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From the 10/15/2021 release of VAERS data:

Found 1,996 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: 1780481 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-10-08
Onset:2021-10-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 42M9S / N/A LA / IM

Administered by: Private       Purchased by: ?
Symptoms: 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: 2021-10-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol, atorvastatin, cilostazole, clonazepam, clopidgrel, furosemide, gabapentin, glipizide, jardiance, keppra, lisinopril, metformin, metoprolol, oxycodone. ivega, pantoprazole, prazosin, potassium, quetiapine, spironolactone, tizanidi
Current Illness: no acute
Preexisting Conditions: PVD, CHF, CAD, seizures, diabetes, schizophrenia, COPD, DJD spine, remote brain injury in infancy, PTSD
Allergies: none
Diagnostic Lab Data: None
CDC Split Type:

Write-up: patient was in his usual state of health with multiple chronic medical conditions when the flu vaccine was administered on Friday 10/8. On Tuesday 10/12 the foster home called to report that the patient was found deceased on the floor. Appears to have died suddenly. There is no way to know if there was a causal relation but felt it was important to report due to timing of death shortly after vaccination.


VAERS ID: 1775807 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-10-07
Onset:2021-10-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ763AC / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-10-08
   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: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: no known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: on 10/08/2021 we received a call from a nurse that the patient was found dead in her bed. she was not having any ailment prior to that.


VAERS ID: 1779214 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-09-10
Onset:2021-10-08
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939906 / 3 RA / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UJ694AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-10-08
   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: loratadine, fluticasone, omeprazole, lisinopril, tizanidine, carvedilol, hydrocortisone tablet, amlodipine, advair, magnesium oxide, potassium chloride liquid, imodium, prochlorperazine, gabapentin, ferrous sulfate, nortriptyline
Current Illness: anemia, ileostomy, type 2 Diabetes mellitus, Wolff-Parkinson-White, chronic pancreatitis, nicotine dependence, adrenal insufficiency, GERD, Crohns, hypertension, mild intermittent asthma, sleep apnea, hypokalemia
Preexisting Conditions: anemia, ileostomy, type 2 Diabetes mellitus, Wolff-Parkinson-White, chronic pancreatitis, nicotine dependence, adrenal insufficiency, GERD, Crohns, hypertension, mild intermittent asthma, sleep apnea, hypokalemia
Allergies: cephalexin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Notified by medical examiner that patient was found deceased at home 10/08/2021, no report of symptoms in interim


VAERS ID: 1762703 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 019F21A / 1 LA / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT7319KA / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-10-04
   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: None discussed or known.
Preexisting Conditions: Pt discussed having heart issues and diabetes during administration, as we discussed possibly considering other vaccines such as pneumonia and shingles vaccines in the future. Nothing documented. Pt did not fill maintenance medications at our pharmacy. Was a new patient to us at time of vaccination.
Allergies: None
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: Pt received vaccines at our pharmacy the morning of 10/4/21. She was monitored for 15 minutes after vaccination and no reactions were noted or observed in the patient waiting time. She left without any known complications. On 10/5/21, the Coroner came to the pharmacy with documents to retrieve medical records for the patient as she had "went into cardiac arrest yesterday and needed these records for the autopsy investigation." After contacting my direct supervisor and he contacted necessary persons to confirm the release of the PHI, we called him back to inform him he could come to pick up records. There was no communication in between the time the patient left the pharmacy without complications from the vaccines and the time the coroner came to pharmacy to retrieve patient records for her death.


VAERS ID: 1754103 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-30
Onset:2021-10-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0202 / 3 LA / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ749AA / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-10-01
   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: 08/04/2021 Jublia 10 % topical solution with applicator 1 application apply to nails daily; cover affected toenail, toenail folds, toenail bed and undersurface of nail x 48 weeks. 07/27/2021 Invokana 100 mg tablet 1 tablet by mouth daily 07
Current Illness: none noted
Preexisting Conditions: E1165 Type 2 Diabetes Mellitus With Hyperglycemia N183 Chronic Kidney Disease, Stage 3 (moderate) E291 Testicular Hypofunction E782 Mixed Hyperlipidemia M5417 Radiculopathy, Lumbosacral Region Sleep Apnea I714 Abdominal Aortic Aneurysm, Without Rupture
Allergies: NKDA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Received call this morning 10/1/2021 from medical examiner that wife found patient deacesed - medical examiner states that he determinded natural causes.


VAERS ID: 1741193 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-09-24
Onset:2021-09-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. P100353144 / UNK LA / SYR

Administered by: Senior Living       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-25
   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: Xanax, Remeron, Zoloft, Ibuprofen, Risperdal, Tramadol, Depakote, Lisinopril, Melatonin, Miralax, Omeprazole, Oxybutrin, Norvasc
Current Illness: shoulder pain and redness
Preexisting Conditions: Resident was started on Hospice for decline in health on 8/11/21
Allergies: NKA
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: resident passed away, no signs or symptoms present


VAERS ID: 1775351 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-18
Onset:2021-09-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA4: INFLUENZA (SEASONAL) (FLUAD QUADRIVALENT) / SEQIRUS, INC. 323503 / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-20
   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: OXYCODONE 10MG,ALPRAZOLAM 0.5MG, TRAZODONE 50MG, GABAPENTIN 300MG, METOPROLOL TARTRATE 25MG, CARISOPRODOL 35MG,, MODERNA PREVIOUSLY MONTHS AGO-
Current Illness: UNKNOWN,
Preexisting Conditions: CHRONIC PAIN/MUSCLE SPASMS/HEART DISEASE OF SOME SORT
Allergies: ENOXAPARIN
Diagnostic Lab Data: NOT KNOWN-SINCE DECEASED
CDC Split Type:

Write-up: SON CAME IN 10/6/21 AND REPORTED HIS MOM WAS REALLY TIRED,LIKE USUAL AFTER HER FLU SHOT,BUT THEY FOUND HER WITHIN 2 DAYS OF FLU SHOT DEAD- APPROXIMATELY 9/19/21 OR 9/20/21


VAERS ID: 1732009 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-09-17
Onset:2021-09-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ689AA / UNK - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Apnoea, Blood creatinine increased, Blood lactic acid, Blood urea normal, Death, Electroencephalogram abnormal, Encephalopathy, Extubation, Malaise, Resuscitation, Troponin increased, Unresponsive to stimuli, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-23
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin 81 mg, atorvastatin 40 mg, metoprolol XL 25 mg,
Current Illness: none
Preexisting Conditions: Age-related macular degeneration, osteoarthritis of spine, normocytic anemia, low testosterone, pulmonary fibrosis, hypertensive heart disease with CHF, CAD, stage 3 CKD, bioprosthetic AVR, dyslipidemia.
Allergies: Ketorolac, penicillin
Diagnostic Lab Data: In ED, troponins up trending from 40 to 294, normal BUN, Cr 1.6, lac 6.7, WBC 18.1. EEG showed slowing indicative of severe encephalopathy. Extubated on 9/20/21.
CDC Split Type:

Write-up: Got flu shot at pharmacy and began feeling unwell. After receiving flu shot, he went out to the car while his wife receive her flu shot. When wife returned to car, patient unresponsive and apneic. Estimated down time 5 minutes. No associated trauma. EMS performed CPR and epinephrine administered. Patient resuscitated but remained unresponsive throughout hospitalization. Patient died on 9/23/21 at 14:20.


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: 1362689 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Leg operation; Wound
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: Computed tomography scan; Result Unstructured Data: Uninformed
CDC Split Type: ARSEQIRUS202102531

Write-up: Stroke; This spontaneous case from was received on 27-May-2021 from other non-health professional via Sinergium Biotech S.A. (reference number: EA6/21) and concerned an 86-year-old, male patient. The patient''s concurrent conditions, information on allergies and concomitant medications were unknown. The patient''s past medical condition included gunshot wound due to which the patient underwent leg surgery some years ago (the notifier could not specify date). The patient''s historical vaccines included Fluxvir (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59) in the past which was tolerated and one dose of Covid Vaccine (Sinopharm) on 21-Mar-2021 (the patient did not receive the second dose). On 18-May-2021, the patient was vaccinated with Fluxvir (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one dose, route of administration: intramuscular and anatomical location: not reported) as flu immunisation. The batch number was not reported (the reporter had no record of the batch number applied). On 19-May-2021, one day after receiving Fluxvir (TIV), the patient suffered from decompensation. The patient was transferred to a local hospital where he was hospitalized. A computed tomography was performed, and the result was not provided. The patient was diagnosed with stroke. On the same day, three hours after the admission, the patient died. As reported, the cause of death was stroke. An autopsy was not performed. The reporter did not provide a causality assessment. The event of stroke was reported as serious due to fatal outcome and was additionally considered to be medically significant by a Physician within Seqirus''s Regulatory Authority Management Department. Company comment: A 86-year-old, male patient suffered a cerebrovascular accident one day after vaccination with the suspect product Fluxvir (TIV). Three hours after the admission, the patient died. As reported, the cause of death was stroke. An autopsy was not performed. More information regarding the underlying medical history, related diagnostic findings and concomitant is needed. Advanced age may have significantly contributed to the development of the event. Due to lack of information, causality for the reported event is unassessable.; Sender''s Comments: A 86-year-old, male patient suffered a cerebrovascular accident one day after vaccination with the suspect product Fluxvir (TIV). Three hours after the admission, the patient died. As reported, the cause of death was stroke. An autopsy was not performed. More information regarding the underlying medical history, related diagnostic findings and concomitant is needed. Advanced age may have significantly contributed to the development of the event. Due to lack of information, causality for the reported event is unassessable.; Reported Cause(s) of Death: Stroke


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: 1345913 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-03
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Dyspnoea, Endotracheal intubation, Laboratory test, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 9
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: COVID-19 VACCINE; LOSARTAN; DIPYRONE
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2021SA171958

Write-up: covid 19; fever; body pain; shortness of breath; This initial Information regarding this unsolicited and serious case was received on 18-May-2021 from a non-healthcare professional (patient''s sister) through Business Partner, which was forwarded to Regulatory Authority on 19-May-2021 with reference (4957). On May 18, 2021 the Regulatory Authority received a report of a serious adverse event after the use of the influenza vaccine. A rapporteur, a lawyer, said that her brother, 73 years old, brown, with a medical history of hypertension and using 10mg losartan since unknown dates, receives the influenza vaccine annually, without further information about the vaccination. The patient received the first dose of the adsorbed vaccine covid-19 (inactivated) on March 24, 2021 and the second dose on April 30, 2021. On May 3, 2021 patient started with the symptoms of fever [pyrexia], body pain [pain] and shortness of breath [dyspnea], as a corrective measure he used dipyrone at a date and dose not informed. According to the rapporteur, the patient was admitted to the hospital on the 29 / apr / 2021 and transferred on the 30 / apr / 2021 to the PRIVATE Hospital (unclear information) needing to be intubated on an unknown date, evolving to death on 12 / May / 2021 as a result of [COVID-19] according to report. The rapporteur reported that she did not have access to the tests and treatments that the patient underwent. The information regarding the dates of hospitalization and the beginning of the events were not clear, we will contact the rapporteur to obtain further clarifications. This case is related to the number 4942 because it is the same patient. Pharmacovigilance opinion: CASE ASSESSMENT: Based on the available information, the Regulatory Authority considered the serious adverse event as "unclassifiable" in terms of causality in relation to the adsorbed vaccine covid-19 (inactivated). Justification: needs more data. - date of Influenza vaccination. The causality classification was made based on the WHO-UMC algorithm. Medical opinion 05/19/2021 14:16:06 -: We can group everything in COVID-19. Justification: needs more data - date of Influenza vaccination Final Opinion: Unclassifiable and not expected. Events: COVID-19 - outcome: fatal - start date: 2021, end date: 12-May-2021 - seriousness: fatal; dyspnoea (shortness of breathe) - outcome: fatal - start date: 03-May-2021 - seriousness: fatal; pyrexia (fever) - outcome: unknown - star date: 03-May-2021 - seriousness: motivated or prolonged hospitalization - Pain (body ache) - outcome: unknown - start date: 03-May-2021 - seriousness: motivated or prolonged hospitalization. Affiliate Comment: 1 No follow up attempt can be done: The reporter only authorized outbound contact from Partner. Therefore, Sanofi has not formal authorization to contact reporter. 2 Collection organization code: It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Suspect Medication: Indication: Active immunization against influenza caused by types A and B of influenza virus - Brand: trivalent influenza vaccine (fragmented and inactivated) - SANOFI - Holder: Regulatory Authority - Active ingredients: trivalent influenza vaccine (fragmented and inactivated) - Category: VACCINE -Prescription: Not informed - Posology: Not informed- Start date: Not informed - End date: Not informed - Lot: NI Concomitant Medication: Indication: COVID-19 prophylaxis - Brand: adsorbed vaccine covid-19 (inactivated)- Holder: Regulatory Authority - Active ingredients: covid-19 adsorbed vaccine (inactivated) - Category: VACCINE- Prescription: Not informed - Dosage: Not informed -Start date: 30 / apr / 2021- End date: 30 / apr / 2021- Batch: 210145. Indication: COVID-19 prophylaxis - Brand: adsorbed vaccine covid-19 (inactivated)- Holder: Regulatory Authority - Active ingredients: covid-19 adsorbed vaccine (inactivated) - Category: VACCINE- Prescription: Not informed - Dosage: Not informed -Start date: 24 / mar / 2021- End date: 24 / mar / 2021- Batch: 210070. Losartan - indication: hypertension Patient medical history, concomitant disease, risk factor: hypertension It is unknown if the patient had any additional medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.; Sender''s Comments: This case concerns a 73 years old male patient who died due to COVID-19, pyrexia, pain and dyspnoea after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The concomitant medication included COVID-19 VACCINE, LOSARTAN and DIPYRONE. The patient''s medical history included hypertension. The patient''s medical condition at time of vaccination and other lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: covid-19


VAERS ID: 1499111 (history)  
Form: Version 2.0  
Age: 1.17  
Sex: Male  
Location: California  
Vaccinated:2021-02-08
Onset:2021-04-01
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT7102JA / 2 RL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. T013205 / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. S029457 / 1 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. T020651 / 1 RL / SC

Administered by: Private       Purchased by: ?
Symptoms: Death, Gene sequencing, Haemophagocytic lymphohistiocytosis, Immunoglobulin therapy, Measles, Morbillivirus test positive, Multiple organ dysfunction syndrome, Pneumonia, Pulmonary mass
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), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 112
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 28 days
   Extended hospital stay? No
Previous Vaccinations: vaccine-associated varicella
Other Medications:
Current Illness: hepatoblastoma diagnosed day of vaccination
Preexisting Conditions: hepatoblastoma on chemotherapy
Allergies:
Diagnostic Lab Data: Explify (RNA and DNA next-generation sequencing) of BAL from 7/8 positive for measles Throat swab sent to CDPH confirmed measles (vaccine strain)
CDC Split Type:

Write-up: progressive pulmonary nodules/pneumonia over a course of three months complicated by HLH and multiorgan failure leading to death. The patient was diagnosed with measles 7/16 started on ribavirin, vitamin A, and high dose IVIG. Death 7/22/2021.


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: 1167577 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-26
Submitted: 0000-00-00
Entered: 2021-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test normal, COVID-19, Death, Endotracheal intubation, Intensive care, Oxygen saturation decreased, Pneumonia, SARS-CoV-2 test positive, Ultrasound Doppler
SMQs:, Angioedema (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   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: Pneumonia (He has been on HIV treatment for 30 years, so he is on antiretroviral therapy for HIV, had pneumonia and thrombosis in the leg 8 years ago, and rhinitis since an unspecified date.); Rhinitis; Thrombosis; Comments: He has been on HIV treatment for 30 years, so he is on antiretroviral therapy for HIV, had pneumonia and thrombosis in the leg 8 years ago, and rhinitis since an unspecified date.
Allergies:
Diagnostic Lab Data: Test Date: 20210320; Test Name: blood test; Result Unstructured Data: blood test were good (SIC); Test Date: 20210320; Test Name: Oxygen saturation decreased; Test Result: 60 %; Result Unstructured Data: decreased; Test Date: 20210320; Test Name: covid-19 virus test; Test Result: Positive
CDC Split Type: BRSA2021SA107677

Write-up: pneumonia; covid 19; oxygen saturation decreased; Initial information received on 25-Mar-2021regarding an unsolicited valid non serious case from physician via Regulatory Authority (under reference BR-SA-SAC20210330001103) and transmitted to Sanofi on 26-Mar-2021. On 25-Mar-2021, Regulatory Authority received a report of a serious adverse event after the use of influenza vaccine, lot not informed. The Reporter, MD, reported the patient, male, medical doctor, 72 years, approximately 98 kg, 180 cm, medical history of HIV treatment for 30 years with antiretroviral therapy, pneumonia and thrombosis in the leg 8 years ago, besides rhinitis since an unspecified date for which he also takes uninformed treatment, he had the influenza vaccine every year of the campaigns. There is no information about the lot of influenza vaccine received by the patient in the 2020 campaign. In addition to influenza vaccine, the patient also received the pneumo 13 vaccine on an uninformed date. On 10-Feb-2021, the patient received the first dose of covid-19 (inactivated) adsorbed vaccine, batch not informed. On 26-Feb-2021 patient tested positive for [COVID-19] and started on unspecified medication on 27-Feb-2021 getting improvement after use, however, on 07-Mar-2021 patient needed to go to hospital and hospitalized on an uninformed date. According to the reporter, patient was admitted to the ICU at Hospital with [pneumonia] in 25% of the lung in a stable condition but without progression. It was informed that after hospitalization the patient remained stable, and that results of unspecified tests and blood test were good (SIC). In unspecified exams performed on 20/Mar/2021, the patient was again informed that they were good (SIC), besides the ultrasound exam for thrombosis monitoring. On an unspecified date, an RTPCT was performed with a positive result for SARS-COV-2. From 20-Mar-2021 to 21-Mar-2021, the reporter reported that the patient''s oxygen saturation decreased, and intubation was indicated; however, he was reevaluated on 21-Mar-2021 and it was not necessary. On 21-Mar-2021, unspecified antibiotic corticoid treatment was reintroduced. The patient was hospitazalized. On 23-Mar-2021, during the early morning hours, the patient was intubated and even after the procedure had a saturation of 60% [decreased oxygen saturation], and died at 9:35 pm. Since no further information is expected, this report is closed, but it can be reopened in view of new data. This case is related to a different case because they have the same patient and reporter, but another suspect product. CASE EVALUATION: Based on the available information, the Regulatory Authority considered the serious adverse event as unrelated as to causality in relation to trivalent influenza vaccine (inactivated and fragmented). Rationale: patient with confirmed SARS infection COV 2. Causality classification was based on the WHO algorithm. The patient did not experience any additional symptoms/events. Medication Details and reason for taking the medicine: Medication used to treat the adverse event; medication: medication not specified, daily dose: NI, route of administration: NI, indication: COVID-19, start date: 27-Feb-2021, stop date: NI. medication: corticosteroid not specified, daily dose: NI, route of administration: NI, indication: COVID-19, start date: 20-Mar-2021, stop date: NI medication: antibiotic not specified. daily dose: NI, route of administration: NI, indication: COVID-19, start date:-Mar-2021, stop date: NI. Patient medical history, concomitant disease, risk factor: He has been on HIV treatment for 30 years, so he is on antiretroviral therapy for HIV, had pneumonia and thrombosis in the leg 8 years ago, and rhinitis since an unspecified date. The patient did not have any additional medical history, concomitant disease or risk factor. Lab data/results: Test: blood test not specified, Date performed: NI, Result: good (SIC) Test: unspecified tests, Date performed: 20-Mar-2021, Result: NI Test: ultrasonography, Date performed: 20-Mar-2021, Result: NI Test: RT-PCR, Date performed: NI, Result: positive for SARS-COV-2 There were no additional lab data/results available.; Sender''s Comments: This case involves a 72-year-old male patient who had covid 19, oxygen saturation decreased and pneumonia after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset was unknown. produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: COVID-19; oxygen saturation decreased; Pneumonia


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: 1040897 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-08
Onset:2020-12-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. P100274349 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Death
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-11
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DESEQIRUS202101358

Write-up: Exitus letalis of unclear cause of death; Cardiac arrhythmia; This spontaneous case was retrieved on 04-Feb-2020 from Regulatory Authority (regulatory reference number: DE-PEI-PEI2021001764), reported by physician and concerned a 67-year-old, male patient. The patient''s concurrent conditions included hypertension. The patient''s concomitant medications were not reported. On 08-Dec-2020, the patient was vaccinated with Flucelvax Tetra (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular, dose and anatomical location: not reported) for prophylactic vaccination. The batch number reported was P100274349. On 11-Dec-2020, three days after receiving Flucelvax Tetra, the patient had cardiac arrhythmia and Exitus letalis of an unclear cause of death. The cause of death was reported as unknown. It was unknown if the autopsy was performed. The outcome of the event cardiac arrhythmia was unknown. The reporter did not provide causality assessment. The events of ''unknown cause of death'' was assessed to be serious due to seriousness criterion of death. Company comment: A 67-year-old patient was administered Flucelvax Tetra. Three days after receiving Flucelvax Tetra, the patient had cardiac arrhythmia and Exitus letalis of an unclear cause. The cause of death was reported as unknow, however, it is suggestive that was associated with the event of arrhythmia. The patient''s concurrent conditions included hypertension. The patient''s concomitant medications were not reported. It was unknown if the autopsy was performed. Causality is assessed as unassessble for the event of death. More information regarding concomitant medications is needed. Causal role of the suspect vaccine was confounded by medical history, and is assessed as unlikely related for the event arrhythmia. (defaults to ''''related'''' in the safety database for reporting purposes).; Sender''s Comments: A 67-year-old patient was administered Flucelvax Tetra. Three days after receiving Flucelvax Tetra, the patient had cardiac arrhythmia and Exitus letalis of an unclear cause. The cause of death was reported as unknow, however, it is suggestive that was associated with the event of arrhythmia. The patient''s concurrent conditions included hypertension. The patient''s concomitant medications were not reported. It was unknown if the autopsy was performed. Causality is assessed as unassessble for the event of death. More information regarding concomitant medications is needed. Causal role of the suspect vaccine was confounded by medical history, and is assessed as unlikely related for the event arrhythmia. (defaults to ''''related'''' in the safety database for reporting purposes).; Reported Cause(s) of Death: Unknown cause of death


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: 901732 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-11-27
Onset:2020-11-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2020-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA4: INFLUENZA (SEASONAL) (FLUAD QUADRIVALENT) / SEQIRUS, INC. 285545 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-11-30
   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: ITSEQIRUS202007603

Write-up: Found dead; This spontaneous case was retrieved on 09-Dec-2020 from Regulatory Authority (regulatory reference number: IT-MINISAL02-646021), reported by a physician and concerned an 80-year-old, female patient. The patient''s medical history and concomitant medications were not reported. On 27-Nov-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: reported as 1 dosage form (DF), route of administration: intramuscular, anatomical location: not reported) as flu vaccination. The batch number reported was 285545. On 29-Nov-2020, 55 hours after receiving Fluad Quadrivalent, the patient was alive and well. On 30-Nov-2020, in the morning, three days after receiving Fluad Quadrivalent, the patient was found dead in bed by her daughter. The cause of death was not reported. It was unknown whether autopsy was performed. The reporter did not provide causality assessment. The case was assessed as serious due to resulting in death. Company comment: An 80-year-old patient was vaccinated with Fluad Quadrivalent. Three days after receiving Fluad Quadrivalent, the patient was found dead in bed by her daughter. The cause of death was not reported. It was unknown whether autopsy was performed. Causality is unassessable for the event of death, due to lack of information.; Sender''s Comments: An 80-year-old patient was vaccinated with Fluad Quadrivalent. Three days after receiving Fluad Quadrivalent, the patient was found dead in bed by her daughter. The cause of death was not reported. It was unknown whether autopsy was performed. Causality is unassessable for the event of death, due to lack of information.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 902679 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-11-27
Onset:2020-11-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA4: INFLUENZA (SEASONAL) (FLUAD QUADRIVALENT) / SEQIRUS, INC. 290994 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 2020-11-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSEQIRUS202007672

Write-up: Sudden death; This spontaneous case retrieved on 14-Dec-2020 from Regulatory Authority (regulatory reference number: IT-MINISAL02-646493), reported by physician and concerned a 83-year-old, male patient. The patient''s medical history and concomitant medications were not reported. On 27-Nov-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; route of administration: intramuscular, dose: 0.5 ml and anatomical location: not reported) as influenza immunisation. The batch number reported was 290994. On 28-Nov-2020, one day after receiving Fluad Quadrivalent, the patient died suddenly without any apparent reason. It was unknown if the autopsy was performed. The reporter did not provide a causality assessment. The event of ''sudden death'' was considered to be serious due to death and medically significant criteria. Company comment: A 83-year-old patient was vaccinated with Fluad Quadrivalent. One day after receiving Fluad Quadrivalent, the patient died suddenly without any apparent reason. It was unknown if the autopsy was performed. The patient''s medical history and concomitant medications were not reported. Causality is unassessable for the event sudden death, due to lack of information.; Sender''s Comments: A 83-year-old patient was vaccinated with Fluad Quadrivalent. One day after receiving Fluad Quadrivalent, the patient died suddenly without any apparent reason. It was unknown if the autopsy was performed. The patient''s medical history and concomitant medications were not reported. Causality is unassessable for the event sudden death, due to lack of information.; Reported Cause(s) of Death: Death without any apparent reason


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: 901489 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-10-21
Onset:2020-11-04
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2020-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER U3J25 / UNK - / OT
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. T016058 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-11-04
   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: prednisolone; PLAQUENIL; BURINEX; INDERAL; SOMAC; DIVISUN; ALDACTONE (spironolactone); PNEUMOVAX23 SYRINGE (DEVICE)
Current Illness: Vaccination
Preexisting Conditions: Medical History/Concurrent Conditions: Autoimmune hepatitis; Cirrhosis liver; Kidney failure; Multiorgan failure; SLE
Allergies:
Diagnostic Lab Data:
CDC Split Type: NO0095075132012NOR001000

Write-up: FOUND DEAD; Information has been downloaded from Regulatory Authority (NO-NOMAADVRE-FHI-2020-00779). This spontaneous report was received from a physician and was referring to a 64 year old male patient. The patient''s concurrent conditions included renal failure, hepatic cirrhosis, autoimmune hepatitis, multiple organ dysfunction syndrome, and systemic lupus erythematosus. The patient''s pertinent medical history, drug reactions or allergies was not reported. Concomitant therapies included prednisolone, hydroxychloroquine sulfate(PLAQUENIL), bumetanide(BURINEX), propranolol hydrochloride(INDERAL), pantoprazole sodium(SOMAC), cholecalciferol(DIVISUN), and spironolactone(ALDACTONE). On 21-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX), 0.5 milliliter, subcutaneously in the patient''s arm, lot # T016058, expiration date was not reported but upon internal review it was confirmed as 31-JAN-2022, (strength, dose number, and frequency were not reported), for immunisation. On the same date, the patient was vaccinated with influenza virus split virion 4v vaccine inactivated(VAXIGRIP TETRA), 0.5 milliliter, intramuscularly in the patient''s arm, lot # U3J25, (strength, dose number, expiration date, and frequency were not reported), for immunisation . On 04-NOV-2020, the patient was found dead (death). The reporter stated that the patient was multimorbid male who experienced no immediate reactions and was found dead in his own home two weeks after vaccination and the cause of death was not recorded on notification and no autopsy was performed. The reporter considered death to be not related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX) nor to influenza virus split virion 4v vaccine inactivated(VAXIGRIP TETRA). Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event of death is considered unlikely related to PNEUMOVAX vaccine. The evidence is not sufficient to suggest a relationship between the PNEUMOVAX vaccine and the reported serious adverse event. The causality assessment is impacted by the confounding factors of patient?s concurrent conditions of renal failure, hepatic cirrhosis, autoimmune hepatitis, multiple organ dysfunction syndrome, and systemic lupus erythematosus. Company Comment- No changes to the product safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the product. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T016058; expirationdate: 31-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender''s Comments: Reporter Comments:Multimorbid male vaccinated with Vaxigriptetra and Pneumovax. No immediate reactions according to reporting physician. Found dead in his own home two weeks after vaccination. Cause of death not recorded on notification. No autopsy was performed. Vaccination deemed to be an unlikely cause of death by Regulatory Authority. Sender Comments: 19-NOV-2020 19-NOV-2020


VAERS ID: 897296 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-10-24
Onset:2020-11-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2020-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER X29 / UNK - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. T012898 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: 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: 2020-11-01
   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: PNEUMOVAX23 SYRINGE (DEVICE)
Current Illness: Elderly; Influenza immunisation; Pneumococcal immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NL0095075132011NLD007997

Write-up: sudden death 1 week after vaccination; Information has been downloaded from Regulatory Authority (NL-LRB-00419758). This spontaneous report was received from a physician and refers to a 76-year-old elderly male patient. His historical vaccine included an unspecified influenza vaccine. The patient''s medical history, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported. On 24-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) liquid for injection, 1 dosage form, lot No. T012898 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 31-MAY-2022. Also, he was vaccinated with influenza virus sag 4v vaccine inactivated (INFLUVAC TETRA) suspension for injection, lot No. X29 as yearly influenza vaccination (expiration date not reported) (strengths, frequencies, routes of administration, and anatomical locations were not reported). The patient died suddenly on 01-NOV-2020, 1 week after vaccination. The cause of death was reported as sudden death, inspection general physician (GP) thinks of possible stomach bleeding. No autopsy was performed. The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) and the patient''s death was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T012898; expirationdate: 31-MAY-2022; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Reported Cause(s) of Death: sudden death, inspection GP thinks of possible stomach bleeding


VAERS ID: 900842 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-11-01
Onset:2020-11-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ536AC / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue
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: Atrial fibrillation; Cardiac failure; Chronic renal failure; Colon cancer; Dementia Alzheimer''s type
Preexisting Conditions: Medical History/Concurrent Conditions: Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: SESA2020SA350268

Write-up: Fatigue; Initial information received on 03-Dec-2020 regarding an unsolicited valid serious case downloaded from the Regulatory Authority database without narrative (level 2A), from physician via Regulatory Authority (under reference number: SE-MPA-2020-007035). The following narrative is based on the information retrieved from all other accessible data. This case involves a 91-year-old male patient who experienced fatigue (tiredness) and died, after he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient had medical history of atrial fibrillation, colon cancer, chronic renal failure, cardiac failure, vascular dementia and dementia alzheimer''s type. Medical treatment, vaccination, family history and concomitant medication were not provided. On an unknown date, in Nov- 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ536AC, expiry date not reported] via an intramuscular route at an unknown administration site for prophylactic vaccination. On an unknown date, in Nov- 2020, the patient developed a serious fatigue (tiredness) (within month) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was leading to death. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment before death. It is unknown if an autopsy was done. The cause of death was not specifically reported.; Sender''s Comments: This case involves a 91-year-old male patient who died with fatigue (within month) after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible with the role of the vaccine. The patient had medical history of atrial fibrillation, colon cancer, chronic renal failure, cardiac failure, vascular dementia and dementia Alzheimer''s type. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, concomitant medication, laboratory investigations, autopsy results and other excluding alternative etiologies for the reported event were not reported and needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Fatigue


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: 902629 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Virginia  
Vaccinated:2020-10-17
Onset:2020-10-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cardiac arrest, Cardioversion, Death, Device dependence, Dialysis, Endotracheal intubation, Fall, Gastrointestinal haemorrhage, Head injury, Infection, Intensive care, Loss of consciousness, Organ failure, Pulse absent, Respiration abnormal, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (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), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-11-12
   Days after onset: 26
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Apixaban, digoxin, lactated ringers, Risaquad, metoprolol succinate
Current Illness: Presyncope/hypotension (10/13/20), consistently COVID positive 7/2020-10/2020
Preexisting Conditions: Atrial fibrillation, chronic systolic heart failure,
Allergies: None
Diagnostic Lab Data: NA--witnessed cardiac arrest
CDC Split Type:

Write-up: Patient had clinically recovered from hypotension and syncope so she was scheduled for discharge. In accordance with hospital policy, patient was offered an influenza vaccine prior to discharge. Approximately 10-15 minutes after receiving the vaccine, patient was being assisted to the bathroom when she lost consciousness, fell backwards, hit her head on the wall, and fell to the floor. The patient became pulseless with agonal breathing. CPR was initiated, an IV was reinserted, and a non-rebreather w/ surgical mask was placed. ROSC was achieved after 20-25 minutes. During the code, the patient received epinephrine x 4, cardioversion x 4, and bicarb x 2. She was intubated and transferred to the ICU where she underwent targeted temperature management. She ultimately sustained end organ damage requiring her to become dialysis dependent. Hospital course was further complicated by a massive GI bleed and infection. Patient ultimately died on 11/12/2020


VAERS ID: 895420 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-10-07
Onset:2020-10-17
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2020-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Cold sweat, Computerised tomogram thorax abnormal, Cough, Death, Myocardial infarction, Pericardial drainage, Pleural effusion, Pneumonia
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-21
   Days after onset: 4
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: Comments: None.
Allergies:
Diagnostic Lab Data: Test Date: 20201019; Test Name: Computerised tomography (CT) examination; Result Unstructured Data: Pericardial effusion.
CDC Split Type: TWSEQIRUS202006051

Write-up: Myocardial infarction with pericardial effusion; Myocardial infarction with pericardial effusion; Pneumonia; This spontaneous case from Regulatory Authority was retrieved on 03-Nov-2020 from Regulatory Authority (regulatory reference number: TW-TFDA-TVS-1090000234) by Regulatory Authority (reference number: ADR2011008), reported by other health professional and concerned a 71-year-old, female patient. The patient''s medical history and concomitant medications were not reported. On 07-Oct-2020, the patient was vaccinated with Flucelvax Quad (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml (single dose), route of administration and anatomical location: not reported) for prevention of influenza disease caused by influenza virus subtypes A and B. The batch number was not reported. On 17-Oct-2020, the patient experienced chest pain, non-productive cough and cold sweat, but did not visit a physician. On 18-Oct-2020, the patient went to the emergency room (ER) by herself. The patient was admitted to a hospital and proceeded to further examination and treatment due to pneumonia. On 19-Oct-2020, the patient was found pericardial effusion by computerised tomography (CT) examination. The patient was transferred to the general hospital and arranged to withdraw pericardial fluid. The patient was diagnosed as myocardial infarction with pericardial effusion. On 21-Oct-2020, the patient died. The outcome of events myocardial infarction with pericardial effusion was reported as fatal (cause of death was also provided as "not reported"). At the time of patient''s death, the outcome of event pneumonia was not reported. The reporter did not provide a causality assessment. The case was assessed as serious due to death. The events of myocardial infarction with pericardial effusion and pneumonia were considered to be serious due to additional criteria of hospitalization and medical significance by a Physician within Regulatory Authority Risk Management Department. Company comment: The patient developed myocardial infarction, pericardial effusion (reported as myocardial infarction with pericardial effusion) and pneumonia approximately 10 days after vaccination with the suspect product, Flucelvax Quad. Chronology seems plausible. Reportedly, the patient died. The outcome of events myocardial infarction with pericardial effusion was reported as fatal (cause of death was also provided as "not reported"). At the time of patient''s death, the outcome of event pneumonia was not reported. The patient''s advanced age (71) may have contributed to development of the events. The patient''s medical history and concomitant medications were not reported. Considering a lack of information regarding medical history and concomitant medications, which is essential with this type of events, causal relationship for all events is assessed as unassessable.; Sender''s Comments: The patient developed myocardial infarction, pericardial effusion (reported as myocardial infarction with pericardial effusion) and pneumonia approximately 10 days after vaccination with the suspect product, Flucelvax Quad. Chronology seems plausible. Reportedly, the patient died. The outcome of events myocardial infarction with pericardial effusion was reported as fatal (cause of death was also provided as "not reported"). At the time of patient''s death, the outcome of event pneumonia was not reported. The patient''s advanced age (71) may have contributed to development of the events. The patient''s medical history and concomitant medications were not reported. Considering a lack of information regarding medical history and concomitant medications, which is essential with this type of events, causal relationship for all events is assessed as unassessable.; Reported Cause(s) of Death: Myocardial infarction with pericardial effusion; Myocardial infarction with pericardial effusion


VAERS ID: 918963 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-10-06
Onset:2020-10-16
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Asthenia, Bacterial test, Blood gases abnormal, Blood lactic acid increased, Blood pressure abnormal, Brain oedema, Cardiac arrest, Cardiac failure, Chest X-ray abnormal, Computerised tomogram, Computerised tomogram head abnormal, Death, Depressed level of consciousness, Dyspnoea, Endotracheal intubation, Hepatic failure, Immunoglobulin therapy, Infection, Inflammation, Intensive care, Lung assist device therapy, Multi-organ disorder, Nasopharyngitis, Pain, Pyrexia, Rash, Resuscitation, Still's disease, Systolic dysfunction, Vaccination complication, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Arthritis (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-03
   Days after onset: 48
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Thyroid disorder (well controlled)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201124; Test Name: Blood gas; Result Unstructured Data: Low; Test Date: 20201123; Test Name: Lactate; Test Result: 2370 {DF}; Test Date: 20201016; Test Name: Fever; Result Unstructured Data: persistent high fever-value not reported; Test Date: 20201124; Test Name: Chest X-ray; Result Unstructured Data: ARDS (acute respiratory distress syndrome); Test Date: 20201127; Test Name: Brain CT; Result Unstructured Data: Severe cerebral edema; Test Date: 202011; Test Name: White count; Result Unstructured Data: High, approximately 20 000 (units not specified)
CDC Split Type: TWSEQIRUS202009162

Write-up: She was suspected as influenza vaccine-induced AOSD (adult onset Still''s disease); High white count; Infection; Inflammation; Asthenia; Sore and pain on whole body; Cold; Persistent high fever; Rash/rash appeared on her abdomen and head; The patient expired; Cerebral edema; Weak consciousness; Acute respiratory distress syndrome; Cardiac arrest; Her organs were impaired, including worse heart contraction and liver failure/malfunction of heart contraction; Her organs were impaired, including worse heart contraction and liver failure; Low blood gas; Her organs were impaired, including worse heart contraction and liver failure; Lactate 2370 mg/ml; Dyspnea; Blood pressure was worsen; This spontaneous case from Regulatory authority was received on 27-Dec-2020 via public media, retrieved on 28-Dec-2020 from regulatory authority (regulatory reference number: TW-TFDA-TVS-1090000588) (reference number: ADR2012008), reported by other non-health professional and concerned a 36-year-old female patient. The patient''s concurrent conditions included thyroid disease which was well controlled. The patient had no medical history for autoimmune disease. The patient''s concomitant medications were not reported. In Sep-2020, the patient delivered her child. On 06-Oct-2020, the patient was vaccinated with Flucelvax Quad (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for prevention of influenza disease caused by influenza virus subtypes A and B. The batch number was not reported. On 16-Oct-2020, ten days after vaccination, the patient experienced sore and pain on whole body, asthenia and persistent high fever (body temperature value was not reported). At first, these were thought as symptoms of cold. On an unknown date in 2020, the patient visited a clinic for treatment, but no details provided. On an unknown date in 2020, fever exacerbated, and the patient developed rash. On an unspecified day in early Nov-2020, the patient visited emergency room. White blood cells count was high, approximately 20000 (units not specified). A subsequent examinations of computerised tomogram (CT) of whole body and bacteria culture were performed (details not provided). However, the etiology of infection or inflammation could not be identified. On an unknown day in Nov-2020, the patient was hospitalized. On an unknown day in Nov-2020, during hospitalization, rash appeared on the patient''s abdomen and head and the physician could not judge the real cause because it might have been caused by antibiotics or steroid. After two-week multiple antibiotics treatment, the fever was still not resolved. However, the patient''s condition was stable at discharge and the physician suggested the patient to go to a hospital for further follow-up. On 18-Nov-2020, the patient was transferred to the hospital for further examination. On 23-Nov-2020, at night, the patient developed dyspnea. On the same day, lactate revealed 2370 mg/ml. On 24-Nov-2020, in the early morning, the patient underwent chest x-ray which revealed ARDS (acute respiratory distress syndrome) and patient''s blood gas was low as well. The patient accepted the intubation treatment and then was transferred to intensive care unit (ICU). On the same day, at dusk, extracorporeal membrane oxygenation (ECMO) treatment was performed. During ECMO on, the patient experienced cardiac arrest. After 12 minutes of cardiopulmonary cerebral resuscitation (CPCR), the patient''s condition was back to return of spontaneous circulation (ROSC) status. However, the patient''s organs were impaired, including worse heart contraction and severe liver failure. According to the clinical symptoms and with the help from a physician friend, the patient''s family thought the patient was suspected as influenza vaccine-induced adult onset Still''s disease (AOSD). On 25-Nov-2020, in the evening, the patient was treated with intravenous immunoglobulin (IVIG). On 26-Nov-2020, the patient''s condition apparently improved. The dose level of vasopressors was reduced (details not provided). The lactate value was decreased (details not provided). Due to condition improved, the team at the hospital discussed with the cardiovascular surgery with university hospital to assess the feasibility to do heart transplantation due to the malfunction of heart contraction. On 27-Nov-2020, the patient experienced weak consciousness and brain CT revealed severe cerebral edema. Because of this, the heart transplantation team thought the patient would become persistent vegetative state even accepting the heart transplantation. On an unknown day in Nov-2020, after five-day course of IVIG treatment, the blood pressure worsened again (details not provided). The dosing of vasopressors was elevated gradually (details not provided). On 30-Nov-2020, the patient''s condition was suddenly exacerbating. The treatment team judged the patient''s condition as low possibility to recover and high possibility to do amputation or become the persistent vegetable state if patient would wake up. The patient''s family agreed not to increase the dose of vasopressors. On 03-Dec-2020, the patient died. The cause of death was unknown. It was not reported if an autopsy was performed. The outcome of the events of ''adult onset Still''s disease'', ''acute respiratory distress syndrome'', ''cardiac failure'', ''myocardial contraction decreased'', '' liver failure'', cerebral edema, ''consciousness decreased'', ''general body pain'', cold, ''white blood cell count high'', asthenia, dyspnea, ''blood gases abnormal'', ''multi-organ disorder'', ''lactate low'', infection, inflammation, ''blood pressure abnormal'', rash and ''fever'' was unknown. The event of ''adult onset Still''s disease'' was assessed as related to Flucelvax Quad while the reporter did not provide a causality assessment for other events. The event of ''death '' was considered to be serious due to seriousness criteria of death and medical significance. Other events were considered to be serious due to seriousness criterion of hospitalization. The events of ''adult onset Still''s disease'', ''acute respiratory distress syndrome'', ''cardiac arrest'', '' myocardial contraction decreased'', ''liver failure'', cerebral edema and ''consciousness decreased'' had additional seriousness criterion of medical significance. Company comment: A 36-year-old female patient was vaccinated with Flucelvax Quad, on 06-Oct-2020. Ten days after vaccination, the patient experienced pain on whole body, asthenia and high fever. At first, these were thought as symptoms of cold. On an unknown date in 2020, fever exacerbated, and the patient developed rash. On 23-Nov-2020, at night, the patient developed dyspnoea and lactate revealed 2370 mg/ml. On 24-Nov-2020, chest x-ray which revealed ARDS (acute respiratory distress syndrome), blood gas was low. The patient was transferred to intensive care unit (ICU). During ECMO on, the patient experienced cardiac arrest. After 12 minutes of cardiopulmonary cerebral resuscitation (CPCR), the patient''s condition was back to return of spontaneous circulation (ROSC) status. However, the patient''s organs were impaired, including worse heart contraction and severe liver failure. According to the clinical symptoms and with the help from a physician friend, the patient''s family thought the patient was suspected as influenza vaccine-induced adult onset Still''s disease (AOSD). On 27-Nov-2020, the patient experienced weak consciousness and brain CT revealed severe cerebral oedema. On 03-Dec-2020, the patient died. The cause of death was unknown. It was not reported if an autopsy was performed. The patient''s concurrent conditions included thyroid disease which was well controlled. The patient had no medical history for autoimmune disease. The patient''s concomitant medications were not reported. In Sep-2020, the patient delivered her child. More information regarding alternative aetiology is needed. With information available, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for all events. With information available, causality is assessed as possibly related for Still''s disease, which probably complicated with heart, liver and lung condition and fatal outcome.; Reporter''s Comments: The patient''s family thought the patient was suspected as influenza vaccine-induced AOSD (adult onset Still''s disease).; Sender''s Comments: A 36-year-old female patient was vaccinated with Flucelvax Quad, on 06-Oct-2020. Ten days after vaccination, the patient experienced pain on whole body, asthenia and high fever. At first, these were thought as symptoms of cold. On an unknown date in 2020, fever exacerbated, and the patient developed rash. On 23-Nov-2020, at night, the patient developed dyspnoea and lactate revealed 2370 mg/ml. On 24-Nov-2020, chest x-ray which revealed ARDS (acute respiratory distress syndrome), blood gas was low. The patient was transferred to intensive care unit (ICU). During ECMO on, the patient experienced cardiac arrest. After 12 minutes of cardiopulmonary cerebral resuscitation (CPCR), the patient''s condition was back to return of spontaneous circulation (ROSC) status. However, the patient''s organs were impaired, including worse heart contraction and severe liver failure. According to the clinical symptoms and with the help from a physician friend, the patient''s family thought the patient was suspected as influenza vaccine-induced adult onset Still''s disease (AOSD). On 27-Nov-2020, the patient experienced weak consciousness and brain CT revealed severe cerebral oedema. On 03-Dec-2020, the patient died. The cause of death was unknown. It was not reported if an autopsy was performed. The patient''s concurrent conditions included thyroid disease which was well controlled. The patient had no medical history for autoimmune disease. The patient''s concomitant medications were not reported. In Sep-2020, the patient delivered her child. More information regarding alternative aetiology is needed. With information available, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for all events. With information available, causality is assessed as possibly related for Still''s disease, which probably complicated with heart, liver and lung condition and fatal outcome.; Reported Cause(s) of Death: The patient expired


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: 1056272 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-09-01
Onset:2020-10-05
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. P100251946 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Guillain-Barre syndrome, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (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 (narrow), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-09
   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: Depression; Gallstones; Secondary progressive multiple sclerosis; Varicose veins
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Traffic accident (Motor)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSEQIRUS202101479

Write-up: GBS illness leading to death; Respiratory failure; This spontaneous case from the United Kingdom was retrieved on 22-Feb-2021 from Regulatory Authority (regulatory reference number: GB-MHRA-EYC 00232843), reported by physician and concerned a 55-year-old, female patient. The patient''s concurrent conditions included depression, gallstones, secondary progressive multiple sclerosis and varicose veins. The patient''s expanded disability status scale scored as seven in 2019. The patient''s past medical history included motor traffic accident in 1990 and laparoscopic cholecystectomy. The patient''s concomitant medications were not reported. The patient''s historical vaccine included influenza virus vaccine in 2011 which resulted in Guillain Barre syndrome (see case 202101492). On an unspecified date in Sep-2020, the patient was vaccinated with Flucelvax Tetra (influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: intramuscular, dose and anatomical location: not reported) for influenza immunisation. The batch number reported was P100251946. On 05-Oct-2020, an unknown amount of time after receiving Flucelvax Tetra, the patient developed severe Guillain Barre syndrome (GBS) which was leading to death. On an unspecified date in 2020, an unknown amount of time after receiving Flucelvax Tetra, the patient developed respiratory failure. On 09-Oct-2020, the patient died. It was reported that severe GBS illness was leading to death. Reported cause of death was respiratory failure. An autopsy was not performed. The reporter did not provide a causality assessment. The events of respiratory failure and ''Guillain Barre syndrome'' were considered as serious due to seriousness criteria of death and medical significance. This case is linked with case 202101492 (the same patient). Company comment: A 55-year-old patient was administered Flucelvax Tetra. On 05-Oct-2020, an unknown amount of time after receiving Flucelvax Tetra, the patient developed severe Guillain Barre syndrome (GBS) which was leading to death. On an unspecified date in 2020, an unknown amount of time after receiving Flucelvax Tetra, the patient developed respiratory failure. On 09-Oct-2020, the patient died. It was reported that severe GBS illness was leading to death. Reported cause of death was respiratory failure. An autopsy was not performed. Causal role of the suspect vaccine is unassessable for both events, due to lack of information regarding chronology and diagnostic findings. Brighton collaboration criteria could not be assessed due to insufficient information provided.; Sender''s Comments: A 55-year-old patient was administered Flucelvax Tetra. On 05-Oct-2020, an unknown amount of time after receiving Flucelvax Tetra, the patient developed severe Guillain Barre syndrome (GBS) which was leading to death. On an unspecified date in 2020, an unknown amount of time after receiving Flucelvax Tetra, the patient developed respiratory failure. On 09-Oct-2020, the patient died. It was reported that severe GBS illness was leading to death. Reported cause of death was respiratory failure. An autopsy was not performed. Causal role of the suspect vaccine is unassessable for both events, due to lack of information regarding chronology and diagnostic findings. Brighton collaboration criteria could not be assessed due to insufficient information provided.; Reported Cause(s) of Death: Respiratory failure; GBS illness leading to death


VAERS ID: 898244 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-10-20
Onset:2020-10-01
Submitted: 0000-00-00
Entered: 2020-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS KX9F7 / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: CSF test abnormal, Death, Dyspnoea, Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Sensory loss
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Cardiomyopathy (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DILTIAZEM; ISDN; PANTOPRAZOLE; ATORVASTATIN
Current Illness: Arterial hypertension; Atherosclerotic cardiovascular disease; Pancreatic mass
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CSF; Result Unstructured Data: (Test Result:abnormal value,Unit:unknown,Normal Low:,Normal High:); Test Name: EMG; Result Unstructured Data: (Test Result:abnormal value,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: CAGLAXOSMITHKLINECA2020AM

Write-up: Guillain Barre syndrome; trouble breathing; Couldn''t feel his legs; Product complaint; Sensory loss; This case was reported by a physician and described the occurrence of guillain barre syndrome in a 74-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number KX9F7, expiry date unknown) for prophylaxis. This case was associated with a product complaint. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Influenza Vaccine Quadrivalent Pre-Filled Syringe Device) injection syringe for prophylaxis. On 20th October 2020, the patient received the 1st dose of FluLaval Tetra 2020-2021 season (intramuscular). On an unknown date, the patient started Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. On 26th October 2020, 6 days after receiving FluLaval Tetra 2020-2021 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), hypoesthesia of limbs (serious criteria hospitalization) and difficulty breathing (serious criteria hospitalization). On an unknown date, the patient experienced pharmaceutical product complaint. The patient was treated with immunoglobulins nos (Immunoglobulin). On an unknown date, the outcome of the guillain barre syndrome, hypoesthesia of limbs and difficulty breathing were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the guillain barre syndrome, hypoaesthesia of limbs and difficulty breathing to be related to FluLaval Tetra 2020-2021 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient lab data include CSF abnormality, EMG abnormality. The patient was hospitalized on 30th October 2020 due to Guillain Barre syndrome, Couldn''t feel his legs and trouble breathing. Treatment received by patient was Immunoglobulin IV. Follow up information received from other healthcare professional on 18th November 2020: The reason of death was reported as Guillain Barre syndrome, Dyspnoea and Sensory loss. It was unknown if autopsy was done. It was unknown if reporter consider Sensory loss to be related to FluLaval Tetra 2020-2021 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. Concomitant medication includes atorvastatin, diltiazem, ISDN, pantoprazole.; Reported Cause(s) of Death: Sensory loss; Dyspnoea; Guillain Barre syndrome


VAERS ID: 903448 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-10-15
Onset:2020-10-01
Submitted: 0000-00-00
Entered: 2020-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA495AB / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Death, Electrocardiogram normal
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-01
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Stent placement (received 3 stents in autumn 2016 (3 years ago))
Allergies:
Diagnostic Lab Data: Test Date: 20201016; Test Name: electrocardiogram; Result Unstructured Data: (Test Result:No abnormalities,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: ITGLAXOSMITHKLINEIT202024

Write-up: Following the inoculation of the flu vaccine on October 15th, the same day my mother experienced an undefined discomfort in the sternum area and two days later she died.; Death; This case was reported by a consumer via regulatory authority and described the occurrence of death in a 69-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number AFLBA495AB, expiry date unknown) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Influenza Vaccine Quadrivalent Pre-Filled Syringe Device) injection syringe for prophylaxis. The patient''s past medical history included stent placement (received 3 stents in autumn 2016 (3 years ago)). On 15th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season (unknown) and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. In October 2020, 2 days after receiving Fluarix Quadrivalent 2020-2021 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device, the patient experienced death (serious criteria death and GSK medically significant). On 15th October 2020, the patient experienced sternal pain (serious criteria death). On an unknown date, the outcome of the death and sternal pain were fatal. The patient died in October 2020. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death and sternal pain to be related to Fluarix Quadrivalent 2020-2021 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional information: Less than a day after receiving Fluarix Quadrivalent 2020-2021 season, the patient experience sternal pain. On 16th October 2020, the patient had electrocardiogram (not under stress) and results came with no abnormalities. Note: in the structural field the event onset date for event death was reported as 15th october 2020, however in reporter''s comment it was clearly mentioned that the patient died 2 days later hence captured TTO accordingly and onset date as partial. Initial information received from consumer via regulatory authority on 16th December 2020: Following the inoculation of the flu vaccine on October 15th, the same day my mother experienced an undefined discomfort in the sternum area and two days later she died. Reporter''s comment: My mother three years ago had received 3 stents in autumn 2016. The day after the 2020 vaccine she did an electrocardiogram (not under stress) because she felt pain in the sternum but there were no abnormalities and they booked another visit for the following week, obviously never performed.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1065347 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-10-27
Onset:2020-10-01
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER U3K351V / UNK RA / OT
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anticoagulant therapy, Cerebral infarction, Death, Dyspnoea, Fatigue, Feeling abnormal, Injected limb mobility decreased, Mobility decreased, Nausea, Pain in extremity, Pneumonia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: enalapril; TROMBYL; metformin; JARDIANCE; atorvastatin; amlodipine; BETOLVEX
Current Illness: Prophylaxis
Preexisting Conditions: Medical History/Concurrent Conditions: Angiopathy; Diabetic foot ulcer; Diabetic neuropathy; Diabetic retinopathy; Hyperlipidaemia; Hypertension; Obesity; Toe amputation; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: SE0095075132102SWE009547

Write-up: Brain infarction; Difficulties breathing; Vomited; Nausea; Out of sorts and tired; Much pain in both arms; Besides a persistent pain she could not lift her arms; Pneumonia; Information has been downloaded from Regulatory Authority (SE-MPA-2021-002443). This spontaneous report was received from a consumer referring to a 58-year old female patient. The patient''s concurrent condition included diabetic retinopathy, toe amputation, diabetic foot, angiopathy, diabetic neuropathy, type 2 diabetes mellitus, obesity, hypertension and hyperlipidaemia. Concomitant therapies included enalapril, aspirin (TROMBYL), metformin, empagliflozin (JARDIANCE), atorvastatin, amlodipine and cyanocobalamin (BETOLVEX). On 27-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) (dose 0.5 ml; strength, route, lot# and expiration date were unknown) in the left arm for prophylaxis. Other suspect therapy included influenza virus split virion 4v vaccine inactivated (VAXIGRIP TETRA) (dose 0.5 ml, via intramuscular route in the right arm, lot# U3K351V; strength, indication and expiration date were unknown). In 2020, the patient experienced pneumonia. In October 2020, the patient experienced much pain in both arms and besides a persistent pain she could not lift her arms (injected limb mobility decreased). On 28-OCT-2020, the patient experienced out of sorts and tired. On 29-OCT-2020, the patient experienced nausea. On 30-OCT-2020, the patient experienced vomited and difficulties breathing. On 31-OCT-2020, the patient experienced brain infarction. On an unknown date, the patient died. All these events resulted in the patient''s death. The outcome of nausea, besides a persistent pain she could not lift her arms, much pain in both arms, difficulties breathing, out of sorts and tired, vomited and pneumonia was unknown. The causality between all events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) and influenza virus split virion 4v vaccine inactivated (VAXIGRIP TETRA) was not provided. All the events were determined to be medically significant by the agency.; Reported Cause(s) of Death: Difficulties breathing; nausea; Pneumonia; Out of sorts and tired; Vomited; Besides a persistent pain she could not lift her arms; Much pain in both arms; Brain infarction


VAERS ID: 1774896 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Unknown  
Vaccinated:2020-09-25
Onset:2020-09-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Brain injury, Cardiac arrest, Death, Intensive care, Life support, Magnetic resonance imaging head abnormal, Mechanical ventilation, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Levothyroxine; Flomax
Current Illness: Unspecified vitamin B deficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2020; Test Name: MRIs; Result Unstructured Data: Brain damage
CDC Split Type: USSEQIRUS202103417

Write-up: Cardiac arrest; Brain damage; Passed away; This spontaneous case was received on 03-Oct-2021 from other non-health professional (consumer''s daughter) via Med Communications (reference number: SEQW21-03202) and concerned a 75-year-old, male patient. The patient''s concurrent conditions included low B vitamin levels. The patient''s concomitant medications included levothyroxine and Flomax (tamsulosin hydrochloride), both used for an unreported indication. It was reported that the patient was healthy and active and had not experienced any anaphylaxis or adverse events previously. Also, the patient was tested negative for COVID 19. It was reported that the patient completed full physical, electrocardiogram (EKG) and lab work prior vaccination and received a ''''clean bill of health''''. On 25-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration: intramuscular, anatomical location: deltoid and indication: not reported) as a prevention of seasonal influenza. The batch number reported was 283847 and expiry date 30-Jun-2021. On 30-Sep-2020, five days after receiving Flucelvax Quadrivalent, the patient suffered a cardiac arrest at home and was not revived for an extended length of time. He was rescued in the emergency room (ER) and was admitted to hospital, in the intensive care unit (ICU). The patient was subjected to several resuscitation attempts and received several epinephrine injections. He was in a hospital for two weeks and maintained on life support and ventilators. However, treating physicians and neurologist determined after several magnetic resonance imaging (MRIs) the patient had gone too long without oxygen and suffered from brain damage. On an unspecified date in Oct-2020, reported as five days after cardiac arrest (discrepant information since it was reported that the patient was hospitalized for two weeks), the patient passed away. The cause of death was not reported. It was not reported if autopsy was performed. The outcome of brain damage and cardiac arrest was not reported. The reporter assessed all events as related to Flucelvax Quadrivalent. The reporter strongly suspected that her healthy and active father had an adverse reaction to Seqirus flu shot. The reporter assessed events of brain damage and cardiac arrest as serious due to hospitalisation and additionally, all events of were considered to be medically significant by a Physician within Seqirus'' Pharmacovigilance and Risk Management Department. Company comment: A 75-year-old, male patient was vaccinated with the suspect product Flucelvax Quadrivalent. Five days after vaccination the patient experienced a cardiac arrest. As reported the patient was too long without oxygen and suffered from brain damage. Brain damage was confirmed after several magnetic resonance imaging (MRIs). Causality for this event is assessed as not related to suspect product based on described alternative aetiology. The patient died after five days (discrepant information). Cause of death and autopsy report have not been provided. Due to limited information causality for the event death is unassessable. Although chronology is plausible, lack of information regarding diagnostic findings preclude proper causality assessment of the reported cardiac arrest. Therefore, causality for this event is unassessable.; Reporter''s Comments: The reporter strongly suspected that her health and active father had an adverse reaction to Seqirus flu shot.; Sender''s Comments: A 75-year-old, male patient was vaccinated with the suspect product Flucelvax Quadrivalent. Five days after vaccination the patient experienced a cardiac arrest. As reported the patient was too long without oxygen and suffered from brain damage. Brain damage was confirmed after several magnetic resonance imaging (MRIs). Causality for this event is assessed as not related to suspect product based on described alternative aetiology. The patient died after five days (discrepant information). Cause of death and autopsy report have not been provided. Due to limited information causality for the event death is unassessable. Although chronology is plausible, lack of information regarding diagnostic findings preclude proper causality assessment of the reported cardiac arrest. Therefore, causality for this event is unassessable.; Reported Cause(s) of Death: Unknown cause of death


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: 891172 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-06
Onset:2020-06-03
   Days after vaccination:210
Submitted: 0000-00-00
Entered: 2020-10-20
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
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-07-01
   Days after onset: 28
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: ESSEQIRUS202005217

Write-up: Pneumonia from COVID-19; This spontaneous case was retrieved on 15-Oct-2020 from Regulatory authority (regulatory reference number: ES-AEMPS-679933), reported by a pharmacist and concerned an 84-year-old, female patient. The patient''s medical history and concomitant medications were not reported. On 06-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] for flu vaccination. The batch number reported was 9153A1A. On 03-Jun-2020, six months and 28 days after receiving Chiromas (TIV), the patient developed pneumonia from COVID-19. On 01-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 Regulatory Authority Risk Management Department. Company comment: A 84-year-old, female patient was administered the suspect product, Chiromas (TIV). The patient developed pneumonia from COVID-19, six months and 28 days after vaccination. Reportedly, the patient died due to the pneumonia from COVID-19. 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 84-year-old, female patient was administered the suspect product, Chiromas (TIV). The patient developed pneumonia from COVID-19, six months and 28 days after vaccination. Reportedly, the patient died due to the pneumonia from COVID-19. 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: 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), Sexual dysfunction (broad)

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: 1641626 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Washington  
Vaccinated:2019-10-31
Onset:2019-11-14
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT6657IVA / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram, Asthenia, Blood test, Death, Electroencephalogram, Lumbar puncture, Magnetic resonance imaging, Positron emission tomogram, Posterior cortical atrophy, Visual field tests, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 595
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multi-vitamin
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Multiple MRIs, Visual Field testing, Blood Work, EEGs, CT Angiography, Lumbar Puncture, PET Scan.
CDC Split Type:

Write-up: 2 weeks after shot complaining of vision issues that worsened over the following months. Eventually called Posterior Cortical Atrophy that spread throughout the brain, leading to full incapacity and death.


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


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