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VAERS ID: 835593 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin E normal, Blood immunoglobulin G normal, Blood immunoglobulin M increased, CD4 lymphocytes decreased, Complement factor C3 decreased, Condition aggravated, Cytomegalovirus infection, Cytomegalovirus test positive, Death, Dyspnoea, Intensive care, Lymphopenia, Mechanical ventilation, Pneumonia, Polymerase chain reaction
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lymphopenia; Primary immunodeficiency syndrome; Rubella; Thrombocytopenia (at the age of 7 days old and was referred to neonatology unit from other hospital)
Allergies:
Diagnostic Lab Data: Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result: increased, Test Result Unit: unknown; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result: increased, Test Result Unit: unknown; Test Name: Blood immunoglobulin A; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Name: Blood immunoglobulin E; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Name: Immunoglobulin G; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Immunoglobulin G; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Name: Immunoglobulin M; Result Unstructured Data: Test Result: antibodies to rubella increased, Test Result Unit: unknown; Test Name: Immunoglobulin M; Result Unstructured Data: Test Result: increased, Test Result Unit: unknown; Test Name: Immunoglobulin M; Result Unstructured Data: Test Result: positive IgM CMV, Test Result Unit: unknown; Test Name: CD4 lymphocytes; Result Unstructured Data: Test Result: decreased, Test Result Unit: unknown; Test Name: Complement factor C3; Result Unstructured Data: Test Result: decreased, Test Result Unit: unknown; Test Name: Lymphocyte count; Result Unstructured Data: Test Result: ranged between 35.6 and 66, Test Result Unit: %; Test Name: Absolute lymphocyte count; Result Unstructured Data: Test Result: ranged between 2760 and 3830, Test Result Unit: /uL; Test Name: Neutrophil count; Result Unstructured Data: Test Result: within normal limits, Test Result Unit: unknown; Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown
CDC Split Type: IDGLAXOSMITHKLINEID2019GS

Write-up: Pneumonia; Dyspnea; Cytomegalovirus (CMV) infection; Lymphopenia; Death NOS; This case was reported in a literature article and described the occurrence of unknown cause of death in a 3-month-old female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included BCG VACCINE for prophylaxis. The patient''s past medical history included thrombocytopenia (at the age of 7 days old and was referred to neonatology unit from other hospital), rubella, lymphopenia and primary immunodeficiency syndrome. Previously administered products included IVIG (received intravenously for 3 days in the previous hospital). On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and BCG VACCINE at an unknown dose. On an unknown date, less than 4 months after receiving Hepatitis B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), pneumonia (serious criteria hospitalization and GSK medically significant), dyspnea (serious criteria hospitalization), cytomegalovirus infection (serious criteria GSK medically significant) and lymphopenia. The patient was treated with ganciclovir. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the pneumonia, dyspnea, cytomegalovirus infection and lymphopenia were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, pneumonia, dyspnea, cytomegalovirus infection and lymphopenia to be related to Hepatitis B vaccine. Additional details were provided as follows: This case was reported in a literature article and described the death NOS, pneumonia, lymphopenia, cytomegalovirus (CMV) infection in a 3-month-old female patient who was vaccinated with unspecified hepatitis B virus (HBV) vaccine; unspecified Bacillus Calmette Guerin (BCG) vaccine (manufacturer unknown for both) for prophylaxis. The patient, at the age of 7 days old, was referred to neonatology unit from other hospital due to thrombocytopenia with mark increased in aspartate aminotransferase (AST) and alanine aminotransferase (ALT). The patient had received intravenous immunoglobulin (IVIG) for 3 days in the previous hospital. The patient''s laboratory tests showed the percentage of lymphocytes ranged between 35.6 % and 66 %. Retrospective calculation revealed total lymphocyte count ranged between 2760 and 3830/microL (normal value more than 3400/microL). Neutrophil count was within normal limits. Levels of immunoglobulin M (IgM) and IgG antibodies to rubella increased, accompanied by increased levels of IgG antibodies to toxoplasma, CMV and herpes simplex virus 1 (HSV1). The patient received packed red cell (PRC) and TC transfusions. The patient was diagnosed as having rubella infection. After 24 days of treatment, the patient was discharged in good condition. The patient had lymphopenia and primary immunodeficiency. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 31 days and 3 months of age , the patient received unspecified hepatitis B virus vaccine (administration route and site unspecified, dosages unknown, batch number not provided) and BCG vaccine (administration route and site unspecified, dosages unknown, batch number not provided) in outpatient clinic. The age at vaccination was not provided. On an unspecified date at age 3 months, an unknown period after vaccination, the patient experienced dyspnea. Subsequently, the patient was admitted to pediatric intensive care unit (PICU) for pneumonia that needed ventilator support. The patient''s laboratory tests again showed lymphopenia. Further exploration found increased levels of IgM, with normal level of IgG, IgA and IgE, also decreased CD4 (cluster of differentiation 4) and C3 levels. Human immunodeficiency virus polymerase chain reaction (HIV PCR) was negative. IgM CMV was positive. The patient was treated with gancyclovir. On an unspecified date, the patient died after 30 days of hospitalization. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as serious due to death/hospitalization. The author stated "Complete blood count (CBC) test result does not automatically include the value of total lymphocytes; it included only the percentage of lymphocytes. Because the lymphocytes percentage were always within normal limits, the treating physicians were not concerned with the low value of total lymphocytes, reflecting the low levels of T and/or B lymphocytes. Unfortunately, the patient then underwent severe infection and further tests found low CD4 lymphocyte levels with increased levels of IgM. There should be an opportunity to explore PID, especially in this case the possibility of Severe Combined Immune Deficiency (SCID), in the first hospitalization during newborn period. If we were aware of PID, this patient could be treated and prevented for possible severe infections". The author concluded "Simple tests such as CBC needs to be interpreted in more detailed of the presence of lymphopenia or neutropenia to be indicative of primary immunodeficiency". This article is not available for regulatory submission due to copyright restriction. Lab Comments: Lab test done on an unknown date. Before vaccination, at the age of 7 days old, the patient was referred to neonatology unit from other hospital due to thrombocytopenia with mark increased in aspartate aminotransferase (AST) and alanine aminotransferase (ALT). The patient''s laboratory tests showed the percentage of lymphocytes ranged between 35.6 % and 66 %. The patient''s laboratory tests showed the percentage of lymphocytes ranged between 35.6 % and 66 %. Retrospective calculation revealed total lymphocyte count ranged between 2760 and 3830/microL (normal value more than 3400/microL). Neutrophil count was within normal limits. Levels of immunoglobulin M (IgM) and IgG antibodies to rubella increased, accompanied by increased levels of IgG antibodies to toxoplasma, CMV and herpes simplex virus 1 (HSV1). After vaccination, the patient''s laboratory tests again showed lymphopenia. Further exploration found increased levels of IgM, with normal level of IgG, IgA and IgE, also decreased CD4 (cluster of differentiation 4) and C3 levels. Human immunodeficiency virus polymerase chain reaction (HIV PCR) was negative. IgM CMV was positive.; Reported Cause(s) of Death: Death NOS


VAERS ID: 835595 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Death, Dizziness, Malaise, Malaria, Rash, Typhoid fever
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Malaria (receieved treatment for malaria a few days after receiving her HPV vaccine); Typhoid (receieved treatment for typhoid a few days after receiving her HPV vaccine)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NGGLAXOSMITHKLINENG2019EM

Write-up: Malaria; Typhoid; General malaise; Dizziness; Her conditioned worsened before she passed away; Rash; This case was reported by a consumer and described the occurrence of rash in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis. Concurrent medical conditions included malaria (receieved treatment for malaria a few days after receiving her HPV vaccine) and typhoid (receieved treatment for typhoid a few days after receiving her HPV vaccine). On an unknown date, the patient received the 1st dose of HPV vaccine (intramuscular). On an unknown date, couple of hours after receiving HPV vaccine, the patient experienced rash (serious criteria death), malaria (serious criteria hospitalization and GSK medically significant), typhoid (serious criteria hospitalization and GSK medically significant), general malaise (serious criteria hospitalization), dizziness (serious criteria hospitalization) and condition aggravated (serious criteria hospitalization). On an unknown date, the outcome of the rash was fatal and the outcome of the malaria, typhoid and condition aggravated were unknown and the outcome of the general malaise and dizziness were not recovered/not resolved. The reported cause of death was rash. It was unknown if the reporter considered the rash, malaria, typhoid, general malaise, dizziness and condition aggravated to be related to HPV vaccine. Additional details were provided as follows: The reported information received was from a third party, not a direct relative of the patient. The age at vaccination was not reported. The patient experienced rash a few hours after receiving HPV vaccine. On visiting the hospital the next day after receiving HPV vaccine,the patient''s reactions were mild and would soon stop. Few days after receiving HPV vaccine, the patient complained of general malaise and dizziness and was admitted in a private hospital and treated for malaria and typhoid. She was later taken to a general hospital where her conditioned worsened before she passed away.; Reported Cause(s) of Death: Rash


VAERS ID: 835698 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (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: CO0095075131909COL010005

Write-up: DEATH; This spontaneous report was received from a regulatory authority refers to a 2-month-old female patient. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiry date, exact dose, anatomical location and route of administration were not reported) for prophylaxis. On an unknown date the, patient died. The cause of death was not reported. It was unknown whether autopsy was performed. The causality assessment was not reported. The agency considered this report to be serious.


VAERS ID: 835837 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Injection site hypersensitivity
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: INSA2019SA263618

Write-up: patient had died; Allergic reaction around the spot of the injection; Initial information received on 20-Sep-2019 regarding an unsolicited valid serious social media case via Newspaper edition received from a consumer via (Patients Parent). This case involves a three months old male patient who experienced allergic reaction around the spot of the injection (injection site hypersensitivity) and died, while he received vaccine POLIOMYELITIS VACCINE (INACTIVATED). 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 POLIOMYELITIS VACCINE (INACTIVATED) in injection form produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a serious allergic reaction around the spot of the injection (vaccination site hypersensitivity) (Unknown latency) following the administration of POLIOMYELITIS VACCINE (INACTIVATED). On an unspecified date, on Wednesday, patient died. The informed police that after a nurse gave patient the vaccine, they took him home and patient went to sleep. However, patient did not wake up in the morning. When they took the infant to a hospital, a doctor informed that the patient had died, said Police Inspector. Allergic reaction around the spot of the injection was observed by the parents. The reporter lodged a complaint with the police alleging that his son died because of the vaccination. The patient body was shifted to Hospital mortuary for post-mortem. A case under (Causing death by negligence) had been registered. The issue had come the notice of the Health Department officials. They would go through the post-mortem report to knew cause of death. (Other relevant tests included no lab data.) Final diagnosis was death NOS and allergic reaction around the spot of the injection. It was not reported if the patient received a corrective treatment. The patient outcome was unknown for allergic reaction around the spot of the injection. It is unknown if an autopsy was done. The cause of death was not reported. List of documents held by sender: none.; Sender''s Comments: In this case, a 3-month-old male patient received a dose of POLIOMYELITIS VACCINE (INACTIVATED) produced by unknown manufacturer and went back home. The patient did not wake up in the morning, and was brought to the hospital and declared death. As per parents, allergic reaction at injection site (reported as injection site hypersensitivity) was observed. Medical history was not provided. The time to onset is unknown. Autopsy result was not available. Moreover, patient''s medical condition at the time of vaccination was not reported. Based upon the reported information, the role of vaccine cannot be assessed; Reported Cause(s) of Death: patient had died


VAERS ID: 835954 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Skin depigmentation
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: CO0095075131909COL010677

Write-up: DEPIGMENTATION OF THE SKIN; This spontaneous report was received from the Agency (HA ref # 2019PVCL1500) and refers to a 9 (age units not reported) female patient. There was no information about the patient''s concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) dose reported as 200 milligram (strength, frequency, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced depigmentation of the skin due to which she died on an unknown date. It was unknown if the autopsy was done. The Agency considered the event of depigmentation of the skin to be possibly related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown).; Reported Cause(s) of Death: DEPIGMENTATION OF THE SKIN


VAERS ID: 835957 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (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: CO0095075131909COL010919

Write-up: death; Information has been received from the agency on 20-SEP-2019 concerning a 4 month old infant female patient. The patient?s concurrent conditions, pertinent medical and concomitant medications were not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), dose, route, anatomical location, lot number and expiration date were not reported. On an unknown date, the patient died form an unknown cause. It was unknown if an autopsy was performed. The agency did not report the causality assessment between the suspect therapy and the patient?s death.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 836034 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (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: CO0095075131909COL012866

Write-up: Lupus erythematosus syndrome; This spontaneous report as received from a regulatory authority refers to female patient with age reported as 17 (units not provided). There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), with dose reported as 4 (units not reported) (route of administration, lot# and expiration date were not reported), for prophylaxis. On an unknown date, the patient experienced systemic lupus erythematosus and died. It was unknown if an autopsy was performed. The cause of death was not reported. The relatedness between the event and the suspect therapy was not reported. The Agency considered the event of systemic lupus erythematosus to be serious.


VAERS ID: 836098 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Condition aggravated, Death, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (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: Lupus erythematosus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL011382

Write-up: Erythematosus lupus empeoring; This spontaneous report was received from a regulatory authority and refers to a 16 (units not provided) female patient. There was no information about the patient''s concomitant therapies or medical history provided. Her concurrent conditions included lupus erythematosus. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (second dose, frequency, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced worsening of lupus erythematosus and died due to it on an unknown date. It was unknown if autopsy was performed. The relatedness between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) was reported as possible.; Reported Cause(s) of Death: Systemic lupus erythematosus


VAERS ID: 836100 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Amaurosis fugax, Death
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal 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: CO0095075131909COL011520

Write-up: transitional blindness; This spontaneous report was received from the Regulatory Authority, concerning a female patient. The patient''s age was reported as 9 (age units were not reported). The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an unspecified human papilloma virus vaccine (manufacturer unknown), dose reported as 6 "I", for prophylaxis (route of adminstration, lot number and expiration date were not reported). On an unknown date, the patient experienced transitional blindness. On an unknown date, she died due to the event. It was not reported if an autopsy was performed. The agency considered transitional blindness to be serious (medically significant) and possibly related to human papilloma virus vaccine (manufacturer unknown).; Reported Cause(s) of Death: transitional blindness


VAERS ID: 836102 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Death
SMQs:, Arthritis (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: CO0095075131909COL011610

Write-up: Joint Pain; This spontaneous report was received from a regulatory authority and refers to a 20 (units not provided) female patient. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown), (frequency, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced joint pain and died due to it on an unknown date. It was unknown if autopsy was performed. The relatedness between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) was reported as possible.; Reported Cause(s) of Death: Arthralgia


VAERS ID: 836159 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Scleroderma
SMQs:, 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: CO0095075131909COL010273

Write-up: SCLERODERMIA; This spontaneous report was received from agency on 20-SEP-2019, referring to a 16 unit unknown female patient. The patient''s medical history, concurrent condition and concomitant medication were unknown. On an unknown date the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (0 ml, frequency, route, batch/lot number and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (0 ml, frequency, route, batch/lot number and expiration date were not reported) for prophylaxis. On an unknown date the patient experienced scleroderma. The event was attributed to vaccination or immunization. On an unknown date the patient died due to the event. It was unknown if an autopsy was performed. The agency considered the event of scleroderma to be possibly related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown).; Reported Cause(s) of Death: SCLERODERMIA


VAERS ID: 836161 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL010979

Write-up: fainting; This spontaneous report as received from a regulatory authority on 20-SEP-2019, concerning a "16" (units not reported) old female patient. The patient''s concurrent conditions, medical history and concomitant medications was not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6,11,16,18) RECOMB.VACC) (manufacturer unknown) (dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced fainting which resulted in the patient''s death. The agency considered the event of fainting to be possibly related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6,11,16,18) RECOMB.VACC) (manufacturer unknown).


VAERS ID: 836162 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (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: CO0095075131909COL011023

Write-up: death; Information has been received from a regulatory authority, on 20-SEP-2019. This spontaneous report refers to male patient of 4 (units not reported). No information was given regarding the patient''s concurrent conditions, concomitant medications or medical history. On an unknown date, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, frequency, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient died and the cause or if an autopsy was performed was not reported. The agency considered the event to be possible related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).


VAERS ID: 836168 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: CO0095075131909COL011498

Write-up: decreased oxygen saturation; This spontaneous report as received from a regulatory authority on 20-SEP-2019, concerning a "16" (units not reported) old female patient. The patient''s concurrent conditions, medical history and concomitant medications was not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6,11,16,18) RECOMB.VACC) (manufacturer unknown), dose: 2 (units not reported) ( dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced decreased oxygen saturation which resulted in the patient''s death. The agency considered the event of decreased oxygen saturation to be possibly related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6,11,16,18) RECOMB.VACC) (manufacturer unknown).


VAERS ID: 836243 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
HPVX: HPV (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: CO0095075131909COL011561

Write-up: Death; This spontaneous report was received the Regulatory Authority referring to a female patient of unknown age. The patient''s pertinent medical history, concurrent conditions, concomitant therapies,and past drug allergies/reactions were not reported. On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine, 500 milligram (strength, route, anatomical location, Lot # an d expiration date were not reported) for prophylaxis or a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). On an unknown date, the patient died, however, the outcome of death was reported as recovered (discrepant information). It was unknown wether an autopsy was performed or not. The Regulatory Authority did not assess a causal relationship between the patient''s death and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).


VAERS ID: 836316 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Transient ischaemic attack
SMQs:, Ischaemic central nervous system vascular conditions (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: CO0095075131909COL010976

Write-up: Transitional ischemical accident; Information has been received from the Health Authority on 20-SEP-2019, referring to a female patient of unknown age. No information was provided regarding the patient''s medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On an unknown date, the patient was vaccinated with human papillomavirus ((manufacturer unknown), at a dose of 10 milligram for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient experienced transitional ischemic accident (transient ischemic attack) and died due to the event on an unspecified date. It was unknown whether an autopsy was performed. The reporter did not provide causality assessment between the event and vaccination with human papillomavirus ((manufacturer unknown). Upon internal review, transient ischemic attack was determined to be a medically significant event.


VAERS ID: 836320 (history)  
Form: Version 2.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (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: CO0095075131909COL011156

Write-up: death; This spontaneous report has been received from regulatory authority, concerning to a 2 year old male patient. The patient''s concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(manufacturer unknown) frequency, dose, lot number, anatomical location and expiration date were not reported) for prophylaxis. After the vacciantion the patient died. It was not reported the cause of death, and if an autopsy was performed. The reporter considered the death to be related to varicella virus vaccine live (oka/merck)(manufacturer unknown).


VAERS ID: 836338 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL011846

Write-up: LEG PAIN; This spontaneous report as received from a regulatory authority refers to a 16 (units not provided) female patient. The patient''s concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) at dose 1 (units not provided) (indication, route of administration, lot# and expiration date were not provided). On an unknown date, the patient died due to leg pain. It was unknown if an autopsy was performed. The reporter considered leg pain to be possibly related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown).; Reported Cause(s) of Death: Leg pain


VAERS ID: 836344 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL011870

Write-up: LEG PAIN; This spontaneous report as received from a regulatory authority refers to a 16 (units not provided) female patient. The patient''s concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) at dose 1 (units not provided) (indication, route of administration, lot# and expiration date were not provided). On an unknown date, the patient died due to leg pain. It was unknown if an autopsy was performed. The reporter considered leg pain to be possibly related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown).; Reported Cause(s) of Death: Leg pain


VAERS ID: 836345 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Death
SMQs:, Arthritis (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: CO0095075131909COL011871

Write-up: Joint Pain; This spontaneous report as received from a regulatory authority refers to a 20 (units not provided) female patient. The patient''s concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) dose reported as 0 mL (indication, route of administration, lot# and expiration date were not provided). On an unknown date, the patient died due to joint pain. It was unknown if an autopsy was performed. The reporter considered leg pain to be possibly related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown).; Reported Cause(s) of Death: Joint Pain


VAERS ID: 836348 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autoimmune nephritis, Death
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL011882

Write-up: AUTOIMMUNE NEPHRITIS; This spontaneous report as received from a regulatory authority refers to a 16 (units not provided) female patient. The patient''s concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) dose reported as 1 (units not provided) (indication, route of administration, lot# and expiration date were not provided). On an unknown date, the patient died due to autoimmune nephritis. It was unknown if an autopsy was performed. The reporter considered autoimmune nephritis to be possibly related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown).; Reported Cause(s) of Death: AUTOIMMUNE NEPHRITIS


VAERS ID: 836350 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Multiple sclerosis
SMQs:, Optic nerve disorders (broad), 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: CO0095075131909COL012183

Write-up: MULTIPLE SCLEROSIS; This spontaneous report has been received from regulatory authority to a female patient (age reported as 16 (units not provided)). No information was provided regarding the patient''s concurrent conditions, concomitant medications or relevant medical history. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (manufacturer unknown) (dose reported as 0 ml; dose#, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced multiple sclerosis. On an unknown date, the patient died due to multiple sclerosis. It was unknown if autopsy was performed. The outcome of multiple sclerosis was reported as fatal. The causality between multiple sclerosis and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) was reported as possible related.; Reported Cause(s) of Death: MULTIPLE SCLEROSIS


VAERS ID: 836356 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Death
SMQs:, Arthritis (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: CO0095075131909COL013030

Write-up: ARTHRALGIA; This spontaneous report as received from a regulatory authority refers to a female patient of unknown age (age reported as 9, no units provided).There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On an unknown date the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown) dose 1000 mg (route, Lot# were not reported.) On an unknown date the patient experienced arthralgia. The patient died on an unknown date. The outcome of arthralgia was fatal. The Agency considered arthralgia to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(manufacturer unknown).; Reported Cause(s) of Death: ARTHRALGIA


VAERS ID: 836357 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (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: CO0095075131909COL013117

Write-up: death; Information has been received from the Health Agency (#2019PVCL1434) on 20-SEP-2019. This spontaneous report was received from a regulatory authority and refers to a 2-year-old male patient. Patient''s concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history were not reported. On an unknown date, the patient started therapy with with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, anatomical location, indication, lot #, and expiration date were not reported). On an unknown date, the patient die. The outcome of death was reported as fatal. The causal relationship between death and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was not reported.


VAERS ID: 836445 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Gait inability
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL012260

Write-up: UNABLE TO WALK; Information was received from the Health Authority concerning a female patient. Her age was reported as 20 (units were not provided). No concurrent condition, medical history, or concomitant therapy was reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (dose reported as "0 ml"; strength, frequency, route, indication and lot# were not reported). On an unknown date, the patient was unable to walk. The outcome of the event was reported as fatal. The date of the patient''s death was unknown. It was not provided if the autopsy was performed or not. The action taken with suspect therapy regarding the event was not reported. The event was considered to be serious by the agency. The reporter considered the event to be possibly related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown).; Reported Cause(s) of Death: Unable to walk


VAERS ID: 836490 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiopulmonary failure, Death
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL010185

Write-up: Cardiorespiratory failure; This spontaneous report was received from Health authority referring to a female patient. Age was reported as 16(units not reported). The patient''s concurrent condition, medical history and concomitant therapy details were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) dose reported as 1(units not reported) (strength, route, lot# and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced cardiorespiratory failure (cardiopulmonary failure). The outcome of cardiopulmonary failure was reported as fatal. The cause of death was unknown. It was unknown if autopsy was performed. The Agency considered cardiopulmonary failure to be possibly related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown).; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 836501 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Condition aggravated, Death, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (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: Lupus erythematosus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL010776

Write-up: This spontaneous report was received from a Regulatory Authority and refers to a female patient of age 16 (units not reported). The patient''s concurrent condition included lupus erythematosus. No information regarding the patient''s medical history and concomitant medications were provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (manufacturer unknown) for prophylaxis (dose reported as 1 with units unspecified; strength, route, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient experienced eritematosus lupus empeoring (systemic lupus erythematosus). On an unknown date, the patient died. The cause of death was unknown. It was also unknown if autopsy was performed. No diagnostic results were reported. The Agency considered event systemic lupus erythematosus to be serious and possibly related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (manufacturer unknown).; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 836503 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (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: CO0095075131909COL010836

Write-up: eritematosus lupus empeoring; This spontaneous report was received from Health authority referring to a female patient. Age was reported as 16(units not reported). The patient''s concurrent condition, medical history and concomitant therapy details were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) dose reported as 0 milliliter (strength, route, lot# and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced eritematosus lupus empeoring (Systemic lupus erythematosus). The outcome of Systemic lupus erythematosus was reported as fatal. Cause of death was unknown. It was unknown if an autopsy was performed. The Agency considered Systemic lupus erythematosus to be possibly related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown).; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 836504 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: CO0095075131909COL010868

Write-up: Depression of the central nervous system; This spontaneous report was received from Health authority referring to a female patient. Age was reported as 20(units not reported). The patient''s concurrent condition, medical history and concomitant therapy details were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) dose reported as 0 milliliter (strength, route, lot# and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced depression of the central and peripheral nervous system (Depressed level of consciousness). The outcome of Depressed level of consciousness was reported as fatal. Cause of death was unknown. It was unknown if an autopsy was performed. The Agency considered Depressed level of consciousness to be possibly related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown).; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 836512 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Gait inability
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL011715

Write-up: Unable to walk; This spontaneous report was received from a regulatory authority (Reference # not provided) on 20-SEP-2019, referring to a female patient with age reported as "20" (units not provided). The patient''s pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) Product dose: 0 Product units: mL and (route not reported). On an unknown date, the patient was unable to walk (gait inability) and due to this condition she died. It was unknown if an autopsy was performed. Gait inability was considered to be possibly related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) or to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown).


VAERS ID: 836556 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Encephalopathy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL010578

Write-up: ENCEPHALOPATHY; This spontaneous report was received from a regulatory authority refers to a female patient of age 13 (units not reported). The patient''s pertinent medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) 1200 milligrams (mg) (strength, route of administration, lot/batch # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced encephalopathy. No diagnostic results were reported. The outcome of encephalopathy was reported as fatal. The patient died on an unknown date. The cause of death was not reported. It was unknown if autopsy was performed or not. Causality assessment between the suspect product and the event was not reported. ; Reported Cause(s) of Death: unknown


VAERS ID: 836572 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: CO0095075131909COL011733

Write-up: depression of the central nervous system; This spontaneous report was received from the Regulatory Health Authority referring to a female patient of unknown age (age: 20 no units reported). The patient''s pertinent medical history, concurrent conditions, concomitant therapies,and past drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (strength, dose, route of administration, anatomical location, lot #, and expiration date) for prophylaxis; or with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (strength, dose, route of administration, anatomical location, lot #, and expiration date) for prophylaxis. On an unknown date, the patient experienced depression of the central nervous system; and then, on an unknown date, she died due to the aforementioned event. It was unknown whether an autopsy was performed or not. The Regulatory Health Authority considered the event depression of the central nervous system to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine; or related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). The Regulatory Health Authority considered the event syncope as serious (death and medically significant).; Reported Cause(s) of Death: depression of the central nervous system


VAERS ID: 836574 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autoimmune nephritis, Death
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL011757

Write-up: Autoimmune nephritis; Information has been received from the Agency on 24-SEP-2019. This spontaneous report has been received from regulatory authority referring to a female patient, age reported as "16". Information regarding the patient''s medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown) dose 2 (strength, frequency, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced autoimmune nephritis (death and medically significant), subsequently, on an unknown date, the patient died. It was not known if an autopsy was performed. The reporter considered autoimmune nephritis to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(manufacturer unknown). The Agency considered the event to be serious.


VAERS ID: 836579 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: CO0095075131909COL012184

Write-up: Decreased saturation oxygen; This spontaneous report was received from a Regulatory Authority and refers to a female patient of age 16 (units not reported). No information regarding the patient''s medical history, concurrent conditions and concomitant medications were provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (manufacturer unknown) for prophylaxis (dose reported as 1 with units unspecified; strength, route, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient experienced decreased saturation oxygen (oxygen saturation decreased). On an unknown date, the patient died. The cause of death was unknown. It was also unknown if autopsy was performed. No diagnostic results were reported. The Agency considered the event oxygen saturation decreased to be possibly related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (manufacturer unknown).; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 836903 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (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: CO0095075131909COL010629

Write-up: DEATH; This spontaneous report was received from a regulatory authority refers to a female patient of unknown age. The patient''s pertinent medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) 160 milligram (strength, route of administration, lot/batch # and expiration date were not reported) for prophylaxis. On an unknown date, the patient died. The cause of death was not reported (outcome was reported as not recovered/not resolved). It was unknown if autopsy was performed or not. Causality assessment between the suspect product and the event was not reported.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 836906 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiopulmonary failure, Death
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL010881

Write-up: Cardiorespiratory failure; Information has been received from the Regulatory Authority (2019PVCL1099) on 20-SEP-2019, concerning to female patient of 16 age (units not provided); The patient''s pertinent concurrent conditions, concomitant therapies, drug reactions and allergies were not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown), dose reported as two (units not provided) for prophylaxis (the concentration, frequency, route and anatomical location of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced cardiorespiratory failure and died It was unknown if an autopsy was done. The causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) and cardiopulmonary failure was reported as possible by the Health Authority.; Reported Cause(s) of Death: Cardiorespiratory failure


VAERS ID: 836910 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Encephalomyelitis
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL011026

Write-up: Encephalomyelitis; Information has been received from the Regulatory Authority (2019PVCL2614) on 20-SEP-2019, concerning to female patient of 13 age (units not provided); The patient''s pertinent concurrent conditions, concomitant therapies, drug reactions and allergies were not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown), the dose was 1200 milligram as prophylaxis (the concentration, frequency, route and anatomical location of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced encephalomyelitis. The outcome of encephalomyelitis was reported as fatal. It was unknown if an autopsy was performed. The causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) and encephalomyelitis was not reported by the Health Authority.


VAERS ID: 836917 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Bacterial infection, 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: CO0095075131909COL011454

Write-up: BACTERIAL INFECTION; Information has been received from the Regulatory Authority on 20-SEP-2019, regarding a female patient of unknown age. The patient''s pertinent past medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not provided. On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown), the dose was reported as 10 milligram as prophylaxis. (strength, frequency, route, anatomical location of administration, lot number and expiration date were not provided). On an unspecified date, the patient experienced bacterial infection. On an unspecified date, the patient died of unknown cause. It was unknown if an autopsy was performed. The causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) and bacterial infection was not provided by the Health Authority.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 836918 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131909COL011473

Write-up: FEVER; Information has been received from the Regulatory Authority on 20-SEP-2019, regarding a female patient of 11 age (units not provided). The patient''s pertinent past medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not provided. On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown), the dose was reported as 342 milligram as prophylaxis. (strength, frequency, route, anatomical location of administration, lot number and expiration date were not provided). On an unspecified date, the patient experienced fever. On an unspecified date, the patient died from an unknown cause. It was unknown if an autopsy was performed. The causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) and fever was not provided by the Health Authority.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 837416 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (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: CO0095075131910COL000394

Write-up: suicide; This spontaneous report was received from a Regulatory Authority and refers to a female patient, age reported as 13 (units were not reported). Her concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), dose reported as 4 (units were not provided) (route of administration, anatomical location, lot number and expiry date were not provided) for prophylaxis. On an unknown date, the patient committed a suicide (reported as event attributable to vaccination or immunization). The outcome of suicide was fatal. It was not specified if autopsy was performed. The relatedness between the suicide and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) was not reported.


VAERS ID: 837417 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), 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: CO0095075131910COL000470

Write-up: septic shock; Information has been received from a regulatory authority and refers to a 2-year-old male patient. His medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with the fourth dose of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown)(exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed septic shock. On an unknown date, the patient died due to septic shock. It was unknown if an autopsy was performed. The causality assessment was not provided.; Reported Cause(s) of Death: SEPTIC SHOCK


VAERS ID: 837418 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), 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: CO0095075131910COL000531

Write-up: SEPTIC SHOCK; Information has been received from a regulatory authority and refers to a 2-year-old male patient. His medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with the third dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) (exact dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient developed septic shock. The outcome of septic shock was reported as fatal. Causality assessment was not provided.; Reported Cause(s) of Death: Septic shock


VAERS ID: 837419 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, 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), Hypersensitivity (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131910COL000712

Write-up: respiratory failure; This spontaneous report was received from an Agency and refers to a 2-year-old male patient. His concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown), dose reported as 4 (units not provided) (strength, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced respiratory failure. Due to the event, he died on an unknown date. It was unknown, if an autopsy was performed. The relatedness between the event of respiratory failure and suspect vaccine was not provided.; Reported Cause(s) of Death: respiratory failure


VAERS ID: 837420 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiopulmonary failure, Death
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131910COL000718

Write-up: CARDIORESPIRATORY FAILURE; This spontaneous report as received from a regulatory authority refers to a female patient (age reported as 16 (units not provided). No information on patient''s concurrent conditions, medical history and concomitant medications was provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) dose reported as 4 (lot#, expiration date, route of administration were not provided) for prophylaxis. On an unknown date, the patient experienced cardiorespiratory failure. The outcome of the event was reported as fatal. The patient died on an unknown date, it was unknown if an autopsy was performed. The relatedness between the event and the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.; Reported Cause(s) of Death: CARDIORESPIRATORY FAILURE


VAERS ID: 837421 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Completed suicide, Death
SMQs:, Suicide/self-injury (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: CO0095075131910COL000722

Write-up: SUICIDE ATTEMPT; This spontaneous report was received from a regulatory authority and refers to a female patient of unknown age. Her age was reported as 13 (unit not provided). The patient''s pertinent medical history, concomitant therapies, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), dose reported as 4 (unit not provided) (lot #, expiry date, anatomical location and route of administration were not provided) for prophylaxis. On an unknown date, the patient attempted suicide, due to which she died on an unknown date. It was unknown whether an autopsy was performed. The regulatory authority did not provide causality assessment. The agency considered this report to be non serious.; Reported Cause(s) of Death: SUICIDE ATTEMPT


VAERS ID: 837422 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, 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), Hypersensitivity (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131910COL000725

Write-up: RESPIRATORY FAILURE; This spontaneous report was received from an Agency and refers to a 2-year-old male patient. The patient''s medical history, concurrent conditions and concomitant drugs were not provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) dose reported as 4 (units not reported) (route, site of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced respiratory failure. On an unknown date, the patient died due to the event. It was unknown if an autopsy was performed. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported.


VAERS ID: 837423 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: 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), Hypersensitivity (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131910COL000726

Write-up: RESPIRATORY FAILURE; This spontaneous report was received from a regulatory authority and refers to a 2-year-old male patient. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) product dose: 3 (units not provided)(dose number, route and site of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced respiratory failure. Outcome of respiratory failure was reported as fatal. The causality assessment was not provided.


VAERS ID: 837424 (history)  
Form: Version 2.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, 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), Hypersensitivity (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131910COL000729

Write-up: RESPIRATORY FAILURE; Information was obtained from the agency (LRN 2019PVCL6455) via a Case Line Listing concerning a 2-year-old male patient. Concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (lot number, expiration date, dose and route of administration were not reported). On an unknown date, the patient experienced respiratory failure. On an unknown date, the patient died due to the event. It was unknown whether autopsy was perfomed. The relatedness between the event and the vaccine was not reported.


VAERS ID: 837457 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Quadriplegia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: CO0095075131910COL000723

Write-up: QUAORIPLEJIA; This spontaneous report was received from a regulatory authority refers to a female patient on unknown age. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) dose 4 (route of administration, strength, frequency, lot #, expiration date and indication were not reported). On an unknown date, the patient experienced quadriplegia. The outcome of the event was reported as fatal. It was not reported if autopsy was performed. The Agency considered the event of quadriplegia to be non-serious. Upon internal review the report was upgraded to priority 2 due to the outcome of the event. The causality assessment between the event and suspect therapy was not reported.


VAERS ID: 837502 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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: CO0095075131910COL001167

Write-up: vaccination complication; Information has been received from the Regulatory Authority on 20-SEP-2019, concerning a 2-year-old male patient. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an unspecified pneumococcal vaccine (reported as "pneumococo purified conjugated polycharized antigens") (manufacturer unknown), dose reported as 4 (units not reported), for prophylaxis (route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced vaccination complication. On an unknown date, he died due to the event. It was not reported if an autopsy was performed. The causal relationship between the suspect vaccine and the event was not reported.; Reported Cause(s) of Death: vaccination complication


VAERS ID: 837503 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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: CO0095075131910COL001278

Write-up: vaccination complication; This spontaneous report was received from the Regulatory Authority, concerning a 2-year-old male patient. The patient''s pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported. On an unknown date, the patient started therapy with hepatitis A vaccine, inactivated (manufacturer unknown) (dose, route of administration, frequency, indication, lot number and expiration date were not reported). Dose reported as 4. On an unknown date, the patient experienced vaccination complication and died. It was not reported if an autopsy was performed. The relatedness between hepatitis A vaccine, inactivated (manufacturer unknown) and the aforementioned event was not reported.; Reported Cause(s) of Death: vaccination complication


VAERS ID: 837591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (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: CO0095075131910COL000905

Write-up: LUPUS ERITEMATOSO SYNDROME; Information has been received from the Agency on 24-SEP-2019, concerning to a female patient with age reported as 16 (units not provided). The patient''s concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), dose reported as 4 (units not reported) (strength, frequency, route of administration, anatomical location, lot #, expiration date were not provided) as prophylaxis. On an unspecified date, the patient experienced lupus erythematous syndrome (systemic lupus erythematosus) and the outcome was fatal. It was unknown if an autopsy was performed, and the cause of death was not reported. The causal relationship between therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and the event was not provided.


VAERS ID: 837592 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Polyneuropathy
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131910COL001082

Write-up: polyneuropathy; Information has been received from Health Authority on 20-SEP-2019. This spontaneous report has been received from a regulatory authority referring to a female patient of unknown age. No information was provided regarding the patient''s medical history, concurrent conditions, drug and allergy history or concomitant medications. On an unknown date, the patient was vaccinated with the fourth dose of human papillomavirus vaccine, unspecified quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(Manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (Manufacturer unknown) (strength, frequency, route of administration, lot# and expiration date were not provided)for prophylaxis. On an unknown date, the patient experienced polyneuropathy. The outcome of polyneuropathy was reported as fatal. No information was provided regarding the patient''s autopsy or the cause of death. At the reporting time, the causal relationship between the event and the suspect therapy was not reported. Upon internal review, the event polyneuropathy was determined to be medically significant.


VAERS ID: 837593 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), 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: CO0095075131910COL001479

Write-up: septic shock; Information was received from Health Authority (agency number was not provided), referring to a 2 years old male patient. The patient''s medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) on a dose reported as 3 (units not reported) for prophylaxis (frequency, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced septic shock. The outcome of septic shock was reported as fatal. The reporter''s causality assessment between the septic shock and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) was not reported. Upon internal review, the septic shock was considered serious due to death seriousness criteria.


VAERS ID: 837594 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

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: CO0095075131910COL001494

Write-up: Vaccination complication; This spontaneous report was received from a regulatory authority referring to a 2 year old male patient. Information regarding the patient''s concurrent conditions, past medical history and concomitant medications was not provided. On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARICELLA VIRUS VACCINE LIVE (OKA/MERCK)), reported as dose 3 (strength, route of administration, lot #, expiration date and indication were not reported). On an unknown date, the patient experienced vaccination complication and the patient died. The cause of death and if an autopsy was performed were unknown. The causality assessment was not reported by the agency.


VAERS ID: 837595 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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: CO0095075131910COL001608

Write-up: Vaccination complication; This spontaneous report has been received from a regulatory authority, concerning to 2-year-old male patient. The patient''s medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) dose reported as 3 (frequency, route, lot number, expiration date and indication were not provided). On an unknown date, the patient experienced a vaccination complication as cause of death. There was unknown if autopsy was performed. The agency did not provide a causal relationship between the vaccination complication and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). The agency considered vaccination complication as non-serious; however, the outcome of vaccination complication was reported as fatal and upon internal review, vaccination complication was determined to be medically significant.; Reported Cause(s) of Death: vaccination complication


VAERS ID: 837802 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), 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: CO0095075131910COL002350

Write-up: Septic shock; Information has been received a from Health Authority (agency number was not provided) on 20-SEP-2019. This spontaneous report was received from a Health Authority, concerning to a 2-year-old, male patient. Information about medical history, concurrent conditions and concomitant medications was not provided. On an unknown date, the patient was vaccinated with the fourth dose of hepatitis a vaccine, inactivated (manufacturer unknown) (reported as hepatitis A purified antigen) (strength, formulation, dose, anatomical location of vaccination, route of administration, indication, lot number and expiration date were not reported). On an unknown date, the patient experienced septic shock and and consequently the patient died. The causality assessment between therapy with hepatitis a vaccine, inactivated (manufacturer unknown) and the aforementioned event was not reported.


VAERS ID: 838299 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-01-16
Onset:2019-09-01
   Days after vaccination:228
Submitted: 0000-00-00
Entered: 2019-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-09-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CLPFIZER INC2019425849

Write-up: patient died; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) for immunization on 16Jan2019, when she was 56 years old. The patient medical history and concomitant medications were not reported. The patient died on an unknown date in Sep2019. Cause of death was unknown. It was not reported if an autopsy was performed. Information on lot number has been requested.; Sender''s Comments: There is no information in the case suggesting a possible contribution of pneumococcal 13-valent conjugate vaccine to the reported death.; Reported Cause(s) of Death: patient died


VAERS ID: 839595 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Albumin urine present, Albuminuria, Anaemia, Beta 2 microglobulin increased, Blood immunoglobulin G increased, C-reactive protein increased, Chest X-ray abnormal, Cognitive disorder, Computerised tomogram thorax abnormal, Condition aggravated, Cough, Death, Electrophoresis protein abnormal, Haemoglobin decreased, Hypogammaglobulinaemia, Immunoglobulin therapy, Immunology test, Light chain analysis abnormal, Light chain analysis decreased, Plasma cell myeloma, Platelet count decreased, Pleural effusion, Pneumonia, Protein urine present, Proteinuria, Pyrexia, Rales, Thrombocytopenia
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Haematological malignant tumours (narrow), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cognitive disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Albumin urine; Result Unstructured Data: Test Result: 288, Test Result Unit: mg/day; Test Name: B2 microglobulin; Test Result: 2 mg/dl; Test Name: Immunoglobulin G; Test Result: 310 mg/dl; Test Name: Chest X-ray; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Computerized tomography; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 121, Test Result Unit: mg/litre; Test Name: Serum protein electrophoresis; Result Unstructured Data: Test Result: hypogammaglobulinemia, Test Result Unit: unknown; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 9.4, Test Result Unit: g/dL; Test Name: Immunofixation; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Kappa/Lambda light chain ratio; Result Unstructured Data: Test Result: 4.95 (with absence of lambda chains in the urines), Test Result Unit: unknown; Test Name: Lambda light chain analysis; Test Result: 39 mg/dl; Test Name: Physical examination; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Platelet count; Result Unstructured Data: Test Result: 100000, Test Result Unit: /uL; Test Name: Protein urine 24 hour; Result Unstructured Data: Test Result: 4600, Test Result Unit: mg/day
CDC Split Type: ITGLAXOSMITHKLINEIT2019GS

Write-up: Fever; Cough; Thrombocytopenia; Cognitive Worsening; bilateral pleural effusion; crackles on the left lung; Anaemia; Proteinuria; Albuminuria; micromolecular myeloma/Multiple Myeloma; Hypogammaglobulinemia; left pneumonia; This case was reported in a literature article and described the occurrence of multiple myeloma in a 87-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Concurrent medical conditions included cognitive disorder. 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 multiple myeloma (serious criteria death and GSK medically significant), hypogammaglobulinemia (serious criteria GSK medically significant), pneumonia (serious criteria GSK medically significant), fever (serious criteria hospitalization), cough (serious criteria hospitalization), thrombocytopenia (serious criteria GSK medically significant), cognitive deterioration, bilateral pleural effusion, crackles lung, anemia, proteinuria and albuminuria. The patient was treated with antibiotics nos (Antibiotic Therapy (Drug Name Unknown)) and immunoglobulin. On an unknown date, the outcome of the multiple myeloma was fatal and the outcome of the hypogammaglobulinemia, fever, cough, thrombocytopenia, cognitive deterioration, bilateral pleural effusion, crackles lung, anemia, proteinuria and albuminuria were unknown and the outcome of the pneumonia was recovered/resolved. The reported cause of death was multiple myeloma. The reporter considered the multiple myeloma, hypogammaglobulinemia, pneumonia, fever, cough, thrombocytopenia, cognitive deterioration, bilateral pleural effusion, crackles lung, anemia, proteinuria and albuminuria to be related to Influenza vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of cognitive worsening, bilateral pleural effusion (mild), pneumonia (left); hypogammaglobulinemia and micromolecular myeloma (a rare form of multiple myeloma) in a 87-year-old female patient who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. The patient had the current history of the cognitive. No information on patient''s past medical or family history or concomitant condition was provided. deterioration On unspecified date, the patient had received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, unknown period after vaccination, the patient with an initial cognitive worsening was admitted to department for fever and cough started. On admission the patient was feverish, physical examination evidenced a mild bilateral pleural effusion, with crackles on the left lung, without significant alterations on abdomen and heart. A chest-radiography and a successive computed tomography (CT) showed a bilateral pleural effusion and a left pneumonia. At laboratory tests, the patient had mild anaemia (hemoglobin Hb 9.4 g/dl), thrombocytopenia (Platelet count 100000/ul) and elevation of C - reactive protein (CRP), (121 mg/l). The serum proteins electrophoresis showed hypogammaglobulinemia, with Immunoglobulin G (IgG), 310 mg/dl, B2 microglobulin was increased (2 mg/dl, normal value less than 0.24) and the patient had proteinuria (4600 mg/24 h; albuminuria: 288 mg/24h). They performed the serum free light chains determination with evidence of low lambda chains level (39 mg/dl, normal value more than 90) and elevation of kappa/lambda ratio (4.95, normal value less than 2.65), with absence of lambda chains in the urines; a successive serum/urine immunofixation showed a monoclonal kappa light chain component. The patient started an empirical antibiotic therapy for pneumonia and intravenous Immunoglobulin infusion. Considering the poor expectative of life and the general conditions of the patient and they decided, according with family, not to perform a bone marrow biopsy; after pneumonia resolution the patient returned home, where the patient died a month later. It was unknown, whether the patients autopsy was performed or not. As the final diagnosis was probably "micromolecular myeloma" with secretion of k light chain only, a rare form of Multiple Myeloma. The cause of death was micromolecular myeloma. This case has been considered as serious due to hospitalization and death. The author did not comment on relationship between the events and unspecified influenza vaccine. The authors stated, "A rare case of hypogammaglobulinemia in elderly age". The author concluded "The final diagnosis was probably "micromolecular myeloma", with secretion of k light chain only, a rare form of Multiple Myeloma". Lab Comments: On an unknown date lab test were performed. physical examination evidenced a mild bilateral pleural effusion, with crackles on the left lung, without significant alterations on abdomen and heart. A chest-radiography and a successive computed tomography (CT) showed a bilateral pleural effusion and a left pneumonia. a successive serum/urine immunofixation showed a monoclonal kappa light chain component. As the final diagnosis was probably "micromolecular myeloma" with secretion of k light chain only, a rare form of Multiple Myeloma.; Reported Cause(s) of Death: micromolecular myeloma


VAERS ID: 839675 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Blister, Chills, Congestive cardiomyopathy, Disseminated varicella zoster vaccine virus infection, Dyspnoea, Erythema, Fatigue, Haemoglobin decreased, Hypotension, Intensive care, Leukopenia, Lymphocyte count decreased, Multiple organ dysfunction syndrome, Neutrophil count decreased, Odynophagia, Ophthalmological examination normal, Platelet count decreased, Polymerase chain reaction positive, Rash, Rash vesicular, Scab, Skin lesion, Thrombocytopenia, White blood cell count decreased
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: methotrexate; hydroxychloroquine sulfate; prednisone
Current Illness: Atrial flutter; Cardiac failure congestive; Chronic obstructive pulmonary disease; Coronary artery disease; Hypertension; Rheumatoid arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac ablation (Successful, performed 2 weeks before the onset of the rash); Chickenpox (as a child)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA0095075131910CAN003493

Write-up: Disseminated varicella zoster vaccine virus infection; This literature marketed report has been received from the authors of an article concerning a 70-year-old male patient. His concurrent conditions included hypertension, coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease and atrial flutter. He also had rheumatoid arthritis, treated with methotrexate, 2.5 mg/d (6 d per week) for 3 years, hydroxychloroquine, 200 mg/d and prednisone, 10 mg/d. In the previous month, his prednisone dosage had been tapered from 10 mg/d. He was not receiving any biologic agents. He also reported a history of chickenpox as a child, and a successful cardiac ablation. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX II) for prophylaxis (strength, dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date, he presented to the emergency department with a 2-week history of rash, which started as a localized eruption on his forehead and progressed to a vesicular rash involving his entire body. Over this same period, he noted increasing shortness of breath, tiredness, painful swallowing and chills. He did not report recent travel. On examination, the patient''s blood pressure was 110/60 mmHg, heart rate 86 beats/min and temperature 36.8?C. On examination, his cardiorespiratory and abdominal systems were initially within normal limits. Dermatologic assessment showed numerous widespread vesicles with erythematous bases across all aspects of his body. His oropharynx was erythematous, with associated lesions. Ocular examination was within normal limits. On admission, the patient''s hemoglobin concentration was 120 g/L, leukocyte count 1.7 x10^9/L, neutrophil count 1.3 x10^9/L, lymphocyte count 0.3 x10^9/L and platelet count 84 x10^9/L. During evaluating this patient, a wide differential diagnosis was considered Given the multiple vesicular and crusted lesions, disseminated varicella zoster virus (VZV) infection was identified as the most likely cause. It was then ascertained from the patient and family that he had received a live attenuated herpes zoster vaccine (zoster vaccine live (ZOSTAVAX II)) about 1 month before the onset of symptoms. With the clinical findings and vaccination history, intravenous treatment with acyclovir was started, 15 mg/kg every 8 h, and continued for the duration of the hospital stay. The patient was placed under airborne isolation. Shortly after admission, he was transferred to the intensive care unit for monitoring. Subsequently, leukopenia and thrombocytopenia developed, with evidence of progressive multiorgan failure with hypotension. Treatment with broad-spectrum antibiotics was started. The patient died on the fifth day after admission to the intensive care unit, following withdrawal of supportive measures and initiation of a palliative approach. Klebsiella spp. Was subsequently cultured from 1 of 2 blood specimens. Polymerase chain reaction testing of a lesional swab obtained at the time of initial presentation confirmed the presence of VZV on the first day after admission, and posthumous viral genotyping by the National Microbiology Laboratory confirmed the presence of the Oka (vaccine) strain. Autopsy findings included multiorgan failure from disseminated VZV infection, with pulmonary and colonic lesions and dilated cardiomyopathy. Upon internal review, the disseminated varicella VZV infection was considered to be a medically significant event. Reported Cause(s) of Death: disseminated vaccine (Oka) strain VZV; Autopsy-determined Cause(s) of Death: multiorgan failure; dilated cardiomyopathy.; disseminated VZV infection, with pulmonary and colonic lesions


VAERS ID: 840366 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Medication errors (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: Wound (1 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (the patient was bitten in an arm by probable rabid dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Suspected vaccination failure; Rabies; Inappropriate schedule of vaccine administered; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 14-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis, Rabies NVS (Rabies Vaccine) for prophylaxis and Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (the patient was bitten in an arm by probable rabid dog) and wound (1 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intramuscular), the 2nd dose of Rabies Vaccine (intramuscular), the 3rd dose of Rabies Vaccine (intramuscular) and the 4th dose of Rabies Vaccine (intramuscular). On an unknown date, unknown after receiving Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), rabies (serious criteria death and GSK medically significant) and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the vaccination failure and rabies were fatal and the outcome of the inappropriate schedule of vaccine administered was unknown. The reported cause of death was vaccination failure and rabies. The reporter considered the vaccination failure and rabies to be related to Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the suspected vaccination failure in 14-years-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). This case corresponds to the table 2 in this literature article. The patient was the part of the study that aimed to investigate how access to Post-Exposure Prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centres, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. . [In this study, specifically, they conducted contact tracing in specific area 1 (2002-2017) and in 14 selected districts in specific area 2 (4 on island, and 10 in mainland, grouping urban municipalities with corresponding rural districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions of specific area 2 (2011-2016). The patients pay for PEP in specific area 1, but in the 28 districts in specific area 2 PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or concomitant condition was provided. On unspecified date, the patient was bitten in an arm by probable rabid dog before the 5 days of vaccination. The patient had a 1 wound. On unspecified dates and 5 days after the bite, the patient had received 4 doses of unspecified rabies vaccine intramuscularly (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of specific area 1, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) and in the specific area 2, most patient were vaccinated with the 4-dose Updated agency ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons)]. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. The patient''s deaths were attributable to delays in PEP administration. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as suspected vaccination failure as the time to onset was unknown. This case has been considered as serious due to suspected vaccination failure and Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and urban centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Suspected vaccination failure; Rabies


VAERS ID: 840367 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Medication errors (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: Wound (1 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (the patient was bitten in an hand by probable rabid dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Suspected vaccination failure; Rabies; Inappropriate schedule of vaccine administered; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 3-year-old female patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis, Rabies NVS (Rabies Vaccine) for prophylaxis and Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (the patient was bitten in an hand by probable rabid dog ) and wound (1 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intramuscular), the 2nd dose of Rabies Vaccine (intramuscular), the 3rd dose of Rabies Vaccine (intramuscular) and the 4th dose of Rabies Vaccine (intramuscular). On an unknown date, unknown after receiving Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), rabies (serious criteria death and GSK medically significant) and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the vaccination failure and rabies were fatal and the outcome of the inappropriate schedule of vaccine administered was unknown. The reported cause of death was vaccination failure and rabies. The reporter considered the vaccination failure and rabies to be related to Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the suspected vaccination failure in 3-years-old female patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). This case corresponds to the table 2 in this literature article. The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. [In this study, specifically, they conducted contact tracing (2002-2017) and in 14 selected districts (4 one place, and 10 in another, grouping places with corresponding districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions (2011-2016). The patients pay for PEP, but in the 28 districts PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or or concomitant condition was provided. On unspecified date, the patient was bitten in an hand by probable rabid dog before the 4 days of vaccination. The patient had an 1 wound. On unspecified dates and 4 days after the bite, the patient had received 4 doses of unspecified rabies vaccine intramuscularly (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of country, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) and in the southern part of the country, most patient were vaccinated with the 4-dose Updated Red Cross ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons)]. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. The patient''s deaths were attributable to delays in PEP administration. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as suspected vaccination failure as the time to onset was unknown. This case has been considered as serious due to suspected vaccination failure and Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Suspected Vaccination failure; Rabies


VAERS ID: 840369 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Medication errors (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: Wound (1 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (the patient was bitten in an head by probable rabid dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Suspected vaccination failure; Rabies; Inappropriate schedule of vaccine administered; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 3-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis and Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (the patient was bitten in an head by probable rabid dog) and wound (1 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intramuscular), the 2nd dose of Rabies Vaccine (intramuscular) and the 3rd dose of Rabies Vaccine (intramuscular). On an unknown date, unknown after receiving Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), rabies (serious criteria death and GSK medically significant) and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the vaccination failure and rabies were fatal and the outcome of the inappropriate schedule of vaccine administered was unknown. The reported cause of death was vaccination failure and rabies. The reporter considered the vaccination failure and rabies to be related to Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the suspected vaccination failure in 3-years-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). This case corresponds to the table 2 in this literature article. The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. . [In this study, specifically, they conducted contact tracing in specific area 1 (2002-2017) and in 14 selected districts in specific area 2 (4 on island, and 10 in mainland, grouping urban municipalities with corresponding rural districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions of specific area 2 (2011-2016). The patients pay for PEP in specific area 1, but in the 28 districts in specific area 2 PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or or concomitant condition was provided. On unspecified date, the patient was bitten in an head by probable rabid dog before the 1 day of vaccination. The patient had an 1 wound. On unspecified dates and 1 day after the bite, the patient had received 3 doses of unspecified rabies vaccine intramuscularly (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of specific area 1, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) and in the specific area 2, most patient were vaccinated with the 4-dose Updated ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons)]. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. The patient''s deaths were attributable to delays in PEP administration. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as suspected vaccination failure as the time to onset was unknown. This case has been considered as serious due to suspected vaccination failure and Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and urban centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Suspected vaccination failure; Rabies


VAERS ID: 840370 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Incomplete course of vaccination, Rabies
SMQs:, Medication errors (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: Wound (1 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (the patient was bitten in an hand by probable rabid dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Rabies; Inappropriate schedule of vaccine administered; Incomplete course of vaccination; This case was reported in a literature article and described the occurrence of rabies in a 6-year-old female patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis and Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (the patient was bitten in an hand by probable rabid dog) and wound (1 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intramuscular), the 2nd dose of Rabies Vaccine (intramuscular) and the 3rd dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine and Rabies Vaccine and not applicable after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant), inappropriate schedule of vaccine administered and incomplete course of vaccination. On an unknown date, the outcome of the rabies was fatal and the outcome of the inappropriate schedule of vaccine administered and incomplete course of vaccination were unknown. The reported cause of death was rabies. The reporter considered the rabies to be related to Rabies Vaccine and Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of rabies virus infection; delayed vaccination schedule and incomplete course of vaccination in 6-years-old female patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). This case corresponds to the table 2 in this literature article. The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. . [In this study, specifically, they conducted contact tracing in specific area 1 (2002-2017) and in 14 selected districts in specific area 2 (4 on island, and 10 in mainland, grouping urban municipalities with corresponding rural districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions of specific area 2 (2011-2016). The patients pay for PEP in specific area 1, but in the 28 districts in specific area 2 PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies in relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or or concomitant condition was provided. On unspecified date, the patient was bitten in an hand by probable rabid dog before the 10 days of vaccination. The patient had an 1 wound. On unspecified dates and 10 days after the bite, the patient had received 2 doses of unspecified rabies vaccine intramuscularly (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of specific area 1, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) and in the specific area 2, most patient were vaccinated with the 4-dose Updated ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons). They considered 3 or more doses of PEP ?complete'' and fewer than 3 doses ?incomplete'']. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. The patient''s deaths were attributable to delays and incomplete schedule in PEP administration. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as serious due to Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and urban centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Rabies


VAERS ID: 840371 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (the patient was bitten in arm and hand by probable rabid dog); Wound (2 wound)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Rabies; Inappropriate schedule of vaccine administered; Incomplete course of vaccination; This case was reported in a literature article and described the occurrence of rabies in a 16-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis and Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (the patient was bitten in arm and hand by probable rabid dog) and wound (2 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intramuscular), the 2nd dose of Rabies Vaccine (intramuscular) and the 3rd dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine and Rabies Vaccine and not applicable after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant), inappropriate schedule of vaccine administered and incomplete course of vaccination. On an unknown date, the outcome of the rabies was fatal and the outcome of the inappropriate schedule of vaccine administered and incomplete course of vaccination were unknown. The reported cause of death was rabies. The reporter considered the rabies to be related to Rabies Vaccine and Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of rabies virus infection; delayed vaccination schedule and incomplete course of vaccination in 16-years-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). This case corresponds to the table 2 in this literature article. The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. . [In this study, specifically, they conducted contact tracing in specific area 1 (2002-2017) and in 14 selected districts in specific area 2 (4 on island, and 10 in mainland, grouping urban municipalities with corresponding rural districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions of specific area 2 (2011-2016). The patients pay for PEP in specific area 1, but in the 28 districts in specific area 2 PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies in relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or or concomitant condition was provided. On unspecified date, the patient was bitten in arm and hand by probable rabid dog before the 6 days of vaccination. The patient had an 2 wound. On unspecified dates and 6 days after the bite, the patient had received 2 doses of unspecified rabies vaccine intramuscularly (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of specific area 1, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) and in the specific area 2, most patient were vaccinated with the 4-dose Updated ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons). They considered 3 or more doses of PEP ?complete'' and fewer than 3 doses ?incomplete'']. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. The patient''s deaths were attributable to delays and incomplete schedule in PEP administration. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as serious due to Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and urban centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Rabies


VAERS ID: 840372 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Incomplete course of vaccination, Rabies
SMQs:, Medication errors (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: Wound (3 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (the patient was bitten in head, hand and trunk by probable rabid dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Rabies; Inappropriate schedule of vaccine administered; Incomplete course of vaccination; This case was reported in a literature article and described the occurrence of rabies in a 7-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis and Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (the patient was bitten in head, hand and trunk by probable rabid dog) and wound (3 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intramuscular), the 2nd dose of Rabies Vaccine (intramuscular) and the 3rd dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine and Rabies Vaccine and not applicable after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant), inappropriate schedule of vaccine administered and incomplete course of vaccination. On an unknown date, the outcome of the rabies was fatal and the outcome of the inappropriate schedule of vaccine administered and incomplete course of vaccination were unknown. The reported cause of death was rabies. The reporter considered the rabies to be related to Rabies Vaccine and Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of rabies virus infection; delayed vaccination schedule and incomplete course of vaccination in 7-years-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. . [In this study, specifically, they conducted contact tracing in specific area (2002-2017) and in 14 selected districts in another area (grouping urban municipalities with corresponding rural districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions of area (2011-2016). The patients pay for PEP in one area, but in the 28 districts in another area PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies in specific area relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or or concomitant condition was provided. On unspecified date, the patient was bitten in head, hand and trunk by probable rabid dog before the 1 day of vaccination. The patient had an 3 wound. On unspecified dates and 1 day after the bite, the patient had received 2 doses of unspecified rabies vaccine intramuscularly (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of area, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) and in the other area, most patient were vaccinated with the 4-dose Updated ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons). They considered 3 or more doses of PEP ?complete'' and fewer than 3 doses ?incomplete'']. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. The patient''s deaths were attributable to delays and incomplete schedule in PEP administration. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as serious due to Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and urban centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur in specific area due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Rabies


VAERS ID: 840373 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Incomplete course of vaccination, Rabies
SMQs:, Medication errors (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: Wound (2 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (the patient was bitten in head and hand by probable rabid dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Rabies; Inappropriate schedule of vaccine administered; Incomplete course of vaccination; This case was reported in a literature article and described the occurrence of rabies in a 8-year-old female patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis and Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (the patient was bitten in head and hand by probable rabid dog) and wound (2 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intramuscular), the 2nd dose of Rabies Vaccine (intramuscular) and the 3rd dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine and Rabies Vaccine and not applicable after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant), inappropriate schedule of vaccine administered and incomplete course of vaccination. On an unknown date, the outcome of the rabies was fatal and the outcome of the inappropriate schedule of vaccine administered and incomplete course of vaccination were unknown. The reported cause of death was rabies. The reporter considered the rabies to be related to Rabies Vaccine and Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of rabies virus infection; delayed vaccination schedule and incomplete course of vaccination in 8-years-old female patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). This case corresponds to the table 2 in this literature article. The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. . [In this study, specifically, they conducted contact tracing in northern part of the country (2002-2017) and in 14 selected districts in southern part of country (4 on island, and 10 in mainland, grouping municipalities with corresponding districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions (2011-2016). The patients pay for PEP, but in the 28 districts PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or or concomitant condition was provided. On unspecified date, the patient was bitten in head and hand by probable rabid dog before the 1 day of vaccination. The patient had an 2 wound. On unspecified dates and 1 day after the bite, the patient had received 2 doses of unspecified rabies vaccine intramuscularly (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of country, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) and most patient were vaccinated with the 4-dose Updated Red Cross ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons). They considered 3 or more doses of PEP ?complete'' and fewer than 3 doses ?incomplete'']. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. The patient''s deaths were attributable to delays and incomplete schedule in PEP administration. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as serious due to Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Rabies


VAERS ID: 840374 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Incomplete course of vaccination, Rabies
SMQs:, Medication errors (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: Wound (had 2 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (bitten in head and trunk by probable rabid dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Rabies; Incomplete course of vaccination; This case was reported in a literature article and described the occurrence of rabies in a 11-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis and Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (bitten in head and trunk by probable rabid dog) and wound (had 2 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intradermal), the 2nd dose of Rabies Vaccine (intradermal) and the 3rd dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine and Rabies Vaccine and not applicable after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the rabies was fatal and the outcome of the incomplete course of vaccination was unknown. The reported cause of death was rabies. The reporter considered the rabies to be related to Rabies Vaccine and Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of rabies virus infection and incomplete course of vaccination in 11-years-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). This case corresponds to the table 2 in this literature article. The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data [In this study, specifically, they conducted contact tracing in specific area 1 (2002-2017) and in 14 selected districts in specific area 2 (4 on island, and 10 in mainland, grouping urban municipalities with corresponding rural districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions of specific area 2 (2011-2016). The patients pay for PEP in specific area 1, but in the 28 districts in specific area 2 PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or concomitant condition was provided. On unspecified date, the patient was bitten in head and trunk by probable rabid dog. The patient had 2 wound. On unspecified dates and on the same day of the bite, the patient had received 2 dose of unspecified rabies vaccine intradermally (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of specific area 1, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) and in the specific area 2, most patient were vaccinated with the 4-dose Updated ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite. They considered 3 or more doses of PEP ?complete'' and fewer than 3 doses ?incomplete'']. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies and developed the rabies, although none were laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as serious due to Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and urban centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Rabies


VAERS ID: 840375 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Incomplete course of vaccination, Rabies
SMQs:, Medication errors (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: Wound (had 1 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (bitten in hand by probable rabid dog before the 3 days of vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Rabies; Inappropriate schedule of vaccine administered; Incomplete course of vaccination; This case was reported in a literature article and described the occurrence of rabies in a 5-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (bitten in hand by probable rabid dog before the 3 days of vaccination) and wound (had 1 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intramuscular) and the 2nd dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine and not applicable after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant), inappropriate schedule of vaccine administered and incomplete course of vaccination. On an unknown date, the outcome of the rabies was fatal and the outcome of the inappropriate schedule of vaccine administered and incomplete course of vaccination were unknown. The reported cause of death was rabies. The reporter considered the rabies to be related to Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of rabies virus infection; delayed vaccination schedule and incomplete course of vaccination in 5-years-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). This case corresponds to the table 2 in this literature article. The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. . [In this study, specifically, they conducted contact tracing in specific area 1 (2002-2017) and in 14 selected districts in specific area 2 (4 on island, and 10 in mainland, grouping urban municipalities with corresponding rural districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions of specific area 2 (2011-2016). The patients pay for PEP in specific area 2, but in the 28 districts in specific area 2 PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or concomitant condition was provided. On unspecified date, the patient was bitten in hand by probable rabid dog before the 3 days of vaccination. The patient had 1 wound. On unspecified dates and 3 days after the bite, the patient had received 1 dose of unspecified rabies vaccine intramuscularly (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of specific area 1, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) and in the specific area 2, most patient were vaccinated with the 4-dose Updated ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons). They considered 3 or more doses of PEP ?complete'' and fewer than 3 doses ?incomplete'']. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. The patient''s deaths were attributable to delays and incomplete schedule in PEP administration. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as serious due to Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and urban centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Rabies


VAERS ID: 840376 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Incomplete course of vaccination, Rabies
SMQs:, Medication errors (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: Wound (had 1 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (bitten in head by probable rabid dog before the 1 day of vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Rabies virus infection; Inappropriate schedule of vaccine administered; Incomplete Course of Vaccination; This case was reported in a literature article and described the occurrence of rabies in a 21-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (bitten in head by probable rabid dog before the 1 day of vaccination) and wound (had 1 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intramuscular) and the 2nd dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine and not applicable after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant), inappropriate schedule of vaccine administered and incomplete course of vaccination. On an unknown date, the outcome of the rabies was fatal and the outcome of the inappropriate schedule of vaccine administered and incomplete course of vaccination were unknown. The reported cause of death was rabies. The reporter considered the rabies to be related to Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of rabies virus infection; delayed vaccination schedule and incomplete course of vaccination in 21-years-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). This case corresponds to the table 2 in this literature article. The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. . [In this study, specifically, they conducted contact tracing in specific area 1 (2002-2017) and in 14 selected districts in specific area 2 (4 on island, and 10 in mainland, grouping urban municipalities with corresponding rural districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions of specific area 2 (2011-2016). The patients pay for PEP in specific area 1, but in the 28 districts in specific area 2 PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or concomitant condition was provided. On unspecified date, the patient was bitten in head by probable rabid dog before the 1 day of vaccination. The patient had 1 wound. On unspecified dates and 1 day after the bite, the patient had received 1 dose of unspecified rabies vaccine intramuscularly (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of specific area 1, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) and in the specific area 2, most patient were vaccinated with the 4-dose Updated ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons). They considered 3 or more doses of PEP ?complete'' and fewer than 3 doses ?incomplete'']. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. The patient''s deaths were attributable to delays and incomplete schedule in PEP administration. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as serious due to Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and urban centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Rabies


VAERS ID: 840377 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Incomplete course of vaccination, Rabies
SMQs:, Medication errors (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: Wound (had 1 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (bitten in leg by probable rabid dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Rabies; Incomplete course of vaccination; This case was reported in a literature article and described the occurrence of rabies in a 85-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. (Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (bitten in leg by probable rabid dog) and wound (had 1 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intradermal) and the 2nd dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine and not applicable after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the rabies was fatal and the outcome of the incomplete course of vaccination was unknown. The reported cause of death was rabies. The reporter considered the rabies to be related to Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of rabies virus infection and incomplete course of vaccination in 85-years-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). This case corresponds to the table 2 in this literature article. The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. . [In this study, specifically, they conducted contact tracing in northern part of country (2002-2017) and in 14 selected districts in southern part of country (4 on island, and 10 in mainland, grouping municipalities with corresponding districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions (2011-2016). The patients pay for PEP, but in the 28 districts PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or concomitant condition was provided. On unspecified date, the patient was bitten in leg by probable rabid dog. The patient had an 1 wound. On unspecified dates and on the same day of the bite, the patient had received 1 dose of unspecified rabies vaccine intradermally (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of country, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) most patient were vaccinated with the 4-dose Updated Red Cross ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons). They considered 3 or more doses of PEP ?complete'' and fewer than 3 doses ?incomplete'']. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as serious due to Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Rabies


VAERS ID: 840378 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Incomplete course of vaccination, Rabies
SMQs:, Medication errors (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: Wound (had 2 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (bitten on head and foot by probable rabid dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Rabies; Incomplete course of vaccination; This case was reported in a literature article and described the occurrence of rabies in a 8-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (bitten on head and foot by probable rabid dog) and wound (had 2 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intradermal) and the 2nd dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine and not applicable after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the rabies was fatal and the outcome of the incomplete course of vaccination was unknown. The reported cause of death was rabies. The reporter considered the rabies to be related to Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of rabies virus infection and incomplete course of vaccination in 8-years-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). This case corresponds to the table 2 in this literature article. The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. . [In this study, specifically, they conducted contact tracing in specific area 1 (2002-2017) and in 14 selected districts in specific area 2 (4 on island, and 10 in mainland, grouping urban municipalities with corresponding rural districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions of specific area 2 (2011-2016). The patients pay for PEP in specific area 1, but in the 28 districts in specific area 2 PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or or concomitant condition was provided. On unspecified date, the patient was bitten on head and foot by probable rabid dog. The patient had an 2 wound. On unspecified dates and on the same day of the bite, the patient had received 1 dose of unspecified rabies vaccine intradermally (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of specific area 1, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) and in the specific area 2, most patient were vaccinated with the 4-dose Updated ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons). They considered 3 or more doses of PEP ?complete'' and fewer than 3 doses ?incomplete'']. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as serious due to Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and urban centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Rabies


VAERS ID: 840379 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Incomplete course of vaccination, Rabies
SMQs:, Medication errors (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: Wound (had 1 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (bitten on head by probable rabid dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Rabies; Incomplete course of vaccination; This case was reported in a literature article and described the occurrence of rabies in a 9-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (bitten on head by probable rabid dog) and wound (had 1 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intradermal) and the 2nd dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine and not applicable after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the rabies was fatal and the outcome of the incomplete course of vaccination was unknown. The reported cause of death was rabies. The reporter considered the rabies to be related to Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of rabies virus infection and incomplete course of vaccination in 9-years-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). This case corresponds to the table 2 in this literature article. The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. . [In this study, specifically, they conducted contact tracing (2002-2017) and in 14 selected districts (4 on island, and 10 in mainland, grouping urban municipalities with corresponding rural districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions (2011-2016). The patients pay for PEP, but in the 28 districts PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or concomitant condition was provided. On unspecified date, the patient was bitten on head by probable rabid dog. The patient had an 1 wound. On unspecified dates and on the same day of the bite, the patient had received 1 dose of unspecified rabies vaccine intradermally (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28), most patient were vaccinated with the 4-dose Updated ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons). They considered 3 or more doses of PEP ?complete'' and fewer than 3 doses ?incomplete'']. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as serious due to Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and urban centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Rabies


VAERS ID: 840380 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Incomplete course of vaccination, Rabies
SMQs:, Medication errors (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: Wound (had 4 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (bitten on arm, hand, trunk and leg by probable rabid dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Rabies; Incomplete course of vaccination; This case was reported in a literature article and described the occurrence of rabies in a 70-year-old female patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (bitten on arm, hand, trunk and leg by probable rabid dog) and wound (had 4 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intradermal) and the 2nd dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine and not applicable after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the rabies was fatal and the outcome of the incomplete course of vaccination was unknown. The reported cause of death was rabies. The reporter considered the rabies to be related to Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of rabies virus infection and incomplete course of vaccination in 70-years-old female patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. . [In this study, specifically, they conducted contact tracing in specific area (2002-2017) and in 14 selected districts in another area (grouping urban municipalities with corresponding rural districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions of area (2011-2016). The patients pay for PEP in specific area, but in the 28 districts in other area PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or or concomitant condition was provided. On unspecified date, the patient was bitten on arm, hand, trunk and leg by probable rabid dog. The patient had an 4 wound. On unspecified dates and on the same day of the bite, the patient had received 1 dose of unspecified rabies vaccine intradermally (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of specific area, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) and in the other area, most patient were vaccinated with the 4-dose Updated ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons). They considered 3 or more doses of PEP ?complete'' and fewer than 3 doses ?incomplete'']. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as serious due to Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and urban centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Rabies


VAERS ID: 840522 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased, Chest X-ray abnormal, Death, Diarrhoea, Haematology test abnormal, Haemoglobin normal, Lung infiltration, Lymphocyte percentage decreased, Lymphopenia, Nasal flaring, Neutrophilia, PO2 normal, Pneumonia, Procalcitonin increased, Rash, Rhonchi, Use of accessory respiratory muscles, Wheezing, White blood cell count, White blood cell count normal
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (narrow), Interstitial lung disease (narrow), Systemic lupus erythematosus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (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: Body temperature; Result Unstructured Data: Test Result: 37.6, Test Result Unit: degree C; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 175.3, Test Result Unit: unknown; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 10.5, Test Result Unit: unknown; Test Name: Heart rate; Result Unstructured Data: Test Result: 194, Test Result Unit: /min; Test Name: Lymphocyte count; Result Unstructured Data: Test Result: 19, Test Result Unit: unknown; Test Name: Oxygen saturation; Result Unstructured Data: Test Result: 70.3, Test Result Unit: unknown; Test Name: PO2; Result Unstructured Data: Test Result: 94, Test Result Unit: unknown; Test Name: Procalcitonin; Result Unstructured Data: Test Result: 6.9, Test Result Unit: unknown; Test Name: Respiratory rate; Result Unstructured Data: Test Result: 63, Test Result Unit: /min; Test Name: Leukocyte count; Result Unstructured Data: Test Result: 13600 (normal), Test Result Unit: unknown; Test Name: Polymorphonuclear count; Result Unstructured Data: Test Result: 75, Test Result Unit: unknown; Test Name: X-ray; Result Unstructured Data: Test Result: showed infiltrate and cavity, Test Result Unit: unknown; Test Name: Hematology test
CDC Split Type: IDGLAXOSMITHKLINEID2019GS

Write-up: Pneumonia; Skin rash; Diarrhea; Nasal flaring; symptoms of wheezing; Rhonchi; Retraction/chest indrawing was positive and severe; Lymphopenia; Neutrophilia; Lung infiltration; This case was reported in a literature article and described the occurrence of pneumonia in a 2-month-old male patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included BCG VACCINE for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and BCG VACCINE at an unknown dose. On an unknown date, less than 3 months after receiving Hepatitis B vaccine, the patient experienced pneumonia (serious criteria death and GSK medically significant), rash, diarrhea, nasal flaring, wheezing, rhonchi, retractive breathing, lymphopenia, neutrophilia and lung infiltration. On an unknown date, the outcome of the pneumonia was fatal and the outcome of the rash, diarrhea, nasal flaring, wheezing, rhonchi, retractive breathing, lymphopenia, neutrophilia and lung infiltration were unknown. The reported cause of death was pneumonia. The reporter considered the pneumonia, rash, diarrhea, nasal flaring, wheezing, rhonchi, retractive breathing, lymphopenia, neutrophilia and lung infiltration to be related to Hepatitis B vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of pneumonia in a 2-month-old male patient, who was vaccinated with unspecified hepatitis B virus vaccine and unspecified Bacillus Calmette-Guerin (BCG) vaccine (manufacturer unknown for both) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was a part of multicenter cohort study that aimed to describe the causes of pneumonia that may change after the introduction of vaccines and to identify biomarkers to differentiate between bacterial and viral infection. The 2-year multicenter cohort study was conducted in children between 2-month and 5-year old with pneumonia in three hospitals since July 2017. The patient had no breast-feeding history of more than or equal to 6 months. The patient had no underlying disease of development delay, congenital heart diseases, asthma and recurrent pneumonia. The patient had no vaccine history of diphtheria, pertussis, and tetanus vaccine (DPT) and Haemophilus influenzae type B (HIB) vaccine. No information on patient''s family history or concomitant medication was provided. On an unspecified date, the patient received unspecified hepatitis B virus vaccine and unspecified Bacillus Calmette-Guerin (BCG) vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). The age of vaccination was not provided. On an unspecified date since July 2017, at the age of 2-months, an unknown period after the vaccination, the patient developed skin rash and had symptoms of diarrhea and had nasal flaring and had symptoms of retraction, ronchi and wheezing. The patient''s oxygen saturation (sat O2) was 70.3 and partial pressure of oxygen (Pa O2) was 94. During examination, the he patient''s vital sign showed: body temperature 37.6 deg. C, pulse 194 times/minute, and respiratory rate was 63 times/minute. The patient chest indrawing was positive and severe. The radiology examination showed infiltrate and cavity. Subsequently the patient was diagnosed with pneumonia with unknown etiology. The patient''s laboratory blood tests showed: hemoglobin (Hb) was 10.5, leucocyte was 13600, lymphocyte was 19, polymorphonuclear leukocytes (PMN) was 75. The patient''s hematology showed lymphopenia, and neutrophilia. The patient had normal leucocyte count. The patient had no leukopenia, no leukocytosis, no neutropenia and no normal lymphocyte count. Biomarker result showed C- reactive protein (CRP) was 175.3 and procalcitonin was 6.9. On an unspecified date, the patient had died. The cause of death was pneumonia. It was unknown if an autopsy was performed. This case has been considered serious due to due to death. The author did not comment on the relationship between the event of pneumonia and unspecified hepatitis B virus vaccine, and unspecified Bacillus Calmette-Guerin (BCG) vaccine. The authors concluded, "Mixed viral and bacterial infection were predominant. Several atypical pathogens were identified. No significant different in biomarkers between viral, bacterial and mixed infection groups was found. This finding highlights the need to improve diagnostic capacity to aid clinicians in pneumonia management." This article corresponding to this case is not available for regulatory submission due to copyright restriction. Lab Comments: Lab test done on an unknown date. The patient chest indrawing was positive and severe. The patient''s hematology showed lymphopenia, and neutrophilia. The patient had no leukopenia, no leukocytosis, no neutropenia and no normal lymphocyte count.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 840595 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-09-11
Onset:2019-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER ROB851M / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AF0233 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Blood glucose increased, Death, Febrile convulsion
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-09-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20190912; Test Name: Serum glucose; Result Unstructured Data: Test Result: 1, Test Result Unit: mmol/l; Test Date: 20190912; Test Name: Serum glucose; Result Unstructured Data: Test Result: 11.1, Test Result Unit: mmol/l; Test Date: 20190911; Test Name: Body temperature; Result Unstructured Data: Test Result: 38.5, Test Result Unit: Centigrade; Test Date: 20190912; Test Name: Body temperature; Result Unstructured Data: Test Result: 39.6, Test Result Unit: Centigrade; Test Date: 20190912; Test Name: Heart rate; Result Unstructured Data: Test Result: 100 /min; Test Date: 20190912; Test Name: Oxygen saturation; Result Unstructured Data: Test Result: 90-92, Test Result Unit: %
CDC Split Type: HUPFIZERINC2019433292

Write-up: multiple febrile seizures; This is a spontaneous report downloaded from the Regulatory Authority HU-OGYI-129919. This is a spontaneous report from a contactable physician received from the Institute. A 5-month-old male patient received on 11Sep2019 pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVENAR 13) Lot AF0233, and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PENTAXIM, lot ROB851M), both intramuscular at 0.5 ml, single for immunization. The patient medical history and concomitant medications were not reported. The patient experienced multiple febrile seizures on 11Sep2019 resulting in death on 12Sep2019. The patient underwent lab tests and procedures which included blood glucose: 1 mmol/l on 12Sep2019 and 11.1 mmol/l on 12Sep2019, body temperature: 38.5 centigrade on 11Sep2019 and 39.6 centigrade on 12Sep2019, heart rate: 100 /min on 12Sep2019, oxygen saturation: 90-92 % on 12Sep2019. The patient died on 12Sep2019. An autopsy was performed and results were not provided. SENDER COMMENT: The event multiple febrile seizures is considered expected for PENTAXIM and PREVENAR 13, febrile seizures are listed in the product information of both vaccines. Severe multiple febrile seizures could lead to circulatory and respiratory arrest. Time-to-onset is considered to be within a day, that allows for causality. There is a possibility that diazepam might have contributed to the respiratory depression. The great fluctuation in blood serum glucose is implying to the other suspected possibility a rapidly progressive meningoencephalitis. As there is still insufficient information causal assessment is currently not possible. The case is considered serious due to the fatal outcome. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Cause of death was the complication of the seizures, repiratory and circulatory (cardiac) arrest.


VAERS ID: 840719 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia bacterial
SMQs:, 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: JP0095075131910JPN001060J

Write-up: Pneumonia bacterial; Information has been received from an other health professional concerning an elderly male patient who was vaccinated with pneumococcal vaccine, polyvalent (23-valent) injection (PNEUMOVAX NP) for prophylaxis (date of vaccination, dose and lot number not reported). No concomitant medications were reported. On an unspecified date, the patient developed pneumonia bacterial. On an unspecified date, the patient died of pneumonia bacterial. It was unknown whether an autopsy was performed. Reporter''s comment: Not provided. The reporting other health professional did not assess the relationship of pneumonia bacterial to pneumococcal Vaccine, Polyvalent (23-valent). Upon internal review, pneumonia bacterial was determined to be medically significant.; Reported Cause(s) of Death: Pneumonia bacterial


VAERS ID: 841675 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-05-13
Onset:2019-07-04
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2019-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS NO BATCH NUMBER / UNK - / OT
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Autonomic nervous system imbalance, Back pain, Blood pressure fluctuation, CSF test abnormal, Computerised tomogram abdomen normal, Computerised tomogram head normal, Computerised tomogram pelvis, Computerised tomogram thorax normal, Cough, Death, Electroencephalogram abnormal, Failure to thrive, Gait disturbance, General physical health deterioration, Guillain-Barre syndrome, Hypotension, Inappropriate antidiuretic hormone secretion, Intensive care, Lower respiratory tract infection, Lumbar puncture abnormal, Nerve conduction studies abnormal, Peak expiratory flow rate decreased, Pneumonia aspiration, Pseudomonas infection, Respiratory failure, Sputum culture positive, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hyponatraemia/SIADH (narrow), Hypertension (broad), Cardiomyopathy (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-09-25
   Days after onset: 83
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 76 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT brain, chest, abdomen and pelvis; Result Unstructured Data: NAD - Nothing abnormal detected.; Test Name: CSF; Result Unstructured Data: Albumino-cytologic dissociation.; Test Name: EEG; Result Unstructured Data: Confirmed diagnosis of GBS.; Test Name: Lumbar puncture; Result Unstructured Data: Confirmed diagnosis of GBS.; Test Name: Nerve conduction studies; Result Unstructured Data: Confirmed diagnosis of GBS.; Test Date: 20190816; Test Name: Nerve conduction studies; Result Unstructured Data: Documented stable appearances - no significant improvement or deterioration was noted and findings remained consistent with demyelinating motor neuropathy.; Test Date: 20190906; Test Name: Nerve conduction studies; Result Unstructured Data: Documented stable appearances - no significant improvement or deterioration was noted and findings remained consistent with demyelinating motor neuropathy.; Test Date: 20190912; Test Name: Sputum pesudomonas; Result Unstructured Data: Pseudomonas.
CDC Split Type: AUSEQIRUS201905173

Write-up: SIADH; Respiratory failure; Tachycardia; Hypotension; Aspiration pneumonia; Sputum pseudomonas; Guillain-Barre syndrome; Death; This is a spontaneous case initially reported by other health professional to Administration (reference number: AU-TGA-0000477321) and initially retrieved on 11-Oct-2019, concerning a 75-year-old, male patient. The patient''s medical history and concomitant medications were not reported. On 13-May-2019, the patient was administered Fluad [influenza virus haemagglutinin; route of administration: intramuscular, dose, batch number, anatomical location and expiry date: not reported] for an unknown indication. On 20-May-2019, the patient was administered co-suspect vaccine, Pneumovax 23 [pneumococcal purified capsular polysaccharides; dose 2 (as reported), route of administration intramuscular, batch number, anatomical location and expiry date: not reported] for an unknown indication. On 04-Jul-2019, 1 month and 21 days after flu vaccination, the patient developed Guillain-Barre syndrome (GBS). On 11-Jul-2019, the patient presented to general practitioner (GP), complaining of unsteady gait, walking very slowly and pain in lower back and hips. Patient''s wife had reported the change in gait, shuffling and walking very, very slowly, plus hip and lower back pain had commenced 1-2 months prior to GP presentation. On the same date, the patient was sent to emergency department (ED) by GP and then transferred to hospital intensive care unit (ICU) for respiratory support due to aspiration pneumonia and suspicion on GBS. On an unspecified date, the patient underwent lumbar puncture, electroencephalogram (EEG) and nerve conduction studies which confirmed diagnosis of GBS. Computerized tomogram (CT) of brain, chest, abdomen and pelvis showed nothing abnormal detected (NAD). Cerebrospinal fluid (CSF) test showed albumino-cytologic dissociation. On an unspecified date early August, the patient acutely worsened. The patient developed autonomic complications: SIADH (inappropriate antidiuretic hormone secretion), blood pressure fluctuations/autonomic dysfunction (tachycardia, hypotension), respiratory deterioration due to difficulty clearing secretions, weak cough and poor peak flows and lower tract respiratory infection (LRTI). On 11-Aug-2019, the patient was transferred from Ward to ICU. On 14-Aug-2019 the patient was transferred to Hospital Neuro Ward and later to ICU for respiratory failure which resolved quickly with HFNP (high flow nasal prong therapy), and transferred back to ward. On 16-Aug-2019 the patient underwent nerve conduction studies which documented stable appearances - no significant improvement or deterioration was noted, and findings remained consistent with demyelinating motor neuropathy. On 06-Sep-2019, the patient underwent nerve conduction studies which documented stable appearances - no significant improvement or deterioration was noted, and findings remained consistent with demyelinating motor neuropathy On 10-Sep-2019 the patient was transferred back to hospital for rehabilitation for ongoing lower limb proximal myopathy, poor cough and difficulty clearing sputum and some autonomic dysfunction (tachycardia, hypotension) whilst an inpatient at hospital. On 12-Sep-2019, the patient was diagnosed with Pseudomonas in sputum culture and was treated with Tazocin (piperacillin sodium, tazobactam sodium) for 5 days. On 25-Sep-2019, after further deterioration his care was changed to comfort only, and the patient died. It was unknown whether autopsy was performed. The patient was treated with Privigen (immunoglobulin human normal) [from 13-Aug-2019 to 18-Aug-2019], Augmentin Duo Forte (amoxicillin trihydrate, clavulanate potassium), atenolol [stop date 09-Sep-2019], fludrocortisone, furosemide, fluid restriction and with physio treatment. Requiring chest physio had good results but failing to thrive on ward, the patient remained generally deconditioned. The outcome of the event respiratory failure was resolved on an unspecific date. The outcome of all other events was not provided, at the time of this report. This case was assessed as serious and the reporter did not provide causality assessment to Fluad.; Sender''s Comments: The patient experienced pneumonia aspiration, pseudomonas infection, inappropriate antidiuretic hormone secretion, respiratory failure, tachycardia, hypotension, Guillain-Barre syndrome and death after vaccination with the suspect product Fluad. Chronology is plausible. Causality was confounded by co suspect vaccine, Pneumovax 23 (pneumococcal purified capsular polysaccharides). No medical history, exact cause of death and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 842275 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, 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: End stage COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZERINC2019451420

Write-up: Progression of COPD disease. Cause of death unknown This is a report from a Non-Interventional Study source. A subject of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The subject had COPD stage IV Gold D with very severe disease and other comorbidities. Concomitant medications were not reported. The subject previously took pneumococcal vaccine for immunization on 21Oct2016. The subject experienced progression of COPD disease, cause of death unknown on an unspecified date. It was unknown if an autopsy was performed. The information on the lot/batch number has been requested. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender''s Comments: There is no reasonable possibility that the event death was related to pneumococcal 13-valent conjugate vaccine. This is more likely associated with the progression of the underlying COPD.; Reported Cause(s) of Death: Cause of death unknown


VAERS ID: 842775 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / OT

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131910JPN002214J

Write-up: Invasive pneumococcal infection; Initial information has been received from a physician concerning an adult patient. The patient was vaccinated with pneumococcal vaccine (PNEUMOVAXNP) for prophylaxis (vaccination date and lot number was not reported.) No concomitant medications reported. On an unspecified date, the patient was vaccinated with pneumococcal vaccine (described above). On an unspecified date, invasive pneumococcal disease developed. On an unspecified date, the patient died of invasive pneumococcal disease. Whether an autopsy was performed was unknown. Reporter''s comment: not provided The reporting physician did not assess the relationship of invasive pneumococcal disease to pneumococcal vaccine. Upon internal review, invasive pneumococcal disease was determined to be medically significant.; Reported Cause(s) of Death: Invasive pneumococcal infection


VAERS ID: 843697 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac disorder (severely disabled with significant cardiac, respiratory and neurodevelopmental problems related to a genetic abnormality); Multiple congenital abnormalities; Neurodevelopmental disorder (severely disabled with significant cardiac, respiratory and neurodevelopmental problems related to a genetic abnormality); Respiratory disorder (severely disabled with significant cardiac, respiratory and neurodevelopmental problems related to a genetic abnormality)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2019SA295057

Write-up: respiratory progressing to cardiac arrest, was unable to be resuscitated; febrile after flu vaccine; child passed away; Initial information received on 24-Oct-2019 regarding an unsolicited valid serious case received from a physician. This case involves a eight months old male patient who experienced respiratory progressing to cardiac arrest, was unable to be resuscitated (cardio-respiratory arrest), febrile (pyrexia) and passed away, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUQUADRI JUNIOR]. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing condition: severely disabled with significant cardiac, respiratory and neurodevelopmental problems related to a genetic abnormality. 17-Oct-2019, the patient received a second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown, the patient experienced a serious respiratory progressing to cardiac arrest, was unable to be resuscitated (cardio-respiratory arrest) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. On an unknown, the patient experienced a serious febrile after flu vaccine (pyrexia) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was hospitalized for this event. On an unknown, the patient passed away due to unknown reason (death) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant and was leading to death. Other relevant tests were not reported. Final diagnosis was cardio-respiratory arrest, pyrexia and death. It was not reported if the patient received a corrective treatment. The patient outcome was reported as unknown for cardio-respiratory arrest and pyrexia. The patient had passed away due to unknown reason. It was unknown if an autopsy was done. The cause of death was not reported. The reporter assessed the causal relationship with suspect vaccine as possible. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a eight months old male who presented with cardio-respiratory arrest and pyrexia one day after vaccination with FLUQUADRI JUNIOR and passed away. Patient''s medical condition includes multiple congenital abnormalities and was severely disabled with significant cardiac, respiratory and neurodevelopment problems related to a genetic abnormality. Origin of the fever was not reported nor lab tests. Autopsy results were not reported neither. Based upon the limited reported information, the role of the vaccine cannot be assessed; Reported Cause(s) of Death: child passed away


VAERS ID: 844005 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Herpes simplex
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: DEGLAXOSMITHKLINEDE2019EM

Write-up: herpes type 1; This case was reported by a physician and described the occurrence of herpes simplex type i in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced herpes simplex type i (serious criteria death). On an unknown date, the outcome of the herpes simplex type i was fatal. The reported cause of death was herpes simplex type i. It was unknown if the reporter considered the herpes simplex type i to be related to Shingrix. Additional case details were reported as follows: The age at vaccination was not reported. The patient died after about 6 months after the 2nd dose of Shingrix and one of the cause was herpes type 1.; Reported Cause(s) of Death: herpes type 1


VAERS ID: 844315 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-10-05
Onset:2019-10-09
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2019-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Drooling, Hyperhidrosis, Musculoskeletal pain, Nausea, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-09
   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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSEQIRUS201905599

Write-up: Shoulder pain; Drooling; Pain in arm; Sweating; Nausea; Patient collapsed on way to taxi and died; This is a spontaneous case reported by pharmacist to Regulatory Authority [regulatory reference number: GB-MHRA-EYC 00209913] and initially retrieved on 25-Oct-2019, concerning a female patient of unreported age. The patient''s medical history and concomitant medications were not provided. On 05-Oct-2019, the patient was administered Fluad TIV [influenza vaccine, inactivated influenza virus surface antigen, egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm, batch number and expiration date: not reported] for influenza immunisation. On an unspecified date in Oct-2019, unknown amount of time after vaccination, the patient experienced nausea, sweating, drooling, pain in arm and shoulder. On 09-Oct-2019, reported as five days after vaccination, the patient contacted Health Service and was advised by a doctor to came to see them. On the way to taxi, the patient collapsed and died. It was unknown if the autopsy was performed. At the time of death, the events of ''nausea'', ''sweating'', ''drooling'', ''shoulder pain'' and ''pain in arm'' were still ongoing. The case was assessed as serious. The reporter did not provide causality assessment. Company Comment: The events of ''circulatory collapse'', ''nausea'', ''sweating'', ''drooling'', ''shoulder pain'' and ''pain in arm'' are considered related to Fluad TIV.; Sender''s Comments: The events of ''circulatory collapse'', ''nausea'', ''sweating'', ''drooling'', ''shoulder pain'' and ''pain in arm'' are considered related to Fluad TIV.; Reported Cause(s) of Death: Circulatory collapse


VAERS ID: 844649 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-01-01
Submitted: 0000-00-00
Entered: 2019-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Acinetobacter test positive, Acute respiratory failure, Adenocarcinoma of colon, Anaemia, Arrhythmia, Atrial fibrillation, Blood bicarbonate increased, Blood lactate dehydrogenase increased, Blood pH normal, Bordetella test positive, Brain natriuretic peptide increased, Bronchoalveolar lavage abnormal, Candida test positive, Cardiac failure, Chest X-ray abnormal, Chronic lymphocytic leukaemia, Colectomy, Coma, Computerised tomogram thorax abnormal, Constipation, Cough, Death, Depressed level of consciousness, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Endotracheal intubation, Enterococcus test positive, Fungal disease carrier, Gastrointestinal hypomotility, Hepatosplenomegaly, Hyperglycaemia, Hypophonesis, Hypotension, Hypoxia, Influenza virus test negative, Intensive care, Leukocytosis, Lung infiltration, Lymphocyte count increased, Lymphocytosis, Multiple organ dysfunction syndrome, Oxygen saturation decreased, PCO2 increased, Platelet count decreased, Pleural effusion, Pneumonia, Polymerase chain reaction, Procalcitonin normal, Productive cough, Pulmonary embolism, Purpura, Purulent discharge, Pyrexia, Renal failure, Respiratory distress, Respiratory failure, Respiratory tract infection, Sedation, Sepsis, Septic shock, Sputum culture positive, Streptococcus test positive, Thrombocytopenia, Vomiting, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Haematological malignant tumours (narrow), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-02-12
   Days after onset: 42
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: Chronic obstructive pulmonary disease (type chronic bronchitis); Dyspnoea; Ischaemic cardiomyopathy; Type 2 diabetes mellitus (on treatment, not complicated)
Preexisting Conditions: Medical History/Concurrent Conditions: Angina of effort
Allergies:
Diagnostic Lab Data:
CDC Split Type: ES0095075131910ESP015173

Write-up: Acute community acquired pneumonia; Bilateral pulmonary thromboembolism; death; failure of several organs (heart, kidney)/ Multiorgan failure; desaturation, bronchospasm/ worsening of the ARI/ serious ARI; Acute abdomen; Coma; Hypergycemia; Complete arrythmia by paroxysmal artrial fibrilation; Sepsis: septic shock; Ascending colon adenocarcinoma (T3N2M0); Chronic lymphocytic leukemia (stage All); This spontaneous report as received from a physician refers to a 73-year-old male patient. The patient''s concurrent conditions included type 2 diabetes mellitus on treatment, not complicated, moderate chronic obstructive pulmonary disease (COPD) type chronic bronchitis, basal dyspnea II-III/IV (no previous hospital admissions due to pneumonia nor acute respiratory insufficiency (ARI), nor oxygen-therapy at home), chronic ischemic cardiopathy (she had effort angina in June 1996, but was asymptomatic since then). The patient was ex-smoker and had no recent international travels and no pets. Historical medications included anti-flu vaccination. On an unknown date (reported as more than 5 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (dose, frequency, route of administration, lot #, expiration date were not provided) for prophylaxis. On unspecified date, in 1997, he was diagnosed with chronic lymphatic leukemia (stage All, at the beginning) with hepatosplenomegaly. It was treated with Chlorambucil since 2002 (leukocytes were higher than 90.000 on an unknown date). On an unknown date, the patient experienced ascending colon adenocarcinoma (T3N2M0). On unspecified date in October 2009, he underwent right hemilectomy (resection ends free of tumoral lesion). On unspecified date, in March 2011, underwent eventration repair with an abdominal net. On unspecified date, after the surgery, the patient experienced bilateral pulmonary thromboembolism. On 01-JAN-2012, the patient was admitted to hospital with acute community-acquired pneumonia (he had cough, fever, sputum, and dyspnea increased). On respiratory auscultation there was noisy breathing, bilateral basal hypophonesis, mostly on the left side. He had partial respiratory insufficiency, on thorax radiography there was right basal alveolar infiltrate and mild left pleural effusion. Urine anti-pneumococcal antigen was positive, nasopharyngeal smear flu test were negative. Antibiotic treatment was started with amoxicillin (+) clavulanic acid. Blood culture was positive for Streptococcus pneumoniae. On 04-JAN-2012, the patient experienced early complications (controlled): hyperglycemia (insulinization) and complete arrythmia by paroxysmal atrial fibrillation. On 24-JAN-2012, the oxygen-therapy was still needed. On 25-JAN-2012, the patient experienced desaturation and bronchospasm. Sputum culture showed Bordetella bronchiseptica. Treatment with levofloxacin was started. On 31-JAN-2012, the patient experienced abdominal complications of vomiting, constipation for 3 days, abdominal distention, painful at diffuse palpation, without peritonism, decreased peristalsis, no bigger masses or megalies, fast atrial fibrillation, fever, worsening of the ARI. The patient was moved to the intensive care unit (ICU) due to serious ARI, abdominal distension, hypoxemia (Oxygen saturation: 75%) and decrease of the consciousness level (coma). Arterial Blood Gas (ABG) results were as follows: pH 7.44, pCO2: 61.7 mmHg, Bicarbonate: 40.7 mmol/L. The patient was sedated, endotracheal intubation was performed: purulent secretions were observed. Additional tests included: Abdominal Rx: big gastric distension with air pattern in small bowel and colon with normal characteristics, abundant fecal remains; Thorax computed axial tomography (CAT): mostly alveolar pattern in right upper lobe (probably related to the bronchoaspiration). Atelectasis in posterior segments ofthe inferior lobes. No pulmonary nodes; Abdominal CAT: No signs of intestinal obstruction; two cystic images in hepatic parenchyma. The patient''s leukocytosis (lymphocytosis) was increasing, lactate dehydrogenase was increasing. Polymerase Chain Reaction (PCR): 55 (unit not provided), procalcitonin: 0.79 (unit not provided), Pro-B-type natriuretic peptide (BNP): 8700 (unit not provided). The patient experienced important hemodynamic worsening: sepsis: septic shock. On 01-FEB-2012, the patient experienced respiratory insufficiency which evolved to respiratory distress (orotracheal intubation was performed). On 01-FEB-2012, he experienced additional dysfunction and failure of several organs (heart, kidney), fever (higher than 38 degrees Celsius), hypotension: noradrenalin was given. Bronchial Alveolar Lavage (BAL) and BAS (more than 10^4): Acinetobacter baumannii, Candida tropicalis (colinization): treatment with Colistin and T?gecycline (high doses), and Voriconazole was started. Blood culture wa s positive for Enterococcus faecium and treatment with Daptomycin was started. Echocardiogram showed contractility alteration, ejection fraction decrease, no vegetations. There were increased pulmonary infiltrates and respiratory secretions. Reticulated ecchymotic purpura in the middle and lateral of the abdomen was observed. lncreased leukocytosis (due to the lymphocytes), with anemia (haemoglobin of 9.2 (unit not provided)) and thrombocytopenia (platelets 57.000 (unit not provided)); IQ alterations and aPTT were observed. On 04-FEB-2012, BAL showed Acinetobacter baumannii and filamentous fungi. On 08-FEB-2012, the patient experienced multiorgan failure. On 12-FEB-2012, the patient died. The cause of death was not reported. It was not reported if the autopsy was performed. The outcome of all events at the time of the patient''s death was unknown. The causality assessment was not provided. Upon internal review the events of acute community acquired pneumonia, ascending colon adenocarcinoma, chronic lymphocytic leukemia, bilateral pulmonary thromboembolism, artrial fibrillation, acute abdomen, coma, multiorgan failure, acute respiratory failure and sepsis were determined to be medically significant. This is one of two reports regarding the same patient.; Sender''s Comments: ES-009507513-1910ESP015155:


VAERS ID: 844762 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-24
Onset:2019-10-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R028634 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia, Respiratory failure, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: 2019-10-25
   Days after onset: 1
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: hepatitis B virus vaccine (unspecified)
Current Illness: General physical condition decreased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075131910CHN016209

Write-up: Severe pneumonia; vomiting; Respiratory failure; This spontaneous report was received from an Agency and refers to a 7-week-old male patient. The patient''s medical history included unspecified BCG Vaccine and unspecified hepatitis B vaccine (reported as Hep B) at zero month (31-AUG-2019) according to the normal schedule. On 24-OCT-2019 the patient received one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # R028634 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 26-JUN-2020) for prophylaxis at a county health center. The patient''s concomitant vaccines included 2nd shot of unspecified hepatitis Bat 1 month (also reported as on 09-OCT-2019). Prior to the vaccination, the patient had a pre-check and had no cough and fever, but the child was in poor condition. During the period between the class-1 vaccination and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccination, no other vaccine was vaccinated. No other vaccine was administered in combination with rotavirus vaccine, live, oral, pentavalent (ROTATEQ). After vaccination the patient went back home. In the afternoon of 24-OCT-2019, the patient experienced vomiting and received infusion treatment in the health center. The town health centers suspected it as pneumonia and suggested further treatment to the hospital as they considered it as a severe condition. The patient was transferred to the hospital for treatment. At around 7 a.m. of the next day (25-OCT-2019), the patient died. The diagnosis of hospital was death due to respiratory failure caused by severe pneumonia. The hospital did not provide the certificate of diagnosis at the reporting time. The county center for disease control and the city center for disease control had communicated with the patient''s parents, autopsy was suggested. The relatives initially agreed but refused the autopsy at the reporting time. By the reporting time, parents of the patient were stable in emotion. The parents had bought the class-2 vaccine insurance at their own expense, the insurance company had stepped in the event. Attempts were making to obtain further information such as the patient''s medical records. Upon internal review, the events of severe pneumonia and respiratory failure were considered to be medically significant.; Reported Cause(s) of Death: Respiratory failure


VAERS ID: 845185 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-04
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: NZ0095075131910NZL016991

Write-up: Gardasil kills three girls; This is a social media spontaneous report which has been received from a freelance research and writer, who wrote and article concerning to a female patient of unknown age. The patient''s medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (strength, dose, frequency, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). The reporter stated that, on an unknown date, quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) killed the patient (death). In addition, it was unknown if an autopsy was performed. The causal relationship between the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the patient''s death was reported as related. This is one of several cases provided by the same reporter.; Sender''s Comments: NZ-009507513-1911NZL000272: NZ-009507513-1911NZL000270: NZ-009507513-1911NZL000271:; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 845186 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-04
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: NZ0095075131911NZL000271

Write-up: Gardasil kills three girls; This is a social media spontaneous report which has been received from a freelance research and writer, who wrote and article concerning to a female patient of unknown age. The patient''s medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (strength, dose, frequency, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). The reporter stated that, on an unknown date, quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) killed the patient (death). In addition, it was unknown if an autopsy was performed. The causal relationship between the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and the patient''s death was reported as related. This is one of several cases provided by the same reporter.; Sender''s Comments: NZ-009507513-1910NZL016991: NZ-009507513-1911NZL000272: NZ-009507513-1911NZL000270:; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 845187 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-04
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: NZ0095075131911NZL000272

Write-up: Gardasil kills three girls; This spontaneous information has been received from a freelance research and writer, who wrote and article concerning to a female patient of unknown age. The patient''s medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (strength, dose, frequency, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). The reporter stated that, on an unknown date, quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) killed the patient (death). The causal relationship between the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and the patient''s death was reported as related. This is one of several cases provided by the same reporter.; Sender''s Comments: NZ-009507513-1910NZL016991: NZ-009507513-1911NZL000271: NZ-009507513-1911NZL000270: NZ-009507513-1911NZL000271: NZ-009507513-1911NZL000270:; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 845458 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-10-05
Onset:2017-10-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A21CC953A ? / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S15112 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ammonia increased, Anion gap increased, Bacterial test negative, Biopsy liver abnormal, Blood bicarbonate decreased, Blood calcium normal, Blood creatine phosphokinase increased, Blood culture negative, Blood glucose increased, Blood lactic acid increased, Blood pH normal, Blood phosphorus normal, Blood potassium increased, Blood pyruvic acid increased, Blood sodium decreased, Blood uric acid increased, C-reactive protein increased, CSF glucose, CSF lactate, CSF protein, CSF virus no organisms observed, Coagulation factor V level normal, Death, Glucose urine absent, Hepatic failure, Hepatocellular injury, Metabolic acidosis, Nervous system disorder, Nitrite urine absent, PCO2, Platelet count increased, Polymerase chain reaction, Procalcitonin increased, Prothrombin level decreased, Transaminases, Urine ketone body absent, White blood cells urine negative, pH urine normal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver-related coagulation and bleeding disturbances (narrow), Lactic acidosis (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-09
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20171008; Test Name: Anion gap; Result Unstructured Data: Test Result: 27, Test Result Unit: unknown; Test Date: 20171008; Test Name: Anion gap; Result Unstructured Data: Test Result: 17, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood bicarbonate; Result Unstructured Data: Test Result: 14, Test Result Unit: mmHg; Test Date: 20171008; Test Name: Blood bicarbonate; Result Unstructured Data: Test Result: 11, Test Result Unit: unknown; Test Date: 201710; Test Name: Blood bicarbonate; Result Unstructured Data: Test Result: 11, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood calcium; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood creatine phosphokinase; Result Unstructured Data: Test Result: elevated, Test Result Unit: unknown; Test Date: 20171007; Test Name: Blood culture; Result Unstructured Data: Test Result: Negative, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood glucose; Result Unstructured Data: Test Result: 2.67, Test Result Unit: g/L; Test Date: 20171008; Test Name: Blood glucose; Result Unstructured Data: Test Result: 12, Test Result Unit: mmol/L; Test Date: 20171008; Test Name: Blood lactic acid; Result Unstructured Data: Test Result: 54, Test Result Unit: mmol/L; Test Date: 20171008; Test Name: Blood pH; Result Unstructured Data: Test Result: 7.36, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood phosphorus; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood potassium; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 201710; Test Name: Blood potassium; Result Unstructured Data: Test Result: elevated, Test Result Unit: unknown; Test Date: 20171007; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: not decreased, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood sodium; Result Unstructured Data: Test Result: 132, Test Result Unit: mmol/L; Test Date: 20171008; Test Name: Blood uric acid; Result Unstructured Data: Test Result: 400, Test Result Unit: mcmol/L; Test Date: 20171006; Test Name: Body temperature; Result Unstructured Data: Test Result: 38.5, Test Result Unit: degree C; Test Date: 20171008; Test Name: Coagulation factor V level; Result Unstructured Data: Test Result: 95, Test Result Unit: percent; Test Date: 20171007; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 120, Test Result Unit: mg/L; Test Date: 20171007; Test Name: Heart rate; Result Unstructured Data: Test Result: 190, Test Result Unit: bpm; Test Date: 20171008; Test Name: PCO2; Result Unstructured Data: Test Result: 3.3, Test Result Unit: KPa; Test Date: 20171007; Test Name: Platelet count; Result Unstructured Data: Test Result: 790000, Test Result Unit: /mm3; Test Date: 20171008; Test Name: Coagulation factor II level; Result Unstructured Data: Test Result: 63, Test Result Unit: percent; Test Date: 20171008; Test Name: Prothrombin level; Result Unstructured Data: Test Result: 67, Test Result Unit: percent; Test Date: 20171008; Test Name: Transaminases; Result Unstructured Data: Test Result: 5N, Test Result Unit: unknown
CDC Split Type: FRGLAXOSMITHKLINEFR201806

Write-up: Hepatic cytolysis; Failure liver; Neurological disorder NOS; Acidosis metabolic; This case was reported by a physician via regulatory authority and described the occurrence of hepatic cytolysis in a 4-month-old male patient who received DTPa (Infanrix) (batch number A21CC953A ?, expiry date unknown) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number S15112, expiry date unknown) for prophylaxis. On 5th October 2017, the patient received Infanrix (unknown) 1 dosage form(s) and PREVENAR 13 (intracardiac) 1 dosage form(s). On 7th October 2017, 2 days after receiving Infanrix, the patient experienced metabolic acidosis (serious criteria death and GSK medically significant). On 8th October 2017, the patient experienced hepatic cytolysis (serious criteria death and GSK medically significant), liver failure (serious criteria death and GSK medically significant) and neurological disorder nos (serious criteria death). On 9th October 2017, the outcome of the hepatic cytolysis, liver failure, neurological disorder nos and metabolic acidosis were fatal. The patient died on 9th October 2017. The reported cause of death was metabolic acidosis. An autopsy was not performed. It was unknown if the reporter considered the hepatic cytolysis, liver failure, neurological disorder nos and metabolic acidosis to be related to Infanrix. Additional details: The age at vaccination was not reported. However age at event was reported as 4 months. Initial information was received from a physician via regulatory authority on 16th April 2018: Failure liver, neurological disorder nos, hepatic cytolysis and acidosis metabolic. Follow up information was received from a duplicate case FR2018GSK084791 via regulatory authority on 14th May 2018: The reporter information updated. The patient''s historical conditions updated. The lab data updated. The event hepatic failure was updated to hepatic insufficiency. The vaccination date updated. The suspect infanrix was updated to infanrix hexa. Follow up information was received from a physician via regulatory authority on 01st Jun 2018: Lot number for infanrix hexa and prevenar 13 was added. Follow up information was received from a physician via regulatory authority on 30th October 2019: The infanrix hexa was change to infanrix. Note: The reported batch number for Infanrix was A21CC953A, based on batch number review, Infanrix hexa was identified as suspect vaccine. However suspect was kept Infanrix as reported. Lab Comments: On 8th October 2017 Ammnonemia 56 mcmol/L, Blood protide 52g/L On 7th October 2017 Procalcitonine 0.75 ng/ml 07 October 2017 -Clinical examination at emergency unit: painful child at palpation of vaccines injection sites ; no neurological abnormality. 08 October 2017 -Cerebral CT-scan: Hypodensities of the subcortical and subentemporal subcortical white matter without contrast enhancement, with no significant mass effect with lesions that appear to extend near the surface of the lateral ventricles.Cerebral arteries permeable without disparity of size and no sign of cerebral venous thrombosis. No sign of Intracranial hypertension. -Lumbar puncture: CSF protein at 1.07 g/L; CSF glucose at 6.1 mmol/L; CSF lactate at 4.7 mmol/L; 2 nucleated elements; no bacteria; detection of herpes virus in CSF negative. -Urine test strip: no ketonuria, no glycosuria, no leukocyturia, negative nitrite; urine pH at 5.5, urine protide ++. Parents refused an autopsy of their child. Considering the suspicion of a metabolic disease, complementary exams were performed; results were negative: -~Chromatography of plasma amino acids: decrease in citrulline related to gastrointestinal involvement with slight elevation of phenylalanine related to liver injury -~Chromatography of urinary organic acids: slight rise in lactic acid and pyruvic acid -~Normal acylcarnitine profile -~Hepatic biopsy showed moderate, isolated macro-vacuolar steatosis, with no specificity but which may be integrated in a context of mitochondrial cytopathy or other metabolic disease ; there was no inflammatory infiltrate or fibrosis and no significant iron overload. Respiratory chain exploration result. Muscle: -~Slight relative decrease in activity of complexes 1, 2, and 4 and strong activity of citrate synthase. -~DNA mitochondrial analysis by long range PCR : no large deletions in muscle -~Quantitative PCR analysis : no depletion of mitochondrial DNA -~Fibroblasts : normal activities -~Liver : normal activities -~Analys; Sender''s Comments: FR2018065408: Previous VAERS submission in paper format; Reported Cause(s) of Death: Metabolic acidosis


VAERS ID: 845516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB855AM / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Autopsy, Cardiac arrest, Death, Diarrhoea, Peritonitis, Rash, Rhinitis, Sepsis, Toxic shock syndrome streptococcal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Infanrix hexa
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteomalacia; Petechia (of small bowels); Pyothorax
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201919

Write-up: Cardiac arrest; Acute peritonitis; Sepsis; Streptococcus pyogenes toxic shock syndrome; Coryza; Rash; Abdominal distension; Diarrhoea; This case was reported by a physician via regulatory authority and described the occurrence of cardiac arrest in a 3-month-old female patient who received Rota (Rotarix liquid formulation) (batch number AROLB855AM, expiry date unknown) for prophylaxis. The patient''s past medical history included pyothorax, osteomalacia and petechia (of small bowels). Concomitant products included DTPa-HBV-IPV+Hib (Infanrix hexa). On an unknown date, the patient received Rotarix liquid formulation (oral). On an unknown date, less than 4 months after receiving Rotarix liquid formulation, the patient experienced cardiac arrest (serious criteria death, GSK medically significant and other: Serious as per reporter), acute peritonitis (serious criteria death, GSK medically significant and other: Serious as per reporter), sepsis (serious criteria death, GSK medically significant and other: Serious as per reporter), streptococcus pyogenes toxic shock syndrome (serious criteria death, GSK medically significant and other: Serious as per reporter), coryza (serious criteria death and other: Serious as per reporter), rash (serious criteria death and other: Serious as per reporter), abdominal distension (serious criteria death and other: Serious as per reporter) and diarrhoea (serious criteria death and other: Serious as per reporter). On an unknown date, the outcome of the cardiac arrest, acute peritonitis, sepsis, streptococcus pyogenes toxic shock syndrome, coryza, rash, abdominal distension and diarrhoea were fatal. The reported cause of death was cardiac arrest, acute peritonitis, sepsis, streptococcus pyogenes toxic shock syndrome, coryza, rash, abdominal distension and diarrhea. An autopsy was performed. It was unknown if the reporter considered the cardiac arrest, acute peritonitis, sepsis, streptococcus pyogenes toxic shock syndrome, coryza, rash, abdominal distension and diarrhoea to be related to Rotarix liquid formulation. Additional details: The age at vaccination was not reported. However, patient could be 2 or 3 month at the time of vaccination. Initial information was received from a Physician via regulatory authority on 31st October 2019: Cardiac arrest, acute peritonitis, sepsis, streptococcus pyogenes toxic shock syndrome, coryza, rash, abdominal distension and diarrhea. Note: The outcome for the events acute peritonitis, sepsis, streptococcus pyogenes toxic shock syndrome, coryza, rash, abdominal distension and diarrhea was reported as not recovered not resolved, but the seriousness criteria was reported as death so the outcome of the events was change to fatal and the events acute peritonitis, sepsis, streptococcus pyogenes toxic shock syndrome, coryza, rash, abdominal distension and diarrhea was also capture as cause of death.; Reported Cause(s) of Death: Cardiac arrest; acute peritonitis; Sepsis; streptococcus pyogenes toxic shock syndrome; coryza; Rash; abdominal distension; Diarrhoea


VAERS ID: 845547 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2019-10-07
Submitted: 0000-00-00
Entered: 2019-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abscess, Anxiety, Deafness, Death, Decreased immune responsiveness, Delirium, Dysstasia, Eye movement disorder, Feeding disorder, Gait inability, Infection transmission via personal contact, Malaise, Mumps, Pain, Respiratory arrest, Swelling face, Tonsillitis, Vaccination failure, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Ocular motility disorders (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-01
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131910GBR015893

Write-up: Unable to walk; Decreased immune responsiveness; Infection transmission via personal contact; eyes had rolled into the back of her head; stopped breathing; worried; suspected vaccination failure; Unable to stand; tonsillitis; Could not eat; becoming delirious; Aching all over body; Could not hear; sick; her face felt swollen; vomiting; Abscess; Mumps; Information has been downloaded from Regulatory Authority (GB-GLAXOSMITHKLINE-GB2019EME186634). This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. Patient''s concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(MEASLES, MUMPS, AND RUBELLA (WISTAR RA 27-3) VIRUS VACC, LIVE) (strength, dose and route not reported) (lot and expiry date were unknown) for prophylaxis. On 07-OCT-2019, the patient experienced abscess, mumps, vomiting and her face felt swollen (swelling face). On 08-OCT-2019, the patient was sick (malaise). On 10-OCT-2019, the patient could not hear(deafness), aching all over body(pain), becoming delirious(delirium) and could not eat (feeling disorder). On an unknown date, the patient was unable to walk (gait inability), decreased immune responsiveness, infection transmission via personal contact, eyes had rolled into the back of her head (eye movement disorder), stopped breathing (respiratory arrest), worried (anxiety), suspected vaccination failure, unable to stand (dysstasia) and tonsillitis. On an unknown date in October 2019, the patient died due to mumps. It was unknown whether the autopsy was performed. The outcome of the events abscess, vomiting, swelling face, sick, deafness, pain, delirium, feeling disorder, gait inability, decreased immune responsiveness, infection transmission via personal contact, eye movement disorder, respiratory arrest, anxiety, suspected vaccination failure, dysstasia and tonsillitis were unknown. The relatedness between the events and the suspect therapy was not provided. The Agency considered all the events to be medically significant.; Sender''s Comments: GB-GLAXOSMITHKLINE-GB2019EME190281:; Reported Cause(s) of Death: Mumps


VAERS ID: 845634 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Intussusception
SMQs:, Gastrointestinal obstruction (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: BRGLAXOSMITHKLINEBR2019AM

Write-up: intussusception; This case was reported by a other health professional via sales rep and described the occurrence of intussusception in a child patient who received Rotavirus vaccine for prophylaxis. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, unknown after receiving Rotavirus vaccine, the patient experienced intussusception (serious criteria death and GSK medically significant). On an unknown date, the outcome of the intussusception was fatal. The reported cause of death was intussusception. It was unknown if the reporter considered the intussusception to be related to Rotavirus vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient was died, due to intussusception, after receiving the rotavirus vaccine. No additional information was provided.; Reported Cause(s) of Death: intussusception


VAERS ID: 845968 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-10-16
Onset:2019-10-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA389CA / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid; Novamin; Pantoprazole; TORASEMID; DEKRISTOL; RIVAROXABAN; OXYCODON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure (NYHA II); Osteoporosis; Pleural effusion; Pulmonary embolism (In September 2019, central, bds. to DVB T); Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE201919

Write-up: Pat. Deceased; This case was reported by a physician via regulatory authority and described the occurrence of unknown cause of death in a 87-year-old patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) (batch number AFLBA389CA, expiry date unknown) for prophylaxis. The patient''s past medical history included pleural effusion, cardiac failure (NYHA II), renal insufficiency, pulmonary embolism (In September 2019, central, bds. to DVB T) and osteoporosis. Concomitant products included folic acid, amikacin sulfate (Novamin), pantoprazole, torasemide (Torasemid), colecalciferol (Dekristol), rivaroxaban and oxycodone (Oxycodon). On 16th October 2019, the patient received Influsplit Tetra 2019/2020 (unknown). On 18th October 2019, 2 days after receiving Influsplit Tetra 2019/2020, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On 18th October 2019, the outcome of the unknown cause of death was fatal. The patient died on 18th October 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 Influsplit Tetra 2019/2020. Additional details: Age at vaccination was not reported however patient could be 86 or 87 years old at time of vaccination. Pleural effusion, cardiac failure (NYHA II), renal insufficiency, pulmonary embolism and osteoporosis were reported as current condition, However captured as historic condition since the patient was died. Initial information was reported by a physician via regulatory authority on 1st November 2019. Unknown cause of death. Sender''s comments: 1. In no case, on my part, is the concrete suspicion of a connection between death and the flu vaccine. There were no symptoms of allergic reaction or feverish infections. 2. Experience has shown that significantly more nursing home patients die off in the fourth quarter than in the other quarters. In the fourth quarter of 2018, 8 out of the 92 patients under my care died. 3. The number of 5 deceased patients (out of a total of 82 home patients) within 2 weeks.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 846013 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (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: VN0095075131911VNM001950

Write-up: died; exhibit unusual symptoms; This spontaneous report was received from a an unspecified reporter via a social media post, and refers to a 3 day old female patient (twin sister case captured under MARRS 1911VNM002082). Information about the patient''s medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided. On an unknown date, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown), for prophylaxis (strength, dose, route, frequency, lot number and expiration date were not provided). On the same date, the patient exhibit unusual symptoms (adverse event) and subsequently died. At the time of reporting, the outcome of the adverse event was unknown. The cause of death was unknown. It was unknown if an autopsy was performed to the patient. The causal relationship between hepatitis b vaccine (recombinant)(manufacturer unknown) and the reported events was not provided. This is one of two reports received from the same reporter regarding different patients.; Sender''s Comments: VN-009507513-1911VNM002082:; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 846014 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse event, Death, Death neonatal
SMQs:, Acute central respiratory depression (broad), Neonatal disorders (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: VN0095075131911VNM002082

Write-up: died; exhibit unusual symptoms; This spontaneous report was received from a an unspecified reporter via a social media post, and refers to a 3 day old female patient (twin sister case captured under MARRS 1911VNM001950). Information about the patient''s medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided. On an unknown date, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown), for prophylaxis (strength, dose, route, frequency, lot number and expiration date were not provided). On an unknown date, the patient exhibit unusual symptoms (adverse event). On the next day (reported as "a day later"), the patient died. At the time of reporting, the outcome of the adverse event was unknown. The cause of death was unknown. It was also unknown if an autopsy was performed to the patient. The causal relationship between hepatitis b vaccine (recombinant)(manufacturer unknown) and the reported events was not provided. This is one of two reports received from the same reporter regarding different patients.; Sender''s Comments: VN-009507513-1911VNM001950:; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 846254 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lactose intolerance
Preexisting Conditions: Medical History/Concurrent Conditions: Neurodermatitis
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: Laboratory test; Result Unstructured Data: Test Result: Globuli against Lactose intolerance, Test Result Unit: unknown
CDC Split Type: DEGLAXOSMITHKLINEDE201920

Write-up: HCP was informed by the police that a patient that received the vaccine died.; vomit was a little amount of blood; This case was reported by a physician via call center representative and described the occurrence of unknown cause of death in a 45-year-old male patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) for prophylaxis. On 4th November 2019, the patient received Influsplit Tetra 2019/2020. On an unknown date, less than a week after receiving Influsplit Tetra 2019/2020, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). In November 2019, the outcome of the unknown cause of death was fatal. The patient died in November 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 Influsplit Tetra 2019/2020. Additional case details were reported as follows: The reporter was a healthcare assistant. The age at vaccination was not reported, however the patient could be 44 or 45 years. The reporter informed that as per her knowledge, the patient did not use any other medication. The healthcare professional (HCP) was informed by the police that the patient died, not sure if it happened on 4th or 5th November 2019. The HCP was contacted for batch number. This was a potential legal case. The reporter consented to follow up and it was preferred via email. This case has been linked with case DE2019EME202247, reported by same reporter. Follow up information received form physician on 6th November 2019: The patient''s historical condition included neurodermitis. Historical drug included creams, if required and hepatitis vaccination. In 2019, globuli against lactose intolerance were detected. In November 2019, less than a week after receiving Influsplit Tetra, the patient vomited with a little amount of blood. Till the evening of 4th November 2019, the patient worked and was in contact with his girlfriend. The patient died in the night from 4th November 2019 to 5th November 2019. The patient has obviously vomited, in the vomit was a little amount of blood. It was reported that obduction would be done. The physician would provide the batch number with the adverse event from which she would fill out and send back. A colleague from the medical department would contact her as well, as the physician had also a medical question. Physician wanted a quality investigation of the vaccine and it was requested to forward the case to the Quality department. Due to the physician, there was a timely relation between the vaccination and the death of the patient. The reporter considered the unknown cause of death to be possibly related to Influsplit Tetra 2019/2020. It was unknown if the reporter considered the vomiting blood to be related to Influsplit Tetra 2019/2020.; Reported Cause(s) of Death: Death NOS


VAERS ID: 846256 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-10-15
Onset:2019-10-25
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2019-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA389CA / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Novaminsulfon; Pantoprazole; Ramipril; ASS; TORASEMID; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dementia; Hypertonus; Renal insufficiency; Squamous cell carcinoma of skin; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEID BIOMEDICAL CORPORATI

Write-up: Pat. Deceased; This case was reported by a physician via regulatory authority and described the occurrence of unknown cause of death in a 96-year-old patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) (batch number AFLBA389CA, expiry date unknown) for prophylaxis. The patient''s past medical history included squamous cell carcinoma of skin, hypertonus, type ii diabetes mellitus, copd, dementia and renal insufficiency. Concomitant products included dipyrone (Novaminsulfon), pantoprazole, ramipril, acetylsalicylic acid (ASS), torasemide (Torasemid) and metoprolol. On 15th October 2019, the patient received Influsplit Tetra 2019/2020 (unknown). On 25th October 2019, 10 days after receiving Influsplit Tetra 2019/2020, 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 patient died on 25th October 2019. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death to be unlikely related to Influsplit Tetra 2019/2020. Additional details: The age at vaccination was not reported. However, patient could be 95 or 96 years at the time of vaccination. Other Assessment: Agency. Inconsistent causal association for the event unknown cause of death. Initial information was received from a Physician via regulatory authority on 4th November 2019: Unknown cause of death. Sender comment: 1. In no case, on my part, is the concrete suspicion of a connection between death and the flu vaccine. There were no symptoms of allergic reaction or feverish infections. 2. Experience has shown that significantly more nursing home patients die off in the fourth quarter than in the other quarters. In the fourth quarter of 2018, 8 out of the 92 patients under my care died. 3. However, the number of 5 deceased patients (out of 82 patients in total) within 2 weeks after vaccination is exceptionally high. The death of the patients was not expected in 4 of the 5 described cases. 4. Concerning prescribed medicines, the only common feature is the novamine sulfone used as a pain-relieving need.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 846257 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-10-16
Onset:2019-10-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2019-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA389CA / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Novaminsulfon; Ramipril; Frusemide; ASS; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis rheumatoid; Atrial fibrillation; Cerebral atherosclerosis; Dementia; Hypertonus; Paraparesis (the legs); Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE201919

Write-up: pulmonary edema; Deceased below the clinical picture of decompensated heart failure with pulmonary edema; This case was reported by a physician via regulatory authority and described the occurrence of lung oedema in a 92-year-old patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) (batch number AFLBA389CA, expiry date unknown) for prophylaxis. The patient''s past medical history included atrial fibrillation, paraparesis (the legs), type ii diabetes mellitus, arthritis rheumatoid, hypertonus, dementia and cerebral atherosclerosis. Concomitant products included dipyrone (Novaminsulfon), ramipril, frusemide, acetylsalicylic acid (ASS) and bisoprolol. On 16th October 2019, the patient received Influsplit Tetra 2019/2020 (unknown). On 26th October 2019, 10 days after receiving Influsplit Tetra 2019/2020, the patient experienced lung oedema (serious criteria death and GSK medically significant) and decompensated heart failure (serious criteria death and GSK medically significant). On an unknown date, the outcome of the lung oedema and decompensated heart failure were fatal. The patient died on 26th October 2019. The reported cause of death was decompensated heart failure and lung oedema. It was unknown if the reporter considered the lung oedema and decompensated heart failure to be related to Influsplit Tetra 2019/2020. Additional details: The age at vaccination was not reported. However, patient could be 91 or 92 years at the time of vaccination. Initial information was received from a Physician via regulatory authority on 4th November 2019: Deceased below the clinical picture of decompensated heart failure with pulmonary edema, Sender comment: 1.In no case on my part there is the concrete suspicion of a connection between death and the flu vaccine. There were no symptoms of allergic reaction or feverish infections. 2. According to experience, significantly more nursing home patients die off in the fourth quarter than in the other quarters. In the fourth quarter of 2018, 8 out of the 92 patients under my care died. 3. However, the number of 5 deceased patients (out of a total of 82 home patients) within 2 weeks of vaccination is exceptionally high. The death of the patients was in 4 of the 5 expected cases not expected. 4. Regarding the prescribed medicines, the only thing that is common is the Novaminsulfone, which is used as a pain-remedy.; Reported Cause(s) of Death: Decompensated heart failure; Lung oedema


VAERS ID: 846437 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Cardio-respiratory arrest, Influenza, Influenza like illness, Influenza virus test positive, Intensive care, Lung infiltration, Polymerase chain reaction positive, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), 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), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Cardiovascular disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: ESIDBIOMEDICALCORPORATION

Write-up: Suspected vaccination Failure; Influenza infection; Cardiorespiratory arrest; Flu like symptoms; pulmonary infiltrates; Acute respiratory distress syndrome; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 82-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis. Concurrent medical conditions included cardiovascular disease, unspecified. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death, hospitalization and GSK medically significant), influenza (serious criteria death and hospitalization), cardiopulmonary arrest (serious criteria hospitalization and GSK medically significant), influenza-like symptoms (serious criteria hospitalization), lung infiltration (serious criteria hospitalization) and acute respiratory distress syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure and influenza were fatal and the outcome of the cardiopulmonary arrest, influenza-like symptoms, lung infiltration and acute respiratory distress syndrome were unknown. The reported cause of death was vaccination failure and influenza. The reporter considered the vaccination failure, influenza, cardiopulmonary arrest, influenza-like symptoms, lung infiltration and acute respiratory distress syndrome to be related to Flu vaccine. Additional details were reported as follows: This case was reported in a literature article and described the suspected vaccination failure in a 82-years-old male who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 2 reported in this literature article. The patient was the part of the prospective registry that aimed to determine the incidence, presentation, and prognosis of influenza virus infections in a cardiac intensive cardiac care unit and secondary to analyze the impact of an active surveillance program for early diagnosis. [In this study, the study was performed in a university hospital with 1,550 beds serving a population of 715,000 inhabitants. The study comprises two different influenza seasons (2014 and 2015), with two differentiated phases. During the first period (baseline), influenza diagnosis was made in accordance with the attending physician''s indication, who requested tests based on clinical suspicion, and no systematic screening was performed (from November 2013 to January 2014). During the second phase (intervention), systematic influenza infection screening was performed in all patients admitted on Monday to Friday. This phase included the last weeks of the first influenza season (February 2014) and the second season period (from January to March 2015)]. The patient had the pre-existing cardiovascular disease. No information on patient family history and concomitant medications. On unspecified date, the patient had received unspecified seasonal influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between November 2013 and March 2015), unknown period after vaccination, the patient was admitted to the cardiac ICU due to the cause of cardiorespiratory arrest. Before hospital admission (i.e previous 7 days) and at the time of admission, the patient had flu like symptoms and has been diagnosed with influenza infection by the reverse transcriptase polymerase chain reaction (RT-PCR). Also the patient was diagnosed with the pulmonary infiltrates and acute respiratory distress syndrome (ARDS). On an unspecified date, the patient died. It was unknown, whether the autopsy was performed or not. The cause of death was influenza infection.[In this study, during the study period (baseline phase from November 2013 to January 2014 and intervention phase in February 2014 and from January to March 2015), 227 patients were admitted to the cardiac ICU, and 17 were diagnosed with influenza infection. Influenza A predominated in 2014 (10 patients) and influenza B in 2015 (5 patients). During the non-screening period (Baseline phase), only 6 patients out of 90 were diagnosed with influenza infection. In contrast, during the screening phase (intervention phase), 4 patients out of 34 were diagnosed in the 2014 season and 7 patients out of 102 in 2015. The presence of flu-like symptoms throughout the admission was common in infected patients, specially fever, headache, and dyspnea. Out of 17 influenza infection, the patient had the flu like symptoms such as fever (8), cough (7), runny nose (5), headache (4), myalgias (2), dyspnea (8) and respiratory failure (7). However, 3 patients who were admitted to the coronary unit for presenting a cardiac arrest, who also were diagnosed with influenza infection, did not suffer any clear-cut influenza symptom. Patients were tested for influenza A or B. Nasopharyngeal swabs were obtained for microbiological diagnosis, but lower respiratory tract samples were also accepted if clinically indicated. A reverse transcriptase polymerase chain reaction (RT-PCR) was used. Influenza A H1N1 and influenza B were detected with real-time RTPCR (RT-PCR Flu A/B Typing Real-time Detection Anyplex)]. This case has been considered as suspected vaccination failure as time to onset was unknown. This case has been considered as serious due to suspected vaccination failure; hospitalization and death. Treatment was unknown. [In this study, improved survival in severe cases was related to early antiviral administration. Out of 17 infected patients, 6 were on mechanical ventilation, 4 patients during no screening phase, and 2 patients during systematic screening. 8 were on Inotropes/vasopressors, 2 were on renal replacement therapy, 1 patient during no screening phase, 1 patient during systematic screening and 5 were on Antimicrobials prescribed at admission) The outcome of other events cardiorespiratory arrest pulmonary infiltrates and acute respiratory distress syndrome (ARDS) were not reported. [In this study, 3 had the death during hospitalization and 2 patients during no screening phase, 1 patient during systematic screening]. The author commented, "In our study, the majority of patients infected with influenza virus did not present an ischemic event, and heart failure was the most common diagnosis of admission. The viral infection could have acted as a trigger for heart failure decompensation in these patients. In fact, patients with influenza infection suffered respiratory distress and extra-hospital cardiac arrest more frequently. It is remarkable that in our study influenza-infected patients were sicker, requiring more often advanced therapies such as respiratory, renal, or inotropic support and had a higher mortality rate, especially those admitted for a cardiac arrest. Previous studies stated that acute respiratory distress syndrome secondary to influenza-related viral pneumonia is the leading cause of mortality. We found a higher mortality among influenza-infected patients and a higher rate of respiratory complications. However, as we have stated, cardiac arrest was the primary reason of admission in deceased patients in this registry. Nevertheless, our study shows that susceptible patients admitted to a cardiac ICU still have a very low rate of influenza vaccination. This proportion is markedly low, taking into account that most of the patients admitted to our unit had factors that increased the risk of complications. Vaccination was not associated with a reduced mortality risk in our study." The author concluded, "Influenza infection is associated with increased morbidity and mortality in patients admitted to the cardiac ICU. Fever and respiratory failure are the hallmark symptoms. During the flu season, a multidisciplinary systematic surveillance program improves the early detection and management of influenza in a cardiac ICU." This is 1 of the 10 valid cases reported in this literature article. Lab Comments: On an unspecified date between November 2013 and March 2015, the patient has been diagnosed with influenza infection by the reverse transcriptase polymerase chain reaction.; Reported Cause(s) of Death: Suspected Vaccination Failure; Influenza Infection


VAERS ID: 846486 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-16
Onset:2019-10-23
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2019-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER AFLBA389CA / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin; Pantoprazole; Acetylsalicyl acid; Tamsulosin; ULTIBRO; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic obstructive pulmonary disease; Coronary artery disease; Hydrocephalus (-malresorptivus); Peripheral arterial occlusive disease; Prostatic carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEID BIOMEDICAL CORPORATI

Write-up: Unknown cause of death; This case was reported by a physician via regulatory authority and described the occurrence of unknown cause of death in a 83-year-old male patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) (batch number AFLBA389CA, expiry date unknown) for prophylaxis. The patient''s past medical history included copd, peripheral arterial occlusive disease, coronary artery disease, prostatic carcinoma, hydrocephalus (-malresorptivus) and atrial fibrillation. Additional patient notes included Med.-History: Y-prosthesisd. Aorta, C2 Misuse. Concomitant products included simvastatin, pantoprazole, acetylsalicylic acid (Acetylsalicyl Acid), tamsulosin hydrochloride (Tamsulosin), glycopyrronium bromide + indacaterol maleate (Ultibro) and metoprolol. On 16th October 2019, the patient received Influsplit Tetra 2019/2020 (unknown). On 23rd October 2019, 7 days after receiving Influsplit Tetra 2019/2020, 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 patient died on 23rd October 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 Influsplit Tetra 2019/2020. Additional details: Age at vaccination was not reported, however the patient could be 83 or 82 years old at time of vaccination. Senders comment: 1.In no case exists on my part the concrete one Suspected one link between Dying and the Flu shot. It happened neither symptoms of a allergic reaction yet feverish infections. 2. According to experience, die significantly more in the fourth quarter Nursing home patients as in the other quarters. In the 4th Quarter of 2018, 8 of 92 cared for by me Hospice patients. 3.The number of 5 deceased Patients (from a total of 82 Home patients) within 2 Weeks after vaccination but extraordinary high. The dying of the Patient was in 4 of the 5 not described expectable. 4. Regarding the prescribed Medication is the only commonality in the as a need for pain prepared Novaminsulfons. Initial information was reported by a physician via regulatory authority on 5th November 2019: Unknown cause of death.; Reported Cause(s) of Death: Unknown cause of death


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