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From the 1/14/2022 release of VAERS data:

Found 22,193 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

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Case Details

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VAERS ID: 1750706 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-08-01
   Days after vaccination:178
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Alanine aminotransferase, Anaemia, Aspartate aminotransferase, Auscultation, Blood alkaline phosphatase, Blood creatinine, Blood folate, Blood lactate dehydrogenase, Blood potassium, Blood pressure decreased, Blood pressure measurement, Blood sodium, Blood thyroid stimulating hormone, Blood urea, Body temperature, C-reactive protein, COVID-19, Chronic kidney disease, Coma scale, Culture stool, Dehydration, Diarrhoea, Disorientation, Gamma-glutamyltransferase, Haemoglobin, Haemoglobin decreased, Heart rate, Hypothermia, Investigation, Lipase, Oxygen saturation, Oxygen saturation decreased, Pallor, Pancreatitis acute, SARS-CoV-2 test, Serum ferritin, Tachycardia, Transferrin saturation, Ultrasound kidney, Vaccination failure, Vitamin B12, Vitamin D, Vomiting, White blood cell count, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Haematopoietic erythropenia (broad), Lack of efficacy/effect (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-29
   Days after onset: 28
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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (complicated by behavioral disorders without follow-up consultation); Carotid endarterectomy; Cerebral atrophy; Cholangitis acute; Cholelithiasis; Chronic renal failure (GFR 32ml / min / m2 and single right kidney); Convulsive seizure (attributed to cortico-subcortical atrophy, patient put on levetiracetam); Crural hernia; Dyslipidemia; Femoral neck fracture; Hypertension arterial; Pancreatic disorder; Pancreatobiliary sphincterotomy; Pott''s disease (to be confirmed with destruction of the left kidney); Right cataract
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: GPT; Result Unstructured Data: Test Result:17 IU/l; Test Date: 20210821; Test Name: GOT; Result Unstructured Data: Test Result:63 IU/l; Test Date: 202108; Test Name: Lung auscultation; Result Unstructured Data: Test Result:no sinoatrial block, vesicular murmur + / +; Comments: no sinoatrial block, vesicular murmur + / +; Test Date: 20210821; Test Name: ALP; Result Unstructured Data: Test Result:84 IU/l; Test Date: 20210821; Test Name: serum creatinine; Result Unstructured Data: Test Result:547 umol/l; Test Date: 20210821; Test Name: Vitamin B9; Result Unstructured Data: Test Result:8.0 nmol/L; Test Date: 20210821; Test Name: LDH; Result Unstructured Data: Test Result:459 IU/l; Test Date: 20210821; Test Name: potassium; Result Unstructured Data: Test Result:4.6 mmol/L; Test Date: 202108; Test Name: blood pressure; Result Unstructured Data: Test Result:121/54; Test Date: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:hypotensive; Test Date: 20210821; Test Name: sodium; Result Unstructured Data: Test Result:147 mmol/L; Test Date: 20210821; Test Name: TSH; Result Unstructured Data: Test Result:1.29 MiU/L; Test Date: 20210821; Test Name: urea; Result Unstructured Data: Test Result:48 mmol/L; Test Date: 202108; Test Name: body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Test Date: 20210826; Test Name: body temperature; Result Unstructured Data: Test Result:hypothermic Centigrade; Test Date: 202108; Test Name: glasgow; Result Unstructured Data: Test Result:15; Test Date: 20210821; Test Name: C-reactive protein; Result Unstructured Data: Test Result:128 mg/l; Test Date: 20210823; Test Name: stool culture; Test Result: Negative ; Test Date: 20210821; Test Name: GGT; Result Unstructured Data: Test Result:11 IU/l; Test Date: 202102; Test Name: hemoglobin; Result Unstructured Data: Test Result:11.2 g/dl; Test Date: 20210821; Test Name: hemoglobin; Result Unstructured Data: Test Result:6.1 g/dl; Comments: aregenerative macrocytic anemia; Test Date: 20210823; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.2 g/dl; Test Date: 20210825; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.1 g/dl; Test Date: 20210826; Test Name: hemoglobin; Result Unstructured Data: Test Result:7.4 g/dl; Test Date: 20210827; Test Name: hemoglobin; Result Unstructured Data: Test Result:7.3 g/dl; Test Date: 202108; Test Name: pulse; Result Unstructured Data: Test Result:102; Comments: bpm; Test Date: 202108; Test Name: Rectal touch; Result Unstructured Data: Test Result:no melena no rectal bleeding brown stools on the f; Comments: no melena no rectal bleeding brown stools on the finger cot; Test Date: 20210825; Test Name: lipase; Result Unstructured Data: Test Result:986 IU/l; Test Date: 202108; Test Name: oxygen saturation; Test Result: 100 %; Test Date: 20210821; Test Name: oxygen saturation; Test Result: 70 %; Comments: in EPHAD; Test Date: 20210821; Test Name: oxygen saturation; Test Result: 83 %; Comments: on arrival to ER; Test Date: 20210812; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Presence of the L452R mutation. Absence of E484K and E484Q mutation; Test Date: 20210821; Test Name: ferritin; Result Unstructured Data: Test Result:2546 ug/L; Comments: ferritinemia; Test Date: 20210821; Test Name: transferrin saturation coefficient; Result Unstructured Data: Test Result:0.13; Test Date: 20210821; Test Name: renal ultrasound; Result Unstructured Data: Test Result:does not find an obstructive cause; Comments: Empty bladder containing urinary catheter balloon. Lipomatous atrophy of the right kidney, it measures 8.5 cm long axis. Absence of pyelocalicular dilation. Simple 22 mm cyst of the superior pole. The left kidney is not visualized in the renal compartment in the left hypochondrium.; Test Date: 20210821; Test Name: Vitamin B12; Result Unstructured Data: Test Result:361 pmol/L; Test Date: 20210821; Test Name: Vitamin D; Result Unstructured Data: Test Result:11.4 ug/L; Test Date: 20210821; Test Name: leukocyte count; Result Unstructured Data: Test Result:5.13 x10 9/l; Test Date: 20210821; Test Name: chest X-ray; Result Unstructured Data: Test Result:poor quality; Comments: bilateral interstitial syndrome, bilateral base blunting
CDC Split Type: FRPFIZER INC202101256743

Write-up: PCR CoVid 19 positive; PCR CoVid 19 positive; Acute pancreatitis due to SarsCoV2; Acute on chronic anemia on digestive hemorrhage; Acute anuric on chronic renal failure; T 35.7 C; SatO2 83% at high concentration oxygen mask at 15L; dehydration; diarrhea; BP 121/54; Skin pallor; temporospatial disorientation; Tachycardiac; episodes of vomiting; abdomen remains tender on palpation; a new drop in hemoglobin to 7.4g / dL; This is a spontaneous report from a contactable physician downloaded from the WEB FR-AFSSAPS-CN20212852. A 87-year-old female patient received the second dose and the first dose of BNT162B2 (COMIRNATY), the second dose on 04Feb2021 (Lot Number: Unknown), the first dose on 13Jan2021 (Lot Number: Unknown), both via intramuscular as single dose for COVID-19 immunization. Medical history included severe chronic renal failure (GFR 32ml / min / m2 and single right kidney), alzheimer''s dementia diagnosed in 2015 complicated by behavioral disorders without follow-up consultation, Pott''s disease (to be confirmed with destruction of the left kidney), HTA from 1982, acute lithiasic cholangitis from 2009, pancreatic reaction from 2009, sphincterotomy from 2009, endarterectomy of left internal carotid from 2009, dyslipidemia, generalized tonicoclonic convulsive seizure (attributed to cortico-subcortical atrophy, patient put on levetiracetam) from 2009, cortico-subcortical atrophy, endoscopic retrograde cholangiopancreatography and sphincterotomy extracting the calculus of the lower common bile duct, prophylactic cholecystectomy initially planned not performed from 2009, right cataract from 2008, bilateral crural hernia from 1955 and Intermediate Hip Prosthesis on left femoral neck fracture from 2017. History of COVID-19 was none. PCR test history was none. Allergic history was unknown. Concomitant medication included acetylsalicylate lysine (KARDEGIC), oxazepam (SERESTA), levetiracetam (KEPPRA [LEVETIRACETAM]), metoprolol succinate (SELOZOK LP), macrogol 4000, potassium chloride, sodium bicarbonate and sodium chloride (MOVICOL [MACROGOL 4000;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]). The patient admitted to the emergency room on 21Aug2021 for 70% desaturation under 10L of O2 at the EHPAD. PCR CoVid 19 positive on 12Aug2021 despite vaccination. Lives in nursing home, treatment before admission: -ASA Kardegic 75mg 0-1-0; oxazepam Seresta 10mg 1-1-1; levetiracetam Keppra 500mg 1-0-1; metoprolol Selozok LP 95mg 1/2-0-0; macrogol Movicol 1-0-0. Rtat PCR Screening. Presence of the L452R mutation. Absence of E484K and E484Q mutations. Sequencing in progress. On arrival at the emergency room, questioning impossible, SatO2 83% at high concentration oxygen mask at 15L. The biological assessment reveals acute renal failure over major chronic (serum creatinine 547umol / L, urea 48mmol / L), renal ultrasound does not find an obstructive cause, probable dehydration on diarrhea, no indication for dialysis after consultation with nephrologists in the face of comorbidities. Opinion taken from the resuscitators and in agreement with the patient''s family, absence of invasive resuscitation in view of the age and comorbidities. Exclusive symptomatic management. The patient was transferred to a conventional CoVid 19 unit for further treatment. Admission clinical examination: T 35.7 C, Pulse 102bpm, BP 121/54, SatO2 100% under 10L; Skin pallor, Glasgow 15, temporospatial disorientation; Skin fold ++; Tachycardiac, no mottling; ASDI no defense; Rectal touch: no melena no rectal bleeding brown stools on the finger cot; Lung auscultation: no sinoatrial block, vesicular murmur + / +; Medical summary of the stay: 1. On the respiratory level; Rapid improvement in the respiratory state in the context of probable inhalation pneumonia on vomiting which explained the initial desaturation. The patient had received DEXAMETHASONE from 22Aug2021 to 27Aug2021 and antibiotic therapy with AUGMENTIN from 22Aug2021 to 26Aug2021. The patient was weaned from oxygen on 26Aug with a good clinical and biological evolution. 2. On the renal level. Severe acute renal failure on chronic renal failure. Probable acute tubular necrosis on dehydration on digestive losses. Gradual improvement in renal function and resumption of diuresis after IV rehydration while remaining vigilant on the risk of cardiac decompensation due to too rapid hypertonic rehydration. 3. On the digestive level. Significant initial digestive losses attributed to a digestive form of SarsCoV2 infection. There were also reportedly episodes of vomiting. The abdomen remains tender on palpation. Absence of faecal faeces on rectal examination carried out twice during hospitalization. The stool culture of 23Aug is negative. Faced with an increase in abdominal pain on 25Aug, a new hepatic assessment was taken as well as a lipase which returned to 986U / L without any significant anomaly in the associated hepatic assessment, in particular without an argument for lithiasic migration. This lipase elevation is attributed to acute SarsCoV2 pancreatitis. In the context, simple symptomatic treatment is instituted. On 26Aug, the patient was hypothermic, hypotensive with mottling, in the hypothesis of a bacteremia at digestive point of call, antibiotic therapy with ROCEPHINE and FLAGYL was started. 4. In terms of anemia. Hemoglobin level at 11.2g / dL in Feb2021. On arrival at the emergency room, anemia at 6.1g / dL aregenerative macrocytic. The patient benefited on 22Aug2021 from the transfusion of a red blood cell with a good transfusion yield (8.2g / dL on 23Aug2021 and 8.1g / dL on 25Aug2021). Probably multifactorial origin of this acute on chronic anemia: anemia unmasked by rehydration; iron deficiency; inflammation; chronic renal failure. There are then no signs of externalization, in particular no melena or rectal blood loss. On 26Aug2021, melena found in the protection with signs of poor clinical tolerance (hypotension, mottling) on a new drop in hemoglobin to 7.4g / dL. Taking into account the age and the comorbidities, it seems unreasonable to consider a fibroscopy, the patient is put on IPP 80mg then 8mg / h IV, receives 500cc of NaCl in free flow and a new red blood cell pellet in a vital emergency. Good response in terms of blood pressure and general condition but poor transfusion performance with a control hemoglobin at 7.3g / dL. A new red blood cell bag was transfused without emergency on 27Aug with a collegial decision not to continue transfusions beyond this in the absence of improvement. Chest x-ray from 21Aug: poor quality x-ray, bilateral interstitial syndrome, bilateral base blunting. Renal ultrasound of 21Aug2021: Results: Empty bladder containing urinary catheter balloon. Lipomatous atrophy of the right kidney, it measures 8.5 cm long axis. Absence of pyelocalicular dilation. Simple 22 mm cyst of the superior pole. The left kidney is not visualized in the renal compartment in the left hypochondrium. Conclusion: Lack of argument for a cause obstructing this acute renal failure.Bio from 21Aug: Na + 147mmol / L, K + 4.6mmol / L; Serum creatinine 547umol / L, Urea 48.1mmol / L; ALP 84U / L, GGT 11U / L, GOT 63U / L, GPT 17U / L; LDH 459U / L; CRP 128mg / L, leukocytes 5.13G / L; Ferritinemia 2546ug / L, transferrin saturation coefficient 0.13; TSH 1.29mIU / L; Vitamin B12 361pmol / L, Vitamin B9 8.0nmol / L; Vitamin D 11.4ug / L; Hb 6.1g / dL aregenerative macrocytic; Co-culture of 23Aug: negative; SarsCoV2 lung disease complicated by aspiration pneumonia; Acute pancreatitis due to SarsCoV2; Acute on chronic anemia on digestive hemorrhage; Acute anuric on chronic renal failure. Faced with the lack of clinical improvement and the patient''s discomfort, a collective decision was taken to exclusively palliative care. MORPHINE for analgesia and MIDAZOLAM for anxiolytic are introduced on 27Aug in the evening. The patient died on 29Aug2021. Autopsy was none. The outcome of vaccination failure, Covid-19, acute pancreatitis, chronic anemia and chronic renal failure was fatal. The outcome of other events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: unknown cause of death; Vaccination failure; PCR CoVid 19 positive; Acute pancreatitis; Chronic anemia; Chronic renal failure


VAERS ID: 1750723 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-08-13
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Body temperature, C-reactive protein, COVID-19, Drug ineffective, Glomerular filtration rate, Neutrophil count, SARS-CoV-2 test, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EU
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic nephropathy; End stage renal failure; Mixed dementia; NIDDM; Obesity; Retinopathy diabetic
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: pulmonary auscultation; Result Unstructured Data: Test Result:unknown results; Test Date: 20210813; Test Name: hyperthermia; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210820; Test Name: C-reactive protein; Result Unstructured Data: Test Result:97; Test Date: 20210813; Test Name: GFR; Result Unstructured Data: Test Result:12 ml/min; Test Date: 20210820; Test Name: neutrophil count; Result Unstructured Data: Test Result:21 x10 9/l; Test Date: 20210813; Test Name: test SARS-Cov-2 PCR; Test Result: Positive ; Comments: DELTA L452R variant; Test Date: 20210820; Test Name: leukocyte count; Result Unstructured Data: Test Result:22 x10 9/l; Comments: inflammatory hyperleukocytosis syndrome
CDC Split Type: FRPFIZER INC202101256730

Write-up: Drug ineffective; COVID-19 / hyperthermia at 38.1 C and cough; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB FR-AFSSAPS-LM20212489. An 87-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular on 06Apr2021 (Lot Number: EW2239) as single dose for COVID-19 immunization. Medical history included obesity, end stage renal failure, mixed dementia, niddm, retinopathy diabetic and diabetic nephropathy. Concomitant medication included furosemide, mirtazapine, repaglinide, atorvastatin, cyamemazine, nicardipine hydrochloride, colecalciferol, bifonazole, candesartan cilexetil, insulin aspart, insulin aspart protamine (crystalline) (NOVOMIX) and methoxy polyethylene glycol-epoetin beta (MIRCERA). Positive PCR test for the DELTA L452R variant. Placed under oxygen therapy in 2L of oxygen. Hospitalized for behavioral disorder on mixed dementia on 29Jul2021 leading to the introduction of olanzapine, improvement of thymia. During hospitalization, on 13Aug2021, the patient was hyperthermia at 38.1 C and cough. But deterioration of respiratory functions up to 15L of 02. Introduction of corticosteroid therapy at 6 mg / day from 13Aug2021, and anticoagulation at a preventive dose with calciparin adapted to renal function (GFR 12 ml / min). Multi-daily monitoring. On 20Aug2021: focus on pulmonary auscultation, inflammatory hyperleukocytosis syndrome at 22 G / L, polynuclear neutrophils 21 G / L and CRP at 97. Antibiotic therapy with AUGMENTIN adapted to renal function. When the daughter was questioned, her mother had expressed the wish not to be resuscitated in case of cardiopulmonary arrest. Progressive worsening with passage to palliative care on 24Aug2021, therapeutic adaptation for palliative purposes. Death on 29Aug2021. In total: serious vaccine failure with the delta variant at 4 months after the end of the full antiCovid-19 vaccine schedule. NB: Accountability made "without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures". On 30Aug2021, the patient experienced death. Autopsy was none. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: infection COVID 19; Drug ineffective


VAERS ID: 1750725 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-09-05
   Days after vaccination:213
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, COVID-19, Cardiac failure, Oxygen saturation, Respiratory distress, SARS-CoV-2 test, Vaccination failure, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-07
   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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EU
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Depressive disorder; Hypercholesterolaemia; Hypertension arterial; Insufficiency renal; Overweight; Pulmonary embolism; Type 2 diabetes mellitus; Venous insufficiency
Allergies:
Diagnostic Lab Data: Test Name: saturation; Test Result: 29 %; Comments: desaturation and cyanosis; Test Date: 20210906; Test Name: saturation; Test Result: 78 %; Comments: respiratory distress; Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: Nasopharyngeal sample, Amplidiag Mobidiag real-time PCR technique, Search for mutation E484K; E484Q; L452R: not carried out because viral load in the sample too low to allow additional investigations
CDC Split Type: FRPFIZER INC202101273881

Write-up: Cardio respiratory decompensation; Covid-19; vomiting; disturbances of consciousness; respiratory distress; Vaccination failure; This is a spontaneous report from a contactable other-healthcare professional downloaded from the WEB, regulatory authority number FR-AFSSAPS-LM20212610. A 90-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EJ6788), via intramuscular route of administration on 04Feb2021 as dose 2, single for covid-19 immunization. The patient received first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EM0477) via intramuscular route of administration on 14Jan2021 as dose 1, single for covid-19 immunization. The patient medical history included venous disease, overweight, hypercholesterolaemia, depression disorder, Insufficiency renal, hypertension arterial, type 2 diabetes mellitus, chronic obstructive pulmonary disease, pulmonary embolism from an unknown date and unknown if ongoing. The patient concomitant medications included bisoprolol fumarate (BISOPROLOL FUMARATE), paracetamol (PARACETAMOL), allopurinol (ALLOPURINOL), ramipril (TRIATEC [RAMIPRIL]), citalopram hydrochloride (CITALOPRAM HYDROCHLORIDE), insulin glargine (LANTUS), fluindione (PREVISCAN [FLUINDIONE]), furosemide (LASILIX [FUROSEMIDE]), macrogol (TRANSIPEG [MACROGOL]), rosuvastatin calcium (CRESTOR), esomeprazole magnesium (INEXIUM [ESOMEPRAZOLE MAGNESIUM]) taken for an unspecified indication, start and stop date were not reported. On unspecified date patient experienced covid-19 and vomiting, on 05Sep2021, the patient experienced vaccination failure, on 06Sep2021 the patient experienced cardiorespiratory decompensation, disturbances of consciousness, respiratory distress. It was reported that cardio respiratory decompensation during the night of Sunday 05Sep2021 to Monday 06Sep2021, prompting emergency hospitalization. The patient was hospitalized for cardiorespiratory decompensation from 06Sep2021 to an unknown date. She is put under oxygen (O2) at 15L then non-invasive ventilation (NIV), furosemide, bicarbonates. The patient underwent lab tests and procedures which included oxygen saturation was 29 % desaturation and cyanosis on unspecified date, oxygen saturation was 78 % respiratory distress on 06Sep2021. Sars-cov-2 test was positive, Nasopharyngeal sample, Amplidiag Mobidiag real-time PCR technique, Search for mutation E484K; E484Q; L452R: not carried out because viral load in the sample too low to allow additional investigations on an unspecified date. Therapeutic measures were taken as a result of cardiorespiratory decompensation, disturbances of consciousness, respiratory distress, vomiting. The patient died on 07Sep2021 and autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; Covid-19; Cardio respiratory decompensation; disturbances of consciousness; respiratory distress; vomiting


VAERS ID: 1750740 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-08-20
   Days after vaccination:200
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, COVID-19 pneumonia, Drug ineffective, Dyspnoea, Hypoxia, Oedema, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   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: Hypertension arterial; Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101256377

Write-up: probable acute pulmonary edema; dyspnea with edema; dyspnea with edema; hypoxia; Drug ineffective; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MP20217586, Safety Report Unique Identifier FR-AFSSAPS-2021129935. A 74-years-old female patient received bnt162b2 (COMIRNATY), the second dose via intramuscular on Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing hypertension arterial, ongoing hypothyroidism, obesity from an unknown date. The patient''s concomitant medications were not reported. The patient experienced covid-19 pneumonia on 20Aug2021, drug ineffective on 20Aug2021, hypoxia on 30Aug2021, dyspnea with edema on an unspecified date, probable acute pulmonary edema on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 20Aug2021. The patient died on 30Aug2021. An autopsy was not performed. The outcome of the events drug ineffective, covid-19 pneumonia and hypoxia was fatal, while other events were unknown. Reporter''s Comments: Record of inefficiency. Person vaccinated against SarsCov2. Vaccination with Comirnaty. Last vaccination carried out in Feb2021. History of disease: Positive PCR test on 20Aug2021. Main clinical signs: dyspnea with edema and probable acute pulmonary edema. Evolution: death on 30Aug2021 by hypoxia. Characterization of the virus: not carried out. Complete file, no further information. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Record of inefficiency. Person vaccinated against SarsCov2. Vaccination with Comirnaty. Last vaccination carried out in Feb2021. History of disease: Positive PCR test on 20Aug2021. Main clinical signs: dyspnea with edema and probable acute pulmonary edema. Evolution: death on 30Aug2021 by hypoxia. Characterization of the virus: not carried out. Complete file, no further information.; Reported Cause(s) of Death: covid pneumonia; Drug ineffective; hypoxia


VAERS ID: 1750752 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7911 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Body temperature, Immunisation, Off label use, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-16
   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: Arteritis obliterans; Ischemic stroke; Peripheral arterial occlusive disease; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: body temperature; Result Unstructured Data: Test Result:39.3 Centigrade; Test Date: 20210916; Test Name: Desaturation; Test Result: 79 %
CDC Split Type: FRPFIZER INC202101256361

Write-up: Anxiety state, unspecified; Vomiting; Pyrexia; Oxygen saturation decreased; DOSE 3 (BOOSTER), SINGLE; DOSE 3 (BOOSTER), SINGLE; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20214079. An 86-year-old female patient received BNT162B2 (COMIRNATY), dose 3 intramuscular at the age of 86-year-old administered in arm left on 16Sep2021 (Lot Number: FG7911) as dose 3 (booster), single for covid-19 immunisation. Medical history included ischemic stroke, peripheral arterial occlusive disease, vascular dementia and arteritis obliterans of the lower extremities. NO COVID-19 and no PCR test. The patient''s concomitant medications were not reported. The patient experienced anxiety state, unspecified, vomiting, pyrexia and oxygen saturation decreased on 16Sep2021. The patient underwent lab tests included body temperature: 39.3 centigrade on 16Sep2021, desaturation: 79 % on 16Sep2021. The outcome of events anxiety state, unspecified, vomiting, pyrexia and oxygen saturation decreased was fatal and others was unknown. The patient died on 16Sep2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Anxiety state, unspecified; Vomiting; Oxygen saturation decreased; Pyrexia


VAERS ID: 1750764 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-07-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Peripheral ischaemia, 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: 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: 202107; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101256326

Write-up: Lower limb ischemia; Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NY20214339. A 78-year-old female patient received bnt162b2 (COMIRNATY), first single dose intramuscularly in Feb2021 (Batch/Lot Number: Unknown) at age of 78-year-old and second single dose intramuscularly in Mar2021 (Batch/Lot Number: Unknown) 78-year-old for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. In Jul2021, the patient experienced vaccination failure and lower limb ischemia which led to death on unspecified date. Patient hospitalized for COVID-19 and acute lower limb ischemia. Complete vaccination schedule in February / March. COVID-19 test positive in Jul2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Vaccination failure; Lower limb ischemia; COVID-19


VAERS ID: 1750765 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-08-26
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-11
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Cardiac valvulopathy; Chronic renal failure; Deep vein thrombosis; Fracture of humerus; Mitral valve repair; Permanent atrial fibrillation; Tabaquism; Venous insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: Angioscanner thoracique; Result Unstructured Data: Test Result:appearance compatible with SARS-CoV2 pneumonia wit; Comments: appearance compatible with SARS-CoV2 pneumonia with moderate impairment (10-25%), right Bochdalek hernia, sliding hiatus hernia; Test Date: 20210828; Test Name: PCR COVID; Test Result: Positive ; Comments: Variant delta; Test Date: 20210901; Test Name: Chest X-ray; Result Unstructured Data: Test Result:diffuse alveolar condensations sparing the left ap; Comments: diffuse alveolar condensations sparing the left apex, compatible with an increase in parenchymal involvement
CDC Split Type: FRPFIZER INC202101273776

Write-up: COVID-19 pneumonitis; Vaccination failure; Acute Respiratory Distress Syndrome; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NY20214407. An 86-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW9127, Expiry date was not reported) via intramuscular route of administration on 14Apr2021 (at the age of 86 years old) as DOSE 2, SINGLE for covid-19 immunisation. Patient also received first dose of (COMIRNATY, Solution for injection, Batch/Lot Number: ET3620, Expiry date was not reported) via intramuscular route of administration on 17Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patients medical history included, Fracture of humerus, Cardiac valvulopathy, Permanent atrial fibrillation, Tabaquism, Deep vein thrombosis, high blood pressure,Venous insufficiency and Chronic renal failure from an unknown date and unknown if ongoing. Concomitant medication(s) included bisoprolol fumarate (BISOPROLOL FUMARATE) taken for hypertension, start and stop date were not reported; potassium chloride (KALEORID LP) taken for hypokalaemia, start and stop date were not reported; fluindione (PREVISCAN [FLUINDIONE]) taken for cardiac valve disease, start and stop date were not reported; allopurinol (ALLOPURINOL) taken for hyperuricaemia, start and stop date were not reported; digoxin (HEMIGOXINE NATIVELLE) taken for atrial fibrillation, start and stop date were not reported; prunus africana extract (TADENAN) taken for benign prostatic hyperplasia, start and stop date were not reported; furosemide (LASILIX SPECIAL [FUROSEMIDE]) taken for chronic kidney disease, start and stop date were not reported; perindopril (PERINDOPRIL) taken for hypertension, start and stop date were not reported. On 26Aug2021 the patient experienced, acute respiratory distress syndrome, covid-19 pneumonitis and vaccination failure. As a treatment patient received augmentin for 7 days, on 28Aug2021 the patient was admitted to the emergency room for increased symptoms. Also received treatment of Oxygen therapy at 2 L / min, dexamethasone, COVITREM-1, roactemra. 01Sep2021: unfavorable development with the need to switch to a Venturi mask with FiO2 at 40%, then increase in oxygen demand until a high concentration mask with 100% FiO2 is put in place. On the chest x-ray, diffuse alveolar condensations sparing the left apex, compatible with increased parenchymal involvement. 02Sep2021: transfer to intensive care. Onset of acute renal failure. Administering a dose of ROACTEMRA. Gradual increase in hypoxemia, despite 100% high-flow oxygen therapy. On 11Sep2021 patient died from acute respiratory distress syndrome. An autopsy was not performed. The patient underwent lab tests and procedures which included computerised tomogram: appearance compatible with sars-cov2 pneumonia with on 28Aug2021 appearance compatible with SARS-CoV2 pneumonia with moderate impairment (10-25%), right Bochdalek hernia, sliding hiatus hernia , sars-cov-2 test: positive on 28Aug2021 Variant delta, x-ray: diffuse alveolar condensations sparing the left apex on 01Sep2021 diffuse alveolar condensations sparing the left apex, compatible with an increase in parenchymal involvement. The outcome for the events was fatal. No follow-up attempts are possible. No further information is expected; Reporter''s Comments: 86-year-old man who presented with SARS-CoV2 pneumonia despite two injections of covid vaccine (COMIRNATY). Respiratory degradation leading to the death of the patient.; Reported Cause(s) of Death: Acute respiratory distress syndrome secondary to COVID lung disease; Acute respiratory distress syndrome secondary to COVID lung disease


VAERS ID: 1750768 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Cardio-respiratory arrest, Computerised tomogram, Computerised tomogram head, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Electroencephalogram, Full blood count, HIV antibody, Hepatitis C virus test, Magnetic resonance imaging, Platelet count, Pleural effusion, SARS-CoV-2 antibody test
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), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 pneumonitis; Gallbladder polyp (end of 2020); Heart malformation; Hepatic cyst (end of 2020); Infectious mononucleosis; Miscarriage; Myocarditis (post Covid treated by Flecaine); Pregnancy ectopic
Allergies:
Diagnostic Lab Data: Test Name: angiography; Result Unstructured Data: Test Result:healthy, network without notable infiltration; Comments: healthy, network without notable infiltration; Test Date: 20210519; Test Name: Chest CT scan; Result Unstructured Data: Test Result:No acute proximal pulmonary embolism. Multiple pat; Comments: No acute proximal pulmonary embolism. Multiple patches of diffused frosted glass within the posterior segments of the upper and lower lobes associated with a bi-basal pneumonia with right pleural effusion.; Test Name: Brain scanner; Result Unstructured Data: Test Result:no intracranial bleeding; Test Name: transthoracic echocardiogram (TTE); Result Unstructured Data: Test Result:last normal; Test Name: ECG; Result Unstructured Data: Test Result:no repolarization abnormalities; Comments: no repolarization abnormalities; Test Name: holter ECG; Result Unstructured Data: Test Result:rare has premature ventricular contraction (PVC); Comments: rare has premature ventricular contraction (PVC); Test Name: Electroencephalography; Result Unstructured Data: Test Result:Table of generalized status epilepticus; Comments: Table of generalized status epilepticus; Test Name: complete blood count (CBC); Result Unstructured Data: Test Result:ok; Test Name: Hepatitis C virus; Test Result: Negative ; Test Name: HIV serology; Test Result: Negative ; Test Date: 20210527; Test Name: Cerebral magnetic resonance imaging (MRI); Result Unstructured Data: Test Result:Diffuse cytotoxic edema of the supra-tentorial bil; Comments: Diffuse cytotoxic edema of the supra-tentorial bilateral and symmetrical white matter in favor of post-anoxic encephalopathy lesions. Possible stigmata of status epilepticus associated with cortical involvement.; Test Name: Functional magnetic resonance imaging (MRI); Result Unstructured Data: Test Result:Very extensive severe SB involvement.; Comments: Very extensive severe SB involvement.; Test Date: 202007; Test Name: myocardial MRI; Result Unstructured Data: Test Result:Viral myocarditis diagnosed on myocardial MRI comp; Comments: Viral myocarditis diagnosed on myocardial MRI complicated by ESV and ESA; Test Name: Platelet; Result Unstructured Data: Test Result:ok; Test Name: COVID-19 serology; Test Result: Negative
CDC Split Type: FRPFIZER INC202101256694

Write-up: Cardio-respiratory arrest; right pleural effusion; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PA20211215. A 42-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular on 17May2021 (Lot Number: Unknown) as 0.3 ml dose for COVID-19 immunization. Medical history included not ongoing myocarditis (post Covid treated by Flecaine) from 01Mar2020, not ongoing non-severe COVID pneumonia from Mar2020, not ongoing infectious mononucleosis from 01Jan2018, discovery of a mitral valve malformation with AV Block: 2nd degree, Mobitz II, known mitral leak in 2007, Viral myocarditis diagnosed on myocardial MRI complicated by ESV and ESA, treated with Flecaine with cardiological monitoring (last normal transthoracic echocardiogram (TTE), holter ECG: rare has premature ventricular contraction (PVC) in Jul2020, 2 children 4 miscarriages (9 months of corticosteroids) and liver cysts and gallbladder polyps (end of 2020). The patient had no known allergy. No cardiac history in siblings of 4. On 05May2021, flecaine stop. Concomitant medication included flecainide acetate (FLECAINE) from an unknown date to 05May2021. The patient previously received aspirin and experienced poorly irrigated placenta. On 19May2021 at 00:35, the patient experienced Cardio-respiratory arrest. On 19May2021 at 00:35, the patient experienced cardiopulmonary arrest, no prodrome, no abnormal motion, eye revulsion, put on cardiac massage immediately. No flow of 1-2min; cardiac massage relayed by BSPP, delivery of an external electric shock without resumption of activity. On arrival of the hospital, Ventricular fibrillation tracing, resumption of cardiac activity after 2 Defibrillation and 300 mg of amiodarone, low flow 30 min. Resuscitation care included: Electroencephalography (EEG): no repolarization abnormalities, Coronary angiography: healthy, network without notable infiltration. EEG: Table of generalized status epilepticus. Brain scanner: no intracranial bleeding. Chest CT scan 19May2021: No acute proximal pulmonary embolism. Multiple patches of diffused frosted glass within the posterior segments of the upper and lower lobes associated with a bi-basal pneumonia with right pleural effusion. Cerebral magnetic resonance imaging (MRI) 27May21: Diffuse cytotoxic edema of the supra-tentorial bilateral and symmetrical white matter in favor of post-anoxic encephalopathy lesions. Possible stigmata of status epilepticus associated with cortical involvement. Functional magnetic resonance imaging (MRI): Very extensive severe SB involvement. No overdose in Flecaine. COVID-19 serology was negative. HIV serology and Hepatitis C virus neg, serology compatible with vaccination for Hepatitis B virus. Complete blood count (CBC) Platelets ok. Evolution: Faced with an extremely unfavorable neurological prognosis, a state of convulsive evil refractory after Cardiac arrest to all optimal and maximalist therapies, a very severe anoxoischemic encephalopathy, it is decided to limit active therapies and a secondary discontinuation of therapies. The patient died on 04Jun2021. Note that a request for support by genetic counseling for investigation and monitoring of the family in this context of rhythm disturbance of unknown etiology in the patient. (14-year-old son who presented cardiological symptoms in July 2020 for which myocarditis was suspected). In total, 42-year-old woman, with ATCD ballooning of the mitral valve in 2016 associated with an Atrioventricular block (AV block) 2, and myocarditis in July 2020 suspected post covid revealed by arrhythmias and treated with Flecaine, which presents a Cardiac arrest recovered from shockable arrhythmia with a normal etiological assessment (normal coronography, angio CT and normal thorax) whose neurological evolution is unfavorable. The patient died on 04Jun2021. Autopsy was unknown. The outcome of cardio-respiratory arrest was fatal. The outcome of other event was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardio-respiratory arrest on VT (Ventricular tachycardia) with very severe anoxo-ischemic encephalopathy of unfavorable outcome after limitation and discontinuation of active therapies.


VAERS ID: 1750790 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214025 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Cardio-respiratory arrest, Confusional state, Hypertension, Hypotonia, Oxygen saturation decreased, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (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), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-12
   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: Major neurocognitive disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Incontinence urinary; Rectal prolapse; Starvation
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Hypotonia; Oxygen saturation decreased; Hypertension arterial; Tachycardia; Cardio-respiratory arrest; Asthenia; Confusion aggravated; This case was received via regulatory authority (Reference number: FR-AFSSAPS-PO20214891) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of HYPOTONIA (Hypotonia), OXYGEN SATURATION DECREASED (Oxygen saturation decreased), HYPERTENSION (Hypertension arterial), TACHYCARDIA (Tachycardia) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in a 93-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214025) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Rectal prolapse, Incontinence urinary and Starvation. Concurrent medical conditions included Major neurocognitive disorder. On 09-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 11-Sep-2021, the patient experienced HYPOTONIA (Hypotonia) (seriousness criterion death), OXYGEN SATURATION DECREASED (Oxygen saturation decreased) (seriousness criterion death), HYPERTENSION (Hypertension arterial) (seriousness criterion death), TACHYCARDIA (Tachycardia) (seriousness criterion death), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death and medically significant), ASTHENIA (Asthenia) and CONFUSIONAL STATE (Confusion aggravated). The patient died on 12-Sep-2021. The reported cause of death was Cardio-respiratory arrest, Hypotonia, Oxygen saturation decreased, Hypertension and Tachycardia. An autopsy was not performed. At the time of death, ASTHENIA (Asthenia) and CONFUSIONAL STATE (Confusion aggravated) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Authority Number: FR-AFSSAPS-PO20214891 This case concerns a 93-year-old, female patient with a history of Starvation and concurrent medical condition of Major neurocognitive disorder, who experienced the fatal unexpected serious events of Cardio-respiratory arrest, Hypotonia, Oxygen saturation decreased, Hypertension arterial and Tachycardia. The events occurred approximately 3 days after the first dose of Spikevax. The rechallenge was not applicable as the events happened after the first dose and no additional dosing will be given. The patient�s advanced age, medical history of Starvation and concurrent medical condition of Major neurocognitive disorder, remain a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 93-year-old, female patient with a history of Starvation and concurrent medical condition of Major neurocognitive disorder, who experienced the fatal unexpected serious events of Cardio-respiratory arrest, Hypotonia, Oxygen saturation decreased, Hypertension arterial and Tachycardia. The events occurred approximately 3 days after the first dose of Spikevax. The rechallenge was not applicable as the events happened after the first dose and no additional dosing will be given. The patient�s advanced age, medical history of Starvation and concurrent medical condition of Major neurocognitive disorder, remain a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Cardio-respiratory arrest; Hypotonia; Oxygen saturation decreased; hypertension; Tachycardia


VAERS ID: 1750804 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004234 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Lung disorder
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: 2021-09-03
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anxiodepressive syndrome; Arachnitis; Chronic alcoholism; Ependymoma; Hepatitis C carrier; Hypertension arterial; Pollen allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Cardio-respiratory arrest; Pneumopathy; This case was received via Regulatory Authority Reference number: FR-AFSSAPS-RS20212846) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) and LUNG DISORDER (Pneumopathy) in a 53-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004234) for COVID-19 vaccination. The patient''s past medical history included Smoker. Concurrent medical conditions included Arachnitis, Hypertension arterial, Pollen allergy, Ependymoma, Chronic alcoholism, Hepatitis C carrier and Anxiodepressive syndrome. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 29-Aug-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death and medically significant) and LUNG DISORDER (Pneumopathy) (seriousness criterion death). The patient died on 03-Sep-2021. The reported cause of death was Pneumopathy and Cardio-respiratory arrest. An autopsy was not performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Company Comment : This case concerns a 53- year-old, female with a history of arachnitis, hypertension, ependymoma, chronic alcoholism, smoker, hepatitis C carrier, anxiodepressive syndrome, who experienced the unexpected serious fatal events od Pneumopathy and cardiorespiratory arrest. The events occurred approximately 6 days after the second dose and unknown latency from the first one of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was not applicable since the patient died after the second and last dose. The medical history of arachnitis, hypertension, ependymoma, chronic alcoholism, smoker, hepatitis C carrier, anxiodepressive syndrome could be potentially confounder for the event and outcome of the case. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation document received on 28 Sep 2021 contains no new information.; Sender''s Comments: This case concerns a 53- year-old, female with a history of arachnitis, hypertension, ependymoma, chronic alcoholism, smoker, hepatitis C carrier, anxiodepressive syndrome, who experienced the unexpected serious fatal events od Pneumopathy and cardiorespiratory arrest. The events occurred approximately 6 days after the second dose and unknown latency from the first one of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was not applicable since the patient died after the second and last dose. The medical history of arachnitis, hypertension, ependymoma, chronic alcoholism, smoker, hepatitis C carrier, anxiodepressive syndrome could be potentially confounder for the event and outcome of the case. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.; Reported Cause(s) of Death: Pneumopathy; Cardio-respiratory arrest


VAERS ID: 1750857 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-16
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 1 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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: Bowel obstruction; Diabetes mellitus; Left hemicolectomy; Limb injury
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101256672

Write-up: huge fatigue; Shock haemorrhagic; Cardio-respiratory arrest; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-ST20213180. A 78-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 19May2021 (Batch/Lot Number: FA4598) as DOSE 1, 0.3ML SINGLE for covid-19 immunisation; dabigatran etexilate mesilate (PRADAXA), oral from an unspecified date (Batch/Lot Number: Unknown) to 16Jun2021, at 110 mg, once daily for an unspecified indication; febuxostat (ADENURIC); silodosin (SILODYX); betaxolol hydrochloride (KERLONE); amiloride hydrochloride, furosemide (LOGIRENE); tiotropium bromide monohydrate (SPIRIVA); formoterol fumarate (FORMOAIR); beclometasone dipropionate (BECLOJET), all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication; gliclazide (DIAMICRON), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for diabetes mellitus. Medical history included diabetes mellitus, Bowel obstruction, Left hemicolectomy, wound in the leg all from an unknown date. The patient''s concomitant medications were not reported. The patient experienced shock hemorrhagic and cardio-respiratory arrest on 16Jun2021, huge fatigue on an unspecified date. Per death certificate, the patient died on 16Jun2021 due to hemorrhage from a wound in the leg. Patient on anticoagulant aggravating this hemorrhage which caused shock and cardio-respiratory arrest. His death was linked to his anticoagulant treatment in connection with his illnesses. The attending physician was contacted on 30Aug2021 but was not aware of the patient''s death. The action taken in response to the events for all suspect drugs was not applicable. The patient died on 16Jun2021. An autopsy was not performed. The outcome of events Shock hemorrhagic and Cardio-respiratory arrest was fatal, of the event fatigue was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Shock hemorrhagic; Cardio-respiratory arrest


VAERS ID: 1750871 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Foetal growth restriction, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101264073

Write-up: intratuerine death; maternal exposure during pregnancy, 2nd trimester; Foetal growth retardation; This is a spontaneous report from a contactable consumer (parent) reporting different events for mother/fetus. This is second of two reports, for the fetus. The first report was downloaded from Regulatory Authority-WEB, The regulatory authority report number FR-AFSSAPS-PA20211492. An unspecified age and gender patient (fetus) received the second dose (initial Pfizer dose) of BNT162B2 (COMIRNATY) via transplacental on 28May2021 (Batch/Lot Number: EX6537) as 0.3 ml dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced intratuerine death. In 2021, the patient experienced foetal growth retardation. On 28May2021, the patient experienced maternal exposure during pregnancy, 2nd trimester. From a fetal point of view, severe intrauterine growth retardation (below the 3rd percentile) diagnosed at 19 weeks of amenorrhea. Therapeutic measures were taken for intratuerine death. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of foetal growth retardation was not recovered. The outcome of death fetal was fatal. The outcome of Maternal exposure during pregnancy, second trimester was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101256690 mother/child, same drug; Reported Cause(s) of Death: intratuerine death


VAERS ID: 1750872 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal hypokinesia, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101287162

Write-up: Decrease in active fetal movements at 28 weeks of pregnancy plus 1 day/. At 11:00 pm: No heart sounds on ultrasound, finding fetal death in utero; received Comirnaty at at 26 weeks of pregnancy.; This is a spontaneous report from a contactable pharmacist. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority-WEB [FR-AFSSAPS-LY202110428]. This pharmacist reported events for both the mother and the baby. This is the baby (fetus) case. A fetus patient of unspecified gender received BNT162B2 (COMIRNATY solution for injection; lot number: FE8244), via transplacental route of administration. The patient''s mother is a 28-year-old female mother who received the dose of BNT162B2 (COMIRNATY solution for injection; lot number: FE8244), via intramuscular on 07Aug2021 (at the age of 28-years-old) at dose number unknown, single in the left arm for COVID-19 immunisation at 26 weeks of pregnancy. The patient''s medical history and concomitant medications were not reported. The mother''s medical history included no smoking and Factor V Leiden mutation (heterozygous). The mother has no concomitant medications. Estimated last menstrual period of the patient''s mother was on 15Feb2021. The pregnancy progressed without any complications. On 22Aug2021 at 17:00, there was a decrease in active fetal movements at 28 weeks of pregnancy plus 1 day. At 23:00, no heart sounds on ultrasound, finding fetal death in utero. The fetus did not show any edema or major malformation, placenta devoid of any unusual areas. Normal amount of anechoic amniotic fluid. The patient died on 22Aug2021 at 23:00. The patient was delivered prematurely on 25Aug2021 by vaginal route. It was unknown if autopsy was done. Outcome of the event fetal movements decreased was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101215949 maternal case;FR-AFSSAPS-LY202110428 AFSSAPS; Reported Cause(s) of Death: Decrease in active fetal movements at 28 weeks of pregnancy plus 1 day/. At 11:00 pm: No heart sounds on ultrasound, finding fetal death in utero


VAERS ID: 1751453 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-09-24
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, 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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101266948

Write-up: death; cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21127667. The patient was a 71-year and 6-month-old male. On 30Jun2021 at an unknown time (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose, at age of 71 years of vaccination, for COVID-19 immunization. Body temperature before vaccination was unknown. Relevant medical history and concomitant medications. On 09Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA2453, Expiration date 31Aug2021). On 24Sep2021, at 10:15 (2 months and 25 days after the vaccination), after taking a bath, following lower extremities weakness of, the patient experienced cardiopulmonary arrest (CPA) with the initial waveform of pulseless electrical activity (PEA). Return of spontaneous circulation (ROSC) was achieved once after cardiopulmonary resuscitation (CPR) AdIA (as rereported) was performed. Then, the patient was observed. After that, cardiac arrest developed again, which led to VFA (as reported). The cardiac condition changed from wide QRS to asystole. Total cardiac arrest duration was more than 22 minutes. Considering the pupillary findings, the resuscitation was stopped. At 11:45, the patient was confirmed dead. It was unknown if an autopsy was perfofmed. The reporting physician classified the event as serious (death) and assessed the causality between the event(s) and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not reported.; Reported Cause(s) of Death: cardiac arrest; Unknown cause of death


VAERS ID: 1751454 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-09-21
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Cardio-respiratory arrest, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-21
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101267251

Write-up: Cardio-respiratory arrest; loss of consciousness and apnea; loss of consciousness and apnea; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21127668. A 90-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY) Solution for injection, via an unspecified route of administration in Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient''s medical history, family history and concomitant medications were not reported. On 21Sep2021 (unknown days after the vaccination), at around 19:00, the patient had loss of consciousness and apnea while taking a bath, and an ambulance was called. At 19:17, the patient was confirmed to have cardio-respiratory arrest by the emergency squad. The patient was emergently transferred to the reporting hospital. At 20:20, the patient died. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. It was not reported whether there was other possible cause of the event such as any other diseases. The lot number for BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1751525 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-08-15
   Days after vaccination:66
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Investigation
SMQs:, Ischaemic 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: 2021-08-24
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: investigations; Result Unstructured Data: Test Result:Unknown results; Comments: Countless investigations after brain hemorrhage
CDC Split Type: NLPFIZER INC202101256680

Write-up: Cerebral infarction; Cerebral infarction; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB NL-LRB-00686668. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: Unknown) as dose 2, single, dose 1 via an unspecified route of administration on 07May2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced cerebral infarction (death, caused or prolonged hospitalization) on 15Aug2021, cerebral infarction on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included investigation: unknown results (Countless investigations after brain hemorrhage). The patient died on 24Aug2021. It was not reported if an autopsy was performed. Treatment included cerebral infarction is treated with hospitalization and IC. The outcome of cerebral infarction is fatal. Drugs and latency: 1. covid-19 vaccin pfizer solution for injection, cerebral infarction: 2 months after start. Case Summary and Reporter''s Comments Text: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Cerebral hemorrhage Date: 07May2021. cerebral hemorrhages (2x). Hospitalization information: Cerebral hemorrhage and complications. Additional information ADR: Twice brain hemorrhage. COVID-19. Previous COVID-19 infection: No. Other diagnostic procedures: Countless investigations after brain hemorrhage. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cerebral hemorrhage


VAERS ID: 1751547 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-08-01
   Days after vaccination:158
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Decreased appetite, General physical health deterioration, Hypogeusia, Hyposmia, Oxygen saturation decreased, Palliative care, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), 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: 2021-09-13
   Days after onset: 43
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in care
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: NOPFIZER INC202101273964

Write-up: palliative care; Oxygen saturation decreased; Fever; Hypogeusia; Cough; hyposmia; COVID-19; Vaccination failure; decreased appetite; reduced general condition; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uz8y39. A 86-years-old female patient received second dose of bnt162b2 (COMIRNATY,Solution for injection, Lot number: EP9598, Expiration date: unknown), via intramuscular on 24Feb2021 and first dose intramuscular on 03Feb2021, single for covid-19 immunisation. Medical history included living in residential institution. The patient''s concomitant medications were not reported. The patient was isolated after COVID-19 was established. Initially the patient was asymptomatic/in habitual state for several days, before she gradually became more tired and with reduced general condition and decreased appetite on Aug2021. The patient became in need of oxygen therapy from 01Sep2021 and also received dexamethasone and penicillin intravenous due to suspicion of bacterial superinfection. The patient was already treated with Fragmin due to immobilisation. She became in need of oxygen therapy by mask (7 L9 to sustain SpO2 $g92 %, fever and cough without clinical suspicion of fluid in lungs/pleura(ascites increase) from sep2021. The patient complained of hypogeusia and hyposmia on sep2021. The patients condition further deteriorated and from 06Sep2021 it was decided to start palliative care. The patient died on 13Sep2021. The Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1751561 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-27
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210959407

Write-up: BODY MALAISE; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300107169] concerned a 79 year old female of an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number, and expiry date were not reported) dose was not reported, 1 total was administered on 26-JUL-2021 for drug used for unknown indication. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On 27-JUL-2021 at 17:00, the patient experienced body malaise, and fever. On an unspecified date, the patient died from body malaise, and fever. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210959407-covid-19 vaccine ad26.cov2.s-body malaise and fever. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BODY MALAISE; FEVER


VAERS ID: 1751562 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Fatigue
SMQs:, Anaphylactic reaction (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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210959477

Write-up: COUGH; FATIGUE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300107179] concerned a 71 year old male with an unspecified race and ethnic origin.. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: Unknown) dose was not reported,1 total administered on 28-JUL-2021 for an unspecified indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 30-JUL-2021, the patient experienced cough and fatigue. On an unspecified date, the patient died due to cough, and fatigue. It was unknown, if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210959477-COVID-19 VACCINE AD26.COV2.S-cough, fatigue. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGH; FATIGUE


VAERS ID: 1751564 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-28
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Cardiogenic shock
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), 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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210959927

Write-up: CARDIOGENIC SHOCK CARDIOPULMONARY ARREST; CARDIOGENIC SHOCK CARDIOPULMONARY ARREST; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300107648] concerned a 66 year old male patient. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total, administered on 26-JUL-2021 for an unknown indication. No concomitant medications were reported. On 28-JUL-2021, the patient experienced cardiogenic shock and cardiopulmonary arrest. On an unspecified date, the patient died from cardiogenic shock and cardiopulmonary arrest. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiogenic shock and cardiopulmonary arrest was fatal. This report was serious (Death).; Sender''s Comments: V0: 20210959927-COVID-19 VACCINE AD26.COV2.S-Cardiogenic shock and cardiopulmonary arrest. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: CARDIOGENIC SHOCK CARDIOPULMONARY ARREST; CARDIOGENIC SHOCK CARDIOPULMONARY ARREST


VAERS ID: 1751568 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Decreased appetite, Diarrhoea, Headache, Malaise, Myalgia, Nausea, Paralysis, Pruritus, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), 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: PHPFIZER INC202101253888

Write-up: Abdominal pain; Malaise; Diarrhoea; Fever; Headache; Appetite lost; Muscle pain; Nausea; Itching; Weakness; Paralysis; This is a spontaneous report from a contactable other hcp. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300106148. A 40-year-old female patient received bnt162b2 (COMIRNATY), vaccinated at age of 40 years old, via an unspecified route of administration on 30Jun2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced abdominal pain, malaise, diarrhoea, fever, headache, appetite lost, muscle pain, nausea, itching, weakness, and paralysis and all on 01Jul2021 18:30 with outcome of 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: Headache; Appetite lost; Muscle pain; Nausea; Itching; Weakness; Paralysis; Abdominal pain; Malaise; Diarrhoea; Fever


VAERS ID: 1751650 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-25
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Administration site pain, Blood test, Brain oedema, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Cerebrovascular accident, Computerised tomogram head, Fatigue, Fibrin D dimer, Heparin-induced thrombocytopenia test, Nausea, Paresis, Platelet count, Thrombocytopenia, Thrombosis, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (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), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-29
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hematuria (Unexplained); Thrombocytopenia (Unexplained); Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: Thrombocyte count; Result Unstructured Data: 70 10*9/L; Test Date: 202109; Test Name: Blood test NOS; Result Unstructured Data: thrombosytopenia; Test Date: 202109; Test Name: Fibrin D dimer; Result Unstructured Data: Increased; Test Date: 202109; Test Name: Head CT; Result Unstructured Data: cerebral sinus thrombosis, bleeding iright hemisphere, cerebral oedema; Test Date: 202109; Test Name: Heparin-induced platelet antibody; Result Unstructured Data: Positive
CDC Split Type: SIJNJFOC20210959243

Write-up: CEREBRAL VENOUS SINUS THROMBOSIS; THROMBOCYTOPENIA; CEREBRAL HEMORRHAGE; STROKE; CEREBRAL EDEMA; BLOOD CLOT; OTHER PARESIS/PARALYSIS; NAUSEA; VOMITING; ADMINISTRATION SITE PAIN; TIREDNESS; This spontaneous report was received from a social media post via a company representative, various news articles and regulatory authority and concerned a 20 year-old female patient. The patient''s weight and height were not reported. The patient''s t medical history included unexplained hematuria and thrombocytopenia starting 23-JUN-2021; it was unknown if these conditions were continuing at present. Previous laboratory results were: 23-JUN-2021 thrombocyte count 70 10*9/L (NR not provided). The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number XE393) 1 dose for prophylactic vaccination on 16-SEP-2021. No concomitant medications were reported. On 25-SEP-2021, 9 days after receiving the vaccine, the patient experienced administration site pain, tiredness and headache. On 26-SEP-2021 she experienced nausea and vomiting. On 27-SEP-2021, the patient became ill with headache, impaired consciousness, blood clot, suffered a stroke and was hospitalized. The patient received a head CT which showed cerebral venous sinus thrombosis, bleeding into the right hemisphere, and cerebral edema. Heparin-induced platelet antibody (anti-PF4) - positive; Fibrin D dimer - increased; blood test (NOS) - thrombocytopenia; HIT. The patient was also experiencing encephalitis, encephalopathy. After extensive consultation with hematologists, internists - specialists in vascular diseases; it was determined to be a VITT syndrome (vaccine induced thrombocytopenic thrombosis) "ot" TTS (thrombosis with thrombocytopenia syndrome). The patient had not taken any medications to accelerate her condition. On 29-SEP-2021, the head of the emergency neurology department reported that the patient had died that morning, adding that it was not yet possible to say exactly whether the it was related with the vaccination of the patient. Although brain death had not been officially confirmed yet, there were positive clinical tests indicating brain death. The physician stated the demonstration of a direct link with the vaccine was a matter of further procedures which have not been carried out; there was a reasonable suspicion that there was a causal link between the vaccination and complication. The outcome of the events as follows: administration site pain was recovered; tiredness, headache, nausea, vomiting were unknown. Outcome of thrombocytopenia, other paresis/paralysis, cerebral hemorrhage, CVST, cerebral edema and stroke were fatal. It was unknown if an autopsy was performed. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. This report was serious (Death, Hospitalization, Medically Important). This case was linked, via the same reporter and social media post, to case 20210550911.; Sender''s Comments: V0: This spontaneous report was received from a social media post, various news articles and regulatory authority and concerned a 20-year-old female patient who experienced cerebral venous sinus thrombosis (CVST) with cerebral hemorrhage, cerebral edema, and thrombocytopenia 11 days after vacine. Medical history included unexplained hematuria and thrombocytopenia (platelet count of 70,000 at that time) starting approximately 3 months prior to vaccination; it was unknown if these conditions were ongoing at the time of the event. No concomitant medications were reported. On day 9, the patient experienced administration site pain, tiredness and headache. On day 10, she experienced nausea and vomiting. On day 11, the patient became ill with headache, impaired consciousness, blood clot, suffered a stroke and was hospitalized. The patient received a head CT which showed CVST, bleeding into the right hemisphere, and cerebral edema. Heparin-induced platelet antibody (anti-PF4) was positive; D dimer was increased; thrombocytopenia was present without a reported value. The patient was also experiencing encephalitis, encephalopathy. After extensive consultation with hematologists, internists - specialists in vascular diseases; it was determined to be a VITT syndrome (vaccine induced thrombocytopenic thrombosis) or TTS (thrombosis with thrombocytopenia syndrome). The patient had not taken any medications to accelerate her condition. Although brain death had not been officially confirmed yet, there were positive clinical tests indicating brain death. Although the pre-existing history of thrombocytopenia approximately 3 months prior to vaccine may have contributed, based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration - BC) and considering the low platelet count and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.; Reported Cause(s) of Death: THROMBOCYTOPENIA; PARESIS; CEREBRAL HEMORRHAGE; CEREBRAL VENOUS SINUS THROMBOSIS; CEREBRAL EDEMA; STROKE


VAERS ID: 1752878 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-07-02
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003188 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Headache, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactose intolerant
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: Decreased appetite; Pain in extremity; Headache; Pyrexia; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Decreased appetite), PAIN IN EXTREMITY (Pain in extremity), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3003188) for COVID-19 vaccination. The patient''s past medical history included Lactose intolerant. Concomitant products included ALLOPURINOL for an unknown indication. On 02-Jun-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced DECREASED APPETITE (Decreased appetite) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Pyrexia) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 03-Jul-2021, DECREASED APPETITE (Decreased appetite), PAIN IN EXTREMITY (Pain in extremity), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue) had resolved. The patient died on 28-Mar-1963. The cause of death was not reported. It is unknown if an autopsy was performed. No treatment medication details was reported. Company comment: This case concerns a male patient, unknown age, with no relevant medical history, who experienced the unexpected events of headache, pain in extremity, pyrexia, fatigue and decreased appetite. The events occurred approximately 1 day after the second dose of Moderna vaccine. The rechallenge is not applicable as a third dose is not expected. The reporter assessed the events as likely related to the product. The events headache, pyrexia and fatigue are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. Regulatory report has Date of Death as 28 March 1963, which is probably an error and may have been date of birth, however, as it is a RA report, it was captured as such.; Reporter''s Comments: The case is non-serious and unlabelled. Due to temporal relationship and the known safety profile of the vaccine, the causality is assessed as probable.; Sender''s Comments: This case concerns a male patient, unknown age, with no relevant medical history, who experienced the unexpected events of headache, pain in extremity, pyrexia, fatigue and decreased appetite. The events occurred approximately 1 day after the second dose of Moderna vaccine. The rechallenge is not applicable as a third dose is not expected. The reporter assessed the events as likely related to the product. The events headache, pyrexia and fatigue are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. Regulatory report has Date of Death as 28 March 1963, which is probably an error and may have been date of birth, however, as it is a RA report, it was captured as such.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1752897 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-07-27
Onset:2021-09-07
   Days after vaccination:407
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       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: 2021-09-08
   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: VALSARTAN; ATORVASTATIN; TAFINLAR; MEKINIST; KARDEGIC; AMLODIPINE; METFORMIN HYDROCHLORIDE
Current Illness: Adenocarcinoma of lung stage IV; Benign neoplasm of prostate; Hypertension arterial; Insulin-requiring type 2 diabetes mellitus (stable); Meningioma (stable); Stable angina pectoris
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Hemorrhage intracerebral; This case was received via regulatory authority (Reference number: FR-AFSSAPS-MP20217501) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CEREBRAL HAEMORRHAGE (Hemorrhage intracerebral) in a 70-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect products included non-company products METFORMIN HYDROCHLORIDE (METFORMINE [METFORMIN HYDROCHLORIDE]) for Insulin-requiring type 2 diabetes mellitus, AMLODIPINE for Hypertension arterial, ACETYLSALICYLATE LYSINE (KARDEGIC) for Cardiovascular event prophylaxis, TRAMETINIB DIMETHYL SULFOXIDE (MEKINIST) for Adenocarcinoma of lung stage IV, DABRAFENIB MESILATE (TAFINLAR) capsule for Adenocarcinoma of lung stage IV, ATORVASTATINE [ATORVASTATIN] for Cardiovascular event prophylaxis and VALSARTAN for Hypertension arterial. The patient''s past medical history included COVID-19 in January 2021. Concurrent medical conditions included Adenocarcinoma of lung stage IV since 17-Jul-2020, Benign neoplasm of prostate since 28-Jan-2019, Hypertension arterial, Meningioma (stable) since 2009, Stable angina pectoris since 2009 and Insulin-requiring type 2 diabetes mellitus (stable). On 27-Jul-2020, the patient started TRAMETINIB DIMETHYL SULFOXIDE (MEKINIST) (Oral) 2 milligram and DABRAFENIB MESILATE (TAFINLAR) (Oral) 100 milligram every twelve hours. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started METFORMIN HYDROCHLORIDE (METFORMINE [METFORMIN HYDROCHLORIDE]) (Oral) 850 milligram once a day, AMLODIPINE (Oral) 10 milligram once a day, ACETYLSALICYLATE LYSINE (KARDEGIC) (Oral) 1 dosage form, ATORVASTATINE [ATORVASTATIN] (Oral) 10 milligram once a day and VALSARTAN (Oral) 160 milligram once a day. On 07-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced CEREBRAL HAEMORRHAGE (Hemorrhage intracerebral) (seriousness criteria death and medically significant). The last dose administered for METFORMIN HYDROCHLORIDE (METFORMINE [METFORMIN HYDROCHLORIDE]) was on 03-Sep-2021, AMLODIPINE (AMLODIPINE) was on 03-Sep-2021, ACETYLSALICYLATE LYSINE (KARDEGIC) was on 03-Sep-2021, TRAMETINIB DIMETHYL SULFOXIDE (MEKINIST) was on 03-Sep-2021, DABRAFENIB MESILATE (TAFINLAR) was on 03-Sep-2021, ATORVASTATINE [ATORVASTATIN] (ATORVASTATINE [ATORVASTATIN]) was on 03-Sep-2021 and for VALSARTAN (VALSARTAN) was on 03-Sep-2021. The patient died on 08-Sep-2021. The reported cause of death was Hemorrhage intracerebral. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information provided. Company Comment: This case concerns a 70-year-old male patient with concurrent medical history of Meningioma, hypertension, Adenocarcinoma of lung stage IV and diabetes and past history of covi-19, who experienced the unexpected fatal event of Hemorrhage intracerebral. The event occurred on an unspecified date after administration of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as information pertaining to the second dose was not disclosed. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by the reported event. Event is confounded by the subject''s underlying history of meningioma, hypertension, and diabetes. Event seriousness assessed as per Regulatory Authority. As this is a fatal event Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation received on 28-SEP-21, contains no new information.; Sender''s Comments: This case concerns a 70-year-old male patient with concurrent medical history of Meningioma, hypertension, Adenocarcinoma of lung stage IV and diabetes and past history of covi-19, who experienced the unexpected fatal event of Hemorrhage intracerebral. The event occurred on an unspecified date after administration of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as information pertaining to the second dose was not disclosed. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by the reported event. Event is confounded by the subject''s underlying history of meningioma, hypertension, and diabetes. Event seriousness assessed as per Regulatory Authority. As this is a fatal event; Reported Cause(s) of Death: Hemorrhage intracerebral


VAERS ID: 1752963 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210959718

Write-up: FATIGUE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300107623] concerned a 55 year old male of an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: unknown) dose was not reported, with frequency time 1 total administered on 29-JUL-2021 for an unknown indication. No concomitant medications were reported. On 30-JUL-2021 at 07:00 hours, the patient experienced fatigue, and was hospitalized on an unspecified date. The number of days hospitalized were unspecified. On an unspecified date, the patient died from fatigue. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was fatal. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0 20210959718-COVID-19 VACCINE AD26.COV2.S-fatigue. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FATIGUE


VAERS ID: 1752966 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), 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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210959893

Write-up: BODY WEAKNESS; LOSS OF APPETITE; FEVER; DIFFICULTY OF BREATHING; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300107475] concerned a 73 year old female of an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 209L21A expiry: unknown) dose was not reported, 1 total administered on 03-AUG-2021 for an unknown indication. No concomitant medications were reported. On 04-AUG-2021, the patient experienced difficulty of breathing. On an unspecified date, the patient experienced body weakness, loss of appetite, and fever. On an unspecified date, the patient died from difficulty of breathing, body weakness, fever, and loss of appetite. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the events difficulty of breathing, body weakness, loss of appetite, and fever was fatal. This report was serious (Death).; Sender''s Comments: V0: 20210959893-COVID-19 VACCINE AD26.COV2.S-difficulty of breathing, body weakness, loss of appetite, fever. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DIFFICULTY OF BREATHING; BODY WEAKNESS; FEVER; LOSS OF APPETITE


VAERS ID: 1752967 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-03
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-03
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210959913

Write-up: DEAD ON ARRIVAL; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300107001] concerned a 66 year old male of an unspecified race and ethnic origin. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 05-AUG-2021 for drug used for unknown indication. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 03-SEP-2021, the patient died of unknown cause of death on arrival at emergency room. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event dead on arrival was fatal. This report was serious (Death).; Sender''s Comments: V0: 20210959913-COVID-19 VACCINE AD26.COV2.S-dead on arrival. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1753062 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-03-16
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-03-16
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210316; Test Name: SARS-COV-2; Result Unstructured Data: Test Result:SARS-COV-2 infection; Comments: SARS-COV-2 infection. Variant PCR-based: n.a. Sequenced variant: n.a. n501y-positive: No.
CDC Split Type: ATPFIZER INC202101262627

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory authority report number is AT-BASGAGES-2021-044516. A 91-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: EJ6134) intramuscular on 04Feb2021 (unknown age at time of vaccination) as single dose, the first dose of bnt162b2 (COMIRNATY, Lot Number: EJ6796) intramuscular on 14Jan2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure and SARS-COV-2 infection on 16Mar2021. Verbatim: Variant PCR-based: n.a. Sequenced variant: n.a. n501y-positive: No. On 16Mar2021 the patient experienced SARS-CoV-2 infection death, vaccination failure. The outcome of the events was fatal. The patient died on 16Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1753063 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-07
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Laboratory 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: 2021-03-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: n501y; Result Unstructured Data: Test Result:positive was no
CDC Split Type: ATPFIZER INC202101262607

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-044517. A 92-year-old female patient received BNT162B2 (COMIRNATY) dose 2 (lot number: Ej6136) Intramuscular on 01Feb2021 at single dose, dose 1 (lot number: Ej6796) Intramuscular on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 07Mar2021 the patient experienced SARS-CoV-2 infection, Vaccination failure. Patient died on 07Mar2021. Unknown if autopsy was done. positive (2021) was No. Regulatory authority comment from 21Sep2021: no further info available (medical history, symptoms,...) No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1753067 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-31
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-03-31
   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: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: n.a. Sequenced variant: B.1.1.7 n501y-positive: yes
CDC Split Type: ATPFIZER INC202101262618

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority AT-BASGAGES-2021-044524 A 66-years-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 11Feb2021 (Batch/Lot Number: EJ6136) as single dose, dose 1 intramuscular on 19Jan2021 (Batch/Lot Number: EL1491) as single dose for covid-19 immunisation. The patient medical history was none. Concomitant medications were not reported. The patient experienced sars-cov-2 infection (covid-19) on 31Mar2021, vaccination failure on 31Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Variant PCR-based: n.a. Sequenced variant: B.1.1.7 n501y-positive: yes). The patient died on 31Mar2021 due to the events. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1753069 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-04-08
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; Test Result: Positive ; Comments: Variant PCR-based: n.a. Sequenced variant: B.1.1.7 n501y-positive: yes
CDC Split Type: ATPFIZER INC202101262614

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number AT-BASGAGES-2021-044526. An 82-year-old female patient received the first dose of bnt162b2 (COMIRNATY) on 14Jan2021 (lot number: EJ6796) Intramuscularly at single dose; the second dose of bnt162b2 (COMIRNATY) on 05Feb2021 (lot number: EJ6134) Intramuscularly at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On unknown date the patient experienced SARS-CoV-2 infection, Vaccination failure. Lab data included covid on unknown date: Variant PCR-based: n.a.; Sequenced variant: B.1.1.7; n501y-positive: yes. The outcome of the events was fatal. Patient died on 08Apr2021. It was unknown reported if patient had an Autopsy. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1753071 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-04-13
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-04-13
   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: Test Name: covid-19 test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ATPFIZER INC202101262622

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority AT-BASGAGES-2021-044528. A 96-year-old female patient received BNT162B2(COMIRNATY), dose 2 intramuscular on 20Jan2021 (Lot Number: EL1491) at single dose, dose 1 intramuscular on 30Dec2020 (Lot Number: EJ6796) at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 13Apr2021 the patient experienced SARS-CoV-2 infection death, Vaccination failure. The patient underwent lab tests included covid-19 test: Unknown results. The outcome of events was fatal. The patient died on 13Apr2021. It was not reported if an autopsy was performed. This report was reported as serious. BASGAGES comment from 21Sep2021: no further info available (medical history, symptoms,...) 1st vaccine batch/lot: EJ6796 2nd vaccine batch/lot: EL1491 No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1753095 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-08-15
   Days after vaccination:163
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-08-15
   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: sars-cov-2 test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n.a. n501y-positive: No.
CDC Split Type: ATPFIZER INC202101262669

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority AT-BASGAGES-2021-045416. A 70-year-old male patient received the second dose and the first dose of BNT162B2 (COMIRNATY), the second dose on 05Mar2021 (Lot Number: EP2166), the first dose on 12Feb2021 (Lot Number: EJ6790), both via intramuscular as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 15Aug2021 the patient experienced SARS-CoV-2 infection death, vaccination failure. Variant PCR-based: B.1.617.2. Sequenced variant: n.a. n501y-positive: No. The patient died on 15Aug2021. Autopsy was unknown. The outcome of 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: 1753108 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-08-18
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-08-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: covid; Result Unstructured Data: Test Result:positive; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n.a. n501y-positive: No.
CDC Split Type: ATPFIZER INC202101262600

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory authority number AT-BASGAGES-2021-045932. A 78-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 10Apr2021 (Batch/Lot Number: EW2246) as dose 2, single; dose 1 intramuscular on 20Mar2021 (Batch/Lot Number: ET1831) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Aug2021, the patient experienced SARS-CoV-2 infection, death, vaccination failure. The patient''s outcome was fatal. The patient underwent lab tests and procedures which included covid: positive on an unknown date (Variant PCR-based: B.1.617.2. Sequenced variant: N.A. n501y-positive: No.). The patient died on 18Aug2021. 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: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1753109 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-08-19
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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: 2021-08-19
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101262631

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-045951. A 71-year-old male patient received bnt162b2 (COMIRNATY), first single dose intramuscular on 10Mar2021 (Batch/Lot Number: ET1831), and second single dose intramuscular on 31Mar2021 (Batch/Lot Number: ET3620) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 19Aug2021 the patient experienced SARS-CoV-2 infection and vaccination failure. Variant PCR-based was not applicable. Variant Sequenced was not applicable. positive was Unknown. The patient died on 19Aug2021 for the SARS-CoV-2 infection. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1753121 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-08-20
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-08-20
   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: 20210820; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2; Sequenced variant: n.a.; n501y-positive: No.
CDC Split Type: ATPFIZER INC202101262660

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable physician downloaded from the regulatory authority AT-BASGAGES-2021-046177. An 89-year-old male patient received 1st dose of BNT162B2 (COMIRNATY, Lot Number: ET1831) via intramuscular on 09Mar2021, 2nd dose of BNT162B2 (COMIRNATY, Lot Number: ET7205) via intramuscular on 30Mar2021, both as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 20Aug2021, the patient experienced SARS-CoV-2 infection with positive SARS-CoV-2 test (Variant PCR-based: B.1.617.2; Sequenced variant: n.a.; n501y-positive: No.). The outcome of the events was fatal. The patient died on 20Aug2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1753125 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-08-26
   Days after vaccination:97
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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: 2021-08-26
   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: Test Name: Variant PCR-based; Result Unstructured Data: Test Result:B.1.617.2; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: not aplicable n501y-positive: No
CDC Split Type: ATPFIZER INC202101262663

Write-up: SARS-CoV-2 infection; Drug ineffective; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-046821. An 81-year-old male patient received the second dose and the first dose of BNT162B2 (COMIRNATY), the second dose on 21May2021 (Lot Number: FC0681), the first dose on 09Apr2021 (Lot Number: ET7205), both via intramuscular as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication was none. On 26Aug2021 the patient experienced SARS-CoV-2 infection death, Vaccination failure. Variant PCR-based: B.1.617.2. Variant Sequenced: not applicable. n501y-positive was none. The patient died on 26Aug2021. Autopsy was unknown. The outcome of events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Drug ineffective; SARS-CoV-2 infection


VAERS ID: 1753197 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Death, Interchange of vaccine products
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-08
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101274870

Write-up: He died from natural causes, from the heart itself.; He died from natural causes, from the heart itself; took the first and second dose of Coronavac in 08Feb and on 08Mar2021 respectively / in 04Sep he took the third dose of Pfizer; took the first and second dose of Coronavac in 08Feb and on 08Mar2021 respectively / in 04Sep he took the third dose of Pfizer; This is a spontaneous report received from a contactable consumer (patient''s daughter). A 90-year-old male patient received BNT162B2 (COMIRNATY) as third dose on 04Sep2021 at single dose (at the age of 90-year-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first and second dose of COVID-19 VACCINE INACT (VERO) CZ02 (CORONAVAC) on 08Feb2021 and 08Mar2021 respectively for COVID-19 immunisation. On 04Sep2021 he took the third dose of Pfizer and four days later he died (on 08Sep2021). The reporter associated the death with vaccination. She informed that he had no comorbidity and was normal. She found it very strange to die right after the vaccination. She asked if there were reports of death after the third dose. She informed that doctors could not specify the relationship with the vaccine. He was not with Covid. He died from natural causes, from the heart itself. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: from the heart itself; died from natural causes


VAERS ID: 1753222 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-06-02
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation, Death, Echocardiogram
SMQs:, Supraventricular tachyarrhythmias (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   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: CARVEDILOL; NIFEDIPIN
Current Illness: Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Echocardiography; Result Unstructured Data: Normal left ventricular pump function with 56%
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DEATH ) and ATRIAL FIBRILLATION in a 70-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3002541) for COVID-19 vaccination. Concurrent medical conditions included Hypertension arterial. Concomitant products included CARVEDILOL and NIFEDIPINE (NIFEDIPIN) for an unknown indication. On 03-May-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced ATRIAL FIBRILLATION (seriousness criterion medically significant). On 03-Jun-2021, ATRIAL FIBRILLATION had resolved. The patient died on 03-Jun-2021. The reported cause of death was Cardiac arrest. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Echocardiogram: normal (normal) Normal left ventricular pump function with 56%. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH and ATRIAL FIBRILLATION to be unlikely related. Treatment information was not provided. A stress test was performed on 17-May-2021, due to atypical chest symptoms. This was negative for relevant ischemia. On 01-Jun-21, relevant dyspnea occurred tachycardic atrial fibrillation with HR 185/min was able to be determined from the symptoms. Beta blocker therapy (metoprolol 2x50 mg) was started immediately with significant improvement in the heart rate (documented by 24-hour ECG). An echocardiography was performed on 03-Jun-2021 to rule out heart failure and aortic pathology. Echocardiography revealed normal left ventricular pump function with 56% and normal dimension. HR had decreased to 100/min, Therapy with Xarelto 1x20 mg was also started. 02-Jun-2021 on metoprolol and improved frequency control. On 03-Jun-2021 in the evening at dinner (in the absence of the family), an event occurred, which was fatal, Resuscitation was unsuccessful. The plate was still full and the patient has not yet started eating. The suspected cause of death is either a sudden cardiac arrest, or a lethal cardiac arrhythmia Company Comment: This case concerns a 70 year old male patient with medical history of Hypertension, who experienced the unexpected serious events of DEATH and ATRIAL FIBRILLATION, within 2-3 days after the second dose of mRNA-1273 vaccine. Limited information regarding the events and cause of death have been provided at this time. However, the patient''s age and medical history of Hypertension are risk factors and confounds causality assessment. The HCP reporter considered DEATH and ATRIAL FIBRILLATION to be unlikely related. Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation document received on 28-Sep-21, added event information into the I-narrative supplement.; Reporter''s Comments: Atrial fibrillation tachycardia occurred in close temporal correlation (the following day) with the second dose of the Moderna COVID-19 vaccine, in a 70-year-old patient known for arterial hypertension. Symptoms rapidly improved with beta-blocker therapy. However, two days after the vaccination, the patient died due to unknown causes (autopsy not performed), likely from a cardiac cause (Cardiac arrest or a lethal cardiac arrhythmia). On 17-May-2021 the patient underwent a stress test due to chest pain, which provided a negative result for ischemia, while on 03-Jun-2021 an echocardiography was performed that excluded heart failure or aortic disease. Atrial fibrillation tachycardia, rhythm disturbances in general or cardiac arrest are not mentioned as possible adverse reactions to the Moderna vaccine in the monograph, or in monographs. there is a case report of a 31-year-old man with Marfan syndrome who, a few hours after vaccination against SARS-CoV-2, experienced atrial fibrillation [1]. To date out of a total of 303,837 reports for Covid-19 Moderna, 873 cases of "atrial fibrillation" (PT), 521 cases of "arrhythmia" (PT) and 426 cases of "cardiac arrest" (PT) are reported. The temporal correlation between the administration of the second dose of the vaccine and the onset of cardiac symptoms, which ended with death of the patient (due to unknown causes), is suggestive; however, the patient had additional cardiovascular risk factors, such as age and hypertension. Therefore, given what we currently know, despite the suggestive temporal correlation, since we cannot exclude other possible causes, we consider the causal correlation between the Moderna vaccine and AF and death as unlikely.; Sender''s Comments: This case concerns a 70 year old male patient with medical history of Hypertension, who experienced the unexpected serious events of DEATH and ATRIAL FIBRILLATION, within 2-3 days after the second dose of mRNA-1273 vaccine. Limited information regarding the events and cause of death have been provided at this time. However, the patient''s age and medical history of Hypertension are risk factors and confounds causality assessment. The HCP reporter considered DEATH and ATRIAL FIBRILLATION to be unlikely related. Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1754423 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: Carotid artery stenosis; Iodine allergy; Lightheadedness (Dizziness: occasional); Stent placement (Stent due to carotid stenosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101272655

Write-up: Death; This is a spontaneous report downloaded from the regulatory authority DCGMA number DE-DCGMA-21189481. This report was forwarded via RA (PEI), however no RA number was provide. A non-contactable physician reported that a 79-Year-old Female patient received bnt162b2 (COMIRNATY) on 10Apr2021 at the age of 79-Year-old (lot unknown) as 0.3 ml single dose for covid-19 immunisation. The patient''s medical history included Iodine allergy, Carotid artery stenosis, Lightheadedness (Dizziness: occasional), all from unspecified date and unknown if ongoing; Stent placement, Stent due to carotid stenosis from an unspecified date and stoped on unspecified date. Concomitant medications were not reported. On 12Apr2021 the patient experienced Death. This report is serious due to death. Relatedness of drug to event Death Result of Assessment was D. Unclassifiable. Source of assessment was PEI. It was unknown if Autopsy Done. The outcome of the event was fatal. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1754424 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain injury, Immune thrombocytopenia, Immunology test, Interchange of vaccine products, Off label use, Purpura, Rhabdomyolysis, Seizure
SMQs:, Rhabdomyolysis/myopathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (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: Hypertension arterial; Hypothyroidism; Psychosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: ELISA; Result Unstructured Data: Test Result:thrombocytopenia; Comments: Free platelet-reactive antibodies as a sign of immune thrombocytopenia detected via ELISA.
CDC Split Type: DEPFIZER INC202101262998

Write-up: Vaxzevria vaccination about 12 weeks before Comirnaty; Vaxzevria vaccination about 12 weeks before Comirnaty; Immune thrombocytopenia; seizure; rhabdomyolysis; purpura; severe hypoxic brain damage; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, DE-DCGMA-21192074, Safety Report Unique Identifier DE-PEI-202100146360. A 72-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 16Jun2021 (at the age of 72-year-old) as dose 2 (initial pfizer dose) at 0.3 ml, single for COVID-19 immunisation. Medical history included ongoing psychosis, ongoing hypertension arterial and ongoing hypothyroidism. The patient''s concomitant medications were not reported. The patient previously received covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA) as dose 1 for COVID-19 immunisation (VAXZEVRIA vaccination about 12 weeks before COMIRNATY). The patient experienced immune thrombocytopenia on an unspecified date in 2021. On 13Jul2021 Free platelet-reactive antibodies as a sign of immune thrombocytopenia detected via ELISA. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. Relatedness of COMIRNATY and to reaction, was assessed as "D. Unclassifiable" by PEI. Reporter''s comment: Course: Suspected preclinical seizure -resuscitation with ROSC - rhabdomyolysis, thrombocytopenia, purpura, severe hypoxic brain damage, seizures -death. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Immune thrombocytopenia; seizures; rhabdomyolysis; purpura; severe hypoxic brain damage


VAERS ID: 1754471 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7011 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Creutzfeldt-Jakob disease
SMQs:, Dementia (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-09-14
   Days after onset: 75
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: Alcohol use; Arterial hypertension; COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101262381

Write-up: Creutzfeld-Jacob disease; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority DE-PEI-202100194927. A 73-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: FE7011, strength: 0.3 ml), at the age of 73 years old, via an unspecified route of administration on 26Jul2021 at single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), arterial hypertension, alcohol use. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot Number: FD9234), at the age of 73 years old, on 23Jun2021 at single dose for COVID-19 immunisation. The patient experienced Creutzfeld-Jacob disease in Jul2021. Duration was reported as 6 weeks. This report was serious - death, hospitalization, life threatening. Assessment of BNT162B2 to Creutzfeld-Jacob disease was assessed as C. Inconsistent causal association to immunization by the PEI. The outcome of event was fatal. The patient died on 14Sep2021. 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: Creutzfeld-Jacob disease


VAERS ID: 1754609 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-11
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-28
   Days after onset: 78
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Infarct myocardial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101262534

Write-up: epileptical attack; stroke; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority -WEB DE-PEI-CADR2021180577, Safety Report Unique Identifier DE-PEI-202100191942. A 77-year-old female patient received bnt162b2 (COMIRNATY) strength: 0.3 mL, via an unspecified route of administration on 19May2021 (Batch/Lot Number: Unknown) as dose number unknown, single for covid-19 immunisation. Medical history included infarct myocardial from Apr2020 and ongoing. The patient''s concomitant medications were not reported. The patient experienced stroke and epileptic seizure / epileptical attack for the first time on 11Jun2021, then in middle July for the second time and finally in August for the third time. As a result, her mother died on 28Aug2021. An autopsy was not performed. The assessment for both events with the suspect product Comirnaty is: D. Unclassifiable. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular; Epileptic fit


VAERS ID: 1754611 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-04
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Chest pain, 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), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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: 2021-08-04
   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:
CDC Split Type: DEPFIZER INC202101272550

Write-up: Cardiac death; Chest pain; unconscious; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority WEB DE-PEI-CADR2021182763 and Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100195376. A 42-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, Lot number unknown), via an unknown route, in Jul2021 at single dose (dose number unknown) for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On the night of 04Aug2021, this patient woke up with severe chest pain. When the rescue workers arrived, the patient was already unconscious and could not be brought back to life despite an hour and a half of attempts at resuscitation. The patient died on 04Aug2021 due to the events. No autopsy was performed. Relatedness of drug to reactions/events Source of assessment Result of Assessment D. Unclassifiable No follow-up attempts are possible. Information about Batch/Lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: chest pain; unconscious; Cardiac death


VAERS ID: 1754688 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-29
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Aortic valve incompetence, Body temperature, Cerebral haemorrhage, Coma scale, Computerised tomogram, Depressed level of consciousness, Hemiparesis, Hydrocephalus, Mitral valve incompetence, Oxygen saturation, Physical examination, Pneumonia, Respiratory distress, Respiratory failure, Respiratory rate, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 14
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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Ex-smoker; Hypertension (with difficult pharmacological control); Mitral insufficiency
Allergies:
Diagnostic Lab Data: Test Name: angiogram; Result Unstructured Data: Test Result:detecting no signs of contrast extravasation; Test Name: body temperature; Result Unstructured Data: Test Result:increased; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:3; Comments: decrease in the level of consciousness up to coma; Test Name: CT scan; Result Unstructured Data: Test Result:a voluminous right cortical intraparenchymal hemat; Comments: a voluminous right cortical intraparenchymal hematoma of 143cc volume was observed that did not condition signs of acute hydrocephalus of unknown etiology; Test Name: oxygen saturation; Result Unstructured Data: Test Result:slight tendency to eupneic desaturation; Test Name: physical examination; Result Unstructured Data: Test Result:NIHSS 25 stands out at the expense of decreased le; Comments: NIHSS 25 stands out at the expense of decreased level of consciousness and right hemispheric symptoms; Test Name: physical examination; Result Unstructured Data: Test Result:with NIHSS 20; Test Name: tachypneic; Result Unstructured Data: Test Result:2 4bpm with a 100% FIO2
CDC Split Type: ESPFIZER INC202101262770

Write-up: the level of consciousness decreased; respiratory distress; hemiparesis; Cerebral haemorrhage; bronchoaspiratory pneumonia; respiratory failure; mild mitral and aortic insufficiency; mild mitral and aortic insufficiency; tachypneic at 2 4rpm with a 100% FIO2; acute hydrocephalus; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB ES-AEMPS-1006839. A 95-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular on 19Apr2021 (Lot Number: EW9127) as 0.3 ml dose for COVID-19 immunization. Medical history included hypertension (with difficult pharmacological control), mild mitral and aortic insufficiency, mild mitral and aortic insufficiency and ex-smoker. Concomitant medication included acetylsalicylic acid (ADIRO), hydrochlorothiazide, losartan potassium (LOSARTAN/HYDROCHLOROTHIAZIDE), omeprazole, sertraline, bimatoprost (LUMIGAN) and ipratropium bromide (ATROVENT). The patient previously received the first dose of BNT162B2 via intramuscular on 25Mar2021 (Batch/Lot Number: ET7205) as single dose for COVID-19 immunization. The patient admitted due to cerebral hemorrhage. History of HTN with difficult pharmacological control, mild mitral and aortic insufficiency. Former smoker. Independent and without cognitive impairment. Usual treatment with Adiro 100mg / d, losartan-hydrochlorothiazide 50 / 12.5mg / 12h, omeprazole 20mg / d, sertraline 50mg / d, lumigan, atrovent. On 29Apr, the level of consciousness decreased and the appearance of hemiparesis on the left side and respiratory distress began, for which he was referred to a hospital. Upon arrival at the ER, he was tachypneic at 2 4rpm with a 100% FIO2. It stabilizes at the respiratory level. On physical examination, NIHSS 25 stands out at the expense of decreased level of consciousness and right hemispheric symptoms. A simple CT scan was performed in which a voluminous right cortical intraparenchymal hematoma of 143cc volume was observed that did not condition signs of acute hydrocephalus of unknown etiology. CT angiography is performed, detecting no signs of contrast extravasation. In this context, acute stroke measures are carried out, under strict blood pressure control, requiring the start of urapidil on 29Apr at 6:38 p.m., which is later suspended. In the Stroke Unit, the patient is stationary with NIHSS 20; No signs of discomfort with a slight tendency to eupneic desaturation that is corrected with oxygen therapy. Poor vital and functional prognosis. In the next 24-48 hours he remains clinically stable, it is decided to place NGS for enteral nutrition. He presented fever in the context of possible bronchial aspiration, so treatment with antibiotic was started. It passes to a neurovascular plant pending evolution. From admission to the ward, the patient presents a progressive neurological and systemic deterioration, with a decrease in the level of consciousness up to coma (Glasgow Coma Scale 3 in the last 4 days) and progressive respiratory failure in the context of probable bronchoaspirative pneumonia and low level of consciousness. Finally exitus on 13May2021. Immediate cause: respiratory failure. Intermediate cause: bronchoaspiratory pneumonia. Root cause: Cortical cerebral hemorrhage possibly secondary to amyloid angiopathy. The patient died on 13May2021. Autopsy was unknown. The outcome of cerebral haemorrhage, bronchopneumonia and respiratory failure was fatal. The outcome of other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Bronchopneumonia; Respiratory failure; Cerebral haemorrhage


VAERS ID: 1754697 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-08-15
   Days after vaccination:191
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cough, Dyspnoea, General physical health deterioration, Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: 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: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Chronic kidney disease; Dyslipidaemia; Hepatopathy; Hypertension arterial; Oligophrenia
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: fever; Result Unstructured Data: Test Result:38.8 Centigrade; Test Date: 2021; Test Name: Oxygen saturation; Test Result: 89 %; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:94-95 %; Comments: with oxygen therapy; Test Date: 2021; Test Name: Oxygen saturation; Test Result: 88 %; Test Date: 20210811; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: ESPFIZER INC202101273608

Write-up: Vaccination failure; COVID-19 respiratory infection; Oxygen saturation low; General physical health deterioration; Breathing difficult; Cough; Fever/38.8 Centigrade; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-976726. An 89-year-old non-pregnant (also at the time of vaccination) female patient received bnt162b2 (COMIRNATY), administered in Arm on 15Jan2021 (Batch/Lot Number: EM0477) as DOSE 1, SINGLE then on 05Feb2021 (Batch/Lot Number: EL8723) as DOSE 2, SINGLE both given via an unspecified route of administration for COVID-19 immunization. Medical history included hepatopathy, abdominal aortic aneurysm, hypertension arterial, chronic kidney disease, dyslipidaemia, and oligophrenia. Concomitant medications were not reported. In 2021 (also reported as 15Jan2021-pending clarification), the patient was institutionalized with productive cough, fever of 38.8 centigrade, oxygen saturation low (sat O2) of 89% and also 88% and breathing difficult. The patient had home oxygen therapy then it normally saturates 94-95%. It was later reported that the patient had vaccination failure as she had COVID-19 respiratory infection with positive COVID-19 antigen test on 15Aug2021 (also reported as 15Jan2021). Despite discharge, she was admitted again due to deterioration of general condition. The patient then died in 2021 due to general physical health deterioration, vaccination failure as she had COVID-19 respiratory infection, Oxygen saturation low and Breathing difficult. Outcome of cough and pyrexia were recovering. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information expected. ; Reported Cause(s) of Death: Oxygen saturation low; COVID-19 respiratory infection; Breathing difficult; Vaccination failure; General physical health deterioration


VAERS ID: 1754698 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-07-30
   Days after vaccination:177
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Chest X-ray, Pyrexia, SARS-CoV-2 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: 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: Medical History/Concurrent Conditions: Cardiac valvulopathy (Mitral); Cognitive deterioration; Hypertension arterial; Permanent atrial fibrillation
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:Bilateral infiltrate more in left hemithorax; Test Date: 20210730; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210807; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ESPFIZER INC202101273589

Write-up: Vaccination failure; COVID-19 pneumonia; Fever; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority number ES-AEMPS-976851. A 91-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Jan2021 (Batch/Lot Number: EM0477) as DOSE 1, SINGLE and then via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: EL8723) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cardiac valvulopathy (Mitral), permanent atrial fibrillation, cognitive deterioration, and hypertension arterial. The patient''s concomitant medications were not reported. On 30Jul2021, the patient experienced fever, vaccination failure, and covid-19 pneumonia. The patient with the pathological history previously described who was admitted for COVID-19 Pneumonia, presenting poor clinical evolution being finally exitus (as reported). The patient underwent lab tests and procedures which included thorax x-ray: bilateral infiltrate more in left hemithorax on 07Aug2021, COVID-19 antigen test: positive on 30Jul2021, and COVID-19 PCR test: positive on 07Aug2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. All events resulted to fatal outcome on unspecified date. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia; Vaccination failure


VAERS ID: 1754784 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Lung neoplasm malignant
SMQs:, Non-haematological malignant tumours (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: Test Name: lung image; Result Unstructured Data: Test Result:clean; Comments: Before vaccination, the lungs were imaged and then they were clean
CDC Split Type: FIPFIZER INC202101262741

Write-up: Lung neoplasm malignant; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number FI-FIMEA-20214851. A 53-years-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 2021 (batch/lot number: unknown) as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lung neoplasm malignant on 01Jul2021. It was reported patient had aggressive lung cancer onset after the second dose of the vaccine. The patient underwent lab tests and procedures which included chest x-ray was clean (before vaccination, the lungs were imaged and then they were clean). 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.; Reported Cause(s) of Death: Lung neoplasm malignant


VAERS ID: 1754793 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-08-01
   Days after vaccination:125
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood sodium, C-reactive protein, COVID-19, Cough, Drug ineffective, Dyspnoea, Heart rate, Hyponatraemia, Investigation, Klebsiella infection, N-terminal prohormone brain natriuretic peptide, Neurological examination, Oedema peripheral, Oxygen saturation, Oxygen saturation decreased, Productive cough, Pulmonary physical examination, SARS-CoV-2 test, Specialist consultation, Sputum test, White blood cell count
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-07
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomyopathy; Carpal tunnel syndrome; Chronic lymphocytic leukaemia (Jan2021, untreated); Gout; Hip prosthesis user; Hypercholesterolaemia; Tachyarrhythmia; Thyroid nodule
Allergies:
Diagnostic Lab Data: Test Name: cardiologic exam; Result Unstructured Data: Test Result:normal; Test Name: cytobacteriological examination of sputum; Result Unstructured Data: Test Result:cam back positive for Klebsiella pneumoniae; Test Date: 20210831; Test Name: leukocyte count; Result Unstructured Data: Test Result:30 x10 9/l; Test Name: blood pressure; Result Unstructured Data: Test Result:130 per 80 mmHg; Test Date: 20210831; Test Name: Hyponatremia; Result Unstructured Data: Test Result:130 mmol/L; Test Date: 20210831; Test Name: CRP; Result Unstructured Data: Test Result:217 mg/l; Test Name: heart rate; Result Unstructured Data: Test Result:100; Comments: bpm; Test Name: digestive examination; Result Unstructured Data: Test Result:normal; Test Name: naurological examination; Result Unstructured Data: Test Result:normal; Test Date: 20210831; Test Name: nptrobnp; Result Unstructured Data: Test Result:21000 ng/L; Test Name: oxygen saturation; Test Result: 75 %; Test Date: 20210831; Test Name: oxygen saturation; Test Result: 46 %; Test Date: 20210905; Test Name: oxygen saturation; Test Result: 89 %; Test Name: pulmonary examination; Result Unstructured Data: Test Result:a bilateral vesicular murmur; Comments: Lung examination finding a bilateral vesicular murmur, symmetrical with bilateral crackling cough with sputum, indrawing, no cyanosis.; Test Date: 20210831; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101262820

Write-up: Hyponatremia at 130 mmol/l; cough with sputum; Drug ineffective; SARS-COV2 pneumonia; pneumoniaie infection / positive pnemoniae; lower limbs oedema; oxygen saturation low/ Blood gases show a saturation of 46%; cough; dyspnea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-AM20212569. A 87-year-old male patient received the second dose and the first dose of BNT162B2 (COMIRNATY), the second dose on 29Mar2021 (Lot Number: ER9470), the first dose in Feb2021 (Lot Number: Unknown), both via intramuscular as single dose for COVID-19 immunization. Medical history included cardiomyopathy, tachyarrhythmia, carpal tunnel syndrome, chronic lymphocytic leukaemia (Jan2021, untreated), gout, thyroid nodule, hip prosthesis user and hypercholesterolaemia. Concomitant medication included pantoprazole, allopurinol, acetylsalicylate lysine (KARDEGIC), spironolactone, furosemide, bisoprolol and amiodarone. In August 2021, the patient experienced cough, lower extremity edema and dyspnea. Emergency room visit on 31Aug2021. On entry inflammatory syndrome with leukocytes at 30 G/l, CRP at 217 mg/l. Hyponatremia at 130 mmol/l and NT pro BNP at 21 000 ng/l. Blood gases show a saturation of 46%. Put on oxygen. Positive COVID test. Introduction of antibiotic therapy associated with corticosteroid therapy. Clinical examination showed a blood pressure of 13/8 cmHg, a heart rate of 100 beats per minute and an oxygen saturation of 75% under 15L. Neurological, digestive and cardiac examination without any particularity. Presence of edema of the lower limbs. ulmonary examination revealed a bilateral, symmetrical vesicular murmur with bilateral crepitus, cough with sputum, draught, no cyanosis. Faced with this oxygen dependence with 15 L oxygen by mask allowing only a 75% saturation, decision to transfer to the intensive care unit with decision not to intubate in view of the history. The general condition then deteriorated with a saturation of 89% on 05Sep2021 under 100% Opti flow and NIV at 95%. The ECBC came back positive for pneumoniae and PIPERACILLIN / TAZOBACTAM was started. On 06Sep2021, the patient was unresponsive. Death on 07Sep2021. Autopsy was unknown. CRPV intervention: recovery of the hospitalization report. The outcome of drug ineffective and COVID-19 was fatal. The outcome of other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute respiratory failure


VAERS ID: 1754826 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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: Advanced cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101278635

Write-up: Death NOS; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-BX20218971. A 72-year-old male patient received the first dose of bnt162b2 (COMIRNATY) Intramuscularly on 20May2021 (lot: EW6126) as single dose for COVID-19 immunisation. No history of COVID. Medical history included Advanced cancer/metastatic cancer. Concomitant medications were not reported. The patient experienced Death 3 days after first dose without further details. It was unknown if Autopsy Done. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1754880 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005285 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-05
   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: GERD
Preexisting Conditions: Medical History/Concurrent Conditions: Arteritis; Intestinal polyp; Tobacco user; Comments: Dose 1: Janssen vaccine, 28-May-2021, left arm, intramuscular injection, batch no.: 21C11-02
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Ventricular fibrillation; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-NY20214297) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of VENTRICULAR FIBRILLATION (Ventricular fibrillation) in a 71-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005285) for Revaccination with different COVID-19 vaccine. Dose 1: Janssen vaccine, 28-May-2021, left arm, intramuscular injection, batch no.: 21C11-02. The patient''s past medical history included Tobacco user, Intestinal polyp and Arteritis in 1996. Concurrent medical conditions included GERD. On 02-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced VENTRICULAR FIBRILLATION (Ventricular fibrillation) (seriousness criteria death and medically significant). The patient died on 05-Sep-2021. The reported cause of death was probable infarctus du myocarde. An autopsy was not performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was reported. No treatment information was reported. patient took Dose 1: Janssen vaccine, 28-May-2021, left arm, intramuscular injection, batch no.: 21C11-02 Moderna reminder on 02-Sep-2021 L arm IM batch 3005285 Company comment: This is a case of Interchange of vaccine products for this 71-year-old male patient with medical history of Tobacco user and Arteritis, who experienced serious unexpected event of ventricular fibrillation. The event occurred approximately 4 days after receiving a dose of mRNA-1273 (it is not specified whether adverse event occurred after the first or second dose) and had a fatal outcome. The patient died on 05-Sep-2021. The reported cause of death was Probable myocardial infarction. An autopsy was not performed. The rechallenge was not applicable as no additional dosing is expected. Medical history of Tobacco user and Arteritis remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation document received on 28-SEP-2021 contains translated verbatim.; Sender''s Comments: This is a case of Interchange of vaccine products for this 71-year-old male patient with medical history of Tobacco user and Arteritis, who experienced serious unexpected event of ventricular fibrillation. The event occurred approximately 4 days after receiving a dose of mRNA-1273 (it is not specified whether adverse event occurred after the first or second dose) and had a fatal outcome. The patient died on 05-Sep-2021. The reported cause of death was Probable myocardial infarction. An autopsy was not performed. The rechallenge was not applicable as no additional dosing is expected. Medical history of Tobacco user and Arteritis remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death.


VAERS ID: 1754914 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute coronary syndrome; Arterial hypertension; Chronic obstructive airways disease; Dermatosclerosis; Insulin-requiring type 2 diabetes mellitus; Ischaemic heart disease; Obesity; Sleep apnea syndrome
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210959880

Write-up: INTERSTITIAL PNEUMONIA DUE TO COVID-19; VACCINATION FAILURE; This spontaneous report received from a health care professional via Regulatory Authority (EVHUMAN Vaccines, FR-AFSSAPS-PV20212858) on 30-SEP-2021 concerned a 58 year old male of an unspecified race and ethnic origin. The patient''s weight was 113 kilograms and height was 170 centimeters. The patient''s concurrent conditions included acute coronary syndrome, sleep apnea syndrome, insulin-requiring type 2 diabetes mellitus, chronic obstructive airways disease, obesity, dermatosclerosis, arterial hypertension and ischaemic heart disease. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-02, expiry: unknown) 0.5 ml dose, frequency time 1 total administered on 27-JUL-2021 for covid-19 vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced interstitial pneumonia due to covid-19 and vaccination failure. On 01-SEP-2021, the patient died from multi organ failure and covid-19. An autopsy was not performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of interstitial pneumonia due to covid-19 and vaccination failure on 01-SEP-2021. The outcome of the events interstitial pneumonia due to covid-19 and vaccination failure was fatal This report was serious (Death). The case was associated with product quality complaint (PQC); Reported Cause(s) of Death: MULTI ORGAN FAILURE; COVID-19


VAERS ID: 1754935 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Body temperature fluctuation, Disturbance in attention, Heart rate, Hypotension, Immunisation, Off label use, Oxygen saturation, Respiratory rate, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-09-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac dysrhythmias; Hypertension arterial; Hypertensive heart disease; Overweight; Type 1 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Haemorrhagic stroke; Hemiplegia; Hyperaldosteronism; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210917; Test Name: hypotension; Result Unstructured Data: Test Result:85/5; Test Date: 20210917; Test Name: fever; Result Unstructured Data: Test Result:35 Centigrade; Test Date: 20210917; Test Name: fever; Result Unstructured Data: Test Result:42 Centigrade; Test Date: 20210917; Test Name: pulse; Result Unstructured Data: Test Result:95; Test Date: 20210917; Test Name: saturation; Result Unstructured Data: Test Result:97; Test Date: 20210917; Test Name: respiratory rate; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC202101262374

Write-up: fever 35 then 42 centigrade; Hypotension 85/5; vigilance disorder; vomiting; third dose; third dose; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-TO20218045. A 64-year-old male patient received the third dose of BNT162B2 (COMIRNATY, Lot Number: unknown), at the age of 64 years old, via intramuscular on 14Sep2021 as booster single dose for COVID-19 immunisation. Medical history included ongoing overweight, ongoing heart rhythm disturbance, hemiplegia, ongoing severe secondary hypertension arterial, ongoing type 1 diabetes mellitus, ongoing hypertensive heart disease per hyperaldosteronism, hyperaldosteronism, COVID-19 (not ongoing), haemorrhagic stroke from 2012 (not ongoing), and type 2 diabetes. The patient''s concomitant medications were not reported. The patient received an injection of BNT162B2 vaccine on 14Sep2021. On 17Sep2021, vigilance disorder, fever 35 then 42 centigrade, hypotension 85/5, pulse 95, saturation 97, respiratory rate normal, 1 vomiting 24 hours after the injection (3rd dose booster, after severe history of COVID). Patient required urgent medical intervention. Seriousness criteria was death, life-threatening. The patient underwent lab tests and procedures which included fever: 35 centigrade, fever: 42 centigrade, hypotension: 85/5, pulse: 95, saturation: 97, respiratory rate: normal, all were on 17Sep2021. The outcome of events vigilance disorder, fever 35 then 42 centigrade, hypotension 85/5, vomiting was fatal. The outcome of other events was unknown. The patient died on 18Sep2021. An autopsy was performed and results were not provided (awaiting autopsy result). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: vigilance disorder; fever 35 then 42 centigrade; Hypotension 85/5; vomiting


VAERS ID: 1754975 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-26
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aortic dissection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOL SANDOZ; AMLODIPINUM; ATORVASTATIN
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of AORTIC DISSECTION in an 81-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 300042723 and 300042460) for COVID-19 immunisation. No medical history was provided by the reporter. Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOL SANDOZ), AMLODIPINE (AMLODIPINUM) and ATORVASTATIN for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 25-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 26-Feb-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced AORTIC DISSECTION (seriousness criteria death and medically significant). The patient died on 27-Feb-2021. The reported cause of death was Type A aortic dissection. It is unknown if an autopsy was performed. Treatment medications included were Dafalgan (paracetamol). On the morning of 02/26/2021, the patient was found barely responsive in her bed. The 82-year-old female patient (weight: 62 kg) was given the first dose of Moderna COVID-19 on 01/28/2021 (COVID-19 mRNA vaccine (nucleoside-modified) batch no.: 300042460) and on 02/25/2021 was vaccinated the second time with Moderna COVID-19 vaccine (COVID- 19 mRNA vaccine (nucleoside-modified) batch no.: 300042723). The patient had a severe reaction to the first Covid-19 vaccination (not specified in more detail). After the second vaccination, the patient took precautionary Dafalgan (paracetamol). On the morning of 02/26/2021, the patient was found barely responsive in her bed. On the same day, the patient was diagnosed with acute aortic dissection of Stanford type A, DeBakey type 1 with subtotal occlusion of the common carotid artery on the right up to the origin of the internal carotid artery. On 02/27/2021, the patient died. Other medications until the occurrence of the ADR: Pantoprazole Sandoz (pantoprazole) 20 mg po 1-0-0-0 Amlodipine Mepha (amlodipine) 10 mg PO 0.5-0-0-0 Atorvastatin Mepha (atorvastatin) 10 mg po 1-0-0-0. This case concerns a 81 year-old female patient with no reported medical history who experienced the unexpected event of aortic dissection which was fatal. The event occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge was not applicable as the event resulted in death. The benefit-risk relationship of mRNA-1273 is not affected by this report. The source document shows a discrepancy in the patient''s age as 81 years vs. 82 years. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation received on 28-SEP-2021 contain significant information that include I narrative updated.; Sender''s Comments: This case concerns a 81 year-old female patient with no reported medical history who experienced the unexpected event of aortic dissection which was fatal. The event occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge was not applicable as the event resulted in death. The benefit-risk relationship of mRNA-1273 is not affected by this report. The source document shows a discrepancy in the patient''s age as 81 years vs. 82 years.; Reported Cause(s) of Death: Type A aortic dissection


VAERS ID: 1755149 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-20
Onset:2021-09-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial ischaemia, SARS-CoV-2 test
SMQs:, Other ischaemic heart disease (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-22
   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: COPD (mild COPD); Prostate cancer; Prostatectomy (prostate ca- prostatectomy 2019)
Allergies:
Diagnostic Lab Data: Test Date: 20210922; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101265201

Write-up: Acute myocardial ischemia; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109231306586340-GL4ES, Safety Report Unique Identifier GB-MHRA-ADR 25983597. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 20Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included prostatectomy in 2019 for prostate CA, mild chronic obstructive pulmonary disease. Patient had not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced acute myocardial ischemia on 22Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 22Sep2021. Patient had not tested positive for COVID-19 since having the vaccine. The patient died on 22Sep2021. It was not reported if an autopsy was performed. The outcome of event Acute myocardial ischemia was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Acute myocardial ischemia


VAERS ID: 1755185 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal hypokinesia, Maternal exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: ultrasound; Result Unstructured Data: Test Result:the baby, fluid and cord flow
CDC Split Type: GBPFIZER INC202101281229

Write-up: Foetal movements decreased; Maternal exposure during pregnancy/Third-trimester (29-40 weeks).; This is a spontaneous report from a contactable consumer (parent/mother). This is the second of 2 reports. The first report is received from the Regulatory Agency (RA), GB-MHRA-WEBCOVID-202109112001135070-KJBAQ. This consumer reported information for both mother and baby. This is the baby case. A female fetus patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW3143) via transplacental route on 27May2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The fetus experienced foetal movements decreased on 10Jun2021, serious for death and hospitalization, and maternal exposure during pregnancy/third-trimester (29-40 weeks) on 27May2021. The clinical course of the event was described as follows: On the morning of 10Jun2021, the mother attended maternity triage at hospital for reduced foetal movements, after a quiet early morning. Baby started moving when mother was hooked up to the CTG, but there was a reduction in fundal height from 33cm (as recorded during regular monitoring on 06Jun2021) to 31cm, when exactly 34 weeks on 10Jun2021 and so forecast to be 34cm. After good movements from baby for the rest of Thursday and all day Friday, she was more subdued on Saturday. At a regular midwife appointment on Sunday, 13Jun2021 (at 34+3), no heartbeat could be found. Mother was walked to maternity triage and this was confirmed further by a midwife and three doctors, including ultrasound checks of the baby, fluid and cord flow. Mother was induced and gave birth at 05:01 at 35+2. The patient (fetus) died on 13Jun2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101191534 Mother case; Reported Cause(s) of Death: Maternal exposure during pregnancy/Third-trimester (29-40 weeks).; Foetal movements decreased


VAERS ID: 1755208 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-09
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-10
   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: QUETIAPINE; TAVOR [LORAZEPAM]; PULMICORT; ATROVENT; LEPONEX
Current Illness: Chronic obstructive pulmonary disease; Schizophrenia; Smoker
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRJNJFOC20210960316

Write-up: SUDDEN DEATH; ASTHENIA; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, GR-GREOF-20218026) on 30-SEP-2021 concerned a 78 year old female. The patient''s weight was 160 kilograms, and height was 75 centimeters. The patient''s concurrent conditions included: chronic obstructive pulmonary disease, smoker, and schizophrenia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, 1 total, administered on 09-SEP-2021 for covid-19 vaccination (1 day). The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included budesonide (twice daily for 252 days) and ipratropium bromide (once daily for 252 days) for chronic obstructive pulmonary disease. Clozapine (50 mg in the morning and 100 mg in the evening for 2079 days), lorazepam( for 1348 days) and quetiapine (50 mg at noon and 200 mg at night for 1348 days) for schizophrenia. On 09-SEP-2021, the patient experienced asthenia. The patient suddenly died on 10-SEP-2021 due to cardio respiratory arrest. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of asthenia and sudden death on 10-SEP-2021. This report was serious (Death).; Reported Cause(s) of Death: CARDIO-RESPIRATORY ARREST


VAERS ID: 1755400 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Thrombophlebitis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101262696

Write-up: Thrombophlebitis; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-789285. This consumer reported different event for the same patient for the second dose of Comirnaty. This is the first of two reports. An 89-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular on 31Mar2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included diabetes. Concomitant medication was not reported. On 05Apr2021, the patient experienced thrombophlebitis. On an unspecified date, the patient died. Autopsy was unknown. Reported Dosage of Comirnaty vaccine: 0.3 mg, cyclical. Comments: 20Sep2021 - With reference to what happened, it was ask: suspected medicinal product lot, concomitant therapies of the patient for the declared pathology and for the others present. results of exams taken. The outcome of event was fatal. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reporter''s Comments: diabetes, pluripathology; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101272620 same patient, different event for 2nd dose of Comirnaty; Reported Cause(s) of Death: Thrombophlebitis


VAERS ID: 1755404 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-07-13
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial tachycardia, Cardiomegaly, Fall, Ischaemia
SMQs:, Cardiac failure (broad), Supraventricular tachyarrhythmias (narrow), Accidents and injuries (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101262445

Write-up: atrial tachycardia; Death by collapse; abnormally enlarged heart; microischemia; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-789580. A 72-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: Unknown), via an unspecified route of administration on 21Apr2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 13Jul2021, patient experienced collapse in the emergency room of PRIVACY (abnormally enlarged heart) and microischemia. Emergency room admission. Impact on quality of life (10/10). On an unspecified date, patient experienced atrial tachycardia. The patient died on an unspecified date. It was not reported if an autopsy was performed. Autopsy recommended, but reporter didn''t want his father to open for 2 time. The outcome of events collapse, abnormally enlarged heart and microischemia was fatal. The outcome of event atrial tachycardia was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death by collapse; abnormally enlarged heart; microischemia


VAERS ID: 1755444 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Body temperature, Cardiac failure, Pneumonia bacterial, Protein induced by vitamin K absence or antagonist II, X-ray
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aspiration; Hepatocellular carcinoma recurrent; Hospitalisation; Oral intake reduced; Transcatheter arterial chemoembolisation
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: auscultation; Result Unstructured Data: Test Result:bilateral pneumonia; Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: before vaccination; Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result:38 or more Centigrade; Test Date: 20210528; Test Name: PIVKA-II; Result Unstructured Data: Test Result:4430; Comments: mAU/mL; Test Date: 20210702; Test Name: PIVKA-II; Result Unstructured Data: Test Result:11034; Comments: mAU/mL; Test Name: X-ray; Result Unstructured Data: Test Result:bilateral pneumonia; Test Date: 20210706; Test Name: X-ray; Result Unstructured Data: Test Result:bilateral pneumonia
CDC Split Type: JPPFIZER INC202101266778

Write-up: Cardiac failure aggravated due to pneumonia bacterial; Bilateral pneumonia/pneumonia bacterial; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21127665. An 84-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 05Jul2021 14:39 (Batch/Lot Number: EW0207; Expiration Date: 30Sep2021) as DOSE 1, SINGLE for covid-19 immunisation at the age of 84-year-old. Medical history included hospitalisation from 02Jul2021 to an unknown date, Post TACE recurrence of hepatocellular carcinoma/advancement of hepatocellular carcinoma recurrent, could not eat orally, aspiration. The patient experienced bilateral pneumonia/ pneumonia bacterial on 06Jul2021, cardiac failure aggravated due to pneumonia bacterial on an unspecified date. Therapeutic measures were taken as a result of bilateral pneumonia. The patient died on 10Jul2021. It was not reported if an autopsy was performed. The outcome of events was fatal. The clinical course was reported as: The patient was an 84-year and 9-month-old male. Body temperature before vaccination was 35.6 degrees Centigrade. Medical history included hospitalization from 02Jul2021, post TACE recurrence of hepatocellular carcinoma (PIVKAII 11034 mAU/mL on 02Jul2021), could not eat orally, and aspiration. The patient was not taking oral drugs, and under hyperalimentation (IVH) management. On 05Jul2021 at 14:39 (the day of vaccination), the patient received?the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via an unspecified route of administration as a single dose (at the age of 89-year-old) for COVID-19 immunization. On 06Jul2021 (1 day after the vaccination), the patient experienced bilateral pneumonia. On 10Jul2021 (5 days after the vaccination), the outcome of the event was fatal. Causes of death was pneumonia and hepatocellular carcinoma. The course of the event was as follows: PIVKAII level at medical visit on 28May2021was 4430 mAU/mL, it increased to 2 times or more on admission on 02Jul2021. The patient could not eat orally because of advancement of hepatocellular carcinoma recurrent, and aspiration was seen. Since Jul2021, the patient had been fasting and intravenous IVH was performed. On 05Jul2021, the first vaccination for novel coronavirus was performed normally after confirming the patient''s intent and obtaining the patient''s consent. On the following day(06Jul2021), a high fever of 38 degree or more was observed. Based on examinations including auscultation and X-ray, bilateral pneumonia was considered, and antibiotics was administered. On 08Jul2021, rale disappeared, and his consciousness level improved that the patient could nod when the patient was talked to. On 10Jul2021, however, the condition suddenly changed, and the patient died. It was explained to the family members that the causes of death were pneumonia and hepatocellular carcinoma, but the family members thought the causality between the event and BNT162b2. The reporting physician classified the event bilateral pneumonia as serious (fatal) and assessed that the event was unrelated to BNT162b2. Other possible cause(s) of the event such as any other diseases was cardiac failure aggravated due to pneumonia bacterial. The reporting physician commented as follows: No treatment for anaphylactic shock was given, and temporal improvement of the symptoms was seen with antibiotic treatment. Based on those, it was considered that the events were unrelated to BNT162b2.; Sender''s Comments: Based on the information provided in the narrative, the relationship between the suspect drug and the events is not related.; Reported Cause(s) of Death: Cardiac failure aggravated; Hepatocellular carcinoma; pneumonia/Bilateral pneumonia


VAERS ID: 1755446 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), 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: JPPFIZER INC202101268990

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This case is 1st of 6 cases. A elderly (at age of 90s to 100s years) patient of an unspecified gender received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (dose number unknown) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced platelets decreased (non-serious) on an unspecified date and death on an unspecified date. Cause of death was unknown and it was not reported if an autopsy was performed. Outcome of the event platelets decreased at the time of death was unknown. The reporting physician commented that the causality between the events and BNT162b2 was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event death and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s) : JP-PFIZER INC-202101269101 Same reporter, same events,different patient;JP-PFIZER INC-202101269194 Same reporter, same events,different patient;JP-PFIZER INC-202101269278 Same reporter, same events,different patient;JP-PFIZER INC-202101269353 Same reporter, same events,different patient;JP-PFIZER INC-202101269416 Same reporter, same events,different patient; Reported Cause(s) of Death: death.


VAERS ID: 1755447 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), 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: Test Name: platelet count; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC202101269101

Write-up: Death; Platelets decreased; This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported same events for 6 patients. This case is the 2nd of 6 reports. An elderly (at age of 90s to 100s years) patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route of administration, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On unknown date, the patient developed platelet decreased, non-serious. On unknown date, the patient experienced death. The cause of death was unknown. Outcome of the event platelets decreased at the time of death was unknown. It was unknown if an autopsy was performed The reporting physician commented that the causality between the events and BNT162B2 was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events death and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : JP-PFIZER INC-202101268990 Same reporter, same events,different patient; Reported Cause(s) of Death: death


VAERS ID: 1755449 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Neoplasm progression
SMQs:, Malignancy related conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
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: Cancer surgery (for oesophageal carcinoma); Chemotherapy; Oesophageal carcinoma; Oesophageal carcinoma recurrent
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101269337

Write-up: progression of oesophageal carcinoma; This is a spontaneous report from a contactable physician via a Pfizer sales representative. An 86-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration at single dose for COVID-19 immunisation on 02Jun2021. Medical history included oesophageal carcinoma (underlying disease). In 2018, the patient started receiving chemotherapy and underwent surgery (for oesophageal carcinoma). In Jun2021, oesophageal carcinoma recurrent was found. The patient was receiving terminal care at home. Concomitant medications and family history were not reported. On 23Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration at single dose for COVID-19 immunisation (at age of 86-year-old). Two doses of vaccination were performed with the wish of the patient. On 14Jul2021 (21 days after the vaccination), the patient died due to underlying disease of oesophageal carcinoma (progression of oesophageal carcinoma). Onset date of the event progression of oesophageal carcinoma was unknown. It was unknown if an autopsy was performed. There was no causal relationship between the event and BNT162b2, as the patient died due to progression of oesophageal carcinoma. Information on the lot/batch number has been requested.; Sender''s Comments: Based on known disease pathophysiology, the event of neoplasm progression is assessed as not related to the drug BNT162B2, and more likely due to underlying medical condition of Oesophageal carcinoma .; Reported Cause(s) of Death: progression of oesophageal carcinoma


VAERS ID: 1755450 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), 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: JPPFIZER INC202101269353

Write-up: death; Platelets decreased; This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 6 patients. This is the 5th of 6 cases. An elderly patient (at age of 90s to 100s years) of an unspecified gender received a single unspecified dose of bnt162b2 (COMIRNATY; Solution for injection, Lot number and Expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation, at the clinic. The patient medical history and concomitant medications were not reported. On an unknown date (unknown day(s) after vaccination), the patient experienced platelets decreased, with unknown outcome. On an unknown date (unknown day(s) after vaccination), the patient experienced death. The outcome was fatal. It was not reported if an autopsy was performed.The reporting physician commented that the causality between the events and BNT162b2 was unknown. The lot number for BNT162b2, was not provided and will be requested during follow up.; 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.,Linked Report(s) : JP-PFIZER INC-202101268990 Same reporter, same events,different patient; Reported Cause(s) of Death: death


VAERS ID: 1755451 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), 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: Test Name: platelets; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC202101269416

Write-up: death; Platelets decreased; This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 6 patients. This is the sixth of six reports. An elderly patient (reported as at age of 90s to 100s years) of an unspecified gender received a single unspecified dose number of BNT162b2 (COMIRNATY, solution for injection, lot number and expiration date not reported) via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunisation, at the clinic. The patient medical history and concomitant medications were not provided. On an unknown date (unknown days after vaccination), the patient experienced platelets decreased. On an unknown date (unknown days after vaccination), the patient experienced death. The outcome of death was fatal, while the outcome of the other event was unknown. It was unknown if an autopsy was performed. The reporting physician commented that the causality between the events and BNT162b2 was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: The event death is assessed as related to COMIRNATY use and documented as such in the global safety database until sufficient information is available to allow an unrelated causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : JP-PFIZER INC-202101268990 Same reporter, same events,different patient; Reported Cause(s) of Death: death


VAERS ID: 1755452 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Cardiac death, Computerised tomogram head normal, Computerised tomogram thorax abnormal, Malaise, Myocarditis, Pulmonary oedema, Resuscitation, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-24
   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: Aortic dissection; Surgery (for abdominal aortic dissection)
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination; Test Date: 20210924; Test Name: Head CT; Result Unstructured Data: Test Result:no abnormalities; Comments: no abnormalities; Test Date: 20210924; Test Name: Chest CT; Result Unstructured Data: Test Result:pulmonary oedemas on the both lungs; Comments: pulmonary oedemas on the both lungs
CDC Split Type: JPPFIZER INC202101269746

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21128854. A 48-year-old female patient received first dose of bnt162b2 (COMIRNATY via an unspecified route of administration on 10Sep2021 15:00 (Lot Number: FF9942; Expiration Date: 30Nov2021) as single dose (at age of 48-year-old) for covid-19 immunisation. Medical history included abdominal aortic dissection, surgery (for abdominal aortic dissection). Concomitant medications were not reported. On 24Sep2021 18:00 patient experienced arrhythmia, on 24Sep2021 18:25 she experienced wheezing breathing and on unknown date she experienced myocarditis and mild malaise. The patient underwent laboratory tests and procedures which included body temperature: 36.1 centigrade on 10Sep2021 before vaccination, computerised tomogram (CT) head: no abnormalities on 24Sep2021, Chest CT: pulmonary edemas on the both lungs on 24Sep2021. Therapeutic measures were taken as a result of arrhythmia. Events arrhythmia and wheezing breathing resulted in emergency room visit. The patient died on 24Sep2021 due to arrhythmia. It was not reported if an autopsy was performed. The clinical course was reported as follows: The patient was a 48-year and 7-month-old female. Body temperature before vaccination was 36.1 degrees centigrade. Medical history included abdominal aortic dissection and the patient underwent surgery for abdominal aortic dissection. On 10Sep2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FF9942, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 24Sep2021 at 18:00 (14 days after the vaccination), the patient experienced arrhythmia. On 24Sep2021 (14 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: Mild malaise persisted for approximately 2 weeks after the vaccination. On 24Sep2021, at 18:25 (14 days after the vaccination), the patient was found to have wheezing breathing sitting in a chair by her family member, and an ambulance was called. Although the patient was emergently transferred, she was confirmed to die at 21:35 (14 days after the vaccination), due to arrhythmia. Head CT at the hospital where the patient was transferred to showed no abnormalities. Chest CT showed pulmonary oedemas on the both lungs (there was a possibility of the effect by cardiopulmonary resuscitation during transfer). Patient died due to arrhythmia, outcome of the other events was unknown. The reporting physician classified the event arrhythmia as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was as follows: The patient had surgical history of abdominal aortic dissection. The reporting physician commented as follows: Although the patient was after surgery for abdominal aortic dissection, her activity of daily living (ADL) was independent. Although malaise persisted after the vaccination, the course was observed without problems in her daily life. Since the course was rapid, and arrhythmia was noted during transfer, a possibility was considerable that the patient had arrhythmia caused by myocarditis.; Reported Cause(s) of Death: Arrhythmia.


VAERS ID: 1755453 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Food allergy
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: JPPFIZER INC202101274264

Write-up: buckwheat allergy; This is a spontaneous report from a contactable consumer received via Medical Information Team. A patient of unspecified age and gender received BNT162b2 (COVID-19 Vaccine -MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE dose (DOSE NUMBER UNKNOWN) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced buckwheat allergy on an unspecified date. According to the reporter, although the reporter did not know if the patient had received the vaccination of Pfizer or MODEERNA, the patient died from buckwheat allergy.The reporter called the call center to ask whether the reporter could get the vaccination although he/she also had food allergy.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: buckwheat allergy


VAERS ID: 1755460 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005239 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Cerebral ventricular rupture
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-20
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Cerebral haemorrhage; Cerebral ventricular rupture; This case was received via the Regulatory Authority (Reference number: JP-TAKEDA-2021TJP095727) on 24-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Regulatory Authority by a clerical work, was received via the RA(Ref, v21128837). The patient''s underlying condition, cerebral arteriovenous malformation, was discussed with the interviewing physician, and the possibility of vaccination was discussed. On 16-Sep-2021, at 11:00, the patient received the 1st dose of this vaccine. Around 20:00, the patient had a headache and vomiting, so the patient''s family called for ambulance. At 20:50, the patient was taken to the hospital. The patients JCS3 was 300 on arrival. CT showed cerebral haemorrhage and cerebral ventricular rupture from cerebral arteriovenous malformation. On 20-Sep-2021, the patient was confirmed dead. The outcome of cerebral haemorrhage and cerebral ventricular rupture was reported as fatal. Follow-up investigation will be made. Company Comment: Although the events "cerebral haemorrhage" and "cerebral ventricular rupture" developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), factors such as concurrent conditions and predisposing factors of the patient may have also had an influence.; Reporter''s Comments: Although the events "cerebral haemorrhage" and "cerebral ventricular rupture" developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), factors such as concurrent conditions and predisposing factors of the patient may have also had an influence.; Sender''s Comments: This case concerns a 15-year-old, male patient with medical history of cerebral arteriovenous malformation, who experienced the unexpected serious adverse event of special interest of cerebral haemorrhage and unexpected serious adverse event of cerebral ventricular rupture . The events occurred approximately 9 hours after the first dose of Spikevax (Moderna COVID-19 vaccine) and had fatal outcome with death occurring 3 days after following day. The rechallenge was not applicable as the events occurred after the first dose. The event was considered related to the vaccine per the reporter''s assessment. The medical history of the patient of previous cerebral arteriovenous malformation remain as a significant confounder. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Cerebral haemorrhage; Cerebral ventricular rupture


VAERS ID: 1755474 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-09-04
   Days after vaccination:194
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Altered state of consciousness, Blood creatinine, Blood urea, C-reactive protein, COVID-19, Chest X-ray, Culture, Dyspnoea, Escherichia test positive, Glomerular filtration rate, Haemoglobin, Lethargy, Lower respiratory tract infection, Lymphocyte count, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Nitrite urine present, Oxygen saturation, Oxygen saturation decreased, Platelet count, Prothrombin time, Red blood cells urine positive, Respiratory rate, SARS-CoV-2 test, Sepsis, Urine analysis, Vaccination failure, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-19
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; COPD; Diverticular disease; Ex-smoker; GERD; Glaucoma; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: creatinine; Result Unstructured Data: Test Result:108; Comments: High fell to normal on 16/09; Test Date: 20210914; Test Name: creatinine; Result Unstructured Data: Test Result:125; Comments: High fell to normal on 16/09; Test Date: 20210915; Test Name: creatinine; Result Unstructured Data: Test Result:103; Comments: High fell to normal on 16/09; Test Date: 20210916; Test Name: creatinine; Result Unstructured Data: Test Result:83; Comments: High fell to normal on 16/09; Test Date: 20210918; Test Name: creatinine; Result Unstructured Data: Test Result:66; Comments: High fell to normal on 16/09; Test Date: 20210911; Test Name: Urea; Result Unstructured Data: Test Result:19; Comments: High throughout (Rise and fall); Test Date: 20210914; Test Name: Urea; Result Unstructured Data: Test Result:32; Comments: High throughout (Rise and fall); Test Date: 20210915; Test Name: Urea; Result Unstructured Data: Test Result:26; Comments: High throughout (Rise and fall); Test Date: 20210916; Test Name: Urea; Result Unstructured Data: Test Result:22; Comments: High throughout (Rise and fall); Test Date: 20210918; Test Name: Urea; Result Unstructured Data: Test Result:13; Comments: High throughout (Rise and fall); Test Date: 20210911; Test Name: Imaging for COVID-Pneumonia; Result Unstructured Data: Test Result:No evidence of consolidation; Comments: No significant abnormality; Test Date: 20210911; Test Name: C-reactive protein; Result Unstructured Data: Test Result:121; Comments: HIGH but consistent fall; Test Date: 20210914; Test Name: C-reactive protein; Result Unstructured Data: Test Result:69; Comments: HIGH but consistent fall; Test Date: 20210915; Test Name: C-reactive protein; Result Unstructured Data: Test Result:58; Comments: HIGH but consistent fall; Test Date: 20210916; Test Name: C-reactive protein; Result Unstructured Data: Test Result:32; Comments: HIGH but consistent fall; Test Date: 20210918; Test Name: C-reactive protein; Result Unstructured Data: Test Result:24; Comments: HIGH but consistent fall; Test Date: 20210912; Test Name: Culture; Result Unstructured Data: Test Result:E coli cultivated; Test Date: 20210911; Test Name: EGFR; Result Unstructured Data: Test Result:58; Comments: Low to normal; Test Date: 20210914; Test Name: EGFR; Result Unstructured Data: Test Result:49; Comments: Low to normal; Test Date: 20210915; Test Name: EGFR; Result Unstructured Data: Test Result:61; Comments: Low to normal; Test Date: 20210916; Test Name: EGFR; Result Unstructured Data: Test Result:79; Comments: Low to normal; Test Date: 20210918; Test Name: EGFR; Result Unstructured Data: Test Result:102; Comments: Low to normal; Test Date: 20210916; Test Name: Haemoglobin; Result Unstructured Data: Test Result:14; Comments: 1 abnormal reading, otherwise within normal; Test Date: 20210911; Test Name: lymphocytes; Result Unstructured Data: Test Result:1.2; Comments: All Low; Test Date: 20210914; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.8; Comments: All Low; Test Date: 20210916; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.6; Comments: All Low; Test Date: 20210918; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.8; Comments: All Low; Test Date: 20210911; Test Name: Neutrophil; Result Unstructured Data: Test Result:11; Comments: All High; Test Date: 20210914; Test Name: Neutrophil; Result Unstructured Data: Test Result:17; Comments: All High; Test Date: 20210916; Test Name: Neutrophil; Result Unstructured Data: Test Result:19; Comments: All High; Test Date: 20210918; Test Name: Neutrophil; Result Unstructured Data: Test Result:11; Comments: All High; Test Date: 20210911; Test Name: NT pro BNP; Result Unstructured Data: Test Result:4277; Comments: High; Test Name: oxygen saturation; Test Result: 87 %; Comments: on RA; Test Date: 20210911; Test Name: Platelet count; Result Unstructured Data: Test Result:363; Comments: High fell to normal on 16/09; Test Date: 20210914; Test Name: Platelet count; Result Unstructured Data: Test Result:364; Comments: High fell to normal on 16/09; Test Date: 20210916; Test Name: Platelet count; Result Unstructured Data: Test Result:291; Comments: High fell to normal on 16/09; Test Date: 20210918; Test Name: Platelet count; Result Unstructured Data: Test Result:208; Comments: High fell to normal on 16/09; Test Date: 20210911; Test Name: PT; Result Unstructured Data: Test Result:10.9; Comments: Normal; Test Name: Respiratory rate; Result Unstructured Data: Test Result:more than 25 bpm; Test Date: 20210911; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:Detected - CT 17; Test Date: 20210912; Test Name: Urine analysis; Result Unstructured Data: Test Result:Positive for nitrites, RBCs; Test Date: 20210911; Test Name: WBC; Result Unstructured Data: Test Result:13.6; Comments: All High; Test Date: 20210914; Test Name: WBC; Result Unstructured Data: Test Result:18.4; Comments: All High; Test Date: 20210916; Test Name: WBC; Result Unstructured Data: Test Result:19.9; Comments: All High; Test Date: 20210918; Test Name: WBC; Result Unstructured Data: Test Result:11.9; Comments: All High
CDC Split Type: MTPFIZER INC202101281111

Write-up: COVID-19; COVID-19; lower respiratory tract infection; sepsis; E coli cultivated in culture; Positive for nitrites, RBCs in urine analysis; Positive for nitrites, RBCs in urine analysis; increasing lethargy; SOB; SpO2 86%; Acute kidney injury; altered consciousness (lethargic); This is a spontaneous report from a contactable physician. A 99-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscularly administered in the left arm on 22Feb2021 (lot number: EL0725) as dose 2, single and intramuscularly administered in the left arm on 01Feb2021 (lot number: EJ6134) as dose 1, single, both for COVID-19 immunization. Medical history included hypertension, chronic obstructive pulmonary disease (COPD), gastrooesophageal reflux disease (GERD), benign prostatic hyperplasia, glaucoma, diverticulum disease and ex- smoker, all from an unknown date and unknown if ongoing. Concomitant medications included latanoprost, ipratropium bromide (ATROVENT), beclomethasone, dutasteride, tamsulosin hydrochloride (COMBODART), omeprazole, brimonidine tartrate (BRYMONT), melatonin (CIRCADIN) and colecalciferol (FORTE D), all taken for unspecified indications, start and stop dates were not reported. The patient experienced sepsis on 19Sep2021, lower respiratory tract infection on an unspecified date, COVID-19 on 11Sep2021, acute kidney injury, altered consciousness (lethargic) on an unspecified date in 2021, increasing lethargy, shortness of breath (SOB), SpO2 86% on 04Sep2021, E. coli cultivated in culture and positive for nitrites, RBCs in urine analysis on 12Sep2021. The patient was hospitalized for COVID-19 from 11Sep2021 to an unknown date for 8 days. It was reported that the patient underwent a nasal swab (RT-PCR) that was positive on 11Sep2021 (new infection). He was admitted from elderly home on 11Sep2021 and died on the 19Sep2021 in the hospital (8 days hospitalization). He had visited emergency department on 04Sep2021 for increasing lethargy, SOB and SpO2 86% RA but discharged back on same day (Covid negative at discharge). Patient deceased in hospital on the 19Sep2021. He had episodes of hypoxia SpO2 - 87% on RA. He had normal face mask - 10L/min, low Saturations, RR more than 25bpm. He had received treatment with Dexamethasone 6mg iv dly from 11Sep2021 to 18Sep2021 and antibiotics - Levofloxacin. It was also reported that the patient had respiratory, renal and neurological symptoms during the COVID-19 illness such as dyspnoea, tachypnoes, hypoxemia. Acute kidney injury. Altered consciousness (lethargic). Primary cause of death was reported as sepsis as a consequence of lower respiratory tract infection as a consequence of COVID-19. Contributory causes included chronic obstructive pulmonary disease. The patient underwent lab tests and procedures which included creatinine: 108 on 11Sep2021, 125 on 14Sep2021, 103 on 15Sep2021, 83 on 16Sep2021, 66 on 18Sep2021 (all were noted to be high fell to normal on 16Sep2021); urea: 19 on 11Sep2021, 32 on 14Sep2021, 26 on 15 Sep2021, 22 on 16Sep2021, 13 on 18Sep2021 [all were noted to be high throughout (rise and fall)]; imaging for COVID-Pneumonia: no evidence of consolidation (no significant abnormality) on 11Sep2021; C-reactive protein: 121 on 11Sep2021, 69 on 14Sep2021, 58 on 15Sep2021, 32 on 16Sep2021, 24 on 18Sep2021 (all were noted to be high but consistent fall); Culture: E coli cultivated on 12Sep2021; EGFR: 58 on 11Sep2021, 49 on 14Sep2021, 61 on 15Sep2021, 79 on 16Sep2021, 102 on 18Sep2021 (all were noted to be low to normal); Haemoglobin: 14 (1 abnormal reading, otherwise within normal) on 16Sep2021; lymphocytes: 1.2 on 11Sep2021, 0.8 on 14Sep2021, 0.6 on 16Sep2021, 0.8 on 18Sep2021 (all low); Neutrophil: 11 on 11Sep2021, 17 on 14Sep2021, 19 on 16Sep2021, 11 on 18Sep2021 (all high); NT pro BNP: 4277 (high); oxygen saturation: 87% on RA on an unspecified date; platelet count: 363 on 11Sep2021, 364 on 14Sep2021, 291 on 16Sep2021, 208 on 18Sep2021 (all noted to be high fell to normal on 16Sep2021); PT: 10.9 (normal) on 11Sep2021; Respiratory rate: more than 25 bpm on an unspecified date; SARS-CoV-2 PCR test: Detected - CT 17 on 11Sep2021; Urine analysis: Positive for nitrites, RBCs on 12Sep2021; and WBC: 13.6 on 11Sep2021, 18.4 on 14Sep2021, 19.9 on 16Sep2021 and 11.9 on 18Sep2021. The patient died on 19Sep2021 due to sepsis as a consequence of lower respiratory tract infection as a consequence of COVID-19. Contributory causes included chronic obstructive pulmonary disease. An autopsy was not performed. The outcome of the events sepsis, lower respiratory tract infection, vaccination failure, COVID-19 was fatal while the outcome of all other events was unknown. No follow-up attempts are needed. No further information is expected.; 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 all reported events cannot be totally excluded.The impact of this report 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: sepsis; lower respiratory tract infection; COVID-19; COVID-19; Chronic obstructive pulmonary disease


VAERS ID: 1755521 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-13
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101263042

Write-up: Cardiac arrest; Scabs in the nose; Bruises all over the body; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00686771. An 83-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previous COVID-19 infection was No. The patient experienced scabs in the nose on 13Feb2021, bruises all over the body on 13Feb2021 and cardiac arrest on 15Feb2021. Bruises and scabs were reported 13Feb2021, but may had been there for longer. The GP (physician) saw no reason for further investigation into the sudden death because there was no indication of a crime. She was old and a heart attack or brain haemorrhage seemed the logical cause of death. Cardiac arrest had officially been reported as the cause of death. There was no diagnostic procedures. The patient died suddenly on 15Feb2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: cardiac arrest; Scabs in the nose; Bruises all over the body


VAERS ID: 1755523 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal growth restriction, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (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: NLPFIZER INC202101277378

Write-up: maternal exposure during pregnancy, first trimester; fetal growth restriction; This is a spontaneous report from a contactable consumer (patient''s mother). This consumer reported information for both mother and fetus. This is a fetal report. Two reports out of three are serious. The original report was downloaded from the Regulatory Authority-WEB NL-LRB-00684090. A fetus patient of an unspecified gender was exposed to bnt162b2 (COMIRNATY) transplacental on 03Aug2021 (lot number and expiry date: unknown) as dose 2, 0.3 ml, single, for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced maternal exposure during pregnancy, first trimester on 03Aug2021, and fetus growth restriction on unspecified date in 2021. The first Covid vaccination took place before mother''s pregnancy, while the second vaccination took place during pregnancy. The fetus stopped dividing at approximately 6 weeks. Miscarriage occurred last week at approximately 10 weeks The fetus died on an unspecified date in 2021. It was unknown if an autopsy was performed. Sender''s comment: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS critera, the reaction was considered as serious by the regulatory authority. Reporter''s comment: BioNTech/Pfizer vaccin (Comirnaty): Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): yes . Date: 22Jun2021. Miscarriage. Additional information ADR: At the time of the second vaccination I was pregnant. According to the gyn''s calculations, a few days later the embryo stopped dividing. Citizen service number available: yes. Confounding factors. Vaccine exposure during pregnancy week: I was not pregnant at the time of the first vaccination. Previous COVID-19 infection: No. Follow-up: Miscarriage occurred last week at approx. 10 weeks. The fetus stopped dividing at approx. 6 weeks. No follow-up attempts are possible, information on batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101263453 mother case;NL-PFIZER INC-202101229191 mother case; Reported Cause(s) of Death: fetal growth restriction


VAERS ID: 1755552 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-10
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), 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: Test Date: 20210815; Test Name: COVID-19 antigen test; Result Unstructured Data: Positive; Test Date: 20210818; Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20210959662

Write-up: COVID-19 CONFIRMED POSITIVE; ANTIGEN POSITIVE; FEVER; DIFFICULTY OF BREATHING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA,PH-PHFDA-300107189] concerned an 85 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported,1 total administered on 29-JUL-2021 for an unspecified indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 10-AUG-2021, the patient experienced fever and difficulty of breathing. On 15-AUG-2021, the patient was tested antigen positive. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. On 18-AUG-2021, the patient was confirmed covid-19 positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The patient was hospitalized for the events for unspecified number of days. On an unspecified date, the patient died from fever, difficulty of breathing, covid-19 confirmed positive, and antigen positive. It was unknown, if an autopsy was performed. COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the patient died from fever, difficulty of breathing, covid-19 confirmed positive, and antigen positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210959662-COVID-19 VACCINE AD26.COV2.S-fever, difficulty of breathing, covid-19 confirmed positive, and antigen positive. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FEVER; DIFFICULTY OF BREATHING; COVID-19 CONFIRMED POSITIVE; ANTIGEN POSITIVE


VAERS ID: 1755557 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-20
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea, Malaise, Nasopharyngitis, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: Test Date: 20210920; Test Name: COVID-19 antigen test; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20210960184

Write-up: COUGH; COLDS; BODY MALAISE; DOB; COVID-19 ANITEN TEST POSITIVE; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [PHIFDA, PH-PHFDA-300107022] concerned a 70 year old male. The patient''s weight, and height were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: unknown) dose was not reported, 1 total, administered on 29-JUL-2021 for drug used for unknown indication. No concomitant medications were reported. On 20-SEP-2021 at 18:00, the patient experienced cough, colds, body malaise, difficulty of breathing (DOB), covid-19 antigen test positive (suspected clinical vaccination failure). The patient was hospitalized on an unspecified date for unspecified days. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. On an unspecified date, the patient died from cough, cold, malaise, difficulty breathing, and covid-19. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of colds, body malaise, difficulty of breathing and covid-19 antigen test positive on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint.; Sender''s Comments: V0: 20210960184-COVID-19 VACCINE AD26.COV2.S � cough, cold, body malaise, difficulty breathing and covid-19 antigen test positive. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210960184-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COUGH; COLDS; BODY MALAISE; DIFFICULTY BREATHING; COVID-19 ANTITEN TEST POSITIVE


VAERS ID: 1755558 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-18
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), 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: PHJNJFOC20210960291

Write-up: BODY WEAKNESS; INTERMITTENT FEVER; LOSS OF APPETITE; This spontaneous report received from a physician via a Regulatory Authority [PHIFDA, PH-PHFDA-300107805] concerned an 81 year old male of unspecified race and ethnicity. The patient''s weight, height were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A (batch 1), and expiry: unknown) dose was not reported, 1 total, administered on 06-AUG-2021 for drug used for unknown indication. No concomitant medications were reported. On 18-SEP-2021 at 09:00, the patient experienced intermittent fever and on the same day the patient experienced loss of appetite. On 22-SEP-2021, the patient experienced body weakness. On an unspecified date, the patient died from intermittent fever, loss of appetite, and body weakness. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of loss of appetite, intermittent fever and body weakness was fatal. This report was serious (Death).; Sender''s Comments: V0: 20210960291-Covid-19 vaccine ad26.cov2.s-loss of appetite, body weakness, and intermittent fever. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: INTERMITTENT FEVER; LOSS OF APPETITE; BODY WEAKNESS


VAERS ID: 1755559 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-09-05
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004222 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death, Hypertension, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-05
   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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHMODERNATX, INC.MOD20213

Write-up: Respiratory Failure; Hypertension; COVID-19 critical; Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), RESPIRATORY FAILURE (Respiratory Failure), HYPERTENSION (Hypertension) and COVID-19 (COVID-19 critical) in a 67-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004222) for COVID-19 immunisation. Concurrent medical conditions included Hypertension. On 20-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced RESPIRATORY FAILURE (Respiratory Failure) (seriousness criteria death and medically significant), HYPERTENSION (Hypertension) (seriousness criterion death) and COVID-19 (COVID-19 critical) (seriousness criterion death). The patient died on 05-Sep-2021. The reported cause of death was Respiratory failure, covid-19 critical and Hypertension. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication reported. No treatment was provided. It was reported that patient was died by immediate cause was respiratory failure, antecedent cause was COVID-19 critical and underlying cause was hypertension. On 31-Aug-2021, it was reported that the patient had unspecified event. Company Comment - This fatal case concerns a 67-year-old male patient with a history of hypertension, who experienced the serious unexpected events respiratory failure, covid-19 and Death. The patient died 16 days after dose of mRNA-1273 Moderna vaccine. Reported cause of death: respiratory failure (immediate), COVID-19 critical (antecedent cause) and hypertension (underlying cause). It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender''s Comments: This fatal case concerns a 67-year-old male patient with a history of hypertension, who experienced the serious unexpected events respiratory failure, covid-19 and Death. The patient died 16 days after dose of mRNA-1273 Moderna vaccine. Reported cause of death: respiratory failure (immediate), COVID-19 critical (antecedent cause) and hypertension (underlying cause). It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Reported Cause(s) of Death: Respiratory Failure; COVID-19 critical; Hypertension


VAERS ID: 1755564 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 056D21A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Death, 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: 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: PHMODERNATX, INC.MOD20213

Write-up: death; FEVER; COUGH; DOB; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (death), PYREXIA (FEVER), COUGH (COUGH) and DYSPNOEA (DOB) in a 54-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 056D21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced PYREXIA (FEVER) (seriousness criterion medically significant), COUGH (COUGH) (seriousness criterion medically significant) and DYSPNOEA (DOB) (seriousness criterion medically significant). On 15-Sep-2021, PYREXIA (FEVER), COUGH (COUGH) and DYSPNOEA (DOB) outcome was unknown. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Regulatory reference: PH-PHFDA-300105540 This case concerns a 54-year-old female patient with no relevant medical history reported, who experienced serious unexpected events of pyrexia, cough and dyspnoea. The events occurred approximately 6 days after receiving a dose of mRNA-1273 (it is not specified whether adverse events occurred after the first or second dose). The patient died on an unknown date. The cause of death is unknown. It is unknown if an autopsy was performed. Rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 54-year-old female patient with no relevant medical history reported, who experienced serious unexpected events of pyrexia, cough and dyspnoea. The events occurred approximately 6 days after receiving a dose of mRNA-1273 (it is not specified whether adverse events occurred after the first or second dose). The patient died on an unknown date. The cause of death is unknown. It is unknown if an autopsy was performed. Rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: unknown


VAERS ID: 1755568 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHMODERNATX, INC.MOD20213

Write-up: came in due to body weakness; This regulatory authority case was reported by an other health care professional and describes the occurrence of in a 91-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 21-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medication were reported. Company Comment: This case concerns a 91-year-old, female patient with no relevant medical history, who experienced the unexpected event of asthenia. The event asthenia occurrence unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. The event asthenia had a fatal outcome. The rechallenge was not applicable since the patient had fatal outcome. The patient age remain a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The RA SD does not contain the onset date, onset latency, onset from the last dose for the event asthenia. It does not also contain the dose number, dosage, dosage form, dosage route and site of administration for the mRNA-1273 vaccine. No past medical history, no laboratory or diagnostics, no treatment information was given.; Sender''s Comments: This case concerns a 91-year-old, female patient with no relevant medical history, who experienced the unexpected event of asthenia. The event asthenia occurrence unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. The event asthenia had a fatal outcome. The rechallenge was not applicable since the patient had fatal outcome. The patient age remain a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The RA SD does not contain the onset date, onset latency, onset from the last dose for the event asthenia. It does not also contain the dose number, dosage, dosage form, dosage route and site of administration for the mRNA-1273 vaccine. No past medical history, no laboratory or diagnostics, no treatment information was given.; Reported Cause(s) of Death: unknown


VAERS ID: 1755572 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Epilepsy, General physical health deterioration, Infection, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PLPFIZER INC202101269645

Write-up: seizures/convulsions; epilepsy; infection; health deteriorated; death; This is a spontaneous report from a contactable physician. An 80-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation at the age of 80-year-old. The patient medical history and concomitant medications were not reported. The patient experienced death, seizures/convulsions, epilepsy, infection, health deteriorated on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The clinical course was reported as: The patient was vaccinated in July/August 2021 with the PFIZER vaccine against covid19. 3 hours after vaccination, she got convulsions, as a result of which she found herself in the neurology department. After leaving the hospital, she caught infections, her health deteriorated, which slowly led to a deterioration in health, epilepsy, and finally death. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event (death, seizures, epilepsy) and the BNT162B2 cannot be excluded. "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate." ; Reported Cause(s) of Death: death


VAERS ID: 1755573 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Death, Malaise, Off label use, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   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: Hypertension (had been treated for many years and had all parameters within the normal range while taking meds); Smoker (but was not diagnosed with any chronic disease)
Allergies:
Diagnostic Lab Data: Test Date: 20210923; Test Name: low-grade fever; Result Unstructured Data: Test Result:low grade fever
CDC Split Type: PLPFIZER INC202101269681

Write-up: Malaise; Pain in arm; Shoulder pain; low grade fever; who took the 3rd dose of your vaccine; Death; This is a spontaneous report from a contactable consumer received by e-mail. A 70-year-old male patient received the third dose of BNT162B2 (COMIRNATY, solution for injection, Lot number unknown), via an unspecified route, on 22Sep2021 at single dose for COVID-19 immunisation. Relevant medical history included hypertension (he had been treated for many years and had all parameters within the normal range while taking medication) and smoker (but was not diagnosed with any chronic disease). No relevant concomitant medications were provided. On 23Sep2021 (the day after receiving the vaccine), the patient complained of malaise and low grade fever. After several hours of improvement (seemed to be feeling better), in the evening he had a pain in his arm and shoulder. The patient left at night (most likely in the morning) from Friday to Saturday. The patient was retired and led a quiet life, almost not exposed to stress at all. The patient received the vaccine at the aesthetic medicine clinic. The doctor was unable to find out the exact cause and recommended that it be reported through the vaccination center. The cause of death was unknown. The outcome of malaise, pain in arm and shoulder and low-grade fever at the time of death was unknown. It was unknown if an autopsy was performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: death


VAERS ID: 1757699 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Back pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210960041

Write-up: LOWER BACK PAIN AND ABDOMINAL PAIN; LOWER BACK PAIN AND ABDOMINAL PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300107014] concerned a 70 year old male of an unspecified race and ethnic origin. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, frequency time 1 total administered on 29-JUL-2021 for drug used for unknown indication. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient came to emergency room due to lower back pain and abdominal pain. He died from low back pain and abdominal pain. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of lower back pain and abdominal pain on an unspecified date. This report was serious (Death, and Life Threatening).; Sender''s Comments: V0: 20210960041-Covid-19 vaccine ad26.cov2.s- Low back pain and abdominal pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: LOW BACK PAIN; ABDOMINAL PAIN


VAERS ID: 1757824 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blindness, Headache, Optic nerve disorder
SMQs:, Glaucoma (broad), Optic nerve disorders (narrow), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 79
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: NLMODERNATX, INC.MOD20213

Write-up: Blind; Hoofdpijn; Headache; Blind; Optic nerve disorder; This case was received via a Regulatory Authority (Reference number: NL-LRB-00684115) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of the second episode of BLINDNESS (Blind) and the first episode of BLINDNESS (Blind) in a 91-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced the first episode of BLINDNESS (Blind) (seriousness criterion medically significant), OPTIC NERVE DISORDER (Optic nerve disorder) and HEADACHE (Headache). On 12-Apr-2021, the patient experienced the second episode of BLINDNESS (Blind) (seriousness criteria death and medically significant) and HEADACHE (Hoofdpijn). The patient died on 02-Jun-2021. The reported cause of death was eventually due to age. It is unknown if an autopsy was performed. At the time of death, OPTIC NERVE DISORDER (Optic nerve disorder), HEADACHE (Hoofdpijn) and HEADACHE (Headache) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medications were not reported. Company Comment: This case concerns a 91 year-old male with no medical history provided, who experienced the unexpected events of Blindness and Optic Nerve Disorder. These events occurred on the same day as the first dose of Spikevax. The patient died on 02-Jun-2021 with reported cause of death due to age.The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29 September 2021 and contains reported cause of death translated as eventually due to age.; Sender''s Comments: This case concerns a 91 year-old male with no medical history provided, who experienced the unexpected events of Blindness and Optic Nerve Disorder. These events occurred on the same day as the first dose of Spikevax. The patient died on 02-Jun-2021 with reported cause of death due to age.The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Eventually due to age


VAERS ID: 1757827 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-14
   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: Diabetes; Dialysis; Heart disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac operation; Cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210959566

Write-up: BLOOD CLOT; COUGHING TEMPERATURE DIFFICULTY BREATHING; COUGHING TEMPERATURE DIFFICULTY BREATHING; COVID-19; This spontaneous report received from a consumer via a Regulatory Authority [PH-PHFDA-300107270] concerned an 81 year old. The patient''s weight was 45 kilograms, and height was not reported. The patient''s past medical history included: using pacemaker to help his heart function, and heart surgery, and concurrent conditions included: dialysis treatment for kidney, heart condition (ailment), and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, 1 total, administered on 28-AUG-2021 for an unspecified indication. The batch number was not reported. Per procedure, no follow up will be requested for this case. Concomitant medications included unspecified medications for diabetes. On 04-SEP-2021, the patient started showings symptoms according to one of his physicians. On an unspecified date, the patient was admitted to hospital being positive. It was reported that few days after the patient was comatosed, he had cardiac arrest. On 14-SEP-2021, the patient passed away. The consultants cleared him of blood clotting. The reporter stated that how would they know the truth as straightaway it was ordered to cremation without having to have autopsy on the patient''s body. According to the reporter it was very clear that the patient contracted the virus after the vaccination which deteriorated his health and was a cause to his death. On 14-SEP-2021, the patient died from coughing temperature difficulty breathing, coughing temperature difficulty breathing, covid-19, and blood clot. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not reported. This report was serious (Death).; Reporter''s Comments: He is on medication for diabetes. Heart ailment and on dialysis treatment for kidney.; Sender''s Comments: V0: 20210959566-covid-19 vaccine ad26.cov2.s- Blood clot, Coughing temperature difficulty breathing, Covid-19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGHING TEMPERATURE DIFFICULTY BREATHING; COUGHING TEMPERATURE DIFFICULTY BREATHING; COVID-19; BLOOD CLOT


VAERS ID: 1757829 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-28
Onset:2021-09-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939900 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), 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: PHMODERNATX, INC.MOD20213

Write-up: difficulty in breathing; fever; body weakness; This regulatory authority case was reported by an other health care professional and describes the occurrence of DYSPNOEA (difficulty in breathing), PYREXIA (fever) and ASTHENIA (body weakness) in a 48-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 939900) for COVID-19 vaccination. No Medical History information was reported. On 28-Aug-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced PYREXIA (fever) (seriousness criterion death) and ASTHENIA (body weakness) (seriousness criterion death). On 07-Sep-2021, the patient experienced DYSPNOEA (difficulty in breathing) (seriousness criterion death). The reported cause of death was Difficulty breathing, Fever and Weakness. It is unknown if an autopsy was performed. 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. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: This case concerns a 48-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Dyspnoea,Pyrexia and Asthenia .The events of Pyrexia and Asthenia occurred approximately 9 days after the first dose of Spikevax and event of Dyspnoea occurred approximately 11 days after the first dose of Spikevax . Patient had a fatal outcome, with death occurring on 11th day. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 48-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Dyspnoea,Pyrexia and Asthenia .The events of Pyrexia and Asthenia occurred approximately 9 days after the first dose of Spikevax and event of Dyspnoea occurred approximately 11 days after the first dose of Spikevax . Patient had a fatal outcome, with death occurring on 11th day. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Difficulty breathing; Fever; Weakness


VAERS ID: 1757964 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: BEMODERNATX, INC.MOD20213

Write-up: Death; Bilateral myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) and MYOCARDITIS (Bilateral myocarditis) in a 17-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 20-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and MYOCARDITIS (Bilateral myocarditis) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MYOCARDITIS (Bilateral myocarditis) outcome was unknown. Concomitant product was not provided. Treatment medication was not reported. Patient died at 17 was reported. Company Comment: This case concerns a 17-year-old male patient with no reported medical history, who experienced the unexpected, serious event of death and expected and AESI event of myocarditis. Time to onset from vaccination was not reported. Date of death was not reported and autopsy report is not available. The rechallenge was not applicable, since vaccination dose number were not specified. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected. This case was linked to MOD-2021-332861 (Patient Link).; Sender''s Comments: This case concerns a 17-year-old male patient with no reported medical history, who experienced the unexpected, serious event of death and expected and AESI event of myocarditis. Time to onset from vaccination was not reported. Date of death was not reported and autopsy report is not available. The rechallenge was not applicable, since vaccination dose number were not specified. The benefit-risk relationship is not affected by this report. Further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1758034 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Creatinine renal clearance, Immunisation, Off label use, 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: 2021-09-16
   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: KARDEGIC; BISOPROLOL; FUMAFER; LOXAPAC [LOXAPINE]; TRANSIPEG [MACROGOL]; OXAZEPAM; PARACETAMOL; PAROXETINE; DIFFU-K; TRAMADOL; SODIUM VALPROATE; ZYMAD; NORMACOL STANDARD; LOXAPAC [LOXAPINE]; INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Arterial hypertension; Artificial cardiac pacemaker user (Pace-maker (Dec2016) for sinus dysfunction, last check-up in Apr2021 with non-anticoagulated AF passages despite a theoretical indication); Bladder retention; Chronic renal failure (Creatinine clearance 31ml / min)); Cognitive disorders; COVID-19; Decompensation cardiac (Patient hospitalized at the end of Jul2021 for cardiac decompensation predominantly on the left side of ischemic and valvular heart disease with FE known to have been preserved, possibly related to the stopping of furosemide on 01Jul2021 and with an absence of compliance with the salt-free diet.); Depressive state; Dyslipidemia; Ischemic heart disease; Stroke; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: creatinine clearance; Result Unstructured Data: Test Result:31 ml/min
CDC Split Type: FRPFIZER INC202101272237

Write-up: death; received the third dose of BNT162B2; received the third dose of BNT162B2; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB [FR-AFSSAPS-CN20212980]. An 87-year-old male patient received the third dose of BNT162B2 (COMIRNATY) via intramuscular on 15Sep2021 (Lot Number: Unknown) at the age of 87-year-old male as single dose for COVID-19 immunization. Medical history included COVID-19 from Oct2020, severe ischemic heart disease with tri-truncular lesions under medical treatment: LVEF 65% from 2014, pace-maker (from Dec2016) for sinus dysfunction, last check-up in Apr2021 with non-anticoagulated AF passages despite a theoretical indication, calcified aortic stenosis moderately tight, stroke, chronic renal failure not explored (Creatinine clearance 31ml / min), Cognitive disorders with behavioral disorders and disinhibition stabilized under treatment, urine retention, depressive syndrome, cardiac decompensation (Patient hospitalized at the end of Jul2021 for cardiac decompensation predominantly on the left side of ischemic and valvular heart disease with FE known to have been preserved, possibly related to the stopping of furosemide on 01Jul2021 and with an absence of compliance with the salt-free diet), arterial hypertension, dyslipidemia and type 2 diabetes. Allergic history was unknown. Concomitant medication included acetylsalicylate lysine (KARDEGIC), bisoprolol, ferrous fumarate (FUMAFER), loxapine (LOXAPAC [LOXAPINE]), macrogol (TRANSIPEG [MACROGOL]), oxazepam, paracetamol, paroxetine, potassium chloride (DIFFU-K), tramadol, sodium valproate, colecalciferol (ZYMAD), sterculia urens (NORMACOL STANDARD), LOXAPINE (LOXAPAC [LOXAPINE]) and insulin. On 16Sep2021, the patient experienced death in bed in 16Sep2021 at 08:35. No adverse effects immediately after vaccination. The outcome of sudden death was fatal. The outcome of other events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1758045 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-20
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
   Days after onset: 34
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: Arterial hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20211001442

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician Via a Regulatory authority (Vaccines, FR-AFSSAPS-NC20214442) on 01-OCT-2021 concerned an 87 year old male of an unspecified race and ethnic origin. The patient''s height and weight were not reported. The patient''s pre-existing medical conditions included: Arterial hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) 1 dosage forms, frequency time 1 total administered on 01-MAR-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 20-JUL-2021, the patient experienced vaccination failure. On 23-AUG-2021, the patient died from vaccination failure. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Reported Cause(s) of Death: VACCINATION FAILURE


VAERS ID: 1758069 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-30
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Multiple organ dysfunction syndrome
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), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Congestive (dilated) cardiomyopathy; Heart disorder; Hypertension arterial; Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Skull trauma
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210823446

Write-up: ARREST CARDIAC; MULTIORGAN FAILURE; This spontaneous report received from a physician via a Regulatory Authority (FR-AFSSAPS-PP20211035) on 30-SEP-2021 and concerned a 60 year old male of unknown race and ethnicity. The patient''s weight was 75 kilograms and height was 175 centimeters. The patient''s past medical history included: skull trauma and concurrent conditions included: hypothyroidism, congestive (dilated) cardiomyopathy, probable heart disease and hypertension arterial. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C13-04, expiry: unknown) 1 dosage forms, 1 total, administered on 29-JUN-2021 for covid-19 vaccination. Drug start period was 2 days. Duration of drug administration was reported as 1 day. No concomitant medications were reported. On 30-JUN-2021, the patient had arrest cardiac and multiorgan failure. It was reported that not explored, described dilatation, who presented a cardio-respiratory arrest the day following the vaccination with unfavorable evaluation through multi-organ failure conducting to death at day 5 after injection. No causality was revealed (ischemic, embolic, toxic, metabolic, infectious, absence of fulminant myocarditis at myocardiac biopsy). The autopsy was refused by the family. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of multiorgan failure on 04-JUL-2021. This report was serious (Death). This case, from the same reporter is linked to 20210764291, 20210801702, 20210764291, 20210832446, 20210858936 and 20210729626. Additional information was received on 30-sep-2021. The following information was updated and incorporated into the case narrative: Cessation date was added for event (multiorgan failure), patient history (Heart disorder) was subsumed under probable heart disease.; Sender''s Comments: V0- 20210823446- Covid-19 vaccine ad26.cov2.S � Arrest cardiac, Multiorgan failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: MULTI ORGAN FAILURE


VAERS ID: 1758142 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Suspected COVID-19, 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: 2021-09-23
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 Name: COVID-19 virus test; Result Unstructured Data: positive
CDC Split Type: ITJNJFOC20211001062

Write-up: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a patient via social media via a company representative concerned a 36-year-old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient got tested positive for Covid-19 (suspected clinical vaccine failure and suspected covid-19 infection), and was admitted in Intensive Care on 06-SEP-2021 after showing positive signs for Covid-19. On 23-SEP-2021, the patient died from covid-19 infection. It was reported that, "He died after days of agony, following a dramatic worsening of his health condition following vaccination". It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected clinical vaccine failure was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). The report was associated with product quality complaint: 90000195633. This case, from the same reporter is linked to 20211001082.; Sender''s Comments: V0: 20211001062-COVID-19 VACCINE AD26.COV2.S-suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211001062-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19 INFECTION


VAERS ID: 1758305 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anosmia, Dizziness, Pain
SMQs:, Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Immune-mediated/autoimmune disorders (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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210960115

Write-up: BODYACHE/ACHE; LOSS OF SMELL; DIZZINESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300107654] concerned a 73 year old female of an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 209C21A, expiry: unknown) dose was not reported, with frequency time 1 total administered on 03-AUG-2021 for an unknown indication. No concomitant medications were reported. On 04-AUG-2021, the patient experienced body ache, loss of smell, and dizziness. On an unspecified date, the patient experienced ache. On an unspecified date, the patient died from body ache/ache, loss of smell, and dizziness. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210960115-covid-19 vaccine ad26.cov2.s-body ache/ache, loss of smell, dizziness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BODYACHE/ACHE; LOSS OF SMELL; DIZZINESS


VAERS ID: 1758306 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-09-18
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004960 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Dizziness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (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), Vestibular disorders (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHMODERNATX, INC.MOD20213

Write-up: cardiac arrest; dizziness; This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIAC ARREST (cardiac arrest) in a 36-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 939900 and 3004960) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Aug-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criteria death and medically significant) and DIZZINESS (dizziness). On 18-Sep-2021, DIZZINESS (dizziness) outcome was unknown. The patient died on 18-Sep-2021. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided by the reporter. Reporter stated CPR at the ambulance for 20 MINS after, declared dead. Regulatory reference: PH-PHFDA-300107482. This case concerns a 36-year-old female patient with no relevant medical history, who experienced the unexpected, serious event of cardiac arrest with fatal outcome. The event occurred 1 day after second dose. The rechallenge was not applicable, since the event occurred after the second dose and is not expected another dose. The benefit-risk relationship is not affected by this report.; Sender''s Comments: This case concerns a 36-year-old female patient with no relevant medical history, who experienced the unexpected, serious event of cardiac arrest with fatal outcome. The event occurred 1 day after second dose. The rechallenge was not applicable, since the event occurred after the second dose and is not expected another dose. The benefit-risk relationship is not affected by this report.; Reported Cause(s) of Death: CARDIAC ARREST


VAERS ID: 1760077 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-08-31
   Days after vaccination:204
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 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: 20210831; Test Name: SARS Covid-2 PCR; Test Result: Positive ; Comments: Variant PCR-based B.1.617.2 Sequenced variant: n.a. n501y-positive: No.
CDC Split Type: ATPFIZER INC202101272368

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-044583. A 95-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 08Feb2021 (Batch/Lot Number: EK9788) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 14Jan2021 (Batch/Lot Number: EJ6797) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Aug2021, the patient experienced SARS-CoV-2 infection, vaccination failure, with fatal outcome. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 31Aug2021 (Variant PCR-based B.1.617.2 Sequenced variant: n.a. n501y-positive: No). 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: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1760078 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-08-10
   Days after vaccination:178
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 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 Name: PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: not available n501y-positive: no
CDC Split Type: ATPFIZER INC202101272104

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Regulatory Authority-WEB (regulatory authority number AT-BASGAGES-2021-044584). A 96-year-old female patient received the first dose of BNT162B2 (COMIRNATY) intramuscular on 20Jan2021 (Lot Number: EL1491) as single dose and the second dose of BNT162B2 (COMIRNATY) intramuscular on 13Feb2021 (Lot Number: EJ6790) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 10Aug2021, the patient experienced vaccination failure and SARS-CoV-2 infection, both with fatal outcome; the patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures on an unspecified date, which included PCR test which was positive (Variant PCR-based: B.1.617.2. Variant Sequenced: not available. n501y-positive: no). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1760155 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-24
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4958 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   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: Ache (persistent pain disorder); Adiposis; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101273429

Write-up: Reaction febrile; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-DCGMA-21191857. A 60-year-old male patient received second dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm left on an unspecified date (Lot Number: FD4958) as single dose for COVID-19 immunisation. Medical history included ongoing adiposis, ongoing hypertension arterial and ongoing ache (pain persistent pain disorder). The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162b2 (COMIRNATY) on an unspecified date (Lot Number: ID014A) as single dose for COVID-19 immunisation. The patient experienced reaction febrile on 24Jun2021. The event was reported as fatal, the patient died on 25Jun2021. It was not reported if an autopsy was performed. The institute assessed relatedness of drug to reaction/event as unclassifiable.; Reported Cause(s) of Death: Reaction febrile


VAERS ID: 1760156 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9234 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration
SMQs:, Medication errors (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Diabetes; Myocardial infarction; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101291842

Write-up: Inappropriate schedule of vaccine administered; Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-DCGMA-21192033], Safety Report Unique Identifier [DE-PEI-202100192626] A 66-Year-old Female patient received the second dose of bnt162b2 (COMIRNATY) Intramuscularly on 14Jun2021 at the age of 66-Year-old as 0.3 ml single dose (lot: FD9234) for covid-19 immunisation. The patient''s medical history included COPD, Diabetes, Osteoporosis, all from an unspecified date and unknown if ongoing; Myocardial infarction from an unspecified date and stoped on an unspecified date. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 03May2021 at the age of 66-Year-old (Batch/LOT number: EX8679) as single dose for covid-19 immunisation. In 2021 the patient experienced Death. This report is serious due to death, life threatening. It was not reported if Autopsy Done. The outcome of the event was fatal.; Reported Cause(s) of Death: Death


VAERS ID: 1760157 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FO30A / 2 - / OT

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

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adipositas; Atrial fibrillation; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101291831

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-DCGMA-21192217 Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100192247 A 63-Year-old Male patient received the second dose of bnt162b2 (COMIRNATY) Intramuscularly on 16Jul2021 (batch/lot: FO30A) at the age of 63-Year-old as single dose for COVID-19 immunisation. The patient''s medical history included Atrial fibrillation, Adipositas, Smoker, all from unspecified date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 18Jun2021 at the age of 63-Year-old (FD9234) as single dose for covid-19 immunisation. In 2021 the patient experienced Death. This report is serious due to death, hospitalization, life threatening. Causal relationship between the event and the administration of CORMINATY was assessed as "Unclassifiable (D)" by the PEI. It was not reported Autopsy Done. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1760182 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-17
Onset:2021-09-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCUY8 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Inappropriate schedule of product administration
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101272767

Write-up: Comirnaty: first dose on 25Feb2021 and second dose on 17Sep2021; Decompensation cardiac; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100196570, from regulatory authority. A 92-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 17Sep2021 (Lot Number: SCUY8) (at vaccination age of 92 years) as dose 2, single for covid-19 immunisation. Previously the patient received the first dose of bnt162b2 for covid-19 immunisation on 25Feb2021. The patient medical history and concomitant medications were not reported. The patient experienced decompensation cardiac (fatal) on 18Sep2021. The patient''s outcome was fatal for Decompensation cardiac. It was also reported that COMIRNATY was administered first dose on 25Feb2021 and second dose on 17Sep2021 (resulting in inappropriate schedule of product administration). The patient died on 18Sep2021. An autopsy was performed on 20Sep2021 and results were not provided. PEI Relatedness of Comirnaty/Decompensation cardiac: Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1760187 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-25
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   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: Coronary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101272952

Write-up: Resuscitation; Acute myocardial infarction; Asystole; This is a spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100196712, from regulatory authority. A 72-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) (at vaccination age of 72 years) as dose 2, single for covid-19 immunisation. Previously the patient received the first dose of bnt162b2 on 29Apr2021 for COVID-19 vaccination. Medical history included coronary artery disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 25Jun2021 the patient experienced resuscitation, acute myocardial infarction, asystole. The outcome of the events was fatal. The patient died on 25Jun2021. It was not reported if an autopsy was performed. PEI Relatedness of drug to reactions/events: D. Unclassifiable No follow-up attempts possible. Information about lot and batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Suspected myocardial infarction; Asystole


VAERS ID: 1760425 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Death
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   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: Exhaustion; General malaise; Infarct myocardial; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101272685

Write-up: Unknown cause of death; Arrhythmia; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority number DE-PEI-CADR2021182599, Safety Report Unique Identifier DE-PEI-202100195723. A 70-year-old female patient received BNT162B2 (COMIRNATY) on 21Jul2021, at single dose, for COVID-19 immunisation. Relevant medical history included infarct myocardial on an unspecified date, in 2016. The patient''s weight was 55 kg, and height was 152 cm. Concomitant medications were unknown. On 22Jul2021, the patient experienced arrhythmia. On 23Jul2021 the patient died. Unknown cause of death was reported. No autopsy was done. The patient''s outcome was: unknown for arrhythmia, fatal for unknown cause of death. This report is serious - death. Result of assessment for Unknown cause of death/PEI / D. Unclassifiable Result of assessment for Arrhythmia/PEI / D. Unclassifiable Sender Comment: The person did not concern have any known allergies. Details of risk factors or previous diseases Minor heart attack 2016, smoker / general malaise, exhaustion. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1760552 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-09-04
   Days after vaccination:192
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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: 2021-09-09
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 antigen test; Test Result: Negative ; Comments: She did an antigen and RT PCR test on 23Aug2021, they were negative before the 23rd; Test Date: 20210823; Test Name: SARS-CoV-2 antigen test; Result Unstructured Data: Test Result:Results not reported; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Negative ; Comments: She did an antigen and RT PCR test on 23Aug2021, they were negative before the 23rd; Test Date: 20210823; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Test Result:Results not reported
CDC Split Type: FRPFIZER INC202101273890

Write-up: Vaccination failure; Suspected Covid-19; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LL20216421. An 84-year-old female patient received two doses of BNT162B2 (COMIRNATY), the 1st injection on 03Feb2021 and the 2nd injection on 24Feb2021, both intramuscularly, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 17Aug2021, appearance of asthenia and hyperthermia. She did an antigen and RT PCR test on 23Aug2021, they were negative before the 23rd. The patient was hospitalized on 04Sep2021. Suspected COVID-19 was reported. The patient died on 09Sep2021. It was unknown if autopsy was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Suspected COVID-19; Drug ineffective


VAERS ID: 1760554 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH9951 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dysphagia, Heart rate, Immunisation, Off label use, Oxygen saturation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIFFU K; IPRATROPIUM; ROSUVASTATINE [ROSUVASTATIN]; NICORANDIL; TRINITRINE; RISPERIDONE; OXAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Aspiration pneumonia (last episode on 03Sep2021); Cardiac pacemaker insertion; COPD; Decompensation cardiac; Deglutition disorder; Dementia aggravated; Dyslipidemia; Hypertension arterial; Infarct myocardial; Living in residential institution; Type I second degree atrioventricular block
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: arterial tension; Result Unstructured Data: Test Result:103/48; Comments: within 1st hour after vaccination; Test Date: 20210914; Test Name: arterial tension; Result Unstructured Data: Test Result:108/56; Comments: 15min later; Test Date: 20210914; Test Name: temperature; Result Unstructured Data: Test Result:35.5; Comments: within 1st hour after vaccination; Test Date: 20210914; Test Name: temperature; Result Unstructured Data: Test Result:35.5; Comments: 15min later; Test Date: 20210914; Test Name: pulse; Result Unstructured Data: Test Result:69; Comments: within 1st hour after vaccination; Test Date: 20210914; Test Name: pulse; Result Unstructured Data: Test Result:69; Comments: 15min later; Test Date: 20210914; Test Name: saturation; Result Unstructured Data: Test Result:96; Comments: within 1st hour after vaccination; Test Date: 20210914; Test Name: saturation; Result Unstructured Data: Test Result:95; Comments: 15min later
CDC Split Type: FRPFIZER INC202101262861

Write-up: Sudden death; deglutition trouble; off label use; booster; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-LM20212591. A 90-year-old male patient received the third dose of BNT162B2 via intramuscular on 14Sep2021 (Lot Number: FH9951) as single dose for COVID-19 immunization. Medical history included deglutition disorder, AFib from 2012, hypertension arterial, dyslipidaemia, COPD, infarct myocardial from 1988, decompensation cardiac from 2012, cardiac pacemaker insertion from 2016, type I second degree atrioventricular block from 2012, dementia aggravated, long-term care unit resident and aspiration pneumonia (last episode on 03Sep2021). Concomitant medications included potassium chloride (DIFFU K), ipratropium, rosuvastatine [rosuvastatin], nicorandil, glyceryl trinitrate (TRINITRINE), risperidone from an unspecified date to 14ep2021 and oxazepam from an unspecified date to 10Sep2021. The patient previously received the second dose and the first dose of BNT162B2, the first dose on 16Feb2021 (Lot Number: EMP6950), the second dose on 09Mar2021 (Lot Number: EP2166), both via an unspecified route of administration as single dose for COVID-19 immunization. Clinical condition (interview with the healthcare team present on 09/14 evening): no change compared to its usual condition on 14Sep2021 after vaccination. No new symptoms, no nurse or doctor intervention. Dined well in the evening of 14Sep2021. In the evening had a bronchial aspiration because congested, without dyspnea. Saturation not measured. Found deceased during the night during the last round of the night shift. In summary: Death in a 90-year-old patient, with multiple pathologies, with swallowing disorders and several episodes of aspiration pneumonia, occurring after the 3rd dose of COVID vaccine, with no identified post-vaccination symptoms, except for am aspiration trouble the evening before his death. Living in medicalised facility for elderly people. General condition: altered, polypathological with swallowing disorder and aspiration complicated by inhalation pneumopathy (last episode on 03Sep2021); fluctuating clinical condition with periods of drowsiness and restlessness. Peri-vaccination monitoring of 14Sep2021 (systematic monitoring sheet): no effect after previous doses. Treatment included, Ongoing as of 14Sep2021, diffu K 600 mg, ipratropium, Rosuvastatin 5 mg: 1: day. Nicorandil 10 mg. Trinitrine 5 mg. Risperidone if needed and Oxazepam 10 if needed (last taken on 10Sep2021). Therapeutic modification in the previous 15 days: switch to taking Risperidone if needed (was under Risperidone 0.5 mg / day systematically before) this treatment was administered every day from 10Sep2021 to 14Sep2012). On 14Sep2021, within 1st hour after vaccination, arterial tension: 103/48, 15min later, arterial tension: 108/56. On 14Sep2021, within 1st hour after vaccination, temperature was 35.5, 15min later, temperature was 35.5. On 14Sep2021, within 1st hour after vaccination, pulse was 69, 15min later, pulse was 69. On 14Sep2021, within 1st hour after vaccination, saturation was 96, 15min later was 95. The patient died on an unspecified date. Autopsy was unknown. The outcome of events was fatal.; Reported Cause(s) of Death: Sudden death; Deglutition disorder; Off label use; Booster


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