT assay used: "HIT ELISA (Immunocor IgG)" (anti-PF4 antibodies) positive = PF4 HIT assay optical density: "Optical density = 2.1"; Test Date: 202104; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210418; Test Name: Platelet count; Result Unstructured Data: Test Result:23; Test Date: 20210423; Test Name: Platelet count; Result Unstructured Data: Test Result:fell below 10; Test Date: 20210424; Test Name: Platelet count; Result Unstructured Data: Test Result:5; Test Date: 20210428; Test Name: Platelet count; Result Unstructured Data: Test Result:marginal improvement in platelet count; Test Date: 20210419; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negaitve
CDC Split Type: GBPFIZER INC2021502908

Write-up: Portal vein thrombosis; Splenic vein thrombosis; mesenteric vein thrombosis; cerebral venous sinus thrombosis; ischaemic/ acute ischaemic right leg; Femoral artery embolism; Ophthalmic vein thrombosis; platelet count <150 A- 109/L; Periorbital infection; provided probable vaccine induced immune thrombocytopenia (VITT); This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104301447214040-BZC6S. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: EN1185) as 1st dose, single for COVID-19 immunisation. Medical history ongoing rheumatoid arthritis (taking regular medicines for rheumatoid arthritis or other types of arthritis except osteoarthr...). The patient does not currently smoke. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient previously took Amoxicillin, Ciprofloxacin, Erythromycin, Penicillin, Tetracycline, Sulfasalazine, Methotrexate, Leflunomide, Codeine, Azathioprine and Telmisartan, and experienced allergy/drug hypersensitivity to these medications. On 18Apr2021, the patient was diagnosed with bilateral superior ophthalmic vein thrombosis. Platelet count was 23. The platelet count was <150 A- 109 /L on 18Apr2021. Patient was given 1AD platelet infusion and started low molecular weight heparin. On unspecified date in Apr2021, the patient had Periorbital infection related to bilateral superior ophthalmic vein thrombosis. On 19Apr2021, the patient developed acute ischaemic right leg due to femoral artery embolism. She was switched to IV unfractionated heparin and transferred to Vascular Surgery for embolectomy. On 20Apr2021, Heparin-induced thrombocytopenia (HIT) gel card was negative but ELISA was positive (HIT ELISA: HIT assay used: "HIT ELISA (Immunocor IgG)" (anti-PF4 antibodies) positive = PF4 HIT assay optical density: "Optical density = 2.1") so patient was switched from IV unfractionated heparin to Fondaparinux. On 23Apr2021, Platelet count fell below 10, so she was started Prednisolone and switched Fondaparinux onto IV Argatroban. Repeat imaging showed persistent bilateral superior ophthalmic vein thrombosis and cerebral venous sinus thrombosis. The lowest platelet count after vaccine (usual normal range 150-450) was 5, on 24Apr2021. It was reported that the report relates to possible blood clots or low platelet counts. Patient was diagnosed with CT and Magnetic resonance imaging (MRI) scans between 18Apr2021 and 26Apr2021. On 26Apr2021, Clinical concern of right leg becoming more ischaemic, and platelet count failed to improve, so given IVIg (1g/kg). Computerised tomography (CT) scan of whole body also revealed portal vein, splenic vein and superior mesenteric vein thrombosis. On 28Apr2021, there was marginal improvement in platelet count, but leg deteriorating so changed from Prednisolone to IV Methylprednisolone and planned for plasma exchange. The haematologist provided probable vaccine induced immune thrombocytopenia (VITT) (as other differential diagnoses excluded) as diagnosis or differential diagnoses. No haemorrhage was identified. The patient does not have a history of, or concurrent, intracranial malignancy. The patient did not have a recent surgical or medical intervention to the central nervous system (including lumbar puncture). The patient did not have a recent trauma/head injury. The patient does not have a history of, or current, malignancy. The patient has a confirmed or suspected autoimmune or inflammatory disease including Rheumatoid Arthritis. No other additional medical history, not already provided, that relates to previous venous or arterial thromboses. Patient has not tested positive for COVID-19 since having the vaccine. On 19Apr2021, COVID-19 virus test was negative. The patient died suddenly on evening of 28Apr2021. The patient died on 28Apr2021. 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: Ophthalmic vein thrombosis; ischaemic/ acute ischaemic right leg; Femoral artery embolism; platelet count <150 A- 109/L; cerebral venous sinus thrombosis; Portal vein thrombosis; Splenic vein thrombosis; mesenteric vein thrombosis; provided probable


VAERS ID: 1318888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH E70141 / 2 - / -

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: 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: Test Date: 20210104; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021507830

Write-up: Death; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA); the Regulatory Authority report number is GB-MHRA-WEBCOVID-202105051521433660-VAZ9L and the Safety Report Unique Identifier is GB-MHRA-ADR 25247437. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10Jan2021 (batch/lot number: E70141) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient''s medical history was not reported. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient tested negative for COVID-19 virus test on 04Jan2021. Concomitant medications were not reported. The patient previously received BNT162B2 via an unspecified route of administration on 20Dec2020 (batch/lot number: Ej0533/v0005) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient has not tested positive for COVID-19 since having the vaccine. It was reported that the patient experienced death on an unspecified date (pending clarification, reported as 26Dec2020). An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1318910 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-01-01
   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: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021507845

Write-up: Death; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202105051742187880-BKSB6. Safety Report Unique Identifier: GB-MHRA-ADR 25248236. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: Not Known) as 2nd dose, single for Covid-19 immunisation. Medical history included steroid therapy (taking regular steroid treatment (e.g. orally or rectally). Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced death on 01Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. The patient died on 01Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1318916 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
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: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021507901

Write-up: Autism; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202105051838482350-WTQWX. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as 1st dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced autism on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 virus test was no - negative COVID-19 test. The patient died on 19Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Autism


VAERS ID: 1318964 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dementia, Fatigue, Headache, Influenza, Lower respiratory tract infection, Pain in extremity, SARS-CoV-2 antibody test
SMQs:, Anaphylactic reaction (broad), Dementia (narrow), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 45
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Suspected COVID-19; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210317; Test Name: covid infection; Test Result: Negative
CDC Split Type: GBPFIZER INC2021514373

Write-up: dementia; chest infection; virus; pain in arm; headache; tired; Cough; This is a spontaneous report from a contactable consumer received from a regulatory (RA). The regulatory authority report number GB-MHRA-WEBCOVID-202105061258374460-YYGXD, Safety Report Unique Identifier GB-MHRA-ADR 25253193. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included dementia from 2019 to an unknown date, Type 2 diabetes mellitus from an unknown date to an unknown date, suspected covid-19 from 15Nov2020 to 18Nov2020. Concomitant medication included metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported. The patient experienced cough (cough) (death) on 06Mar2021, dementia (dementia) (medically significant) on an unspecified date, chest infection (lower respiratory tract infection) (medically significant) on an unspecified date, virus (influenza) (non-serious) on an unspecified date, pain in arm (pain in extremity) (non-serious) on an unspecified date, headache (headache) (non-serious) on an unspecified date, tired (fatigue) (non-serious) on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 antibody test negative on 17Mar2021. The patient died on 21Apr2021 due to cough, at the time of death he was recovered from all other events (recovered date unspecified). It was not reported if an autopsy was performed. The clinical course was reported as follows: 2nd Pfizer jab on 04Mar2021, developed cough on 06Mar2021, rang GP a week later as cough worsening, prescribed antibiotics and said the cough was unfortunately a side effect of the vaccine. Cough and breathing deteriorated and ambulanced to ER on 19Mar2021 for further tests then admitted to Adult Frailty Unit; doctors said he had had a side effect to the vaccine and that he had a nasty chest infection but was expected to recover. After a long in patient stay and despite my father in law having dementia, as his careers (me and my husband) were not allowed access to visit him until 12Apr2021 when he was in "end of life care" and the doctor said he only had a few days to live. He sadly passed away on 21Apr2021. Under a campaign regulation, we should have been allowed to visit every day and assist with his care needs and to advocate for him, especially as he only spoke another language. We shielded him through the whole pandemic and the whole family had covid19 following an outbreak at our daughters school with 2 teachers testing positive in November 2020; he had minor symptoms as we kept him shielded (slight pain in arm and bit tired for a few days but otherwise fine). Following government advice he had his first Pfizer vaccine on 18Dec2020 and only mild side effects tired for a few days and bit of a headache. Is there any research being done looking at the effects of the covid19 vaccines on those who have already had the virus and recovered? At the time government guidelines said that even if you''ve had the virus, still get the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Suspect Reactions. Please provide details of any relevant investigations or tests conducted: "GP insisted on doing a covid19 test to rule out a covid infection-done 17.3.21 and negative". Additional information: Type 2 Diabetic (on Metformin, Asprin, Lipotor). Dementia (diagnosed 2019). Otherwise very healthy. Not had a COVID-19 test. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021529167; Reported Cause(s) of Death: Cough


VAERS ID: 1319043 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-05-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20211

Write-up: Unevaluable event; This regulatory authority case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion death). The patient died on 08-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. On unknown date, patient had a negative COVID-19 virus test. Company Comment: A male patient of an unknown age who received mRNA-1273 died 3 days after he received the first dose of vaccine. No medical conditions or concomitant products were provided. Very limited information has been reported at this time. Further information is not expected.; Sender''s Comments: A male patient of an unknown age who received mRNA-1273 died 3 days after he received the first dose of vaccine. No medical conditions or concomitant products were provided. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1319046 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
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: COVID-19 virus test; Result Unstructured Data: Test Result:Negative
CDC Split Type: GBPFIZER INC2021529906

Write-up: Pneumonia aspiration; This is a spontaneous report received from a contactable consumer from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202105101016391890-ACXFI, Safety Report Unique Identifier GB-MHRA-ADR 25270081. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not known) as for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pneumonia aspiration with fatal outcome. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on an unknown date. The patient died on 09May2021. It was not reported if an autopsy was performed. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information expected; Information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Pneumonia aspiration


VAERS ID: 1319053 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL7834 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 60
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021400534

Write-up: the clot she developed has brought about her passing this morning; unwell; This is a spontaneous report from a contactable consumer or other non hcp. A 67-year-old female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL7834; Expiration Date: not provided), via intramuscular, administered in arm on 09Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 12Feb2021, 3 days after vaccine the patient began to feel unwell, diagnosed clot and sent to hospital. After several days on ward with oxygen no improvement so transferred into critical care. After all attempts nothing could be done. The patient was hospitalized for 10 days. Therapeutic measures were taken prescribed two courses of Antibiotics over phone by GP, deteriorated during and after the two courses. As a result of the clot she developed has brought about her passing this morning, unwell. The patient died on 14Apr2021. An autopsy was not performed. The reported cause of death was the clot she developed has brought about her passing this morning. The outcome of event was fatal and not recovered/not resolved.; Reported Cause(s) of Death: the clot she developed has brought about her passing this morning


VAERS ID: 1319065 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, General physical health deterioration, Mobility decreased
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
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: MIRAMEL; KALCIPOS; AMITRIPTYLINE; GALFER; DELTACORTRIL [PREDNISOLONE ACETATE]; OMEPRAZOLE; MONTELUKAST; ATORVASTATIN; AMLODIPINE TEVA; GABAPENTIN; FUROSEMIDE; SERTRALINE; AZITHROMYCIN; NUPRIN [ACETYLSALICYLIC ACID]; BETMIGA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery; COPD; Polymyalgia; Surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021528678

Write-up: Increasing shorness of breath; difficulty moblising; coughing; condition deteriorated; This is a spontaneous report from a contactable consumer. An 86-year-old male patient received bnt162b2 (COMIRNATY, lot number: EW2243), dose 2 via an unspecified route of administration on 07Apr2021 as 2nd dose, single for covid-19 immunisation. Medical history included polymyalgia, well controlled COPD, previous spinal surgery, heart bypass from 2017. Concomitant medications included pramipexole dihydrochloride monohydrate (MIRAMEL); calcium carbonate (KALCIPOS); amitriptyline; ferrous fumarate (GALFER); prednisolone acetate (DELTACORTRIL); omeprazole; montelukast; atorvastatin (ATORVASTATIN); amlodipine besilate (AMLODIPINE TEVA); gabapentin; furosemide; sertraline; azithromycin; acetylsalicylic acid (NUPRIN); mirabegron (BETMIGA). The patient previously received first dose of bnt162b2 (COMIRNATY, lot number: ED9605) on 24Feb2021 for COVID-19 Immunization and experienced fatigue, malaise and diagnosed with right sided pneumonia. Increasing shortness of breath, difficulty moblising and coughing post 2nd vaccine. Admitted to hospital 17Apr2021, 10 days after 2nd vaccine was administered. Treated extensively in hospital with IV antibiotics and oxygen therapy. Oxygen requirements increased and condition deteriorated - transferred to high dependency unit - High flow oxygen and antibiotics. Death cause was Awaiting death certificate. Number of days of hospitalization was 26. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient died on 01May2021. An autopsy was not performed.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021528823 same patient, reporter,drug/different event; Reported Cause(s) of Death: Increasing shorness of breath; difficulty moblising; coughing; condition deteriorated


VAERS ID: 1319073 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-04-22
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1B002A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Coronary artery disease
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), Other ischaemic heart disease (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidaemia; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC2021542424

Write-up: CORONARY ARTERY DISEASE; SUDDEN CARDIAC ARREST; This is a spontaneous report from a non-contactable healthcare professional (HCP) via the Regulatory Authority - (regulatory authority number: DH/21/2071), based on information received by Pfizer from BioNtech SE (manufacturer control number HK-Fosun-2021FOS000887), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. On 18Apr2021, a 43-year-old male patient received first dose of bnt162b2 (COMIRNATY, batch/lot number: 1B002A) via unknown route at single dose at the age of 43-year-old for COVID-19 immunization. Medical history included hyperlipidaemia and obesity. Concomitant medication(s) and past product were not reported. There was no record that the patient complained of feeling unwell during observation at the Vaccination Centre. The patient experienced sudden cardiac arrest at home on 22-Apr-2021 and showed no vital signs upon arrival at the hospital. Resuscitation at the hospital was performed but in vain and the patient passed away on the same night on 22Apr2021. The event coronary artery disease met the seriousness criterion of death. Sudden cardiac arrest was considered as Important Medical Event. The preliminary autopsy findings were coronary artery disease. An autopsy was performed on an unknown date and the reported cause of death was coronary artery disease. Causality assessment for COMIRNATY for Cardiac arrest, Coronary artery disease was Possible per Reporter and per Company (BioNtech SE). No further information is possible.; Reported Cause(s) of Death: CORONARY ARTERY DISEASE; Autopsy-determined Cause(s) of Death: CORONARY ARTERY DISEASE


VAERS ID: 1319074 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1B002A / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), 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: 2021-04-22
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC2021543109

Write-up: RUPTURED MYOCARDIAL INFARCTION; UNCONSCIOUS ON A BED; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (Regulatory authority report number: DH/21/2087) based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS000902), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. On 12Apr2021, a 66-year-old female patient received the 2nd dose of Tozinameran (COMIRNATY) (lot number: 1B002A) via unknown route at single dose for COVID-19 immunization. The first dose was received on an unknown date. Medical history, concomitant medications and past product were not reported. The patient was unconscious on a bed in the morning of 22Apr2021. The patient was certified dead at the scene and her body was sent to a public mortuary. The preliminary autopsy findings were ruptured myocardial infarction. Ruptured myocardial infarction met the seriousness criterion of death. Unconscious on a bed and ruptured myocardial infarction were considered as Important Medical Events. At the time of the report, the outcome of unconscious on a bed was unknown. The patient died on 22Apr2021. An autopsy was performed on an unknown date and the reported cause of death was ruptured myocardial infarction. Initial report was received on 23-Apr-2021. he regulatory authority report number is DH/21/2087. The causality between the reported events and the suspected vaccine is possible.; Reported Cause(s) of Death: RUPTURED MYOCARDIAL INFARCTION; Autopsy-determined Cause(s) of Death: RUPTURED MYOCARDIAL INFARCTION


VAERS ID: 1319078 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   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: Hypertension; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC2021539838

Write-up: UNKNOWN CAUSE OF DEATH; UNCONSCIOUS; CHEST PAIN; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority (regulatory authority number: not applicable), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS001079), license party for bnt162b2(COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Hong Kong department of health. The regulatory authority report number is not applicable. A 46-year-old male patient received the 2nd dose of TOZINAMERAN (COMIRNATY) (lot number: unknown) on 27Apr2021 via unknown route at single dose for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history included hypertension and smoking. Concomitant medications and past product were not reported. There was no record that the patient complained of feeling unwell during observation at the vaccination centre. The patient experienced chest pain on 04May2021 and had not sought medical advice. Patient was found unconscious at home in the evening of 05May2021. He was sent to hospital but passed away after failure in resuscitation. Unknown cause of death met the seriousness criterion of death. The event unconscious was considered as Important Medical Event. The patient died on 05May2021. It was unknown if an autopsy was performed and no cause of death was reported. At the time of the report, the outcomes of chest pain and unconscious were unknown. Follow-up closed, no further information is possible. The reported events were considered possibly related to the suspect vaccine.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1319079 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-30
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1B002A / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Lower respiratory tract infection
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), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   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: Bronchoscopy; COVID-19 immunization; Myelofibrosis; Nasopharyngeal carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC2021539842

Write-up: CHEST INFECTION; CARDIAC ARREST; This is a spontaneous report from a contactable other HCP via Regulatory Authority (regulatory authority report number: DH/21/2371), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS001080), license party for bnt162b2 (COMIRNATY). On 12-Apr-2021, a 58-year-old female patient started to receive 2nd dose of Tozinameran (COMIRNATY) (lot number: 1B002A) via unknown route at unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history included myelofibrosis, nasopharyngeal carcinoma and bronchoscopy. Concomitant medication(s) and past product were not reported. The patient experienced chest infection and cardiac arrest on 30-Apr-2021, 18 days after vaccination with the 2nd dose. Chest infection and cardiac arrest met the seriousness criterion of death and were considered as Important Medical Events. The patient died on 30-Apr-2021. Whether an autopsy was performed was unknown and the reported causes of death were chest infection and cardiac arrest. The actions taken for Tozinameran (COMIRNATY) were not applicable. At the time of the report, the outcomes of the events were fatal. Follow-up closed, no further information is possible.; Reported Cause(s) of Death: CHEST INFECTION; CARDIAC ARREST


VAERS ID: 1319089 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G267614A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Death, Heart rate, Oxygen saturation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   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: BISOCARD; VALSOCARD HCT; XANAX SR; SCIPPA; MILURIT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Bronchitis; Hypertension; Obesity; Panic disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210403; Test Name: Blood pressure; Result Unstructured Data: 125/70 mmHg; Test Date: 20210403; Test Name: Body temperature; Result Unstructured Data: 35.8 degrees Celsius; Test Date: 20210403; Test Name: Pulse rate; Result Unstructured Data: 80/min; Test Date: 20210403; Test Name: Oxygen saturation; Test Result: 96 %; Result Unstructured Data: 96%
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death) in a 41-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G267614A) for COVID-19 vaccination. The patient''s past medical history included Arrhythmia, Obesity, Panic disorder, Hypertension and Bronchitis. Previously administered products included for Bronchitis: Zinnat. Concomitant products included BISOPROLOL FUMARATE (BISOCARD), HYDROCHLOROTHIAZIDE, VALSARTAN (VALSOCARD HCT), ALPRAZOLAM (XANAX SR), ESCITALOPRAM OXALATE (SCIPPA) and ALLOPURINOL (MILURIT) for an unknown indication. On 03-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Death occurred on 03-Apr-2021 The patient died on 03-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Blood pressure measurement: 125/70 mmHg 125/70 mmHg. On 03-Apr-2021, Body temperature: 35.8 35.8 degrees Celsius. On 03-Apr-2021, Heart rate: 80 80/min. On 03-Apr-2021, Oxygen saturation: 96 % 96%. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 was Not applicable. The cause of Death is not reported. The patient died approximately 6 hours after vaccination with COVID-19 Vaccine Moderna. There is no information about the cause of death or whether autopsy was done. The causal relationship between the reported death and the vaccine is unassessable. The case is serious due to fatal outcome.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the death, a causal relationship cannot be excluded. Cause of death not provided.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1319090 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-21
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH WE2239 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Drug ineffective, SARS-CoV-2 test positive
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: 2021-04-21
   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: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: COVID-19 virus test positive; Result Unstructured Data: Test Result:Positive
CDC Split Type: HUPFIZER INC2021506510

Write-up: Death; COVID-19 virus test positive; Covid 19 test positive on 17th day after first dose (Drug Ineffective); This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-257321. A 72-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in Arm Left on 05Apr2021 (Batch/Lot Number: WE2239) as 1st dose, 0.3 ml single for COVID-19 immunization. Medical history included COVID-19. The patient''s concomitant medications were not reported. On 20Apr2021, the patient started having breathing difficulties and on 21Apr2021 early morning had to call an ambulance. The EMT confirmed the Covid-19 infection (positive), but the patient died at 05:30 on 21Apr2021 before arriving in the hospital. It was not reported if an autopsy was performed. Sender Comment: According to the product characteristics of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient got infected with the virus 16 days after the first dose, therefore immunity may have not developed yet. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. Follow-up activities closed. No routine follow-up is possible for EV-WEB ICSRs.; Reported Cause(s) of Death: COVID-19; COVID-19


VAERS ID: 1319092 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, COVID-19 pneumonia, Cardiac arrest, Cardiovascular disorder, SARS-CoV-2 test
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), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 17
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: VALSACOR; METFOGAMMA; BISOBLOCK
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension; Hypothyroidism; Obesity; Ophthalmologic treatment; Rheumatological examination
Allergies:
Diagnostic Lab Data: Test Date: 20210405; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021535755

Write-up: COVID-19 pneumonia; cardiovascular instability; bradycardia; asystole; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB HU-OGYI-282221. A 61-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 02Apr2021 (Batch/Lot Number: EW2239) as 1st dose, 0.3ml single for covid-19 immunisation. Medical history included obesity, diabetes mellitus, hypothyroidism, hypertension, ophthalmological and rheumatology treatment. Concomitant medications included valsartan (VALSACOR), metformin hydrochloride (METFOGAMMA) and bisoprolol fumarate (BISOBLOCK). The patient experienced covid-19 pneumonia on 05Apr2021. The patient was hospitalized for covid-19 pneumonia from 16Apr2021. On 05Apr2021, the patient was tested positive to COVID-19 with a rapid test. On 16Apr2021, she was taken to the hospital by an ambulance with dyspnea. COVID-19 pneumonia was verified. On 22Apr2021, the patient experienced cardiovascular instability, bradycardia and asystole; resuscitation was unsuccessful. The patient underwent lab tests and procedures which included COVID-19 test: positive on 05Apr2021. The patient died on 22Apr2021 due to COVID-19 pneumonia. It was unknown if an autopsy was performed. The outcome of the other events was unknown. Sender Comment: COVID-19 pneumonia was detected 3 days after vaccination with COMIRNATY. Immunity did not develop within 3 days after vaccination. The causal relationship between the vaccine and the event is unlikely. The case is considered serious due to fatal outcome.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1319093 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-22
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Faeces pale, SARS-CoV-2 test
SMQs:, Biliary system related investigations, signs and symptoms (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   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: NACL; L-THYROXINE [LEVOTHYROXINE]; NEBILET; GORDIUS; LERCATON; KALDYUM; APRANAX [NAPROXEN]; QUAMATEL; STADALAX; CORDAFLEX; FRONTIN; IMOVANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic sclerosis; Breast adenocarcinoma; Cardiac insufficiency; Hepatomegaly; Hospitalization; Hypertension; Hypothyreosis; Icterus; Ischemic heart disease; Malignant neoplasm papilla of Vater (biliary cancer - hospitalized); Polyarthritis; Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210316; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210324; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210329; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021535756

Write-up: Death; stool become acholic; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number HU-OGYI-285021. An 84-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: ET7205), intramuscular, administered in Arm Right on 31Mar2021 as 2nd dose, 0.3 mL single for COVID-19 immunization while hospitalized. Medical history included aortic arteriosclerosis, breast adenocarcinoma, hypothyreosis, icterus, ischemic heart disease, hypertension, hepatomegaly, cardiac insufficiency, malignant neoplasm papilla of vater (biliary cancer), polyarthritis, and surgery (unspecified) all from an unknown date. The patient was hospitalized on 16Mar2021 because of Vater papilla carcinoma and was in a severely bad condition. The patient underwent lab tests and procedures which included 3 COVID 19 tests, COVID-19 antigen test: negative on 16Mar2021, COVID-19 PCR test: negative on 24Mar2021 and 29Mar2021. Concomitant medications included nacl (NACL); levothyroxine (L-THYROXINE); nebivolol hydrochloride (NEBILET); gabapentin (GORDIUS); lercanidipine hydrochloride (LERCATON); potassium chloride (KALDYUM); naproxen (APRANAX); famotidine (QUAMATEL); bisacodyl (STADALAX); nifedipine (CORDAFLEX); alprazolam (FRONTIN); and zopiclone (IMOVANE) all taken for an unspecified indication, start and stop date were not reported. On 24Apr2021 05:55, the patient passed away without any alarming signs. On 22Apr2021, two days before, her stool become acholic which is associated with her biliary cancer. The reporting physician assessed the adverse event as related to the patients primary disease (malignant neoplasm papilla of vater - biliary cancer). The outcome of the event "her stool become acholic" was unknown. The patient died on 24Apr2021. An autopsy was performed and results were not provided. Sender Comment: As the reporter physician assessed the fatal outcome as related to the patients primary disease, the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Sender''s Comments: The events acholic stools and death are likely due to the underlying medical condition and are unrelated to BNT162B2.; Reported Cause(s) of Death: Death


VAERS ID: 1319110 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-04-05
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Syncope
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), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   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: Hypertension (Controlled); Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021521776

Write-up: CARDIAC ARREST; UNEXPECTED COLLAPSE YESTERDAY WHILE OUT FOR A WALK; This is a spontaneous report downloaded from the regulatory authority-WEB, IE-HPRA-2021-071055. A 77-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: ER7812) at 0.3 mL, single for covid-19 immunisation. Medical history included prostate cancer and controlled hypertension. It was noted that the patient was in good general health, active and well. The patient''s concomitant medications were not reported. On 16Mar2021, the patient was vaccinated with his first dose of Comirnaty (batch number: ER7812). On 05Apr2021, 20 days post vaccination; the patient experienced an unexpected collapse while he was out for a walk. It was reported that the patient experienced a witnessed cardiac arrest with unsuccessful cardiopulmonary resuscitation (CPR) attempts. The patient was very well until his collapse with no immediate side effects following vaccination. The patient died on 05Apr2021. The reporter stated that he did not believe that the vaccine and the outcome were related, and post mortem was to be arranged. Autopsy results not available. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on available information and known drug profile, in agreement with the reporting physician that the reported collapse and cardiac arrest were unrelated to bnt162b2. These were intercurrent medical conditions. Case will be reassessed if additional information is received.; Reported Cause(s) of Death: CARDIAC ARREST; UNEXPECTED COLLAPSE YESTERDAY WHILE OUT FOR A WALK


VAERS ID: 1319111 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / -

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: 2021-03-20
   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: Congestive heart failure; COPD; IHD; Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021521753

Write-up: CVA; This is a spontaneous report from a contactable physician downloaded from the regulatory-WEB, regulatory authority number IE-HPRA-2021-071224. An 84-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on 12Mar2021 (batch/lot number ep9605 and expiry date unknown) as 1st dose, 0.3 ml single for covid-19 immunization. The patient''s medical history included IHD, congestive heart failure, lung cancer and COPD. Concomitant medications were not reported. On 17Mar2021, the patient experienced CVA (cerebrovascular accident) and died following vaccination. On 20Mar2021, the patient experienced death. The patient died on 20Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on known drug profile and available information it is unlikely that the cerebrovascular accident with a fatal outcome was causally related to bnt162b2. This is an intercurrent medical condition. The patient''s history of congestive heart failure, ischemic heart disease and COPD may have contributed to the cerebrovascular accident. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: CVA


VAERS ID: 1319142 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Aphasia, Behaviour disorder, Confusional state, Hallucination, Muscle rigidity, Neurological symptom
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 20
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021501510

Write-up: Onset of severe neurological symptoms, body stiffness, loss of speech, alterations in habitual behavior and character, etc.; Onset of severe neurological symptoms, body stiffness, loss of speech, changes in habitual behavior and character, etc.; Onset of severe neurological symptoms, body stiffness, loss of speech, changes in habitual behavior and character, etc.; Onset of severe neurological symptoms, body stiffness, loss of speech, changes in habitual behavior and character, etc.; confused state (hallucinations, partial memory loss); confused state (hallucinations, partial memory loss); confused state (hallucinations, partial memory loss); This is a spontaneous report downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-723266. A contactable consumer reported that a 92-year-old female patient received BNT162B2 (COMIRNATY), via intramuscular route administered in left arm on 03Apr2021 (Batch/Lot Number: ET3620) as 2nd dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. First dose of BNT162B2 (COMIRNATY) was administered on 12Mar2021. The patient was healthy without significant comorbidities. She was autonomous and self-sufficient until the time of vaccination, so much so that she lived alone, 24 hours after vaccination. She was found on the ground with a prior confused state (hallucinations, partial memory loss) and with severe evident neurological symptoms, body stiffness, loss of speech, alterations in habitual behavior and character, etc. on 03Apr2021. Events were reported as serious due to hospitalization. ''Severe neurological symptoms, body stiffness, loss of speech, changes in habitual behavior and character, etc.'' were reported as fatal events. Outcome of confused state (hallucinations, partial memory loss) was unknown. The patient died on 23Apr2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reporter''s Comments: Healthy patient, no significant comorbidities, autonomous and self-sufficient until the time of vaccination, so much so that she lived alone, 24 hours after vaccination, she was found on the ground with a prior confused state (hallucinations, partial memory loss) and with evident neurological signs after 10 hrs (severe stiffness of the body, loss of speech).; Reported Cause(s) of Death: Onset of severe neurological symptoms, body stiffness, loss of speech, alterations in habitual behavior and character, etc.; Onset of severe neurological symptoms, body stiffness, loss of speech, changes in habitual behavior and character, etc.; Onse


VAERS ID: 1319463 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1742 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Apnoeic attack, Arthralgia, Blood immunoglobulin G, Blood immunoglobulin M, COVID-19, COVID-19 pneumonia, Computerised tomogram, Cough, Diarrhoea, Dyspnoea, Loss of consciousness, Myalgia, Obstructive airways disorder, Oxygen saturation, Oxygen saturation decreased, Pulse absent, Pyrexia, Respiratory distress, Rhinorrhoea
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: IgG; Result Unstructured Data: Test Result:19.88; Test Date: 20210331; Test Name: IgM; Result Unstructured Data: Test Result:12.78; Test Date: 20210330; Test Name: Tomography; Result Unstructured Data: Test Result:COVID-19; Test Date: 20210404; Test Name: Oxygen saturation; Test Result: 30 %
CDC Split Type: MXPFIZER INC2021514582

Write-up: COVID-19 pneumonia; Oxygen saturation of 30%; Unconscious at arrival to Hospital; airway compromised by gastric content; Apneic; central pulse not palpable; COVID-19; Dysopnea/Respiratory distress; Fever of 38 degrees Celsius; Diarrhea; Rhinorrhea; Cough; Dysopnea/Respiratory distress; Myalgia; Arthralgia; This is a Spontaneous report from a non-contactable Other Health Professional. This is a report received from Agency Regulatory Authority via email. Regulatory authority report number is 12907-5 A 62-years-old male patient received bnt162b2 (BNT162B2), via intramuscular, administered in Arm Left on 12Mar2021 (Batch/Lot Number: ER1742; Expiration Date: 30Jun2021) as 1st dose single for covid-19 immunisation.Age at vaccination 62 years. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced fever of 38 degrees celsius on 22Mar2021 , diarrhea on 22Mar2021 , rhinorrhea on 22Mar2021 , cough on 22Mar2021 , dysopnea/respiratory distress on 22Mar2021 , myalgia on 22Mar2021 , arthralgia on 22Mar2021 , covid-19 on 30Mar2021 , covid-19 pneumonia on 04Apr2021 , oxygen saturation of 30% on 04Apr2021 , unconscious at arrival to hospital on 04Apr2021 , airway compromised by gastric content on 04Apr2021 , apneic on 04Apr2021 , central pulse not palpable (on 04Apr2021. The patient underwent lab tests and procedures which included blood immunoglobulin g: 19.88 on 31Mar2021 , blood immunoglobulin m: 12.78 on 31Mar2021 , computerised tomogram: covid-19 on 30Mar2021 , oxygen saturation: 30 % on 04Apr2021. The patient died for the events n 04Apr2021. Clinical picture: 62-year-old male, unknown personal background, with a background of covid-19 vaccination in PRIVACY on 12Mar2021, begins with symptoms on 22Mar2021 of type of flu mentioned by the patient''s wife, letting go a week without presenting an improvement, they go to a doctor on 30Mar2021 where they diagnosed covid-19 by tomography and on 31Mar2021 they go to take quantitative antibodies at laboratory, resulting in IgM 12.78 and IgG 19.88. Continues treatment at home with supplemental oxygen without presenting an improvement, it is brought to this unit on 03Apr2021 in a private vehicle from their home, in treatment with supplemental oxygen for pneumonia by sarscov2, relatives refer important desaturation as low as 30% prior to his transfer to this unit. Unconscious patient is received on admission, airway compromised by gastric content, apneic, non-palpable central pulse. Family members refer at least 10 minutes of cessation of breathing until the arrival at this unit. Declaring date of death 03Apr2021. 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: unconscious at arrival to hospital; airway compromised by gastric content; fever of 38 degrees celsius; diarrhea; rhinorrhea; cough; dysopnea/respiratory distress; dysopnea/respiratory distress; myalgia; arthralgia; Covid-19; covid-19 pneumonia; oxyg


VAERS ID: 1319464 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH R9449 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Haemorrhagic disorder, Livedo reticularis, Nausea, Respiratory distress, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021514600

Write-up: Dizziness; Nausea; Dysopnea/Respiratory distress; hemorrhagic manifestations; syncope; marbled coloring on face and anterior thorax at sternum level; This is a Spontaneous report from a non-contactable Other Health Professional. This is a report received from the regulatory authority. Regulatory authority report number is 13384-5. A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in arm left on 13Apr2021 11:00 Lot Number: R9449; Expiration Date: 01Jul2021 as 1ST DOSE, SINGLE at the age of 68 years for covid-19 immunisation. No pregnant. The patient medical history and concomitant medications were not reported. On 13Apr2021 11:45 the patient experienced dizziness, nausea, dysopnea/respiratory distress, hemorrhagic manifestations, syncope and marbled coloring on face and anterior thorax at sternum level. Clinical picture: son referred that after 45 min of vaccination upon entering their home, the patient refers to sudden onset characterized by dizziness, nausea, marbled coloration on the face, respiratory distress of 2 min of evolution, the marble coloration also appears in the anterior thorax to the height of the sternon, culminating in fainting, when the emergency arrived in less than 5 min she no longer had vital signs. The patient died on 13Apr2021. 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: Dizziness; Nausea; Dysopnea/Respiratory distress; hemorrhagic manifestations; syncope; marbled coloring on face and anterior thorax at sternum level


VAERS ID: 1319465 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7934 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Chest pain, Cough, Dyspnoea, Fatigue, Headache, Nausea, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210330; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: MXPFIZER INC2021514601

Write-up: Fever of 38 degrees Celsius; Headache; Asthenia/ fatigue; Asthenia/ fatigue; Adynamia; Cough; Pneumonia; Nausea; Chest pain; Dyspnea; This is a spontaneous report from a non-contactable unspecified Healthcare professional received from Regulatory Authority via email. Regulatory authority report number is 13388-5 A 64-year-old male patient first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in the arm left on 24Mar2021 (Lot Number: ER7934; Expiration Date: 30Jun2021) as a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 30Mar2021 the patient experienced fever of 38 degrees Celsius, headache, asthenia/ fatigue, adynamia, cough, pneumonia, nausea, chest pain and dyspnea. All the events were serious for hospitalization and fatal. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Clinical picture: Current suffering started 6 days after vaccination when presenting productive cough, without adding other data, one day prior to admission the family members referred to headache, nausea, asthenia, chest pain, dyspnea and fever. No follow-up attempts are possible, no further information is expected.; Reported Cause(s) of Death: fever of 38 degrees Celsius; headache; asthenia; fatigue; adynamia; cough; pneumonia; nausea; chest pain; dyspnea


VAERS ID: 1319466 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Cough, Dyspnoea, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: 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: MXPFIZER INC2021514602

Write-up: chest pain; cough; dyspnoea; respiratory distress; This is a spontaneous report from a non-contactable Health Care Professional received from Regulatory Authority. Regulatory authority report number is 13512-5. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in left arm on 12Apr2021 (Batch/Lot Number: EW4109; Expiration Date: 01Jul2021) at the age of 88 years, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Apr2021 the patient experienced cough, dyspnoea, respiratory distress. On unknown date the patient experienced chest pain. The events were serious as fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cough; dyspnoea; respiratory distress; chest pain


VAERS ID: 1319467 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2245 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Nausea, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: 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: CAPTOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021514603

Write-up: death; respiratory distress; dyspnoea; nausea; This is a spontaneous report from a non-contactable Health Care Professional received from the regulatory authority via email. Regulatory authority report number is 13697-5. A 72-years-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine Lot. EW2245; Expiration Date: 01Jul2021) intramuscularly, in the left arm, at single dose, on 19Apr2021, for COVID-19 immunisation. Relevant medical history included chronic hypertension from an unknown date and unknown if ongoing. Concomitant medications included captopril from an unspecified date, for chronic hypertension. On 19Apr2021, 12 hours after the vaccination, the patient experienced nausea, dyspnoea, respiratory distress. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of all events was reported as fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: nausea; dyspnoea; respiratory distress; death


VAERS ID: 1319468 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2245 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cyanosis, Headache, Hypoglycaemia, Hypothermia, Respiratory acidosis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021514604

Write-up: Cyanosis; hypothermia; hypoglycemia; respiratory acidosis; headache; syncope; This is a spontaneous report from a non-contactable healthcare professional. This is a report received from the regulatory authority via email. Regulatory authority report number is 14063-5. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 74-year-old, intramuscular, administered in left arm on 23Apr2021 (Lot Number: EW2245; Expiration Date: 01Jul2021) as 2nd dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced cyanosis, hypothermia, hypoglycemia, respiratory acidosis on 23Apr2021 after 30 mins from the vaccination and was admitted to the hospital (shock area) on the same day and was treated with epinephrine 2 mg IV, atropine 1 mg IV. The patient also experienced headache and syncope on 23Apr2021 after 30 mins from the vaccination. The patient died on an unspecified date due to the events. It was unknown if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Headache; Syncope; Cyanosis; Hypothermia; Hypoglycemia; Respiratory acidosis


VAERS ID: 1319591 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-27
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Apraxia, Cerebral artery thrombosis, Cerebrovascular accident, Computerised tomogram head, Malaise, Perfusion brain scan
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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: Test Name: CT angio; Result Unstructured Data: Test Result:an oclusion of (a) carotis interna vision, dissect; Comments: an oclusion of (a) carotis interna vision, dissection, and pinpoint stenosis of M1 a segment. cerebri media left; Test Date: 20210429; Test Name: CT Cerebrum; Result Unstructured Data: Test Result:no bleeding; Test Name: CT perfusion; Result Unstructured Data: Test Result:defect in media and anterior area to the left
CDC Split Type: NLPFIZER INC2021521575

Write-up: Thrombosis A. Cerebri Media Left; drop things out of the hands several times in the evening before; sudden unwell; Cerebrovascular accident; This is a spontaneous report from a contactable physician downloaded from the regulatory authority NL-LRB-00530101. A 76-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 12Apr2021 as unknown, 0.3 ml, single for covid-19 immunisation. No previous COVID-19 infection. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebrovascular accident (caused or prolonged hospitalization), malaise (caused or prolonged hospitalization) and apraxia (drop things out of the hands several times in the evening before) (caused or prolonged hospitalization), all on 27Apr2021 and Thrombosis A. Cerebri Media Left (death) on 01May2021 following administration of bnt162b2. Treatment for Cerebral artery thrombosis was treated with palliatief, cerebrovascular accident was treated with trombolyse en trombectomie in universitair centrum and malaise was treated with trombolyse en trombectomie. The case was assessed as serious. Additional information ADR, have things dropped out of your hands several times before. All of a sudden, in the evenings of the bank, not in touch. Acute to hospital, where thrombolysis and thrombectomy occurred. Unfortunately, did not improve and died on 3 May. No necropsy. The diagnostic procedures included CT Cerebrum on 29Apr2021 showed no bleeding, CT perfusion on unknown date showed a defect in media and anterior area to the left. CT angio on unknown date showed an oclusion of (a) carotis interna vision, dissection, and pinpoint stenosis of M1 a segment. cerebri media left. The outcome was not recovered for malaise and apraxia; recovering from cerebrovascular accident. The patient died on 03May2021 due to cerebral artery thrombosis. Autopsy was not performed. Report Note: Not sure if this has already been reported, it seems from the letters that the specialists have not thought that this would have a connection with the vaccine. Wife was also surprised by this suggestion, but not reported by regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Thrombosis A. Cerebri Media Left


VAERS ID: 1319621 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 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: 2021-04-30
   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: NOPFIZER INC2021521529

Write-up: Death. He is found dead in the home for unknown reasons. Apparently received covid-19 vaccine the day before/sudden death unexplained; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority number is NO-NOMAADVRE-FHI-2021-U1pyed, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00027948. A 62-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, lot number: EW6126), intramuscular, on 29Apr2021, as 1st dose, single, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 30Apr2021, the patient experienced unexplained sudden death. The patient was found dead in the home for unknown reasons. Apparently, he received COVID-19 vaccine the day before (29Apr2021). It was unknown if autopsy was performed. The health authority assessed the event as serious (death, medically significant). Assessed the causal relationship between COMIRNATY and the reported event as Possible. Health Authority Comment: Reporter''s qualification: Physician. more information about this case has been requested. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death. He is found dead in the home for unknown reasons. Apparently received covid-19 vaccine the day before/sudden death unexplained


VAERS ID: 1319628 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001937 / 1 - / OT

Administered by: Unknown       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: 2021-04-16
   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: Churg Strauss syndrome; COPD; Trigeminal neuralgia (Autopsy asked for, but no performed at the time of the report.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20211

Write-up: SUDDEN DEATH; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SUDDEN DEATH (SUDDEN DEATH) in a 77-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001937) for COVID-19 vaccination. Concurrent medical conditions included COPD, Trigeminal neuralgia (Autopsy asked for, but no performed at the time of the report.) and Churg Strauss syndrome. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 16-Apr-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SUDDEN DEATH (SUDDEN DEATH) to be possibly related. No Concomitant medications were reported by the reporter. Treatment medications were not reported. Action taken with mRNA-1273 in response to the drug was not applicable. The reporter (29 years old physician) was asked in the feedback to provide an update on the autopsy result when they are available. Based on the current available information and temporal association between the use of the product and the death, a causal relationship cannot be excluded. Cause of death not provided. Awaiting translation; Reporter''s Comments: .; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the death, a causal relationship cannot be excluded. Cause of death not provided. Awaiting translation; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1319682 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Haemorrhagic stroke
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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? 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: TROMALYT; TOPAMAX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021518504

Write-up: Hemorrhagic stroke; Derrame cerebral; This is a spontaneous report received from a contactable Consumer or other non professional downloaded from regulatory authority. The regulatory authority report number is PT-INFARMED-R202105-26. Other case identifier number: PT-INFARMED-R202104-3252. A 71-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 28Apr2021 (Batch/Lot Number: EY2172) as 1ST DOSE, 0.3ML SINGLE for covid-19 immunisation. The patient''s medical history was not reported. Concomitant medications included acetylsalicylic acid (TROMALYT); topiramate (TOPAMAX); taken for an unspecified indication, start and stop date were not reported. On 28Apr2021, the patient experienced derrame cerebral (cerebrovascular accident). On 29Apr2021, the patient experienced hemorrhagic stroke (haemorrhagic stroke) life-threatening and fatal. The autopsy report was done, autopsy results are not available. The outcome of the event cerebrovascular accident was unknown. Reporter''s comments: Concomitant medication-Tromalyt 150mg, Topomax 25mg. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Concomitant medication-Tromalyt 150mg, Topomax 25mg.; Reported Cause(s) of Death: Hemorrhagic stroke


VAERS ID: 1319695 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-15
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: 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: ROPFIZER INC2021527383

Write-up: some of the patients died; This is a spontaneous report from a contactable physician. This report was received via a sales representative. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, death cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1319703 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: XARELTO
Current Illness: Cardiovascular disease, unspecified; Chronic obstructive pulmonary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021521630

Write-up: Pain in stomach; BREATHING PROBLEMS; This is a spontaneous report from a contactable nurse downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is [SE-MPA-2021-032760]. An 81-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Lot Number: ER7812), via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. Medical history included unspecified cardiovascular disease and Chronic obstructive pulmonary disease; both were ongoing. Concomitant medication included rivaroxaban (XARELTO), oral from 12Jun2014 at 20 mg, once a day. The day after the vaccination on 20Mar2021, the patient experienced pain in stomach/abdominal pain and breathing difficulty. When the breathing problems did not go away, they called for an ambulance, but the man died at home. The patient died on unspecified date in 2021. Cause of death was abdominal pain and breathing difficulty. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: abdominal pain; breathing difficulty


VAERS ID: 1319704 (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: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Depressed level of consciousness, Productive cough, Transient ischaemic attack
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), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS; ENALAPRIL
Current Illness: Atrial fibrillation
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke (two strokes); TIA (several transient ischaemic attacks)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021521620

Write-up: Depressed level of consciousness; Coughed up yellow mucus; TIA; STROKE; This is a spontaneous report from a contactable consumer from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-033389. An 89-year-old female patient received bnt162b2 (COMIRNATY), dose 1 (lot number: EJ6795) on unspecified date in Jan2021 as 1st dose, single and second dose (lot number: EJ6134) on unspecified date in Jan2021, 3 weeks after 1st dose as 2nd dose, single; both via an unspecified route on for covid-19 immunisation. Medical history included two stroke, several transient ischaemic attacks and ongoing atrial fibrillation. Concomitant medications included apixaban (ELIQUIS) and enalapril both taken for an unspecified indication, start and stop date were reported. It was reported that the patient got her first TIA-stroke nine days after the first dose of bnt162b2. The patient spoke incoherently and inadequately. The patient was taken to the hospital on unspecified date in Jan2021. The patient came home again the next day. Two days later, she speaks incoherently again and does not feel well. Coughed up yellow mucus, blood pressure and heart rate cannot be taken according to the reporter. An ambulance arrives and the patient was taken to the hospital. The patient received second dose three weeks after the first. Ten days later the patient became limp in the left side and very stiff in the body, the head hung to the left, but the woman could talk. The next day, the patient was taken to hospital. Depressed level of consciousness. The patient died three days later after palliative care. The outcome of event coughed up yellow mucus was unknown. The patient died on unspecified date. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-2021527225 the same patient, diffrent dose and events; Reported Cause(s) of Death: TIA; stroke; Depressed level of consciousness


VAERS ID: 1319705 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Fatigue, General physical health deterioration, Pain
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (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: ALVEDON; SAROTEN; TAMOXIFEN EBB; TARGINIQ
Current Illness: Depression; Leg ulcer; Peripheral arteriosclerosis
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer metastatic; Rectal prolapse
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021521617

Write-up: tiredness; DECLARATION AT, LYING IN BED; pain in her body; fell asleep 37 days after the vaccination and died; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is [SE-MPA-2021-033837]. An 87-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot: EJ6136), via an unspecified route of administration on Feb2021 as 2 nd dose, single for covid-19 immunisation. Medical history included ongoing depression; ongoing leg ulcer; ongoing peripheral arteriosclerosis; rectal prolapse (unknown if ongoing) and breast cancer metastatic. Concomitant medications included paracetamol (ALVEDON); amitriptyline hydrochloride (SAROTEN); tamoxifen citrate (TAMOXIFEN EBB); naloxone hydrochloride, oxycodone hydrochloride (TARGINIQ) and Novum. The reported suspect adverse events were tiredness and general physical health deterioration in Mar2021. According to the physician, the patient was tired and complaining about pain in her body, about a month after the vaccination (in Mar2021). She fell asleep 37 days after the vaccination in 2021 and died. Physician assessed as serious, death. The outcome of coma and pain was unknown. The patient died in 2021 due to fatigue and general physical health deterioration and breast cancer metastatic (medical history). It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: breast cancer metastatic; tiredness; DECLARATION AT, LYING IN BED


VAERS ID: 1322656 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease progression, Fall, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021531570

Write-up: Concomitant disease progression; Fall; Peripheral swelling; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 546651. An 87-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced concomitant disease progression; fall; peripheral swelling on 10Apr2021 with fatal outcome. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Concomitant disease progression; Fall; Peripheral swelling


VAERS ID: 1322657 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Peripheral swelling, Tachycardia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Dehydration (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: DEXTRAN 70; GLUCOSE MONOHYDRATE; PRAVASTATIN; ALLOPURINOL; AMLODIPINE; BIMATOPROST; HYPROMELLOSE; IRBESARTAN; PANTOPRAZOLE; TRIMETHOPRIM; VALACICLOVIR
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021531978

Write-up: Chest pain; Dyspnoea; Peripheral swelling; Tachycardia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 547090. A 79-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient''s medical history was not reported. Concomitant medications included dextran 70; glucose monohydrate; pravastatin sodium (PRAVASTATIN); allopurinol; amlodipine; bimatoprost; hypromellose; irbesartan; pantoprazole; trimethoprim; valaciclovir hydrochloride (VALACICLOVIR). Historical vaccine included 1st dose of bnt162b2 for covid-19 immunisation on 11Apr2021 (21 days prior to 2nd dose). On 01May2021, the patient experienced Chest pain; Dyspnoea; Peripheral swelling; and Tachycardia, which resulted in death. Onset Time in Days was provided as 0 days. The outcome of the event was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Chest pain; Dyspnoea; Peripheral swelling; Tachycardia


VAERS ID: 1322658 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-17
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: AUPFIZER INC2021531979

Write-up: Adverse event following immunisation with outcome fatal; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 547096. A 65-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration in Mar2021 at single doses for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced adverse event following immunization on 31Mar2021 with outcome of fatal. The Medicine/Onset Time in Days with event ''adverse event following immunization'' reported as 8 days. The patient died in 2021. 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: Adverse event following immunisation with outcome fatal


VAERS ID: 1322659 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-01
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation
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: AUPFIZER INC2021531980

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional via the Regulatory authority. Regulatory authority report number is 547411. An 88-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 19Mar2021 for Covid-19 immunisation. The patient experienced adverse event following immunisation on 01May2021. The outcome of event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1322660 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, 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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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:
CDC Split Type: AUPFIZER INC2021531981

Write-up: Dyspnoea; pyrexia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 547782. A male patient of an unspecified age received bnt162b2 (COMIRNATY) dose 2 via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 08Apr2021 for COVID-19 immunisation. The patient experienced dyspnoea and pyrexia on 01May2021. The patient died in May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Dyspnoea; pyrexia


VAERS ID: 1322661 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-03
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease aggravated, Dyspnoea, Pyrexia, Somnolence
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Dyspnoea; Pyrexia; Somnolence
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021531982

Write-up: Concomitant disease aggravated; Dyspnoea; Pyrexia; Somnolence; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 548356. A 69-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown single dose for covid-19 immunisation. Medical history included ongoing dyspnoea, ongoing pyrexia, ongoing somnolence. The patient''s concomitant medications were not reported. The patient experienced concomitant disease aggravated, dyspnoea, pyrexia, somnolence on 03Apr2021. The medicine onset time in days was reported as 3 days. The patient died on an unspecified date. 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: Concomitant disease aggravated; Dyspnoea; Pyrexia; Somnolence


VAERS ID: 1322662 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-22
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (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: AUPFIZER INC2021531983

Write-up: Sepsis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 548513. A 95-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced sepsis on 22Apr2021. She died on an unspecified in 2021 due to sepsis. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sepsis


VAERS ID: 1322663 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-28
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021531984

Write-up: Dyspnoea; Oedema peripheral; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 549073. An 80-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 28Apr2021, the patient experienced dyspnoea, and oedema peripheral. The patient died on an unspecified date in 2021. Outcome was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Dyspnoea; Oedema peripheral


VAERS ID: 1322664 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-17
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: AUPFIZER INC2021531985

Write-up: adverse event following immunisation with fatal outcome; This is a spontaneous report from a contactable other health professional via the Regulatory authority. Regulatory authority report number is 549386. A 71-year-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced adverse event following immunisation on 03May2021 with fatal outcome. The patient died on an unspecified date. The cause of death was unknown. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: adverse event following immunisation with fatal outcome


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