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From the 9/17/2021 release of VAERS data:

Found 15,386 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 1038989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aerococcus urinae infection, Body temperature, Death, Hyperthermia, Pyrexia, Urological examination, Urosepsis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral amyloid angiopathy; Hypertension arterial; NIDDM
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: body temperature; Result Unstructured Data: Test Result:38 degrees; Test Date: 20210128; Test Name: cytobacteriological examination of the urine; Result Unstructured Data: Test Result:positive for Aerococcus Urinae
CDC Split Type: FRPFIZER INC2021151099

Write-up: Death unexplained; Aerococcus Urinae in urine; Fever (38 degrees); hyperthermia; possible context of sepsis with urinary origin; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB (FR-AFSSAPS-RS20210133). A 93-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6788), intramuscularly in the left arm, on 21Jan2021 at a single dose for SARS-CoV-2 vaccination. Medical history included hypertension arterial, non-insulin-dependent diabetes mellitus (NIDDM), and cerebral amyloid angiopathy. The patient was not previously diagnosed with COVID-19. The patient''s concomitant medications were not reported. The patient experienced fever (38 degrees) on 24Jan2021 and death unexplained on 30Jan2021, which were reported as fatal. The patient also experienced hyperthermia on 24Jan2021, Aerococcus Urinae in urine on 28Jan2021, and possible context of sepsis with urinary origin in Jan2021. The clinical course was reported as follows: The patient had an onset of fever (body temperature of 38 degrees on 24Jan2021) and hyperthermia. On 26Jan2021, there was alteration of the general condition and the patient therefore remained in bed. On 28Jan2021, the cytobacteriological examination of the urine collected was positive for Aerococcus Urinae; hence, the patient was treated with ceftriaxone sodium (ROCEPHIN). On 30Jan2021, the patient was found dead (as reported: it is concluded that she died in a possible context of sepsis with urinary origin). Therapeutic measures were taken as a result of fever (38 degrees), hyperthermia, Aerococcus Urinae in urine, and possible context of sepsis with urinary origin, which included unspecified antipyretics and ceftriaxone sodium as aforementioned. The patient died on 30Jan2021. The cause of death was assessed as possible context of sepsis with urinary origin (reported as death unexplained). It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: possible context of sepsis with urinary origin


VAERS ID: 1038993 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-02-03
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Dehydration, Depressed level of consciousness, Diarrhoea, Dyspnoea, Erythema, Haematochezia, Respiratory distress, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Behavior disorder; COVID-19; CVA (Sylvian left stroke and post stroke comitiality); Disorder personality; Hypertension; Non-insulin-dependent diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021151655

Write-up: Respiratory distress; Obtundation; Erythema; Emesis; Dehydration; mucous diarrhea appeared with traces of blood/diarrhea; mucous diarrhea appeared with traces of blood/diarrhea; Dyspnoea; disturbance of consciousness; This is a spontaneous report from a contactable Physician downloaded from the Medicines Agency (MA) -WEB with Regulatory authority report number FR-AFSSAPS-TO20210399. A 90-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EJ6788), intramuscularly on 26Jan2021 at single dose in right arm for COVID-19 vaccination. Medical history included COVID-19 from an unknown date and not ongoing; Cerebrovascular accident (CVA, Sylvian left stroke and post stroke comitiality) from an unknown date and unknown if ongoing, Hypertension from an unknown date and unknown if ongoing, Atrial fibrillation from an unknown date and unknown if ongoing; Non-insulin-dependent diabetes mellitus from an unknown date and unknown if ongoing; Behavioral and personality disorders from an unknown date and unknown if ongoing. The patient''s concomitant medication included anticoagulant for Atrial Fibrillation. The patient experienced respiratory distress, obtundation, erythema, emesis, dehydration, diarrhoea, all on 03Feb2021. On the morning of 03Feb2021, mucous diarrhea appeared with traces of blood. Then very profuse vomiting (several liters) and repeated very quickly evolving into dehydration. Then respiratory distress without hindrance. Dyspnoea and significant desaturation poorly compensated (72 percent to 80 percent) by O2 therapy at 8L/minute. Finally, disturbance of consciousness with opposition to treatment. Then death. After the death an erythema extended to the level of the upper right limb was noted. The patient died on 03Feb2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: mucous diarrhea appeared with traces of blood; Dyspnoea; disturbance of consciousness; Respiratory distress; Obtundation; Erythema; Vomiting; Dehydration; Diarrhoea


VAERS ID: 1038995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-22
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Heart rate, Oxygen saturation, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALPRAZOLAM; METFORMIN; MACROGOL; ZOPICLONE; MIRTAZAPINE; HALDOL; PARACETAMOL; NORMACOL [CALENDULA OFFICINALIS;RHAMNUS FRANGULA]; EXACYL; LANSOPRAZOLE; TERCIAN [CYAMEMAZINE TARTRATE]
Current Illness: Alzheimer''s disease (marked cognitive disorders/which are increasing; cognitive deterioration.); Anxiety depression
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer (without treatment (date unspecified).); Constipation
Allergies:
Diagnostic Lab Data: Test Date: 20210114; Test Name: blood pressure; Result Unstructured Data: Test Result:13/5 mmHg; Test Date: 20210114; Test Name: heart rate; Result Unstructured Data: Test Result:72/min; Test Date: 20210114; Test Name: oxygen saturation; Test Result: 94 %; Comments: in ambient air
CDC Split Type: FRPFIZER INC2021150318

Write-up: vomiting; Death unexplained; This is a spontaneous report from a contactable other health professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number is FR-AFSSAPS-TS20210173. A 92-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: EM0477), intramuscular on 18Jan2021 at single dose (reported as "1 DF") for COVID-19 vaccination. Co-suspect medication included cyamemazine tartrate (TERCIAN), via an unspecified route of administration from 20Jan2021 at 25 mg, 2x/day (25 mg x 2 / d) for an unspecified indication. Medical history included constipation, ongoing long-standing anxiety-depressive background, marked cognitive disorders (Alzheimer''s disease). Cancer of the left breast, without treatment (date unspecified). Patient had been living in a geriatric long-stay ward since Mar2019. Patient with no history of swallowing disorders. Food composed of a chopped texture. For several weeks, cognitive disorders which are increasing, refusal of food more and more frequent in this context of cognitive deterioration. No cardiovascular or respiratory disorders. The patient''s concomitant medications included usual treatment with alprazolam, metformin, macrogol, zopiclone, mirtazapine, haloperidol (HALDOL) from an unspecified date to 20Jan2021 in the morning and replaced this on 20Jan2021 by cyamemazine tartrate (TERCIAN), paracetamol, calendula officinalis, rhamnus frangula (NORMACOL) if constipation, tranexamic acid (EXACYL) and lansoprazole. Pre-vaccination consultation on 14Jan2021, the patient underwent lab test included: BP "13/5" mmHg (as reported), heart rate 72 / min, oxygen saturation 94% in ambient air. First injection of BNT162B2 vaccine on 18Jan2021. Good tolerance. No modification the following days, in particular no digestive disorder. However, an anxious patient, modification of the treatment by replacing HALDOL by TERCIAN on 20Jan2021. On 22Jan2021, around 3 p.m., i.e. 2 hours after the end of the meal, the patient was found in her room in her marbled chair, deceased, with traces of vomiting on the floor of the room. Unclear if it was post-vomiting (reported as "post-vomiting?"). In total, unexplained death in a context of vomiting in an elderly patient, 4 days after a 1st injection of BNT162B2 vaccine and 2 days after the replacement of HALDOL by TERCIAN. The action taken in response to the event for cyamemazine tartrate was not applicable. The patient died on 22Jan2021 for unexplained death in a context of vomiting. An autopsy was not performed.; Reported Cause(s) of Death: vomiting; Death unexplained


VAERS ID: 1038996 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Death, Diarrhoea, Fatigue, General physical health deterioration, Heart rate, Hypotension, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood stool (for several weeks (unsure if it was tumor)); Blood urine (for several weeks (unsure if it was tumor))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: BP; Result Unstructured Data: Test Result:90/50 mmHg; Comments: During the night: RAS, calls for a drink, constant measurements: BP at 120/90; Test Date: 20210125; Test Name: BP; Result Unstructured Data: Test Result:120/90 mmHg; Test Date: 20210125; Test Name: pulse rate; Result Unstructured Data: Test Result:74 /min; Test Date: 20210125; Test Name: oxygen saturation; Test Result: 94 %
CDC Split Type: FRPFIZER INC2021151652

Write-up: deterioration of the contemporary general state; Hypotension with blood pressure (BP) at 90/50 mm Hg; tired ++; increase in asthenia; episode of diarrhea; Death unexplained; This is a spontaneous report from a contactable other Health Professional downloaded from the Medicines Agency (MA) -WEB, regulatory authority number is FR-AFSSAPS-TS20210174. A 100-year-old female patient received BNT162B2 (COMIRNATY, lot number EM0477), via intramuscular on 19Jan2021 at single dose for Covid-19 vaccination. The patient medical history included resident in nursing home. The caregivers have observed blood in the stool and urine for several weeks (unsure if it was tumor (reported as "tumor?")). But no investigation carried out in agreement with the patient and the family due to the terrain and the absence of reported pain. The patient concomitant medications were not reported. No information on chronic treatment (no access to software after death). Alteration of general condition for several weeks, clinical condition deteriorating. The patient vaccinated on 19Jan2021 by BNT162B2 in the establishment. No particular event in the course. On 25Jan2021, (Day 6 of vaccination), the patient experienced increase in asthenia which had been present for several weeks, episode of diarrhea, wishes to remain lying down and did not go to the chair. Taking of constants: Hypotension with blood pressure (BP) at 90/50 mm Hg and saturation at 94 percent. During the night: RAS, calls for a drink, constant measurements: BP at 120/90 and pulse at 74/min. Review at 1:30 am: coherent remarks, says she was tired ++, no other symptomatology. On 26Jan2021, toilet in the morning: RAS. Discovery dead in her chair at 9 a.m. In total, death on Day 7 from the vaccine in a very old patient, with deterioration of the contemporary general state of digestive and urinary hemorrhagic manifestations evolving for several weeks. A priori, there is no argument allowing to question the role of the vaccine in this death. The outcome of the event hypotension was recovering; of the events tired ++, increase in asthenia, episode of diarrhea was unknown. The patient died on 26Jan2021 for unexplained death and reduced general condition. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained; Reduced general condition


VAERS ID: 1039006 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Multiple organ dysfunction syndrome, SARS-CoV-2 test
SMQs:, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Ischaemic heart disease; Comments: Heart disease, diabetes Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021155260

Write-up: Multiple organ failure; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the RA. Regulatory authority report number GB-MHRA-APPCOVID-202102131221504710, Safety Report Unique Identifier GB-MHRA-ADR 24756997. A 76-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. Medical history included myocardial ischaemia, diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced multiple organ failure on 01Feb2021 with outcome of fatal. The patient underwent lab tests included covid-19 virus test: negative on 04Feb2021. The patient died on 06Feb2021. It was not reported if an autopsy was performed. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts possible; information regarding batch/lot cannot be obtained.; Reported Cause(s) of Death: Multiple organ failure


VAERS ID: 1039718 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, 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), Other ischaemic heart disease (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia (treated with ferrous sulphate); Chest pain (awaiting diagnostic angiogram)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021152883

Write-up: Cardiac arrest; cardiac cause; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102111011108460, Safety Report Unique Identifier GB-MHRA-ADR 24740421. A 49-year-old female patient received the 1st does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot # unknown) at single dose on 06Feb2021 for covid-19 immunisation. Medical history included anaemia, chest pain awaiting diagnostic angiogram. Unsure if patient has had symptoms associated with COVID-19. Patient had not a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medication were unknown. The patient previously took ferrous sulphate (manufacturer unknown, tablets) for anaemia. The patient experienced cardiac arrest and cardiac cause on 06Feb2021. Therapeutic measures were taken as a result of events. The patient died on 06Feb2021. Outcome of events was fatal. It was not reported if an autopsy was performed. Course of events: Patient had COVID vaccine approximately 10-15 mins prior to presenting with cardiac arrest in the Emergency Department. She was brought in by her husband who noted she put her hands to her chest and grasped prior to collapse in the car after the vaccine. She was then brought round to A&E where cardiopulmonary resuscitation (CPR) was started. She was noted to be in PEA arrest and doses of adrenaline (1:10 000), with IV Fluids. Cardiac Arrest Team decided to thrombolyse her given possible cardiac cause given recent history. She was subsequently thrombolysed with tenecteplase. However she did not regain output and CPR was stopped approximately 70 mins after she presented. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1039720 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4176 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENDROFLUMETHIAZIDE; CARMELLOSE; DOXYCYCLINE; EUMOVATE; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease stage 3; Dry eyes; Eczema; Glaucoma; Hypertension; Prostatism; Rosacea
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021155648

Write-up: Loose stools; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202102121322200950, Safety Report Unique Identifier GB-MHRA-ADR 24749491. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. The relevant medical history included CKD (Chronic kidney disease) stage 3, hypertension, eczema, glaucoma, dry eyes, rosacea and prostatism, all from an unspecified date. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medications included bendroflumethiazide from 13Jan2011 for hypertension, carmellose from 20Nov2013 for dry eye, doxycycline from 10Jun2013 for rosacea, clobetasone butyrate (EUMOVATE) from 11Jul1991 for eczema, tamsulosin from 13Jun2018 for prostatism. The patient experienced loose stools on an unspecified date. The seriousness criteria was reported as death. The patient died on 12Feb2021. Case narrative: Patient found deceased at home address, loose stool around his person. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of the event was fatal. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: loose stools


VAERS ID: 1039724 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021155158

Write-up: Found dead; This is a spontaneous report from a contactable consumer. This is a report received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202102130938244340, Safety Report Unique Identifier GB-MHRA-ADR 24753885. A 33-year-old patient of an unspecified gender received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 10Feb2021 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient died (found dead) on 10Feb2021. It was not reported if an autopsy was performed. Patient had not tested positive for COVID-19 since having the vaccine. Serious criteria was reported as death, hospitalization, life threatening. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Found dead


VAERS ID: 1039833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Melaena
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARBASALAATCALCIUM; FUROSEMIDE; PANTOPRAZOL [PANTOPRAZOLE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis (recently diagnosed as severe and symptomatic with life expectancy between 0.5 - 1 year); Decompensation cardiac
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021158434

Write-up: Death; melaena; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB (NL-LRB-00439484). A 92-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, on 03Feb2021 at a single dose for COVID-19 immunisation. Medical history included decompensation cardiac and aortic valve stenosis (recently diagnosed as severe and symptomatic with life expectancy between 0.5 - 1 year). Concomitant medications included carbasalate calcium (CARBASALAATCALCIUM), furosemide (MANUFACTURER UNKNOWN), and pantoprazole (PANTOPRAZOL). The patient experienced melaena on 03Feb2021. The patient also experienced death on 05Feb2021, which was reported as fatal. The clinical course was reported as: The reporter described that the patient was recently diagnosed with a severe symptomatic aortic valve stenosis, with a life expectancy between 0.5 - 1 year. At time of vaccination, melaena was suspected. The patient deceased 44 hours after vaccination. The clinical outcome of melaena was unknown. The cause of death was reported as unknown. 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: Unknown cause of death


VAERS ID: 1039867 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUPRENORPHINE; MIDAZOLAM; HEMINEVRIN [CLOMETHIAZOLE EDISILATE]; ZOPICLONE; HIPREX [METHENAMINE HIPPURATE]; FURIX [FUROSEMIDE]; ROBINUL; MIRTAZAPINE; DUROFERON; HALDOL; MORPHINE; FOLIC ACID; MEMANTINE; METOPROLOL; ALVEDON; MINIDERM [GLYCEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Aortic valve insufficiency; Dementia; Hypertension; Late effects of cerebral stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021151995

Write-up: breathing difficulties; wheezy breathing; Death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-002698. Other case identifier number SE-MPA-1612445101419. A 77-year-old male patient received second dose of bnt162b2 (COMIRNATY, lot/batch number unknown), intramuscular in Feb2021 at 0.3 mL, single for covid-19 immunisation. Medical history included alzheimers disease, dementia, hypertension, aortic valve insufficiency, late effects of cerebral stroke. Patient received first dose of bnt162b2 (COMIRNATY) on 12Jan2021 for covid-19 immunisation. Concomitant medications were Alvedon, Duroferon, Furix, Haldol, Heminevrin, Hiprex, Miniderm, Robinul, acetylsalicylic acid, buprenorphine, folic acid, memantine, metoprolol, midazolam, mirtazapine, morphine, zopiclone. The reporter wrote "Patient had breathing difficulties with wheezy breathing...". The patient died within 24 hours after vaccination in Feb2021. Event reported as serious due to death. No autopsy performed. The outcome of events was fatal. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death; breathing difficulties; wheezy breathing


VAERS ID: 1040506 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood culture, Blood culture positive, Cholecystitis, Pyrexia, Sepsis, Ultrasound abdomen
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Living in nursing home; Polyneuropathy; Prostatic cancer; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: Blood culture; Result Unstructured Data: Positive for e.coli; Test Date: 20210120; Test Name: Ultrasound abdomen; Result Unstructured Data: Findings compatible with cholecystitis.
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: SEPSIS; cholecystitis; FEVER; Blood cultures positive for E. Coli; A regulatory authority report was received from a physician concerning a 95-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced sepsis and fever. The patient''s medical history, as provided by the reporter, included polyneuropathy, prostatic cancer, atrial fibrillation, urinary tract infection, and living in a nursing home. No relevant concomitant medications were reported. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for the prophylaxis of COVID-19 infection. On 20 Jan 2021, a blood culture showed positive for E. coli and an abdominal ultrasound showed findings compatible with cholecystitis. Action taken with mRNA-1273 was not applicable as the patient deceased. The patient died on 22 Jan 2021. The cause of death was reported as sepsis, fever, and cholecystitis. Plans for an autopsy were not provided.; Reporter''s Comments: This case concerns a 95-year-old male, who experienced a serious unexpected fatal events of sepsis and pyrexia, with blood culture positive for E. coli and ultrasound with cholecystitis. Events began the same day as the first dose of mRNA-1273. Autopsy not provided. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: sepsis; fever; cholecystitis


VAERS ID: 1042049 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Pneumonia, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: covid-19 virus test; Result Unstructured Data: Test Result:covid-19
CDC Split Type: DEPFIZER INC2021113667

Write-up: Respiratory failure; Pneumonia; covid-19; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-PEI2021001974. An 86-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 16Jan2021 at single dose for covid-19 immunization. Medical history included dementia, stroke, and atrial fibrillation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced covid-19 on 19Jan2021; the patient also experienced respiratory failure and pneumonia on an unspecified date, which were serious as they were life threatening, and lead to death. Details were as follows: covid-19 on 19Jan2021 was noted. Also reported unknown after vaccination, the patient developed respiratory failure and pneumonia, reported as lasting until 29Jan2021. The patient was dead and condition was reported as life threatening. Death cause was reported as respiratory failure and pneumonia. The patient died on 29Jan2021. It was not reported if an autopsy was performed. The patient under lab test include covid-19 virus test: covid-19 on 19Jan2021. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up. Follow-up (15Feb2021): This follow-up is being submitted to notify that the batch number is not available, follow-up activities not applicable, information about lot/batch number cannot be obtained. Further follow-up information will be provided automatically upon availability via MA.; Reported Cause(s) of Death: pneumonia; respiratory failure


VAERS ID: 1044939 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: ELIQUIS; BETAHISTINE; CITALOPRAM; SPIRONOLACTONE; ESCITALOPRAM; AMIODARONE; OMEPRAZOLE; VISTA CAL D
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (requiring anticoagulants)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021158450

Write-up: Sudden death without known cause on 24/01/2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (BE-FAMHP-DHH-N2021-76192). A 95-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6134), via an unspecified route of administration, on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (requiring anticoagulants). Concomitant medications included apixaban (ELIQUIS), betahistine (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), amiodarone (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), and calcium, colecalciferol (VISTA CAL D) taken as nutritional supplement. The patient experienced sudden death without known cause on 24/01/2021 (on 24Jan2021). It was reported that the patient was previously in good health. The patient died on 24Jan2021. The cause of death was reported as sudden death without known cause. It was not reported if an autopsy was performed. The causality assessment to the event was reported as unclassified by the Agency. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - Evolution of the ADR - Died Previously in good health, history of atrial fibrillation requiring anticoagulants; Reported Cause(s) of Death: Sudden death without known cause


VAERS ID: 1044940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder
SMQs:, Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EVISTA; SIPRALEXA; LIPITOR [ATORVASTATIN]; ASAFLOW; L-THYROXIN [LEVOTHYROXINE]; OMEPRAZOLE; MOVICOL NEUTRAL; DAFALGAN FORTE; TARDYFERON; BURINEX; LORMETAZEPAM; RAMIPRIL; BRILIQUE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain lesion; Dementia; Gamma nail fixation (the right hip after a fall on 29Dec2020); Non ST segment elevation myocardial infarction; STEMI
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021158453

Write-up: Cardiovascular problem; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB BE-FAMHP-DHH-N2021-76210. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 Vaccination. Medical history included non-STEMI, STEMI, a gamma nail on the right hip after a fall (the right hip after a fall on 29Dec2020), extensive vascular ischemic cerebral lesions and dementia. Concomitant medication included raloxifene hydrochloride (EVISTA), escitalopram oxalate (SIPRALEXA), atorvastatin (LIPITOR), acetylsalicylic acid (ASAFLOW), levothyroxine (L-THYROXIN) , omeprazole, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL NEUTRAL), paracetamol (DAFALGAN FORTE), ferrous sulfate (TARDYFERON), bumetanide (BURINEX), lormetazepam, ramipril and ticagrelor (BRILIQUE). The patient experienced cardiovascular problem (death) on 30Jan2021. The patient died of cardiovascular problem on 30Jan2021. It was not reported if an autopsy was performed. Comirnaty/ Sudden death/ Agency (WHO)/ unclassifiable. Reporter''s comments: Treatment - No. Evolution of the ADR - Died. Situations - Other: administration - no direct causation suspected at present. The patient received the first vaccination on 21Jan2021. On 30Jan2021, she was found dead in bed by the nursing staff of the rest home where she was staying during the week round. No complaints were registered between the administration of the vaccination and the date of death. No follow-up attempts possible. No further information expected, information about lot/batch number cannot be obtained.; Reporter''s Comments: Treatment - No. Evolution of the ADR - Died. Situations - Other: administration - no direct causation suspected at present. The patient received the first vaccination on 21Jan2021. On 30Jan2021, she was found dead in bed by the nursing staff of the rest home where she was staying during the week round. No complaints were registered between the administration of the vaccination and the date of death.; Reported Cause(s) of Death: Cardiovascular problem


VAERS ID: 1044950 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Left ventricular failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: DEPFIZER INC2021160519

Write-up: Decompensation cardiac; Failure heart left; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021002453. A male patient of an unspecified age received bnt162b2 (COMIRNATY) batch no.: EL1491, subcutaneous on 04Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY) for covid-19 immunisation on 14Jan2021. On the same day after vaccination (04Feb2021) the patient developed Failure heart left and Decompensation cardiac, lasting for 3 day(s). The patient is dead. The patient died in Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Failure heart left; Decompensation cardiac


VAERS ID: 1044951 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-19
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Aortic aneurysm, COVID-19 pneumonia, Drug ineffective, SARS-CoV-2 test, Superinfection bacterial
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (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), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: Chronic renal insufficiency; Dementia Alzheimer''s type; Eye prosthesis user
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021160520

Write-up: Acute respiratory failure; Covid-19 pneumonia; Covid-19 pneumonia; Superinfection bacterial; Aortic aneurysm; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is DE-PEI-PEI2021002456. A 77 years old male patient received the first dose of bnt162b2 (COMIRNATY, batch/Lot number: EM0477 and Expiration Date unknown) via an unspecified route of administration on 01Jan2021 at single dose for COVID-19 immunization.Medical history included Chronic renal insufficiency, Eye prosthesis user, Dementia Alzheimer''s type, all unknown if it was ongoing. Concomitant medication was not reported. On 19Jan2021 after vaccination the patient developed acute respiratory failure, COVID-19 pneumonia, superinfection bacterial, aortic aneurysm, lasting for unknown. The patient is dead on 19Jan2021. Death cause was reported as COVID-19 pneumonia. Diagnosis was confirmed by positive COVID-19 PCR test in 2021. Unknown if autopsy had been done. Outcome of events was fatal. Events were assessed by the regulator as "C. Inconsistent causal association ". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute respiratory failure; Superinfection bacterial; Aortic aneurysm; COVID-19 pneumonia


VAERS ID: 1044952 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective
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: 2021-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma prostate; Coronary heart disease; Dementia Alzheimer''s type; Diabetes mellitus; Hyperthyroidism; Left bundle branch block; Lumbalgia; Melanoma; Struma nodosa
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021160523

Write-up: Covid-19 Pneumonia; Covid-19 Pneumonia; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB with regulatory authority number DE-PEI-PEI2021002458. An 84 years old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, lot/batch number: EM0477), via an unspecified route of administration on 01Jan2021 at single dose for covid-19 immunization. Medical history included diabetes mellitus, Dementia Alzheimer''s type, Hyperthyroidism, Struma nodosa, Coronary heart disease, Melanoma, Carcinoma prostate, Lumbalgia, Left bundle branch block, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced covid-19 pneumonia after vaccination on 26Jan2021. Death cause was reported as COVID-19 pneumonia. The patient died on 26Jan2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1044957 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   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: Cardiac disorder; Disorder renal
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021160561

Write-up: Weakness; malaise; chills; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB DE-PEI-PEI2021002504. An elderly male patient was vaccinated with the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunisation. Medical history included disorder renal and cardiac disorder, both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 01Jan2021 after vaccination the patient developed Malaise and Weakness and Chills and Exitus letalis, lasting for unknown. The patient died on 07Jan2021. It was not reported if an autopsy was performed. The outcome of events Malaise, Weakness and Chills was fatal. The cause of death was Malaise, Weakness and Chills. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Weakness; malaise; chills


VAERS ID: 1044958 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021160562

Write-up: Vomiting; Lethal death; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021002513. An 81-year-old patient of an unspecified gender received the first dose of bnt162b2 (COMIRNATY, lot# EM0477), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On the same day after vaccination (14Jan2021), the patient developed vomiting with fatal outcome; lethal death, lasting for unknown. The patient died on 14Jan2021. It was not reported if an autopsy was performed. Causal relationship between the events and the administration of bnt162b2 was assessed as "unclassifiable " by the Agency. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Lethal death; Vomiting


VAERS ID: 1044959 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, General physical condition abnormal, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (only minor symptoms); COVID-19 virus test positive
Allergies:
Diagnostic Lab Data: Test Date: 20201223; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021160564

Write-up: Exitus letalis; Deterioration in general condition; Weakness; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB DE-PEI-PEI2021002518 and received via Regulatory Authority. A 90-years-old male patient received his first dose of bnt162b2 (COMIRNATY), lot number: EK9788, intramuscular on 25Jan2021 at single dose for covid-19 immunisation. Medical history included covid-19 from 13Jan2021 and unknown if ongoing with only minor symptoms, COVID-19 virus test positive on 23Dec2020. The patient''s concomitant medications were not reported. On 26Jan2021 after vaccination the patient developed Deterioration in general condition and Weakness and experienced exitus letalis (as reported) on 27Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 23Dec2020. The patient died on 27Jan2021. The outcome of events Deterioration in general condition and Weakness was fatal. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Exitus letalis; Deterioration in general condition; Weakness


VAERS ID: 1044966 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
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: 20210107; Test Name: Covid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021164985

Write-up: Coronavirus infection; This is a spontaneous report from a contactable consumer or other non hcp based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty. An elderly patient (79-year-old) of an unspecified gender received bnt162b2 (COMIRNATY, Lot EM0477), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced coronavirus infection (death) on an unspecified date. Symptoms included dizziness, pain in groin, nausea, vomiting, loss of consciousness. The patient underwent lab tests and procedures which included Covid test: positive on 07Jan2021. The patient died on 18Jan2021. 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: Coronavirus infection


VAERS ID: 1044967 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: COVId-19 rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021164988

Write-up: Died/ cause of death was not reported; Corona disease/ COVId-19 rapid test positive; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Biontech Manufacturer control number: 15873, license party for Comirnaty. This reporter reported similar events for 39 patients. This is the 18th of 39 reports. An approximately 90 years old patient of unspecified gender received bnt162b2 (COMIRNATY, lot number: EM0477), via unspecified route of administration on 31Dec2020 at single dose for COVID-19 vaccination. The Patient experienced Corona disease. A COVID rapid test was positive on 05Jan2021. Patient died on 08Jan2021. The patient had no symptoms. The cause of death was not reported. It was unknown if autopsy was done. The outcome of the event corona disease/ COVId-19 rapid test positive was unknown, while the other event was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter/product, similar event, different patient; Reported Cause(s) of Death: Died/ cause of death was not reported


VAERS ID: 1044968 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Necrosis, Pain in extremity, SARS-CoV-2 test positive, Wound
SMQs:, Accidents and injuries (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: COVID PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021165010

Write-up: Coronavirus infection; several wounds and necroses; several wounds and necroses; limb pain; positive PCR test; This is a spontaneous report from a contactable consumer. This is a report based on information received by Pfizer from Biontech, license party for Comirnaty (Biontech ticket reference number 15873). An 83-year-old patient of an unspecified gender received the first dose of BNT162B2 (COMIRNATY, lot EM0477), via an unspecified route of administration at the age of 82-year-old on 31Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced coronavirus infection on an unspecified date, positive PCR test on 06Jan2021, several wounds and necroses, limb pain on an unspecified date. The patient died on 12Jan2021 due to coronavirus infection. It was unknown if an autopsy was performed. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: coronavirus infection


VAERS ID: 1044969 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: Rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021165016

Write-up: had a positive rapid test for COVID-19/ reported to have had COVID-19 disease; This is a spontaneous report received from a contactable consumer employee of a nursing home based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty. This reporter reported similar events for 39 patients. This is the 25th of 39 reports. An 87-year-old patient of unspecified gender received bnt162b2 (COMIRNATY, lot number: EM0477), via unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient was reported to have had a positive rapid test for COVID-19 on 07Jan2021. She was reported to have had COVID-19 disease. Symptoms included body temperature over 39 degrees Celsius and diarrhea. The patient died on 22Jan2021. It was not reported if the autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter/product, similar event, different patient; Reported Cause(s) of Death: had a positive rapid test for COVID-19/ reported to have had COVID-19 disease


VAERS ID: 1044970 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Coronavirus test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: Coronavirus rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021165112

Write-up: Coronavirus infection identified via quick test; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number:15873] from a non-contactable consumer, license party for Comirnaty. A patient about 91-year-old of an unspecified gender received 1st dose of bnt162b2 (COMIRNATY, lot: EM0477), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had a positive COVID 19 quick test on 05Jan2021. The patient died on 15Jan2021. It was unknown if autopsy was done or not. Outcome of positive COVID 19 quick test was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021165108 PFIZER INC; Reported Cause(s) of Death: Coronavirus infection identified via quick test


VAERS ID: 1044971 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210104; Test Name: COVID rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021165114

Write-up: Coronavirus infection/positive rapid test; This is a spontaneous report from a non-contactable consumer or other non hcp. This is a report based on information received by Pfizer from Biontech, license party for Comirnaty [Biontech ticket reference number 15873]. A 88-years-old (at time of vaccination) patient of an unspecified gender started to receive first dose of bnt162b2 (COMIRNATY, lot EM0477), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced coronavirus infection, positive rapid test on 04Jan2021 with outcome of fatal. Patient had no symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Jan2021. The patient died on 22Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 PFIZER INC; Reported Cause(s) of Death: coronavirus infection


VAERS ID: 1044972 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-01-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis, Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 7
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: FURIX [FUROSEMIDE]; DIGOXIN DAK; PAMOL; HJERTEMAGNYL [ACETYLSALICYLIC ACID]
Current Illness: Heart failure; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy; Diuretic therapy; Heart rate irregular; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021158671

Write-up: Consciousness decreased; Cerebral thrombosis (died on 31Jan2021); This is a spontaneous report downloaded from the Regulatory Authority-WEB [DK-DKMA-WBS-0030642]. The case was received from a contactable physician via The Agency. A 97-years-old female patient started to receive bnt162b2 (COMIRNATY,Batch numbers: EJ6797, Exp date: 30Apr2021) , intramuscular on 23Jan2021 at 1 DF, single dose for covid-19 immunisation. Medical history included ongoing heart failure, heart rate irregular and pain. She was in Diuretic therapy and Anticoagulant therapy. She was living in a nursing home. She was well before the vaccination on 23Jan2021. Concomitant medication included furosemide (FURIX [FUROSEMIDE]) oral from 09Jun2020 at 40 mg, daily for diuretic therapy, digoxin (DIGOXIN DAK) oral from 09Jun2020 at 62.5 ug, daily for heart rate irregular, paracetamol (PAMOL) oral from 27Dec2018 at 1000 mg, as needed for Pain, acetylsalicylic acid (HJERTEMAGNYL [ACETYLSALICYLIC ACID]) oral from 09Jun2020 at 75 mg, daily for Anticoagulant therapy. On 01Jan2021, the patient was vaccinated with first dose of COMIRNATY(Batch numbers: EJ6136, exp date 30Apr2021). On 24Jan2021, the day after the second vaccination the patient developed cerebral thrombosis and consciousness decreased. The ADRs were by the reporter reported as fatal and resulting in hospitalisation (24Jan2021). She is discharged to loving care at the nursing home and dies on 31Jan2021 at 00:51. The outcome of Cerebral thrombosis was fatal and the outcome of Consciousness decreased was unknown. Reported cause of death was cerebral thrombosis. Usual confirmation of death was performed on 31Jan2021 and here rigor mortis and livor mortis were found, nothing else. There is no information regarding test results. Causality: The physician does not know if it is an adverse reaction related to the vaccine, but due to the time context the physician is probably in doubt to report. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral thrombosis


VAERS ID: 1044973 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Culture urine, General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: MIANSERIN [MIANSERIN HYDROCHLORIDE]; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; RISPERIDON KRKA; CIRCADIN; KININ [QUININE HYDROCHLORIDE]; SELEXID [PIVMECILLINAM HYDROCHLORIDE]; MEMANTINE RATIOPHARM; NORSP
Current Illness: General physical condition decreased (Increasingly weakened); Living in nursing home; Obsessive-compulsive disorder; Osteoarthritis; Varicose veins
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Dementia Alzheimer''s type; Mental disorder; Nocturnal leg muscle cramps; Pain; Restlessness; Sleeplessness; Urinary tract infection (Several past infections)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Urine culture; Result Unstructured Data: Test Result:No growth
CDC Split Type: DKPFIZER INC2021158666

Write-up: General physical condition decreased (aggravated further), resulting in death; General physical condition decreased (aggravated further), resulting in death; This is a spontaneous report received from a contactable physician, downloaded from the regulatory authority, regulatory authority number DK-DKMA-WBS-0031458, Safety Report Unique Identifier DK-DKMA-ADR 24677060. An 84-years-old female patient received second dose of bnt162b2 (COMIRNATY, lot number: EJ6136, expiration date: 30Apr2021), via an unspecified route of administration, on 27Jan2021 at single dose for COVID-19 immunisation. Co-suspect product included buprenorphine (NORSPAN) via cutaneous from 22Jan2021 to 28Jan2021 at 1DF weekly (strength: 5 microgram/hour) for pain. Medical history included urinary tract infection (several past infections) from an unknown date and unknown if ongoing, ongoing obsessive-compulsive disorder, ongoing varicose veins, ongoing osteoarthritis, general physical condition decreased from 25Jan2021 and ongoing (increasingly weakened), Dementia Alzheimer''s type, sleeplessness, nocturnal leg muscle cramps, restlessness, constipation, pain and mental disorder. The patient was living in a nursery home. On 06Jan2021 the patient was vaccinated with the first dose Comirnaty (Batch EM0477) for COVID-19 immunisation. Concomitant medication included mianserin hydrochloride (MIANSERIN) from 07Aug2020 for Restlessness, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) from 18Jan2021 for constipation, risperidone (RISPERIDON KRKA) from 04Dec2020 for mental disorder, melatonin (CIRCADIN) from 08Nov2019 for sleeplessness, quinine hydrochloride (KININ) from 03Oct2012 for nocturnal leg muscle cramps, pivmecillinam hydrochloride (SELEXID) from 26Jan2021 for urinary tract infection, memantine hydrochloride (MEMANTINE RATIOPHARM) from 06Nov2020 for Dementia Alzheimer''s type. The patient experienced general physical condition decreased (aggravated further), resulting in death on 27Jan2021. The patient did not experience fever or any other adverse reaction after the vaccinaiton. No treatment due to the ADRs was reported. Test results included urine culture in Jan2021: No growth. General physical condition decreased was fatal on 01Feb2021. This was the only reported cause of death. The patient died on 01Feb2021. An autopsy was not performed. The action taken of buprenorphine was not reported. The reporter''s causality: The physician reported that it is uncertain whether or not there is a connection between the general physical condition decreased and the vaccination, but she suspects, that it might have made her general physical condition worse, and therefore resulted in death. The treatment with Norspan might also have contributed to the decreased general physical condition. If the Agency receives supplemental significant information regarding this case the case will be re-submitted. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: General physical condition decreased; general physical condition decreased (aggravated further)


VAERS ID: 1044975 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, General physical health deterioration, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIUM D [CALCIUM;COLECALCIFEROL]; SERTRALIN ORION; CIRCADIN; PAMOL; AVAMYS; BUPRENORPHINE TEVA [BUPRENORPHINE]; COMBAR; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; LAXOBERAL; DUTASTERIDE
Current Illness: Alzheimer''s disease; COVID-19; General physical health deterioration; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Constipation; Depression; Pain; Sleeplessness; Urination difficulty
Allergies:
Diagnostic Lab Data: Test Date: 20210102; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158660

Write-up: Circulatory collapse; Weakness generalised, aggravated; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [DK-DKMA-WBS-0031497]. A 93-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Batch/Lot number: EJ6797, Expiration Date: 30Apr2021) via intramuscular at single dose on 31Dec2020 for COVID-19 immunisation. Medical history included ongoing living in nursing home; ongoing general physical health deterioration, it was generally weakened and fragile; ongoing COVID-19 since Dec2020; ongoing Alzheimer''s disease, was severe Alzheimer''s, eventually he did not receive medication due to palliative treatment; allergic rhinitis; pain; sleeplessness; depression; urination difficulty; constipation. The day before the vaccination, the COVID19 infection had hit the nursing home, and spread the following week among residents and staff. Past drug included many times vaccinated with flu vaccines, the last being influenza vaccine (FLUZONE) on 09Nov2020 for influenza immunisation, without having responded to the vaccines. Concomitant medication included calcium/colecalciferol (CALCIUM D, film-coated tablet) from 22Jan2019 to 08Jan2021 for vitamin supplementation; sertraline hydrochloride (SERTRALIN ORION, film-coated tablet) from 09Apr2019 to 08Jan2021 for depression; melatonin (CIRCADIN, prolonged-release tablet) from 24Oct2019 to 08Jan2021 for sleeplessness; paracetamol (PAMOL, film-coated tablet) from 04Mar2015 to 08Jan2021 for pain; fluticasone furoate (AVAMYS, nasal spray, suspension) from 19May2020 to 08Jan2021 for allergic rhinitis; buprenorphine (BUPRENORPHINE TEVA, transdermal patch, strength reported as 10 microgram/hour) from 16Apr2020 to 08Jan2021 for pain; mirtazapine (COMBAR, film-coated tablet) from 04Jun2019 to 08Jan2021 for depression; macrogol 3350/potassium chloride/sodium bicarbonate/sodium chloride (MOVICOL, powder for oral solution) from 26May2020 to 08Jan2021 for constipation; sodium picosulfate (LAXOBERAL, oral drops, solution) from 11Jun2019 to 08Jan2021 for constipation; dutasteride (capsule, hard) from 17Mar2018 to 08Jan2021 for urination difficulty. On 01Jan2021, the patient developed circulatory collapse and weakness generalised, aggravated. He had no other reactions to the vaccine, but due to the COVID19 infection, the physician had difficulty separating the course of the disease and the adverse reactions. Regarding the COVID19 infection, he was hypoxic and respiratory affected. He was treated with remdesivir. He lost consciousness and was discharged for palliative care at the nursing home. COVID-19 virus test on 02Jan2021 was positive. The ADR general physical health deterioration and circulatory collapse were fatal. The patient died on 09Jan2021. Reported causes of death were circulatory collapse and general physical health deterioration. Autopsy was not performed. Causality: The physician expected that the patient would have died within a few months. It was not inconceivable that the total load had been fatal. The physician had reported a number of fatal cases with nursing home residents who have died o/ with COVID19 infection and who became infected with COVID during the same time period as the vaccine was given. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Circulatory collapse; Weakness generalised, aggravated


VAERS ID: 1044976 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-02
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OXABENZ; MIRTAZAPINE; BUPRENORPHINE; RISPERIDON KRKA
Current Illness: Alzheimer''s disease (Alzheimer''s disease (severe degree))
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Nervousness; Pain; Restlessness
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Comments: Test performed shortly after death
CDC Split Type: DKPFIZER INC2021158655

Write-up: Sudden cardiac death; This is a spontaneous report downloaded from the Regulatory Authority-WEB DK-DKMA-WBS-0031988. The case was received from a contactable physician via The Agency. A 64-years-old female patient received second dose of bnt162b2 (COMIRNATY, lot number: EK9788, Expiration Date: 31May2021), intramuscular on 29Jan2021 at single dose for covid-19 immunisation, risperidone (RISPERIDON KRKA, strength: 0.5 mg), oral from 21Jan2021 to 27Jan2021 at 0.5 mg once a day, then oral from 28Jan2021 to an unspecified date at 1 mg once a day for psychosis. Medical history included ongoing Alzheimer''s disease (severe degree), Pain, Nervousness, Dementia and Restlessness. On 08Jan2021 the patient was vaccinated with the first dose of COMIRNATY (batch number: EM0477). Concomitant medication included oxazepam (OXABENZ) from 08Jan2021 for dementia, mirtazapine from 16Sep2019 for Nervousness, buprenorphine from 05Nov2020 for pain. On 02Feb2021 the patient developed Sudden cardiac death. The patient has not been ill or had other illness before Sudden cardiac death. The patient did not experience any other ADRs due to the vaccinations with COMIRNATY. Sudden cardiac death was by the physician reported as being life threatening and fatal. No treatment or medical procedure due to the Sudden death cardiac was reported. The patient underwent lab tests and procedures which included sars-cov-2 test: Test performed shortly after death: Negative. The patient died on 02Feb2021. It was not reported if an autopsy was performed. The physician believed that a forensic inquest has been made or will be made soon. Due to the temporal correlation the reporting physician suspected a causal relationship between Sudden cardiac death and COMIRNATY. However, the patient was also treated with other medications which could have caused the death. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1044977 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COVID-19 (Patient concurrent conditions included General physical health deterioration, COVID-19.); General physical health deterioration (Patient concurrent conditions included General physical health deterioration.); Living in nursing home (there was a covid-19 outbreak among several residents and staff.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158646

Write-up: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient .; COVID-19; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DK-DKMA-WBS-0032135. A 79-years-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6797), intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Medical history included general physical health deterioration, COVID-19 and the patient was living in nursing home, where there was a covid-19 outbreak among several residents and staff, all ongoing. The patient''s concomitant medications were not reported. On 03Jan2021 the patient developed Death. No treatment due to the death was reported. Reported causes of death: death and of/with COVID-19. Only normal confirmation of death was performed post mortem. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on Jan2021. The patient died on 03Jan2021. An autopsy was not performed. The reporter stated that it was not inconceivable that the total liability of Covid-19 disease and the vaccination had been fatal for the patient. Sender Comment: Comment from Agency: Version 001 has not been submitted to Regulatory Authority. Health Authority should therefore consider version 2 as the initial report. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19; Death


VAERS ID: 1044978 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COVID-19; General physical health deterioration; Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158635

Write-up: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient; Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB DK-DKMA-WBS-0032140. An 85-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6797), via intramuscular on 31Dec2020 at single dose for COVID-19 immunisation. The relevant medical history included living in nursing home, COVID-19, general physical health deterioration, all from unspecified dates and ongoing. Concomitant medications were not reported. The physician reported the occurrence of death. It was not inconceivable that the total liability of Covid-19 disease and the vaccination had been fatal for the patient. No treatment due to the event was reported. On 22Jan2021 the patient died. The reported cause of death was of/with COVID-19. The autopsy was not performed. Only usual confirmation of death was performed post-mortem. No findings were reported. The patient underwent lab test included COVID-19 virus test which showed positive in Jan2021. The outcome of the event was fatal. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient; Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the pat


VAERS ID: 1044979 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Body temperature, Cough, Dyspnoea, Pulmonary embolism, X-ray
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MIRTAZAPIN ACTAVIS; BETOLVEX [CYANOCOBALAMIN ZINC TANNATE]; METOPROLOL SUCCINATE; PANODIL; ALLOPURINOL; TRAJENTA; HJERTEMAGNYL [ACETYLSALICYLIC ACID]; MELATONIN; TRIMOPAN [CITALOPRAM HYDROBROMIDE]; FURIX [CEFUROXIME]; VITAMIN D [VITAMIN D N
Current Illness: Artificial cardiac pacemaker user; Atrial fibrillation; General physical health deterioration; Renal insufficiency (increasing renal insufficiency the past year)
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic (previous alcoholic); Arthritis gouty; Difficulty sleeping; Heart rate irregular; Mood altered; Pain; Sleeplessness; Type 2 diabetes mellitus; Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210201; Test Name: Body temperature; Result Unstructured Data: Test Result:No fever; Test Date: 202101; Test Name: X-ray; Result Unstructured Data: Test Result:suspicion of pneumonia which was disproved
CDC Split Type: DKPFIZER INC2021163664

Write-up: Respiratory difficulty; Cough; Respiratory difficulty; Lung embolism; Anaemia; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. This is a report received from the regulatory authority. The regulatory authority report number is DK-DKMA-WBS-0032205; Safety Report Unique Identifier: DK-DKMA-ADR 24698262. An 85-year-old male patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: EJ6134 and Expiration Date: 30Apr2021), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing renal insufficiency (increasing renal insufficiency the past year) from an unknown date, ongoing atrial fibrillation from an unknown date, ongoing artificial cardiac pacemaker user from an unknown date, ongoing general physical health deterioration from an unknown date, alcoholic from an unknown date and unknown if ongoing (previous alcoholic), arthritis gouty from an unknown date and unknown if ongoing, vitamin B12 deficiency from an unknown date and unknown if ongoing, sleeplessness from an unknown date and unknown if ongoing, heart rate irregular from an unknown date and unknown if ongoing, difficulty sleeping from an unknown date and unknown if ongoing, mood altered from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing, Type 2 diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medications included mirtazapine (MIRTAZAPIN ACTAVIS; 15 mg) taken for difficulty sleeping from 21Jan2021 to an unknown date, cyanocobalamin zinc tannate (BETOLVEX [CYANOCOBALAMIN ZINC TANNATE]; 1 mg) taken for Vitamin B12 deficiency from 06Jul2017 to an unknown date, metoprolol succinate (METOPROLOL SUCCINATE, "HEXAL"; 50mg) taken for Heart rate irregular from 07Jul2016 to an unknown date, paracetamol (PANODIL; 1000 mg) taken for pain from 31Jan2019 to an unknown date, allopurinol (ALLOPURINOL, "DAK"; 100 mg) taken for arthritis gouty from 24Feb2013 to an unknown date, linagliptin (TRAJENTA; 5 mg) taken for Type 2 diabetes mellitus from 20Aug2020 to an unknown date, acetylsalicylic acid (HJERTEMAGNYL [ACETYLSALICYLIC ACID]; 75 mg) taken for Anticoagulant therapy from 25Feb2013 to an unknown date, melatonin (MANUFACTURER UNKNOWN; 3 mg) taken for Sleeplessness from 03Oct2019 to an unknown date, citalopram hydrobromide (TRIMOPAN [CITALOPRAM HYDROBROMIDE]; 100 mg) taken for prophylaxis urinary tract infection from 02Nov2017 to an unknown date, cefuroxime (FURIX [CEFUROXIME]; 40 mg) taken for diuretic therapy from an unknown date to an unknown date, vitamin D [vitamin d nos] (MANUFACTURER UNKNOWN; 25 ug) taken for Vitamin supplementation from 16Nov2017 to an unknown date, potassium chloride (KALEORID; 750 mg) taken for Potassium supplementation from 21Mar2019 to an unknown date. The patient previously received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EJ6797) for COVID-19 immunization on 30Dec2020. On 22Jan2021, the patient experienced cough (death, hospitalization), and respiratory difficulty (hospitalization). On 01Feb2021, the patient experienced respiratory difficulty (death, hospitalization). On an unspecified date, the patient experienced anaemia (death) and lung embolism (death, medically significant). The patient was hospitalized for respiratory difficulty and cough from 22Jan2021 to 24Jan2021. The patient was also hospitalized again for respiratory difficulty (for the 01Feb2021 onset) on unknown dates. The clinical course was reported as follows: On 22Jan2021, the same date as the second COMIRNATY vaccine was administered, the patient developed difficulty breathing and cough. The difficulty breathing was recovered on 24Jan2021 (as reported); however, the difficulty breathing restarted on 01Feb2021. The physician reported that the difficulty breathing caused hospitalisation from 22Jan2021-24Jan2021 (22-24Feb2021 as reported) and as being fatal (the patient died on 01Feb2021). The patient during the hospitalization was treated with an unknown penicillin and clarithromycin due to a suspicion of pneumonia; which was disproved by x-ray. The treatment with an unknown penicillin and clarithromycin was continued. From 28Jan2021, the patient was treated with codeine phosphate hemihydrate in an attempt to reduce his cough. the patient was treated with furosemide (FURIX) on 01Feb2021 for difficulty breathing. The patient underwent lab tests and procedures which included body temperature: no fever on 01Feb2021, X-Ray: suspicion of pneumonia which was disproved in Jan2021. Therapeutic measures were taken as a result of cough, and respiratory difficulty. The clinical outcome of the event, respiratory difficulty (for the 22Jan2021 onset), was recovered on 24Jan2021. The clinical outcome of the events: cough (outcome also reported as unknown), respiratory difficulty (for the 01Feb2021 onset), anaemia, lung embolism was fatal. The patient died on 01Feb2021 due to anaemia, lung embolism, and difficulty breathing (as reported). An autopsy was not performed. Causality: The reporting physician had reported the case because of the temporal correlation between the patient''s death and COMIRNATY. The physician had a small suspicion that it can be caused by COMIRNATY, but other factors may also have contributed. The physician mentioned lung embolism and anaemia as contributing factors to the patient''s death. If the Agency receives supplemental significant information regarding this case the case will be re-submitted. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Anaemia; Lung embolism; Difficulty breathing


VAERS ID: 1044993 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE; ZOPICLONE; FEROPLEX; TRAZODONE; DISTRANEURINE [CLOMETHIAZOLE]; CLOPIDOGREL; LEVETIRACETAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Chronic liver disease; Cognitive impairment; Dyslipidemia; Epilepsy; Hypertension; Living in nursing home
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021158467

Write-up: Heart arrest; This is a spontaneous report from a contactable other Healthcare Professional downloaded from the Regulatory Authority-WEB, Regulatory Authority number ES-AEMPS-738908. A 93-year-old male patient received the second dose of bnt162b2 (COMIRNATY), batch/lot number: EM0477, intramuscularly on 28Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history included Chronic kidney disease, Chronic liver disease, Living in nursing home, cognitive impairment, epilepsy, hypertension, and dyslipidaemia. Concomitant medications included omeprazole 20 mg/12H, zopiclone 7.5 mg / night, iron succinyl-protein complex (FEROPLEX) 800mg / day, trazodone 100mg / night, clomethiazole (DISTRANEURINE) 2 / day, clopidogrel 75mg / day, levetiracetam 500mg / 8 hour. The patient previously received the first dose of bnt162b2 intramuscularly on 07Jan2021 at 0.3 mL, single for covid-19 immunisation. The patient experienced heart arrest on 30Jan2021 and died on 30Jan2021. They notify the Emergency Coordinating Center for sudden death. Death was certified. An autopsy was not performed. The outcome of heart arrest was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: heart arrest


VAERS ID: 1044995 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-31
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic stroke
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: OPTOVITE B12; ADIRO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021158470

Write-up: Hemorrhagic stroke; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB and received via Regulatory Authority ES-AEMPS-742671. A 91-year-old male patient received first dose of BNT162B2 (COMIRNATY, lot number: unknown) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 vaccination, (second dose via intramuscular on 04Feb2021 at 0.3 ml single for COVID-19 vaccination, as reported); acetylsalicylic acid (ADIRO, 100 mg tablet) oral from 2018 at unknown dose and frequency for an unspecified indication. Medical history included Vitamin B12 deficiency. Concomitant medications included cyanocobalamin (OPTOVITE B12) for Vitamin B12 deficiency. The patient experienced haemorrhagic stroke on 31Jan2021, the event caused the patient death (on 01Feb2021, as reported). COVID-19 has not happened. The action taken to the event for acetylsalicylic acid was not applicable. It was unknown if an autopsy was done or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1044997 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-19
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood cholesterol, Blood potassium, Blood triglycerides, Cardio-respiratory arrest, Drowning, Drug level, Haemoglobin, International normalised ratio, Laboratory test, 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), Accidents and injuries (narrow), Hostility/aggression (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: Adalimumab
Current Illness: Ventriculo-peritoneal shunt (after TBI)
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; Traumatic brain injury
Allergies:
Diagnostic Lab Data: Test Name: cholesterol; Result Unstructured Data: Test Result:246; Comments: prior to 24Nov2020; Test Date: 20210119; Test Name: cholesterol; Result Unstructured Data: Test Result:229; Test Date: 20210119; Test Name: K; Result Unstructured Data: Test Result:4.36; Test Date: 20210119; Test Name: Triglycerides; Result Unstructured Data: Test Result:139; Test Name: pharmacokinetic study of adalimumab; Result Unstructured Data: Test Result:8030; Comments: prior to 24Nov2020; Test Date: 20210119; Test Name: pharmacokinetic study of adalimumab; Result Unstructured Data: Test Result:in the therapeutic range; Test Date: 20210119; Test Name: Hb; Result Unstructured Data: Test Result:15; Test Date: 20210119; Test Name: INR; Result Unstructured Data: Test Result:0.87; Test Date: 20210119; Test Name: laboratory tests; Result Unstructured Data: Test Result:normal; Test Date: 20200311; Test Name: an antigen test for COVID-19; Test Result: Negative
CDC Split Type: ESPFIZER INC2021158463

Write-up: drowning; cardiorespiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB manufacturer report number ES-AEMPS-745520. A 43-years-old male patient received fist dose of BNT162B2 (COMIRNATY), intramuscular on 13Jan2021 at 0.3 ml, single for COVID-19 immunisation; adalimumab, subcutaneous from 26Feb2020 to 2020 at 40 mg once a day (induction 160 mg), then via an unspecified route of administration, from 08May2020 to 2020 at 40 mg/ 10 days, then from 03Nov2020 to an unspecified date at 8 mg, then from an unspecified date to 15Jan2021 at 40 mg/14 days, for Crohn''s disease. Medical history included Traumatic brain injury (TBI) from 1998, ventriculo-peritoneal bypass valve (after TBI) in 1998, Crohn''s disease from 2011. Concomitant medications were not reported. On 19Jan2021 patient went for a digestive control visit, being asymptomatic of his digestive pathology, with normal laboratory tests and with pre-dose adalimumab levels in the therapeutic range. It is decided to keep the same treatment. On 19Jan2021: cholesterol 229, Triglycerides (TG) 139, Hb 15, international normalized ratio (INR) 0.87, K 4.36 (prior to 24Nov2020: Cholesterol 246 and pharmacokinetic study of adalimumab pre-dose adalimumab levels of 8030). On 19Jan2021 they notify the medical emergency service for finding the patient submerged in a public swimming pool. Advanced CPR measures are initiated without response, first recorded rhythm: asystole. Resuscitation maneuvers were stopped when the pool cameras verified that the patient had been submerged for 30 minutes. Death due to cardiorespiratory arrest due to drowning by immersion was reported. The family is notified, which is the one that communicates the information to the digestive service. Pending autopsy by court order. Lab data included: on 11Mar2020 an antigen test for COVID-19 by contact with a possible case, which was negative. The action taken to the events for adalimumab was permanently withdrawn on 15Jan2021. It was unknown if an autopsy was done or not. Pfizer is a marketing authorization holder of adalimumab in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of adalimumab has submitted the same report to the regulatory authorities No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: drowning; cardiorespiratory arrest


VAERS ID: 1044998 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-31
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Blood alkaline phosphatase, Blood lactate dehydrogenase, Gamma-glutamyltransferase, Haemoglobin, Haemophagocytic lymphohistiocytosis, Hepatic failure, Hepatitis acute, Lymphocyte count, Multiple organ dysfunction syndrome, Neutrophil count, Pharyngotonsillitis, Platelet count, Respiratory failure, Shock, White blood cell count
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Agranulocytosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Oropharyngeal infections (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 7
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: TOCILIZUMAB; PARACETAMOL; ATROVENT; PARACETAMOL; NOLOTIL [METAMIZOLE MAGNESIUM]; PREDNISONE; NOLOTIL [METAMIZOLE MAGNESIUM]; VENTOLINE [SALBUTAMOL]; AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]; SYMBICORT; URBASON [METHYLPREDNISOLONE]; ENANTYUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; COVID-19 pneumonia (Covid-19); Esophageal candidiasis; Herpes zoster; Mononucleosis; Pharyngotonsillitis; Pollen allergy; Tuberculous pneumonia (any form)
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:880; Test Date: 20210206; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:2714; Test Date: 20210204; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:1061; Test Date: 20210206; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:4708; Test Date: 20210206; Test Name: ALK phosph; Result Unstructured Data: Test Result:79; Test Date: 20210206; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:126000; Test Date: 20210204; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:76; Test Date: 20210205; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:127; Test Date: 20210204; Test Name: Haemoglobin; Result Unstructured Data: Test Result:14; Test Date: 20210206; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11,8; Test Date: 20210204; Test Name: Lymphocytes; Result Unstructured Data: Test Result:150; Test Date: 20210206; Test Name: Lymphocytes; Result Unstructured Data: Test Result:210; Test Date: 20210204; Test Name: Neutrophils; Result Unstructured Data: Test Result:2400; Test Date: 20210206; Test Name: Neutrophils; Result Unstructured Data: Test Result:500; Test Date: 20210204; Test Name: Platelet count; Result Unstructured Data: Test Result:132000; Test Date: 20210206; Test Name: Platelet count; Result Unstructured Data: Test Result:59000; Test Date: 20210204; Test Name: WBC; Result Unstructured Data: Test Result:2700; Test Date: 20210206; Test Name: WBC; Result Unstructured Data: Test Result:800
CDC Split Type: ESPFIZER INC2021159400

Write-up: Multiple organ failure; suspected hemophagocytic syndrome; Hepatitis acute; liver failure; refractory shock; pharyngotonsillitis; respiratory failure; increased transaminases; This is a spontaneous report from a contactable physician downloaded from the Agency ES-AEMPS-747344. A 26-year-old male patient received first dose of BNT162B2 (COMIRNATY) Lot number EL1491, Intramuscular on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 pneumonia on 26Oct2020 (Bilateral pneumonia. No mechanical ventilation. Confirmed by PCR), Esophageal candidiasis in 2015, Pollen allergy in 2008, Asthma in 2008, Mononucleosis in 2015, Tuberculous pneumonia (any form) in 2003, Herpes zoster on 03Jun2011, Pharyngotonsillitis in 2015. Concomitant medications included tocilizumab from Nov2020 for COVID-19 pneumonia, paracetamol administration in hospital emergencies on 30Jan2021 and 01Feb2021, ipratropium bromide (ATROVENT) administration in hospital emergencies on 30Jan2021, paracetamol tablet from 30Jan2021, metamizole magnesium (NOLOTIL) administration in hospital emergencies on 01Feb2021, prednisone tablet from 30Jan2021, metamizole magnesium (NOLOTIL) Capsule, hard from 01Feb2021, salbutamol (VENTOLINE) from 30Jan2021, amoxicillin, clavulanic acid (AUGMENTINE) from 01Feb2021, budesonide, formoterol fumarate (SYMBICORT) from 03Nov2020, methylprednisolone (URBASON) administration in hospital emergencies on 30Jan2021, dexketoprofen trometamol (ENANTYUM) administration in hospital emergencies on 01Feb2021, and salbutamol administration in hospital emergencies on 30Jan2021. The patient started with symptoms of pharyngotonsillitis on 31Jan2021, various antibiotic treatments Amoxicillin-clavulanic, cefditoren. He developed respiratory failure and increased transaminases. Evolution with liver failure, refractory shock, Hepatitis acute, suspected hemophagocytic syndrome, Multiple organ failure on 04Feb2021. The patient was hospitalized for all events. The patient died on 07Feb2021 due to liver failure, refractory shock, Hepatitis acute, suspected hemophagocytic syndrome, Multiple organ failure. Autopsy was done. In lung biopsy and liver postmortem, HSV-1 in high quantity. The patient underwent lab tests and procedures which included alanine aminotransferase: 880 on 04Feb2021, alanine aminotransferase: 2714 on 06Feb2021, aspartate aminotransferase: 1061 on 04Feb2021, aspartate aminotransferase: 4708 on 06Feb2021, ALK phosph: 79 on 06Feb2021, Lactate dehydrogenase: 126000 on 06Feb2021, gamma-glutamyltransferase: 76 on 04Feb2021, gamma-glutamyltransferase: 127 on 05Feb2021, haemoglobin: 14 on 04Feb2021, haemoglobin: 11,8 on 06Feb2021, Lymphocytes: 150 on 04Feb2021, Lymphocytes: 210 on 06Feb2021, Neutrophils: 2400 on 04Feb2021, Neutrophils: 500 on 06Feb2021, platelet count: 132000 on 04Feb2021, platelet count: 59000 on 06Feb2021, WBC: 2700 on 04Feb2021, WBC: 800 on 06Feb2021. The outcome of pharyngotonsillitis, respiratory failure, increased transaminases was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hepatitis acute; liver failure; refractory shock; suspected hemophagocytic syndrome; Multiple organ failure; Autopsy-determined Cause(s) of Death: HSV-1


VAERS ID: 1045000 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2021-01-05
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: COVID-19; Test Result: Positive
CDC Split Type: ESPFIZER INC2021163688

Write-up: COVID-19; This is a spontaneous report from a contactable consumer. This report was downloaded from Medicines Agency (MA) regulatory authority-WEB and received via Regulatory Authority ES-AEMPS-735202. An elderly (over 65 years old) male patient received the 1st dose bnt162b2 (COMIRNATY) , via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced covid-19 (positive for COVID-19) on 05Jan2021 with outcome of fatal. The patient died on 25Jan2021. It was not reported if an autopsy was performed. The cause of death was covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1045006 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-27
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Seizure, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE HYDROCHLORIDE]; PANADOL FORTE [PARACETAMOL]; MELATONIN ORION; VENLAFAXIN KRKA; MEMANTIN ORION; AMLODIPIN ORION [AMLODIPINE BESILATE]; OPAMOX; OXYNORM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Depression; Gout; Hyperplasia of the prostate; Hypertension; Insomnia; Pain; Restlessness
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021159025

Write-up: Sudden death; sudden seizure; a sudden stroke of a brain or heart origin; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB FI-FIMEA-20210540. A 77-year-old male patient received his first dose of bnt162b2 (COMIRNATY, lot number EJ6795), intramuscular on 14Jan2021 at single dose for COVID-19 vaccination. Medical history included Alzheimer''s disease, hypertension, prostate hyperplasia, gout, depression, pain, insomnia and restlessness. Concomitant medication included cyanocobalamin, folic acid, pyridoxine hydrochloride (TRIOBE), paracetamol (PANADOL FORTE) for pain, melatonin (MELATONIN ORION) for insomnia, venlafaxine hydrochloride (VENLAFAXIN KRKA) for depression, memantine hydrochloride (MEMANTIN ORION) for Alzheimer''s disease, amlodipine besilate (AMLODIPIN ORION) for hypertension, oxazepam (OPAMOX) for restlessness and oxycodone hydrochloride (OXYNORM). The patient experienced sudden death on 27Jan2021. The patient died of a sudden seizure 13 days after the vaccination on 27Jan2021. There were no specific symptoms during or after administration of the vaccine and well-being was normal between administration and death. Sudden seizure appeared on the night of January 27, 2021, the patient was found in a semi-sitting position, gasping breathing, pale face, and no speech contact could be made with him. Shortly thereafter, he became lifeless. Resuscitation was not performed according to treatment guidelines. Underlying diseases: Alzheimer''s disease, hypertension, prostate hyperplasia, gout, depression. First dose of vaccine. Based on preliminary data and event data, reporter thought it wa unlikely that the administration of the vaccine would have resulted in death. Death compatible rather with a sudden stroke of a brain or heart origin, to which the underlying diseases were predisposing. The patient died on 27Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: sudden death; sudden seizure; a sudden stroke of a brain or heart origin


VAERS ID: 1045007 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: THYROXIN; FRAGMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Hypertension; Pancreatic cancer metastatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021159024

Write-up: General physical health deterioration/The general well-being deteriorated rapidly; This is a spontaneous report from a non-contactable other healthcare professional downloaded from the Medicines Agency (MA) Regulatory authority-WEB FI-FIMEA-20210542. An 80-year-old female patient receive BNT162B2 (COMIRNATY, lot number was EJ6134 and expiration date was unknown) via intramuscular on 27Jan2021 at single dose for COVID-19 vaccination. Medical history included extensive metastatic pancreas cancer diagnosed in Dec2020, flimmer (atrial fibrillation) and hypertension (HTA). Patient received palliative care policy. Concomitant medication included levothyroxine sodium (THYROXIN) and dalteparin sodium (FRAGMIN). Patient had general physical health deterioration on 27Jan2021. The general well-being deteriorated rapidly from the day of vaccination (27Jan2021), although even before that the general well-being had decreased. The patient died due to general well-being deteriorated on 30Jan2021. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: General physical health deterioration/The general well-being deteriorated rapidly


VAERS ID: 1045010 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tahor; KEPPRA; DIFFU K; SERESTA; METFORMIN; IMOVANE; KARDEGIC; LASILIX FAIBLE; TIAPRIDAL; EUPANTOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use (quitted); Aortic stenosis (calcified); Arterial hypertension; Epilepsy (sequelae); Fall (without sequelae, without secondary clinical modification); Hospitalisation; NIDDM; Peripheral arterial occlusive disease; Stroke (sylvian); Tobacco user (quitted)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021159139

Write-up: Death unexplained; This is a spontaneous report from a contactable physician from PHYSICIAN downloaded from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-AM20210181. A 75-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6788) intramuscular on 19Jan2021 at single dose for covid-19 immunization, and atorvastatin calcium (TAHOR) film-coated tablet oral at 1 DF once a day, levetiracetam (KEPPRA) oral at 2 DF once a day, potassium chloride (DIFFU K) oral at 3 DF once a day, oxazepam (SERESTA) oral 3 DF once a day, Metformin oral 3 DF once a day, zopiclone (IMOVANE) oral at 1 DF once a day, acetylsalicylate lysine (KARDEGIC) oral at 1 DF once a day, furosemide (LASILIX FAIBLE) oral at 1 DF once a day, tiapride hydrochloride (TIAPRIDAL) oral at 145 mg once a day, for unspecified indications. Medical history included Stroke, Arterial hypertension, NIDDM, Aortic stenosis, Peripheral arterial occlusive disease, tobacco user, alcohol use, epilepsy (sequelae), hospitalized since 19Oct2020, fall on 17Jan2021 without sequelae, without secondary clinical modification. Patient well balanced with regard to his chronic pathologies and generally stable. The patient''s concomitant medications were not reported. The patient first injected on 19Jan2021, very well tolerated, no clinical degradation. On 24Jan2021, patient found deceased, death unexplained. No autopsy, no obvious clinical or biological explanation. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1045014 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: Anticoagulant therapy; Bronchial superinfection; COPD (Severe); Fall (Repeated); Heart failure (under diuretic therapy); Major neurocognitive disorder (of vascular origin); Prostate cancer (with bone metastases); Respiratory failure (Many episodes of); Steroid dependence (Cortico-dependence)
Allergies:
Diagnostic Lab Data: Test Name: PCR test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC2021159141

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB, Regulatory authority report number FR-AFSSAPS-CN20210263. A 92-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EM0477), via intramuscular at left arm on 14Jan2021 at 0.3 mL, single for COVID-19 vaccination. The patient''s medical history included severe chronic obstructive pulmonary disease (COPD), bronchial superinfection, many episodes of respiratory failure, cortico-dependence, heart failure under diuretic therapy, prostate cancer with bone metastases, major neurocognitive disorders of vascular origin, repeated falls and anticoagulant therapy. The patient had no history of COVID-19. Patient had PCR test history with unknown results. COVID-19 risk factors included heart and respiratory failure. Allergic history was unknown. Concomitant medications were not reported. Death was observed on 16Jan2021, without signs of poor tolerance since vaccination. Patient was found dead in bed in the morning. The patient died on 16Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1045017 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic bronchitis; Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: PCR SARS-COV 2; Test Result: Positive
CDC Split Type: FRPFIZER INC2021159140

Write-up: COVID-19 aggravated/Fever/ PCR test which turns out to be positive/ suspicion of bronchitis/ deterioration of the patient''s condition; This is a spontaneous report from a contactable other HCP from the Medicines Agency (MA) regulatory authority-WEB FR-AFSSAPS-LY20210485. An 88-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6788), intramuscularly on 19Jan2021 at single dose, for covid-19 immunisation. Medical history included chronic bronchitis, autonomy: GIR 1, and living in nursing home from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Usual treatment not known. On 19Jan2021, in the morning, 1st injection of bnt162b2, after pre-vaccination consultation. At this time, no symptoms. Stable state of health throughout the day. On 20Jan2021, faced with the presence of a fever at the end of the day, he benefits from a PCR test which turns out to be positive (but the result will not be discovered by the nursing home until 23Jan2021). On 21Jan2021, prescription of antibiotics on suspicion of bronchitis. In the following days, deterioration of the patient''s condition, with several trips to / from the hospital with return to nursing home as soon as the patient''s condition stabilizes. On 28Jan2021, hospitalization. On 30Jan2021, death. COVID-19 cluster in the facility. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Jan2021. The outcome of the event was fatal. The patient died on 30Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 aggravated/Fever/ PCR test which turns out to be positive/ suspicion of bronchitis/ deterioration of the patient''s condition


VAERS ID: 1045021 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN; SERESTA; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Breast cancer NOS; Cardiac failure; Hypertension; Mitral valve replacement
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: oxygen saturation; Test Result: 74 %
CDC Split Type: FRPFIZER INC2021160040

Write-up: Death unexplained; Oxygen saturation decreased; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB FR-AFSSAPS-MA20210320. A 93-year-old female patient received first dose of bnt162b2 (COMIRNATY) (lot/batch number EJ6788), intramuscular on 28Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included cardiac failure/heart failure from an unknown date and unknown if ongoing, rhythm disturbances, bio-mitral prosthesis, left breast cancer, hypertension. Patient considered to be at risk of developing a severe form of COVID-19. Patient who did not have COVID-19. Concomitant medications included apixaban, oxazepam (SERESTA), paracetamol, mirtazepam. The patient experienced death unexplained on 02Feb2021, oxygen saturation decreased (death) on 29Jan2021. Appearance of a 74% in O2 desaturation with rapid degradation of the patient during the weekend of 30-31Jan. Unconfirmed suspicion of COVID-19 (no PCR performed). The patient died on 02Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained; Oxygen saturation decreased


VAERS ID: 1045024 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood pressure systolic decreased, Blood pressure systolic increased, Cardiac arrest, Fatigue, Hypoperfusion, Pain in jaw
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Hypertension (narrow), Cardiomyopathy (broad), Osteonecrosis (broad), Respiratory failure (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ISOPTINE; KARDEGIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial (main antecedent of hypertension treated and balanced with Isoptine 120 mg and Kardegic 75 mg)
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: blood pressure; Result Unstructured Data: Test Result:110/70 mmHg; Comments: At 10h, her blood pressure was 110/70 mmHg; Test Date: 20210202; Test Name: systolic pressure; Result Unstructured Data: Test Result:80 mmHg; Comments: her blood pressure (in self-measurement) was 80 mmHg systolic at 7 a.m.
CDC Split Type: FRPFIZER INC2021159195

Write-up: Cardiac arrest; Pain jaw; Hypoperfusion; Fatigue; 80 mmHg systolic; This is a spontaneous report from a contactable physician from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-PB20210242. A 93-year-old female patient received BNT162B2 (COMIRNATY, lot number: EK9788) first dose on 01Feb2021 intramuscular on Arm Left at single dose for COVID-19 immunisation. Medical history included Hypertension arterial (with the main antecedent of hypertension treated and balanced with Isoptine 120 mg and Kardegic 75 mg) from unspecified date and unknown if ongoing. Concomitant medication included verapamil hydrochloride (ISOPTINE) 120 mg and acetylsalicylate lysine (KARDEGIC) 75 mg, both for hypertension. Patient was described as being very active, autonomous (shopping alone), with the main antecedent of hypertension treated and balanced with Isoptine 120 mg and Kardegic 75 mg. No Covid test performed and patient not having had Covid. On 01Feb2021, she was vaccinated with COMIRNATY, the first intramuscular injection in the left arm. The day after the vaccination, on 02Feb2021, she presented with fatigue, cold hands, pain in the jaw and her blood pressure (in self-measurement) was 80 mmHg systolic at 7 a.m. At 10h, her blood pressure was 110/70 mmHg, then the patient went into cardiac arrest a few minutes later, after a first cardiac massage, her heart started again and then she had a second cardiac arrest with a sign of ischemia of the brainstem ( pronation of both upper limbs) motivating a second cardiac massage. Patient also had Hypoperfusion. After a deep breath, the patient died. It was unknown if autopsy was done. The outcome of events Pain jaw, Hypoperfusion, Fatigue was not recovered. The outcome of event 80 mmHg systolic was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1045025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cholecystitis
SMQs:, Infectious biliary disorders (narrow), Gallbladder related disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gallstones; Hypertension arterial; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021160042

Write-up: Cholecystitis; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-PB20210243. A 94-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6795), intramuscularly on 21Jan2021 at single dose for COVID-19 vaccination. Medical history included hypertension arterial, gallstones and stroke, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced cholecystitis on 30Jan2021. On 31Jan2021, cholecystitis prompting hospitalization, with fatal outcome. She had an anticoagulant for treatment (not specified), did not have Covid and did not have a test. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cholecystitis


VAERS ID: 1045028 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Alzheimer''s disease; Anxiodepressive syndrome; Behaviour disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021159196

Write-up: Intracranial haematoma; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-PO20210283. An 85-year-old female patient received her first dose of bnt162b2 (COMIRNATY, lot EJ6788), intramuscularly on left arm on 02Feb2021 at single dose for COVID-19 immunization. Medical history included Alzheimer''s disease, Anxiodepressive syndrome, behaviour disorder, atrial fibrillation (AFib). The patient''s concomitant medications were not reported. On 03Feb2021, the patient was unwell. No particular symptoms, no change in general condition or behavior between vaccination and malaise. The patient was hospitalized urgently. An intracranial hematoma was detected. The evolution was rapidly pejorative leading to the death of the patient. The report was under investigation. The patient did not have COVID-19. She had not been tested. The patient died on 03Feb2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected. Batch/lot number already obtained.; Reported Cause(s) of Death: Intracranial haematoma


VAERS ID: 1045029 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic obstructive pulmonary disease; Chronic renal failure; Constipation (Before vaccination, the patient complained of constipation, but stool in the evening); Hypertension arterial; Insulin-requiring type 2 diabetes mellitus; Prosthesis implantation; Sleep apnea syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021160041

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-RE20210233. An 87-year-old male patient received first dose of BNT162B2 (COMIRNATY, batch/lot number: EJ6788) intramuscularly in the right arm on 29Jan2021 at single dose for covid-19 immunisation. Medical history included chronic renal failure, chronic obstructive pulmonary disease, insulin-requiring type 2 diabetes mellitus (Insulin-dependent diabetes), atrial fibrillation, sleep apnoea syndrome, hypertension arterial, aortic prosthesis. Before vaccination, the patient complained of constipation, but stool in the evening. The patient''s concomitant medications were not reported. Patient was considered to be at risk of developing a severe form of the disease COVID-19, not having contracted COVID-19 and not being tested. First vaccination with BNT162B2 in the right arm on 29Jan2021. After the vaccination, watched by her daughter during the day, at her home. Nothing to report, no clinical signs. Sudden death of the patient occurred at 14:00 on 30Jan2021, at his home noted by the caregiver. The patient died on 30Jan2021. Cause of death reported as sudden death. It was not reported if an autopsy was performed. Outcome is fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1045034 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Diarrhoea, Heart rate, Hypotension, Malaise, Oxygen saturation, Oxygen saturation decreased, Respiratory depression, SARS-CoV-2 test, Septic shock, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   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: Dementia Alzheimer''s type; Hip prosthesis insertion (Total right hip replacement); Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer (right breast neoplasia); Depression
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: Blood pressure; Result Unstructured Data: Test Result:115 / 77 mmHg; Test Date: 20210204; Test Name: heart rate; Result Unstructured Data: Test Result:110 / minute; Test Date: 20210204; Test Name: desaturation; Test Result: 80 %; Comments: 80 percent desaturation; Test Date: 20210204; Test Name: desaturation; Result Unstructured Data: Test Result:91-92 %; Comments: a rise in saturation to 91-92 percent; Test Date: 20210205; Test Name: Covid-19 virus test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021159199

Write-up: septic shock; acute respiratory depression; Hypotension; Oxygen saturation decreased; Feeling sick; Diarrhea; Tachycardia; This is a spontaneous report from a contactable Physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-TO20210407. This is a report received from the Regulatory Authority. A 92-year-old female patient received her first dose of bnt162b2 (COMIRNATY, lot number EJ6788), intramuscularly on right arm on 04Feb2021 at single dose for COVID-19 vaccination. Medical history included breast cancer (right breast neoplasia), ongoing dementia alzheimer''s type, ongoing hip prosthesis insertion (Total right hip replacement), ongoing hypothyroidism, depression from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced hypotension, oxygen saturation decreased, feeling sick, diarrhea and tachycardia on 04Feb2021. Serious criteria reported as death and hospitalization for events. Faint-like discomfort with profuse diarrhea, grayish face complexion, regular tachycardia 110 / minute, 80 percent desaturation. Placed in decubitus raised legs with emergency O2 put on (3 liters / minute with nasal glasses to obtain a rise in saturation to 91-92 percent). Follow-up 30 minutes after: blood pressure 115 / 77mm Hg, Regular heartbeats 85 bpm, Stay on watch. Suspicion of Covid-19 infection negative on 05Feb2021. Hospitalized for septic shock on 06Feb2021 at a urinary call point in a context of acute respiratory depression. Implementation of antibiotic therapy with Rocephin on 06Feb2021. The patient died on 06Feb2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained.; Reported Cause(s) of Death: Hypotension; Oxygen saturation decreased; Feeling sick; Diarrhea; Tachycardia; septic shock; acute respiratory depression; Respiration failure


VAERS ID: 1045037 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type (advanced); Fibrillation atrial; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: desaturation; Test Result: 77 %
CDC Split Type: FRPFIZER INC2021160106

Write-up: Fever; 77 percent desaturation; Acute respiratory distress syndrome; This is a spontaneous report from a contactable Physician downloaded from the regulatory authority-WEB FR-AFSSAPS-TO20210500. An 89-years-old female patient started to receive bnt162b2 (COMIRNATY, lot EJ6788), intramuscular on 02Feb2021 at 1 DF, single for covid-19 immunisation. Medical history included advanced Alzheimer''s dementia, arterial hypertension, atrial fibrillation. The patient''s concomitant medications were not reported. The patient experienced fever, 77 percent desaturation, acute respiratory distress syndrome on 05Feb2021 with urgent medical intervention and palliative care, leading to death on 7Feb2021. Therapeutic measures were taken as urgent medical intervention and palliative care. The patient died on 07Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute respiratory distress syndrome; 77 percent desaturation; fever


VAERS ID: 1045038 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Circulatory collapse, Diarrhoea, Faecal vomiting, Gastrointestinal haemorrhage, Hypotension, Oxygen saturation decreased, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), 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), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   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: PROPYLEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (Anticoagulated); Dementia; Hyperthyroidism (Hyperthyroidism under propylex); TIA
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021159198

Write-up: Haemorrhage of digestive tract; Fecal vomiting; Collapse cardiovascular; Anaphylactic shock; Hypotension; Tachycardia; Oxygen saturation decreased; Diarrhea/black diarrhea; This is a spontaneous report from a contactable physician from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-TO20210508. A 90-year-old female patient received bnt162b2 (COMIRNATY) (lot no EJ6788) intramuscularly on left arm on 26Jan2021 at a single dose for COVID-19 immunisation. Medical history included hyperthyroidism under propylex, atrial fibrillation (anticoagulated), transient ischaemic attack (TIA), dementia, all unknown if ongoing. Concomitant medication included propylthiouracil (PROPYLEX) for hyperthyroidism. CLINICAL SIGNS: 28Jan2021: picture of anaphylactic shock, hypotension, tachycardia, desaturation (oxygen saturation decreased) and diarrhea. 29Jan2021: picture of digestive hemorrhage with black diarrhea and fecal vomiting, collapse (collapse cardiovascular). EVOLUTION: Death. All events were considered serious as fatal. Patient died on 29Jan2021 due to anaphylactic shock, hypotension, tachycardia, desaturation (oxygen saturation decreased), diarrhea, digestive hemorrhage with black diarrhea, fecal vomiting, collapse (collapse cardiovascular). It was unknown if an autopsy was performed or not. Reporting physician considered COVID-19 vaccination caused the death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Haemorrhage of digestive tract; Anaphylactic shock; Collapse cardiovascular; Oxygen saturation decreased; Fecal vomiting; Tachycardia; Hypotension; Diarrhea/black diarrhea


VAERS ID: 1045039 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Disease Parkinson''s; Ischaemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: General physical health deterioration (for 1 month); Living in nursing home; Myocardial infarction; Wheelchair user
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021160108

Write-up: Edema pulmonary; flare-up of heart failure; This is a spontaneous report from a contactable consumer from the Medicines Agency (MA) Regulatory authority-WEB regulatory authority number FR-AFSSAPS-TS20210221. A 91-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 21Jan2021 12:35 at single dose for covid-19 immunisation. Medical history included ongoing Ischaemic heart disease; ongoing Disease Parkinson''s; Living in nursing home (in EHPAD); myocardial infarction from 2009 and unknown if ongoing; Use a wheelchair from an unknown date and unknown if ongoing; Alteration of the general condition for 1 month. The patient''s concomitant medications were not reported. The patient experienced edema pulmonary on 23Jan2021 and died on 23Jan2021.Post-injection monitoring: no arterial hypertension. Monitoring for 48 hours: nothing to report. 23Jan2021 in the morning he did not feel well.Call from the doctor who came to see him in the morning.On arrival, there were clinical signs of the beginning of pulmonary edema. The patient received medical care but death at 4:32 p.m.In all, a fatal flare-up of heart failure on day 2 of vaccination with Comirnaty in a patient with ischemic heart disease who has had a deterioration in his general condition for 1 month. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: flare-up of heart failure; Edema pulmonary


VAERS ID: 1045309 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORIZAL PLUS; SPIRIVA; CELMANTIN; XOZAL
Current Illness: Arterial hypertension; Hyperlipidaemia
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021159093

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB GR-GREOF-20211011 and received via Regulatory Authority. An 86-year-old male patient received the first dose of bnt162b2 (COMIRNATY), lot number: EL1491, via an unspecified route of administration on 21Jan2021 at 0.3 mL, single for covid-19 immunisation. Medical history included pneumonia, ongoing arterial hypertension, ongoing hyperlipidaemia. Concomitant medications included amlodipine besilate, hydrochlorothiazide, olmesartan medoxomil (ORIZAL PLUS), tiotropium bromide (SPIRIVA), rosuvastatin calcium (CELMANTIN), levocetirizine dihydrochloride (XOZAL). The patient experienced death on 22Jan2021. The patient died on 22Jan2021. An autopsy was not performed. Serious criteria for the case was reported as fatal and medical significant. Reporter''s comments: the patient received the first dose of comirnaty on 21/1/2021. One week later his daughter called at the vaccination center and reported the patient''s death on 22/1/2021. According to the medical history he has presented pneumonia and on vaccination day he had arterial hypertension, hyperlipidaemia and was under medication (inhalation) with celmantin, orizal plus, spiriva and xozal. There was no problem during the vaccination and the patient was discharged from the vaccination center by the protocol. Clinically he was in very good condition. He didn''t present adverse reaction at the vaccination center. Sender''s comments: On 8/2/2021 the national organization received the first information. On 1/2/2021 started the investigation. On 9/2/2021 the case was examined by the national pharmacovigilance committee/working group. Initial report with additional information. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The patient received the first dose of comirnaty on 21/1/2021. One week later his daughter reported the patient''s death on 22/1/2021. According to the medical history he has presented pneumonia and on vaccination day he had arterial hypertension, hyperlipidaemia and was under medication (inhalation) with celmantin, orizal plus, spiriva and xozal. There was no problem during the vaccination and the patient was discharged from the vaccination center by the protocol. Continued in narraitve; Reported Cause(s) of Death: death


VAERS ID: 1045321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypotension, Melaena
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Gastrointestinal haemorrhage (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Cognitive impairment; Hospitalization (patient was a long stay resident); Hyperlipidemia; Hypernatremia; Hypertension; Normal pressure hydrocephalus; Panic attack; Peptic ulcer disease; Vertigo
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021158957

Write-up: HYPOTENSIVE; MELAENA; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB (IE-HPRA-2021-065097). An 86-year-old female patient received the first dose of bnt162b2 (COMIRNATY) on 14Jan2021 at a single dose for COVID-19 immunisation. Medical history included panic attack, hypernatremia, vertigo, anxiety, hypertension, peptic ulcer disease, hyperlipidemia, normal pressure hydrocephalus, cognitive impairment. Since 2009, the patient was a long stay resident. The patient''s concomitant medication was not outlined at the time of reporting. On 16Jan2021, the patient became hypotensive and developed melaena. The patient was treated conservatively. On 23Jan2021, the patient died. Cause of death was reported as hypotensive and melaena. The reporting physician outlined that the patient''s death was more coincidental than a reaction and the patient''s death was only reported due to the proximate time interval to the vaccine. The case was reported to the coroner who requested an autopsy. The reporting physician commented that had the patient not received the vaccine, the deterioration would have been treated the same way but she would not have had coroner involvement or the autopsy. The outcome of the events was fatal. An autopsy was cone but autopsy results was not available. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected. ; Reported Cause(s) of Death: MELAENA; HYPOTENSIVE


VAERS ID: 1045359 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, Regurgitation, Somnolence, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   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: BISOPROLOL HEMIFUMARATE; TAREG; TAVOR [LORAZEPAM]; LASITONE; ELIQUIS; LASIX [FUROSEMIDE]; CACIT VITAMINA D3; PANTOPRAZOLE SODIUM SESQUIHYDRATE; ALENDRONATE SODIUM; PAROXETINE; TACHIDOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Decompensation cardiac; Depression; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021158456

Write-up: Regurgitation after dinner in the evening of vaccination day. Muscle pain and drowsiness already pre-existing to vaccination have been reported. Episode of bilious vomiting on the 30Jan following day death; Regurgitation after dinner in the evening of vaccination day. Muscle pain and drowsiness already pre-existing to vaccination have been reported. Episode of bilious vomiting on the 30Jan following day death; Regurgitation after dinner in the evening of vaccination day. Muscle pain and drowsiness already pre-existing to vaccination have been reported. Episode of bilious vomiting on the 30Jan following day death; Regurgitation after dinner in the evening of vaccination day. Muscle pain and drowsiness already pre-existing to vaccination have been reported. Episode of bilious vomiting on the 30Jan following day death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-673481. A 92-year-old female patient received BNT162B2 (COMIRNATY; Lot number EJ6797), intramuscular in the left arm on 25Jan2021 as the first single dose for covid-19 immunisation. Medical history included atrial fibrillation, decompensation cardiac, depression and hypertension from unknown dates and unknown if ongoing. Concomitant medication included bisoprolol fumarate (BISOPROLOL HEMIFUMARATE), valsartan (TAREG), lorazepam (TAVOR), furosemide, spironolactone (LASITONE), apixaban (ELIQUIS) , furosemide (LASIX), calcium carbonate, colecalciferol (CACIT VITAMINA D3), pantoprazole sodium sesquihydrate (MANUFACTURER UNKNOWN), alendronate sodium (MANUFACTURER UNKNOWN), paroxetine (MANUFACTURER UNKNOWN), codeine phosphate, paracetamol (TACHIDOL). On 26Jan2021, the patient experienced regurgitation after dinner in the evening of vaccination day. muscle pain and drowsiness already pre-existing to vaccination have been reported. episode of bilious vomiting on the 30Jan following day death. The events were serious as it lead to death. An end date of the events was reported as 31Jan2021. The patient died on 31Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Waiting for the clinical report and the indication of the lot number; Reported Cause(s) of Death: Regurgitation after dinner in the evening of vaccination day. Muscle pain and drowsiness already pre-existing to vaccination have been reported. Episode of bilious vomiting on the 30Jan following day death


VAERS ID: 1045454 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Cardiac arrest, Malaise, Myalgia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MACROGOL; ENALAPRIL; ELIQUIS; CRANBERRY
Current Illness: Hospitalization
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:unknown results; Test Date: 20210203; Test Name: Body temperature; Result Unstructured Data: Test Result:increased
CDC Split Type: NLPFIZER INC2021158432

Write-up: dead on 05Feb2021, Acute cardiac arrest was considered the cause of death; Did not feel fit/malaise; Muscle pain/Myalgia; Subfebrile complaints/body temperature increased; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB regulatory authority number NL-LRB-00439119. An 88-year-old female patient received bnt162b2 (COMIRNATY, batch/lot: EM0477), via an unspecified route of administration on 02Feb2021 at single dose for covid-19 vaccination. Medical history included ongoing staying at a psychogeriatric ward. Concomitant medication included macrogol, enalapril tablet 10mg, apixaban (ELIQUIS) Film-coated tablet 5 mg, cranberry. The patient was staying at a psychogeriatric ward and experienced myalgia, body temperature increased and malaise on 03Feb2021, which had recovered the following day. Event details: The patient had subfebrile complaints the day after vaccination (03Feb2021) and did not feel fit; also had some muscle pain. The day after (04Feb2021), there was no fever and she was not sick. She was found dead in bed in the morning on 05Feb2021. Acute cardiac arrest was considered the cause of death for external examination. The patient underwent lab test included body temperature on an unspecified date with unknown results. The patient recovered from body temperature increased, malaise, and myalgia on 04Feb2021, and the outcome of cardiac arrest was fatal. The patient died on 05Feb2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Acute cardiac arrest


VAERS ID: 1045455 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic bronchitis; Diabetes mellitus non-insulin-dependent; Heart failure; Insufficiency renal (moderate renal insufficiency)
Preexisting Conditions: Medical History/Concurrent Conditions: Agitated (Patient was improving, but to what extent by which day is not clear); Bladder infection; Breast ductal carcinoma (declared "clean" in same year as diagnosis); Confusion (Patient was improving, but to what extent by which day is not clear); Consciousness decreased (Patient was improving, but to what extent by which day is not clear); Food refusal; Thrombosis leg
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: CT scan (brain); Result Unstructured Data: Test Result:unknown result; Comments: sent home; Test Date: 20210127; Test Name: COVID-19 test; Result Unstructured Data: Test Result:negative
CDC Split Type: NLPFIZER INC2021158436

Write-up: Her death on 05Feb2021 unexpected; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, Regulatory authority number NL-LRB-00441023. A 93-year-old female patient received BNT162B2 (COMIRNATY, Lot number: EJ6134) at single dose for COVID-19 immunization on 02Feb2021. Medical history included Breast ductal carcinoma in 1999 (declared "clean" in same year as diagnosis), chronic bronchitis, diabetes mellitus non insulin dependent, insufficiency renal, thrombosis leg, heart failure, bladder infection (Urinary tract infection) since 24Jan2021, confusion, agitated on 25Jan2021, food refusal, consciousness decreased since 27Jan2021. Relevant concomitant drugs were unknown. Past drug therapy included glimepiride tablet 1mg for Non-insulin-dependent diabetes mellitus, metformin tablet 500mg for Non-insulin-dependent diabetes mellitus, rivaroxaban tablet 20mg, pantoprazole tablet gastro-resistant 20mg, metoprolol tablet 100mg, isosorbide mononitrate tablet 20mg, ramipril tablet 10mg, bumetanide, beclerolometasone / formoterolometasone / formoterolometasone powder 100 / 6ug / dose, amoxicillin / clavulanic acid tablet 500 / 125mg, Xarelto for DVT prophylaxis, Foster inhalatie powder 100/6UG/DOSE, promocard, augmentin for Urinary tract infection since 24Jan2021. This 93-year old woman living indecently, with her daughter, needed more care over the past 3 months, but still did housework herself, eg ironing. Nine days prior to vaccination patient had fell ill, suspected urinary tract infection treated with amoxicillin / clavulan. Next day (GP home visit): confused and agitated., 2 days after (6 days prior to vaccination) that: refuses to eat and drink (including any medication), consciousness decreased, delirium. The patient was taken to Emergency: extensively tested, including CT scan of head, COVID test negative, sent home. 2 days later (4 days prior to vaccination) restarted taking glimeperide, xarelto, pantopraxol. As heart rhythm and blood pressure stayed within limits other medication not restarted at this point. Patients condition fluctuates but got increasingly better, back to eating lunch at the table. Day after vaccination was a good day and physician proposed to lower the frequency of house calls. Day 3 after vaccination found death (sudden death). Physician''s opinion on relationship with vaccination: ''we will never know''. Comments: This 93 year old was vaccinated with the Pfizer vaccine on 2-2-2021. (batch number: EJ6134) Her death on 05Feb2021 unexpectedly. She was a 93 year old woman living independently together with her daughter, single. In 1999 duct carcinoma and 1999 declared ''clean''. For years chronic bronchitis, requiring inhalation therapy. Also known with diabetes mellitus 2 and moderate renal insufficiency. Leg thrombosis and decompensation Cordis. Some inconveniences not contributing further. Medication: glimepiride and metformin. Xarelto and pantoprazole. Metoprolol, promocard, ramipril and bumetanide.Foster inhalation. On 24Jan she became ill and got augmentin from the General practice center doctor due to an alleged bladder infection. She became more in need of care in the last 3 months but did some things herself such as ironing. 25Jan home visit, confused and angry. 26Jan staying at home and letting nature take its course. 27Jan drinking and not eating and not being able to take medication. Emergency department assessment: Delirium, lowered consciousness. Completely checked up to CT brain with unknown result, Covid (-). Back home to fix up. 29Jan restart on the basis of the blood sugars glimepiride and xarelto. Pantoprazole also Other medications based on blood pressure and pulse. Because these values remained good, no restart has been done. The days after changing getting better and at the table before lunch. 03Feb suggested a good day and reduction of home visits. Vaccinated the day before. (EJ6134) Found 05Feb dead in the morning. You can see from the report that she was recovering. I dare not say whether the vaccine was the cause. Years ago an 80-year-old woman was vaccinated (flu), who was found dead and healthy the next day. I then passed that case on to regulatory authority. Conclusion: We will never know whether the death was caused by the vaccination. The woman had been ill. Died not following the vaccination. Hence my report, so that you and society can benefit from it. Don''t register, you don''t know. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: We will never know whether the death was caused by the vaccination. The woman had been ill. Died not following the vaccination. Hence my report, so that you and society can benefit from it. Don''t register, you don''t know.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1045456 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENALAPRIL MALEATE
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT scan of the brain; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021158442

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00441065. Safety Report Unique Identifier is NL-LRB-00442329. An 86-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunisation. Medical history included ongoing hypertension. Concomitant medication included enalapril maleate (MANUFACTURER UNKNOWN). The patient experienced cerebral haemorrhage on 06Feb2021, which was serious as it lead to death. The event occurred 3 hours after vaccination. The patient underwent lab tests and procedures which included CT scan of the brain with unknown results on an unspecified date. The patient died on 06Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no cerebral haemorrhage Additional information ADR: A few hours after the vaccination, this patient had a brain haemorrhage, which was so great that the patient died from it. There were no more treatment options. BSN available: yes confounding factors confounding factors: hypertension COVID19 Previous COVID-19 infection: No Other diagnostic procedures: CT scan of the brain; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1045457 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FERROFUMARAAT; FOLIUMZUUR; LORAZEPAM; CLOPIDOGREL
Current Illness: Estimated glomerular filtration rate decreased (33 ml/min)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Estimated glomerular filtration rate; Result Unstructured Data: Test Result:33 ml/min; Comments: decreased
CDC Split Type: NLPFIZER INC2021158437

Write-up: Sudden death; This is a spontaneous report received from a contactable Physician, downloaded from the Regulatory Authority NL-LRB-00441525. A male aged 91 years received BNT162B2 (COMIRNATY, Lot number EM0477) on 30Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing estimated glomerular filtration rate decreased (33 ml/min). Concomitant medications included ferrofumaraat, clopidogrel, folic acid (FOLIUMZUUR), lorazepam. Physician reported that patient suffered from constipation, but was treated and recovered (as reported). Patient died after that. The patient suddenly passed away on 02Feb2021. The cause of death was suddenly passed away. It was unknown whether autopsy was done. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Suddenly passed away


VAERS ID: 1045458 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOL; ZOLPIDEM; LOPERAMIDE; FOLIUMZUUR; SOTALOL; CITALOPRAM; FUROSEMIDE
Current Illness: Cardiac disorder; Vascular dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Tuberculosis
Allergies:
Diagnostic Lab Data: Test Name: lab; Result Unstructured Data: Test Result:55
CDC Split Type: NLPFIZER INC2021158439

Write-up: Sudden death; This is a spontaneous report received from a contactable Physician, downloaded from the regulatory authority NL-LRB-00441531. An 82-year-old female patient received bnt162b2 (COMIRNATY, lot number EM0477), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunisation. Medical history included tuberculosis, ongoing cardiac disorder, ongoing vascular dementia. Concomitant medication included omeprazole (OMEPRAZOL), zolpidem, loperamide, folic acid (FOLIUMZUUR), sotalol, citalopram and furosemide. The patient experienced sudden death on 29Jan2021. The patient underwent lab tests and procedures which included eGFR (glomerular filtration rate): 55 on unknown date. The patient was found deceased on the toilet the day after vaccination. Reported other possible cause was suspicion of colon malignity. The patient died on 29Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death; suspicion of colon malignity


VAERS ID: 1045461 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Blood glucose, Blood pressure measurement, Body temperature, C-reactive protein, Cough, Heart rate, Oxygen saturation, Pyrexia, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OLANZAPINE TEVA; LAXOBERAL; WELLBUTRIN Retard; LACTULOSE MIP; DUROGESIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure; Atrial fibrillation (ATRIAL FIBRILLATION AND FLUTTER); Cardiac failure; Depression; Hypertension; Living in nursing home; Reduced general condition (Reduced general condition for some time but had been up and around. The symptoms that started the day after vaccination (2nd dose) were new.)
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: Blood glucose; Result Unstructured Data: Test Result:6,5; Test Date: 20210128; Test Name: Blood pressure; Result Unstructured Data: Test Result:121/83; Test Date: 20210128; Test Name: Body temperature; Result Unstructured Data: Test Result:36,9; Test Date: 20210130; Test Name: Body temperature; Result Unstructured Data: Test Result:39,4; Test Date: 202101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:22; Test Date: 20210128; Test Name: Pulse rate; Result Unstructured Data: Test Result:85; Test Date: 20210128; Test Name: Oxygen saturation; Test Result: 88 %; Test Date: 20210128; Test Name: Respiratory rate; Result Unstructured Data: Test Result:12
CDC Split Type: NOPFIZER INC2021158452

Write-up: FEVER; ACUTE COUGH; APNOEA; This is a spontaneous report from a contactable health Professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is NO-NOMAADVRE-FHI-2021-Uj5xz. Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014817. An 85-year-old male patient received BNT162B2 (COMIRNATY; Lot number EM0477), intramuscular on 27Jan2021 as single dose for covid-19 immunisation. Medical history included Living in nursing home, cardiac failure, hypertension, acute renal failure, reduced general condition (reduced general condition for some time but had been up and around. The symptoms that started the day after vaccination (2nd dose) were new), depression and atrial fibrillation (atrial fibrillation and flutter), from unknown dates. Concomitant medication included olanzapine (OLANZAPINE TEVA), sodium picosulfate (LAXOBERAL), bupropion hydrochloride (WELLBUTRIN RETARD), lactulose (LACTULOSE MIP), fentanyl (DUROGESIC). The patient experienced apnoea on 28Jan2021, acute cough on 28Jan2021, fever on 30Jan2021. The patient underwent lab tests and procedures which included blood glucose: 6,5 on 28Jan2021, blood pressure measurement: 121/83 on 28Jan2021, body temperature: 36,9 on 28Jan2021, body temperature: 39,4 on 30Jan2021, c-reactive protein: 22 on Jan2021, heart rate: 85 on 28Jan2021, oxygen saturation: 88 % on 28Jan2021, respiratory rate: 12 on 28Jan2021. The patient died on 31Jan2021. It was not reported if an autopsy was performed. Details were as follows: the day after being administered the second dose of BNT162B2, the patient developed acute cough/mucus production and short episodes of apnea with slight twitches. The body temperature was normal, but he became increasingly febrile two days later. He then also stopped eating, got breathing problems, became less conscious and died in the evening on day 4 after the vaccination. The patient was multimorbid and living in a nursing home. He had reduced general condition for some time, but had been up and around. The symptoms that started on the day after the second vaccination were new. Vascular disease has been stated as the cause of death. An ADR report has been submitted since the symptoms started the day after the vaccination. Sender''s Comments: Fever is a known side effect after vaccination. It cannot be ruled out that the vaccine has contributed to any of the symptoms the patient experienced the day after the patient had received the second dose. Causal connection with the further course is more difficult to assess. When vaccinating marginal patients with underlying diseases and risk factors for disease, some serious events, including acute illness and / or death, may occur relatively shortly after vaccination, without any connection to vaccination. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: VASCULAR DISORDER


VAERS ID: 1045462 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BNT03 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Nausea, Pallor, Restlessness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Frailty; Living in care (DNR code)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021158454

Write-up: They were not a visible side effect. The patient received vaccine 28Jan2021 second dose of vaccine. Deaths 03Feb2021. Just suspected possible side effect. Not sure .; slightly nauseous; unease/restless; acute breathing difficulties; pale; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (NO-NOMAADVRE-FHI-2021-Uny5z and NO-NOMAADVRE-E2B_00014868). A 92-year-old female patient received the second dose of BNT162B2 (COMIRNATY; Lot number: BNT03), intramuscularly in the right arm, on 28Jan2021 at a single dose for COVID-19 vaccination. Medical history included living in care (do not resuscitation (DNR) code) and frail. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY) in Jan2021 for COVID-19 immunization; the patient had no complications after the first dose of Comirnaty three weeks before, but it is stated in the report that she was frail (DNR code). The patient experienced acute breathing difficulties and pale in 2021 and felt slightly nauseous and unease/restless on 02Feb2021. It was reported that on 03Feb2021: they were not a visible side effect. The patient received vaccine 28Jan2021 second dose of vaccine. Deaths 03Feb2021. Just suspected possible side effect. Not sure. The event was reported as fatal. The clinical course was reported as follows: The patient developed acute breathing difficulties, got pale and died six days after being administered the second dose. On the day before death, she had been slightly nauseous and unease, but any possible adverse reactions had not been observed. The patient had no complications after the first dose of three weeks before, but it is stated in the report that she was frail (DNR code). The clinical outcome of acute breathing difficulties, pale, slightly nauseous, and unease/restless was unknown. The patient died on 03Feb2021. The cause of death was not reported. It was not reported if an autopsy was performed. The reporter suspects causality between the vaccine and the death but was not certain. Sender''s Comment: Background: Several cases have been reported in which elderly, frail patients have died after vaccination against Covid-19. When vaccinating marginal patients with underlying diseases and risk factors for disease, some serious events, including acute illness and / or death, may occur relatively soon after vaccination, without any connection to vaccination. It is difficult to imagine how this vaccine will cause sudden difficulty breathing six days after vaccination, and without other concomitant symptoms, as in the present case. This suggests that the symptoms had another cause. The report contains relatively little information, but according to international criteria, the causal link with vaccination is still considered possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the message is classified as serious. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: DEATH


VAERS ID: 1045465 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: Cognitive impairment; Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210131; Test Name: C-reactive protein; Result Unstructured Data: Test Result:About 90-94
CDC Split Type: NOPFIZER INC2021158458

Write-up: CRP was about 90-94; GENERAL PHYSICAL CONDITION DECREASED; This is a spontaneous report from a contactable nurse downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uq7ng, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014862. A 103-years-old female patient received the second dose of bnt162b2 (COMIRNATY, lot# EM0477), intramuscular at left arm on 28Jan2021 11:35 at single dose for covid-19 immunization. Medical history included living in nursing home and cognitive failure. The patient''s concomitant medications were not reported. The patient experienced general physical condition decreased on 29Jan2021 with outcome of fatal. The clinical course was reported as follow: patient was reduced on 29Jan2021, denied food and drink, on 31Jan2021 she was no longer contactable and was put on palliative care, died 01Feb2021 at 22:35. The nurse was asked by the doctor to report the event due to strong time relation to the vaccine. After vaccine the patient had no nausea or fever. No infection sign before 31Jan2021, then CRP was about 90-94 with outcome of unknown. The patient underwent lab tests included c-reactive protein: about 90-94 on 31Jan2021. The patient died on 01Feb2021. It was not reported if an autopsy was performed. Sender''s Comment: When vaccinating patients with frailty who are ill with underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or something else incidental, at the same time a cause that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal relationship with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is also classified as serious, even though a causal link between the vaccine and the death has not been established. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: GENERAL PHYSICAL CONDITION DECREASED


VAERS ID: 1045495 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood sodium, Fatigue, General physical health deterioration, Hypernatraemia
SMQs:, Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Cognitive impairment; Fibrillation cardiac NOS; Multimorbidity
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: blood sodium; Result Unstructured Data: Test Result:153
CDC Split Type: SEPFIZER INC2021158459

Write-up: Hypernatremia; Reduced general condition; more tired; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, Regulatory Authority number SE-MPA-2021-002838. Other case identifier number SE-MPA-1612528958083. A 91-year-old female patient received second dose of bnt162b2 (COMIRNATY, lot# EJ6795) via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunisation. Medical history included multimorbidity, fibrillation cardiac NOS, cardiac failure, cognitive impairment. The patient had been walking shorter distances with a walker. Concomitant medication included apixaban (ELIQUIS). No previous drug reactions. The day after the patient received dose 2 of the vaccination, she became more tired and was bedridden. Ate and drank were ok. Vital parameters were stable. Nine days after vaccination, lab of Na was 153, otherwise essentially were ok. The patient developed reduced general condition and hypernatremia in Jan2021. The patient became increasingly tired and died quietly about 2 weeks after the vaccination with bnt162b2. Cause of death was reduced general condition and hypernatremia. It was not reported if an autopsy was performed. The outcome of event fatigue was unknown, outcome of events reduced general condition and hypernatremia was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Reduced general condition; Hypernatremia


VAERS ID: 1045496 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute left ventricular failure, Arrhythmia, Myocardial infarction, Pulmonary artery thrombosis, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Pulmonary embolism; Type 2 diabetes mellitus; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021151993

Write-up: Pulmonary artery thrombosis; acute left ventricular failure; pulmonary edema; arrhythmia; myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-003041. Other case identifier number SE-MPA-1612771616648. A 78-years-old female patient received bnt162b2 (COMIRNATY, Batch/lot number: EJ6134), intramuscular on an unspecified date in Jan2021 at 0.3 mL single dose for covid-19 immunisation. Medical history included vascular dementia, type 2 diabetes mellitus, hypertension, pulmonary embolism, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. According to the reporter the woman died of cardiac stress (left ventricular failure with pulmonary edema, arrhythmia or myocardial infarction can not be ruled out, according to the reporter) secondary to thrombosis in the pulmonary artery, three days after the vaccination with bnt162b2 in Jan2021. Indicated cause of death: acute left ventricular failure. The events outcome was fatal. It was not reported if an autopsy was performed. The report was assessed as serious, death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: myocardial infarction; arrhythmia; Acute left ventricular failure; thrombosis in the pulmonary artery; pulmonary edema


VAERS ID: 1045497 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Coma scale, Depressed level of consciousness, Head injury, Heart rate, Heart rate decreased, Hypothermia, Investigation
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (severe)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: body temperature; Result Unstructured Data: Test Result:34 Centigrade; Comments: four days later; Test Date: 202101; Test Name: RLS; Result Unstructured Data: Test Result:lowered RLS; Test Date: 202101; Test Name: heart rate; Result Unstructured Data: Test Result:low; Test Date: 202101; Test Name: head examination; Result Unstructured Data: Test Result:superficial head injury
CDC Split Type: SEPFIZER INC2021151994

Write-up: Hypothermia/the temperature was 34 degrees; lowered RLS; low heart rate; superficial head injury; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-003055. Other case identifier number SE-MPA-1612780626657. An 82-year-old female patient received second dose of bnt162b2 (COMIRNATY, lot number EJ6134) intramuscular in Jan2021 at single dose for COVID-19 immunisation. Medical history included severe dementia and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY, lot number EJ6795) in Dec2020 and dose two 21 days later in Jan2021. Two days after dose two was given in Jan2021, the patient collapsed and was then examined in the emergency room with a low heart rate and a superficial head injury. Four days later the temperature was 34 degrees (hypothermia) with lowered RLS in Jan2021. The patient died due to hypothermia 17 days after vaccination two was given in 2021. The outcome of event hypothermia was fatal; of other events was unknown. Event hypothermia was assessed as serious, Death by the reporter. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hypothermia


VAERS ID: 1045498 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD; Asperger''s disorder; Chronic obstructive pulmonary disease; Congenital oesophageal anomaly; Hepatitis C; Pulmonary fibrosis; Respiratory congenital anomaly; Right ventricular failure
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:38 degrees
CDC Split Type: SEPFIZER INC2021158460

Write-up: Breathing difficult; Fever; tiredness; This is a spontaneous report from a contactable nurse downloaded from the Regulatory Authority, Regulatory Authority number SE-MPA-2021-003068. Other case identifier number SE-MPA-1612791403816. A 47-year-old female patient received the first dose of bnt162b2 (COMIRNATY) (Batch/lot number: EJ6134) intramuscularly in Jan2021 at 0.3ml single for COVID-19 immunisation. Medical history included congenital oesophageal anomaly, respiratory congenital anomaly, chronic obstructive pulmonary disease, pulmonary fibrosis, attention deficit hyperactivity disorder (ADHD), Asperger''s disorder, hepatitis C, right ventricular failure, all unknown if ongoing. Concomitant medications were not reported (Current medication list was missing). Patient developed fever and breathing difficult in Feb2021. According to the reporting nurse the woman (patient), five days after the vaccination with Comirnaty, developed tiredness, fever (38 degrees) and difficulty breathing in Feb2021. The woman herself called an ambulance, she was given Alvedon and Ventoline and booked an appointment at the health center the following day. The next morning, the woman was found dead on the floor of her home (Feb2021). It was not reported if an autopsy was performed. Report assessed the events as serious, Death.; Reported Cause(s) of Death: Breathing difficult; Fever; tiredness


VAERS ID: 1045499 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: SEPFIZER INC2021158469

Write-up: Fever; Oxygen saturation decreased; Cough; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-003137. Other case identifier number SE-MPA-1612828705321. An 85-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation. Medical history included dementia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient developed fever, oxygen saturation decreased, cough in Jan2021. The reaction occurred the day after the first vaccination with bnt162b2. Other possible causes of the side effect, according to the consumer: "COVID-19, but there was a visit stop at the special home care living, and no infection in residents/staff". The time relationship between the date of the vaccination with bnt162b2 and the death was not stated in the report. There was no further information about the death in the report. Therapeutic measures were taken as a result of all events. The patient died in 2021. It was not reported if an autopsy was performed. Outcome of events were fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fever; Oxygen saturation decreased; Cough


VAERS ID: 1045500 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Death, Peripheral swelling, Seizure
SMQs:, Cardiac failure (narrow), Angioedema (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic subdural hematoma; Fibrillation cardiac NOS; Hypertension; Myocardial infarct; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021158466

Write-up: Died after vaccination; repeated absence attacks that turned into seizures; Heart failure; Swollen legs; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-003164. Other case identifier number SE-MPA-1612855306187. A 79-year-old male patient received bnt162b2 (COMIRNATY) (Batch/lot number: EJ6796) intramuscularly in Jan2021 at 0.3 ml single for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, cardiac fibrillation, hypertension, chronic subdural hematoma and a previous myocardial infarction. Concomitant medications were not reported. The reported adverse reaction is died in Jan2021 after vaccination. The patient began to have repeated absence attacks that turned into seizures, became uncontactable. Swollen legs. Heart failure was suspected. Treatment with Furix given. They deduced this to previous myocardial infarction and cardiac fibrillation. As well as the absence attacks to his subdural hematoma. However, it is unclear whether any of the above may have been exacerbated by vaccination, the reporter states. The outcome of events repeated absence attacks that turned into seizures, Swollen legs, Heart failure was unknown. The patient died 16 days after Comirnaty. It was unknown if an autopsy was performed or not. Report assessed event died after vaccination as serious, death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1045502 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Crepitations, Death, Decreased appetite, Diarrhoea, Dyspnoea, Fatigue, Pyrexia, Urine output decreased
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRTAZAPINE; MEMANTINE; RISPERDAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021158461

Write-up: Death for unknown reason; Slight fever; Decreased appetite; Loose stools; urine volume decreased (she also had a decreased fluide intake); more tired; slight dyspnoea; crackles; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-003234. Other case identifier number SE-MPA-1612867407348. An 80-year-old female received bnt162b2 (COMIRNATY, Expiration Date unknown) second dose in Feb2021 (Lot Number EJ6136) and first dose in Jan2021 (Lot Number EL1484), both via Intramuscular at 0.3ml single dose for COVID-19 immunisation. The patient''s medical history included dementia Alzheimer''s type and unknown if was ongoing. The concomitant medications included mirtazapine from 28Jan2019 to Feb2021; memantine from 06Aug2019 to Feb2021; risperidone (RISPERDAL) from 12Oct2019 to Feb2021. Patient developed decreased appetite, slight fever and loose stools the day after first dose in Jan2021. She got better but a few days before the second dose Comirnaty (21 days after 1st dose) patient got worsened with decreased appetite, stopped eating, urine volume decreased (she also had a decreased fluide intake) that continued after the second dose. The woman got more tired, had a slight dyspnoea and crackles the last days. Dies calmly four days after the second dose Comirnaty. During her last days patient also received single dose of morphine and Robinul. The MPA will request further information. The outcome of events was fatal. Unknown if autopsy had been done. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: decreased appetite; fever; loose stools; urine volume decreased; tiredness; dyspnoea; crackles; unknown cause of death


VAERS ID: 1045506 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood sodium, Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Diabetes; Hypertension; Parkinson''s disease; Renal failure; Rheumatic disorder
Allergies:
Diagnostic Lab Data: Test Name: Creatinine value; Result Unstructured Data: Test Result:worsened; Test Name: Sodium value; Result Unstructured Data: Test Result:worsened
CDC Split Type: SEPFIZER INC2021158468

Write-up: Diarrhoea; Vomiting; This is a spontaneous report from a contactable nurse downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-003489. Other case identifier number SE-MPA-1613029319186. An 80-year-old male patient started to receive bnt162b2 (COMIRNATY) Batch/lot number: EJ6134, intramuscular in Jan2021 at single dose for covid-19 immunisation. Medical history included Alzheimer''s disease from an unknown date and unknown if ongoing, Renal failure from an unknown date and unknown if ongoing , diabetes from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, parkinson''s disease from an unknown date and unknown if ongoing, rheumatic disorder from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced diarrhoea and vomiting in Jan2021. Man with gradually deteriorating general condition due to severe kidney failure and dementia. Expected palliative care. Blood samples was taken before vaccination. The test results arrived after vaccination and showed worsened Creatinine value and a high Sodium value. The patient was tired and exhausted, did not receive food and drink. The man died four days after the vaccination was given. The patient underwent lab tests and procedures which included blood creatinine: worsened, blood sodium: worsened. The patient died in 2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Diarrhoea; Vomiting


VAERS ID: 1048218 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure diastolic, Blood pressure systolic, Body temperature, Fatigue, Gait disturbance, Heart rate, Hypophagia, Hypotonia, Marasmus, Oxygen saturation, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   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; MOLAXOLE
Current Illness: Alzheimer''s disease; Aortic valve stenosis; Atrial flutter; Bee sting hypersensitivity (Bee sting allergy); Chronic atrial fibrillation (chronic atrial fibrillation arrhythmia); Conduct behaviour disorder (other organ. Personality and behavioral disorders since 04Jul2017); Delusion (delusional disorder since 04Jul2017); Dysphagia; Hearing loss; Osteoporosis; Personality disorder (other organ. Personality and behavioral disorders since 04Jul2017)
Preexisting Conditions: Medical History/Concurrent Conditions: Fall (Fall on 31Oct2019); Joint arthroplasty; Subarachnoid haemorrhage (Smallest subarachnoid hemorrhage on the left frontal)
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: Diastolic blood pressure; Result Unstructured Data: Test Result:60 mmHg; Test Date: 20210206; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:110 mmHg; Test Date: 20210206; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Test Date: 20210206; Test Name: Heart rate; Result Unstructured Data: Test Result:99; Comments: CPM; Test Date: 20210206; Test Name: Oxygen saturation; Test Result: 93 %; Test Date: 20210206; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: ATPFIZER INC2021159812

Write-up: patient died on 07Feb2021 from Marasmus; powerless; Fatigue; limp; Floppy; reduced oral intake; This is a spontaneous report from other healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB AT-BASGAGES-2021-01701 and received via Regulatory Authority. A 91-year-old female patient received the second dose of BNT162B2 (COMIRNATY, batch/lot number: EJ6136), Intramuscular at single dose on 04Feb2021 for COVID-19 immunisation. The patient''s medical history and concurrent conditions included ongoing other organ. Personality and behavioral disorders since 04Jul2017, ongoing delusional disorder since 04Jul2017, ongoing Alzheimer''s disease since 04Jul2017, ongoing Hearing loss since 04Jul2017, Atrial flutter and atrial fibrillation since 04Jul2017, Smallest subarachnoid hemorrhage on the left frontal since 20Feb2019 and unknown if ongoing, ongoing chronic atrial fibrillation arrhythmia since 07May2019, ongoing Aortic valve stenosis since 07May2019, ongoing Osteoporosis since 07May2019, Fall on 31Oct2019, ongoing Dysphagia since 06May2020 and ongoing Bee sting allergy. Above all, paradoxical moderate to high-grade aortic valve stenosis with a BSA of 1 cm since 05May2019; Mainly right occipital hemorrhage since 20Feb2019; VLC frontalis right and VLC occipitalis since 20Feb2019; VLC reg frontal since 31Oct2019; VLC min intranasal dext, fract dent 1., 1.2, 1.3 since 12Aug2020; VLC reg periorb dext since 31Oct2019; Presence of orthopedic. Joint implants since 04Jul2017. Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOLAXOLE) for obstipation from 22Aug2019, rivaroxaban (XARELTO) from 04Mar2019 to 03Feb2021 and then from 05Feb2021 for Atrial fibrillation. The patient previously received the first dose of BNT162B2 (COMIRNATY) for COVID-19 immunisation on 14Jan2021. At the time of vaccination there were no signs of infection. A rapid antigen test was carried out on 06Feb2021, but it was negative. On 06Feb2021 12:00, the patient experienced tiredness, floppy, weakness. On 06Feb2021 at 12 o''clock the patient felt tired, limp, powerless. Due to reduced oral intake, 500 ml NaCl 0.9% infusion was administered sc. Vital signs included RR (Systolic blood pressure /Diastolic blood pressure) 110/60 mmHg, pulse 99 CPM, temperature 36.9 ? C, Oxygen saturation 93% on 06Feb2021. On 07Feb2021 08:45 the patient experienced Death NOS death. The patient''s outcome was not recovered/not resolved. The patient died on 07Feb2021 from Marasmus. No autopsy was arranged according to the medical officer. Cause of death according to the death certificate was senile marasmus. Other essential Disease conditions that contributed to death (according to death certificate): SDAT (Senile dementia of Alzheimer''s type), VHFL, aortic valve stenosis. Health Authority Comment: Confounding factors: elderly age, underlying disease (atrial fibrillation) Temporal relationship: 3 days The causal relationship between the product/substance COMIRNATY / TOZINAMERAN and tiredness, weakness and floppy is assessed as Possible. The causal relationship between the product/substance COMIRNATY / TOZINAMERAN and Death NOS is assessed as possible. The information provided in this individual case does not warrant a change in the product information or other measures. The case will be closed at this time. The topic will be monitored closely. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: senile marasmus


VAERS ID: 1048219 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THROMBO ASS
Current Illness: Aortic stenosis; Aortic valve stenosis (aortic valve stenosis); Arteriosclerosis; Atrial fibrillation (atrial fibrillation); Geromarasmus (Marasmus seni); Hypertension arterial (art. hypertension)
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction (Status post cerebral insult); Coronary disease (coronary heart disease); Myocardial infarct (status post myocardial infarction)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021164867

Write-up: died on 20Jan2021, vaccination on 19Jan2021; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority- WEB [AT-BASGAGES-2021-02012] received via Regulatory Authority. A 89-year-old male patient received bnt162b2 (COMIRNATY, lot# EJ6797), intramuscular on 19Jan2021 at single dose for vaccination. Medical history included cerebral infarction (status post cerebral insult) from an unknown date and not ongoing, ongoing hypertension arterial, ongoing arteriosclerosis, ongoing geromarasmus (marasmus seni), myocardial infarct (status post myocardial infarction) from an unknown date and not ongoing, ongoing atrial fibrillation, ongoing aortic valve stenosis, coronary disease from an unknown date and unknown if ongoing, ongoing aortic stenosis. Concomitant medication included acetylsalicylic acid (THROMBO ASS) and unspecified antihypertensive drug. The patient experienced died on 20Jan2021, vaccination on 19Jan2021 (Decompensation cardiac) on 20Jan2021 10:00. There were no allergies or intolerances. He had no signs of infection. According to the daughter - a doctor herself (she does not attribute the death to the vaccination) - there were no symptoms after the vaccination. His wife helped him use the toilet at night, and in the morning he was found dead in bed. The patient never tested positive for SARS-CoV2. The disease leading immediately to death (not the mode of death): cardiac decompensation. Previous causes: decompensated aortic valve stenosis, coronary heart disease. Other major disease states that contributed to death: arterial hypertension, Marasmus seni. The patient died on 20Jan2021. An autopsy was not performed. Sender Comment: BASGAGES-comment: Follow-up information has been requested. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: decompensated aortic valve stenosis; coronary heart disease; arterial hypertension; Marasmus seni; cardiac decompensation


VAERS ID: 1048221 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid, Inflammatory marker test, Multiple organ dysfunction syndrome, Myocarditis, Septic shock
SMQs:, 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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (not hospitalized)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Lactate values; Result Unstructured Data: Test Result:increased; Test Date: 202101; Test Name: Inflammation values; Result Unstructured Data: Test Result:increased
CDC Split Type: ATPFIZER INC2021164871

Write-up: Septic shock; extensive myo- and pericarditis; Multiple organ failure despite hemofiltration; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB AT-BASGAGES-2021-02122. An 81-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Medical history included covid-19 not ongoing not hospitalized. The patient''s concomitant medications were not reported. The patient experienced septic shock, extensive myo- and pericarditis, multiple organ failure despite hemofiltration on 14Jan2021. The events were fatal. The patient underwent lab tests and procedures which included Lactate values and Inflammation values: increased in Jan2021. The patient died on 16Jan2021. An autopsy was performed that revealed carditis pericardium myocardium. Comirnaty/ all events/ Primary source/ Certain. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Septic shock; extensive myo- and pericarditis; Multiple organ failure despite hemofiltration; Autopsy-determined Cause(s) of Death: Carditis pericardium myocardium


VAERS ID: 1048230 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, General physical health deterioration, Malaise, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; METFORMIN; DONEPEZIL; ASAFLOW; LORMETAZEPAM; TAMSULOSINE [TAMSULOSIN]; SOTALOL; ALLOPURINOL; PROLOPA; PARACETAMOL; DIPIPERON; BURINEX; DUROGESIC; INSUMAN BASAL; OZEMPIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronavirus infection; Dementia (clinical frailty score of 7); Diabetes; Hyperlipidemia; Hypertension; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021158451

Write-up: suspected myocardial infarction (not further specified); 2 days after vaccination unwell at night, clammy and very rapid deterioration; 2 days after vaccination unwell at night, clammy and very rapid deterioration; 2 days after vaccination unwell at night, clammy and very rapid deterioration; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. This is a report received from the Regulatory Authority. Regulatory authority report number was BE-FAMHP-DHH-N2021-76257. An 80-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EM0477), via an unspecified route of administration on 28Jan2021 as a single dose for COVID-19 vaccination. Medical history included diabetes, dementia (severe dementia with clinical frailty score of 7), hypertension, obesity, and hyperlipidaemia; all from unknown dates and coronavirus infection in Apr2020 to an unknown date. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), donepezil (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASAFLOW), lormetazepam (MANUFACTURER UNKNOWN), tamsulosin (TAMSULOSINE), sotalol (MANUFACTURER UNKNOWN), allopurinol (MANUFACTURER UNKNOWN), benserazide hydrochloride/levodopa (PROLOPA), paracetamol (MANUFACTURER UNKNOWN), pipamperone hydrochloride (DIPIPERON), bumetanide (BURINEX), fentanyl (DUROGESIC), insulin human injection, isophane (INSUMAN BASAL), and semaglutide (OZEMPIC); all taken for unknown indications from unknown dates and unknown if ongoing. On 30Jan2021, 2 days after vaccination, the patient was unwell at night, clammy and had a very rapid deterioration. The clinical outcomes of unwell, clammy, and rapid deterioration were fatal. The patient died on 30Jan2021. It was not reported if an autopsy was performed. The physician comments included suspected myocardial infarction (not further specified). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Suspected myocardial infarction; Reported Cause(s) of Death: very rapid deterioration; unwell; clammy


VAERS ID: 1048234 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Coma, Death, Disturbance in attention, Peripheral vascular disorder
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   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: CITALOPRAM; ENTRESTO; SPIRICORT; TORASEMIDE; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: blood glucose; Result Unstructured Data: Test Result:22 mmol/L
CDC Split Type: CHPFIZER INC2021172023

Write-up: Death; Coma; Circulatory disorder peripheral; Vigilance decreased; This is a spontaneous report received from a contactable physician via the regulatory authority. Regulatory authority report number CH-SM-2021-10507. A 95-year-old female patient received first dose of BNT162B2 (COMIRNATY), intramuscular at arm right on 15Jan2021 (at the age of 95 years) at single dose for COVID-19 immunization. The patient medical history included severe terminal heart failure from an unknown date and unknown if ongoing. The patient''s concomitant medication included citalopram, sacubitril valsartan sodium hydrate (ENTRESTO), prednisolone (SPIRICORT), torasemide, clopidogrel. The patient experienced vigilance decreased on 17Jan2021, coma and circulatory disorder peripheral, both on 21Jan2021. The patient underwent lab tests and procedures which included blood glucose: 22 mmol/l on 17Jan2021. The patient outcome of the events was fatal. The patient died on 22Jan2021. An autopsy was not performed. A causal relationship between COMIRNATY and death, vigilance decreased, coma and circulatory disorder peripheral was assessed as being unlikely. Sender''s comment: elderly patient with terminal cardiac failure, general state of decay since one month (before receiving the vaccine) who died in temporal correlation to the COMIRNATY vaccine (in particular there was a worsening of vigilance and high glycemia (non-diabetic patient) detected two days after vaccination).Unfortunately no other blood samples were taken and there was no sugar value on 21Jan2021, a value that could have confirmed hyperglycemia with possible hyperglycemic coma that could then lead to death. Autoimmune problems related to vaccines are discussed, so in the overall evaluation of this case could be considered also an autoimmune type I diabetes. However, there is no supporting data and so we leave this as a hypothesis/speculation. The lack of perfusion in the arm of the vaccination could be due to a venous thrombosis of the arm favored also by severe cardiac insufficiency (we do not know if there was a prothrombotic state) and unfortunately has not been made any assessment (Duplex, other Imaging) that can confirm this hypothesis. A possible immobilization of the arm due to pain of the vaccine (so indirect cause, not the vaccine itself but the vaccination procedure) could have favored a thrombosis in the arm, but here it is only speculation as the data to confirm have been requested but are not available (because not performed). That said, in the absence of reliable data and given the very advanced age, the severe terminal failure and the general state of decay that began well before the vaccine, we have judged the causal correlation between death and the vaccine as improbable, improbable also the disturbance of circulation in the arm (because in the absence of data for WHO we must go down a step possible-$gunlikely).; Reported Cause(s) of Death: deterioration of the general condition


VAERS ID: 1048236 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, C-reactive protein, COVID-19, Chest X-ray, Computerised tomogram, Diarrhoea, Lymphocyte count, Respiratory distress, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   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: Arterial hypertension; Dyslipidemia; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: Chest X-ray; Test Result: Positive ; Comments: Parenchymal thickening in the left mid-basal and right supradiaphragmatic sites; Test Date: 20210119; Test Name: CT angiogram; Test Result: Positive ; Comments: Picture compatible with SARS-CoV-2 disease; Test Date: 20210119; Test Name: C-reactive protein; Result Unstructured Data: Test Result:92 mg/l; Test Date: 20210119; Test Name: Lymphocyte count; Result Unstructured Data: Test Result:0.60 x10 9/l; Test Date: 20210119; Test Name: SARS-CoV-2 swab; Test Result: Positive
CDC Split Type: CHPFIZER INC2021168874

Write-up: COVID-19/CT angiogram confirming a picture compatible with SARS-CoV-2 disease; Diarrhea; Asthenia; Respiratory distress; This is a spontaneous report received from a contactable pharmacist via agency, the regulatory authority. Regulatory authority report number CH-SM-2021-11420. An 89-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 17Jan2021 at single dose for COVID-19 immunisation. Medical history included arterial hypertension, dyslipidemia and type 2 diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced covid-19 on 19Jan2021, diarrhea on 18Jan2021, asthenia on 18Jan2021, respiratory distress on 18Jan2021. The patient was hospitalized for the event from 19Jan2021 to an unknown date. The events were also fatal. Clinical course: On 17Jan2021 she received the administration of the first dose of Comirnaty. The next day (18Jan2021) she began to manifest diarrhea, asthenia and respiratory distress because of which, on 19Jan2021, she presented at the emergency room. Laboratory tests showed an inflammatory syndrome with C Reactive Protein at 92 mg/L (normal range less than 5 mg/L) and lymphocyte count at 0.6x10E9/L (on 19Jan2021) (normal range 1.50-4.00x10 9/l). On the same day, a SARS-CoV-2 swab is performed, which is positive, a chest X-ray showing parenchymal thickening in the left mid-basal and right supradiaphragmatic areas, and a CT angiogram confirming a picture compatible with SARS-CoV-2 disease. The woman was hospitalized on 19Jan2021 and treated pharmacologically with dexamethasone (6mg for 7-10 days). On 20Jan2021, respiratory distress worsens so high-flow oxygen therapy is required. The subsequent course was unfavorable with progressive deterioration of general conditions and worsening of the respiratory picture. The woman died of COVID-19 on 22Jan2021. An autopsy was not done. A causal relationship between Comirnaty and all events was assessed as being unlikely. Agency assessed this case as serious, results in death. Sender''s comment: COVID-19 infection (confirmed by swab on 19Jan2021), with diarrhea, asthenia and respiratory distress in a polymorbid elderly woman (89 years old) on 18Jan2021, the day after vaccination with the first dose of Comirnaty (17Jan2021). At the hospital, laboratory and imaging investigations show a picture compatible with SARS-CoV-2 disease. The woman dies from the viral infection due to progressive worsening of her general condition. In the Swiss monograph of Comirnaty it is reported that the duration of protection offered by the vaccine is not known, since it is still being determined in ongoing clinical trials, and, as with any vaccine, vaccination with Comirnaty may not protect all recipients. In particular, it is reported that subjects may not be fully protected until 7 days after the second dose of the vaccine. Although the woman did not present with any symptoms at the time of the first vaccination, the fact that she was not swabbed for COVID-19 before vaccination does not allow us to exclude that the infection was already ongoing before vaccination. In addition, the timing of the onset of the symptomatology described here, one day after the first vaccination, speaks against a causal role of Comirnaty, in agreement with what has been reported in the monograph, namely the possibility that vaccinated subjects are not fully protected until 7 days after the second dose (which the woman did not receive) and are therefore susceptible to COVID-19 infection in the period between the first and second dose of vaccine. On the basis of these considerations, in the current state of knowledge, the Comirnaty-COVID-19 causal link is judged unlikely. Note the rapidity of the lethal event for COVID-19 from the time of onset of symptoms (only 5 days).; Reported Cause(s) of Death: Diarrhea; Asthenia; Respiratory distress; COVID-19


VAERS ID: 1048245 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: General physical condition decreased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021164541

Write-up: General physical condition deterioration; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, Regulatory Authority number DE-DCGMA-21187965. A 95-year-old female patient was vaccinated with bnt162b2 (COMIRNATY, lot# unknown), the first dose on an unspecified date and the second dose on 22Jan2021, both via an unspecified route of administration at single dose for prophylactic vaccination. Medical history included general physical condition decreased since 01Jan2021 and ongoing. Concomitant medication was not reported. The patient experienced general physical condition deterioration after 1st on an unspecified date with outcome of unknown. 13 days after the second dose of vaccination the patient developed general physical condition decreased on 03Feb2021 with outcome of fatal. The patient was dead on 03Feb2021 due to general physical condition decreased. It was not reported if an autopsy was performed. Causal relationship between the event and the administration of bnt162b2 was assessed as "C. Inconsistent causal association" by the Regulatory Authority. Reporter comment: General physical condition deterioration after 1st and 2nd vaccination, but also fragile before that. The causal relationship cannot be clearly established, the general physical condition was also fragile beforehand, but significantly reduced after the two vaccinations. Temporal Connection exited (03Feb2021) after 2nd vaccination (22Jan2021). No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reporter''s Comments: General physical condition deterioration after 1st and 2nd vaccination, but also fragile before that. The causal relationship cannot be clearly established, the general physical condition was also fragile beforehand, but significantly reduced after the two vaccinations. Temporal Connection exited (03Feb2021) after 2nd vaccination (22Jan2021).; Reported Cause(s) of Death: General physical condition deterioration


VAERS ID: 1048251 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, Renal failure, Urosepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
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: Mental disability
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021160565

Write-up: Fever; Kidney failure; Urosepsis; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021002337. A 64-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation. Medical history included mental disability from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced Fever and Renal failure and Urosepsis on an unspecified date, lasting for unknown. The patient died on 04Feb2021. An autopsy was not performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Fever; Urosepsis; Renal failure


VAERS ID: 1048252 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Multi-organ disorder, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-02
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201229; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: qualitative
CDC Split Type: DEPFIZER INC2021164676

Write-up: Multi-organ disorder; SARS-CoV-2 PCR test: positive; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory authority- WEB [DE-PEI-PEI2021002546] received via Regulatory Authority. An 87-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 29Dec2020 at single dose for prophylactic vaccination. The patient''s medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included SARS-CoV-2 PCR test: positive, qualitative on 29Dec2020 4 h after vaccination. 5 days after vaccination the patient developed multi-organ disorder, lasting for unknown. Outcome of event SARS-CoV-2 PCR test: positive was unknown. The patient was dead on 02Jan2021. Reported cause of death was multi-organ disorder. It was unknown if an autopsy was performed. Reporter''s comments: 4 h after vaccination: SARS-CoV-2 PCR positive. Sender Comment: Multi-morbid full-time nursing home resident died on 02Jan2021 of her many illnesses. No symptoms developed after vaccination. Causality assessment by RA for Comirnaty / Multi-organ disorder: D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: 4 h after vaccination: SARS-CoV-2 PCR positive; Reported Cause(s) of Death: Multi-organ disorder


VAERS ID: 1048253 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-02-05
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 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: 2021-02-10
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positive NA
CDC Split Type: DEPFIZER INC2021164677

Write-up: vaccinated with two doses of Comirnaty/ COVID-19 virus test positive; Diagnosis was confirmed by COVID-19 virus test (result: positiv/positive, unit: NA); This is a spontaneous report from non-contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021002548. A 69-year-old male patient received two doses of bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Dec2020 (lot number: EJ6796, first dose) and on 26Jan2021 (second dose, lot number: EK9788) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After vaccination the patient experienced COVID-19 virus test positive on 05Feb2021 and developed Death on 10Feb2021, lasting for unknown. The patient was dead and was hospitalized. Diagnosis was confirmed by COVID-19 virus test (result: positiv/positive, unit: NA) on 05Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Lethal outcome/Death; Diagnosis was confirmed by COVID-19 virus test (result: positiv/positive, unit: NA); vaccinated with two doses of Comirnaty/ COVID-19 virus test positive


VAERS ID: 1048254 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-01-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Diabetes mellitus; Hematoma subdural; Palliative care
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021164728

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number DE-PEI-PEI2021002560. An 86-year-old male patient was vaccinated with BNT162B2 (COMIRNATY), (lot number: EM0477) intramuscularly on 23Jan2021 at a single dose for COVID-19 immunization. The patient medical history included: palliative care, hematoma subdural, dementia, diabetes mellitus. Concomitant medication was not reported. 4 days after vaccination on 27Jan2021, the patient developed death, lasting for unknown. The patient was dead. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1048255 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021164500

Write-up: General physical health deterioration; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number DE-PEI-PEI2021002561. A 98-year-old male patient received the second dose bnt162b2 (COMIRNATY), intramuscular on 03Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose bnt162b2 (COMIRNATY) in Jan2021 for covid-19 immunization, and had been tolerated. On 05Feb2021 after vaccination the patient developed general physical health deterioration, lasting for 5 days. No treatment, no hospitalization. The patient died in Feb2021. It was not reported if an autopsy was performed. The outcome of event general physical health deterioration was fatal. Event Assessment: For both events / RA / D. Unclassifiable. No follow-up attempts possible, batch/lot number cannot be obtained.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1048258 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dehydration, Hypotension, Infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Arrhythmia related investigations, signs and symptoms (broad), 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), Cardiomyopathy (broad), Respiratory failure (broad), Dehydration (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   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: ATORVASTATIN; L-THYROXIN [LEVOTHYROXINE]; METOPROLOL; ACETYLSALICYLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Dementia; Hyperuricaemia; Hypotensive; Hypothyroidism; Renal insufficiency; Syncope (Hospitalized for hypotonic circulatory dysregulation)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021164727

Write-up: Multi-infarction syndrome; Exsiccosis; Asystolia; Hypotension; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB Regulatory Authority number DE-PEI-PEI2021002567. An 85-year-old female patient received bnt162b2 (COMIRNATY, batch/lot number: EK9788), intramuscularly on 11Feb2021 at single dose for covid-19 immunization. Medical history included hyperuricaemia, hypothyroidism, syncope from Sep2020 to an unknown date (Hospitalized for hypotonic circulatory dysregulation), renal failure, aortic valve incompetence, dementia. Concomitant medication included atorvastatin, levothyroxine] (L-THYROXIN), metoprolol, acetylsalicylic acid. The patient died from multi-infarction syndrome, exsiccosis, asystolia and hypotension on 11Feb2021, lasting for unknown. It was not reported if an autopsy was performed. The causality for Comirnaty with events infarction, exsiccosis, asystolia, hypotension per Regulatory Authority/ C. was inconsistent causal association. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Multi-infarction syndrome; Exsiccosis; Hypotension; Asystolia


VAERS ID: 1048259 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Diet refusal, General physical health deterioration, Restlessness, SARS-CoV-2 test, SARS-CoV-2 test positive, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 13
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: Basal cell carcinoma; Coxarthrosis; Dementia Alzheimer''s type; Prostatic adenoma; Squamous cell carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positiv/positive NA; Test Date: 20210110; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Test Result:positiv/positive NA
CDC Split Type: DEPFIZER INC2021164542

Write-up: Sudden death; Refusal to eat; Deterioration in general condition; Restlessness; cough; COVID-19 PCR test/COVID-19 rapid POC test : positiv/positive NA; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-PEI2021002569. An 83-years-old male patient received first dose of bnt162b2 (COMIRNATY, Lot# no.: EM0477), via an unspecified route of administration on 01Jan2021 at single dose for covid-19 immunisation. Medical history included Dementia Alzheimer''s type, Coxarthrosis, Basal cell carcinoma, Squamous cell carcinoma, Prostatic adenoma. The patient''s concomitant medications were not reported. The patient experienced refusal to eat on 15Jan2021, cough on 12Jan2021, deterioration in general condition on 15Jan2021, restlessness on 12Jan2021. Clinical course reported as: 11 day(s) after vaccination the patient developed Cough and Restlessness and General physical health deterioration and Diet refusal, lasting for 12 day(s). The patient underwent lab tests and procedures which included COVID-19 PCR test: positiv/positive NA on 11Jan2021, COVID-19 rapid POC test: positiv/positive NA on 10Jan2021. The patient died on 23Jan2021. It was not reported if an autopsy was performed. Events refusal to eat, cough, deterioration in general condition, restlessness were reported as serious with seriousness criterion death. Cause of death was reported as sudden death. No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Restlessness; General physical health deterioration; cough; Refusal to eat; Sudden death


VAERS ID: 1048262 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-12
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210112; Test Name: coronavirus rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021164941

Write-up: patient contracted Coronavirus/coronavirus rapid test: positive on 12Jan2021/symptoms were reported as loss of appetite and weakened; patient contracted Coronavirus/coronavirus rapid test: positive on 12Jan2021/symptoms were reported as loss of appetite and weakened; This is a spontaneous report from a non-contactable consumer based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty.This consumer reported similar events for 39 reports. This is the second of the 39 reports. A 78-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY) lot# EM0477, via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced patient contracted coronavirus on 12Jan2021,symptoms were reported as loss of appetite and weakened. The patient underwent lab tests and procedures which included coronavirus rapid test: positive on 12Jan2021. The patient died on 22Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter, same drug, different patients, similar events; Reported Cause(s) of Death: patient contracted Coronavirus/coronavirus rapid test: positive on 12Jan2021/symptoms were reported as loss of appetite and weakened; patient contracted Coronavirus/coronavirus rapid test: positive on 12Jan2021/symptoms were reported as loss of appet


VAERS ID: 1048263 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Coronavirus test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: Coronavirus rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021164984

Write-up: patient contractred Coronavirus; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty. The reporter reported similar events for 39 patients, this is the 15th of 39 reports. A 91-year-old patient of an unspecified gender received 1st dose of bnt162b2 (COMIRNATY, lot number EM0477), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient contractred coronavirus (covid-19) (death) on an unspecified date. The patient underwent lab tests and procedures which included coronavirus rapid test: positive on 05Jan2021. The patient died on 09Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter/drug, similar events, different patient; Reported Cause(s) of Death: patient contractred Coronavirus


VAERS ID: 1048264 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronavirus infection, Dysphagia, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 11
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: 20210105; Test Name: COVId-19 rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021165007

Write-up: swallowing difficult; COVId-19 rapid test: positive; Coronavirus infection detected via quick test; This is a spontaneous report received from a contactable employee of a nursing home based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty. The reporter reported similar events for 39 patients, this is the 21th of 39 reports. An approximately 90 years old patient of an unspecified gender received 1st dose of bnt162b2 (COMIRNATY, lot# EM0477), via an unspecified route of administration at single dose on 31Dec2020 for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced coronavirus infection detected via quick test (death) on 05Jan2021, swallowing difficult (non-serious) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVId-19 rapid test: positive on 05Jan2021. The patient died on 16Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter/drug, similar events, different patients.; Reported Cause(s) of Death: Coronavirus infection detected via quick test


VAERS ID: 1048265 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronavirus infection, Dysphagia, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 Quick test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021165011

Write-up: Coronavirus infection; Swallowing disorder; COVID-19 quick test positive; This is a spontaneous report received from a contactable employee of a nursing home based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty. The reporter reported similar events for 39 patients, this is the 23th of 39 reports. A 90-year-old (at time of vaccination) patient of an unspecified gender received first dose of bnt162b2 (COMIRNATY, Lot number: EM0477) via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced coronavirus infection and swallowing disorder on an unspecified date. Patient had COVID-19 quick test positive on 07Jan2021. Outcome of "Coronavirus infection" was fatal, of other events was unknown. The patient died on 15Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter/drug, similar events, different patients; Reported Cause(s) of Death: Coronavirus infection


VAERS ID: 1048266 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronavirus infection, Dysphagia, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210101; Test Name: Covid-19 rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021165026

Write-up: Coronavirus infection; swallowing difficulty; Covid-19 rapid test positive; This is a spontaneous report received from a contactable employee of a nursing home based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty. The reporter reported similar events for 39 patients, this is the 30th of 39 reports. A 101-year-old patient of an unspecified gender received first dose of bnt162b2 (COMIRNATY, Lot number: EM0477) via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced coronavirus infection and swallowing difficulty on an unspecified date. Patient had Covid-19 rapid test positive on 01Jan2021. Outcome of "Coronavirus infection" was fatal, of other events was unknown. The patient died on 11Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter/drug, similar events, different patients; Reported Cause(s) of Death: Coronavirus infection


VAERS ID: 1048267 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy, Obstructive airways disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021168762

Write-up: died of vomit in his airways; died of vomit in his airways; epileptic attack; This is a spontaneous report from a contactable consumer or other non-healthcare professional and two other healthcare professionals, based on information received by Pfizer from Biontech [manufacturer control number: 16401], license party for bnt162b2 (COMIRNATY). A 32-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Feb2021 at single dose for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient in good health condition, was vaccinated on 12Feb2021. Patient died on 13Feb2021 due to vomit in his airways after an epileptic attack, signs of hashish consumption (joint). It was not reported if an autopsy was performed. The outcome of event ''epileptic attack'' was unknown. Lot/batch number has been requested.; Reported Cause(s) of Death: vomit in his airways; vomit in his airways


VAERS ID: 1048268 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIUM & VITAMIN D3; DURAPHAT; KALIUMKLORID ORIFARM; FUROSEMID ORIFARM; BETMIGA; PAMOL; XARELTO; TOILAX; ALNOK; PANTOPRAZOLE TEVA; GANGIDEN; METOPROLOLSUCCINAT HEXAL
Current Illness: COVID-19; General physical health deterioration; Living in nursing home (there was a covid-19 outbreak among several residents and staff.)
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Constipation; Esophageal acid reflux; Heart rate irregular; Hyperactive bladder; Pain
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158654

Write-up: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB and received via Regulatory Authority DK-DKMA-WBS-0032128. Safety Report Unique Identifier (DK-DKMA-ADR 24692697). An 86-year-old male patient received first dose bnt162b2 (COMIRNATY) Lot # EJ6797, intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Medical history included Esophageal acid reflux, Allergy, Hyperactive bladder, Constipation, Heart rate irregular, pain,ongoing Living in nursing home (there was a covid-19 outbreak among several residents and staff), ongoing general physical health deterioration and ongoing COVID-19. Concomitant medication included calcium carbonate, colecalciferol (CALCIUM & VITAMIN D3) from 07Feb2019 as Calcium supplementation, sodium fluoride (DURAPHAT)from 20Nov2019 as Dental disorder prophylaxis, potassium chloride (KALIUMKLORID ORIFARM) from 14Jan2019 as Potassium supplementation, furosemide (FUROSEMID ORIFARM) from 14Jan2019 as diuretic therapy, mirabegron (BETMIGA) from 02Jun2020 for Hyperactive bladder, paracetamol (PAMOL) from 09Sep2019 for pain, rivaroxaban (XARELTO) from 05Dec2019 as Thrombosis prophylaxis, bisacodyl (TOILAX) from 13Mar2019 for Constipation, cetirizine hydrochloride (ALNOK) from 06Feb2019 for Allergy, pantoprazole sodium sesquihydrate (PANTOPRAZOLE TEVA) from 25-Sep2019 for Esophageal acid reflux, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (GANGIDEN) from 19Feb2019 for Constipation, metoprolol succinate (METOPROLOLSUCCINAT HEXAL) from 28Feb2019 for Heart rate irregular. The patient experienced death on 05Jan2021. it was not inconceivable that the total liability of covid-19 disease and the vaccination has been fatal for the patient. The patient underwent lab tests and procedures which included COVID-19 virus test: positive in Jan2021. The patient died on 05Jan2021. An autopsy was not performed. The ADRs were by the physician reported as Fatal. Reported cause of death: Death and of/with COVID-19. Only usual confirmation of death was performed post mortem. No findings were reported. If the Medicines Agency receives supplemental significant information regarding this case the case will be re-submitted. Sender Comment: COMMENT from MA: Version 001 has not been submitted to RA. Agency should therefore consider version 2 as the initial report. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient


VAERS ID: 1048269 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-13
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Pyrexia, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: CALCIUM AND VIT D; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; CENTYL MED KALIUMKLORID; OLANZAPIN STADA; ELOCOM; MAGNESIA [MAGNESIUM HYDROXIDE]; PANTOPRAZOL KRKA; IBUMETIN; PARACETAMOL ORIFARM; SERTRALIN A
Current Illness: COVID-19; General physical health deterioration; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (for many years before he came to the nursery home); Cerebral haemorrhage (with sequelae (psychosis, burns with ulcer, fungal infec, vomiting blood, haemorrhage, immobility)); Constipation; Depression; Eczema; Edema; Esophageal acid reflux; Mental disorder; Pain; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210103; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210104; Test Name: COVID-19 virus test; Test Result: Inconclusive ; Test Date: 20210106; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210113; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158652

Write-up: COVID-19; Respiratory failure; Fever; COVID-19 test 13Jan2021: Positive; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB [DK-DKMA-WBS-0032130]. The case was received from a contactable physician via The Agency. A 70-years-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6797, Expiration Date: 30Apr2021), intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Medical history included Living in nursing home from 2018 and ongoing, alcohol abuse for many years before he came to the nursery home not ongoing, ongoing covid-19, ongoing general physical health deterioration, cerebral haemorrhage from 2010 not ongoing with sequelae (psychosis, burns with ulcer, fungal infec, vomiting blood, haemorrhage, immobility), vitamin D deficiency, edema, eczema, constipation, mental disorder, esophageal acid reflux, depression, pain. The patient lived in a nursery home and there were a covid-19 outbreak among several residents and staff. Concomitant medication included calcium, colecalciferol (CALCIUM AND VIT D) from 05Mar2017 for Vitamin D deficiency, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) from 08Aug2017 for Constipation, bendroflumethiazide, potassium chloride (CENTYL MED KALIUMKLORID) from 23Apr2020 for Edema, olanzapine (OLANZAPIN STADA) from 16Feb2017 for mental disorder, mometasone furoate (ELOCOM) from 02Apr2020 for Eczema, magnesium hydroxide (MAGNESIA) from 04Aug2017 for constipation, pantoprazole sodium sesquihydrate (PANTOPRAZOL KRKA) from 10Sep2020 for Esophageal acid reflux, ibuprofen (IBUMETIN) from 10Sep2020 for pain, paracetamol (PARACETAMOL ORIFARM) from 21Nov2019 for pain, sertraline hydrochloride (SERTRALIN ACCORD) from 06Mar2019 for Depression. Past vaccines included Pneumovax (Pneumococcal vaccine, 23-valent) on 11May2020 and Influenza (Influenza Type A and Influenza Type B vaccine, 4-valent) on 20Oct2020. On 18Jan2021 the patient developed fever and respiratory insufficiency and died on 19Jan2021. The ADRs were by the reporter reported as fatal. Reported cause(es) of death was respiratory insufficiency and COVID 19. The reporter was in doubt about how long the vaccine affected the immune system, the reporter thought that the patient may have a worsening course of the disease with covid due to the vaccine, even though the patient did first become ill 2 weeks after the vaccine. The patient underwent lab tests and procedures which included COVID-19 test 03Jan2021: Negative, 04Jan2021: Inconclusive, 06Jan2021: Negative, 13Jan2021: Positive. The patient died on 19Jan2021. An autopsy was not performed. Only ordinary confirmation of death was performed post-mortem. The reporter stated that it was not inconceivable that the total liability of Covid-19 disease and the vaccination had been fatal for the patient. Senders comment: COMMENT from Agency: Version 001 has not been submitted to Regulatory Authority. Health Authority should therefore consider version 2 as the initial report. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 test 13Jan2021: Positive; COVID-19; Respiration failure; Fever


VAERS ID: 1048270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: General physical health deterioration; Living in nursing home (There was a covid-19 outbreak among several residents and staff)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158644

Write-up: Death with COVID-19/COVID-19 virus test, Jan2021, positive; Death with COVID-19/COVID-19 virus test, Jan2021, positive; This is a spontaneous report from a contactable physician received from the Medicines Agency. Regulatory authority report number DK-DKMA-WBS-0032136. A 91-year-old female patient received the first dose bnt162b2 (COMIRNATY, Batch number/lot number: EJ6797), intramuscular on 31Dec2020 at single dose for covid-19 immunization. The patient''s concurrent conditions included general physical health deterioration, the patient was living in nursing home, where there was a covid-19 outbreak among several residents and staff. The patient''s concomitant medications were not reported. The patient experienced covid-19 in Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive in Jan2021. The patient died on 16Jan2021. An autopsy was not performed. Reported cause of death was death with COVID-19. The outcome was fatal.; Reported Cause(s) of Death: Death with COVID-19/COVID-19 virus test, Jan2021, positive; Death with COVID-19/COVID-19 virus test, Jan2021, positive


VAERS ID: 1048271 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   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: ALENDRONAT SANDOZ; ARICEPT; BETOLVEX [CYANOCOBALAMIN-TANNIN COMPLEX]; METFORMIN ACTAVIS; VISCOTEARS; VITAMIN D [COLECALCIFEROL]
Current Illness: COVID-19; Feverish; General physical health deterioration; Hyperthyroidism; Living in nursing home (there was a covid-19 outbreak among several residents and staff.); Renal impairment (One functional kidney); Urinary infection
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Dry eyes; Osteoporosis; Type 2 diabetes mellitus; Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210103; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158642

Write-up: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient .; COVID-19 virus test positive; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [DK-DKMA-WBS-0032137]. Safety Report Unique Identifier DK-DKMA-ADR 24693268. The case was received from a contactable physician via The Medicines Agency (MA). An 87-year-old female patient received first dose of bnt162b2 (COMIRNATY, Batch number: EJ6797, Expiration Date: 30Apr2021) intramuscular on 31Dec2020 at single dose for covid-19 immunization. Medical history included Osteoporosis, Dementia Alzheimer''s type, Vitamin B12 deficiency, Type 2 diabetes mellitus, Dry eyes, General physical health deterioration, COVID-19, Feverish, Urinary infection, Hyperthyroidism, Renal impairment (One functional kidney) and the patient was living in nursing home (there was a covid-19 outbreak among several residents and staff). Concomitant medications include alendronate sodium (ALENDRONAT SANDOZ) for Osteoporosis from 24Apr2020, donepezil hydrochloride (ARICEPT) from 17Jun2019 for dementia Alzheimer''s type, cyanocobalamin-tannin complex (BETOLVEX) since 20Oct2014 for Vitamin B12 deficiency, metformin hydrochloride (METFORMIN ACTAVIS) from 11Mar2020 for Type 2 diabetes mellitus, carbomer (VISCOTEARS) from 28Aug2019 for dry eyes, colecalciferol (VITAMIN D) from 30Apr2020 for Osteoporosis. Past vaccinations included PNEUMOVAX (Pneumococcal vaccine, 23-valent) (batch number: S014391) and FLUZONE (Influenza Type A and Influenza Type B vaccine, 3-valent) (batch number: UJ459AB). Past drug included OXYGEN in Apr2020. On 31Dec2020, the patient was vaccinated with COMIRNATY first dose (Batch number: EJ6797) dosed 1 DF for COVID-19 immunization. The patient got unwell on 02Jan2021 and had COVID-19 virus test positive on 03Jan2021. The patient did not need respirator but quickly gets very unwell. Receives palliative treatment with oxygen and Imacilin (AMOXICILLIN) due to mucus accumulation. Patient death occurred on 06Jan2021. Reported cause(es) of death: Death and of/with COVID-19. Only normal confirmation of death was performed. No findings were reported. Causality: It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient .


VAERS ID: 1048272 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Diarrhoea, Oxygen saturation, Pyrexia, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   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: TAMSULOSIN TEVA; PAMOL; GABAPENTIN ORIFARM; AMLODIPIN KRKA; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; COLECALCIFEROL; LAXOBERAL; NITROFURANTOIN "DAK"; MORFIN ABCUR; DURAPHAT; SERTRALIN ORION
Current Illness: Anxiety; Constipation; Dementia; General physical health deterioration; Hypertension; Living in nursing home; Neuropathic pain; Pain; Type II diabetes mellitus; Urination difficulty
Preexisting Conditions: Medical History/Concurrent Conditions: Dental caries; Prophylaxis urinary tract infection; Vitamin D3 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210112; Test Name: Oxygen saturation; Test Result: 94 %; Test Date: 20210103; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210106; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158638

Write-up: diarrhea but his fluid intake was fine; body temperature: 37.7 centigrade; Respiratory insufficiency; COVID-19; This is a spontaneous report from contactable physician downloaded from the Agency Regulatory-WEB DK-DKMA-ADR 24693280. An 86-years-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6797), intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Medical history included dementia from 2016 and ongoing, living in nursing home from 2016 and ongoing, ongoing general physical health deterioration, ongoing Type II diabetes mellitus, ongoing hypertension, ongoing neuropathic pain, ongoing anxiety, ongoing difficulty in urination, ongoing pain, ongoing constipation, Vitamin D3 deficiency, Prophylaxis urinary tract infection and Dental caries. Past vaccines included Pneumovax (Pneumococcal vaccine, 23-valent) on 11May2020 and Fluzone (Influenza Type A and Influenza Type B vaccine, 3-valent) on 20Oct2020. Concomitant medication included tamsulosin hydrochloride (TAMSULOSIN TEVA) from 06Apr2016 for urination difficulty, paracetamol (PAMOL) from 02Jun2014 for pain, gabapentin (GABAPENTIN ORIFARM) from 07Nov2019 for Neuropathic pain, amlodipine besilate (AMLODIPIN KRKA) from 11Sep2020 for hypertension, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) from 02Jul2015 for constipation, colecalciferol from 11Jan2016 for Vitamin D3 deficiency, sodium picosulfate (LAXOBERAL) from 06Jun2019 for Constipation, nitrofurantoin (NITROFURANTOIN "DAK") from 09Jan2017 for Prophylaxis urinary tract infection, morphine hydrochloride (MORFIN ABCUR) from 18Jan2021 for pain, sodium fluoride (DURAPHAT) from 15Dec2017 for Dental caries, sertraline hydrochloride (SERTRALIN ORION) from 25Jul2016 for Anxiety. On 06Jan2021 the patient was tested positive for COVID-19 and on 07Jan2021 he developed symptoms with weakened respiration treated with oxygen. On 12Jan2021 the patients general conditions was worsened but stabil. He had diarrhea but his fluid intake was fine. The patient was treated with morfine subcutaneously to reduce oxygen consumption. On 20Jan2021 the patient developed respiratory insufficiency and died. Respiratory insufficiency was by the reporter reported as fatal. Reported cause(es) of death was Respiratory insufficiency and of/with COVID 19. The patient underwent lab tests and procedures which included body temperature: 37.7 centigrade on 08Jan2021, oxygen saturation: 94 % on 12Jan2021, COVID-19 virus test: negative on 03Jan2021, positive on 06Jan2021. The patient died on 20Jan2021. An autopsy was not performed. Only ordinary inquest was performed post-mortem on 21Jan2021. The outcome for body temperature: 37.7 centigrade and diarrhea but his fluid intake was fine was unknown. The reporter stated that it was not inconceivable that the total liability of Covid-19 disease and the vaccination had been fatal for the patient. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19; Respiratory insufficiency


VAERS ID: 1048273 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: General physical health deterioration; Living in nursing home (there was a covid-19 outbreak among several residents and staff)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158633

Write-up: Death; COVID-19/COVID-19 disease; COVID-19/COVID-19 disease; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [DK-DKMA-WBS-0032141]. The case was received from a contactable physician via The Medicines Agency (MA). An 88-year-old female patient received first dose of BNT162B2 (COMIRNATY, batch/lot number: EJ6797, expiration date: 30Apr2021) intramuscular on 31Dec2020 at single dose for COVID-19 immunisation. Medical history included general physical health deterioration, was living in nursing home (there was a COVID-19 outbreak among several residents and staff), both ongoing. Concomitant medications were not reported. On 14Jan2021 the patient developed death. Reported cause(es) of death: Death and of/with COVID-19. Only normal confirmation of death was performed post mortem. It was reported that it is not inconceivable that the total liability of COVID-19 disease and the vaccination has been fatal for the patient. Lab data included: in Jan2021, COVID-19 virus test was positive. Autopsy was not done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19/COVID-19 disease; Death; COVID-19/COVID-19 disease


VAERS ID: 1048274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-15
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Heart rate, Oxygen saturation, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO; KLORAMFENIKOL VISKOES DAK; BETOLVEX [CYANOCOBALAMIN-TANNIN COMPLEX]; RISPERDAL; IMOZOP; ARAX; LAXOBERAL; SAPIMOL; ESOMEPRAZOL KRKA
Current Illness: Atrial fibrillation; Cerebral infarct; Chronic renal insufficiency; General physical health deterioration; Living in nursing home (there was a covid-19 outbreak among several residents and staff.); Renal cysts; Type 2 diabetes mellitus; Vascular dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchospasm; Bypass surgery; Constipation; Esophageal acid reflux; Eye infection; Insomnia; Mania; Pain; Prostate cancer (Possibly Prostate cancer. Not diagnosed due to comorbidity); Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Pulse rate; Result Unstructured Data: Test Result:76; Comments: 76 Unit not specified; Test Date: 202101; Test Name: Oxygen saturation; Test Result: 88 %; Test Date: 20210115; Test Name: Oxygen saturation; Test Result: 92 %; Test Date: 20210106; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210113; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:unknown results; Comments: Test lost; Test Date: 20210118; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158632

Write-up: COVID-19/ COVID-19 virus test, positive; COVID-19/ COVID-19 virus test, positive; Respiratory insufficiency. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient.; This is as spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is DK-DKMA-WBS-0032145. Safety Report Unique Identifier DK-DKMA-ADR 24693311. An 84-year-old male patient received first dose of bnt162b2 (COMIRNATY, Lot number: EJ6797, expiration date: 30Apr2021) intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Medical history included bypass surgery from 2008 and not ongoing, conditions included pain, vitamin b12 deficiency, esophageal acid reflux, insomnia, eye infection, constipation, mania, bronchospasm, ongoing general physical health deterioration, ongoing type 2 diabetes mellitus, ongoing chronic renal insufficiency, renal cysts from 2014 and ongoing, vascular dementia from 2015 and ongoing, atrial fibrillation from 2018 and ongoing, cerebral infarct from 2019 and ongoing, undiagnosed prostate cancer and unknown if ongoing, possibly prostate cancer, not diagnosed due to comorbidity, the patient was ongoing living in nursing home, there was a covid-19 outbreak among several residents and staff. Concomitant medication included hydroxyzine hydrochloride (ARAX) from 14Dec2020 for pain, cyanocobalamin-tannin complex (BETOLVEX) from 25Jan2016 for vitamin B12 deficiency, esomeprazole magnesium (ESOMEPRAZOL KRKA) from 23Dec2020 for esophageal acid reflux, zopiclone (IMOZOP) from 15Sep2020 for insomnia, chloramphenicol (KLORAMFENIKOL VISKOES DAK) from 08Dec2020 for eye infection, sodium picosulfate (LAXOBERAL) from 15Sep2020 for constipation, risperidone (RISPERDAL) from 17Sep2020 for mania, ipratropium bromide, salbutamol sulfate (SAPIMOL) from 13Sep2020 for bronchospasm and xarelto (rivaroxaban) from 12Apr2018 as thrombosis prophylaxis. The patient previously received Influvectra (Influenza Type A and Influenza Type B vaccine, 4-valent) on 22Dec2020 for immunisation, pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 19May2020 for immunisation. The patient experienced respiratory insufficiency, it is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient, in an 84 year old male patient vaccinated with bnt162b2. On 15Jan2021 the patient developed respiratory insufficiency, the patient was sweaty, did not react to voice or touch, the patient had apnoea, pain, increased fever and secretion and was treated palliatively with subcutaneous morphine. Spacer pressurised inhalation, prednisolone and furosemide (FURIX), but not with oxygen. On 18Jan2021 the patient was tested positive with COVID-19 and on 19Jan2021 the patient died. Respiratory insufficiency was reported by the physician as fatal. Reported causes of death: Death and of/with COVID-19. The patient underwent lab tests and procedures, which included test results COVID-19 virus test on 06Jan2021 as negative, COVID-19 virus test on 13Jan2021 as unknown result, test lost, COVID-19 virus test on 18Jan2021 as positive; Oxygen saturation on 15Jan2021 as 92%, Oxygen saturation on Jan2021, 88%, Pulse rate on Jan2021 as 76, unit not specified. Only ordinary inquest was performed post-mortem. No findings were reported. The patient died on 19Jan2021.An autopsy was not performed and the reported cause of death was Respiratory insufficiency and COVID-19. Causality from the reporter: it is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient.; Reported Cause(s) of Death: COVID-19/ COVID-19 virus test, positive; COVID-19/ COVID-19 virus test, positive; Respiratory insufficiency


VAERS ID: 1048275 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Exposure to COVID-19; General physical health deterioration; Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158626

Write-up: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient; COVID-19; This is a spontaneous report from a contactable physician. This is a report received from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority number DK-DKMA-WBS-0032146. Safety Report Unique Identifier DK-DKMA-ADR 24693314. An 86-year-old male patient received the first dose of bnt162b2 (COMIRNATY), batch/lot number: ej6797, intramuscularly on 31Dec2020 at single dose for covid-19 immunisation. Medical history included ongoing general physical health deterioration, and the patient was living in nursing home where there was a covid-19 outbreak among several residents and staff (concurrent condition). There was no information regarding concomitant medication and past medication. On 10Jan2021 the patient died. Reported cause of death was death and of/with COVID-19. Only normal confirmation of death was performed post mortem. No findings were reported. An autopsy was not performed. The adverse drug reactions (ADRs) were by the physician reported as fatal. No treatment due to the ADRs was reported. The patient underwent lab tests which included Covid-19 virus test in Jan2021, positive. About causality, the physician stated that It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient; COVID-19


VAERS ID: 1048276 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-13
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COVID-19; General physical health deterioration; Living in nursing home (there was a covid-19 outbreak among several residents and staff)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021158625

Write-up: Covid-19; Death. It is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient.; This is a spontaneous report downloaded from the Regulatory Authority-WEB DK-DKMA-ADR 24693323. The case was received from a contactable physician via The Agency. A 92-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot number: ej6797, expiration date: 30Apr2021) intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Medical history included patient concurrent conditions included Covid-19 and general physical health deterioration and Living in nursing home in which there was a covid-19 outbreak among several residents and staff. Concomitant medications were not provided. The patient was death on 13Jan2021, which the reporting physician described the occurrence of death, it is not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient, in a 92 years old female patient vaccinated with bnt162b2. Reported cause(es) of death: Death and of/with COVID-19. Only normal confirmation of death was performed post mortem. The patient underwent lab tests and procedures, which included Covid-19 test on Jan2021 as positive. The patient died on 13Jan2021. An autopsy was not performed and the reported cause of death was death and COVID-19. Causality from the reporter: it was not inconceivable that the total liability of Covid-19 disease and the vaccination has been fatal for the patient. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19; Death


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