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From the 7/23/2021 release of VAERS data:

Found 1,949 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: 1381539 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-22
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021634811

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory Authority report number is 557967. An 87-year-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (unknown if first or second dose) for COVID-19 immunisation and influenza vaccine inact split 3v (FLUARIX) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On 22May2021, the patient experienced adverse event following immunisation with fatal outcome. The patient died on an unspecified date in 2021. The cause of death was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1413624 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-05-16
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 22
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: PROLOPA; SYNTHROID; MANTIDAN; VITAXON [CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE;THIAMINE HYDROCHLORIDE]; OMEGA-3 [OMEGA-3 NOS]; MAGNESIUM; PROPOLIS; OSCAL D [CALCIUM CARBONATE;VITAMIN D NOS]; ASPIRIN [ACETYLSALICYLIC ACID]; DASTENE; CENTRUM
Current Illness: Parkinson''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: Surgery (more than 10 years ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: BRSA2021SA203122

Write-up: COVID-19 PCR test positive; Covid-19; This initial Information regarding this unsolicited valid serious death case was received on 14-Jun-2021 from a non-healthcare professional (unknown relationship with patient) through Business Partner, which was forwarded to Regulatory Authority on 15-Jun-2021. On 14Jun2021, Regulatory Authority received a report of a serious adverse event after the use of influenza vaccine through the customer service. The reporter, profession not informed, reports that the patient, (comorbidity, continuous medication use, and unknown demographics), received the first dose of the adsorbed covid-19 (inactivated) vaccine on 12/Feb/2021 and on 10/Mar/2021. On 16/May/2021 the patient had the first symptom of Covid-19 [Covid-19] (patient had unspecified treatment for 7 days), and on 24/May/2021 the patient underwent PCR (Polymerase chain reaction) test: positive. On an unspecified date the patient had to be admitted to the ICU (intensive care unit) and died on 07/Jun/2021 as a result of complications in the disease-related condition. On 14/Jun/2021 after receiving the initial e-mail, we received more information about the case, in which data from the reporter, the patient, medical history, concomitant and treatment medications, and the evolution of the patient''s condition were reported. On the same date, we received information about the patient''s vaccination status, in which he reports receiving the influenza vaccine in 2021, batch not informed. Here is additional information: reporter, biochemical engineer. Patient: 174 cm, weight 89 kg, It was reported that the patient was medicated with influenza vaccine in 2021, after administration of covid-19 (inactivated) adsorbed vaccine, within the recommended interval between vaccine administration (more than 15 days). For treatment of the serious adverse event, the patient was medicated from 17/Mai/2021, with Zinnat (Cefuroxime), 1g/day; Atrovent (ipratropium bromide), 1 drop/mL, 5 mL, inhalation with saline. Beginning on 21/May/2021, with a positive result for COVID, he was medicated with moxifloxacin hydrochloride 400 mg/day; Atrovent (ipratropium bromide), 5 drops/mL, 5 mL serum; and beginning on 24/May/2021 the patient was hospitalized at Hospital, in which the patient underwent submitted to unspecified tests. The reporter reported that on 21/May/2021 the patient had a pharmacy test for COVID (corona virus disease) with a positive result. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Concomitant medications: Prolopa BD (levodopa and benserazide hydrochloride), Syntroid (levothyroxine sodium), Mantidam (amantadine hydrochloride), Vitaxon(multivitamin), Omega 3, Magnesium, propolis, Oscal (calcium and vitamin D), Aspirin Prevent (acetylsalicylic acid), Dastene (Dutasteride), Centrum tabs man (multivitamin), Magnen B6(magnesium glycinate), Glifage (metformin), and simvastatin, without further information about the therapies. The patient received the first dose of the adsorbed covid-19 (inactivated) vaccine on 12/Feb/2021 and on 10/Mar/2021. Patient medical history, concomitant disease, risk factor: Medical history of surgery for placing a saphenous vein graft more than 10 years ago, but with cardiologist follow-up, led a healthy and normal life and atypical Parksonism, since date not informed. It is unknown if the patient had any additional medical history, concomitant disease or risk factor. Lab data/results: Exam: SARS-COV-2 (Severe acute respiratory syndrome coronavirus 2) TEST Date: 24 May 2021 Result: positive. It is unknown if there were additional lab data/results available.; Sender''s Comments: This case concerns 86-year-old male patient who had Covid-19 (corona virus disease), COVID-19 PCR (Polymerase chain reaction) test positive and died after vaccination with INFLUENZA VACCINE (TRIVALENT) (unknown manufacturer) and COVID-19 VACCINE INACT (not produced by sanofi pasture). The time to onset is unknown. Medical condition at the time of vaccination was Parkinson''s disease. The patient''s past vaccinations and tolerance, autopsy result and other laboratory test ruling out alternate etiologies were needed to fully assess the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: COVID-19; COVID-19 PCR test positive


VAERS ID: 1264201 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-03-09
Onset:2021-03-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS A5FK9 / N/A LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood electrolytes, Blood gases, Chest X-ray, Coagulation test, Computerised tomogram pancreas, Death, Haematology test, Intensive care, Respiratory viral panel, Resuscitation, SARS-CoV-2 test, Toxicologic test, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Miralax (daily) As needed: Tylenol, Albuterol, Glycerin Suppository
Current Illness: No acute illness at time of vaccination
Preexisting Conditions: Microcephaly with abnormal brain imaging, swallowing dysfunction with G Tube placement, Spastic quadriplegia, severe intellectual and neurologic impairment
Allergies: No known allergies
Diagnostic Lab Data: Chest Xray (3/14 and 3/15) and Pan CT scan: 3/14/2021 Multiple blood gases, hematology, electrolytes, coagulation panel COVID testing, respiratory viral panel, tox screen
CDC Split Type:

Write-up: The vaccine was given in clinic on March 9, 2021. On March 14, 2021 she was found at home, unresponsive in her chair. CPR was administered, 911 was called and she was brought to the ER and subsequently admitted to the PICU. Brain death examinations were completed x 2 and she was pronounced dead on 3/17/2021


VAERS ID: 1094197 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-02-26
Onset:2021-03-11
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014M20A / 2 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 010M20A / 1 LA / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ500AB / 1 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. T033663 / 1 LA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS ZJ432 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Feeling abnormal
SMQs:, Dementia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS, LASIX, PROTONIX,ALTACE, TRADJENTA, LUMIGAN, AMIODARONE, METOPROLOL
Current Illness: UNKNOWN
Preexisting Conditions: HBP, DIABETES, MAY BE OTHERS
Allergies: UNKNOWN
Diagnostic Lab Data: UNKNOWN - CONTACT PHYSICIAN OR HOSPITAL I AM NOT AWARE IF HE WAS TAKEN TO HOSPITAL OR DR''S OFFICE YESTERDAY OR NOT.
CDC Split Type:

Write-up: DEATH - PT''S WIFE CALLED 3-11 TO TELL US PATIENT WAS FEELING BAD, AND TO ASK WHAT TO DO. WE SENT A PULSEOXIMETER, AND ADVISED TO CONTACT DR. - ON MORNING OF 3-12, PT''S WIFE CALLED TO TELL US HE HAD PASSED AWAY DURING THE NIGHT.


VAERS ID: 1033467 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-03-23
Onset:2021-01-29
   Days after vaccination:312
Submitted: 0000-00-00
Entered: 2021-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, Cyanosis, Dyspnoea, Hyperhidrosis, Hypertension, Hypoxia, Pallor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Speech loss; Stroke
Allergies:
Diagnostic Lab Data: Test Name: covid 19; Test Result: Positive ; Result Unstructured Data: results and units were unknown
CDC Split Type: BRSA2021SA051803

Write-up: acute respiratory failure; cyanosis of extremities; dyspnoea; show profuse sweating; desaturation; pallor; covid 19; arterial hypertension; Initial information regarding this valid serious unsolicited case downloaded from regulatory authority database without narrative (level 2A), was received on 09-Feb-2021 from consumer/ non-health care professional via Health Authorities (Health Authority Reference Number BR-SA-SAC20210212001254). The following narrative is based on the information retrieved from all other accessible data. This case involves a 73-year old elderly female patient who experienced respiratory failure, cyanosis of extremities (cyanosis), dyspnoea, show profuse sweating (hyperhidrosis), desaturation (hypoxia), pallor, arterial hypertension (hypertension) and covid 19 (covid-19), while she received vaccine INFLUENZA VACCINE and COVID-19 VACCINE. Medical history included Stroke, Speech loss and was Bedridden. Past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing arterial hypertension. Concomitant medications were not reported. On 23-Mar-2020, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination. On an unknown date, the patient received COVID-19 VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination. On 29-Jan-2021, patient experienced acute respiratory failure, cyanosis of extremities (cyanosis), dyspnoea, show profuse sweating (hyperhidrosis), desaturation (hypoxia), pallor, arterial hypertension (hypertension) and covid 19 (covid-19), 10 months 6 days following the administration of suspect vaccine. The patient was hospitalized for these events (seriousness). Seriousness criteria was assessed as medically significant as per important medical event (IME) list for the event acute respiratory failure and Hypoxia, and COVID-19 as per reporter. It was not reported if the patient received a corrective treatment. Outcome of the events was fatal on 30-Jan-2021 for acute respiratory failure. There will be no information available regarding batch number in this case.; Sender''s Comments: This case concerns a 73-year-old female patient who experienced acute respiratory failure, cyanosis, dyspnoea, hyperhidrosis, hypoxia, pallor, hypertension and covid-19 after vaccination with company suspect INFLUENZA VACCINE and non-company suspect COVID-19 VACCINE. The time to onset was compatible with the events. Relevant laboratory test results included: COVID-19 - Positive [results and units were unknown] and Medical history included Stroke, Speech loss and was Bedridden. At the time of the event, the patient had ongoing arterial hypertension. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: severe acute respiratory failure; cyanosis of extremities; dyspnoea; show profuse sweating; desaturation; pallor; arterial hypertension; COVID-19


VAERS ID: 1006029 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT7108NA / 6 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multivitamin
Current Illness: none
Preexisting Conditions: expressive language delay
Allergies: none
Diagnostic Lab Data: I do not have records from the ED to know what they did
CDC Split Type:

Write-up: Patient had a syncopal event at night about 2 1/2 weeks after vaccination. He was found unresponsive the next morning and taken to ER, where he could not be revived.


VAERS ID: 981315 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 7A2S2 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray normal, Death, Dyspnoea, Endotracheal intubation, Hepatic cirrhosis, Nasal flaring, Oxygen saturation decreased, Tachypnoea, Wheezing
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 6
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hospital meds the day of the event: furosemide, KCL, albumin, ceftriaxone, dexmedetomodine, lactulose, midodrine, octreotide, pantoprazole, and rifaximin
Current Illness: alcoholic cirrhosis and esophageal varices
Preexisting Conditions: of alcoholic cirrhosis and esophageal varices
Allergies: NKDA
Diagnostic Lab Data: Patient recovered from event but passed 1/19/2021 - Primary cause of death per records - acute decompensated cirrhosis.
CDC Split Type:

Write-up: After vaccine was given, patient was cleaned up after having a bowel movement and shortly after, patient became tachypneic with nasal flaring and verbalized the words "can''t breathe." Dr. was notified and came to the bedside to assess. Patient had audible upper airway wheezes and orders obtained for Epi, benadryl and solumedrol. RT also came to bedside to assist. 1mg Epi x2 given 25mg Benadryl given 125mg Solumedrol given Anesthesia was called for intubation due to continuing low sats. -7.5 ETT noted at 22@lip -OG@60 Both were cleared via CXR. -0307: patient sedated and resting comfortably.


VAERS ID: 942246 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: Oregon  
Vaccinated:2020-12-11
Onset:2020-12-20
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT7081LA / 2 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS B23EA / 1 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. S022754 / 1 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. S025911 / 1 RL / SC

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Blood glucose decreased, Blood glucose increased, Cardiac arrest, Chest X-ray abnormal, Cough, Death, Echocardiogram abnormal, End-tidal CO2 decreased, Endotracheal intubation, Endotracheal intubation complication, Faeces hard, Infantile apnoea, Pulse absent, Pyrexia, Resuscitation, Retching, Seizure, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), 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) (narrow), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Enfamil Gentlease Formula
Current Illness: No known illness.
Preexisting Conditions: No known chronic/ long-standing health conditions.
Allergies: NKMA
Diagnostic Lab Data: Initial cap glucose- Undetectable 12/21/2020 12/21/2020 16:29(pm) Glucose- 37 mg/dL 12/21/2020 16:36(pm) Glucose- 46 mg/dL 12/21/2021 16:50(pm) Glucose- 244 mg/dL
CDC Split Type:

Write-up: On 12/20/2020, dad of patient called our office after hours. Nurse triage line took the call. Dad''s reported that pt had a fever of 100.6 F (max temp) and hard stools. Pt was given a dose of Tylenol and 10-15 minutes later, pt vomited. Triage nurse advised that dad follow up with PCP office when open in the AM. Dad called our office at 10:25am on 12/21/2020 stating that pt fever had lifted, but pt vomited a total of 5 times since the night before, with the last episode at 7:45 am on 12/21/2020. Pt had adequate fluid intake and urine output and stool had softened. MA advised continued home care. Appropriate triage advice was given and documented. At 16:43(pm) on 12/21/20, dad called back to clinic stating patient symptoms had worsened and they were at the emergency department. Dad disconnected call before speaking with the MA. The MA attempted to call dad back, but there was no answer. A message was left for dad to return call. On 12/22/20 at 12:44(pm), dad called in to clinic to report that pt had died- cause unknown. Our clinic obtained records from Hospital. The ED report stated that pt presented to the emergency department via EMS Code 3 in cardiac arrest. Unknown downtime prior to the initiation of chest compressions. Pt was staying with grandparents. When grandma went to wake pt from his nap, he was not responsive. When grandma tried to pick him up, there was possibly some brief, generalized seizure activity as well as coughing and gagging. Child remained unresponsive and was taken by private vehicle to outside Urgent Care where pt was found to be apneic and in asystole. An AED was applied, no shock advised. EMS was called and CPR was started. EMS placed an endotracheal tube and established IO access. 4 rounds of epinephrine were administered during the course of the prehospital resuscitation which was approximately 15-20 minutes. Presenting rhythm was asystole. No change in rhythm upon transport and arrival. Immediately upon arrival the pediatric transport team was activated and the pediatric intensivist was paged. Chest compressions were resumed according to protocol. Additional inter osseous access was established in the left proximal tibia. Fluid bolus was initiated. Serial doses of epinephrine were administered every 4 minutes throughout the resuscitation. The child also received several boluses of IV bicarb. Online consultation by ED physician with PICU attending was established early in the resuscitation course. It was agreed by ED physician and PICU attending that the peds transport team would be dispatched urgently to the ED location in anticipation of possible ROSC and need for emergent transport to PICU. It was agreed by ED physician and PICU attending that transportation would not be initiated with the child still undergoing resuscitation requiring chest compressions prior to ROSC. Initially, endotracheal tube position felt to be acceptable based on the clinical evaluation, however chest x-ray did demonstrate some degree of right mainstem intubation, after which the tube was pulled back approx 2cm and subsequent x-ray showed the ETT tip in good position approx 1 cm above the carina. Initial end-tidal CO2 was 14 on arrival, this continued to trend downward until undetectable throughout the course of the resuscitation. At no point were there palpable pulses or other evidence of return of circulation throughout the resuscitation. Capillary blood glucose was initially undetectable. The child received serial boluses of D 25 via IO line for a tital of 30 g dextrose after which CBG ultimately came up to 244. Multiple efforts were made throughout the resuscitation to achieve IV access and to obtain blood for laboratory studies. All efforts were unsuccessful, making it impossible to obtain any labs throughout the course of the resuscitation. Attempts to obtain even capillary blood samples via heel stick for CBG measurements were extremely difficult. Resuscitation continued for 49 minutes after ED arrival. A total of at least 65 minutes of CPR time. Bedside ultrasound was used to look for cardiac activity during the last 5 pulse checks of the resuscitation, demonstrating cardiac standstill. Despite the efforts and interventions mentioned, ROSC was never obtained and the code was discontinued at 17:03(pm). The child''s parents were informed of his death upon their arrival to the ED at approximately 17:40(pm). Family was given time with the pt. The medical examiner arrived and discussed case at 19:11(pm). At 19:49(pm) Medical Examiner was interviewing grandparents along with 2 County Detectives. The medical examiner took custody of the pt at 21:52(pm). Evidence bag was sent with the medical examiner. Pt received vaccinations 10 days prior to death. We are still waiting for M.E. report, as we do not have any further information as to why pt passed.


VAERS ID: 906303 (history)  
Form: Version 2.0  
Age: 0.58  
Sex: Female  
Location: North Carolina  
Vaccinated:2020-12-17
Onset:2020-12-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UJ350AA / UNK RL / IM
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS DE7TB / UNK LL / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 4CL44 / UNK RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH D12971 / UNK LL / IM

Administered by: Public       Purchased by: ?
Symptoms: Autopsy, Cyanosis, Death, Resuscitation, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: none
Preexisting Conditions: unknown
Allergies: none
Diagnostic Lab Data: body sent for autopsy
CDC Split Type:

Write-up: unknown if adverse effect, parents found baby unresponsive and blue and called 911 and CPR started and baby expired unknown cause


VAERS ID: 908105 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: California  
Vaccinated:2020-12-09
Onset:2020-12-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS HG9N2 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-18
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: hypertension, depression
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt experienced chill, fever and tiredness. on 12/22, pt''s family reported pt passed away. not certain about the relationship between her death and the flu shot but just reporting it


VAERS ID: 903560 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2020-12-01
Submitted: 0000-00-00
Entered: 2020-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Autoimmune disorder (compromised immune system)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2020AM

Write-up: died / deathly ill; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a 58-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Concurrent medical conditions included autoimmune disorder (compromised immune system). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. In December 2020, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The patient died in December 2020. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were received as follows: The age at vaccination was not reported. The patient died in December of 2019. He got deathly ill right after he got a flu shot. He had a compromised immune system so the reporter wanted to know why did they give him the shot.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 897563 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Utah  
Vaccinated:2020-11-17
Onset:2020-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT7011NA / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-11-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: No known allergies
Diagnostic Lab Data: Not known
CDC Split Type:

Write-up: Flu shot given on 11/17/2020 at 3:10 pm and patient died on 11/18/2020 at approx. 10:30 am at his home.


VAERS ID: 955091 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Nevada  
Vaccinated:2020-11-16
Onset:2020-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ535AB / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Aphasia, Biopsy brain abnormal, Central nervous system lesion, Coma, Dysarthria, Dysphagia, Endotracheal intubation, Facial spasm, Life support, Magnetic resonance imaging brain abnormal, Muscular weakness, Myoclonus, Pneumonia aspiration, Seizure
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (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), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt rec''d flu vaccine (lot # 2202: UJ535AB) at a pharmacy on 11/16/2020. The next day he developed right hemifacial spasm and palatal myoclonus. 11/17/2020 BRAIN MRI showed a small left frontal non-enhancing lesion, initially thought to possibly be a subacute stroke. However, he worsened and developed anarthria, aphagia, right arm wkns, and aspiration pneumonia necessitating intubation. Repeat BRAIN MRI 11/24/2020 was worse. He had the 1st of 2 brain biopsies 11/28/2020, which pathology was resulted as "reactive changes" but was non-diagnostic. He had add''l BRAIN MRIs that showed continued worsening of the left hemisphere lesion and subsequent involvement of the right hemisphere. A 2nd brain brain biopsy was done 12/16/2020, which pathology was also resulted as "reactive changes" but was also non-diagnostic. The pt has a h/o "low-grade" T-cell lymphoma, but neither biopsy samples had evidence of lymphoma in CNS or of obvious features to suggest other neoplasm, vasculitis, granulomatous disease, infection, or demyelination. This is a very odd / challenging case. Initially despite the timing I did not consider the flu vaccine to be relevant / causative. However, there is no other obvious possible etiology. Hence I would consider the flu vaccine probably related to his CNS problem and a serious adverse reaction. He eventually started having seizures. He remains in a coma on life support. His family is going to withdraw care 1/8/2020.


VAERS ID: 1011981 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Florida  
Vaccinated:2020-11-13
Onset:2020-11-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT7049JA / 1 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-11-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: ADHD, Anxiety, Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Suicide


VAERS ID: 893940 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2020-10-30
Onset:2020-10-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Gestational diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt is a G1P0, recently diagnosed with gestational diabetes. Gestational age 30 weeks. Intrauterine fetal demise occurred around 24-36 hours after vaccination.


VAERS ID: 893464 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Rhode Island  
Vaccinated:2020-10-27
Onset:2020-10-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 542MY / N/A LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atrovent, baclofen, Famotidine, flonase, gabapentin, glycopyrrolate, lansoprazole, montelukast, oxcarbazepine, miralax, sennosides, tizanidine, Pediasure Peptide 1.5 nutritional formula PRN: tylenol, motrin, diastat
Current Illness: Increase in spasticity Elevated blood pressure
Preexisting Conditions: Spastic Quadriplegia, Feeding tube dependence (J Tube placed), malnutrition, sliding hiatal hernia, GERD, epilepsy, dysphagia, constipation, tracheobronhomalacia, visual impairment,
Allergies: Seasonal allergies No allergies to food, medications, products
Diagnostic Lab Data: Noe
CDC Split Type:

Write-up: Patient was put to bed at 10pm in his usual state of health. Parents found him unresponsive at 1am when they went to check on him per family routine. EMS was called. He was brought to the ER and was pronounced dead.


VAERS ID: 904045 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Michigan  
Vaccinated:2020-10-26
Onset:2020-10-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ484AB / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-11-01
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: He developed COVID19 symptoms the day after vaccination, tested positive, and subsequently passed away.


VAERS ID: 1012692 (history)  
Form: Version 2.0  
Age: 1.42  
Sex: Female  
Location: Minnesota  
Vaccinated:2020-10-26
Onset:2020-10-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 49TM3 / 4 RL / IM
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 2SM24 / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. T001208 / 3 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH DL2861 / 4 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: mild URI symptoms the month prior, so didn''t have her vaccines at that time. She came back for vaccines on 10/26/2020.
Preexisting Conditions: none
Allergies: Amoxicillin allergy
Diagnostic Lab Data: She had not been ill, had no testing done prior to her death.
CDC Split Type:

Write-up: This child died unexpectedly the following morning in her sleep. She has been diagnosed with SUDC (sudden unexplained death of a child). Preliminary autopsy did not uncover any medical issues or problems. There is further testing being done and it may be a few months before all tests are done and final report is available. I do not submit this event as evidence of the cause of this child''s death. However, I need to report this event as it is not clear whether or not the vaccine(s) are related. I had initially planned to wait until final autopsy results were available, but that is taking very long and I wanted to make this report. I submit it today and can provide final autopsy report when I receive it.


VAERS ID: 1191957 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2020-10-26
Onset:2020-10-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. 279839 / UNK AR / SYR

Administered by: Senior Living       Purchased by: ?
Symptoms: Death, Dysstasia, Fall, Gait inability, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-11-26
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Guillain Barre Syndrome within 24 hours of receiving vaccine. Was unable to stand or walk, fell several times.


VAERS ID: 897458 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-10-26
Onset:2020-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UJ449AB / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Condition aggravated, Death, Loss of consciousness, Presyncope, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), 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) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type: CASA2020SA303409

Write-up: vasovagal reaction to the injection; Cardiac arrest; convulsions; quickly lost consciousness; Initial information was received on 27-Oct-2020 regarding an unsolicited valid serious case from the other health care professional. This case involves a 87-years-old female patient who quickly lost consciousness (loss of consciousness), cardiac arrest, convulsions (seizure) and vasovagal reaction to the injection (presyncope), while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. Patient had underlying heart conditions. Concomitant medication, medical treatments, vaccinations and family history were not provided. On 26-Oct-2020, the patient received a dose of 0.5 mL suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (lot number: UJ449AB, expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On 26-Oct-2020, the patient had cardiac arrest, quickly lost consciousness (loss of consciousness) and convulsions (seizure) (serious events) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant and cardiac arrest was leading to death. Coroner confirmed that it was not caused by the vaccine but a vasovagal reaction to the injection (presyncope) occurred (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that 25 other residents received the same vaccine but there were no adverse reactions. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. It was unknown if an autopsy was done. The cause of death was reported as Cardiac arrest. Additional information was received on 12-Nov-2020. New event cardiac arrest was added. Cause of death was updated.; Sender''s Comments: Additional information received on 12-Nov-2020 changes the previous assessment of the case. This case concerns a 87-year-old female patient who had cardiac arrest, loss of consciousness, seizure, and presyncope after vaccination with FLUZONE HIGH DOSE. Patient had underlying heart conditions (unspecified). It was reported that Coroner confirmed that it was not caused by the vaccine but a vasovagal reaction to the injection. The cause of death was cardiac arrest. Further information regarding autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 893549 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: California  
Vaccinated:2020-10-21
Onset:2020-10-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2020-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS XJ3ZT / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Endotracheal intubation, Loss of consciousness, Malaise, Resuscitation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: gabapentin, omeprazole, hydrocodone-acetaminophen, duloxetine, trazodone, cyclobenzaprine
Current Illness: oral lesion/growth that was scheduled for biopsy on 10/29/20
Preexisting Conditions: chronic migraine, interstitial cystitis, gerd, recurrent depression, anxiety
Allergies: none
Diagnostic Lab Data: As reported by daughter: no MI, no brain aneurysm, no PE, no intoxication
CDC Split Type:

Write-up: Sudden death on 10/25/20, 9:15AM. Patient''s adult daughter reports patient awoke on 10/25/20 AM feeling unwell and eventually lost consciousness. Had to be resuscitated and eventually intubated.


VAERS ID: 892415 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Illinois  
Vaccinated:2020-10-21
Onset:2020-10-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ546AA / N/A AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Death, Decreased appetite, Intensive care, Lethargy, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-24
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE, LISINOPRIL, PREDNISONE, TERAZOSIN, ELIQUIS, ADV
Current Illness: CANCER (PITUITARY GLAND TUMOR, NOT DISCLOSED)
Preexisting Conditions: COPD, HYPERTENSION, BPH, OSTEOPOROSIS, HYPOTHYROIDISM
Allergies: PENICILLINS, OTHERWISE NOT SPECIFIED
Diagnostic Lab Data: BLOODWORK DONE WHEN ADMITTED TO ICU BUT WAS NOT SPECIFIED TO ME
CDC Split Type:

Write-up: Pt felt ill later in the day on 10/21/2020 and vomited. Pt was described as lethargic on 10/22 and 10/23 and lack of appetite also observed those days. Pt was brought to local ER where he was admitted to the ICU. He had bloodwork done when admitted to ICU but was not specified to me. Pt died 10/24 around 3AM


VAERS ID: 890008 (history)  
Form: Version 2.0  
Age: 1.08  
Sex: Male  
Location: Texas  
Vaccinated:2020-10-14
Onset:2020-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT7081JA / 1 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Influenza virus test negative, SARS-CoV-2 test negative
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: febrile seizure at 8mo after Pentacel, RotaTeq, Engerix-B, and Prevnar. Event self-resolved, never occurred again
Other Medications: Acetaminophen taken after vaccination
Current Illness: history of single febrile seizure 5/8/2020
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: COVID and flu negative
CDC Split Type:

Write-up: Child found deceased in bed.


VAERS ID: 1116157 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: Unknown  
Vaccinated:2020-09-23
Onset:2020-10-15
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT7081JA / UNK LL / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UJ185AA / UNK RL / OT
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. S038146 / UNK LL / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: acetaminophen
Current Illness: Drug use for unknown indication; Prophylaxis
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Seizure
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075132103USA003934

Write-up: the patient found deceased in bed (death); This spontaneous report was received from a physician via Sanofi (manufacturer control # 2020SA294858) on 15-MAR-2021, referring to a 13-month-old male patient. The patient''s medical history included seizure and coronavirus disease of 2019 (COVID-19). He had no pre-existing physician-diagnosed allergies and birth defects and at the time of reporting. It was known if the patient had any additional medical history, concomitant disease or risk factor. Past medical treatment(s), vaccination(s) and family history were not reported. On 23-SEP-2020 the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (albumin status recombinant Human albumin (rHA) (lot # S038146, expiration date was not reported, upon internal validation established as 25-MAY-2021, strength was not reported) 0.5 milliliter, subcutaneously in the left thigh for prophylactic vaccination. On the same date, the patient was also vaccinated with hib conj vaccine (tet toxoid) (ACTHIB) (lot # UJ185AA, expiration date, strength and route were unknown) 0.5 milliliter in right vastus lateralis for prophylactic vaccination. On 14-OCT-2020, the patient was vaccinated with influenza virus split virion 4v vaccine inactivated (FLUZONE) prefilled syringe (lot # UT7081JA, expiration date was 30-JUN-2021, strength was not reported) 0.5 milliliter intramuscularly in left vastus lateralis for prophylactic vaccination. Either on 14-OCT-2020 or 15-OCT-2020, the patient received a dose (once) of acetaminophen (PARACETAMOL) (lot #, expiration date, strength and route were not reported) 4 ml for an unknown indication and then the patient was put to bed at usual time. At that time the body temperature of the patient was 97.7 degrees Fahrenheit. In the morning of 15-OCT-2020, the patient was found deceased in bed. No other illness and symptoms were reported. At the time of reporting, it was unknown if the autopsy was conducted, and the cause of death was not determined. The cation taken with acetaminophen(PARACETAMOL) was not applicable. The causality assessment between death and all suspect therapies was not provided.; Reported Cause(s) of Death: unknown cause of death; cause of death was not determined


VAERS ID: 889726 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Illinois  
Vaccinated:2020-10-11
Onset:2020-10-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ467AB / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fibromyalgia, hyperhidrosis, dont know of any other conditions she might have
Preexisting Conditions:
Allergies: Morphine, Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death


VAERS ID: 896168 (history)  
Form: Version 2.0  
Age: 2.0  
Sex: Female  
Location: Arizona  
Vaccinated:2020-10-05
Onset:2020-10-11
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2020-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT7035LA / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Constipation, Death, Faecal volume increased, Gastric dilatation, Intra-abdominal fluid collection, Ultrasound abdomen abnormal, Urinary system X-ray, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: Nasal saline drops, multivitamin
Current Illness:
Preexisting Conditions: systolic heart murmur
Allergies: no known allergies
Diagnostic Lab Data: 10/11/20 KUB x-ray and abdominal ultrasound. Markedly enlarged fluid distended stomach. This limits evaluation for direct findings of volvulus. Markedly distended presumed stomach in the abdomen. Moderate to large colonic stool volume suggesting constipation. Numerous punctate calcific densities in the left lateral abdomen likely related to stool contents.
CDC Split Type:

Write-up: Pt was seen in ED with abdominal pain, distention, and vomiting. Was flown to another Hospital. Unknown until notification of death. No other information known.


VAERS ID: 916803 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2020-10-06
Onset:2020-10-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR - / 4 - / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-10-18
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lisinopril, Novolog,, Lantus Solostar, Gabapentin, Glusosamine-chondrotin, Lanaoprost, Alphagan, Metoprol Tartrate, Colocrys. . as needed, Chlorthlidone.
Current Illness: none
Preexisting Conditions: large T-cell lymphoma, HTN, Gout, recieving treatment for fluide in lags
Allergies: N?A
Diagnostic Lab Data: Hospitalized 10/11/2020 and died 11/18/2020
CDC Split Type:

Write-up: respitory colase


VAERS ID: 946972 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Michigan  
Vaccinated:2020-10-08
Onset:2020-10-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ500AB / UNK RA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3454N / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Cough, Death, Hyperhidrosis, Nausea, Respiratory arrest, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoxetine, Allopurinol, Omeprazole, Nadolol, Furosemide, Finasteride, Ramipril, Atorvastatin, Hydralazine, Metformin, Tamsulosin
Current Illness: None
Preexisting Conditions: Benign Prostatic Hypertrophy, Overactive Bladder, Diastolic Congestive Heart Failure, Diabetes Mellitus, Essential Hypertension, Gastroesophageal Reflux Disorder, Generalized Anxiety Disorder, Gout, Hyperlipidemia, Obstructive Sleep Apnea, Osteoarthritis, Paroxysmal Atrial Fibrillation, Cervical Spine Stenosis, Lumbar Spine Stenosis
Allergies: Mirtazapine, Myrbetriq, Penicillin
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient received first dose of Shingrix and annual flu vaccine on 10/8/20. Patient''s home care therapist called on 10/9/20 that patient developed nausea, vomiting, sweating, and cough after receiving the vaccines. Called patient later that day for follow-up and his wife reported he was feeling better, but was not planning to get the second dose of Shingrix in the future. Did not receive further communication regarding the patient, until on 12/24/20 spoke to patient''s wife who reports the patient expired on 10/10/20. He went to bed the evening of 10/9/20, she woke up at 1:30AM on 10/10/20 and heard the patient take two deep breaths and then he stopped breathing. She called the funeral home who had her call the police and the medical examiner was notified.


VAERS ID: 890866 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Florida  
Vaccinated:2020-09-28
Onset:2020-09-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR U5516AA / 2 AR / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Blood creatine phosphokinase increased, Death, Rhabdomyolysis
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received a call from beach saying that this patient died. Wife said that she believes it was as a result of a flu-clinic done on 9/28/20 where the patient received a flu-shot. She said that the patient was found dead in his room. Doctor said that he had elevated CPK levels. He died as a result of rhabdomyolysis. Patient''s wife said it was the flu-shot that killed him.


VAERS ID: 886926 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-09-21
Onset:2020-09-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER Q20200604 / UNK - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. S020307 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075132009CHN009056

Write-up: death; This spontaneous report was received from an unspecified reporter via Center for Disease Control and Prevention (CDC) concerning to a 87 years old male patient. The patient''s medical history, concurrent conditions and concomitant therapies were not provided. On 21-SEP-2020, he was vaccinated with one dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX) (lot#S020307, expiry date: 24-JAN-2021) and influenza virus vaccine (unspecified) (lot# Q20200604, expiry date: 08-JUN-2021) (strength, dose and route were not provided for any suspect therapy). On the same date before 6pm, he died. The cause of death as well as was if an autopsy was performed were unknown. The causal relationship between the patient''s death and the suspect therapy was not provided. Lot investigation was initiated due to patient''s death.


VAERS ID: 900124 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Florida  
Vaccinated:2020-09-15
Onset:2020-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA4: INFLUENZA (SEASONAL) (FLUAD QUADRIVALENT) / SEQIRUS, INC. 279793 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Death, Feeling cold
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-09-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clopidogrel 75mg once a day, Rosuvastatin 10mg once a day
Current Illness:
Preexisting Conditions:
Allergies: no allergies to medications
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient relayed to daughter that he was cold and was having chills. He stated he was going to take a shower. He passed away sometime after this and was found 2 days later per his daughter. Date of death was listed as 9/17/2020 on death certificate.


VAERS ID: 890067 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Nevada  
Vaccinated:2020-09-08
Onset:2020-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ460AB / 1 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 4F99G / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Mechanical ventilation
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-12
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Diabetes, CVD, and hyperlipidemia
Allergies: NOne
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Wife called us on 10/15 to inform that patient did not do well after the vaccines. He was on ventilator for 5 days, then passed away.


VAERS ID: 884618 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Nevada  
Vaccinated:2020-08-31
Onset:2020-09-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2020-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUR4: INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) / PROTEIN SCIENCES CORPORATION QFAA2006 / 1 LA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS MT7C9 / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-09-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: oxycodone 15 mg, morphine sulfate ER 15 mg, carisoprodol 350 mg, levothyroxine 100 mcg, alprazolam 1 mg
Current Illness: unknown
Preexisting Conditions: hypothyroidism, postlaminectomy syndrome, cervical disc displacement, anxiety
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient passed away on September 3, 2020, three days after receiving her vaccines. Her husband believes her death was related to the vaccines and states she was having "all the side effects" but he would not inform us what those side effects included.


VAERS ID: 881505 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Iowa  
Vaccinated:2020-08-29
Onset:2020-08-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ454SB / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-08-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Pulmonary eosinophilia, asthma, GERD, type 2 diabetes mellitus, COPD
Allergies: No known drug allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death. Patient found unresponsive in pharmacy parking lot 4 hours later


VAERS ID: 881609 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Unknown  
Vaccinated:2020-08-26
Onset:2020-08-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2020-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 279734 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-08-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MYCOPHENOLATE; SIMVASTATIN; ALOPURINOL; FUROSEMIDE; PREDNISONE; GABAPENTIN; HUMALOG; LANTUS; SYNTHROID; POTASSIUM CHLORIDE; METOPROLOL; AMLODIPINE; AZATHIOPRINE; BUMETANIDE; METOLAZONE
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS202004250

Write-up: The patient was found deceased; This is a spontaneous case, initially received from pharmacist via Med Communication (reference number: SEQW20-01021) on 28-Aug-2020 with two additional documents received on 31-Aug-2020 (being processed together), concerning a 78-year-old female patient. The patient''s medical history was not reported. The patient''s concomitant medications included mycophenolate, simvastatin, alopurinol, furosemide, prednisone, gabapentin, Humalog (insulin lispro), Lantus (insulin glargine), Synthroid (levothyroxine sodium), potassium chloride, metoprolol, amlodipine, azathioprine, bumetanide and metolazone, all for an unknown indication. On 26-Aug-2020, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; batch number: 279734, anatomical location: deltoid, dose: 0.5 ml, route of administration: intramuscular and expiration date: 04-May-2021] for an influenza prophylaxis. On 28-Aug-2020, two days after taking Fluad (TIV), the patient died. The cause of death was unknown and it was unknown if autopsy was done. The case was assessed as serious due to seriousness criteria of death and medically significance. The reporter did not provide causality assessment to Fluad (TIV). Company comment: A 78-year-old female patient was administered Fluad (TIV) vaccine. Reportedly, the patient died two days after vaccination. The cause of death was not provided. It was unknown if autopsy was performed. Patient''s advanced maternal age may have contributed to development of the event. More information regarding medical history and autopsy results is needed. With information available, causality is unassessable.; Sender''s Comments: A 78-year-old female patient was administered Fluad (TIV) vaccine. Reportedly, the patient died two days after vaccination. The cause of death was not provided. It was unknown if autopsy was performed. Patient''s advanced maternal age may have contributed to development of the event. More information regarding medical history and autopsy results is needed. With information available, causality is unassessable.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 890336 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-26
Onset:2020-07-02
   Days after vaccination:219
Submitted: 0000-00-00
Entered: 2020-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153A1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-07-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202005216

Write-up: Pneumonia from COVID-19; This spontaneous case from Spain was retrieved on 15-Oct-2020 from EudraVigilance (regulatory reference number: ES-AEMPS-679932), reported by a pharmacist and concerned a 75-year-old, male patient. The patient''s medical history and concomitant medications were not reported. On 26-Nov-2019, the patient was vaccinated with Chiromas (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: single dose, route of administration: intramuscular and anatomical location: not reported] as flu vaccination. The batch number reported was 9153A1A. On 02-Jul-2020, seven months and six days after receiving Chiromas (TIV), the patient developed pneumonia from COVID-19. On 03-Jul-2020, the patient died due to the pneumonia from COVID-19. It was unknown if the autopsy was done. The reporter did not provide causality assessment. The event of ''COVID-19 pneumonia'' was considered serious due to the criterion of medical significance and fatal outcome by a Physician within Seqirus'' Pharmacovigilance and Risk Management Department. Company comment: A 75-year-old, male patient was administered the suspect product, Chiromas (TIV). The patient developed COVID-19 infection, seven months and six days after vaccination. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related.; Sender''s Comments: A 75-year-old, male patient was administered the suspect product, Chiromas (TIV). The patient developed COVID-19 infection, seven months and six days after vaccination. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. ES-AEMPS-630523:; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 890335 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-04
Onset:2020-07-01
   Days after vaccination:240
Submitted: 0000-00-00
Entered: 2020-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-07-03
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202005215

Write-up: Pneumonia from COVID-19; This spontaneous case was retrieved on 15-Oct-2020 from regulatory reference number: ES-AEMPS-679931), reported by a pharmacist and concerned a 92-year-old, male patient. The patient''s medical history and concomitant medications were not reported. On 04-Nov-2019, the patient was vaccinated with Chiromas (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose reported as single dose, route of administration: intramuscular and anatomical location: not reported) as flu vaccination. The batch number reported was 9153B1A. On 01-Jul-2020, seven months and 27 days after receiving Chiromas (TIV), the patient developed pneumonia from COVID-19. On 03-Jul-2020, the patient died due to pneumonia from COVID-19. It was unknown if the autopsy was done. The reporter did not provide causality assessment. The event of ''COVID-19 pneumonia'' was considered serious due to the criterion of medical significance and fatal outcome by a Physician within Seqirus'' Pharmacovigilance and Risk Management Department. Company comment: The 92-year-old patient was administered suspect product, Chiromas (TIV). Reportedly, approximately eight months after vaccination, the patient developed COVID-19 pneumonia. Chronology is unsuggestive. It was reported that the patient died due to COVID-19 pneumonia. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological and chronological implausibility, causal role of the suspect vaccine is assessed as not related.; Sender''s Comments: The 92-year-old patient was administered suspect product, Chiromas (TIV). Reportedly, approximately eight months after vaccination, the patient developed COVID-19 pneumonia. Chronology is unsuggestive. It was reported that the patient died due to COVID-19 pneumonia. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological and chronological implausibility, causal role of the suspect vaccine is assessed as not related. ES-AEMPS-630523:; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 873255 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-14
Onset:2020-05-14
   Days after vaccination:182
Submitted: 0000-00-00
Entered: 2020-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-05-21
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003801

Write-up: Pneumonia from COVID-19; This is a spontaneous case, reported by pharmacist to Regulatory Authority(regulatory reference number: ES-AEMPS-638334) and initially retrieved on 11-Jun-2020, concerning a 91-year-old, female patient. The patient''s medical history and concomitant medications were not reported. On 14-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one dose; route of administration: intramuscular; anatomical location, batch number and expiry date: not reported] as flu vaccination. On 14-May-2020, six months after vaccination, the patient developed pneumonia from COVID-19. On 21-May-2020, the patient died due to the pneumonia from COVID-19. It was unknown if the autopsy was done. The event of ''COVID-19 pneumonia'' was considered serious due to seriousness criterion of death and medical significance. The reporter did not provide causality assessment to Chiromas (TIV). Company comment: A 91-year-old, female patient experienced COVID-19 pneumonia, six months after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown if autopsy was performed. Considering unsuggestive chronology and biological implausibility, causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 91-year-old, female patient experienced COVID-19 pneumonia, six months after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown if autopsy was performed. Considering unsuggestive chronology and biological implausibility, causality is assessed as not related to the suspect vaccine. ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 871630 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-08
Onset:2020-04-29
   Days after vaccination:173
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-05-06
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003581

Write-up: Pneumonia from COVID-19; This is a spontaneous case, reported by pharmacist to Regulatory Authority (regulatory reference number: ES-AEMPS-630975) and initially retrieved on 21-May-2020, concerning an 89-year-old, male patient. The patient''s medical history and concomitant medications were not reported. On 08-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; batch number: 9153B1A; dose: 0.5 ml; route of administration: intramuscular; anatomical location and expiry date: not reported] as flu vaccination. On 29-Apr-2020, five months and 21 days after vaccination, the patient developed pneumonia from COVID-19. On 06-May-2020, the patient died due to the pneumonia from COVID-19. It was unknown if the autopsy was done. The event of ''COVID-19 pneumonia'' was considered serious due to the criterion of medical significance and fatal outcome. The reporter did not provide causality assessment. This case is linked with the case 202003587 (Regulatory Authority link). Company comment: A 89-year-old, male patient experienced COVID-19 pneumonia, five months and 21 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 89-year-old, male patient experienced COVID-19 pneumonia, five months and 21 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523:; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 871627 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-07
Onset:2020-04-14
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-04-26
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003586

Write-up: Pneumonia from COVID-19; This is a spontaneous case, reported by pharmacist to Regulatory authority (reference number: ES-AEMPS-630545) and initially retrieved on 21-May-2020, concerning a 75-year-old, male patient. The patient''s medical history and concomitant medications were not reported. On 07-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; batch number: 9153B1A; dose: 0.5 ml; route of administration: intramuscular; anatomical location and expiry date: not reported] as flu vaccination. On 14-Apr-2020, five months and seven days after vaccination, the patient developed pneumonia from COVID-19. On 26-Apr-2020, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. The event of COVID-19 pneumonia was considered serious due to the criterion of medical significance and fatal outcome. The reporter did not provide causality assessment to Chiromas (TIV). The case is linked to case 202003587 (regulatory authority link). Company comment: A 75-year-old, male patient experienced COVID-19 pneumonia, five months and seven days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 75-year-old, male patient experienced COVID-19 pneumonia, five months and seven days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523: ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 873254 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-05
Onset:2020-04-06
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2020-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Death
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), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-04-16
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003802

Write-up: Pneumonia from COVID-19; Acute respiratory failure; This is a spontaneous case , reported by pharmacist (regulatory reference number: ES-AEMPS-638333) and initially retrieved on 11-Jun-2020, concerning a 86-year-old male patient. The patient''s medical history and concomitant medications were not reported. On 05-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, dose reported as one, batch number, anatomical location and expiry date: not reported] for flu vaccination. On 06-Apr-2020, five months and one day after vaccination, the patient developed pneumonia from COVID-19 and acute respiratory failure. On 16-Apr-2020, the patient died. Cause of death were pneumonia from COVID-19 and acute respiratory failure. It was unknown if autopsy was done. The events of COVID-19 pneumonia and acute respiratory failure were considered serious due to seriousness criterion of death and medical significance. The reporter did not provide causality assessment to Chiromas (TIV). This case is linked with the case 202003587 (Regulatory Authority link). Company comment: A 86-year-old, male patient experienced COVID-19 pneumonia and acute respiratory failure, five months after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia and acute respiratory failure. It was unknown if autopsy was performed. The event of acute respiratory failure was likely associated with COVID-19. Considering unsuggestive chronology and biological implausibility, causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 86-year-old, male patient experienced COVID-19 pneumonia and acute respiratory failure, five months after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia and acute respiratory failure. It was unknown if autopsy was performed. The event of acute respiratory failure was likely associated with COVID-19. Considering unsuggestive chronology and biological implausibility, causality is assessed as not related to the suspect vaccine. ES-SEQIRUS-202003587:Regulatory authority link ES-AEMPS-630523:; Reported Cause(s) of Death: Pneumonia from COVID-19; Acute respiratory failure


VAERS ID: 873194 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-14
Onset:2020-03-30
   Days after vaccination:137
Submitted: 0000-00-00
Entered: 2020-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153A1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, Death
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), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-04-21
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003770

Write-up: Respiratory infection by COVID-19; Acute respiratory insufficiency; This is a spontaneous case reported by pharmacist to Regulatory Authority (reference number: ES-AEMPS-635507) and initially retrieved on 08-Jun-2020, concerning a 79-year-old, male patient. The patient''s medical history and concomitant medications were not reported. On 14-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, dose reported as one, batch number, anatomical location and expiry date: not reported] for flu vaccination. On 30-Mar-2020, four months and sixteen days after vaccination, the patient developed acute respiratory insufficiency and respiratory infection by COVID-19. On 21-Apr-2020, the patient died. Cause of death was acute respiratory insufficiency and respiratory infection by COVID-19. It was unknown if autopsy was done. The events of ?acute respiratory insufficiency'' and ?respiratory infection by COVID-19'' were considered serious due to the criterion of death. The reporter did not provide causality assessment to Chiromas (TIV). This case is linked with the case 202003587 (Regulatory Authority link). Company comment: A 79-year-old male patient developed COVID-19 and acute respiratory failure four months and sixteen days after vaccination with the suspect product Chiromas (TIV) for flu. Chronology seems unsuggestive. On 21-Apr-2020, the patient died. Cause of death was acute respiratory insufficiency and respiratory infection by COVID-19. It was unknown if autopsy was done. The patient''s medical history and concomitant medications were not reported. With information presented, causality is assessed as unrelated to the product for both events. COVID provides more plausible aetiology.; Sender''s Comments: A 79-year-old male patient developed COVID-19 and acute respiratory failure four months and sixteen days after vaccination with the suspect product Chiromas (TIV) for flu. Chronology seems unsuggestive. On 21-Apr-2020, the patient died. Cause of death was acute respiratory insufficiency and respiratory infection by COVID-19. It was unknown if autopsy was done. The patient''s medical history and concomitant medications were not reported. With information presented, causality is assessed as unrelated to the product for both events. COVID provides more plausible aetiology. ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Respiratory infection by COVID-19; Acute respiratory insufficiency


VAERS ID: 871632 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-12-04
Onset:2020-03-26
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-30
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003585

Write-up: Pneumonia from COVID-19; This is a spontaneous case, reported by a pharmacist to regulatory authority (regulatory reference number: ES-AEMPS-630996) and initially retrieved on 21-May-2020, concerning an 84-year-old, female patient. The patient''s medical history and concomitant medications were not provided. On 04-Dec-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 9153B1A, anatomical location and expiry date: not reported] for flu vaccination. On 26-Mar-2020, 3 months 22 days after vaccination, the patient developed pneumonia from COVID-19. On 30-Mar-2020, the patient died and pneumonia from COVID-19 was reported as cause of death. It was unknown if autopsy was performed. The event of ?COVID-19 pneumonia'' was considered serious due to criteria of death and medical significance. The reporter did not provide a causality assessment to Chiromas (TIV). This case is linked to case 202003587 (Regulatory Authority link). Company comment: A 84-year-old, female patient experienced COVID-19 pneumonia, 3 months 22 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 84-year-old, female patient experienced COVID-19 pneumonia, 3 months 22 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523: ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 871633 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-14
Onset:2020-03-26
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-05-09
   Days after onset: 44
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003584

Write-up: Pneumonia from COVID-19; This is a spontaneous case, reported by pharmacist to regulatory authority (regulatory reference number: ES-AEMPS-630999) and initially retrieved on 21-May-2020, concerning a 73-year-old, male patient. The patient''s medical history and concomitant medications were not reported. On 14-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular, batch number: 9153B1A, anatomical location and expiry date: not reported] as flu vaccination. On 26-Mar-2020, four months and 12 days after vaccination, the patient developed pneumonia from COVID-19. On 09-May-2020, 45 days after the onset, the patient died. The cause of death was reported as pneumonia from COVID-19. It was unknown whether autopsy was performed. The event of COVID-19 pneumonia was assessed as serious due to the criterion of medical significance and fatal outcome. The reporter did not provide causality assessment to Chiromas (TIV). This case is linked to case 202003587 (regulatory authority link). Company comment: A 73-year-old, male patient experienced COVID-19 pneumonia, 4 months 12 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, 45 days after the onset, the patient died. The cause of death was reported as pneumonia from COVID-19. It was unknown whether autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 73-year-old, male patient experienced COVID-19 pneumonia, 4 months 12 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, 45 days after the onset, the patient died. The cause of death was reported as pneumonia from COVID-19. It was unknown whether autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523: ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 871626 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-10-30
Onset:2020-03-25
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-28
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003587

Write-up: Pneumonia from COVID-19; This is a spontaneous case, reported by pharmacist to Regulatory Authority (regulatory reference number: ES-AEMPS-630523) and initially retrieved on 21-May-2020, concerning a 84-year-old, female patient. The patient''s medical history and concomitant medications were not reported. On 30-Oct-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; batch number: 9153B1A; dose: 0.5 ml; route of administration: intramuscular; anatomical location and expiry date: not reported] as flu vaccination. On 25-Mar-2020, four months and 25 days after vaccination, the patient developed pneumonia from COVID-19. On 28-Apr-2020, the patient died due to the pneumonia from COVID-19. It was unknown if the autopsy was done. The event of ''COVID-19 pneumonia'' was considered serious due to the criterion of medical significance and fatal outcome. The reporter did not provide causality assessment. This case is linked with the cases: 202003580, 202003581, 202003582, 202003583, 202003584, 202003585 and 202003586 (Regulatory Authority link). Company comment: A 84-year-old, female patient experienced COVID-19 pneumonia, four months and 25 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 84-year-old, female patient experienced COVID-19 pneumonia, four months and 25 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630999: ES-AEMPS-630975: ES-AEMPS-630996: ES-AEMPS-630974: ES-AEMPS-630545: ES-AEMPS-630989: ES-AEMPS-630547:; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 871629 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-05
Onset:2020-03-25
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003583

Write-up: Suspected COVID-19; This is a spontaneous case reported by pharmacist to Regulatory authority (reference number: ES-AEMPS-630974) and initially retrieved on 21-May-2020, concerning a 76-year-old, female patient. The patient''s medical history and concomitant medications were not reported. On 05-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; batch number: 9153B1A; dose: 0.5 ml; route of administration: intramuscular; anatomical location and expiry date: not reported] as flu vaccination. On 25-Mar-2020, four months and twenty days after vaccination the patient developed suspected COVID-19 and died. Cause of death was reported as suspected COVID-19. It was unknown if autopsy was done. The event of ''suspected COVID-19'' was considered serious due to the criterion of fatal outcome. The reporter did not provide causality assessment to Chiromas (TIV). The case is linked to 202003587 (regulatory authority link). Company comment: A 76-year-old, female patient experienced suspected COVID-19 pneumonia, four months and twenty days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to suspected COVID-19 pneumonia. It was unknown if autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 76-year-old, female patient experienced suspected COVID-19 pneumonia, four months and twenty days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to suspected COVID-19 pneumonia. It was unknown if autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523: ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Suspected COVID-19


VAERS ID: 871628 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-04
Onset:2020-03-22
   Days after vaccination:139
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-25
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003580

Write-up: COVID-19 pneumonia; This is a spontaneous case, reported by a pharmacist to Regulatory Authority (regulatory reference number: ES-AEMPS-630547) and initially retrieved on 21-May-2020, concerning an 82-year-old, male patient. The patient''s medical history and concomitant medications were not provided. On 04-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 9153B1A, anatomical location and expiry date: not reported] for flu vaccination. On 22-Mar-2020, 4 months 18 days after vaccination, the patient developed pneumonia from COVID-19. On 25-Mar-2020, the patient died from pneumonia from COVID-19 which was reported as cause of death. It was unknown if autopsy was performed. The event of ?COVID-19 pneumonia'' was considered serious due to criteria of death and medical significance. The reporter did not provide a causality assessment to Chiromas (TIV). This case is linked to case 202003587 (Regulatory Authority link). Company comment: A 82-year-old, male patient experienced COVID-19 pneumonia, 4 months 18 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 82-year-old, male patient experienced COVID-19 pneumonia, 4 months 18 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523: ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 871631 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-04
Onset:2020-03-20
   Days after vaccination:137
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-24
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003582

Write-up: Pneumonia from COVID-19; This is a spontaneous case, reported by a pharmacist to regulatory authority (regulatory reference number: ES-AEMPS-630989) and initially retrieved on 21-May-2020, concerning a 73-year-old, male patient. The patient''s relevant medical history and concomitant medications were not reported. On 04-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, batch number: 9153B1A, anatomical location and expiration date: not reported] for flu vaccination. On 20-Mar-2020, the patient developed pneumonia due to coronavirus infection COVID-19. On 24-Mar-2020, the patient died due to COVID-19 pneumonia. It was unknown whether autopsy was performed. The event of COVID-19 pneumonia was considered as serious due to seriousness criteria of death and medical significance (per company). The reporter did not provide causality assessment to Chiromas (TIV). This case is linked to case 202003587 as regulatory authority link. Company comment: A 73-year-old, male patient experienced COVID-19 pneumonia, 4 months 16 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown whether an autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 73-year-old, male patient experienced COVID-19 pneumonia, 4 months 16 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown whether an autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523: ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 891171 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-28
Onset:2020-03-20
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2020-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-04-16
   Days after onset: 27
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: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202005214

Write-up: COVID-19; This spontaneous case was retrieved on 15-Oct-2020 from Regulatory Authority (reference number: ES-AEMPS-679917), reported by pharmacist to and concerned a 75-year-old, female patient. The patient''s medical history and concomitant medications were not reported. On 28-Nov-2019, the patient was vaccinated with CHIROMAS (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, dose reported as one, anatomical location: not reported] for flu vaccination. The batch number was not reported. On 20-Mar-2020, three months and 21 days after vaccination, the patient developed COVID-19. On 16-Apr-2020, the patient died. Cause of death was COVID-19. It was unknown if autopsy was done. The reporter did not provide causality assessment to CHIROMAS (TIV). The event of ''COVID-19'' was considered serious due to the criterion of medical significance and fatal outcome by a Physician within and Risk Management Department. Company comment: A 75-year-old, female patient was administered the suspect product, CHIROMAS (TIV). The patient developed COVID-19 infection, three months and 21 days after vaccination. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. Sender''s Comments: A 75-year-old, female patient was administered the suspect product, CHIROMAS (TIV). The patient developed COVID-19 infection, three months and 21 days after vaccination. Reportedly, the patient died due to COVID-19 infection. It was not reported whether autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering biological implausibility, causal role of the suspect vaccine is assessed as not related. ES-AEMPS-630523: Reported Cause(s) of Death: COVID-19


VAERS ID: 869747 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-09-30
Onset:2020-02-17
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2020-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER AFLBA376BA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza, Superinfection bacterial, Vaccine breakthrough infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; Essential hypertension (Benign); Obstructive bronchitis; Osteoporosis; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2020GS

Write-up: Vaccine breakthrough infection/ Vaccination failure; Influenza; Superinfection bacterial; This case was reported by a physician via regulatory authority and described the occurrence of vaccine breakthrough infection in a 70-year-old female patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) (batch number AFLBA376BA, expiry date unknown) for prophylaxis. Concurrent medical conditions included type ii diabetes mellitus, obstructive bronchitis, osteoporosis, chronic obstructive pulmonary disease and essential hypertension (Benign). On 30th September 2019, the patient received Influsplit Tetra 2019/2020 (intramuscular). On 17th February 2020, 140 days after receiving Influsplit Tetra 2019/2020, the patient experienced vaccine breakthrough infection (serious criteria death, hospitalization and GSK medically significant), influenza (serious criteria death and hospitalization) and superinfection bacterial (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccine breakthrough infection, influenza and superinfection bacterial were fatal. The reported cause of death was influenza, vaccine breakthrough infection and superinfection bacterial. It was unknown if the reporter considered the vaccine breakthrough infection, influenza and superinfection bacterial to be related to Influsplit Tetra 2019/2020. Additional details: The age at vaccination was not provided but the patient could be 70 years or less than 70 year old. As per the confirmation received, event- vaccine breakthrough infection was considered as vaccination failure and influenza as that of target disease. More information about the same, if any, is expected in follow up. Initial information was reported by a Physician via regulatory authority on 27th April 2020: influenza, vaccine breakthrough infection and superinfection bacterial.; Reported Cause(s) of Death: Influenza; Vaccine breakthrough infection; Superinfection bacterial


VAERS ID: 860822 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Unknown  
Vaccinated:2019-11-08
Onset:2020-02-06
   Days after vaccination:90
Submitted: 0000-00-00
Entered: 2020-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 2LL97 / N/A RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza, Influenza A virus test positive, Lung assist device therapy, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-09
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Influenza A positive
CDC Split Type:

Write-up: Patient was diagnosed with Influenza A and had severe respiratory distress. Was placed on ECMO


VAERS ID: 860962 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2020-01-28
Onset:2020-02-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2020-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UJ310AB / 1 LA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 7RK7K / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cardiac arrest, Death, Hypoxia, Influenza, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: Unlnown
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client passed away on 2/4/2020 at 0832 AM. Cause of death states hypoxia, respiratory failure, cardiac arrest and influenza. Unknown if the vaccines were linked to death in anyway. Reported due to close timing the vaccines were administered to death.


VAERS ID: 867687 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: California  
Vaccinated:2019-10-09
Onset:2020-01-17
   Days after vaccination:100
Submitted: 0000-00-00
Entered: 2020-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK - / -
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. - / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Albumin CSF, CSF immunoglobulin G index, CSF test, Death, Encephalitis, Hypoxic-ischaemic encephalopathy, Magnetic resonance imaging, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-01-25
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI CSF, Albumin CSF, IgG CSF encephalitis, meningitis panel
CDC Split Type:

Write-up: Acute bilateral cerebellitis, respiratory failure, anoxic encephalopathy, death. Presented to Hospital on 1/17/2020, expired 1/25/2020.


VAERS ID: 857115 (history)  
Form: Version 2.0  
Age: 1.08  
Sex: Female  
Location: Montana  
Vaccinated:2020-01-14
Onset:2020-01-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2020-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UJ058AB / 4 RL / SYR
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT6647JA / 1 RL / SYR
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. R013540 / 3 LL / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AL8457 / 1 LL / SYR

Administered by: Private       Purchased by: ?
Symptoms: Cardio-respiratory arrest, 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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetaminophen (Tylenol) 160 mgi/5mL Solution
Current Illness: None
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient arrived to hospital by EMS, CPR in progress. On arrival, patient had no spontaneous cardiac activity or respirations.


VAERS ID: 863176 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Illinois  
Vaccinated:2020-01-15
Onset:2020-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Biopsy, Death, Diarrhoea, Graft versus host disease in gastrointestinal tract, Muscle spasms
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-09
   Days after onset: 25
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 also had developed odd myalgias shortly after transplant that improved with steroids.
Allergies:
Diagnostic Lab Data: Upper GI Endoscopic Biopsy, 22-Jan-2020, Severe acute GVHD
CDC Split Type:

Write-up: Patient received the Fluarix Quadrivalent vaccination on 01/15/2020, approximately 6 months after his stem cell transplant. The next day he developed diarrhea that progressed over the weekend with abdominal pain and cramping requiring hospital admission. Upon admission he was found to have acute graft-versus-host disease (GVHD) of the GI tract, potentially incited by the immune activation from his influenza vaccination. Unfortunately the patient''s GVHD was refractory to multiple lines of therapy and led to his death less than a month after presentation.


VAERS ID: 857584 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: California  
Vaccinated:2020-01-01
Onset:2020-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS QS 2019-20 / 1 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, General physical health deterioration, Laboratory test, Life support, Organ failure, Pneumonia, 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), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (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: 2020-01-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Acetaminophen Albuterol Benzonatate Ipratropium-Albuterol Ketorolac Sodium Chloride Anti Depressant
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 10 Days on life support with constant tests, no improvement, quick decline. Currently obtaining full records.
CDC Split Type:

Write-up: Given while ill with fever and flu. Quick deterioration. Lung and blood infection. Sepsis within 24 hours. Life support with organ failure. Death in one week time.


VAERS ID: 853847 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Illinois  
Vaccinated:2019-12-15
Onset:2019-12-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UJ308AB / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: history of stroke
Preexisting Conditions:
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died within hours of receiving fluzone hd.


VAERS ID: 854824 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: New York  
Vaccinated:2019-10-16
Onset:2019-12-11
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUR4: INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) / PROTEIN SCIENCES CORPORATION - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Gait inability, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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:

Write-up: 12/6/19 - Presented to Emergency Rm with acute lower extremity weakness 12/7/19 Presented to ER cannot walk. Sent to Hospital 12/30/19 Expired


VAERS ID: 857606 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Michigan  
Vaccinated:2019-12-10
Onset:2019-12-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK UN / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Cardiac arrest, Death, Life support, Loss of consciousness, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-14
   Days after onset: 4
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amlodipine 10 mg aspirin 81 mg carvedilol 25 mg cyanocobalamin 2500 mcg fenofibrate 160 mg finasteride 1 mg furosemide 20 mg gabapentin 300 mg glimepiride 4 mg hydralazine 25 mg x3 hydrochlorothiazide 25 mg insulin glargine 300 u/ml janumet
Current Illness:
Preexisting Conditions: Hypertension Neuropathy Carpal Tunnel Diabetes 2 Anesthesia of skin Trigger FInger
Allergies: Sulfa (sulfonamide antibiotics) anaphylaxis Penicillins Anaphylaxis
Diagnostic Lab Data: Her doctors in the hospital were not in communication with her doctors outside of the hospital. She had a stress test done a week prior and quite a few labs within pryor. Most of her labs were normal. Her kidneys were beginning to weaken and she had just gotten a recommendation to see a nephrologist. The doctors in the hospital said that she didn''t have a heart attack. There was no heart damage. Her EF was 65. Earlier that day, when she got the vaccines, her vitals were BP 150/64, Temp 97.6 Pulse 89, Oxygen 96%. Her reason for the visit: healthcare maintenance and alopecia. Her death certificate says acute coronary arrest (days), respiratory failure (days). Again , her hospital doctors weren''t in communication with her regular doctors. The office visit clearly showed no signs of respiratory distress. She was with a friend in a car at the time and her friend said that she was fine right up until she died.
CDC Split Type:

Write-up: On 12/10 around 3pm she had a 2 vaccines. Fluzone High Dose 180 mcg/0.5mL and Varicella-zoster 50 mcg/o.5mL. At 9:20pm, after going out to a movie, she suffered sudden cardiac arrest. 911 was immediately called. She never regained consciousness and was taken off of life support on 12/14. I asked multiple doctors why they thought her heart stopped and none of them knew why. I explained to them that I (her daughter) have a genetic condition called MCAS which has been linked to Kounis Syndrome which can cause coronary vasospasms. I was told it was too rare to consider. A couple of weeks later I found her vaccination papers. I called her doctor''s office to let them know. The woman on the phone pulled up her name. As she was reading, she said that they hadn''t been informed and thanks for letting them know and suddenly her entire tone changed and she said I''d have to talk to someone else and hung up. I believe she was trying to transfer me but I can''t help but wonder if she was having a small reaction earlier that day in the office and they let her go.


VAERS ID: 864208 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-28
Onset:2019-12-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2020-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Antibody test negative, Death, Influenza, Pneumococcal infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylactic vaccination
Preexisting Conditions: Medical History/Concurrent Conditions: Decreased immune responsiveness; Poliomyelitis; Comments: Previous Polio patient.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DK0095075132002DNK010698

Write-up: Pneumococcal infection; Influenza; patient developed influenza despite the influenza vaccine; Every second year throughout many years, antibodies were measured following pneumococcal vaccination, and antibodies were very low already 24 months after the vaccinations; This spontaneous report was received from a general practitioner via an sales representative referring to a 67-year-old female patient. The patient''s medical histories included polio and poor response to vaccines. In 2018, the patient was vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVENAR). Concurrent condition was not reported. Every second year throughout many years, antibodies were measured following pneumococcal vaccination, and antibodies were very low already 24 months after the vaccinations (antibody test negative). The patient therefore received frequent pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) re-vaccinations since the patient was a high-risk patient. On 28-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) (strength, dose, route, lot #, expiration date and anatomical location were not reported) for prophylaxis. On the same date, the patient was vaccinated with influenza virus vaccine (unspecified) (strength, dose, route, lot #, expiration date and anatomical location were not reported) for prophylactic vaccination. In late December 2019, the patient developed influenza despite influenza virus vaccine (unspecified). The patient was hospitalized due to the influenza and there was a fatal outcome, and the date of death was unknown. At the hospital, a pneumococcal infection was also diagnosed. The outcome of influenza, pneumococcal infection and vaccination failure was fatal. The outcome of antibodies were very low was unknown. If an autopsy was performed and cause of death were unknown. The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) and the events was unknown. Upon internal review, pneumococcal infection was determined to be medically significant.


VAERS ID: 852775 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-15
Onset:2019-11-24
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2019-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA422AA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Guillain-Barre syndrome, Hypoaesthesia, Neurological examination
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: 2019-12-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEO-LOTAN PLUS; ZUGLIMET; IPAMIX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20191128; Test Name: Neurological examination; Result Unstructured Data: Test Result: unknown, Test Result Unit: unknown
CDC Split Type: ITGLAXOSMITHKLINEIT201922

Write-up: from 24/11/2019 astenia ipostenia hipoesthesia lower limbs with initial progressive initiative arts upper arts. suspect sindrome guillain-barre ''(progressive paralysis).; from 24/11/2019 astenia ipostenia hipoesthesia lower limbs with initial progressive initiative arts upper arts. suspect sindrome guillain-barre ''(progressive paralysis).; from 24/11/2019 astenia ipostenia hipoesthesia lower limbs with initial progressive initiative arts upper arts. suspect sindrome guillain-barre ''(progressive paralysis).; from 24/11/2019 astenia ipostenia hipoesthesia lower limbs with initial progressive initiative arts upper arts. suspect sindrome guillain-barre ''(progressive paralysis).; This case was reported by a physician via regulatory authority and described the occurrence of paralysis ascending in a 81-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number AFLBA422AA, expiry date unknown) for prophylaxis. Concomitant products included hydrochlorothiazide + losartan potassium (Neo-Lotan Plus), metformin hydrochloride (Zuglimet) and indapamide (Ipamix). On 15th November 2019, the patient received Fluarix Tetra 2019-2020 season (subcutaneous) 1 dosage form(s). On 24th November 2019, 9 days after receiving Fluarix Tetra 2019-2020 season, the patient experienced paralysis ascending (serious criteria death and GSK medically significant), hyposthenia (serious criteria death), asthenia (serious criteria death) and hypesthesia (serious criteria death). On an unknown date, the outcome of the paralysis ascending, hyposthenia, asthenia and hypesthesia were fatal. The patient died on 1st December 2019. The reported cause of death was hyposthenia, asthenia, paralysis ascending and hypoesthesia. It was unknown if the reporter considered the paralysis ascending, hyposthenia, asthenia and hypesthesia to be related to Fluarix Tetra 2019-2020 season. Additional details; The age at vaccination was not reported however patient could be 80 or 81 years old at the time of vaccination. On 28th November 2019, Neurological examination was done. Initial information was reported by a physician via regulatory authority on 11th December 2019; From 24/11/2019 astenia ipostenia hipoesthesia lower limbs with initial progressive initiative arts upper arts. Suspect sindrome guillain-barre ''(progressive paralysis) Reporter''s comment: Felt the physician on 03/12/2019 for clarifications about the report. The patient has carried out the vaccine on 11/15/2019 for the first time (he had never made it back). The symptoms are verified after 9 days from the vaccination on 11/24/2019: Astenia, ipostenia, hypoesthesia lower limbs with initial progressive development of upper arts. Suspect sindrome guillain-barre ''(progressive paralysis). The patient has been recovered to the hospital. Sender''s comment: Rest pending for delivery by the doctor of the report form with addition of the requested information.; Reported Cause(s) of Death: Hyposthenia; Asthenia; Paralysis ascending; Hypesthesia


VAERS ID: 854704 (history)  
Form: Version 2.0  
Age: 103.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-15
Onset:2019-11-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS A031840034 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aphasia, Asthenia, Cerebrovascular accident, Death, Decreased appetite, Presyncope
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-26
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRIATEC [RAMIPRIL]; CARDIOASPIRIN; LANSOPRAZOLE; ZYLORIC; LASIX [FUROSEMIDE SODIUM]
Current Illness: Cardiomyopathy; Decompensation cardiac
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSEQIRUS201907433

Write-up: Suspected cerebral stroke; Inappetence; Aphasia; Asthenia; Presyncope; This is a spontaneous cas, reported by physician to Agency (reference number: IT-MINISAL02-594481) and initially retrieved on 23-Dec-2019 with additional information (being processed together) retrieved on 24-Dec-2019, concerning a 103-year-old, female patient. The patient''s current condition included cardiac decompensation and cardiomyopathy. The patient''s concomitant medications included Triatec (ramipril), Cardioaspirin (acetylsalicylic acid), Zyloric (allopurinol), Lasix (furosemide sodium) and lansoprazole, all for an unknown indication. On 15-Nov-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; batch number: A031840034; dose reported as one dosage form; route of administration: intramuscular; anatomical location and expiry date: not reported] as flu vaccination. On 19-Nov-2019, four days after vaccination, it was suspected that the patient experienced cerebral stroke. The patient also experienced aphasia, inappetence, asthenia and presyncope. On an unknown date in Nov-2019, the patient had slight recovery of her state. On 24-Nov-2019, the patient experienced new worsening. On 26-Nov-2019, the patient died. It was unknown if autopsy was done. The events of inappetence, aphasia, asthenia, presyncope and stroke were considered serious due to fatal outcome. The reporter did not provide causality assessment. Company comment: All events are considered as related to Fluad (TIV).; Sender''s Comments: All events are considered as related to Fluad (TIV).; Reported Cause(s) of Death: Suspected cerebral stroke; Inappetence; Aphasia; Asthenia; Presyncope


VAERS ID: 864321 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Colorado  
Vaccinated:2019-11-16
Onset:2019-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UJ293AA / UNK UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Acute cardiac event, Asthenia, Dehydration, Diarrhoea, Gastrointestinal disorder, Nausea, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Noninfectious diarrhoea (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: acidophilus, famotidine, potassium chloride ER, quetiapine, Ativan, tums
Current Illness: Was hospitalized for acute urinary retention, low grade fever with initial suspicion for pneumonia that was subsequently ruled out. Patient was discharged on 11/18/2019. During the hospital stay she had an influenza vaccine administered, Fluzone high dose lot #UJ293AA on 11/16/2019. She developed nausea, vomiting and diarrhea that her physician, MD was concerned could be related to the vaccine. The patient died suddenly at her assisted living facility while on the toilet on 11/19/2019. This was thought to be an acute cardiac event, possibly an arrhythmia related to dehydration she sustained due to the gastrointestinal symptoms she was experiencing.
Preexisting Conditions: hypertensive heart disease, cardiomegaly, GERD, anxiety, dementia, iron deficiency anemia
Allergies: NKDA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Nausea, vomiting and diarrhea 48-72 hours after administration of the vaccine. Unknown whether this was the result of the vaccination or something else. The patient was frail, had underlying heart conditions and died of a cardiac event which likely was related to dehydration sustained from these symptoms.


VAERS ID: 864315 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-02
Onset:2019-11-15
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2020-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 259141B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood blister, Brain death, C-reactive protein increased, Circulatory collapse, Computerised tomogram head abnormal, Death, Haemoglobin normal, Immune thrombocytopenia, Intensive care, Life support, Neutrophil count decreased, Platelet count normal, Subarachnoid haemorrhage, White blood cell count normal
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (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), Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-18
   Days after onset: 3
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: IRON
Current Illness: Anaemia; Renal stone
Preexisting Conditions: Medical History/Concurrent Conditions: Hip replacement; Lithotripsy; Pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20191117; Test Name: CT scan of head; Result Unstructured Data: A fatal subarachnoid haemorrhage was identified.; Test Date: 20191117; Test Name: PLT
CDC Split Type: GBSEQIRUS202002300

Write-up: Fatal subarachnoid haemorrhage; Collapsed; ITP (Immuno thrombocytopenic purpura); This is a spontaneous case from, reported by other non-health professional to agency (reference number: 2020-0040501) on 03-Mar-2020, concerning a 70-year-old, male patient. The patient''s relevant medical history included recent lithotripsy for recurrent renal stones, mild anaemia, hip replacement in Aug-2019 and pneumonia in 2017. The patient''s concomitant medication included unspecified iron supplements for mild anaemia. On 02-Sep-2019, the patient''s haemoglobin (Hb) was at 103, white blood cell (WBC) count was at 4.4, neutrophils (N) were at 1.84, platelet (Plt) count was at 236 and C-reactive protein (CRP) was at 15.3. The units were not specified. There was concern over a suspected lower respiratory tract infection and subsequent suspicion of a pulmonary embolism, but both were ruled out. On 17-Sep-2019, the patient''s Hb was at 103, WBC count was at 5.2, N were at 2.88, Plt count was at 187 and CRP was at 21. The units were not specified. On 02-Oct-2019, the patient was administered Fluad (TIV) vaccine [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; batch number: 259141B1A, expiration date: 31-May-2020, dose, route of administration and anatomical location: not reported] for an unknown indication. On 31-Oct-2019, the patient''s Hb was at 125, WBC count was at 5.4, N were at 3.28 and Plt count was at 213. The units were not specified. On 15-Nov-2019, on Friday, the patient developed blood filled blisters for which he sought medical attention. On 16-Nov-2019, on Saturday, the patient developed a purpura to his back. It was reported that at this point in time the patient otherwise did not feel unwell. On 17-Nov-2019, on Sunday morning, the patient collapsed at home and was taken to the hospital. A computed tomography (CT) scan of his head identified a fatal subarachnoid haemorrhage. The blood test results revealed a Plt count of 6, Hb was at 127, WBC was at 8.2, N were at 5.07 and CRP was at 18.9. The patient was diagnosed with immune thrombocytopenic purpura (ITP) and placed on organ support on the intensive care unit (ICU). On 18-Nov-2019, 24 hours after being placed on organ support, brainstem death was confirmed and the patient passed away. At the time of this report, the outcome for the events of ITP and circulatory collapse was not reported. The event of ?subarachnoid haemorrhage'' was considered as serious due to criterion of death, hospitalisation and medical significance, while the events of ?immune thrombocytopenic purpura'' and ?circulatory collapse'' were considered as serious due criterion of hospitalisation and medical significance, per company. The reporter stated that she believed there was a reasonable possibility that the flu vaccine may had caused the acute underlying ITP. The reporter did not provide causality assessment for the event of ?subarachnoid haemorrhage'' and ?circulatory collapse''. Company comment: The patient experienced immune thrombocytopenic purpura (ITP) one month and 13 days after receiving Fluad (TIV) vaccine. The patient also collapsed, developed subarachnoid haemorrhage and eventually died. Chronology is plausible. Causal role of the vaccine is assessed as possibly related for ITP, since research showed that influenza vaccinations increase the risk of ITP. Although circulatory collapse and subarachnoid haemorrhage were likely attributed to ITP, patient advanced age (70) may have contributed to development of the events, causality is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).; Sender''s Comments: The patient experienced immune thrombocytopenic purpura (ITP) one month and 13 days after receiving Fluad (TIV) vaccine. The patient also collapsed, developed subarachnoid haemorrhage and eventually died. Chronology is plausible. Causal role of the vaccine is assessed as possibly related for ITP, since research showed that influenza vaccinations increase the risk of ITP. Although circulatory collapse and subarachnoid haemorrhage were likely attributed to ITP, patient advanced age (70) may have contributed to development of the events, causality is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).; Reported Cause(s) of Death: Fatal subarachnoid haemorrhage


VAERS ID: 850728 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-13
Onset:2019-11-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 0864C1A / UNK LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiomyopathy, Death, Expired product administered
SMQs:, Cardiomyopathy (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia aggravated; Ischemic stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSEQIRUS201906461

Write-up: Death; Cardiomyopathy; Expired Fluad (TIV) vaccine was administered to patient; This is a spontaneous case from the country, reported by physician to Agency (regulatory reference number: IT-MINISAL02-588041) and initially retrieved on 29-Nov-2019, concerning a 93-year-old, female patient. The patient''s relevant medical history included ischemic stroke and dementia aggravated. The patient''s concomitant medications were not reported. On 13-Nov-2019, the patient was administered Fluad TIV [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, batch number: 0864C1A, anatomical location: left deltoid and expiration date reported as ''Jun-2019''] (explicitly coded as ''Expired vaccine used'') for flu. It was reported that vaccine was administered at home. On 14-Nov-2019, the patient developed cardiomyopathy. On the same day, the patient died. It was unknown if the autopsy was done. Cause of death was not provided. At the time, of initial reporting the outcome of cardiomyopathy was not reported. The event of death was considered as serious due to criterion of fatal outcome and medical significance and cardiomyopathy was considered as serious due to criterion of medical significance. The causality assessment was not provided. Company comment: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Sender''s Comments: The events of death and cardiomyopathy were considered as related to Fluad TIV while the event of expired vaccine used was considered as not related to Fluad TIV.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 852688 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Ohio  
Vaccinated:2019-11-11
Onset:2019-11-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abnormal behaviour, Autopsy, Completed suicide
SMQs:, Suicide/self-injury (narrow), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-12-08
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Multiple fevers throughout history of immunizations
Other Medications: Adderall Vit D Fluoxetine
Current Illness: pyelonephritis Fever Renal Lithiasis
Preexisting Conditions: Autism ADHD
Allergies: Sulfa Milk Garlic
Diagnostic Lab Data: Please refer to Coroner?s report
CDC Split Type:

Write-up: Patient has Autism. Shortly after shot he began acting different & this was noticed by school, family & friends. Almost a month afterwards, despite seeming much happier & outgoing, he committed suicide.


VAERS ID: 848765 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: New York  
Vaccinated:2019-11-07
Onset:2019-11-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 2LL97 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: metformin, enalapril, amlodipine, lipitor, vitamin d, hydroxyzine, januvia
Current Illness: DM, HTN, obesity, chronic urticaria, urinary frequency
Preexisting Conditions: as above
Allergies: mold, pollen,
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Pt was reported to be found dead the morning after vaccination. There is no clear association between vaccination and death, considering patient age and comorbidities. Medical examiner office informed clinic the next day


VAERS ID: 850493 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-06
Onset:2019-11-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 259146C11 / UNK - / OT
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. S008678 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD; Dementia; Heart disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSEQIRUS201906361

Write-up: Temporal correlation between influenza and pneumococcal vaccination and death; This is a spontaneous case, initially reported by physician and initially retrieved from Regulatory Authority (Authority Number: IT-MINISAL02-589091) on 28-Nov-2019, concerning a 94-year-old, female patient. The patient''s current conditions included COPD (chronic obstructive pulmonary disease) with frequent exacerbations, heart disease in feeble compensation and dementia decompensated. The patient''s concomitant medication was not reported. On 06-Nov-2019, the patient was administered Fluad [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; route of administration: intramuscular, batch number: 259146C11, dose, anatomical location and expiry date: not reported] for H1N1 influenza immunisation. On the same date, the patient was administered co-suspect vaccine Pneumovax [pneumococcal vaccine polysacch 23v; batch number: S008678, dose, route of administration, anatomical location and expiry date: not reported] for an unknown indication. On 08-Nov-2019, two days after vaccination, the patient died. It was unknown whether autopsy was performed. The outcome of the event was fatal. The reporter considered the event of death as temporarily related to vaccination, but did not suppose a causal correlation given the precariousness of the pre-existing clinical picture in (high age) elderly patient. The event was assessed as serious due to the criterion of death and medically significant. Company causality: The event was considered as related to Fluad (TIV).; Reporter''s Comments: Reporter''s comment: I report for the temporal correlation, but I do not suppose a causal correlation given the precariousness of the pre-existing clinical picture in (high age) elderly patient.; Sender''s Comments: The event was considered as related to Fluad (TIV).; Reported Cause(s) of Death: Unknown cause of death


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type:

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


VAERS ID: 849895 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-04
Onset:2019-11-01
Submitted: 0000-00-00
Entered: 2019-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA411AE / UNK LA / OT

Administered by: Other       Purchased by: ?
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE201921

Write-up: The patient was found dead in the apartment the day after the vaccination; This case was reported by a physician via regulatory authority and described the occurrence of found dead in a 45-year-old male patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) (batch number AFLBA411AE, expiry date unknown) for prophylaxis. On 4th November 2019, the patient received Influsplit Tetra 2019/2020 (intramuscular). In November 2019, 1 day after receiving Influsplit Tetra 2019/2020, the patient experienced found dead (serious criteria death and GSK medically significant). On an unknown date, the outcome of the found dead was fatal. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the found dead to be related to Influsplit Tetra 2019/2020. Additional information: The age at vaccination was not reported however patient could be 44 or 45 years old at the time of vaccination. The agency assessment was reported as D. Unclassifiable. The anatomical location of vaccine was reported as left upper arm. Initial information was received from a Physician via regulatory authority on 22nd November 2019: The patient was found dead in the apartment the day after the vaccination. Sender''s comments: Since October multiple vaccinations. On 04.11 more vaccinations with the same batch number.; Reported Cause(s) of Death: Unknown cause of death


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

Administered by: Pharmacy       Purchased by: ?
Symptoms: Aspiration, Cyanosis, Death, Pulse absent, Resuscitation, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levemir, Pravastatin, Furosemide, Lisinopril, Latanoprost
Current Illness: Diabetes, COPD
Preexisting Conditions: Diabetes, COPD
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

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


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

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

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

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


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

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

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

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


VAERS ID: 847211 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-10-16
Onset:2019-10-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2019-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Thyroxine; ASS; Vigantoletten; NORSPAN; PIPAMPERON; TAVOR (NOS); BISOPROLOL
Current Illness: Arthrosis multiple; Coronary heart disease; Dementia; Hypertonus; Osteoporosis; Pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2019EM

Write-up: patient died; This case was reported by a physician via other manufacturer and described the occurrence of unknown cause of death in a 88-year-old patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) for prophylaxis. Concurrent medical conditions included hypertonus, coronary heart disease, osteoporosis, dementia, arthrosis multiple and pain. Concomitant products included thyroxine sodium (Thyroxine), acetylsalicylic acid (ASS), ergocalciferol (Vigantoletten), buprenorphine (Norspan), pipamperone hydrochloride (Pipamperon), ambiguous medication nos (Tavor (Nos)) and bisoprolol. On 16th October 2019, the patient received Influsplit Tetra 2019/2020. On 19th October 2019, 3 days after receiving Influsplit Tetra 2019/2020, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). The patient was treated with dipyrone (Novaminsulfon). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 19th October 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influsplit Tetra 2019/2020. Additional details were provided as follows: The age at vaccination was not reported but it could be 87 years or 88 years. The patient also received Alendronsr as concomitant medication. The reporter stated, there was an increased occurrence of death cases in an old people''s home with timely relatedness with a Tetravalent Influenza Vaccination With Influsplit tetra. The patient was vaccinated with the tetravalent vaccine Infulsplit, batch number was provided via telephone on the 25th October 2019 (but was not mentioned in the source document). As per reporter, there was no causality suspected and this cases had no causal relatedness between the vaccination and the death of the patient. Neither Symptoms like allergic reactions nor symptoms like febrile infections occurred. The reporter asked about information regarding similar reports from other medical practices. The reporter provided more information about the incident. In the timeframe of 4th October 2019 to 25th October 2019, total 5 patients were died in an old people''s home of 74 vaccinated patients. The vaccinations took place from 15th October 2019 to 17th October 2019. The reporter further added, as per their experience, outstandingly more patients of a retirement home died in the 4. Quartal as in the other Quartals. In the 4. Quartal of 2018, 8 out of 92 patients were died in the retirement home where the reporter was taking care. The amount of 5 patients who died out of totally 82 patients from the retirement home during 2 weeks after the vaccination was although exceptional. The death was not predictable at 4 out of the deceased patients. This is 1 of 5 cases reported by the same reporter.; Reported Cause(s) of Death: Death NOS


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

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

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

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


VAERS ID: 851942 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2019-10-09
Onset:2019-10-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS J9F97 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Chest X-ray abnormal, Condition aggravated, Cough, Decreased appetite, Dyspnoea, Increased tendency to bruise, International normalised ratio increased, Lacrimation increased, Memory impairment, Prothrombin time prolonged, Pruritus, Rhinorrhoea
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Lacrimal disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-25
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Megestrol Acetate 40mg oral tablet, Coumadin 2mg oral tablet, Amiodarone HCL 200mg oral tablet, Toprol XL 25mg oral tablet, Potassiu, CL ER 20 MEQ tablet, Amitiza 8mcg oral capsule, Norco 10-325mg oral tablet, Doxazosin Mesylate 8mg tab, Am
Current Illness: Pulmonary edema, Left lower lobe pneumonia, Loss of appetite
Preexisting Conditions: Nonsustained paroxysmal ventricular tachycardia, Dysphagia, BMI 20, Nutritional marasmus, Opiod use, CAD, Unspecified disorders arteries and arterioles, Presence of cardiac pacemaker, Sick sinus syndrome, Elevated troponin, Incarcerated ventral hernia, Tinea unguium, Syncope due to orthostatic hypotension, Weakness, Pruritic rash, Ventral hernia w/o obstruction, Partial intestinal obstruction, Pneumonia, Hematemesis, Ileus, Noninfective gastroenteritis and colitis, Pain in thoracic spine, Other specified abnormal findings of blood chemistry, Vomiting, unspecified, Viral intestinal infection, Corns and callosities, Nail dystrophy, Osteophyte, left foot, Pain in left ankle and joints of left foot, Other symptoms and signs involving the musculoskeletal system, Pain in left foot, Ingrowing nail, Chronic sinusitis, unspecified, Other dorsalgia, Essential (primary) hypertension, Paroxysmal atrial fibrillation, Long term (current) use of anticoagulants, Hyperlipidemia, unspecified, Hypothyroidism, unspecified, Abdominal aortic aneurysm, w/o rupture, Nonrheumatic aortic (valve) insufficiency, Benign prostatic hyperplasia w/o lower urinary tract symptoms, Umbilical hernia w/o obstruction or gangrene
Allergies: NKA
Diagnostic Lab Data: 10/09/19 Chest Xray-Atelectasis noted L$gR 10/11/19 PT/INR-abnormal (high)
CDC Split Type:

Write-up: 10/09/2019-Patient presented to PCPs office with chief complaint of watery eyes, runny nose, cough, and SOB. Generalized weakness worsening and appetite continues to decline. Memory continues to decline, Itching in hands. Spontaneous bruising. Treatment-Add Megace for appetite, Hold Coumadin and recheck Friday, Increase Ensure to 3 times daily as tolerated, Eat greens today


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSEQIRUS201905599

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


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

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

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

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


VAERS ID: 972898 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Ohio  
Vaccinated:2019-09-30
Onset:2019-10-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ249AA / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Encephalopathy, Haemophagocytic lymphohistiocytosis, Laboratory test, Malaise, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-09
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: pred forte right eye, zaditor right eye, finasteride 5 mg daily, aspirin 81 mg daily, MVI, xyzal 5 mg daily, saw palmetto, antivert 25 mg TID PRN, pantoprazole 40 mg daily, lisinopril 20 mg daily, verapamil 180 mg daily, atorvastatin 20 mg
Current Illness:
Preexisting Conditions: HTN, high cholesterol, BPH, meniere''s
Allergies: NKDA
Diagnostic Lab Data: Many tests performed during hospitalization 10/06/2019 through 10/09/2019
CDC Split Type:

Write-up: 5 days after receiving the vaccination the patient developed generalized malaise progressing to encephalopathy. He was admitted to the hospital with presumed septic shock, and work-up revealed hemophagocytic lymphohistiocytosis. He died from the disease process 9 days after vaccination.


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Abilify, fluoxetine
Current Illness:
Preexisting Conditions: Cerebral palsy, Generalized anxiety disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type:

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


VAERS ID: 884284 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Utah  
Vaccinated:2019-09-30
Onset:2019-09-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-04
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death 11/04/2019


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

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

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

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


VAERS ID: 821744 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2019-06-01
Submitted: 0000-00-00
Entered: 2019-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Endotracheal intubation, Influenza, Intensive care, Malaise, Vaccination failure
SMQs:, Angioedema (broad), Lack of efficacy/effect (narrow), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-23
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUGLAXOSMITHKLINEAU2019AP

Write-up: Influenza; very sick; suspected vaccination failure; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a 43-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. In June 2019, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza a virus infection (serious criteria death and hospitalization) and sickness. On 23rd June 2019, the outcome of the influenza a virus infection was fatal. On an unknown date, the outcome of the vaccination failure and sickness were unknown. The patient died on 23rd June 2019. The reported cause of death was influenza a virus infection. It was unknown if the reporter considered the vaccination failure, influenza a virus infection and sickness to be related to Influenza vaccine. Additional case details were reported as follows: The age at vaccination was not reported. The patient was working with acute medical patients in the hospital unit and had a 3 and half year old son. The patient''s wife posted a heartfelt plea for support and pictures of patient on Facebook the day after he was rushed to hospital. The patient was following a battle with influenza A the last eight days. Unfortunately, it had hit him and his body was quite hard. In June 2019, the patient was admitted to the hospital. The patient was very sick. A specialized retrieval team was sent to provide cardiac and respiratory support (extracorporeal membrane oxygenation). The patient was intubated and they supported his heart. He was critical and they did not have any time frame for him. The patient''s wife asked to send their thoughts as the patient very much needed it that time. The patient was in intensive care unit when he passed away. It was unknown if an autopsy was done. The tribute was given to chief executive at hospital by patient''s grieving family, friends and colleagues and staff at hospital were in shock. The staff at hospital stated that the patient was with them for a short time, but had connected with so many of their staff who were understandably shocked that his life was taken away. The nurses who worked with the patient''s wife were equally upset, knowing how challenging a time this had been for her and their young son. The nurse and colleague had started a account to support the patient''s family and said she had kept the account open for donations to support. She also stated that the patient and his wife were very friendly and compassionate and always looked out for others. The hospital staff had banded together to collect food donations for bereaved family. A spokesman from Department of Health and Human Services said the flu could strike anyone in the community, even normally healthy people with no underlying health issues. The hospital''s staff were regularly informed about their risk from influenza and were encouraged to get immunized. They also offer a free flu immunization program to their staff and volunteers each year. Their staff were also educated in the correct hand hygiene techniques to reduce the risk of passing on or contracting infection. The hospital staff were encouraged to stay home if they were sick and advised to see their GP (general practioner), which had followed. There have been more than one and half times as many confirmed flu cases so far, this year than in the whole of 2018, as per new data. But despite the surge in early cases, experts said this year''s season was not worse than average, and an early start to flu season could mean an early end. This year to date, there were 97,920 laboratory confirmed cases of influenza, compared with 58,870 cases for the whole of 2018, according to the latest data from the National Notifiable Diseases Surveillance System (NNDSS). An infectious diseases expert at the hospital had said while a flu vaccine did not prevent people from getting influenza 100 percent of the time, it did make a difference, essentially the people could halve the risk of catching flu by vaccination. It was not perfect, but it was more than helpful. This case was considered as suspected vaccination failure as the details regarding time to onset for the event was unknown at the time of reporting.; Reported Cause(s) of Death: Influenza A


VAERS ID: 827846 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-05-14
Onset:2019-06-01
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2019-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray, Death, Depressed level of consciousness, Endotracheal intubation, Guillain-Barre syndrome, Intensive care, Lumbar puncture, Magnetic resonance imaging, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-25
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Cholecystectomy; COPD; Dyslipidaemia; Gastroesophageal reflux disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSEQIRUS201904251

Write-up: Obtunded; Ventilator-aquired pneumonia; Respiratory failure; Guillain-Barre syndrome; This is a serious spontaneous case reported from other health care professional to TGA (reference number: AU-TGA-0000469653) and initially retrieved on 26-Jul-2019, concerning an 80-year-old female patient. The patient''s medical history included dyslipidaemia, gastroesophageal reflux disease (GORD), chronic obstructive pulmonary disease (COPD), cholecystectomy and anaemia. On 14-May-2019, the patient administered Fluad [influenza virus haemagglutinin, dose reported as: 1 dose unspecified, route of administration intramuscular, anatomical location, batch number, expiry date: not reported] for vaccination. On 09-Jun-2019, the patient developed Guillain-Barre syndrome. On 12-Jun-2019, the patient was admitted to intensive care unit (ICU) with respiratory failure and was obtunded. The patient was intubated on admission and underwent on following procedures: chest x-ray, magnetic resonance imaging (MRI) and lumbar puncture, however results were not provided. During ICU admission the patient developed ventilator-acquired pneumonia and escalation of antimicrobial therapy. The patient died on 25-Jun-2019. As reported, nerve conduction studies were ordered but patient died before it was performed. The outcome of the events of respiratory failure, obtundation and ventilator-acquired pneumonia was unknown. The reporter assessed the case as serious (death, hospitalization) and possibly related to Fluad.; Sender''s Comments: The patient developed Guillain-Barre syndrome, respiratory failure, depressed level of consciousness and pneumonia bacterial after vaccination with the suspect product Fluad (TIV). Chronology is plausible. Reportedly, the patient died due to Guillain-Barre syndrome. Medical history of chronic obstructive pulmonary disease and advanced age (80) may have contributed to development of the events. More information regarding autopsy and concomitant drugs is needed. Based on provided information, causality is assessed as related for all events except for pneumonia bacterial (reported as ventilator-acquired pneumonia).; Reported Cause(s) of Death: Guillain-Barre syndrome


VAERS ID: 858439 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-05-03
Onset:2019-05-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2020-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Adenovirus test positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase, Blood bilirubin normal, Blood glucose normal, Blood thyroid stimulating hormone increased, Cough, Cytomegalovirus test negative, Dialysis efficacy test, Encephalitis cytomegalovirus, Encephalopathy, Eosinophil percentage, Epstein-Barr virus antibody positive, Fatigue, Gait disturbance, Gamma-glutamyltransferase increased, HIV antibody negative, HIV test negative, Haemoglobin urine present, Hepatitis, Herpes simplex test positive, Herpes virus infection, Increased bronchial secretion, International normalised ratio normal, Monocyte count, Mononucleosis heterophile test negative, Neutrophil percentage increased, Paresis, Platelet count normal, Polymerase chain reaction, Protein urine present, Thyroxine free normal, Urinary sediment present, Urine ketone body present, White blood cell count increased, White blood cells urine negative
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-10
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HPV VACCINE; BECLOMETHASONE [BECLOMETASONE]; PURAN T4; ACICLOVIR; IMMUNOGLOBULIN [IMMUNOGLOBULINS NOS]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20190529; Test Name: ALT; Test Result: 1033 {DF}; Result Unstructured Data: 1033; Test Date: 20190529; Test Name: AST; Test Result: 1450 {DF}; Result Unstructured Data: 1450; Test Date: 20190605; Test Name: Alkaline phosphatase; Test Result: 343 {DF}; Result Unstructured Data: 343; Test Date: 20190529; Test Name: BILIRRUBINAS; Test Result: 0.38 {DF}; Result Unstructured Data: 0.38; Comments: Direct: 0,02 Indirect: 0,36; Test Date: 20190604; Test Name: BILIRRUBINAS; Result Unstructured Data: No changes Type; Test Date: 20190529; Test Name: Blood glucose; Test Result: 90 {DF}; Result Unstructured Data: 90; Test Date: 20190603; Test Name: TSH dosage; Test Result: 3.82 {DF}; Result Unstructured Data: 3.82; Test Date: 20190604; Test Name: Type Kt; Test Result: 75.8 {DF}; Result Unstructured Data: 75.8; Test Date: 20190529; Test Name: SEROLOGY FOR CITALOMEGALOVIRUS; Test Result: Negative ; Test Date: 20190529; Test Name: Eosinophils; Test Result: 0.5 %; Test Date: 20190529; Test Name: IgM Epstein Barr; Test Result: 14 {DF}; Result Unstructured Data: 14; Test Date: 20190529; Test Name: IgM Epstein Barr; Test Result: 12.9 {DF}; Result Unstructured Data: 12.9; Test Date: 20190529; Test Name: GAMMA/GT; Test Result: 17 {DF}; Result Unstructured Data: 17; Test Date: 20190605; Test Name: ANTI-HERPES IGG TYPE 2; Result Unstructured Data: Reagent greater than 2.47; Test Date: 20190605; Test Name: ANTI-HERPES IGG TYPE 2; Result Unstructured Data: Reagent greater than 30; Test Date: 20190605; Test Name: ANTI-HERPES IGM TYPE 1; Test Result: 2.47 {DF}; Result Unstructured Data: 2.47; Test Date: 20190605; Test Name: ANTI-HERPES IGM TYPE 1; Result Unstructured Data: Reagent greater than 30; Test Date: 20190529; Test Name: ANTI HVA; Test Result: Negative ; Test Date: 20190603; Test Name: HIV SEROLOGY; Result Unstructured Data: NORMAL; Test Date: 20190604; Test Name: Tipo INR; Test Result: 1.22 {DF}; Result Unstructured Data: 1.22; Test Date: 20190529; Test Name: Lymphocytes; Test Result: 15.1 %; Test Date: 20190529; Test Name: Monocytes; Test Result: 7.2 %; Test Date: 20190529; Test Name: Neutrophils; Test Result: 75.7 %; Test Date: 20190529; Test Name: Platelets; Test Result: 373 {DF}; Result Unstructured Data: 373; Test Date: 20190529; Test Name: PCR; Test Result: 10.10 {DF}; Result Unstructured Data: 10.10; Test Date: 20190603; Test Name: Free T4; Test Result: 1.18 {DF}; Result Unstructured Data: 1.18; Test Date: 20190529; Test Name: URINE TEST; Result Unstructured Data: KETONICAL BODIES ++, HEMOGLOBIN +++, SOME EPITHELIAL CELLS BY FIELD, LEUKOCYTES LESS THAN 1 P/C, RED BLOOD CELLS LESS THAN 1P/C, GRANULOSOS CYLINDERS 5 P/C;; Test Date: 20190603; Test Name: URINE TEST; Result Unstructured Data: HEMOGLOBIN +++, PROTEIN +.; Test Date: 20190529; Test Name: Leukocytes; Test Result: 16980 {DF}; Result Unstructured Data: 16980
CDC Split Type: BRSA2020SA020509

Write-up: Hepatitis; Encephalopathy; Secretion; Cough; Positive adenovirus; Herpes positive / Herpes virus infection; Abdominal pain; Prostration; Change of gait and difficulty walking; Paresis; Initial information regarding an unsolicited valid serious case received from a nurse via physician and other health Care Professional via agency (under the reference number: IBFV-2020-1751) on 23-Jan-2020 and transmitted to sanofi on 23-Jan-2020. This case involves a 12 years old male patient who experienced abdominal pain (abdominal pain), paresis (paresis), prostration (fatigue), change of gait and difficulty walking (gait disturbance), secretion (increased bronchial secretion), cough (cough), positive adenovirus (adenovirus test positive), herpes positive / herpes virus infection (herpes virus infection), hepatitis (hepatitis) and encephalopathy (encephalopathy), while he received INFLUENZA VACCINE (TRIVALENT). Medical history, medical treatment, vaccination and family history were not provided. On 03-May-2019, Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation; On 18-MAR-2007, BECLOMETHASONE [BECLOMETASONE] (BECLOMETHASONE [BECLOMETASONE]) for Asthma and LEVOTHYROXINE SODIUM (PURAN T4) for Hypothyroidism; On 06-Jun-2019, ACICLOVIR (ACICLOVIR) for Herpes virus infection; and On 10-Jun-2019, IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN [IMMUNOGLOBULINS NOS]). On 03-May-2019, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer (lot number not reported) via an intramuscular route in the right deltoid. On 09-May-2019, the patient developed a serious paresis (paresis) 6 days following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. On 27-May-2019, the patient developed a serious change of gait and difficulty walking (gait disturbance) 24 days following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. On 29-May-2019, the patient developed a serious abdominal pain (abdominal pain) and prostration (fatigue) 26 days following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. On 03-Jun-2019, the patient developed a serious secretion (increased bronchial secretion), cough (cough), positive adenovirus (adenovirus test positive) and herpes positive / herpes virus infection (herpes virus infection) 1 month following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. On an unknown date, the patient developed a serious hepatitis (hepatitis) and encephalopathy (encephalopathy) (unknown latency) following the administration of INFLUENZA VACCINE (TRIVALENT). These events were assessed as medically significant and was leading to death. Relevant laboratory test results included: Alanine aminotransferase - On 29-May-2019: 1033 [1033] Aspartate aminotransferase - On 29-May-2019: 1450 [1450] Blood alkaline phosphatase - On 05-Jun-2019: 343 [343] Blood bilirubin - On 29-May-2019: 0.38 [0.38]; on 04-Jun-2019: No changes Type [No changes Type] Blood glucose - On 29-May-2019: 90 [90] Blood thyroid stimulating hormone - On 03-Jun-2019: 3.82 [3.82] Dialysis efficacy test - On 04-Jun-2019: 75.8 [75.8] Encephalitis cytomegalovirus - On 29-May-2019: Negative Eosinophil count - On 29-May-2019: 0.5 % Epstein-Barr virus antibody - On 29-May-2019: 14 [14] then 12.9 [12.9] Gamma-glutamyltransferase - On 29-May-2019: 17 [17] HIV antibody - On 29-May-2019: Negative HIV test - On 03-Jun-2019: NORMAL [NORMAL] Herpes simplex - On 05-Jun-2019: Reagent greater than 2.47 [Reagent greater than 2.47] then Reagent greater than 30 [Reagent greater than 30] then 2.47 [2.47] then Reagent greater than 30 [Reagent greater than 30] International normalised ratio - On 04-Jun-2019: 1.22 [1.22] Lymphocyte count - On 29-May-2019: 15.1 % Monocyte count - On 29-May-2019: 7.2 % Neutrophil count - On 29-May-2019: 75.7 % Platelet count - On 29-May-2019: 373 [373] Polymerase chain reaction - On 29-May-2019: 10.10 [10.10] Thyroxine free - On 03-Jun-2019: 1.18 [1.18] Urine analysis - On 29-May-2019: KETONICAL BODIES ++, HEMOGLOBIN +++, SOME [KETONICAL BODIES ++, HEMOGLOBIN +++, SOME EPITHELIAL CELLS BY FIELD, LEUKOCYTES LESS THAN 1 P/C, RED BLOOD CELLS LESS THAN 1P/C, GRANULOSOS CYLINDERS 5 P/C;]; on 03-Jun-2019: HEMOGLOBIN +++, PROTEIN +. [HEMOGLOBIN +++, PROTEIN +.] White blood cell count - On 29-May-2019: 16980 [16980] (Other relevant tests included Bast: 1%. monoteste: negative. Type KTTP: 27.6. Ctrl: 31.1) Final diagnosis were (fatal) paresis, (fatal) change of gait and difficulty walking, (fatal) prostration, (fatal) abdominal pain, (fatal) herpes positive / herpes virus infection, (fatal) positive adenovirus, (fatal) cough, (fatal) secretion, (fatal) encephalopathy and (fatal) hepatitis. It was not reported if the patient received any corrective treatment. On 10-JUN-2019, the patient outcome was reported as Fatal from the all events. It is unknown if an autopsy was done. The cause of death was reported as Abdominal pain, Paresis, Fatigue, Gait disturbance, Cough, Increased bronchial secretion, Adenovirus test positive, Herpes virus infection, Hepatitis and Encephalopathy.; Sender''s Comments: This case concerns an 12 year old male patient who presented with abdominal pain, paresis, fatigue, gait disturbance, increased bronchial secretion, cough, adenovirus test positive, herpes virus infection, hepatitis and encephalopathy, after vaccination with INFLUENZA VACCINE (TRIVALENT) (unknown manufacturer). The time to onset is compatible with the role of vaccine. Laboratory data were reported. The event is most likely the infectious origin. However, patient''s past medical history, medical condition at time of vaccination ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Abdominal pain; Paresis; Prostration; Walking difficulty; Cough; Tracheo-bronchial secretion excess; Adenovirus serology test positive; Herpes viral infection NOS; Hepatitis; Encephalopathy


VAERS ID: 876918 (history)  
Form: Version 2.0  
Age: 1.58  
Sex: Male  
Location: Foreign  
Vaccinated:2019-04-10
Onset:2019-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER S50117091 / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER S50117091 / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Diarrhoea, Diet refusal, Groin abscess, Haemorrhage, Hordeolum, Induration, Injection site abscess, Injection site pain, Injection site reaction, Pallor, Peau d'orange, Purulent discharge, Regurgitation, Resuscitation, Skin lesion, Unresponsive to stimuli
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular infections (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-13
   Days after onset: 3
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: Antiviral prophylaxis; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075132007BRA006925

Write-up: abscess in the left groin; pain in the administration; pain at the administration site; abscess at the administration site; hordeolum in the right eyelid; face cellulite; self-limited diarrhea; refused solid food; This spontaneous report was received from a physician via Regulatory Authority (two-way agreement) concerning a 19-month-old male patient. The patient''s pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 10-APR-2019, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) 180170, intramuscularly (dose, frequency and the expiration date were not reported) for antiviral prophylaxis. Lot number 180170 is an invalid lot number for hepatitis a vaccine, inactivated. Other suspect therapies included varicella virus vaccine live (unspecified) lot # S50117091, subcutaneously (dose, frequency and the expiration date were not reported) for prophylaxis; measles virus vaccine live (enders-edmonston), mumps virus vaccine live (jeryl lynn), rubella virus vaccine live (wistar ra 27/3) lot# 187VVA057Z, intramuscularly (dose, frequency and the expiration date were not reported) and influenza virus vaccine (unspecified) Lot# S50117091 (also reported as 190042) intramuscularly (dose, frequency and the expiration date were not reported). On the same date, the patient experienced self-limited diarrhea (diarrhea) and refused solid food (eating disorder). On 11-APR-2019, the patient''s mother noticed an abscess in the left groin (groin abscess) and the patient complained of pain (injection site pain/ administration site pain), the mother made a compress with warm water, a purulent discharge came from the abscess (injection site abscess), the mother also noticed a hordeolum in the right eyelid (hordeolum) and face cellulite (peau d''orange). On 12-APR-2019, with the increase of the lesion, hardening and bleeding, the mother took the patient to the Emergency Department, there was also a report that the child regurgitated cow''s milk, but ingested solid foods. At the Emergency Department, the patient was evaluated by a doctor and treatment with amoxicillin + clavulanate was indicated, and he was hospitalized. On 13-APR-2019, the patient was medicated with the antibiotic and at 10:30 pm, the mother had the child asleep in her lap and noticed the pale child, called the local nurse, resuscitation maneuvers were performed, and the child did not respond to commands. On 13-APR-2019, the patient died. The cause of death was unknown (reported as the body was sent to "IML" and the agency file did not describe the cause of death). It was unknown whether an autopsy was performed. The outcome of groin abscess, injection site abscess, injection site pain and administration site pain were reported as fatal. The outcome of diarrhoea was reported as recovered on 10-APR-2019 and peau d''orange was reported as recovered on 13-APR-2019. The outcome of eating disorder and hordeolum was unknown. The relatedness between the suspect therapies and the events was not provided. Upon internal review, groin abscess was determined to be medically significant.; Reported Cause(s) of Death: unknown cause of death


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

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

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

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


VAERS ID: 812406 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-30
Onset:2019-03-05
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2019-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA326AA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardiac failure, Coma, Culture throat, Death, Influenza, Pneumonitis, Polymerase chain reaction, Respiratory failure, Sepsis, Vaccination failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (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), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-27
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin; Coumadin; Ramipril; Aliflus; Sertraline; HALCION; BRETARIS GENUAIR; BISOPROLOL FUMARATE; VASCOMAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR; Result Unstructured Data: Test Result: unknown, Test Result Unit: unknown
CDC Split Type: ITGLAXOSMITHKLINEIT201907

Write-up: Vaccination failure; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; This case was reported by a physician via regulatory authority and described the occurrence of vaccination failure in a 74-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2018-2019 season) (batch number AFLBA326AA, expiry date unknown) for prophylaxis. Concomitant products included metformin hydrochloride (Metformin), warfarin sodium (Coumadin), ramipril, fluticasone propionate, salmeterol xinafoate (Aliflus), sertraline, triazolam (Halcion), aclidinium bromide (Bretaris Genuair), bisoprolol fumarate and manidipine hydrochloride (Vascoman). On 30th October 2018, the patient received Fluarix Tetra 2018-2019 season (unknown). On 5th March 2019, 126 days after receiving Fluarix Tetra 2018-2019 season, the patient experienced influenza a virus infection (serious criteria death), sepsis (serious criteria death and GSK medically significant), decompensation cardiac (serious criteria death and GSK medically significant), coma (serious criteria death and GSK medically significant), stemi (serious criteria death and GSK medically significant), respiration failure (serious criteria death and GSK medically significant) and pneumonitis (serious criteria death). On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant). Fluarix Tetra 2018-2019 season was discontinued. On 27th March 2019, the outcome of the influenza a virus infection, sepsis, decompensation cardiac, coma, stemi, respiration failure and pneumonitis were fatal. On an unknown date, the outcome of the vaccination failure was unknown. The patient died on 27th March 2019. The reported cause of death was sepsis, decompensation cardiac, coma, stemi, pneumonitis, influenza a virus infection and respiration failure. It was unknown if the reporter considered the vaccination failure, influenza a virus infection, sepsis, decompensation cardiac, coma, stemi, respiration failure and pneumonitis to be related to Fluarix Tetra 2018-2019 season. Additional details: Age at vaccination was not reported however patient could be 73 or 74 years old at time of vaccination. On an unknown date PCR was performed with unknown results. Initial information was reported by a physician via regulatory authority on 1st May 2019. Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic heart failure. Reporter''s Comments: Laboratory tests performed: PCR on a throat swab. Sender''s Comments: "Waiting for the physician report." Lab Comments: On an unknown date, PCR was performed with unknown results.; Reported Cause(s) of Death: Sepsis; Decompensation cardiac; Coma; STEMI; Pneumonitis; Influenza A virus infection; Respiration failure


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ZOLOFT; TERCONAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Neurofibromatosis; Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 20190214; Test Name: Biophysical profile; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190221; Test Name: Biophysical profile; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190301; Test Name: Biophysical profile; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190109; Test Name: Non stress test; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190122; Test Name: Non stress test; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190125; Test Name: Non stress test; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190213; Test Name: Non stress test; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190109; Test Name: Ultrasound; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190123; Test Name: Ultrasound; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190129; Test Name: Ultrasound; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.; Test Date: 20190207; Test Name: Ultrasound; Result Unstructured Data: Polycystic kidneys, oligohydramnios, anhydramnios.
CDC Split Type: USSEQIRUS201904742

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


VAERS ID: 806644 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-12-10
Onset:2019-02-26
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2019-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 0942A1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiogenic shock, Cough, Death, Dyspnoea, H3N2 influenza, Influenza A virus test positive, Interstitial lung disease, Pneumonia, Polymerase chain reaction positive, Sopor, Vaccination failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-08
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: Influenza A virus test; Test Result: Positive
CDC Split Type: ITSEQIRUS201902655

Write-up: Cardiogenic Shock; Bronchopneumonic outbreak [in interstitial lung disease]; [Bronchopneumonic outbreak] in interstitial lung disease; Sopor; Influenza A H3N2; Dry cough; Dyspnoea; Inefficacy of flu vaccination; Positive results, for influence A H3N2; This is a spontaneous case from country, reported by a physician to Agency (regulatory reference number: IT-MINISAL02-536805) and initially retrieved on 18-Mar-2019, concerning a 78-year-old, elderly female patient. On 10-Dec-2018, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 0942A1A, anatomical location and expiry date: not reported] for vaccination. On 26-Feb-2019, 2 months and 16 days after vaccination, the patient experienced dry cough, dyspnoea and sopor. On an unspecified date, the patient was hospitalized. During hospitalization, polymerase chain reaction (PCR) on nasal buffer was performed and the results were positive for influenza A H3N2 (reported as vaccination failure). On 28-Feb-2019, the patient experienced bronchopneumonia outbreak in interstitial lung disease. On 04-Mar-2019, the patient was transferred to a different hospital. On 08-Mar-2019, the patient experienced cardiogenic shock and died. The reporter assessed the case as serious (death and hospitalization).; Reporter''s Comments: A 78-year-old female patient experienced dry cough, dyspnoea, sopor and was diagnosed to have influenza, 2 months and 16 days after Fluad (TIV) vaccination (coded to H3N2 influenza and vaccination failure). The patient subsequently experienced bronchopneumonia outbreak in interstitial lung disease, cardiogenic shock and died. Considering the fact that vaccine needs minimum 2-3 weeks to provide immune protection against influenza, vaccination failure and causal role of suspect vaccine for the fatal event of H3N2 influenza cannot be ruled out and were assessed as related to suspect vaccine. Despite temporal association between vaccination and fatal events of bronchopneumonia outbreak in interstitial lung disease and cardiogenic shock, the clinical course suggests the reported influenza and its complications as a more plausible explanation for the events. Hence, the company assessed the causality as not related to suspect vaccine.The company assessed the events cardiogenic Shock, H3N2 influenza and vaccination failure as serious (medically significant).; Reported Cause(s) of Death: Cardiogenic shock; Sopor; Bronchopneumonic outbreak; Interstitial lung disease; Influenza A H3N2; Inefficacy of flu vaccination


VAERS ID: 801449 (history)  
Form: Version 2.0  
Age: 1.33  
Sex: Male  
Location: North Carolina  
Vaccinated:2019-02-07
Onset:2019-02-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS GD47F / 2 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. R013302 / 1 RL / SC

Administered by: Private       Purchased by: ?
Symptoms: Influenza virus test negative, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D
Current Illness: Anemia diagnosed on 2/7/19
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data: Flu test at ER - negative results
CDC Split Type:

Write-up: 2/7/19 - well visit - VARIVAX and FLULAVAL given. 2/8/19 - phone call from parent - fever "high" no temp avail. gave MOTRIN. 2/9/19 - ER visit high fever Tmax 102.5 exam normal d/c to home. 2/12/19 - phone call from parent - concern for vomiting at 4:30pm. Advice given.


VAERS ID: 806371 (history)  
Form: Version 2.0  
Age: 0.92  
Sex: Female  
Location: Arkansas  
Vaccinated:2019-02-07
Onset:2019-02-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LL / SYR
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. - / UNK RL / SYR
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RL / SYR
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RL / SYR
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK LL / SYR
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Death, Eyelid function disorder, Febrile convulsion, Pyrexia, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-02
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol for pain.
Current Illness: None
Preexisting Conditions: None.
Allergies: Latex
Diagnostic Lab Data: Blood and urine testing.
CDC Split Type:

Write-up: 4 hours after my daughter got her shots her fever wouldn''t go down. At 11pm that night she begain to have complex febrial seizures. She had 3 that night. After coming home she wasn''t the same. One of her eyes didn''t open as much as it should have and she was slower. Almost a month later she died in her sleep because of another febrial seizure.


VAERS ID: 890303 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:2019-02-01
Submitted: 0000-00-00
Entered: 2020-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Computerised tomogram thorax abnormal, Cough, Death, Diarrhoea, Fatigue, H1N1 influenza, Hypotension, Influenza A virus test positive, Intensive care, Legionella infection, Legionella test positive, Pneumonia, Polymerase chain reaction positive, Pyrexia, Rhinorrhoea, Sepsis, Vaccination failure
SMQs:, Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-01
   Days after onset: 149
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Angioimmunoblastic T-cell lymphoma; Chronic myelomonocytic leukemia (received a matched related donor (MRD) stem cell transplant (SCT) (in October 2018))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 201902; Test Name: Body temperature; Result Unstructured Data: (Test Result:39,Unit:degree C); Test Date: 201902; Test Name: Body temperature; Result Unstructured Data: (Test Result:40,Unit:degree C); Test Date: 201902; Test Name: CT chest; Result Unstructured Data: (Test Result:showed left upper lobe pneumonia,Unit:unknown); Test Date: 201902; Test Name: urinary antigen test; Result Unstructured Data: (Test Result:Legionella pneumophila serotype 1 positive,Unit:unknown); Test Date: 2019; Test Name: Polymerase chain reaction; Result Unstructured Data: (Test Result:see text,Unit:unknown); Test Date: 201902; Test Name: Nasopharyngeal swab; Result Unstructured Data: (Test Result:Influenza A virus type: H1N1 positive,Unit:unknown); Test Date: 2019; Test Name: Nasopharyngeal swab; Result Unstructured Data: (Test Result:positive for influenza A/H1pdm09,Unit:unknown); Test Date: 2019; Test Name: Nasopharyngeal swab; Result Unstructured Data: (Test Result:positive for influenza A/H1pdm09,Unit:unknown); Comments: A repeat RP2 panel was still positive for influenza A virus. Neuraminidase sequence was WT (Wild-type) and Polymerase sequence was I38T.
CDC Split Type: USGLAXOSMITHKLINEUS2020GS

Write-up: Hypotension; Sepsis; Loose stool; suspected vaccination failure; influenza A/H1pdm09/influenza A H1 2009 (Influenza A virus type: H1N1); Chills; Rhinorrhea; recurrent high fevers; Dry cough; left upper lobe pneumonia; Tiredness; Death NOS; Legionella pneumophila; This case was reported in a literature article and described the occurrence of unknown cause of death in a 66-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. Previously administered products included fludarabine, melphalan, alemtuzumab, total body irradiation, tacrolimus (prophylaxis) and rituximab (detectable circulating EBV DNA prior to transplant). Concurrent medical conditions included angioimmunoblastic t-cell lymphoma and chronic myelomonocytic leukemia (received a matched related donor (MRD) stem cell transplant (SCT) (in October 2018)). On an unknown date, the patient received Flu vaccine. In February 2019, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), h1n1 influenza (serious criteria hospitalization), chills (serious criteria hospitalization), rhinorrhea (serious criteria hospitalization), fever (serious criteria hospitalization), dry cough (serious criteria hospitalization) and legionella pneumophila infection (serious criteria GSK medically significant). In July 2019, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced lobar pneumonia (serious criteria GSK medically significant), hypotension (serious criteria hospitalization), sepsis (serious criteria hospitalization and GSK medically significant), loose stools (serious criteria hospitalization) and tiredness. The subject was treated with oseltamivir, antibiotics nos, baloxavir marboxil and azithromycin. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure, h1n1 influenza, chills, rhinorrhea, fever, legionella pneumophila infection, lobar pneumonia, hypotension, sepsis, loose stools and tiredness were unknown and the outcome of the dry cough was recovered/resolved. The subject died in July 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, vaccination failure, h1n1 influenza, lobar pneumonia, hypotension, sepsis, chills, rhinorrhea, fever, dry cough, loose stools, legionella pneumophila infection and tiredness to be related to Flu vaccine. Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure in a 66-years-old female patient, who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was a part of the study which described the clinical and virological responses to oseltamivir and baloxavir treatment in five allogeneic SCT recipients, and molecular characteristics of the influenza virus population before and after treatment. [It was used baloxavir to treat five allogeneic SCT recipients that were still symptomatic and shedding influenza virus after completing one or more treatment courses of oseltamivir and characterized the viral isolates before and during treatment. Allogeneic SCT patients with influenza A virus infection who received oseltamivir with no resolution of symptoms and were persistently positive for influenza A virus by the FilmArray Respiratory Pathogen two panel were included in the study]. The patient had angioimmunoblastic T-cell lymphoma (AITL) in partial remission and chronic myelomonocytic leukemia (CMML) who received a matched related donor (MRD) stem cell transplant (SCT) (in October 2018). The patient received fludarabine, melphalan, alemtuzumab, and total body irradiation (TBI 400cGy) as conditioning and tacrolimus as post-transplant graft-versus-host disease (GVHD) prophylaxis. Because of detectable circulating EBV DNA prior to transplant, the patient received one dose of rituximab with her transplant conditioning. The patient received Rituximab in prior 6 months. Time duration from SCT was 0.30 years. The patient had not active GVHD. The patient (setting) was from inpatient. No information on patient''s family history was provided. On an unspecified date, the patient received annual unspecified seasonal influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date in February 2019, an unknown period after the vaccination, the patient experienced chills, rhinorrhea, cough, and fever to 39 degree Celsius and was diagnosed with influenza A H1 2009 (Influenza A virus type: H1N1) using the RP2 panel. Nasopharyngeal swab in universal viral transport media (BD) was collected as part of routine clinical care. The patient did not receive immunosuppressive therapy at the time of influenza diagnosis. Oseltamivir therapy was initiated (for 5 days), but 5 days later the patient presented to the emergency department with recurrent high fevers to 40 degree Celsius, chills, rhinorrhea, dry cough, and loose stool. CT chest showed left upper lobe pneumonia, and a repeat RP2 panel was still positive for influenza A virus. The infection type was pneumonia. The patient was admitted to the intensive care unit for hypotension/sepsis and received broad-spectrum antibiotics and baloxavir 40 mg for influenza. The next day, a urinary antigen test for Legionella pneumophila serotype 1 was reported to be positive and antibiotic treatment with azithromycin 500 mg daily was started. The co-pathogen included Legionella. Her symptoms rapidly improved but the patient continued to complain of persistent cough and tiredness, and the RP2 panel was still positive for influenza A. A second dose of baloxavir 40 mg was administered 4 days after the initial dose, and the patient was discharged home two days later. When the patient returned to clinic for follow-up 1 and 3 weeks after discharge, her symptoms were much improved, the patient had no cough, but was positive for influenza A/H1pdm09 at both visits. The influenza outcome was persistent shedding. Neuraminidase sequence was WT (Wild-type) and Polymerase sequence was I38T. This case has been considered as suspected vaccination failure being the time to onset was unknown. On an unspecified date in July 2019, the patient died from progressive disease. It was unknown whether the patient''s autopsy was performed or not. [Nasopharyngeal swabs in universal viral transport media (BD) were collected as part of routine clinical care using standard procedures. Influenza was detected using the RP2 panel. Nucleic acid was isolated both using an automated platform (easyMAG) and using QIAamp kit in accordance with the manufacturers'' protocols. Nucleic acids extracted using the easyMAG platform were tested by real-time reverse transcriptase-PCR to confirm the presence of influenza virus. Nucleic acids extracted using QIAamp kits were sequenced with next-generation sequencing methods for whole-genome analysis. A total of five patients who were both symptomatic and persistently positive for influenza A on the RP2 panel after receiving oseltamivir were treated with baloxavir. Oseltamivir was administered at the standard dose of 75 mg twice/day orally. Baloxavir was administered orally as a single or two doses of 40 or 80 mg, based on weight, according to manufacturer''s instructions. All patients were profoundly immunocompromised because of allogeneic lymphodepleting SCT. In addition, two had received rituximab (monoclonal antibody directed to the lymphocyte surface protein CD20) within 6 months of influenza diagnosis, two had received prolonged immunosuppressive treatment for graft-versus-host disease (GVHD), and one was obese, a predisposing condition for severe influenza. All patients had coinfection with other pathogens, four of them had pneumonia and were hospitalized]. This case has been considered serious due to suspected vaccination failure, death and hospitalization. The author commented, "It has been repeatedly reported that the treatment of influenza in immunocompromised hosts is problematic, requiring prolonged treatment courses, causing an increased risk of the development of antiviral-resistant influenza variants. Moreover, because uncomplicated influenza in this patient population may present with few initial symptoms and no fever, the diagnosis is often delayed, and treatment with NAI is often initiated after the preferred 48-hour window from onset of symptoms. Baloxavir has been recently approved for the treatment of uncomplicated influenza. It has been shown that treatment with baloxavir is associated with a more rapid viral clearance. Here, we describe the treatment of five allogeneic SCT recipients with baloxavir who were still positive for influenza A after oseltamivir treatment. In 4 of these subjects, including those with demonstrated oseltamivir-resistant variants, treatment with baloxavir was followed by clinical improvement and viral clearance. Three patients did not have any detectable NAI resistance-associated changes in the influenza viruses sequenced at the time they received baloxavir, and we cannot exclude the possibility that more prolonged oseltamivir treatment may have also been effective for symptom resolution and viral clearance. We found that one of the treated subjects developed a PA variant after two doses of baloxavir. Although the patient improved and eventually cleared the infection, the potential for transmission of variant virus raises concern. Despite the small patient number and the lack of a control group, our data suggest that baloxavir may be a useful treatment option for infections with influenza virus with NAI-resistant variants, and/or in SCT patients who fail NAI treatment for other reasons. Combination therapy, including baloxavir and oseltamivir, has shown synergistic activity in vitro. This treatment option might be more effective and may decrease the emergence of resistant influenza variants in the immunocompromised host." The author concluded, "Our data suggest that baloxavir treatment can be effective in treating neuraminidase inhibitor-resistant influenza in profoundly immunocompromised patients. Randomized clinical trials are needed to define the role of baloxavir alone and combined with oseltamivir for the treatment of influenza in SCT recipients and other immunocompromised populations." This is 1 of the 3 valid cases reported in the same literature article.; Sender''s Comments: US-GLAXOSMITHKLINE-US2020GSK203425:Same reporter; Reported Cause(s) of Death: death NOS


VAERS ID: 805571 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-01-25
Onset:2019-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 254682 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Haemophagocytic lymphohistiocytosis, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATORVASTATIN
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSEQIRUS201902550

Write-up: Sepsis; Macrophage activation syndrome; This is a spontaneous case, initially reported by a physician to regulatory authority (regulatory reference number: GB-MHRA-EYC 00195313) and initially retrieved by Seqirus on 04-Mar-2019, concerning a 66-year-old, elderly, male patient. The patient''s current condition included hypertension. The patient did not have any known allergies and otherwise was very well. The patient''s concomitant medication included atorvastatin. On 25-Jan-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, batch number: 254682, route of administration: intramuscular, anatomical location and expiry date: not reported] as flu vaccination. On 26-Jan-2019, one day after vaccination, the patient experienced macrophage activation syndrome and on unspecified date, the patient experienced sepsis. The patient was hospitalised and died on 28-Jan-2019. The autopsy was done. The cause of death was reported as macrophage activation syndrome. The reporter assessed this case as serious (fatal and hospitalization).; Reporter''s Comments: A 66-year-old male patient experienced macrophage activation syndrome (MAS), one day after vaccination with Fluad TIV. Considering the plausible temporal relationship between vaccination to event onset, possible autoimmune inflammatory basis of the event, the company assessed causality of MAS as related to suspect vaccine. The patient also had sepsis, unspecified period after receipt of suspect vaccine. However, considering the inactivated nature of vaccine and infective nature of the event, the causal role of suspect vaccine can be ruled out. The sepsis could have contributed to MAS.; Reported Cause(s) of Death: Macrophage activation syndrome


VAERS ID: 828941 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-12-10
Onset:2019-01-21
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2019-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 254690 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-06
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SENNA [SENNOSIDE A+B]; CYANOCOBALAMIN; OMEPRAZOLE; FOLIC ACID; CALCIUM +VIT D; CETIRIZINE; TRIMETHOPRIM
Current Illness: Dementia; Gastrooesophageal reflux disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSEQIRUS201900716

Write-up: Patient died; Given 2nd Fluad vaccine; This is a serious spontaneous case, initially received from other health professional (registered nurse) on 21-Jan-2019, concerning a 95-year-old elderly female patient. The patient''s current condition included dementia (since 19-May-2015). The concomitant medications of the patient included omeprazole for gastro-oesophageal reflux disease (reported as GORD), trimethoprim for urinary tract infection (UTI) prophylaxis, Senna, cyanocobalamin, folic acid, vitamin D with calcium and cetirizine. On 10-Dec-2018, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 254690, expiration date: 30-Jun-2019 and anatomical location: left arm] as she was over 65 years. On 21-Jan-2019, 42 days after 1st administration, the patient was administered a second dose of Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 254690, expiration date: 30-Jun-2019 and anatomical location: left arm] (explicitly coded as extra dose administered) as she was over 65 years. At the time of reporting, it was unknown if the patient experienced any adverse event. It was reported that, there was not any planned surgery or any condition which required surgery. On 06-Feb-2019, 16 days after the administration of second dose of Fluad (TIV) the patient died. The cause of death was not reported. The autopsy was not performed. The reporter was unable to provide any information, as the notes did not belong to her, it belonged to GP surgery.Hence the case was considered as lost to follow-up. Follow up received from other health professional (lead nurse) on 01-Apr-2019: The case was upgraded from non-serious to serious, as new event ?death'' was added. Added primary reporter''s email address and secondary reporter (lead nurse) in the general tab. Added GORD (gastro-oesophageal reflux disease) as current condition and start date of dementia (19-May-2015) in the patient tab. Anatomical location of vaccination was added as left arm for both the regimens in the product tab. Indication of Trimethoprim (UTI prophylaxis) and omeprazole were (GORD) added in the product tab. It was unknown if the patient experienced any adverse event. It was reported that that the patient died on 06-Feb-2019. The cause was death was not reported. It was unknown if the autopsy was performed or not. Added new event, "patient died" in the event tab. The narrative was amended accordingly. Non-significant follow up received from other health professional (lead nurse) on 17-Apr-2019: The details of secondary reporter (first name, institution, city, county, postal code and phone number) were added in the general tab. No changes were made in narrative. Follow up received from the other health professional (nurse) on 03-May-2019: The secondary reporter''s information details were added in the general tab. The reporter confirmed the vaccination dates as 10-Dec-2018 (1st dose) and 21-Jan-2019 (2nd dose). It was reported that, there was not any planned surgery or any condition which required surgery. The autopsy information updated in patient tab (no autopsy was performed). At the time of this report, no cause of death was available. The narrative was amended accordingly. Non-significant follow up received from other health professional on 14-May-2019: No additional information was received; hence no changes were made in the narrative. Non-significant follow up received from other health professional (nurse) on 15-May-2019: The reporter stated that, she was unable to pass on the follow up information as these notes were no longer belong to us as her GP surgery. No new information was received, hence no changes were made in the narrative.; Reporter''s Comments: A 95-year-old, female patient was administered 2 doses of Fluad TIV 42 days apart (considered as extra dose administered). The patient died, 16 days after receipt of second dose of Fluad TIV. Considering the lack of information regarding cause of death and the events prior to death, the causality assessed as unassessable. The progressive age of the patient, underlying conditions (gastro-oesophageal reflux disease, dementia) are considered as known risk factors. The company assessed the causality of the event extra dose administered as not related considering the accidental nature of the event. The case will be further assessed upon receipt of follow up information.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 795791 (history)  
Form: Version 2.0  
Age: 0.75  
Sex: Male  
Location: South Carolina  
Vaccinated:2019-01-10
Onset:2019-01-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT6259MA / 1 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood glucose, Body temperature decreased, Cardiac arrest, Cyanosis, Death, Endotracheal intubation, Resuscitation, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: Upper respiratory illness
Preexisting Conditions: None
Allergies: None known
Diagnostic Lab Data: Blood glucose noted in ED record
CDC Split Type:

Write-up: Per ER report, patient received his Flu vaccine at his 9 month well check. Parents took him home. He fed and then went down for a nap. One to two hours later mother reports finding the child cyanotic and unresponsive. EMS called and found him in asystole. EMS attempted resuscitation en route to ER by placing IO and attempted intubation. He was given epinephrine x 2. CPR continued in the ED. Warmed to 35.4, intubated with 3.5 cuffed ET and received multiple rounds of epinephrine. Chest compressions were recorded for 18 minutes. Time of death was called at 1814.


VAERS ID: 808139 (history)  
Form: Version 2.0  
Age: 1.33  
Sex: Male  
Location: Ohio  
Vaccinated:2018-12-11
Onset:2019-01-03
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2019-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS T79X3 / 4 LL / IM
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS F4T2K / 1 RL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS 4337E / 4 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W33489 / 4 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My Son went to the doctor for shots on December 11 2018. He got DTP/DTap /HIB/PCV/and Influenza (flu shot). This was his first time getting the flu shot. Research says it takes 2 weeks for the flu shot to start to take effect. Approx 3 weeks later we found our Son unresponsive on 1/3/2019.


VAERS ID: 812329 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-23
Onset:2018-12-27
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2019-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA322CA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Cough, Death, Dependence on respirator, Influenza, Influenza A virus test positive, Polymerase chain reaction positive, Pyrexia, Respiratory disorder, Respiratory distress, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (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: 2019-01-16
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR; Result Unstructured Data: Test Result: Influenza A NA, Test Result Unit: unknown
CDC Split Type: DEGLAXOSMITHKLINEDE201907

Write-up: ARDS; respiratory disorder requiring ventilation; respiratory disorder requiring ventilation; Influenza A; Respiratory distress; fever; Dry cough; Vaccination failure; This case was reported by a physician via regulatory authority and described the occurrence of ards in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2018/2019) (batch number AFLBA322CA, expiry date unknown) for prophylaxis. On 23rd October 2018, the patient received Influsplit Tetra 2018/2019 (intramuscular). On 27th December 2018, 65 days after receiving Influsplit Tetra 2018/2019, the patient experienced influenza a virus infection, vaccination failure (serious criteria GSK medically significant), respiratory distress (serious criteria GSK medically significant), fever and dry cough. On an unknown date, the patient experienced ards (serious criteria death and GSK medically significant), respiratory disorder nos (serious criteria death) and dependence on ventilator (serious criteria death and GSK medically significant). On 16th January 2019, the outcome of the ards, respiratory disorder nos and dependence on ventilator were fatal. On an unknown date, the outcome of the influenza a virus infection, vaccination failure, respiratory distress, fever and dry cough were unknown. The patient died on 16th January 2019. The reported cause of death was respiratory disorder, acute respiratory distress syndrome and dependence on ventilator. It was unknown if the reporter considered the ards, respiratory disorder nos, dependence on ventilator, influenza a virus infection, vaccination failure, respiratory distress, fever and dry cough to be related to Influsplit Tetra 2018/2019. Additional details: Age at vaccination was not reported however patient could be 71 or 72 years old at time of vaccination. On an unknown date, PCR was performed with results Influenza A NA. PEI assessment of causality was reported as Unclassifiable. Batch number for Influsplit Tetra 2018/2019 was reported as ASLBA322CA however on batch number review it was corrected to AFLBA322CA. Initial information was reported by a physician via regulatory authority on 30th April 2019. ARDS , espiratory disorder nos, Dependence on ventilator,influenza a virus infection, vaccination failure, respiratory distress, fever and dry cough. Lab Comments: On an unknown date PCR was performed with result Influenza A NA.; Reported Cause(s) of Death: Respiratory disorder; Acute respiratory distress syndrome; Dependence on ventilator


VAERS ID: 797713 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: New York  
Vaccinated:2018-12-08
Onset:2018-12-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UJ043AB / N/A RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Breath sounds abnormal, Death, Dysphagia, Resuscitation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-12-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: risperidone; omeprazole; DEPAKOTE; calcium +D; ENSURE
Current Illness: Dysphagia; Bronchiectasis; Latent Tuberculosis; Pulmonary nodule; Mild dementia; Breast cancer; Bipolar disorder; Low weight
Preexisting Conditions: As above
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: The following is history obtained from family after the event: The patient left the office, went for breakfast, developed difficulty swallowing in the restaurant and was making sounds in her chest when breathing, was driven home by family, was not answering her family verbally, then EMS was called and they could not revive her, she was sent to the ER.


VAERS ID: 890675 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:2018-12-01
Submitted: 0000-00-00
Entered: 2020-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Blood culture negative, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Coronavirus infection, Coronavirus test positive, Cough, Death, Dyspnoea, Enterovirus infection, Fatigue, Gene sequencing, Influenza, Influenza A virus test positive, Intensive care, Pneumonia bacterial, Polymerase chain reaction positive, Productive cough, Pyrexia, Respiratory failure, Rhinovirus infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-01
   Days after onset: 396
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunocompromised; Neoplasm malignant
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myeloid leukemia (underwent a matched related donor (MRD) stem cell transplant (SCT) in November 2016); Graft versus host disease
Allergies:
Diagnostic Lab Data: Test Date: 201812; Test Name: Blood cultures; Result Unstructured Data: (Test Result:negative,Unit:unknown); Test Date: 201812; Test Name: Body temperature; Result Unstructured Data: (Test Result:39,Unit:degree C); Test Date: 201812; Test Name: Chest x-ray; Result Unstructured Data: (Test Result:see text,Unit:unknown); Test Date: 201812; Test Name: Chest computerized tomography; Result Unstructured Data: (Test Result:see text,Unit:unknown); Test Date: 201812; Test Name: next-generation sequencing; Result Unstructured Data: (Test Result:see text,Unit:unknown); Test Date: 201812; Test Name: RT-PCR; Result Unstructured Data: (Test Result:see text,Unit:unknown); Test Date: 201812; Test Name: Nasopharyngeal swab; Result Unstructured Data: (Test Result:positive for influenza A,Unit:unknown); Comments: Chest x-ray showed bilateral interstitial opacifications suggesting a possible superimposed bacterial pneumonia. RP2 (Respiratory Pathogen two panel) was positive for influenza A/H1pdm09 (Influenza A virus type: H1N1) and coronavirus 229E.Chest computerized tomography (CT) performed 3 weeks after admission showed variable change in multilobar pneumonia with improvement within the left upper lobe and progression in the left lower lobe. Weekly RP2 panels during this period were positive for influenza A and coronavirus 229E. A RP2 panel performed at discharge was positive for influenza A/H1pdm09, but it was unable to detect the virus in the same specimen by real-time RT-PCR or next-generation sequencing.At that time, the patient was asymptomatic and the RP2 panel was negative for influenza and still positive for coronavirus 229E. Neuraminidase sequence was H275Y and Polymerase sequence was WT (Wild-type).
CDC Split Type: USGLAXOSMITHKLINEUS2020GS

Write-up: suspected vaccination failure; influenza A/H1pdm09; coronavirus 229E; shortness of breath; Cough/productive cough; Fever; Death NOS; rhinovirus/enterovirus; rhinovirus/enterovirus; Fatigue; Bacterial pneumonia; Acute respiratory distress syndrome; hypoxic respiratory failure; This case was reported in a literature article and described the occurrence of unknown cause of death in a 61-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. The subject''s past medical history included acute myeloid leukemia (underwent a matched related donor (MRD) stem cell transplant (SCT) in November 2016) and graft versus host disease. Previously administered products included fludarabine, melphalan, alemtuzumab, tacrolimus (prophylaxis), steroids and ruxolitinib. Concurrent medical conditions included neoplasm malignant and immunocompromised. On an unknown date, the patient received Flu vaccine. In December 2018, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), influenza a virus infection (serious criteria hospitalization), coronavirus infection (serious criteria hospitalization), pneumonia bacterial (serious criteria GSK medically significant), acute respiratory distress syndrome (serious criteria GSK medically significant), hypoxic respiratory failure (serious criteria GSK medically significant), shortness of breath (serious criteria hospitalization), cough (serious criteria hospitalization), fever (serious criteria hospitalization), enterovirus infection (serious criteria GSK medically significant), rhinovirus infection and fatigue. In January 2020, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). The subject was treated with tacrolimus, oseltamivir, antibiotics nos, steroids nos (Steroids), prednisone, ruxolitinib, oxygen and baloxavir marboxil. In January 2020, the outcome of the unknown cause of death was fatal. On an unknown date, the outcome of the vaccination failure, influenza a virus infection, coronavirus infection, pneumonia bacterial, shortness of breath, cough, fever, enterovirus infection and rhinovirus infection were unknown and the outcome of the acute respiratory distress syndrome, hypoxic respiratory failure and fatigue were recovered/resolved. The subject died in January 2020. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, vaccination failure, influenza a virus infection, coronavirus infection, pneumonia bacterial, acute respiratory distress syndrome, hypoxic respiratory failure, shortness of breath, cough, fever, enterovirus infection, rhinovirus infection and fatigue to be related to Flu vaccine. Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure in a 61-years-old female patient, who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was a part of the study which described the clinical and virological responses to oseltamivir and baloxavir treatment in five allogeneic SCT recipients, and molecular characteristics of the influenza virus population before and after treatment. [It was used baloxavir to treat five allogeneic SCT recipients that were still symptomatic and shedding influenza virus after completing one or more treatment courses of oseltamivir and characterized the viral isolates before and during treatment. Allogeneic SCT patients with influenza A virus infection who received oseltamivir with no resolution of symptoms and were persistently positive for influenza A virus by the FilmArray Respiratory Pathogen two panel were included in the study]. The patient had a history of acute myeloid leukemia (AML). The patient underwent a matched related donor (MRD) stem cell transplant (SCT) in November 2016 conditioned with fludarabine, melphalan, and alemtuzumab and received tacrolimus as post-transplant graft-versus-host disease (GVHD) prophylaxis. Time duration from SCT was 2.12 years. The patient had active GVHD. The patient (setting) was from inpatient. The patient''s post-transplant course was complicated by cytogenetic disease relapse at 1 year. The patient received two donor lymphocyte infusions, which successfully controlled her malignancy but resulted in GVHD necessitating prolonged immunosuppression with systemic steroids, tacrolimus, and ruxolitinib. No information on patient''s family history was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date in end of December 2018, an unknown period after the vaccination, the patient was admitted to an outside hospital complaining of shortness of breath, cough, and fever to 39 degree Celsius for 2 days prior to admission. Nasopharyngeal swab in universal viral transport media (BD) was collected as part of routine clinical care. The patient was found to be positive for influenza A. Chest x-ray showed bilateral interstitial opacifications suggesting a possible superimposed bacterial pneumonia. The infection type was pneumonia. The patient required high flow oxygen and was admitted to the intensive care unit. The patient was treated with oseltamivir, broad-spectrum antibiotics, and steroids for possible acute respiratory distress syndrome. Blood cultures were negative. After 4 days, the patient was transferred to the hospital, and on admission, RP2 was positive for influenza A/H1pdm09 (Influenza A virus type: H1N1) and coronavirus 229E. The patient received immunosuppressive therapy at the time of influenza diagnosis included prednisone 20 mg once a day (QD)/Ruxolitinib 5 mg twice a day (BID), Tacrolimus. The patient did not receive Rituximab in prior 6 months. The co-pathogen included rhinovirus/enterovirus. Treatment with oseltamivir for 5 days and broad-spectrum antibiotics for possible bacterial superinfection was continued for 10 days of total course. Despite this treatment, the patient continued to experience profound fatigue, productive cough, and hypoxic respiratory failure requiring oxygen supplementation (2-4L). Chest computerized tomography (CT) performed 3 weeks after admission showed variable change in multilobar pneumonia with improvement within the left upper lobe and progression in the left lower lobe. Weekly RP2 panels during this period were positive for influenza A and coronavirus 229E. Because of the concern for oseltamivir-resistant influenza, the patient received baloxavir (80 mg), once. The patient''s respiratory status, cough, and fatigue rapidly improved, and the patient was discharged home four days after baloxavir treatment. A RP2 panel performed at discharge was positive for influenza A/H1pdm09, but it was unable to detect the virus in the same specimen by real-time RT-PCR or next-generation sequencing. The patient missed follow-up appointments because of severe weather conditions and was readmitted for unrelated issues one month after discharge. At that time, the patient was asymptomatic and the RP2 panel was negative for influenza and still positive for coronavirus 229E. The influenza outcome was clearance. Neuraminidase sequence was H275Y and Polymerase sequence was WT (Wild-type). This case has been considered as suspected vaccination failure being the time to onset was unknown. On an unspecified date in January 2020, the patient succumbed to fatal complications of GVHD. It was unknown whether the patient''s autopsy was performed or not. [Nasopharyngeal swabs in universal viral transport media (BD) were collected as part of routine clinical care using standard procedures. Influenza was detected using the RP2 panel. Nucleic acid was isolated both using an automated platform (easyMAG) and using QIAamp kit in accordance with the manufacturers'' protocols. Nucleic acids extracted using the easyMAG platform were tested by real-time reverse transcriptase-PCR to confirm the presence of influenza virus. Nucleic acids extracted using QIAamp kits were sequenced with next-generation sequencing methods for whole-genome analysis. A total of five patients who were both symptomatic and persistently positive for influenza A on the RP2 panel after receiving oseltamivir were treated with baloxavir. Oseltamivir was administered at the standard dose of 75 mg twice/day orally. Baloxavir was administered orally as a single or two doses of 40 or 80 mg, based on weight, according to manufacturer''s instructions. All patients were profoundly immunocompromised because of allogeneic lymphodepleting SCT. In addition, two had received rituximab (monoclonal antibody directed to the lymphocyte surface protein CD20) within 6 months of influenza diagnosis, two had received prolonged immunosuppressive treatment for graft-versus-host disease (GVHD), and one was obese, a predisposing condition for severe influenza. All patients had coinfection with other pathogens, four of them had pneumonia and were hospitalized]. This case has been considered serious due to suspected vaccination failure, death and hospitalization. The author commented, "It has been repeatedly reported that the treatment of influenza in immunocompromised hosts is problematic, requiring prolonged treatment courses, causing an increased risk of the development of antiviral-resistant influenza variants. Moreover, because uncomplicated influenza in this patient population may present with few initial symptoms and no fever, the diagnosis is often delayed, and treatment with NAI is often initiated after the preferred 48-hour window from onset of symptoms. Baloxavir has been recently approved for the treatment of uncomplicated influenza. It has been shown that treatment with baloxavir is associated with a more rapid viral clearance. Here, we describe the treatment of five allogeneic SCT recipients with baloxavir who were still positive for influenza A after oseltamivir treatment. In 4 of these subjects, including those with demonstrated oseltamivir-resistant variants, treatment with baloxavir was followed by clinical improvement and viral clearance. Three patients did not have any detectable NAI resistance-associated changes in the influenza viruses sequenced at the time they received baloxavir, and we cannot exclude the possibility that more prolonged oseltamivir treatment may have also been effective for symptom resolution and viral clearance. We found that one of the treated subjects developed a PA variant after two doses of baloxavir. Although the patient improved and eventually cleared the infection, the potential for transmission of variant virus raises concern. Despite the small patient number and the lack of a control group, our data suggest that baloxavir may be a useful treatment option for infections with influenza virus with NAI-resistant variants, and/or in SCT patients who fail NAI treatment for other reasons. Combination therapy, including baloxavir and oseltamivir, has shown synergistic activity in vitro. This treatment option might be more effective and may decrease the emergence of resistant influenza variants in the immunocompromised host." The author concluded, "Our data suggest that baloxavir treatment can be effective in treating neuraminidase inhibitor-resistant influenza in profoundly immunocompromised patients. Randomized clinical trials are needed to define the role of baloxavir alone and combined with oseltamivir for the treatment of influenza in SCT recipients and other immunocompromised populations." This is 1 of the 3 valid cases reported in the same literature article.; Sender''s Comments: US-GLAXOSMITHKLINE-US2020GSK205640:Same reporter US-GLAXOSMITHKLINE-US2020GSK205641:Same reporter; Reported Cause(s) of Death: death NOS


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