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| Table |
 |   | |
| Age | Count | Percent |
| 12-17 Years | 6 | 0.07% |
| 17-44 Years | 181 | 2.15% |
| 44-65 Years | 462 | 5.5% |
| 65-75 Years | 622 | 7.4% |
| 75+ Years | 1,959 | 23.31% |
| Unknown | 5,175 | 61.57% |
| TOTAL | 8,405 | 100% |
| Case Details |
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: Diarrhoea; This is a spontaneous report from a contactable other healthcare professional via Agency and downloaded from the Regulatory Authority GB-MHRA-WEBCOVID-20201212222117, Safety Report Unique Identifier GB-MHRA-ADR 24542707 and EU-EC-10007191252. An elderly patient of an unspecified gender received bnt162b2 (batch/lot number not provided), via an unspecified route of administration in 2020 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced diarrhoea in 2020. The patient died due to diarrhoea on 10Dec2020. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information on the lot/batch number not obtainable. No further information is expected.; Reported Cause(s) of Death: diarrhoea | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: Asystole; Circulatory collapse; This is a spontaneous report from a contactable pharmacist received from Agency and downloaded from the Regulatory Authority-WEB GB-MHRA-WEBCOVID-20201214111558, Safety Report Unique Identifier GB-MHRA-ADR 24542972 and EU-EC-10007191566 received via Regulatory Authority. An adult female patient received bnt162b2 (batch/lot number not provided), via an unspecified route of administration on 13Dec2020 at single dose for COVID-19 vaccination. The patient''s medical history was not reported. Concomitant medication included sildenafil, acetylsalicylic acid, allopurinol, levothyroxine, spironolactone, amiloride hydrochloride, furosemide and desogestrel. The patient experienced asystole on 13Dec2020, circulatory collapse on 13Dec2020. The patient died due to asystole and circulatory collapse on 13Dec2020. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information about batch number is not obtainable. No further information is expected.; Reported Cause(s) of Death: circulatory collapse; Asystole | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: the patient died; This is a spontaneous report from a contactable consumer through a Pfizer employee. A 98-99 years old patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration possibly on 27Dec2020 at single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient died on 29Dec2020. Event details: The Pfizer employee was informed, by a member of the Covid vaccine team at the ministry of health, that an elderly person 98-99 years old, who used to stay in an elderly home, who also had other serious diseases and received the vaccine possibly on 27Dec2020, had died this morning (29Dec2020). As it was mentioned to the Pfizer employee, they were ''sure'' that the cause of death did not related to the vaccine. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: unknown cause of death | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: cardiac arrest; heart failure; did not feel well, lost consciousness and died; did not feel well, lost consciousness and died; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 08:30 at single dose for covid-19 immunisation. Medical history included suffered from the past from heart attacks, active heart disease, malignant disease. The patient''s concomitant medications were not reported. A man of 75 years old, who suffers from many different background diseases, died (this morning 28Dec2020) from cardiac arrest, two hours after he received the injection. The man received the injection at 8.30am, and after he was feeling okay he was released to go home. After a while when he was home he did not feel well, lost consciousness and died, and he was pronounced dead from heart failure. The patient died on 28Dec2020. It was not reported if an autopsy was performed. The outcome of the event cardiac arrest and heart failure was fatal while the outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-2020517177 same reporter, same vaccine, reporting similar events in different patients.; Reported Cause(s) of Death: heart failure; cardiac arrest | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: found dead in his bed; This is a spontaneous report from a contactable healthcare professional received via the Ministry of Health department of epidemiology. The department of epidemiology reported similar events for two patients. This is the second of two reports. A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK4175), via an unspecified route of administration on 24Dec2020 as a single dose for COVID-19 immunization. Medical history included schizophrenia, very heavy smoker for almost 50 years, emphysema, and tumor resection in the bladder. The patient''s concomitant medications were not reported. On 28Dec2020, the patient was found dead in his bed. It was reported that the patient did not have any complaints in the days following the vaccination. Then, on 28Dec2020, the patient was found dead. The cause of death was unknown. It was not reported if an autopsy was performed.; Sender''s Comments: A reasonable possibility that the event unknown cause of death is related to vaccination with BNT162B2 cannot be completely excluded until further information regarding clinical course and death cause is provided. Of note, the patient did not have any complaints in the days following the vaccination. The case was confounded by the patient''s underlying conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 same reporter, same vaccine, reporting similar events in different patients.; Reported Cause(s) of Death: found dead in his bed | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: died the day after receiving the first injection of vaccine against Covid-19 in suspected cardiac arrest; This is a spontaneous report from a web page with a contactable physician as publisher. A multi-sick, elderly patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid vaccination. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient died the day after vaccination of a suspected heart stop. The patient died the day after receiving the first injection of vaccine against covid-19. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about LOT/batch number cannot be obtained.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular the following relevant information is not available: complete medical history and complete demographics, treatment dates and dose, concomitant medications (if any), event descriptors, autopsy report. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: suspected heart stop | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: deceased on 31Dec2020 with no previous side effect; This is a spontaneous report from a contactable physician via "Pfizer". An 87-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: "not known because vaccination team vaccinated at care home"), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient''s medical history included upper respiratory tract infection, changing patient weakness; both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced: deceased on 31Dec2020 with no previous side effect; which resulted in death on 31Dec2020. The clinical course was reported as follows: the patient received the first dose of the PFIZER-BIONTECH COVID-19 MRNA VACCINE on 29Dec2020; and the patient was deceased on 31Dec2020 with no previous side effect. The patient received the vaccination with a negative COVID-test on 25Dec2020; "in case of upper respiratory tract infection and changing patient weakness". The physician reported that "after good breakfast at 09:13 found without vital signs during routine control." The clinical outcome of the event was fatal. The patient died on 31Dec2020 due to unknown cause of death. It was unknown if an autopsy was performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender''s Comments: The limited information available does not allow a meaningful assessment by the company. The advance old patient had upper respiratory tract infection, changing patient weakness; further information such as complete medical history, concomitant treatments, particularly death cause and autopsy results are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: deceased on 31Dec2020 with no previous side effect | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: Sudden death; This is a spontaneous report from a contactable physician and consumer. A 41-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: UNKNOWN), via an unspecified route of administration on 30Dec2020 at 0.3 mL single dose for COVID-19 immunisation. Medical history included hypertension. The patient''s concomitant medications were not reported. On 01Jan2021, the patient experienced sudden death. The clinical course was as follows: The patient didn''t experience any adverse event at the moment of inoculation with COVID-19 vaccine or the following days. On 01Jan2021, at lunch time, two days after receiving the vaccine, the patient was found unresponsive in her bed by her partner. The cause of death was unknown. It was reported that an autopsy would be performed in the next days; the results were not yet available. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: The reported information is limited and does not allow a meaningful assessment of the case. It will be reassessed upon receipt of follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Sudden death | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: cardiac arrest; This is a spontaneous report from a contactable physician. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Dec2020 as single dose for covid-19 immunization. Medical history included asthma and a little overweight from an unknown date. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest on an unspecified date, which was serious as it lead to death. The patient died on an unspecified date. It was not reported if an autopsy was performed. This batch/lot number is not available despite the follow-up attempts made. No further information is expected.; Sender''s Comments: The reported information is limited and does not allow a meaningful assessment of the case. It will be reassessed upon receipt of follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: cardiac arrest | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: Atrial fibrillation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. The regulatory authority report number is GB-MHRA-EYC 00236011. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ0553), intramuscular on 18Dec2020 at 0.3 mL, single for covid-19 immunization. Medical history included ongoing hypothyroidism, ongoing diabetes, ongoing atrial fibrillation, ongoing frailty and, ongoing osteoporosis, all from unknown dates. Concomitant medication included prednisolone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), salbutamol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), doxycycline (MANUFACTURER UNKNOWN). The patient experienced atrial fibrillation on an unspecified date, which was serious as it was medically significant, involved hospitalization and lead to death. Clinical course was as follows: the patient was vaccinated. Consent was obtained and a pre immunization checklist was completed. She was observed following the administration of the vaccine, and no adverse effects were noted. She returned home. She became unwell and was admitted to hospital approximately 24 hours later. The patient was admitted to the hospital 24 hours following the vaccination, and subsequently died later, while in the hospital. The full clinical details were unknown, but the diagnosis from Accident & Emergency was atrial fibrillation. It is not clear if this had any relation to the vaccine that was administered, but could not be excluded, per the reporter. The patient died on 20Dec2020. It was not reported if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Atrial fibrillation | ||||||||||||||||
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https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=ON&VAX=COVID19&DIED=Yes&STATE=FR
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