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From the 5/7/2021 release of VAERS data:

Found 1,944 cases where Vaccine is FLU(H1N1) or FLU3 or FLU4 or FLUA3 or FLUA4 or FLUC3 or FLUC4 or FLUN(H1N1) or FLUN3 or FLUN4 or FLUR3 or FLUR4 or FLUX or FLUX(H1N1) or H5N1 and Patient Died



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 473098 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-29
Entered: 2012-11-06
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cardiac disorder, Death, Pleural effusion
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012DE096951

Write-up: Case number PHHY2012DE096951, is an initial spontaneous report received from a consumer via e-mail on 25 Oct 2012. This report refers to a female patient of unknown age. The patient''s medical history and concomitant medications were not reported. She was vaccinated with influenza vaccine INN (batch number and manufacturer unknown) on an unknown date. Two weeks after vaccination the patient developed "problems" with her heart (details not provided). Subsequently the patient suffered from "water in the lungs" (details not provided). In 2011 the patient died. The cause of death was not reported. The causal relationship was not reported.


VAERS ID: 473745 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-11-08
Entered: 2012-11-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory failure, Cardiac arrest, Cardiomegaly, Chest X-ray abnormal, Cough, Death, Dyspnoea, Endotracheal intubation, Full blood count, Haemoptysis, Headache, Hypotension, Infection, Influenza, Influenza like illness, Kidney infection, Lung infection, Lung infiltration, Pain, Pneumonia, Pyrexia, Resuscitation, Rhinitis, Septic shock, Severe acute respiratory syndrome, Tuberculosis, Urinary tract infection, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was pregnant, six months gestational age at time of adverse event, and had a history of hypertension in her last pregnancy. The patient was reported as had a full vaccination schedule for diphtheria and tetanus (dT) and influenza vaccines. History of adverse event to previous administration of vaccine or drug was reported as unknown. The patient''s family history was reported as unknown.
Allergies:
Diagnostic Lab Data: 23 September 2012, reported worsening of radiographic images (not specified).
CDC Split Type: 201210247

Write-up: Initial report was received from a healthcare professional via the local affiliate on 31 October 2012. Other adverse events, regarding the patient''s children, are reported in case numbers 2012-09098 and 2012-09099. A 22-year-old female patient received a dose of INFLUENZA VACCINE, manufacturer and lot number unknown, (route, site and side, dose in series not reported) on an unknown date and she died on 23 September 2012. The patient was pregnant, six months gestational age at time of adverse event, and had a history of hypertension in her last pregnancy. The patient was reported as had a full vaccination schedule for diphtheria and tetanus (dT) and influenza vaccines. History of adverse event to previous administration of vaccine or drug was reported as unknown. The patient''s family history was reported as unknown. Symptoms of suspect of influenza A/H1N1 and fever started on 18 September 2012. The patient was admitted to the hospital on 21 September 2012 at 18:00pm, presenting with moderate cough, generalized pain, mild dyspnea and headache. She was hospitalized and started to receive antibiotics. On the next morning, 22 September 2012, the patient presented with hemoptysis, fever, dyspnea and hypotension. A complete blood count (results not reported) and chest X-ray were performed, which revealed presence of cardiomegaly and bilateral pulmonary infiltrates. The patient continued treatment of antibiotics, intravenous hydration and oxygen and she was transferred to a contact isolation room. On 23 September 2012, her condition remained serious, with an increase of the leukocytes (11,600 to 30,300) and worsening of radiographic images. At the end of the day, the patient was intubated to receive ventilator support. She had three cardiac arrests. Resuscitation was performed, but with no success. Her death was confirmed on 23 September 2012 at 21:40pm, with a death diagnosis suggestive of Severe Acute Respiratory Syndrome. According to news lay media, a health care professional who evaluated the patient who was treated at the emergency room on Thursday, 20 September 2012 with virus "virose", informed that the patient was treated and released from care that day. On Friday, 21 September 2012, she returned to the emergency unit with a worse health condition and was hospitalized. According to the the family, the patient presented with symptoms of flu-like illness, including coryza, dry cough, fever and body aches, between Tuesday, 18 September 2012 and Wednesday 19 September 2012. The patient was admitted and started treatment of antibiotics. She presented with an infectious condition, which indicated a clinical investigation with radiologic and laboratory testing, which revealed some changes compatible with pneumonia and tuberculosis. With the results of the exams, associated with the clinical diagnosis, it was concluded that the patient started an asymptomatic urinary tract infection that had reached her kidneys. There was a spread of the infection that reached her lungs and caused pneumonia (onset reported as unknown month in 2012), and later she also developed symptoms of tuberculosis. The patient''s condition advanced very fast. On Sunday, 23 September 2012, the patient died at approximately 22:00pm. The death was caused by acute respiratory failure and septic shock secondary to a serious infection. No additional information was provided at the time of the report. The patient''s outcome was reported as fatal on 23 September 2012. Documents held by sender: none.


VAERS ID: 474376 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-11-15
Entered: 2012-11-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza
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: Unknown
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201210421

Write-up: Initial report received on 06 November 2012 from a healthcare professional via the local affiliate, local reference number BR-BT2012-0445. A 4 year old male patient with unknown medical/family history died on an unknown date by influenza A/H1N1 after receiving 2 days prior a vaccination with Influenza vaccine (manufacturer name, lot number unknown). It was unknown if the patient had been hospitalized. The local affiliate has requested additional information. Outcome was fatal. The reporter for this case is the same as case 2012-07585 and 2012-07591, and 2012-08549. Documents held by sender: none.


VAERS ID: 477911 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-12
Entered: 2012-12-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Influenza, Influenza A virus test positive, Polymerase chain reaction
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Risk factors included the "presence of specific comorbidities (heart disease, lung disease, kidney disease, hemoglobinopathy, immunsuppression, diabetes, obesity, puerperium and smoking.)", and "specific symptoms (dyspnea, diarrhea, vomiting, chest pain, hemoptysis, pneumonia, and wheezing)".
Allergies:
Diagnostic Lab Data: The patients were diagnosed with influenza A/H1N1, with an exam performed by reverse transcription and PCR.
CDC Split Type: 201211651

Write-up: This case was received via a search of the scientific literature in a foreign country via local affiliate on 03 December 2012. The case is invalid, no patient identifiers. A cluster of 131 unknown patients received INFLUENZA VACCINE, manufacturer unknown, (lot number, route, site, side, dose in series reported as unknown) on unknown dates of administration and were diagnosed with influenza A/H1N1 with an exam performed by reverse transcription and polymerase chain reaction (PCR). Of these patients, seven died and 39 required hospitalization. No information was available on patients'' vaccination, only that patient had been vaccinated against influenza on an unknown date. Past medical history and treatments were reported as unknown. There was no information available about the patients and no additional information was provided. The patient''s outcome were reported as unknown, seven of which were fatal. The following is verbatim from the aforementioned article: Abstract "Objective: To evaluate pandemic influenza A (H1N1) 2009 in hospitalized patients in order to identify risk factors for hospitalization and, consequently, for the worsening of the disease. Methods: This retrospective observational study was conducted between March and December of 2010. The data were collected from the Ministry of Health National Case Registry Database. We included only patients (inpatients and outpatients) in whom H1N1 infection was confirmed (via laboratory testing) during the study period. The variables regarding demographic and clinical characteristics were statistically evaluated in order to compare the hospitalization rates in the presence or absence of these factors. Risk factors were identified by logistic regression analysis. Results: We included 4,740 patient with laboratory confirmation of H1N1 infection. Of these, 1,911 individuals were hospitalized, and 258 (13.5%) died. The risk factors for hospitalization were age (20-29 years), presence of specific comorbidities (heart disease, lung disease, kidney disease, hemoglobinopathy, immunosuppression, diabetes, obesity, puerperium, and smoking), a high number of comorbidities, and specific symptoms (dyspnea, diarrhea, vomiting, chest pain, hemoptysis, pneumonia, and wheezing). Higher levels of education and early use of oseltamivir were found to be protective factors. Hospitalization contributed to an increase in survival. Conclusions: Knowledge of the epidemiological characteristics that can be associated with hospitalization, disease severity, and mortality can be helpful in the adoption of preventive measures, as well as in the early diagnosis and treatment of disease, which might contribute to the reduction in the numbers of hospitalizations and deaths." Documents held by sender: None.


VAERS ID: 483590 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-06
Entered: 2013-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
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: Aortic stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0864334A

Write-up: This case was reported by a physician, via a GSK sales representative, and described the occurrence of death (cause undetermined) in a male subject in his 80s who was vaccinated with influenza virus vaccine (manufacturer unspecified). Concurrent medical conditions included heart disease with aortic stenosis. In 2010, the subject received a dose of seasonal influenza vaccine (unknown manufacturer, unknown batch number and unknown injection site). The same day, the subject died. The cause of death was undetermined. It was unknown whether an autopsy was performed. The reporting attending physician considered that the event was unrelated (chronological coincidence) to vaccination with seasonal influenza vaccine.


VAERS ID: 483863 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-05-08
Onset:0000-00-00
Submitted: 2013-02-07
Entered: 2013-02-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4388AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aortic stenosis, Cardiac failure, Death, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient was reported as cardiac
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201301702

Write-up: This initial case report is part of a batch of reports associated with several products that was received on 30 January 2013 by the Sanofi Pasteur affiliate who received the report from the Ministry of Health. A male patient (age reported as 76 years), with a medical history of cardiac disorder (the patient was reported as "cardiac") and no reported concomitant therapies, had received his dose of FLUZONE, lot number U4388AA, (route and anatomical site of administration not reported) during a campaign on 08 May 2012. Three hours post-vaccination, the patient died. According to the death certificate, the patient had ventricular fibrillation, heart failure and aortic stenosis. The patient''s outcome was fatal (death). The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. Documents held by sender: None.


VAERS ID: 484349 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-09
Onset:0000-00-00
Submitted: 2013-02-12
Entered: 2013-02-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4387AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Erythema, Feeling hot, Gait disturbance, Pain, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s medical history and concomitant medications were not reported.
Allergies:
Diagnostic Lab Data: Laboratory data was not reported.
CDC Split Type: 201301795

Write-up: This initial case report is part of a batch of reports associated with several products that was received on 04 February 2013 by the Sanofi Pasteur affiliate who received the report the Ministry of Health. A female patient whose medical history and concomitant therapies were not reported, received a dose of FLUZONE; lot number U4387AA, (route and anatomical site of administration not reported) on 9 May 2012. On an unspecified date, post-vaccination, the patient experienced pain, redness, heating, generalized urticaria and difficulty in walking. The patient died on an unspecified date (outcome was fatal). The action regarding next vaccinations was reported as: ignored. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. Causality assessment by the PNI: Discarded (event assessed as coincidental with vaccination, ie, it would have occurred even if vaccination had not taken place). Documents held by sender: None.


VAERS ID: 484374 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-18
Onset:0000-00-00
Submitted: 2013-02-12
Entered: 2013-02-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4387AA / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure congestive, Death, Pneumonia aspiration, Sepsis
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported.
Allergies:
Diagnostic Lab Data: Not reported.
CDC Split Type: 201301787

Write-up: This initial case report is part of a batch of reports associated with several products that was received on 04 February 2013 by the Sanofi Pasteur affiliate who received the report from the Ministry of Health. A female patient (whose medical history and concomitant therapies were not reported, had received her 1st dose of FLUZONE, lot number U4387AA, (route and anatomical site of administration not reported) on 18 May 2012. On an unspecified date, post-vaccination, the patient developed congestive heart failure, aspirative pneumonia, septicemia and subsequently died. The outcome was fatal (date of death was not reported). The action regarding next vaccinations is reported as: ignored. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The causality assessment by the PNI: Discarded (event assessed as coincidental with vaccination, ie, it would have occurred even if vaccination had not taken place). Documents held by sender: None.


VAERS ID: 485198 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-21
Entered: 2013-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1302KOR009332

Write-up: Information has been received froM a physician, author of the published literature article. The authors analyzed surveillance data from 1994 to 2011 identified by the Adverse Events Following Immunization (AEFI) rapid response team to describe the epidemiology of sudden death in the first 2 years of life following immunization. Since 1994, the AEFI rapid response team is dispatched within 24 hours to launch an in-depth epidemiologic investigation and causality assessment when any case of death temporally associated with immunization is reported to the AEFI surveillance system. Because the passive surveillance system is subject to underreporting, the authors supplemented the data by including cases identified from the Vaccine Injury compensation Program (VICP) (they excluded duplicate reports). While sudden deaths in childhood have been reported most in infancy (age <1 year), the authors included young children in the second year of life, in accordance with guidance of the Brighton Collaboration Unexplained Sudden Death Working Group. For each sudden death case, the authors reviewed the demographic information, interval from immunization to presentation, vaccine(s) used, findings from postmortem examination, and examination of the death scene. The authors first classified the sudden death cases into categories according to the presence of identified cause of death. The cases with identified cause of death were further categorized into the following groups: congenital abnormality; accidental injury; infectious diseases; and malignancy. The authors then categorized the cases with no identified cause of death as follows: Sudden unexpected death in children (SUDC) (deaths in the second year of life); and sudden unexpected death in infancy (SUDI) (deaths in the first year of life). Any SUDI case meeting Brighton Collaboration case definition (BCCD) of unexplained sudden death levels I or II were classified as possible sudden infant death syndrome (SIDS) (deaths in the first year of life which remain unexplained after autopsy). Of 45 cases of sudden death, the authors identified 23 cases with cause of death, and 22 cases without explanation of death. The 23 cases with identified explanation of death were classified as follows: 13 infectious diseases; seven accidental injuries; two congenital abnormalities; and one malignancy case. All of five cases that were classified as asphyxia were confirmed from review of investigation data that included postmortem autopsy and death scene examination reports. The authors classified 22 cases with no identified explanation of deaths in two age groups: two SUDC cases; and 20 SUDI cases. The SUDI cases included six BCCD I cases and three BCCD II cases, which were then classified as possible SIDS cases. Hepatitis B (HepB) was found to be the most frequent vaccine with temporal association with death (n = 11), followed by acellular diphtheria-tetanus-pertussis vaccine (DTaP) (n =4), Bacillus Calmette-Guerin (n = 2), Japanese encephalitis vaccine (n = 2), Haemophilus influenza vaccine (Hib; n = 2), and H1N1 (n = 2). Combination of DTaP and IPV (inactivated polio vaccine) was found to be the most frequently identified vaccine (n = 10), followed by DTaP+OPV (live attenuated polio vaccine; n = 5), and Hib+PCV (pneumococcal conjugate vaccine; n = 2). Of 31 cases with identified interval between immunization and the time of death, the most frequent interval was 6-24 h (n = 16), followed by 24-72 h (11 = 8) and 0-6 h (n = 5). The interval between immunization and time of death was not identified in 14 cases. Two cases of HepB and one case each of DTaP, DTaP+IPV and DTaP+OPV were found to have an interval between 0 and 6 h. This report concerns about two infant patients (age and gender unknown) who on an unspecified date were vaccinated with a dose of Influenza Virus Vaccine (Hib) (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (both lot and dose number not reported, route of administration not reported). On an unspecified date the patients experienced Sudden infant death syndrome. Additional information has been requested. This report is linked to MARRS case 1302KOR007184, same literature article.


VAERS ID: 485459 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-22
Onset:0000-00-00
Submitted: 2013-02-22
Entered: 2013-02-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 098617901 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, 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), Noninfectious encephalitis (narrow), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-04
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013034788

Write-up: This legal report (initial receipt 12-Feb-2013) concerns a male patient, age not specified. On 22-Oct-2010, the patient received ENZIRA (batch number: 17901). On 04-Jan-2011, the patient died. His death certificate listed the cause of death as respiratory failure and acute disseminated encephalomyelitis. The medical officer who examined the claim stated that the vaccine received did not contain the swine flu strain. No further information was provided.


VAERS ID: 487928 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-10
Onset:0000-00-00
Submitted: 2013-03-27
Entered: 2013-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) / GLAXOSMITHKLINE BIOLOGICALS A81CA097A / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Activities of daily living impaired, Asthenia, Autopsy, Cataplexy, Condition aggravated, Convulsion, Death, Depressed level of consciousness, Depression, Disturbance in attention, Dizziness, Dyspnoea, Epilepsy, Fatigue, General physical health deterioration, Hypersomnia, Hypoventilation, Hypoxia, Increased upper airway secretion, Motor dysfunction, Muscle disorder, Muscle twitching, Narcolepsy, Neck pain, Neuromyopathy, Oxygen saturation decreased, Panic attack, Poor quality sleep, Respiration abnormal, Respiratory disorder, Sleep disorder, Snoring, Somnolence, Tremor, Vertigo, Weight increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-01
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: Botulinum toxin; Cyanocobalamin; Lansoprazole; Fluticasone+salmeterol; Frusemide; Amoxicillin trihydrate
Current Illness: Adipositas; Airway infection; Alveolar hypoventilation; Ataxia; Disability; Dyspnea; Fatigue increased; Increased secretion in airways; Involuntary movement; Muscle atrophy; Paresis; Polyneuropathy; Reflux unspecified; Tremor; Wheelchair user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy, 06Oct2012, No pathological; C-reactive protein, 21Oct2009, elevated; Oxygen saturation, 22Dec2009, Mild hypoxemia u
CDC Split Type: B0821742A

Write-up: This case was reported by a physician via a regulatory authority (# NO-NOMAADVRE-FHI-2012-14600) and described the occurrence of worsening of symmetrical polyneuropathy in a 32-year-old female subject who was vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline) and with an unspecified Influenza vaccine (manufacturer unspecified). From birth she had a hereditary motoric neuropathy with ataxia. She had considerable paresis in both arms and legs (in legs almost paralysis) and used a wheelchair since adolescence. She had a weight of 140 kg. The last years she also had tremor and involuntary movements in neck/head and hands treated with botox injections. On 21 October 2009, the subject received unspecified dose of PANDEMRIX H1N1(parenteral, unknown site of injection). In 2009, the subject experienced dizziness. On an unspecified date, the subject experienced dyspnea, loss of strength, pain in neck (the pain aggravated), weight increased (she gained weight. Her appetite was normal) and reduced general condition she was out of form and her general physical condition was reduced. She had a minimum of physical activities, but had training with the physiotherapist. In January 2010, 3 months after vaccination with PANDEMRIX H1N1, the subject experienced excessive daytime sleepiness (tendency of falling asleep), concentration impaired, sleep disturbed. Her sleep was disturbed especially the last months. Often she woke up in the night, seldom sleeping a whole night continuously. She snored in the night. The subject was hospitalised. The months before she died, her respiratory function worsened and she was given some kind of a respiratory machine to use at home, but she found it difficult to use. Breathing worsened. The regulatory authority reported that the events were possibly related to vaccination with PANDEMRIX H1N1. The subject died on 1 October 2010 from unspecified cause. The report said that the conclusion in the post mortem report was that no significant pathologic changes was found at neuropathologic examination of the brain. They assumed that the death had a relation to her diagnosis familiar neuropathy, but this is an assumption, without concrete evidence. Follow-up information received on 7 September 2012: According to letter from the neurologist (private clinic), he had no information. It seemed that planned investigations had not been followed up by the subject. Neither had there been any new communication with the subject. Additional information from the neurologic polyclinic was received for the period of 4 August 2008 until 24 March 2012. Regarding the MFN2 gene sequencing, the findings was possibly without clinical importance. The subject received BOTOX treatment each third month from 16 September 2008 until 10 June 2009. At that time the subject reported minimal effect, and she also reported relatively moderate afflictions. Follow-up information received on 5 November 2012: A few days before 26 September 2012, the subject experienced seizure: subject''s consciousness was decreased for some seconds, then she recovered. Follow-up information received on 12 December 2012: On 22 December 2009, oxygen saturation test showed mild hypoxemia despite of oxygen given: 1l O2 at 9. Since autumn 2009, the subject experienced periods of depression. In 2010, panic attacks have been noted (precise onset date was unknown). On 19 July 2010, alveolar hypoventilation was diagnosis (onset date of the event was in 2010). On 6 October 2010, autopsy did not show any pathological findings in brain or elsewhere. Follow-up information received on 20 March 2013 from a drug insurance including report from physician: Medical condition included a non-specific progressing polyneuropathy with muscular atrophy. The subject''s sister had the same condition. No known genetic cause was found. The symptoms started in childhood. Concurrent medications included BOTOX, Vitamin B12, LANZO, SERETIDE, FURIX and IMACILLIN. In May 2008, she consulted a neurologist and stated that she had increasing fatigue and lack of energy. Since March 2009, she has been in need of additional personal assistance and claimed fatigue. At the same time she was transferred to 100% disability pension. She had constant tremor that has been treated with BOTOX injections. The last injection was in September or November 2009. On 21 October 2009, the subject received an unspecified dose of Influenza vaccine (unknown route and injection site, batch and manufacturer unspecified). At the same time treated with antibiotics due to likely airway infection (elevated C-reactive Protein). Less than one month after vaccination with Influenza vaccine, the subject felt tired, had increased vertigo, bad sleep, increasing secretion. The subject received the PANDEMRIX H1N1 on 10 November 2009. On 12 November 2009, the subject started treatment with vibramycin. In 2009, less than 3 months after vaccination with Influenza vaccine and less than 2 months after vaccination with PANDEMRIX H1N1, the subject experienced narcolepsy. In December 2009, 1 month after vaccination with PANDEMRIX H1N1 and 2 months after vaccination with Influenza vaccine, the subject could not walk and had further impaired motor function particularly in the left upper extremity. During 2008/2009, the subject experienced progressing dyspnea and secretion in the airways and she could not cough up, especially when lying. Evaluation revealed alveolar hypoventilation likely due to her muscle/nerve disease and adipositas. In 2009, the subject experienced narcolepsy that led to reduced general condition and possibly contributed to her death on 1 October 2010. In January 2010, the subject consulted a neurologist and she stated that after the last BOTOX injection she felt tired and unwell and had not regained her previous condition. She had concentration problems, slept more, and had increased pain in the neck and vertigo. The neurologist suggested further evaluation. On 22 September 2010, 10 months after PANDEMRIX H1N1 and 11 months after vaccination with Influenza vaccine, her General Practitioner noted that she was feeling severely fatigue, slept a lot and had increasing tremor. The subject became very tired when reading and watching TV and felt reduced strength in her arms. On 24 September 2010, 10 months after PANDEMRIX H1N1 and 11 months after vaccination with Influenza vaccine, the subject experienced an episode with twitching that was perceived as a first time epileptic episode. The following days, she had more similar episodes lasting few seconds without unconsciousness and with convulsions localised to the head and arms. She had also lively dreams and sometimes not sure what was dream or reality. She was referred to a neurologist for evaluation as the General Practitioner considered narcolepsy and cataplexy. In December 2009, the subject was treated with Bilevel Positive Airway Pressure and further adjustment of the treatment was done during hospitalisation. Other adjustment was planned to January 2010 but the patient refused it. In January 2010, she was also treated with SERETIDE. On 01 October 2010, the subject died at home. The autopsy did not reveal a specific cause of death and it was concluded that the death most likely was due to her neuromuscular disease. Evaluations/tests concerning narcolepsy and cataplexy were not performed before the subject died.


VAERS ID: 489009 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-03-14
Onset:0000-00-00
Submitted: 2013-04-10
Entered: 2013-04-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 090634602 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
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: EPILIM; Antidepressants; XANAX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013035374

Write-up: This regulator report (initial receipt: 04-Apr-2013) concerns a male patient. Concomitant medications included valproate sodium, alprazolam and desvenlafaxine. On 14-Mar-2013 the patient received FLUVAX (batch number: 090634602) 1 dose unspecified, 1 time intramuscularly. On an unspecified date, the patient was found deceased in bed. The cause of death was not known. Reporter''s comment: The reporter considered the event as possible in relation to FLUVAX.


VAERS ID: 489022 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-04-11
Entered: 2013-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Bone loss, Breast pain, Bronchitis, Confusional state, Death, Diarrhoea, Dysphagia, Ear pain, Fall, Fungal infection, Mucous stools, Oesophagitis, Renal cyst, Respiratory distress, Upper limb fracture
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (broad), Osteoporosis/osteopenia (narrow), Osteonecrosis (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Disodium clodronate; Alendronate sodium; FOSAVANCE; Ibuprofen
Current Illness: Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0079383A

Write-up: This case was reported by a consumer via a regulatory authority (DE-PEI-PEI2013018868) and described the occurrence of death (not other specified) in an 83-year-old female subject who was vaccinated with Influenza vaccine, Tetanus vaccine. Information in this case was very inconsistent and incomplete, for this reason PEI requested data entry. Concurrent medical conditions included osteoporosis. Concurrent medications included BONEFOS, FOSAMAX, FOSAVANCE and Ibuprofen. In 2004 the subject received unspecified dose of Influenza vaccine (oral). On an unspecified date the subject received unspecified dose of Tetanus vaccine (oral). The consumer (the subject''s daughter) reported the following: After the last two vaccinations with influenza vaccine, the subject fell each time and was hospitalised. In 2004 the subject broke her arm when falling and was in hospital for more than three weeks. FOSAMAX was continued during that time, but not according to recommended scheme and with severe adverse reactions since that time. Additional events reported were: confusion, bronchitis, diarrhea, ear pain, esophagitis, fungal infection, mucus in stool, renal cyst, respiratory distress, swallowing disorder, bone loss in jaw and breast pain. The subject died on an unspecified date. The date probably was the 22 January 2006, as this was reported as end date for all events and medications. The cause of death was not specified. It was unknown whether an autopsy was performed. Follow-up information has been requested by PEI.


VAERS ID: 489728 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-04-19
Entered: 2013-04-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cerebrovascular accident, Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

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: 2013035440

Write-up: This serious consumer report (initial receipt: 11-Apr-2013) concerns an elderly patient in his 70 - 80''s. On 3 separate occasions, the patient was administered FLUVAX (batch number was not reported) and within 1 - 2 weeks of administration, he experienced a heart attack or stroke. The doctor did not attribute the stroke or heart attack to FLUVAX administration. The events occurred years ago (no specific dates known). The patient had since died at 85 years of age, no related to FLUVAX administration. Cause(s) of death: Unknown cause of death.


VAERS ID: 494300 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-06-14
Entered: 2013-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Chills, Death, Dyspnoea, Influenza, Influenza A virus test positive, Myalgia, Pyrexia, Rhinitis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), 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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: H1N1 influenza PCR, Positive
CDC Split Type: B0899558A

Write-up: This case was reported in a literature article and described the occurrence of death due to unknown causes in an elderly subject of unspecified gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced influenza A (H1N1). The subject was hospitalized. The H1N1 was confirmed by Reverse Transcription Polymerisation Chain Reaction. The subject died from death due to unknown causes. It was unknown whether an autopsy was performed. Two cases were identified in this study (see case B0899639A). Summary of the literature article: The objective of this study was to evaluate the 2009 Pandemic Influenza A (H1N1) in the elderly and identify the clinical characteristics, mortality and prognostic factors of the infection in these patients. This was an observational, retrospective study. Data were collected from the National Notifiable Diseases, from the foreign Ministry of Health. Only patients 60-year-old or more that had laboratory confirmed infections were included. The socio-demographic and clinical variables and outcomes were evaluated to compare mortality rates in the presence or absence of these factors. The main symptoms of the patients who died, in decreasing order of frequency, were dyspnea, coryza, fever, myalgia and chills. The age groups 60-69 years and 80 years had mortality rates higher than the average total of 16.1%. The highest mortality rate was observed in patients over the age of 80 years. Two patients of the seven patients in this age group died. Among the subjects included in the study, 38 (40.9%) patients had been previously vaccinated against seasonal influenza, two (5.3%) of which died. Comparing among the 15 patients who died, only 2 (13.3%) of these patients had been previously vaccinated. Therefore, 86.7% of the deaths occurred in unvaccinated elderly patients, suggesting that vaccination may reduce the number of influenza-associated deaths. The mortality rate observed in unvaccinated patients was 15% (6/40) and was significantly (p<0.05) higher than that observed among the vaccinated patients, which was 5.2% (2/38). Similarly, the hospitalization rate among unvaccinated patients, which was 62.5% (25/40), was significantly higher than that observed among those who received the influenza vaccine, which had a rate of 44.7% (17/38). With regard to hospitalization, 58.1% of the elderly were hospitalized as a result of the disease. Hospitalization was also significantly correlated with outcome (p=0.003), with an increased rate of death being observed in those that were hospitalized. The rate of oseltamivir treatment was 88.6% in this study. Early treatment within 2 days after the onset of symptoms was significantly associated with a lower risk of emergency admissions and death in hospitalized patients who contracted the 2009 Pandemic Influenza A (H1N1). The results agreed with other studies suggesting that oseltamivir treatment was beneficial. Authors'' results suggest benefits that elderly persons may receive from vaccination.


VAERS ID: 494302 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-06-14
Entered: 2013-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Chills, Death, Dyspnoea, Influenza, Influenza A virus test positive, Myalgia, Pyrexia, Rhinitis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), 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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: H1N1 influenza PCR, Positive
CDC Split Type: B0899639A

Write-up: This case was reported in a literature article and described the occurrence of death due to unknown causes in an elderly subject of unspecified gender who was vaccinated with Influenza vaccine unspecified, (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced influenza A (H1N1). The subject was hospitalised. The H1N1 was confirmed by Reverse Transcription Polymerisation Chain Reaction. The subject died from death due to unknown causes. It was unknown whether an autopsy was performed. Two cases were identified in this study (see case B0899558A). Summary of the literature article: The objective of this study was to evaluate the 2009 Pandemic Influenza A (H1N1) in the elderly and identify the clinical characteristics, mortality and prognostic factors of the infection in these patients. This was an observational, retrospective study. Data were collected from the National Notifiable Diseases, from the foreign Ministry of Health. Only patients 60-year-old or more that had laboratory confirmed infections were included. The socio-demographic and clinical variables and outcomes were evaluated to compare mortality rates in the presence or absence of these factors. The main symptoms of the patients who died, in decreasing order of frequency, were dyspnea, coryza, fever, myalgia and chills. The age groups 60-69 years and 80 years had mortality rates higher than the average total of 16.1%. The highest mortality rate was observed in patients over the age of 80 years. Two patients of the seven patients in this age group died. Among the subjects included in the study, 38 (40.9%) patients had been previously vaccinated against seasonal influenza, two (5.3%) of which died. Comparing among the 15 patients who died, only 2 (13.3%) of these patients had been previously vaccinated. Therefore, 86.7% of the deaths occurred in unvaccinated elderly patients, suggesting that vaccination may reduce the number of influenza-associated deaths. The mortality rate observed in unvaccinated patients was 15% (6/40) and was significantly (p<0.05) higher than that observed among the vaccinated patients, which was 5.2% (2/38). Similarly, the hospitalization rate among unvaccinated patients, which was 62.5% (25/40), was significantly higher than that observed among those who received the influenza vaccine, which had a rate of 44.7% (17/38). With regard to hospitalization, 58.1% of the elderly were hospitalized as a result of the disease. Hospitalization was also significantly correlated with outcome (p=0.003), with an increased rate of death being observed in those that were hospitalized. The rate of oseltamivir treatment was 88.6% in this study. Early treatment within 2 days after the onset of symptoms was significantly associated with a lower risk of emergency admissions and death in hospitalized patients who contracted the 2009 Pandemic Influenza A (H1N1). The results agreed with other studies suggesting that oseltamivir treatment was beneficial. Authors results suggest benefits that elderly persons may receive from vaccination.


VAERS ID: 495650 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-11-02
Onset:0000-00-00
Submitted: 2013-07-02
Entered: 2013-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Cough, Death, Hypoxia, Pulmonary fibrosis, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (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: Prednisolone
Current Illness: Pulmonary fibrosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2001GB01438

Write-up: Case previously recorded as MA2001-0722. We received the following information from the regulatory agency: An 80 year old man was vaccinated for the first time with a virus influenza vaccine i.m. and PNEUMOVAX II vaccine i.m. on 02 NOV 2000. Activation of lung fibrosis with increasing SOBOE and progressive cough after flu and PNEUMOVAX II injections. Died from progressive CFA after 8 months. Required increased steroids (prednisolone increased from usual 10 mg daily to 30 mg). Oxygen saturation 60% on exercise. Died of respiratory failure with hypoxia. Cryptogenic pulmonary fibrosis had been stable for 3 years. Assessment: Seriousness criterion: death. Causality: unrelated. No. 434541. Following an internal review on 25 Jun 2013, it was found that the case PHHY2001GB01969 was identical to this case PHHY2001GB01438. Hence all the information of this case PHHY2001GB01438 was merged into the case PHHY2001GB01969 and this case PHHY2001GB01438 will be deactivated.


VAERS ID: 495670 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-10-23
Onset:0000-00-00
Submitted: 2013-07-02
Entered: 2013-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Dyspnoea, General physical health deterioration, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Prednisolone; Azathioprine
Current Illness: Crohn''s disease; Idiopathic pulmonary fibrosis, As reported: alveolitis fibrosing
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2003GB00628

Write-up: Case previously recorded as SI2003-0083. A 53 year-old woman was vaccinated with an infuenza virus vaccine (manufact. unk.) on 23 OCT 2002. Patient had a history of crptogenic fibrosing alveolitis and Crohn''s disease since many years, treated with prednisolone and azathioprine. One-two weeks after receiving the flu jab the patient experienced aggravation with shortness of breath. Patient was admitted to hospital. Her condition continued to deteriorate. Patient died due to pulmonary embolus. The reporter considered the reaction to be serious for the following reasons: involved or prolonged in patient hospitalization; patient died due to reaction. No further information. Following an internal review received on 25 Jun 2013, it was identified that the case PHHY2003GB00628 was a duplicate of the case PHHY2003GB00609 and hence all the information of PHHY2003GB00628 was merged to PHHY2003GB00609 and PHHY2003GB00628 will be deactivated.


VAERS ID: 495672 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-10-23
Onset:0000-00-00
Submitted: 2013-07-02
Entered: 2013-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Dyspnoea, General physical health deterioration, Pulmonary embolism, Pulmonary fibrosis
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prednisolone; Azathioprine
Current Illness: Pulmonary fibrosis, alveolitis fibrosing; Crohn''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2003GB00609

Write-up: Case previously recorded as MA2003-0125. We received from the regulatory agency the following information: A 53-year-old woman was vaccinated with a virus influenza vaccine (batch-no. and manufacturer unknown) i.m. on 23 OCT 2002. She was suffering from cryptogenic fibrosing alveolitis and Crohn''s disease for many years. 1-2 weeks after receiving the flu jab the patient experienced aggravation of lung fibrosis with shortness of breath and was admitted to hospital. The patient''s condition continued to deteriorate. The patient died due to pulmonary embolus. Medical history: alveolitis fibrosing and Crohn''s disease. Assessment: Seriousness criteria: hospitalisation, fatal outcome. Causality: unrelated. No. 454191. Following an internal review received on 25 Jun 2013, it was identified that cases PHHY2003GB01709 and PHHY2003GB00628 were duplicates of the case PHHY2003GB00609 and hence all the information of PHHY2003GB01709 and PHHY2003GB00628 was merged to PHHY2003GB00609. PHHY2003GB01709 and PHHY2003GB00628 were deactivated. The suspect product was recoded from BEGRIVAC unknown to seasonal influenza vaccine (manufacturer and batch number unknown). Concomitant medications included prednisolone 10 mg and azathioprine 100 mg used for treating Crohn''s disease. It was reported that no autopsy was performed. It was mentioned that the case was assessed as unrelated to the vaccine since cryptogenic fibrosing alveolitis was a chronic and irreversible interstitial lung disease with a 5-year survival rate of 30 to 50 % after diagnosis.


VAERS ID: 495677 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-10-23
Onset:0000-00-00
Submitted: 2013-07-02
Entered: 2013-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Dyspnoea, General physical health deterioration, Pulmonary embolism, Pulmonary fibrosis
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Azathioprine; Prednisolone
Current Illness: Idiopathic pulmonary fibrosis; Crohn''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2003GB01709

Write-up: Case previously recorded as PJP-2003-00095. An ASPP (Anonymised Single Patient Print) was received from a regulatory authority on 10 March 2003 concerning a 53 year old female vaccinee who was hospitalised due to shortness of breath and aggravation of lung fibrosis, then died due to a pulmonary embolus 1 - 2 weeks after vaccination with virus influenza (brand unspecified) on 23 October 2002. The vaccinee had a history of cryptogenic fibrosing alveolitis and Crohn''s disease for many years. Concomitant medications taken included prednisolone and azathioprine. On an unspecified date, one to two weeks following influenza vaccination the vaccinee experienced aggravated lung fibrosis with shortness of breath. The vaccinee was admitted to hospital where her condition continued to deteriorate. The vaccinee died due to pulmonary embolus. No autopsy was performed. There was insufficient information to determine the reporter''s causality assessment. Following an internal review received on 25 Jun 2013, it was identified that the case PHHY2003GB01709 was a duplicate of the case PHHY2003GB00609 and hence all the information of PHHY2003GB01709 was merged to PHHY2003GB00609 and the case PHHY2003GB01709 will be deactivated.


VAERS ID: 496315 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-10-23
Onset:0000-00-00
Submitted: 2013-07-09
Entered: 2013-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Dyspnoea, General physical health deterioration, Idiopathic pulmonary fibrosis, Pulmonary embolism, Pulmonary fibrosis
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prednisolone; Azathioprine
Current Illness: Unknown
Preexisting Conditions: Post inflammatory pulmonary fibrosis, regional enteritis of unspecified s
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0906066A

Write-up: This case was reported by the foreign regulatory authority and described the occurrence of alveolitis fibrosing in a 53-year-old female subject who was vaccinated with Influenza vaccine (unspecified). The subject''s medical history included post inflammatory pulmonary fibrosis and regional enteritis of unspecified site. Concurrent medications included Prednisolone and Azathioprine. On 23 October 2002 the subject received unspecified dose of Influenza vaccine (unspecified) (0.5 ml, intramuscular). In 2002, 1 to 2 weeks after vaccination with Influenza vaccine (unspecified), the subject experienced alveolitis fibrosing, pulmonary embolism and shortness of breath. The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening. The regulatory authority reported that the events were not related to vaccination with Influenza vaccine (unspecified). The subject died in 2002 from pulmonary embolism. It was unknown whether an autopsy was performed. Agency verbatim text: Case previously recorded as MA2003-0125. We received from the Agency the following information: A 53-year-old woman was vaccinated with a virus influenza vaccine (batch-no. and manufacturer unknown) i.m. on 23 OCT 2002. She was suffering from cryptogenic fibrosing alveolitis and Crohn''s disease for many years. 1-2 weeks after receiving the flu jab the patient experienced aggravation of lung fibrosis with shortness of breath and was admitted to hospital. The patient''s condition continued to deteriorate. The patient died due to pulmonary embolus. Medical history: alveolitis fibrosing and Crohn''s disease. Assessment: Seriousness criteria: hospitalisation, fatal outcome. Causality: unrelated. Agency-no. 454191. Following an internal review received on 25 Jun 2013, it was identified that cases PHHY2003GB01709 and PHHY2003GB00628 were duplicates of the case PHHY2003GB00609 and hence all the information of PHHY2003GB01709 and PHHY2003GB00628 was merged to PHHY2003GB00609. PHHY2003GB01709 and PHHY2003GB00628 were deactivated. The suspect product was recoded from BEGRIVAC unknown to seasonal influenza vaccine (manufacturer and batch number unknown). Concomitant medications included Prednisolone 10 mg and Azathioprine 100 mg used for treating Crohn''s disease. It was reported that no autopsy was performed. It was mentioned that the case was assessed as unrelated to the vaccine since cryptogenic fibrosing alveolitis was a chronic and irreversible interstitial lung disease with a 5-year survival rate of 30 to 50% after diagnosis.


VAERS ID: 497685 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-07-25
Entered: 2013-07-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza, Serology test, Tuberculosis
SMQs:, Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-07-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient''s history was unknown.
Allergies:
Diagnostic Lab Data: Serology testing was performed. Results were not available.
CDC Split Type: 201307958

Write-up: Initial information was received on 18 July 2013 through the local affiliate from the lay media. A 59-year-old male patient received an injection of influenza vaccine, manufacturer and lot number unknown (route, site and side of vaccination were not reported) on an unknown date in 2013. According to the reporter, all persons had been vaccinated at the beginning of the year. An unspecified amount of time later, the patient had suspected influenza A/H1N1. The patient was hospitalized for four days. There was no confirmation regarding the cause of death, as there were two suspects that were under evaluation: influenza A/H1N1 and tuberculosis. Serologies were collected and sent to the laboratory, but resullts were not available. No additional information was provided. The patient''s outcome was reported as fatal on 17 July 2013. Documents held by sender: None.


VAERS ID: 498840 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-07
Entered: 2013-08-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza
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: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 201308186

Write-up: Initial case was received on 29 July 2013 from a non health care professional "lay media" via the local affiliate which involves a cluster of two elderly patients. Two unidentified elderly patients ages over 60 year, "came to death due to influenza virus infection after receiving influenza vaccine (manufacturer, lot number, route and site of administration not reported) in the same year." No further information was available at the time of the report. Outcome was fatal. Documents held by sender: none.


VAERS ID: 499330 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-13
Entered: 2013-08-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza, Influenza A virus test positive
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: The patient had a history of lung and liver disease.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201308319

Write-up: Initial report was received on 02 August 2013 from a non health care professional "lay media" via the local affiliate. A 62 year-old male patient (date of birth not reported) with a history of lung and liver disorder "came to death due to H1N1 virus infection, even after being vaccinated with Influenza vaccine (manufacturer, batch number, route, site and date of administration not reported). The patient had a positive serology to Influenza A/H1N1 virus. No further information was available at the time of the report. Outcome was fatal. Documents held by sender: none.


VAERS ID: 499584 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-14
Entered: 2013-08-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza, Influenza virus test positive
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: The patient had an unspecified chronic illness.
Allergies:
Diagnostic Lab Data: Positive serology to influenza virus.
CDC Split Type: 201308550

Write-up: Initial report was received from a non-healthcare professional (lay media) through the local affiliate on 08 August 2013. The reporter reported another case of death caused by influenza virus which was captured in case number 2013-08186. A patient (age, gender and date of birth not reported) with chronic illness received an injection of influenza vaccine (manufacturer, lot number, route, site and date of administration unknown) in 2013 and an unspecified amount of time later died due to influenza virus infection. The patient had a positive serology to influenza virus. No additional information was provided. Outcome was fatal. Documents held by sender: None.


VAERS ID: 500129 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-21
Entered: 2013-08-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspiration, Autopsy, Death, Laboratory test normal, Lung infiltration, Pneumonia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-02
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient had pneumonia the week prior to death.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201308658

Write-up: Initial report was received on 12 August 2013 from lay media via the local affiliate. Verbatim from the report: "This is a spontaneous report of serious adverse events. We collected through lay media, the information about some children of the city that presented suspect of influenza A/H1N1, however, according to the City Hall data, 100% of the children were vaccinated against influenza. On 02/Aug/2013, a 10-month-old baby died after a respiratory arrest. The mayor reported that the patient had presented pneumonia a week before he died. On 02/Aug/2013, the parents took him to the hospital at noon, where tests were performed and did not detect any abnormalities. At 18 o''clock, the parents returned with the child to the emergency room, and he was presenting a respiratory crisis. According to the physician, the baby has arrived at the hospital with a respiratory arrest, with lungs infiltrated, although at noon lungs were clean, and died. The medical staff was not suspicious of influenza A/H1N1, because the patient did not present symptoms of infection, and the main suspect was bronchoaspiration. The result of the autopsy performed on the body of the baby should be released within 15 days. No additional information was provided." The reporter for this case is the same as for 2013-08659 and 2013-08660. Documents held by sender: none.


VAERS ID: 500726 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-27
Entered: 2013-08-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 201308842

Write-up: Initial report was received on 16 August 2013 from the lay media via the local affiliate. Verbatim from the report: "The case was collected in lay media. This is a spontaneous reporting of serious adverse events. The reporter informed that a man of 83 years old was admitted to a private hospital in the city and died within the end of July/2013 due to H1N1 virus infection. According to the city Health Department, the man had been vaccinated. No additional information was provided." No further information was available at the time of the report. Documents held by sender: none.


VAERS ID: 501657 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-30
Entered: 2013-09-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza, Influenza virus test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient had a history of diabetes and rheumatism. Family history was unknown.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201309161

Write-up: Initial report was received 23 August 2013 from an affiliate who received the report via a lay media report. A 75-year-old male, with a history of diabetes and rheumatism, had received an Influenza Vaccine (manufacturer, lot number, route, site and date of administration unknown). The patient died on 14 August 2013, victim of H3N2 influenza virus infection. Serologic testing was confirmed on 21 August 2013 by the agency. Additionally, the reporter informed that the man had been vaccinated against influenza and sought care at a health facility after developed flu symptoms for three days. Despite starting treatment with TAMIFLU, the man succumbed to complications (not specified). Hospitalization was reported as unknown and the patient''s family history was unknown. No additional information was provided. Additional information has been requested from the agency. Documents held by sender: None.


VAERS ID: 508000 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-12
Entered: 2013-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Complementary investigations were unknown.
CDC Split Type: 201307455

Write-up: Initial report received from scientific literature search on 19 June 2013. This case is invalid as individual patient identifiers are missing. Introduction: The aim of this study was to investigate the incidence of adverse effects and protective effects from influenza vaccine among elderly individuals who were vaccinated through the public healthcare system. Methods: A prospective cohort study was conducted between May and September 2008. A group of 341 patients was recruited, among whom 289 had been vaccinated through the public system (VSUS) and 52 had not been vaccinated (NV). The incidence of protective effects was observed by comparing the VSUS and NV groups. Results: It was observed that 22.5% of the vaccinated subjects exhibited at least one adverse effect. Comparing the VSUS and NV groups in relation to the incidence of flu symptoms presented during the winter, at least one symptom was observed in 47% and 28.8% (RR- 1.11, 1.02-1.22; p=0.0156), respectively. CONCLUSIONS: These findings demonstrate that the incidence of adverse effects was low. The high incidence of flu symptoms in the VSUS group, in comparison with NV, may be related to the profile of subjects who are in the habit of getting vaccinated against influenza. A cluster of 289 patients, whose medical history and concomitant medications were unknown, had received a dose of Influenza vaccine (Manufacturer and batch number unknown, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date, 11 patients presented local pain, 2 patients experienced local hyperemia, 3 patients experienced local induration, 20 patients presented fever, 34 patients presented malaise, 16 patients experienced muscle pain, 22 patients experienced headache, 1 patient experienced lymph node edema, 3 patients developed diarrhea, 4 patients developed vomiting, 25 patients experienced nasal discharge, 10 patients developed chest pain, 16 patients experienced cough, 2 patients developed ear pain, 8 patients developed arthralgia, 37 patients developed chills, 42 patients experienced sore throat and 7 patients experienced pain when moving eyes. Complementary investigations and corrective treatments were unknown. At the time of this report, the outcome was unknown. Follow-up information was received on 10 August 2013 from the health care professional via the local affiliate. Based upon new information received, it was determined this case meets seriousness criteria and has been upgraded from non-serious to serious. "The reporter informed that she could not find the documents where there was information about the patients. She informed that none of the patients was hospitalized at that time and all of them recovered. According to her, some patients died but due to other causes that were not breathing problems." No further information was available at the time of the report. Outcomes were reported as recovered (also reported as some patients died). Documents held by sender: None. Follow up information received from a healthcare professional on 30 September 2013. The reporter informed that she could not find the documents where there was information about the patients and, therefore, had no more information about this case. Thus, this case was considered closed (end of follow-up). No additional information was provided. This case is a summary case of 289 patients who received influenza vaccine and of which some patients had died. Document held by sender: none.


VAERS ID: 507947 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-16
Entered: 2013-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Death, Gastrointestinal disorder, Granulomatosis with polyangiitis, Nervous system disorder, Renal disorder, Sinus disorder
SMQs:, Interstitial lung disease (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013038208

Write-up: This literature report (initial receipt 17-Sep-2013) concerns a 20 year old male. On an unspecified date, the patient received an influenza vaccination (non-CSL influenza vaccine, manufacturer and batch number not specified). On an unspecified date, the patient developed a relapse of AAV (Antineutrophil Cytoplasmic Antibody Vasculitis). The disease type was GPA (granulomatosis with polyangiitis). The ANCA type was cytoplasmic (c). Organs involved included kidney, brain, GI (gastrointestinal) tract and sinus. Treatment included MMP, prednisone (P) and plasma exchange (PE). The outcome was reported as fatal. Follow up (02-Oct-2013), non-CSL influenza vaccine (patient received influenza vaccine in 2004, CSL influenza vaccine was first registered in 2005). Cause of death is unknown.


VAERS ID: 508079 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-12
Entered: 2013-10-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza
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: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2013SA097982

Write-up: Initial report received from a consumer (online newspaper) on 20 September 2013. This summary case concerns 07 elderly patients of unspecified age, who received Influenza vaccine (manufacturer unknown, batch number was unknown, route, dose number and anatomical site of administration were not reported) on an unspecified date in 2013. The patient''s concomitant medications and family history was unknown. On an unspecified date in 2013 after vaccination, the patients had fatal influenza virus infection. The information about laboratory investigations and corrective treatments was unknown. List of documents held by the sender none.


VAERS ID: 508080 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-12
Entered: 2013-10-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza
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: The patient had unspecified chronic disease.
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2013SA097998

Write-up: Initial report received from a consumer (online newspaper) on 30 September 2013. A patients of unspecified demographics, who received Influenza vaccine (manufacturer unknown, batch number was unknown, route, dose number and anatomical site of administration were not reported) on an unspecified date in 2013. The patient''s concomitant medications and family history was unknown. Patient had unspecified chronic disease. On an unspecified date in 2013 after vaccination, the patient had fatal influenza virus infection. The information about laboratory investigations and corrective treatments was unknown. List of documents held by the sender none.


VAERS ID: 513085 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-22
Onset:0000-00-00
Submitted: 2013-11-07
Entered: 2013-11-14
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 133401 / UNK UN / IM

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013DE126188

Write-up: Case number PHHY2013DE126188 is an initial spontaneous report received from Foreign Health Authority (reference number: DE-PEI-PEI2013065018) ON 05 Nov 2013. This report refers to an elderly male patient. His medical history and concomitant medication were not reported. His vaccination history included administration of Td-RIX (other manufacturer, batch number unknown) in 1998, PNEUMOVAX 23 (other manufacturer, batch number unknown) on 14 Mar 2009 and two doses of INFLUSPLIT SSW (other manufacturer, batch number unknown) on 19 Sep 2011 and 25 Sep 2012. He did not experience any adverse events with these vaccinations. On 22 Oct 2013, he was vaccinated with BEGRIPAL 2013/2014 (batch number: 133401) intramuscularly. On an unspecified date, after vaccination, he died due to an unspecified cause. He was not hospitalized, before his death. It was unknown whether autopsy was performed. No further information was provided.


VAERS ID: 514487 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-23
Onset:0000-00-00
Submitted: 2013-11-25
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 24449421A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
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: ASS (Acetylsalicylic acid); Ramipril
Current Illness:
Preexisting Conditions: Smoker; Alcohol abuse; Arterial hypertension; Severe obstructive sleep apnea syndrome; Head tremor; Nicotine abuse; Contusion of breast; Suspected acute bronchitis; Orthostatic syncope; Orthostatic dysregulation; Severe snoring
Allergies:
Diagnostic Lab Data: Blood pressure, 180/90 mmHg, Apr-2011; MCV, 96.6 fl, 13-Mar-2012
CDC Split Type: 2013039164

Write-up: This health authority report (initial receipt 11-Nov-2013) concerns a 70-year old male patient. The patient''s medical history included smoking, alcohol abuse, head tremor, nicotine abuse and contusion of breast (since 25-Oct-1991). The patient was hospitalised from 19-Nov-2008 until 22-Nov-2008 for orthostatic syncope associated with alcohol use (10 small beers) and nicotine abuse. The patient was hospitalised after loss of consciousness in the evening (after alcohol intake) and in the morning after breakfast, again the patient''s legs had turned weak, sweating and had hit his head upon falling. The patient denied drinking alcohol regularly. This was due to orthostatic dysregulation. However, his long term EKG (electrocardiogram) was normal. Also his physical examination and EKG at rest was normal. His chest x-ray showed left pleural sinus was not sharp, indicating possible pleural fibrosis or effusion, abdominal sonography showed cholecystolithiasis with 3 stones, small haemangioma in right liver lobe. The patient was diagnosed with suspected acute bronchitis, severe obstructive sleep apnoea syndrome, arterial hypertension and was hospitalised from 27-Apr-2011 until 29-Apr-2011. In Apr-2011, the patient''s blood pressure was at 180/90 mmHg and on 13-Mar-2013, the patient underwent lab test for MCV (mean corpuscular volume) which was at 96.6 fl. It was reported that snoring and light sleep had led to his hospitalisation. For the past 3-4 years the patient had difficulty falling asleep for up to 2 hours, several times per week and had an imperative urge to fall asleep after lunch for the past 3-4 years. The patient has an involuntary tremor of head, starting a few years ago. The patient underwent neurological examination which was normal except for a mild tremor of head (in rest). His Epworth Sleepiness scale was 0/24 (normal). The patient underwent polysomnography on 27/28 Apr-2011 which showed severe obstructive breathing disorder in sleep, including severe snoring and decreasing oxygen saturation in all positions. His chest x-ray was normal. He underwent a duplex sonography of cerebral arteries which showed moderate atherosclerosis without evidence of stenosis. ENT (ear, nose and throat) examination was normal. His concomitant medications included acetylsalicylic acid and ramipril. On 23-Oct-2013, the patient was vaccinated with intramuscular AFLURIA (batch number: 24449421A). On 30-Oct-2013, the patient was found dead in his apartment after the door had been opened by the police. He had a plaster on the upper arm and the vaccination card was found on the desk suggesting that he had been vaccinated recently. It was estimated that the death had occurred between 23-Oct-2013 and 25-Oct-2013. The cause of death was reported as unknown. Outcome was reported as death.


VAERS ID: 514787 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-25
Entered: 2013-11-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (OPTAFLU) / NOVARTIS VACCINES AND DIAGNOSTICS 036031A / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Malaise, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (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: No other medications
Current Illness: Cardiac disorder, Advanced cardiopath patient, Severe problems due to his cardiac disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013ES134162

Write-up: Case number PHHY2013ES134162 is a combined spontaneous report initially received from a CEO of vaccines via Health Authority and follow ups from a physician via Health Authority on 22 Nov 2013. This report refers to a 75 year old male patient. He was an advanced cardiopath patient (had severe problems due to his cardiac disease). He was vaccinated with OPTAFLU (batch number: 036031A) on an unspecified date. After vaccination he went to have breakfast. He did not feel well and went to the toilet where he was found dead, 40 minutes after OPTAFLU administration. Cardiopulmonary resuscitation was performed without success. Cause of the death was reported as cardiac arrest (not acute myocardial infarction, although it could not be ruled out). No information regarding autopsy was reported. HA physician believed that the death was due to the underlying disease and assessed as not suspected to OPTAFLU.


VAERS ID: 518512 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-23
Onset:0000-00-00
Submitted: 2013-12-26
Entered: 2014-01-06
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Aphasia, Apnoea, Blood test, Body temperature increased, Chest X-ray, Coma, Computerised tomogram, Condition aggravated, Convulsion, Death, Dyspnoea, General physical health deterioration, Grand mal convulsion, Incontinence, Mobility decreased, Respiratory disorder, Respiratory failure, Respiratory rate, Tachycardia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-11-09
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Clonazepam; KEPPRA; Lamotrigine; Midazolam; Thiamine; Vitamin B complex
Current Illness: Lennox-Gastaut syndrome; Convulsion, Frequently
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, unknown; Chest X-ray, unknown; Computerised tomogram, unknown
CDC Split Type: PHFR2013GB007336

Write-up: Case number PHFR2013GB007336, is an initial spontaneous report received from the consumer via health authority (reference number: 22356018) on 23 Dec 2013. This report refers to a 20-year-old male patient. His medical history included Lennox-Gastaut syndrome and frequent seizures. His concomitant medication included clonazepam, KEPPRA, lamotrigine, midazolam, thiamine, vitamin B complex strong. He was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on 23 Oct 2013. One day after vaccination, his body temperature increased and had difficulty in respiration. He became tachycardiac and his seizures increased from his base line target of below 10 to 30, then 50 and in the final days over a hundred grand mal seizures. He was admitted in the hospital and was released as no chest infection was found. It was reported that he was prescribed paracetamol to lower body temperature. It was reported that his seizures and body temperature increased after his discharge and he was readmitted later in the same week. Lab tests such as blood tests, chest X-ray and computed tomogram was performed. His seizures were stabilized and he was also treated with anti-retroviral TAMIFLU, because of possible link to vaccine causing serious deterioration of his health. It was reported that he also experienced and speech loss on 24 Oct 2013, incontinence on and mobility decreased on 24 Oct 2013, apnea on 30 Oct 2013, respiration irregularity and respiratory rate on 02 Nov 2013. On 09 Nov 2013 he slipped into coma and he died of respiratory failure. The event outcome for apnea was completely recovered. The event outcome for coma, condition aggravated, general physical health deterioration, incontinence, mobility decreased, respiratory irregularity, respiratory rate, seizure grand mal, speech loss, tachycardia, temperature elevation was condition unchanged. The event outcome for respiratory failure was fatal. The causality was assessed as suspected to the vaccination with influenza vaccine.


VAERS ID: 520381 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-20
Entered: 2014-01-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Adverse drug reaction, Death, Idiopathic thrombocytopenic purpura, Ill-defined disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014JP005372

Write-up: An initial literature report received from a health authority on 13 JAN 2014. The article was presented with adverse reactions to influenza vaccine of season 2012 reported from OCT 2012 through the end of MAR 2013. The date of the adverse reactions reported by medical institutions were tabulated and evaluated by the regulatory agency together with those reported by the marketing authorization holders and the necessity of safety measures were discussed in the article. This report refers to a patient whose identifiers, medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date the vaccine was of season 2012). It was reported that on an unknown date the patient died due to idiopathic thrombocytopenic purpura. It was reported that the death might be associated with the vaccination or most likely caused by an adverse reaction to the drug used for the treatment of an underlying disorder.


VAERS ID: 522105 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-04
Entered: 2014-02-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Condition aggravated, Death, Influenza like illness, Motor neurone disease
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Unknown
Current Illness:
Preexisting Conditions: Motor neuron disease; The patient had motor neuron disease.
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA013108

Write-up: Case retrieved from the literature on 23 January 2014. This case is linked to 2014SA013070, 2014SA013079, 2014SA013082 and 2014SA013109 (same reporter). The following is verbatim from the article abstract: This report summarizes passive surveillance data for adverse events following immunization (AEFI) reported to the Administration for 2011, and describes reporting trends over the 12-year period 2000 to 2011. There were 2,327 AEFI records for vaccines administered in 2011, a decrease of 40% from 3,894 in 2010. The decrease in 2011 was attributable to a decline in reporting following seasonal influenza (2,354 to 483) and pandemic H1N1 (pH1N1) influenza vaccines (514 to 2). However, reporting rates for some other vaccines were higher in 2011 compared with 2010. The 13-valent pneumococcal conjugate vaccine (13vPCV) replaced the 7-valent pneumococcal conjugate vaccine (7vPCV) and was suspected of involvement in 236 AEFI cases (40 per 100,000 doses). An increase in the number of reports following rotavirus (from 40 to 56 per 100,000 doses), and the hexavalent infant vaccine (from 27 to 40 per 100,000 doses), may have been due at least in part to co-administration with 13vPCV. Reports following DTPa-IPV also increased (from 94 to 139 per 100,00 doses), continuing a trend since 2009. AEFI reports following receipt of the 23-valent pneumococcal vaccine also increased markedly in those aged 65 years, from 155 to 288 records. In response to the increase in reports following 23vPPV, boosters are no longer recommended for those without medical risk factors. The most commonly reported reactions were injection site reactions, fever, allergic reactions and malaise. Only 7% of all the reported adverse events were categorized as serious, as per the database definitions, although some events classified as non-serious may have caused severe illness. Three deaths were temporally associated with vaccination; however, all were attributed to causes other than vaccination. The increase in 2011 was predominantly due to reports of injection site reactions (49% increases in 2011). Increases in some instances may also be partly attributable to an increasing propensity to report AEFI. A male patient (middle-aged) with history of motor neuron disease, had received a dose of Influenza vaccine (manufacturer unknown, batch number, route and site of administration was not reported) on an unspecified date. On an unspecified date, the patient developed flu-like illness after vaccination and had a cardiac arrest. The patient died after 4 days of vaccination. The cause of death was documented as complications of motor neuron disease. Cause(s) of Death: disease complication.


VAERS ID: 522107 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-04
Entered: 2014-02-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Death, Nervous system disorder
SMQs:, Noninfectious encephalitis (narrow), Demyelination (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA013109

Write-up: Case retrieved from the literature on 23 January 2014. This case is linked to 2014SA013070, 2014SA013079, 2014SA013082 and 2014SA013108 (same reporter). The following is verbatim from the article abstract: This report summarizes data for adverse events following immunization (AEFI) for 2011, and describes reporting trends over the 12-year period 2000 to 2011. There were 2,327 AEFI records for vaccines administered in 2011, a decrease of 40% from 3,894 in 2010. The decrease in 2011 was attributable to a decline in reporting following seasonal influenza (2,354 to 483) and pandemic H1N1 (pH1N1) influenza vaccines (514 to 2). However, reporting rates for some other vaccines were higher in 2011 compared with 2010. The 13vPCV replaced the 7vPCV and was suspected of involvement in 236 AEFI cases (48 per 100,000 doses). An increase in the number of reports following rotavirus (from 40 to 56 per 100,000 doses), and the hexavalent infant vaccine (from 27 to 40 per 100,000 doses), may have been due at least in part to co-administration with 13vPCV. Reports following DTaP-IPV also increased (from 94 to 139 per 100,000 doses), continuing a trend since 2009. AEFI reports following receipt of the 23-valent pneumococcal vaccine also increased markedly in those aged 65 years, from 155 to 288 records. In response to the increase in reports following 23vPPV, boosters are no longer recommended for those without medical risk factors. The most commonly reported reactions were injection site reactions, fever, allergic reactions and malaise. Only 7% of all the reported adverse events were categorized as serious, as per the database definitions, although some events classified as non-serious may have caused severe illness. Three deaths were temporally associated with vaccination; however, all were attributed to causes other than vaccination. The increase in 2011 was predominantly due to reports of injection site reactions (49% increases in 2011). Increases in some instances may also be partly attributable to an increasing propensity to report AEFI. A patient (elderly), had received a dose of seasonal influenza vaccine (manufacturer unknown, batch number, route and site of administration was not reported) on an unspecified date. On an unspecified date, the patient developed progressive neurological dysfunction. The patient died 29 days after receiving vaccination. The cause of the death was documented as acute disseminated encephalomyelitis (ADEM).


VAERS ID: 524212 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-03-01
Onset:0000-00-00
Submitted: 2014-02-28
Entered: 2014-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER K7004 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abortion spontaneous, Death, Foetal heart rate abnormal
SMQs:, Foetal disorders (narrow), Termination of pregnancy and risk of abortion (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: 2014040909

Write-up: This health authority report (initial receipt 13-Feb-2014) concerns a patient (foetus). On the 01-Mar-2013, the foetus received influenza (manufacturer and batch number not reported) from the mother in utero (see 2014040810). On an unspecified date after vaccination, the patient had an absence of foetal heartbeat which resulted in a spontaneous abortion. Corrective treatment and laboratory investigations were not reported. The patient''s outcome was fatal. Reporter comments: The regulator reported the case as possible in relation to the influenza vaccine.


VAERS ID: 527128 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-27
Entered: 2014-03-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Arrhythmia; Cardiac failure congestive; Diabetes mellitus
Preexisting Conditions: Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014NZ036122

Write-up: Case number PHHY2014NZ036122 is an initial literature report received on 23 Mar 2014. The author described the spontaneous reports of adverse event related to seasonal influenza vaccine. This report refers to a patient of unspecified age and gender. The patient''s medical history included diabetes, myocardial infarction, cardiac arrhythmia and congestive heart failure. On an unknown date, the patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown). After an unknown duration, the patient died of further myocardial infarction. It was unknown if an autopsy was performed. The event was assessed as temporally related to influenza vaccination by author.


VAERS ID: 528179 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-11
Entered: 2014-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death neonatal, Foetal exposure during pregnancy, Neonatal asphyxia, Neonatal disorder
SMQs:, Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014NL044365

Write-up: Case number PHHY2014NL044365, is an initial literature report received on 08 Apr 2014. The authors described about a prospective cohort and spontaneously reported pregnancy-related adverse reactions with H1N1 influenza vaccination during pregnancy. This case refers to a stillborn fetus to a mother of unknown age. The mother medical history included obesity. The mother was vaccinated with H1N1 influenza (manufacturer and batch number: not reported) at week 29 of pregnancy (see linked mother case: PHHY2014NL044360). The fetus was exposed to the vaccine via transplacental route. The baby had a normal birth weight and there was no congenital malformations. The neonate died one week postpartum due to asphyxia during birth. The authors stated that there were no signs of an association between the perinatal death and the vaccination. The authors concluded that the present study adds further reassurance for the safe use of adjuvanted vaccines during pregnancy and facilitates decision making in future pandemics and epidemics.


VAERS ID: 536513 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-09
Entered: 2014-07-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Death
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT083306

Write-up: Case number PHHY2014IT083306 is an initial spontaneous report received from the consumer via foreign internet site on 05 Jul 2014. This report refers to a patient of unknown age and gender. The patient''s medical history and concomitant medications were not reported. The patient was vaccinated with AGGRIPAL (batch number: unknown) on an unspecified date. Four days after vaccination patient died due to a cerebral stroke. The causality of the event was not reported.


VAERS ID: 537884 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-25
Entered: 2014-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Biopsy, Cardiac failure, Death, Heart transplant, Heart transplant rejection, Immunosuppression, Pericardial excision, Post procedural complication, Tricuspid valve incompetence
SMQs:, Cardiac failure (narrow), Pulmonary hypertension (narrow), Cardiomyopathy (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: Cyclosporin; Azathioprine; Mycophenolate mofetil; Interleukin-2; Methylprednisolone; Prednisone; Tacrolimus; Gancyclovir
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B1016651A

Write-up: This case was reported in a literature article and described the occurrence of heart failure in a subject aged between 10 and 19 years old of unspecified gender who was vaccinated with influenza vaccine (manufacturer unspecified), HepB vaccine and unspecified Pneumococcal vaccine. The subject had undergone an orthotopic heart transplant between November 1992 and December 2008. This was the subject''s first heart transplant and only this organ was transplanted. Historical medication for this subject was not specified but the authors commented that the preoperative immunosuppressive protocol for subjects transplanted until June 1999 consisted of induction with cyclosporine 5 mg/kg and azathioprine 4 mg/kg per os (PO). The preoperative immunosuppressive protocol for subjects who underwent transplant after June 1999 included anti-interleuken-2 receptor monoclonal antibody, mycophenolate mofetil 1.5-2.0 g PO and cyclosporine 3-4 mg/kg PO (discontinued after January 2007). In addition to this, all the subjects received SOLUMEDROL 500 mg intravenous (IV) intraoperatively and the subjects transplanted after June 1999 also received methylprednisolone 500 mg IV during the procedure. Concurrent medication was not specified but the authors explained that the subjects were treated with immunosuppression and infection prophylaxis postoperatively. This postoperative immunosuppression treatment included cyclosporine (maintained around 400 ng/ml during the first year and then 250-300 ng/ml) and azathioprine (1.0-2.0 mg/kg/day to maintain white blood cell count (WBC) $g4,000/mm3) until June 1999. Between June 1999 and January 2007 the subjects received mycophenolate mofetil 1-3 g/day, anti-interleukin-2 receptor monoclonal antibody (to maintain a WBC of 4,000-6,000/L) and cyclosporine (trough levels maintained during the first year at 300-400 ng/mL and at 150-200 ng/mL thereafter). After January 2007 cyclosporine was substituted with methylprednisolone 125 mg (one injection every 8 h for 3 injections), prednisone (initially 1 mg/kg/day, decreasing to 0.25 mg/kg/day at 1 month, to 0.1 mg/kg/day at 6 months and discontinued after 1 year if possible) and FK 506 (trough levels of 10-15 ng/ml during the first year and 6-8 ng/ml afterwards). In addition to this some subjects received gancyclovir IV for 4 weeks before the transplant procedure. On unspecified dates, at an unspecified time before the heart transplant procedure the subject received an unspecified pneumococcal vaccine, an unspecified influenza vaccine and an unspecified hepatitis B vaccine (if the subject was negative for HBsAg and HBsAb) (administration site and routes unspecified, batch numbers not provided). Surveillance EMB was performed using a percutaneous right internal jugular approach on a scheduled basis, every week for 1 month, every month for 3 months, and at 6 months and 1 and 2 years. In the event of clinical suspicion of rejection, further biopsy was performed. On an unknown date, at least 6 months after the heart transplantation, the subject suffered from significant tricuspid regurgitation that required a pericardiectomy and subsequently developed heart failure. The subject died from heart failure. It was unknown whether an autopsy was performed. The author did not comment on any causal relationship with the vaccines. The author''s conclusion stated that in this study of subjects after heart transplantation, the incidence of moderate-to-severe tricuspid regurgitation was 10.4% and moderate-to-severe mitral regurgitation occurred less frequently than tricuspid regurgitation. The long term results of atrioventricular function after heart transplantation in adults were excellent regardless of anastomotic technique. Older donor age was the important factor associated with development of postoperative moderate-to-severe tricuspid regurgitation. This is 1 of the 5 valid cases reported in the same literature article.


VAERS ID: 537887 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-25
Entered: 2014-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Heart transplant, Tricuspid valve incompetence
SMQs:, Cardiac failure (broad), Pulmonary hypertension (narrow), Cardiomyopathy (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: Cyclosporin; Azathioprine; Mycophenolate mofetil; Interleukin-2; Methylprednisolone; Prednisone; Tacrolimus; Gancyclovir
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B1016653A

Write-up: This case was reported in a literature article and described the occurrence of death (cause undetermined) in a subject of at least 17 years old of unspecified gender who was vaccinated with influenza vaccine (unspecified, manufacturer unspecified), HepB and unspecified pneumococcal vaccine. The subject had undergone an orthotopic heart transplant between November 1992 and December 2008. This was the subject''s first heart transplant and only this organ was transplanted. Historical medication for this subject was not specified but the authors commented that the preoperative immunosuppressive protocol for subjects transplanted until June 1999 consisted of induction with cyclosporine 5 mg/kg and azathioprine 4 mg/kg per os (PO). The preoperative immunosuppressive protocol for subjects who underwent transplant after June 1999 included anti-interleukin-2 receptor monoclonal antibody, mycophenolate mofetil 1.5-2.0 g PO and cyclosporine 3-4 mg/kg PO (discontinued after January 2007). In addition to this, all the subjects received SOLUMEDROL 500 mg intravenous (IV) intraoperatively and the subjects transplanted after June 1999 also received methylprednisolone 500 mg IV during the procedure. Concurrent medication was not specified but the authors explained that the subjects were treated with immunosuppression and infection prophylaxis postoperatively. This postoperative immunosuppression treatment included cyclosporine (maintained around 400 ng/ml during the first year and then 250-300 ng/ml) and azathioprine (1.0-2.0 mg/kg/day to maintain white blood cell count (WBC) $g4,000/mm3) until June 1999. Between June 1999 and January 2007 the subjects received mycophenolate mofetil 1-3 g/day, anti-interleukin-2 receptor monoclonal antibody (to maintain a WBC of 4,000-6,000/?L) and cyclosporine (trough levels maintained during the first year at 300-400 ng/mL and at 150-200 ng/mL thereafter). After January 2007 cyclosporine was substituted with methylprednisolone 125 mg (one injection every 8 h for 3 injections), prednisone (initially 1 mg/kg/day, decreasing to 0.25 mg/kg/day at 1 month, to 0.1 mg/kg/day at 6 months and discontinued after 1 year if possible) and FK 506 (trough levels of 10-15 ng/ml during the first year and 6-8 ng/ml afterwards). In addition to this some subjects received gancyclovir IV for 4 weeks before the transplant procedure. On unspecified dates, at an unspecified time before the heart transplant procedure the subject received an unspecified pneumococcal vaccine, an unspecified influenza vaccine and an unspecified HepB vaccine (if the subject was negative for HBsAg and HBsAb) (administration site and routes unspecified, batch numbers not provided). Surveillance EMB was performed using a percutaneous right internal jugular approach on a scheduled basis, every week for 1 month, every month for 3 months, and at 6 months and 1 and 2 years. In the event of clinical suspicion of rejection, further biopsy was performed. On an unknown date, at least 6 months after the heart transplantation, the subject experienced significant tricuspid regurgitation and then died from unknown causes. It was unknown whether an autopsy was performed. The author did not comment on any causal relationship with the vaccines. The author''s conclusion stated that in this study of subjects after heart transplantation, the incidence of moderate-to-severe tricuspid regurgitation was 10.4% and moderate-to-severe mitral regurgitation occurred less frequently than tricuspid regurgitation. The long-term results of atrioventricular function after heart transplantation in adults were excellent regardless of anastomotic technique. Older donor age was the important factor associated with development of postoperative moderate-to-severe tricuspid regurgitation. This case is 1 of 5 valid cases reported in the same literature article.


VAERS ID: 537900 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-25
Entered: 2014-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Biopsy, Cardiac failure, Death, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative, Mitral valve incompetence, Pericarditis constrictive
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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: Cyclosporine; Azathioprine; Mycophenolate mofetil; Interleukin-2; Methylprednisolone; Prednisone; Tacrolimus; Ganciclovir
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B1016657A

Write-up: This case was reported in a literature article and described the occurrence of heart failure in a subject aged of at least 17 years old of unspecified gender who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified), Hepatitis B vaccine and unspecified Pneumococcal vaccine. The subject had undergone an orthotopic heart transplant between November 1992 and December 2008. This was the subject''s first heart transplant and only this organ was transplanted. Historical medication for this subject was not specified but the authors commented that the preoperative immunosuppressive protocol for subjects transplanted until June 1999 consisted of induction with cyclosporine 5 mg/kg and azathioprine 4 mg/kg per os (PO). The preoperative immunosuppressive protocol for subjects who underwent transplant after June 1999 included anti-interleukin-2 receptor monoclonal antibody, mycophenolate mofetil 1.5-2.0 g PO and cyclosporine 3-4 mg/kg PO (discontinued after January 2007). In addition to this, all the subjects received SOLUMEDROL 500 mg intravenous (IV) intraoperatively and the subjects transplanted after June 1999 also received methylprednisolone 500 mg IV during the procedure. Concurrent medication was not specified but the authors explained that the subjects were treated with immunosuppression and infection prophylaxis postoperatively. This postoperative immunosuppression treatment included cyclosporine (maintained around 400 ng/ml during the first year and then 250-300 ng/ml) and azathioprine (1.0-2.0 mg/kg/day to maintain white blood cell count (WBC) $g4,000/mm3) until June 1999. Between June 1999 and January 2007 the subject received mycophenolate mofetil 1-3 g/day, anti-interleukin-2 receptor monoclonal antibody (to maintain a WBC of 4,000-6,000/?L) and cyclosporine (trough levels maintained during the first year at 300-400 ng/mL and at 150-200 ng/mL thereafter). After January 2007 cyclosporine ws substituted with methylprednisolone 125 mg (one injection every 8 h for 3 injections), prednisone (initially 1 mg/kg/day, decreasing to 0.25 mg/kg/day at 1 month, to 0.1 mg/kg/day at 6 months and discontinued after 1 year if possible) and FK 506 (trough levels of 10-15 ng/ml during the first year and 6-8 ng/ml afterwards). In addition to this some subjects received ganciclovir IV for 4 weeks before the transplant procedure. On unspecified dates, at an unspecified time before the heart transplant procedure the subject received an unspecified pneumococcal vaccine, an unspecified influenza vaccine and an unspecified hepatitis B vaccine (if the subject was negative for HBsAG and HBsAb) (administration site and routes unspecified, batch numbers not provided). Surveillance EMB was performed using a percutaneous right internal jugular approach on a scheduled basis, every week for 1 month, every month for 3 months, and at 6 months and 1 and 2 years. In the event of clinical suspicion of rejection, further biopsy was performed. On an unknown date, at least 6 months after the heart transplantation, the subject experienced a significant mitral regurgitation. Later on, the subject had a constrictive pericarditis that required a pericardectomy and subsequently developed heart failure and died. It was unknown whether an autopsy was performed. The author did not comment on any causal relationship with the vaccines. The author''s conclusion stated that in this study of subjects after heart transplantation, the incidence of moderate-to-severe tricuspid regurgitation was 10.4% and moderate-to-severe mitral regurgitation occurred less frequently than tricuspid regurgitation. The long-term results of atrioventricular function after heart transplantation in adults were excellent regardless of anastomotic technique. Older donor age was the important factor associated with development of postoperative moderate-to-severe tricuspid regurgitation. This case is 1 of the 5 valid cases reported in the same literature article.


VAERS ID: 565216 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-12-11
Entered: 2014-12-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Foetal exposure during pregnancy, Stillbirth, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2014031205

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of stillbirth in a patient exposed to BOOSTRIX in utero. Co-suspect product exposures included Influenza vaccine unspecified. On 10th October 2014, the mother received BOOSTRIX and Influenza vaccine unspecified. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was diagnosed with stillbirth (serious criteria death and GSK medically significant). On an unknown date, the outcome of the stillbirth was fatal. The reported cause of death was stillbirth. An autopsy was not performed. It was unknown if the reporter considered the stillbirth to be related to BOOSTRIX and Influenza vaccine unspecified. Verbatim: Patient with low risk uncomplicated pregnancy received routine seasonal influenza and pertussis vaccine at community midwife clinic. Sudden onset heavy vaginal bleeding less than 12 hours after the vaccination resulting in a catastrophic placental abruption. Medically Significant Details: Catastrophic placental abruption with loss of 30 weeks (30/40) infant who was stillborn. The patient (mother) was taking 1. seasonal flu vaccine, 2. whooping cough vaccine for pregnancy.


VAERS ID: 573678 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-12-27
Onset:0000-00-00
Submitted: 2015-01-10
Entered: 2015-01-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR K1326 / 4 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 2015SA001413

Write-up: Initial unsolicited report received from pediatrician via our partner company on 06 January 2015. A 12-month-old male patient, whose concomitant medication was not reported had received 0.5 ml of booster dose (4th dose) of ACTHIB (batch number K1326) subcutaneously in right upper arm and a dose of INFLUENZA VACCINE (batch number, dose, dose in series, route and site of administration was not reported both on 27 December 2014. The patient had no underlying diseases, no concurrent condition, no historical condition, no history of adverse drug reaction and no allergy history. On 31-Dec-2014, the patient died at another hospital. According to the mother, the prosecutors said that there was no relationship between the vaccination and his death. Laboratory investigation and corrective treatment was not reported. Reporting physician''s seriousness assessment: Serious Reporting physician''s causality assessment: Not provided Documents held by sender: none.


VAERS ID: 574453 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-01-29
Entered: 2015-01-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015IT010210

Write-up: Case number PHHY2015IT010210 is an initial spontaneous report from lay press (journalist) on 26 Jan 2015. This report refers to a 92-year-old male patient. He was vaccinated with FLUAD (batch number: not reported) on an unknown date. On an unknown date, after vaccination the patient died (reason unspecified). It was reported that autopsy performed to the patient stated that there was no causal relationship between the death and vaccine administration.


VAERS ID: 574454 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-01-29
Entered: 2015-01-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015IT010208

Write-up: Case number PHHY2015IT010208, is an initial spontaneous report from a consumer (journalist) received on 26 Jan 2015. This report refers to a 70-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUAD (batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient died. The result of the autopsy performed revealed that there was no causal relationship between the death and FLUAD.


VAERS ID: 574716 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-02-09
Entered: 2015-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHFR2015GB001219

Write-up: Case number PHFR2015GB001219 is an initial spontaneous report from a physician via medical affairs received on 03 Feb 2015 and a follow up report from the physician received on 05 Feb 2015. This report refers to a patient of an unknown age and gender. The patient was vaccinated with an influenza vaccine (manufacturer and batch number: not reported, conservatively coded as influenza vaccine INN) on an unknown date. On an unknown date, after vaccination the patient died due to influenza infection. The causality of the event was not reported. This case closed as lost to FU, as the physician refused to provide further information. Follow up report from the physician received on 05 Feb 2015: Changed the product coding from OPTAFLU to influenza vaccine INN.


VAERS ID: 575057 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-02-19
Entered: 2015-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2015GSK016061

Write-up: This case was reported by a non-health professional via interactive digital media and described the occurrence of influenza in a patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving influenza vaccine, the patient experienced influenza (serious criteria death). On an unknown date, the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the influenza to be related to influenza vaccine. Additional details were provided as follows: This case referred to a report where it was stated that an unspecified number of patients had died, possibly due to a lack of effect of the 2014-2015 season flu vaccine. This case was linked to case GB2015GSK016060 which was reported in the same article. No reporter''s details were provided to ensure FU.


VAERS ID: 567071 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-02
Entered: 2015-02-25
   Days after submission:176
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Mitral valve prolapse
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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE68002

Write-up: A solicited report had been received from a health professional via Post-Licensure Surveillance of Influenza Vaccine from regulatory authority concerning a 25 year old, Male subject, who had been receiving FLUMIST quadrivalent, (intranasal). FLUMIST quadrivalent started on an unknown date. The patient experienced Idiopathic Mitral Prolapse. The patient died from the event of Idiopathic Mitral Prolapse on an unspecified date. An autopsy was performed. Assessment of the Serious criteria for the report was as follows: Death. Based on the information in this report, and awaiting the reporter''s assessment, the company physician considered the event idiopathic mitral prolapse to be unrelated to the FLUMIST.


VAERS ID: 567074 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-06
Entered: 2015-02-25
   Days after submission:142
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Laboratory test normal, Microscopy, Toxicologic test normal
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: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE77154

Write-up: A report has been received from a literature source, via regulatory authority, Vaccine Adverse Event Reporting System (VAERS) concerning a 19 years old female patient enrolled in an unsponsored non-interventional/post-marketing study. The patient died 10 days after receiving LAIV3, HPV and meningococcal conjugated vaccines. Despite and extensive postmortum examination including microscopic, neuropathological, toxicological, and chemical evaluation, the cause of death could not be ascertained. Assessment of seriousness criteria of the event was as follows: Death. Autopsy was performed. The company physician assessed the causality for the event, death with the suspect drug of FLUMIST as yes.


VAERS ID: 567078 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-06
Entered: 2015-02-25
   Days after submission:142
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Death, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE77060

Write-up: A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning a 41 year old, male patient. The patient''s medical history, concomitant disease and concomitant medications were not reported. On an unknown date, the patient received nasal FLUMIST (intranasal). After eleven days, the patient was hospitalized due to respiratory failure because of acute respiratory distress syndrome and possible community-acquired pneumonia. The outcome of the event of possible community-acquired pneumonia was unknown. The patient died from the event of respiratory faliure due to acute respiratory distress syndrome after twenty days of vaccine administration. The company physician assessed the event of respiratory failure to acute respiratory distress syndrome to be serious with death and hospitalization as serious criteria. The company physician captured the additional the event of possible community-acquired pneumonia and assessed it to be serious with hospitalization as serious criteria. Based on the information in this report, and awaiting the reporter''s assessment, the company physician considered the event of respiratory failure due to acute respiratory distress syndrome and possible community-acquired pneumonia to be not related to FLUMIST.


VAERS ID: 567080 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-08
Entered: 2015-02-25
   Days after submission:140
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Congestive cardiomyopathy, Death
SMQs:, Cardiomyopathy (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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions: Cardiac disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE77073

Write-up: A report had been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning a 21 year old, male subject, who had been receiving FLUMIST (intranasal). The patient''s medical history included heart disease. FLUMIST (Intranasal) started on an unknown date. It was reported that an autopsy determined the cause of death was dilated cardiomyopathy. The patient died from the event of dilated cardiomyopathy on an unspecified date. An autopsy was performed. The reporter''s description of the event(s) was as follow. A 21-year-old male with a family history of heart disease died 3 days after receiving LAIV3. An autopsy determined the cause of death was dilated cardiomyopathy. Assessment of the serious criteria for the report was as follows: Death. Based on the information in this report and awaiting the reporter''s assessment, the company physician considered the causality between the event dilated cardiomyopathy with the suspect drug of FLUMIST to be unrelated.


VAERS ID: 575279 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-02-25
Entered: 2015-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza
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: 2015049051

Write-up: This medically confirmed health authority report (initial receipt 17-Feb-2015) concerns an unknown age and gender patient. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date following the vaccination, the patient died due to influenza infection. The causality of the event was not reported. The outcome was reported as fatal. Reporter''s comments: The regulatory authority assessed the case as serious (fatal). This case was closed as lost to follow-up as the physician refused to provide further information.


VAERS ID: 576831 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-07
Entered: 2015-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cerebral atrophy congenital, Congenital anomaly, Foetal exposure during pregnancy, Ischaemia, Mechanical ventilation, Spinal muscular atrophy
SMQs:, Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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: Azathioprine
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2015043359

Write-up: This retrospective pregnancy case was reported by a physician via regulatory authority and described the occurrence of cerebral atrophy congenital in a patient exposed to Influenza vaccine in utero. The mother received the product for routine immunization. Co-suspect product exposures included azathioprine unknown. The parent''s medical history included investigation (all genetic investigations normal), pregnancy loss (three times previously), ulcerative colitis and influenza vaccine. On an unknown date, the 30-year-old mother received Influenza vaccine (intramuscular) and azathioprine 50 mg once daily. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The action taken with azathioprine was unknown. The patient was diagnosed with cerebral atrophy congenital (serious criteria death, GSK medically significant, congenital anomaly and other), ischaemia (serious criteria death, congenital anomaly and other) and spinal muscular atrophy congenital (serious criteria death, congenital anomaly and other). On an unknown date, the outcome of the cerebral atrophy congenital was fatal and the outcome of the ischaemia and spinal muscular atrophy congenital were not recovered/not resolved. The reported cause of death was cerebral atrophy congenital. An autopsy was not performed. It was unknown if the reporter considered the cerebral atrophy congenital, ischaemia and spinal muscular atrophy congenital to be related to Influenza vaccine and azathioprine. Regulatory authority verbatim: Mum pregnant and baby delivered at term, which then died at 23 days. Atrophy of cervical spinal cord and medulla oblongata noted. Baby was ventilator dependent and care was withdrawn. Unknown cause of ischaemia/atrophy of cord - developed antenatally. Medically significant details: Mum was unwell for 2 weeks post-influenza injection. Mother had had three previous pregnancy losses, but all genetic investigations were normal.


VAERS ID: 576940 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-15
Entered: 2015-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Atrophy, Cerebral atrophy, Death, Foetal exposure during pregnancy, Ischaemia, Malaise, Mechanical ventilation, Spinal cord ischaemia
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: Azathioprine
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015050284

Write-up: This medically confirmed regulatory report (initial receipt 01-Apr-2015) concerns a foetus patient. The 30 year-old mother had a medical history of ulcerative colitis and had three previous pregnancy losses, but all genetic investigations were normal. She was unwell for two weeks post influenza injection (see case 2015050283). On an unspecified date, the foetus was exposed to Influenza virus vaccine, manufacturer and batch number not provided via the transplacental route of administration for vaccination in the mother. The foetus was also exposed to azathioprine 50mg once a day via the transplacental route of administration for ulcerative colitis in the mother. On an unspecified date, the patient was delivered at term. The patient had an atrophy of cervical spinal cord and medulla oblongata, and was ventilator-dependent and care was withdrawn. The patient died at 23 days. The cause of ischaemia/atrophy of cord was unknown - they developed antenatally. The outcome was reported as fatal. Cause(s) of death: Unknown case of death.


VAERS ID: 579688 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-04-23
Onset:0000-00-00
Submitted: 2015-05-21
Entered: 2015-05-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4386AA / 4 UN / UN
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / UNKNOWN MANUFACTURER UI086AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: Con Meds = Unknown; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SA067461

Write-up: This unsolicited case report is part of a batch of reports associated with several products that was received by our affiliate which received the report from the Agency on 14 May 2015. A male patient (age reported was not reported), whose medical history and concomitant therapies were not reported, had received a 1st booster of Influenza USP Trival A-B subvirion vaccine, lot number U4386AA, route and site of administration was not reported on 23 Apr 2014. The patient also received campaign dose of TD, lot number UI086AA route and site of administration was not reported on 23 Apr 2014. On an unspecified date, post-vaccination, the patient was dead. The reported diagnosis was not reported. The patient''s pregnancy information was reported as not informed and lactent information was not reported. The patient underwent medical care. The patient received emergency care on unspecified date. The outcome was reported as recovered as death. Lab tests unknown. Cause(s) of Death: Death.


VAERS ID: 580434 (history)  
Form: Version 1.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-05-27
Onset:0000-00-00
Submitted: 2015-05-22
Entered: 2015-05-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI090AB / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds -Unknown; Prev Meds -Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 2015SA067460

Write-up: This unsolicited case report is part of a batch of reports associated with several products that was received by our affiliate which received the report from the Health on 14 May 2015. A female patient born (age not reported), whose medical history and concomitant therapies were not reported, had received a campaign dose of Influenza Vaccine, lot number UI090AB (route and site of administration were not reported) on 27-May-2014. On an unspecified date, the patient experienced local event: Polyradiculitis (GBS). The diagnoses were not reported. The patient underwent medical care in the Intensive Care Unit. The outcome was reported as death.


VAERS ID: 580311 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-29
Entered: 2015-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Pneumonia, Sepsis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: No other medications
Current Illness: Systemic lupus erythematosus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PH2015GSK073381

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a unk subject who received Flu seasonal TIV Dresden. Concurrent medical conditions included systemic lupus erythematosus. On an unknown date, not applicable after receiving Flu seasonal TIV Dresden and 1 year after receiving Flu seasonal TIV Dresden and 10PN-PD-Dit vaccine, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included severe - grade 3 sepsis with serious criteria of death and GSK medically significant and pneumonia with serious criteria of GSK medically significant. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included sepsis (fatal) and pneumonia (unknown). The reported cause of death was sepsis. It was unknown if the investigator considered the sepsis and pneumonia to be related to Flu seasonal TIV Dresden and 10PN-PD-Dit vaccine. It was unknown if the investigator considered the vaccination failure to be related to 10PN-PD-Dit vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a possible vaccination failure in a patient of unspecified gender and age, who had been vaccinated with an unspecified pneumococcal vaccine and an unspecified influenza vaccine (manufacturers unknown). The patient''s concurrent medical conditions included systematic lupus erythematosus. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received one dose of an unspecified pneumococcal vaccine and one dose of an unspecified influenza vaccine (dosages unspecified; administration sites and routes unknown; batch numbers not provided). On an unspecified date, within 1 year of the vaccination, the patient developed pneumonia followed by severe sepsis and death. The authors identified the sepsis as the cause of death but they did clarify if a post-mortem had been performed. Please note that this case has been considered a possible vaccination failure as time to onset was not specified, no laboratory confirmation was provided and it was unknown if the schedule was completed. This was a serious case as the outcome was fatal. Treatment was unknown. The authors did not comment on any causal relationship between the vaccine and the event. The authors concluded that "while various guidelines recommend vaccination among patients with systemic lupus, we have observed that better outcome is seen among patients with low disease activity and those with little or no intake of immunosuppressive agents. These factors should be well accounted for to ensure the best vaccination outcomes among lupus patients." This case is 1 of the 5 valid cases reported in the same literature article (see case PH2015GSK073372).


VAERS ID: 581008 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:2014-05-19
Onset:0000-00-00
Submitted: 2015-06-02
Entered: 2015-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 12PVPO240 / 3 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA847AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Death, Febrile convulsion, Pneumonia, Pyrexia, Sepsis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 05/19/2014, Body temperature, higher than 39 degree C
CDC Split Type: BR2015GSK075190

Write-up: This case was reported by a healthcare professional (Immunization Program) and described the occurrence of pneumonia in a 6-month-old patient who received ROTARIX (batch number QROLA847AA, expiry date unknown). Co-suspect products included pneumococcal vaccine (batch number 12PVPO240, expiry date unknown), DTPA-HBV-HIB and Flu Seasonal TIV Dresden (Influenza vaccine unspecified). On 19th May 2014, the patient received the 2nd dose of ROTARIX (oral), Pneumococcal vaccine (intramuscular), DTPA-HBV-HIB and Influenza vaccine unspecified. On 19th May 2014, less than a day after receiving ROTARIX and Influenza vaccine unspecified and an unknown time after receiving DTPA-HBV-HIB, the patient experienced febrile seizure (serious criteria GSK medically significant and other: per reporter), vomiting (serious criteria other: per reporter) and fever (serious criteria other: per reporter). On an unknown date, the patient experienced pneumonia (serious criteria death, hospitalization, GSK medically significant and other: per reporter) and septicemia (serious criteria death, hospitalization, GSK medically significant and other: per reporter). On an unknown date, the outcome of the pneumonia and septicemia were fatal and the outcome of the febrile seizure, vomiting and fever were unknown. The reported cause of death was pneumonia and septicemia. The reporter considered the pneumonia, septicemia, febrile seizure, vomiting and fever to be unrelated to ROTARIX and Influenza vaccine unspecified. Additional details were reported as follows: There was a discrepancy regarding the onset date of febrile seizure, vomiting and fever (higher than 39 Deg C). 9 May 2014 was reported although the narrative stated the events occurred at an unspecified time after vaccination. The patient admitted at hospital care on June 17th of 2014. There was no information about the date of the death. According to death declaration, the death was caused by septicemia and pneumonia not specified. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.


VAERS ID: 581520 (history)  
Form: Version 1.0  
Age: 0.58  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-29
Entered: 2015-06-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: Con Meds-Unknown; Prev Meds-Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: unknown
CDC Split Type: 2015SA070225

Write-up: Initial unsolicited report received from a healthcare professional (pediatrician) on 22 May 2015. A 07-month-old patient (gender not reported), whose medical history and concomitant therapy were not reported, had received a dose of FLUQUADRI (batch number, cycle dose in series, route and site of vaccination were not reported) on an unspecified date. Relationship as per reporter might not be related to the vaccine. It was reported that patient was passed away on an unspecified date. Corrective treatment and lab investigations were not reported. At the time of this report, the outcome was reported as fatal/death. Documents held by sender: none.


VAERS ID: 583825 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-25
Entered: 2015-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza virus test positive, Respiratory distress, Stem cell transplant, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Hypersensitivity (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Ill-defined disorder, required hematopoietic stem cell transplantation after the vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Patient was found to have anti-haemagglutinin inhibition antibody level against the H1 influenza stain of 1:80 30 days after the vaccination. The infecting strain was identified as seasonal influenza H1N1.
CDC Split Type: BR2015GSK089561

Write-up: This case was reported in a literature article and described the occurrence of respiratory distress in a unk subject who received Flu seasonal TIV Dresden. Concurrent medical conditions included ill-defined disorder (required hematopoietic stem cell transplantation after the vaccination). On an unknown date, 180 days after receiving Flu seasonal TIV Dresden, the subject developed respiratory distress. Serious criteria included death and GSK medically significant. Additional event(s) included vaccination failure with serious criteria of GSK medically significant and H1N1 influenza. The outcome of respiratory distress was fatal. The outcome(s) of the additional event(s) included vaccination failure (unknown) and H1N1 influenza (unknown). The reported cause of death was respiratory distress. It was unknown if the investigator considered the respiratory distress to be related to Flu seasonal TIV Dresden. The investigator considered that there was a reasonable possibility that the vaccination failure and H1N1 influenza may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Patient was found to have anti-haemagglutinin inhibition antibody level against the H1 influenza strain of 1:80 30 days after the vaccination. The infecting strain was identified as seasonal influenza H1N1. Additional information received: This case was reported in a literature article and it described the occurrence of a possible vaccination failure in a patient of unspecified gender and age who had received an unspecified trivalent influenza vaccine (manufacturers unknown). The patient''s concurrent condition included an unspecified medical problem for which they required hematopoietic stem cell transplantation after the vaccination. The patient received the vaccine as part of a clinical study with the following exclusion criteria: hematopoietic stem cell transplantation planned for within a week of the recruitment date; egg, chicken protein, neomycin or thimerosal allergy history; past history of severe reaction following influenza vaccine or prior influenza vaccine received less than 6 months before the transplant date. No further information on the patient''s concurrent medical conditions, history or concomitant medication was provided. On an unspecified date between October 2007 and 2009, the patient received a dose of an unspecified Southern-hemisphere trivalent influenza vaccine (dosage for adults unknown, 0.25 mL for children from 6 months to under 3 years of age or 0.5 mL for children between 3 and 8 years of age; administration routes and sites unspecified; batch numbers not provided). On an unspecified date between October 2007 and January 2010, an unknown period after the transplant and within 180 days of the vaccination, the patient was diagnosed with influenza H1N1 (no pandemic according to authors). The patient developed respiratory distress syndrome and died 5 days after the influenza diagnosis. This case was classified as a possible vaccine failure as no other information regarding the time to onset was provided. This was a serious case as the outcome was fatal. Cause of death was respiratory distress syndrome. It was not specified if a post-mortem was performed. Patient was found to have anti-haemagglutinin inhibition antibody level against the H1 influenza strain of 1:80 30 days after the vaccination. The infecting strain was identified as seasonal influenza H1N1. Treatment was unknown. The authors considered that the vaccine had not been effective. The authors concluded that "despite the poor immunogenicity of the vaccine reflected by the low seroresponse and seroprotective rates during follow-up, the pretransplant vaccine efficacy was more than 65%. Previously, we observed a vaccine efficacy of 80% after influenza vaccination at day 180. Unfortunately, the statistical analysis of other relevant risk factors, such as type of immunosuppressive therapy, the occurrence of acute or chronic graft-versus-host disease and the presence of lymphopenia, was not possible because of the small number of patients with influenza. Severe influenza in otherwise healthy individuals is influenced by the viral pathogenicity and the host immune response, which is inherently different in hematopoietic stem cell transplantation recipients because of the immature Band T-cell reconstitution. A future vaccination strategy might be to vaccinate the recipient pretransplant and boost this response early within 3 months after transplantation in the recipient. Efforts should also therefore be made to limit the risk of influenza exposure in hematopoietic stem cell transplantation recipients". This case is 1 of the 2 valid vases reported in the same literature article (see case BR2015GSK089714).


VAERS ID: 585585 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-07-13
Entered: 2015-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Polymerase chain reaction positive, Respiratory failure, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
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), 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: No other medications
Current Illness: Lung transplant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unknown date: Nasopharyngeal swab showed a positive polymerase chain reaction for RSV
CDC Split Type: AU2015GSK098860

Write-up: This case was reported in a literature article and described the occurrence of respiratory failure in a adult subject who received 10PN-PD-Dit vaccine. Concurrent medical conditions included lung transplant. On an unknown date, an unknown time after receiving 10PN-PD-Dit vaccine and Flu seasonal TIV Dresden, the subject developed respiratory failure. Serious criteria included death and GSK medically significant. Additional event(s) included respiratory syncytial virus infection. The subject was treated with ribavirin and prednisolone. The outcome of respiratory failure was fatal. The outcome(s) of the additional event(s) included respiratory syncytial virus infection (unknown). The reported cause of death was respiratory failure. It was unknown if the investigator considered the respiratory syncytial virus infection to be related to 10PN-PD-Dit vaccine and Flu seasonal TIV Dresden. Relevant Tests: Lab tests performed on unknown date: Nasopharyngeal swab showed a positive polymerase chain reaction for RSV. Additional information was provided: This case was reported in a literature article and it described the occurrence of respiratory failure in an adult between 18 and 73 years of age and of unspecified gender who had received an unspecified pneumococcal vaccine and unspecified influenza vaccines (manufacturers unknown). The patient had received the pneumococcal vaccination as preparation for a lung transplant (underlying pathology unspecified). Concurrent immunosuppressive treatment included cyclosporine (monitored using C2 levels or tacrolimus), with prednisolone (0.1-0.15 mg/kg/day) and azathioprine (1-2 mg/kg/day), mycophenolate mofetil or everolimus. Other concurrent medication included routing Pneumocystis jirovecii prophylaxis (either sulfamethoxazole and trimethoprim, or dapsone or inhaled pentamidine if allergic to sulfamides); chlamydia prophylaxis (roxithromycin or azithromycin as tolerated) and cytomegalovirus prophylaxis if considered to be at risk (intravenous ganciclovir or oral valganciclovir). No further details on their medical or family history, concurrent medication or concomitant conditions were provided. On an unspecified date before the transplant, the patient received an unspecified pneumococcal vaccine. On unspecified dates after the transplant, the patient received an annual unspecified influenza vaccine. Dosages were unknown; administration routes and sites were unspecified and batch numbers were not provided. On an unspecified date between December 2011 and May 2014, an unknown period after the pneumococcal vaccination and the transplant, the patient developed symptoms of a lower respiratory tract infection that was identified as a respiratory syncytial virus infection. 235 days after the infection the patient died of respiratory failure. This was a serious case as it was fatal. Cause of death was respiratory failure. It was unknown if a post-mortem was performed. A nasopharyngeal swab taken at the time of the lower respiratory tract infection symptoms and analysed within 24 hours of collection showed a positive polymerase chain reaction for respiratory syncytial virus. Treatment for the respiratory syncytial infection consisted of experimental administration of an intravenous loading dose of ribavirin 33 mg/kg in 3 doses on day 1; followed by a maintenance dose of oral ribavirin at 20 mg/kg divided into 2 doses per day for a minimum of 6 days. The patient was also commenced on an increased dose of oral prednisolone 1 mg/kg (maximum 60 mg/day), that was reduced by 5 mg every second day until the usual baseline dose was reached. The authors did not comment on any causal relationship between the vaccines and the events. The authors concluded that "In conclusion, we present to our knowledge the largest cohort of lung transplant recipients treated with oral ribavirin for respiratory syncytial virus. Oral ribavirin appears to be effective and well-tolerate alternative to intravenous or inhaled ribavirin and provides considerable cost savings and reduction in length of hospital stay. Further studies are required to confirm the optimal dosing strategy and to determine the long-term benefits of ribavirin in preventing the development of chronic lung allograft dysfunction". This case is 1 of the 7 valid cases reported in the same literature article.


VAERS ID: 585595 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-07-13
Entered: 2015-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Circulatory collapse, Death, Polymerase chain reaction positive, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow), 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: No other medications
Current Illness: Lung transplant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unknown date. Nasopharyngeal swab showed positive polymerase chain reaction for RSV.
CDC Split Type: AU2015GSK098863

Write-up: This case was reported in a literature article and described the occurrence of death in a adult subject who received 10PN-PD-Dit vaccine. Concurrent medical conditions included lung transplant. On an unknown date, an unknown time after receiving 10PN-PD-Dit vaccine and Flu seasonal TIV Dresden, the subject developed death. Serious criteria included death and GSK medically significant. Additional event(s) included collapse circulatory with serious criteria of death and GSK medically significant and respiratory syncytial virus infection. The subject was treated with ribavirin and prednisolone. The outcome of death was fatal. The outcome(s) of the additional event(s) included collapse circulatory (fatal) and respiratory syncytial virus infection (unknown). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the death, collapse circulatory and respiratory syncytial virus infection to be related to 10PN-PD-Dit vaccine and Flu seasonal TIV Dresden. Relevant Tests: Lab tests performed on unknown date. Nasopharyngeal swab showed positive polymerase chain reaction for RSV. Additional information was provided: This case was reported in a literature article and it described the occurrence of respiratory syncytial virus infection in an adult between 18 and 73 years of age and of unspecified gender who had received an unspecified pneumococcal vaccine and unspecified influenza vaccines (manufacturers unknown). The patient had received the pneumococcal vaccination as preparation for a lung transplant (underlying pathology unspecified). Concurrent immunosuppressive treatment included cyclosporine (monitored using C2 levels or tacrolimus), with prednisolone (0.1-0.15 mg/kg/day) and azathioprine (1-2 mg/kg/day), mycophenolate mofetil or everolimus. Other concurrent medication included routine Pneumocystis jiroveci prophylaxis (either sulfamethoxazole and trimethoprim, or dapsone or inhaled pentamidine if allergic to sulfamides); chlamydia prophylaxis (roxithromycin or azithromycin as tolerated) and cytomegalovirus prophylaxis if considered to be at risk (intravenous ganciclovir or oral valganciclovir). No further details of their medical or family history, concurrent medication or concomitant conditions were provided. On an unspecified date before the transplant, the patient received an unspecified pneumococcal vaccine. On unspecified dates after the transplant, the patient received an annual unspecified influenza vaccine. Dosages were unknown; administration routes and sites were unspecified and batch numbers were not provided. On an unspecified date between December 2011 and May 2014, an unknown period after the pneumococcal vaccination and the transplant, the patient developed symptoms of a lower respiratory tract infection that was identified as a respiratory syncytial virus infection. The patient collapsed at home 35 days after the infection and died. This was a serious case as it was fatal. Cause of death was unknown. It was not specified if a post-mortem was performed. A nasopharyngeal swab taken at the time of the lower respiratory tract infection symptoms and analysed within 24 hours of collection showed a positive polymerase chain reaction for respiratory syncytial virus. Treatment for the respiratory syncytial infection consisted of experimental administration of an intravenous loading dosage of ribavirin 33mg/kg in 3 doses on day 1; followed by a maintenance dose of oral ribavirin at 20mg/kg divided into 2 doses per day for a minimum of 6 days. The patient was also commenced on an increased dose of oral prednisolone 1 mg/kg (maximum 60 mg/day), that was reduced by 5 mg every second day until the usual baseline dose was reached. The authors did not comment on any causal relationship between the vaccines and the events. The authors concluded that "In conclusion, we present to our knowledge the largest cohort of lung transplant recipients treated with oral ribavirin for respiratory syncytial virus. Oral ribavirin appears to be an effective and well-tolerated alternative to intravenous or inhaled ribavirin and provides considerable cost savings and reduction in length of hospital stay. Further studies are required to confirm the optimal dosing strategy and to determine the long-term benefits of ribavirin in preventing the development of chronic lung allograft dysfunction". This case is 1 of the 7 valid cases reported in the same literature article.


VAERS ID: 585596 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-07-13
Entered: 2015-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Polymerase chain reaction positive, Respiratory failure, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
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), 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: No other medications
Current Illness: Lung transplant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unknown date. Nasopharyngeal swab showed a positive polymerase chain reaction for RSV
CDC Split Type: AU2015GSK098861

Write-up: This case was reported in a literature article and described the occurrence of respiratory failure in a adult subject who received 10PN-PD-Dit vaccine. Concurrent medical conditions included lung transplant. On an unknown date, an unknown time after receiving 10PN-PD-Dit vaccine and Flu TIV Dresden, the subject developed respiratory failure. Serious criteria included death and GSK medically significant. Additional event(s) included respiratory syncytial virus infection. The subject was treated with ribavirin and prednisolone. The outcome of respiratory failure was fatal. The outcome(s) of the additional event(s) included respiratory synctial virus infection (unknown). The reported cause of death was respiratory failure. It was unknown if the investigator considered the respiratory failure and respiratory syncytial virus infection to be related to 10PN-PD-Dit vaccine and Flu TIV Dresden. Relevant Tests: Lab tests performed on unknown date. Nasopharyngeal swab showed a positive polymerase chain reaction for RSV. Additional information was provided: This case was reported in a literature article and it described the occurrence of respiratory failure in an adult between 18 and 73 years of age and of unspecified gender who had received an unspecified pneumococcal vaccine and unspecified influenza vaccines (manufacturers unknown). The patient had received the pneumococcal vaccination as preparation for a lung transplant (underlying pathology unspecified). Concurrent immunosuppressive treatment included cyclosporine (monitored using C2 levels or tacrolimus), with prednisolone (0.1-0.15 mg/kg/day) azathioprine (1-2 mg/kg/day), mycophenolate mofetil or everolimus. Other concurrent medication included routine Pneumocystis jiroveci prophylaxis (either sulfamethoxazole and trimethoprim, or dapsone or inhaled pentamidine if allergic to sulfamides); chlamydia prophylaxis (roxithromycin or azithromycin as tolerated) and cytomegalovirus prophylaxis if considered to be at risk (intravenous ganciclovir or oral valganciclovir). No further details on their medical or family history, concurrent medication or concomitant conditions were provided. On an unspecified date before the transplant, the patient received an unspecified pneumococcal vaccine. On unspecified dates after the transplant, the patient received an annual unspecified influenza vaccine. Dosages were unknown; administration routes and sites were unspecified and batch numbers were not provided. On an unspecified date between December 2011 and May 2014, an unknown period after the pneumococcal vaccination and the transplant, the patient developed symptoms of a lower respiratory tract infection that was identified as a respiratory syncytial virus infection. 298 days after the infection the patient died of respiratory failure. This was a serious case as it was fatal. Cause of death was respiratory failure. It was unknown if a post-mortem was performed. A nasopharyngeal swab taken at the time of the lower respiratory tract infection symptoms and analysed within 24 hours of collection showed a positive polymerase chain reaction for respiratory syncytial virus. Treatment for the respiratory syncytial infection consisted of experimental administration of an intravenous loading dose of ribavirin 33 mg/kg in 3 doses on day 1; followed by a maintenance dose of oral ribavirin at 20 mg/kg divided into 2 doses per day for a minimum of 6 days. The patient was also commenced on an increased dose of oral prednisolone 1 mg/kg (maximum 60 mg/day), that was reduced by 5 mg every second day until the usual baseline does was reached. The authors did not comment on any causal relationship between the vaccines and the events. The authors concluded that "In conclusion, we present to our knowledge the largest cohort of lung transplant recipients treated with oral ribavirin for respiratory syncytial virus. Oral ribavirin appears to be an effective and well-tolerated alternative to intravenous or inhaled ribavirin and provides considerable cost savings and reduction in length of hospital stay. Further studies are required to confirm the optimal dosing strategy and to determine the long-term benefits of ribavirin in preventing the development of chronic lung allograft dysfunction". This case is 1 of the 7 valid cases reported in the same literature article.


VAERS ID: 609644 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-16
Entered: 2015-09-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Lower respiratory tract infection
SMQs:, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2014GSK054817

Write-up: This case was reported in a literature article and described the occurrence of death in a elderly patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Influenza vaccine unspecified 2013-2014 season at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine unspecified 2013-2014 season, the patient experienced death (serious criteria death and GSK medically significant) and chest infection (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the death and chest infection were fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death and chest infection to be related to Influenza vaccine unspecified 2013-2014 season 4. Additional information was provided: This case was reported in a literature article and describe the occurrence of death in an elderly subject who was vaccinated with unspecified influenza vaccine. No information on the patient''s past medication or family history was provided. No concomitant medications were reported. On an unspecified date, the patient received unspecified annual influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date, the patient died (cause of death unspecified). The information about autopsy was not provided. This case was speculatively considered as the index case for the outbreak of H3N2 influenza in the hospital. The treatment for the adverse event was not reported. The authors did not comment on causality relationship between the vaccine and the event. The author''s conclusion stated that "A combination of factors resulting in this outbreak were identified: Low vaccine efficacy in the elderly rendering them susceptible, an unusual environment with increased bed movement and aerosolising procedures, increased nosocomial transmission potential in an open plan unit, reduced suspicion of influenza causing an outbreak in April, testing delay without nosocomial transmission potential in an open plan unit, reduced suspicion of influenza causing an outbreak in April, testing delay without onsite laboratory, and delay in results over bank holidays if not marked urgent. The points to be further considered were: Earlier typing to confirm possible outbreaks, improving awareness of out of hours testing arrangements, and reviewing prophylaxis guidance in vaccinated high risk/ elderly patients, if protection by vaccination is unreliable".


VAERS ID: 605320 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-23
Entered: 2015-10-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Atrophy, Cerebral atrophy congenital, Death neonatal, Foetal exposure during pregnancy, Ischaemia, Mechanical ventilation
SMQs:, Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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: Azathioprine (NGX)
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015GB039240

Write-up: Case number PHHY2015GB039240, is an initial spontaneous report from a physician via RA (ADR 22921631) received on 01 Apr 2015 via Agency. This report refers to an 23-days-old baby patient (delivered at full term) of unknown gender. The patient''s medical historical and concomitant medications were not reported. Mother''s medical history included ulcerative colitis and pregnancy loss (3 times). All genetic investigations were normal and she was vaccinated with influenza virus vaccine. On an unknown date, the patient''s mother took azathioprine (manufacturer, formulation unknown) at a dose of 50 mg/day for colitis ulcerative. Mother was unwell for 2 weeks post-influenza injection. Unknown cause of ischemia and atrophy of cord developed antenatally. When the baby was born, atrophy of cervical spinal cord and medulla oblongata were noted. Baby was ventilator dependent and care was withdrawn. On 23rd day of the birth, the baby died. The events were considered as serious (death, congenital anomaly and medically significant) by the physician. The causality of the events was not reported. Following an internal review of the information received on 01 Apr 2015, Following correction was done: Case classification was added as Pregnancy Prospective Related. Suspect drug was coded as influenza virus vaccine - unknown inn (nvd).


VAERS ID: 609458 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-13
Entered: 2015-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza A virus test positive, Influenza like illness, Polymerase chain reaction positive, Smear buccal abnormal, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: In 2013, virology laboratory received nasopharyngeal swabs or tracheal aspirates. All samples were tested by real time RT-PCR to detect influenza A (Flu-A) and influenza B (Flu-B) genomes. 2013, Polymerase chain reaction, Flu A, positive; 2013, Smear buccal, Flu A, positive.
CDC Split Type: AR2015GSK162391

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a adult subject who received Flu seasonal TIV Dresden. In 2013, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included unknown cause of death with serious criteria of death, hospitalization and GSK medically significant and influenza like illness with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included unknown cause of death (fatal) and influenza like illness (fatal). The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the vaccination failure may have been caused by Flu seasonal TIV Dresden. It was unknown if the investigator considered the unknown cause of death and influenza like illness to be related to Flu seasonal TIV Dresden. Relevant Tests: In 2013, virology laboratory received nasopharyngeal swabs or tracheal aspirates. All samples were tested by real time RT-PCR to detect influenza A (Flu-A) and influenza B (Flu-B) genomes. Diagnostic results (unless otherwise stated, normal values were not provided): In 2013, Polymerase chain reaction result was Flu A unknown. On an unknown date, Smear buccal result was Flu A unknown. Additional information was provided: This case was reported in a literature article and it described the occurrence of a possible vaccine failure in an adult patient of unspecified gender and age who had received an unspecified influenza vaccine (manufacturer unknown). The event occurred during an H1N1 influenza outbreak in the late autumn-winter of 2013. No information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received an unspecified influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date in 2013 (between weeks 21 and 31), an unknown period after the vaccination, the patient developed influenza-like illness, tested positive for influenza A and later passed away. Please note that this case has been classified as a possible vaccination failure as no information on the time to onset was provided. This was a fatal case. The direct cause of death was unspecified. It is unknown if a post-mortem was performed. Either a nasopharyngeal swabs or tracheal aspirates from the patient tested positive for influenza A on real time reverse transcription polymerase chain reaction. Treatment was unknown. The authors did not comment on any possible causal relationship between the vaccine and the events. The authors concluded that "Most patients had comorbidities, with low vaccination rates. The CURB-65 was not good predictor. The mortality was high. Only the need of mechanical ventilation assistance and cancer were predictors of mortality".


VAERS ID: 610673 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-01-27
Onset:0000-00-00
Submitted: 2015-11-18
Entered: 2015-11-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADCIRCA; Macitentan; Prednisone; CRESTOR; Amitriptyline; ATIVAN; Vitamin D; ELIQUIS; Pantoprazole
Current Illness: Pulmonary arterial hypertension; Sarcoidosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA2015GSK163708

Write-up: This case was reported by a consumer via patient support programs and described the occurrence of condition aggravated in a 55-year-old female patient who received Canadian seasonal Influenza vaccine unspecified. Co-suspect products included Pneumococcal vaccine and ADCIRCA for pulmonary hypertension. Concurrent medical conditions included pulmonary arterial hypertension and sarcoidosis. Concomitant products included macitentan, prednisone, CRESTOR, amitriptyline, ATIVAN, Vitamin D, ELIQUIS and pantoprazole. On an unknown date, the patient received Canadian seasonal Influenza vaccine unspecified at an unknown dose and Pneumococcal vaccine at an unknown dose. On 27th January 2014, the patient started ADCIRCA 40 mg at an unknown frequency. On an unknown date, an unknown time after receiving seasonal Influenza vaccine unspecified and Pneumococcal vaccine, the patient experienced condition aggravated (serious criteria death and hospitalization). On 12th November 2015, the outcome of the condition aggravated was fatal. The patient died on 12th November 2015. The reported cause of death was condition aggravated. The reporter considered the condition aggravated to be related to seasonal Influenza vaccine unspecified and Pneumococcal vaccine. Additional information was provided as follows: The case received via patient support programs (for ADCIRCA). The patient had pulmonary arterial hypertension and sarcoidosis as current condition. On an unknown date, the patient received a dose of seasonal Influenza vaccine unspecified and Pneumococcal vaccine as per the physician''s advice. On an unknown date, the patient''s general condition aggravated (turned for the worst). On 10th November 2015, the patient was hospitalised. On 12th November 2015 in the morning, the patient passed away. No consent for follow-up was provided.


VAERS ID: 614717 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-01
Entered: 2015-12-14
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUENZ TETRA) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Death, Respiratory disorder
SMQs:, 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: Concomitant Drugs Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SF21800

Write-up: A report received from a pharmacist concerning two children. This is the report of the second patient, concerning a child of an unknown age and ethnicity. No information was provided about concomitant medications, concurrent diseases and relevant history. The patient received nasal FLUENZA TETRA (intranasal) with unknown dose and frequency on an unspecified date. Indication of FLUENZ TETRA was not provided. The patient experienced respiratory side effects on an unspecified date. The patient died due to respiratory side effects. Date of death was unknown. The company physician assessed the case to be serous with death criterion.


VAERS ID: 616563 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-11-17
Onset:0000-00-00
Submitted: 2015-12-11
Entered: 2015-12-23
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. FJ2188 / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Bacteraemia, Cardiac arrest, Cough, Death, Haemolytic uraemic syndrome, Malaise, Pneumonia pneumococcal, Pneumonia streptococcal, Pyrexia, Streptococcus test positive, Ultrasound abdomen, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Haemolytic disorders (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Renovascular disorders (broad), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-27
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: CALPOL; Ibuprofen
Current Illness:
Preexisting Conditions: Previously well, no previous hospital admissions. No recurrent infections. Fully vaccinated. No known allergies. No sickle cell .
Allergies:
Diagnostic Lab Data: Blood culture, S. pnuemoniiae serotype 19A; Ultasound abdomen, spleen present
CDC Split Type: 2015SF26184

Write-up: A report has been received from physician via MHRA concerning, a 2 year old, female patient. Concomitant medications included paracetamol and ibuprofen. Patient concomitant diseases and relevant history were not reported. Patient received FLUENZ TETRA (intranasal), 1.0 dosage form started on 17-Nov-2015. Nasal flu vaccine at the General Practice surgery. 5 days later, start of systemic symptoms with fever, vomiting and cough, simultaneously for 2 siblings who has the nasal flu vaccine. Younger sibling did not receive flu vaccine and is asymptomatic. Admitted to hospital. Streptococcus pneumonia and bacteraemia with associated haemolytic uraemic syndrome on both siblings. Two days later, cardiac arrest and death. Parents very concerned about the fact that both siblings received flu vaccine a few days prior to both siblings becoming very unwell. Yellow card for older siblings will also be done. Investigation needed regarding the link between nasal flu vaccine and invasive streptococcus pneumonia infection. The patient was also unwell which started on 23-Nov-2015. The patient died from streptococcus pneumoniae pneumonia on 27-Nov-2015 and at the time of reporting, the s. pneumonia haemolytic uremic syndrome, fever, vomiting, cough, bacteraemia, cardiac arrest and unwell was ongoing. The patient died on 27-Nov-2015. The cause of death was streptococcus pneumoniae pneumonia. It was unknown whether autopsy was performed or not. Reporter assessed streptococcus pneumoniae pneumonia to be serious with the criteria of death and s. pneumonia haemolytic uremic syndrome, fever, vomiting, cough, bacteraemia, cardiac arrest and unwell to be serious with hospitalization and important medical event.


VAERS ID: 620381 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-21
Entered: 2016-01-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Pneumonia, Sepsis
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: No other medicaitons
Current Illness: Systemic lupus erythematosus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2016PH006148

Write-up: Case number PHHY2016PH006148, is an initial literature case report received on 16 Jan 2016. The author in the article discussed about the outcomes of influenza and/or pneumococcal vaccination among systemic lupus erythematosus (SLE) patient seen at hospital. The patients were interviewed at baseline (two weeks prior to vaccination) to determine the medications they took and their disease activity prior to vaccination and one year after the patients were followed up and were asked regarding vaccine related outcomes such as development of flu, flu like symptoms or pneumonia during the interim. This report refers to a patient of unknown demographics. The patient was vaccinated with influenza vaccine (manufacturer and bath number: not reported) and pneumococcal vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient expired due to severe sepsis from pneumonia. The author stated that the patients with adverse outcomes were pooled and compared with the group who did not suffer any unwanted events and they noted that the patients who suffered from adverse outcomes had a longer standing disease and higher steroid doses with a higher baseline disease activity. The author concluded that though various guidelines recommend vaccination among patients with systemic lupus, they observed that better outcome was seen among patients with low disease activity and those with little or no intake of immunosuppressive agents. These factors should be well accounted to ensure the best vaccination outcomes among lupus patients.


VAERS ID: 623599 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-24
Entered: 2016-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Death, H1N1 influenza, Lower respiratory tract infection, Lymphopenia, Upper respiratory tract infection
SMQs:, Haematopoietic leukopenia (narrow), Interstitial lung disease (broad), Systemic lupus erythematosus (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:
Preexisting Conditions: Non-Hodgkin''s Lymphoma refractory.
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLBEH2016058133

Write-up: Case Narrative: This medically confirmed literature report (initial receipt 19-Jan-2016) concerns an adult hematology-oncology patient (age, range 39-67 years; patient 5). The patient has a medical history of refractory T-cell non-Hodgkin lymphoma. Concomitant medications include a pre-allogeneic hematopoietic stem cell transplantation (pre-allo-HSCT) conditioning regimen. On an unknown date, the patient received a [?] well-matched'' influenza virus vaccine (brand and batch unknown). On an unknown date following influenza vaccination during the corresponding season, the hospitalized patient showed prolonged A(H1N1)pdm09 virus excretion sometime between November 2009 and April 2013. The patient experienced A(H1N1)pdm09 virus infection with no seroprotective HI Ab titers during onset of mild upper respiratory tract infection (URTI). Patient also developed severe lower respiratory tract infection (LRTI) and fatal viral ARDS. Oseltamivir ($g48 hr) and zanimivir ([?]48 hr) antiviral treatment was provided. Viral clearance did not occur. The patient''s serum HI titers were $g40 for the duration of A(H1N1)pdm09 infection. The patient displayed prolonged viral excretion during periods CD4+ and CD8+ T-cell lymphopenia. Virus excretion duration was not influenced by antiviral treatment, seroprotective HI titers or antibody-dependent cell-mediated cytotoxicity (ADCC) markers. The patient developed severe viral LRTI during profound CD4+ and CD8+ T-cell lymphopenia and intercurrent combined absence of ADCC markers. The onset of severe viral LRTI and ARDS during profound CD4+ and CD8+ T-cell lymphopenia coincided with innate cell-mediated immune reconstitution. The patient manifested granulocyte, monocyte and NK cell reconstitution after recent allo-HSCT. Viral clearance did not occur during profound CD4+ T-cell and CD8+ T-cell lymphopenia. Severe viral LRTI manifested during profound CD4+ and CD8+ T-cell lymphopenia and intercurrent absence of ADCC markers. The outcome was reported as death.***Case correction 16-Feb-2016: Core and assessments for AEs 1 to 6 and overall company assessment changed to unlisted for a fatal outcome. Reporter''s Comments: Reporter''s comments: The pathogenesis of severe influenza LRTI and ARDS remains unclear and is likely multifactorial. Patient 5 with (transient) profound T-cell lymphopenia and absence of ADCC markers developed severe virus-associated LRTI and ARDS during innate cell reconstitution. Our findings suggest that profound CD4+ and CD8+ T-cell lymphopenia and (transient) absence of ADCC markers may have provided a window of opportunity for the virus to reach lower alveolar compartments and trigger severe immunopathology by the excessive influx of neutrophils and macrophages. Vaccine improvements are needed to raise immunogenicity in this vulnerable patient group. Prolonged influenza virus excretion is associated with T-cell lymphopenia in hematology-oncology patients. CD8+ T-cells and ADCC markers afford clinical protection and combined CD4+ and CD8+ T-cell responses mediate viral clearance. Sender''s Comments: Company comments: Seriousness: Serious. Fatal. Listedness: Listed. Assessment based on the CCDS for CLS H1N1 Influenza Vaccine. Events reported are in the context of a potential lack of effect to the vaccine. Immunological response may be diminished if the patient is undergoing corticosteroid and immunosuppresant treatment. In this case, the patient is undergoing immunopuppressive treatment for stem cells transplant. This case is therefore assessed as listed. Causality: Unassessable. For the given population in the study, immunogenicity may not be as immediate or as robust as in healthier population. Although the author had specified the laboratory parameters and the clinical presentation during the time interval in scope of the article, there is no information on when the vaccine was received prior to onset of symptoms. A seroprotective response to influenza vaccines is anticipated 2 weeks after the vaccine is received, and laboratory parameters may not exhibit antibodies if investigated earlier. Company evaluation and comment: updated 22-Feb-2016. Seriousness: Serious. Fatal. Listedness: Unlisted. Assessment based on the CCDS for CLS H1N1 Influenza Vaccine, ARDS is unlisted. H1N1 Influenza infection and all other events are also unlisted due to fatal outcome. Causality: Unassessable. Events reported are in the context of a potential lack of effect to the vaccine. Immunological response may be diminished if the patient is undergoing corticosteroid and immunosuppressant treatment. In this case, the patient is undergoing immunosuppressive treatment for stem cells transplant. For the given population in the study, immunogenicity may not be as immediate or as robust as in healthier population. Although the author had specified the laboratory parameters and the clinical presentation during the time interval in scope of the article, there is no information on when the vaccine was received prior to onset of symptoms. A seroprotective response to influenza vaccines is anticipated 2 weeks after the vaccine is received, and laboratory parameters may not exhibit antibodies if investigated earlier.


VAERS ID: 628234 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-21
Entered: 2016-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2016GSK038708

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a adult female patient who received Flu seasonal TIV Dresden. On an unknown date, the patient received Flu seasonal TIV Dresden at an unknown dose. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Flu seasonal TIV Dresden. Additional details were provided as follows: The reporter reported that she did not want to be vaccinated because of the adverse events, especially for the vaccine against influenza. She reported that she believed the vaccine against influenza had killed her mother. No other information would be provided.


VAERS ID: 629019 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-23
Entered: 2016-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

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: No other medications
Current Illness: Myocardial ischaemia; Cardiac failure congestive
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ2016GSK040703

Write-up: This case was reported in a literature article and described the occurrence of sudden cardiac death in a subject who received Flu seasonal TIV Dresden. Concurrent medical conditions included myocardial ischemia and congestive heart failure. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed sudden cardiac death. Serious criteria included death and GSK medically significant. The outcome of sudden cardiac death was fatal. The reported cause of death was cardiac arrest. It was unknown if the investigator considered the sudden cardiac death to be related to Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of sudden cardiac death in a patient of unspecified gender and age who had received an unspecified influenza vaccination (manufacturer unknown). The patient''s concomitant condition included myocardial ischemia and congestive cardiac failure. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received an unspecified influenza vaccination. Dosage unknown; administration route and site unspecified; batch number was not provided. On an unspecified date between, an unknown time after the vaccination, the patient died of a sudden cardiac event. The death was reported to the national Centre for Adverse Reactions Monitoring. This was a fatal case. Cause of death was an unspecified cardiac event and it is unknown if a post-mortem was performed. Treatment was unknown. The authors commented that there was a temporal relationship between the vaccine and the event. The authors did not include any conclusion.


VAERS ID: 629844 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-09-17
Onset:0000-00-00
Submitted: 2016-03-29
Entered: 2016-03-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 30349421A / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cerebral haemorrhage, Death
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBBEH2016060368

Write-up: This consumer spontaneous report (initial receipt 16-Mar-2016) concerns a 40 year-old male patient. On the 17-Sep-2015, the patient received Enzira (Influenza virus vaccine polyvalent, batch number 30349421A). On an unspecified date, the patient developed a bleed in his brain. He died on the 09-Nov-2015. The outcome was fatal. Reporter''s Comments: The patient''s family thought that the reason for his death was the administration of the vaccine. Sender''s Comments: Company comments: Seriousness: Serious. Fatal outcome. Listedness: Unlisted. Assessment according to the CSL Inactivated Influenza Virus Vaccine CCDS and Afluria Product Information, bleed in the brain is unlisted. Causality: Unassessable. Time to onset of intracranial bleeding was not specified but fatal outcome was approximately 7 weeks following vaccination. There was insufficient information for causality assessment such as past medical history, concomitant treatment, risk factors of intracranial bleeding, sequence of events which led to fatal outcome, results of investigation and coroners (autopsy) findings. Causality is therefore unassessable. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 634215 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-02
Entered: 2016-05-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Influenza vaccine, Prophylaxis, one dose received on an unknown date
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR2016GSK061067

Write-up: This case was reported by a consumer via local affiliate and described the occurrence of pneumonia in a adult female patient who received Seasonal Influenza vaccine. Previously administered products included Influenza vaccine (one dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Seasonal Influenza vaccine. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced pneumonia (serious criteria death and GSK medically significant). On an unknown date, the outcome of the pneumonia was fatal. The reported cause of death was pneumonia. It was unknown if the reporter considered the pneumonia to be related to Seasonal Influenza vaccine. Additional details were received as follows: The age at vaccination was not reported. The reporter stated that, the patient received 2 dosage of Influenza vaccine (vaccine''s manufactory was not informed) and presented with pneumonia. A year from the date of reporting, the patient had died. The reporter related the patient''s death to Influenza vaccine. No further information was provided.


VAERS ID: 639044 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-01
Onset:0000-00-00
Submitted: 2016-06-14
Entered: 2016-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy bronchus abnormal, Bronchoscopy, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Cough, Death, Dyspnoea, Eosinophil percentage increased, Exposure during pregnancy, General physical health deterioration, HIV test negative, Haemoglobinuria, Hepatitis viral test negative, Lung adenocarcinoma, Lung infection, Mycobacterium test negative, Neutrophil percentage increased, Pneumonia klebsiella, Pneumothorax, Productive cough, Rales, Sepsis, Weight decreased, Wheezing, White blood cell count increased
SMQs:, Haemolytic disorders (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (broad), Proteinuria (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: neutrophil count; Test Result: 83 %; Test Name: eosinophil count; Test Result: 5.4 %; Test Name: leucocyte count; Result Unstructured Data: 21580 cell(s)/cubic millimeter
CDC Split Type: BRSA2016SA108607

Write-up: Initial unsolicited pregnancy report received from the literature on 01 June 2016. Introduction: Lung adenocarcinoma usually occurs in male smoker patients after the 5th decade of life. Typical images are unilateral peripheral lesions invading pleura or causing bronchial obstruction. Scarcely adenocarcinoma simulates CAP, particularly in patients below 30 years, non-smokers and, occurring during pregnancy, is associated to high risk of death. Discussion: When an adenocarcinoma appears as consolidation is often misdiagnosed as CAP mainly if affecting a young nonsmoker patient. Although uncommon during pregnancy, lung cancer has a worse prognosis and a longer delay to be diagnosed because of a reluctance of both physician and patient to expose the fetus to radiation and take medication. In this case symptoms started during pregnancy, but adenocarcinoma was investigated with bronchoscopy after several months of therapeutic failure. Conclusion: The lesson brought by this case is the need of bronchoscopy for differential diagnosis of pulmonary consolidations in cases of therapeutic failures, even in nonsmoking young patients, mostly if a pregnant woman. This case involves 23-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Anti-Influenza Vaccine) (batch number, route and site of administration: not reported) on an unspecified date in November 2013 while she was pregnant. Pregnancy information included LMP: not reported, estimated delivery date: December 2013, pregnancy trimester: third (late pregnancy). It was reported that the patient was non-smoker. Patient''s medical history and concomitant medications were not reported. On an unspecified date in November 2013, following the vaccination, the patient had cough, mucoid sputum and dyspnea. The patient denied chest pain, hemoptysis and fever. The patient decided to wait for the child birth in December to be treated. On unspecified date, post vaccination, the patient had weight loss of 14 Kg in 6 months. On an unspecified date in June 2014, post vaccination, patient was in poor general condition, had crackling rales and diffuse bilateral wheezing. On an unspecified date, post vaccination, patient had extensive bilateral consolidation, pneumothorax on the right side, adenocarcinoma with invasive focus in bronchial wall and sepsis secondary to KPC lung infection. In June 2014, the patient was admitted in tertiary hospital. Laboratory investigations included chest x-rays, Computerized tomography (CT) which confirmed bilateral consolidation, especially in the lower lobes and basal portions of the upper lobes, negative HIV Rapid Test and AFB (Acid Fast Bacillus) in sputum, negative serology for viral hepatitis and HIV, anatomopathology of lung sample obtained by transbronchial biopsy: adenocarcinoma with invasive focus in bronchial wall. Leukocytosis (21,580/mm3) with 17576 (83%) neutrophils, 1365 (5.4%) eosinophil, hemoglobinuria (+++). In January 2014, patient started corrective treatment antibiotic (with no improvement). Patient changed antibiotics. In June 2014 she started using Azithromicin and Cefuroxime. The patient was treated with Carbotaxol (negative EGFR gene excluded additional oral chemotherapy) for six months. Pregnancy outcome was reported as live birth. The patient died in December 2014 due to sepsis secondary to KPC lung infection. Autopsy was not reported. Documents held by sender: none.; Sender''s Comments: The reported symptoms and investigations are consistent with the diagnosis of adenocarcinoma of lung. The cause of death was reported as sepsis secondary to KPC lung infection. Date of Influenza vaccination and the exact time to onset is unknown. Although the patient was a non-smoker, no information about other risk factors including exposure to asbestos or other carcinogens like radon gas, metal dust, family history, etc. was reported. Complete information on detailed autopsy results, vaccination details, medical history, etc. will be needed for further assessment. However, based on the nature of the event, a role of the vaccine seems unlikely.; Reported Cause(s) of Death: sepsis secondary to KPC lung infection; sepsis secondary to KPC lung infection.


VAERS ID: 640568 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-23
Entered: 2016-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Biopsy bone marrow abnormal, Biopsy skin abnormal, Blood bilirubin increased, Blood lactate dehydrogenase increased, Chemotherapy, Chest X-ray abnormal, Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal, Death, Epstein-Barr virus test negative, General physical health deterioration, Haemoglobin decreased, Hepatic function abnormal, Histiocytosis haematophagic, Hyperbilirubinaemia, Hyperferritinaemia, Injection site nodule, Injection site ulcer, Lymphadenopathy, Neoplasm skin, Pancytopenia, Platelet count decreased, Pleural effusion, Polymerase chain reaction positive, Pyrexia, Red blood cell count decreased, Skin plaque, Splenomegaly, T-cell lymphoma, T-lymphocyte count decreased, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Skin tumours of unspecified malignancy (narrow), Malignant lymphomas (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow), Infective pneumonia (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On unknown date, histopathologic examination of the lesion showed a granulomatous and mixed cellular infiltration. The biopsy showed an ulcerated epidermis and infiltration of atypical lymphoid cells along the full thickness of the dermis which extended into the subcutaneous fat with an angiocentric pattern. The biopsy from the red plaque on the trunk showed infiltration of small to large lymphoid cells with irregular nuclei around dermal appendages and blood vessels. PCR showed monoclonal rearrangement, indicating the presence of a monoclonal T-cell population. T-lymphocyte subtype, CD4 18% (N: 40-55%), CD8 27% (N: 18-30%), and CD4/CD8: 0.67 (N: 0.9-3.6). Abdomen CT scan showed mild bilateral pleural effusion, left axillary adenopathy, and splenomegaly. Bone marrow biopsy demonstrated dyshaematopoiesis of myeloid cells and erythroid cells.
CDC Split Type: CN2016GSK089431

Write-up: This case was reported in a literature article and described the occurrence of T-cell lymphoma in a 27-year-old male patient who received FLUARIX. On an unknown date, the patient received FLUARIX. On an unknown date, several days after receiving FLUARIX, the patient experienced injection site nodule and injection site ulcer. On an unknown date, several months after receiving FLUARIX, the patient experienced T-cell lymphoma (serious criteria death and GSK medically significant), hemophagocytic syndrome (serious criteria death and GSK medically significant), fever (serious criteria death), skin plaque (serious criteria death), pancytopenia (serious criteria death and GSK medically significant), hepatic function disorder (serious criteria death), splenomegaly (serious criteria death), hyperferritinemia (serious criteria death), hyperbilirubinemia (serious criteria death and GSK medically significant) and skin tumor (serious criteria death). The patient was treated with topical antibiotic (NOS), dexamethasone, HEPATOPROTECT, ifosfamide, pirarubicin, vindesine, methylprednisolone and arsenic trioxide. On an unknown date, the outcome of the T-cell lymphoma, hemophagocytic syndrome, injection site nodule, injection site ulcer, fever, skin plaque, pancytopenia, hepatic function disorder, splenomegaly, hyperferritinemia, hyperbilirubinemia and skin tumor were fatal. The reported cause of death was hemophagocytic syndrome and T-cell lymphoma. The reporter considered the T-cell lymphoma to be related to FLUARIX. It was unknown if the reporter considered the hemophagocytic syndrome, injection site nodule, injection site ulcer, fever, skin plaque, pancytopenia, hepatic function disorder, splenomegaly, hyperferritinemia, hyperbilirubinemia and skin tumor to be related to FLUARIX. Additional information was provided: This case was reported in a literature article and described the occurrence of peripheral T-cell lymphoma, not otherwise specified (NOS) in 27-year-old male who was vaccinated with FLUARIX (GlaxoSmithKline). No information on patient''s medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received an injection of FLUARIX on the left upper arm (administration route unspecified; dosages unknown batch number not provided). On an unspecified date, an unknown period after vaccination with FLUARIX, the patient developed a nodule and ulcer at the inoculation site of vaccine on the left upper arm. Within a few days after the injection, the nodule grew to 2 cm in diameter. The patient was presented at a peripheral hospital and was treated with topical antibiotics, but the lesion continued to increase in size and gradually became more indurated and ulcerated. There was no regional lymphadenopathy. Five months after the initial presentation, debridement of the lesion was done. Histopathologic examination of the specimen showed a granulomatous and mixed cellular infiltration. Subsequently, the patient was diagnosed with granulomatous reaction following vaccination. However, over a period of 2 months, the lesion continued to enlarge while the patient became febrile along with the appearance of numerous red plaques on his trunk and limbs. The patient was then referred to another hospital for evaluation of the enlarging ulcer, plaques and fever. Skin biopsies for histopathology, immunohistochemistry and molecular analyses were obtained from the ulcerated tumour on the left arm and a plaque on the trunk. The biopsy from the left arm showed an ulcerated epidermis and infiltration of atypical lymphoid cells along the full thickness of the dermis which extended into the subcutaneous fat with an angiocentric pattern. Re-evaluation of the initial biopsy also revealed infiltration of atypical lymphocytes. The biopsy from the red plaque on the trunk showed infiltration of small to large lymphoid cells with irregular nuclei around dermal appendages and blood vessels. Immunohistochemistry on the specimen from the left arm lesion showed the majority of the lymphoid cells to be positive for CD3, CD7, and CD2; but negative for CD4, CD8, CD10, CD19, CD30, CD79, Bcl-2, and Bcl-6. The pan B-cell marker CD20 was negative and betaF1 staining was negative on paraffin sections. Natural killer (NK) lineage marker CD56 and the cytotoxic effectors granzyme B and perforin were strongly expressed. The Ki-67 proliferation index was relatively high. Infiltrating cells of the trunk biopsy were positive for CD3, CD2, and CD56, and negative for CD4, CD8, CD10, CD19, CD30, and CD34, and expressed granzyme B and perforin weakly. Immunohistochemistry and molecular analysis of the skin biopsies excluded extranodal NK/T-cell lymphoma, primary cutaneous CD4-positive small/medium T-cell lymphoma (CD4+SMTL), primary cutaneous CD8-positive aggressive epidermotropic T-cell lymphoma (CD8+AECTCL), and primary cutaneous gamma/delta T-cell lymphoma (CGD-TCL). In situ hybridization with fluorescein conjugated ribonucleic acid (RNA) probe for the small Epstein-Barr virus (EBV)-encoded ribonucleic acid (RNA)1 and 2 (EBER1/2) showed no evidence of EBV infection. Using a primer for the V and J regions of T-cell receptor (TCR) gamma chain, polymerase chain reaction (PCR) showed monoclonal rearrangement, indicating the presence of a monoclonal T-cell population. T-cell lymphoma cell line Jurkat and B-cell lymphoma cell line Raji used as positive controls. Laboratory evaluation revealed pancytopenia [red blood cell count of 3.36 x 10E12/L (normal range (N): 4-5.5 x 10E12/L), white blood cell count of 1.98 x 10E9/L (N: 4-10 x 10E9/L), haemoglobin 90 g/L (N: 120-160 g/L), platelet count 76 x 10E9/L (N: 100-300 x 10E9/L), T-lymphocyte subtype, CD4 18% (N: 40-55%), CD8 27% (N: 18-30%), and CD4/CD8: 0.67 (N: 0.9-3.6).], hyperbilirubinemia [total bilirubin 24.8 mcmol/L (N: 2-18 mcmol/L)], transaminitis (aspartate aminotransferase (AST) 223 U/L (N: less than 64 U/L), alanine aminotransferase (ALT) 283 U/L (N: less than 64 U/L) and raised lactic dehydrogenase 723 U/L (N: 80-285 U/L) levels. A chest X-ray showed mildly increased pulmonary markings and a chest and abdomen computed tomographic (CT) scan showed mild bilateral pleural effusion, left axillary adenopathy, and splenomegaly. Examination of the oral cavity and pharynx was unremarkable. A bone marrow biopsy demonstrated dyshaematopoiesis of myeloid cells and erythroid cells. Subsequently, after discussion with hematology and pathology colleagues, the patient was diagnosed with peripheral T-cell lymphoma, not otherwise specified (NOS). The patient received 15 mg dexamethasone daily for high fever and liver-protective drugs for elevation of liver enzymes. The fever persisted and the tumour on his left arm enlarged to 8 x 10 cm in diameter with obvious necrosis. The patient was then transferred to the department of haematology. Combination chemotherapy with ifosfamide, pirarubicin, vindesine, and methylprednisolone were administered due to his severe systemic symptoms. Two days later, the laboratory data revealed progressively abnormal liver function tests (AST at 667 U/L and ALT at 1,060 U/L). The combination chemotherapy was changed to arsenic trioxide and dexamethasone. Although plaques on the trunk showed some improvement, the patient''s general condition continued to deteriorate as he developed progressive liver dysfunction and severe hyperbilirubinemia (total bilirubin at 196.2 and direct bilirubin at 179.3 units and normal values not provided for both). A bone marrow biopsy showed infiltration with abnormal cells. On the 46th day of hospitalisation, the patient died. It was unknown if an autopsy was performed. This case was considered serious due to death. The authors commented that "The association of the lymphoma with the vaccination and the underlying mechanisms for the occurrence of T-cell lymphoma were unclear". The authors concluded that "Influenza virus vaccine (FLUARIX) administered to our patient has been standardized for the influenza season and is formulated to contain hemagglutinin, Triton X-100, and Tween 80. The vaccine does not contain preservatives and aluminum adjuvant. Most experts consider that chronic antigenic stimulation, local infection, inflammatory responses, and even the patient''s immune status might play an important role in the process of malignant transformation. Our patient''s clinical course was characterized by high fever, pancytopenia, splenomegaly, hyperferritinemia, and hemophagocytosis in the bone marrow; features suggesting that lymphoma-associated hemophagocytic syndrome (LAHS) should be considered as the cause of death. In general, cutaneous T-cell lymphomas expressing CD56, granzyme B, and perforin often exhibit a rapidly progressive course and poor response to chemotherapy". This article is not available for regulatory submission due to copyright restriction.


VAERS ID: 649432 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-01
Onset:0000-00-00
Submitted: 2016-08-26
Entered: 2016-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVAX) / CSL LIMITED - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood test abnormal, Foetal death, Foetal exposure during pregnancy, Foetal hypokinesia, Foetal movement disorder, Hypoxia, Laboratory test normal, Stillbirth, Trisomy 21
SMQs:, Asthma/bronchospasm (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-06
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: 20121028; Test Name: Heart rate; Result Unstructured Data: Test result: fine.; Test Date: 20121028; Test Name: Blood pressure; Result Unstructured Data: Test result: good all the way through; Test Date: 20121028; Test Name: Blood pressure; Result Unstructured Data: Test result: perfect.; Test Name: Blood tests, cord, placenta and tissues test; Result Unstructured Data: Test results: Down''s syndrome; positive.; Test Date: 20121111; Test Name: Weight; Result Unstructured Data: test result: on delivery foetus was normal weight and size.; Test Date: 20121028; Test Name: Growth measure; Result Unstructured Data: Additional test on 28-Oct-2012, growth measure was fine.
CDC Split Type: GBBEH2016072953

Write-up: This spontaneous case, initially received on 23-Aug-2016, was reported by a non health professional and concerns a 1-hours-old male patient. Weight: 3.1 kg (also reported as 3.25 kg); Height: 47 cm. Linked case: GB-BEH-2016072951 (mother''s case). The patient''s mother is fit, healthy and has had four previous pregnancies resulting in live births. There is no family history of miscarriages or still births in the family. Throughout the mother''s fifth pregnancy, bloods and blood pressure were good/perfect. The mother had no known allergies. At every appointment throughout the mother''s pregnancy, the patient''s growth, heart and movement were perfect. The patient''s heart was strong throughout pregnancy. At a midwife''s appointment three days prior to vaccination, the patient''s growth and heart beat were checked and the mother''s blood pressure and pulse were also checked. The results were fine, the patient (foetus) was very active (he never liked to be prodded) and his heart was beating strong, everything was fine. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for vaccination from 01-NOV-2012 to 01-NOV-2012. Dose regimen: Not reported, Route of administration: Transplacental. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient received REPEVAX for vaccination. Dose regimen: Not reported, Route of administration: Transplacental. Batch number: Not reported. Adverse reactions/events and outcomes: After the injections, things started to slow down. On 06-Nov-2012 (reported as four and five days post vaccination), the patient''s mother noticed a decrease in the patient''s (foetal) movements / movements stopped (stop date: 09-Nov-2012, medically significant, outcome: not recovered / not resolved). The patient''s mother lost slight blood / started to lose pink (vaginal) fluid / blood and lose a little bit of (vaginal) mucus. The hospital told the patient''s mother this was normal and not to go to the hospital. The patient''s father called the delivery suite to see if the patient''s mother should attend. They informed the patient''s father that everything was fine and it could be a mucus plug. From this point, the patient''s mother noticed a decrease in the patient''s movements (medically significant, outcome: not recovered / not resolved), this was not normal as the patient had always been so strong and moved all the time. The patient''s father telephoned a further three times over the next days as the movements had stopped completely. In the end, the patient''s mother had to wait to be seen at a routine midwife appointment three days later. At this appointment, the midwife could not find a heart beat (medically significant, outcome: not reported) and discovered that the patient had died. On 11-Nov-2012, the male patient was delivered asleep (medically significant, outcome: fatal) at 36 weeks gestation. The patient was of normal weight and size for the (gestational) age of 36.5 weeks. He measured 47cm and weighed 3.1 kg (also reported as 3.25 kg), these measurements are bang on with what he should have been for 36 weeks (gestation). The patient died of hypoxia with an unknown cause (start date reported as 09-Nov-2012) medically significant, outcome: fatal). A post mortem was not carried out on the patient but all blood tests, his cord, placenta and also tissue were tested. The results showed that the patient had Down''s syndrome (medically significant, outcome: not reported). The placenta was in perfect condition and working order. The patient''s parents believe the patient to be only slightly (Down''s syndrome) as there were no visible signs of this. The outcome for foetal exposure during pregnancy is unknown (start date: 01-Nov-2012). Special circumstances for all events: drug exposure during pregnancy. The patient died on 06-Nov-2012. Cause of death: hypoxia, stillbirth. Relevant test results: 28-Oct-2012 test name: heart rate, result: fine. 28-Oct-2012 test name: blood pressure, result: good all the way through. 28-Oct-2012 test name: blood pressure, result: perfect. Unspecified date: Blood tests, cord, placenta and tissues test; results: Down''s syndrome; positive. 11-Nov-2012 test name: weight, test result: on delivery foetus was normal weight and size. Additional test on 28-Oct-2012, growth measure was fine. Parent (maternal) relevant test results: 28-Oct-2012 test name: blood pressure. test result: normal (everything was fine). 28-Oct-2012 test name: pulse, test result: normal (everything was fine). 06-Nov-2012 test name: vaginal discharge, test result: abnormality (patient started to lose pink fluid, started to lose little bits of mucus and blood). Test name: normal birth, comments: fifth pregnancy, all 4 prior resulted in live births. Reporter''s Comments: Reporter''s assessment: The health authority considered all event(s) as serious (patient died, other medically significant) and reported the preferred term foetal exposure during pregnancy. The patient''s father has a strong belief that the whooping cough vaccination caused the patient''s death on and around four days after vaccination. The patient''s parents stated that everything went downhill once the vaccines were given. They have a strong belief that all the vaccines together killed the patient. Sender''s Comments: Company comments and assessments: Listedness: Unlisted. Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL''s Influenza Virus Vaccine, all events are unlisted except foetal drug exposure which is listed as vaccination is not contraindicated in pregnant women. Causality: Unrelated. The foetus was exposed (via the mother) to Influenza vaccine in 3rd trimester at approximately 35 week gestation. Baby was diagnosed with Down''s syndrome post birth and cause of death was reported as hypoxia. The mother did not report any systemic vaccine side effects and there was a delay of 6 days before decreased foetal movement was noted. It is also not known if antenatal corticosteroids were administered to reduce complications of prematurity such as respiratory distress syndrome which is associated with foetal death. Although the etiology of foetal death is not known in 25-60% of all cases, it can be broadly attributable to foetal, maternal, or placental pathology. In this case, advanced maternal age over 35 years, presence of Down''s syndrome and absence of any immediate vaccination related systemic adverse events, causality is considered unrelated to vaccination. Reported Cause(s) of Death: Hypoxia; Stillbirth.


VAERS ID: 651104 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-05
Entered: 2016-09-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Angiotensin converting enzyme, Antinuclear antibody negative, Blood bicarbonate decreased, Blood lactate dehydrogenase, Blood pH increased, Brucella test negative, CSF glucose normal, CSF protein increased, CSF red blood cell count positive, CSF test normal, Chest X-ray normal, Coma, Computerised tomogram normal, Constipation, Cytomegalovirus test negative, Death, Dysarthria, Dysphagia, Electrocardiogram normal, Endotracheal intubation, Epstein-Barr virus test negative, Facial paresis, Gait disturbance, General physical health deterioration, Herpes simplex test negative, Hydrocephalus, Hyperreflexia, Hyperventilation, Immunoglobulin therapy, Intention tremor, Muscular weakness, Mycobacterium tuberculosis complex test negative, Nuclear magnetic resonance imaging brain abnormal, PCO2 decreased, PO2 increased, Parvovirus B19 test negative, Plasmapheresis, Polymerase chain reaction, Respiratory alkalosis, Sedation, Tachypnoea, Tongue movement disturbance, Toxoplasma serology negative, Treponema test negative, Tumour marker test, Typhus rickettsia test, Urinary retention, Varicella virus test negative, Viral test negative, Weaning failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lactic acidosis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests were performed on unknown date. The PCR in CSF for herpes simplex, varicella zoster, cytomegalovirus, Epstein-Barr virus, JC and tuberculosis were negative as well as serology for measles, parvovirus B19, Brucella, Toxoplasma, Borrelia, Rickettsia and VSRL. Levels of angiotensin converting enzyme in serum and CSF were normal, and tumour markers and antinuclear antibodies were negative. Cranial MRI showed bilateral focal lesions in the white matter which were hyperintense in T2, with minimal enhancement after contrast. In a second MRI, performed one month after the first, involvement of deep grey substance was observed with extensive oedema of the white matter of both cerebral hemispheres and cere-bellum, with brainstem compression and secondary triventricular hydrocephalus. Blood bicarbonate, 14.6 mmol/L; Blood lactate dehydrogenase, 4.7 mmol/L; Blood pH, 7486; CSF glucose, 69 mg/dL; CSF protein, 61 mg/dL; CSF red blood cell count positive, 28 /mm3; CSF test, 11 /mm3; Chest x-ray, normal; Computerised tomogram, normal; Electrocardiogram, normal; Nuclear magnetic resonance imaging, brain; Nuclear magnetic resonance imaging, bilateral focal lesions, brain; PCO2, 12 mmHg; PO2, 126 mmHg
CDC Split Type: ES2016GSK122678

Write-up: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 63-year-old male patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, 14 days after receiving Influenza vaccine, the patient experienced acute disseminated encephalomyelitis (serious criteria death and GSK medically significant), hyperpnea (serious criteria death), coma (serious criteria GK medically significant), hydrocephalus (serious criteria death and GSK medically significant), dysarthria (serious criteria hospitalization), dysphagia (serious criteria hospitalization), facial weakness (serious criteria hospitalization), gait disturbance (serious criteria hospitalization), urinary retention (serious criteria GSK medically significant). tongue movement impaired, intention tremor, weakness of arms, constipation and tachypnea. The patient was treated with methylprednisolone, remifentanil, midazolam and immunoglobulins nos. On an unknown date, the outcome of the acute disseminated encephalomyelitis, hypernea and hydrocephalus were fatal and the outcome of the coma, dysarthria, dysphagia, facial weakness, gait disturbance, urinary retention, tongue movement impaired, intention tremor, weakness of arms, constipation and tachypnea were unknown. The reported cause of death was central neurogenic hyperventilation. The reporter considered the acute disseminated encephalomyelitis and hyperpnea to be possibly related to Influenza vaccine. It was unknown if the reporter considered the coma, hydrocephalus, dysphagia, facial weakness, gait disturbance, urinary retention, tongue movement impaired, intention tremor, weakness of arms, constipation and tachypnea to be related to Influenza vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of post-vaccination acute disseminated encephalomyelitis and central neurogenic hyperventilation (CNH) in a 63-year-old male patient who was vaccinated with unspecified trivalent adjuvant flu vaccine (manufacturer unknown). The patient had no personal medical history. No information on patient''s family history or concurrent condition or concomitant medication was provided. On an unspecified date, at the age of 63 years, the patient received unspecified trivalent adjuvant flu vaccine (administration route and site unspecified: dosage unknown; batch number not provided). On an unspecified date, approximately 2 weeks after vaccination with unspecified trivalent flu vaccine, the patient experienced dysarthria. dysphagia, peripheral facial weakness and gait disturbance without fever, headache or prodromal signs of infection. These symptoms had gradually appeared after vaccination. 2 weeks later, the patient was admitted to the hospital. On admission, the examination showed neither impairment of consciousness nor visual field or ocular motility disorder. The patient had sever dysarthria with palatial and tongue movement restrictions, intention tremor, abnormal heel-knee test and proximal weakness of the left arm. The tendon reflexes were hyperactive, without clonus, while both proprioception and vibratory sensation were preserved. Laboratory tests: chest x-ray, electrocardiogram (ECG) and Chest-abdomen computed tomography (CT) scan were normal. Cerebrospinal fluid (CSF) analysis showed: 11 cells/mm3, 28 red blood cells/mm3, proteins 61 mg/dL and glucose 69 mg/dL. There were no neoplastic cells or oligoclonal bands or intrathecal IgG synthesis. The polymerase chain reaction (PCR) of CSF for herpes simplex, varicella zoster, cytomegalovirus, Epstein-Barr virus, John Cunningham (JC) virus and tuberculosis were negative as well as serology for measles, parvovirus B19, Brucella, Toxoplasma, Borrelia, Rickettsia and venereal disease research laboratory (VDRL). Levels of angiorensin converting enzyme in serum and CSF were normal, and tumour markers and antinuclear antibodies were negative. Cranial magnetic resonance (MRI) showed bilateral focal lesions in the white matter which were hyperintense on T2, with minimal enhancement after contrast. During the hospital stay, the patient developed constipation and urinary retention. On accounts of medical history, lab tests and MRI results, the patient was diagnosed with post-vaccination acute disseminated encephalomyelitis and treated with high dose methylprednisolone. Due to the emergence of a significant tachypnea, the patient was admitted to intensive care. The arterial blood gas analysis showed the following results: 7.486 pH, PaO2: 126 mmHG, PaCo2: 12 mmHG, HCO33: 14.6 mmol/L. The blood lactate was 4.7 mmol/L (VN less than 2 mmol/L). Since the patient had hyperpnoea and difficulty to protect the airway due to involvement of the lower cranial nerves, the patient was intubated and sedated with remifentanil and midazolam, which decreased the respiratory alkalosis. Repeated attempts to disconnect the respirator failed due to severe hyperventilation, ruling out concomitant infection, lunch disease or heart disease, therefore intravenous treatment was started with immunoglobulins for 5 days and 5 plasmapheresis sessions were performed. Despite treatment, the patient progressively deteriorated and went into a coma. in a second MRI, performed one month after the first, involvement of deep grey substance was observed with extensive oedema of the white matter of both cerebral hemispheres and cerebellum, with brainstem compression and secondary triventricular hydrocephalus. The patient developed CNH, refractory to treatment of the primary disease of acute disseminated encephalomyelitis. With the patient''s family consent, the life-sustaining treatments were limited. Subsequently, the patient died in the unit. The patient died from central neurogenic hyperventilation. It was not reported if autopsy was performed. This case was considered serious due to death. The authors considered the events post-vaccination acute disseminated encephalomyelitis and CNH possibly related to the unspecified adjuvant flu vaccine. The authors concluded that "The CNH forecast is ominous, with a survival of only a few months in most of the reported cases. In our patient, the CNH was refractory to treatment of the primary disease, consistent with increased severity and extent of brain and brain stem lesions. Although this adverse reaction to the flu vaccine was not communicated to the pharmacovigilance service, its causation was considered at least possible using the Karch and Lasagna algorithm".


VAERS ID: 651105 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-06
Entered: 2016-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Angiotensin converting enzyme, Blood bicarbonate decreased, Blood gases abnormal, Blood lactic acid increased, Blood pH increased, Blood test normal, Borrelia test negative, Brucella test negative, CSF cell count increased, CSF glucose normal, CSF oligoclonal band absent, CSF protein increased, CSF red blood cell count positive, CSF test abnormal, Chest X-ray normal, Coma, Computerised tomogram abdomen normal, Computerised tomogram thorax normal, Constipation, Cytomegalovirus test negative, Death, Dysarthria, Dysphagia, Electrocardiogram normal, Endotracheal intubation, Epstein-Barr virus test negative, Facial paresis, Gait disturbance, General physical health deterioration, Herpes simplex test negative, Hydrocephalus, Hyperventilation, Immunoglobulin therapy, Intensive care, Measles antibody negative, Mechanical ventilation, Muscular weakness, Mycobacterium tuberculosis complex test negative, Nuclear magnetic resonance imaging brain abnormal, PCO2 decreased, PO2 increased, Parvovirus B19 test negative, Plasmapheresis, Polymerase chain reaction, Respiratory alkalosis, Scan with contrast abnormal, Tachypnoea, Toxoplasma serology negative, Tremor, Treponema test negative, Tumour marker test, Typhus rickettsia test, Urinary retention, Varicella virus test negative, Viral test negative, White matter lesion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lactic acidosis (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Procedure, Intensive care; Procedure, Endotracheal intubation; Procedure, Mechanical ventilation, Repeated attempts to disconnect the respirator failed because of severe hyperventilation; Treatment, Immunoglobulin IV, for 5 days; Procedure, Plasmapheresis, 5 sessions
Allergies:
Diagnostic Lab Data: Blood gases, Abnormal, Significant, pH: 7,486, PaO2: 126 mm Hg, PaCO2: 12 mm Hg, HCO3: 14.6 mmol/l; Blood lactic acid, 4.7 mmol/l, Significant, Normal value less than 2 mmol/l; CSF test, Abnormal, Significant, CSF analysis results were: 11 cell/mm^3, 28 RBC/mm^3, protein 61 mg/l and glucose 69 mg/dl. There were no neoplastic cells, oligoclonal bands or intrathecal IgG synthesis; Nuclear magnetic resonance imaging, Abnormal, brain, Significant, Bilateral, focal white matter lesions that were hyperintense on T2, with minimal enhancement following contrast; Nuclear magnetic resonance imaging, Abnormal, brain, A second MRI, performed a month after the first, showed deep grey matter involvement with extensive white matter edema in both brain hemispheres and the cerebellum brain stem compression, and secondary triventricular hydrocephalus
CDC Split Type: PHHY2016ES120524

Write-up: Case number PHHY2016ES120524 is an initial literature report received on 01 Sep 2016. The author described the first case of central neurogenic hyperventilation (CNH) secondary to acute disseminated encephalomyelitis following trivalent flu vaccination. This report refers to a 63 year old male patient with no personal history of interest. He was vaccinated with trivalent adjuvanted influenza vaccine (manufacturer and batch number: not reported) on an unknown date. He was admitted to the hospital for dysarthria, dysphagia, peripheral facial weakness and gait disorder, but with no fever, headache or prodromal signs of infection. The symptomatology had gradually appeared, starting approximately 2 weeks after receiving flu vaccine, which was one month before hospitalization. An examination at the time of admission showed no level of consciousness disorder and normal campimetry and eye mobility. He had severe dysarthria with restricted palate lift and tongue movement, intention tremor, abnormal left heel-knee test and proximal weakness in the left arm. Tendon reflexes were hyperactive, without clonus, while both proprioception and vibration sensitivity were conserved. The blood tests, chest-x-ray, electrocardiogram (ECG) and chest and abdomen computed tomography (CT) scans were normal. The cerebrospinal fluid (CSF) analysis results were: 11 cell/mm^3, 28 RBC/mm^3, protein 61 mg/l and glucose 69 mg/dl. There were no neoplastic cells, oligoclonal bands or intrathecal IgG synthesis, polymerase chain reaction (PCR) on CSF for Herpes simplex, Varicella zoster, Cytomegalovirus, Epstein-Barre, John Cunningham (JC) virus and tuberculosis were negative. Serum tests for measles, Parvo virus B19, Brucella, Toxoplasma, Borrelia, Rickettsia and Venereal Disease Research Laboratory (VDRL) were negative. The serum and CSF had normal levels of angiotensin converting enzyme and were negative for tumor markers and antinuclear antibodies. A cranial magnetic resonance imaging (MRI) showed bilateral, focal white matter lesions that were hyperintense on T2, with minimal enhancement following contrast. During hospitalization, the patient developed constipation and urinary retention. Based on the medical history, lab tests and MRI results, he was diagnosed with post-vaccination acute disseminated encephalomyelitis and began receiving high dose methylprednisolone treatment. The patient was admitted to intensive case because of serious tachypnea. Arterial gasometry results were: pH 7.486, partial pressure of oxygen in the arterial blood (PaO2): 126 mm Hg, partial pressure of carbon dioxide in the arterial blood (PaCO2): 12 mm Hg and bicarbonate (HCO3): 14.6 mmol/l. His arterial lactate was 4.7 mmol/l (normal value less than 2 mmol/l). Given the hyperpnea and difficulty protecting the airway because of lower cranial nerve involvement, the patient was intubated and sedated with remifentanil and midazolam, after which the respiratory alkalosis decreased. Repeated attempts to disconnect the respirator failed because of severe hyperventilation. Having ruled out concomitant infection, pulmonary involvement, or heart disease, the patient then received 5 days of intravenous immunoglobulin treatment and 5 plasmapheresis sessions. Despite the treatment, the patient progressively declined and entered a coma. A second MRI, performed a month after the first, showed deep grey matter involvement with extensive white matter edema in both brain hemisphere and the cerebellum, brain stem compression, and secondary triventricular hydrocephalus. In agreement with the patient''s family, vital support treatment was limited. He died shortly afterward in the unit. The author stated that in this patient, the CNH was refractory to primary disease treatment, as evidenced by the patient''s condition worsening and the brain and brainstem lesions spreading. The author concluded the article stating that although this adverse reaction to the flu vaccine was not reported to the pharmacovigilance department, its causal relationship was considered at least possible, according to the Karch and Lasagna algorithm.


VAERS ID: 651137 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-06
Entered: 2016-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Influenza like illness, Influenza virus test positive, Polymerase chain reaction, Respiratory failure, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad)

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: No other medications
Current Illness: Unknown
Preexisting Conditions: Respiratory failure
Allergies:
Diagnostic Lab Data: Lab test performed on unknown date; Polymerase chain reaction, influenza
CDC Split Type: ES2016GSK128867

Write-up: This case reported in a literature article and described the occurrence of unknown cause of death in a elderly subject who received Flu seasonal TIV Dresden. The subject''s past medical history included respiratory failure. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. Additional events included vaccination failure with serious criteria of death, hospitalization and GSK medically significant and influenza with serious criteria death and hospitalization. The outcome of unknown cause of death was fatal. The outcome of the additional events included vaccination failure (fatal) and influenza (fatal). The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the unknown cause of death, vaccination failure and influenza may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Lab test performed on unknown date Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Polymerase chain reaction result was influenza unknown. Additional information was provided: This case was reported in a literature article and described the occurrence of suspected vaccination failure in an adult patient aged older than 65 of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was a part of a retrospective, comparative study about the prognostic factors of mortality in a group of patients infected with influenza virus. In the study, a case was defined as a patient who was hospitalized for greater than 24 hours with influenza-like symptoms and had laboratory detection by the reverse transcriptase-polymerase chain reaction test of influenza virus. The patients were divided into two groups: Dead and survival patients. The study population comprised all adult patients, who were admitted to Hospital between March and September 2014 and tested for the presence of influenza infection based on clinical suspicion. No information on patient''s medical history or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified influenza virus vaccine (administration route and site unknown, dosages unknown; batch number not provided). On an unspecified date, an unknown period after unspecified influenza virus vaccine, the patient developed influenza-like symptoms. Between March and September 2014, the patient was hospitalised. Subsequently, the patient had developed severe respiratory failure (In this study, 16 patients had a sepsis of respiratory origin). On an unspecified date, the patient died. The cause of the death was unknown. (In this study, 17 of the patient died as a direct result of infection. Mortality was significantly higher in women. The age was higher in mortality group of patients (72[13] versus 67 [19]). It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset is unspecified. Laboratory detection by the reverse transcriptase-polymerase chain reaction test revealed positive for influenza virus. (In this study, the viral load of influenza was higher (values not provided). Regarding the presence of mono or coinfection by influenza A and B and between the different genotypes not significantly differences were found. Neither the simultaneous isolation of other viruses significantly influenced mortality). This case has been considered serious due to death. Treatment was unknown. (In this study, only 5 patients were treated with oseltamivir with no influence on evolution). The authors did not comment on the event of influenza virus infection with unspecified influenza virus vaccine. The authors concluded "Mortality by influenza virus is low but is more frequent in female, elderly patients without vaccination. Viral load of influenza virus would be a predictor factor of mortality".


VAERS ID: 661803 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2016-10-13
Onset:0000-00-00
Submitted: 2016-10-27
Entered: 2016-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER N3E661V / UNK LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B234AA / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Multiple organ dysfunction syndrome, Sepsis
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Vaccines, Prophylaxis, were well tolerated
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2016GSK156700

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sepsis in a 83-year-old female patient who received BOOSTRIX (batch number AC37B234AA, expiry date unknown). Co-suspect products included VAXIGRIP vaccine (batch number N3E661V, expiry date unknown). Previously administered products included Unspecified vaccines (were well tolerated). On 13th October 2016, the patient received BOOSTRIX (intramuscular) and VAXIGRIP vaccine (intramuscular). In October 2016, 1 day after receiving BOOSTRIX, the patient experienced sepsis (serious criteria death, hospitalization, GSK medically significant and life threatening) and multi-organ failure (serious criteria death, hospitalization, GSK medically significant and life threatening). On an unknown date, the outcome of the sepsis and multi-organ failure were fatal. The patient died in October 2016. The reported cause of death was sepsis and multi-organ failure. It was unknown if the reporter considered the sepsis and multi-organ failure to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX in the right deltoid and VAXIGRIP in the left deltoid. Approximately 24 hours after receiving BOOSTRIX and VAXIGRIP, the patient had sepsis with multi-organ failure and approximately 24 hours later, the events resulted in death. It was not reported whether an autopsy was performed. It was unknown if the reporter considered the sepsis and multi-organ failure to be related to VAXIGRIP. The regulatory authority has requested follow-up information.


VAERS ID: 666136 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-14
Entered: 2016-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Malaise, Thrombotic thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, arterial (narrow), Renovascular disorders (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2016GSK167951

Write-up: This case was reported in a literature article and described the occurrence of thrombotic thrombocytopenic purpura in a 28-year-old subject who received Flu seasonal TIV Dresden. On an unknown date, 4 days after receiving Flu seasonal TIV Dresden, the subject developed thrombotic thrombocytopenic purpura. Serious criteria included death and GSK medically significant. Additional event(s) included unwell. The outcome of thrombotic thrombocytopenic purpura was fatal. The outcome(s) of the additional event(s) included unwell (unknown). The reported cause of death was thrombotic thrombocytopenic purpura. The investigator considered that there was a reasonable possibility that the thrombotic thrombocytopenic purpura and unwell may have been caused by Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of thrombotic thrombocytopenic purpura (TTP) in a 28-year-old patient of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was a part of the report that summarised national passive surveillance data for adverse events following immunisation (AEFI) reported to the Administration to 28 February 2013. The report focused on AEFI reported for vaccines administered during 2012 and trends in AEFI reporting over a 13-year period 1 January 2000 to 31 December 2012. AEFI were notified to the Administration by state and territory health departments, health professionals, vaccine manufacturers and members of the public. All reports are assessed using internationally consistent criteria entered into the Adverse Drug Reactions System (ADRS) database. No information on patient''s family history or concurrent condition or concomitant medication was provided. On an unspecified date between 1 January 2012 and 31 December 2012, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date, 2-3 days post vaccination, the patient became unwell. Subsequently, the patient developed TTP. 2 days after onset of symptoms, the patient died. The cause of death was documented as TTP. It was not reported if an autopsy was performed. This case has been considered serious due to death. The author stated that the death was temporally associated with receipt of vaccines. The death was investigated by the Administration and no clear causal relationship with vaccination was found. Treatment was unknown. The authors suspected the event of TTP related to unspecified influenza vaccine. The authors concluded that "The total number of reported AEFI in 2012 was reduced by 22% compared with 2011. Reports of ISR following DTPa-IPV at 4 years decreased in 2012 compared with 2011 but remained higher than in previous years. Reporting rates for most of the vaccines were similar to 2011 or lower in 2012, particularly in the 2 to less than 7 year age group. The majority of AEFIs reported to the Administration were mild transient events and the data reported here are consistent with an overall high level of safety for vaccines included in the NIP schedule". This is 1 of the 6 valid cases reported in the same literature article.


VAERS ID: 666962 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-18
Entered: 2016-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Malaise, Thrombotic thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, arterial (narrow), Renovascular disorders (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: AUSA2016SA207728

Write-up: Initial unsolicited report received from the literature on 11 November 2016. The following is verbatim from the article: Abstract: This report summarises passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2012. It also describes reporting trends over the 13-year period 1 January 2000 to 31 December 2012. There were 1,897 AEFI records for vaccines administered in 2012, a decrease of 22 percent from 2,417 in 2011. The decrease in 2012 compared with 2011 was mainly attributable to a drop in the reports following receipt of the 23-valent pneumococcal polysaccharide vaccine (405 reduced to 133). However, reporting rates for some other vaccines such as rotavirus and varicella vaccines were higher in 2012 than 2011. Although an increase was observed in estimated reporting rates for rotavirus and varicella in children aged less than 7 years in 2012 compared with 2011, it was not statistically significant. There were 370 AEFI records (37.2 per 100,000 doses) for the pneumococcal conjugate vaccine in 2012, which was fewer than in 2011 (43.4 per 100,000 doses). The most commonly reported reactions were injection site reactions (40 percent), fever (22 percent), allergic reactions (19 percent) and rash (10 percent). Only 7 percent of all the reported adverse events were categorized as serious. There were 2 reports of death, which were investigated by the TGA and no clear causal relationship with vaccination was found. This case involves a 28 year old patient (gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose, site and route of administration were not reported for all vaccines) on an unspecified date. Patient''s medical history and concomitant medications were not reported. On an unspecified date, two to three day following the vaccination patient felt unwell. On unspecified day, following the vaccination patient developed thrombotic thrombocytopenic purpura. Patient''s lab data and corrective treatment were not reported. The outcome for unwell was not reported. On unspecified date, patient was died due to thrombotic thrombocytopenic purpura after 2 days of symptoms onset. It was unknown if autopsy was done. Documents held by sender: none. Sender''s Comments: This case is extract from literature Surveillance of adverse events following immunization, 2012. This is a poorly documented death case of 28 years (gender not specified) who became unwell 2-3 days post vaccination with SEASONAL INFLUENZA VACCINE and developed thrombotic thrombocytopenic purpura (TTP) (on an unspecified date after receiving the vaccine) and died 2 days after onset of symptoms. The cause of the death was reported as TTP. This case is also investigated by the Therapeutic Goods Administration (TGA) and no clear causal relationship with vaccination was found. However details regarding patient''s medical history, previous vaccination history, time to onset of TTP, autopsy and results of investigations are deficit to complete assessment of this case. Reported Cause(s) of Death: thrombotic thrombocytopenic purpura.


VAERS ID: 667121 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-18
Entered: 2016-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure acute, Death
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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: RUPFIZER INC2016533894

Write-up: This is a spontaneous report from contactable physician supplied to safety via Pfizer Regional Medical Adviser and from a regional immunologist. A 60-year-old male patient of an unspecified race received PREVENAR 13 intramuscular on an unspecified date in 2016 at 0.5 ml single for immunisation. Concomitant medication included influenza vaccine (unknown manufacturer) given on the same unspecified date in 2016 for influenza vaccination. The patient medical history was not reported. The patient died due to acute cardiac failure on an unspecified date in 2016 (on the second day after vaccinations with pneumococcal 13-val conj vac (dipht crm197 protein) and influenza vaccine). It was not reported if an autopsy was performed. The first reporting physician assessed the causality between the event and pneumococcal 13-val conj vac (dipht crm197 protein) as unknown. The reporting regional immunologist considered there was not a reasonable possibility that acute cardiac failure was related to pneumococcal 13-val conj vac (dipht crm197 protein). Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: patient medical history and autopsy results. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: acute cardiac failure.


VAERS ID: 667237 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-19
Entered: 2016-11-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Unknown
Symptoms: Asthma, Death
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2016SF14292

Write-up: The report had been received from a physician. The report concerns a 6 years old patient. The patient''s medical history included asthmatic. Concurrent disease and concomitant products were not reported. The patient received Fluenz (intranasal). Shortly after receiving LAIV, the patient died. The immediate cause of death was acute asthma. Underlying cause continued to be investigated by authorities. Evidence suggested respiratory infection. It was unknown if autopsy was performed. The event of respiratory infection had been identified from the source document nad added as ana dverse event by the company physician. According to the reporter the event was considered as serious with the serious criteria of death, the company physician consdiered the event of respiratory infection as serious with the serious criteria of important medical event. Sender''s Comments: Respiratory tract infection and fatal event of asthma are not listed in company core data sheet of Fluenz tetra. Patient''s relevant condition of asthma as risk factor along with respiratory tract infection could be contributory for asthma. There is limited information on patient''s concurrent conditions, personal hygiene, autopsy report, and aetiologic and diagnostic workup which facts makes individual causal assessment difficult. Reported Cause(s) of Death: ACUTE ASTHMA; RESPIRATORY INFECTION.


VAERS ID: 673666 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-19
Entered: 2016-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2016GSK187737

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 5-year-old subject who received Flu seasonal TIV Dresden. On an unknown date, 2 days after receiving Flu seasonal TIV Dresden, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. The investigator considered the unknown cause of death to be possibly related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of death NOS in a 5-year-old child of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). The patient was a part of the report that summarized data for adverse events following immunisation (AEFI) reported to the Administration for 2013. The report focused on AEFI reported for vaccines administered during 2013 and trends in AEFI reporting over the 14-year period 1 January 2000 to 31 December 2013. AEFI were notified to the Administration by state and territory health departments, health professionals, vaccine manufacturers and members of the public. All reports are assessed using internationally consistent criteria entered into the Adverse Drug Reactions System (ADRS) database. The patient had multiple unspecified underlying medical problems. No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 1 January 2013 and 31 December 2013, the patient received FLUARIX (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date, 2 days after vaccination, the patient died. It was not reported if the autopsy was performed. The cause of death was unknown. This case has been considered serious due to death. The authors commented that "All deaths were investigated by the Administration and no clear causal relationship with vaccination was found. The death NOS was temporally associated with the receipt of vaccine." The authors concluded that "The total number of reported AEFI in 2013 increased by 59% compared with 2012, due to an increasing trend in propensity to report. The higher reporting rates may also be in response to the activities undertaken by the Administration and the state and territory health departments to encourage and facilitate reporting of AEFI. Reporting rates for the majority of the vaccines were higher than 2012. Increases were most marked in the 7 to under 20 year age group following extension of HPV to boys and associated enhanced surveillance. The majority of AEFIs reported to the Administration were mild transient events. The data reported here are consistent with an overall high level of safety for vaccines included in the schedule". This is 1 of the 9 valid cases reported in the same literature article.


VAERS ID: 681155 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-09-14
Onset:0000-00-00
Submitted: 2017-02-03
Entered: 2017-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adenocarcinoma, Asthma, Blood test, Bronchoscopy abnormal, C-reactive protein increased, Chest X-ray, Chest X-ray abnormal, Chest pain, Computerised tomogram liver abnormal, Computerised tomogram thorax abnormal, Death, Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Haemoptysis, Headache, Hepatic lesion, Hypoxia, Lung cancer metastatic, Lymph node pain, Malaise, Metastases to bone, Metastases to liver, Myalgia, Pain, Pneumonia, Pulmonary embolism, Syncope, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), 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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASPIRIN; bendroflumethiazide; cholecalciferol; ursodiol
Current Illness: Biliary cirrhosis primary; Flu vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131701GBR014528

Write-up: Information has been received from a consumer via the Agency (HA# GB-MHRA-EYC 00149108) on 31-JAN-2017, referring to a 68 year old female patient with biliary cirrhosis primary. On 14-SEP-2016 and 12-OCT-2016, the patient was vaccinated with HBVAXPRO, each time, 10 microgram, parenteral respectively. Other suspect therapy included influenza virus vaccine (unspecified) (manufacturer unknown). Concomitant therapies included aspirin, bendroflumethiazide, cholecalciferol and ursodeoxycholic acid. On an unknown date, the patient experienced lymph node aches, headaches for 5 weeks, dizziness and fainting, asthma-like symptoms, muscle pain, pain, fatigue, vague illness, most of these were still ongoing. The patient had never felt so ill in all her life, she was supposed to have another dose in three months but she would never have another one of these, she did not know if this had happened because they gave her the flu jab at the same time. Seek advice details: the patient had been going to the doctors for the last three weeks, they had only just decided to do chest x-rays and so forth, they did do an electrocardiogram and blood tests, the patient was now finding it difficult to breathe. Then it was informed that this patient with a diagnosis of metastatic carcinoma of the lung was admitted to hospital 2 months ago but sadly passed away last month in hospital. From the death notification: the patient was admitted with increasing shortness of breathe despite being on antibiotic therapy for pneumonia. A computerized tomography pulmonary angiography (CTPA) was performed which showed acute on chronic pulmonary embolisms bilaterally for which she was started on treatment dose dalteparin before being switched to rivaroxaban. The computerized tomography (CT) also showed a lesion in the right lobe of her liver and lytic lesions in her ribs. A bronchoscopy was performed and this found a primary adenocarcinoma of which metastasis to the liver and bone. During the admission she became increasingly hypoxic with some specks of haemoptysis. She also had a raised white blood count and C-reactive protein and was started on intravenous antibiotics. A chest x-ray also showed some new consolidation. Despite antibiotic therapy the patient required more oxygen to maintain her oxygen saturations and the patient was due to start of Optiflow therapy. The patient did not recover from lymph node aches, headaches for 5 weeks, dizziness and fainting, asthma-like symptoms, muscle pain, pain, fatigue, vague illness. The outcome of the event breathing difficult was unknown. The patient had an episode where she developed central chest pain with no electrocardiogram (ECG) changes and passed away soon after this. Causality assessment for all events were not reported. All events were considered to be medically significant by Agency.


VAERS ID: 681778 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-10-12
Onset:0000-00-00
Submitted: 2017-02-07
Entered: 2017-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Blood test, Bronchoscopy abnormal, C-reactive protein increased, Chest X-ray abnormal, Chest pain, Computerised tomogram thorax abnormal, Death, Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Haemoptysis, Headache, Hepatic lesion, Hypoxia, Lung adenocarcinoma, Lung consolidation, Lymph node pain, Malaise, Metastases to bone, Metastases to liver, Myalgia, Osteolysis, Pain, Pneumonia, Pulmonary embolism, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Non-haematological malignant tumours (narrow), 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: Aspirin; Bendrofluemethiazide; Colecalciferol; Ursodeoxycholic acid
Current Illness: Biliary cirrhosis primary
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHFR2017GB000952

Write-up: Case number PHFR2017GB000952, is a spontaneous report received from a consumer via health authority (health authority number: GB-MHRA-ADR 23740950) on 31 Jan 2017. This report refers to a 68 years old female patient. Past medical history was not reported. Current condition included primary biliary cirrhosis. Concomitant medications included Aspirin, colecalciferol and ursodeoxycholic acid. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) on an unspecified date. The patient was also vaccinated with HBVAXPRO(manufacturer unknown and batch number: not reported) at a dose of 10 mcg parenteraly on 14 Sep 2016. On 12 Oct 2016, the patient again received HBVAXPRO vaccine at a dose of 10 mcg parenteraly on 14 Sep 2016. On an unknown date, the patient developed lymph node aches, headaches for 05 weeks, dizziness and fainting, asthma like symptoms, muscle pain, pain, fatigue and vague illness. It was reported that most of these were still ongoing. The patient stated that she had never felt so ill in all her life. She was supposed to have another dose in three months but she would never had another one of these. She mentioned that she did not know if this had happened because they gave her the flu jab at the same time. The patient had been going to the physician for the last three weeks, they had only just decided to do chest x-rays and so forth, they did do an electrocardiogram and blood tests (unspecified results). The patient stated that she was not finding it difficult to breath. On an unspecified date the patient was diagnosed with metastatic carcinoma of the lung and was admitted to hospital for 02 months ago but sadly passed away last month in the hospital. It was reported that the patient was admitted with increasing shortness of breath despite being on antibiotic therapy for pneumonia. A computerized tomography pulmonary angiography (CTPA) was performed which showed acute on chronic pulmonary embolisms bilaterally for which she was started on treatment dose dalteparin before being switched to rivaroxaban. The computerized tomography (CT) also showed a lesion in the right lobe of her liver and lytic lesions in her ribs. A bronchoscopy was performed and this found a primary adenocarcinoma of which metastasis to the liver and bone. During the admission she became increasingly hypoxic with some specks of haemoptysis. She also had a raised while blood count and c-reactive protein and was started on intravenous antibiotics. A chest x-ray also showed some new consolidation. Despite antibiotic therapy the patient required more oxygen to maintain her oxygen saturations and the patient was due to start of optiflow therapy. The patient had an episode where she developed central chest pain with no electrocardiogram (ECG) changes and passed away soon after this. The outcome of the event dyspnoea was unknown. The outcome of the events lymph node pain, headache, dizziness, syncope, asthma, myalgia, pain, fatigue and malaise was reported as condition unchanged. The case was assessed as serious (medically significant). The causality of the events were not reported. The case was assessed as lost to follow up at initial.


VAERS ID: 685066 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-07
Entered: 2017-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ES2017GSK031130

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly subject who received Flu seasonal TIV Dresden. On an unknown date, less than a year after receiving Flu seasonal TIV Dresden, the subject developed unknown cause of death. Serious criteria included death, hospitalization and GSK medically significant. The outcome of unknown cause of death was fatal. The reported caused of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described death NOS in an adult aged 65 or more of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was a part of the prospective study that aimed to analyse the clinical characteristics and outcomes of pneumococcal pneumonia, empyema, and primary bacteraemia that have occurred in adult patients aged more that or equal to 65 years and to describe serotype distribution since PCV-13 authorization compared with the previous period (2006-2010), including a sub-analysis of very elderly patients (80 years). The study was conducted in two hospitals from 01 June 2010 to 30 June 2015. (In this study, out of the total 30 patient died, 10 were female). No information on patient''s medical history or family history or concurrent condition or concomitant condition was provided. On an unspecified date during the year prior to admission, the patient received unspecified seasonal influenza vaccine (administration route unknown; dosage unknown; batch number not provided). On an unspecified date between 1 June 2010 and 30 June 2015, (In this study, out of 262 episodes (involving 243 patients; range: 1-4 episodes per patient), 249 episodes were pneumonias, 11 were primary bacteremia''s, and 2 were empyema''s). Subsequently, on an unspecified date, the patient died. The cause of death was unknown. It was not reported if the autopsy was performed. (In this study, out of total 30 patients died during hospitalisation, 14 were attributed to PCV-13 serotype infected, 22 had bacteraemia, 8 had CNS vascular disease, 6 had dementia and 20 had septic shock. 10 patients had invasive ventilation whereas 15 had ICU admission). This case has been considered serious due to death/hospitalisation. Treatment was unknown. The authors did not comment on the relationship between death NOS and unspecified seasonal influenza vaccine. However, the authors stated "Mortality was related with the presence of complications at admission". The authors concluded that "despite the fact that the elderly patient seen at the hospital with pneumococcal pneumonia, empyema or primary bacteraemia had a high burden of comorbidities, the rate of pneumococcal vaccination in our setting was very low. Except for septic shock, the main outcome variables (including mortality) were similar to the ones observed in the period preceding PCV-13 authorization. Serotypes included in PCV-13 were responsible for most pneumococcal infections although a decreasing tendency was observed during the study period, probably due to the effect of paediatric vaccination. The implementation of the new (2015) ACIP recommendations in our setting could improve this scenario". The article is not available for submission due to copyright restriction.


VAERS ID: 685277 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-03
Entered: 2017-03-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ2017GSK030271

Write-up: This case was reported in a literature article and described the occurrence of myocardial infarction in a subject who received Flu seasonal TIV Dresden. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed myocardial infarction. Serious criteria included death and GSK medically significant. The outcome of myocardial infarction was fatal. The reported cause of death was myocardial infarction. The investigator considered the myocardial infarction to be unlikely related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of myocardial infarction in a patient of unspecified age and gender who was vaccinated with unspecified 2016 seasonal influenza vaccine (manufacturer unknown). No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified 2016 seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date in 2016, an unknown period after vaccination, the patient developed myocardial infarction. On an unspecified date, the patient died of myocardial infarction. It was unknown if an autopsy was performed. [The majority of reports were submitted by nurses (80%), followed by GPs (14%) and pharmacists (5%)]. This case has been considered serious due to death/per Centre. [A serious adverse event is determined by Centre according to internationally agreed criteria (i.e., results in death or is life threatening, causes or prolongs hospitalisation, results in persistent or significant disability/incapacity or is a congenital abnormality]. The treatment for the event of myocardial infarction was not reported. The authors stated "the death was considered unlikely to be due to the vaccination".


VAERS ID: 686356 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-17
Entered: 2017-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Influenza virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified date. Influenza virus test, confirmed influenza
CDC Split Type: ES2017GSK038017

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a elderly female subject who received Flu seasonal TIV Dresden. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included influenza with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza (fatal). The reported cause of death was influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Lab tests performed on unspecified date Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was confirmed influenza. Additional information was provided. This case was reported in a literature article and described the occurrence of suspected vaccination failure in a female patient aged between 75 and 79-year who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown). The patient was a part of the cross-sectional study that aimed to determine the costs associated with laboratory-confirmed influenza-related hospitalization in patients aged equal to or more than 65 year and to assessed the effect of influenza immunisation in reducing costs due to hospitalisation. The study was performed in patients admitted to 20 hospitals from 7 regions during the 2013-14 and 2014-15 influenza seasons. No information on patient''s medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal influenza vaccine (administration route and site unknown; dosages unknown; batch number not provided). The patient received vaccination either in 2013-14 or 2014-15 influenza season. The patient received seasonal influenza vaccine equal to or more than 15 days prior to hospital admission. In this study, information on the influenza vaccination status was obtained from vaccination registers, hospital medical records, vaccination cards or primary healthcare records. On an unspecified date either in 2013-14 or 2014-15, at least 15 days after vaccination, the patient was hospitalised due to influenza infection. (In this study, the mean hospital and intensive care unit (ICU) stays were 1-138 days and 1-86 days respectively. Out of total 728 number of confirmed influenza hospitalisations, 483 admissions were due to influenza, 160 due to primary influenza pneumonia and 85 due to secondary influenza pneumonia). Subsequently, the influenza was confirmed by laboratory. On an unspecified date, the patient died due to influenza. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/hospitalisation/suspected vaccination failure. Treatment was unknown. The authors did not comment on the relationship between the event of influenza infection and unspecified seasonal influenza vaccination. The authors stated "Although influenza vaccination of the elderly may not achieve significant savings in mean hospitalization costs, it can lessen the degree of severity and avoid complications. This study focused on the direct medical costs of laboratory confirmed influenza-related hospitalizations in patients aged equal to or more than 65 y. Future studies should include direct non-medical cost and indirect costs, including transportation, to accurately measure the annual social and economic burden and impact attributed to influenza infections". This is 1 of the 2 valid cases reported in the same literature article.


VAERS ID: 686359 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-17
Entered: 2017-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Influenza virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified date. Influenza virus test, confirmed influenza
CDC Split Type: ES2017GSK038020

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a elderly male subject who received Flu seasonal TIV Dresden. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included influenza with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza (fatal). The reported cause of death was influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Lab tests performed on unspecified date. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was confirmed influenza unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of suspected vaccination failure in a male patient aged more than 90-year who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown). The patient was part of the cross-sectional study that aimed to determine the costs associated with laboratory-confirmed influenza-related hospitalization in patients aged equal to or more than 65 year and to assess the effect of influenza immunisation in reducing costs due to hospitalisation. The study was performed in patients admitted to 20 hospitals from 7 regions during the 2013-14 and 2014-15 influenza seasons. No information on patient''s medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal influenza vaccine (administration route and site unknown; dosages unknown; batch number not provided). The patient received vaccination either in 2013-2014 or 2014-2015 influenza season. The patient received seasonal influenza vaccine equal to or more than 15 days prior to hospital admission. In this study, information on the influenza vaccination status was obtained from vaccination registers, hospital medical records, vaccination cards or primary healthcare records. On an unspecified date either in 2013-2014 or 2014-2015, at least 15 days after vaccination, the patient was hospitalised due to influenza infection. (In this study, the mean hospital and intensive care unit (ICU) stays were 1-138 days and 1-86 days respectively. Out of total 728 number of confirmed influenza hospitalisations, 483 admissions were due to influenza, 160 due to primary influenza pneumonia and 85 due to secondary influenza pneumonia). Subsequently, the influenza was confirmed by laboratory. On an unspecified date, the patient died due to influenza. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/hospitalization/suspected vaccination failure. Treatment was unknown. The authors did not comment on the relationship between the event of influenza infection and unspecified seasonal influenza vaccination. The authors stated "Although influenza vaccination of the elderly may not achieve significant savings in mean hospitalization costs, it can lessen the degree of severity and avoid complications. This study focused on the direct medical costs of laboratory confirmed influenza-related hospitalizations in patients aged equal to or more than 65 y. Future studies should include direct non-medical cost and indirect costs, including transportation, to accurately measure the annual social and economic burden and impact attributed to influenza infections in this country". This is 1 of the 2 valid cases reported in the same literature article.


VAERS ID: 686720 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-08
Entered: 2017-03-20
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2010GSK000118

Write-up: This case was reported by a consumer via market research programs and described the occurrence of pulmonary embolism in a patient who received Flu seasonal TIV Dresden. On an unknown date, the patient received Flu seasonal TIV Dresden at an unknown dose. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the patient experienced pulmonary embolism (serious criteria death and GSK medically significant). On an unknown date, the outcome of the pulmonary embolism was fatal. The reported cause of death was pulmonary embolism. It was unknown if the reporter considered the pulmonary embolism to be related to Flu seasonal TIV Dresden. Additional information was provided: This case is one of the multiple cases reported following the market research. Age at vaccination was not reported. The question and the reply for this case were: Could you tell us what you recall having seen/read/heard regarding vaccines during the last 12 months? Influenza vaccine led to fatal pulmonary embolism. Adjuvants included in vaccines are full of toxic products for the body.


VAERS ID: 686921 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-12
Entered: 2017-03-22
   Days after submission:37
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2015GSK186205

Write-up: This case was reported by a consumer via market research programs and described the occurrence of vaccination failure in a female patient who received Flu seasonal TIV Dresden. On an unknown date, the patient received the 1st dose of Flu seasonal TIV Dresden. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu seasonal TIV Dresden. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: in the case of a future pregnancy, if a healthcare professional recommend you to vaccinate against seasonal influenza during your pregnancy to protect your baby, would you do it? If not, why? My grandmother died because of the flu when it was the first time she got vaccinated. The patient died on an unknown date. This case was considered as suspected vaccination failure as the details regarding time to onset for the event and lab test confirmation were unknown at the time of reporting. MAH Comment: Suspected reasonable causal relationship based on the event vaccination failure is upgraded from ''Unknown'' to ''Yes'' as the event is listed with Flu seasonal TIV vaccine Dresden vaccine and for the event Influenza is downgraded from ''Unknown'' to ''No'' as there is not enough evidence to establish a causal relationship with the Flu seasonal TIV vaccine Dresden vaccine.


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