National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

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

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



Case Details

This is page 134 out of 172

Result pages: prev   35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172   next


VAERS ID: 1442250 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC2021792558

Write-up: death; This is a spontaneous report from a contactable other hcp. The other HCP reported same event for two patients (his grandfather and father). This is the report for grandfather. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. 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) : TR-PFIZER INC-2021718548 Same reporter/drug/event, different patients; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1442719 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021722193

Write-up: This is a spontaneous report received via a Pfizer sponsored program from a non-contactable other hcp (nurse) who wishes to remain anonymous. An 85-years-old patient of an unspecified gender received unknown dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient was admitted to ICU within 7 days of receiving the covid vaccine. The patient passed away (death, hospitalization) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The clinical outcome for events was fatal. The reporter did not give consent to be contacted. No further information was available at the time of this report.; Sender''s Comments: The advanced old patient''s death is more likely related to the underlying serious disease unrelated to vaccine use; however, There is no information in the case suggesting a possible contribution of the Pfizer suspect product to the patient death, therefore the event does not meet reportability to EEA. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. Reported Cause(s) of Death: An 85-year-old patient was admitted to ICU within 7 days of receiving the Covid vaccine. The patient passed away


VAERS ID: 1442721 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Discoloured vomit, Faeces discoloured, Fatigue
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood dyscrasia; Gout; Hypertension; Iron deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021769733

Write-up: This is a spontaneous report from a contactable other hcp. A 73-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) unknown number dose at the age of 73-year-old on 18Jun2021 (Batch/Lot Number: FD0927) as single dose for covid-19 immunization. Medical history included hypertension, gout, iron deficiency, blood dyscrasia. The patient''s concomitant medications were not reported. The patient experienced dark vomit, dark stools, fatigue on 20Jun2021. The patient was hospitalized on 20Jun2021. The following day, 21Jun2021, the patient developed diarrhoea which was dark in colour, the condition of the patient suddenly changed and the patient succumbed to illness (death) on 21Jun2021. The patient died on 21Jun2021. It was unknown if an autopsy was performed. The outcome of the event was Fatal. No further information was available at the time of this report.; Sender''s Comments: Based on available information provided by the reporter, it appears unlikely that vaccine BNT162B2 contributed to the reported events; the events likely represent intercurrent medical conditions in this elderly patient with history of hypertension, blood dyscrasia, iron deficiency. This case will be reassessed upon receipt of follow-up information. 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: Dark vomit; Fatigue; Dark stools; Diarrhoea dark in colour


VAERS ID: 1442722 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-13
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021770204

Write-up: This is a spontaneous report from a contactable healthcare professional. A 71-years-old male patient received BNT162b2 (COMIRNATY) dose 1 administration on 28May2021 10:17 (Lot Number: FA7812; Expiration Date: 30Sep2021) as single dose for covid-19 immunization. Medical history included hypertension and hypercholesterolemia. The patient''s concomitant medications were not reported. The patient was admitted with Covid-19 pneumonia, hospitalization on 07Jun2021, the patient was reported to have experienced shortness of breath. Outcome of the events Covid-19 pneumonia and shortness of breath was unknown. Patient died on 13Jun2021. It was not reported if an autopsy was performed.; Sender''s Comments: The reported event of death is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. Conversely, Covid-19 pneumonia that occurred just a few days earlier may have contributed to the patient''s demise. Covid-19 pneumonia and shortness of breath are unrelated to BNT162B2, these are intercurrent conditions in this elderly patient with underlying hypertension and hypercholesterolemia. This case will be re-evaluated upon receipt of additional information. 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: 1442734 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-19
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac arrest, Metabolic acidosis, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to insect sting; Coronary disease (2- Vascular coronary heart disease, clinically with good pumping function and low pressure)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210667913

Write-up: TACHYARRHYTHMIA ABSOLUTA; ASYSTOLE; SHOCK; METABOLIC ACIDOSIS; This spontaneous report received from a physician via a Regulatory Authority concerned a 49 year old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient''s past medical history included coronary disease, and allergy to insect sting. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD985 expiry: unknown) dose was not reported, with frequency 1 total administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the patient experienced tachyarrhythmia absoluta, asystole, shock and metabolic acidosis. On 22-JUN-2021, the patient died from multiple organ failure. 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 tachyarrhythmia absoluta, asystole, shock and metabolic acidosis on 22-JUN-2021. This report was serious (Death).; Sender''s Comments: V0: 20210667913-Covid-19 vaccine ad26.cov2.s -Tachyarrhythmia absoluta, asystole, shock and metabolic acidosis. 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: MULTIPLE ORGAN FAILURE


VAERS ID: 1442883 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-08
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain compression, Brain oedema, Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypothyreosis (Hypothyroidism); Thrombosis of venous sinuses (Condition after sinus vein thrombosis)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021728633

Write-up: with massive compression and displacement of the midline; accompanying edema; Extensive cerebral mass hemorrhage of the entire right cerebral hemisphere including trunk ganglia with massive compression and displacement of the midline, accompanying edema and lower as upper entrapment.; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority number AT-BASGAGES-2021-31831. A 77-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 19May2021 (Batch/Lot Number: FA4598) as dose 2, single for covid-19 immunization. The patient''s medical history included ongoing thrombosis of venous sinuses (Condition after sinus vein thrombosis), ongoing hypothyreosis (hypothyroidism). The patient''s concomitant medications were not reported. The patient received the first dose of COMIRNATY on 07Apr2021 (lot:ET7205) for covid-19 immunisation. The patient experienced with massive compression and displacement of the midline, accompanying edema and extensive cerebral mass hemorrhage of the entire right cerebral hemisphere including trunk ganglia with massive compression and displacement of the midline, accompanying edema and lower as upper entrapment on 08Jun2021. The outcome of the events 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 batch number already obtained.; Reported Cause(s) of Death: massive compression and displacement of the midline; accompanying edema; Cerebral haemorrhage death


VAERS ID: 1442954 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood count, Blood electrolytes, Blood glucose, Glomerular filtration rate, Investigation, Renal function test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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: XARELTO; ATOZET; NIFEDIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Cardioembolic stroke (under treatment with rivaroxaban (XARELTO)); Ex-smoker; Hypercholesterolemia; Hypertension; Infarction; Ischemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210308; Test Name: blood count; Result Unstructured Data: Test Result:normal; Test Date: 20210308; Test Name: electrolytes; Result Unstructured Data: Test Result:within the norm; Test Date: 20210308; Test Name: glucose; Result Unstructured Data: Test Result:within the norm; Test Date: 20210308; Test Name: GFR; Result Unstructured Data: Test Result:50 ml/min; Test Date: 20210308; Test Name: investigation; Result Unstructured Data: Test Result:no biological sign of inflammation, liver tests al; Comments: no biological sign of inflammation, liver tests aligned; Test Date: 20210308; Test Name: renal function; Result Unstructured Data: Test Result:stable
CDC Split Type: CHPFIZER INC2021733399

Write-up: Sudden death; This is a spontaneous report received from a contactable physician via regulatory authority. Regulatory authority report number CH-SM-2021-15519. A 85-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 09Apr2021 (Lot Number: EP9605) at the age of 85-years-old as single dose for covid-19 immunisation. Medocal history included ischemic heart disease, with a history of infarction in 1981 (monotruncal involvement) but stable since then, and a history of stroke probably of cardioembolic origin (cardioembolic stroke) in 1997 under treatment with rivaroxaban (XARELTO); hypercholesterolaemia; hypertension; occasional alcohol use; former smoking had been discontinued in 1981. The patient was seen on 08Mar2021 by his attending physician for a check-up which showed no change compared to the last check-up (blood count reported as normal, renal function stable with an estimated GFR of 50 ml/min, no biological sign of inflammation, liver tests aligned, glucose and electrolytes within the norm). He had no new complaints at this appointment. This patient would not have had any particular symptoms recently. Nitroglycerin had been prescribed as a backup for several years, but which the patient was not taking. This patient was not known to any allergies. Concomitant medication(s) included rivaroxaban (XARELTO) taken for cardioembolic stroke; atorvastatin calcium, ezetimibe (ATOZET) taken for hypercholesterolaemia; nifedipine taken for hypertension. On 13Apr2021, 4 days after vaccination, he was found unconscious on the ground in his garden by his wife. She called the emergency services who attempted resuscitation measures without success. The patient experienced sudden death on 13Apr2021. An autopsy was not performed. A causal relationship between Comirnaty and sudden death was assessed as being unlikely. Health Authority assessed this case as serious, fatal outcome. Health Authority Comment: This patient died suddenly 4 days after the second dose of Comirnaty vaccine. Health Authority publications report 76 cases of death after COVID-19 vaccination, after a varying length of time. The average age of the deceased was 82 years and most of them had serious pre-existing diseases. There is currently no evidence that either mRNA vaccine resulted in an increase in deaths. According to the latest report of the Health Authority, 513 post-vaccination deaths with Comirnaty have been reported. The Regulatory Authority reported 377 deaths in patients over 85 years of age after vaccination with Comirnaty and 302 in patients aged 65 to 85 years. In this particular case, a discussion on the imputability of the Comirnaty vaccine remains difficult without knowing the cause of death and in the absence of warning signs or symptoms. The chronology is compatible, but risk factors are present (advanced age, anticoagulation, history of ischemic heart disease even if stable). In view of the above, the imputability of Comirnaty seems possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1442987 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood fibrinogen, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Computerised tomogram head, Fibrin D dimer, Immune thrombocytopenia, International normalised ratio, Mechanical ventilation, PCO2, Platelet count, Prothrombin time, Thrombin time, Thromboelastogram, Thrombosis, Venogram
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), 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), Acute central respiratory depression (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No history of any pre-existing arterial and/or venous thrombotic disease/complications or hormonal therapy prior to the ictus. No medical history of any known pre-existing diseases and /or regular medication intake.
Allergies:
Diagnostic Lab Data: Test Name: Platelet count; Result Unstructured Data: 48 g/L; Test Name: Prothrombin time; Result Unstructured Data: 8.6 S; Test Name: International normalized ratio; Result Unstructured Data: 1.0; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 19.9 S; Test Name: Thrombin clotting time; Result Unstructured Data: 18.8 S, lower than 25; Test Name: Fibrinogen; Result Unstructured Data: 294 mg/dL; Test Name: Venogram; Result Unstructured Data: large-scale sinus thrombosis and ICH; Test Name: Thromboelastography; Result Unstructured Data: roTEG K: 10 min (NR: 3-10); Test Name: Thromboelastography; Result Unstructured Data: roTEG ME: 52 (NR 80-150); Test Name: Fibrin D dimer; Result Unstructured Data: $g35 mg/L; Test Name: Assisted ventilation; Result Unstructured Data: preoperative ventilator settings: APRV 20/10, 2.5 s/2.5 s, fiO2 30%; Test Name: PCO2; Result Unstructured Data: 32.2 mmHg; Comments: Preoperative; Test Name: Head CT; Result Unstructured Data: large-scale sinus thrombosis and ICH; Test Name: Thromboelastography; Result Unstructured Data: roTEG R: 12 min (NR 8-16)
CDC Split Type: DEJNJFOC20210700505

Write-up: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; CEREBRAL SINUS VENOUS THROMBOSIS; INTRA-CEREBRAL HAEMORRHAGE; This spontaneous report was received after SARS-CoV-2-Vaccination in Vaccine Induced Thrombotic Thrombocytopenia. This report concerned a 44 year old female. The authors shed light on the detrimental course that patients may take after admission for intracranial bleeding in the context of vaccine-induced immune thrombotic thrombocytopenia. Further, they proposed specific actions to be taken and to be avoided by physicians of various specialties in the joint treatment of these complex patients. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included no history of any pre-existing arterial and/or venous thrombotic disease/complications or hormonal therapy prior to the ictus, and no medical history of any known pre-existing diseases and /or regular medication intake. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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. The patient presented to the Emergency Department with progressive headache on 12 day after vaccine administration. The patient suffered rapid neurological deterioration within a few hours. Head computed tomography imaging including venograms revealed large-scale sinus thrombosis and ICH (intracerebral hemorrhage) resulting in a mass effect with clinical signs of herniation warranting emergent surgical intervention. Laboratory data (dates unspecified) included: Activated partial thromboplastin time, Assisted ventilation (NR: not provided) preoperative ventilator settings: APRV 20/10, 2.5 s/2.5 s, fiO2 30%, Fibrin D dimer (NR: 0 - 0.5) $g35 mg/L, Fibrinogen (NR: 180 - 355) 294 mg/dL, International normalized ratio (NR: not provided) 1.0, PCO2 (NR: 35 - 46) 32.2 mmHg, Platelet count (NR: 150 - 370) 48 g/L, Prothrombin time (NR: 7.6 - 9.8) 8.6 S, Thrombin clotting time (NR: not provided) 18.8 S, and Thromboelastography (NR: not provided) roTEG K: 10 min (NR: 3-10), roTEG ME: 52 (NR 80-150), roTEG R: 12 min (NR 8-16). Given that immune-mediated thrombocytopenia was suspected, therapy with intravenous immunoglobulin (IVIg at 1 g/kg) and corticosteroids was immediately initiated after consultation with the Hematology department as management was extrapolated from the treatment of immune HIT (Heparin-induced thrombocytopenia). Given radiographic/clinical signs of impending herniation and the urgent need for decompressive surgery, platelets were given perioperatively despite the suspicion of anti-PF4 antibodies. Intraoperatively, severe bleeding and venous stasis posed a challenge to the surgeon requiring immaculate hemostasis despite a cautious intraoperative strategy with an effort to avoid injury to the brain. The use of artificial hemostyptics and further transfusions controlled intraoperative bleeding, thereby allowing for sufficient surgical decompression of the affected hemisphere via DC (decompressive craniectomy). The patient was transferred to the Neuro-intensive care unit for further therapy postoperatively. Argatroban was employed for anticoagulation. Ultimately, the patient succumbed to her extensive cranial injuries. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of vaccine induced immune thrombotic thrombocytopenia (coded as thrombosis and thrombocytopenia), cerebral sinus and vein thrombosis and intra cerebral haemorrhage on an unspecified date. This report was serious (Death and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: This spontaneous report from literature concerns a 44 year-old female who was hospitalized for vaccine-induced immune thrombotic thrombocytopenia 12 days after receiving the Janssen Covid-19 vaccine and subsequently died. She had no pre-existing medical conditions including no arterial and/or venous thrombotic disease/complications or hormonal therapy and was not taking regular medications. The patient presented to the Emergency Department with progressive headache after suffering rapid neurological deterioration within a few hours. CT Head including venograms revealed large-scale sinus thrombosis and intracerebral hemorrhage resulting in a mass effect with clinical signs of herniation warranting emergent surgical intervention. Laboratory data included: Fibrin D dimer (NR: 0 - 0.5) $g35 mg/L, Fibrinogen (NR: 180 - 355) 294 mg/dL, Platelet count (NR: 150 - 370) 48 g/L. Corrective treatment included IVIg at 1 g/kg & corticosteroids. Platelets were given perioperatively despite the suspicion of anti-PF4 antibodies. The use of artificial hemostyptics & further transfusions controlled intraoperative bleeding, thereby allowing for sufficient surgical decompression of the affected hemisphere via decompressive craniectomy. Argatroban was employed for anticoagulation. The patient died from her extensive cranial injuries. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition), 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: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; CEREBRAL SINUS AND VEIN THROMBOSIS; INTRA-CEREBRAL HAEMORRHAGE; VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA


VAERS ID: 1442999 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021753195

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, Safety Report Unique Identifier DE-PEI-202100102742. A 56-year-old female patient received bnt162b2 (COMIRNATY) second dose at the age of 56-year-old (Batch/LOT number: FC3095) on 10Jun2021 as 0.3 ml single dose for COVID-19 immunization. The patient''s weight and height were not reported. Medical history and Concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY) first dose on 29Apr2021 for COVID-19 vaccination. The patient experienced Unknown cause of death on 14Jun2021 and reported as serious. Relatedness of drug to event was Unclassifiable. An Autopsy has been Done and the results was not available. The outcome of the event was fatal. No follow-up activities possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1443001 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
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: 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
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021753145

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100104162. A 76-year-old female patient bnt162b2 (COMIRNATY) unknown number dose at the age of 76-year-old (Batch/lot number UNKNOWN) on 07May2021 as 0.3 ml single dose for COVID-19 immunisation. The patient''s weight and height were not reported. Medical history included COPD. Concomitant medications were not reported. The patient experienced unknown cause of death and reported as serious. Relatedness of drug to event was Unclassifiable. It was unknown if Autopsy Done. The outcome was fatal. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1443003 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Hypercholesterolaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021753155

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100104166. An 82-year-old male patient received bnt162b2 (COMIRNATY) second dose at the age of 82-year-old (Batch/LOT number: UNKNOWN) on 13May2021 as 0.3 ml single dose for COVID-19 immunization. The patient''s weight and height were not reported. Medical history included Arterial hypertension and Hypercholesterolaemia. Concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY) first dose on 01Apr2021 for COVID-19 immunization and experienced no adverse event. The patient experienced Unknown cause of death and reported as serious. Event Result of Assessment was UNCLASSIFIABLE. It was unknown if Autopsy Done. The outcome of the event was fatal. No follow-up activities possible. Batch/LOT number possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1443004 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ABX3519 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Arterial hypertension; Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021753158

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100104167. An 68-year-old male patient received bnt162b2 (COMIRNATY) unknown number dose at the age of 68-year-old (Batch/LOT number: ABX3519) on 26May2021 as 0.3 ml single dose for COVID-19 immunization. The patient''s weight and height were not reported. Medical history included Diabetes mellitus, Arterial hypertension, Apoplexy. Concomitant medications were not reported. The patient experienced Unknown cause of death and reported as serious. Relatedness of drug to event was Indeterminate. No Autopsy Done. The outcome of the event was fatal. No follow-up activities possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1443743 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021733162

Write-up: passed away 3 days after vaccination; This is a spontaneous report based on information received by Pfizer from the Company [manufacturer control number: 66014], license party for Comirnaty, by a non-contactable consumer. An 89-year-old female patient received bnt162b2 (COMIRNATY) unknown number dose on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Reporter had the information from the physician included, an elderly lady (approx. 89-year-old) died 3 days after Comirnaty vaccination/passed away 3 days after vaccination. It was unknown if Autopsy Done. The outcome of the event was Fatal. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021733164 same reporter; Reported Cause(s) of Death: passed away 3 days after vaccination


VAERS ID: 1443858 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-09
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrioventricular block complete, Blood pressure measurement, Cardio-respiratory arrest, Death, Heart rate, Investigation, Malaise, Oxygen saturation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COTRIATEC; ISOPTINE; LEVOTHYROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (treated with Cotriatec 5 / 12.5 morning and evening and Isoptine LP 240 mg 1 / day); Hypothyroidism (treated with Levothyrox 25 ug / day); Osteoarthritis; Pulmonary embolism (after venous stripping)
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: Blood pressure; Result Unstructured Data: Test Result:15/8; Test Date: 20210509; Test Name: heart rate; Result Unstructured Data: Test Result:100; Test Date: 202101; Test Name: biological assesment; Result Unstructured Data: Test Result:normal; Test Date: 20210509; Test Name: oxygen saturation; Test Result: 98 %
CDC Split Type: FRPFIZER INC2021728839

Write-up: Death; cardio respiratory arrest; 3rd degree atrioventricular block; patient did not feel well, felt malaise; This is a spontaneous report downloaded from the Regulatory Authority. The regulatory authority report number is FR-AFSSAPS-2021052273. A contactable physician reported that an 83-year-old female patient received BNT162B2 (COMIRNATY), via intramuscular route administered in left arm on 05May2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included hypertension treated with Cotriatec 5 / 12.5 morning and evening and Isoptine LP 240 mg 1 / day, osteoarthritis, hypothyroidism treated with Levothyrox 25 ug / day, and pulmonary embolism in 1986 (after venous stripping). Patient had no history of COVID-19 and no PCR test history. Allergic history was unknown. Patient was seen in consultation on 15Apr2021 by her attending physician for prescription renewal, no deterioration in general condition, no change in treatment. Blood pressure at 15/8 but white coat effect, auto normal measurements at home. Last biological assessment in Jan2021: Normal. Concomitant medications included hydrochlorothiazide, ramipril (COTRIATEC) and verapamil hydrochloride (ISOPTINE) both taken for hypertension; and levothyroxine sodium (LEVOTHYROX) taken for hypothyroidism. In the morning of 09May2021, the patient did not feel well, felt malaise. She laid down at noon and asked her husband to warn the neighbors. Ambulance call. During their care, the patient experienced cardio-respiratory arrest. External cardiac massage was started immediately by the paramedics at 13:39, then call emergency medical services. Arrival at the emergency medical services at 2 p.m., Orotracheal intubation was conducted. VC. Variable flow ventilation. Administration of adrenaline 1 mg was performed with immediate resumption, tachycardia 100, pulse well perceived, oxygen saturation 98% under ventilation. Patient stayed in bilateral mydriasis, then the pulse slowed down gradually with impregnable blood pressure. Bav3 (3rd degree atrioventricular block) aspect around 35. Patient was asystole again at 2:30 p.m. and resuscitation was stopped. Declaration of death without obstacle. Scientific autopsy was refused by the family. Outcome of patient did not feel well, felt malaise, cardio-respiratory arrest, and 3rd degree atrioventricular block was not recovered. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1443896 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood glucose, Blood potassium, Blood sodium, Blood urea, C-reactive protein, Cardiac arrest, Cardio-respiratory arrest, Fall, Fibrin D dimer, Haemoglobin, Loss of consciousness, Platelet count, Protein total, Prothrombin time, Pulse abnormal, Troponin, Ultrasound Doppler, Ultrasound scan, Vaccination site pain, White blood cell count
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 (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Overweight
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: Bicarbonates; Result Unstructured Data: Test Result:13.1; Test Date: 20210512; Test Name: CPK; Result Unstructured Data: Test Result:hemolyzed; Test Date: 20210512; Test Name: Creatinine; Result Unstructured Data: Test Result:156 umol/l; Test Date: 20210512; Test Name: Fibrinogen; Result Unstructured Data: Test Result:2.90; Test Date: 20210512; Test Name: Glycemia; Result Unstructured Data: Test Result:3.6; Test Date: 20210512; Test Name: potassium; Result Unstructured Data: Test Result:hemolyzed; Test Date: 20210512; Test Name: Sodium; Result Unstructured Data: Test Result:141; Test Date: 20210512; Test Name: Urea; Result Unstructured Data: Test Result:4.8 mmol/L; Test Date: 20210512; Test Name: CRP; Result Unstructured Data: Test Result:19; Test Date: 20210512; Test Name: D dimers; Result Unstructured Data: Test Result:$g4000; Test Date: 20210512; Test Name: Hemoglobin; Result Unstructured Data: Test Result:17.1; Test Date: 20210512; Test Name: Platelets; Result Unstructured Data: Test Result:91000; Test Date: 20210512; Test Name: Proteins; Test Result: 62 g; Test Date: 20210512; Test Name: prothrombin time; Test Result: 54 %; Test Date: 20210512; Test Name: troponin; Result Unstructured Data: Test Result:hemolyzed; Test Date: 20210512; Test Name: transcranial doppler; Result Unstructured Data: Test Result:No circulation; Comments: No circulation but Doppler made during an episode of return to spontaneous circulation.; Test Date: 20210512; Test Name: venous doppler; Result Unstructured Data: Test Result:No argument in favor of a; Comments: No argument in favor of a recent deep or superficial venous thrombosis of the upper limbs and lower limbs on the proximal stages.; Test Date: 20210512; Test Name: Ultrasound; Result Unstructured Data: Test Result:Veins of the upper limbs depressible; Comments: No visible intracavitary thrombus.; Test Date: 20210512; Test Name: Leukocytes; Result Unstructured Data: Test Result:11850
CDC Split Type: FRPFIZER INC2021728850

Write-up: Cardiopulmonary arrest / asystole; Cardiac arrest; unconscious; Found as if he had fallen from his office chair; weak pulse; patient complained of pain in the right arm (vaccinated arm) since the vaccine injection; This is a spontaneous report from contactable physicians downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021054034. A 58-year-old male patient received the first dose of BNT162B2 (COMIRNATY), intramuscular, administered in right arm on 10May2021 (Batch/Lot Number: FA5831) as single dose for covid-19 immunisation. Medical history included overweight, and Covid-19 from an unknown date and unknown if ongoing. No known other history, no treatment according to his family but not much information. The patient''s concomitant medications were not reported. The patient complained of pain in the right arm (vaccinated arm) since the vaccine injection on 10May2021; he experienced cardiopulmonary arrest, cardiac arrest, unconscious, and weak pulse on 12May2021. The clinical course was as follows: patient was a foreman in the building, he was found 48 hours later, on 12May2021 around noon, in his office, alone, face down, unconscious, no longer breathing. Found as if he had fallen from his office chair. Last seen by his colleagues at 11:15 a.m. Cardiac arrest, therefore without witness. Patient had not eaten, no trace of food around the patient, found in the office with an open computer, payroll for his temporary workers being filled. No trace of contusion on the body. Called to Emergency Services at 12:06 p.m., triggering emergency and ambulance then emergency medical and resuscitation service immediately. On arrival from the emergency medical and resuscitation services: Long-term external cardiac massage with semi-automatic defibrillator installed, two rhythm analysis done but no shock. Ventilation with BAVU (self-filling balloon with unidirectional valve) by emergency medical technicians. Warm body, non-reactive intermediate pupils (no mydriasis). No collateral circulation, Normal complexion: neither pale, nor gray, nor cyanotic. No stiffness. Cardiopulmonary arrest noted, asystole. Administration of 1 mg of adrenaline first dose at 12:18 p.m. then 1 mg / 4 min. Orotracheal intubation. Some secretions aspirated, no sign of massive inhalation, no foreign body. BAVU balloon ventilation with 100% oxygen then mechanical ventilation. At 12:22 p.m.: Ventricular fibrillation motivating the realization of an external electric shock at 200 J then immediate resuscitation. Adrenaline pursuit. Decision to administer Cordarone 300 mg by IVD. At 12:30 p.m.: new ventricular fibrillation with 2nd external electric shock of 200 J. At 12:34 pm new ventricular fibrillation with 3rd external electric shock. Installation of an electric epinephrine syringe pump 5 mg / h. Continuation of resuscitation. Also, administration of 1 vial of calcium gluconate and 1 vial of Cordarone. It was noted that the patient complained of pain in the right arm (vaccinated arm) since the vaccine injection. No edema of this upper right limb. Ultrasound on the spot carried out by the emergency services: Veins of the upper limbs depressible, no visible intracavitary thrombus. Organization of evacuation to the emergency department of the nearest hospital center. In the emergency room: Has had a few episodes of spontaneous heartbeat resumption with very very weak pulse at the carotid level but not at the femoral level. Tension between 2 and 4. Increased adrenaline doses up to 20 mg/h. Biological assessment taken after almost 1 hour of cardiopulmonary resuscitation (12May2021): Fibrinogen: 2.90, hemoglobin 17.1, leukocytes 11,850, platelets 91,000, (prothrombin time) TP 54%, D-dimers more than 4000, hemolyzed troponin, protein 62 g, sodium 141, hemolyzed potassium, bicarbonates 13.1, glycemia 3.6, urea 4.8 mmol / L, creatinine 156 umol / L, CRP 19, hemolyzed CPK (creatinine phosphokinase). Request for a venous Doppler: No argument in favor of a recent deep or superficial venous thrombosis of the upper limbs and lower limbs on the proximal stages. Transcranial Doppler: No circulation but Doppler done during an episode of return to spontaneous circulation. Patient died of cardiopulmonary arrest/cardiac arrest. Asystole and death pronounced on 12May2021 at 13:40. Outcome of the other evens was unknown. An autopsy was performed and results were not provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiopulmonary arrest / asystole; Cardiac arrest


VAERS ID: 1443992 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Cardiac arrest, Fatigue, Feeling abnormal, Investigation, Pain in extremity
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Tendinopathies and ligament 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: Medical History/Concurrent Conditions: Actinic keratosis; Ectopic pregnancy; Non-tobacco user; Thyroidectomy partial; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210408; Test Name: Assessment/preventive examinations; Result Unstructured Data: Test Result:Normal
CDC Split Type: FRPFIZER INC2021728678

Write-up: Arrest cardiac/cardiac arrest; feels bad; abdominal pain; left arm pain; fatigue; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-2021056790. A 62-year-old female patient received bnt162b2 (COMIRNATY; batch/lot number: EX6537; expiration date not provided), intramuscular (anatomical location: administered in Arm Left) on 09May2021 as DOSE 1, SINGLE for covid-19 immunisation. Patient''s medical history included ''actinic keratosis/acne keratosis'' (dermatological monitoring), ''ectopic/ extrauterine pregnancy'', ''urinary infection/urinary tract infection'', and ''thyroidectomy partial'' all from unspecified dates and unknown if ongoing. It was reported that patient did not present a cardiovascular risk factor, no known heart disease. It was also reported that patient is a non-sedentary patient (gym, walking), very healthy lifestyle, and no tobacco. Patient''s family history included ''Father at 65: ischemic heart disease (former smoker, still alive)''. Concomitant medications were not reported. The patient experienced ''Arrest cardiac/cardiac arrest'' on 15May2021 (also reported as 16May2021); fatigue, abdominal pain, left arm pain, and ''feels bad'' on 14May2021. Patient''s clinical course is as follows: It was reported that patient had a consultation on 08Apr2021 with her attending physician. It was mentioned that patient had a normal assessment, up-to date and normal preventive examinations. The patient received the first IM injection of Comirnaty on Sunday 09May2021 in the left arm. It was reported that there was possible anginal pain the week following the vaccination. Consultation on Friday 14May with a general practitioner different from patient''s general practitioner mentioned fatigue, abdominal pain, and left arm pain. Symptomatic prescription was metopimazine (VOGALENE). During the night of Friday 14May, it was reported that patient ''feels bad''. On Saturday 15May, the night of 15 to 16, the patient suffered cardiac arrest, her husband performed cardiopulmonary resuscitation and called the emergency medical aid service. It was reported that urgent medical intervention was required. The patient died from cardiac arrest at the end of the night on 16May. The events ''arrest cardiac/cardiac arrest'' was assessed as serious (Fatal and Medically significant). Outcome of the event ''Arrest cardiac/cardiac arrest'' was fatal; outcome of the remaining events was unknown. The patient died on 16May2021. It was reported that autopsy was not scheduled for 19May2021. Reported cause of death was ''Arrest cardiac/cardiac arrest''. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Arrest cardiac/cardiac arrest


VAERS ID: 1443996 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-04-21
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6784 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test, 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: 2021-05-02
   Days after onset: 11
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: Cerebellar ischaemia; Complete rupture of rotator cuff; Cranial arteritis; Drug-induced hepatitis (under NSAIDs); Extrasystoles atrial; Fall (repeated falls); Hypertension arterial; Obesity; Polymyalgia rheumatica
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer (treated by lumpectomy, radiotherapy and hormone therapy); Cataract bilateral NOS (bilateral cataract); Femur fracture (fracture of the right femur osteosynthesized by plate and strapping on 01Feb2020); Herniated disc; Horton''s disease; Knee total replacement (Knee replacement in 2000 and 2008 right Knee replacement recovery in Nov2019); Prolapsed disc NOS; Rhizomelic pseudopolyarthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210428; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728644

Write-up: Vaccination failure; pneumonia with desaturation, Worsening of the condition; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-2021056901. A 92-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 08Feb2021 (Batch/Lot Number: EJ6784) as dose 2, single; intramuscular, administered in left arm on 18Jan2021 (Batch/Lot Number: EM0477; Expiration Date: 30Apr2021) as dose 1, single for covid-19 immunisation. Medical history included knee total replacement from 2000 to an unknown date (knee replacement in 2000 and 2008, right knee replacement recovery in Nov2019), breast cancer from 2016 to an unknown date treated by lumpectomy, radiotherapy and hormone therapy, ongoing obesity, ongoing drug-induced hepatitis under NSAIDs, femur fracture (fracture of the right femur osteosynthesized by plate and strapping on 01Feb2020), ongoing supraventricular extrasystoles , ongoing cerebellar ischaemia, prolapsed disc NOS, ongoing cranial arteritis, ongoing polymyalgia rheumatica, repeated falls, Hypertension arterial, cataract bilateral NOS, complete rupture of rotator cuff, disc hernia, Horton''s disease and rhizomelic pseudopolyarthritis. Concomitant medications were not reported. On 21Apr2021, the patient presented with pneumonia with desaturation. Worsening of the condition. The patient had PCR negative on 23Apr2021. The patient had hospitalization on 28Apr2021. PCR carried out found positive. The patient died on 02May2021. It was not reported if an autopsy was performed. Product investigation received on 21Jun2021 which stated that this record will not require further investigation as the Lot reported has been previously investigated as part of PR ID 5941493 and the following is the Conclusion field from that investigation: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5595397 (see File attachment in this investigation record). The complaint for adverse event/LOE of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EM0477. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; pneumonia with desaturation. Worsening of the condition.


VAERS ID: 1444184 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral artery thrombosis, Ischaemic stroke, SARS-CoV-2 test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Anticoagulant therapy; Atrial fibrillation; Cardiac failure; Chronic obstructive airways disease; Hypertension arterial; Ischaemic heart disease; Mitral incompetence; Peripheral arterial occlusive disease; Pulmonary arterial hypertension; Sleep apnea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021728833

Write-up: Ischemic stroke; thrombosis of the left middle cerebral artery; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority number FR-AFSSAPS-2021066451. A 90-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 05May2021 (Lot Number: EX6537) as single dose for COVID-19 immunization. Medical history included Sleep apnea syndrome, Hypertension arterial, Chronic obstructive airways disease, Peripheral arterial occlusive disease, Cardiac failure, Pulmonary arterial hypertension, Mitral incompetence, Atrial fibrillation, Ischaemic heart disease, Anaemia, Anticoagulated patient. The patient''s concomitant medications were not reported. On 05May2021, 1st injection of the COMIRNATY vaccine, batch EX6537, in intramuscularly left arm. On 08May2021, occurrence of an ischemic stroke with thrombosis of the left middle cerebral artery. Patient was hospitalized. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08May2021. Death in the aftermath. The patient died on 08May2021. It was not reported if an autopsy was performed. Report requested on 03Jun2021. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: thrombosis of the left middle cerebral artery; Ischemic stroke


VAERS ID: 1444185 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Arteritis obliterans (arteriopathy obliterating of the lower limbs); Cardioverter placement; Cholecystectomy; Coronary arterial stent insertion (7 coronary stents 2014); Coronary bypass; Ex-smoker (Smoking cessation 1990); Sleep apnoea syndromes; Stroke (Sylvien D stroke with left lower limb sequelae May 2017)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021732541

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is [FR-AFSSAPS-2021066479]. A 78-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 16Apr2021 (Batch/Lot Number: EW2246) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Sylvien D stroke with left lower limb sequelae from May2017, sleep apnoea syndrome, coronary arterial stent insertion from 2014 (7 coronary stents 2014), appendicectomy, cholecystectomy, cardioverter placement, arteriopathy obliterating of the lower limbs, coronary bypass, coronary bypass surgery from 1991 and smoking cessation from 1990. The patient''s concomitant medications were not reported. The patient experienced Sudden death overnight following vaccination (dose 1). The patient died on 17Apr2021. It was not reported if an autopsy was performed. Death certificate made by medical emergency service doctor on 17Apr2021, doubt about the responsibility of the vaccine, without further information. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1444272 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-11
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   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: Bronchial carcinoma; Myelodysplastic syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Sudden death; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001413) for COVID-19 vaccination. Concurrent medical conditions included Bronchial carcinoma and Myelodysplastic syndrome. On 07-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 11-Apr-2021. 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. Concomitant medication information not reported. Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded. The translation of the source document has been requested. Sender''s (Case) Safety Report Unique Identifier number for this case is FR-AFSSAPS-2021076930; Sender''s Comments: Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded. The translation of the source document has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1444296 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-04-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Arthralgia, Arthritis, Biopsy skin, Cutaneous vasculitis, Death, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Systemic lupus erythematosus (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), Vasculitis (narrow), Hypersensitivity (narrow), Arthritis (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 12
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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder neoplasm; Bladder polypectomy; Fracture of pelvis; Memory disturbance (excl dementia); Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: Skin biopsy; Result Unstructured Data: Test Result:histological appearance in favour of leukocytoclas; Comments: histological appearance in favour of leukocytoclastic vasculitis.
CDC Split Type: FRPFIZER INC2021728928

Write-up: Arthralgia in the left wrist; microcrystalline arthritis; Leukocytoclastic vasculitis; Acute kidney failure; died; rash on the lower limbs; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-AM20211504. Safety Report Unique Identifier: FR-AFSSAPS-2021064293. An 85-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 28Mar2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included memory disturbance (excl dementia), stroke, bladder tumour at loss to follow-up after removal of bladder polyps for 1 year, fracture of pelvis from an unknown date. Concomitant medications included paracetamol taken for an unspecified indication, start and stop date were not reported. On 01Apr2021, onset of arthralgia in the left wrist and rash on the lower limbs. Skin biopsy: histological appearance in favour of leukocytoclastic vasculitis. The patient was hospitalised for obstructive acute kidney failure in the context of a bladder tumour. The patient died on 13Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: died


VAERS ID: 1444329 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-04-22
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / -

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: 2021-04-28
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of lung (end of life of a pulmonary neoplasia); Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: Covid-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728675

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer downloaded from the WEB, regulatory authority number FR-AFSSAPS-AN20212122. Safety Report Unique Identifier FR-AFSSAPS-2021067825. An 85-year-old male patient received BNT162B2 (COMIRNATY), via intramuscular on 26Jan2021 (Batch/Lot Number: UNK) as dose 1, single, then via an unspecified route of administration on 16Feb2021 (Lot Number: EJ6789) as dose 2, single for COVID-19 immunisation. Medical history included cancer of lung from an unknown date (also reported as pulmonary neoplasia) and living in nursing home from 18Jan2021. The patient''s concomitant medications were not reported. Patient information regarding COVID-19 virus: person at risk of developing a severe form of COVID-19 disease was answered as yes / no (as reported), previous Covid-19: yes (pulmonary neoplasia), Covid-19 test: PCR / serology: positive on 22Apr2021, unknown allergy / hypersensitivity medical history. It was reported that the patient presented vaccination failure 2 months after first and second administration (also reported as more than 2 months after a complete vaccination schedule) of COMIRNATY. It was stated that patient was vaccinated with a first and a second dose of COMIRNATY vaccine on 26Jan2021 and 16Feb2021. More than 2 months later, on 22Apr2021 the PCR was positive. It was further reported that the patient was already very fragile because he arrived in the nursing home for the end of life of a pulmonary neoplasia. His condition was already degraded when he entered on 18Jan2021. According to the director, her death was more related to her pulmonary neoplasia than to COVID. The patient underwent lab tests and procedures which included Covid-19 PCR test: positive on 22Apr2021. The outcome of the events was fatal. The patient died on 28Apr2021. An autopsy was not performed. Investigational results received on 21Jun2021 regarding the complaint for this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced ID resulted in the following conclusion: Reference PR ID 5732035 (see File attachment in this investigation record) The complaint for LOE/adverse event of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6789. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cancer pulmonaire


VAERS ID: 1444389 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   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: SINEMET; SEROPLEX; LYRICA; GUTRON; FLUCORTAC; DIFFU K; ELIQUIS; LASILIX [FUROSEMIDE]; NEOMERCAZOLE
Current Illness: COPD
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Hyperthyroidism; Insulin-requiring type 2 diabetes mellitus; Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20201201; Test Name: Covid-19 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021728903

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-CF20210886. Additional case identifier includes: FR-AFSSAPS-2021054111. An 86-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in the right arm on 16Apr2021 (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunisation. Medical history included insulin-requiring type 2 diabetes mellitus, chronic obstructive pulmonary disease (COPD) ongoing, anxiodepressive syndrome, Parkinson''s disease, and hyperthyroidism. Concomitant medications included carbidopa, levodopa (SINEMET); escitalopram oxalate (SEROPLEX); pregabalin (LYRICA); midodrine hydrochloride (GUTRON); fludrocortisone acetate (FLUCORTAC); potassium chloride (DIFFU K); apixaban (ELIQUIS); furosemide (LASILIX [FUROSEMIDE]); and carbimazole (NEOMERCAZOLE); all taken for an unspecified indication, start and stop date were not reported. The patient tested negative for Covid-19 test on 01Dec2020. The patient has never contracted COVID-19. On 25Apr2021, the patient experienced cardio-respiratory arrest. The event was described as follows: On 25Apr2021, the patient presented with initial hypotension, followed by cardiopulmonary arrest resulting in coma and death within the following hours (afternoon) at home. The patient required emergency medical services (emergency room visit), no hospitalization. The patient died due to cardiopulmonary arrest on 25Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: cardiopulmonary arrest/ Cardio-respiratory arrest


VAERS ID: 1444447 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-04-20
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, COVID-19, Chest scan, Computerised tomogram head, Fall, SARS-CoV-2 test, Vaccination failure, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 40
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 19 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID; LAMOTRIGINE; COUMADIN; RISPERDAL; CHOLECALCIFEROL; ALENDRONIC ACID; BISOPROLOL; ESOMEPRAZOLE; OXAZEPAM; PARACETAMOL; CALCIUM VITAMIN D3 [CALCIUM;COLECALCIFEROL]; FERRO-GRAD; VITAMIN C [ASCORBIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Anaemia (chronic multitransfuse anaemia); Arthrosis; Bimalleolar fracture (Left bi-malleolar fracture); Chronic myelomonocytic leukaemia (chronic myelomonocytic leukaemia with chronic multitransfuse anaemia); Cognitive disturbance (Moderate cognitive impairment with mini-mental state at 20/30 in May2014); Epilepsy (Sequelae vascular epilepsy); Hypercholesterolaemia; Hypertension arterial; Ischaemic stroke (Sylvian superficial left stroke); Osteoarthritis; Pneumopathy (Right basal pneumopathy); Polymyalgia rheumatica; Rhizomelic pseudopolyarthritis (Rhizomelic pseudopolyarthritis secondary to chronic myelomonocytic leukaemia); Sleep apnoea syndromes (not treated with a device); Thrombosis venous deep (Left twin deep vein thrombosis); Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: chest scan; Result Unstructured Data: Test Result:Covid19 involvement; Comments: does not show recent intracranial bleeding but moderate Covid19 involvement between 25 and 50%; Test Name: Computerised tomography brain and chest scan; Result Unstructured Data: Test Result:Covid19 involvement; Comments: does not show recent intracranial bleeding but moderate Covid19 involvement between 25 and 50%; Test Name: c-reactive protein; Result Unstructured Data: Test Result:decrease; Test Date: 20210420; Test Name: Covid19 PCR; Test Result: Positive ; Comments: Different variant
CDC Split Type: FRPFIZER INC2021729370

Write-up: PCR COVID-19 positive/fever of 39?, respiratory congestion and a neurological delay; Vaccination failure/PCR COVID-19 positive/fever of 39?, respiratory congestion and a neurological delay; fall with subsequent onset of vomiting; fall with subsequent onset of vomiting; This is a spontaneous report from a contactable physician downloaded from the WEB FR-AFSSAPS-2021065905. A 92-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 18Feb2021 (Lot Number: EK9788) as DOSE 2, SINGLE, dose 1 intramuscular on 14Jan2021 (Lot Number: unknown) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included chronic myelomonocytic leukaemia (chronic myelomonocytic leukaemia with chronic multitransfuse anaemia, no immunosuppressive treatment), Type II diabetes mellitus, polymyalgia rheumatica, Pneumopathy from May2014 (Right basal pneumopathy), Hypertension arterial, atrial fibrillation, hypercholesterolaemia, Cognitive disturbance from May2014 (Moderate cognitive impairment with mini-mental state at 20/30 in May2014), Arthrosis, Epilepsy (Sequelae vascular epilepsy), Ischaemic stroke from 2012 (Sylvian superficial left stroke), Thrombosis venous deep (Left twin deep vein thrombosis), Sleep apnoea syndromes (not treated with a device), Rhizomelic pseudopolyarthritis (Rhizomelic pseudopolyarthritis secondary to chronic myelomonocytic leukaemia), bimalleolar fracture (Left bi-malleolar fracture), chronic multitransfuse anaemia, Osteoarthritis. Concomitant medications included folic acid (FOLIC ACID); lamotrigine (LAMOTRIGINE); warfarin sodium (COUMADIN); risperidone (RISPERDAL); cholecalciferol (CHOLECALCIFEROL); alendronic acid (ALENDRONIC ACID); bisoprolol (BISOPROLOL); esomeprazole (ESOMEPRAZOLE); oxazepam (OXAZEPAM); paracetamol (PARACETAMOL); calcium, colecalciferol (CALCIUM VITAMIN D3); ferrous sulfate (FERRO-GRAD); ascorbic acid (VITAMIN C). The patient experienced PCR covid-19 positive on 20Apr2021, vaccination failure on 21Apr2021, fall with subsequent onset of vomiting of food on 20Apr2021. The patient died on 30May2021. Outcome of fall and vomiting was recovered. It was not reported if an autopsy was performed. The clinical course was reported as follows: Patient on 20Apr2021 suffered a fall with subsequent onset of vomiting of food on several occasions. Referred to the emergency department at the end of the day in view of a fever of 39?, respiratory congestion and a neurological delay. Covid19 polymerase chain reaction test performed that came back positive with the variant. Computerised tomography brain and chest scan did not show recent intracranial bleeding but moderate Covid19 involvement between 25 and 50%. Patient hospitalized on 21Apr2021. Dual antibody therapy on 21Apr2021 (bamlanivimab and etesevimab). Antibiotic initially introduced with amoxicillin;clavulanic acid (AUGMENTIN) then piperacillin sodium;tazobactam sodium (TAZOCILLIN) due to the persistence of fever and inflammatory syndrome. In view of a suspicion of deterioration related to Covid19, treatment of 7 days with Dexamethasone from 27Apr2021 to 03May2021. Eventually favourable evolution with decrease in C-reactive protein and oxygen weaning. Discharge from the hospital on 10May2021. Afterward, deterioration of her general condition with confinement to bed, increase in cognitive problems and appearance of awareness problems. The patient was described as uncomfortable at the residential care home: Transfer to a palliative care department on 22May2021. Deceased on 30May2021. Investigation result received from Product Complaint Team: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: PCR COVID-19 positive/fever of 39?, respiratory congestion and a neurological delay; Vaccination failure/PCR COVID-19 positive/fever of 39?, respiratory congestion and a neurological delay


VAERS ID: 1444455 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Nausea, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   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: Cognitive impairment; Dyslipidaemia; Hypertension arterial; Ischaemic heart disease (stented in 2005); Obstructive arteriosclerosis of lower extremities; Tabaquism; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty (DIC angioplasty on residual stenosis 30%); Carotid artery stenosis (Primary right carotid stenosis 50%.); Chronic alcoholism (weaned in 2018); DIC; Effusion pleural (2 pleural effusions punctured); Ischaemic stroke (Right superficial sylvian ischemic stroke in Nov2018); Restenosis; Smoker; Stent placement
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021728864

Write-up: sudden death; Cough increased; Nausea; This is a spontaneous report from a contactable physician downloaded from the WEB FR-AFSSAPS-GR20211643. Safety Report Unique FR-AFSSAPS-2021054687. A 78-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 17Mar2021 (Lot Number: ET3620) as dose 2, single for COVID-19 immunisation. Medical history included ongoing dyslipidaemia, ongoing tabaquism, Chronic alcoholism on an unknown date (weaned in 2018), ongoing Ischaemic heart disease (stented in 2005), ongoing Cognitive Impairment, ongoing Hypertension arterial (HTA), ongoing Obstructive arteriosclerosis of lower extremities (AOMI), ongoing Type 2 diabetes mellitus, Right superficial sylvian ischemic stroke from Nov2018 to an unknown date, 2 pleural effusions punctured on an unknown date, restenosis in 2012, active smoking on an unknown date, DIC angioplasty on residual stenosis 30% in 2017, Primary right carotid stenosis 50% on an unknown date. Unknown history of COVID-19 infection and Long-term treatments were not known. The patient''s concomitant medications were not reported. On 19Mar2021, the patient experienced sudden death. On 18Mar2021, onset of nausea and increased cough. Differential diagnosis: Cardiovascular (CV) risk factors and extensive medical history. Progress: The patient died on the night of 19Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cough increased; Nausea; sudden death


VAERS ID: 1444465 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, International normalised ratio, Overdose, Platelet count, Pulmonary embolism, X-ray
SMQs:, Embolic and thrombotic events, venous (narrow), Drug abuse and dependence (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 13
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: ESOMEPRAZOLE; ALPRAZOLAM; COUMADINE; CARDENSIEL; TAMSULOSIN; VENOFER; ARANESP; UVEDOSE; VITAMIN B1 [THIAMINE]; VITAMIN B6; AMIODARONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiorenal syndrome; Congestive (dilated) cardiomyopathy; Dialysis; Ex-tobacco user; Implantable defibrillator insertion; Mitral incompetence
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: platelets; Result Unstructured Data: Test Result:168; Comments: normal; Test Date: 20210524; Test Name: Chest CT scan; Result Unstructured Data: Test Result:Cardiomegaly; Comments: Cardiomegaly with several left and right intraventricular images compatible with thrombi. Right lower lobe pulmonary embolism. Weak pleural effusion on the right. Ground glass of the lower right lobe compatible with infectious disease.; Test Date: 20210324; Test Name: International normalised ratio; Result Unstructured Data: Test Result:1.85; Test Date: 20210331; Test Name: International normalised ratio; Result Unstructured Data: Test Result:1.28; Test Date: 20210407; Test Name: International normalised ratio; Result Unstructured Data: Test Result:1.58; Test Date: 20210519; Test Name: International normalised ratio; Result Unstructured Data: Test Result:1.69; Comments: underdosed; Test Date: 20210524; Test Name: International normalised ratio; Result Unstructured Data: Test Result:1.8; Comments: underdosed; Test Date: 20210524; Test Name: radiological monitoring; Result Unstructured Data: Test Result:pulmonary nodules size progression; Comments: Progression in the size of pulmonary nodules
CDC Split Type: FRPFIZER INC2021728840

Write-up: Embolism pulmonary; Dose3 of Comirnaty; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB FR-AFSSAPS-GR20212118. Safety Report Unique Identifier FR-AFSSAPS-2021069287. A 79-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 11May2021 (Batch/Lot Number: Unknown) as dose 3, 0.3 ml, single for covid-19 immunisation. Medical history included congestive cardiomyopathy, implantable defibrillator insertion, dialysis, cardiorenal syndrome, mitral valve incompetence, and ex-tobacco user from an unknown date and unknown if ongoing (Severe hypokinetic dilated cardiomyopathy; massive functional mitral insufficiency; implantation of a defibrillator; dialysis 3 / week for 4 years on a cardio renal syndrome (type II) in connection with a dilated heart disease, severe hypokinetic; probable pulmonary neoplastic pathology without histological confirmation; weaned smoking greater than 70package-year). Concomitant medications included esomeprazole; alprazolam; warfarin sodium (COUMADINE); bisoprolol fumarate (CARDENSIEL); tamsulosin; saccharated iron oxide (VENOFER); darbepoetin alfa (ARANESP); colecalciferol (UVEDOSE); thiamine (VITAMIN B1); vitamin b6; and amiodarone; all were taken for an unspecified indication, start and stop date were not reported. Patient previously received bnt162b2 (COMIRNATY), on 05Feb2021, Dose1 and on 05Mar2021, Dose2 for covid-19 immunization. On 11May2021, Dose3 of Comirnaty. The patient experienced embolism pulmonary on 24May2021 and died due to this event. On 24May2021 hospitalization. Chest CT scan: Cardiomegaly with several left and right intraventricular images compatible with thrombus. Right lower lobe pulmonary embolism. Weak pleural effusion on the right. Ground glass of the lower right lobe compatible with infectious disease. Differential diagnosis: International normalised ratio (INR) underdosed on 24May2021 (at 1.8) but also on 19May2021 (at 1.69). However, the patient had already presented an INR <2 for several consecutive weeks without thrombosis: INR = 1.85 on 24Mar2021, to 1.28 on 31Mar2021, to 1.58 on 07Apr2021. No argument for a Thrombosis with thrombocytopenia syndrome: platelets normal at 168 G/l 24May2021. No PCR Sars-Cov-2 realised on 24May2021 Progression in the size of pulmonary nodules (under simple radiological monitoring) . The outcome of the event was death on 24May2021 at 18:40 (reported as of unknown case). Therapeutic measures were taken as a result of embolism pulmonary. The patient died on 24May2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.; Reported Cause(s) of Death: Embolism pulmonary


VAERS ID: 1444472 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-05
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Fall, General physical health deterioration, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Accidents and injuries (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021728892

Write-up: Drug ineffective; COVID-19 respiratory infection; deterioration of the general condition; fall; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LL20211636. A 95-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 18Feb2021 (Batch/Lot Number: Unknown) as single, dose 1 intramuscular on 28Jan2021 (Batch/Lot Number: Unknown) as single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced drug ineffective and COVID-19 respiratory infection on 05Mar2021. On 05Mar2021 day 15, after the last injection, appearance of the first symptoms of a pneumopathy, a deterioration of the general condition and fall. Outcome of the events drug ineffective and COVID-19 respiratory infection was reported as fatal. The patient died on 20Mar2021. It was unknown if an autopsy was performed. Outcome of events deterioration of the general condition and fall was unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: COVID-19 respiratory infection; Drug ineffective


VAERS ID: 1444481 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-24
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood albumin, Blood calcium, Blood electrolytes, Blood lactate dehydrogenase, Blood test, Body mass index, Body temperature, C-reactive protein, Computerised tomogram, Computerised tomogram head, Creatinine renal clearance, Electromyogram, Electroneuromyography, Fall, Glomerular filtration rate, Guillain-Barre syndrome, Haemoglobin, Intestinal infarction, Investigation, Laboratory test, Lipase, Liver function test, Lumbar puncture, Neurological examination, Polymerase chain reaction, Polyneuropathy, SARS-CoV-2 test, Sepsis, Urine analysis, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Peripheral neuropathy (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), Guillain-Barre syndrome (narrow), Accidents and injuries (narrow), Ischaemic colitis (narrow), Demyelination (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ROSUVASTATINE [ROSUVASTATIN]; ENALAPRIL MALEATE; METFORMINE [METFORMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Hypertension arterial; Type 2 diabetes mellitus (non-insulin dependant diabetes)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Albuminemia; Result Unstructured Data: Test Result:31 g/l; Test Date: 2021; Test Name: serum calcium; Result Unstructured Data: Test Result:2.47; Test Date: 2021; Test Name: electrolytes; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: LDH; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: platelets; Result Unstructured Data: Test Result:normal to 323 000; Test Date: 2021; Test Name: BMI; Result Unstructured Data: Test Result:25; Comments: 62 kg, 159 cm; Test Date: 20210330; Test Name: fever; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210405; Test Name: abdominal CT scan with injection; Result Unstructured Data: Test Result:compatible with a superior mesenteric infarction; Comments: moderate distension of the small bowel without clear functional syndrome, but a clear sign of parietal suffering of the small bowel suggesting an extensive jejunal and ileal necrosis. No mesenteric arterial occlusion detected, pneumoperitoneum. intermittent intestinal claudication is found preceding admission and compatible with mesenteric angina; Test Date: 20210324; Test Name: cerebral CT; Result Unstructured Data: Test Result:does not find constituted stroke; Test Date: 2021; Test Name: CRP; Test Result: Negative ; Test Date: 2021; Test Name: Creatinine clearance; Result Unstructured Data: Test Result:57 ml/min; Test Date: 20210324; Test Name: Electromyography (EMG); Result Unstructured Data: Test Result:conductive disorders; Comments: conductive disorders and the clinical picture is typical of polyradiculoneuritis; Test Date: 2021; Test Name: Stimulation electroneuromyography; Result Unstructured Data: Test Result:polyradiculoneuritis; Comments: segmental demyelination (elongated distal latency, signal dispersion on the peripheral nerves, the presence of conduction block, elongation F-wave or no wave F) and axonal damage, greater at the level of the motor nerves (secondary axonal damage?) in favor of acute polyradiculoneuritis; Test Date: 2021; Test Name: normoglycemic and glomerular filtration; Result Unstructured Data: Test Result:61 ml/min; Test Date: 2021; Test Name: hemoglobin; Result Unstructured Data: Test Result:13.5; Test Date: 20210405; Test Name: anti-GM1 and Anti-DG1b antibodies; Test Result: Positive ; Test Date: 2021; Test Name: Bacteriological test; Test Result: Negative ; Comments: no Campylobacter, Clostridium difficile and other negative; Test Date: 2021; Test Name: hemostasis; Result Unstructured Data: Test Result:normal; Comments: Prothrombin Ratio 92% Partial thromboplastin time ratio 1.03; Test Date: 20210405; Test Name: Botulinum toxin, Campylobacter jejuni and fetus; Result Unstructured Data: Test Result:negative; Test Date: 2021; Test Name: Methicillin Sensitive Staphylococcus Aureus; Result Unstructured Data: Test Result:Methicillin Sensitive Staphylococcus Aureus; Test Date: 2021; Test Name: lipase; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: liver function; Result Unstructured Data: Test Result:normal; Test Date: 20210324; Test Name: lumbar puncture; Result Unstructured Data: Test Result:cytological albumino dissociation; Comments: cytological albumino dissociation with 0.67 of cell-free protein; multiplex real time PCR (meningitis / encephalitis panel) negative; Test Date: 2021; Test Name: lumbar puncture; Result Unstructured Data: Test Result:multiplex real time PCR (meningitis / encephalitis; Test Date: 20210324; Test Name: neurological picture; Result Unstructured Data: Test Result:motor deficit; Comments: motor deficit type to IM with areflexia; Test Date: 20210405; Test Name: faecal PCR; Test Result: Negative ; Test Date: 20210324; Test Name: COVID PCR test; Test Result: Negative ; Test Date: 2021; Test Name: urinary infection; Result Unstructured Data: Test Result:urinary infection with E Coli; Test Date: 2021; Test Name: leukocytosis; Result Unstructured Data: Test Result:9970
CDC Split Type: FRPFIZER INC2021728626

Write-up: Infarction mesenteric; acute anuric renal failure by tubular necrosis; Guillain Barre syndrome; fall; Sepsis; polyradiculoneuritis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-LM20210817. Safety Report Unique Identifier FR-AFSSAPS-2021012313. An 87-year-old male patient received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) intramuscular on 05Mar2021 as dose 1, single for COVID-19 vaccination. Medical history included type 2 diabetes mellitus (non-insulin dependant diabetes), Afib, Hypertension arterial. Concomitant medications included rosuvastatine [rosuvastatin] (ROSUVASTATINE [ROSUVASTATIN]); enalapril maleate (ENALAPRIL MALEATE) and metformine [metformin] (METFORMINE [METFORMIN]). Around 24Mar2021 diarrhea after ingestion of dandelion salad, of short duration 24 h then remission. On 24Mar2021 (19day after vaccination): he presented a muscular weakness responsible for a fall which required an intervention of the firefighters at the home. Transfer to the emergency room with a neurological picture of motor deficit type to IM with areflexia. The cerebral CT does not find constituted stroke. The lumbar puncture found a cytological albumino dissociation with 0.67 of cell-free protein. Transfer to Neurology: the neurological picture will be completed on 26Mar2021 due to the absence of 4 members. Electromyography (EMG): conductive disorders and the clinical picture was typical of polyradiculoneuritis. Transfer to continuous monitoring unit for administration of IV Ig and close monitoring given the vital respiratory risk given the rapid onset of the motor deficit. The patient experienced Guillain barre syndrome (life threatening) on 24Mar2021. On 30Mar2021: Sepsis with profuse diarrhea and appearance of mottling + fever 38C Infectious assessment carried out: introduction of C3G + Flagyl with bolus of Amiklin Stop sedation with PROPOFOL Mechanically ventilated pneumonia with E.Coli and S. Aureus: under Claforan and Orbenine. 31Mar2021: Guillain Barre Syndrome in an 87-year-old patient in good general condition. Slight recovery of motor skills of the lower limbs + cranial pairs. Mechanical ventilation. Re-evaluation of antibiotic therapy based on results A Botulism test request has been made. Details concerning lumbar puncture: multiplex real time PCR (meningitis / encephalitis panel) negative. Details about Stimulation electroneuromyography: case for segmental demyelination (elongated distal latency, signal dispersion on the peripheral nerves, the presence of conduction block, elongation F-wave or no wave F) and axonal damage, greater at the level of the motor nerves (secondary axonal damage?) in favor of acute polyradiculoneuritis. Further laboratory tests in 2021 at admission normoglycemic and glomerular filtration with 61 ml / min, normal electrolytes, serum calcium at 2.47, normal liver function tests, normal lipase, normal LDH, negative CRP, hemoglobin 13.5, leukocytosis 9970 and platelets normal to 323 000. Normal hemostasis with 92% protrombin ratio, partial thromboplastin time ratio 1.03. Albuminemia 31 g / l. Bacteriological evaluation: gastrointestinal panel negative (no Campylobacter, Clostridium difficile and other negative). Botulism: ?? Still in intensive care. 62 kg, 159 cm, BMI 25. Admission on 25Mar2021: patient conscious and oriented, dysphonia, difficulty off the head of the plan of bed, no facial nerve paralysis, no gag reflex, weak cough, motor deficit of 4 members dominate the belts, osteotendinous reflex abolished the 4 limbs. Negative COVID PCR. Creatinine clearance 57 mL / min. Despite IVIg: worsening of the neurological picture, hemodynamic instability due to dysautonomia of Guillain-barre with Noradrenaline and Loxen, ventilation impairment with inhalation pneumonia leading to a tracheotomy (29Mar21). In terms of infection: early Ventilator-associated pneumonia with Methicillin Sensitive Staphylococcus Aureus and E Coli complicated by Methicillin Sensitive Staphylococcus Aureus bacteremia and urinary infection with E Coli, treated with Orbenin and cefotoxamine. Transition to acute anuric renal failure by tubular necrosis on 05Apr2021. Several diarrheal episodes without documented germ, the 05Apr21 table worsened suddenly with acute abdomen and cessation of materials and gas, abdominal CT scan with injection: moderate distension of the small bowel without clear functional syndrome, but a clear sign of parietal suffering of the small bowel suggesting an extensive jejunal and ileal necrosis. No mesenteric arterial occlusion detected, pneumoperitoneum. The doctors evoke a picture compatible with a superior mesenteric infarction, rejected with the surgery. On resumption of the history, intermittent intestinal claudication is found preceding admission and compatible with mesenteric angina. No details regarding the date of vaccination. Note in the reaction report: "PRN, mesenteric infarction and the absence of embolic aetiology (no arrhythmia, patient on preventive anticoagulant treatment and absence of visible mesenteric arterial occlusion, all the data raise the issue of question on another etiology related to the anti-Covid 19 vaccination. Botulinum toxin negative, Campylobacter jejuni and fetus negative, faecal, PCR negative AC anti-GM1 and Anti-DG1b positive Death on 05Apr2021 at 22:45 (hospital report validated on 17May2021 addition: antecedent, EI]. The patient experienced infarction mesenteric on 05Apr2021. Outcome of the event Guillain Barre Syndrome was recovering, while unknown for the other events. The patient died on 05Apr2021 due to infarction mesenteric. 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: Infarction mesenteric


VAERS ID: 1444507 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Asthenia, Blood pressure measurement, Body temperature, Cerebrovascular accident, Change of bowel habit, Confusional state, Cyanosis, Discomfort, Epilepsy, Eye movement disorder, Faeces discoloured, General physical health deterioration, Heart rate, Heart rate increased, Hemiplegia, Hypertension, Hypothermia, Nasopharyngitis, Peripheral swelling, Salivary hypersecretion, Scan brain, Seizure, Tremor
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 6
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: UVEDOSE; LERCANIDIPINE CRISTERS; PANTOPRAZOLE ALMUS; MACROGOL BIOGARAN; LAMALINE [CAFFEINE;PAPAVER SOMNIFERUM LATEX;PARACETAMOL]; TEMESTA [LORAZEPAM]; VITAMIN B12 [VITAMIN B12 NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Arterial hypertension; Bullous pemphigoid; Constipation; COVID-19 (Hospitalized, symptomatic with lower respiratory infection.); Difficulty in walking; Hemicolectomy; Movement disorder; Polyposis coli (requiring two hemicolectomies); Sleep disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: Blood pressure; Result Unstructured Data: Test Result:17/11; Test Date: 20210126; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Test Date: 20210128; Test Name: Heart rate; Result Unstructured Data: Test Result:150; Test Date: 202101; Test Name: Cerebral scan; Result Unstructured Data: Test Result:not showing signs ischemic or hemorrhagic
CDC Split Type: FRPFIZER INC2021728896

Write-up: Epileptic attack; convulsive seizure; left hemiplegia with phasic disorders; left hemiplegia with phasic disorders; Degradation of the general condition; heart rate 150; blood pressure 17/11; discomfort with rolled up eyes; discomfort with rolled up eyes; MI tremor; salivation; confusion; cold; cyanotic legs; left foot swollen; Stroke; hypothermia 35.8 C; general weakness; delayed stool; yellow stools; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-LY20212431. A 97-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), intramuscular, administered in the left arm, on 22Jan2021 (Batch/Lot Number: EJ6788), as dose 1, single, for COVID-19 immunisation. Medical history included constipation, anxiodepressive syndrome, arterial hypertension polyposis coli requiring two hemicolectomies, bullous pemphigoid, sleep disorder, and moving with difficulty (difficulty in walking) all from unknown date not reported if ongoing or not; and COVID-19 (hospitalized, symptomatic with lower respiratory infection) on 31Oct2020 to an unspecified date. Concomitant medications included colecalciferol (UVEDOSE Oral solution, strength: 1000 iU); lercanidipine hydrochloride (LERCANIDIPINE CRISTERS Film-coated tablet, strength: 10 mg); pantoprazole sodium sesquihydrate (PANTOPRAZOLE ALMUS Gastro-resistant tablet, strength: 20 mg); macrogol 4000 (MACROGOL BIOGARAN); caffeine, papaver somniferum latex, paracetamol (LAMALINE Capsule); lorazepam (TEMESTA Tablet, strength: 1 mg); vitamin B12, all taken for unspecified indications, start and stop dates not reported. On 26Jan2021, the patient experienced stroke which required unspecified treatment (as reported). On 26Jan2021, the patient experienced general weakness with OMI G (as reported), hypothermia 35.8 C with delayed stool then yellow stools. On 28Jan2021, the patient experienced discomfort with rolled up eyes, MI tremor, salivation, heart rate 150, blood pressure 17/11 (as reported), confusion, cold, cyanotic legs (left foot swollen) and epileptic attack. Epileptic attack required hospitalization and the establishment of treatment with Keppra morning and evening IV. On 29Jan2021, the patient presented with left hemiplegia with phasic disorders requiring morphine and Hypnovel. In front of suspicion of stroke, cerebral scanner not showing signs ischemic or hemorrhagic. There was also degradation of the general condition preventing the realization of a new imaging. On 31Jan2021, the patient experienced convulsive seizure. On 01Feb2021, it was decided to set up end-of-life support. The patient died on 01Feb2021. The cause of death was stroke (as reported). It was not reported if an autopsy was performed. The outcome of stroke was fatal. The outcome of the remaining events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1444508 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-28
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Behaviour disorder, Blood glucose, Body temperature, Cardiac arrest, Hyperglycaemia, Hypothermia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), 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), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: ZYMAD; GLUCOPHAGE [METFORMIN HYDROCHLORIDE]; KARDEGIC; MADOPAR; TOUJEO; PRAVASTATINE ARROW
Current Illness: Cholelithiasis (untreated complicated biliary tract lithiasis); Obesity (since 2006); Parkinson''s syndrome; Sleep apnoea; Type II diabetes mellitus (Unbalanced T2D)
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholism (Auto-intoxication and exposure since 2016. In EPHAD, alcohol prohibition.); Benign prostatic hypertrophy; Gait inability; Haemorrhage subdural (traumatic, in 2016); Living in nursing home; Neoplasm of the prostate (unknown or unpredictable evolution, benign prostate hypertrophy in 2009); Smoker; Spinal stenosis NOS (Operated (date not specified), Narrowing of the spinal canal); Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210130; Test Name: blood sugar; Result Unstructured Data: Test Result:2.37 g/l; Comments: hyperglycemia; Test Date: 20210130; Test Name: body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: hypothermia
CDC Split Type: FRPFIZER INC2021728907

Write-up: Arrest cardiac; Presentation of hypothermia at 35.9 C; weakness in walking; hyperglycemia at 2.37 g / L; aggravation of behavioral disorders visible by urination in unsuitable places (corridors, elevators); This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number is FR-AFSSAPS-LY20212457. An 83-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administered in left arm on 22Jan2021 (Batch/Lot Number: EJ6788) as dose 1, single for COVID-19 immunisation. Medical history included traumatic haemorrhage subdural in 2016, ongoing Type II diabetes mellitus (unbalanced T2D), ongoing Sleep apnoea, ongoing Cholelithiasis (untreated complicated biliary tract lithiasis), Vitamin D deficiency, ongoing obesity since 2006, Spinal stenosis NOS (narrowing of spinal canal, date operated not specified), ongoing Parkinson''s syndrome, Neoplasm of the prostate (unknown or unpredictable evolution) from 2005, benign prostate hypertrophy in 2009, alcoholism (auto-intoxication and exposure to alcohol since 2016 = oenolism), active smoking, patient living in nursing home, moves with cane (gait and motility abnormality). Concomitant medications included colecalciferol (ZYMAD); metformin hydrochloride (GLUCOPHAGE); acetylsalicylate lysine (KARDEGIC); benserazide hydrochloride, levodopa (MADOPAR); insulin glargine (TOUJEO); pravastatin sodium (PRAVASTATINE ARROW); all taken for an unspecified indication, start and stop date were not reported. On 28Jan2021, alteration of the patient''s behavior with aggravation of behavioral disorders visible by urination in unsuitable places (corridors, elevators). The patient does not present any complications related to his pathologies. On 30Jan2021, sudden onset of a deterioration in the general condition of the patient who began to feel ill while smoking a cigarette outside. Presentation of hypothermia at 35.9 C, hyperglycemia at 2.37 g / L, weakness in walking requiring emergency medical intervention by the EHPAD medical staff. Sudden cardiac arrest with ineffective cardiac massage. No autopsy required in the context of an isolated person. In total, sudden death due to cardiac arrest on Day 8 of the first vaccination with COMIRNATY. Outcome of cardiac arrest was fatal, while rest of events was unknown. The patient died on 30Jan2021. An autopsy was not performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1444648 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-05-03
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RISPERIDONE; DIFFU K
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Skull trauma
Allergies:
Diagnostic Lab Data: Test Date: 20210502; Test Name: PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728878

Write-up: Vaccination failure; Covid-19; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20211545, Safety Report Unique Identifier FR-AFSSAPS-2021053045. A 92-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 09Feb2021 (lot number: EJ6789) as dose 2, single and on 19Jan2021 (lot number: EJ6795) as dose 1, single for COVID-19 immunisation. Medical history included skull trauma on road accident. Concomitant medications included risperidone and potassium chloride (DIFFU K). The patient had the 1st dose on 19Jan2021 and 2nd dose on 09Feb2021. The patient had a vaccination failure and the patient presented with fever on 02May2021, then desaturated on 05May2021 and he died on 06May2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included positive polymerase chain reaction (PCR) test on 03May2021. As of 21Jun2021, investigational result from regulatory authority team was reported as follows: a sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation resulted in the following conclusion: the investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lots EJ6789 and EJ6795. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Manufacturing site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The regulatory authority process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or corrective action were identified as the complaint was not confirmed.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021718442 Diffrent patient, same reporter, same event, same suspected drug;FR-PFIZER INC-2021718399 Diffrent patient, same reporter, same event, same suspected drug;FR-PFIZER INC-2021718925 Diffrent patient, same reporter, same event, same suspected drug;FR-PFIZER INC-2021718387 Diffrent patient, same reporter, same event, same suspected drug;FR-PFIZER INC-2021718379 Diffrent patient, same reporter, same event, same suspected drug;FR-PFIZER INC-2021718931 Diffrent patient, same reporter, same event, same suspected drug;FR-PFIZER INC-2021729179 Diffrent patient, same reporter, same event, same suspected drug;FR-PFIZER INC-2021718394 Diffrent patient, same reporter, same event, same suspected drug;FR-PFIZER INC-2021718431 Diffrent patient, same reporter, same event, same suspected drug; Reported Cause(s) of Death: COVID-19


VAERS ID: 1444660 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-02
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood creatinine, Blood culture, Blood potassium, C-reactive protein, COVID-19, COVID-19 pneumonia, Cardio-respiratory arrest, Condition aggravated, Drug ineffective, Dyspnoea, Electrocardiogram, Haemoglobin, Haemoptysis, Interstitial lung disease, Neutrophil count, Oxygen saturation, Productive cough, SARS-CoV-2 test, Troponin
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INSULATARD [INSULIN HUMAN INJECTION, ISOPHANE]; ASPIRINE PROTECT; BISOCE; METFORMIN; GLICLAZIDE MYLAN; CORTANCYL; MIANSERIN; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Colectomy partial; Infarct myocardial; Interstitial pneumonitis (Chronic, recently put on O2 at home); Ischaemic heart disease (with myocardial infarction in 2015: 3 stents placed.); Non-insulin-dependent diabetes mellitus; Phimosis; Pulmonary fibrosis; Stent placement (3 stents placed); Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: Creatinine; Result Unstructured Data: Test Result:16 mg/l; Test Date: 20210402; Test Name: blood cultures; Result Unstructured Data: Test Result:Unknown results; Comments: in examination; Test Date: 20210402; Test Name: potassium; Result Unstructured Data: Test Result:5.4; Test Date: 20210402; Test Name: CRP; Result Unstructured Data: Test Result:45; Test Date: 20210402; Test Name: ECG; Result Unstructured Data: Test Result:small shift in the inferior territory; Test Date: 20210402; Test Name: Hb; Result Unstructured Data: Test Result:12.1 g/dl; Test Date: 20210402; Test Name: Neutrophils; Result Unstructured Data: Test Result:19391; Test Name: O2 saturation; Test Result: 99 %; Comments: under 15l/min; Test Date: 20210402; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: with screening revealing mutations suggestive of the 20I/501Y.V1 variant; Test Date: 20210402; Test Name: troponin; Result Unstructured Data: Test Result:467 pg/mL
CDC Split Type: FRPFIZER INC2021728602

Write-up: worsening of his Diffuse interstitial lung disease; worsening of his Diffuse interstitial lung disease; pulmonary infection related to a severe Covid-19 infection; increase in dyspnea; lumbar pain when coughing; productive cough, sometimes tinged with blood; productive cough, sometimes tinged with blood; respiratory exhaustion and cardiorespiratory arrest; Drug ineffective; COVID-19 confirmed by positive PCR COVID-19 test; This is a spontaneous report from a contactable pharmacist downloaded from the WEB, regulatory authority number FR-AFSSAPS-NT20212048, Safety Report Unique Identifier FR-AFSSAPS-2021071613. An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Feb2021 (Batch/Lot Number: Unknown), and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), both as single doses for COVID-19 immunization. Medical history included Non-insulin-dependent diabetes mellitus from 1990, Ischaemic heart disease (with myocardial infarction in 2015: 3 stents placed), phimosis, Stroke from 2012, Colectomy partial, Interstitial pneumonitis (Chronic, recently put on O2 at home), and pulmonary fibrosis. Concomitant medications included insulin human injection, isophane (INSULATARD [INSULIN HUMAN INJECTION, ISOPHANE]), acetylsalicylic acid (ASPIRINE PROTECT), bisoprolol fumarate (BISOCE), metformin, gliclazide (GLICLAZIDE MYLAN), prednisone (CORTANCYL), mianserin, and simvastatin. Patient received a complete vaccination regimen as part of anti-Covid-19 prophylaxis, with Comirnaty, second dose received on 23Feb2021. The patient was hospitalized from 23Mar2021 to 30Mar2021 for worsening of his Diffuse interstitial lung disease, corticosteroid therapy at 40 mg and then at 20 mg/day. An increase in dyspnea was noted as soon as he was discharged, with a positive COVID-19 PCR test on 02Apr2021 (also reported as 05Apr2021), with screening revealing mutations suggestive of the 20I/501Y.V1 variant. A pulmonary infection image related to a severe Covid-19 infection was evoked, with a need for high-flow O2, rejected for resuscitation given the age and the underlying pulmonary fibrosis. The clinical examination shows an oriented patient, with dyspnea on speech, lumbar pain when coughing, with a productive cough, sometimes tinged with blood. He is apyretic, with an O2 saturation of 99% under 15l/min. Laboratory tests shows Hb at 12.1 g/dl, Neutrophils at 19391, CRP at 45, Creatinine at 16 mg/l, potassium at 5.4, troponin increased to 467 pg/ml, blood cultures in examination. The ECG shows a small shift in the inferior territory. The patient receives high concentration mask O2 (12l/min test) combined with dexamethasone, Lovenox and furosemide. On 06Apr2021, the patient desaturates heavily despite maximum mask O2 flow, distressed. Initiation of diuretic treatment without any improvement (in view of the suspicion of associated Acute coronary syndrome). Addition of morphine in ISE because of distressing dyspnea. The patient then rapidly presented with signs of respiratory exhaustion and cardiorespiratory arrest on 07Apr2021 at 7 am in the presence of the care team. In total, pulmonary COVID on fragile pulmonary fibrosis terrain on O2. Rapid worsening despite maximal medical treatment. Evolution: Patient died on 07Apr2021 at 7am. The outcome of the events Drug ineffective, COVID-19 confirmed by positive PCR COVID-19 test, respiratory exhaustion and cardiorespiratory arrest was fatal while for the rest of the events was unknown. The patient underwent lab tests and procedures which included blood creatinine: 16 mg/l on 02Apr2021, blood culture: unknown results on 02Apr2021 in examination, blood potassium: 5.4 on 02Apr2021, c-reactive protein: 45 on 02Apr2021, electrocardiogram: small shift in the inferior territory on 02Apr2021, haemoglobin: 12.1 g/dl on 02Apr2021, neutrophil count: 19391 on 02Apr2021, oxygen saturation: 99 % on an unspecified date under 15l/min, SARS-CoV-2 test: positive on 02Apr2021 with screening revealing mutations suggestive of the 20I/501Y.V1 variant, troponin: 467 pg/ml on 02Apr2021. The patient died on 07Apr2021. It was not reported if an autopsy was performed. NB: Imputability without prejudice to the elements of investigation which could be carried out within the framework of legal procedures. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Drug ineffective; COVID-19 confirmed by positive PCR COVID-19 test; respiratory exhaustion and cardiorespiratory arrest


VAERS ID: 1444691 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-14
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, C-reactive protein, Cerebral haemorrhage, Fall, Haemoglobin, Prothrombin level
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LAROXYL; ROSUVASTATINE [ROSUVASTATIN]; PANTOPRAZOLE; CORDARONE; SINTROM
Current Illness: AFib; CVA
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve repair NOS; Arrhythmia (complete arrhythmia due to atrial fibrillation); Cognitive disturbance (Cognitive disorders (Alzheimer''s?)); Urinary tract infection (Repeated urinary tract infections / catheterization on urethral stricture)
Allergies:
Diagnostic Lab Data: Test Name: Creatinine; Result Unstructured Data: Test Result:84 umol/l; Test Name: C reactive protein; Result Unstructured Data: Test Result:6 mg/l; Test Name: hemoglobin; Result Unstructured Data: Test Result:10.7 g/dl; Test Name: Prothrombin; Test Result: 26 %
CDC Split Type: FRPFIZER INC2021732656

Write-up: This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority. The regulatory authority report number is [FR-AFSSAPS-PA20210888] and Safety Report Unique Identifier [FR-AFSSAPS-2021063554]. A 81-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 05Mar2021 (Batch/Lot Number: Unknown) as dose 1, 0.3mL single for covid-19 immunisation; acenocoumarol (SINTROM), oral from an unspecified date (Batch/Lot Number: Unknown), at unknown dose for thrombosis prophylaxis. Medical history included ongoing atrial fibrillation, cerebrovascular accident from an unknown date to 2014, aortic valve repair from 2012 to an unknown date, cognitive disorder (Cognitive disorders (Alzheimer''s?)), urinary tract infection (Repeated urinary tract infections / catheterization on urethral stricture), arrhythmia (complete arrhythmia due to atrial fibrillation). Concomitant medications included amitriptyline hydrochloride (LAROXYL); rosuvastatine [rosuvastatin] (ROSUVASTATINE [ROSUVASTATIN]); pantoprazole (PANTOPRAZOLE); amiodarone hydrochloride (CORDARONE). The patient experienced cerebral haemorrhage (death) on 14Mar2021. The patient underwent lab tests and procedures which included blood creatinine: 84 umol/l, c-reactive protein: 6 mg/l, haemoglobin: 10.7 g/dl, prothrombin level: 26 %. The action taken in response to the events for acenocoumarol was unknown. The patient died on 29Mar2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: Confirmed a posteriori by the emergency report. 81-year-old male. History / field: aortic valve for aortic stenosis in 2012. 2014 ischemic stroke. Repeated urinary tract infections / catheterization on urethral stricture. complete arrhythmia due to atrial fibrillation. Cognitive disorders (Alzheimer''s?). Long-term treatment: SINTROM, CORDARONE, LEVOTHYROX, ROSUVASTATINE, LAROXYL, PANTOPRAZOLE. On 05Mar2021: first dose of vaccine by COMIRNATY (LOT UNKNOWN). On 14Mar2021: the wife calls for the occurrence in the night of a complaint of pain + "feeling of dying" of a patient without precise localization. ; vomited around 4 a.m. then went back to bed. At 6 o''clock, fell from his height with no obvious context. At the Emergency Department at 15:30 p.m. Clinical: disoriented, headache, stiff neck, reactive symmetrical pupils; eupneic Imaging: left intra-parenchymal fronto-parietal hematoma with mass effect and sub-falcorial engagement; Notice large guard of neurosurgery: important intraparenchymal hematoma of the crossroads, without intraventricular bleeding or engagement; 81-year-old patient with loss of autonomy: rejected from neurosurgery. No aggressive resuscitation. Additional report available: hemoglobin = 10.7 g/dl ; C reactive protein = 6 mg/L, Creatinine = 84 ?mol/L; Prothrombin = 26 %. In total: cerebral hemorrhage 10 days after vaccination with Comirnaty, and immediately after fall in height, in an 81-year-old patient on anticoagulant: Declaration by the family; no link with the vaccine is mentioned in the emergency report. +++ roles of Sintrom (Prothrombin = 26%) and fall. Update 08Jun21: Added Sintrom / Brain Hemorrhage Accountability. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Fall in height; Cerebral haemorrhage


VAERS ID: 1444702 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Coma, Coma scale, Computerised tomogram head, Electrocardiogram, Heart rate, Oxygen saturation, Physical examination, Respiratory acidosis
SMQs:, 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), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   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: Decompensation cardiac
Allergies:
Diagnostic Lab Data: Test Date: 20210428; Test Name: blood sugar; Result Unstructured Data: Test Result:7 mmol/l; Test Date: 20210428; Test Name: blood pressure; Result Unstructured Data: Test Result:13/7; Test Date: 20210428; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:8; Test Date: 20210428; Test Name: cerebral CT; Result Unstructured Data: Test Result:no bleeding, no sign of recent ischemia; Test Date: 20210428; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm, normal repolarization, normal conduc; Comments: sinus rhythm, normal repolarization, normal conduction; Test Date: 20210428; Test Name: hearth rate; Result Unstructured Data: Test Result:100 bpm; Test Date: 20210428; Test Name: Saturation; Test Result: 95 %; Comments: under 2L; Test Date: 20210428; Test Name: examination; Result Unstructured Data: Test Result:no sign of focusing reactive pupils, abdomen sensi; Comments: no sign of focusing reactive pupils, abdomen sensitive to the hypogastrium, regular heart sounds, no short breaths, crackling right base no respiratory distress acute
CDC Split Type: FRPFIZER INC2021728856

Write-up: Acidosis respiratory; Coma; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PB20212750. An 87-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: ET6956), intramuscular, administered in arm right on 27Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history included decompensation cardiac from an unknown date. The patient''s concomitant medications were not reported. On 28Apr2021, the patient experienced acidosis respiratory and coma. The outcome of the events was fatal. Clinical course details: On 28Apr2021, the Glasgow coma scale 8 cannot be woken up. On examination, there was no sign of focusing reactive pupils, abdomen sensitive to the hypogastrium, regular heart sounds, no short breaths, crackling right base no respiratory distress acute, SaO2 95% under 2L, blood pressure 130/70, 100 bpm, afebrile, glucose 7mmol / l. On ECG, sinus rhythm, normal repolarization, normal conduction. On cerebral CT, no bleeding, no sign of recent ischemia, EEG requested but not possible, and MRI impossible because not transportable. So probable stroke of the trunk not yet visible on the CT scan. Neurological picture in the foreground, with coma and hypoventilation responsible for acidosis. Decision to favor comfort care in the face of the absence of reservations: proportionate sedation if signs of discomfort. On 29Apr2021, death of the patient. The patient died on 29Apr2021. Cause of death were acidosis respiratory and coma. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acidosis respiratory; Coma


VAERS ID: 1444723 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine, Blood creatine increased, Cerebral infarction, Glomerular filtration rate, Glomerular filtration rate decreased, Neurological examination, Respiratory disorder, Respiratory rate, Scan brain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COUMADIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac valve disease (with sequelae 25% LVEF); Cardioverter placement; Dizziness; Hepatitis C; Implantable defibrillator user; Iodine allergy; Ischaemic heart disease (with sequelae 25% LVEF); Labyrinthine dysfunction; Left ventricular ejection fraction decreased; Permanent atrial fibrillation; Prosthesis implantation; Viral hepatitis B
Allergies:
Diagnostic Lab Data: Test Date: 20210320; Test Name: Creatinemia; Result Unstructured Data: Test Result:196uM; Test Date: 20210320; Test Name: GFR; Result Unstructured Data: Test Result:21 mL / min / 1.73 m2; Test Date: 20210324; Test Name: neurological condition; Result Unstructured Data: Test Result:stable.; Test Date: 20210324; Test Name: Respiratory rate; Result Unstructured Data: Test Result:28 /min; Comments: Oxygen 1L / min with the mask and Some bronchial rales; Test Date: 20210325; Test Name: Respiratory rate; Result Unstructured Data: Test Result:10 /min; Test Date: 20210319; Test Name: brain scan; Result Unstructured Data: Test Result:shows a left M1 occlusion; Test Date: 20210320; Test Name: brain scan; Result Unstructured Data: Test Result:does not find any intracerebral hemorrhage or peri; Comments: does not find any intracerebral hemorrhage or peri-cerebral collection.; Test Date: 20210324; Test Name: brain scan; Result Unstructured Data: Test Result:No argument in favor of a hemorrhagic transformati
CDC Split Type: FRPFIZER INC2021728871

Write-up: Infarct cerebral; not doing so well on the respiratory plan: respiratory rate was 28 / min/respiratory rate is 10 / min; Creatinemia was 196uM; GFR: 21 mL / min / 1.73 m2; This is a spontaneous report from a contactable consumer downloaded from the WEB FR-AFSSAPS-PC20210623, Safety Report Unique Identifier FR-AFSSAPS-2021023140. A 77-year-old female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 intramuscular on 18Mar2021 (at the age of 77-year-old) (Batch/Lot number was not reported) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included ischaemic heart disease and valvular heart disease with sequelae 25% Left ventricular ejection fraction (LVEF) decreased, iodine allergy, permanent atrial fibrillation, cardioverter placement, hepatitis c, viral hepatitis b, with defibrillator, and some dizziness secondary to labyrinthine toxicity of antibiotic therapy and mechanical and mitral aortic valves. The patient was independent and walked without assistance. The patient''s concomitant medication included warfarin sodium (COUMADIN). On 19Mar2021, the patient experienced infarct cerebral. On 19Mar2021, at 19:30, the patient was found to have a deficit on the right side with a right hemiparesis and a deviation of the left gaze. A brain scan was performed and showed a left M1 occlusion. On 20Mar2021, a left sylvic thrombectomy was performed. A brain scan did not find any intracerebral hemorrhage or peri-cerebral collection. On 23Mar2021, the patient was vigilant, aphasic and does not respond to simple orders. Comfortable, eupneic in ambient air under 1L of O2 with nasal cannula. Creatinemia was 196uM and GFR: 21 mL / min / 1.73 m2. Treatment of patient included analgesics, coantalgics and psychotropic drugs: paracetamol 1gx4 if necessary, glucose 5% 1L, and furosemide, O2 1L. On 24Mar2021, a brain scan was performed to look for a hemorrhagic transformation of the left sylvian stroke. No argument in favor of a hemorrhagic transformation. The patient was not doing so well on the respiratory plan: respiratory rate was 28 / min; Oxygen 1L / min with the mask and some bronchial rales and his neurological condition was stable. On 25Mar2021, the patient was non-vigilant. His respiratory rate was 10 / min. Coantalgic and psychotropic treatment combined morphine 1mg / h SC, paracetamol 1gx4 SC if necessary was given. In total, the patient was hospitalized for an extensive left sylvic infarction the day after the dose 1 of the vaccine with failure of thrombectomy and secondary aphasia. The patient died 10 days after vaccination. Outcome of not doing so well on the respiratory plan: respiratory rate was 28 / min/respiratory rate was 10 / min was unknown. The patient died on 28Mar2021. It was not reported if an autopsy was performed. No follow-up Information on batch/lot number cannot be obtained attempts are possible. No further information expected.; Reported Cause(s) of Death: Infarct cerebral


VAERS ID: 1444770 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-13
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Angiotensin converting enzyme, Antibody test, Antineutrophil cytoplasmic antibody, Asthenia, Atrioventricular block, Bartonella test, Blood calcium, Blood glucose, Blood phosphorus, Bundle branch block right, Cerebral haemorrhage, Coma scale, Computerised tomogram head, Coxiella test, Depressed level of consciousness, Dizziness, Electrocardiogram, Electrophoresis protein, Eosinophil count, Facial paralysis, HIV antibody, Haemorrhage intracranial, Haemorrhagic stroke, Hemiparesis, Hepatitis B virus test, Hepatitis C antibody, Infarction, Investigation, Leukoencephalopathy, Magnetic resonance imaging head, Mycobacterium test, Myocardial infarction, Neurological examination, Physical examination, Pulmonary sepsis, Rheumatoid factor, Sputum culture, Urinary sediment
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Conduction defects (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 9
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: BISOPROLOL; COVERAM; LANSOPRAZOLE; TAHOR; XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antibiotic therapy; Antiplatelet therapy; Cigarette smoker (30 packages (PA)); Coronary artery aneurysm; Coronary heart disease; Hypertension arterial; Ischaemic heart disease (with multiple coronary aneurysms.); Pulmonary tuberculosis (Empirical anti-tuberculosis treatment from August 2020 to February 2021.); Vitamin K antagonist
Allergies:
Diagnostic Lab Data: Test Date: 20210516; Test Name: Brain CT; Result Unstructured Data: Test Result:subject to non-comparable modalities, stable aspec; Comments: subject to non-comparable modalities, stable aspect of the right thalamic haematoma and of the right deep haemorrhagic spots and cerebellum, doubt about the appearance of a right lateropontine gap. Neurosurgical opinion: no surgical management, no indication to introduce corticosteroids.; Test Name: Q fever and bartonella negative; Test Result: Negative ; Test Date: 20210513; Test Name: ECG; Result Unstructured Data: Test Result:RSR, BAV1 (atrioventricular block), BBD (right bra; Comments: RSR, BAV1 (atrioventricular block), BBD (right branch block), inferior infarct sequelae.; Test Name: Protein electrophoresis; Result Unstructured Data: Test Result:Protein electrophoresis with non-specific beta-gam; Comments: Protein electrophoresis with non-specific beta-gamma block.; Test Name: No hypereosinophilia; Result Unstructured Data: Test Result:No hypereosinophilia; Comments: No hypereosinophilia; Test Name: hepatitis B viral load; Test Result: Negative ; Test Name: HIV-HCV serology; Test Result: Negative ; Test Name: HIV-HCV serology; Test Result: Negative ; Test Date: 20210513; Test Name: clinical examination; Result Unstructured Data: Test Result:unremarkable; Test Date: 20210513; Test Name: Brain MRI; Result Unstructured Data: Test Result:no recent cerebral infarction. Deep right thalam; Comments: no recent cerebral infarction. Deep right thalamic haematoma of 19 mm, without signs of cerebral involvement. Multiple superficial and deep supra- and subcentral microbleeds. Advanced vascular leukopathy.; Test Date: 202001; Test Name: Quantiferon positive; Test Result: Positive ; Comments: . Quantiferon positive in January 2020, associated with multiple thoracic adenomegaly. Empirical anti-tuberculosis treatment from August 2020 to February 2021.; Test Date: 20210513; Test Name: neurological examination; Result Unstructured Data: Test Result:central right facial paralysis, no sign of neurolo; Comments: central right facial paralysis, no sign of neurological localisation, no meningeal or cerebellar syndrome, no pyramidal syndrome.; Test Date: 20210513; Test Name: HD (Haemodynamic) stable, eupneic in AA (ambient air),; Result Unstructured Data: Test Result:HD (Haemodynamic) stable, eupneic in AA (ambient a; Comments: HD (Haemodynamic) stable, eupneic in AA (ambient air),; Test Name: rheumatoid factors; Test Result: Negative ; Test Name: Koch bacilli sputum negative; Test Result: Negative ; Test Name: urine sediment; Result Unstructured Data: Test Result:No urine sediment abnormality.; Comments: No urine sediment abnormality; Test Date: 20201208; Test Name: cardiac angioscan; Result Unstructured Data: Test Result:stability of the aneurysmal ectatic lesions of the; Comments: stability of the aneurysmal ectatic lesions of the coronary network with appearance in comparison of a partial thrombosis of the right coronary, partial regression of the right upper laterotracheal mediastinal adenopathies and stability of the other mediastinal laminar formations.; Test Name: plasma angiotensin measurement; Result Unstructured Data: Test Result:normal plasma angiotensin measurement without argu; Comments: normal plasma angiotensin measurement without argument for sarcoidosis.; Test Name: anti-stroke antibodies; Test Result: Positive ; Test Name: ANCA; Test Result: Negative ; Test Name: Q fever and bartonella negative; Test Result: Negative ; Test Name: phospho-calcium balance; Result Unstructured Data: Test Result:Normal phospho-calcium balance; Comments: Normal phospho-calcium balance; Test Date: 20210513; Test Name: Blood glucose test; Result Unstructured Data: Test Result:6.5 mmol/L; Test Name: phospho-calcium balance; Result Unstructured Data: Test Result:Normal phospho-calcium balance; Comments: Normal phospho-calcium balance; Test Date: 20210517; Test Name: GCS; Result Unstructured Data: Test Result:11; Comments: Glasgow coma scale
CDC Split Type: FRPFIZER INC2021728770

Write-up: Haemorrhagic stroke; inferior and anterior myocardial infarction; worsening of the state of consciousness (swallowing disorder, oxygen dependence 3 l); dizziness; Patient who consulted the emergency department for asthenia with right facial paralysis.; Patient who consulted the emergency department for asthenia with right facial paralysis/general; BAV1 (atrioventricular block); BBD (right branch block); Deep right thalamic haematoma/Multiple superficial and deep supra-and subcentral microbleeds/cerebral haemorrhage; Advanced vascular leukopathy; Interior infarct; pulmonary sepsis; hemiparesis; intracranial hemorrhage; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PC20211361, Safety Report Unique Identifier: FR-AFSSAPS-2021062925. A 79-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), intramuscular on 20Apr2021 (Batch/Lot Number: Unknown) (at the age of 79-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension arterial, pulmonary tuberculosis (Empirical anti-tuberculosis treatment from August 2020 to February 2021), ischaemic heart disease in Jan2020 with multiple coronary aneurysms, Cigarette smoking from 2005 (30 packages (PA)), coronary heart disease with multiple coronary aneurysms diagnosed in Jan2020 (Comprehensive aetiological work-up. The most common aetiology of aneurysms, atherosclerosis, is not retained in view of the very atypical profile of these aneurysms which are supra-centimetric in size and in a patient with controlled cardiovascular risk factors), introduction of vitamin K antagonis and antiplatelet agent. The patient''s history included negative human immunodeficiency virus (HIV)-hepatitis C virus (HCV) serology; positive anti-stroke antibodies with a negative hepatitis B viral load; Q fever and bartonella negative; Protein electrophoresis with non-specific beta-gamma block; Antineutrophil cytoplasmic antibody (ANCA) negative, rheumatoid factors negative; No urine sediment abnormality; No hypereosinophilia; Koch bacilli sputum negative; Quantiferon positive in Jan2020, associated with multiple thoracic adenomegaly; Normal phospho-calcium balance and normal plasma angiotensin measurement without argument for sarcoidosis (introduction of vitamin K antagonist, followed by antiplatelet agent, then Xarelto in view of the partially thrombosed appearance of the right coronary network); cardiac angioscan on 08Dec2020: stability of the aneurysmal ectatic lesions of the coronary network with appearance in comparison of a partial thrombosis of the right coronary, partial regression of the right upper laterotracheal mediastinal adenopathies and stability of the other mediastinal laminar formations. Concomitant medications included bisoprolol; amlodipine besilate, perindopril arginine (COVERAM); lansoprazole; atorvastatin calcium (TAHOR) and rivaroxaban (XARELTO) from Feb2021 to 18May2021. On 13May2021, the patient who consulted the emergency department for asthenia with right facial paralysis. According to the patient, notion of general weakness on the same day around 10:00 after defecation effort. Then onset of dizziness and right facial paralysis noted at around 13:00. The patient experienced Haemorrhagic stroke. In the emergency room, Haemodynamic (HD) stable, eupneic in AA (ambient air), HGT (Blood glucose test): 6.5 mmol/l. Neurological examination: central right facial paralysis, no sign of neurological localisation, no meningeal or cerebellar syndrome, no pyramidal syndrome. The rest of the clinical examination was unremarkable. Electrocardiogram (ECG): RSR, BAV1 (atrioventricular block), BBD (right branch block), inferior infarct sequelae. Brain Magnetic resonance imaging (MRI): no recent cerebral infarction. Deep right thalamic haematoma of 19 mm, without signs of cerebral involvement. Multiple superficial and deep supra-and subcentral microbleeds. Advanced vascular leukopathy. Neurosurgical opinion: no indication for surgery for this haematoma which was fairly typical of bleeding on hypertension. Evolution marked on 16May2021: appearance of a new deficit in the left hemisphere. Brain computerized tomogram (CT): subject to non-comparable modalities, stable aspect of the right thalamic haematoma and of the right deep haemorrhagic spots and cerebellum, doubt about the appearance of a right lateropontine gap. Neurosurgical opinion: no surgical management, no indication to introduce corticosteroids. On 17May2021: in the morning, worsening of the state of consciousness, Glasgow coma scale (GCS): 11. Initiation of antibiotic therapy with CEFOTAXIME 1 g/8 h in the hypothesis of inhalation pneumopathy (swallowing disorder, oxygen dependence 3 l, biological inflammatory syndrome). On 18May2021: Appearance of an inferior and anterior myocardial infarction following discontinuation of Xarelto in the context of cerebral haemorrhage. After collegial discussion with cardiologist, neurologist, cardiac surgery: decision not to carry out coronary angiography in view of giant aneurysmal lesions and the risk of bleeding (treatment with Karegic and Plavix necessary thereafter) and no cardiac surgery in this context (pulmonary sepsis, hemiparesis on three floors, intracranial hemorrhage). Medical treatment retained (Lasilix 40 mg IV (intravenous), Bisoce and IEC (angiotensin converting enzyme inhibitor) to be continued). Unfavourable evolution. The outcome of the events was unknown except for haemorrhagic stroke. The patient died due to haemorrhagic stroke on 22May2021 at 00:30. It was unknown if autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1444831 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Medication errors (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ABASAGLAR; NOVORAPID; CORTANCYL; DIFFU K; CALCIT [CALCIUM CITRATE;COLECALCIFEROL]; CELLCEPT [MYCOPHENOLATE MOFETIL]; SOLUPRED [METHYLPREDNISOLONE]; THEALOSE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Age-related macular degeneration; Blood pressure high; Bullous pemphigoid; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: PCR COVID-19 test; Result Unstructured Data: Test Result:positive, no variant
CDC Split Type: FRPFIZER INC2021728895

Write-up: Vaccination failure; COVID-19 pneumonitis; first dose on 18Mar2021/second dose on 02Apr2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RN20211338, Safety Report Unique Identifier FR-AFSSAPS-2021052082. A 90-year-old male patient received second dose of bnt162b2 (COMIRNATY; Batch/Lot number was not reported) intramuscularly on 02Apr2021 as dose 2, single and first dose intramuscularly on 18Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included age-related macular degeneration, type 2 diabetes mellitus, high blood pressure and bullous pemphigoid. Concomitant medications included insulin glargine (ABASAGLAR); insulin aspart (NOVORAPID); prednisone (CORTANCYL); potassium chloride (DIFFU K); calcium citrate, colecalciferol (CALCIT); mycophenolate mofetil (CELLCEPT); methylprednisolone (SOLUPRED); hyaluronate sodium, trehalose (THEALOSE). The patient received the first dose on 18Mar2021 and the second dose on 02Apr2021. It was reported that the patient had vaccination failure and COVID-19 pneumonitis on 16Apr2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive, no variant on 16Apr2021. Patient was treated with high-dose oxygen therapy, antibiotic therapy with TAZOCILLINE and corticosteroid therapy however patient died on 27Apr2021 at 10:15. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: COVID-19 pneumonitis


VAERS ID: 1444941 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood glucose, Blood pressure measurement, Body temperature, Heart rate, Hypoglycaemia, Oxygen saturation, Respiratory distress
SMQs:, Anaphylactic reaction (broad), 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), 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 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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: LEPTICUR; VITASCORBOL [ASCORBIC ACID]; GLICLAZIDE; AMLODIPINE; ZOPICLONE; TARDYFERON; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; TAMSULOSIN; CHOLECALCIFEROL; DOLIPRANE; LOXAPAC [LOXAPINE HYDROCHLORIDE]; H
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: blood sugar; Result Unstructured Data: Test Result:1.61 g/l; Comments: At 11:30 am, No disturbance of consciousness, feeds alone; Test Date: 20210525; Test Name: blood sugar; Result Unstructured Data: Test Result:0.56 g/l; Comments: At 1:00 pm, re-sweetened with orange juice + 2 sachets of powdered sugar + a jam. No disturbance of consciousness, nor signs of hypoglycemia; Test Date: 20210525; Test Name: blood sugar; Result Unstructured Data: Test Result:0.41 g/l; Comments: At 1:30 p.m., given a glass of orange juice + 3 sachets of powdered sugar + 2 jam. G5% infusion placed subcutaneously. No signs of hypoglycemia or disturbance of consciousness.; Test Date: 20210525; Test Name: blood sugar; Result Unstructured Data: Test Result:0.45 g/l; Comments: At 2:30 p.m., Infusion torn off. Constants in the standards. Patient re-sweetened.; Test Date: 20210525; Test Name: blood sugar; Result Unstructured Data: Test Result:0.63 g/l; Comments: At 3.20 p.m.; Test Date: 20210525; Test Name: blood sugar; Result Unstructured Data: Test Result:0.74 g/l; Comments: At 3.45 p.m; Test Date: 20210525; Test Name: blood sugar; Result Unstructured Data: Test Result:1.68 g/l; Comments: At 4 p.m.; Test Date: 20210525; Test Name: blood sugar; Result Unstructured Data: Test Result:1.57 g/l; Comments: At 5 p.m.; Test Date: 20210525; Test Name: BP; Result Unstructured Data: Test Result:11/5; Test Date: 20210525; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210525; Test Name: pulse; Result Unstructured Data: Test Result:94; Test Date: 20210525; Test Name: saturation; Test Result: 45 %; Test Date: 20210525; Test Name: saturation; Test Result: 50 %; Test Date: 20210525; Test Name: saturation; Test Result: 70 %; Comments: At 5 p.m
CDC Split Type: FRPFIZER INC2021728800

Write-up: Respiratory distress; Consciousness abnormal; Hypoglycaemia; This is a spontaneous report from a contactable pharmacist downloaded from the WEB FR-AFSSAPS-TS20212230. Sender (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021068396. A 78-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 25May2021 (Batch/Lot Number: Unknown) as single for COVID-19 immunisation; insulin aspart (NOVORAPID), subcutaneous on 25May2021 11:00 (Batch/Lot Number: Unknown), at 12 iU, single for diabetes; insulin glargine (ABASAGLAR), subcutaneous from 29Mar2021 (Batch/Lot number was not reported) to an unspecified date, at 12 iU, 3x/day (8hours) for diabetes. Medical history included diabetes from an unknown date and unknown if ongoing. Concomitant medications included tropatepine hydrochloride (LEPTICUR); ascorbic acid (VITASCORBOL); gliclazide; amlodipine; zopiclone; ferrous sulfate (TARDYFERON); macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL); tamsulosin; cholecalciferol; paracetamol (DOLIPRANE); loxapine hydrochloride (LOXAPAC); haloperidol (HALDOL); phenoxymethylpenicillin benzathine (ORACILLIN); metoclopramide hydrochloride (PRIMPERAN); lorazepam (TEMESTA); carbohydrates nos, fructooligosaccharides, lipids nos, minerals nos, proteins nos, vitamins nos (CLINUTREN DESSERT HP/HC); all taken for an unspecified indication, start and stop date were not reported. The patient experienced respiratory distress, consciousness abnormal and hypoglycaemia on 25May2021. The events were described as follows: patient who since 29Mar2021 has been treated with Abasaglar insulin pen 12 IU at 8 hours and Novorapid Flexpen insulin pen (2 IU if blood sugar at 2 - 2.5 g / l, 4 IU if 2.5 - 3 g / l, 6 IU if greater than 3 g / l). Administration of the 2nd injection of Comirnaty on 25May2021 in the morning (time not specified). The patient received on 25May2021 at 11 a.m. 12 IU rapid insulin Novorapid Flexpen instead of the prescribed slow insulin Abasaglar. At 11:30 am, blood sugar at 1.61 g / l. Had a lunch high in slow and fast sugars. No disturbance of consciousness, feeds alone. At 1 p.m., blood sugar at 0.56: re-sweetened with orange juice and 2 sachets of powdered sugar and a jam. No disturbance of consciousness, nor signs of hypoglycemia. At 1:30 p.m., blood sugar at 0.41: given a glass of orange juice and 3 sachets of powdered sugar and 2 jam. G5% infusion placed subcutaneously. No signs of hypoglycemia or disturbance of consciousness. At 2:30 p.m., blood sugar at 0.45. Infusion torn off. Constants in the standards. Patient re-sweetened. At 3 p.m .: The patient took 2 slices of sandwich bread with jam + apple juice. Slow motion and and looks confused. At 3.20 p.m., 0.63 g / l. The doctor asks for it to be sweetened again. Infusion impossible because despite slowing down, the patient withdraws it. Took a compote, which he regurgitated (Has been fed regularly since late morning). At 3.45 p.m., 0.74 g / l, bulk. At 4 p.m., 1.68 g / l, hypotonia, no reaction under stimulation with pale complexion and cyanosis at the fingertips. Bronchial aspiration with removal of brown secretion without real effectiveness on its size. BP 11/5, pulse 94 and resteapyretic at 36.6 Centigrades. Put under O2 in the mask other concentration because 45%, ambient air saturation. This subsequently maintains 50% under 12l. At 5 p.m., blood sugar at 1.57 g / l and saturation at 70% under 12l of O2. Seems to have an indrawing breath and moans. An aerosol is subsequently ineffective. Had an injection of IM ceftriaxone. Stay calm, move at times but no reaction. Around 6.30 p.m., presence of brown vomiting: aspiration necessary with further removal of the secretion but still very present congestion. Abdomen swollen but very flexible. An enema with Normacol is performed (Transit monitoring usually impossible because going to the toilet alone). No food possible or taking treatment this evening. Patient died around 8.15 p.m. In total, hypoglycaemia difficult to ascertain following an error in administration of 12 IU of Novorapid Flexpen pen instead of Abasaglar pen, with disturbance of consciousness. When the blood sugar was normalized, respiratory distress then death of the patient. Outcome of the events respiratory distress and consciousness abnormal was reported as fatal (also reported that cause of death was unknown). Outcome of event hypoglycaemia was recovered with sequel. The action taken in response to the events for insulin aspart was permanently withdrawn on 25May2021 11:00. The patient died on 25May2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Consciousness abnormal; Respiratory distress


VAERS ID: 1444949 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021741268

Write-up: unknown cause of death; This is a spontaneous report from a non-contactable psychiatrist (and deputy). A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The psychiatrist reported in a video "I Have a friend who just lost a friend himself, who was vaccinated and who lost his life, he was perfectly well". The patient died on an unspecified date. The cause of death was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1445162 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 53-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 2021 The patient died in 2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1445254 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 12
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: MOMETASONE; APRANAX [NAPROXEN]; ULPRIX; TRAMADOL; ZOLEDRONIC ACID; CALCIUM-D-SANDOZ
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Anemia; Arthritis; Bone cancer; Hypercholesteraemia; Liver metastases; Lung adenocarcinoma metastatic; Squamous cell carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210508; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021730994

Write-up: This is a spontaneous report from a contactable physician, regulatory authority or other manufacturer number HU-OGYI-414921. A 67-years-old male patient received the first dose of 0.3 ml COMIRNATY (BioNTech Manufacturing GmbH/Pfizer) intramuscularly (Lot /batch number: EW4815, expiry date: unknown) on 19Apr2021 in the left arm for prevent Covid-19. Medical history also included allergic rhinitis, anemia, arthritis from 2012 and hypercholesterinemia from 2012, all unknown if it was ongoing. Also included Squamous cell carcinoma, Liver metastases, Lung adenocarcinoma metastatic and Bone cancer, all from 2019 and unknown if it was ongoing. Concomitant drugs were 100 mg tramadol twice daily, 3.5 mg zolendronic acid, mometasone nasal spray, naproxen (APRANAX, Film-coated tablet) 550 mg, calcium carbonate; cholecalciferol (CALCIUM-D-SANDOZ, Effervescent tablet) and pantoprazole sodium sesquihydrate (ULPRIX,Gastro-resistant tablet) 40 mg. The patient was in the Covid Department between 26Apr2021-28Apr2021 due to suspected Covid-19, but his antigen and PCR tests were negative on 08May2021. On 04May2021 he was admitted in the Pulmonology Department due to increasing dyspnea. The patient has lung adenocarcinoma with metastases involving bones, bone marrow and liver for which he receives chemo-radiotherapy. The patient received oxygen and drug therapy, but his condition progressed and passed away on 08May2021 at 18:15 (no autopsy). Based on the hospital discharge summary, the cause of death was his advanced, lung adenocarcinoma with metastases. Sender Comment: As the patient died because of his advanced lung adenocarcinoma with metastases, the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: advanced, lung adenocarcinoma with metastases


VAERS ID: 1445255 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-23
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Confusional state, Death, Hyponatraemia, Hypotonia, Inflammation, Ketoacidosis, Laboratory test, Liver function test decreased, Loss of consciousness, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Pancreatitis; Prostate cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: Laboratory test; Result Unstructured Data: Test Result:severe ketoacidosis; Test Date: 20210424; Test Name: Laboratory test; Result Unstructured Data: Test Result:decreased liver function; Test Date: 20210424; Test Name: Laboratory test; Result Unstructured Data: Test Result:hyponatremia; Test Date: 20210424; Test Name: Laboratory test; Result Unstructured Data: Test Result:anemia; Test Date: 20210424; Test Name: Laboratory test; Result Unstructured Data: Test Result:elevated inflammatory parameters; Test Date: 20210424; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210424; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021730993

Write-up: death; uncontactable state; severe ketoacidosis; decreased liver function; hyponatremia; anemia; elevated inflammatory parameters; hypotonic; confused the day before with speech problems and could not move his right arm; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority - WEB regulatory authority or other manufacturer number HU-OGYI-415021. A 68-years-old male patient received the first dose of 0.3 ml COMIRNATY (BioNTech Manufacturing GmbH/Pfizer) intramuscularly (Lot /batch number: ET3620, expiry date: unknown) on 31Mar2021 in the left arm for prevent Covid-19. Medical history included pancreatitis from 2008, diabetes mellitus and malign prostate cancer, all unknown if it was ongoing. Concomitant drugs were not reported. The patient was transferred to hospital on 24Apr2021 in an uncontactable state. According to the patient''s son, he become confused the day before with speech problems and could not move his right arm. His Covid-19 antigen and PCR tests were negative on 24Apr2021. Laboratory result showed severe ketoacidosis, decreased liver function, hyponatremia, anemia and elevated inflammatory parameters. The patient''s condition progressed and was hypotonic during the whole hospitalization. Patient passed away on 25Apr2021 at 00:15 (no autopsy). The outcome of other events were unknown. Sender Comment: The reporter physician assessed the event of death as related to the patients primary disease (malign prostate cancer), therefore the causal relationship is unlikely between the suspected drug and the adverse event. The case is serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1445257 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001946 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic bronchitis; Hypertension; Ischemic cardiomyopathy; Nephrosclerosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH in an 82-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001946) for COVID-19 vaccination. Concurrent medical conditions included Ischemic cardiomyopathy, Chronic bronchitis, Hypertension and Nephrosclerosis. On 01-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 04-May-2021 The patient died on 04-May-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH to be not related. No concomitants were provided by the reporter. No treatment information was provided by the reporter. As per autopsy, the event is related to patient''s primary diseases. As per reporter''s assessment, death is not related to the vaccine. This case concerns an 82 year old (unknown gender) with medical history of Ischemic Cardiomyopathy, chronic bronchitis, hypertension and nephrosclerosis who died 4 days after being given with the 1st dose of the vaccine. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: This case concerns an 82 year old (unknown gender) with medical history of Ischemic Cardiomyopathy, chronic bronchitis, hypertension and nephrosclerosis who died 4 days after being given with the 1st dose of the vaccine. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Death


VAERS ID: 1445258 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Angiogram, Aphasia, Cardiac failure, Cardiopulmonary failure, Cerebral infarction, Cerebrovascular accident, Computerised tomogram head, Dysarthria, Fall, Hemiparesis, Inflammation scan, Investigation, Monoparesis, Multiple fractures, Pneumonia, Renal function test, Renal impairment, SARS-CoV-2 test, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Osteoporosis/osteopenia (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Hypertension; Hypothyreosis; Ischemic heart disease; Metastatic breast cancer
Allergies:
Diagnostic Lab Data: Test Name: CT angiography; Result Unstructured Data: Test Result:left middle cerebral artery; Comments: confirmed left middle cerebral artery occlusion in segment M2; Test Name: Acute cranial CT; Result Unstructured Data: Test Result:ruled out bleeding; Test Name: inflammatory parameters; Result Unstructured Data: Test Result:high; Test Name: necroenzyme; Result Unstructured Data: Test Result:high degree of necroenzyme elevation; Test Name: renal function; Result Unstructured Data: Test Result:severely impaired renal function values; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021770882

Write-up: motor aphasia, mild; dysarthria; right upper limb 4/5 paresis; stroke; Hemiparesis (right); Fall; broke her right radial bone; impaired renal function; NSTEMI; cardiorespiratory failure; hypnoid confusion; cardiac failure; left middle cerebral artery occlusion/cerebral infarction; hypostatic bronchopneumonia; This is a spontaneous report from a contactable physician, received from the regulatory authority, downloaded from the Regulatory Authority -WEB. The regulatory authority report number is HU-OGYI-456021. A 77-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Tozinameran, Regulatory Authority: BioNTech Manufacturing GmbH/ Pfizer, strength: 30 ug, lot/batch number: ET6956) concentrate for dispersion for injection, intramuscularly, at left arm, on 26Apr2021 (unknown age at time of vaccination), at 0.3 mL single dose for COVID-19 immunisation. Medical history included ischemic heart disease, hypothyreosis, hypertension, atrial fibrillation, metastatic breast cancer, all from an unspecified date and not ongoing. The patient''s concomitant medications included unspecified anticoagulant therapy. The patient previously received the first dose of BNT162B2 (COMIRNATY, lot/batch number: ET3620) on 22Mar2021 for COVID-19 immunisation. The patient experienced motor aphasia, mild, dysarthria, right upper limb 4/5 paresis, stroke, and hemiparesis (right) on unspecified date; fall and broke her right radial bone on 29Apr2021. The events were serious with criteria of hospitalization. Narrative: This serious case was reported by a physician on 07Jun2021, concerning death after the administration of Comirnaty. On an unknown date, the patient was transported to the emergency department due to sudden onset of mild motor aphasia, dysarthria, and right upper limb 4/5 paresis. The symptoms referred to stroke in the dominant hemisphere. COVID 19 PCR test was negative. Acute cranial CT ruled out bleeding, CT angiography confirmed left middle cerebral artery occlusion in segment M2. Thrombolysis with respect to the time factor, uncertain onset of symptoms was not considered. The patient was referred to thrombectomy, but no intervention was recommended. LMWH and circulatory improvement infusions were used. On the night of 29Apr2021, the patient fell off the bed, broke her right radial bone, which was treated in traumatology. Despite the treatment used, right hemiparesis progressed and hypnoid confusion developed. In laboratory tests, a high degree of necroenzyme elevation, severely impaired renal function values, and high inflammatory parameters were observed. Internal medicine and cardiology consultations were held, and in addition to her underlying disease, the possibility of NSTEMI was raised in the background of laboratory abnormalities, however, intervention was not considered based on the patient''s condition. On 03May2021 at 13:07 (7 days after Comirnaty vaccination), the patient died among the symptoms of cardiorespiratory failure. Autopsy was done, cause of death included cardiac failure, cerebral infarction and hypostatic bronchopneumonia. Therapeutic measures were taken as a result of the events. The outcome of cardiac failure, left middle cerebral artery occlusion/ cerebral infarction and hypostatic bronchopneumonia was fatal; outcome of other events was unknown. Sender Comment: The event and the vaccine is considered not related. The case is serious due to hospitalization and fatal outcome. Documents Held by Sender included autopsy record, medical record. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on information provided, the events of fell off the bed, broke her right radial bone are accident but unrelated to BNT162B2. Other events are more likely related to pre-existing diseases but unrelated to BNT162B2.; Reported Cause(s) of Death: cardiac failure; cerebral infarction; hypostatic bronchopneumonia


VAERS ID: 1445263 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-02
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEMODERNATX, INC.MOD20212

Write-up: sudden collapse; sudden collapse and death; This regulatory authority case was reported by a physician and describes the occurrence of FALL (sudden collapse) and SUDDEN DEATH (sudden collapse and death) in a 78-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001177) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 30-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 02-May-2021, the patient experienced FALL (sudden collapse) (seriousness criterion death) and SUDDEN DEATH (sudden collapse and death) (seriousness criterion death). The patient died on 02-May-2021. 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. Concomitant products were not provided/unknown. Treatment medication were not reported/unknown. This case concerns a 78-year-old female patient who experienced sudden collapse and died after receiving second dose of mRNA-1273. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: This case concerns a 78-year-old female patient who experienced sudden collapse and died after receiving second dose of mRNA-1273. Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1445269 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET2838 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021785953

Write-up: passed away in her home; This is a spontaneous report received from a contactable other HCP via Regulatory Authority. An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose (Batch: ET2838) on 31May2021 as single dose for COVID-19 immunisation. Medical history included Hypertension and dementia. Concomitant medications were not reported. The patient experienced hospitalization and death/Passed away in her home. A nursing patient who was treated in the home care unit who was a candidate for transfer to a nursing home. She completed the second vaccine on 31May2021 before being transferred to a nursing home. All reports were received by medical staff. It was not reported if Autopsy Done. The outcome of the event was Fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information and the known product profile, the causal relationship of the reported fatality and the use of BNT162B2 cannot be fully excluded. The advanced age and the underlying illness may be considered as risk factors. However, there is still limited information available which precludes a more meaningful assessment. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1445322 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   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: LEVEMIR; NOVORAPID; COTAREG; AMLODIPINA; ASA; MESOGLYCAN; LOW MOLECULAR WEIGHT HEPARIN; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic; Hypertensive; Obesity; Varicose veins of lower extremities
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021753092

Write-up: This is a spontaneous report from a contactable physician, regulatory authority number IT-MINISAL02-744597. A 57-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 23May2021 (Batch/Lot Number: FA8016) as single dose for COVID-19 immunisation. Medical history included obese, diabetic, hypertensive patient with venous varices in the lower limbs. Concomitant medication(s) included insulin detemir (LEVEMIR); insulin aspart (NOVORAPID); hydrochlorothiazide, valsartan (COTAREG); amlodipine (AMLODIPINA); asa (ASA); mesoglycan (MESOGLYCAN); pantoprazole (PANTOPRAZOLE), all taken for an unspecified indication, start and stop date were not reported; low molecular weight heparin (LOW MOLECULAR WEIGHT HEPARIN) taken for phlebitis, start and stop date were not reported. It was reported unexpected death. death due to causes under investigation on 24May2021. The patient died on 24May2021. It was not reported if an autopsy was performed. The reporter informed the PRIVACY station who started the procedure to request the autopsy examination of the lady who died on 24May2021. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: unexpected death. death due to causes under investigation


VAERS ID: 1445343 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Confusional state, Dizziness, Impaired quality of life, Vertigo
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CONGESCOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (intake of 2 tablets per day for high blood pressure); Walking difficulty (the patient had walking problems, which worsened after vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021758572

Write-up: Impact on quality of life; Within few days of the first administration of the Pfizer COVID vaccine, the subject began to show signs of mental confusion and dizziness resulting in cerebral hemorrhage.; Within few days of the first administration of the Pfizer COVID vaccine, the subject began to show signs of mental confusion and dizziness resulting in cerebral hemorrhage.; Within few days of the first administration of the Pfizer COVID vaccine, the subject began to show signs of mental confusion and dizziness resulting in cerebral hemorrhage.; Within few days of the first administration of the Pfizer COVID vaccine, the subject began to show signs of mental confusion and dizziness resulting in cerebral hemorrhage.; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB regulatory authority number IT-MINISAL02-745788. A 86-years-old male patient received first dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number: EP2166), via an intramuscular route on 03Mar2021 as dose 1, 0.3 ml single in the right arm for covid-19 immunisation. The patient medical history included hypertension (intake of 2 tablets per day for high blood pressure) and walking difficulty, which worsened after vaccination. The patient concomitant medications included bisoprolol fumarate (CONGESCOR) for hypertension from an unknown date and unknown if ongoing. On 08Mar2021, the patient experienced Within few days of the first administration of the Pfizer COVID vaccine, the subject began to show signs of mental confusion and dizziness resulting in cerebral hemorrhage.On 10Mar2021 first access to the emergency room, family members report that the patient in a confusional state may had accidentally ingested some mouthwash. On 11Mar2021 second access to the emergency room following which he is hospitalized in neurology and had Impact on quality of life (10/10). Reporter stated that there were no other pathologies. the patient was in good health confirmed by blood tests carried out in the recent period prior to vaccination.The patient died on unspecified date and autopsy results was unknown. The outcome of the events was fatal. Sender''s comments:requested clinical documentation of hospitalization No follow-up attempts are needed. No further information is expected. Health Authority comment:The patient suffered from hypertension resulting in a daily intake of 2 tablets per day for high blood pressure and 1 tablet per day for the heart (CONGESCOR). There were no other pathologies. The patient was in good health confirmed by blood tests carried out in the recent period prior to vaccination. the patient had walking problems, which worsened after vaccination.; Reported Cause(s) of Death: Dizziness; Cerebral haemorrhage; Mental confusion; Head revolving around; Impact on quality of life


VAERS ID: 1445346 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARDIOASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Factor II mutation (genetic mutation of the g202 10 a gene (factor II) in the form of heterozygot diagnosed in 02Dec); Obesity; Thrombosis venous deep
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021758440

Write-up: Bilateral massive pulmonary embolia after two days after administration of anti-covid II dose vaccine; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-746030. A 54-years-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Lot number: unknown), dose 2 intramuscular on 14Jun2021 as 2nd single dose for COVID-19 immunization. Medical history included asthma, deep vein thrombosis, obesity and genetic mutation of the g202 10 a gene (factor II) in the form of heterozygot diagnosed in 02Dec. Concomitant medication included acetylsalicylic acid (CARDIOASPIRIN). The patient experienced bilateral massive pulmonary embolia after two days after administration of COVID-19 2nd dose vaccine (pulmonary embolism) (death) on 16Jun2021. The patient died on 17Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; batch/lot number cannot be obtained. No further in-formation is expected.; Reported Cause(s) of Death: Bilateral massive pulmonary embolia after two days after administration of anti-covid II dose vaccine


VAERS ID: 1445356 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   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: Dialysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021770546

Write-up: Died of pulmonary embolism; This is a spontaneous report received from a contactable consumer, received from regulatory authority, downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-746669. A 50-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via intramuscular, administered in right arm (also reported as right shoulder) on 10May2021 (unknown at time of vaccination) as single dose for COVID-19 immunisation. Medical history included dialysis. The patient''s concomitant medications were not reported. The patient experienced "died of pulmonary embolism" on 11May2021. Reporter''s comments: Patient on dialysis. The outcome of the event was fatal. The patient died on 11May2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information on lot and batch numbers cannot be obtained.; Reporter''s Comments: Patient on dialysis; Reported Cause(s) of Death: Died of pulmonary embolism


VAERS ID: 1445447 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure systolic, Blood pressure systolic increased, Body temperature, Cerebral haemorrhage, Facial paralysis, Magnetic resonance imaging head, Monoplegia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AZILVA
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:110-140; Comments: before onset, Blood pressure systolic was 110-140; Test Date: 20210531; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 202104; Test Name: Head MRI; Result Unstructured Data: Test Result:micro-bleeding spots; Comments: micro-bleeding spots at the Bilateral cerebral hemisphere and Cerebellar hemisphere
CDC Split Type: JPPFIZER INC2021729666

Write-up: systolic blood pressure was fluctuating between 110 and 140 mmHg; Right frontal lobe Subcortical haemorrhage; Consciousness disturbed; left facial paralysis; left upper limb paralysis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21114808. A 91-year and 4-month old female patient received the first dose of BNT162B2 (COMIRNATY; lot number: EY4834; Expiration Date: 31Aug2021), via an unspecified route of administration on 31May2021 09:18 (at the age of 91-years-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hypertension. Concomitant medication included ongoing azilsartan (AZILVA). The patient''s body temperature before the vaccination was 36.5 degrees Centigrade. On 31May2021 at 09:18 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY). On 04Jun2021 at 15:00 (4 days/5 hours/42 minutes after the vaccination), the patient experienced right frontal lobe subcortical haemorrhage. On 04Jun2021 (4 days after the vaccination), the patient was admitted to the hospital. On 11Jun2021 (11 days after the vaccination), the outcome of the event "right frontal lobe subcortical haemorrhage" was fatal. The course of the event was as follows: On 04Jun2021, at 15:00 (4 days, 5 hours, and 42 minutes after vaccination), the patient sat down at her room. Consciousness disturbed, right conjugate deviation, left facial paralysis, and left upper limb paralysis were found. The patient emergently transferred to the hospital. The patient diagnosed with Right frontal lobe Subcortical haemorrhage. On 11Jun2021, the patient died. The outcome of the event "right frontal lobe subcortical haemorrhage" was fatal; while unknown for the other events. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death, hospitalization) 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: On unknown date in Apr2021, head MRI showed micro-bleeding spots in the both cerebral hemispheres and the cerebellar hemisphere. Reporter''s comment: The patient was originally pointed out to have micro-bleeding spots on the head MRI. Until the onset of the event, the systolic blood pressure was fluctuating between 110 and 140 mmHg. The causality between the event and BNT162b2 vaccination was unassessable.; Reporter''s Comments: The patient was originally pointed out to have micro-bleeding spots on the head MRI. Until the onset of the event, the systolic blood pressure was fluctuating between 110 and 140 mmHg. The causality between the event and BNT162b2 vaccination was unassessable.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1445468 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-05-31
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Computerised tomogram thorax, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Pericardial effusion, Pleural effusion, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (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), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer surgery (about 10 years before); Gastric cancer; Hospitalization NOS; Inappetence (in late May2021); Lung cancer; Malaise (in late May2021)
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Chest CT; Result Unstructured Data: Test Result:revealed findings of a small volume of pericardial; Comments: revealed findings of a small volume of pericardial fluid and pleural effusion but did not show signs of relapse; Test Date: 20210612; Test Name: SpO2; Result Unstructured Data: Test Result:decreased; Comments: after vaccination
CDC Split Type: JPPFIZER INC2021730468

Write-up: Cardio-respiratory arrest; Decreased SpO2; Mild difficulty breathing and wheezing during body movement; Mild difficulty breathing and wheezing during body movement; findings of a small volume of pericardial fluid and pleural effusion; findings of a small volume of pericardial fluid and pleural effusion; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21114784. The patient was an 80-year-old female. Medical history included surgery for gastric cancer and lung cancer (about 10 years before), inappetence and malaise (in late May2021), and admitted to the hospital (08Jun2021). Body temperature before vaccination, family history, and concomitant medications were not reported. It was not provided whether there were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 22May2021 (the day of the first vaccination), the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number and Expiration date not reported). On 12Jun2021 just after 14:00 in the afternoon (the day of the second vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021), at the age of 80-year-old, via an unspecified route of administration as a single dose for COVID-19 immunisation. On 12Jun2021 at 20:30 (about 6.5 hours after the second vaccination), the patient experienced decreased SpO2 and mild difficulty breathing and wheezing during body movement. On 14Jun2021 at 15:30 (2 days after the second vaccination), the patient experienced cardio-respiratory arrest. On 14Jun2021 (2 days after the second vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: The patient underwent surgery for gastric cancer and lung cancer about 10 years before. In late May2021, the patient complained of inappetence and malaise, and these symptoms did not improve. On 22May2021 (the day of the first vaccination), the patient received a vaccination against the coronavirus. On 08Jun2021, the patient was admitted to the hospital. On 12Jun2021 just after 14:00 (the day of the second vaccination), the patient received the second vaccination. Around 20:30 (about 6.5 hours after the second vaccination), the patient had no respiratory discomfort but had decreased SpO2; she started receiving oxygen 1L and was observed. The patient had mild difficulty breathing and wheezing during body movement and continued to receive oxygen 1L. On 14Jun2021 (2 days after the second vaccination), the patient made no complaints such as respiratory discomfort, but at 15:30, she experienced cardio-respiratory arrest. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. It was not reported whether there was other possible cause of the events such as any other diseases. The reporting physician commented as follows: Chest computerised tomography (CT) performed on 31May2021 revealed findings of a small volume of pericardial fluid and pleural effusion but did not show signs of relapse. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Decreased SpO2; Dyspnoea; wheezing during body movement; Cardio-respiratory arrest


VAERS ID: 1445487 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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: Aplastic anaemia; Bronchitis chronic; Megacolon; Parkinson''s disease; Perianal abscess
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021734990

Write-up: Respiratory arrest; suspected aggravated pneumonia aspiration; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114955. The patient was an 85-year and 10-month-old female. Body temperature before vaccination was 36.5 degrees Centigrade (on 15Jun2021). Medical history included bronchitis chronic, megacolon, aplastic anaemia, Parkinson''s disease and perianal abscess. Concomitant medications and family history were not provided. On 15Jun2021 at 14:00 (the day of vaccination) (85-year-old at vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY3860, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jun2021 at 02:30 (1 day after the vaccination), the patient experienced suspected aggravated pneumonia aspiration and respiratory arrest. On 16Jun2021 at 03:51 (1 day after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 15Jun2021 at 18:00, when her body temperature was measured, no pyrexia was noted. On 16Jun2021, the patient was found in respiratory arrest. At the time of discovery, hot flash was present and multiple frothy sputum was also recognized. On the same day at 03:51, the patient''s death was confirmed. There was a high possibility that pneumonia aspiration caused the event and the event was considered to be acute aggravation. The reporting physician classified the events as serious (fatal outcome) and assessed that the events were not related to BNT162b2. Bronchitis chronic and Parkinson''s disease were considered as possible causes of the events. The reporting physician commented as follows: Given that multiple sputum as well as hot flash was present, it was likely to consider that pneumonia aspiration acutely worsened.; Reported Cause(s) of Death: Respiratory arrest; suspected aggravated pneumonia aspiration


VAERS ID: 1445489 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Oxygen saturation, Oxygen saturation decreased, Regurgitation
SMQs:, Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchopulmonary aspergillosis; Gastrostomy; Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: Before vaccination; Test Date: 20210617; Test Name: SpO2; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC2021735002

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114988. The patient was an 83-year and 3-month-old male. Body temperature before vaccination was 37.0 degrees Centigrade. Medical history included pneumonia aspiration and bronchopulmonary aspergillosis. He underwent gastrostomy. Concomitant medications included oral clopidogrel sulfate (CLOPIDOGREL Tablet). Family history was not provided. On 16Jun2021 at 10:45 (the day of vaccination) at the age of 83-year-old, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY4834, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 17Jun2021 at 06:17 (19 hours and 32minutes after the vaccination), the patient died. It was not reported if an autopsy was performed. The cause of the death was not reported. The course of the events was as follows: The patient had received the treatment for pneumonia aspiration at a previous hospital. Thereafter, bronchopulmonary aspergillosis was combined. The patient underwent gastrostomy. The patient needed total assistance and he received tube feeding. On 16Jun2021 at 10:45 (the day of vaccination), BNT162b2 was injected into the left deltoid. On 17Jun2021 at 00:30 (13hours and 45minutes after the vaccination), reflux of liquid food and decreased SpO2 (oxygen saturation percutaneous) were noted, sand uction was performed. However, at 06:17 (19 hours and 32minutes after the vaccination), the patient died. "Consent of end-of-life care when the patient''s condition suddenly changed" had been obtained from his family. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Reflux, vomiting and aspiration (of tube feeding food) were reported as other possible causes of the event. The outcome of the events reflux of liquid food and decreased SpO2 was unknown.; Reported Cause(s) of Death: Death


VAERS ID: 1445490 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Subdural haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   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: JANUVIA [SITAGLIPTIN PHOSPHATE]; AMITIZA; LANSOPRAZOLE; METHYCOBAL; TOFRANIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021735055

Write-up: Acute subdural haemorrhage; cardio-respiratory arrest; This is a spontaneous report from a contactable other healthcare professional (HCP) received from the Regulatory Authority. Regulatory authority report number is v21115013. The patient was a 94-year-old female. On 14Jun2021, Body temperature before vaccination was 36.4 degrees centigrade. Family history was not reported. Medical history included hypertension and diabetes mellitus. No allergy was present. No pyrexia or physical deconditioning was noted within the past month. Concomitant medications included sitagliptin phosphate (JANUVIA), lubiprostone (AMITIZA), lansoprazole, mecobalamin (METHYCOBAL), and imipramine hydrochloride (TOFRANIL). On 14Jun2021 at 14:15 (the day of vaccination) at the age of 94 years old, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 15Jun2021 at unknown time (1 day after the vaccination), the patient experienced acute subdural haemorrhage. The course of the event was as follows: On 14Jun2021 at 14:15 (the day of vaccination), the patient received a vaccination against the new coronavirus inside the reporting hospital. The patient had no problem during the in-hospital observation and went back to the facility. On 15Jun2021 at 15:00 (1 day after the vaccination), the patient was found in a state of cardio-respiratory arrest at the facility she was staying in and underwent resuscitation. However, on the same day (15Jun2021) at 15:34, her death was confirmed by the physician of the doctor car. On 15Jun2021 (1 day after the vaccination), the outcome of the event Acute subdural haemorrhage was fatal. The outcome of cardio-respiratory arrest was unknown. It was unknown whether autopsy was done. The reporting other HCP classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was currently under close examination. The reporting other HCP commented as follows: Although the causal relationship with the vaccination against the new coronavirus was unknown, we considered it necessary to make a report because of the death confirmed about 12 hours after the vaccination. ; Reported Cause(s) of Death: Acute subdural haemorrhage


VAERS ID: 1445491 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Depressed level of consciousness, Fibrin D dimer, Fibrin D dimer increased, Malaise, Pneumonia, Venous thrombosis limb
SMQs:, Cardiac failure (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DIFENIDOL HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Urine volume decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210614; Test Name: D-dimer; Result Unstructured Data: Test Result:increased
CDC Split Type: JPPFIZER INC2021735104

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21115007. The patient was a 91-year and 2-month-old male. Body temperature before vaccination was 36.5 degrees centigrade. The medical history included the urine volume decreased since 03Jun2021. Family history were not provided. Concomitant medication included difenidol hydrochloride tablet. On 07Jun2021 in the afternoon (the day of vaccination, at the age of 91-year-old), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 07Jun2021 (the day of the vaccination), the patient experienced cardiac failure and suspected lower extremities phlebothrombus of. The course of the events was as follows: On 03Jun2021, the urine volume decreased. On 07Jun2021 (the day of vaccination), the patient visited the urology department. On 14Jun2021 (7 days after vaccination), the patient was judged to have cardiac failure because he had small amount of both pleural effusions and oedema. D-dimer also increased. A direct oral coagulant (DOAC) and a diuretic were prescribed. On 16Jun2021 (9 days after vaccination), since the urine volume decreased, and the patient had malaise, he was emergently transferred at 23:19. The patient was diagnosed with cardiac failure and pneumonia, and he was admitted to the hospital. A treatment with a drip infusion was initiated. On 17Jun2021 at 07:10 (10 days after vaccination), the patient had depressed level of consciousness. The carotid artery was not palpable. At 07:40, the patient died. It was unknown if an autopsy was performed. The patient was hospitalized for cardiac failure congestive and pneumonia from 16Jun2021 to 17Jun2021. The reporting physician classified the events as serious (hospitalization) and assessed that the causality between the events and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was cardiac failure. The outcome of the events Pneumonia, Depressed level of consciousness, Lower extremities phlebothrombus of, Fibrin D dimer increased, and Malaise was unknown. The patient died due to Cardiac failure on 17Jun2021.; Reported Cause(s) of Death: Cardiac failure/small amount of both pleural effusions and oedema


VAERS ID: 1445492 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-13
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pyelonephritis acute, Sepsis, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   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: XARELTO
Current Illness: Atrial fibrillation
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Eating disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021735127

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21115069. The patient was a 91-year and 11-month-old male. Body temperature before vaccination was 36.3 degrees Centigrade. The family history was not provided. The patient had medical history of ongoing atrial fibrillation, for which he was orally taking rivaroxaban (XARELTO), and Dementia with Eating disorder. On 01Jun2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) (at age of 91 years old) via an unspecified route of administration as a single dose for COVID-19 immunization. On 13Jun2021 at 15:40 (12 days/one hour/40 minutes after the vaccination), the patient experienced pyelonephritis acute and sepsis. On 14Jun2021 (13 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was being admitted to the hospital for dementia. In mid-May2021, eating disorder was aggravated, and the patient was unable to orally take at all. Although fluid replacement was performed every day, debility was progressed, and the patient was physically at the end of life. On 13Jun2021 (12 days after vaccination), in the afternoon on the previous day of the death, the patient had pyrexia. On 14Jun2021, at 09:30 (12 days, 19 hours, and 30 minutes after vaccination), the patient had septic shock. Based on the results of examination, the patient was diagnosed with pyelonephritis acute, and he died. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented as follows: It was considered that the event was unrelated to BNT162b2 vaccination.; Sender''s Comments: Based on known disease pathophysiology, the event of pyelonephritis acute assessed as not related to BNT162B2, and more likely due to underlying medical condition of atrial fibrillation .; Reported Cause(s) of Death: Pyelonephritis acute; Sepsis


VAERS ID: 1445493 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Cardiac arrest, Cyanosis, Respiration abnormal, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   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: Brain neoplasm malignant
Preexisting Conditions: Medical History/Concurrent Conditions: Consciousness disturbed; Obstruction lung disease
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Comments: 14:02; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021735132

Write-up: weak respiration; cyanosis; blood pressure decreased; Suspected anaphylaxis; cardiac arrest; respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21115068. The patient was an 81-year and 3-month-old male. Body temperature before vaccination was 36.2 degrees centigrade. Family history was not reported. Medical history included end-stage malignant brain tumour (suspected glioblastoma) since October 2020 and ongoing, prolonged consciousness disturbed, obstructive respiration. On 18Jun2021 at 13:47 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscularly at age of 81 years as a single dose for COVID-19 immunization. On 18Jun2021 at around 14:00 (around 13 minutes after the vaccination), the patient experienced suspected anaphylaxis. On 18Jun2021 (on the same day of the vaccination), the outcome of the event was fatal. The course of the event was as follows: In October 2020, the patient was diagnosed with brain tumour (suspected glioblastoma) with a probable prognosis of a few months to half a year at longest. On 12Nov2020, the patient was referred to the reporting hospital and transferred from another hospital with the possibility of dying at the hospital. Although the patient had prolonged consciousness disturbed, it was in remittance for relatively a long time. However, disease status was progressing including progress of obstructive respiration. On 18Jun2021, around 15 minutes after the intramuscular injection of the vaccine (at 14:02), the patient developed cyanosis, blood pressure decreased, and weak respiration. The patient was treated with adrenaline (BOSMIN), etc.; however, the patient had respiratory arrest and cardiac arrest. The reporting physician classified the event 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 association of underlying disease commented by the reporter as follows: Possibility could not be completely denied that the vaccine triggered the event. However, since the patient was at end-stage of malignant brain tumour, it was considered probable that the condition was associated with underlying disease itself. The outcome of the events suspected anaphylaxis was fatal, other events was unknown. The patient died on18Jun2021. It was unknown if autopsy done.; Reported Cause(s) of Death: Suspected anaphylaxis; probable that the condition was associated with underlying disease/ end-stage of malignant brain tumour


VAERS ID: 1445495 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-09
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TRAZENTA; METGLUCO; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hyperlipidaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021735158

Write-up: Acute aortic dissection; This is a spontaneous report from the contactable physician received via the Agency. The patient was a non-pregnant 79-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received linagliptin (TRAZENTA); metformin hydrochloride (METGLUCO); atorvastatin within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included diabetes mellitus and hyperlipidaemia. On 04Jun2021 at 14:00 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Batch/Lot Number: FA5829; Expiration Date: 31Aug2021) intramuscularly in the left arm for covid-19 immunisation. On 09Jun2021 at 22:00 (5 days after the vaccination), the patient developed acute aortic dissection. The event required the patient to visit a health clinic/an emergency room. The event resulted in death. The outcome of the event was fatal and it was unknown whether the treatment was performed for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient died of acute aortic dissection on 10Jun2021. It was unknown whether an autopsy was performed. The course of the event was as follows: On 04Jun2021 (the day of vaccination), the patient received BNT162b2. On 09Jun2021 (5 days after the vaccination), the patient developed acute aortic dissection and was urgently transferred to the hospital. On the next day of 10Jun2021 (6 days after the vaccination), the patient died.; Sender''s Comments: A causal association between BNT162B2 and the event acute aortic dissection cannot be excluded based on a compatible temporal relation. Contributory role of underlying medical conditions should also be considered. Case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Acute aortic dissection


VAERS ID: 1445500 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure congestive
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VASOLAN [ISOXSUPRINE HYDROCHLORIDE]; REMINYL; URIEF; E KEPPRA; LIPITOR [ATORVASTATIN]; TEGRETOL; MAGMITT; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure congestive; Cerebral infarction; Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210611; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021738452

Write-up: cardiac failure congestive; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115170. The patient was an 88-year-old male. Body temperature before vaccination was 36.5 degrees centigrade. Medical history included cardiac failure congestive, atrial fibrillation, cerebral infarction and dementia. Concomitant medications included isoxsuprine hydrochloride (VASOLAN [ISOXSUPRINE HYDROCHLORIDE]); galantamine hydrobromide (REMINYL); silodosin (URIEF); levetiracetam (E KEPPRA); atorvastatin (LIPITOR [ATORVASTATIN]); carbamazepine (TEGRETOL); magnesium oxide (MAGMITT); warfarin (WARFARIN). On 11Jun2021 at 10:40 (the day of vaccination), the patient received?the first single dose of BNT162b2 (COMIRNATY, Lot Number: FA7338; Expiration Date: 30Sep2021) at the age of 88-year-old, via an unknown route of administration for COVID-19 immunisation. On 14Jun2021 at 05:30 (3 days after the vaccination), the patient experienced cardiac failure congestive. On 14Jun2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: After the vaccination, the patient''s condition was the same as usual with no problems. Three days after the vaccination, on 14Jun2021 at 05:30 in the morning, the patient''s wife sleeping beside him noticed that the patient was in cardio-respiratory arrest. After a physician''s visit was requested, the physician visited the patient and confirmed his death. The patient had been treated with oral drugs for cardiac failure congestive, atrial fibrillation, cerebral infarction, dementia with symptomatic epilepsy and others since before. Dementia and behavioral and psychological symptoms of dementia (BPSD) were continuing. Because shortness of breath and others worsened recently, the patient was referred to the cardiovascular department of the hospital and being treated with such as a diuretic drug. The patient presented with no problems at the time of the vaccination. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Another possible cause of the event was cardiac failure. The reporting physician commented that cardiac failure acute was considered.; Reported Cause(s) of Death: Acute congestive cardiac failure


VAERS ID: 1445516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MAGNESIUM OXIDE; FERROMIA; LUNESTA; CLARITHROMYCIN; CARBOCISTEINE; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atypical mycobacterial infection; Gastric cancer (underwent surgery in 1990); Insomnia; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021769368

Write-up: cardio-respiratory arrest; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a 73-year-old female. The patient had medical histories of insomnia, non-tuberculosis mycobacterial infection, rheumatoid arthritis, and postoperative gastric cancer (underwent surgery in 1990). The patient family history was not provided. The concomitant medications included magnesium oxide Tablet at 1000 mg daily, sodium ferrous citrate (FERROMIA) Tablet at 50 mg daily, eszopiclone (LUNESTA) Tablet at 1 mg daily, clarithromycin Tablet at 200 mg daily, L-carbocisteine (CARBOCISTAINE) Tablet at 500 mg daily, esomeprazole magnesium (NEXIUM) Tablet at 20 mg daily, and acetylsalicylic acid (BAYASPIRIN) Tablet at 100 mg daily. On unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 17Jun2021 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration for COVID-19 immunization. On 19Jun2021 (2 days after vaccination), the patient visited the reporting hospital. On 22Jun2021 (5 days after vaccination), the family found the patient dead at her home. When the patient was found dead, she had cardio-respiratory arrest. The patient was emergently transferred to another hospital. Thereafter, the witness test by the police was performed. Since the medical certificate was not seen, the cause of death was unknown (as reported); however, it was not suicide. Thereafter, an autopsy was not to be performed. The reporting physician classified the event as serious (death) and assessed that the event was possibly related to BNT162b2. The outcome of cardio-respiratory arrest was fatal. An autopsy was not performed. The cause of death was cardio-respiratory arrest. Information on the lot/batch number has been requested.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on the information currently available, a causal association between the reported event cardio-respiratory arrest and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: cardio-respiratory arrest


VAERS ID: 1445517 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-07
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021770976

Write-up: intestinal bleed; This is a spontaneous report from a contactable other health professional received via The Agency. The patient was an 84-year-old male. It was unknown if the patient received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 24May2021 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization at a clinic/emergency room. On 07Jun2021 (14 days after the vaccination), the patient experienced intestinal bleed. He underwent surgery. On 16Jun2021 (23 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The event resulted in death/hospitalization/emergency room/department or urgent care. It was unknown if the patient has been tested for COVID-19 since the vaccination. The assessment of causality between the event and BNT162b2 was not provided. The outcome of intestinal bleed was fatal.; Sender''s Comments: Based on the very limited information provided, the event intestinal bleed due to unspecified cause is considered more likely an intercurrent medical condition in this elderly patient and not related to BNT162B2. The case is to be reevaluated once medical histories, concomitant medications, clinical course and final etiological diagnosis become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: intestinal bleed


VAERS ID: 1445535 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783505

Write-up: For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.; the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer received from Medical Information Team. This consumer reported similar events for 30 patients. This is the second of 30 reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown), on an unspecified date (unknown age at time of vaccination) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Verbatim: Journalist requires information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comments that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The outcome of "For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose" was fatal; outcome of other event was unknown. The patient died on an unspecified date. It was unknown if an autopsy was performed. The cause of death was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.


VAERS ID: 1445536 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783513

Write-up: died with the first dose; according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer received from Medical Information Team. This consumer reported same events for 30 patients. This is the 10th of 30 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unknown route on an unspecified date (Batch/Lot Number: Unknown) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died with the first dose on an unspecified date. It was not reported if an autopsy was performed. Journalist required information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. The reporter commented that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. Applicant agreed to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: died with the first dose


VAERS ID: 1445537 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783514

Write-up: particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose; they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer. This is the 11th of 30 reports made by same report, same drug, same event, different patient. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 unknown on an unspecified date (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. Journalist requires information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comments that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event Death was fatal. The information on the batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.


VAERS ID: 1445538 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783515

Write-up: died with first dose; the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer received from Medical Information Team. This is the 12th of 30 reports made by same report, same drug, same event, different patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unknown route on an unspecified date (Batch/Lot Number: Unknown) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died with the first dose on an unspecified date. It was not reported if an autopsy was performed. Journalist required information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. The reporter commented that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. Applicant agreed to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: died with first dose


VAERS ID: 1445539 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783516

Write-up: 6 people died with the complete scheme and 24 with the first dose; the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer received from Medical Information Team. The reporter reported same events for 30 patients, this is the 13th of 30 reports. A patient of unspecified age and gender received bnt162b2 (Batch/Lot Number: Unknown), first dose via an unspecified route on an unspecified date as dose 1, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient died with the first dose of vaccine on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Journalist requires information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comments that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. Applicant agrees to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: 6 people died with the complete scheme and 24 with the first dose


VAERS ID: 1445540 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783518

Write-up: died; they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer. Received from Medical Information Team. This consumer reported similar events for 30 patients. This is the 15th of 30 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died with the first dose on unknown date. Journalist required information as they were conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comment that several patients had died after the application of the complete scheme or the first dose, they suspected that it might be due to the fact that according to the information collected they were taking up to 7.5 doses from the vials and according to what they understand there were a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient died on an unspecified date. It was unknown if an autopsy was performed.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: died


VAERS ID: 1445541 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783520

Write-up: died; the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer received from Medical Information Team. The reporter reported same events for 30 patients, this is the 17th of 30 reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via unknown route of administration on an unspecified date (Batch/Lot Number not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the event was fatal. Journalist requires information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comments that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. Applicant agrees to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: died


VAERS ID: 1445542 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783521

Write-up: For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.; the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer via Medical Information Team. This is the 18th of 30 reports made by same report, same drug, same event, different patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unknown route of administration on an unspecified date (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Journalist required information as they were conducting an investigation of vaccines against COVID-19 including that of Pfizer. Reporter commented that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient in this case is one of the 24 with the first dose. The patient died on an unspecified date. It was not reported if an autopsy was performed. Applicant agrees to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.


VAERS ID: 1445543 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783522

Write-up: died with first dose; they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses; This is a spontaneous report from a contactable consumer received from Medical Information Team. This is the 19th of 30 reports made by same report, same drug, same event, different patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unknown route on an unspecified date (Batch/Lot Number: Unknown) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died with the first dose on an unspecified date. It was not reported if an autopsy was performed. Journalist required information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. The reporter commented that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. Applicant agreed to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: died with first dose


VAERS ID: 1445544 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783523

Write-up: for the particular case of the pfizer vaccine, the patient died with the first dose; taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer received from Medical Information Team. This consumer reported same events for 30 patients. This is the 20 th of 30 reports. A patient of unspecified age and gender received bnt162b2, via unknown route of administration on an unspecified date (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced for the particular case of the pfizer vaccine, the patient died with the first dose. The patient died on an unspecified date. It was not reported if an autopsy was performed. Verbatim: Journalist requires information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comments that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. Applicant agrees to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: for the particular case of the pfizer vaccine, the patient died with the first dose


VAERS ID: 1445545 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783524

Write-up: died with the first dose; according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer received from Medical Information Team. This is the 21th of 30 reports made by same report, same drug, same event, different patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unknown route on an unspecified date (Batch/Lot Number: Unknown) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died with the first dose on an unspecified date. It was not reported if an autopsy was performed. Journalist required information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. The reporter commented that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. Applicant agreed to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: died with the first dose


VAERS ID: 1445546 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783525

Write-up: died; taking up to 7.5 doses from the vials and according to what they understand there were a maximum of 5 doses; This is a spontaneous report from a contactable consumer, received from medical information team. This consumer reported same events for 30 patients. This is the 22th of 30 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 unknown on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date with the first dose. Journalist required information as they were conducting an investigation of vaccines against COVID-19 including that of Pfizer. He commented that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they were taking up to 7.5 doses from the vials and according to what they understand there were a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient died on unknown date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 different patient, same AE, same product; Reported Cause(s) of Death: died


VAERS ID: 1445547 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783526

Write-up: died with the first dose.; taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer or other non-healthcare professional, received from medical information team. This is the 23rd of 30 reports made by same report, same drug, same event, different patient. A patient of unspecified age and gender received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), dose 1 unknown on an unspecified date (Batch/Lot Number: unknown) as 1st dose, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died with the first dose on an unspecified date. It was not reported if an autopsy was performed. It was commented that several patients had died after the application of the complete scheme or the first dose, they suspect that it might be due to the fact that according to the information collected they were taking up to 7.5 doses from the vials and according to what they understand there were a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: died with the first dose


VAERS ID: 1445548 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783527

Write-up: died with the first dose; according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer received from Medical Information Team. This consumer reported same events for 30 patients. This is the 24th of 30 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unknown route on an unspecified date (Batch/Lot Number: Unknown) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died with the first dose on an unspecified date. It was not reported if an autopsy was performed. Journalist required information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. The reporter commented that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. Applicant agreed to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: died with the first dose


VAERS ID: 1445549 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783528

Write-up: died with the first dose; died with the first doseaccording to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer received from Medical Information Team. This consumer reported same events for 30 patients. This is the 25th of 30 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unknown route on an unspecified date (Batch/Lot Number: Unknown) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died with the first dose on an unspecified date. It was not reported if an autopsy was performed. Journalist required information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. The reporter commented that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. Applicant agreed to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: died with the first dose


VAERS ID: 1445550 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783529

Write-up: For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.; taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses.; This is a spontaneous report from a contactable consumer. Received from Medical Information Team. This is the 26 of 30 reports made by same report, same drug, same event, different patient.A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 unknown on an unspecified date (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization. The patient experienced for the particular case of the pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient died on an unspecified date.It was not reported if an autopsy was performed.Verbatim: Journalist requires information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comments that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.Applicant agrees to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1445551 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783530

Write-up: For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.; taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer. Received from Medical Information Team. This is the 27 of 30 reports made by same report, same drug, same event, different patient.A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 unknown on an unspecified date (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced for the particular case of the pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.The patient died on an unspecified date. It was not reported if an autopsy was performed.Verbatim: Journalist requires information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comments that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.Applicant agrees to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1445552 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783532

Write-up: 6 people died with the complete scheme and 24 with the first dose.; are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer or other non hcp. This reporter reported similar events for 30 patients, this is the 29th report. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 unknown on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the first dose of bnt162b2 for covid-19 immunisation. Several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient died on an unspecified date. It was not reported if an autopsy was performed. information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 same reporter, different patient, same AE, same product; Reported Cause(s) of Death: 6 people died with the complete scheme and 24 with the first dose.


VAERS ID: 1445553 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783533

Write-up: 6 people died with the complete scheme and 24 with the first dose; are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer or other non hcp. This reporter reported similar events for 30 patients, this is the 30th report. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 unknown on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the first dose of bnt162b2 for covid-19 immunisation. Several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient died on an unspecified date. It was not reported if an autopsy was performed. information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 same reporter, different patient, same AE, same product; Reported Cause(s) of Death: 6 people died with the complete scheme and 24 with the first dose


VAERS ID: 1445587 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRAVASTATIN SANDOZ; CETIRIZIN; KLEXANE; PARACET [PARACETAMOL]; LAXOBERAL; ALBYL-ENTEROSOLUBILE; SOLU-MEDROL; RITUXIMAB; OCTAGAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multifocal motor neuropathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021680622

Write-up: CARDIAC ARREST; Comirnaty Dose 1 given on 17Mar2021 and Dose 2 on 28Apr2021 (Day 43); The initial case was missing the following minimum criteria: a Pfizer suspect product. Upon receipt of follow-up information on 18Jun2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-RELISM-2021-Uxz2mx. An 84-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 28Apr2021 (Batch/Lot Number: ET3045) as DOSE 2, SINGLE, and intramuscular on 17Mar2021 (Batch/Lot Number: EP9605) as DOSE 1, SINGLE for COVID-19 immunisation; rituximab, intravenous from 02Jun2021 (Batch/Lot Number: Unknown) to 02Jun2021, at 500 mg Singel infusion. Infusion number two, last infusion Oct2020 for multifocal motor neuropathy; immunoglobulin human normal (OCTAGAM), intravenous from 01Jun2021 (Batch/Lot Number: Unknown) to 01Jun2021, at 60 g, monthly, Singel infusion approximately every fourth week. Infusion number 18 for multifocal motor neuropathy. The patient medical history included multifocal motor neuropathy. Concomitant medications included pravastatin sodium; cetirizine hydrochloride (CETIRIZIN) taken for premedication; enoxaparin sodium (KLEXANE) taken for thrombosis prophylaxis; paracetamol (PARACET) taken for premedication; sodium picosulfate (LAXOBERAL); acetylsalicylic acid, magnesium oxide (ALBYL-ENTEROSOLUBILE); methylprednisolone sodium succinate (SOLU-MEDROL) taken for premedication; start and stop date were not reported for all concomitant medications. The patient experienced cardiac arrest on 02Jun2021. Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: An 84-year-old man with multifocal motor neuropathy died after a unwitnessed cardiac arrest at the nursing home the same day as discharge from the neurological department. The day before he died, he got his 18th infusion with Octagam, and the same day as he died, he got his second infusion with rituximab. He was vaccinated with Comirnaty both first and second dose in advance of this event. The action taken in response to the event for rituximab and immunoglobulin human normal was not applicable. Therapeutic measures were taken as a result of cardiac arrest which included unsuccessful CPR. The patient died on 02Jun2021. It was not reported if an autopsy was performed (requested autopsy by emergency doctor). The Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY), rituximab (RITUXIMAB) and immunoglobulin human normal (OCTAGAM) and the reported event as Possible. Reporter''s comments: Unwitnessed cardiac arrest at the nursing home. Discharge from the neurological department 02Jun2021. Tried CPR without success. Requested autopsy by emergency doctor. Sender''s comment: Clinical experience shows that administration of monoclonal antibody (IVIg; Octagam) is associated with thromboembolic events, such as myocardial infarction which may lead to cardiac arrest. Angina pectoris, cardiac arrhythmias such as atrial flutter or fibrillation, heart failure and / or myocardial infarction have occurred in patients treated with rituximab (MabThera). Different heart disorders are listed with different frequency in the approved regional drug review. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: * Unwitnessed cardiac arrest at the nursing home * Discharge from the neurological department 02/Jun/2021 * Tried CPR without success. * Requested autopsy by emergency doctor. 09Jun20211, Pharmacovigilance: additional information received.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1445619 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-30
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Cerebrovascular accident
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROMODERNATX, INC.MOD20212

Write-up: Stroke; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and CARDIO-RESPIRATORY ARREST in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001943) for COVID-19 vaccination. Concurrent medical conditions included Arterial hypertension. On 27-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion death). On 05-Jun-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Irresuscitable cardio-respiratory arrest) (seriousness criterion death). The patient died on 05-Jun-2021. The reported cause of death was irresuscitable cardio-respiratory arrest and Stroke. An autopsy was not performed. No concomitant products were reported. No treatment information provided. Action taken with mRNA-1273 in response to the drug was not applicable. Company comment: Very limited information regarding these events has been provided at this time. An autopsy was not performed. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Additional information received on 29-June-2021 included gender of patient is changed, medical history, death date and new event Irresuscitable cardio-respiratory arrest was added.; Reporter''s Comments: The medical assessor of the Competent Authority requested the investigation of the case at Regulatory Authority, to no result yet.; Sender''s Comments: Very limited information regarding these events has been provided at this time. An autopsy was not performed. No further information is expected.; Reported Cause(s) of Death: Irresuscitable cardio-respiratory arrest; stroke


VAERS ID: 1446051 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH E14834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerotic gangrene, Blood calcium, Blood calcium decreased, Blood chloride, Blood chloride increased, Blood creatinine, Blood creatinine increased, Blood magnesium, Blood magnesium decreased, Blood phosphorus, Blood phosphorus increased, Blood potassium, Blood potassium increased, Blood sodium, Blood sodium decreased, Blood urea, Blood urea increased, Carbon dioxide, Carbon dioxide decreased, Coagulopathy, Coma, Computerised tomogram head, Glomerular filtration rate, Glomerular filtration rate decreased, Haematocrit, Haematocrit decreased, Haemoglobin, Haemoglobin decreased, Ischaemic stroke, Mean cell haemoglobin concentration, Mean cell haemoglobin concentration decreased, Neutrophil count, Neutrophil count increased, Peripheral arterial occlusive disease, Red blood cell count, Red blood cell count decreased, Thrombosis, White blood cell count, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   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: BRILINTA; AVELON; CARDIFEN; CLEXANE; GLUCOPHAGE [METFORMIN HYDROCHLORIDE]; HUMALOG MIX; LIPOGEN [GEMFIBROZIL]; PEPLOC [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; PERFALGAN; SODIUM CHLORIDE; SPIRACTIN (SPIRONOLACTONE); STILPANE [CAFFEINE;CODEINE PH
Current Illness: Type I diabetes mellitus with renal manifestations
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial disorder; Artificial cardiac pacemaker user; Atherosclerosis; Cellulitis of legs; Coronary bypass; Drug allergy (penicillin and sulfonamide); Ischaemic ulcer; Penicillin allergy; Sulfonamide allergy; Vascular disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Calcium; Result Unstructured Data: Test Result:2.08 mmol/L; Test Date: 20210608; Test Name: Chloride; Result Unstructured Data: Test Result:104 mmol/L; Test Date: 20210610; Test Name: Chloride; Result Unstructured Data: Test Result:105 mmol/L; Test Date: 20210612; Test Name: Chloride; Result Unstructured Data: Test Result:110 mmol/L; Test Date: 20210608; Test Name: Creatinine; Result Unstructured Data: Test Result:102 umol/l; Test Date: 20210610; Test Name: Creatinine; Result Unstructured Data: Test Result:122 umol/l; Test Date: 20210612; Test Name: Creatinine; Result Unstructured Data: Test Result:134 umol/l; Test Date: 20210610; Test Name: Magnesium; Result Unstructured Data: Test Result:0.65 mmol/L; Test Date: 20210612; Test Name: Magnesium; Result Unstructured Data: Test Result:0.72 mmol/L; Test Date: 20210610; Test Name: Phosphate; Result Unstructured Data: Test Result:1.62 mmol/L; Test Date: 20210612; Test Name: Phosphate; Result Unstructured Data: Test Result:1.46 mmol/L; Test Date: 20210608; Test Name: Potassium; Result Unstructured Data: Test Result:5.1 mmol/L; Test Date: 20210610; Test Name: Potassium; Result Unstructured Data: Test Result:5.8 mmol/L; Test Date: 20210612; Test Name: Potassium; Result Unstructured Data: Test Result:4.6 mmol/L; Test Date: 20210608; Test Name: Sodium; Result Unstructured Data: Test Result:137 mmol/L; Test Date: 20210610; Test Name: Sodium; Result Unstructured Data: Test Result:134 mmol/L; Test Date: 20210612; Test Name: Sodium; Result Unstructured Data: Test Result:138 mmol/L; Test Date: 20210608; Test Name: Urea; Result Unstructured Data: Test Result:9.6 mmol/L; Test Date: 20210610; Test Name: Urea; Result Unstructured Data: Test Result:10.3 mmol/L; Test Date: 20210612; Test Name: Urea; Result Unstructured Data: Test Result:12.8 mmol/L; Test Date: 20210608; Test Name: Carbon dioxide; Result Unstructured Data: Test Result:24 mmol/L; Test Date: 20210610; Test Name: Carbon dioxide; Result Unstructured Data: Test Result:15 mmol/L; Test Date: 20210612; Test Name: Carbon dioxide; Result Unstructured Data: Test Result:18 mmol/L; Test Date: 20210610; Test Name: CT BRAIN; Result Unstructured Data: Test Result:lschaemic heart disease; Comments: There is hypodensity and oedema of the right cerebral hemisphere effacing the sulcal markings and causing mass effect on the right lateral ventricle. This involves the vascular territories of the right middle cerebral and right anterior cerebral arteries. There is no displacement of the midline structures. There is no intracranial haemorrhage. The brainstem and the cerebellar hemispheres. There is a hypodensity in the central right mid brain which may represent microvascular disease or osmotic demyelination. No surface collection. The skull base and vault are intact.; Test Date: 20210608; Test Name: eGFR (CKD-EPI); Result Unstructured Data: Test Result:48 ml/min; Test Date: 20210610; Test Name: eGFR (CKD-EPI); Result Unstructured Data: Test Result:39 ml/min; Test Date: 20210612; Test Name: eGFR (CKD-EPI); Result Unstructured Data: Test Result:34 ml/min; Test Date: 20210608; Test Name: Haematocrit; Test Result: 37.5 %; Test Date: 20210610; Test Name: Haematocrit; Test Result: 27.1 %; Test Date: 20210608; Test Name: Hemoglobin; Result Unstructured Data: Test Result:11.7 g/dl; Test Date: 20210610; Test Name: Hemoglobin; Result Unstructured Data: Test Result:8.4 g/dl; Test Date: 20210608; Test Name: MCHC; Result Unstructured Data: Test Result:31.2 g/dl; Test Date: 20210610; Test Name: MCHC; Result Unstructured Data: Test Result:31 g/dl; Test Date: 20210608; Test Name: Neutrophils; Result Unstructured Data: Test Result:6.58 x10 9/l; Test Date: 20210610; Test Name: Neutrophils; Result Unstructured Data: Test Result:8.97 x10 9/l; Test Date: 20210608; Test Name: Red blood cell count; Result Unstructured Data: Test Result:4.05 x10 12/l; Test Date: 20210610; Test Name: Red blood cell count; Result Unstructured Data: Test Result:2.90 x10 12/l; Test Date: 20210608; Test Name: White blood cell count; Result Unstructured Data: Test Result:9.64 x10 9/l; Test Date: 20210610; Test Name: White blood cell count; Result Unstructured Data: Test Result:10.64 x10 9/l
CDC Split Type: ZAPFIZER INC2021737244

Write-up: Major right hemisphere ischaemic stroke - left paralysis; Coagulation disorder; Coma; Atherosclerosis of arteries of extremities with gangrene; Atherosclerosis of arteries of extremities with gangrene; Acute thrombosis of right leg; Chloride high; Potassium high; White blood cell count high; Neutrophils high; Sodium low; Calcium low; Magnesium low; Phosphate high; Red blood cell count low; Haematocrit low; MCHC low; Haemoglobin low; Carbon dioxide low; Urea high; Creatinine high; eGFR low; This is a spontaneous report from a contactable physician. A 71-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01Jun2021 (Batch/Lot Number: E14834) as single dose for covid-19 immunisation at the age of 71-year-old. Medical history included previous coronary bypass surgery, arteriosclerosis, Arterial disease - Vasculopathy, Ischaemic ulcer of right ankle, Multiple allergies to various medications, drug hypersensitivity (penicillin and sulfonamide), ongoing diabetes mellitus with renal complications-insulin dependent, Cellulitis of the other parts of limb, cardiac pacemaker. Concomitant medications included ticagrelor (BRILINTA); moxifloxacin hydrochloride (AVELON); nifedipine (CARDIFEN); enoxaparin sodium (CLEXANE); metformin hydrochloride (GLUCOPHAGE [METFORMIN HYDROCHLORIDE]); insulin lispro, insulin lispro protamine suspension (HUMALOG MIX); gemfibrozil (LIPOGEN [GEMFIBROZIL]), pantoprazole sodium sesquihydrate (PEPLOC [PANTOPRAZOLE SODIUM SESQUIHYDRATE]); paracetamol (PERFALGAN); sodium chloride (SODIUM CHLORIDE), spironolactone (SPIRACTIN (SPIRONOLACTONE), caffeine, codeine phosphate, meprobamate, paracetamol (STILPANE [CAFFEINE;CODEINE PHOSPHATE;MEPROBAMATE;PARACETAMOL]); cetirizine hydrochloride (TEXA ALLERGY). On 08Jun2021, the patient experienced atherosclerosis of arteries of extremities with gangrene and acute thrombosis of right leg, hospitalized for them on 08Jun2021. on 10Jun2021, the patient experienced coagulation disorder, coma and major right hemisphere ischaemic stroke-left paralysis, hospitalized on unspecified date. The event Major right hemisphere ischaemic stroke - left paralysis resulted in death. The outcome of other events was unknown. The patient underwent lab tests and procedures which included blood calcium (2.15-2.50): 2.08 mmol/l on 10Jun2021, blood chloride (98-107): 104 mmol/l on 08Jun2021, blood chloride: 105 mmol/l on 10Jun2021, blood chloride: 110 mmol/l on 12Jun2021, blood creatinine (49-90): 102 umol/l on 08Jun2021, blood creatinine: 122 umol/l on 10Jun2021, blood creatinine: 134 umol/l on 12Jun2021, blood magnesium (0.66-1.07): 0.65 mmol/l on 10Jun2021, blood magnesium: 0.72 mmol/l on 12Jun2021, blood phosphorus (0.78-1.42): 1.62 mmol/l on 10Jun2021, blood phosphorus: 1.46 mmol/l on 12Jun2021, blood potassium (3.5-5.1): 5.1 mmol/l on 08Jun2021, blood potassium: 5.8 mmol/l on 10Jun2021, blood potassium: 4.6 mmol/l on 12Jun2021, blood sodium (136-145): 137 mmol/l on 08Jun2021. Blood urea (<8.4): 9.6 mmol/L on 08Jun2021, Blood urea:10.3 mmol/L on 10Jun2021, Blood urea:12.8 mmol/L on 12Jun2021; Carbon dioxide (22-29): 24 mmol/L on 08Jun2021, 15 mmol/L on 10Jun2021, 18 mmol/L on 12Jun2021; eGFR (CKD-EPI) ($g90): 48 ml/min on 08Jun2021, 39 ml/min on 10Jun2021, 34 ml/min on 12Jun2021; Haematocrit (36-46): 37.5 % on 08Jun2021, 27.1 % on 10Jun2021; Hemoglobin (12-15): 11.7 g/dl on 08Jun2021, 8.4 g/dl on 10Jun2021; MCHC (32-36): 31.2 g/dl on 08Jun2021, 31 g/dl on 10Jun2021; Neutrophils (2-7.5): 6.58 x10 9/l on 08Jun2021, 8.97 x10 9/l on 10Jun2021; Red blood cell count (3.80-4.80): 4.05 x10 12/l on 08Jun2021, 2.90 x10 12/l on 10Jun2021; White blood cell count (3.92-9.88): 9.64 x10 9/l on 08Jun2021, 10.64 x10 9/l on 10Jun2021. CT BRAIN on 10Jun2021: lschaemic heart disease. Peripheral arterial disease. Acute occlusion right leg treated. Malignant hypertension. Now unresponsive. Query intracranial haemorrhage. There is hypodensity and oedema of the right cerebral hemisphere effacing the sulcal markings and causing mass effect on the right lateral ventricle. This involves the vascular territories of the right middle cerebral and right anterior cerebral arteries. There is no displacement of the midline structures. There is no intracranial haemorrhage. The brainstem and the cerebellar hemispheres. There is a hypodensity in the central right mid brain which may represent microvascular disease or osmotic demyelination. No surface collection. The skull base and vault are intact. Features suggest an infarct of at least greater than 6 hours duration in the right cerebral hemisphere involving 2 vascular territories. No haemorrhage. The patient died on 12Jun2021. It was not reported if an autopsy was performed.; Sender''s Comments: Based on the current available limited information and the plausible drug-event association, a possible contributory role of the suspect product BNT162B2 to the development of the event ischemic stroke with a fatal outcome, peripheral arterial occlusive disease, Artherosclerotic gangrene, coagulopathy, coma cannot be fully assessed/excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Major right hemisphere ischaemic stroke - left paralysis


VAERS ID: 1446052 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-31
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Drug ineffective, Pneumonia, Pyrexia, SARS-CoV-2 antibody test, Sepsis, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Hypertension; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Diverticular disease; Hypothyroidism; Microscopic hematuria; Obstructive sleep apnea hypopnea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: SARS-CoV-2 antibody test; Test Result: Positive
CDC Split Type: ZAPFIZER INC2021738273

Write-up: Covid-19 pneumonia; Covid-19 pneumonia; Fever; Sepsis; Covid 19 Pneumonia; Death; This is a spontaneous report from a contactable physician. A 62-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 17May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 62-year-old. Medical history included ongoing hypertension, hypothyroidism, sleep apnoea syndrome, haematuria, ongoing type 2 diabetes mellitus, influenza like illness at the time of receiving the vaccine on 27May2021 (as reported), diverticular disease. The patient''s concomitant medications were not reported. The patient experienced covid-19 pneumonia, fever, sepsis on 31May2021. The patient was hospitalized for the events, and the outcome of the events was unknown. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 31May2021. The patient died on unspecified date in 2021. It was not reported if an autopsy was performed. The lot/batch number has been requested.; Reported Cause(s) of Death: Death


VAERS ID: 1447573 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002919 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Pneumonia aspiration, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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:
Current Illness: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Hip fracture; Ischemic stroke; Pneumonia aspiration
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Pneumonia aspiration; Diarrhoea; Fever; Emesis; This regulatory authority case was reported by a physician and describes the occurrence of PNEUMONIA ASPIRATION (Pneumonia aspiration), DIARRHOEA (Diarrhoea), PYREXIA (Fever) and VOMITING (Emesis) in a 97-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002919) for COVID-19 vaccination. The patient''s past medical history included Ischemic stroke in 2014, Hip fracture in April 2021, COVID-19 and Pneumonia aspiration in May 2021. Concurrent medical conditions included Hypertension arterial. On 14-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced PNEUMONIA ASPIRATION (Pneumonia aspiration) (seriousness criteria death and medically significant), DIARRHOEA (Diarrhoea) (seriousness criterion death), PYREXIA (Fever) (seriousness criterion death) and VOMITING (Emesis) (seriousness criterion death). The patient died on 16-Jun-2021. The reported cause of death was Fever, Diarrhoea, Pneumonia aspiration and Emesis. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment Medication information was provided. No concomitant medication information was provided. Action taken with mRNA-1273 was not applicable. Company Comment: This is a case of a 97-year-old female patient with medical history of hypertension arterial and recent pneumonia aspiration (one month prior to events) who developed Pneumonia aspiration, Diarrhoea, Pyrexia and Vomiting and died. Autopsy was not performed. Very limited information regarding these events has been provided at this time. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Translation received on 29-Jun-2021 and does not contain any new information; Sender''s Comments: This is a case of a 97-year-old female patient with medical history of hypertension arterial and recent pneumonia aspiration (one month prior to events) who developed Pneumonia aspiration, Diarrhoea, Pyrexia and Vomiting and died. Autopsy was not performed. Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Fever; Diarrhoea; Pneumonia aspiration; emesis


VAERS ID: 1447575 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6984 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021758601

Write-up: Death NOS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS 2021077746. A 65-year-old female patient received bnt162b2 (COMIRNATY) first dose (Batch/LOT number: FC6984) Intramuscularly, Injection site Not specified, on 09Jun2021 as single dose for COVID-19 immunization. The patient''s weight and height were not reported. Medical history and Concomitant medications were not reported. The patient received an injection of COMIRNATY vaccine on 09Jun2021. On 10Jun2021 she was taken into care with urgent medical intervention for life-threatening conditions. Death/unknown cause of the patient was on 10Jun2021. 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/Death


VAERS ID: 1447616 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-05-25
   Days after vaccination:109
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Intestinal ischaemia
SMQs:, Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENTRESTO; FUROSEMIDE; KALEORID; KARDEGIC; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Follicular lymphoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Mesenteric ischaemia; This regulatory authority case was reported by a pharmacist and describes the occurrence of INTESTINAL ISCHAEMIA (Mesenteric ischaemia) in a 77-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cardiac failure and Follicular lymphoma. Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), FUROSEMIDE, POTASSIUM CHLORIDE (KALEORID), ACETYLSALICYLATE LYSINE (KARDEGIC) and BISOPROLOL for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced INTESTINAL ISCHAEMIA (Mesenteric ischaemia) (seriousness criteria death and medically significant). The reported cause of death was death due to mesenteric ischaemia. 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. Action taken with mRNA-1273 in response to the event was not applicable. Treatment medication information were not reported. Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021078084. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the medical history of Cardiac failure and Follicular lymphoma could be a contributory factor. Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Upon follow-up receipt: Follow-up information processed with initial report contains no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the medical history of Cardiac failure and Follicular lymphoma could be a contributory factor.; Reported Cause(s) of Death: Death due to Mesenteric ischaemia


VAERS ID: 1448030 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective, Fraction of inspired oxygen, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Medication errors (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 39
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVEMIR; NOVORAPID; SALAZOPYRIN; VENTOLIN ACCUHALER; CALCIUM CARBONATE; COLECALCIFEROL; LANSOPRAZOLE; FERROUS FUMARATE; FOLIC ACID; ATORVASTATIN; NAPROXEN; LEVOTHYROXINE; CINNARIZINE; PARACETAMOL; ACICLOVIR; RAMIPRIL; AMOXICILLIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Fraction of inspired oxygen; Test Result: 22 %; Test Date: 20210602; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021737909

Write-up: COVID-19 Pneumonia; COVID-19 Pneumonia; first dose on 09Feb2021/second dose on 28Apr2021; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106171317276640-W3GDN, Safety Report Unique Identifier is GB-MHRA-ADR 25491690. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date for both doses were unknown), first dose on 09Feb2021 and second dose on 28Apr2021 (at the age of 57-years); both via unspecified route of administration at single dose for COVID-19 immunisation. Medical history was not reported. Unsure if patient has had symptoms associated with COVID-19. Unsure if patient is enrolled in clinical trial. Concomitant medications included insulin detemir (LEVEMIR), insulin aspart (NOVORAPID), sulfasalazine (SALAZOPYRIN), salbutamol sulfate (VENTOLIN ACCUHALER) from 30May2021, calcium carbonate, colecalciferol, lansoprazole, ferrous fumarate, folic acid, atorvastatin, naproxen, levothyroxine, cinnarizine from 10May2021 and no longer taking, paracetamol, aciclovir from 08Feb2021, ramipril, and amoxicillin from 30May2021. The patient previously took folic acid, colecalciferol, theophylline (SLO-PHYLLIN), salazopyrin, insulin detemir (LEVEMIR), methotrexate, cinnarizine, ramipril, calcium carbonate, salbutamol sulfate (VENTOLIN), naproxen, ferrous fumarate, insulin degludec, levothyroxine, insulin aspart (NOVORAPID), amoxicillin, aciclovir, lansoprazole, and atorvastatin. The patient had received both COVID vaccines and experienced severe COVID-19 pneumonia on 02Jun2021. The event was considered medically significant. It was progressively increasing in terms of respiratory support. Now on continuous positive airway pressure (CPAP) 12 and 15L/min oxygen (O2). Work of breathing has been increasing despite increase in Support. The patient had the following lab tests: fraction of inspired oxygen was 22% in Jun2021 and positive COVID-19 virus test on 02Jun2021. The patient died on 06Jun2021 due to COVID-19 pneumonia. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 pneumonia


VAERS ID: 1449027 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death
SMQs:

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: Haemodialysis; Renal failure chronic
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210611; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021738526

Write-up: Death; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21115190. The patient was a 65-year and 7-month-old male. Body temperature before vaccination was 36.0 degrees centigrade. Medical history included hypertension and regular hospital visits for maintenance haemodialysis 3 times a week for renal failure chronic. Family history and concomitant medications were not reported. On 11Jun2021 at 13:30 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration as a single dose at the age of 65-year-old for COVID-19 immunisation. On 16Jun2021 at 07:04 (5 days after the vaccination), the patient experienced death. On 16Jun2021 (5 days after the vaccination), the outcome of the event was fatal. It was unknown whether autopsy was done. The course of the event was as follows: On 11Jun2021 (the day of vaccination), after completing dialysis, the patient received a vaccination. Thereafter, no pyrexia was noted. On 14Jun2021 (3 days after the vaccination), the patient underwent dialysis as usual and had no problem. On 15Jun2021 (4 days after the vaccination), the patient had dinner as usual. On 16Jun2021 in the morning (5 days after the vaccination), the patient was found in rigor mortis in the living room by his wife. The reporting physician classified the event as serious (death) and assessed the causality between the event and bnt162b2 as unassessable. Other possible causes of the event such as any other diseases were hypertension and ongoing maintenance haemodialysis 3 times a week for renal failure chronic. The reporting physician commented as follows: The event occurred 5 days after the vaccination, and the definite causal relationship was unknown.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1449041 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   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: Medical History/Concurrent Conditions: Hypertension; Ischaemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: Before vaccination; Test Date: 20210618; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: At back home after vaccination; Test Date: 20210619; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade
CDC Split Type: JPPFIZER INC2021739483

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115195. The patient was a 92-year and 4-month-old male. Body temperature before vaccination was 37.1 degrees Centigrade. The family history was not provided. The patient had medical histories of hypertension and ischaemic heart disease. On 28May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY2173, Expiration date 31Aug2021). On 18Jun2021 at 13:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization at age of 92-year. On 19Jun2021 at 12:30 (23 hours after the vaccination), the patient experienced cardiac arrest. On 19Jun2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 18Jun2021 (the day of vaccination), the patient had fall at his home before the vaccination, and he had bruise in the low back. Since the body temperature at the hospital visit was 37.1 degrees Celsius, it was judged that the vaccination was possible. At 13:30, the patient received the second dose of BNT162b2 vaccination (Lot#FA2453) (route of administration was not provided). The patient was followed up for 30 minutes within the hospital after the vaccination. Since no changes were observed, the patient went home. After the patient went home, the body temperature was 36.0 degrees Celsius, and he had inappetence. Thus, the patient went to bed without taking meals. On 19Jun2021 (one day after vaccination), the body temperature was 36.6 degrees Celsius. The patient was instructed to take liquid in a sitting position. At 12:30 (23 hours after vaccination), the patient became unable to stand up to go to the restroom assisted with his wife, and he had respiratory arrest and cardiac arrest. At 12:40 (23 hours and 10 minutes after vaccination), the patient was confirmed to die. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was geromarasmus. The reporting physician commented as follows: It was considered that the event was caused by geromarasmus.; Sender''s Comments: There was not a reasonable possibility that the event Cardiac arrest was related to the BNT162b2. This 92 year old patient''s advanced age, medical history of hypertension and ischaemic heart disease and underlying conditions provide plausible explanations.; Reported Cause(s) of Death: Respiratory arrest; Cardiac arrest


VAERS ID: 1449043 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Marasmus
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KETAS; THEODUR; OLMESARTAN; LEBENIN-S; MAGNESIUM OXIDE; SENNOSIDE [SENNOSIDE A+B CALCIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral artery stenosis; Cerebral atrophy; Constipation; Dementia; Dementia Alzheimer''s type; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021739628

Write-up: Geromarasmus; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115265. The patient was an 86-year and 2-month-old female. Body temperature before vaccination was 36.8 degrees Centigrade. Medical history included dementia Alzheimer''s type, left cerebral artery stenosis, cerebral atrophy, hypertension, constipation and dementia. Oral concomitant medications included ibudilast (KETAS), theophylline (THEODUR), olmesartan, bifidobacterium longum, enterococcus faecalis, lactobacillus acidophilus (LEBENIN-S), magnesium oxide and sennoside A and B calcium (SENNOSIDE). Family history was not provided. On 16Jun2021 at 14:08 (the day of vaccination)(at age of 86-year-old), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY5420, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 17Jun2021 at 08:24 (1 day after the vaccination), the patient died of geromarasmus. It was not reported if an autopsy was performed. The course of the events was as follows: The patient was admitted to a medical facility because of dementia Alzheimer''s type. On 16Jun2021, after the first dose of the vaccination, her vital signs were stable and she was having dinner as usual. In the midnight of the same day, it was confirmed that the patient was sleeping. On 17Jun2021 at 07:00, it was confirmed that the patient died on the bed. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. Dementia Alzheimer''s type was considered as a possible cause of the event. The reporting physician commented as follows: The dementia had advanced, the patient had been bedridden since last year and the disuse condition had progressed. Given that her vital signs were stable and no adverse reactions were noted after the vaccine, the event was considered to be due to geromarasmus.; Sender''s Comments: Based on the available information, patient''s age and comorbidities. the event is most likely related to an inter current or underlying condition hence unrelated to the suspect drug.; Reported Cause(s) of Death: Geromarasmus


VAERS ID: 1449060 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-28
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cerebral infarction, Decreased appetite
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lumbago
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021741759

Write-up: Appetite impaired; Energy decreased; the patient looked as if she developed cerebral infarction/stroke; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a 97-year-old female. Medical history included lumbago. On 20May2021 (the day of vaccination) (at age of 97-year-old), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and expiration date were not reported) intramuscularly as a single dose for COVID-19 immunization. On 28May2021 (8 days after the vaccination), the patient looked as if she developed cerebral infarction. On 17Jun2021 (28 days after the vaccination), the patient died of stroke. The course of the event was as follows: The patient lived in an elder care facility. Eight days after the first vaccination, the patient looked as if she developed cerebral infarction. The patient gradually had appetite impaired and energy decreased. Subsequently, the patient was cared for as if the patient was dying and on 17Jun2021, the patient died. Although definitive diagnosis was not made by CT or MRI, it was considered that the vaccine was probably the cause of cerebrovascular disorder, which led to death. No other information was available. The reporting physician considered the cause of death was stroke. The outcome of events ''Appetite impaired'' and ''Energy decreased'' was unknown. The reporting physician classified the event as serious (death) and assessed that the event was probably related to BNT162b2.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available clinical data and the HCP reporter assessment, the contributory role of vaccination with BNT162B2 to event ''cerebral infarction'' with fatal outcome cannot be totally ruled out. The patient''s age is an established risk factor for the occurrence of the event. This case will be re-evaluated if additional relevant information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: cerebral infarction/stroke


VAERS ID: 1449062 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Vomiting
SMQs:, Acute pancreatitis (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Thrombocytosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021741800

Write-up: Stroke; vomiting; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a 74-year-old female. Medical history included non-ongoing cerebral haemorrhage from unspecified date and thrombocytosis from unspecified date. On 18Jun2021 at 12:00 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, lot number, and expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 20May2021 (2 days after the vaccination), the patient experienced stroke. On 21Jun2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 18Jun2021 at 12:00, the patient received COMIRNATY. On 20Jun2021, the patient ate bread and vomited. The patient was emergently transferred to a hospital. On the following day on 21Jun2021 in the morning, the patient died at the hospital where the patient was transferred. The reporting physician classified the event as serious (death) and assessed that the event was possibly related to BNT162b2.; Sender''s Comments: Based on the information available, a causal association between BNT162B2 and the reported stroke 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Stroke


VAERS ID: 1449237 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Confusional state, Dyspnoea, Electrocardiogram, Fall, Incorrect dose administered, Loss of consciousness, Myocardial ischaemia, Off label use, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), 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), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Name: ECG; Result Unstructured Data: Test Result:acute myocardial ischemia AMI; Comments: Suspicion of acute myocardial ischemia AMI (NVI, lower wall infarction).
CDC Split Type: NOPFIZER INC2021728857

Write-up: fever/acute fever (38.5, measured axillary); confusional state/confused; dyspnea/short of breath; syncope; falls over; loses consciousness; Cardiac arrest/persistent asystole; acute myocardial ischemia AMI (NVI, lower wall infarction); received a total of three vaccine doses (all Comirnaty) in six weeks/supplementary vaccination (third dose), following advice from Regulatory Authority; received a total of three vaccine doses (all Comirnaty) in six weeks/supplementary vaccination (third dose), following advice from Regulatory Authority; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is NO-NOMAADVRE-FHI-2021-U4nxpr. A 70-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in left arm on 02Jun2021 at 08:42 (Batch/Lot Number: FC2336) (at the age of 70-years-old) as dose 3, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccines included BNT162B2 (COMIRNATY) via unknown route of administration on 21Apr2021 (Lot number: unknown) as dose 1, single; and via intramuscular, administered in left arm on 05May2021 (Lot number: unknown) (at the age of 70-years-old) as dose 2, single for COVID-19 immunization and experienced drug dose administration interval too short, both without complications. The patient experienced fever, confusional state, dyspnea, and syncope on 02Jun2021. Course of event were as follows: The patient received a total of three vaccine doses (all Comirnaty) in six weeks. He was vaccinated with the first dose on 21Apr2021, without complications. He was registered for dose no. 2 of the vaccine, and it was to be given on 02Jun2021, 6 weeks after dose no. 1. However, he showed up at the vaccination center on 05May2021, with his own opinion that he had been given an appointment to receive dose no. 2 that day. He was not registered for vaccination that day but was still cleared by the reception for vaccination. Vaccination with dose no. 2 was performed that day (05May2021), without complications. Dose no. 2 was thus given two weeks after dose no. 1, instead of 6 weeks after dose no. 1. Immediately after dose no. 2 of the vaccine was given, during the observation period at the vaccination center, it was discovered that the patient had received dose no. 2 at shorter intervals after dose no. 1 than originally planned. The error was detected when the vaccination was to be registered in the vaccination register. The patient was informed of this. The vaccine team conferred with Regulatory Authority regarding the consequences of too short an interval between dose no. 1 and dose no. 2. It was stated that these two doses had to be considered as one dose, and that the next dose (a third) was necessary to achieve full effect. In addition, a valid vaccine passport would require documented doses at the right interval. Due to this, the patient was called in for supplementary vaccination (third dose), following advice from Regulatory Authority, which was performed on 02Jun2021. On 02Jun2021 (four weeks after dose no. 2 and six weeks after dose no. 1), the patient therefore showed up for the appointment he had received notification of. Approximately 12 hours after vaccination with this third dose, he developed an acute fever (38.5, measured axillary), and he was confused. He allegedly refused to contact a doctor. He woke up later in the night and was described as further confused and short of breath. It is said that he then at about the same time falls over and loses consciousness. It was perceived as cardiac arrest and CPR was started. Ambulance personnel once achieved to get the heart beating again. ECG at that time with suspicion of acute myocardial ischemia AMI (NVI, lower wall infarction). Shortly after, a new cardiac arrest. Resuscitation was attempted again but ended after about 30 minutes due to persistent asystole (this information was orally referred from the emergency room). Fatal outcome. The patient died on 02Jun2021. An autopsy has been performed and results were not provided. Cause of death was asystole. The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Asystole


VAERS ID: 1449310 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-25
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Haemoptysis, Haemorrhage, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   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: VARFINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fontan procedure (At 6 years old); Univentricular heart (Submitted to Fontan surgery at 6 years old)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021743882

Write-up: Hemoptysis; Fever; Active hemorrhage; This is a spontaneous report from a contactable consumer. A 33-years-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: ET6956) via intramuscular route on 21Apr2021 as a dose 1, single dose for covid-19 immunization and second dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: EX8680) via intramuscular route on 19May2021 as a dose 2, single for covid-19 immunization. Medical history included univentricular heart (submitted to Fontan surgery at 6 years old). Concomitant medication included warfarin sodium (VARFINE). On 25May2021, the patient experienced sudden onset of haemoptysis, fever with active haemorrhage, without focus identification. Remaining exams without changes. The patient was initially hospitalized at a hospital of the redence area and subsequently transferred to a central hospital, intensive care unit. The patient died on 29May2021. The reported cause of death was haemoptysis, fever and haemorrhage. It was not reported if an autopsy was performed. The outcome of the events was fatal.; Reported Cause(s) of Death: Hemoptysis; Fever; Active hemorrhage


VAERS ID: 1449565 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Breast pain, Malaise, Myocarditis, Sudden cardiac death, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Lipodystrophy (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: 2021-06-14
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100110047

Write-up: Ventricular fibrillation; Myocarditis; Sudden cardiac death; Breast pain; Malaise; This regulatory authority case was reported by a physician and describes the occurrence of VENTRICULAR FIBRILLATION (Ventricular fibrillation), MYOCARDITIS (Myocarditis), BREAST PAIN (Breast pain), MALAISE (Malaise) and SUDDEN CARDIAC DEATH (Sudden cardiac death) in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 10-Jun-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced BREAST PAIN (Breast pain) (seriousness criterion death) and MALAISE (Malaise) (seriousness criterion death). On 14-Jun-2021, the patient experienced VENTRICULAR FIBRILLATION (Ventricular fibrillation) (seriousness criteria death and medically significant), MYOCARDITIS (Myocarditis) (seriousness criteria death and medically significant) and SUDDEN CARDIAC DEATH (Sudden cardiac death) (seriousness criteria death and medically significant). The patient died on 14-Jun-2021. The reported cause of death was Sudden cardiac death. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered VENTRICULAR FIBRILLATION (Ventricular fibrillation), MYOCARDITIS (Myocarditis), BREAST PAIN (Breast pain), MALAISE (Malaise) and SUDDEN CARDIAC DEATH (Sudden cardiac death) to have an unknown relationship. Concomitant medication were not provided. Treatment medication was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. Company comment: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1449666 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-06
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: 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: ISJNJFOC20210703796

Write-up: DEATH; This spontaneous report received from a consumer (social media: news) concerned a patient of unspecified age (individual 56-74 years old), sex, 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, frequency one total, dose, therapy start date were not reported administered 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 experienced death and cause of death was unknown. 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). This case, from the same reporter is linked to 20210703944.; Sender''s Comments: V0; 20210703796-covid-19 vaccine ad26.cov2. s- Death. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1449667 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-27
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Death, Malaise, Product preparation issue
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), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: Decompensation cardiac; Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure; Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: General malaise; Arrest cardiac; Death; solution for haemodialysis; This regulatory authority case was reported by a physician and describes the occurrence of MALAISE (General malaise), CARDIAC ARREST (Arrest cardiac), DEATH (Death) and PRODUCT PREPARATION ISSUE (solution for haemodialysis) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3002543 and 3001941) for COVID-19 vaccination. The patient''s past medical history included Thoracic aortic aneurysm and Chronic respiratory failure. Concurrent medical conditions included Obesity and Decompensation cardiac since 20-Feb-2005. On 22-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form in total. On 27-May-2021, the patient experienced PRODUCT PREPARATION ISSUE (solution for haemodialysis) (seriousness criterion death). On 01-Jun-2021, the patient experienced MALAISE (General malaise) (seriousness criterion death), CARDIAC ARREST (Arrest cardiac) (seriousness criteria death and medically significant) and DEATH (Death) (seriousness criteria death and medically significant). The patient died on 01-Jun-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. No treatment information was not given No concomitant medication information was provided. Lab data included Hemoglobin test done on 01-06-2021. Action taken with mRNA-1273 in response to the event was not applicable. This is a report of death in a polymorbid 85 years old male, after second product dose. Concomitant medication was not provided. Autopsy was not provided. This a regulatory/spontaneous report of death, xx days after receiving the product in a 85 years old male with multiple concomitant conditions. Concomitant medication was not provided. Autopsy was not provided. Very limited information regarding the event has been provided for inferring causality. Further information is not expected. The event PT: product preparation issue, for which causality is not applicable, was captured from SD. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Translation received on 01-07-2021 and does not contain any new information; Reporter''s Comments: paziente con pluripatologie (Scompenso Cardiaco, Insufficienza Respiratoria Cronica, Obesita, Aneurisma Aorta Toracica) deceduto per arresto cardiocircolatorio in data 01/06/2021 dopo somministrazione di Vaccino Moderna 2 dose lotto n 3002543 scad 22/11/2021 somministrato in data 27 Maggio 2021 (1 dose Moderna 22 Aprile 2021 h 16.15 lotto 3001941); Sender''s Comments: This a regulatory/spontaneous report of death, xx days after receiving the product in a 85 years old male with multiple concomitant conditions. Concomitant medication was not provided. Autopsy was not provided. Very limited information regarding the event has been provided for inferring causality. Further information is not expected. The event PT: product preparation issue, for which causality is not applicable, was captured from SD.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1449886 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-23
Submitted: 0000-00-00
Entered: 2021-07-06
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: 2021-06-23
   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: DIPIPERON; AKINETON [BIPERIDEN]; NEXIAM [ESOMEPRAZOLE MAGNESIUM]; RIVOTRIL
Current Illness:
Preexisting Conditions: Comments: Acquired a hammer toe, m reflux esophagitis disease (2001), sliding hernia (2004), laparoscopic ovariectomy on the left endometrial polyp (2007), HK correction of cystic ovary (on AUG-2009) and psychiatric admissions.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210701033

Write-up: PATIENT PASSED AWAY ON 23-JUN-2021, 14 DAYS AFTER THE VACCINATION, DUE TO SUDDEN DEATH IN HER SLEEP; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, BE-FAMHP-DHH-N2021-98519] concerned a 76-year-old female patient of unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included an acquired a hammer toe, m reflux esophagitis disease (2001), sliding hernia (2004), laparoscopic ovariectomy on the left endometrial polyp (2007), HK correction of cystic ovary (on AUG-2009) and psychiatric admissions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: J.XD975 and expiry: unknown) dose was not reported, 1 total, administered on 08-JUN-2021 for covid-19 immunization (drug start period: 14 days). Concomitant medications included Akinetone (biperiden), Rivotril (clonazepam), Nexiam (esomeprazole magnesium), and Dipiperon (pipamperone hydrochloride), all drugs used for unknown indication. On 23-JUN-2021, 14 days after the vaccination, the patient passed away due to sudden death in her sleep. Cause of death was unknown. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event ''patient passed away on 23-JUN-2021, 14 days after the vaccination, due to sudden death in her sleep'' was fatal. This report was serious (Death).; Reporter''s Comments: Treatment ? No Evolution of ADR ?Passed away Examinations - N/A.; Sender''s Comments: V0 20210701033-COVID-19 VACCINE AD26.COV2.S-''patient passed away on 23-JUN-2021, 14 days after the vaccination, due to sudden death in her sleep''. 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


Result pages: prev   35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=134&PERPAGE=100&VAX=COVID19&VAXTYPES=COVID-19&DIED=Yes

Government Disclaimer on use of this data


Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166