National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

Found 8,467 cases where Patient Died

Case Details

This is page 45 out of 85

Result pages: prev   1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85   next


VAERS ID: 738249 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-02-19
Entered: 2018-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Central nervous system infection, Death, Meningitis meningococcal, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK026298

Write-up: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a year after receiving Meningococcal ACWY-CRM vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included neisseria meningitides meningitis with serious criteria of death and GSK medically significant and central nervous system infection with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included neisseria meningitides meningitis (fatal) and central nervous system infection (fatal). The reported cause of death was neisseria meningitides meningitis and central nervous system infection. The investigator considered that there was a reasonable possibility that the vaccination failure, neisseria meningitides meningitis and central nervous system infection may have been cause by Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient of unspecified age and gender who was vaccinated with unspecified quadrivalent meningococcal (groups A, C, W, and Y) vaccine (manufacturer unknown). The patient was the part of active surveillance for primary infectious disease deaths in a specific group over 16 years (1998 - 2013), identified 217 deaths. This study probably presented nearly complete capture of all specific group infectious disease deaths resulting from: the established reporting of deaths through specific administrative systems and aggressive follow-up of deaths by The Mortality Surveillance Division (MSD) staff. No information on medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified quadrivalent meningococcal (groups A, C, W, and Y) vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient had blood-borne infection. The patient developed Neisseria meningitis infection. 2 months after vaccination, the patient had central nervous system (CNS) death from Neisseria meningitis infection. Typing of the isolate associated with death was not performed. It was not reported if the autopsy was performed. This case has been considered as suspected vaccination failure being full schedule and confirmed lab serotype was unknown. This case has been considered serious due to death/suspected vaccination failure. The author did not comment on the relationship between Neisseria meningitis infection and unspecified quadrivalent meningococcal (groups A, C, W, and Y) vaccine. The author concluded, ''The time lag between death and notification of the MSD at the start of this surveillance program was 24 to 48 hours. The lag at the end of the reported surveillance period was 8 to 24 hours. The MSD surveillance system identified an agent in 140 of 217 (64.5%) uniformed deaths. In a similar program by the Centers for Disease Control and Prevention, in 122 cases with specimens, an agent could be identified in 34 (28%). Medical Mortality Registry (MMR) data and information provided strong support for re-establishing the specific group adenovirus vaccination program, which ceased in 1999 and was finally re-established in 2011. MMR data and information also assisted in monitoring the specific group meningococcal vaccine program, helped to describe the virulence of circulating influenza viruses, and identified areas where deadly malaria infections were not being prevented.''


VAERS ID: 738637 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-11-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 AR / UN

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Coma, Contusion, Death, Dyspnoea, Fatigue, General physical health deterioration, Haemoglobin decreased, Injection site haemorrhage, Lethargy, Leukaemia, Life support, Lymphadenopathy, Meningitis, Menorrhagia, Oropharyngeal pain, Pain, Pain in extremity, Pallor, Petechiae, Pyrexia, Sepsis, Swelling, Transfusion, White blood cell count decreased
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Haematological malignant tumours (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-03
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 304 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131802USA010929

Write-up: This spontaneous report was received from a medical assistant (patient''s mother) refers to 16 years old female patient. Pertinent medical history and concomitant medication were not reported. On an unknown date in October 2006, the patient was vaccinated with first dose of GARDASIL for prophylaxis, lot# 0668F, expiry date 21-NOV-2008 (strength, dose were unknown) in the office. After the first dose of GARDASIL the patient always felt tired. The patient also complained all the time that her legs ached. It was hard for her to get across campus because she felt very winded all the time. On an unknown date in November 2006, the patient was vaccinated with second dose of GARDASIL in her arm. After second vaccination, her arm would not stop bleeding and the reporter had to hold it until it stopped bleeding. The patient became very puffy, lethargic and on and off she''d have a sore throat. The patient had not received the third dose of GARDASIL. It was reported that, the patient experienced 104-105 fever at home and she kept going through ibuprofen. Her body was aching and she didn''t know, her period too that would just be prolonged, she had a sore throat and some swollen lymph nodes. The physician thought it was tonsillitis, hence she was prescribed of amoxicillin. After two-week round of antibiotics, the patient came back because she hadn''t gotten any better. She looked white as a ghost, very weak. The reporter had to almost carry her into the doctor''s office. The patient was very pale, she looks anemic. The hemoglobin was 4. She had bruising on her legs and petechiae. The patient was hospitalized. On an unknown date in March 2007, the patient was diagnosed with leukemia. The patient received blood transfusion. The reporter stayed in the hospital for 10 months pretty much straight. They weren''t allowed to leave because of her white blood cell count and her contacting other viruses. So, they were allowed to leave if her blood count was high enough. On an unknown date in October 2007, the patient experienced first coma and was supported with life support. On 03-JAN-2008, in the morning, the reporter was informed that, her daughter was having trouble breathing and experienced second coma. The patient''s condition got deteriorated and they couldn''t tell if there was any brain function. As of 03-JAN-2008, the patient had meningitis and sepsis. The patient died on 03-JAN-2008 due to deterioration of leukemia. It was unknown if the autopsy was performed. The outcome of leukemia was reported as fatal. The causality was not reported. The reporter considered the event leukemia as serious due to hospitalization and medically significant. Reported Cause(s) of Death: Leukemia deteriorated.


VAERS ID: 738795 (history)  
Form: Version 2.0  
Age: 1.5  
Sex: Female  
Location: Kentucky  
Vaccinated:2016-07-26
Onset:2016-07-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2018-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4958AA / 4 LG / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. M022531 / 2 LG / IM

Administered by: Private       Purchased by: ?
Symptoms: Electroencephalogram abnormal, Febrile convulsion
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-12
   Days after onset: 469
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations: see Temp VAERS # 134280; MMRV (Merck) and Hep A (Merck)- febrile seizure, 12 months old, vaccines given on 1-29-16
Other Medications: MOTRIN; TYLENOL; Amoxicillin
Current Illness: viral illness, fever, febrile seizure 7-16-2016
Preexisting Conditions: known febrile seizures
Allergies: None
Diagnostic Lab Data: EEG- Aug 1, 2016- signs that she had seizure activity
CDC Split Type:

Write-up: Complex febrile seizures- 2 within 24 hour period; up to 8 minutes; MOTRIN/TYLENOL; CIPRODEX gtts; OMNICEF.


VAERS ID: 739780 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Unknown  
Vaccinated:2016-11-07
Onset:2016-11-01
Submitted: 0000-00-00
Entered: 2018-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Contusion, Death, Decreased appetite, Depression, Fatigue, Headache, Hot flush, Injection site pain, Limb discomfort
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Depression (excl suicide and self injury) (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2017SA236193

Write-up: Based on information received on 15 Nov 2017, the following information has been amended: vaccine preferred name changed from "INFLUENZA QUADRIVALENT RECOMBINANT VACCINE" to "INFLUENZA VACCINE". Initial unsolicited case received from a consumer (patient wife) via other company Astellas Pharma under the MFR control number: 2016US015482 on 15 Nov 2017. This case involves 67-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE and a dose of PNEUMOCOCCAL VACCINE (Batch numbers, expiry date, dose, dose in series, route and site of administration were not reported for both the vaccines) on 07 Nov 2016. The patient also started treatment with 160 mg and 120 mg dose of XTANDI (Manufacturer: Astellas Pharma) (Batch numbers reported as 1539683PC and 1543982PC, expiry date not reported) daily once orally from an unknown dates for prostate cancer with metastasis and metastatic castrate resistant prostate cancer. (It was reported as patient had no changes after starting the drug and patient was enrolled in patient support program). Patient current condition was reported as pain. Other medical history was not reported. Concomitant medications were not reported. On an unknown date, after receiving the treatment with XTANDI, patient developed first episode of fatigue. On an unknown date in Jul 2016 and Oct 2016, after receiving the treatment with XTANDI, patient developed fatigue (second and third episode). On an unknown date in Nov 2016, following the vaccination and after the administration of XTANDI patient developed soreness in the arm and achiness at injection sites. On an unknown date, following the vaccination and after the administration of XTANDI, patient developed bruising, depression, hot flashes, loss of appetite, joint aches and headache. On an unknown date, following the vaccination and after the administration of XTANDI, patient died due to unknown cause. Patient relevant lab tests and corrective treatment were not reported. The outcome of the events fatigue, Hot flashes, soreness in the arm and achiness at injection sites were reported as not recovered and the outcome of all the other events were not reported. It was not known, whether autopsy was performed to the patient. The patient wife assessed the causal relationship between the suspect drug XTANDI and with the event soreness in arm as not related. List of documents held by sender: none. Sender''s Comments: The patient died post vaccination with influenza vaccine (Mfr Unk) and Pneumococcal vaccine. Time to onset was not reported. Patient had an ongoing medical condition of prostate cancer with metastasis and metastatic castrate resistant prostate cancer for which he was being treated with XTANDI. No autopsy results were available. Reported events may be related to preexisting medical condition which could have as well resulted in death. Based upon reported information the role of the vaccine cannot be established. Autopsy report confirming the cause of death is required to further assess the case. Reported Cause(s) of Death: Deceased.


VAERS ID: 740050 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: New York  
Vaccinated:2018-02-01
Onset:2018-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI883AB / N/A - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-01
   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: No info- he doesn''t come here- his wife only called so that we would report incident
Current Illness: Apparently there were, but his wife was not willing to discuss--- she stated that he has many problems and never elaborated
Preexisting Conditions: Apparently there were, but his wife didn''t elaborate--- His wife stated that she was under pressure from her family to report this. She doesn''t believe the flu shot had anything to do with it, but she wanted to report it since he died the same day he received it. She said that you can contact her if need be at his contact info.
Allergies: None that we know of
Diagnostic Lab Data: We have none available to us
CDC Split Type:

Write-up: Patient died at 5:15 the same day--- his wife performed cpr on patient until medical help arrived.


VAERS ID: 740671 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-03-13
Entered: 2018-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal tenderness, Appendicitis, Appendicitis perforated, Areflexia, Autopsy, Blood culture negative, C-reactive protein increased, Chest X-ray abnormal, Contusion, Death, Depressed level of consciousness, Fever neonatal, Full blood count abnormal, General physical health deterioration, Gram stain negative, Hypoglycaemia, Hypokalaemia, Hypokinesia, Intensive care, Intestinal dilatation, Irritability, Leukocytosis, Lumbar puncture normal, Megacolon, Metabolic acidosis, Neonatal hypotension, Neonatal hypoxia, Nitrite urine absent, Oedema, Protein urine present, Pulseless electrical activity, Pupils unequal, Resuscitation, Selective eating disorder, Serositis, Tachycardia, Urinary system X-ray, Urine leukocyte esterase, White blood cell count increased, X-ray abnormal
SMQs:, Acute renal failure (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Lactic acidosis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal perforation (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Nystatin
Current Illness: Candida infection, at ten days old and was managed with nystatin
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified dates. Radiographic studies performed included a Kidneys, Ureter, and Bladder (KUB) (showed absence of air in the rectum, oedema of the bowel walls, but no free air on cross table film. Abdominal X-ray, Distended bowel; Blood culture, negative; C-reactive protein, 194.6 mg/L, elevated; Chest X-ray, bilateral pulmonary opacities; Full blood count, leukocytosis; Gram stain, negative; Lumbar puncture, clear fluid with a negative Gram stain; Nitrite urine, negative; Protein urine, 25 mg/dL; Urine leukocyte esterase, negative; White blood cell count, 43800/uL, elevated; White blood cell count, 28500/uL
CDC Split Type: US2018GSK041389

Write-up: This case was reported in a literature article and described the occurrence of acute appendicitis in a 18-day-old male patient who received Hepatitis B vaccine. Concurrent medical conditions included thrush (at ten days old and was managed with nystatin). Concomitant products included nystatin. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, 18 days after receiving Hepatitis B vaccine, the patient experienced acute appendicitis (serious criteria death, hospitalization and GSK medically significant), appendicitis perforated (serious criteria death, hospitalization and GSK medically significant), serositis (serious criteria death and hospitalization), megacolon (serious criteria death, hospitalization and GSK medically significant), fever neonatal (serious criteria hospitalization and GSK medically significant), pulseless electrical activity (serious criteria hospitalization and GSK medically significant), hypokalemia (serious criteria hospitalization and GSK medically significant), obtundation (serious criteria hospitalization and GSK medically significant), hypoxia (serious criteria hospitalization and GSK medically significant), metabolic acidosis (serious criteria hospitalization), feeding disorder (serious criteria hospitalization), abdominal tenderness (serious criteria hospitalization), leukocytosis (serious criteria hospitalization), abdominal distension (serious criteria hospitalization), edema (serious criteria hospitalization), anisocoria (serious criteria hospitalization), contusion of trunk (serious criteria hospitalization), absent reflex (serious criteria hospitalization), movements reduced (serious criteria hospitalization), distended bowel (serious criteria hospitalization), hypoglycemia (serious criteria hospitalization), wide complex tachycardia (serious criteria hospitalization), irritability (serious criteria hospitalization) and hypotension (serious criteria hospitalization). The patient was treated with antibiotics NOS. On an unknown date, the outcome of the acute appendicitis, appendicitis perforated, serositis and megacolon were fatal and the outcome of the fever neonatal, pulseless electrical activity, hypokalemia, obtundation, hypoxia, metabolic acidosis, feeding disorder, abdominal tenderness, leukocytosis, abdominal distension, edema, anisocoria, contusion of trunk, absent reflex, movements reduced, distended bowel, hypoglycemia, wide complex tachycardia, irritability and hypotension were unknown. The reported cause of death was appendicitis. An autopsy was performed. The autopsy determined cause of death was serositis, megacolon and appendicitis perforated. The reporter considered the acute appendicitis, appendicitis perforated, serositis, megacolon, fever neonatal, pulseless electrical activity, hypokalemia, obtundation, hypoxia, metabolic acidosis, feeding disorder, abdominal tenderness, leukocytosis, abdominal distension, edema, anisocoria, contusion of trunk, absent reflex, movements reduced, distended bowel, hypoglycemia, wide complex tachycardia, irritability and hypotension to be related to Hepatitis B vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of acute neonatal appendicitis in a 18-day-old male patient who was vaccinated with unspecified hepatitis-B virus vaccine (manufacturer unknown). The patient was born at full term via spontaneous vaginal delivery following an unremarkable pregnancy. No information on patient''s medical history or family history was provided. On an unspecified date shortly after birth, the patient received unspecified hepatitis-B virus vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The patient stayed in the newborn nursery for two days prior to discharge. At 10 days old, the patient was diagnosed with thrush and was managed with nystatin. On an unspecified date, 19 days after vaccination, the patient presented at an emergency department with 1-day complaints of increased fussiness and difficulty feeding and was noted to have slightly distended and tender abdomen (a clinical picture of a possible small bowel obstruction). A septic workup was performed and included a complete blood count (CBC) (revealed leukocytosis of 28.5k/UL), a negative blood culture, a lumbar puncture (clear fluid with a negative Gram stain), urinalysis (25mg/dL protein with negative nitrite and leukocyte esterase), and elevated C-Reactive Protein (CRP) (194.6mg/L). The patient was subsequently started on antibiotics for neonatal fever. During his three days of hospitalization, the clinic team requested a transfer to the paediatric Intensive Care Unit (ICU) due to worsening of abdominal distension, increasing white count to 43.81k/UL, and suspicions of small bowel obstruction. The patient further deteriorated during transfer and was significantly obtunded on arrival to the paediatric ICU. He was grossly oedematous, with abdominal distension, anisocoria, bruising along the right flank, absence of reflexes, and minimal spontaneous movement. Radiographic studies performed included a Kidneys, Ureter, and Bladder (KUB) (showed absence of air in the rectum, oedema of the bowel walls, but no free air on cross table film), an abdominal X-ray (showed a mild-to-moderate degree of gaseous distension of the bowel), and a chest X-ray (showed bilateral pulmonary opacities). The patient was acutely managed for hypoxia associated with severe metabolic acidosis, hypokalaemia, hypotension, and hypoglycemia. He subsequently had several episodes of recurrent wide complex tachycardia and pulseless electrical activity. After multiple resuscitations, the patient was pronounced dead several hours after the transfer. An autopsy was performed and the most significant findings were gangrenous appendicitis with evidence of rupture and marked acute serositis identified in the rectal serosa and focally in the mesenteric peritoneum. There was dilation of the transverse colon and proximal descending colon but no obstruction of the bowel was identified. This case has been considered serious due to death/hospitalisation. The author did not comment on the relationship between the event of acute neonatal appendicitis and unspecified hepatitis-B virus vaccine. The authors stated, "Acute neonatal appendicitis is more common in males, with up to a half of all reported cases involving premature infants. The different factors attributing to the low incidence include funnel-shaped appendix with a wide opening into the cecum, soft liquid diet, lack of faecalith, recumbent posture, and the presumed infrequent occurrence of viral-induced lymphatic hyperplasia in the periappendiceal region. Perforation plays a significant role in determining the prognosis. Due to the delayed diagnosis and management, the incidence of perforation and subsequent peritonitis is high in neonatal appendicitis. Other factors contributing to the increased susceptibility to perforation in this population include the thin appendiceal wall, a nondistensible cecum, a relatively small omentum insufficient to wall of infection, and a small capacity of the abdominal cavity, resulting in easy dissemination of infection. Similar to this case, acute appendicitis remains a diagnostic challenge and, in the majority of cases, is discovered only on postmortem examination. A high index of clinical suspicion and meticulous analysis of clinical features can lead to early diagnosis and more timely surgical intervention to reduce the associated high mortality rate".


VAERS ID: 740847 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: South Carolina  
Vaccinated:2018-03-06
Onset:2018-03-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2018-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5288AA / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. G9H24 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S70879 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N021101 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-13
   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: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: On 03/13/2018 this patient expired with SIDS. This report is being generated because do not know if vaccines were a contributing factor. There was smoking around child, and child had been sleeping with mother at checkup visit.


VAERS ID: 740872 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2018-02-15
Onset:2018-02-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI830AB / UNK GM / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S74423 / UNK GM / IM

Administered by: Other       Purchased by: ?
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-28
   Days after onset: 13
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: LP showing albuminocytologic dissociation; OSH EMG consistent with AIDP/GBS
CDC Split Type:

Write-up: Pt. was given the flu vaccine on admission to the hospital as part of their admission assessment procedure on 2/15/2018. Guillain-Barre syndrome was diagnosed on 2/27/2018, treated with IV fluids, IVIG, steroids.


VAERS ID: 741848 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Arizona  
Vaccinated:2017-11-29
Onset:2017-11-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5169AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI822AAA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR N1G511M / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S89080 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N010709 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-30
   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: None known
Current Illness: None known
Preexisting Conditions: None known
Allergies: None known
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient expired.


VAERS ID: 742230 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

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: Medical History/Concurrent Conditions: Cardiac disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131803USA011289

Write-up: This initial spontaneous report was received from the mother of a "college aged" female patient via a company representative. Concurrent conditions included an unspecified heart condition. Concomitant medications were not provided. On unspecified dates, the patient received her first, second and third doses of the human papilloma virus (HPV) vaccine (manufacturer not specified). The company representative stated she had heard of a mother (gave mother''s first name) who was telling people that her daughter died after receiving the third dose of a series of HPV vaccine. It was not stated which HPV vaccine the patient received. The mother has already filed a federal lawsuit. The cause of death was not specified. Upon internal review, death was considered medically significant. Additional information is not expected as there was no contact information.


VAERS ID: 742777 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Washington  
Vaccinated:2018-02-02
Onset:2018-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5418AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S43262 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N005626 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-03
   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: none
Current Illness: none
Preexisting Conditions: none
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: 24-48 hours after patient received vaccines, Patient was found dead in crib, no clearly identifiable cause of death.


VAERS ID: 742892 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2018-03-29
Onset:2018-03-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P3777 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prevacid; Aspirin; hydrochlorothiazide; Xanax; Miralax
Current Illness: None reported
Preexisting Conditions: GERD
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient passed away suddenly without previous illness. Patient complained of chest pain to her husband several hours before the event as reported by Dr.


VAERS ID: 743048 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Unknown  
Vaccinated:2015-09-01
Onset:2018-03-16
   Days after vaccination:927
Submitted: 2018-03-29
   Days after onset:13
Entered: 2018-04-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L72442 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-16
   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: Aspirin; nifedipine; quinapril
Current Illness:
Preexisting Conditions: No known drug allergies
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: AE reported to pharmacy team member on 3-28-18 that patient is deceased as of 3-16-18. No additional details provided.


VAERS ID: 743123 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: California  
Vaccinated:2018-02-08
Onset:2018-02-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 5J594 / 7+ LA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. N026812 / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M17013 / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5563AA / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Influenza, Respiratory distress, Septic shock
SMQs:, Anaphylactic reaction (broad), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: vaginal itching
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received immunizations on 2/8/18. She presented to ED on 2/11/18 in respiratory distress/ septic shock and passed away the same day, presumably from Influenza B.


VAERS ID: 743156 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Vermont  
Vaccinated:2018-02-21
Onset:2018-02-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK - / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

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: 2018-03-01
   Days after onset: 7
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:
CDC Split Type:

Write-up: Found unresponsive the next morning face down in bassinet. Survived unresponsive ~ 1 week.


VAERS ID: 743343 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Georgia  
Vaccinated:2018-04-03
Onset:2018-04-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS NX952 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cough, Death, Dyspnoea, Sinusitis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-04-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient''s granddaughter stated that the evening that the vaccine was received (4/3), the patient was having difficulty breathing with cough and sinus inflammation. The patient had no other symptoms the next morning (4/4), but she took a nap later in the morning and didn''t wake up.


VAERS ID: 743378 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Unknown  
Vaccinated:2018-03-27
Onset:2018-03-27
   Days after vaccination:0
Submitted: 2018-04-06
   Days after onset:10
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS XC534 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac disorder, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-27
   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: No other medications
Current Illness: Unknown
Preexisting Conditions: Hypertension; Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018056955

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of heart disease, unspecified in a 62-year-old male patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). The patient''s past medical history included hypertension and diabetes. On 27th March 2018 11:30, the patient received SHINGRIX. On 27th March 2018 18:00, 6 hrs 30 min after receiving SHINGRIX, the patient experienced heart disease, unspecified (serious criteria death). On 27th March 2018 18:00, the outcome of the heart disease, unspecified was fatal. The patient died on 27th March 2018. The reported cause of death was heart disease, unspecified. It was unknown if the reporter considered the heart disease, unspecified to be related to SHINGRIX. Additional details were provided as follows: At 6 pm, the patient passed away. The healthcare professional explained that the coroner reported that the patient passed away due to heart issues etc. The pharmacist was sure that the patient also passed away due to heart issues. The pharmacist called into medical information to confirm that other patients had not passed away due to the SHINGRIX vaccine.


VAERS ID: 743431 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? 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: US0095075131804USA001041

Write-up: This spontaneous report was received from a non-healthcare professional via Pfizer refers to a 17 years old female patient. Patient''s medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dosing information was not provided) for prophylaxis. On an unknown date, the patient died. It was unknown if the autopsy was performed. The cause of death was unknown. Reporter considered the event to be related to GARDASIL. Upon internal review, death was determined to be medically significant. This is one of the two reports received from the same reporter.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 743447 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Washington  
Vaccinated:2018-04-05
Onset:2018-04-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS CH2X7 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-04-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Don''t know
Current Illness: Do not know .
Preexisting Conditions: Eye drop for dry eyes. Urgency bladder problems.
Allergies: No known allergies
Diagnostic Lab Data: Don'' t know the cause of death. Tried calling family and unable to reach them.
CDC Split Type:

Write-up: Patient''s daughter came to the pharmacy at 5:30PM on 4/5/2018 and informed us patient died.


VAERS ID: 743633 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2018140264

Write-up: This is a spontaneous report from a Pfizer-sponsored program comScore Quant Concept Testing. A contactable consumer reported for a female patient (his/her mother) of an unspecified age and race who received PREVNAR 13 at single dose on unknown date for immunization via unspecified route. Relevant medical history and concomitant medication were unknown. The patient died of pneumonia. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected. Reported Cause(s) of Death: Died of pneumonia.


VAERS ID: 744185 (history)  
Form: Version 2.0  
Age: 0.0  
Sex: Male  
Location: Washington  
Vaccinated:2017-09-10
Onset:2017-09-19
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2018-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS PN595 / 1 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Respiratory tract congestion, Rhinorrhoea
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-28
   Days after onset: 39
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None known
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Extreme congestion (runny nose, etc) starting about a week after birth/vaccination and up until his death on 10/28/17.


VAERS ID: 744430 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Drug ineffective, Malaise, Pneumonia
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131804USA004283

Write-up: This spontaneous report has been received from a physician via a company representative referring to a male patient of unknown age reported as "in his 80''s or 90''s". Information regarding the patient''s medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown dates "for five consecutive years", the patient was vaccinated with one dose of PNEUMOVAX 23 (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown dates "for five consecutive years", the patient was hospitalized for pneumonia and while he was still sick, received a dose of PNEUMOVAX 23 every time he was hospitalized. It was also mentioned, that the PNEUMOVAX 23 was ineffective in preventing pneumonia for the patient (drug ineffective). Subsequently, on an unknown date, the patient died from an unknown cause. It was not known if an autopsy was performed. At the reporting time, the outcome of pneumonia, drug ineffective and malaise were unknown. The causality assessment between therapy with PNEUMOVAX 23 and the events was not reported. Upon internal review, pneumonia was determined to be medically significant. This is one of two cases from the same reporter. Sender''s Comments: US-009507513-1804USA004352: Reported Cause(s) of Death: Cause of death unknown.


VAERS ID: 744493 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-04-16
Entered: 2018-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK065061

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a adult subject who received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described death not otherwise specified (NOS) in a patient aged between 18 and 70 years of unspecified gender who was vaccinated with ENGERIX (GlaxoSmithKline). The patient was part of a post hoc analysis that compared the safety of HBsAg-1018 with ENGERIX-B, in 3 randomised, observer-blinded, active-controlled, multi-center phase 3 trials in adults. Eligible participants in HBV-10 and HBV-16 were generally healthy volunteers but HBV-23 did not specify that participants must be generally healthy. Subjects in all three pivotal trials were serum negative for HBsAg, anti-HBs, and anti-HBc; had no history of HBV infection; had no history of prior immunization with any hepatitis B vaccine; did not have human immunodeficiency virus infection; had no autoimmune disease; and were not pregnant. No information on patient''s family history or concomitant medication was provided. On an unspecified date, the patient received ENGERIX intramuscularly (administration site unspecified, dosage unknown; batch number not provided). [In this study, ENGERIX-B (GlaxoSmithKline Biologicals) consists of 20 mcg of recombinant HBsAg combined with 0.5 mg of aluminum hydroxide adjuvant per 1.0 mL dose. Participants in the ENGERIX-B group received the Food and Drug Administration (FDA) approved regimen of intramuscular injections at weeks 0, 4, and 24]. The age at vaccination was not provided. On an unspecified date, and unknown period after vaccination, the patient died. It was reported that the patient died due to illicit or therapeutic drug overdose. It was unknown if an autopsy was performed. This case has been considered serious due to death. The authors commented "Most deaths occurred in participants with significant pre-existing disease, comorbidities, or contributory social circumstances. The only imbalance in causes of death between the vaccine groups was in deaths due to illicit or therapeutic drug overdose (HBsAg-1018: n: 6 HBsAg-Eng: n:1". The authors concluded "the safety profile of HBsAg-1018 is similar to that of ENGERIX-B with vaccine-associated adverse events limited to mild to moderate local and systemic post-injection reactions. There is no evidence for a causal association between HBsAg-1018 and autoimmune or cardiovascular events. Although current hepatitis B vaccines have addressed a medical need in infants and adolescents, there remains a large unmet need in adults. A two dose hepatitis B vaccine with an acceptable safety profile should provide improved seroprotection and a significant public health benefit to adults 18 years of age or older". This is 1 of the 4 valid cases reported in the same literature article.


VAERS ID: 744725 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2018SA106974

Write-up: The following is verbatim from the article: BACKGROUND: Influenza-associated pediatric deaths became a notifiable condition in 2004. METHODS: We analyzed deaths in children aged less than 18 years with laboratory-confirmed influenza virus infection reported to the Centers for Disease Control and Prevention during the 2010-2011 to 2015-2016 influenza seasons. Data were collected with a standard case report form that included demographics, medical conditions, and clinical diagnoses. RESULTS: Overall, 675 deaths were reported. The median age was 6 years (interquartile range: 2-12). The average annual incidence was 0.15 per 100 000 children (95% confidence interval: 0.14-0.16) and was highest among children aged less than 6 months (incidence: 0.66; 95% confidence interval: 0.53-0.82), followed by children aged 6-23 months (incidence: 0.33; 95% confidence interval: 0.27-0.39). Only 31% (n = 149 of 477) of children aged 6 months had received any influenza vaccination. Overall, 65% (n = 410 of 628) of children died within 7 days after symptom onset. Half of the children (n = 327 of 654) had no preexisting medical conditions. Compared with children with preexisting medical conditions, children with none were younger (median: 5 vs 8 years old), less vaccinated (27% vs 36%), more likely to die before hospital admission (77% vs 48%), and had a shorter illness duration (4 vs 7 days; P less than .05 for all).CONCLUSIONS: Each year, influenza-associated pediatric deaths are reported. Young children have the highest death rates, especially infants aged less than 6 months. Increasing vaccination among children, pregnant women, and caregivers of infants may reduce influenza associated pediatric deaths. This case involves a two patients (age reported as less than seven months) who were partially vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. The patient''s medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient died due to influenza. The patients were less than 7 months of age and therefore did not have time for full vaccination before death. The median time from symptom onset to death was 5 days (IQR: 2-11 days). Relevant lab investigations and corrective treatment were not reported. It was not reported if the autopsy was performed or not. List of documents held by sender: none. Sender''s Comments: This literature article describes two patients (less than 7 months of age, other details unknown) who died in association with Influenza infection. These patients were partially immunized with Influenza vaccine (unknown manufacturer). It is not a case of vaccination failure as complete immunization schedule was not followed. Time to onset, type and serotype of influenza infection are not reported. Based upon the reported information, the role of vaccine cannot be assessed. Reported Cause(s) of Death: Influenza.


VAERS ID: 745051 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Unknown  
Vaccinated:2017-11-01
Onset:2018-01-31
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2018-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-14
   Days after onset: 14
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Suspected acute disseminated encephalomyelitis. It is unknown if the vaccine was actually given- an order was placed, but record of administration unclear.


VAERS ID: 745235 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Female  
Location: New Mexico  
Vaccinated:2018-03-08
Onset:2018-03-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 2F977 / 2 LG / SYR
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. N024571 / 2 LG / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T52790 / 2 LG / SYR
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N022174 / 2 MO / PO

Administered by: Military       Purchased by: ?
Symptoms: Body temperature increased, Cardiac monitoring, Cardiac monitoring abnormal, Consciousness fluctuating, 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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-10
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: They took no lab tests at the Emergency room.
CDC Split Type:

Write-up: After the vaccinations had been administered, the lady in the Immunizations department at the clinic who administered them, told me that if her fever went above 102 to take her in. By 6 pm that evening, I took her to the ER after rectally taking her temperature and it being 103.4. She was in and out of consciousness on our way and would not smile or react to me. They hooked her to a heart monitor machine and her HR reached as high as 212.


VAERS ID: 745519 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Michigan  
Vaccinated:2018-02-07
Onset:2018-02-18
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2018-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS DN277 / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. N031493 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S58705 / 2 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS XR9AE / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-18
   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: None
Current Illness: None
Preexisting Conditions: Death. Ruled SIDS
Allergies: None
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: He was normal. He went to sleep and never woke up. 11 days after his vaccines.


VAERS ID: 747685 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Male  
Location: Arizona  
Vaccinated:2018-05-03
Onset:2018-05-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS Y5475 / 1 LL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS 5Z7PT / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR N1K921M / 1 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T62563 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N032565 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: no
Current Illness: Hydronephrosis
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data: Unknown at this time.
CDC Split Type:

Write-up: Death on 05/04/2018 from unknown causes at this time. Vaccines given on 05/03/2018 in office.


VAERS ID: 748549 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Nevada  
Vaccinated:2017-05-31
Onset:2017-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Blood test, Cardiac disorder, Cerebrovascular accident, Computerised tomogram, Death, Decreased appetite, Dehydration, Diarrhoea, Feeling abnormal, Nausea, Nuclear magnetic resonance imaging, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-07-15
   Days after onset: 44
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Losartan; Finesteride; Atorvastatin; Potassium; Gabapentin; Aspirin
Current Illness: None
Preexisting Conditions: Very healthy
Allergies: CT scan contrast
Diagnostic Lab Data: MRI; CT scan; many blood tests
CDC Split Type:

Write-up: Diarrhea, nausea, dehydration, loss of weight, weakness, loss of appetite. On May 31, 2017, my husband went to the hospital for his annual checkup. At that time his primary care doctor commented that he was in very good shape for an 83 year old man. Then he gave him a pneumonia shot, PREVNAR 13. He said that it might make him a little sick but that would go away. Within a day or so he began feeling bad, threw up every thing he ate, got severe diarrhea and got very weak. Started getting dehydrated, and lost weight. We took him to the doctor again and he ran tests. The doctor was very surprised at how he looked. Even commented that he looked awful. Sent him home with some medication. But within a few days we took him back to the Emergency Room. They sent him home with medication. A few days later we took him to the emergency room again. And then to an other Emergency room. Still no results. Back to the hospital, and they were required to admit him They ran many tests. CT scan, MRI. Then one night he developed a heart problem (he never had any heart issues up till then). They moved him to another hospital. Cardiac ward. They did more tests and found that he had 2 massive strokes. He died on July 15, 2017. Up until the time he got that PREVNAR 13 shot he was a very healthy man. At 83 years old he could outwork a man 40 years old. He never had any heart issues. The most health problem he had was a prostate problem. Which he was being treated for. None of the doctors could find a reason for him being so sick. It all started with the shot that he was given on May 31. I would like some answers. What killed him? Was it the shot?


VAERS ID: 749388 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Herpes zoster disseminated
SMQs:, Sepsis (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunosuppression
Preexisting Conditions: Medical History/Concurrent Conditions: Transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131805USA003734

Write-up: This spontaneous report was received from a physician via a company representative. The physician heard about this shingles case study which was presented during a meeting, referring a male patient of an unknown age. The patient was considered "immunosuppressed" and he had a transplant surgery in an unspecified date for an unspecified cause/reason. Information regarding drug reactions, allergies or concomitant medications was not mentioned. In an unspecified date in 2012, the patient was vaccinated with ZOSTAVAX (dose, anatomical location and patient route of administration, lot # and expiration date were not reported). On an unmentioned date, after getting vaccinated the patient experienced disseminated shingles virus. It was unknown which the outcome of shingles was. Furthermore, on an unspecified date due to an unspecified cause the patient died. It was not known if an autopsy was performed. The causal relationship between shingles and death, with vaccination with ZOSTAVAX was not reported. Upon internal review, the event Herpes zoster disseminated was considered to be medically significant.; Reported Cause(s) of Death: died due to an unspecified cause.


VAERS ID: 749562 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: North Carolina  
Vaccinated:2017-05-09
Onset:2017-05-17
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2018-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: don''t have
CDC Split Type:

Write-up: My two month old daughter passed a week after receiving shots.


VAERS ID: 750873 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Male  
Location: Arizona  
Vaccinated:2018-05-17
Onset:2018-05-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS DB5H3 / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. N034410 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T62563 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS 3497Z / 1 MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, CSF glucose decreased, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Death, Gram stain positive, Intensive care, Meningitis
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-05-22
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: LP was performed which showed findings consistent with meningitis WBC 62, RBC 75, Protein greater than 600, Glucose less than 2
CDC Split Type:

Write-up: Patient was seen for WCC on 5-17-2018 vaccines administered. Returned to clinic on 5-18-2018 triaged had a temp of 101.4 assessed by an FNP reassurance given along with the 24 hour triage line. Family traveled he was given IV fluids and subsequently transferred to an ED, received one dose of ceftriaxone 50mg/kg then transferred to another ED for a higher level of care. An LP was performed which showed findings consistent with meningitis WBC 62, RBC 75, Protein greater than 600, Glucose less than 2, culture positive fror gram-positive cocci in pairs. Given one dose of Vanco and transferred to PICU where he stayed for 2 days he passed away 05-22-2018 at 1842.


VAERS ID: 751040 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2018-05-22
Onset:2018-05-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2018-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Acidosis, Acute kidney injury, Anion gap, Atrial fibrillation, Blood creatine phosphokinase increased, Blood creatinine increased, Blood lactic acid, Blood potassium normal, Blood sodium decreased, Carbon dioxide decreased, Endotracheal intubation, Hypotension, Immediate post-injection reaction, Malaise, Myalgia, Procalcitonin increased, Pyrexia, Respiratory failure, Seizure, Septic shock, Troponin increased, Viral test, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2018-05-30
   Days after onset: 4
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None - up to one month prior of vaccination. Of note, patient has biopsy proven primary membranous nephropathy with recent treatment of rituximab on 3/18. Otherwise feeling well up until he received SHINGRIX vaccine.
Preexisting Conditions: chronic kidney disease (baseline SCr 1.8); hyperlipidemia; hypertension; sleep apnea
Allergies: No known allergies
Diagnostic Lab Data: 5/29/18: Na 129; K 5.0; SCr 5.49; CO2 9.5; AG 16; CK 3878; troponin 0.221; lactic acid 9.7; procalcitonin 42.20; WBC 34.4; Septic shock requiring five vasopressors to maintain mean arterial pressure of 65; Seizure episodes requiring fosphenytoin and levetiracetam; Viral serologies sent.
CDC Split Type:

Write-up: Patient was seen in the office a few weeks ago and was feeling well. Apparently, he received recent SHINGRIX vaccine and immediately started feeling worse after. Patient presented to hospital on 5/26 with fevers, malaise and myalgias. Serum creatinine was 4 on admission. Patient was started on broad spectrum antibiotics and developed worsening acidosis. He was eventually intubated for respiratory failure. He developed atrial fibrillation with rapid ventricular rate and was started on vasopressors for hypotension. Transferred to Regional hospital for acute renal failure and septic shock.


VAERS ID: 751362 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: New Jersey  
Vaccinated:2018-05-17
Onset:2018-05-19
   Days after vaccination:2
Submitted: 2018-06-01
   Days after onset:13
Entered: 2018-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS 73T35 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Premature baby
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018096074

Write-up: This case was reported by a physician via call center representative and described the occurrence of death NOS in a 3-month-old male patient who received HIBERIX (batch number 73T35, expiry date 9th June 2019). The patient''s past medical history included prematurity. On 17th May 2018, the patient received the 1st dose of HIBERIX (intramuscular) .5 ml. On 19th May 2018, 2 days after receiving HIBERIX, the patient experienced death NOS (serious criteria death and GSK medically significant). On 19th May 2018, the outcome of the death NOS was fatal. The reported cause of death was death. It was unknown if the reporter considered the death NOS to be related to HIBERIX. Additional details were provided as follows: The patient was born prematurely. The estimated delivery due date was 8th April 2018 and his birth weight was 1.440 kg. At 12:00 the patient received HIBERIX in the right thigh. There was no cause of death known. The patient was taken to the emergency room where he was pronounced dead.


VAERS ID: 752841 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Florida  
Vaccinated:2017-10-03
Onset:2017-10-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2018-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK RA / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthropathy, Blood test normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Death, Grip strength decreased, Muscular weakness, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain, Periarthritis, Resuscitation, Vaccination complication, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-22
   Days after onset: 106
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CENTRUM SILVER; Vitamin C; Fish Oil; Low-Dose Aspirin
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Blood work-normal 10-23-17; Complete physical-normal 10-23-17; MRI 10-25-17 mild arthropathy
CDC Split Type:

Write-up: By October 8th patient felt extreme shoulder pain. On 10/23/17 appt. with Dr. - given 10-23-17 appt. with Dr.-given complete physical. Diagnosis: frozen shoulder. Five additional appointments - condition appointments-condition worsened. Twelve appointments with PT - no Therapist-no improvement. Pain spread throughout body, limb weakness, weight loss, could not hold eating utensils. Doctor and Physical Therapist Providers both recommended neurology group/no appt. until 02-03-18 apt until 2-03-18 died waiting. My husband was an active active, robust man until this vaccine shot. He weighed 175 pounds on October 1st, 2017, and at his last appointment on January 3rd, 2018, he registered 150 pounds. He could not hold a fork or juice glass. Both Dr. and Therapist said they could no longer help him and recommended the Neurologist Neurologists the first week in January. His appointment was set for February 3rd and he called every day to see if there was a cancellation; but he died 10 ten days before. He awakened at 1:00 to use the bathroom. When his legs gave out, I called 911 and did chest thrusts. The ambulance took him to the Hospital hospital where he died within one hour. Therapist said from his first appointment, on November 15th, that the cause was the flu shot. All symptoms point to Chronic Inflammatory Demyelinating Polyneuropathy. Here is a strong man who had never been hospitalized since a tonsillectomy at age 5 who dies from a vaccination designed to keep him healthy. What are the statistics of death from a flu shot? What compensation for wrongful death is covered by the FDA? Pharmacy certainly shuns responsibility for having an inexperienced girl administer the shot. I think there should be a precise warning given at the time of the shot, shot as opposed to the generic list of possible side effects. We wasted months treating a frozen should shoulder rather than see seeing a neurologist. I have saved all receipts and reports in my file. And you are welcome to verify husband''s patient''s physical condition from any of the 136 units in our condo who saw him walking daily, fishing, playing tennis, etc. You can also check with our neighbors who saw him boating, cycling, gardening, etc. etc.. One week before the vaccination he drove 1600 miles (with overnight stops along the way, of course). I will, and do, miss my loving husband of fifty three years-as years - as do our children and his twin sister. It is a difficult time for all of us.


VAERS ID: 753090 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-06-06
Entered: 2018-06-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal rigidity, Activated partial thromboplastin time shortened, Agitation, Anxiety, Aspiration pleural cavity, Asthenia, Bacterial infection, Blood bilirubin normal, Blood electrolytes normal, Blood lactate dehydrogenase increased, Blood uric acid increased, Blood uric acid normal, Breath sounds abnormal, C-reactive protein increased, Cardiac murmur, Chemotherapy, Chest X-ray abnormal, Coagulation test normal, Computerised tomogram abdomen abnormal, Computerised tomogram abdomen normal, Computerised tomogram pelvis, Computerised tomogram thorax abnormal, Cough, Crepitations, Croup infectious, Death, Decreased appetite, Dyspnoea, Echocardiogram normal, Empyema, Gastrointestinal examination normal, Haematocrit normal, Haemoglobin normal, Heart rate increased, Heart rate normal, Influenza, Intensive care, International normalised ratio normal, Lymphocyte percentage, Malaise, Mediastinal mass, Monocyte percentage increased, Neoplasm malignant, Neurological examination normal, Neutrophil percentage, Non-Hodgkin's lymphoma, Oropharyngeal pain, Orthopaedic examination normal, Orthopnoea, Oxygen saturation decreased, Oxygen therapy, Pallor, Pericardial effusion, Platelet count normal, Pleural effusion, Pleural fluid analysis, Pneumonia mycoplasmal, Precursor T-lymphoblastic lymphoma/leukaemia, Prothrombin time normal, Pyrexia, Red blood cell sedimentation rate increased, Respiratory rate increased, Rhinorrhoea, Streptococcus test negative, Superior vena cava stenosis, Tachycardia, Tachypnoea, Tracheal deviation, Tracheal stenosis, Transaminases, Use of accessory respiratory muscles, Vein disorder, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Malignant lymphomas (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Haematological malignant tumours (narrow), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow), Dehydration (broad), 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, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol
Current Illness: Croup infectious; Cough, 2 weeks; Cardiac murmur
Preexisting Conditions: Dexamethasone, croup infectious, 5-day course
Allergies:
Diagnostic Lab Data: On an unspecified date, rapid test was performed which showed negative results. On an unspecified date, Chest X ray was performed which revealed a right lower lobe pleural effusion. On an unspecified date, the patient''s head and neck examinations were performed which showed mild rhinorrhea. He had full range of motion at the neck with no evidence of cervical lymphadenopathy. On an unspecified date, cardiac examination was performed, which showed a harsh 2/6 systolic murmur at the left lower sternal border with no evidence of rubs or gallops, and normal central and peripheral pulses. On an unspecified date, pulmonary examination showed coarse breath sounds bilaterally with intermittent crackles and decreased breath sounds in the right lower lobe, without increased work of breathing or tachypnea. On an unspecified date, Physical examination was performed, which showed that the patient''s abdomen was soft, nontender with normal bowels sound. There was no hepatosplenomegaly, but slight generalized and no axillary lymphadenopathy was noted. Voluntary guarding was noted. On an unspecified date, the patient''s Genito-urinary examination was performed which was unremarkable and there was no noted inguinal lymphadenopathy. On an unspecified date, musculoskeletal examinations were performed which showed normal gait, full range of motion at all joints and no evidence of edema or swelling. On an unspecified date, neurological examination was performed, which revealed that, he had no focal neurological deficits and his cranial nerves were intact. On an unspecified date, (CT) scan of the chest, abdomen, and pelvis was performed, which showed a heterogeneous anterior mediastinal mass causing tracheal narrowing and deviation. A moderate size right pleural effusion and a small pericardial effusion were also noted, abdominal or pelvic abnormalities were noted. On an unspecified date, pleurocentesis was performed which showed T-cell lymphoblastic lymphoma. On an unspecified date, chest X-ray of anterior, posterior and lateral view was again performed which showed right lower lobe pleural effusion as well as right round paratracheal/anterior mediastinal mass with slight leftward shift of mediastinal structures. Blood lactate dehydrogenase, 1078 U/L, elevated; Blood pressure measurement, 95/62 mmHg, Inconclusive; Blood uric acid, 5.4 mg/dL, elevated; Body temperature, 37.20 degree C, Inconclusive; Body temperature, 101F, Inconclusive; C-reactive protein, 6.2 mg/dL, elevated; Haematocrit, 34%, Inconclusive; Haemoglobin, 12 g/dL, Inconclusive; Heart rate, 106 beats/minute, Inconclusive; Lymphocyte count, 22.7%, Inconclusive; Monocyte count, 9.5%, Inconclusive; Neutrophil count, 66%, Inconclusive; Oxygen saturation, 90%, depressed; Oxygen saturation, 98%; Oxygen saturation, 97%, Inconclusive, on room air; Red blood cell sedimentation rate, 108 mm/h, elevated; Respiratory rate, 32 beats/minute, Inconclusive; White blood cell count, 14600, Inconclusive
CDC Split Type: 201701692

Write-up: This initial Literature serious spontaneous case, was received from health professional (Physician) on 25-Sep-2017, concerning a 09-year-old male child patient. On an unspecified date, the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, manufacture and trade name was not provided). A 9-year-old otherwise healthy male presented to the emergency department (ED) with 3 weeks of decreased energy, decreased appetite, and a 2-week history of persistent cough. The patient was initially seen at an outside hospital ED 2 weeks before this most recent ED visit, predominantly for cough, and was discharged home with albuterol without a specific diagnosis. Two days after his initial ED visit, he went to see his primary care physician, was diagnosed with croup, and prescribed a 5-day course of dexamethasone. On an unspecified date, after the administration of vaccine, the patient started coughing again, predominantly at night. Three days prior, he was seen again by his primary care physician and was diagnosed with mycoplasma pneumonia. On the same day, a rapid strep was sent and it was negative. The patient was started on a 5-day course of azithromycin but had persistent and worsening cough. The morning of his visit to the ED, the patient was seen by his primary care physician and was given an albuterol treatment, which helped his cough. He was noted to be febrile to 101-degree F at his physician''s office. This was the first time during his course of illness that he had a fever. His cough was now also associated with rhinorrhea and mild sore throat. On an unspecified date, chest x-ray (CXR) was performed, which showed right lower lobe pleural effusion. On review of systems, he denied any chest pain, abdominal pain, nausea, vomiting, diarrhea, constipation, rashes, myalgia, arthralgia, weight loss, or night sweats. He had no recent travel or sick contacts, and there was no known human immunodeficiency virus or tuberculosis exposure. He was living with his mother who did not know his complete past medical history, but she stated that he was healthy, his immunizations were up to date, and he did not have any known allergies. His family history was unknown. He was taking albuterol as needed for cough and was on day 3 of 5 of azithromycin when he presented to ED for further evaluation. On an unspecified date in initial examination, he was well appearing and active but noted to be coughing frequently. His vital signs revealed a temperature of 37.20 degrees C, a heart rate of 106 beats per minute, a respiratory rate of 32 breaths per minute, a blood pressure of 95/62 mmHg, and an oxygen saturation of 97% on room air. His weight was 36.9 kg. His head and neck exam was notable only for mild rhinorrhea. He had full range of motion at the neck with no evidence of cervical lymphadenopathy. On an unspecified date, cardiac examination was performed, which showed a regular rate and rhythm, a harsh 2/6 systolic murmur at the left lower sternal border with no evidence of rubs or gallops, and normal central and peripheral pulses. It was reported that, the patient''s family was not aware that he had a heart murmur. On an unspecified date, on pulmonary examination, the patient had coarse breath sounds bilaterally with intermittent crackles and decreased breath sounds in the right lower lobe, without increased work of breathing or tachypnea. He had a persistent dry cough, worse when supine, with significant orthopnea. No axillary lymphadenopathy was noted. His abdomen was soft, non tender, and with normal bowels sounds. There was no hepatosplenomegaly, but slight generalized voluntary guarding was noted. On an unspecified date, genito-urinary examination was performed which was unremarkable, and there was no noted inguinal lymphadenopathy. On an unspecified date, musculoskeletal examination was performed, where the patient had a normal gait, full range of motion at all joints, and no evidence of edema or swelling. On an unspecified date, neurological examination was performed, where the patient had no focal neurological deficits and his cranial nerves were intact laboratory evaluation was significant for a white blood cell count of 14,600 (with 66% segmented neutrophils, 22.7% lymphocytes, and 9.5% monocytes). His hemoglobin was 12 g/dL, and his hematocrit was 34%. Platelets are within normal limits at 312,000 per micro liter. Inflammatory markers were elevated with a C-reactive protein of 6.2 mg/dL and an erythrocyte sedimentation rate of 108 mm/h. Coagulation studies were within normal limits: prothrombin time, 11.8 seconds, international normalized ratio, 1.8; and partial prothrombin time, 26 seconds. Lactic dehydrogenase was elevated at 1078 U/L, and uric acid was within upper limits of normal at 5.4 mg/dL. Electrolytes were within normal limits, as were his bilirubin and liver transaminase. His previously obtained CXR was solely an anterior/posterior view. On an unspecified date, CXR (X ray) with both anterior/posterior and lateral was performed again noted the right lower lobe pleural effusion as well as the right round paratracheal/anterior mediastinal mass with a slight leftward shift of mediastinal structures. On an unspecified date, computed tomography (CT) scan of the chest, abdomen, and pelvis was performed, which showed a heterogeneous anterior mediastinal mass causing significant tracheal narrowing and deviation. The left innominate and subclavian veins were not seen, likely owing to mass effect. A moderate size right pleural effusion and a small pericardial effusion were also noted. In addition, there was narrowing of the superior vena cava. No abdominal or pelvic abnormalities were noted. This constellation of findings was consistent with malignant neoplasm with lymphoma the most likely etiology. During his ED course, the patient had episodes of unrelenting cough, stating that he was unable to catch his breath. During these episodes, he would be tachycardic to the 150 seconds and his saturation would decrease to 90% on room air. He was extremely anxious and agitated. Oxygen was administered via a non-rebreather mask, subsequent to which the patient calmed down and had improved vital signs. Once calm, he was weaned back to room air and maintained oxygen saturations around 93% to 95%. He was given nebulized saline and racemic epinephrine treatments, which seemed to alleviate his symptoms. He was transitioned to 1 L of oxygen via nasal cannula, and his oxygen saturation rose to 98%. Oncology was consulted, and at that time, there was discussion about pursuing emergent radiation versus observing the patient after initiating high dose steroids. Given his inability to tolerate the supine position, he was admitted to the pediatric intensive care unit on high-dose steroids. Allopurinol and rasburicase were given before steroids to reduce the risks of tumor lysis syndrome and major electrolyte instability. At the time of admission to the pediatric intensive care unit, he was noted to be alert but ill appearing and pale, with mild tachypnea and tripod positioning. A pleurocentesis performed on hospital day number 1 was diagnostic for T-cell lymphoblastic lymphoma. He was started on chemotherapy according to protocol. Additional initial workup included an echocardiogram, which was within normal limits. He was discharged on hospital day number 14 on continued chemotherapy and initially did well. Unfortunately, he died from complications of his disease 7 months after his initial diagnosis. Autopsy performed was unknown Croup was initially on the primary care physician''s differential; however, croup is not a common diagnosis for children in this age group. Often, imaging is obtained in these instances if croup is diagnosed. With his recent onset of fever, a significant bacterial infection such as an empyema or viral influenza was unlikely, but a viral pneumonia was still a possibility, especially with evidence of pleural effusions on his most recent CXR. In assessing the complete blood count, tuberculosis is less likely with a normal lymphocyte percentage and pertussis is less likely with the lack of monocytosis.


VAERS ID: 754900 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS201810

Write-up: This case was reported by a physician via call center representative and described the occurrence of death nos in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced death nos (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the death nos was fatal. The reported cause of death was unknown cause of death. The reporter considered the death nos to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that, one of his patient told him that she did not want to get the 2nd shot of SHINGRIX because of what the patient overheard beauty parlor talk that someone was admitted to the hospital and died from the SHINGRIX vaccine. The physician did not have any additional information regarding the patient who died from the SHINGRIX.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 755074 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Georgia  
Vaccinated:2018-06-01
Onset:2018-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 RL / SYR

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, Dyskinesia, Epistaxis, Irritability, Muscle twitching, Nervous system disorder, Pyrexia, Resuscitation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-06-03
   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: Children''s Tylenol
Current Illness:
Preexisting Conditions: She was born prematurely. She and her identical twin sister were born at 33w5d. Both spent 11 days in the NICU. They were cleared as healthy baby girls and released.
Allergies:
Diagnostic Lab Data: She had an Autopsy done but I have yet to receive the results.
CDC Split Type:

Write-up: Both my identical twin daughters received an oral liquid vaccination as well as 3 shots to both their upper thighs on Friday, June 1, 23018 around 3 pm. Later that evening, approx 4 hours later, my daughter was having what I would now consider being neurological issues, flailing of the arms and legs and twitching. I kept an eye on her and it seemed to calm down some. I was informed that the emergency room doesn''t really do much for infants so I did not take her to the hospital. Saturday, June 2, 2018, around 10 am both my girls were running ridiculously high fevers, I called their Pediatrician and informed her about what was happening to them. and she made the comment that they had been switching around the vaccinations because they were causing infants to have high fevers. She informed me to give them Tylenol. I did and the fevers did go down. Around 2 am Sunday, June 3, 2018, I rechecked their temperature for the 3rd or 4th time and I was happy to see they both had low-grade fevers of 99.2 and 99.1, Patient''s being 99.2. I Fed both girls again around 5:30 a.m. they went back to sleep. I went back into their room to check on them because they were being fussy so i put them on their bellies and that seemed to calm them down and they went back to sleep. I awoke around 7:30 a.m. to my baby dead in her crib. She was still on her stomach, I believe she was face down but cannot remember 100%. When I flipped her over she had blood coming out of her nose and she was dead. She was still warm as if she were sleeping, her sister is just fine. We attempted CPR while waiting on the ambulance. She was rushed to the emergency room where they were unable to revive her. I cannot accept that it was caused by anything other than those vaccinations. We are currently waiting for the Autopsy Report to come back. We had her sister checked out by their Pediatrician the same day and she is just fine.


VAERS ID: 755211 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: Unknown  
Vaccinated:2018-06-14
Onset:2018-06-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5344AA / 4 LL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. N031001 / 1 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 77D2K / 1 LL / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2018-06-16
   Days after onset: 1
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertrophic cardiomyopathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131806USA009994

Write-up: This spontaneous report was received from a Registered Nurse via a company representative referring to a 15 month old female patient. The patient''s concurrent conditions included hypertrophic cardiomyopathy. There was no concomitant medications reported. On 14-JUN-2018, the patient was vaccinated with VAQTA 25/0.5 (dose, route, lot number and expiration date were not reported) for prophylaxis. Other suspect therapies administered on that same date included VARIVAX (dose, route, lot number and expiration date were not reported) and another unspecified vaccine, both administered for prophylaxis. On 15-JUN-2018, the patient was lethargic and was taken to the office, later she was taken to the hospital and was admitted. The nurse reported that patient died next day (16-JUN-2018). It was also informed that an autopsy was done, but the results were not available at the reporting time. The nurse reported that patient was a twin and that the other unspecified 15 month old twin also received the same vaccinations (no further information was provided). The causality assessment between the events and the suspect therapies was not provided. The event lethargy was considered as disability and life threatening as serious criteria by the reporter.; Reported Cause(s) of Death: death.


VAERS ID: 756119 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: California  
Vaccinated:2018-05-23
Onset:2018-05-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P3777 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Decreased appetite, Fall, Immediate post-injection reaction, Injection site pain, Lethargy, Malaise, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-06-17
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: RANEXA ER; Donepezil; Memantine; Clonidine; Benazepril; Gabapentin; NORCO; Escitalopram; Omeprazole; Pravastatin
Current Illness:
Preexisting Conditions: Hypertension; Angina; Acid reflux; Depression; Hypercholesterolemia; Alzheimer''s; Pain
Allergies: Aspirin; codeine
Diagnostic Lab Data: Medical tests/lab results were not available to pharmacist. Patient was evaluated at an urgent care.
CDC Split Type:

Write-up: Immediately following the SHINGRIX injection, patient complained of pain at the injection site. Patient was advised to take TYLENOL to relieve symptoms. Six days following the injection on 5-29-18, the patient''s daughter came to the pharmacy to explain her mother was experiencing continued pain, fever, loss of appetite, nausea, lethargy, and malaise. The pharmacist advised the patient to supplement her hydration with extra electrolytes to prevent dehydration and for the patient to seek further evaluation/treatment at urgent care. Two days later on 5-31-18 the patient''s daughter returned to pharmacy again to report patient was feeling better. On June 17, 2018, a different daughter called the pharmacy to inform the staff that patient unfortunately passed away following a fall. The daughter did not give details to her mother''s death, and she did not disclose to the pharmacist that the SHINGRIX vaccine contributed to her death.


VAERS ID: 756227 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Florida  
Vaccinated:2008-07-01
Onset:2008-08-26
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2018-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-26
   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: None
Current Illness: Diarrhea
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: Death, ruled SIDS.


VAERS ID: 756669 (history)  
Form: Version 1.0  
Age: 97.0  
Sex: Male  
Location: Illinois  
Vaccinated:2017-06-09
Onset:2017-06-10
   Days after vaccination:1
Submitted: 2017-07-07
   Days after onset:27
Entered: 2018-06-29
   Days after submission:357
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. M029681 / 2 LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Blood culture negative, Hypersensitivity, Injection site erythema, Injection site pain
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-11
   Days after onset: 274
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Lower back pain-geriatric outpatient appointment
Preexisting Conditions: Coronary artery disease; Hypertension; Hyperlipidemia; Hearing loss; Chronic post-traumatic stress disorder; Prostate cancer; Congestive heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient arrived at geriatric clinic for lower back pain and was worked up for preventative health. He was indicated for PNEUMOVAX 23 having received PREVNAR 13 on year prior. After arriving to the ER for what seemed to be a hypersensitivity reaction, he was admitted for concern of cellulitis. When blood cultures showed no growth and patient''s symptoms were resolving, he was discharged. Redness, pain/tenderness at injection site.


VAERS ID: 757414 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2016-01-01
Submitted: 0000-00-00
Entered: 2018-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131807USA001721

Write-up: This spontaneous report was received from a physician via field representative refers to a 15 year old female patient. The patient''s pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date in 2011 (at her age of 11), the patient was vaccinated with first dose of GARDASIL 9 (anatomical location, dose, route, frequency, expiration date and lot number were not specified) as prophylaxis. Thereafter, the patient received her second and third dose on an unknown date in 2015 (reported as 4 years later) and in November 2015 respectively (inappropriate schedule of drug administration). In January 2016, the patient died (death) when she was 15 years old. It was unknown, if any lab diagnostics/studies were performed. The cause of death was unknown. It was unknown, if an autopsy was performed. The reporter did not assess the causality of the event death with GARDASIL 9. Product quality complaint was not involved.; Reported Cause(s) of Death: Unknown.


VAERS ID: 757651 (history)  
Form: Version 2.0  
Age: 1.92  
Sex: Female  
Location: Nebraska  
Vaccinated:2015-07-28
Onset:2015-09-02
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2018-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK UN / SYR
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, Diarrhoea, Immediate post-injection reaction, Injection site pain, Sudden infant death syndrome
SMQs:, Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-09-02
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: No illnesses at all.
Preexisting Conditions: None
Allergies: Strawberries
Diagnostic Lab Data: Toxicology report at the morgue. Autopsied following death of the patient. Death certificate states natural causes with vaccines listed by name as factors involved. The doctors called it a rare form of toddler SIDS. Patient''s Mother asked for a copy of the patient''s shot records and was given only part of the record by the family doctor.
CDC Split Type:

Write-up: Diahrrea immediately following vaccines. Leg couldn''t be touched for three days due to extreme pain in injection site. Patient died 5 weeks after vaccines were given.


VAERS ID: 758500 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Florida  
Vaccinated:2015-07-01
Onset:2016-07-05
   Days after vaccination:370
Submitted: 0000-00-00
Entered: 2018-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Emotional distress, Encephalitis viral, Herpes zoster, Intensive care, Pneumonia, Quality of life decreased, Transient ischaemic attack
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-05
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131807USA004943

Write-up: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient''s medical history, concurrent conditions and concomitant medication use were not provided. On or about July 2015, the patient was inoculated with ZOSTAVAX, (lot number and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles but caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX the patient was admitted to an intensive care unit for a transient ischemic attack, viral encephalitis, pneumonia and herpes zoster. Thereafter, the patient was diagnosed with transient ischemic attack, viral encephalitis, pneumonia and herpes zoster. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 05-JUL-2016. The patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and ultimately death. Upon internal review transient ischemic attack, viral encephalitis, pneumonia and death were considered medically significant events. Transient ischemic attack, viral encephalitis, pneumonia and herpes zoster were reported to be disabling. Additional information has been requested. Reported Cause(s) of Death: death.


VAERS ID: 758807 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2017-01-07
Submitted: 0000-00-00
Entered: 2018-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / UN

Administered by: Public       Purchased by: ?
Symptoms: Blister, Death, Herpes zoster, Rash vesicular
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine health maintenance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131807USA005428

Write-up: Information has been received regarding a case in litigation from a lawyer and the spouse of a female patient of unknown age. No information was received regarding the patient''s past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a health department, as recommended for routine adult health maintenance for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of persistent strain condition of herpes zoster/shingles and ZOSTAVAX did not prevent shingles as intended is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The patient died on 07-JAN-2017; cause of death not provided. It is unknown if an autopsy was performed. Upon internal review, death was determined to be medically significant. Additional information has been requested. Reported Cause(s) of Death: Death.


VAERS ID: 760416 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Ohio  
Vaccinated:2010-01-27
Onset:2015-01-19
   Days after vaccination:1818
Submitted: 0000-00-00
Entered: 2018-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, Death, Herpes zoster, Pain, Rash vesicular
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-24
   Days after onset: 767
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine health maintenance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131807USA009208

Write-up: Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and the spouse of a deceased male consumer. The patient''s prior concurrent conditions, medical history and concomitant medications are unknown. On or about 27-JAN-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a county health district as recommended for routine adult health maintenance for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 19-JAN-2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed FAMVIR, acetaminophen, NORCO and NEURONTIN for management of his painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses and pain and suffering and other damages. On 24-FEB-2017, the patient passed away. The cause of death was not reported. Upon internal review, passed away was considered to be medically significant. Additional information has been requested. Reported Cause(s) of Death: passed away.


VAERS ID: 761392 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Maine  
Vaccinated:2017-12-11
Onset:2018-01-01
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI852AB / 2 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Abnormal loss of weight, Anaemia, Anorectal discomfort, Anti-aquaporin-4 antibody negative, Anti-ganglioside antibody negative, Anti-thyroid antibody negative, Anti-thyroid antibody positive, Anti-transglutaminase antibody negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Antiphospholipid antibodies negative, Anxiety, Asthenia, Back pain, Blood albumin normal, Blood creatine phosphokinase increased, Blood folate normal, Blood heavy metal normal, Blood magnesium normal, Blood thyroid stimulating hormone normal, Borrelia test negative, Burning sensation, C-reactive protein normal, CSF cell count normal, CSF glucose normal, CSF protein increased, Cardiac telemetry normal, Cognitive disorder, Complement factor C3, Complement factor C4, Complement factor normal, Completed suicide, Computerised tomogram abnormal, Constipation, Death, Decreased appetite, Dyspnoea, Dysuria, Ehrlichia test, Electroencephalogram normal, Electromyogram normal, Epstein-Barr virus test negative, Fall, Feeling abnormal, Feeling jittery, Gastrointestinal pain, Globulins increased, Glycosylated haemoglobin normal, Gram stain negative, Gun shot wound, HIV test negative, Head discomfort, Headache, Herpes simplex test negative, Hypoaesthesia, Infrequent bowel movements, Limb discomfort, Memory impairment, Metabolic function test normal, Micturition urgency, Muscle twitching, Muscular weakness, Nausea, Neck pain, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Oesophagogastroduodenoscopy, Pain in extremity, Panic attack, Paraesthesia, Polymerase chain reaction, Protein total increased, Renal cyst, Suicidal ideation, Treponema test negative, Varicella virus test positive, Vitamin B1, Vitamin B12 normal, Vitamin D, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Suicide/self-injury (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-07-10
   Days after onset: 189
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish oil 1-2 times weekly, amlodipine 5mg daily, timolol 0.25% 1gtt each eye BID, PRILOSEC 20mg 2-3 times weekly, ibuprofen 800mg as needed, TYLENOL ES 500mg as needed
Current Illness:
Preexisting Conditions: Hypertension (stable), impaired fasting glucose, history of skin cancer, actinic keratosis, fatty infiltration of liver, chronic GERD, hypercholesterolemia, had Shingles 2017.
Allergies: muscle aches with statins, otherwise NKDA
Diagnostic Lab Data: *3/10/18 MRI brain, cervical, thoracic, and lumbar spine Brain: symmetric bilateral periventricular signal hyperintensity as well as seen in a pericallosal distribution suggestive of a demyelinating process. This might be confirmed with evaluation of CSF. Vascular structures as covered demonstrate a normal flow void. Spine: foraminal narrowing at C4, C5 but no cord signal abnormality or suggestion of cervical stenosis. Of note on T spine was predominantly erythropoietic red marrow suggestive of anemia and 1.3cm hyperintense cyst R kidney *3/17/18 MRI brain, cervical and thoracic spine: Brain: small focal and more patchy regions of T2 and T2 FLAIR signal hyperintensity within the supratentorial periventricular, centrum semiovale, and to lesser extent subcortical white matter appear entirely unchanged when compared to the 3/10/2018 exam. Although the possibility of a demyelinating process was raised on the report from the previous brain MRI and that such process cannot with certainty be excluded, I favor that these represent sequela of chronic microvascular ischemic change.*3/17/18 CT CAP: negative except fatty liver *3/19/18 EEG: negative *3/14/18 EMG: negative CBC: WBC count 3.2 on 3/18/18; (WBC count 3.6 on 3/17; 6.5 on 3/6). Otherwise normal CMP: 3/17/18: Total protein 8.5, alb 3.7, globulin 4.8 CRP: normal 1.0 CK normal (298) TSH: normal Vit B12: normal Vit B1: normal Vit D: low normal at 26.6 Folate normal Mg normal Hgb A1c normal at 5.6 heavy metals panel negative HIV negative lyme negative, anaplasma negative, ehrlichia negative EBV negative varicella zoster ab Ig positive (immune) treponemia pallidum Ab IgG + RPR negative Syphilis ab TP-PA indeterminate tissue transglutaminase negative complement C3,C4 normal thyroglobulin Ab negative thyroid peroxidase Ab 422.9 (<100) ANA negative Sjogrens Ab negative ACE negative Paraneoplastic auto antibody eval negative P-ANCA, C-ANCA negative Antiphospholipid Ab negative AntiMog Ab negative NMO/AQP4 FAC serum negative Ganglioside Ab panel negative CSF: 3/9/18: protein 101 (15-45); glucose 67, cell counts normal. MS panel elevated albumin but normal ratios. 3/19/18: protein 98, glucose 59, cell counts normal flow cytometry negative for lymphoma VZV PCR; Varicella zoster Ab IgG, IgM - negative HSV negative CSF gram stain negative. EGD 5/18/18, MRI brain and c-spine 5/17/18. EMG 4/27/18
CDC Split Type:

Write-up: Patient first evaluated by Clinic 3/2018. Reports in January 2018 reported some low back pain after working with a snow blower. A few weeks after this, noted some rectal and bladder burning and ''urgency'' - lasted 4-5 days and then resolved. Toward the end of Jan, flew to and back and had trouble getting out the airplane seat. In February 2018 went snowshoeing and fell, noted legs aching. Noted decreased power in the quads bilaterally and this progressed to a feeling ''like my legs are disconnected from me, like my quads are weak.'' Early March 2018, symptoms progressed and more noticeable. Felt like knees might give out when getting up and down. Went to the ED - had cardiac/syncope r/o on telemetry. Didn''t mention his lower extremity concerns during that visit. Symptoms continued. In April, patient reported legs "feeling buzzy", some numbness in upper extremities, particularly bilat pinky fingers, pins and needles from biceps to tips of fingers. Towards end of April, some abdominal pain reported, intermittently, decreased appetite. Some SOB, had panic attack, situational anxiety. Patient seen again in May, continued progression of paresthesias in upper extremities. Reports having "fogginess" worse in AM, feeling jittery, sometimes has the sense that "brain is on fire." Reported feeling anxious, ongoing. Frontal HA and neck pain reported. Situational anxiety ongoing. Passive suicidal thoughts with no plan or intent. End of May reported arms and legs feeling worse, losing strength despite exercise; unintended weight loss, GI cramps; twitching in arms, legs, hands, L$gR; headaches; mild cognitive foggy feeling; anxiety. Seen by office in early June, reported legs still feeling numb and "on fire", but overall better; HA and neck pain. Late June reported feeling jittery, anxious, with sense of doom. Again reported passive suicidality with no plan or intent; continued weight loss, bowel movements every 3-4 days with abdominal cramping, nausea. Discussed seeing a psychiatrist for ongoing anxiety. Seen multiple times between March and July with ongoing symptoms; saw several specialists for workup during this time. Most recently seen by our office 7/2/2018, plan to return to work discussed. Ongoing HAs, constipation, situational anxiety. Called office 7/9 feeling jittery and with mental fogginess and forgetfulness, SOB with exercise. Plan to see gastroenterology 7/10 for further testing. 7/10/18 self inflicted gunshot wound, patient deceased.


VAERS ID: 763575 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-08-01
Entered: 2018-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Anti-VGCC antibody negative, Anti-ganglioside antibody negative, Anti-muscle specific kinase antibody negative, Antinuclear antibody negative, Autopsy, CD4 lymphocytes decreased, CSF protein increased, Central nervous system lesion, Death, Demyelination, Electromyogram abnormal, General physical health deterioration, Gliosis, Immunoglobulin therapy, Mechanical ventilation, Muscular weakness, Noninfective encephalitis, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Nystagmus, Pneumonia, Quadriplegia, Respiratory failure, White matter lesion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: HIV infection, CD4 count: 533/uL; Hypertension; Type 2 diabetes mellitus; Blindness
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On an unspecified date: Anti-nuclear, anti-VGCC (voltage-gated calcium channel), anti-MUSK and anti-GQ1b antibodies were found to be negative. On an unspecified date: On 16th day of hospitalization, magnetic resonance imaging (MRI) of brain showed innumerable foci of T2 flair hyperintensity involving brain and spinal cord. On an unspecified date: Electromyography (EMG) demonstrated a severe diffuse demyelinating pattern. CSF protein, elevated
CDC Split Type: 201803018

Write-up: This literature report, initially received on 23-Jul-2018, was reported by other health professional and concerns a 65-year-old, elderly, male patient. The patient''s current conditions included human immunodeficiency virus (HIV) infection (CD4 count 533/uL), hypertension, diabetes mellitus type II and blindness (since an unspecified date). On an unspecified date, the patient was administered Influenza Vaccine (dose, route of administration, batch number, anatomical location and expiry date, manufacturer and trade name: not reported). On an unspecified date, 03 days after vaccination, the patient was admitted to the hospital for acute weakness of all extremities. Initial laboratory workup was performed and showed elevated protein in cerebrospinal fluid and no evidence of infection was noted. Anti-nuclear, anti-VGCC (voltage-gated calcium channel), anti-MUSK and anti-GQ1b antibodies were found to be negative. The patient was treated with intravenous immunoglobulin and steroids for possible Guillan-Barre Syndrome, however his condition deteriorated, and he developed respiratory failure which required mechanical ventilation. The patient also experienced complete quadriplegia, nystagmus and multilobar pneumonia. Electromyography (EMG) showed a severe diffuse demyelinating pattern. On 16th day of hospitalization, magnetic resonance imaging (MRI) of brain showed innumerable foci of T2 flair hyperintensity involving brain and spinal cord. On 17th day of hospitalization, the patient died and permission for autopsy was granted. The autopsy was performed and neuropathologic examination showed multiple soft lesions with tan discoloration throughout the brain and spinal cord, predominantly involving periventricular white matter, bilateral basal ganglia, corpus callosum, cerebellar white matter, pons, medulla and upper cervical spinal cord. Microscopic examination showed discrete areas of demyelination surrounding vessels, with patchy macrophage aggregation, sparse CD8+ lymphocyte infiltration and mild reactive gliosis at the periphery. In a few of the lesions, the infiltrate was composed of neutrophils. Inflammation was perivascular or in the brain parenchyma and did not involve the vessel wall. No hemorrhage or viral inclusions were identified. Luxol fast blue stain demonstrated loss of myelin within the lesions. Neurofilament Immunohistochemical stain highlighted relative preservation of axons, although spheroids and axonal disruption were also present. The findings were more consistent with diagnosis of acute disseminated encephalomyelitis (ADEM). The outcome of the events respiratory failure, multilobar pneumonia and symptoms of ADEM (acute weakness of all extremities, complete quadriplegia, nystagmus, elevated protein in cerebrospinal fluid and severe diffuse demyelinating pattern) was not reported. The reporter assessed this case as serious (death and hospitalization).


VAERS ID: 763518 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / 3 - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Hepatic failure
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131807USA012494

Write-up: This spontaneous report was received from a registered pharmacist via a company representative, who refers to an adult female patient between 20 and 21 years old. The patient''s concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date in 2013 (reported as approximately 5 years ago), the patient received the complete vaccination series of three doses of GARDASIL 9 (lot #, expiration date, dose, and route of administration were not provided for all) for prevention of human papilloma virus (HPV). On an unknown date in 2013 (reported as approximately 5 years ago after complete series of vaccination), the patient developed liver failure. The outcome of the event was unknown. On an unspecified date, after developing liver failure the patient died. Cause of death was not provided. It was unknown if autopsy was performed. The causal relationship between the events and therapy with GARDASIL 9 was not provided by the reporter. Upon internal review, the event of liver failure was determined to be medically significant. Reported Cause(s) of Death: Unknown by reporter.


VAERS ID: 763777 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Varicella post vaccine
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Autoimmune disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131807USA012959

Write-up: This literature marketed report has been received from the authors of the published article, and refers to an adult patient with a chronic autoimmune disease. The authors obtained data on varicella deaths for 2012-2016 using the Mortality Multiple Cause of Death public use records from the Center. A death from varicella was defined as one for which varicella diagnosis was listed on the death certificate. On an unknown date, the patient was vaccinated with a 1 dose of varicella virus vaccine live (Oka/Merck) (manufacturer unknown) injection (exact dose, vaccination site, route of administration, lot# and expiration date were not provided). On an unknown date, the patient died and varicella was listed as the underlying cause. The patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) within 1 month prior to death. Varicella-zoster virus (VZV) specimens were unavailable for laboratory testing. It was unknown if an autopsy was performed. The authors considered varicella post vaccine to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown). This is one of several reports derived from the same literature article (linked with MARRS # 1808USA000251 and 1402USA010964). Sender''s Comments: US-009507513-1402USA010964: US-009507513-1808USA000251: Reported Cause(s) of Death: varicella listed as the underlying cause of death.


VAERS ID: 763778 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Varicella post vaccine
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunosuppression; Renal failure chronic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131808USA000251

Write-up: This literature marketed report has been received from the authors of the published article, titled as stated above and refers to an adult patient with a chronic renal failure on immunosuppressive treatment. The authors obtained data on varicella deaths for 2012-2016 using the Mortality Multiple Cause of Death public use records from the Center for Health Statistics. A death from varicella was defined as one for which varicella diagnosis was listed on the death certificate. On an unknown date, the patient was vaccinated with 1 dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) injection (exact dose, site of administration, route of administration, lot# and expiration date were not provided). On an unknown date, the patient died and varicella was listed as the underlying cause. The patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) within 1 month prior to death. The patient was confirmed to have vaccine-strain varicella-zoster virus (VZV). It was unknown if an autopsy was performed. The authors considered varicella post vaccine to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown). A copy of the published article is attached as further documentation of the patient''s experience. This is one of several reports derived from the same literature article (linked with MARRS # 1807USA012959 and 1402USA010964). Sender''s Comments: US-009507513-1402USA010964: US-009507513-1807USA012959. Reported Cause(s) of Death: varicella listed as the underlying cause of death.


VAERS ID: 763982 (history)  
Form: Version 2.0  
Age: 2.0  
Sex: Female  
Location: Unknown  
Vaccinated:1997-12-12
Onset:2018-07-06
   Days after vaccination:7511
Submitted: 0000-00-00
Entered: 2018-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 UN / SC

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fatigue, Joint swelling, Measles antibody negative
SMQs:, Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Egg allergy (Has become less severe over time); Milk allergy (Has become less severe over time)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131807USA011635

Write-up: This spontaneous report was received from the patient''s mother, concerning a 2 year old female patient. The patient did not have any medical history to report. Her concurrent conditions included allergy to dairy and egg. The patient did not have any concomitant medications to report. On 12-DEC-1997, the patient was vaccinated with the first dose of M-M-R II subcutaneously for prophylaxis lot #0015E (strength, dose, frequency and expiration date were not reported). On the same date, 3 hours after receiving the vaccination with M-M-R II, the patient began to experiencing a severe reaction including joint swelling, fatigue and generalized weakness. The patient sought for medical attention and was treated with prednisolone sodium phosphate (PEDIAPRED) liquid and a 6 day steroid regimen. On an unknown date, the patient recovered from joint swelling. On an unknown date in March 2001, the patient received a second "graduated dose style" of M-M-R II subcutaneously for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). The patient did not have any reaction following this administration. On 06-JUL-2018, when the patient was 22 year old, the patient had a measles titer test performed and it was failed, there was no immunity. On an unknown date, approximately in 2018, the patient died. It was unknown if an autopsy was performed. At the time of reporting, the outcome of fatigue, generalized weakness, measles titer failed and no immunity was unknown. The causal relationship between the vaccination with M-M-R II and the events was not provided by the reporter.; Reported Cause(s) of Death: Did the patient died: yes.


VAERS ID: 764964 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Female  
Location: Iowa  
Vaccinated:2017-07-05
Onset:2017-08-06
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2018-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 2YZ27 / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. N000238 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R70448 / 2 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS Z23PT / 2 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Crying, Death, Diet refusal, Middle insomnia, Pain, Respiratory arrest, Screaming, Sudden infant death syndrome, Teething
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None She was completely healthy little baby girl
Preexisting Conditions: none
Allergies: None
Diagnostic Lab Data: There was an autopsy done that where they confirmed SIDS. At this point I started looking into other things due to the fact I wasn''t going to accept that my healthy happy beautiful baby girl went to sleep and never woke up. I had been on the phone with the autopsy guy and the moment I had asked if he would be able to tell if vaccinations killed my daughter he was quick to ignore the question and get off the phone. It also took me almost a whole year to finally get the doctor office to give me the correct papers I needed to do this. Some of them got rude with me over this vaccination deal.
CDC Split Type:

Write-up: Our daughter was healthy with no issues whatsoever until after her four month shots. She had them and she changed. From the day she was born she slept through the night and always woke up at 6am which was so different from our son who was up multiple times in the night. But after her four month shots. We noticed that she would wake up through night a lot more. She wouldn''t want to eat through the night. She would cry and scream like she was in pain. But there was never anything wrong. She was always a happy baby and so healthy. I also had a normal pregnancy. It was unlike her. However she had her bottom teeth and was chewing a lot on things so my husband and I thought it was just teething. About a month after her vaccinations she passed away. On August 6th of 2017 She had stopped breathing and was having issues August 5th late ate night and was pronounced dead on August 6th around 1 am.


VAERS ID: 765023 (history)  
Form: Version 2.0  
Age: 0.58  
Sex: Male  
Location: Kentucky  
Vaccinated:2018-04-26
Onset:2018-04-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 7275T / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. N012920 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 570899 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-04-27
   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
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Coroner/pathologist
CDC Split Type:

Write-up: Infant found about 5AM 4-27-18, in its bed, deceased. Coroner states autopsy suspects death about 2AM 4-27-2018.


VAERS ID: 765061 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: US0095075131808USA004043

Write-up: Information has been received from an online article. On unknown dates, numerous people (demographics not provided) were vaccinated with ZOSTAVAX (lot numbers, dosages and routes of administration not provided). It was noted that the ZOSTAVAX vaccine to prevent varicella, the adult version of chickenpox was causing numerous people who got the shot to suffer injuries and/or death. The causes of death were not provided. It is unknown if autopsies were performed. It was alleged that the vaccine for shingles wasn''t safe and could cause serious adverse effects. It was reported that patient injuries from the ZOSTAVAX ranged from shingles itself, which the vaccine was supposed to prevent, to serious personal injuries such as blindness and paralysis. Other reports of adverse effects from ZOSTAVAX included brain damage and death. "But the thousands of people who took the shot [ZOSTAVAX] and are now permanently injured or dead...." According to data compiled by a law firm, ZOSTAVAX "is only effective in about 51% of people who get the shot. And many of those who receive the [ZOSTAVAX] vaccine end up getting shingles anyway." "There is some indication that the vaccination is linked to death." "The NCIS (The National Vaccine Information Center) analysis indicates that there were more than 1,100 serious adverse event reports made to the Vaccine Adverse Events Reporting System from 1990 until September 2015 related to shingles-containing vaccinations. Of these reports, 90 were for deaths associated with the shingles vaccine." The outcome of injuries and/or death is fatal, and the outcome of the blindness, paralysis, brain damage, and shingles is unknown. Upon internal review, injuries and/or death, blindness, paralysis, and brain damage were determined to be medically significant. Blindness, paralysis, brain damage, and shingles were considered to be disabling. Additional information is not expected.; Reported Cause(s) of Death: Death.


VAERS ID: 765844 (history)  
Form: Version 2.0  
Age: 1.33  
Sex: Male  
Location: New Jersey  
Vaccinated:2018-06-01
Onset:2018-06-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2018-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5454AB / 4 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On June 8th 2018 death occurred.


VAERS ID: 767019 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Georgia  
Vaccinated:2018-08-07
Onset:2018-08-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Unknown       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: 2018-08-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: HIV positive
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2018GS

Write-up: This case was reported by a physician via sales rep and described the occurrence of cardiac arrest in a 37-year-old male patient who received BOOSTRIX for prophylaxis. Co-suspect products included PNEUMOVAX for prophylaxis. Concurrent medical conditions included HIV positive. In August 2018, the patient received BOOSTRIX and PNEUMOVAX. In August 2018, 10 hrs after receiving BOOSTRIX, the patient experienced cardiac arrest (serious criteria death and GSK medically significant). In August 2018, the outcome of the cardiac arrest was fatal. The patient died in August 2018. The reported cause of death was cardiac arrest. The reporter considered the cardiac arrest to be unrelated to BOOSTRIX. Additional information was received as follows: The reporter said that the event occurred about a week before the reporting date. Ten hours after vaccination, the patient was brought to the hospital in full cardiac arrest and he died. The reporter did not think to call GlaxoSmithKline. He did not think that either vaccine caused the death of the patient. The reporter agreed to be followed up and said the best way to contact was via email. Reported Cause(s) of Death: Cardiac arrest.


VAERS ID: 767323 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Unknown  
Vaccinated:2018-06-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. 25429 / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Death, Headache
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-08-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131808USA008458

Write-up: This spontaneous report was received from a pediatric nurse practitioner and a nurse via a company representative and refers to a 14 year old male patient. The patient''s concurrent condition, medical history and concomitants medications were not reported. On unknown date 5 to 6 weeks prior to the patient''s death (also reported as ''''last Wednesday''''), the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) for immunisation (also reported as vaccination). On unknown date, the patient complained of a headache after received GARDASIL 9 but the patient was not seen for this initial headache. On unspecified date, the patient developed a severe headache and went to hospital emergency room, from there he was transferred to the hospital, where he later passed away of acute disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was performed. The causality between the event and GARDASIL 9 was not provided by the reporters. However, an unspecified physician from the hospital reported that, the patient''s death was related to the GARDASIL 9. Upon internal review, the event of acute disseminated encephalomyelitis was considered to be medically significant. Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis.


VAERS ID: 767664 (history)  
Form: Version 2.0  
Age: 0.0  
Sex: Female  
Location: Maryland  
Vaccinated:2018-08-19
Onset:2018-08-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS F32XZ / UNK RL / IM

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Bradycardia, Death, Endotracheal intubation, Hypotension
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Respiratory failure (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-08-21
   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: Epo; Fe; Vit D; Vit E; folic acid; caffeine
Current Illness: Extreme IUGR and premature
Preexisting Conditions: Ex 28 2/7 wk IUGR triplet
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Baby had increased episodes of apnea, bradycardia, requiring intubation and support for hypotension (Dopamine, hydrocortisone). She expired within.


VAERS ID: 768094 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131808USA009998

Write-up: This spontaneous report was received from a pharmacist via a company representative and refers to a elderly male patient of unknown age. Information regarding the patient''s pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date in 2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were not provided) for prophylaxis. At the same time, the patient received also a dose of influenza virus vaccine (unspecified) (reported as "Flu vaccine") (dose, route, lot # and expiration date were not provided) for an unknown indication. The pharmacist stated that, on an unknown date in 2017 (reported as "next day"), the elderly patient got sick and was hospitalized. The pharmacist reported that, shortly after that, the patient passed away on an unknown date in 2017. The cause of date was not reported. It was unknown if autopsy was done. The outcome of malaise was not reported. The causality between the events and PNEUMOVAX 23 was not reported. Reported Cause(s) of Death: Pharmacist reported the "elderly man passed away shortly after".


VAERS ID: 768177 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Allergic reaction to excipient, Anaphylactic reaction, Apparent life threatening event, Death, Resuscitation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Neonatal disorders (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Meat allergy (Alpha-gal allergy, transmitted via tick bite)
Preexisting Conditions: Medical History/Concurrent Conditions: Tick bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131808USA009300

Write-up: This spontaneous report as received from a physician, who read in an article that was published recently about a female patient of unknown age. The patient''s concurrent conditions included an allergy to meat called "alpha-gal allergy" that was transmitted via tick bite. There was no information about the patient''s medical history or concomitant medication. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) for prevention of shingles (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date in 2006, the patient died after resuscitation attempts in an unspecified emergency room, due to an anaphylactic reaction to the porcine gelatin content of ZOSTAVAX. The reporter considered the aphylactic reaction to be a life threatening event that required intervention to prevent serious criteria. It was unknown if an autopsy was performed. The reporter considered anaphylactic reaction to be related to ZOSTAVAX. Upon internal review, the event anaphylactic reaction was considered to be medically significant. This is one of two reports received from the same reporter. Sender''s Comments: US-009507513-1808USA009391: Reported Cause(s) of Death: Anaphylactic reaction to the porcine gelatin content of ZOSTAVAX.


VAERS ID: 769676 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131809USA000416

Write-up: This spontaneous report was received from a consumer who saw a video on the internet referring to a female patient of unknown age. No information was provided regarding the patient''s medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient experienced reactions after the vaccination and subsequently died due to an unspecified reason; it was unknown whether an autopsy was performed. The reporter did not provided causality assessment between the adverse reaction and vaccination with GARDASIL 9. Upon internal review the patient''s death was determined to be medically significant. This is one of several cases received from the same reporter. Sender''s Comments: US-009507513-1809USA001815: Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 769678 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131809USA001815

Write-up: This spontaneous report was received from a consumer who saw a video on the internet referring to several female kids of unknown age. No information was provided regarding the patient''s medical history, concurrent conditions or concomitant medications. On an unknown date, the patients were vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On unknown dates, the patients died after the vaccination due to an unspecified reason; it was unknown whether an autopsy was performed. The reporter did not provided causality assessment between the patients'' deaths and vaccination with GARDASIL 9. Upon internal review the patient''s death was determined to be medically significant. This is one of several cases received from the same reporter. Sender''s Comments: US-009507513-1809USA000416: Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 769783 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: California  
Vaccinated:2010-02-01
Onset:2010-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / 1 RL / IM

Administered by: Public       Purchased by: ?
Symptoms: Pyrexia, Rash, Swelling, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-01
   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: VENTOLIN
Current Illness: None
Preexisting Conditions: Asthma
Allergies: No
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Syncope, rash, swelling, fever.


VAERS ID: 770068 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Texas  
Vaccinated:2018-09-04
Onset:2018-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI994AA / 1 RA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 4LP5Y / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Death, Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-09-07
   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: Fenofibrate, metoprolol, NORVASC, NOVOLOG, furosemide, omeprazole, gabapentin, atorvastatin, VASCEPA
Current Illness:
Preexisting Conditions: ''weak heart''
Allergies: penicillin, minocycline
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient received both vaccines on Tuesday afternoon. On Wednesday evening, she felt ''achy'' and ''had chills''. She passed away in her sleep on Thursday evening/Friday morning after 2:00am. The family said that she had a ''weak heart'' and that they don''t think her death was caused by the vaccines, but they also wanted us to report her death ''just in case'' because of the close proximity of her death to the vaccines.


VAERS ID: 772315 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2018-08-30
Onset:2018-09-03
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2018-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5986AA / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR 5446AA / 5 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-09-03
   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: none
Current Illness: none reported
Preexisting Conditions: Cerebral Palsy, asthma, lung disease, GERD
Allergies: NKA
Diagnostic Lab Data: none
CDC Split Type: AR1813

Write-up: Client passed away 9/3/2018 at home.


VAERS ID: 772560 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2018378783

Write-up: This is a spontaneous report from a Pfizer-sponsored program comScore Monthly DTC Tracker. A contactable consumer reported similar events for two patients. This is 1st of two reports. An elderly patient of an unspecified gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for pneumonia. The patient''s medical history and concomitant medications were not reported. The patient had the darn pneumonia shots and 5 months later the patient died from pneumonia. Before the patient got the shot the patient was as healthy as can be. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-2018378995 same reporter/product/event, different patients; Reported Cause(s) of Death: died from pneumonia; died from pneumonia.


VAERS ID: 772561 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2018378995

Write-up: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for two patients. This is 2nd of two reports. An elderly patient of an unspecified gender received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for pneumonia. The patient medical history and concomitant medications were not reported. The patient had the pneumonia shots and 5 months later the patient died from pneumonia. Before got the shot the patient was as healthy as could be. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-2018378783 different patient, same product/event; Reported Cause(s) of Death: 5 months later they both died from pneumonia; 5 months later they both died from pneumonia.


VAERS ID: 772577 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Arizona  
Vaccinated:2016-09-22
Onset:2016-09-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED WT56007 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Coma, Gait inability, Imaging procedure abnormal, Intraventricular haemorrhage, Skull fractured base, Subarachnoid haemorrhage, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (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), Haemorrhagic central nervous system vascular conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-09-24
   Days after onset: 2
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Contact hospital - too many to list
Current Illness: Arteriovenous malformations; Colitis with colon ulcers
Preexisting Conditions: Refractory ITP with dangerously low platelet counts.
Allergies: sulfa drugs; dapsone; oxycodone; romiplostim
Diagnostic Lab Data: Rapid response called. Patient taken to ED. Imaging revealed subarachnoid and intraventricular hemorrhage with non-displaced longitudinal fracture of the occipital bone extending into the left temporal bone. No response at all to commands. Coma state. Patient had a DNR.
CDC Split Type:

Write-up: Patient drove himself to the facility for an appt. for a blood draw. His appt. was the next week....so while he was there he decided to get the Influenza vaccine (9:49 a.m. on Sept. 22, 2016). At 10:18 a.m. he had collapsed outside the double doors as he was exiting the hospital and hit the concrete. He was seen sitting and scooting on his walker after receiving the shot which was unusual. When he reached the exit doorway, he stood up, walked out to drive home and collapsed.


VAERS ID: 773178 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: Illinois  
Vaccinated:2018-09-18
Onset:2018-09-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5518AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. R004185 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W11304 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R002516 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-09-21
   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: prevacid
Current Illness:
Preexisting Conditions: possible reflux
Allergies: NKDA
Diagnostic Lab Data: unknown. Likely autopsy
CDC Split Type:

Write-up: Received call from patient parent. Patient died on Friday September 21st in the ER. Limited details available. Believe autopsy is pending.


VAERS ID: 773501 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2016-02-19
Onset:2016-02-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH M27554 / UNK RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Bedridden, Crying, Death, Decubitus ulcer, Infected skin ulcer, Laboratory test normal, Myalgia, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-14
   Days after onset: 84
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Preservision Areds Softgel; Synthroid; Miralax; Colace; Lasix; Calcium+D3 ER; Prozac; Gabapentin; Aspirin 81; Tenormin; Benadryl
Current Illness:
Preexisting Conditions: Neuropathy,hypertension,macular degeneration
Allergies: Vancomycin
Diagnostic Lab Data: Had complete set of labs done for her yearly physical, on Feb, 17, 2016. All results came back in the normal range.
CDC Split Type:

Write-up: Had pain in R arm that night...All muscles were painful in A m. following shot. Cried out with movement. Became bedridden because of the terrific pain to get her up. Eventually developed bedsore due to this, which became infected. Died on May 14, 2016.


VAERS ID: 774211 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Unknown  
Vaccinated:2018-04-25
Onset:2018-08-06
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2018-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Death, Echocardiogram, Electrocardiogram, Electroencephalogram, Gait disturbance, Guillain-Barre syndrome, Lumbar puncture, Mechanical ventilation, Nerve conduction studies, Nuclear magnetic resonance imaging, Plasmapheresis, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2018-09-16
   Days after onset: 41
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: High blood pressure; Diastolic congestive heart failure; Neuropathy
Allergies: penicillin
Diagnostic Lab Data: MRI; Spinal Taps; Nerve and electrical tests; EEG; Blood tests; EKG; Echocardiogram
CDC Split Type:

Write-up: My mother mother, was diagnosed with Guillain-Barre syndrome. She was in the hospital for two weeks, and then in another hospital before she was diagnosed. She was in respiratory failure from August 10th and never recovered. She was in a third hospital for acute illness when she passed away. We had the breathing tube removed when we realized there was no hope of a recovery. The only different medicine she had had was the new vaccine for shingles. She had the first dose on April 25th, 2018 and never had the second dose. I had read that flu vaccines could cause Guillain-Barre, usually closer to the time of the vaccine. But given how Guillain-Barre is so rare and the shingle vaccine is so new, I wondered if there was a connection. The beginning symptoms of Guillain-Barre seem harder to decipher with an elderly patient that already had trouble walking and that already had neuropathy. It took many tests and many doctors, in 2 different hospitals, almost 3 weeks to confirm the diagnosis. Even with plasmapheresis, there was no significant change in her condition.


VAERS ID: 774701 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions: Medical History/Concurrent Conditions: Epstein-Barr virus infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131809USA010085

Write-up: This spontaneous report as received from a consumer and refers to her mother''s aunt, a 91-year-old female patient. The patient had a medical history of Epstein-Barr virus infection. The patient''s concurrent conditions, concomitant medications and drug reactions/ allergies were not reported. On an unspecified date, the patient was vaccinated with a dose of an unspecified pneumonia vaccine (manufacturer unknown) (captured as PNEUMOVAX23) and a dose of an influenza virus vaccine at the same time for prophylaxis (dose number, route, and lot # were not reported). On the same day at night, the patient passed away. The cause of death was not reported. It was unknown, if an autopsy was performed. The reporter''s causality assessment was not provided. This was one of two reports received from a same reporter.; Sender''s Comments: US-009507513-1809USA010075:; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 774823 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Laboratory test normal, Pyrexia, Toxicologic test normal, Viral myocarditis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Eczema
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA268144

Write-up: Initial unsolicited report received from the literature on 22-Sep-2018. This case is linked to cases 2018SA268028, 2018SA268912, 2018SA268046, 2018SA268054, 2018SA268066, 2018SA268077, 2018SA268091, 2018SA268096, 2018SA268116, 2018SA268136, 2018SA268154, 2018SA268180, 2018SA268794, 2018SA268803, 2018SA268809, 2018SA268813, 2018SA268832, 2018SA268839, 2018SA268849, 2018SA268859, 2018SA268864, 2018SA268872, 2018SA268876, 2018SA268889, 2018SA268901, 2018SA268907, 2018SA268912, 2018SA268929, 2018SA268936, 2018SA268946, 2018SA268957, 2018SA268965, 2018SA268974, 2018SA268988, 2018SA268995, 2018SA269004 and 2018SA269014. Abstract: Aim: To characterize cases of myocarditis (MC) and pericarditis (PC) recorded in the Vaccine Adverse Event Reporting System (VAERS). Methods: Cases were extracted from VAERS (2011-2015) and assessed for causality using standardized WHO algorithm. Disproportionality analysis was performed through reporting odds ratio (ROR) with 95% CI. MEDLINE was also searched. Results: In VAERS, 199 cases of MC or PC were collected, among which 149 reported smallpox vaccine. The remaining were: 15 cases in ''YOUNGER GROUP'' (YG; b18 years old) and 35 in ''OLDER GROUP'' (OG; N18 years old). Main reported vaccines were against Human Papilloma Virus (n = 6) in YG and influenza (n = 16) in OG. Causality always resulted "undeterminate" for YG, whereas either "undetermined" (30 cases) and "correlated" (3 cases) for OG. Statistically significant ROR was found in YG for meningococcal vaccine (ROR = 3.55; 95%CI = 1.23-10.24) and in OG for thyphoid vaccine (11.13; 7.73-16.03), Japanese encephalitis vaccine (8.54; 2.7-27.01), anthrax (25.5; 18.8-34.5), and, as expected, smallpox (71.88; 49.25-104.89). In MEDLINE, 91 articles were found: positive/possible causality was frequently reported. Conclusions: MC and PC after immunization appear extremely rare; only in very few cases can a role of vaccine be actually identified. Signals for vaccines against typhus, Japanese encephalitis, anthrax and meningococcus warrant monitoring. This case involves a 1 years old male patient who experienced viral myocarditis, while he received vaccines HAEMOPHILUS TYPE B (HIB) VACCINE, HEPATITIS A VACCINE, HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE and MMR. The patient''s past medical history included eczema and rhinitis allergic. Concomitant medication not reported. On an unknown date, the patient received a dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient received a dose of suspect HEPATITIS B VACCINE, HEPATITIS A VACCINE, MMR and PNEUMOCOCCAL VACCINE (all not produced by Sanofi Pasteur lot number not reported). On an unknown date, the patient developed a serious viral myocarditis with the symptom of pyrexia, three months following the administration of HIB VACCINE, HEPATITIS A VACCINE, PNEUMOCOCCAL VACCINE, HEPATITIS B VACCINE and MMR. The event was leading to death. Other relevant tests included normal laboratory and toxicologic tests. Final diagnosis was (fatal) viral myocarditis. It was not reported if the patient received a corrective treatment. It is unknown if an autopsy was done for this patient. Reporter assessed the causality with vaccines as undetermined. List of documents held by sender: none. Sender''s Comments: This fatal case is retrieved from a literature VAERS review and concerns a one-year-old male patient who received HEPATITIS A VACCINE, PNEUMOCOCCAL VACCINE, HEPATITIS B VACCINE, HIB VACCINE and MMR VACCINE and experienced Viral myocarditis and Pyrexia 3 months following the vaccinations. Patient''s history included Eczema and Rhinitis allergic. Time to onset is too long to be compatible with a role of the vaccines, moreover vaccination with several vaccines make the assessment of a particular vaccine difficult. Based on available information on latency and a nature of the event the role of vaccines seems unlikely. Reported Cause(s) of Death: Viral myocarditis.


VAERS ID: 775088 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Death, Diarrhoea, Fatigue, Influenza like illness, Myocarditis, Nausea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA268794

Write-up: Initial information received on 22-Sep-2018 regarding an unsolicited valid serious case received from a literature. Abstract- To characterize cases of myocarditis (MC) and pericarditis (PC) recorded in the Vaccine Adverse Event Reporting System (VAERS). Methods: Cases were extracted fromVAERS (2011-2015) and assessed for causality using standardized WHO algorithm. Disproportionality analysis was performed through reporting odds ratio (ROR) with 95%CI. Database was also searched. results: In VAERS, 199 cases of MC or PC were collected, among which 149 reported smallpox vaccine. The remaining were: 15 cases in ''YOUNGER GROUP'' (YG; b18 years old) and 35 in ''OLDER GROUP'' (OG; N18 years old). Main reported vaccines were against Human Papilloma Virus (n = 6) in YG and influenza (n = 16) in OG. Causality always resulted "undeterminate" for YG, whereas either "undetermined" (30 cases) and "correlated" (3 cases) for OG. Statistically significant ROR was found in YG for meningococcal vaccine (ROR = 3.55; 95%CI = 1.23-10.24) and in OG for thyphoid vaccine (11.13; 7.73-16.03), Japanese encephalitis vaccine (8.54; 2.7-27.01), anthrax (25.5; 18.8-34.5), and, as expected, smallpox (71.88; 49.25-104.89). In database, 91 articles were found: positive/possible causality was frequently reported. Conclusions: MC and PC after immunization appear extremely rare; only in very few cases can a role of vaccine be actually identified. Signals for vaccines against typhus, Japanese encephalitis, anthrax and meningococcus warrant monitoring. This case is linked to cases 2018SA268028, 2018SA268912, 2018SA268046, 2018SA268054, 2018SA268066, 2018SA268077, 2018SA268091, 2018SA268096, 2018SA268116, 2018SA268136, 2018SA268144, 2018SA268154, 2018SA268180, 2018SA268803, 2018SA268809, 2018SA268813, 2018SA268832, 2018SA268839, 2018SA268849, 2018SA268859, 2018SA268864, 2018SA268872, 2018SA268876, 2018SA268889, 2018SA268901, 2018SA268907, 2018SA268929, 2018SA268936, 2018SA268946, 2018SA268957, 2018SA268965, 2018SA268974, 2018SA268988, 2018SA268995, 2018SA269004, 2018SA269014 (same literature article). This case involves a 61 years old male patient who experienced myocarditis/biopsy-proven myocarditis, diarrhoea, fatigue, influenza like illness and nausea, while he received vaccine INFLUENZA VACCINE. The patient''s medical history included Asthma. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. On an unknown date ?the patient developed a serious myocarditis/biopsy-proven myocarditis, diarrhoea, fatigue, influenza like illness and nausea, four- months following the administration of INFLUENZA VACCINE. This event was leading to death. Autopsy revealed myocarditis. No specific lab data reported. Final diagnosis was (fatal) nausea, (fatal) influenza like illness, (fatal) fatigue, (fatal) diarrhoea and (fatal) myocarditis/biopsy-proven myocarditis. The patient didn''t receive any corrective treatment. The patient outcome is reported as fatal on an unknown date for all the events. An autopsy was done. The results of autopsy showed Myocarditis. The Causality assessment (AEFI) was Undetermined. List of documents held by sender: none.; Sender''s Comments: This literature article describes a 61 years old male patient who experienced myocarditis/biopsy-proven myocarditis, diarrhea, fatigue, influenza like illness and nausea, four- months after vaccination with INFLUENZA VACCINE produced by unknown manufacturer resulting in death. The date of vaccinations, the date of events, the date of death was not reported. No information regarding medical history and tolerance to previous vaccinations was reported. Also there is no information regarding virus strain, lab tests confirming the diagnosis and patient''s immunological response to assess a potential vaccination failure However, Autopsy confirmation provided myocarditis as the factor. Based upon reported information, the role of vaccine cannot be assessed.; Autopsy-determined Cause(s) of Death: myocarditis.


VAERS ID: 776286 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2018-10-01
Onset:2018-10-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2018-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U1998AE / 1 RL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. R009953 / 1 RL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. R002938 / 1 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Blood lead normal, Death, Full blood count normal, Pathology test, Pyrexia, Toxicologic test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-05
   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: Zantac, Motrin, maybe Tylenol but unsure
Current Illness: 8/31/18 - diagnosed with left acute otitis media. Started Amoxil. (resolved) 9/19/18 - diagnosed with hand, foot, mouth (resolved)
Preexisting Conditions: Previously healthy
Allergies: None
Diagnostic Lab Data: All pending with medical examiner. Of note, CBC and lead screen were normal on 10/1/18 as part of his well check.
CDC Split Type:

Write-up: Received vaccines 10/1/18. Patient developed fever on of 10/3/18. Tmax 101. Mom gave Motrin before bed that night. Checked on him before she went to bed and his temp was 99. Next morning he was found dead in crib. No blankets, stuffed animals in crib. Autopsy found no signs of trauma. Tox screen, tissue samples still pending.


VAERS ID: 777032 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131810USA002241

Write-up: This social media spontaneous report was received from a consumer, who made a post on 08-SEP-2018 that included a video. The title of the video was "manufactured crisis - HPV , hype and horror", in which a reporter mentioned information about an unspecified number of female patients of unknown age. The patients'' medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the patients were vaccinated with GARDASIL for prophylaxis (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided). On an unspecified date, unspecified patients were going to have menopause (premature menopause) and infertility. (It was stated that those patients had 16 years old). Also, an unspecified number of patients experienced fatigue, could not breath, presented asthma, fell on the ground (fall), experienced a seizure, loss of consciousness, depression, anxiety, had an ovarian dysfunction (ovarian disorder) and presented a miscarriage. On an unspecified date, an unspecified patients died. The cause of death was not provided and it was unknown if autopsy was performed or not. At the reporting time, the outcome of loss of consciousness, fatigue, asthma, fall, infertility, anxiety, depression, ovarian disorder, dyspnoea, premature menopause, seizure and abortion spontaneous was not reported. The reporter did not assess the relatedness between GARDASIL and the aforementioned events. Upon internal review, the events seizure, abortion spontaneous and loss of consciousness were determined to be medically significant.


VAERS ID: 777077 (history)  
Form: Version 2.0  
Age: 1.33  
Sex: Male  
Location: California  
Vaccinated:2017-02-14
Onset:2017-02-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5157AA / 4 LL / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5359DA / 2 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 37H34 / 3 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M034188 / 4 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N55175 / 4 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Passing.


VAERS ID: 777311 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Foetal exposure during pregnancy, Intensive care, Pertussis
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2018GS

Write-up: This retrospective pregnancy case was reported in a literature article and described the occurrence of pertussis in a infant. The mother received DTPa (Reduced antigen) (dTpa vaccine.) for prophylaxis. The patient''s mother''s last menstrual period and the estimated date of delivery was unknown. The pregnancy resulted in a live neonate with no apparent congenital anomaly. On an unknown date, at [weeks gestation], the infant was born via unknown delivery. The infant was diagnosed with pertussis. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included maternal exposure during pregnancy. The outcome of pertussis was fatal. The outcome(s) of the additional event(s) included maternal exposure during pregnancy (unknown). The reported cause of death was pertussis. The investigator considered that there was a reasonable possibility that the pertussis may have been caused by dTpa vaccine. Additional information was provided. This retrospective pregnancy case was reported in a literature and described the occurrence of pertussis infection in an infant aged less than 4 months of unspecified gender whose mother was vaccinated with unspecified tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine (manufacturer unknown) during pregnancy (trimester unknown) for prophylaxis. The patient was part of study that interviewed the prenatal care providers to ascertain possible reasons for low Tdap vaccine coverage among pregnant women whose infants developed pertussis in 2016. The patient''s mother''s last menstrual period and the estimated date of delivery was unknown. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient''s mother was vaccinated with unspecified Tdap vaccine (administration route and site unspecified; dosage unknown, batch number not provided) during pregnancy (trimester unknown). The patient''s mother had received vaccine outside the recommended 27-36 week time frame. [In this study, 5 mothers received Tdap vaccine outside the recommended 27-36 week time frame (1 at 26, 1 at 38, and 1 at 39 weeks'' gestation and 2 at 37 weeks). The maternal age of vaccination was not provided. The patient was exposed to vaccine in utero. On an unknown gestation week, the patient was born via unknown delivery method. On an unspecified date in 2016, an unknown period after exposure to vaccination, the patient developed pertussis infection. Subsequently, the patient was admitted to intensive care unit (ICU). On an unspecified date, the patient died. It was unknown if an autopsy was performed. In this study, it was reported that in 2016, a low-incidence pertussis year, 114 pertussis cases, which included two pertussis-related deaths, occurred among infants aged less than 4 months. This case has been considered serious due to death/hospitalisation. The treatment was unknown. The author did not comment on relationship between the event of pertussis infection and unspecified Tdap vaccine. The author concluded "In this state, pharmacists are permitted to provide immunizations, and all routinely recommended adult vaccines are covered by insurance when given in a provider''s office or in a pharmacy. Recent state regulations require pharmacists to notify providers of immunizations administered and to enter all doses into the State''s Immunization Registry, making it possible for providers to know whether vaccine referrals to pharmacies are successful. However, stocking vaccines on-site in prenatal clinics is the best way to ensure that all pregnant women are vaccinated and reduce the incidence of pertussis among infants too young to be vaccinated." This is 1 of 3 valid cases reported in this literature article. Reported Cause(s) of Death: Pertussis infection.


VAERS ID: 778063 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2016-08-15
Submitted: 0000-00-00
Entered: 2018-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blister, Death, Herpes zoster, Rash vesicular, Vaccination failure
SMQs:, Severe cutaneous adverse reactions (broad), Lack of efficacy/effect (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine health maintenance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131810USA004344

Write-up: Information regarding a case in litigation has been received from a lawyer and the spouse of a deceased male patient of unknown age. No information was received regarding the patient''s past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain condition of herpes zoster. On or about 15-AUG-2016, the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the vaccination failure and herpes zoster/shingles was unknown. As a direct and proximate result of using the ZOSTAVAX vaccine, and/or despite using ZOSTAVAX for the sole purpose of preventing shingles of preventing shingles, the patient suffered from shingles and/or other painful herpes zoster-related injuries and required extensive medical and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. On 29-APR-2018, the patient passed away. The cause of the patient''s death was not reported. It is unknown if an autopsy was performed. Upon internal review, death was determined to be medically significant. Additional information has been requested. Reported Cause(s) of Death: Death.


VAERS ID: 778079 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Autoimmune disorder, Dizziness, Fatigue, Headache, Hypoaesthesia, Infection, Inflammation, Injury, Nausea, Neck pain, Paralysis, Rash, Rheumatoid arthritis, Sinus congestion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131810USA005156

Write-up: This spontaneous report was received from a physician via social media refers to a male patient of unknown age. The patient''s pertinent medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with GARDASIL (lot#, expiry frequency, route and dose of administration unknown) for prophylaxis. Other suspect therapies included GARDASIL 9 (lot#, expiry frequency, route and dose of administration unknown) for prophylaxis. On an unknown date, the patient experienced auto immune disease (autoimmune disorder), side effect (adverse event), inflammation, neck pain, nausea, neck pain, rheumatoid arthritis, infection, injury, paralysis, tiredness (fatigue), rash, dizziness, arrhythmia, headache, fainting (syncope), numbness (hypoesthesia), and sinus congestion. The patient died on an unknown date.The outcome of arrhythmia, syncope, headache, dizziness, nausea, fatigue, inflammation, neck pain, adverse event, infection, injury, rash, hypoesthesia, sinus congestion, paralysis and rheumatoid arthritis was unknown. The causality of all the events were not reported. Upon internal review the events death, arrhythmia, autoimmune disorder, paralysis, and rheumatoid arthritis were considered to be medically significant.; Sender''s Comments: US-009507513-1810USA005156:


VAERS ID: 778735 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2018-09-28
Onset:2018-10-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2018-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS PK9RY / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-03
   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: Warfarin, Metoprolol, cartia xt, tamsulosin
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: nkda
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: Pt had stroke and died 10/3/18.


VAERS ID: 778893 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Oregon  
Vaccinated:2016-06-01
Onset:2016-10-19
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2018-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Bedridden, Confusional state, Death, Depressed level of consciousness, Gait disturbance, Loss of personal independence in daily activities, Mobility decreased, Pyrexia, Skin warm, Speech disorder
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-29
   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: Carbadopa levodopa And levathroxin
Current Illness: None
Preexisting Conditions: Parkinsons disease
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever. Confusion. Got up to go to the bathroom but did not need to go. Then said he went in his depends. Next morning he asked me what all that was about. I said I don''t know. It was not his normal state if being. I attributed it to the flu vaccine. Dad started getting weaker and weaker and having trouble walking. He could not get out of bed. He was finally confined to bed and needed 100% assistance. He had to start using the commode only. With help. Also depends undergarments all the time. Dad was bed bound and could do nothing. We had the tv on for him and music but he did not watch. Dad was having a harder and harder time of it. Everyday he got worse. I called Dr and he recommended hospice. Dad got weaker and could not talk anymore. He understood but could not speak. I could not understand why dad went downhill so fast could not move and could not speak. I called hospice knowing they help with the last 6 months of life if someone is dying. Hospice cake. Dad did not rouse when they pushed on his sternum. He was very hot. Hospice said he would be dead in 3 days. I was astounded. Why was my dad dying like this? I thought he would have 6 months at least. Dad could not talk but did waken somewhat when I had family say goodbye to him in the phone. I know it was the flu vaccine that made dad go downhill like that in one month and a half and die. The flu shot killed him. Dad wasn''t like that before. Dad could walk and talk. No more after the flu vaccine. The heavy metals in the flu vaccine like mercury could have given him heavy metal poisoning and also made his Parkinson''s worse. Dad was 90 years old. Your form keeps telling me he was 89 he was 90. Flue vaccine: influenza PF Quad ped/adol/Adult psat type t or vial dosage .5 milaliters right side. Dad died unexpectedly October 29th 2016, a month and 2 weeks after the flu shot, at the age of 90 years old.


VAERS ID: 779618 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Washington  
Vaccinated:2018-09-25
Onset:2018-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5437AA / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS LH3RJ / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T94424 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N030174 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-09-26
   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: Infant TYLENOL prior to vaccinations on 9/25/2018 according to hospital records.
Current Illness: Recent very mild cough according to hospital records. None noted at well child visit on 9/25/2018
Preexisting Conditions: none noted
Allergies: None noted
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: Child found unresponsive at 0450 am on 9/26/18 and EMS called immediately. CPR was initiated. Child was last seen breathing at midnight. Child taken to the emergency department at hospital. Child pronounced dead at 5:44 am.


VAERS ID: 779821 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2017-02-08
Submitted: 0000-00-00
Entered: 2018-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Blister, Death, Herpes zoster, Rash vesicular
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-08
   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: Routine health maintenance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131810USA005863

Write-up: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2009, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2014, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. On 08-FEB-2017, the patient passed away. The cause of death and autopsy results were unknown. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.


VAERS ID: 780163 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2018-01-18
Submitted: 0000-00-00
Entered: 2018-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, Death, Herpes zoster, Rash vesicular
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-18
   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:
Current Illness: Routine health maintenance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131810USA005867

Write-up: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2015, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated in the center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. On 18-JAN-2018, the patient passed away. Cause of death was unknown. It was unknown if autopsy was performed. Outcome of the events was unknown. Causality assessment was related. Additional information has been requested.


VAERS ID: 780202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Illinois  
Vaccinated:2010-12-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blister, Death, Herpes zoster, Rash vesicular
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine health maintenance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131810USA006511

Write-up: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 27-DEC-2010, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 07-JAN-2016, the patient was treated in a primary care center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages until her death. On an unspecified date, the patient died. It was unknown if autopsy was done. The outcome of other events was unknown. Causality assessment was related. Additional information has been requested.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 780527 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Male  
Location: Florida  
Vaccinated:2018-10-11
Onset:2018-10-12
   Days after vaccination:1
Submitted: 2018-10-19
   Days after onset:7
Entered: 2018-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. YF38707 / 2 LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Bilirubin conjugated increased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood lactate dehydrogenase increased, Blood urine present, Bradycardia, Cardio-respiratory arrest, Chromaturia, Death, Diarrhoea, Fatigue, Haematuria, Haemoglobin decreased, Haptoglobin abnormal, Hyperbilirubinaemia, Hypotension, Life support, Malaise, Nausea, Packed red blood cell transfusion, Protein total decreased, Pyrexia, Resuscitation, Specific gravity urine normal, Urine ketone body absent, Urobilinogen urine increased, Vomiting, White blood cell count, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), 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), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (narrow), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No known allergies
Allergies:
Diagnostic Lab Data: 10/12/2018 04:25 Urine, UrColor, Red; Appear, Clear; USpGrav, 1.023; Urobil, 4; UrBlood, Large; UrBili, Neg; UKetone, Neg; 10/14/2018 23:00 PLASM, Protein, 6.0; Albumi, 3.5; TotBili, 15.1; DirBili, 49; ALT, 88; AST, 52; 10/14/2018 11:30 PLASM, Protein, 7.0; Albumi, 3.9; TotBili, 23.0; DirBili, 42; ALT, 84; AST, 66; 10/14/2018 06:30 SERUM, 6.5; 10/13/2018 23:35 PLASM, Protein, 6.8; Albumi, 3.8; TotBili, 19.5; DirBili, 32; ALT, 68; AST, 65; 10/12/2018 06:00 PLASM, Protein, 6.8; Albumi, 3.8; TotBili, 15.5; DirBili, 1.2; ALT, 29; AST, 46; AlkPhos, 81; 04/12/2018 00:40 PLASM, Protein, 7.1; Albumi, 4.0; TotBili, 0.6; DirBili, 0.2; ALT, 29; AST, 23; AlkPhos, 69
CDC Split Type:

Write-up: A 47 year old male with history of HTN, obesity, hyperlipidemia, obstructive sleep apnea, depression and anxiety, presents to ER on 10/12/18 with chief complaints of fatigue, weakness and hematuria x 1 day. Pt reported symptoms began after getting the flu shot the day prior. 1 episode of diarrhea in ED but none at home. Returned from 5 week trip, about 3 weeks prior to presentation. He received a flu vaccine immediately prior to the onset of his Sx and associates his Sx with this event. He reported that following said flu vaccination, he began to feel ill with fatigue and nausea/vomiting. No other medication changes. GI was consulted and felt that his unconjugated hyperbilirubinemia was not due to biliary causes. His hemolysis labs (haptoglobin and LDH) returned positive. Heme/onc was consulted. His Hbg downtrended 12-$g 7.7-$g 4.9, and he was noted to spike fever on 10/14 prior to his significantly reduced Hb at 12:30 am. He received 2UPRBC with f/u Hb to 6.9. WBC trended up from 15 (PMN 12)-$g 20.38 (PMN 17.39)-$g 22.5 (PMN 18.93)-$g 25.2 (PMN 55.67)-$g 29.02 (PMN 27.22). Bilirubin total (with indirect predominance throughout): 15.5-$g 19.5-$g 23. Patient initially stabilized with steroids, and determination was made to limit transfusion to keep Hbg greater than 6 to prevent worsening hemolysis. However, at approximately 23:00 10/14/18, patient had acute respiratory distress associated with bradycardia and hypotension, and then suffered cardiopulmonary arrest. He underwent multiple rounds of CPR and ACLS. Patient ultimately expired.


VAERS ID: 781140 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Female  
Location: Ohio  
Vaccinated:2018-09-06
Onset:2018-10-13
   Days after vaccination:37
Submitted: 2018-10-23
   Days after onset:10
Entered: 2018-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 250802 / UNK LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. R021048 / UNK RA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Erythema, Peripheral swelling, Sepsis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2018-10-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Redness, swelling of arm, sepsis.


VAERS ID: 781641 (history)  
Form: Version 2.0  
Age: 0.5  
Sex: Male  
Location: North Carolina  
Vaccinated:2018-02-06
Onset:2018-02-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-08
   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: ZANTAC
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: Death. 02/08/2018.


VAERS ID: 781658 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2018-10-17
Onset:2018-10-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2018-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS ZA72G / 1 LA / IM

Administered by: Work       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: 2018-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: severe anemia, was being worked up
Preexisting Conditions: none
Allergies: unknown
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Sudden death. Highly unlikely to be related, but I feel it needs to be reported. Agency investigating death, and were also advised.


VAERS ID: 781804 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Male  
Location: Missouri  
Vaccinated:2018-10-10
Onset:2018-10-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5515AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T94426 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS G5JL7 / 1 MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Blood glucose decreased, Death, Hypotonia, Resuscitation
SMQs:, Peripheral neuropathy (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-13
   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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: 10/13/18 - Glucose - < 20
CDC Split Type:

Write-up: Patient found in bed, limp and apneic, at 4 AM and rushed to hospital emergency room where efforts to revive were unsuccessful.


VAERS ID: 782046 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2018-09-28
Onset:2018-10-11
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2018-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. 252226 / 1 LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W51762 / UNK RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cardiac arrest, Death, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (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), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-11
   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: KEPPRA; FAMOTIDINE; BENZONATATE; ONDANSETRON HCL; HYDROCHLOROTHIAZIDE; GABAPENTIN; METOPROLOL SUCC ER; HYDROCODONE-ACETAMINOPHEN; LOSARTAN POTASSIUM; WARFARIN SODIUM; PROAIR HFA; MCG/ACT INHALATION AEROSOL SOLUTION
Current Illness:
Preexisting Conditions: Epilepsy Marfan syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My husband died after a seizure on October 11, 2018. His heart stopped. He was pronounced dead at Hospital. He had Marfan syndrome and a 4.9 abdominal aneurysm. He had never taken the flu shot since a time several years ago when he ended up getting the flu after taking it. He was due for surgery soon, so he agreed to take it.


VAERS ID: 782184 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131810USA009562

Write-up: This spontaneous report was received from an unspecified reporter referring to unknown number of female patients of unknown ages. Information about concomitant medication, pertinent medical history and drug reactions was not provided. On an unknown date the patients were vaccinated with GARDASIL 9 for prophylaxis (strength, dose, frequency, route, lot # and expiration date were not reported). The reporter stated the patients all over were being devastated by GARDASIL 9, and that the GARDASIL 9 was killing as many people as it wanted (death). The reporter considered death to be related to GARDASIL 9. It was unknown if autopsy was done. This is one of two reports received from the same reporter.; Sender''s Comments: US-009507513-1810USA010304:


VAERS ID: 782839 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

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: US0095075131810USA012438

Write-up: This initial spontaneous report was received on 25-OCT-2018 from a physician via a company field representative and refers to a 12 year old patient of unknown gender. The patient had no pertinent medical history or drug reactions/allergies and was taking no concomitant medications. On an unspecified date, the patient received GARDASIL intramuscularly for the indication of human papilloma virus (HPV) vaccination (dose and lot # not provided). It was unspecified how many doses in the series the patient received. An unspecified period of time after receiving GARDASIL, the patient died. Cause of death was not specified. There were no lab diagnostics/studies performed. The physician did not provide causality assessment. The physician told the field representative that Merck was sued. Upon internal review, death was considered medically significant. Additional information has been requested.; Reported Cause(s) of Death: Cause of Death: Unknown by reporter.


VAERS ID: 783466 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2015-12-01
Onset:2015-12-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Ophthalmic herpes zoster
SMQs:, Ocular infections (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-27
   Days after onset: 330
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: US0095075131810USA012712

Write-up: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient''s medical history, concurrent conditions and concomitant medication use were not provided. The patient''s husband reported that on or about December 2015, the patient received the ZOSTAVAX, (lot# and route unknown) vaccine for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered multiple outbreaks of shingles around her left eye. She passed away from an unrelated medical condition on 27-OCT-2016. As a direct and proximate result of ZOSTAVAX the patient''s symptoms have resulted in physical limitations not present prior to using this product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Upon internal review multiple outbreaks of shingles around her left eye and passed away were considered medically significant events. Additional information has been requested.; Reported Cause(s) of Death: passed away.


VAERS ID: 783606 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Unknown  
Vaccinated:2018-10-15
Onset:2018-10-16
   Days after vaccination:1
Submitted: 2018-10-23
   Days after onset:7
Entered: 2018-11-02
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. YF39608 / 2 RA / UN

Administered by: Other       Purchased by: Other
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: 2018-10-16
   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:
Current Illness: None
Preexisting Conditions: Vitamin D deficiency; Constipation; Anemia; Neoplasm of right upper lobe of lung; Unintentional weight loss; Adenomatous polyp of colon; Gastro-esophageal reflux 1/19/16 EGD reflux esophagitis, gastric intestinal metaplasia. F/U January 2017; Seen in hospital anticoagulation clinic risk assessment completed 2/3/17; Atrial flutter goal INR 2.0 to 3.0; COPD - chronic obstructive pulmonary disease; Benign prostatic hypertrophy with outflow obstruction; Allergic rhinitis; Posttraumatic stress disorder; Insomnia related to PTSD; FH: Bowel cancer brother diagnosed colon cancer age 64, died age 65 Fpr colonoscopy 4/13/2004 1/19/16 colonoscopy. Multiple adenomas. Poor prep future care consult ordered for F/U April 2016. 4/19/16 colonoscopy. No polyps. F/U April 2021; HLD - hyperlipidemia; Chronic low back pain multilevel spinal canal stenosis; Coronary artery disease; History of coronary artery bypass grafting; Benign essential hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received immunization on 10/15/18 and passed away the next morning on 10/16/18. He had multiple other comorbidities, but death was sudden.


VAERS ID: 784357 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Male  
Location: California  
Vaccinated:2018-10-09
Onset:2018-10-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5169AA / 4 LL / IM
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS Y279A / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI914AAA / 4 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-12
   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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found unconscious the morning of 10/12 in the crib. Declared dead shortly after. Autopsy pending.


VAERS ID: 784375 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: California  
Vaccinated:2018-10-02
Onset:2018-10-11
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2018-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 9A2KC / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. R005116 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W00305 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS 3EM4N / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Infantile spitting up, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None at time
Current Illness: Thrush, poor weight gain due to mothers diet; yet on Enfamil gained the weight and mother diet change allowed production of sufficient breast milk. Mother went to jail Sept 29 2018 and baby was strictly on formula from that date till her death.
Preexisting Conditions: None known
Allergies: None known
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Child seemed to spit up more after so the night before attempted to schedule every 3hrs 4ounces water 2 scoops of infant Enfamil (yellow) and 8:06 am woke to child obviously stopped breathing, performed CPR till fire dept. arrived to take over and ambulance arrived then rush her to the hospital. Coroner case.


Result pages: prev   1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=45&PERPAGE=100&DIED=Yes


Copyright © 2020 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166