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VAERS ID: 810943 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Nebraska  
Vaccinated:2019-04-18
Onset:2019-04-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UJ104AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X49147 / 2 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R007986 / 2 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Cardiac arrest, Death, Diarrhoea, Resuscitation
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), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-21
   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:
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: The child had seen his pediatric provider 2 days prior to presentation to emergency department and had immunizations. The day prior to presentation, the child was seen for loose stools. He was described as nontoxic in appearance and feeding okay with normal urinary output. Presented to the emergency department via ambulance with CPR in progress after suffering an in-home arrest. Resuscitation was terminated after patient''s arrival and patient was pronounced as deceased.


VAERS ID: 811041 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Death, Respiratory failure, Tryptase increased
SMQs:, Anaphylactic reaction (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 (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypokalaemia (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: CEFTRIAXONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Drug allergy; Hepatitis C; Hereditary onycho-osteodysplasia; Comments: hereditary onychoosteodysplasia
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2019SA111401

Write-up: Initial literature full article received on 08-Apr-2019 regarding an unsolicited valid serious case. This case was linked to 2019SA111409, 2019SA111422, 2019SA106595, 2019SA111434, 2019SA111441, 2019SA111446 (same literature). Literature abstract: Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Methods: We identified domestic reports of anaphylaxis within VAERS using a combination of Medical Dictionary for Regulatory Activity queries and Preferred Terms. We performed a descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given. We reviewed all serious reports and all nonserious reports with available medical records to determine if they met the Brighton Collaboration case definition for anaphylaxis or received a physician''s diagnosis. Results: During the analytic period, VAERS received 467,960 total reports; 828 met the Brighton Collaboration case definition or received a physician''s diagnosis of anaphylaxis: 654 (79%) were classified as serious, and 669 (81%) had medical records available. Of 478 reports in children aged less than 19 years, 65% were male; childhood vaccines were most commonly reported. Of 350 reports in persons aged 19 years or greater, 80% were female, and influenza vaccines were most frequently reported. Overall, 41% of reports described persons with no history of hypersensitivity. We identified 8 deaths, 4 among persons with no history of hypersensitivity. This case involves a 42 years old female patient who experienced Anaphylactic reaction, respiratory failure and increased serum tryptase level while she received vaccines INFLUENZA VACCINE (TRIVALENT). The patient''s past medical history included Asthma; Hereditary onycho-osteodysplasia; allergies to penicillin, quinolones, and naproxen; hepatitis C infection. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapy included ceftriaxone via intramuscular route. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a serious Anaphylactic reaction, respiratory failure and increased serum tryptase level, 2 minutes following the administration of INFLUENZA VACCINE, (TRIVALENT). These events were leading to death. Other lab test not reported. Final diagnosis was (fatal) Anaphylactic reaction, respiratory failure and increased serum tryptase level. It was not reported if the patient received a corrective treatment. It was not reported if an autopsy was performed. However, the cause of death was reported as Anaphylactic reaction.; Sender''s Comments: This case is from a literature article concerning a 02-year-old male patient who died due to anaphylactic reaction followed by cardiopulmonary arrest and increased tryptase 20 minutes after vaccination with INFLUENZA VACCINE (Inactivated influenza), MEASLES-MUMPS-RUBELLA VIRUS VACCINE and VARICELLA VACCINE. Past medical history included Hypoplastic left heart syndrome with subsequent cavopulmonary shunt procedure performed and periodic Cyanosis. Patient was born premature at 33 weeks gestation. Patient''s medical condition at time of vaccination and clinical course of the events are not reported. The cause of death was due to anaphylactic reaction and Postmortem lab tests revealed increased serum tryptase level. Rapid onset of symptoms after vaccination suggests vaccine played a role in this episode of anaphylaxis. Although, based upon the available information and nature of the event with multiple suspects, the role of individual vaccine cannot be assessed.; Reported Cause(s) of Death: Anaphylactic reaction.


VAERS ID: 811042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Autopsy, Death, Respiratory tract oedema, Tryptase increased, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: increased serum tryptase level; Result Unstructured Data: increased serum tryptase level
CDC Split Type: USSA2019SA111409

Write-up: Initial literature full article received on 08-Apr-2019 regarding an unsolicited valid serious case. This case was linked to 2019SA111401, 2019SA111422, 2019SA106595, 2019SA111434, 2019SA111441, 2019SA111446 (same literature). Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Conclusion: Anaphylaxis after vaccination is rare and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur. This case involves a 43 years old female patient who experienced anaphylactic reaction, while she received vaccines INFLUENZA VACCINE (QUADRIVALENT). The patient''s past medical history included hypertension; depression; patient had no hypersensitivities. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapy was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown site of administration. On an unknown date, within one day the patient developed a serious anaphylactic reaction with symptoms patches of urticaria, airway swelling increased (Respiratory tract oedema) and serum tryptase level increased following the administration of INFLUENZA VACCINE, (QUADRIVALENT). The event anaphylactic reaction was leading to death. Lab test included increased serum tryptase level. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. Autopsy was performed and the cause of death was reported as anaphylactic reaction. Outcome for all the events was fatal. List of document held: none; Sender''s Comments: This case is from a literature article concerning a 43-year-old female patient who died due to Anaphylactic Reaction followed by patches of urticaria and airway swelling following Morning after vaccination with INFLUENZA VACCINE (QUADRIVALENT). Time to onset is compatible. Past medical history included hypertension; depression but no hypersensitivities. Autopsy results confirming the cause of death was due to Anaphylactic Reaction. Further information with patient''s medical condition at time of vaccination, clinical course of the events, laboratory results, concomitant therapy, family history including respiratory allergies, such as asthma and drug allergies are needed to reassess the role of vaccine.; Reported Cause(s) of Death: Anaphylactic reaction.


VAERS ID: 811043 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Autopsy, Cardio-respiratory arrest, Death, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy NOS; Asthma; Chronic headaches; Gout; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2019SA111422

Write-up: Initial literature full article received on 08-Apr-2019 regarding an unsolicited valid serious case. This case was linked to 2019SA111401, 2019SA111409, 2019SA106595, 2019SA111434, 2019SA111441, 2019SA111446 (same literature). Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Conclusion: Anaphylaxis after vaccination is rare and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur. This case involves a 46 years old male patient who experienced acute asthmatic bronchitis, wheezing and subsequent cardiopulmonary arrest, while he received vaccine INFLUENZA VACCINE (TRIVALENT). The patient''s past medical history included, asthma; unspecified allergies; chronic headaches; gout and Hypertension. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapy was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a serious acute asthmatic bronchitis (asthma) with wheezing and had subsequent cardiopulmonary arrest (Cardio-respiratory arrest) (unknown latency) following the administration of INFLUENZA VACCINE, (TRIVALENT). The event acute asthmatic bronchitis was leading to death. Brighton level was 2. Lab test not reported. Final diagnosis was (fatal) Acute asthmatic bronchitis and subsequent cardiopulmonary arrest. It was not reported if the patient received a corrective treatment. It was not reported if an autopsy was performed or not, however documented cause of death was reported as acute asthmatic bronchitis. Outcome for all the events was fatal. List of document held: none; Sender''s Comments: This case is from a literature article concerning a 46-year-old male patient who died due to Acute asthmatic Bronchitis followed by wheezing with Subsequent cardiopulmonary arrest after vaccination with INFLUENZA VACCINE (TRIVALENT). Time to onset is unknown. Past medical history included Asthma; unspecified allergies; chronic headaches; gout; hypertension. Autopsy results confirming the cause of death was due to Acute asthmatic bronchitis. Further information with patient''s medical condition at time of vaccination and clinical course of the events, laboratory results, concomitant therapy, family history are needed for reassessment. Based upon the available information and considering the reported cause of death which is unrelated to vaccination, the role of individual vaccine is unlikely.; Reported Cause(s) of Death: Acute asthmatic bronchitis.


VAERS ID: 811044 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Medical History: None.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2019SA111434

Write-up: Initial information received from a literature article on 08-Apr-2019. This case is linked to cases 2019SA111409, 2019SA111401, 2019SA111422, 2019SA111446, 2019SA111441 and 2019SA106595 (same reporter). Literature abstract: Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Methods: We identified domestic reports of anaphylaxis within VAERS using a combination of Medical Dictionary for Regulatory Activity queries and Preferred Terms. We performed a descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given. We reviewed all serious reports and all nonserious reports with available medical records to determine if they met the Brighton Collaboration case definition for anaphylaxis or received a physician''s diagnosis. Results: During the analytic period, VAERS received 467,960 total reports; 828 met the Brighton Collaboration case definition or received a physician''s diagnosis of anaphylaxis: 654 (79%) were classified as serious, and 669 (81%) had medical records available. Of 478 reports in children aged less than 19 years, 65% were male; childhood vaccines were most commonly reported. Of 350 reports in persons aged 19 years or greater, 80% were female, and influenza vaccines were most frequently reported. Overall, 41% of reports described persons with no history of hypersensitivity. We identified 8 deaths, 4 among persons with no history of hypersensitivity. This case involves a 65 years old male patient who experienced anaphylactic reaction, while she received vaccine INFLUENZA VACCINE (TRIVALENT). Medical History: None. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious anaphylactic reaction with symptoms like airway oedema and cardiopulmonary arrest, 15 minutes following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. No lab data was reported. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. The patient was died on an unknown date. It was unknown if an autopsy was done. However, the cause of death was reported as Anaphylactic reaction. Document held by the sender: none.; Sender''s Comments: This literature article describes a case of 65 years old male patient who was died due to anaphylactic reaction after vaccination with INFLUENZA TRIVALENT VACCINE. Time to onset is compatible with the role of vaccine. However, there was no information regarding lab tests ruling out alternate etiologies. The result of Autopsy should be provided to fully assess the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Anaphylactic shock.


VAERS ID: 811045 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; Coronary artery disease; Comments: Relevant Medical History: No hypersensitivities
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2019SA111441

Write-up: Initial information regarding this serious valid case received from a literature article on 08-Apr-2019. This case is linked to cases 2019SA111409, 2019SA111401, 2019SA111422, 2019SA111434, 2019SA111446 and 2019SA106595 (same reporter). Literature abstract: Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Conclusion: Anaphylaxis after vaccination is rare and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur. This case involves a 70 years old male patient who experienced anaphylactic reaction, while he received vaccine INFLUENZA VACCINE (TRIVALENT). Patient had a medical history of chronic obstructive pulmonary disease and coronary artery disease but no hypersensitivities. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious anaphylactic reaction with breathing difficult (Dyspnoea) and cardiopulmonary arrest (Cardio-respiratory arrest) 258 minutes following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. No Lab data was reported. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. The patient was died on an unknown date. (outcome fatal). It was unknown if an autopsy was done. The documented cause of death was reported as anaphylactic reaction. Document held by the sender: none.; Sender''s Comments: This case concerns a 70-year old male infant who died due to anaphylactic reaction with symptoms like difficulty in breathing and cardiopulmonary arrest, 258 minutes after vaccination with INFLUENZA TRIVALENT VACCINE. It was further reported that the most probable cause of death could be anaphylactic reaction. Notably, a history of chronic obstructive pulmonary disease and coronary artery disease, can increase the likelihood of a severe or even fatal episode of anaphylaxis, however no conclusion on the cause of death can be made at this point, as no autopsy results are available. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Anaphylactic reaction.


VAERS ID: 811046 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Cardiac arrest, Death, Feeling abnormal, Hypotension, Syncope, Ventricular fibrillation, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: Hypertension; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2019SA111446

Write-up: Initial information received from a literature article on 08-Apr-2019. This case is linked to cases 2019SA111409, 2019SA111401, 2019SA111422, 2019SA111434, 2019SA111441 and 2019SA106595 (same reporter). Literature abstract: Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Methods: We identified domestic reports of anaphylaxis within VAERS using a combination of Medical Dictionary for Regulatory Activity queries and Preferred Terms. We performed a descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given. We reviewed all serious reports and all nonserious reports with available medical records to determine if they met the Brighton Collaboration case definition for anaphylaxis or received a physician''s diagnosis. Results: During the analytic period, VAERS received 467,960 total reports; 828 met the Brighton Collaboration case definition or received a physician''s diagnosis of anaphylaxis: 654 (79%) were classified as serious, and 669 (81%) had medical records available. Of 478 reports in children aged less than 19 years, 65% were male; childhood vaccines were most commonly reported. Of 350 reports in persons aged 19 years or greater, 80% were female, and influenza vaccines were most frequently reported. Overall, 41% of reports described persons with no history of hypersensitivity. We identified 8 deaths, 4 among persons with no history of hypersensitivity. This case involves a 84 years old female patient who experienced anaphylactic reaction, while she received vaccine INFLUENZA VACCINE (TRIVALENT). The patient''s past medical history included Drug hypersensitivity and Hypertension. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious anaphylactic reaction with symptoms like felt funny (feeling abnormal), ventricular fibrillation (later speculated because of hypotension), cardiac arrest, wheezing and collapsed (circulatory collapse) 2 min following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. No Lab data was reported. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. The patient was died on an unknown date. It was unknown if an autopsy was done. The cause of death was reported as Anaphylactic reaction. Document held by the sender: none.; Sender''s Comments: This case involves a 84-year-old female patient who was died due to anaphylactic reaction on an unknown date after vaccinated with INFLUENZA TRIVALENT VACCINE . The time to onset is compatible with the role of vaccine. Medical records indicate anaphylactic reaction. However, there was no information regarding lab tests ruling out alternate etiologies. The result of Autopsy should be provided to fully assess the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: anaphylactic reaction.


VAERS ID: 811125 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131904USA009137

Write-up: This spontaneous report as received from a consumer regarding unspecified female patients of unknown age. The information on medication history, concurrent conditions, concomitant medicaitons, drug allergies and reactions were unknown. On unknown dates, the patients were vaccinated with GARDASIL (dose, units, frequency, batch and lot# number, expiry date were unknown) for prophylaxis. Other suspect therapy include CERVARIX. On unknown dates, 879 patients experienced disability (from an unspecified adverse event), 99 patients died, 5352 patients did not recover (from an unspecified adverse event), 500 patients had abnormal papsmear, 202 patients experienced cervical dysplasia, 57 patients experienced cervix carcinoma, 502 patients had adverse event which was life threatening, 9545 patients had to visit emergency room (from an unspecified adverse event), 2717 patients were hospitalized and 218 patients extended the hospital stay (from an unspecified adverse event), 3625 experienced serious adverse events (from an unspecified medically significant adverse event), 25636 experienced non serious adverse events. The outcome of "disability (from an unspecified adverse event)", abnormal papsmear, cervical dysplasia, cervix carcinoma, "adverse event which was life threatening", "visit emergency room (from an unspecified adverse event)", "hospitalized and extended the hospital stay (from an unspecified adverse event)", unspecified medically significant adverse event and non serious adverse event was unknown. Causality assessment was unknown. Upon internal review, the events cervix carcinoma was determined to be medically significant. This is one of the multiple reports from the same reporter.


VAERS ID: 811126 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131904USA009240

Write-up: This spontaneous report as received from a consumer regarding unspecified female patients of unknown age. The patients current condition include prophylaxis. The information on medication history, concurrent conditions, concomitant medicaitons, drug allergies and reactions were unknown. On unknown dates, the patients were vaccinated with GARDASIL (dose, units, frequency, batch and lot# number, expiry date were unknown) for prophylaxis. Other suspect therapy include CERVARIX. On unknown dates, 9 patients experienced disability (from an unspecified adverse event), 8 patients died, 124 patients did not recover (from an unspecified adverse event), 16 patients had adverse event which was life threatening, 354 patients had to visit emergency room (from an unspecified adverse event), 65 patients were hospitalized, 5 patients extended the hospital stay (from an unspecified adverse event), 80 patients experienced serious adverse events (from an unspecified medically significant adverse event), 1169 experienced non serious adverse events. The outcome of "disability (from an unspecified adverse event)","adverse event which was life threatening", "visit emergency room (from an unspecified adverse event)", "hospitalized and extended the hospital stay (from an unspecified adverse event)", unspecified medically significant adverse event and non serious adverse event was unknown. Causality assessment was unknown. This is one of the multiple reports from the same reporter.


VAERS ID: 811352 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131904USA010149

Write-up: This spontaneous report was received from social media, refers to an unspecified group of young female patients (reported as young girls). The patient''s medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, frequency, route of administration, expiry date and lot # were not specified) for prophylaxis. It was reported in the social media report that dangerous bills were being processed, not only to mandate this lethal injection but to allow minors to receive it without parental consent. This vaccine was presented under the guise of prophylactic treatment to prevent STDs. GARDASIL was given to millions of young girls in more than 52 countries around the world. On unknown dates, GARDASIL had caused unfathomable suffering, loss of life (death) and unspecified injuries in the unspecified number of girls. Cause of death was not reported. It was unknown if autopsy was performed. Outcome of the events unfathomable suffering and unspecified injuries were not reported. Causality of the events were not reported. This is one of the several reports.; Reported Cause(s) of Death: loss of life (death).


VAERS ID: 811493 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2013-10-12
Submitted: 0000-00-00
Entered: 2019-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Arthralgia, Back pain, Brain oedema, Hypokinesia, Nausea, Pain, Paraesthesia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131904USA009465

Write-up: This spontaneous report was received from social media "Revolution For Choice", via a vendor regarding a 16 year old female patient. The patient''s medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot # and date of expiry were unknown) for prophylaxis. On an unknown date, the patient experienced swollen brain (brain oedema), anxiety, no movement (hypokinesia), tingliness (paraesthesia), pain/extreme pain/body pain, constant nausea, worst start to hurt her knees and back (back pain and arthralgia. The outcome of anxiety, back pain, body pain, arthralgia, nausea, pain, paraesthesia, hypokinesia and brain oedema was unknown. On 12-OCT-2013, the patient had died suddenly on bed. The cause of death was not reported. It was not reported if autopsy was performed. The causality assessment was not reported. Upon internal review, event of brain oedema was considered to be medically significant. This is one of the several reports.; Reported Cause(s) of Death: sudden death.


VAERS ID: 811494 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Injury, Pain
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131904USA010409

Write-up: This spontaneous report was received from social media, refers to unspecified number of young male patients. The patient''s medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with GARDASIL (dose, frequency, route of administration, expiry date and lot # were not specified) for prophylaxis. On an unknown date, the patients experienced injury (majority injuries) and pain (unfathomable pain). On an unknown date, the patients died due to unknown reason. It was also reported on an unknown date that, dangerous bills were passed to mandate the suspect GARDASIL (lethal injection) and also allow the minors to receive without "Parental Consent" as prophylactic treatment to prevent STD''s (sexually transmitted diseases) in millions of boys in more than 52 countries around the world. The outcome of pain and injury was unknown. The causality assessment was not reported. This was one of the several reports.


VAERS ID: 811881 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2019-03-05
Onset:2019-03-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. YF44209 / UNK RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. R016638 / UNK LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac disorder, Condition aggravated, Death, Product storage error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-30
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 19 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALBUTEROL [SALBUTAMOL]; INCRUSE ELLIPTA; CARVEDILOL; ATORVASTATIN; FUROSEMIDE; SPIRIVA; LISINOPRIL; CLOPIDOGREL; IPRATROPIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congestive heart failure; COPD; Coronary heart disease; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS201902617

Write-up: This is a spontaneous case, initially received from other health professional on 07-Mar-2019, concerning a 59-year-old, adult male patient. The patient''s current conditions included hypertension, coronary heart disease, chronic obstructive pulmonary disease (COPD) and biventricular congestive heart failure (reported as medical history). The patient''s concomitant medications included Albuterol, INCRUSE ELLIPTA, carvedilol, atorvastatin, furosemide, SPIRIVA, lisinopril, clopidogrel and ipratropium bromide. It was reported that on 11-Feb-2019, vaccines reached lowest temperature of 32.4 F (first excursion) and it was out of range for 1 hour. On 02-Mar-2019, temperature of the vaccines again reached 26.2 for 1 1/2 hours. On 05-Mar-2019, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: YF44209 and expiry date: 30-Jun-2019] which underwent temperature excursion for active immunization against influenza. On the same day, the patient was also administered with non-company suspect vaccine PNEUMOVAX [anatomical location: left deltoid, dose, route of administration, batch number and expiry date: not reported] for immunization against pneumococcal disease. It was reported that, on an unspecified date, the patient passed away due to cardiac complications of pre-existing medical conditions. The reporter assessed the case as non-serious. Case re-opened for completion of full data entry: 07-Mar-2019. Follow up received from other health professional on 17-Apr-2019: It was reported that they had no information on the patient, until they were recently informed that the patient passed away due to cardiac complications of pre-existing medical conditions. Hence, the event ''cardiac disorder'' with fatal outcome was added in the event tab. Hence, the classification ''special case with no AE'' was deleted in general tab. The case was upgraded from non-serious to serious. The case outcome was changed from unknown to fatal. The narrative and case comment were amended accordingly. Reporter''s Comments: A 59-year-old male patient with concurrent conditions hypertension, coronary heart disease, chronic obstructive pulmonary disease (COPD) and biventricular congestive heart failure was administered AFLURIA QUADRIVALENT vaccine which underwent temperature excursion. The patient died due to cardiac complications, unspecified period post vaccination. Despite the lack of onset latency, the company assessed the causality of the event cardiac disorder as not related, considering the pre-existing heart conditions as the alternative aetiology. The event incorrect product storage assessed as not related to suspect vaccine, considering the incidental nature of the event and the event drug administration error assessed as not related to suspect vaccine, considering the accidental nature of the event. The company assessed the event ''cardiac disorder'' as serious (medically significant). Reported Cause(s) of Death: Due to cardiac complications of pre-existing medical condition.


VAERS ID: 812751 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Allergic reaction to excipient, Death
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2019SA121062

Write-up: Initial information received on 30-Apr-2019 regarding an unsolicited valid serious case received from other health professional. This case involves male patient who died after a reaction to horse serum in a tetanus vaccine, while he received vaccine TETANUS TOXOID. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, patient died after a reaction to horse serum in a tetanus vaccine following the administration of TETANUS TOXOID. This event was leading to death. (Other relevant tests included no lab data.) Final diagnosis was (fatal) patient died after a reaction to horse serum in a tetanus vaccine. It was not reported if the patient received a corrective treatment. The outcome is reported as Fatal. It is unknown if an autopsy was done. The cause of death was reported as Allergic reaction to drug excipient. Information on the batch number was requested. Documents held by sender: none. Sender''s Comments: This case concerns a male patient of an unknown age who died after a reaction to horse serum in a tetanus vaccine after vaccination with TETANUS TOXOID produced by unknown manufacturer. No conclusion can be made at this point, as no autopsy results are available. This case lacks important data such as past medical history of the patient and of his family, medical circumstances in the previous days and autopsy findings, to assess it.. Reported Cause(s) of Death: reaction to horse serum in a tetanus vaccine.


VAERS ID: 812827 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2019188203

Write-up: This is a spontaneous report from a contactable consumer (who reported for the mother) via Pfizer sponsored program. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (unknown manufacturer) on an unspecified date at single dose for pneumococcal immunisation. The patient medical history and concomitant medications were not reported. The patient died of pneumonia on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Pfizer is the Marketing Authorization holder of pneumococcal 13-val conj vaccine (dipht crm197 protein) in reporter''s country. This may be a duplicate report in situations where another Marketing Authorization holder of pneumococcal 13-val conj vaccine (dipht crm197 protein) has submitted the same report to the regulatory authorities. No follow-up attempts are possible, information about batch number cannot be obtained. Reported Cause(s) of Death: died of pneumonia; died of pneumonia.


VAERS ID: 813123 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131905USA001628

Write-up: This spontaneous report was received from a journalist and refers to unspecified number of female patients of unknown age (reported as young). There was no information about the patients'' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with GARDASIL for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported). On unknown dates (reported as follow vaccinations), the patients experienced life-threatening or lethal side effects. The cause o f death was not provided. The outcome of the events was unknown. The relatedness between the events and the GARDASIL was not provided. This is one of several reports received from the same reporter. Sender''s Comments: US-009507513-1905USA003023: US-009507513-1905USA003024: US-009507513-1905USA003025: US-009507513-1905USA003113.


VAERS ID: 813426 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131905USA004177

Write-up: This spontaneous report was received from a physician, via a company representative, referring to four female patients of unknown age. The patients'' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (manufacturer unknown) for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients died. It was unknown if an autopsy was performed. The causality assessment was not provided.; Sender''s Comments: US-009507513-1905USA004181: US-009507513-1905USA004180: US-009507513-1905USA004179: US-009507513-1905USA004178: US-009507513-1905USA004182: US-009507513-1904USA013391:


VAERS ID: 813427 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131905USA004178

Write-up: This spontaneous report was received from a physician, via a company representative, referring to six male patients of unknown age. The patients'' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (manufacturer unknown) for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients died. It was unknown if an autopsy was performed. The causality assessment was not provided. ; Sender''s Comments: US-009507513-1905USA004181: US-009507513-1905USA004180: US-009507513-1905USA004179: US-009507513-1904USA013391: US-009507513-1905USA004182: US-009507513-1905USA004177:


VAERS ID: 813610 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2018-10-19
Onset:2018-10-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK UN / UN
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. - / UNK UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, Myocardial infarction, Myocarditis, Nausea
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-21
   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: aspirin; lisinopril; LOPRESSOR; NORCO; MIRALAX; XANAX
Current Illness: CHF and Cardiomyopathy
Preexisting Conditions: None known
Allergies: COREG; ketorolac; ROBAXIN; SKELAXIN; tramadol
Diagnostic Lab Data: Autopsy done 10/22/2018. Marked changes to the heart muscle suggests of remote myocarditis
CDC Split Type:

Write-up: Became nauseous all day Saturday and Sunday morning, had heart attack Sunday in morning


VAERS ID: 813993 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: New York  
Vaccinated:2019-05-04
Onset:2019-05-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 23JK5 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS201908

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of death nos in a 61-year-old male patient who received SHINGRIX (batch number 23JK5, expiry date 13th April 2020) for prophylaxis. On 4th May 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2019, 4 hrs after receiving SHINGRIX, the patient experienced death nos (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death nos was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death nos to be related to SHINGRIX. Additional details were provided as follows: The patient tolerated the SHINGRIX dose at the pharmacy with no noted issues. The reporter had no specific details on cause of death. Follow up information received on 9th May 2019: Following a review of the inventory status for batch number 23JK5 the entire batch has been distributed as of on 12th April 2019. With regards to the complaint history for this batch number to date there were two complaints neither of which were related to the nature of the reported adverse event. There was no product quality issue noted by the pharmacist upon vaccination and the cause of death for the patient was currently unknown. The pharmacist did not have reason to believe that the vaccine was compromised, but she would like further guidance to be certain. Reported Cause(s) of Death: Death NOS.


VAERS ID: 813998 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Virginia  
Vaccinated:2019-04-26
Onset:2019-05-13
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2019-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Respiratory arrest, Respiratory tract congestion, Skin warm
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was very congested, her body was very hot and she stopped breathing in her sleep.


VAERS ID: 814543 (history)  
Form: Version 2.0  
Age: 3.0  
Sex: Male  
Location: Unknown  
Vaccinated:2019-03-12
Onset:2019-03-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-05-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. R025297 / UNK UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Death, Sneezing
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Developmental delay; Facial dysmorphism; Hairy elbow syndrome; Muscle hypotonia; Short stature
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131905USA005765

Write-up: This spontaneous report as received from a physician via a company representative refers to a 3-year-old male patient with Wiedemann-Steiner syndrome (captured as short stature, developmental delay, muscle hypotonia, facial dysmorphism and hairy elbow syndrome). No other information regarding his pertinent medical history, drug reactions or allergies and concomitant medications was reported. On 12-MAR-2019, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot # R025297 has been verified to be a valid lot number, expiration date 08-JUN-2020) (exact dose, route of administration and injection site were not provided) as immunization for the prevention of pneumococcal disease. On 13-MAR-2019, he began to experience coughing and sneezing. The patient did not seek medical treatment for the events. On 14-MAR-2019, the patient died. The cause of death was unknown. It was unknown what medical intervention was sought or performed on 14-MAR-2019 or if an autopsy was performed. The outcome of the coughing and sneezing was unknown. The relatedness between the events and the suspect vaccine was not provided.


VAERS ID: 815315 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019AM

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that what adults did not know about vaccines could kill them. Many adults were unaware that vaccines kill. The reporter''s friend''s dad died from a flu shot. The reporter''s friend''s baby died from her 4 month vaccines (unspecified).; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 815530 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. 252226 / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Alpha 1 foetoprotein normal, Death, Death neonatal, Foetal exposure during pregnancy, Prenatal screening test, Ultrasound antenatal screen normal
SMQs:, Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Normal pregnancy conditions and outcomes (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE; RHOPHYLAC; HUMULIN; METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Down''s syndrome (The father of baby-maternal uncle with down syndrome.); Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 20181212; Test Name: MSAFP/serum markers; Result Unstructured Data: no major congenital malformations were noted. Test Date: 20181116; Test Name: Prenatal screening test; Result Unstructured Data: no major congenital malformations were noted on first trimester screening. Test Date: 20181212; Test Name: Prenatal screening test; Result Unstructured Data: no major congenital malformations were noted on second trimester screening. Test Date: 20190109; Test Name: Ultrasound scan; Result Unstructured Data: no major congenital malformations were noted.
CDC Split Type: USSEQIRUS201903453

Write-up: This is a spontaneous case, initially received from other health professional on 14-May-2019, concerning a female neonate patient. The patient''s family history included Down syndrome (father of baby-maternal uncle with Down syndrome). The patient''s mother was a 34-year-old who had 2 previous pregnancies reported with one previous spontaneous abortion and one previous full-term live birth. The patient''s maternal history included no congenital malformation and paternal history included Down syndrome. The current condition of patient''s mother included hyperthyroidism, anxiety, gestational and chronic hypertension, Rh-negative and diabetes mellitus. The concomitant medication of the patient''s mother included sertraline for hypertension, RHOPHYLAC (anti-D immunoglobulin) for Rh-negative, HUMULIN for diabetes mellitus and metformin for chronic hypertension. The patient''s mother did not use tobacco, alcohol or illicit drugs during pregnancy. The mother''s last menstrual period (LMP) date was 20-Aug-2018. On 06-Nov-2018, the patient''s mother had undergone ultrasound scan and no major congenital malformations were noted. On 09-Nov-2018, at the gestational age of 11 weeks, the patient''s mother received FLUCELVAX QIVc [route of administration: transplacental, batch number: 252226, dose, frequency, anatomical location and expiry date: not reported) for an unknown indication. The foetus was exposed to FLUCELVAX QIVc via transplacental route for an unknown indication. On 16-Nov-2018, the patient''s mother had undergone prenatal test (first trimester screening) and no major congenital malformations were noted. On 12-Dec-2018, the patient''s mother had had undergone prenatal test (second trimester screening) and no major congenital malformations were noted. On the same day, the patient''s mother underwent Maternal Serum Alpha-Fetoprotein Screening (MSAFP)/serum markers test and no major congenital malformations were noted. On 09-Jan-2019, the patient''s mother underwent prenatal test (anatomy ultrasound) and no major congenital malformations were noted. The patient''s mother gave a live birth to a female neonate at the gestational age of 37.1 weeks via vaginal method of delivery. The characteristics of the neonate included birth weight: 2806 grams, head circumference, length and appearance, pulse, grimace, activity, and respiration (APGAR) scores were not provided. No major congenital malformations (MCMs) were identified at birth. Six months after vaccination, the neonate died (reported as deceased). The mother''s estimated delivery date (EDD) was reported as 27-May-2019. The reporter assessed the case as serious (death). This case (201903453) is linked to 201903452 (mother case). Reporter''s Comments: A female neonate patient died (2 days post delivery), 6 months after maternal receipt of FLUCELVAX vaccine at 11 weeks of gestational age (considered as foetal exposure during pregnancy). The autopsy result is awaited. Considering the time frame of event, lack of detection of congenital anomalies in prenatal tests and post delivery, the event death assessed as not related to suspect vaccine. The maternal concurrent medical conditions hyperthyroidism, anxiety, gestational and chronic hypertension, Rh-negative and diabetes mellitus and concomitant medications are considered as risk factors. The case will be further assessed upon receipt of follow up information. The event foetal exposure during pregnancy assessed as not related considering the intended use of the vaccine. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 815652 (history)  
Form: Version 2.0  
Age: 0.5  
Sex: Female  
Location: Arizona  
Vaccinated:2019-05-21
Onset:2019-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 74FN7 / 3 LL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS FG97X / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X90022 / UNK LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R029814 / 3 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Death, Resuscitation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-22
   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: None
Current Illness: Mild congestion earlier in month. Ongoing teething.
Preexisting Conditions: None
Allergies: No known allergies
Diagnostic Lab Data: Hospital was where she was taken.
CDC Split Type:

Write-up: Child tolerated administration of vaccines well. Child left office with family after appointment. Our office was notified the following day (5/22/2019) that child died overnight. She was found unresponsive. She was taken to an Emergency Department. Resuscitation was attempted.


VAERS ID: 816253 (history)  
Form: Version 2.0  
Age: 0.58  
Sex: Male  
Location: Unknown  
Vaccinated:2002-11-12
Onset:2002-11-21
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2019-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U0904CA / 1 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNAGIS
Current Illness:
Preexisting Conditions: lung disease, high blood pressure
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe respiratory distress throughout the night prior to his death, requiring increased nebulizer treatments.


VAERS ID: 816579 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Georgia  
Vaccinated:2011-01-25
Onset:2011-01-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Chills, Death, Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-31
   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: None
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: SIDS
CDC Split Type:

Write-up: Fever chills DIED a week after.


VAERS ID: 817340 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Ohio  
Vaccinated:2019-01-15
Onset:2019-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W51924 / UNK AR / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Bladder catheterisation, Bladder dysfunction, Coma, Death, Hospice care, Immobile, Laboratory test, Pneumonia, Urinary tract infection
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-11
   Days after onset: 115
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: Carbidopa-levodopa
Current Illness: None
Preexisting Conditions: Parkinson''s; (old age?)
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Total immobility, terribly weak, bladder not working within days, eventual urinary tract infection w. use of catheter. Home w cath., in a few days, another U.R.I infection. My husband was given a pneumonia shot 1/15/19 after a routine Dr''s. visit, within weeks he had full blown pneumonia. He was totally immobile. He said, "get an ambulance". In Emer. room a great number of tests. Dr. looked in the room and said, "we don''t know what it is!" Days later, after admission to hospital we were told it was pneumonia. In days, his bladder quit and he was sporting a catheter. In days we were in a nursing home. He received some therapy, after 30 days they said he no longer needed "nursing" care, we came home and in three days he had a UTI. Back to the hospital, wearing diapers, weak, etc. 5 days in hosp. to another nursing home. Same nursing home where our 37 yr. old grandson is a patient. After ? days, another UTI antibiotics. Not much progress. Within days, comatose, eight days in that state. Dead late in day on May 11, with hospice in attendance. What an ordeal. All this after the pneumonia shot. Every day prior to these events, he was walking on the track and the "x" (a mile!). I can provide witnesses to verify this information!


VAERS ID: 817274 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Combined immunodeficiency syndrome (severe combined immunodeficiency disease)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: This case was reported in a literature article and described the occurrence of pneumonia in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included combined immunodeficiency syndrome (severe combined immunodeficiency disease). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed pneumonia. Serious criteria included death and GSK medically significant. The outcome of pneumonia was fatal. The reported cause of death was pneumonia. The investigator considered that there was a reasonable possibility that the pneumonia may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of pneumonia in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had severe combined immunodeficiency disease (SCID). No information on patient''s medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed pneumonia. On an unspecified date, the patient died. The cause of death was pneumonia. It was unknown if an autopsy was performed. This case has been considered as serious due to death. The treatment was unknown. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB". This is 1 of the 11 valid cases reported in this literature article. The article corresponding to this case is not available for submission due to copyright restriction. Reported Cause(s) of Death: Pneumonia.


VAERS ID: 817275 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Combined immunodeficiency syndrome (severe combined immunodeficiency disease)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included combined immunodeficiency syndrome (severe combined immunodeficiency disease). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the unknown cause of death may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of death not otherwise specified (NOS) in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had severe combined immunodeficiency disease (SCID). No information on patient''s medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as serious due to death. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB" This is 1 of the 11 valid cases reported in this literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 817276 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia, Respiratory failure
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)

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: HIV infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: This case was reported in a literature article and described the occurrence of respiratory failure in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included HIV infection. On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed respiratory failure. Serious criteria included death and GSK medically significant. Additional event(s) included pneumonia with serious criteria of GSK medically significant. The outcome of respiratory failure was fatal. The outcome(s) of the additional event(s) included pneumonia (unknown). The reported cause of death was respiratory failure. The investigator considered that there was a reasonable possibility that the respiratory failure and pneumonia may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of pneumonia and respiratory failure in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had human immunodeficiency virus (HIV) infection. No information on patient''s medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed pneumonia. On an unspecified date, the patient died. The cause of death was respiratory failure. It was unknown if an autopsy was performed. This case has been considered as serious due to death. The treatment was unknown. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB". This is 1 of the 11 valid cases reported in this literature article. The article corresponding to this case is not available for submission due to copyright restriction. Reported Cause(s) of Death: Respiratory failure.


VAERS ID: 817277 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Diarrhoea, Human bocavirus infection, Rotavirus test positive
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: IPEX syndrome (Immune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX) syndrome)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Stool analysis
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: This case was reported in a literature article and described the occurrence of human bocavirus infection in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included ipex syndrome (Immune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX) syndrome). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed human bocavirus infection. Serious criteria included death and hospitalization. Additional event(s) included diarrhea with serious criteria of hospitalization. The outcome of human bocavirus infection was fatal. The outcome(s) of the additional event(s) included diarrhea (unknown). The reported cause of death was human bocavirus infection. The investigator considered that there was a reasonable possibility that the human bocavirus infection and diarrhea may have been caused by Rotavirus vaccine. Relevant Tests: Lab tests were performed on unspecified date between Feb 2006 to Dec 2015. Patient''s stool sample tested for detection of rotavirus. Patient was found positive for rotavirus vaccine strain. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Stool analysis result was see text. Additional information was provided. This case was reported in a literature article and described the occurrence diarrhea and human bocavirus infection of in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had Immune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX) syndrome. No information on patient''s medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed diarrhea and subsequently, hospitalised. Patient''s stool sample tested for detection of rotavirus. Patient was found positive for rotavirus vaccine strain. On an unspecified date, the patient died due to human bocavirus infection. It was unknown if an autopsy was performed. This case has been considered as serious due to death/hospitalisation. The treatment was unknown. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB" This is 1 of the 11 valid cases reported in this literature article. Lab Comments: Lab tests were performed on unspecified date between Feb 2006 to Dec 2015. Patient''s stool sample tested for detection of rotavirus. Patient was found positive for rotavirus vaccine strain.; Reported Cause(s) of Death: Human bocavirus infection.


VAERS ID: 817681 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Areflexia, Autonomic nervous system imbalance, Biopsy, Bradycardia, CSF cell count, CSF lymphocyte count normal, CSF monocyte count increased, CSF protein increased, CSF red blood cell count, CSF white blood cell count negative, Computerised tomogram abnormal, Cytology normal, Death, Decreased vibratory sense, Dehydration, Demyelinating polyneuropathy, Electromyogram abnormal, Endotracheal intubation, Gait inability, Guillain-Barre syndrome, Hypotension, Immunoglobulin therapy, Mechanical ventilation, Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Plasmapheresis, Respiratory distress, Sepsis, Tachycardia, Walking aid user, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Brain metastases; Melanoma limited to extremity (right thigh melanoma resection 3 years before); Metastatic melanoma (BRAF-V600 wildtype)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Brain computerized tomography; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: CSF cell count; Result Unstructured Data: Test Result: negative cytology, Test Result Unit: unknown; Test Name: Cerebrospinal fluid lymphocyte count; Test Result: 44 %; Test Name: CSF monocyte count; Test Result: 56 %; Test Name: Cerebrospinal fluid protein; Test Result: 37 mg/dl; Test Name: Cerebrospinal fluid protein; Test Result: 91 mg/dl; Test Name: CSF red blood cell count; Result Unstructured Data: Test Result: 21, Test Result Unit: unknown; Test Name: CSF red blood cell count; Result Unstructured Data: Test Result: 0, Test Result Unit: unknown; Test Name: CSF white blood cell count; Result Unstructured Data: Test Result: 7, Test Result Unit: unknown; Test Name: CSF white blood cell count; Result Unstructured Data: Test Result: 0, Test Result Unit: unknown; Test Name: Electromyogram; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Nerve conduction studies; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Nuclear magnetic resonance imaging brain; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Physical examination; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: weakness of the lower and then upper; lost the ability to walk; Tendon reflex absent; respiratory distress; tachycardia; severely hypotension; possible sepsis; dehydration; Guillain-Barre syndrome/relapse of postvaccination GBS; dysautonomia; acute inflammatory demyelinating polyneuropathy; severely bradycardic; bilateral finger and toe paresthesia; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included nivolumab for metastatic melanoma. Concurrent medical conditions included melanoma limited to extremity (right thigh melanoma resection 3 years before), metastatic melanoma (BRAF-V600 wildtype) and brain metastases. On an unknown date, the patient received Flu vaccine at an unknown dose and nivolumab 240 mg at an unknown frequency. On an unknown date, 21 days after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria death, hospitalization and GSK medically significant), dysautonomia (serious criteria death and hospitalization), demyelinating polyneuropathy (serious criteria hospitalization and GSK medically significant), weakness of limbs (serious criteria hospitalization), unable to walk (serious criteria hospitalization), tendon reflex absent (serious criteria hospitalization), respiratory distress (serious criteria hospitalization and GSK medically significant), tachycardia (serious criteria hospitalization), hypotension (serious criteria hospitalization), bradycardia (serious criteria hospitalization and GSK medically significant), sepsis (serious criteria hospitalization and GSK medically significant), dehydration (serious criteria hospitalization) and paresthesia. The patient was treated with immunoglobulins nos (Immunoglobulin), prednisone, operations and procedures (Plasma Exchange) and mesalazine (Midodrine (Mesalazine)). The action taken with nivolumab was unknown (Dechallenge was unknown). On an unknown date, the outcome of the guillain barre syndrome and dysautonomia were fatal and the outcome of the demyelinating polyneuropathy, weakness of limbs, unable to walk, tendon reflex absent, respiratory distress, tachycardia, hypotension, bradycardia, sepsis, dehydration and paresthesia were unknown. The reported cause of death was guillain barre syndrome and dysautonomia. The reporter considered the guillain barre syndrome, dysautonomia, demyelinating polyneuropathy, weakness of limbs, unable to walk, tendon reflex absent, respiratory distress, tachycardia, hypotension, bradycardia, sepsis, dehydration and paresthesia to be related to Flu vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of Guillain-Barre Syndrome in a 66-year-old male who was vaccinated with unspecified flu vaccine (manufacturer unknown) for prophylaxis. He had a history of right thigh melanoma resection 3 years before. No information on patient''s family history or concomitant medication was provided. On an unspecified date, the patient received unspecified flu vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. The patient could be 65 or 66 years of age. The co-suspect product included Nivolumab. On an unspecified date, about 3 weeks after receiving a flu vaccination, the patient developed bilateral finger and toe paresthesia followed by weakness of the lower and then upper limbs. Examination 12 days after the onset of initial symptoms and a day after he lost the ability to walk revealed strength of 3/5 in upper-limb muscles, hip flexors, quadriceps, hamstrings, and 2/5 in the ankle dorsiflexors and plantar flexors, as assessed according to the Medical Research Council scale. Pinprick sensation was diminished up to the ankles and fingertips, vibration was lost at the toes, and deep tendon reflexes were absent at the knees and ankles. Cerebrospinal fluid (CSF) analysis showed white blood cell, 7 (56% monocytes, 44% lymphocytes); red blood cell, 21; protein, 37 mg/dL; and a negative cytology. A nerve conduction study 34 days after the flu vaccination demonstrated absent bilateral sural and right median sensory responses, prolonged distal and F wave latencies of the right median nerve, as well as very low amplitudes and very slow conduction velocities of all the motor responses. The results of nerve conduction study for the right median motor nerve were motor distal latency (MDL) was 8.2 milliseconds (ms) (normal value 4.1 ms), Distal amplitude was 1.0 millivolts (mV) (normal value 5.0), Proximal amplitude was 1.0 mV, conduction velocity in meter per second (CV (m/s)) was 44.5 (48.0), F Wave latency was found to be 40.5 mV (30.0). The results of nerve conduction study for the reft tibial motor nerve were MDL was found to be 5.8 ms (6.0), distal amplitude was 0.5 mV (5.0), Proximal amplitude was 0.07 mV, CV was 25.4 m/s (38.0). The results of nerve conduction study for the right tibial motor nerve were MDL was found 6.5 ms (6.0), distal amplitude was 0.15 mV (5.0), Proximal amplitude was 0.1 mV, CV was 23.5 m/s (38.0). The results of nerve conduction study for the right radial sensory nerve were distal amplitude was found to be 18.2 mV (15.0), CV was 57.5 m/s (50). The distal amplitude for the bilateral median sensory nerve was found to be 0 mV (15). The distal amplitude for the bilateral sural sensory nerve was found to be 0 mV (5). Needle electromyography (EMG) showed neurogenic recruitment in all the muscles tested in bilateral lower and right upper limbs and positive waves/fibrillation potentials in the cervical and lumbar paraspinal muscles. He was diagnosed with postvaccination GBS, and intravenous immunoglobulin (IVIg) 2 g/ kg was then administered over a period of 5 days. Brain MRI showed a 4 X 5-mm enhancing lesion with associated T2 hyperintensity and restricted diffusion in the right superior medial precentral gyrus, consistent with a brain metastasis. Computed tomography scan of the abdomen and pelvis showed multiple hepatic hypodense nodules, biopsy of which demonstrated metastatic melanoma, BRAF-V600 wildtype. His weakness initially improved after IVIg treatment to the point that he was able to ambulate 100 feet with an assistive device. However, his weakness worsened about 3 weeks later when he lost his ability to ambulate. At that time, the treating physicians considered the possibility of acute onset chronic inflammatory demyelinating neuropathy or paraneoplastic neuropathy. He then received IVIg 1 g/kg divided over a period of 2 days and was started on prednisone 60 mg/day and received nivolumab 240 mg, which was repeated after 13 days. His motor strength further declined dramatically about 12 days after the first dose of nivolumab, so that he was unable to sit in the wheelchair, resulting in his transfer to hospital. Physical examination revealed motor strength of 3/5 in upper extremities, 1/5 hip flexion and hip extension, and 0/5 in remaining lower extremity muscle groups. His deep tendon reflexes were trace in the upper extremities and absent at the knees and ankles, and there was diminished pinprick sensation in stocking/glove distribution and absent vibratory sensation at the toes. CSF analysis showed white blood cell, 0; red blood cell, 0; and protein, 91 mg/dL. A follow-up EMG study 91 days after the flu vaccination showed severely prolonged distal latencies, reduced amplitudes, very slow conduction velocities, and markedly prolonged F wave latencies. Temporal dispersion of the compound muscle action potential was present with distal stimulation of all the motor nerves, and there was conduction blocks in the right ulnar motor response with stimulation below and above the elbow. On day 91 after vaccination nerve conduction study was performed, The results of nerve conduction study for the right median motor nerve were MDL was 20.52 ms (4.1), distal amplitude was 1.0 mV (5.0), Proximal amplitude was 0.9 mV, CV was 26.5 m/s (48.0), F Wave Lat. was 66.0 mV (30.0). The results of nerve conduction study for the right ulnar motor nerve were MDL was 6.51 ms (3.8), distal amplitude was 1.0 mV (5.0), proximal amplitude was 0.6 mV (B.elbow) and 0.3 mV (A.elbow), CV was 27.2 m/s (48.0) and 21.6 m/s (48.0), F Wave Lat. (mV) was not reported (31.0). The results of nerve conduction study for the left tibial motor nerve were MDL was 18.28 ms (6.0), Distal amplitude was 0.3 mV (5.0), proximal amplitude was 0.1 mV, CV was found to be 16.1 m/s (38.0). The results of nerve conduction study for the right peroneal motor nerve were MDL was 22.5 ms (6.0), distal amplitude was 0.1 mV (3.0), proximal amplitude was 0.0 mV. The distal amplitude for the right radial sensory nerve, Bilateral median sensory nerve and Bilateral sural sensory nerve was respectively found to be 0 mV (15), 0 mV (15) and 0 mV (5). Needle EMG showed positive waves and fibrillation potentials and no motor unit activation in the right tibialis anterior and quadriceps, as well as severely reduced recruitment in right first dorsal interosseous, biceps, and deltoid. Antibodies to ANNA-1, Amphiphysin, ANNA-2, CRMP-5, PCA-1, PCA-2, PCA-Tr, GM1, and GD1b were negative. On day 2 of hospitalization, he developed respiratory distress, tachycardia, and hypotension. He was intubated and placed on mechanical ventilation, and then started on plasma exchange (PLEX). During the hospitalization, there were wide fluctuations in heart rate and blood pressure, which were partly attributed to dysautonomia secondary to acute inflammatory demyelinating polyneuropathy (AIDP) because they were persistent between the sessions of PLEX and present after other potential causes such as possible sepsis and dehydration were appropriately treated. He was started on midodrine on day 5 of hospitalization, but on day 9 became severely hypotensive and bradycardic, requiring pressure support, and subsequently expired as the family withdrew life-sustaining therapies. His GBS disability score during the course of his disease starting with administration of influenza vaccine was 2 (between day 20 and 30); 2-4 (between day 30 and 40), 3-4 (between day 40 and 60), 3-4 (between day 60 and 90), 5-6 (between day 90 and 100). Dysautonomia contributed to fatal outcome in the patient. It was unknown if autopsy was performed. The case is considered serious due to death and hospitalization. The author considered the event of Guillain-Barre Syndrome related to unspecified flu vaccine. The author stated ?The subacute course of the neuropathy in our patient and the timing of vaccination were consistent with a postinfluenza virus vaccination GBS''. The authors concluded, ?Our patient is the first report of severe GBS relapse after treatment with nivolumab, which was administered during a treatment-related fluctuation. We conclude that administration of checkpoint inhibitor. treatment during the acute stage of GBS may result in a severe, potentially fatal exacerbation and recommend exercising caution in starting administration of such treatments in patients who are in the acute stage or early in the recovery phase of GBS. Further studies for targeted therapies to treat life threatening AEs are warranted". Lab Comments: Lab tests were performed on unspecified dates A nerve conduction study 34 days after the flu vaccination demonstrated absent bilateral sural and right median sensory responses, prolonged distal and F wave latencies of the right median nerve, as well as very low amplitudes and very slow conduction velocities of all the motor response; needle electromyography (EMG) showed neurogenic recruitment in all the muscles tested in bilateral lower and right upper limbs and positive waves/fibrillation potentials in the cervical and lumbar paraspinal muscles. His motor strength further declined dramatically about 12 days after the first dose of nivolumab, so that he was unable to sit in the wheelchair, resulting in his transfer to our center. Physical examination revealed motor strength of 3/5 in upper extremities, 1/5 hip flexion and hip extension, and 0/5 in remaining lower extremity muscle groups. His deep tendon reflexes were trace in the upper extremities and absent at the knees and ankles, and there was diminished pinprick sensation in stocking/glove distribution and absent vibratory sensation at the toes. A follow-up EMG study 91 days after the flu vaccination showed severely prolonged distal latencies, reduced amplitudes, very slow conduction velocities, and markedly prolonged F wave latencies. Temporal dispersion of the compound muscle action potential was present with distal stimulation of all the motor nerves, and there was conduction blocks in the right ulnar motor response with stimulation below and above the elbow. Needle EMG showed positive waves and fibrillation potentials and no motor unit activation in the right tibialis anterior and quadriceps, as well as severely reduced recruitment in right first dorsal interosseous, biceps, and deltoid. Antibodies to ANNA-1, Amphiphysin, ANNA-2, CRMP-5, PCA-1, PCA-2, PCA-Tr, GM1, and GD1b were negative.; Reported Cause(s) of Death: Guillain Barre syndrome; dysautonomia


VAERS ID: 818175 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Michigan  
Vaccinated:2019-04-01
Onset:2019-04-15
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2019-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 445J4 / 2Y9R4 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Dysarthria, Hallucination, Laboratory test, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-23
   Days after onset: 38
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KETOCONAZOLE 2% CREAM, PRIMIDONE, DOXAZOSIN MESYLATE, LISINOPRIL, CALCIUM, ASA 81MG, LASIX, POTASSIUM, VIT D, ALENDRONATE, AMLODIPINE, CITALOPRAM HYDROBROMIDE, ATORVASTATIN CALCIUM, NAPROXEN, ALBUTEROL INH & NEBULIZER, BUDESONIDE/FORMOTER,
Current Illness: NONE KNOWN
Preexisting Conditions: 1. Hypertension 2. Hyperlipidemia 3. Peripheral Vascular Disease 4. Abdominal Aortic Aneurysm 5. Congestive heart failure 6. Lymphedema of lower extremities 7. H/O DVT 8. Vitamin B12 Deficiency 9. Vitamin D Deficiency 10. Chronic Obstructive Pulmonary Disease 11. Sleep Apnea 12. Gastroesophageal Reflux Disorder 13. Colon Polyp 14. Benign Prostatic Hypertrophy 15. Polyarthralgia 16. Osteopenia/Osteoporosis 17. Anxiety disorder 18. Onychogryphosis 19. Dermatophytosis 20. Partial Hearing Loss 21. Obesity
Allergies: NKDA
Diagnostic Lab Data: Unsure of all tests done.
CDC Split Type:

Write-up: Patient''s daughter called the clinic to inform the staff that the patient passed away. She reports that a couple of weeks after getting the vaccine, the patient began experiencing weakness in his knees, slurring of his words and developed hallucinations. Patient was ultimately admitted to ER and passed away 10 days later.


VAERS ID: 818256 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Virginia  
Vaccinated:2019-03-19
Onset:2019-03-28
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2019-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 2HC47 / 1 LL / SYR
UNK: VACCINE NOT SPECIFIED (OTHER) / UNKNOWN MANUFACTURER UI959AAB / 1 LL / SYR
UNK: VACCINE NOT SPECIFIED (OTHER) / UNKNOWN MANUFACTURER X49142 / 1 RL / SYR
UNK: VACCINE NOT SPECIFIED (OTHER) / UNKNOWN MANUFACTURER G3747 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-28
   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:

Write-up: death


VAERS ID: 818499 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Colorado  
Vaccinated:2019-06-06
Onset:2019-06-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UJ096AAA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. R021370 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X70863 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R029817 / UNK OT / OT

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Cardiac arrest, Death, Incorrect route of product administration, Respiratory arrest, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-08
   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: Aspirin, Lasix, Digoxin
Current Illness: Cough
Preexisting Conditions: Hypoplastic Left Heart syndrome Pulmonary Valve Disease
Allergies: None Known
Diagnostic Lab Data: Autopsy in process.
CDC Split Type:

Write-up: Patient quit breathing at home on 06/08/19. Parents started CPR and called 911. Patient taken to hospital, arrived in asystole. Unable to be revived. Underlying medical conditions as noted above. *Note - RotaTeq vaccine given via G-Tube*


VAERS ID: 818703 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Illinois  
Vaccinated:2019-06-12
Onset:2019-06-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 74FN7 / UNK RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. R027327 / UNK LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X93780 / UNK RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R034878 / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: fetal growth restriction, hypospadias
Allergies: none
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Unknown-Received a call that patient died 6/12/2019 @ Hospital


VAERS ID: 818717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019AM

Write-up: death; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter''s friend''s father died after flu shot. The reporter stated that either the vaccines are safe or they are not.; Reported Cause(s) of Death: Death NOS


VAERS ID: 819042 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131906USA003831

Write-up: Death; Herpes zoster; This spontaneous report was received from a lawyer and patient''s spouse regarding a case in litigation referring to male patient who would be 76-year-old. No information was provided regarding medical history, concurrent conditions or concomitant medications. On an unknown date in 2013, at approximately age of 70, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. On an unspecified date, the patient died. The cause of the patient''s death is unknown. It is unknown if an autopsy was performed. The outcome of the event herpes zoster was not reported. The reporter considered the death and herpes zoster to be related to zoster vaccine live (ZOSTAVAX).; Reported Cause(s) of Death: Death


VAERS ID: 819187 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: New Hampshire  
Vaccinated:2018-11-29
Onset:2018-11-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5527AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. R006746 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R013288 / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, Diet refusal, Lethargy, Microscopy, Toxicologic test
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: Full Body & Brian Autopsy: Internam examination Microscopic examination Toxicology
CDC Split Type:

Write-up: Vaccines were given in the morning of 11/29/2018. Pt was lethargic and was refusing to eat. On 11/29/2018 pt passed away in his crib, sleeping around 10:45am.


VAERS ID: 819224 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Rash, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 47 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019AM

Write-up: rash; thrombocytopenia; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a 5-day-old male patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, less than a day after receiving Hepatitis B vaccine, the patient experienced rash (serious criteria death and hospitalization) and thrombocytopenia (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the rash and thrombocytopenia were fatal. The reported cause of death was rash and thrombocytopenia. It was unknown if the reporter considered the rash and thrombocytopenia to be related to Hepatitis B vaccine. Additional details were provided as follows: Within 12 hours after vaccination, the patient had a rash and within 24 hours severe thrombocytopenia set in and he was in fatal state from then on. The patient suffered nearly his entire life. His parent''s literally lived at the hospital and never left his side. The patient lived for 47 days after receiving the vaccine. No doctors, nurses, staff would even consider the vaccination as the source.; Reported Cause(s) of Death: Rash; Thrombocytopenia


VAERS ID: 819648 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Human papilloma virus test positive, Papilloma viral infection
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131906USA005971

Write-up: patient died; tested post mortem blood samples and found fragments of foreign DNA in her spleen and these were positive for human papilloma virus; This spontaneous report has been received from a physician as a social media post referring to a female patient of unknown age.Information on patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with third dose Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, anatomical location, route, lot# and expiry date was not reported) for prophylaxis. On an unknown date, the patient died in her sleep six months after her third Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection due to unknown reason. On an unknown date, the autopsy (reported as post-martem blood test) was performed which showed fragments of foreign deoxyribose nucleic acid (DNA) in patient''s blood and spleen and those samples were positive for human papilloma virus (HPV) (Human papilloma virus test positive). Physician also reported that it was not the result of natural HPV infection, most likely the DNA was bound to aluminum, which was also found in the patient. The physician further mentioned that HPV gene was foreign DNA and its detection six months after the injection was not normal. The physician also tested five samples of the vaccine sent from somewhere else and found HPV vaccine in each. Causality assessment between the events and the suspect therapy was unknown.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 819943 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Wisconsin  
Vaccinated:2019-05-24
Onset:2019-05-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2019-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: I don?t know what hep b they gave him just that it was the hep b shot. His records are closed right now. He died exactly a week later on the 31st of May. We had some people say to report his death to you just in case. He didn?t have any other symptoms so I have no idea if it?s related. As of now we are being told it was sids.


VAERS ID: 820360 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: South Carolina  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131906USA007946

Write-up: Wrongful death; Shingles; This initial spontaneous report was received from a lawyer and patient representative regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. In 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Shingles and she was treated by a physician for the event. On an unspecified date the patient died. It was unknown the cause of the death as well as whether an autopsy was performed. The outcome of the event herpes zoster was not reported. The reporter considered the events of shingles and wrongful death to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of death was considered to be medically significant. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 820916 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, H1N1 influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: Suspected vaccination failure; swine flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and swine influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the swine influenza was fatal. The reported cause of death was swine influenza. It was unknown if the reporter considered the vaccination failure and swine influenza to be related to Influenza vaccine. Additional information was provided as follows: The age at vaccination was not reported. This case was reported by the patient''s brother. The patient received Flu shot and had swine flu. As per reporter, the patient died from this flu shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.; Reported Cause(s) of Death: Swine flu


VAERS ID: 821397 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: Death NOS; This case was reported in a literature article and described the occurrence of unknown cause of death in a 12-year-old female subject who received HPV vaccine unknown for prophylaxis. On an unknown date, several hours after receiving HPV vaccine unknown, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to HPV vaccine unknown. Additional information was provided. This case was reported in a literature article and described the death NOS in a 12-year-old female who was vaccinated with unspecified human papillomavirus (HPV) vaccine (manufacturer unknown) case for prophylaxis. The patient was a part of the study that employed the Twitter data to understand content characteristics and the patterns of content flow of the conversations about the HPV vaccine debate. [In this study, Twitter activity related to HPV vaccination was collected in one-week period datasets, started from 20th September 2016 for ten weeks]. No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received the injection of unspecified HPV vaccine (administration site and route unspecified; dosages unknown; batch number not provided). On an unspecified, hours after vaccination, the patient died. The cause of death was not reported. It was unknown if an autopsy was performed. The authors did not comment on the relationship between the event of ?death NOS'' and unspecified HPV vaccine. The authors stated, "Our findings show that positive emotion is positively correlated with cluster density, an indicator of strong ties and rapid information flow. In the case of negative emotion, we found that anger is a significant negative predictor for graph density. We also found a correlation between certainty and tentativeness; both at cluster as well as at tweet level, suggesting that clusters bring together people who are sure about the HPV vaccine and people who are exploring for answers." The article corresponding to this case is not available for regulatory submission due to copyright restriction. This is 1 of the 3 valid cases reported in the same literature article.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 821408 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Nevada  
Vaccinated:2019-04-29
Onset:2019-04-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abnormal behaviour, Crying, Death, Endotracheal intubation, Malaise, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Dementia (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lovenox shot, blood pressure medicine. Lasix and one other
Current Illness: He had 2 viruses.
Preexisting Conditions: He had down syndrome and 2 heart defects. One was repaired other we were waiting to have repaired
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: He had gotten his 2 month old shots because he was behind due to a 10 week stay in the hospital. That night i he was crying. I thought it had to do with vaccines. I gave him tylenol like the drs had said. It cintinued thru the night. Next morning I went to his gi Dr. Told her he was pulling. She said its normal when they are sick. I went home. Took a nap w9ke up to him crying. I called his drs office and said he had to be seen. I drive there. And as I took him out of his car seat. He stopped breathing. They did cpr but werent successful. Paramedic arrived and incubated him. Went to the er where they pronounced he was dead


VAERS ID: 822551 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Louisiana  
Vaccinated:2015-04-28
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Herpes zoster disseminated, Multi-organ disorder
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-07-03
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: Routine health maintenance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131907USA002868

Write-up: severe outbreak of disseminated shingles/ affected other organs and other bodily systems; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. Pt visited pharmacy to fill a prescription and pharmacist suggested that she should get zoster vaccine live (ZOSTAVAX) vaccination. On 28-APR-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, on or before 01-JUN-2015, pt suffered a severe outbreak of disseminated shingles that eventually covered her body which forced her to be admitted to hospital. Due to the debilitating and severe shingles outbreak, which affected other organs and other bodily systems, pt died on 03-JUL-2015. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt''s injuries and death were caused by the zoster vaccine live (ZOSTAVAX) vaccine. Due to the shingles and resulting injuries, pt suffered excruciating physical pain and suffering, mental anguish and emotional distress, and loss of enjoyment of life prior to her death. Upon internal review, the event of disseminated shingles was considered to be medically significant.; Reported Cause(s) of Death: severe outbreak of disseminated shingles/ debilitating and severe shingles outbreak which affected other organs and other bodily systems


VAERS ID: 822687 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2019288834

Write-up: My mother got a pneumonia vaccine and died of pneumonia.; My mother got a pneumonia vaccine and died ofpneumonia.; This is a spontaneous report from a contactable consumer (patient''s son/daughter) from a Pfizer Sponsored Program Comscore DTC Ad Testing with Pricing Language. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient got a pneumonia vaccine on an unspecified date and died of pneumonia on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 823271 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: California  
Vaccinated:2019-07-01
Onset:2019-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 4RB3J / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Decreased appetite
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS201912

Write-up: Death / Death NOS; Had not eaten; This case was reported by a physician via call center representative and described the occurrence of unknown cause of death in a 6-week-old female patient who received HBV (Engerix B) (batch number 4RB3J, expiry date unknown) for prophylaxis. On 1st July 2019, the patient received Engerix B. On 2nd July 2019, 1 days after receiving Engerix B, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and appetite absent. On 2nd July 2019, the outcome of the unknown cause of death was fatal and the outcome of the appetite absent was recovered/resolved. The patient died on 2nd July 2019. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death to be related to Engerix B. It was unknown if the reporter considered the appetite absent to be related to Engerix B. Additional details were provided as follows: The patient was not known to have any pre-existing health conditions. The patient had not eaten since the morning of 2nd July 2019 (for 12 hours) and died on the way to the hospital. The patient''s parents believed that, the patient''s death was due to the vaccine. But the physician stated that, the patient could had passed away due to other reasons, of which she did not provide. The reporter also stated that, two other patients received vaccines of the same lot and nothing had been reported. The physician would like to be followed up with as soon as possible so she would know what the next steps would be for investigation. No other details were provided.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 823475 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2019-07-10
Onset:2019-07-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS E97CH / 1 LA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 37RY4 / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-11
   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: Unknown
Current Illness: Unknown
Preexisting Conditions: Hepatitis C
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died 7/11/2019


VAERS ID: 823707 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Female  
Location: Kentucky  
Vaccinated:2019-06-26
Onset:2019-07-11
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2019-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UJ096AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X62332 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R027191 / 2 MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Meningitis, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt''s mother states that pt had fever for 24hrs, stopped breathing and was rushed to Hospital, but was deceased on arrival. Coroner contacted mother and informed her that pt appeared to have had meningitis (H. Flu), but death listed as non-conclusive.


VAERS ID: 823758 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:2019-06-20
Onset:2019-07-04
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2019-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Blood culture negative, Brain death, Brain herniation, CSF culture negative, CSF test normal, Computerised tomogram head abnormal, HIV test negative, Herpes simplex test negative, Laboratory test, Malaise, Polymerase chain reaction, Posturing, Pyrexia, Respiration abnormal, Respiratory viral panel, Seizure, Ventricular drainage, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Bactrim for acne prophylaxis
Current Illness: None
Preexisting Conditions: Acne
Allergies: None
Diagnostic Lab Data: HIV, respiratory viral panel, HSV CSF PCR negative. Blood and CSF cultures negative. Autopsy testing pending. Encephalitis panel submitted by outside hospital.
CDC Split Type:

Write-up: The patient was visiting, where she received the Men B vaccine about 2 weeks before presenting to our hospital gravely ill. Within days of receiving the vaccine she developed malaise. A few days before presenting to our hospital she developed subjective fevers and worsening malaise. On the day of presentation she had persistent vomiting, then had a seizure (no history of seizures) that was treated with anti-epileptics at an outside hospital. She was transferred to our institution and, en route, developed agonal breathing and abnormal posturing, with uncal herniation found on head CT soon after arrival. She received ceftriaxone and acyclovir and underwent external ventricular drain placement, but was declared brain dead <24 hours after arrival at our hospital. Autopsy is underway, but no causative agent has been identified yet. - Note: As the MenB vaccine was given somewhere else, we do not know the exact date / details of the vaccine (date listed in this form is estimated, as the family stated it was given 2 weeks before she presented to our hospital on 7/4/19)


VAERS ID: 824300 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumococcal infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131907USA005332

Write-up: The unspecified patient received a dose of PNEUMOVAX 23 on an unspecified date. The patient died, on an unspecified date a few years later.; Pneumococcal infection; This spontaneous report was received from a physician via a company representative concerning to a female patient in her 70''s. The patient''s concurrent conditions included diabetes mellitus. The patient''s medical history, allergies, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route of administration, lot # and expiration date were not provided). The reporter indicated that on an unknown date (reported as "a few years later" after the vaccination), the patient was hospitalized, and she had may been experienced a pneumococcal infection. On an unknown date, she died from an unknown cause of death, at an unspecified hospital. It was also unknown if treatment was given fir the adverse events, if laboratory diagnostics or studies were performed or if the patient sought medical attention. The causality assessment between the events pneumococcal infection and the patient''s death and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. Upon internal review, the pneumococcal infection was considered to be a medically significant event.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 825382 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Iowa  
Vaccinated:0000-00-00
Onset:2017-08-24
Submitted: 0000-00-00
Entered: 2019-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131907USA012451

Write-up: shingles; died; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient that currently would be 76 years old. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2009, the patient (pt) was inoculated with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions by a pharmacist at the pharmacy.On an unknown date, the pt suffered from the following injuries resulting from pt''s zoster vaccine live (ZOSTAVAX) use: shingles. Pt received unspecified treatment from a healthcare provider at a hospital. Pt died due to unknown reason on 24-AUG-2017. It was unknown if autopsy was performed. The outcome of shingles was unknown. The events were considered to be related to the suspect therapy.


VAERS ID: 825394 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Ill-defined disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS201904102

Write-up: Health Problems; This is a spontaneous case, initial and follow up versions, received on 03-Jul-2019 (both versions being processed together), concerning a patient of unspecified age (reported as sixties) and gender. On an unspecified date, the patient was administered INN Flu Vaccine Pandemic (reported as swine flu vaccine) [influenza virus vaccine monovalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication. On an unspecified date after vaccination, the patient developed unspecified health problems (ill-defined disorder). It was reported that the patient was in 60s and ended up dying. It was unknown whether autopsy was performed. The reporter assessed the case as serious (death). Significant case amendment (03-Jul-2019): The report type of the case was changed from invalid to valid in the general tab. The determined causality and reported causality in the event assessment tab were amended accordingly. The narrative was amended accordingly.; Reporter''s Comments: A patient of unspecified age (reported as sixties) and gender developed unspecified health problems (ill-defined disorder), on an unknown day after administration of INN Flu Vaccine. The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported event, vaccination details, concurrent medical conditions, autopsy report and investigations to provide alternate aetiologies. Hence the causal role of suspect vaccine was assessed as unassessable. The case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Health problems


VAERS ID: 825395 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Ill-defined disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS201904103

Write-up: Health problems; This is a spontaneous case, initial and follow up versions, received on 03-Jul-2019 (both versions being processed together), concerning a patient of unspecified age (reported as sixties) and gender. On an unspecified date, the patient was administered INN Flu Vaccine Pandemic (reported as swine flu vaccine) [influenza virus vaccine monovalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication. On an unspecified date after vaccination, the patient developed unspecified health problems (ill-defined disorder). It was reported that the patient was in 60s and ended up dying. It was unknown, whether autopsy was performed. The reporter assessed the case as serious (death).; Reporter''s Comments: A patient of unspecified age (reported as sixties) and gender developed unspecified health problems (ill-defined disorder), on an unknown day after administration of INN Flu Vaccine. The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported event, vaccination details, concurrent medical conditions, autopsy report and investigations to provide alternate aetiologies. Hence the causal role of suspect vaccine was assessed as unassessable. The case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Health problems


VAERS ID: 826060 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131907USA014251

Write-up: three days after vaccination the patient died; This spontaneous report was received from a nurse practitioner via a company representative and refers to a healthy female patient of unknown age. The patient''s concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), (unidentified Merck hpv vaccine administered; name, dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, reported as three days after vaccination, the patient died. The cause of death was unknown. It was unknown if an autopsy was done. The relatedness between the patient''s death and suspect vaccine was not provided.


VAERS ID: 826259 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray normal, Death, Gene sequencing, H3N2 influenza, Influenza, Influenza A virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2015; Test Name: Gene sequencing; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 2015; Test Name: Influenza virus test positive; Result Unstructured Data: Test Result: influenza A/H3N2 virus infection, Test Result Unit: unknown; Test Date: 2015; Test Name: X-ray; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: Suspected vaccination failure; Influenza A/H3N2 virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 76-year-old male subject who received Flu vaccine for prophylaxis. Previously administered products included Influenza vaccine (at some point of time during the last 5 influenza seasons). On an unknown date, less than a year after receiving Flu vaccine, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included influenza a virus infection with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza a virus infection (fatal). The reported cause of death was influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza a virus infection may have been caused by Flu vaccine. Relevant Tests: The nasopharyngeal (NP) swab sample was collected on 18 February 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. No data was available on influenza virus sequencing for the sample. The patient was not diagnosed with pneumonia by chest X ray. The cluster identified for influenza A/H3N2 was corresponding to the 3C.2a genetic clade. Diagnostic results (unless otherwise stated, normal values were not provided): In 2015, Gene sequencing result was see text , Influenza virus test positive result was influenza A/H3N2 virus infection unknown and X-ray result was see text . Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a 76 years old male who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplementary table S1 reported in this literature article. The patient was part of cross-sectional study that aimed to characterize the microbiota of the nasopharynx by analyzing samples from individuals diagnosed with influenza A virus (IAV) H3N2 or influenza B virus (IBV) (Yamagata or Victoria) infections during the 2014-2015 influenza season and in healthy controls. The study investigated in more detail the relationship between host factors, such as age or vaccination status, and the respiratory microbiome in a specific influenza season that could help to better identify factors that contributed to influenza disease severity. The patient received influenza virus vaccine at some point of time during the last 5 influenza seasons. The patient was not immunocompromised. No information on patient''s family history or concomitant medication was provided. On an unspecified date during the 2014-2015 influenza season, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age at vaccination was not provided but it could be 75 or 76 years old. On an unspecified date at 76 years of age, during the 2014-2015 influenza season, an unknown period (in same season) after vaccination, the patient was hospitalized and the nasopharyngeal (NP) swab sample was collected on 18 February 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. No data was available on influenza virus sequencing for the sample. The patient was not diagnosed with pneumonia by chest X ray. The cluster identified for influenza A/H3N2 was corresponding to the 3C.2a genetic clade. On an unspecified date, the patient died. It was unknown if an autopsy was performed. [In this study, the influenza virus-infected individuals had a slightly lower prevalence and abundance of Streptococcus, an enrichment of Dolosigranulum, and very low prevalence of Corynebacterium. 4 microbial community types (NP types) in the subjects tested. NP type A was significantly enriched in influenza infection, while NP type B dominated in the control group. While both community types C and D were slightly enriched in influenza patients, it was not at a significant level. In the influenza virus-infected subjects only, the less common influenza-associated NP type D was found predominantly in the young (less than 18 years old). NP type A was comprised primarily of Streptococcus and Dolosigranulum; NP type B, enriched was dominated by a combination of Streptococcus, Corynebacterium, and Comamonadaceae. NP type C was dominated by Moraxella, while NP type D had an overrepresentation of Staphylococcus. The different communities did not associate differently with either of the flu types (IAV versus IBV)]. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered as serious due to death/suspected vaccination failure / hospitalisation. Treatment was unknown. The outcome of event was death. The authors stated, "Influenza infection was shown to be significantly associated with microbial composition of the nasopharynx according to the virus type and the vaccination status of the patient. We identified four microbial community types across the combined cohort of influenza patients and healthy individuals with one community type most representative of the influenza virus-infected group. We also identified microbial taxa for which relative abundance was significantly higher in the unvaccinated elderly group; these taxa include species known to be associated with pneumonia. Our results suggest that there is a significant association between the composition of the microbiota in the nasopharynx and the influenza virus type causing the infection. We observe that vaccination status, especially in more senior individuals, also has an association with the microbial community profile. This indicates that vaccination against influenza, even when ineffective to prevent disease, could play a role in controlling secondary bacterial complications. The reasons for enhanced susceptibility to severe bacterial disease after influenza infection remain poorly defined. viral infection can disrupt this equilibrium and cause loss of some microbial populations and/or overgrowth of other pathogens, resulting in disease. Disruption of the URT microbiota has been found to be associated with community-acquired pneumonia. Even an unmatched influenza vaccine could prevent severe disease by modulating the respiratory bacterial communities. IAV and IBV virus infections were associated with a significantly different microbial community profile than that for uninfected individuals. Overall, these observations suggest that Corynebacterium could potentially protect the respiratory tract from pathogenic bacteria such as S. aureus and S. pneumoniae that are the most common cause of post-influenza pneumonia. We studied the composition of the nasopharynx microbiota at diagnosis, we cannot determine whether differences between healthy controls and influenza virus-infected individuals are due to the infection, the presence of a microbial community that predisposes to infection, or a combination of both. The effectiveness of the influenza vaccine varies in different seasons due to a number of factors, such as vaccine strain mismatch and host immune status, including history of previous influenza vaccination. We suggest that another potential factor is the host microbiome. It showed that in influenza virus-infected individuals the lack of vaccination in the current season is associated with the enrichment of different microbial taxa, such as Moraxella and Streptococcus, depending on the type of influenza virus (IAV versus IBV)". The authors concluded, "Our aims in this study were to determine whether the microbiota of the nasopharynx was different in individuals with influenza infection and to identify factors associated with the variations observed between infected subjects in different age groups. We found that during influenza infection, the nasopharyngeal microbiota of vaccinated individuals was strongly associated with higher levels of specific microbial taxa, with different microbial profiles relative to virus types and clades. These observations provide new insight into influenza infection and highlight a need for more studies to explore the mechanism of how influenza vaccines-live attenuated or killed-interact with the respiratory microbiota". This is 1 of the 127 valid cases reported in the same literature article. Lab Comments: The nasopharyngeal (NP) swab sample (sample ID A059) was collected on 18 February 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. No data was available on influenza virus sequencing for the sample. The patient was not diagnosed with pneumonia by chest X ray. The cluster identified for influenza A/H3N2 was corresponding to the 3C.2a genetic clade.; Reported Cause(s) of Death: Influenza A/H3N2 virus infection


VAERS ID: 826261 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray normal, Death, Gene sequencing, H3N2 influenza, Influenza, Influenza A virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2015; Test Name: Gene sequencing; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 2015; Test Name: Influenza virus test positive; Result Unstructured Data: Test Result: influenza A/H3N2 virus infection, Test Result Unit: unknown; Test Date: 2015; Test Name: X-ray; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: Suspected vaccination failure; Influenza A/H3N2 virus infection; This case was reported in a literature article and described the occurrence of vaccination failure in a 84-year-old female subject who received Flu vaccine for prophylaxis. Previously administered products included Influenza vaccine (at some point of time during the last 5 influenza seasons). On an unknown date, less than a year after receiving Flu vaccine, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included influenza a virus infection with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza a virus infection (fatal). The reported cause of death was influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza a virus infection may have been caused by Flu vaccine. Relevant Tests: The nasopharyngeal (NP) swab sample was collected on 23 February 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. No data was available on influenza virus sequencing for the sample. The patient was not diagnosed with pneumonia by chest X ray. Diagnostic results (unless otherwise stated, normal values were not provided): In 2015, Gene sequencing result was see text unknown, Influenza virus test positive result was influenza A/H3N2 virus infection unknown and X-ray result was see text unknown. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a 84 years old female who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to from supplementary table S1 reported in this literature article. The patient was part of cross-sectional study that aimed to characterize the microbiota of the nasopharynx by analyzing samples from individuals diagnosed with influenza A virus (IAV) H3N2 or influenza B virus (IBV) (Yamagata or Victoria) infections during the 2014-2015 influenza season and in healthy controls. The study investigated in more detail the relationship between host factors, such as age or vaccination status, and the respiratory microbiome in a specific influenza season that could help to better identify factors that contributed to influenza disease severity. The patient received influenza virus vaccine at some point of time during the last 5 influenza seasons. The patient was not immunocompromised. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date during the 2014-2015 influenza season, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age at vaccination was not provided but it could be 83 or 84 years old. On an unspecified date at 84 years of age, during the 2014-2015 influenza season, an unknown period (in same season) after vaccination, the patient was hospitalized and the nasopharyngeal (NP) swab sample was collected on 23 February 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. No data was available on influenza virus sequencing for the sample. The patient was not diagnosed with pneumonia by chest X ray. On an unspecified date, the patient died. It was unknown if an autopsy was performed. [In this study, the influenza virus-infected individuals had a slightly lower prevalence and abundance of Streptococcus, an enrichment of Dolosigranulum, and very low prevalence of Corynebacterium. 4 microbial community types (NP types) in the subjects tested. NP type A was significantly enriched in influenza infection, while NP type B dominated in the control group. While both community types C and D were slightly enriched in influenza patients, it was not at a significant level. In the influenza virus-infected subjects only, the less common influenza-associated NP type D was found predominantly in the young (less than 18 years old). NP type A was comprised primarily of Streptococcus and Dolosigranulum; NP type B, enriched was dominated by a combination of Streptococcus, Corynebacterium, and Comamonadaceae. NP type C was dominated by Moraxella, while NP type D had an overrepresentation of Staphylococcus. The different communities did not associate differently with either of the flu types (IAV versus IBV)]. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered as serious due to death/suspected vaccination failure/hospitalisation. Treatment was unknown. The outcome of event was death. The authors stated, "Influenza infection was shown to be significantly associated with microbial composition of the nasopharynx according to the virus type and the vaccination status of the patient. We identified four microbial community types across the combined cohort of influenza patients and healthy individuals with one community type most representative of the influenza virus-infected group. We also identified microbial taxa for which relative abundance was significantly higher in the unvaccinated elderly group; these taxa include species known to be associated with pneumonia. Our results suggest that there is a significant association between the composition of the microbiota in the nasopharynx and the influenza virus type causing the infection. We observe that vaccination status, especially in more senior individuals, also has an association with the microbial community profile. This indicates that vaccination against influenza, even when ineffective to prevent disease, could play a role in controlling secondary bacterial complications. The reasons for enhanced susceptibility to severe bacterial disease after influenza infection remain poorly defined. viral infection can disrupt this equilibrium and cause loss of some microbial populations and/or overgrowth of other pathogens, resulting in disease. Disruption of the URT microbiota has been found to be associated with community-acquired pneumonia. Even an unmatched influenza vaccine could prevent severe disease by modulating the respiratory bacterial communities. IAV and IBV virus infections were associated with a significantly different microbial community profile than that for uninfected individuals. Overall, these observations suggest that Corynebacterium could potentially protect the respiratory tract from pathogenic bacteria such as S. aureus and S. pneumoniae that are the most common cause of post-influenza pneumonia. We studied the composition of the nasopharynx microbiota at diagnosis, we cannot determine whether differences between healthy controls and influenza virus-infected individuals are due to the infection, the presence of a microbial community that predisposes to infection, or a combination of both. The effectiveness of the influenza vaccine varies in different seasons due to a number of factors, such as vaccine strain mismatch and host immune status, including history of previous influenza vaccination. We suggest that another potential factor is the host microbiome. It showed that in influenza virus-infected individuals the lack of vaccination in the current season is associated with the enrichment of different microbial taxa, such as Moraxella and Streptococcus, depending on the type of influenza virus (IAV versus IBV)". The authors concluded, "Our aims in this study were to determine whether the microbiota of the nasopharynx was different in individuals with influenza infection and to identify factors associated with the variations observed between infected subjects in different age groups. We found that during influenza infection, the nasopharyngeal microbiota of vaccinated individuals was strongly associated with higher levels of specific microbial taxa, with different microbial profiles relative to virus types and clades. These observations provide new insight into influenza infection and highlight a need for more studies to explore the mechanism of how influenza vaccines-live attenuated or killed-interact with the respiratory microbiota". This is 1 of the 127 valid cases reported in the same literature article. Lab Comments: The nasopharyngeal (NP) swab sample (sample ID A073) was collected on 23 February 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. No data was available on influenza virus sequencing for the sample. The patient was not diagnosed with pneumonia by chest X ray.; Reported Cause(s) of Death: Influenza A/H3N2 virus infection


VAERS ID: 826262 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray normal, Death, Gene sequencing, H3N2 influenza, Influenza, Influenza A virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunocompromised
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2015; Test Name: Gene sequencing; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 2015; Test Name: Influenza virus test positive; Result Unstructured Data: Test Result: influenza A/H3N2 virus infection, Test Result Unit: unknown; Test Date: 2015; Test Name: X-ray; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: Suspected vaccination failure; Influenza A/H3N2 virus infection; This case was reported in a literature article and described the occurrence of vaccination failure in a 86-year-old female subject who received Flu vaccine for prophylaxis. Previously administered products included Influenza vaccine (at some point of time during the last 5 influenza seasons). Concurrent medical conditions included immunocompromised. On an unknown date, less than a year after receiving Flu vaccine, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included influenza a virus infection with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza a virus infection (fatal). The reported cause of death was influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza a virus infection may have been caused by Flu vaccine. Relevant Tests: The nasopharyngeal (NP) swab sample was collected on 1 January 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. Influenza virus sequencing and 16S rRNA gene sequencing for the sample was done. The cluster identified for influenza A/H3N2 was corresponding to the 3C.2a genetic clade. The patient was not diagnosed with pneumonia by chest X ray. Diagnostic results (unless otherwise stated, normal values were not provided): In 2015, Gene sequencing result was see text unknown, Influenza virus test positive result was influenza A/H3N2 virus infection unknown and X-ray result was see text unknown. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a 86 years old female who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplementary table S1 reported in this literature article. The patient was part of cross-sectional study that aimed to characterize the microbiota of the nasopharynx by analyzing samples from individuals diagnosed with influenza A virus (IAV) H3N2 or influenza B virus (IBV) (Yamagata or Victoria) infections during the 2014-2015 influenza season and in healthy controls. The study investigated in more detail the relationship between host factors, such as age or vaccination status, and the respiratory microbiome in a specific influenza season that could help to better identify factors that contributed to influenza disease severity. The patient received influenza virus vaccine at some point of time during the last 5 influenza seasons. The patient was immunocompromised. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date during the 2014-2015 influenza season, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age at vaccination was not provided but it could be 85 or 86 years old. On an unspecified date at 86 years of age, during the 2014-2015 influenza season, an unknown period (in same season) after vaccination, the patient was hospitalized and the nasopharyngeal (NP) swab sample (sample ID A213) was collected on 1 January 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. Influenza virus sequencing and 16S rRNA gene sequencing for the sample was done. The cluster identified for influenza A/H3N2 was corresponding to the 3C.2a genetic clade. The patient was not diagnosed with pneumonia by chest X ray. On an unspecified date, the patient died. It was unknown if an autopsy was performed. [In this study, the influenza virus-infected individuals had a slightly lower prevalence and abundance of Streptococcus, an enrichment of Dolosigranulum, and very low prevalence of Corynebacterium. 4 microbial community types (NP types) in the subjects tested. NP type A was significantly enriched in influenza infection, while NP type B dominated in the control group. While both community types C and D were slightly enriched in influenza patients, it was not at a significant level. In the influenza virus-infected subjects only, the less common influenza-associated NP type D was found predominantly in the young (less than 18 years old). NP type A was comprised primarily of Streptococcus and Dolosigranulum; NP type B, enriched was dominated by a combination of Streptococcus, Corynebacterium, and Comamonadaceae. NP type C was dominated by Moraxella, while NP type D had an overrepresentation of Staphylococcus. The different communities did not associate differently with either of the flu types (IAV versus IBV)]. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered as serious due to death/suspected vaccination failure/hospitalisation. Treatment was unknown. The outcome of event was death. The authors stated, "Influenza infection was shown to be significantly associated with microbial composition of the nasopharynx according to the virus type and the vaccination status of the patient. We identified four microbial community types across the combined cohort of influenza patients and healthy individuals with one community type most representative of the influenza virus-infected group. We also identified microbial taxa for which relative abundance was significantly higher in the unvaccinated elderly group; these taxa include species known to be associated with pneumonia. Our results suggest that there is a significant association between the composition of the microbiota in the nasopharynx and the influenza virus type causing the infection. We observe that vaccination status, especially in more senior individuals, also has an association with the microbial community profile. This indicates that vaccination against influenza, even when ineffective to prevent disease, could play a role in controlling secondary bacterial complications. The reasons for enhanced susceptibility to severe bacterial disease after influenza infection remain poorly defined. viral infection can disrupt this equilibrium and cause loss of some microbial populations and/or overgrowth of other pathogens, resulting in disease. Disruption of the URT microbiota has been found to be associated with community-acquired pneumonia. Even an unmatched influenza vaccine could prevent severe disease by modulating the respiratory bacterial communities. IAV and IBV virus infections were associated with a significantly different microbial community profile than that for uninfected individuals. Overall, these observations suggest that Corynebacterium could potentially protect the respiratory tract from pathogenic bacteria such as S. aureus and S. pneumoniae that are the most common cause of post-influenza pneumonia. We studied the composition of the nasopharynx microbiota at diagnosis, we cannot determine whether differences between healthy controls and influenza virus-infected individuals are due to the infection, the presence of a microbial community that predisposes to infection, or a combination of both. The effectiveness of the influenza vaccine varies in different seasons due to a number of factors, such as vaccine strain mismatch and host immune status, including history of previous influenza vaccination. We suggest that another potential factor is the host microbiome. It showed that in influenza virus-infected individuals the lack of vaccination in the current season is associated with the enrichment of different microbial taxa, such as Moraxella and Streptococcus, depending on the type of influenza virus (IAV versus IBV)". The authors concluded, "Our aims in this study were to determine whether the microbiota of the nasopharynx was different in individuals with influenza infection and to identify factors associated with the variations observed between infected subjects in different age groups. We found that during influenza infection, the nasopharyngeal microbiota of vaccinated individuals was strongly associated with higher levels of specific microbial taxa, with different microbial profiles relative to virus types and clades. These observations provide new insight into influenza infection and highlight a need for more studies to explore the mechanism of how influenza vaccines-live attenuated or killed-interact with the respiratory microbiota". This is 1 of the 127 valid cases reported in the same literature article. Lab Comments: The nasopharyngeal (NP) swab sample was collected on 1 January 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. Influenza virus sequencing and 16S rRNA gene sequencing for the sample was done. The cluster identified for influenza A/H3N2 was corresponding to the 3C.2a genetic clade. The patient was not diagnosed with pneumonia by chest X ray.; Reported Cause(s) of Death: Influenza A/H3N2 virus infection


VAERS ID: 826263 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray normal, Death, Gene sequencing, H3N2 influenza, Influenza, Influenza A virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2015; Test Name: Gene sequencing; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 2015; Test Name: Influenza virus test positive; Result Unstructured Data: Test Result: influenza A/H3N2 virus infection, Test Result Unit: unknown; Test Date: 2015; Test Name: X-ray; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: Suspected vaccination failure; Influenza B virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 79-year-old male subject who received Flu vaccine for prophylaxis. Previously administered products included Influenza vaccine (at some point of time during the last 5 influenza seasons). On an unknown date, less than a year after receiving Flu vaccine, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included influenza b virus infection with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza b virus infection (fatal). The reported cause of death was influenza b virus infection. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza b virus infection may have been caused by Flu vaccine. Relevant Tests: The nasopharyngeal (NP) swab sample was collected on 15 April 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza B virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. 16S rRNA gene sequencing for the sample was done and no data was available for influenza virus sequencing. The patient was not diagnosed with pneumonia by chest X ray. Diagnostic results (unless otherwise stated, normal values were not provided): In 2015, Gene sequencing result was see text unknown, Influenza virus test positive result was influenza A/H3N2 virus infection unknown and X-ray result was see text unknown. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a 79 years old male who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplementary table S1 reported in this literature article. The patient was part of cross-sectional study that aimed to characterize the microbiota of the nasopharynx by analyzing samples from individuals diagnosed with influenza A virus (IAV) H3N2 or influenza B virus (IBV) (Yamagata or Victoria) infections during the 2014-2015 influenza season in healthy controls. The study investigated in more detail the relationship between host factors, such as age or vaccination status, and the respiratory microbiome in a specific influenza season that could help to better identify factors that contributed to influenza disease severity. The patient received influenza virus vaccine at some point of time during the last 5 influenza seasons. The patient was not immunocompromised. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date during the 2014-2015 influenza season, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age at vaccination was not provided but it could be 78 or 79 years old. On an unspecified date at 79 years of age, during the 2014-2015 influenza season, an unknown period (in same season) after vaccination, the patient was hospitalized and the nasopharyngeal (NP) swab sample was collected on 15 April 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza B virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. 16S rRNA gene sequencing for the sample was done and no data was available for influenza virus sequencing. The patient was not diagnosed with pneumonia by chest X ray. On an unspecified date, the patient died (emergency room). It was unknown if an autopsy was performed. [In this study, the influenza virus-infected individuals had a slightly lower prevalence and abundance of Streptococcus, an enrichment of Dolosigranulum, and very low prevalence of Corynebacterium. 4 microbial community types (NP types) in the subjects tested. NP type A was significantly enriched in influenza infection, while NP type B dominated in the control group. While both community types C and D were slightly enriched in influenza patients, it was not at a significant level. In the influenza virus-infected subjects only, the less common influenza-associated NP type D was found predominantly in the young (less than 18 years old). NP type A was comprised primarily of Streptococcus and Dolosigranulum; NP type B, enriched was dominated by a combination of Streptococcus, Corynebacterium, and Comamonadaceae. NP type C was dominated by Moraxella, while NP type D had an overrepresentation of Staphylococcus. The different communities did not associate differently with either of the flu types (IAV versus IBV)]. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered as serious due to death/suspected vaccination failure/hospitalisation. Treatment was unknown. The outcome of event was death. The authors stated, "Influenza infection was shown to be significantly associated with microbial composition of the nasopharynx according to the virus type and the vaccination status of the patient. We identified four microbial community types across the combined cohort of influenza patients and healthy individuals with one community type most representative of the influenza virus-infected group. We also identified microbial taxa for which relative abundance was significantly higher in the unvaccinated elderly group; these taxa include species known to be associated with pneumonia. Our results suggest that there is a significant association between the composition of the microbiota in the nasopharynx and the influenza virus type causing the infection. We observe that vaccination status, especially in more senior individuals, also has an association with the microbial community profile. This indicates that vaccination against influenza, even when ineffective to prevent disease, could play a role in controlling secondary bacterial complications. The reasons for enhanced susceptibility to severe bacterial disease after influenza infection remain poorly defined. viral infection can disrupt this equilibrium and cause loss of some microbial populations and/or overgrowth of other pathogens, resulting in disease. Disruption of the URT microbiota has been found to be associated with community-acquired pneumonia. Even an unmatched influenza vaccine could prevent severe disease by modulating the respiratory bacterial communities. IAV and IBV virus infections were associated with a significantly different microbial community profile than that for uninfected individuals. Overall, these observations suggest that Corynebacterium could potentially protect the respiratory tract from pathogenic bacteria such as S. aureus and S. pneumoniae that are the most common cause of post-influenza pneumonia. We studied the composition of the nasopharynx microbiota at diagnosis, we cannot determine whether differences between healthy controls and influenza virus-infected individuals are due to the infection, the presence of a microbial community that predisposes to infection, or a combination of both. The effectiveness of the influenza vaccine varies in different seasons due to a number of factors, such as vaccine strain mismatch and host immune status, including history of previous influenza vaccination. We suggest that another potential factor is the host microbiome. It showed that in influenza virus-infected individuals the lack of vaccination in the current season is associated with the enrichment of different microbial taxa, such as Moraxella and Streptococcus, depending on the type of influenza virus (IAV versus IBV)". The authors concluded, "Our aims in this study were to determine whether the microbiota of the nasopharynx was different in individuals with influenza infection and to identify factors associated with the variations observed between infected subjects in different age groups. We found that during influenza infection, the nasopharyngeal microbiota of vaccinated individuals was strongly associated with higher levels of specific microbial taxa, with different microbial profiles relative to virus types and clades. These observations provide new insight into influenza infection and highlight a need for more studies to explore the mechanism of how influenza vaccines-live attenuated or killed-interact with the respiratory microbiota". This is 1 of the 127 valid cases reported in the same literature article. Lab Comments: The nasopharyngeal (NP) swab sample was collected on 15 April 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza B virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. 16S rRNA gene sequencing for the sample was done and no data was available for influenza virus sequencing. The patient was not diagnosed with pneumonia by chest X ray.; Reported Cause(s) of Death: Influenza B


VAERS ID: 826511 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131907USA016835

Write-up: unspecified amount of patients died after GARDASIL 9 treatments; This spontaneous report was received from a consumer, who read on internet on a website regarding to unspecified number of female patients of unknown age. The patients'' medical history, history of drug reactions/ allergies, concurrent conditions and concomitant medications were unknown to the reporter. On an unknown date, the unspecified number of patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot# and expiry date were not reported) for prophylaxis. On an unknown date, after an unspecified amount of doses the patients died (death) for an unspecified reason. It was unknown if an autopsy was performed. It was unknown to reporter whether the patients received any treatment, also unknown if they sought medical attention and there was any hospitalization or prolonged hospitalization. No product quality compliant (PQC) was reported. The causality assessment was not provided by the reporter. Upon internal review, the event death was determined to be medically significant.; Reported Cause(s) of Death: died after GARDASIL 9 treatments for an unspecified reason


VAERS ID: 827169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse event, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019AM

Write-up: side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a female patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, less than a day after receiving Bexsero, the patient experienced adverse event (serious criteria death). On an unknown date, the outcome of the adverse event was fatal. The reported cause of death was adverse event. It was unknown if the reporter considered the adverse event to be related to Bexsero. Additional details were reported as follows: This case received from media. The reporter knew someone who''s daughter took the vaccine and died within 24 hours from side effects. As per the reporter for extremely rare disease versus the side effects, its worth the risk not paying for your (GSK) vaccine.; Reported Cause(s) of Death: Adverse event


VAERS ID: 827871 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Varicella zoster pneumonia
SMQs:, Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: US0095075131908USA000444

Write-up: varicella pneumonia; death; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequent to pt''s inoculation, pt was treated by a healthcare provider for varicella penumonia. As a direct and proximate result of the patient''s use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had suffered serious injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. On an unknown date, the patient died due to unknown reason. It was not reported if an autopsy was performed. The outcome of varicella pneumonia was unknown. The reporter considered varicella zoster pneumonia to be related to Zoster Vaccine Live (ZOSTAVAX). The causality between the Zoster Vaccine Live (ZOSTAVAX) and death was not provided. Upon internal review, the event of varicella pneumonia was considered to be medically significant.


VAERS ID: 828199 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2018-01-30
Onset:2018-01-30
   Days after vaccination:0
Submitted: 2019-04-24
   Days after onset:448
Entered: 2019-08-12
   Days after submission:110
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Feeling abnormal, Immediate post-injection reaction
SMQs:, Dementia (broad), Hypersensitivity (narrow)

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

Write-up: Happened at urgent care on 01/30/18. Patient received a flu vaccine that morning and stated he started feeling bad immediately. He went back to urgent care and was given a shot in the hip and sent home. He was found dead the next morning with no apparent cause.


VAERS ID: 828414 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Montana  
Vaccinated:0000-00-00
Onset:2018-04-17
Submitted: 0000-00-00
Entered: 2019-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-04-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131908USA002796

Write-up: shingles; Death; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist in pharmacy. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of shingles was not provided. On 17-APR-2018, the patient died. Information regarding cause of death and autopsy was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).


VAERS ID: 829148 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Connecticut  
Vaccinated:2019-08-01
Onset:2019-08-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2019-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UJ123AAA / 1 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-08-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Hydronephrosis
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Baby was found unresponsive in swing and pronounced dead on 8/10/19


VAERS ID: 829166 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Kentucky  
Vaccinated:2019-08-08
Onset:2019-08-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, 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: 2019-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Extensive Autopsy
CDC Split Type:

Write-up: Unexplained sudden death


VAERS ID: 829207 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:2018-07-17
Onset:2019-07-21
   Days after vaccination:369
Submitted: 0000-00-00
Entered: 2019-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Gastroenteritis, Intussusception, Malaise, Organ failure, Sepsis, X-ray gastrointestinal tract abnormal
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), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Noninfectious diarrhoea (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2018-07-31
   Days after onset: 355
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: Patient had a cold,
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: xray - intussusception- telescoping of the small and larger intestine blood test -
CDC Split Type:

Write-up: on July 17th of 2018 patient was given her routine shots. a week after recieving the vaccines patient became very ill with a really bad stomach virus called gastroenteritis.gastroenteritis ended up turning into intussusception virus. Patient was diagnosed with sepsis, and organ failure.


VAERS ID: 829381 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2019-07-17
Submitted: 0000-00-00
Entered: 2019-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019AM

Write-up: patient passed away; This case was reported by a other health professional via patient support programs and described the occurrence of unknown cause of death in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On 17th July 2019, less than 2 years after receiving Shingrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On 17th July 2019, the outcome of the unknown cause of death was fatal. The patient died on 17th July 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient passes away on 17th July 2019 by unknown cause. The reporter did not agree to follow up.; Reported Cause(s) of Death: Death NOS


VAERS ID: 830007 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Antibody test negative, Areflexia, Autonomic nervous system imbalance, Biopsy liver abnormal, Blood pressure fluctuation, Bradycardia, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis abnormal, Cytology normal, Death, Decreased vibratory sense, Dehydration, Demyelinating polyneuropathy, Disability assessment scale score decreased, Electromyogram abnormal, Endotracheal intubation, Gait inability, Guillain-Barre syndrome, Heart rate abnormal, Hepatic mass, Hypotension, Immunoglobulin therapy, Lymphocyte percentage increased, Mechanical ventilation, Metastatic malignant melanoma, Monocyte percentage increased, Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Plasmapheresis, Polyneuropathy in malignant disease, Protein total decreased, Protein total increased, Red blood cell count decreased, Red blood cell count increased, Respiratory distress, Sensory loss, Sepsis, Tachycardia, Walking aid user, White blood cell count decreased, Withdrawal of life support
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Malignancy related conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Hypertension (broad), Cardiomyopathy (broad), Demyelination (narrow), Skin malignant tumours (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Dehydration (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer surgery (three years ago)
Allergies:
Diagnostic Lab Data: Test Name: protein; Test Result: 91 {DF}; Test Name: rbc; Result Unstructured Data: 21; Test Name: rbc; Result Unstructured Data: 0; Test Name: white blood cell; Result Unstructured Data: 7; Test Name: white blood cell; Result Unstructured Data: 0; Test Name: lymphocytes; Test Result: 44 %; Test Name: monocytes; Test Result: 56 %; Test Name: protein; Test Result: 37 {DF}
CDC Split Type: USSA2019SA230137

Write-up: Guillain-Barre syndrome, acute inflammatory demyelinating polyneuropathy (AIDP); weakness of the lower and upper limbs; bilateral finger and toe paresthesia; dysautonomia; paraneoplastic neuropathy; respiratory distress; expired as the family withdrew life-sustaining therapies; dehydration; metastatic melanoma; tachycardia; hypotension; bradycardic; Sepsis; lost the ability to walk; Initial unsolicited valid serious case report received from a literature article on 16-Aug-2019. The following is verbatim from the article: Cancer immunotherapy with checkpoint inhibitors may result in neuromuscular immune-related adverse reactions, including Guillain-Barre syndrome (GBS)-like disease. On the other hand, checkpoint inhibitor therapy may result in exacerbation of underlying autoimmune diseases such as myasthenia gravis and multiple sclerosis. We present a patient who developed a severe and fatal relapse of postvaccination GBS after he was treated with nivolumab, a monoclonal antibody directed to programmed death-1 (PD-1), during a GBS treatment-related fluctuation. We recommend that caution be exercised in starting treatment with PD-1 inhibitors in the acute stage or early in the recovery period of GBS. Key Words: Guillain-Barre syndrome, checkpoint inhibitor, dysautonomia, nivolumab, PD-1. This case involves a 66 years old male patient who experienced weakness of the lower and upper limbs, bilateral finger and toe paresthesia, dehydration, metastatic melanoma, guillain-barre syndrome, respiratory distress, tachycardia, hypotension, acute inflammatory demyelinating polyneuropathy (aidp), guillain barre syndrome, bradycardic, sepsis, paraneoplastic neuropathy and dysautonomia, while he received vaccine INFLUENZA VACCINE. The patient''s past medical history included Cancer surgery with three years ago. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a serious weakness of the lower and upper limbs (muscular weakness), bilateral finger and toe paresthesia (paraesthesia), dehydration, metastatic melanoma (metastatic malignant melanoma), Guillain-Barre Syndrome, acute inflammatory demyelinating polyneuropathy, respiratory distress on day 2 of hospitalization, tachycardia, hypotension, (aidp), guillain barre syndrome (demyelinating polyneuropathy), bradycardic (bradycardia), sepsis, paraneoplastic neuropathy, (polyneuropathy in malignant disease), lost the ability to walk and dysautonomia (autonomic nervous system imbalance) (Unknown latency) following the administration of INFLUENZA VACCINE. These events was leading to death. Patient was also hospitalized for these events. Relevant laboratory test results included: Lymphocyte count - On an unknown date: 44 % Monocyte count - On an unknown date: 56 % Protein total - On an unknown date: 37 mg/dL, on an unknown date: 91 mg/dL. Red blood cell count - On an unknown date: [21], on an unknown date: [0]. White blood cell count - On an unknown date: [7], on an unknown date: [0]. (Other relevant tests included Examination 12 days after the onset of initial symptoms and a day after he lost the ability to walk revealed strength of 3/5 in upper-limb muscles, hip flexors, quadriceps, hamstrings, and 2/5 in the ankle dorsiflexors and plantar flexors, as assessed according to the Medical Research Council scale.) Pinprick sensation was diminished up to the ankles and fingertips, vibration was lost at the toes, and deep tendon reflexes were absent at the knees and ankles and a negative cytology. A nerve conduction study 34 days after the flu vaccination demonstrated absent bilateral sural and right median sensory responses, prolonged distal and F wave latencies of the right median nerve, as well as very low amplitudes and very slow conduction velocities of all the motor responses, needle electromyography (EMG) showed neurogenic recruitment in all the muscles tested in bilateral lower and right upper limbs and positive waves/fibrillation potentials in the cervical and lumbar paraspinal muscles. Brain MRI showed a 4 3 5-mm enhancing lesion with associated T2 hyperintensity and restricted diffusion in the right superior medial precentral gyrus, consistent with a brain metastasis. Computed tomography scan of the abdomen and pelvis showed multiple hepatic hypodense nodules, biopsy of which demonstrated metastatic melanoma, BRAF-V600 wildtype. His weakness initially improved after IVIg treatment to the point that he was able to ambulate 100 feet with an assistive device. However, his weakness worsened about 3 weeks later when he lost his ability to ambulate. His motor strength further declined dramatically about 12 days after the first dose of nivolumab, so that he was unable to sit in the wheelchair, resulting in his transfer to our center. Physical examination revealed motor strength of 3/5 in upper extremities, 1/5 hip flexion and hip extension, and 0/5 in remaining lower extremity muscle groups. His deep tendon reflexes were trace in the upper extremities and absent at the knees and ankles and there was diminished pinprick sensation in stocking/glove distribution and absent vibratory sensation at the toes. A follow-up EMG study 91 days after the flu vaccination showed severely prolonged distal latencies, reduced amplitudes, very slow conduction velocities, and markedly prolonged F wave latencies. Temporal dispersion of the compound muscle action potential was present with distal stimulation of all the motor nerves, and there was conduction blocks in the right ulnar motor response with stimulation below and above the elbow. Needle EMG showed positive waves and fibrillation potentials and no motor unit activation in the right tibialis anterior and quadriceps, as well as severely reduced recruitment in right first dorsal interosseous, biceps, and deltoid. Antibodies to ANNA-1, Amphiphysin, ANNA-2, CRMP-5, PCA-1, PCA-2, PCA-Tr, GM1, and GD1b were negative. He was intubated and placed on mechanical ventilation, and then started on plasma exchange (PLEX). During the hospitalization, there were wide fluctuations in heart rate and blood pressure, which were partly attributed to dysautonomia secondary to acute inflammatory demyelinating polyneuropathy (AIDP) because they were persistent between the sessions of PLEX and present after other potential causes such as possible sepsis and dehydration were appropriately treated. He was started on midodrine on day 5 of hospitalization, but on day 9 became severely hypotensive and bradycardic, requiring pressure support, and subsequently expired as the family withdrew life-sustaining therapies. His GBS disability score4 during the course of his disease starting with administration of influenza vaccine The patient was treated with 2 g/kg IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) over a period of 5 days for Guillain-Barre syndrome, 60 mg/kg PREDNISONE (PREDNISONE) for 2 daysand 240 mg NIVOLUMAB (NIVOLUMAB) which was repeated after 13 days. Final diagnosis was (fatal) dysautonomia, (fatal) paraneoplastic neuropathy, (fatal) sepsis, (fatal) bradycardic, (fatal) acute inflammatory demyelinating polyneuropathy (aidp), guillain barre syndrome, (fatal) Severe hypotension, (fatal) tachycardia, (fatal) respiratory distress, (fatal) guillain-barre syndrome, (fatal) metastatic melanoma, (fatal) dehydration, (fatal) bilateral finger and toe paresthesia and (fatal) weakness of the lower and upper limbs. The patient outcome was reported as fatal for all the event. The cause of death was reported conservatively captured as Muscular weakness, Paraesthesia, Demyelinating polyneuropathy, Polyneuropathy in malignant disease, Respiratory distress, Hypotension, Autonomic nervous system imbalance, Sepsis, Tachycardia, Dehydration, Metastatic malignant melanoma, Guillain-Barre syndrome and Metastatic malignant melanoma as it was unknown if an autopsy was done. List of document held by sender: none.; Sender''s Comments: This literature case concerns a 66 years old male patient died due to exacerbation of post influenza vaccination GBS after treatment with Nivolumab for metastatic melanoma. The time to onset is unknown. Moreover, patient''s medical condition and lab test at the time of vaccination were not reported. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: weakness of the lower and upper limbs; bilateral finger and toe paresthesia; acute inflammatory demyelinating polyneuropathy (AIDP), Guillain Barre syndrome; paraneoplastic neuropathy; respiratory distress; hypotension; dysautonomia; Sepsis; tachycar


VAERS ID: 830566 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131908USA007430

Write-up: The patient developed a fever, was hospitalized at an unspecified hospital for an unspecified length of time; The patient "eventually died" on an unspecified date several years ago. Cause of death: unknown; This spontaneous report was received from the pharmacist via a company representative, referring to a 16-year-old female patient. The patient''s current conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unknown date (reported as "several years ago"), the patient received unidentified Merck hpv vaccine administered (name and lot for prophylaxis (dose, strength, lot# and expiration date were not reported) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, strength, lot# and expiration date were not reported). The patient was vaccinated at the clinic of an unspecified physician, not at a pharmacy. On an unspecified date (reported as "several years ago"), the patient developed a fever, was hospitalized at an unspecified hospital for an unspecified length of time and received an unknown type of treatment. On an unknown date, the patient eventually died from an unknown cause. It was unknown if an autopsy was performed. At the time of this report, the causality assessment between the unidentified Merck hpv vaccine administered (name and lot number not provided) and the events, were not reported. The reporter considered the event of fever to be life threatening.


VAERS ID: 831053 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Ohio  
Vaccinated:2019-07-13
Onset:2019-07-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2019-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Death, Dyspnoea, Endotracheal intubation, Endotracheal intubation complication, Intensive care, Patient restraint, Pharyngeal swelling, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-19
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Escitalopram 10 mg once daily Amlodipine 5 mg once daily Lisinopril 40 mg once daily Pravastatin 40 mg once daily Biotin 1,000 mcg once daily Cyanocobalamin 1,000 mcg once daily Lutein 20 mg once daily Dulera 200-5 mcg/puff 2 puffs BID
Current Illness: COPD, hypertension, CKD, prostate cancer s/p cryoablation, GERD, HLD, depression
Preexisting Conditions: COPD, hypertension, CKD, prostate cancer s/p cryoablation
Allergies: Levofloxacin (anaphylaxis), aspirin (eye edema), cephalexin (hives), hydrogen peroxide (rash), lanolin (rash), macrobid (nausea/vomiting), penicillin G (hives), adhesive tape (redness, blisters), naproxen (nausea/vomiting), sulfa antibiotics (nausea/vomiting), simvastatin (impaired concentration)
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presented to the emergency department with tongue and throat swelling. According to hospital visit note, approximately 15 minutes prior to arrival, pt had an unknown exposure and began developing swelling in his throat and tongue. He felt that it began affecting his breathing, and he immediately came into the Emergency Department. He was not having any rash, abdominal pain, vomiting, diarrhea, chest pain or palpitations, but was having some difficulty breathing. He received epinephrine, Benadryl, Pepcid and steroids, and after a few minutes, he was felt to require intubation. Anesthesia was called for an airway alert. Attempts at oral intubation had failed and anesthesia then proceeded with fiberoptic nasotracheal intubation. Once the airway was secured, he was admitted to the Intensive Care Unit on a propofol drip for sedation and placed in restraints. Patient expired 07/19/19.


VAERS ID: 831902 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anti-neuronal antibody, Antibody test negative, Areflexia, Asthenia, Autonomic nervous system imbalance, Blood pressure fluctuation, Bradycardia, CSF lymphocyte count normal, CSF monocyte count increased, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis abnormal, Cytology normal, Death, Decreased vibratory sense, Demyelinating polyneuropathy, Electromyogram abnormal, Endotracheal intubation, Gait inability, Guillain-Barre syndrome, Heart rate abnormal, Hepatic mass, Hypotension, Immunoglobulin therapy, Mechanical ventilation, Metastases to central nervous system, Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Plasmapheresis, Respiratory distress, Sensory loss, Tachycardia, Walking aid user, Withdrawal of life support
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Hypertension (broad), Cardiomyopathy (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NIVOLUMAB
Current Illness: Metastatic melanoma
Preexisting Conditions: Medical History/Concurrent Conditions: Melanoma; Tumor resection (3 years before)
Allergies:
Diagnostic Lab Data: Test Name: Antibodies test; Result Unstructured Data: Antibodies to ANNA-1, Amphiphysin, ANNA-2, CRMP-5, PCA-1, PCA-2, PCA-Tr, GM1, and GD1b were negative.; Test Name: Computed tomography scan of the abdomen and pelvis; Result Unstructured Data: Showed multiple hepatic hypodense nodules.; Test Name: Cerebrospinal fluid analysis; Result Unstructured Data: Showed white blood cell, 7 (56% monocytes, 44% lymphocytes); red blood cell, 21; protein, 37 mg/dL; and a negative cytology.; Test Name: Cerebrospinal fluid analysis; Result Unstructured Data: Showed white blood cell, 0; red blood cell, 0; and protein, 91 mg/dL.; Test Name: Needle electromyography; Result Unstructured Data: Showed neurogenic recruitment in all the muscles tested in bilateral lower and right upper limbs and positive waves/fibrillation potentials in the cervical and lumbar paraspinal muscles.; Test Name: Needle electromyography; Result Unstructured Data: Showed severely prolonged distal latencies, reduced amplitudes, very slow conduction velocities, and markedly prolonged F wave latencies; temporal dispersion of the compound muscle action potential was present with distal stimulation of all the motor nerves, and there were conduction blocks in the right ulnar motor response with stimulation below and above the elbow; positive waves and fibrillation potentials and no motor unit activation in the right tibialis anterior and quadriceps, as well as severely reduced recruitment in right first dorsal interosseous, biceps, and deltoid.; Test Name: Nerve conduction studies; Result Unstructured Data: Demonstrated absent bilateral sural and right median sensory responses, prolonged distal and F wave latencies of the right median nerve, as well as very low amplitudes and very slow conduction velocities of all the motor responses.; Test Name: Brain MRI; Result Unstructured Data: Showed a 4 x 5-mm enhancing lesion with associated T2 hyperintensity and restricted diffusion in the right superior medial precentral gyrus, consistent with a brain metastasis.
CDC Split Type: USSEQIRUS201904421

Write-up: Postvaccination Guillain-Barre syndrome; This is a literature case, initially received on 20-Aug-2019, concerning a 66-year-old, male patient. The patient had a history of a right thigh melanoma resection 3 years before. The patient''s current medical history included metastatic melanoma. On an unknown date, the patient was administered Flu Vaccine [influenza vaccine, route of administration, anatomical location, batch number, expiry date and dose: not reported] for unknown indication. On an unreported date, about 3 weeks after receiving a flu vaccination, the patient developed bilateral finger and toe paraesthesia followed by weakness of the lower and then upper limbs. Examination 12 days after the onset of initial symptoms and a day after he lost the ability to walk revealed strength of 3/5 in upper-limb muscles, hip flexors, quadriceps, hamstrings, and 2/5 in the ankle dorsiflexors and plantar flexors, as assessed according to the Medical Research Council scale. Pinprick sensation was diminished up to the ankles and fingertips, vibration was lost at the toes, and deep tendon reflexes were absent at the knees and ankles. Cerebrospinal fluid (CSF) analysis showed white blood cell, 7 (56% monocytes, 44% lymphocytes); red blood cell, 21; protein, 37 mg/dL; and a negative cytology. A nerve conduction study 34 days after the flu vaccination demonstrated absent bilateral sural and right median sensory responses, prolonged distal and F wave latencies of the right median nerve, as well as very low amplitudes and very slow conduction velocities of all the motor responses; needle electromyography (EMG) showed neurogenic recruitment in all the muscles tested in bilateral lower and right upper limbs and positive waves/fibrillation potentials in the cervical and lumbar paraspinal muscles. The patient was diagnosed with postvaccination Guillain-Barre syndrome, and intravenous immunoglobulin (IVIg) 2 g/kg was then administered over a period of 5 days. Brain magnetic resonance imaging (MRI) showed a 4 x 5-mm enhancing lesion with associated T2 hyperintensity and restricted diffusion in the right superior medial precentral gyrus, consistent with a brain metastasis. Computed tomography scan of the abdomen and pelvis showed multiple hepatic hypodense nodules. His weakness initially improved after IVIg treatment to the point that he was able to ambulate 100 feet with an assistive device. However, his weakness worsened about 3 weeks later when he lost his ability to ambulate. At that time, the treating physicians considered the possibility of acute onset chronic inflammatory demyelinating neuropathy or paraneoplastic neuropathy. He then received IVIg1 g/kg divided over a period of 2 days and was started on prednisone 60 mg/day and received nivolumab 240mg, which was repeated after 13 days. His motor strength further declined dramatically about 12 days after the first dose of nivolumab, so that he was unable to sit in the wheelchair, resulting in his transfer to Medical Center, Department of Neurology. Physical examination revealed motor strength of 3/5 in upper extremities, 1/5 hip flexion and hip extension, and 0/5 in remaining lower extremity muscle groups. His deep tendon reflexes were trace in the upper extremities and absent at the knees and ankles, and there was diminished pinprick sensation in stocking/glove distribution and absent vibratory sensation at the toes. CSF analysis showed white blood cell, 0; red blood cell, 0; and protein, 91 mg/dL. A follow-up EMG study 91 days after the flu vaccination showed severely prolonged distal latencies, reduced amplitudes, very slow conduction velocities, and markedly prolonged F wave latencies. Temporal dispersion of the compound muscle action potential was present with distal stimulation of all the motor nerves, and there were conduction blocks in the right ulnar motor response with stimulation below and above the elbow. Needle EMG showed positive waves and fibrillation potentials and no motor unit activation in the right tibialis anterior and quadriceps, as well as severely reduced recruitment in right first dorsal interosseous, biceps, and deltoid. Antibodies to ANNA-1, Amphiphysin, ANNA-2, CRMP-5, PCA-1, PCA-2, PCA-Tr, GM1, and GD1b were negative. On day 2 of hospitalization, he developed respiratory distress, tachycardia, and hypotension. He was intubated and placed on mechanical ventilation, and then started on plasma exchange (PLEX). During the hospitalization, there were wide fluctuations in heart rate and blood pressure, which were partly attributed to dysautonomia secondary to acute inflammatory demyelinating polyneuropathy (AIDP) because they were persistent between the sessions of PLEX and present after other potential causes such as possible sepsis and dehydration were appropriately treated. The patient was started on midodrine on day 5 of hospitalization, but on day 9 became severely hypotensive and bradycardic, requiring pressure support, and subsequently died as the family withdrew life-sustaining therapies. The reporter stated that dysautonomia, which contributed to fatal outcome in our patient, was the initial manifestation of GBS. Although it is likely that checkpoint inhibitors treatment with nivolumab given during a recovery stage of AIDP resulted in disease exacerbation, the possibility of primary disease progression in our patient cannot be completely excluded. Company comment: Patient developed Guillain-Barre syndrome approximately three weeks after administration of unspecified Flu vaccine, therefore the temporal relationship is plausible. Several Flu vaccines have been linked to Guillain-Barre syndrome. Co-suspect drug nivolumab may have contributed to exacerbation of this adverse event. Based on the available information the event of Guillain-Barre syndrome is assessed as related to the suspect product.; Reporter''s Comments: Patient developed Guillain-Barre syndrome approximately three weeks after administration of unspecified Flu vaccine, therefore the temporal relationship is plausible. Several Flu vaccines have been linked to Guillain-Barre syndrome. Co-suspect drug nivolumab may have contributed to exacerbation of this adverse event. Based on the available information the event of Guillain-Barre syndrome is assessed as related to the suspect product.; Reported Cause(s) of Death: Postvaccination Guillain-Barre syndrome


VAERS ID: 832488 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2019-08-15
Onset:2019-08-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS TE493 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Autopsy, Coronary artery disease, Death, Incoherent, Pain
SMQs:, Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Other ischaemic heart disease (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-08-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none reported
Current Illness: none reported
Preexisting Conditions: none reported
Allergies: none reported
Diagnostic Lab Data:
CDC Split Type:

Write-up: Daughter came in on 9/7/19 to report that her mother passed away. She reported that patient was complaining to friends 8/15/19 thursday night of soreness due shingrix. on the same day 08/15/19 at about 9:20pm her grand daughter was texting her but is she is not making sense anymore. She was found deceased on 8/18/19 , decomposed and autopsy report''s caused of death is Coronary Artery Disease. She was cremated on 8/20/19 Tuesday


VAERS ID: 832500 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Florida  
Vaccinated:2018-05-28
Onset:2018-06-07
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2019-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-06-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Autopsy done
CDC Split Type:

Write-up: Baby died days after vaccine


VAERS ID: 833913 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Idaho  
Vaccinated:2019-09-14
Onset:2019-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UI992AAA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AA7112 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R034878 / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-09-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Neosure formula
Current Illness: None noted
Preexisting Conditions: None
Allergies: None Known
Diagnostic Lab Data: Coroner case
CDC Split Type:

Write-up: Child died.


VAERS ID: 834405 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2018-09-19
Onset:2018-09-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LG / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / 4 LG / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 LG / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 LG / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 LG / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-09-22
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None.
Current Illness: None.
Preexisting Conditions: None.
Allergies: None.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Running a fever, loss of appetite.


VAERS ID: 835232 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Culture positive, Death, Encephalopathy, Mechanical ventilation, Pertussis, Pneumonia, Polymerase chain reaction positive, Respiratory failure, Sepsis, Vaccination failure, White blood cell count normal
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: HIV infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: White blood cell count; Result Unstructured Data: Test Result: 8.71, Test Result Unit: x 10^9/L
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: Suspected vaccination failure; Pertussis; Pneumonia; Sepsis; Encephalopathy; Cough; Respiratory Failure; This case was reported in a literature article and described the occurrence of vaccination failure in a 48-year-old patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. Concurrent medical conditions included hiv infection. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, more than a week after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria death, hospitalization and GSK medically significant), pertussis (serious criteria death, hospitalization and GSK medically significant), pneumonia (serious criteria death, hospitalization and GSK medically significant), sepsis (serious criteria death, hospitalization and GSK medically significant), encephalopathy (serious criteria death, hospitalization and GSK medically significant), cough (serious criteria death and hospitalization) and respiratory failure (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure, pertussis, pneumonia, sepsis, encephalopathy, cough and respiratory failure were fatal. The reported cause of death was pertussis, pneumonia, sepsis, encephalopathy, respiratory failure, vaccination failure and cough. It was unknown if the reporter considered the vaccination failure, pertussis, pneumonia, sepsis, encephalopathy, cough and respiratory failure to be related to dTpa vaccine. Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure, sever pertussis infection, pneumonia, sepsis, encephalopathy in an adult patient of 48-year-old of unspecified gender who was vaccinated with unspecified tetanus, diphtheria & acellular pertussis (Tdap) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to result section reported in this literature article. The patient was the part of the Enhanced Pertussis Surveillance (EPS) as part of the Emerging Infections Program Network. The aim of the study was to characterize severe pertussis cases, defined as those that require hospitalization, and compare hospitalized and non-hospitalized pertussis patients, identify risk factors for hospitalization, and describe the clinical course and underlying health conditions of hospitalized pertussis patients. The patient had a concurrent history of human immunodeficiency virus infection. No information on patient''s family history or concomitant medication. On unspecified date, at least 14 days prior to cough onset, the patient had received unspecified tetanus, diphtheria & acellular pertussis (Tdap) vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. [In this study, 15942 cases of pertussis were reported in the surveillance area, patients aged more or equal to 12 years were considered up to date if they had received Tdap. For this analysis, only documented vaccine doses administered at least 14 days prior to cough onset. Fewer hospitalized patients were up to date on pertussis-containing vaccines]. On unspecified date in between 1st January 2011 and 31st December 2015, at least 14 days after vaccination, the patient had the onset of cough and was admitted. The patient had an infection which was laboratory confirmed by culture or polymerase chain reaction (PCR). During the admission, the patient had diagnosed with the pneumonia, sepsis (not further described), and encephalopathy. The patient had the normal white blood cell (WBC) of 8.71 ? 109/L. The patient had a respiratory failure that required mechanical ventilation. On an unspecified date, the hospitalized pertussis patients died from their infection. It was unknown, whether the autopsy was performed or not. [In this study, pertussis cases were classified according to the Council of State and Territorial Epidemiologists case definition. For hospitalized pertussis patients, defined as those admitted to an inpatient care facility, observation unit, or emergency department for more or equal to 24 hours as a result of pertussis infection. Among these cases, 15 427 occurred in patients treated as an outpatient and 515 occurred in patients who were hospitalized; 107 hospitalized patients required admission to the intensive care unit (ICU). Overall, the most common hospital admission diagnoses included cough, "pertussis", respiratory distress and or failure, bronchiolitis or bronchitis, and pneumonia. Among all hospitalized patients (515), the median length of time from onset to hospitalization was 11 days, ranging from 7 days in infants aged less than 2 months to 17 days in persons aged equal or more than 65 years. The median length of hospital stay was 3 (1.7-6.9 days) and ICU stay was 4 (2-9 days). The hospitalized patients received a macrolide antibiotic within 14 days of symptom onset, and had an infection that was laboratory confirmed by culture or polymerase chain reaction (PCR). Traditional pertussis clinical symptoms were more commonly reported in hospitalized patients symptoms included paroxysmal cough, post-tussive vomiting, whoop, cyanosis and apnea. Among patients who were tested during their hospitalization, 31 of 350 had a maximum white blood cell (WBC) count that surpassed 30 ? 109/L (previously associated with an increased risk of pertussis-related infant deaths and 54 of 271 had a viral codetection (diagnosed through PCR, direct fluorescent antibody testing, culture, or rapid antigen tests). Overall, 127 of hospitalized pertussis patients developed pneumonia, developed new-onset seizures, and developed encephalopathy]. This case was considered as suspected vaccination failure as the vaccination schedule and time to onset were unknown. This case was considered as serious due to suspected vaccination failure and death. The author commented, "Pertussis vaccination according to Advisory Committee on Immunization Practices (ACIP) recommendations is not only effective at preventing disease but has also been shown to reduce the clinical severity of pertussis illness. Although high amounts of missing vaccination information in adolescents and adults precluded our ability to fully assess this association in older age groups, a recent publication suggested that adolescents and adults vaccinated with Tdap have reduced incidence of post-tussive vomiting, a marker of more clinically significant illness. Thus, although vaccinated persons may still remain at risk for pertussis infection, these data highlight the role that pertussis vaccination plays in the prevention of severe and potentially life-threating infections, suggesting an added benefits of vaccination that goes beyond disease prevention. We are unable to determine whether certain underlying conditions are risk factors for severe pertussis or, rather, whether persons with these conditions are hospitalized at greater rates due to a perception of increased risk for severe disease". The author concluded, "Our analysis shows that severe pertussis infections that require hospitalization are not limited to infants; certain risk factors, such as key underlying medical conditions, may predispose an individual to more severe infections. Continued monitoring of pertussis hospitalizations through enhanced surveillance systems such as EPS will help better define populations at increased risk of severe disease in order to appropriately target and prioritize current and future pertussis prevention and control strategies. Individuals at the extreme ends of life may be the most vulnerable to severe pertussis infections, though hospitalization was reported across all age groups. Continued monitoring of severe pertussis infections will be important to help guide prevention, control, and treatment options". Lab Comments: Lab test done on an unspecified date between 1st January 2011 and 31st December 2015. The patient had an infection which was laboratory confirmed by culture or polymerase chain reaction (PCR).; Reported Cause(s) of Death: Pertussis; Pneumonia; sepsis (not further described); Encephalopathy; Respiratory failure; Suspected Vaccination failure; Cough


VAERS ID: 835525 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2018-10-16
Onset:2019-03-01
   Days after vaccination:136
Submitted: 0000-00-00
Entered: 2019-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. 252664 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Apgar score abnormal, Caesarean section, Congenital cystic kidney disease, Death neonatal, Foetal exposure during pregnancy, Oligohydramnios, Premature baby
SMQs:, Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-01
   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: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ZOLOFT; TERCONAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Neurofibromatosis; Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 20190214; Test Name: Biophysical profile; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190221; Test Name: Biophysical profile; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190301; Test Name: Biophysical profile; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190109; Test Name: Non stress test; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190122; Test Name: Non stress test; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190125; Test Name: Non stress test; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190213; Test Name: Non stress test; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190109; Test Name: Ultrasound; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190123; Test Name: Ultrasound; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190129; Test Name: Ultrasound; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190207; Test Name: Ultrasound; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.
CDC Split Type: USSEQIRUS201904742

Write-up: Polycystic kidney; Anhydramnios (and oligohydramnios); (Anhydramnios and) oligohydramnios; Fetal exposure during pregnancy; Preterm birth; Infant passed away 10 minutes shy of being 24 hours old; This is an observational serious study case, initially received from other health professional on 20-Sep-2019, concerning a 24-hour-old female neonate subject. The mother was a 30-year-old subject (Ethnicity: Not reported) of body weight: 197 lbs, height: 65 inches and body mass index (BMI): 32.8, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The mother''s historical condition included neurofibromatosis. The mother''s current conditions included yeast, HSV 2, anxiety and migraines. Concomitant medication included prenatal vitamins (unspecified vitamins), terconasole and Zoloft (sertraline hydrochloride). The subject''s mother obstetrical history noted that the mother had five previous pregnancies with 2 full term live birth, 2 preterm live birth and 1 elective abortion. The subject''s mother had no maternal or paternal history with major congenital malformations. The mother did not have a prior history of use of illicit drugs during pregnancy. The subject''s mother had a prior history of using alcohol (reported as 2 or less). The mother''s last menstrual period (LMP) date was 25-Jun-2018 and the pregnancy was singleton. The estimated delivery date (EDD) and the corrected estimated date of delivery (CEDD) were 01-Apr-2019. On 21-Aug-2018, 04-Sep-2018 and 02-Oct-2018, the subject''s mother underwent Ultrasound scan and no major congenital malformation noted. On 16-Oct-2018, at gestation age of 16 weeks, the subject''s mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose, expiration date, route of administration, and anatomical location: not reported] (explicitly coded as ?Fetal exposure during pregnancy''] for influenza immunisation. On 18-Oct-2018, the subject''s mother underwent ultrasound scan and quad screen and no major congenital malformation noted. On 09-Jan-2019, the subject''s mother underwent ultrasound scan and non stress test and polycystic kidneys, oligohydramnios and anhydramnios noted. On 22-Jan-2019, the subject''s mother underwent non stress test and polycystic kidneys, oligohydramnios and anhydramnios noted. On 23-Jan-2019, the subject''s mother underwent ultrasound scan and polycystic kidneys, oligohydramnios and anhydramnios noted. On 25-Jan-2019, the subject''s mother underwent non stress test and polycystic kidneys, oligohydramnios and anhydramnios noted. On 29-Jan-2019, the subject''s mother underwent ultrasound scan and polycystic kidneys, oligohydramnios and anhydramnios noted. On 07-Feb-2019, the subject''s mother underwent genetic testing and no major congenital malformation noted. Ultrasound scan was performed on the same day and the results showed polycystic kidneys, oligohydramnios and anhydramnios noted. On 13-Feb-2019, the subject''s mother underwent non stress test and polycystic kidneys, oligohydramnios and anhydramnios noted. On 14-Feb-2019, 21-Feb-2019 and 01-Mar-2019, the subject''s mother underwent biophysical profile and polycystic kidneys, oligohydramnios and anhydramnios noted. At gestational age of 36.3 weeks, the mother delivered live birth, female neonate by Caesarean section (explicitly coded as ?Premature baby''). The neonate''s birth weight was 2780 g, head circumference and length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 1 at one minute, 3 at five minutes and 5 at ten minutes. Major congenital malformations (MCM) identified at birth were oligohydramnios, anhydramnios and polycystic kidneys. Other factors contributing to the MCM were unknown. As reported: "Baby passed away 10 minutes shy of being 24 hours old."(outcome: fatal). Information regarding autopsy was not reported. This case is linked to 201904743, corresponding mother case. Company Comment: Reportedly, the female neonate subject was delivered as premature baby with congenital cystic kidney disease, oligohydramnios and anhydramnios after foetal exposure during pregnancy, at gestation age of 16 weeks, with the suspect product Flucelvax QIV. Chronology is plausible. The neonate died at 24 h and 10 minutes of age. Mother''s medical history of HSV 2 and neurofibromatosis may have contributed to development of the events. Causality was confounded by therapy with multiple concomitant medications. Foetal exposure during pregnancy is assessed as not related. For all other events, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter''s Comments: Reportedly, the female neonate subject was delivered as premature baby with congenital cystic kidney disease, oligohydramnios and anhydramnios after foetal exposure during pregnancy, at gestation age of 16 weeks, with the suspect product Flucelvax QIV. Chronology is plausible. The neonate died at 24 h and 10 minutes of age. Mother''s medical history of HSV 2 and neurofibromatosis may have contributed to development of the events. Causality was confounded by therapy with multiple concomitant medications. Foetal exposure during pregnancy is assessed as not related. For all other events, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reported Cause(s) of Death: Unknown


VAERS ID: 836425 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Female  
Location: Georgia  
Vaccinated:2019-09-09
Onset:2019-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 74FN7 / UNK LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. R027327 / UNK RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X93780 / UNK LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R034105 / UNK - / UN

Administered by: Private       Purchased by: ?
Symptoms: Anaphylactoid reaction, Autopsy, Death, Tryptase increased
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-09-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Anaphylactoid reaction based on postmortem tryptase level of 87.1 ng/ml. This postmortem level is elevated.


VAERS ID: 837061 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Human papilloma virus test positive, Papilloma viral infection, Product quality issue
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: human papilloma virus test; Test Result: Positive
CDC Split Type: US0095075131909USA012460

Write-up: died after hpv vaccine; HPV 16,11,18 (first vial tested and turn out to be positive); PQC Present: Yes; This spontaneous report was received from a consumer via social media referring to a female patient of unknown age. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route, lot# and expiry date were not reported) for prophylaxis. On an unknown date, the patient died after administration of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). It was reported that the first vial was sent to the reporter by the local paediatrician. The reporter tested the vial and was turned to be positive (Human papilloma virus test positive and product quality issue). Cause of death was unknown and it was unknown whether autopsy was performed. The outcome of papilloma viral infection and product quality issue was unknown. The reporter considered the event of death and human papilloma virus test positive as related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). Causality assessment for product quality issue was not reported. This is one of the several reports received from the same reporter.; Sender''s Comments: US-009507513-0807USA02497:Same reporter US-009507513-1609USA002149:Same reporter; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 837132 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Human papilloma virus test positive, Papilloma viral infection, Product quality issue
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Human papilloma Virus test; Test Result: Positive
CDC Split Type: US0095075131909USA012618

Write-up: died from Hpv vaccine; HPV 16 11 18 (first vial tested and turned out to be positive); PQC present: Yes/sent me at the first vial so i tested and it turned out to be positive altogether 16 vials; This spontaneous report was received from a consumer via social media referring to a patient of unknown age and gender. The patient''s pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, anatomical location, lot# and expiry date not reported) for prophylaxis. On an unknown date, the patient died from quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). It was reported that, the first vial was sent to the reporter by the local paediatrician. The reporter tested the vial and was turned to be positive with strains HPV 16, 11, 18 (Human papilloma virus test positive and product quality issue). Cause of death was unknown and it was unknown whether autopsy was performed. The outcome of papilloma viral infection and product quality issue was unknown. The reporter considered the event of death as related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). Causality assessment for human papilloma virus test positive and product quality issue was not reported. This is one of the several reports received from the same reporter.; Sender''s Comments: US-009507513-1909USA012460:same reporter US-009507513-0807USA02497:same reporter; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 837231 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Georgia  
Vaccinated:2019-08-30
Onset:2019-08-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 4RR52 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Acute myocardial infarction, Death, Laboratory test
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-09-07
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: diclofenac 1% gel, fluticasone nasal spray, rizatriptan ODT, famotidine, celecoxib, doxepin, zolpidem
Current Illness: migraines, meralgia paresthecia, basal cel carcinoma of face, psoriatic arthritis
Preexisting Conditions: PE (2008) treated with Warfarin for 1 year
Allergies: NKDA
Diagnostic Lab Data: Extensive 8/30/19 through 9/7/19
CDC Split Type:

Write-up: STEMI (likely unrelated), complex treatment course, died 9/7/19


VAERS ID: 837317 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2017-09-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131909USA012757

Write-up: death; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 61-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 23-SEP-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, exact dose, dose# and route not specified) at a pharmacy. On an unknown date in 2017, reported as within one month after receiving zoster vaccine live (ZOSTAVAX), and as a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. On an unknown date, the patient died. The cause of death and if autopsy was done was unknown. The outcome of the event of shingles was not reported. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX). The relatedness between the event of death and zoster vaccine live (ZOSTAVAX) was not reported.


VAERS ID: 837824 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS201917

Write-up: Guillain-Barre Syndrome; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced guillain barre syndrome (serious criteria death and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was fatal. The reported cause of death was guillain barre syndrome. It was unknown if the reporter considered the guillain barre syndrome to be related to Flu trivalent vaccine Additional details were received as follows: The age at vaccination was not reported. The patient had a flu injection in 1978, and experienced Guillain-Barre Syndrome, and died on 23rd August 2018. The reporter consented to follow up. This case was linked with case US2019170062, reported by same reporter.; Reported Cause(s) of Death: Guillain Barre syndrome


VAERS ID: 839106 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Idaho  
Vaccinated:2019-10-01
Onset:2019-10-01
   Days after vaccination:0
Submitted: 2019-10-08
   Days after onset:7
Entered: 2019-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 2277M / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Death, Incoherent, Lethargy, Speech disorder
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-01
   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: Abilify, fluoxetine
Current Illness:
Preexisting Conditions: Cerebral palsy, Generalized anxiety disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. presented to clinic (Urgent Care) with mom on 10/1/19 at approx. 1945. He was lathargic, responsive to sternal rub, nonverbal and incoherent. 911 was called, pt. was taken by ambulance to the ED. Pt passed away on the evening of 10/1/19.


VAERS ID: 840255 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: California  
Vaccinated:2019-05-15
Onset:2019-06-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2019-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Autoimmune disorder, Autopsy, Blood test normal, Death, Dysphagia, Dyspnoea, Gastrointestinal disorder, Headache, Lacrimation decreased, Neuralgia, Pain, Palpitations
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Lacrimal disorders (narrow), Dehydration (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-05
   Days after onset: 126
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: no
Diagnostic Lab Data: All blood tests that would rule out underlying cause of the burning nerve pain. BUT YOU WILL NEED TO SPEAK TO DR. Unfortunately, it is my understanding that he has moved on from his affilation to teach at medical school. I think you can track him down with the number I provided for him on this form. Chemistries (if glucose is high test for DM; if renal is high consider Fabry, mercury toxicity) Complete blood count (if low, consider B12 or copper deficiency, lead/arsenic toxicity) AST, ALT (liver function; if abnormal consider hepatitis or alcohol) Hemoglobin A1c (if high, consider 2 hour GTT) TSH thyroid screening Vitamin B12 levels(if 200-500pg/dl consider methylmalonic acid level) ESR (sedimentation rate; if elevated, consider inflammatory/dysimmune conditions) ANA (antinuclear antibodies; higher titers suggest lupus or dysimmune conditions) Anti-Ro (SS-A) and anti-La (SS-B) (if present, consider Sj?gren?s disease) CRP (C-reactive protein; if elevated, consider inflammatory/dysimmune conditions) Complement component C3 (if low, consider dysimmune conditions including lupus) Complement component C4 (dysimmunity; if low C3+C4, consider classic pathway) Hepatitis C serology (if abnormal consider testing for cryoglobulins) Lyme antibodies by Western blot (for inhabitant or visitor to endemic area) SPEP/IFIX (immunofixation tests for lymphoproliferative disorders) Free #312; #955; light chains (tests for less common lymphoproliferative disorders) IgA anti-TTG (transglutaminase antibodies; if present consider celiac sprue)
CDC Split Type:

Write-up: Death within 4 months of receiving the booster TDAP. My sister passed away this past Sat, Oct 5th. She was a healthy, happy 56-year-old women. Her death makes no sense and we have not been provided with any answers from medical professionals. In a nutshell, my sister started having minor pain in her head (ear area) in early June 2019, exactly two weeks after receiving the TDAP booster shot. The nerve pain that she had been experiencing had progressed to an unbearable state within a few short months. Before all this happened, she was a healthy, active woman. She was never officially diagnosed with an illness/disease because her neurologist was not able to find an underlying cause after subjecting her to every logical test available. She was prescribed with pain medication, but the pain became too intense for her to bear. The doctor suggested that she might be suffering with Small Fiber Neuropathy (SFN) condition, but it was just a suggestion. In just a few short months the symptoms progressed to the point where she felt burning pain throughout her entire body. The pain was transient and intense. She was desperate for relief and answers. Approximately four weeks before her death her symptoms progressed to affect her autoimmune system and she began to have trouble swallowing, producing tears, breathing, heart palpitations, and digestive issues. She believed that she would not survive this pain and accompanying symptoms (she feared the autoimmune symptoms). After her own online research and was convinced that all these symptoms were as a result of a reaction, she had from the TDAP booster. Everything she believed that was going to happen to her, did. I wonder if she was also right about the TDAP booster shot being the catalyst for her ultimate death. Her body is with the coroner now and we are awaiting the autopsy report to understand the cause of death but I am wondering if there are any tests that can be performed that could determine if the TDAP played any role in the symptoms she was experiencing as described above and her ultimate, untimely, early death. Please call me so I can provide additional information. She visited the neurologist only twice and was told that her blood tests were perfect...all of the blood tests that were given to her came out clean. Yet, she passed away within four months of receiving the TDAP booster.


VAERS ID: 843109 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Injury
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131910USA014612

Write-up: dies from Gardasil vaccine injuries; 3 years of suffering; This information was obtained from a website and refers to a female patient of unknown age. No information regarding the patient''s pertinent medical history, concomitant medications, drug reactions and allergies was provided. On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (dose, route of administration, lot number and expiration date were not provided). On an unknown date, the patient experienced unspecified injuries. On an unknown date, the patient experienced an unspecified adverse event, which caused suffering lasting 3 years. On an unknown date, at the age of 19 years, the patient died of the unspecified injuries. It was unknown if the autopsy was performed. The outcome of the unspecified adverse event was unknown. The reporter considered the event of unspecified injuries to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The relatedness between the unspecified adverse event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.; Sender''s Comments: US-009507513-1910USA012728:


VAERS ID: 843208 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019AM

Write-up: Died following his DTP; This case was reported by a consumer via interactive digital media and described the occurrence of death in a 20-month-old patient who received DTPa (DTPa vaccine) for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, less than 2 years after receiving DTPa vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to DTPa vaccine. Additional details were provided as follows; The age at vaccination was not reported, however the patient could be 20 months old or less than that at time of vaccination. The reporter friends son died following his DTP. The reporter stated that their lives are ruined forever. Th reporter stated that everyone needs to educate themselves beyond their pediatricians who receive a handsome bonus annually depending on the amount of vaccines administered. The number of vaccines children receive these days was completely ridiculous. Many at once and we were always told to give our babies Tylenol following the shots. Th reporter stated that Tylenol inhibits the liver''s processing of these toxins further and everyone''s quick to judge until their child loses his life or was vaccine injured.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 843302 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131910USA013736

Write-up: After three years of suffering, 19 Year old girl dies from GARDASTL vaccine injury; This spontaneous report was received from a consumer via a company representative through an online article referring to a 19 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided. On an unknown date the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dosage detail, route, strength, lot # and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (it was unclear which the two products was involved). On an unknown date (reported as after three years of suffering), the patient died from vaccine injury. It was unknown if an autopsy was performed. The reporter considered the event to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).; Reported Cause(s) of Death: vaccine injury


VAERS ID: 843319 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS201919

Write-up: Heart Attack; This case was reported by a consumer via call center representative and described the occurrence of heart attack in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced heart attack (serious criteria death and GSK medically significant). On an unknown date, the outcome of the heart attack was fatal. The reported cause of death was heart attack. It was unknown if the reporter considered the heart attack to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported, however the patient was over 75 years. The patient received Shingrix at some point had a heart attack and died. The reporter did not give consent for follow up. This is 1 of 3 cases reported.; Reported Cause(s) of Death: Heart attack


VAERS ID: 844189 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2019-10-29
Onset:2019-10-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UJ288AB / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Aspiration, Cyanosis, Death, Pulse absent, Resuscitation, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-29
   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: Levemir, Pravastatin, Furosemide, Lisinopril, Latanoprost
Current Illness: Diabetes, COPD
Preexisting Conditions: Diabetes, COPD
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient Fainted when he got to his cart. Pharmacist rushed to his side. He was already blue, and pharmacist could not feel a pulse. Patient was moved quickly to start CPR. CPR was started and patient was aspirating. Mouth and nose were cleared out. CPR was continued. Patient was aspirating and breaths could not me administered. CPR was continued until EMT arrived. EMT continued CPR. Patient was not responsive. EMT called time of death.


VAERS ID: 844239 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131910USA013063

Write-up: Died unexpectedly in 2008, shortly after receiving the Gardasil human papillomavirus (HPV) vaccine; This spontaneous report was received from a lawyer via social media referring to a 21 years old female patient. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided. On an unknown date in 2008, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (vaccine dosage detail, route of administration, lot# and expiration date were not reported) for prophylaxis. The patient died unexpectedly shortly after receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The reporter considered death unexpectedly to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).


VAERS ID: 844360 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Illinois  
Vaccinated:2019-10-07
Onset:2019-10-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 260389 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Areflexia, Asthenia, Diarrhoea, Guillain-Barre syndrome, Immunoglobulin therapy, Mechanical ventilation, Muscular weakness, Neck pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2019-10-28
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: NONE LISTED
Preexisting Conditions: Constipation, Degenerative Joint Disease, Chronic pain, Peripheral Arterial Occlusive DiseaseAllergies: NKA
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: Patient experienced neck pain and diarrhea which then progressed to weakness. On 10/16/19 daughter drove to hospital. Patient was transferred to Medical Center. Patient with weakness starting in lower extremities, then upper extremities, areflexic bilateral upper and lower. Dx w/Guillain-Barre Sysndrome. Patient on ventilator support and receiving immunoglobulin


VAERS ID: 845122 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Ohio  
Vaccinated:2019-04-07
Onset:2019-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / N/A UN / SYR
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / N/A UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-14
   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: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Im not sure what all my new born son received as his records are being held from me


VAERS ID: 845673 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Wyoming  
Vaccinated:2019-07-28
Onset:2019-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK LL / SYR
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Cerebral disorder, Death, Hypersomnia, Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-08-04
   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: Tylenol for fever
Current Illness: Brain bleed since 10 days old
Preexisting Conditions:
Allergies: No
Diagnostic Lab Data: We got an autopsy was ruled at SUIDS
CDC Split Type:

Write-up: He got air bubbles on the brain ... he had a high fever slept all day long minus 3 hours a day


VAERS ID: 846472 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Kansas  
Vaccinated:2019-11-04
Onset:2019-11-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUR4: INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) / PROTEIN SCIENCES CORPORATION QFAA1920 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-05
   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: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Family reported death from unknown cause. Coroners report did not identify cause of death. Patient died driving on the way to work 8 hours after receiving vaccination.


VAERS ID: 846844 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Ohio  
Vaccinated:2016-05-31
Onset:2016-06-15
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2019-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5100AA / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS PK95A / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M79319 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. MO14318 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: DEATH


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