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VAERS ID: 446226 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-12-22
Entered: 2011-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / UNK UN / UN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Risk factor(s): Advanced maternal age, Obesity, Chlamydia infection and complicated pregnancy, Congenital malformations in past pregnancies, Uncontrolled diabetes, Chronic hypertension, positive Down''s Syndrome screening, macrocytic hyperchromic anaemia, smoking, history of intrauterine fetal death, Alcohol use, Drug use, Diabetes mellitus type 1, Diabetes mellitus type II, Gestational diabetes, Urinary tract infection, Diabetes mellitus, Hypothyroidism; Pregnant: Yes; Result: STILL BIRTH
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011030539

Write-up: This literature report (initial receipt 14-Dec-2011) concerns VAERS (Vaccine Adverse Event Reporting System) reports received through 01-Mar-2010, on pregnant women who were vaccinated with the seasonal influenza vaccine on the same date as the H1N1 during 01-Oct-2009 through 28-Feb-2010. Foreign reports were excluded. Risk factors for spontaneous abortions included the following; advanced maternal age equal or $g35 years (25 patients), smoking (7 patients), history of intrauterine fetal death (4 patients), hypothyroidism (4 patients), diabetes mellitus type 1 (1 patient), diabetes mellitus type II (1 patient), history of gestational diabetes (1 patient), alcohol or drug use (2 patients), obesity (1 patient) and other (1 patient). ''Other'' risk factors for spontaneous abortions were defined as the following; chlamydia infection with complicated pregnancy. Risk factors for stillbirth included the following; advanced maternal age equal or $g35 years (5 patients), smoking (3 patients), history of intrauterine fetal death (2 patients), diabetes mellitus type 1 (1 patient), history of gestational diabetes (1 patient), alcohol or drug use (4 patients), obesity (3 patients) and other (7 patient). ''Other'' risk factors for stillbirth included the following; congenital malformations in past pregnancies, uncontrolled diabetes, chronic hypertension, positive Down Syndrome screening and macrocytic hyperchromic anaemia. From 01-Oct-2009 through 28-Feb-2010, VAERS received a total of 10,186 reports after H1N1 vaccination; 422 of these reports involved pregnant women. The author excluded 128 pregnancy reports in which no AE was reported after the administration of inactivated or live H1N1. These pregnant women are being followed up prospectively as part of a separate CDC (Centres for Disease Control and Prevention) study that seeks to assess delivery and infant outcomes. Of the remaining 294 reports, 31 reports (10.5%), the seasonal influenza vaccine was administered on the same date at the H1N1 (WAVES 2011030537). Of the 294 reports, the median maternal age was 30 years (range 15 - 46 years). Median onset interval (adverse event onset date and vaccination date) was 2 days (range 0 - 84 days). Median gestational age at time of H1N1 vaccination was 13 weeks (range 3 - 39 weeks). The H1N1 was reported as administered mostly during the first (133; 53.8%) and second trimester of pregnancy (67; 27.1%). Sixty reports (20.4%) were coded as serious, including 2 maternal deaths. Serious reports corresponded to 59 pregnant women who were hospitalized for any reason and 1 to an infant born with a congenital anomaly. The most frequent pregnancy-specific AE reported following H1N1 administration was SAB (spontaneous abortion) in 121 women (41.2% of reports), followed by stillbirth in 19 women (6.5% of reports), preterm delivery of 7 women (one case where the infant of one mother died approximately one month after delivery), threatened abortion in 4 women, preterm labor in 3 women, maternal death in 2 women, preeclampsia in 2 women, intrauterine growth restriction in 2 women, fetal hydronephrosis in 1 woman, fetal tachycardia in 1 woman, cleft lip in 1 woman, neonatal intraparenchymal hemorrhage in 1 woman and intrauterine fetal death in 1 woman. Most SAB reports (n = 62) were received in Nov-2009 but reporting rapidly declined thereafter. All stillbirths were reported during Oct-2009 and Nov-2009 with 10 and 9 reports, respectively. In 42.4% of the SAB reports, the onset interval from the day of vaccination to onset of AE was 0-3 days (61 reports with onset of 0-6 days). In 47.4% of stillbirth reports, the onset interval was 0-6 days. The author did not observe any clustering of SAB or stillbirth cases by geographic location or lot number. Ninety-five SABs (78.5%) and 18 stillbirths (94.7%) were verified by review of medical records. Five fetal adverse outcomes were reported: 2 cases of intrauterine growth restriction and 1 case each of hydronephrosis, tachycardia, and cleft lip. The maternal deaths included 1 patient who experienced hemorrhagic shock because of uterine atony following a cesarean section and 1 patient who experienced a ruptured aortic aneurysm, which resulted in cardiac tamponade and subsequent death. A mild fetal hydronephrosis was detected in the patient during an ultrasound exam at 36 weeks'' gestation. However a postnatal ultrasound examination of the infant performed on day 2 of life failed to confirm the presence of hydronephrosis. Cause of death was not reported. Only 1 congenital anomaly was reported to VAERS: a cleft lip in an infant born to a 23 year old woman who was vaccinated at 19 weeks'' gestation. The cleft lip was first detected during a prenatal ultrasound examination at 22 weeks'' gestation. Cause of death was not reported. Because cleft lip was embryologically determined during the first trimester of pregnancy, it is implausible to consider vaccination at 19 weeks'' gestation as a possible causative agent. The most common non pregnancy specific AEs were non anaphylactic allergic reactions (36), constitutional symptoms (28), and local reactions (10). Two hundred thirty-five of the total reports (79.9%) did not require hospitalization. Five cases of Bells'' palsy and 1 case of anaphylaxis (meeting Brighton Collaboration case definition) were reported. No cases of Guillain-Barre syndrome were identified. There were 8 cases of paraesthesia''s, 5 cases each of syncope and dizziness, 3 cases each of hypoesthesia and headache and 25 cases of ''other'' Other events included anxiety, arthralgia, asthenia, asthma, arthritis, blurred vision, chest pain, chronic bronchitis, cough, diarrhoea, dyspnoea, eye swelling, influenza, influenza-like illness, lip injury, nail bleeding, panic attack, shingles, sneezing, tachycardia, tremors, unusual taste, upper respiratory tract and wheezing. One hundred twenty-one cases of SAB after H1N1 vaccination were reported to VAERS of which 95 were verified. Medical records were not received for 16 reports, and in 10 reports, the available records were not sufficient to confirm the initial diagnosis of SAB. Risk factors for SAB were identified in 47 (49.5%) of the 95 verified reports. Thirty-six women had only 1 risk factor for SAB. The most common risk factor was advanced maternal age (defined as age $g or = 35 years) in 25 reports (26.3%). Nineteen stillbirths were reported to VAERS. Of 18 with verified diagnosis, 13 (72.2%) had at least 1 maternal risk factor for stillbirth (eg, obesity) or a pathological finding that may have contributed to the fetal demise. Fourteen of 18 reports had pathology reports. Pathological/placental or other findings were present in 13 of the 14 reports and included chorioamnionitis in 7 reports and 2 reports each of tight nuchal cord, fetal-maternal hemorrhage, and fetal growth restriction. Of note, the 6 adverse event cases involving live H1N1 included 1 case of spontaneous abortion, 2 cases of general/constitutional symptoms, 1 case each of dizziness, headache, and ''other''. The event outcome was not reported.


VAERS ID: 446303 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Idaho  
Vaccinated:2011-10-26
Onset:2011-11-03
   Days after vaccination:8
Submitted: 2011-12-27
   Days after onset:54
Entered: 2011-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA651AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Diplopia, Facial paresis, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture abnormal, Nerve conduction studies abnormal, Ophthalmoplegia, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (narrow), Ocular motility disorders (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-04-18
   Days after onset: 167
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 60 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Peripheral neuropathy History of Bells palsy 2009
Allergies:
Diagnostic Lab Data: Nerve conduction test and lumbar puncture consistent with diagnosis. Pls note pt is now in acute care hospital setting.
CDC Split Type:

Write-up: Facial weakness, double vision, numbness tingling of extremities. Progressed to ophthalmoplegia, severe weakness, DX as Guillain Barre syndrome pt hospitalized.


VAERS ID: 446306 (history)  
Form: Version 1.0  
Age: 36.0  
Sex: Male  
Location: Texas  
Vaccinated:2011-08-01
Onset:2011-08-01
   Days after vaccination:0
Submitted: 2011-12-20
   Days after onset:141
Entered: 2011-12-27
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3694BA / UNK UN / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Abdominal pain upper, Activities of daily living impaired, Allergy test negative, Arthralgia, Asthenia, Asthma, Balance disorder, Biopsy, Biopsy lip, Blister, Blood test, Burning sensation, Cellulitis, Central nervous system lesion, Chills, Cold sweat, Colonoscopy, Coordination abnormal, Crying, Diarrhoea, Disability, Dizziness, Dysarthria, Dyspnoea, Ear discomfort, Echocardiogram, Electroencephalogram normal, Erythema, Extraocular muscle paresis, Eye pain, Eye pruritus, Eyelid oedema, Fatigue, Feeling abnormal, Formication, Gait disturbance, Gastrooesophageal reflux disease, Haematochezia, Head discomfort, Headache, Herpes zoster, Hyperaesthesia, Hypoaesthesia, Impaired work ability, Induration, Influenza like illness, Insomnia, Joint stiffness, Malaise, Memory impairment, Mental impairment, Motor dysfunction, Muscle spasms, Muscular weakness, Nausea, Nerve conduction studies, Nerve injury, Nuclear magnetic resonance imaging brain abnormal, Ocular hyperaemia, Oedema peripheral, Oesophageal pain, Oesophageal ulcer, Oesophagitis, Ophthalmological examination abnormal, Pain, Pain in extremity, Panic attack, Paraesthesia, Pruritus, Rash macular, Respiratory tract congestion, Sensation of heaviness, Sjogren's syndrome, Throat irritation, Throat tightness, Vision blurred, Vomiting, X-ray gastrointestinal tract abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), 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 (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Lacrimal disorders (narrow), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Meclizine 12.5mg; Cephalexin
Current Illness: 2 hrs after shot shortness of breath; Difficulty breathing
Preexisting Conditions: Temporal lobe epilepsy (released when I was 13)
Allergies:
Diagnostic Lab Data: Blood work equivocal - neurologist diagnosed possible Sjorgens syndrome waiting results - see notes; MRI - 1" lesion left temporal lobe
CDC Split Type:

Write-up: Aug. 1, 2011 Insect bite got infected went to clinic. Dr. gave Tdap and 2 antibiotics; Meclizine 12.5, cephalexin for infection and Staph, 2 hours after felt shortness of breath, dizzy, lightheaded, left shoulder arm tingly called clinic said don''t worry keep taking antibiotics. I have been to neurologist - 2 MRI found 1" lesion left temporal lobe, along neurosurgeon, cardiologist, rheumatologist, ENT, ophthalmologist, dermatologist, GI, dentist. No answers! Friday, July29 On Friday afternoon around 4:30p.m. I got in the shower and noticed a bite from an insect of some sort. On Saturday, July went to ask pharmacist to look at it. She said it looked infected and that I needed to go to the doctor. On Monday, August 1 I went to work and reported it to, Safety Director. She advised me to go to the clinic. I saw Dr. Dr. saw my foot and said that I had cellulitis and possible staph infection. She prescribed two antibiotics. One to treat staph and to fight infection. Meclizine 12.5 mg take one tablet by mouth twice daily as needed. The other antibiotic was cephalexin take one capsule by the mouth 4xs a day. That afternoon when I sat down to eat lunch I took the two pills prescribed. Shortly after, I was feeling lightheaded, dizzy, clammy, short of breath and chills. I went home still feeling bad, called clinic, told them my symptom sent back to my they told me everything was fine just continue taking antibiotics. Monday, August 8 Dr. saw for follow up and said that I could go back to work. Tuesday August 9&10 I went back to my regular work load which is installing a/c units. Wednesday, August 10 After lunch and got back to work site I felt lightheaded and dizzy. It was scary feeling was picked up by my boss and driven home. I was told to see my primary doctor which did. I saw Dr. at office. She said didn''t know what was going on with me and said to go to the emergency room if I got worse. Thursday, August 11 That evening I felt same symptoms felt lightheaded, dizzy, chills, and clammy. So I went to the emergency room thinking I was having a reaction to the vaccine; tetanus and/or antibiotics. Dr. was 18 attending physician. After having blood test, EKG and fluids given to me, Dr. concluded that there was nothing life threatening was told to go back to work on August 18. Wednesday August 17th Dr. office advised me to return back to work with lightheadedness. Friday, August 19 I returned back to work on light duty in the office. I still feel lightheaded and dizzy. I felt like needles were sticking in my head. My vision seemed to be blurred and severe headache. It''s the closest I''ve felt to deal. I felt that over the weekend. Monday, August 22 I worked all day 8:00-5:00 in the office but continued to feel lightheaded. Tuesday, August 23 I had two Dr. appointments one to cardiologist for echocardiogram and the other to an allergist. I gave blood and administered allergy tests along with asthma. Results were no known allergies at this time. He said it might be possible serum sickness. Safety Director finally gave me a nurse card. She said if anything else comes up medically to contact nurse. Wednesday, August 24 worked for five hours between going to draw blood again for allergy testing and going to have sonogram done on heart. Thursday, August 25 I was still working on light duty in the office I continue to have lightheadedness but I worked 8:00-5:00. Friday, August 26 I worked 8:00-5:00 felt lightheaded throughout the day. Saturday, August 27 noticed red blister on right cheek under eye. It was sensitive and blisters began to get bigger. Sunday, August 28 The blisters went from dime size to a fifty cent piece. I went to Urgent Care I saw Dr. She diagnosed it as Shingles. She prescribed Valacyclovir 1mg Three times a day. I felt achy, lightheaded, clammy, burning sensation, itching. She also prescribed Hydrocortisone cream for itching. Monday, August 29 I went to work 8:00-5:00 still feeling lightheaded and dizzy. I was working in office on light duty. Tuesday, August 30 I went to work 8:00-5:00 still feeling lightheaded and dizzy noticing blister drying up. Wednesday, August 31 I went to work 8:00-5:00 still feeling lightheaded, dizzy and achy. Thursday, September 1 I made appointment to go back to see Dr. at office. She is requesting more blood work. She is continuing to research allergic reactions from vaccine. I am still feeling lightheaded at times. It is sporadic. She has advised me to stay on light duty until all of the tests results are back. Friday, September 2 Blisters are going away but still feel lightheaded at times. Saturday, September 3 late that evening I noticed a knot on the right forearm sensitive, tender and swollen. I don''t know what it is. I am finished taking valacyclovir. I still feel lightheaded and dizzy, congested. Sunday, September 4 I woke up dizzy and lightheaded. Monday, September 5 I went to work. I left from desk around 12:00 to go eat as I walked into Cafe sat down felt on edge my left side of face felt numb and tingled. I have pressure in ears and head gets pain in it. Feels like I''m stomping and eyes are blurred vision I feel tired. Coordination is off and this has gone on since August 1 when I was diagnosed with cellulitis in right foot and was given a tetanus shot and prescribed two antibiotics. I''m not the same since this happened. Nothing is changing. It comes and goes. I''m always on the edge. I lose focus can''t concentrate and feels like memory plays tricks on me. Sometimes I walk around wondering what I''m doing I forget what I''m doing. My head feels heavy, I''m weak like I was struck by lightning, blurred vision, don''t go away. Left side of head around my temple and all on my head. My jaw sometimes feels like Lockjaw and it sometimes slurred speech. Pretty much my left side of face and head my left arm and my knees, my toes and fingers get tingly and numb. My coordination is off and so is my motor skills. I can''t think straight I''m sick of it. Even felt nauseous. I have had stomach pains. I feel spaced out---- nose sometimes gets numb and tingly my left eye has been red and I feel brain dead. Tuesday September 6 Just feel in a daze. Wednesday, September 7-October 10 night trying to go to sleep. It was difficult due to shortness of breath. But finally around 1:30a.m. fell asleep with gf. November 3 I got up to go to work. I felt a little off balance eyes blurred and tired. Blisters on face getting bigger. At work answering phones and feeling a little dizzy 11:45 am I went to lunch at 12:30 and I was starting to feel strange again I stopped and ate. I felt I was wired on drugs then when left it was like my throat was tight and was real dizzy and eyes were blurred and felt like I was going to stop breathing and die. My ears, eyes and motor ability was impaired. I am so tired of feeling like this. It''s scary. I have dealt with burning sensation in my nose, throat and had acid reflux and nausea, vomiting. I''ve dealt a lot of pain suffering 2:10 pain in my knees. Last night was feeling weak in legs, arms my head my eyes are weird in legs, arms my head. My eyes are weird. I went to my friend''s house and felt like I was going to fall over trying to walk in his door. I was slowed down. Friday, November 4 I woke up tired I''m at work answering phones no attack yet. That evening my energy was very bad. I was dizzy felt retarded like I had blurred vision and was very slow at moving weak knees and arm and legs I went to Dr. Saturday, November 5 Just laid around and was tired weak had blood in my stool twice. Monday, November 7 I went back to my neurologists EEG results were negative. He said didn''t find anything that looked to be a worry. As a matter of fact, he said it''s probably the Sjogren''s Syndrome causing the effects. Tuesday, November 8 8:10 am I went to eye doctor and had an eye exam done and of course nothing wrong that he could see my right eye 20-20 left eye was harder to read the line like the right and was like 20-35. My eyes get red mainly my left eye gets a bull red color day to day. Stayed home blurred vision due to dilation of eyes. November 9 Worked in office answering phones no weird feelings present while sitting it seems to come around eating and sun and heat. I got home around 5:30 pm and started feeling strange. Dizzy, short breath, itchy feet on the top of hands and feet. My joints hurt in my wrists and fingers my hands get splotchy red stripes across them and itch. November 10 Thursday morning woke up feeling dizzy, drunk feeling I have no idea what''s going on with my eyes and brain. I feel stupid retarded feeling. I ate some yogurt and couple pieces of chocolate and I''m feeling weird dizzy, short of breath, and my eyes feel weird and my brain something is attacking 9:30 am I feel strange, dizzy and brain. November 11th I went to work feel weird like something going on with my brain and vision. Balance and joint pain, red on hands pain comes and goes feel brain fog. Fatigue dizzy went to rheumatologist; blood test unequivocal for Sjogren''s syndrome was referred to dermatology, Dr. look at spot on face needs to be blistered before biopsy. Back at work no changes dizzy. Phone call from a radiologist for an appointment Jan 3. 9:15 am. Saturday, November 12 no change felt a little dizzy. Sunday, November 13 I went to mall walked around for an hour came back to truck and I was feeling tired, dizzy went home and watched tv and around 11:30 I went to lay down as I shut my eyes. I felt short of breath and had a panic of some sort. I had difficult time breathing. I was up to 3:30 am unable to go to sleep my body got numb and tingly. Monday, November 14 I went to draw blood went to lawyers office for consultation stayed with my parents around 10:30 I felt a little numb in my arms. I went to bed on October 10 I went to work light duty in office. I felt weird at 12:30 when I left to lunch feet and toes numb and face numb and tingly, dizzy and lightheaded, driving to go eat. Joints, muscles are weak like I have nerve damage, my eyes are blurred and my head and face are tingly. I cried a few min. and I''m not the same I feel fatigue tired like I don''t care anymore. Around 2:45 p.m. I called clinic and talked to someone and told her what all I''ve been through and she gave me a lot number and the name of the tetanus shot they gave me. Diphtheria Tetanus Exp. 2013 Lot#U3696BA the manufacturers name is SANOFI Pasteur Ingredients she said were Thimerosal, Aluminum Adjutant Residual Formaldehyde. Then she said someone would be getting back to me very soon. Never heard from anyone. I called office to see if they had made my other three appointments. She said she was faxing my referrals to them and I would be hearing from them soon. October 13 Went to another neurologist Dr. to get some answers. They did a serious blood test. Waiting for results. Went home feeling weak and dizzy. My arms felt heavy like lead like I could barely hold anything and it comes and goes. It''s a crawling feeling, numbness and fatigue. October 14- went to work answered phones. I did ok up till lunch. I went out to eat and felt weird again like my vision was blurred again, and I was off balance. Friday evening my gf came over. We went to dinner I drove and started having blurred vision in the dark on highway I was feeling weird around 8:00p.m. Saturday, October 15 I went to my parents ranch to get away the day to spend the night. It was a struggle to walk around to the feeders but I tried to work my muscles my vision and balance was off a bit it comes and goes. Sometimes I feel almost normal then here comes that feeling numbness, cramps in arms, joints, blurred fuzzy vision. Itchy on head sometimes feel like needles are stabbing me in stomach and head. Sunday October 16 I felt good most of the day up till the evening around 7:00 pm when I was going to eat I started feeling strange up to be time around 11:00 went to be woke up dizzy, and my fingers and toes and feet were numb and tingle last night, and was having needles stabbing me in my stomach and a pain in my head on left side like crawling weird pains. October 17th Monday morning woke up dizzy drove to work sitting to answer phones my head feels weird and face is a little numb on left side. Someone from my work come in to talk to me to say she and co-worker want to have a conference call meeting with me to go over my vacation time left and my opinions. October 18th 8:30 am went to my neurologist. Dr. to do a nerve study and get blood results and get diagnosed with Sjogren''s syndrome. I am being sent to a rheumatologist so I wait. 9:26 am I have a funny burning sensation in my throat esophagus. November 1 - Woke up in the middle of night stomach cramps then had bowel movement went back to bed. Got up again and had acid reflux threw up twice in toilet. I drove to work answering phones. Left work 1 hour early flu like symptoms diarrhea and throwing up. November 2 Stayed home sick getting a little better. That evening noticed red spot on my face started blistering again what was said to be shingles. My head was not feeling right and my vision is still fuzzy. My neighbor said my left eye was red and puffy. That problem. My walking was a little unsteady my knees felt like they were going to buckle very weak. November 15 woke up at 5:50 am a little dizzy. Pain in left eye sometimes itchy and weak. November 16 Pretty much the same comes and goes numbness and dizzy talked to co-worker. He is putting me on short term disability. November 17 Last day of work. November 18-23 weak, slow, fatigue and lots of joint pain I had GI doctor had colonoscopy and upper GI found ulcer in esophagus. (Esophagitis) prescribed NEXIUM. Still feel lightheaded, fatigue and dizzy, and joint pain. November 29 went to Dr.; she referred to ENT to take biopsy of mouth to determine if I have Sjogren''s Syndrome. November 29-December 6 dizzy, lightheaded, joint pain and fatigue. Friday, December 9 Extremely dizzy, very fatigue moved very slowly. Saturday, December 10 Very fatigue joint tenderness in knuckles, wrists, left shoulder I could hardly walk very tired and slowed down. Motor coordination very weak. Sunday, December 11 very tired and laid on couch most of the day no energy. Monday, December 12 Still very tired and laid around joint pain. Tuesday, December 13 Went to see ENT Dr. consult. Wednesday, December 14 Dr. did lip biopsy had to put 2-3 stitches on left side of mouth and took skin from right side too. I felt lightheaded, no energy tired joint pain throughout body. Friday December 16 2:00 pm driving to back; had difficulty breathing nose numb, shortness of breath lasted two hours almost had to pull over and call EMS left shoulder tingly, weak knees, ankles, knuckles, wrist, all joint areas very painful. December 17-21 Very fatigue, joint pain, knuckles pain in the center of my palm. December 22 Going back to ENT to get results of lip biopsy; extreme fatigue, pain in joints especially knuckles and hands cramping wrists. Jan. 3 3rd MRI. Jan. 4 GI follow up visit for esophagitis. Jan. 5 Dr. rheumatologist follow up. Feb. 6 follow up with neurologist Dr. from 3rd MRI.


VAERS ID: 446332 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Male  
Location: Georgia  
Vaccinated:2011-11-18
Onset:2011-11-20
   Days after vaccination:2
Submitted: 2011-12-22
   Days after onset:32
Entered: 2011-12-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH505AA / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Aphagia, Death, Headache, Malaise
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-11-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had a medical history of increased blood pressure and "Dbj". It was unknown if the patient had any illnesses at the time of vaccination, or had any vaccinations within 4 weeks of the influenza vaccine. The patient''s concomitant medications were unknown. It was reported that the patient had no previous influenza vaccines.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201112429

Write-up: Initial report was received on 19 December 2011 from a consumer who is also the patient''s parent and additional information was received from a health care professional. A 43-year-old male patient received an injection (route and site not reported) of INFLUENZA VACCINE, Sanofi Pasteur Inc. lot not reported, on 17 November 2011 (also reported as 18 November 2011). The patient had a medical history of increased blood pressure and "Dbj". It was unknown if the patient had any illnesses at the time of vaccination, or had any vaccinations within 4 weeks of the influenza vaccine. The patient''s concomitant medications were unknown. It was reported that the patient had no previous influenza vaccines. The parent stated that the patient was seen by her on 18 November 2011 and he had been sick after receiving the influenza vaccine and was having a severe headache and could not eat. The patient had called 911 on Sunday and was taken to a hospital. The patient died on 21 November 2011. The outcome was reported as fatal. Documents held by sender: None.


VAERS ID: 446850 (history)  
Form: Version 1.0  
Age: 0.56  
Sex: Female  
Location: New York  
Vaccinated:2011-10-31
Onset:2011-11-01
   Days after vaccination:1
Submitted: 2011-12-20
   Days after onset:49
Entered: 2012-01-05
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4176BA / 1 RL / IM

Administered by: Military       Purchased by: Public
Symptoms: Death, Laboratory test, Pyrexia, X-ray
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-11-03
   Days after onset: 2
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: Nebulizers; Diuretics; Antireflux meds; Pain mgmt
Current Illness: Vent dependent; BPD
Preexisting Conditions: Former 24 week premature infant - in hospital NICU throughout her life.
Allergies:
Diagnostic Lab Data: All radiographic/laboratory data unable to explain fever or death
CDC Split Type:

Write-up: Infant developed very high fever (sepsis ruled out) hours after vaccine. Despite maximal medical support, infant died. No explanation for fever could be found.


VAERS ID: 447405 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2011-02-19
Submitted: 2012-01-13
   Days after onset:328
Entered: 2012-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA592AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Chest X-ray abnormal, Cough, Death, Hypotension, Incorrect storage of drug, Increased upper airway secretion, Influenza, Influenza A virus test positive, Lung disorder, Mechanical ventilation, Pyrexia, Sepsis, Tachypnoea, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebral palsy; Inability to move; Inability to speak; Intellectual disability; Neurological impairment
Preexisting Conditions: Aspiration pneumonia
Allergies:
Diagnostic Lab Data: Body temperature, 19Feb2011, 38.4deg.C; Chest x-ray, 19Feb2011, lung opacities; Oxygen saturation, Feb2011, 88%; Respiratory rate, Feb2011, 24bpm
CDC Split Type: B0774395A

Write-up: This case was reported in a literature article and described the occurrence of influenza A in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). This case corresponds to patient A in the literature article. The subject''s medical history included aspiration pneumonia and history of abnormalities noted on chest radiography. Concurrent medical conditions included inability to move, inability to speak, cerebral palsy, intellectual disability and neurological impairment. Between October and November 2010, the subject received an unspecified dose of FLULAVAL (administration site and route unknown) which was incorrectly stored: the vaccine refrigerator temperature was considerably below optimal temperature during the investigation. On 19 February 2011, within months of vaccination with FLULAVAL, the subject experienced fever (38.4 deg.C). His oxygen saturation was 88% on room air. On illness day 2, the subject developed mild cough and wheezing. On day 3, he became tachypneic and required increased respiratory suctioning. On day 5, the subject was hospitalised with fever (38.5 deg.C) and respiratory rate of 24 bpm. On day 6, he was tested positive for influenza A and developed both acute respiratory distress syndrome requiring mechanical ventilation and sepsis with hypotension requiring vasopressor support. On day 7, the chest radiography showed diffuse lung opacities that progressed to complete opacity of both lungs. The subject was treated with ciprofloxacin, Piperacillin, Tazobactam, vancomycin, Oseltamivir, oxygen, mechanical ventilation and vasopressor. The subject died in February 2011 on day 8, the cause of death was not reported. It was unknown whether an autopsy was performed. Summary of the literature article: Children with neurological and neurodevelopmental conditions are at increased risk for severe outcomes from influenza, including death. In April 2011, the state Department of Health and CDC investigated an influenza outbreak that began in February 2011 in a residential facility for 130 children and young adults with neurologic and neurodevelopmental conditions. This report summarizes the characteristics and clinical courses of 13 severely ill residents with suspected or confirmed influenza; 10 were hospitalized, and seven died. Diagnosis is challenging in this population, and clinicians should consider influenza in patients with neurologic and neurodevelopmental conditions who have respiratory illness or a decline in baseline medical status when influenza is circulating in the community. The findings in this report are subject to at least two limitations. First, a broad case definition was used to identify suspected cases, and not all ill residents underwent diagnostic testing; thus, respiratory pathogens other than influenza might have contributed to this outbreak. Second, residents of this facility are considerably more medically fragile than subjects with mild neurologic and neurodevelopmental conditions; therefore, this report is not generalizable to all patients with neurologic and neurodevelopmental conditions or all patients in residential-care centers. The authors'' conclusion stated that prompt testing, early and aggressive antiviral treatment, and antiviral chemoprophylaxis are important for these subjects. When influenza is suspected, antiviral treatment should be given as soon as possible after symptom onset, ideally within 48 hours. Treatment should not wait for laboratory confirmation of influenza. During outbreaks, antiviral chemoprophylaxis should be provided to all residents of institutional facilities (e.g., nursing homes and long-term care facilities), regardless of vaccination status. Residential facilities for subjects with neurologic and neurodevelopmental conditions are encouraged to vaccinated all eligible residents and staff members against influenza.


VAERS ID: 447716 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2012-01-19
Onset:2012-01-20
   Days after vaccination:1
Submitted: 2012-01-20
   Days after onset:0
Entered: 2012-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4000AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916974 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1393AA / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-20
   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: Infant TYLENOL; Simply Saline
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Jan 20 2011 5 pm Call from hosp/med ctr. Mother accompanied infant to ER. Resp difficulty infant had cardiac arrest. Expired. Infant had been sleeping in parent bed with his father.


VAERS ID: 448161 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: California  
Vaccinated:2011-09-23
Onset:2011-10-01
   Days after vaccination:8
Submitted: 2012-01-26
   Days after onset:117
Entered: 2012-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0621AA / UNK - / SC

Administered by: Other       Purchased by: Private
Symptoms: Blister, Burning sensation, Herpes zoster, Oropharyngeal pain, Rash, Urinary tract infection
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: 2012-01-04
   Days after onset: 95
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lyrica, Ramipril, Norco, Methotrexate, Carvedilol, Amlodipine, Omeprazole, Ferrous Sulfate, Crestor, Furosemide, Clotrimozole, Humera
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Contracted Shingles, Urinary Tract Infection
CDC Split Type:

Write-up: Sore throat, blisters on scalp, burning sensation, rash.


VAERS ID: 448347 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Indiana  
Vaccinated:2012-01-26
Onset:2012-01-29
   Days after vaccination:3
Submitted: 2012-01-30
   Days after onset:1
Entered: 2012-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3892BA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0894AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F56177 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB200A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received report from hospital that patient had died from SIDS.


VAERS ID: 448515 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-01-31
Entered: 2012-02-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Neoplasm malignant
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1201USA03255

Write-up: Information has been received from a pharmacist concerning a consumer''s female friend, who on an unknown date, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). It was reported that the patient was diagnosed with an unspecified type of cancer on an unspecified date shortly after the vaccination with ZOSTAVAX (Merck). It was also reported that the patient died six months after she was diagnosed with cancer. It was reported that the cancer was not a congenital anomaly. At the time of the report, the cause of the patient''s death is unknown. Additional information has been requested.


VAERS ID: 448544 (history)  
Form: Version 1.0  
Age: 0.97  
Sex: Male  
Location: West Virginia  
Vaccinated:2012-01-25
Onset:2012-01-27
   Days after vaccination:2
Submitted: 2012-02-01
   Days after onset:5
Entered: 2012-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4231BB / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-27
   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: amoxicillin-potassium clavulanate 600 mg-42.9 mg/5 mL Oral Susp, 1/2 Teaspoon(s), PO, BID, 10 days, for a total of 50, start on January 18, 2012 and end on January 27, 2012.
Current Illness: NASAL CONGESTION
Preexisting Conditions: ATRIAL SEPTAL DEFECT AT BIRTH PLANNED TO RECHECK AT 1 YEAR OF AGE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: UNKNOWN- ADVERSE EVENT ONSET TIME IS UNKNOWN.


VAERS ID: 448732 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Florida  
Vaccinated:2010-04-07
Onset:2010-04-07
   Days after vaccination:0
Submitted: 2012-02-03
   Days after onset:667
Entered: 2012-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3500AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. D890Y / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E01563 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1442Y / 1 MO / PO

Administered by: Unknown       Purchased by: Private
Symptoms: Crying, Decreased appetite, Emotional distress, Hypotonia, Muscular weakness, Posture abnormal, Screaming
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-09
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Lazy, limp, screaming, inconsolable, couldn''t hold himself up on his legs, hung his head and could hold it up for a few seconds like he could before, wouldn''t eat much, tried but cried instead.


VAERS ID: 448750 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: New Hampshire  
Vaccinated:2011-11-25
Onset:2012-01-09
   Days after vaccination:45
Submitted: 2012-02-03
   Days after onset:25
Entered: 2012-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3866AA / 2 UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVR982BB / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 916617 / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0677AA / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0103201201

Write-up: None stated.


VAERS ID: 449138 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-06
Entered: 2012-02-08
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201201249

Write-up: Initial report was retrieved via the scientific literature on 30 January 2012. From the published article: Objective: The objective of the study was to evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), in pregnant women who received H1N1 to assess for potential vaccine safety problems. Study Design: The authors reviewed reports of adverse events (AEs) in pregnant women who received H1N1 vaccines from Oct. 1, 2009, through Feb. 28, 2010." Results: The results found 422 reports which involved pregnant women. Of the 422 reports, 128 were reports in which there were no AEs were reported. Of the remaining 294 reports, 288 had received inactivated vaccines and 6 had received lived vaccines. Medical records were obtained for 240 reports (81.6%). Sixty reports (20.4%) were coded as serious, including 2 maternal deaths. Serious reports corresponded to 59 pregnant women who were hospitalized for any reason and one to an infant born with a congenital anomaly. Of the reported cases 121 women had spontaneous abortions (at less than 20 weeks gestation) with onset interval from the day of vaccination to onset of AE reported as 0-3 days (61 reports with onset of 0-6 days). Stillbirths were reported in 19 women with the onset interval from the day of vaccination to onset of AE was 0-6 days. It was noted that there was no observed clustering of spontaneous abortions or stillbirth cases by geographic location or lot number. There were two maternal deaths which included one patient who experienced hemorrhagic shock because of uterine atony following a cesarean section and one patient who experienced a ruptured aortic aneurysm, which resulted in cardiac tamponade and subsequent death. Other pregnancy-specific outcomes reported included: preterm delivery, threatened abortion, preterm labor, preeclampsia, intrauterine growth restriction, fetal hydronephrosis (which was later determined not to be present), fetal tachycardia, neonatal intraparenchymal hemorrhage and intrauterine fetal death. The most common nonpregnancy specific AEs were nonanaphylactic allergic reactions, constitutional symptoms, and local reactions. Other non-pregnancy-specific outcomes reported included: paresthesias, Bell''s palsy, syncope, dizziness, hypoesthesia, headache and one case of anaphylaxis. There were no cases of Guillain-Barre syndrome identified. Conclusion: During October 2009 through February 2010, approximately 3% of reports to VAERS after H1N1 vaccine were of pregnant women who experienced at least 1 AE after vaccination. Among 294 VAERS reports of AEs in pregnant women after H1N1 vaccination with inactivated and live vaccines, the authors did not observe any unusual patterns of adverse maternal or fetal outcomes. The reporter for this case is also the reporter for case 2012-01250. Documents held by sender: none.


VAERS ID: 449283 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Female  
Location: Texas  
Vaccinated:2011-10-04
Onset:2011-10-11
   Days after vaccination:7
Submitted: 2012-01-23
   Days after onset:104
Entered: 2012-02-09
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR IU465AA / 2 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Anion gap increased, Aspartate aminotransferase increased, Basophil percentage decreased, Bilirubin conjugated, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased, Blood chloride decreased, Blood creatinine increased, Blood glucose increased, Blood magnesium decreased, Blood phosphorus, Blood potassium decreased, Blood sodium decreased, Blood urea increased, Blood urea nitrogen/creatinine ratio, Carbon dioxide decreased, Death, Eosinophil percentage decreased, Feeling cold, Globulins increased, Granulocyte percentage, Haematocrit normal, Haemoglobin normal, Immunoglobulins, Laboratory test, Livedo reticularis, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased, Mean platelet volume increased, Monocyte percentage, Platelet count decreased, Protein total decreased, Protein total normal, Pulse absent, Red blood cell count normal, Red cell distribution width increased, Respiratory arrest, Resuscitation, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amiloride HCl 5mg tab; Cetirizine HCl 10mg tab; Epinephrine 0.3mg auto injector ea; Flunisolide, 0.025% 200D nasal inh spray; Ketotifen fumarate, 0.025% oph soln; Magnesium Cl 535mg (64mg mag) SR tab; Mometasone 200mcg inh; Omeprazole 20mg
Current Illness: None noted
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 10/11/2011, Na, 122 mmol/L L; K, 3.7 mmol/L; Cl, 62 mmol/L L; CO2, 20.0 mmol/L L; Glucose, 493 mg/dL H; BUN, 78 mg/dL H; Creat, 7.3 mg/dL H; AST, 197 U/L H; ALT, 79 U/L H; ALP, 71 U/L; T. Bil, 1.0 mg/dL; D Bili mg/dL; Alb, 2.5 G/dL L; Calcium, 6.9 mg/dL L; PO4, mg/dl; Mg, 0.9 mEq/L L; Ani Gap, 40.0 mmol/L H; BUN/Cr, 10.7; Glob, 3.6 G/dL; T Prot, 6.1 G/dL; WBC, 19.3 K/cu mm H; RBC, 4.21 M/cu mm; Hgb, 14.9 g/dL; Hct, 40.8%; MCV, 96.9 fL; MCH, 35.4 pg H; MCHC, 36.5 g/dL, RDW, 14.4%; Plt, 134.0 K/cu mm L; MPV, 14.1 fL H; Lymph, 12.7% L; Mono, 5.9%; Gran, 64.5%; Eos, 0%; Baso, 0%; IM, 1.0%; Ly, 1.67 K/cu mm; 10/04/2011, Na, 134 mmol/L; K, 2.8 mmol/L L; Cl, 98 mmol/L; CO2, 22.2 mmol/L; Glucose, 93 mg/dL; BUN, 4 mg/dL L; Creat, 0.5 mg/dL; AST, 133 U/L H; ALT, 79 U/L; ALP, 71 U/L; T. Bil, 0.6 mg/dL; Alb, 3.2 G/dL; Calcium, 8.7 mg/dL; Ani Gap, 14.0 mmol/L; BUN/Cr, 7.5 L; Glob, 3.3 G/dL; T Prot, 6.5 G/dL; WBC, 8.0 K/cu mm; RBC, 3.61 M/cu mm L; Hgb, 12.7 g/dL; Hct, 38.0%; MCV, 105.3 fL H; MCH, 35.2 pg H; MCHC, 33.4 g/dL; RDW, 15.4%; Plt, 200.0 K/cu mm; MPV, 10.1 fL; Lymph, 20.8%; Mono, 7.0%; Gran, 70.3%; Eos, 0.5%; Baso, 0.4%
CDC Split Type:

Write-up: Patient was found down by significant other and brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of resuscitation, time of death was called.


VAERS ID: 449334 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:2009-01-01
Onset:2011-08-27
   Days after vaccination:968
Submitted: 2012-02-09
   Days after onset:166
Entered: 2012-02-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Death, Gene mutation identification test positive
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-27
   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: Gene mutation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: diagnostic laboratory, genetic mutation (FUS): positive
CDC Split Type: WAES1202USA00710

Write-up: Information has been received from a physician concerning a 19 year old female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported, dose number unknown). Approximately a year and a half prior to developing the onset of rapidly progressive ALS (amyotrophic lateral sclerosis). It was unknown if the patient was on any medications or had concomitant vaccinations. Patient died within a year of symptom onset. Patient was found to be positive for a genetic mutation (FUS) recently recognized as associated with early-onset, rapidly progressive ALS. Her parents also had the mutation. It was not reported if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 449429 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Male  
Location: California  
Vaccinated:2012-01-25
Onset:2012-01-26
   Days after vaccination:1
Submitted: 2012-02-10
   Days after onset:15
Entered: 2012-02-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER WL00041788 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH WL0043329 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. WL00042295 / 1 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Autopsy, Blood culture positive, Culture urine positive, Death, Dyspnoea, Lung infiltration, Pyrexia, Resuscitation, Streptococcus test positive
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-27
   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: None
Preexisting Conditions: Umbilical hernia
Allergies:
Diagnostic Lab Data: Blood & urine cultures positive for both, hemolytic Streptococcus. Preliminary autopsy report -$g polymorphonuclear leukocyte infiltration of lungs and other organs.
CDC Split Type:

Write-up: Within hours of vaccination (night of vaccination day) infant became febrile. At approximately 2:00AM on 1/26/2012, he was taken to hospital because of breathing difficulty. Infant was resuscitated at hospital but expired on 1/27/2012.


VAERS ID: 449546 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Kentucky  
Vaccinated:2012-01-23
Onset:2012-01-25
   Days after vaccination:2
Submitted: 2012-02-14
   Days after onset:20
Entered: 2012-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4083AA / UNK RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 917737 / UNK LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1512AA / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-25
   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: Mylicon
Current Illness: No
Preexisting Conditions: Premature Birth Live Child 36 weeks Gestation
Allergies:
Diagnostic Lab Data: Autopsy results pending
CDC Split Type:

Write-up: Baby found dead by mother.


VAERS ID: 449871 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-17
Entered: 2012-02-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Caesarean section, Death, Live birth, Maternal exposure during pregnancy, Post procedural complication, Shock haemorrhagic, Uterine atony
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Caesarean section
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012US012947

Write-up: Case number PHHY2012US012947 is an initial literature report received on 14 Feb 2012. The authors published the adverse events following administration of H1N1 to pregnant women that were reported to Vaccine Adverse Event Reporting System (VAERS). This case refers to a female patient (age not specified). She was vaccinated with H1N1 (manufacturer and batch number: unknown) between 01 Oct 2009 to 28 Feb 2010. She was pregnant at the time of vaccination. On an unspecified date she had a cesarean section and she gave birth to a live neonate. Following caesarean the patient experienced uterine atony which led to hemorrhagic shock. The patient died due to hemorrhagic shock. The causality of the case was not reported. The authors stated that the VAERS database search did not reveal any clustering of spontaneous abortions, still births or congenital anomalies. Authors concluded that the pregnant women who were vaccinated with H1N1 inactivated and live vaccines did not show unusual pattern of maternal or fetal outcomes.


VAERS ID: 450086 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Illinois  
Vaccinated:2012-02-06
Onset:2012-02-07
   Days after vaccination:1
Submitted: 2012-02-22
   Days after onset:15
Entered: 2012-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ADEN_4_7: ADENOVIRUS TYPES 4 & 7, LIVE, ORAL (NO BRAND NAME) / TEVA PHARMACEUTICALS 348000018 / UNK UN / UN
FLUN3: INFLUENZA (SEASONAL) (FLUENZ) / MEDIMMUNE VACCINES, INC. 04949221AA / UNK UN / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB221AA / 1 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4256AA / 1 UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B075BA / 1 UN / IM

Administered by: Military       Purchased by: Military
Symptoms: Bacterial test negative, Blood culture negative, CSF culture negative, Cold agglutinins negative, Culture urine negative, Death, Diarrhoea, Dizziness, Drug screen negative, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Intensive care, Laboratory test abnormal, Legionella test, Lung infiltration, Mechanical ventilation, Multi-organ failure, Mycoplasma test, Pyrexia, Respiratory arrest, Respiratory syncytial virus test negative, Sputum culture, Streptococcus test negative, Treponema test negative, Treponema test positive, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-02-10
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADENOVIRUS VACCINE 06 FEB 2012
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: SHE HAD A POSITIVE RPR. ALL OF THE FOLLOWING WERE NEGATIVE: RESP - FLU A/B, H1N1, RSV, M PNEUMONIA, SPUTUM CX; BLOOD - CX, MHA-TP, COLD AGGLUTININS; CSF - BACT AND VIRAL CX, GRP B STREP, STREP PNEUMO, HIB, NEISSERIA MEN A/C/Y/W135, NEISSERIA MEN B/E COLI K1-0 AGS; URINE - CX, LEGIONELLA AG, DRUG SCREEN
CDC Split Type:

Write-up: PATIENT PRESENTED WITH VOMITING AND DIARRHEA ON 8 FEB. AAS SHOWED PULM INFILTRATE. PT STARTED ON PO ABX. PT STARTED FEELING FEVERISH ON THE EVENING OF 8 FEB. 9 FEB WOKE UP FEELING LIGHTHEADED AND DIZZY. TAKEN BY AMBULANCE TO ED, WHERE SHE SUFFERED RESP ARREST. CODED 3 TIMES. ADMITTED TO ICU ON VENT. DEVELOPED MULTI-ORGAN SYSTEM FAILURE. DIED ON 10 FEB.


VAERS ID: 450410 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-24
Entered: 2012-02-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1202USA03017

Write-up: Information has been received from a pharmacist concerning an unspecified patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, batch # and route not reported) for prevention of shingles. The pharmacist stated that she heard from an unspecified pharmacist who stated that he heard from another unspecified person that the patient died after receiving ZOSTAVAX (Merck). Attempts are being made to verify the existence of an identifiable patient. No further information is available.


VAERS ID: 450453 (history)  
Form: Version 1.0  
Age: 1.07  
Sex: Male  
Location: Maine  
Vaccinated:2012-02-07
Onset:2012-02-08
   Days after vaccination:1
Submitted: 2012-02-22
   Days after onset:14
Entered: 2012-02-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4003AA / 4 RL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4149CA / 1 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0852AA / 1 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F17155 / 1 LL / IM

Administered by: Public       Purchased by: Public
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: 2012-02-08
   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: None
Current Illness: None known
Preexisting Conditions: None known
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found unresponsive by babysitter. EMS called to scene. Patient transported to ER at Medical Center. Time of death noted to be 20:48 on 2/8/12 by ER.


VAERS ID: 450655 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Michigan  
Vaccinated:2012-02-23
Onset:0000-00-00
Submitted: 2012-02-27
Entered: 2012-02-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1441AA / 2 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1495AA / 3 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-02-26
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:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None at time of service. Pt. expired 2-26-12.


VAERS ID: 450719 (history)  
Form: Version 1.0  
Age: 0.22  
Sex: Male  
Location: Minnesota  
Vaccinated:2012-01-30
Onset:2012-02-06
   Days after vaccination:7
Submitted: 2012-02-17
   Days after onset:11
Entered: 2012-02-28
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B323AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH524AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F65442 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41A213A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-02-06
   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: Ear infection and Bronchiolitis 1/16/12
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient at daycare, took nap at 12 Noon still sleeping at 2pm; found blue and unresponsive at 3pm.


VAERS ID: 450832 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2011-10-04
Onset:2011-10-14
   Days after vaccination:10
Submitted: 2012-02-29
   Days after onset:138
Entered: 2012-02-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED N57307 / 1 LA / IM

Administered by: Other       Purchased by: Other
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: 2011-10-19
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma (None listed on consent form at time of vaccination)
Allergies:
Diagnostic Lab Data: Autopsy performed that concluded pt had myocarditis in Rt ventricle/AV node.
CDC Split Type:

Write-up: Patient started feeling flu-like symptoms (nausea, diarrhea, extreme exhaustion) on 10/14/11 that lasted 2-3 days. Patient later passed away while playing Squash/handball on 10/19/11.


VAERS ID: 451000 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: California  
Vaccinated:2010-02-08
Onset:2010-02-16
   Days after vaccination:8
Submitted: 2012-03-03
   Days after onset:746
Entered: 2012-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB731AA / 1 LA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB2327AA / 1 RA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Activated partial thromboplastin time shortened, Aspiration pleural cavity, Chest X-ray abnormal, Coagulopathy, Computerised tomogram abnormal, Gastrointestinal haemorrhage, Haematocrit decreased, Haematoma, Haemoglobin decreased, Injection site reaction, International normalised ratio increased, Oedema peripheral, Oesophageal varices haemorrhage, Packed red blood cell transfusion, Platelet count decreased, Platelet transfusion, Pleural effusion, Prothrombin time prolonged, Swelling, Syncope, Ultrasound scan abnormal, Vaccination site haematoma, Vaccination site swelling
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-03-03
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? Yes
Previous Vaccinations: swelling of left arm at innoculation site~Pneumo (no brand name)~1~64.92~Patient
Other Medications: Protonix 40mg QD; Spiranolactone 25mg QAM; Toprol XL 25 mg QD; Lactulose 10 gm/15 3 TSP BID
Current Illness:
Preexisting Conditions: Decompensated liver disease, diabetes type 2, hepatic hypertension, osteoarthritis, atrial fibrillation
Allergies:
Diagnostic Lab Data: Left pleural effusion noted on 2/8/10 encompassing 3/4 of the left lung field increased significantly from 2/8/10 to 2/12/10 when a thorocentesis was performed. Subsequent CXR showed increase in pleural effusion of left lung on 2/16/10. CT scan on 2/17/2010 showed edema in left chest and left arm, fluid along the left deltoid and large left pleural effusion. Subsequent ultrasounds of left arm continued to show hypoechoic area in left upper arm measuring 17x5x6 cm. No evidence of DVT. 3/3/10 hgb 4.2 hematocrit 11.3 platelets 82. 3/1/10 hgb 8.3 hct 23.7 platelets 128, Protime 27.9, INR 2.6. 2/16/10 hgb 6.8 hct 18.6, platelet 128, Protime 30.0, INR 2.9. 2/10/10 hgb 11.8, hct 32.8, platelet 90, protime 26.2, INR 2.4, PTT 50.0. Baseline: 12/12/2009 Hgb 12.0, hct 34.2, platelet 98, protime 19.1, INR 2.5. From 02/16/10-3/3/10 Patient received several units of PRBCs, platelets and albumin.
CDC Split Type:

Write-up: Coagulopathy noted prior to scheduled thorocentesis. 02/16/10 syncope episode, GI bleed secondary to rupture of esophageal varices, INR increased to 2.4 swelling and hematoma beginning on left arm around vaccination site which grew over the course of approximately 5 days to entire arm, hand, shoulder and half of back. Left pleural effusion.


VAERS ID: 451286 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2012-01-12
Onset:2012-01-13
   Days after vaccination:1
Submitted: 2012-01-18
   Days after onset:5
Entered: 2012-03-08
   Days after submission:50
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4165AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F6117 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1456AA / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Death, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-13
   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: TRI-VI-SOL multivitamins, take by mouth once daily
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient received her 4 month vaccines (PENTACEL - (DTaP-Hib-IPV), PREVNAR 13 (pneumococcal 13 Conj) and Rotavirus oral vaccine) on 1/12/12 around 12 noon. On 1/13/12 at 1022 our office received a call from Dad stating patient stopped breathing at daycare, 911 called. At 1652 on 1/13/12 the coroner called to report her death.


VAERS ID: 451373 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Male  
Location: Connecticut  
Vaccinated:2012-03-02
Onset:2012-03-09
   Days after vaccination:7
Submitted: 2012-03-09
   Days after onset:0
Entered: 2012-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0599AA / 1 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0814AA / 1 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Otitis - conjunctivitis syndrome dx''ed that day
Preexisting Conditions: Mild dev. delay
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Unexplained crib death 7d after MMR + VARIVAX.


VAERS ID: 451473 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Female  
Location: Kansas  
Vaccinated:2012-01-16
Onset:2012-02-10
   Days after vaccination:25
Submitted: 2012-03-09
   Days after onset:28
Entered: 2012-03-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0952AA / 1 RA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0826AA / 1 LL / UN

Administered by: Other       Purchased by: Other
Symptoms: Cholecystectomy, Cholecystitis, Death, Herpes zoster, Rash, Respiratory failure, Skin lesion, Varicella, Varicella virus test positive, Viraemia
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-02-19
   Days after onset: 9
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: Unknown
Current Illness: End stage renal disease (ESRD); Lupus erythematosus; Transplant failure
Preexisting Conditions: Renal transplant
Allergies:
Diagnostic Lab Data: Cholecystectomy, 02/11/12; Serum varicella zoster, VZV positive
CDC Split Type: WAES1202USA04133

Write-up: Information has been received from a Doctor of microbiology and a licensed practical nurse (LPN) concerning a 45 year old female with end stage renal disease (ESRD), lupus, a history of renal transplant that was failing so patient was being considered for another one; who on an unspecified date, may have been vaccinated or exposed to someone who was vaccinated with a dose of VARIVAX (Merck) (manufacturer unknown) (lot number, dose and route not reported). The LPN reported that after much investigation it could not be determined if the patient had ever received a VARIVAX (Merck) (manufacturer unknown) or if she was exposed to chicken pox, and stated that the office would not have authorized or administered a live vaccine to a immunosuppressed patient. The Doctor of Microbiology reported that on 10-FEB-2012, the patient was admitted to the hospital with a diagnosis of cholecystitis. On 11-FEB-2012 a cholecystectomy was performed. On 15-FEB-2012, rash and skin lesions appeared. On an unspecified date, strain identification for samples was found to be varicella zoster virus (VZV) positive in the lab. The patient experienced respiratory failure on 19-FEB-2012 and died at 11:28 hours. The doctor of microbiology reported that there was "disseminated varicella" at time of death. The cause of death was respiratory failure secondary to herpes zoster viremia. It was unknown if an autopsy was performed (death certificate showed No for autopsy). Additional information has been requested.


VAERS ID: 451752 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: California  
Vaccinated:2010-12-06
Onset:2010-12-14
   Days after vaccination:8
Submitted: 2012-03-09
   Days after onset:451
Entered: 2012-03-14
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 1416Z / UNK RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Cardiac failure congestive, Cough, Death, Dyspnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-26
   Days after onset: 12
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: None
Preexisting Conditions: Aortic stenosis; Dementia; CAD; HTN; GERD; Chronic renal insuff; Dyslipidemia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Admitted 12/16/10 for cough x 3 days, and SOB. Found to be in CHF. Hospitalized for approximately 8 days and released to hospice. Patient expired 12/26/10. Patient had ZOSTAVAX 10 days prior to admission.


VAERS ID: 452127 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2012-02-15
Onset:0000-00-00
Submitted: 2012-03-20
Entered: 2012-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4115AA / 1 RL / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC070BA / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 917787 / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1474AA / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-02-16
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 passed away the day after his well exam. Vaccines were not indicated as a reason for death.


VAERS ID: 452215 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Arizona  
Vaccinated:2007-04-09
Onset:2007-04-11
   Days after vaccination:2
Submitted: 2012-03-21
   Days after onset:1806
Entered: 2012-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2570BA / 2 LA / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UFO65AB / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y1032 / 2 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08681F / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0022U / 2 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin decreased, Haematocrit decreased, Haemoglobin decreased, Laboratory test, Lymphocyte count increased, Neutrophil count normal, Platelet count normal, Pyrexia, Red blood cell count decreased, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-04-18
   Days after onset: 7
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: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: marked elevation in white blood cell count with no evidence of bleeding (34,200/mL); low hemoglobin (9.9 gm/dL) and hematocrit (27.6%) (no trauma); 21,500 lymphocytes/mL; 7900 neutrophils/mL; 3.4 mil red blood cells/mL; ALT 285 U/L; AST 358 U/L; Albumin 2.1 gm/dL; 450,000 platelets/mL; and some more
CDC Split Type:

Write-up: Onset of fever; fever never went away.


VAERS ID: 452383 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Ohio  
Vaccinated:2011-11-03
Onset:2011-12-02
   Days after vaccination:29
Submitted: 2012-03-25
   Days after onset:113
Entered: 2012-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH475AB / UNK LA / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-12-02
   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: 1. September 18, 2011 - Sick with cold/flu 2. October 9, 2011 - vomited through nose, dry heaves 3. October 19, 2011 - diagnosed with sinus infection; dizzy; short of breath; labwork - prescribed calcium awaiting urinalysis results for f
Current Illness: IN-PATIENT STAY 11/1-6/2011
Preexisting Conditions: DIABETES DIAGNOSED 5/2011
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: DEATH.


VAERS ID: 452453 (history)  
Form: Version 1.0  
Age: 0.78  
Sex: Male  
Location: Kentucky  
Vaccinated:2012-02-20
Onset:0000-00-00
Submitted: 2012-03-26
Entered: 2012-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4231B / 2 LL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-26
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: Cold; No routine med
Preexisting Conditions: Baby born 3 wks premature
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Baby died at home DOA at hosp.


VAERS ID: 452597 (history)  
Form: Version 1.0  
Age: 1.22  
Sex: Female  
Location: Alabama  
Vaccinated:2012-03-27
Onset:2012-03-28
   Days after vaccination:1
Submitted: 2012-03-28
   Days after onset:0
Entered: 2012-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1586AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 917243 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0979AA / 1 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-28
   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: Lissencephaly; Perimembranous VSD; PFO; seizures
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Per parent, patient acting appropriately yesterday afternoon and last night - playful. Parent woke up around 4:15 am and child not breathing.


VAERS ID: 452752 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: California  
Vaccinated:2012-03-28
Onset:2012-03-29
   Days after vaccination:1
Submitted: 2012-03-30
   Days after onset:1
Entered: 2012-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4155AA / 1 LL / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC029CA / 2 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 917242 / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1195AA / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Pulse absent, Sudden infant death syndrome, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetaminophen
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: SIDS evaluation via coroner''s office
CDC Split Type:

Write-up: 2 month old found pulseless & unresponsive at home 7am 21 hrs after 2 month vaccines.


VAERS ID: 452753 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: California  
Vaccinated:2012-03-23
Onset:2012-03-27
   Days after vaccination:4
Submitted: 2012-03-30
   Days after onset:3
Entered: 2012-04-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4043AD / 1 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Intensive care
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-27
   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:
Current Illness: Status post 2 recent spinal surgeries
Preexisting Conditions: Rett''s syndrome
Allergies:
Diagnostic Lab Data: Recent PICU stay d/c 2/28/12
CDC Split Type:

Write-up: 11 y/o female with Rett''s syndrome, scoliosis, has had 2 recent spinal surgeries (1/31/12 anterior, 2/8/12 posterior).


VAERS ID: 453010 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2012-03-20
Onset:2012-03-29
   Days after vaccination:9
Submitted: 2012-04-04
   Days after onset:6
Entered: 2012-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0692AA / 2 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Loestrin 1/20mg one daily. Cetraxal 0.2% solution 2 drops bid for 7 days
Current Illness: none
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Undetermined cause death occurred nine days after 2nd injection of Gardasil. 1st dose on 01/31/2012.


VAERS ID: 453048 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-04
Entered: 2012-04-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abscess drainage, Adenovirus test, Antibody test negative, Anticonvulsant drug level therapeutic, Bacterial test negative, Biopsy brain abnormal, Biopsy skin abnormal, Brain death, Brain oedema, CSF culture negative, CSF glucose decreased, CSF glucose normal, CSF lymphocyte count increased, CSF measles antibody negative, CSF monocyte count decreased, CSF protein increased, CSF protein normal, CSF virus no organisms observed, CSF white blood cell count increased, Central nervous system inflammation, Central nervous system lesion, Chills, Chronic granulomatous disease, Computerised tomogram head normal, Conjunctival hyperaemia, Conjunctivitis, Cryptococcus test, Cytomegalovirus test negative, Death, Demyelination, Electroencephalogram abnormal, Encephalitis, Encephalitis post measles, Enterovirus test negative, Eosinophilia, Epstein-Barr virus test negative, Eye pain, Fungal test negative, Graft versus host disease, Headache, Herpes simplex serology negative, Immunoglobulin therapy, Immunohistochemistry, Inflammation, Intensive care, Liver abscess, Lumbar puncture, Lumbar puncture abnormal, Lymphadenitis, Lymphocyte percentage, Medical induction of coma, Mental impairment, Microscopy, Monocyte percentage, Morbillivirus test positive, Mumps antibody test negative, Mycobacterium test negative, Nervous system disorder, Neurological decompensation, Neutropenia, Neutrophil percentage increased, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging brain normal, Ophthalmological examination normal, Partial seizures, Photophobia, Polymerase chain reaction, Pyrexia, Rash, Rash erythematous, Rash pruritic, Red blood cells CSF positive, Staphylococcal abscess, Status epilepticus, Stem cell transplant, Viral test negative, Withdrawal of life support
SMQs:, Liver infections (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Conjunctival disorders (narrow), Ocular infections (broad), Skin tumours of unspecified malignancy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Malignant lymphomas (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Opportunistic infections (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Chronic granulomatous disease
Preexisting Conditions: Lymphadenitis; Liver abscess; Incisional drainage
Allergies:
Diagnostic Lab Data: Electroencephalography, Showed focal status epilepticus (epilepsia partialis continua) involving the right frontal cortex; magnetic resonance, No neurologic abnormalities were noted on brain; spinal tap, on day +43 was significant for glucose 43 mg/dL, protein 77 mg/dL, 51 WBCs/mm3 (88% lymphocytes, 8%; magnetic resonance, Brain MRI on day +45 showed bilateral patchy areas of cortical swelling and signal abnormality; diagnostic laboratory, Measles studies of the brain tissue were positive by reverse transcriptase-PCR for wild-type measle; brain biopsy, on day +53 demonstrated numerous eosinophilic intranuclear inclusion bodies and minimal perivascular; spinal tap, on day +49 showed less inflammation, with glucose 59 mg/dL, protein 54 mg/dL, 9 WBCs/mm3, and 294 re; cerebrospinal fluid, for bacteria, fungi, mycobacteria, and viruses were negative. Cryptococcal antigen was negative; enterovirus PCR, Negative; Epstein-Barr virus PCR, Negative; serum Herpes virus Ab, Polymerase chain reaction was negative; serum Herpes virus Ab, Polymerase chain reaction was negative; cytomegalovirus antigen, Antigenemia was negative; cerebrospinal fluid, No antibodies to measles, mumps, varicella, adenovirus, HSV-1/2, or lymphocytic choriomeningitis vir
CDC Split Type: WAES1203USA03678

Write-up: Information has been received from a physician, author of a literature article, title as stated above, concerning a 13 year old male patient who on an unspecified date, was vaccinated with a dose of MMR II (dose, route and lot number not reported). Measles inclusion body encephalitis (MIRE) was a disease of the immunocompromised host and typically occurred within 1 year of acute measles infection or vaccination. In addition to acute encephalitis and subacute sclerosis panencephalitis in immunocompetent hosts, measles virus could cause measles inclusion body encephalitis (MIBE) in immunocompromised hosts. MIBE presented typically with focal and intractable seizures within 1 year of initial measles infection. The mortality rate was high, and no effective treatment existed. The patient was a 13-year-old boy who received a diagnosis of X-linked chronic granulomatous disease (CGD) at 2 years of age after serratia lymphadenitis. The patient traveled frequently to urban, most recently 4 years before this illness. He received 1 documented MMR at one year of age, and had no history of a measles-like illness or measles exposure at any time. A second MMR was not documented. Despite prophylactic therapy for CGD with trimethoprim-sulfamethoxazole and thrice-weekly y-interferon, he had multiple staphylococcal liver abscesses that required extensive surgical drainage. Poor compliance with interferon was documented. Because of the severity of his repeated infections, SCT was performed. The conditioning regimen comprised fludarabine (180 mg/m2), busulfan (6.4 mg/kg), and equine anti-thymocyte globulin (ATG). Because of fever and chills after equine ATG, he received rabbit ATC for the last 3 days. On day -1, he began graft-verus-host disease (GVHO) prophylaxis with cyclosporine (CsA) and on day 0 with mycophenolate mofetil. He received anti-infective prophylaxis with oral acyclovir, itraconazole, intravenous vancomycin, and weekly CMV-immune globulin. On SCT day +10, he was admitted for fever and neutropenia and treated with broad-spectrum antibiotics. On day +11, a pruritic, erythematous rash developed, and his CsA dose was increased to treat presumed GVHD. Rash and low-grade fever persisted, and conjunctivitis and photophobia developed. Skin biopsy was consistent with GVHD; oral steroids were started with improvement in the rash. By day +19, he had engrafted with 99% donor chimerism by variable N-terminal repeats. On day +23, he presented with fever, headache, and eye pain. Head computed tomography scan and ophthalmologic examination were normal. Lumbar puncture showed 13 white blood cells (WBCs; 30% neutrophils, 52% lymphocytes, and 18% monocytes), glucose of 50 mg/dL, and protein of 34 mg/dL. Bacterial fungal and viral cultures were negative; cryptococcal antigen was negative. His symptoms improved, and he was discharged on day +27. By day +33, he had worsening erythematous rash on his face, arms, and trunk, and corticosteroids were increased to treat GVHD. On day +38, he was admitted to Hospital with afebrile focal seizures involving his left hand. Immunosuppressive medications on admission included CsA, mycophenolate mofetil, and prednisone. CsA was stopped and tacrolimus was started for possible CsA-induced seizures. The seizures progressed to involve his chin and tongue despite anticonvulsant therapy with clonazepam and valproic acid. Electroencephalogram showed focal status epilepticus (epilepsia partialis continua) involving the right frontal cortex. No neurologic abnormalities were noted on brain magnetic resonance imaging (MRI). He was transferred to the intensive care unit, where a continuous infusion of midazolam followed by a phenobarbital coma were unsuccessful in completely controlling seizures. Subclinical seizures persisted despite phenobarbital levels $g300 ug/mL. Lumbar puncture on day +43 was significant for glucose of 43 mg/dL, protein of 77 mg/dL, 51 WBCs/mm3 (88% lymphocytes, 8% monocytes, and 4% neutrophils), and 8 red blood cells/mm3. A repeat lumbar puncture on day +49 showed less inflammation, with glucose 59 mg/dL, protein 54 mg/dL, 9 WBCs/mm3, and 294 red blood cells/mm3. Spinal fluid cultures for bacteria, fungi, mycobacteria, and viruses were negative. Cryptococcal antigen was negative. Polymerase chain reaction (PCR) for herpes simplex virus (HSV) -1 and 2, human herpesvirus-6, enterovirus, Epstein-Barr virus, and arboviruses were negative. CMV antigenemia was negative. No antibodies to measles, mumps, varicella, adenovirus, HSV-1/2, or lymphocytic choriomeningitis virus were detected in the spinal fluid. Brain MRI on day +45 showed bilateral patchy areas of cortical swelling and signal abnormality, predominantly involving the frontal and temporal lobes, compatible with meningoencephalitis. A right frontal lobe lesion showed restricted diffusion. In retrospect, the initial MRI showed a small focus of signal abnormality in the right frontal cortex. Subsequent brain MRIs on day +49 and day +55 showed progressive involvement of the cerebral cortex and the basal ganglia. Treatment dose intravenous acyclovir was started on day +44 and was changed to intravenous gancyclovir on day +47. Brain biopsy on day +53 demonstrated numerous eosinophilic intranuclear inclusion bodies and minimal perivascular inflammatory reaction. Inclusions of varied sizes were seen in astrocytes, oligodendroglial cells, and neurons. Electron microscopic examination showed that the inclusions were clusters of relatively long, curved, tubular structures consistent with paramyxovirus nucleocapsids. Extensive demyelination of axons was seen. Immunohistochemistry for HSV-1/2, CMV, human immunodeficiency virus, adenovirus, and Epstein-Barr virus was negative. Measles studies of the brain tissue performed at the Centers for Disease Control and Prevention were positive by reverse transcriptase (RT)- PCR for wild-type measles virus, genotype D3, and by immunohistochemistry for measles nucleoprotein. Measles virus was isolated using the B95a marmoset lymphoblastoid cell line, and genotype D3 was confirmed by nucleotide sequence analysis of RT-PCR products. In addition, repeat skin biopsy on day +61 was consistent with GVHD. After demonstration of intranuclear inclusion bodies, intravenous ribavirin was initiated on day +57 (loading dose of 30 mg/kg, then 15 mg/kg every 6 hours for 16 doses, and then 7.5 mg/kg every 8 hours). Despite ribavirin and intensive supportive therapy, the patient''s neurologic status continued to deteriorate, and brain death was determined on day +70. Ribavirin was discontinued. Life support was stopped with the family''s agreement on day +92, and the patient died. No postmortem study was permitted. Immunohistochemistry and RT-PCR of the initial skin biopsy (day +15) were negative for measles virus. RT-PCR performed on the donor stem cells was negative for measles virus. MIBE occurred typically in immunocompromised patients within 1 year of measles infection. Patients usually presented with afebrile focal seizures and altered mentation. The seizures tended to be refractory to anticonvulsant therapy, and electroencephalogram often showed epilepsia partialis continua. The clinical features of the authors'' patient was consistent with this picture. Imaging studies such as brain MRI and computed tomography were often normal. Diagnosis required brain biopsy. The diagnosis of MIBE could be confirmed by RT-PCR for measles virus RNA or by immunohistochemistry. The prognosis was poor, with a 76% mortality rate, and all survivors manifesting significant neurologic sequelae. This case was unusual given the absence of apparent recent measles exposure or vaccination. The patient had not traveled outside during the year before SCT. The authors'' patient was born during the epidemic of 1989-1991 (birth year 1989) and had traveled only to foreign country, where the D3 genotype had not been endemic in recent years. An undiagnosed case of measles in the period 1989-1991 would suggest a latency period of 12 years, which was not typical of MIBE. The median length of time from acute measles infection or exposure to MIBE onset was 4 months. It was unlikely that the authors'' patient''s history of CGO placed him at increased risk for measles complications, but his SCT clearly did. The authors'' patient might have had a measles infection or exposure that was not recognized, although this was unlikely with his close medical supervision and prolonged hospitalizations the preceding year. The authors'' patient had a rash with conjunctival injection 27 days before the seizure onset, and skin biopsy suggested GVHO. The authors believed that the rash and conjunctivitis were not manifestations of measles because the skin biopsy obtained soon after rash onset was consistent histologically with GVHD, and immunohistochemistry and RT-PCR both were negative for measles virus. The authors also doubt that the stem cell donor was the source of measles infection as she had no history of measles-like infection or travel to an endemic area, and RT-PCR on the donor stem cells was negative for measles. MIBE had been reported 9 months after measles vaccination; however, the authors'' patient received the measles vaccination many years before SCT, and the identification of genotype D3 was inconsistent with the well-established vaccine virus genotype (vaccine genotype was genotype A). This case demonstrated the diagnostic utility of a brain biopsy in cases of encephalitis of unknown cause, particularly in immunocompromised individuals. Early brain biopsy might enable diagnosis and early institution of antiviral therapy. The utility of ribavirin or other therapies was unknown in MIBE. Ribavirin inhibits measles replication in vitro and had been used with some success to treat measles infections in immunocompetent hosts The authors'' patient, suggested the possibility of a long latency period between measles infection and onset of MIBE. The authors'' case illustrated the importance of early brain biopsy in cases of obscure encephalitis or encephalopathy in the immunocompromised host. Additional information has been requested.


VAERS ID: 453774 (history)  
Form: Version 1.0  
Age: 1.06  
Sex: Male  
Location: Massachusetts  
Vaccinated:2012-03-06
Onset:0000-00-00
Submitted: 2012-04-16
Entered: 2012-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1416AA / 1 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0872AA / 1 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0977AA / 1 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol/DUONEB (PRN)
Current Illness: None
Preexisting Conditions: Mild Persistent Asthma
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt. received vaccines (MMR & Varicella) on 3/6/12. On 3/25/12 was found dead in crib (still waiting for autopsy results).


VAERS ID: 453833 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: Georgia  
Vaccinated:2011-07-25
Onset:2011-07-26
   Days after vaccination:1
Submitted: 2012-04-16
   Days after onset:265
Entered: 2012-04-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0657AA / UNK UN / SC

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-07-26
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Hypertension; Cholesterol high; Metabolic syndrome; Vitamin D deficiency; Impaired fasting glucose
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1204USA01511

Write-up: Information has been received from an office manager (Bachelor of Science) from a physician''s office concerning a 56 year old male patient with hypertension, high cholesterol, metabolic syndrome, vitamin d deficiency and impaired fasting glucose who on 25-JUL-2011 was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 mL, subcutaneous (lot # 670613/0657AA). It was reported that the patient died on 26-JUL-2011 after receiving the ZOSTAVAX (Merck). The office manager stated that on 25-JUL-2011, the patient received ZOSTAVAX (Merck) and flew out of town and was found dead in a department store on 26-JUL-2011. The reporter indicated that on 10-APR-2012, the patient''s wife went to the physician''s office and showed them the death certificate. The cause of death was unknown. The reporter considered the event to be disabling and immediately life-threatening. A lot check has been initiated. Additional information has been requested.


VAERS ID: 453867 (history)  
Form: Version 1.0  
Age: 0.43  
Sex: Male  
Location: New Hampshire  
Vaccinated:2012-04-04
Onset:2012-04-14
   Days after vaccination:10
Submitted: 2012-04-17
   Days after onset:3
Entered: 2012-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B315D / 2 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH399AB / 2 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 917243 / 2 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0040AE / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-04-14
   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:
Preexisting Conditions: Hx - NICU - drug withdrawal
Allergies:
Diagnostic Lab Data: None
CDC Split Type: NH041720126

Write-up: Hx - child in NICU r/t drug withdrawal.


VAERS ID: 453949 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-17
Entered: 2012-04-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Pneumococcal infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1204USA01551

Write-up: Information has been received from a published article. Abstract: Introduction: Invasive Streptococcus pneumoniae disease (IPD) carries a high risk of death, approximately 15% to 20% in pneumonia, 40% in meningitis and 10% to 15% in septicemia. The occurrence of 2 or more IPD (recurrent) in the same individual is uncommon. The authors investigated the clinical features of patients with recurrent IPD to assess whether they possessed risk factors that increased their likelihood of recurrent IPD. Methods: Between 1983 and 2010, the authors identified 27 patients with recurrent IPD during inpatient surveillance of 889 patients with IPD in their city, by recovery of pneumococci from otherwise sterile sites. Serotype/serogroup (ST/SG) was determined by capsular swelling and the penicillin MIC by E-strip. Clinical data were abstracted from hospital charts. Results: Sixteen (59%) of 27 patients were 65 years and older at first IPD, males predominated (67%), two-thirds had pneumonia and 21 (78%) had the same clinical diagnosis at both IPD. Four (80%) of 5 patients with the same ST experienced their second IPD 1 to 6 months apart, unlike most patients with discordant ST/SGs (P = 0.047). Eighty-four percent of ST/SGs were included in the PNEUMOVAX 23 and occurred as often during the first and second IPD. Twenty (77%) of 26 adults suffered from comorbid diseases placing them at high risk of IPD, including multiple myeloma, HIV/AIDS, neoplasia of hematological origin and sickle cell disease. Conclusions: Recurrent IPD occurred uncommonly. Comorbid conditions including multiple myeloma and immunosuppressive/immunodeficient conditions, chronic alcoholism and splenectomy represented unique risk factors for recurrent IPD but did not predict recurrences. Results: Continuous surveillance of IPD among inpatients residing in the city, and environs from 1983 to 2010 identified 989 individuals with IPD, 813 adults and 176 children, and recurrent IPD was detected in 26 adults (a total of 28 episodes) and 1 child, for recurrence rates of 3.4% and 0.6%, respectively. Sixteen (61.5%) of 26 adults were 65 years or older when they had their first IPD. Males accounted for 18 (66.7%) of the patients. All 5 adults who died during their second IPD were 65 years or older when they experienced their first IPD. However, the case fatality rate (CFR) of the age group 65 years and older was not significantly different from the nil CFR of the age group 30 to 64 years (P =0.12), likely due to the small Ns. Three females (33.3%) and 2 males (13.3%) died, also not a significant difference (P=0.29). Of the 5 patients who died, 3 had pneumonia at their second IPD, 1 had septicemia and 1 had meningitis, the second of 2 meningitis illnesses. Only 5 (19.2%) of 26 adults received PPV23 before their second IPD and none of them died. Three of these vaccinated adults suffered from multiple myeloma. The other adult with multiple myeloma did not receive PPV23. Three adults received PPV23 during or after their second IPD. No data were available on vaccine administration for the other 18 adults including 1 male with multiple myeloma. Although, no data were available on vaccine administration for the only child with recurrent IPD, he was born after routine immunization of infants and children with PCV7 was initiated and was aged 1 year at the first IPD and it seemed likely that he had received at least 1 dose of PCV7. The time interval between consecutive episodes of IPD varied from 1 month to 15 years. Of 10 consecutive episodes that occurred 1 to 12 months apart, the second IPD of 4 (80%) of 5 with the same ST/SG and 6 (28.6%) of 21 with different ST/SG occurred within 12 months of the first IPD (P =0.055). Three patients did not have the isolate from their second IPD available for serotyping. The occurrence of 3 consecutive IPD with the same ST/SG each more than 1 month apart suggests that these recurrent IPD were reinfections, as opposed to relapses. Twenty-two (75.9%) of 29 consecutive episodes of IPD showed the same diagnosis each episode. Recurrent pneumonia/pneumonia episodes accounted for slightly more than one-half of consecutive episodes and occurred across the spectrum of time intervals from 1 month to 15 years apart. By comparison, the few recurrent septicemia/septicemia episodes occurred 1 to 12 months apart and the 2 meningitis/meningitis episodes occurred 7 or more years apart. Overall, 45 (84.9%) of 53 ST/SGs recovered from patients with recurrent IPD were included in PPV23, with about the same proportion of vaccine ST/SGs in the first, second and third episodes, namely 85.2%, 83.3% and 100%, respectively (P=1.00). Only 5 ST/SGs not included in PPV23 were recovered, totaling 8 isolates. Of the 50 isolates tested for penicillin susceptibility during all recurrent IPD, 9 (18.0%) were intermediate, including 2 from non-PPV23 ST/SGs, and 5 (10.0%) were resistant to penicillin. Three (33.3%) of 9 patients with intermediate or resistant ST/SGs died during their second or third IPD compared with 2 (11.8%) deaths among the 17 patients with penicillin-susceptible ST/SGs (P =0.30). Immunosuppressive/immunodeficient comorbid diseases occurred in 21 (80.8%) of 26 adults, 10 (100%) of 10 adults in the 30 to 64 year age group and 11 (68.8%) of 16 adults in the 65 years and older age group (P =0.12). Four patients had multiple myeloma, 6 had solid cancers, 5 had lymphoma/leukemia, 1 had HIV, 4 had chronic renal disease and 5 had chronic alcoholism. Eight (80%) of 10 adults in the 30 to 64 years age group and 9 (56.3%) of 16 adults in the 65 years and older age group had only 1 immunosuppressive/immunodeficient comorbid disease. Additionally, only 2 adults had a splenectomy before their first IPD. One adult in the 30 to 64 years age group sustained a gunshot wound to the head before his first of 2 meningitis illnesses, about 8 years apart, and he survived. Of the 5 patients who died, 3 had comorbid diseases that increased their risk of IPD, including 1 patient had alcoholism and chronic obstructive pulmonary disease (COPD); 1 patient had chronic renal failure, colon cancer, arteriosclerotic heart disease, COPD and hypertension and 1 patient had colon cancer. Nineteen (73.0%) of 26 adults had arteriosclerotic heart disease or COPD or hypertension, 14 (87.5%) of 16 adults in the 65 years and older age group and 5 (50.0%) of 10 adults in the 30 to 64 years old age group. Eight (50%) of 16 adults in the age group 65 years and older had 2 or all 3 of these comorbid diseases, as might be expected among a group of elderly adults. This report concerns a female patient among the three adults who received PNEUMOVAX 23 during or after their second IPD. The female patient was one of the 5 adults who died during their second IPD. She had experienced her first IPD when she was 65 years or older. The reporter commented as follows: Five patients with 6 episodes of IPD in our study each of whom had been immunized with PPV23 before their second IPD had ST/SGs included in PPV23 and can be considered as vaccine failures. Pre- and postvaccine antibody levels were not available for any patients. PPV23 has about 70% effectiveness in immunocompetent adults. However, 3 patients had multiple myeloma, 1 had chronic alcoholism and 1 was old when immunized and thus immunization with PPV23 likely failed to induce protective antibody levels accounting for their becoming infected with vaccine types. Nonetheless, adults at high risk need to be immunized with PPV23, according to the recommended schedule of immunizations, once when identified before the age of 65 years and again after 65 years, with at least a 5-year interval between doses of vaccine. Polyvalent conjugate pneumococcal vaccines under investigation in adults might provide an approach, either alone or in combination with PPV23, for improved protective efficacy in adults at high risk. This is one of several reports received from same source. Additional information has been requested.


VAERS ID: 454143 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: Unknown  
Vaccinated:2012-03-26
Onset:2012-04-01
   Days after vaccination:6
Submitted: 2012-04-20
   Days after onset:19
Entered: 2012-04-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 1269AA / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-04-01
   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: Unknown
Current Illness: Sulfonamide allergy; Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1204USA02546

Write-up: Information has been received from a registered pharmacist concerning a 69 year old female patient with sulfa and amoxicillin allergies who on 26-MAR-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (dose and route not provided) (lot # 671144/1269AA, expiration date 05-NOV-2012). The pharmacist informed that the patient died approximately on 02-APR-2012 "around 1 week after receiving the ZOSTAVAX (Merck)". The pharmacist indicated that no adverse reaction was reported or any physical symptoms other than the death and that the patient did not seek medical attention. The cause of death was not provided. A lot check has been initiated. Additional information is not expected.


VAERS ID: 454298 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2012-04-13
Onset:2012-04-14
   Days after vaccination:1
Submitted: 2012-04-25
   Days after onset:11
Entered: 2012-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB550AA / 1 LA / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH157AA / 2 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1251AA / 1 RA / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F22722 / 2 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1210AA / 1 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-04-14
   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: asthma, overweight
Allergies:
Diagnostic Lab Data: An autopsy is being performed.
CDC Split Type: AR1207

Write-up: Child was found dead on the morning of 04/14/2012.


VAERS ID: 454460 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Colorado  
Vaccinated:2012-03-30
Onset:2012-04-07
   Days after vaccination:8
Submitted: 2012-04-26
   Days after onset:19
Entered: 2012-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B315AA / 1 UN / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0958AA / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916977 / 1 UN / UN

Administered by: Public       Purchased by: Public
Symptoms: Hypotonia, Resuscitation, Unresponsive to stimuli
SMQs:, Peripheral neuropathy (broad), 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), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-04-07
   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: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Father of baby said baby suddenly went limp and unresponsive, was transported to hospital via ambulance CPR in progress.


VAERS ID: 454494 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031599

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, pre-existing conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused out analyses on those patients from who S. aureus was isolated from a specimen collected within three days of hospital admission. as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC of the 88 children, 47 (53%) were boys and the medical age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age (Figure 1). Fifty-six (66% of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (2 0f 6) refers to 6 of 11 children who were completely vaccinated. S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolated were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454497 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031422

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, preexisting conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused our analyses on those patients from whom S. aureus was isolated from a specimen collected within three days of hospital admission, as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were boys and the median age at death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age. Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (1 of 6) relates to 6 of 11 children who were completely vaccinated. Authors comment: S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolates were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454503 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Immunocompromised
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031837

Write-up: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (4 of 10) concerns a 38-year-old male patient, who had a medical history of immunodeficiency. The patient died of respiratory failure (under review), nineteen days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454505 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: 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: Febrile seizures (one after measles, mumps, rubella vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031818

Write-up: This literature report concerns a series of 10 cases of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (1 of 10) concerns a 1-year-old male patient, who had a medical history of febrile seizures after mumps/measles/rubella. The patient died of sudden death, with no evidence of trauma, one day after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporter comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454507 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Utah  
Vaccinated:2011-12-22
Onset:2012-04-08
   Days after vaccination:108
Submitted: 2012-04-25
   Days after onset:17
Entered: 2012-04-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3984AA / UNK UN / UN

Administered by: Public       Purchased by: Public
Symptoms: Abortion spontaneous, Foetal death, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-04-08
   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: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201204016

Write-up: Initial case was received from a health care professional on 16 April 2012. This case contains information to describe the fetal death; information for the mother was captured in case number 2011-12525. A male fetus was exposed while in utero to ADACEL, lot number C3984AA. His mother was vaccinated on 22 December 2011 (weeks gestation was not reported). The mother''s last menstrual period was on 04 November 2011. On 08 April 2012, the mother had a miscarriage which resulted in an early fetal death between 20-27 weeks gestation (exact weeks gestation not reported). The outcome was fatal. Documents held by sender: None.


VAERS ID: 454521 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Sudden 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: 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: Encephalopathy; Central apnea; Traumatic brain damage; Seizures
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031835

Write-up: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (2 of 10) concerns a 2-year-old female patient, who had a medical history of encephalopathy, central apnea, traumatic brain damage, seizures. The patient died of sudden death cardiopulmonary arrest after H1N1 vaccination (type: monovalent inactivated, split-virus vaccine; manufacture: unknown). Time to onset was 0 day. Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454522 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: 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: 2012031680

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, preexisting conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained from all patients from whom S. aureus was isolated from one of the designated sites. We focused our analyses on those patients from whom S. aureus was isolated from a specimen collected within three days of hospital admission, as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were boys and the median age at death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age. Most were white. Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received as least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (case 1 of 4) relates to 4 of 11 children whose vaccination status could not be determined, but they received at least one dose of vaccine. Authors comment: S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolates were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454523 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031677

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, pre-existing conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused out analyses on those patients from who S. aureus was isolated from a specimen collected within three days of hospital admission. as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC of the 88 children, 47 (53%) were boys and the medical age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age (Figure 1). Fifty-six (66% of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (5 of 6) relates to 6 of 11 children who were completely vaccinated. S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolated were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454525 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Rett syndrome; Severe muscle wasting; Physical disability
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031836

Write-up: This literature report concerns a series of 10 cases of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (3 of 10) concerns a 19-year-old female patient, who had a medical history of Rett syndrome and severe muscle wasting/physical disability. The patient died of Bilateral pneumonia and respiratory failure, nine days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454526 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031683

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, pre-existing conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused out analyses on those patients from who S. aureus was isolated from a specimen collected within three days of hospital admission. as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC of the 88 children, 47 (53%) were boys and the medical age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age (Figure 1). Fifty-six (66% of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (4 of 4) relates to 4 of 11 children whose vaccination status could not be determined, but they received at least one dose of vaccine. S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolated were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454529 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031681

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, pre-existing conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused out analyses on those patients from who S. aureus was isolated from a specimen collected within three days of hospital admission. as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC of the 88 children, 47 (53%) were boys and the median age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age (Figure 1). Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (2 0f 4) relates to 4 of 11 children whose vaccination status could not be determined, but they received at least one dose of vaccine. S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolated were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454530 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031676

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, pre-existing conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused out analyses on those patients from who S. aureus was isolated from a specimen collected within three days of hospital admission. as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC of the 88 children, 47 (53%) were boys and the median age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age (Figure 1). Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (4 0f 6) relates to 6 of 11 children who were completely vaccinated. S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolated were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454531 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031678

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, preexisting conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained from all patients from whom S. aureus was isolated from one of the designated sites. We focused our analyses on those patients from whom S. aureus was isolated from a specimen collected within three days of hospital admission, as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were boys and the median age at death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age. Most were white. Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (case 6 of 6) related to 6 to 11 children who were completely vaccinated. Authors comment: S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolates were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454532 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031679

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, pre-existing conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused out analyses on those patients from who S. aureus was isolated from a specimen collected within three days of hospital admission. as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC of the 88 children, 47 (53%) were boys and the median age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age (Figure 1). Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case relates to 1 of 11 children who was partially vaccinated. S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolated were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454533 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Death, Influenza A virus test negative, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hyperlipidemia; Hypertension; Pulmonary embolism; Deep vein thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031838

Write-up: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (5 of 10) concerns a 46-year-old female patient, who had a medical history of hypertension, hyperlipidemia, pulmonary embolism and deep vein thrombosis. The patient died of pulmonary embolus (negative for H1N1 in lung tissue) two days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine;manufacturer: unknown). VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipts of H1N1 vaccine: 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454534 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031682

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, preexisting conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained from all patients from whom S. aureus was isolated from one of the designated sites. We focused our analyses on those patients from whom S. aureus was isolated from a specimen collected within three days of hospital admission, as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were boys and the median age at death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age. Most were white. Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (case 3 of 4) relates to 4 of 11 children whose vaccination status could not be determined, but they received at least one dose of vaccine. Authors comment: S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolates were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454535 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Accidental death, Road traffic accident
SMQs:, Accidents and injuries (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: Driver involved in motor vehicle crash leaving clinic after H1N1 vaccination.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031841

Write-up: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involve 2 children, 7 adults and 1 elderly reported. This case (7 of 10) concerns a 56-year-old female patient, who was involved in motor vehicle crash leaving clinic after H1N1 vaccination and died of trauma. Vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Time to onset was 0 day. Reporter''s comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of death occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454537 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial sepsis, Cardio-respiratory 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), Respiratory failure (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypertension; Diabetes; Peripheral vascular disease; End stage renal disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031842

Write-up: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly. This case (9 of 10) concerns a 61-year-old male patient, who had a medical history of hypertension, diabetes, peripheral vascular disease and end stage renal disease. The patient died of cardiac / respiratory arrest and gram-negative sepsis, 13 days after H1N1 vaccination (type: monovalent, inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporters comments: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454538 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Lung cancer; Hypertension; Recurrent deep venous thrombosis; Atrial fibrillation; Hyperlipidemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031844

Write-up: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly. This case (10 of 10) concerns a 77-year-old male patient, who had a medical history of lung cancer, atrial fibrillation, recurrent deep venous thrombosis, hypertension and hyperlipidemia. The patient died of suspected myocardial infarction, two days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine: manufacture: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454540 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiovascular disorder, Death
SMQs:, Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Type 2 diabetes; Stroke; Chronic obstructive pulmonary disease; Emphysema; Substance abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031839

Write-up: This literature report concerns a series of 10 cases of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (6 of 10) concerns a 49-year-old patient, who had a medical history of Type 2 diabetes, stroke, chronic obstructive pulmonary disease, emphysema and substance abuse. The patient died of a suspected cardiovascular event three days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacturer: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454541 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: End-stage renal disease; Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031840

Write-up: This literature report concerns a series of 10 cases of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (7 of 10) concerns a 53-year-old female patient, who had a medical history of end-stage renal disease and atrial fibrillation. The patient died (of unknown cause) (under review), five days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454552 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: 2012031675

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, preexisting conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained from all patients from whom S. aureus was isolated from one of the designated sites. We focused our analyses on those patients from whom S. aureus was isolated from a specimen collected within three days of hospital admission, as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were boys and the median age at death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age. Most were white. Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (case 3 of 6) relates to 6 of 11 children who were completely vaccinated. Authors comment: S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolates were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454679 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Female  
Location: Louisiana  
Vaccinated:2012-03-20
Onset:2012-03-23
   Days after vaccination:3
Submitted: 2012-04-30
   Days after onset:38
Entered: 2012-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B329BA / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1476AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F75398 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1693AA / 3 MO / PO

Administered by: Unknown       Purchased by: Private
Symptoms: Brain death, Brain oedema, Cerebrovascular accident, Convulsion, Laboratory test normal, Muscle twitching, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-28
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: She had diahhrea for 6 days! Ran fever on and off the day I took her to the doctor.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Started having twitches wasn''t responsive at daycare. Pooped all over herself. Father picked her up and took her to the pediatrician. They called the hospital ambulance came and picked her up. They said it looked like she was having seizures gave her Adavant. Thought she had an infection but everything came back negative. She was having seizures and brain swelling. They couldn''t control them. She then suffered a massive stroke and was brain dead. Didn''t start acting like this until two days after her shots.


VAERS ID: 454855 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: California  
Vaccinated:2012-04-30
Onset:2012-05-01
   Days after vaccination:1
Submitted: 2012-05-02
   Days after onset:1
Entered: 2012-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B329AB / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH561AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F92472 / 2 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB214A / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-01
   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: None
Current Illness: No illness at time of vaccination.
Preexisting Conditions: No pre-existing Physician-Diagnosed Allergies, Birth Defects, or Medical conditions at time of vaccination.
Allergies:
Diagnostic Lab Data: Under investigation
CDC Split Type:

Write-up: Unknown, coroner suspected SIDS.


VAERS ID: 455297 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Male  
Location: Unknown  
Vaccinated:1982-05-01
Onset:0000-00-00
Submitted: 2012-05-09
Entered: 2012-05-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1982-05-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1205USA00738

Write-up: Information has been received from a consumer, concerning a 16 month old brother, who approximately in May 1982 ("30 years ago"), was vaccinated with a dose of MMR II (Lot #, dose and route not reported). It was reported that approximately in May 1982 ("30 years ago") the patient died after getting a MMR II shot. The cause of death was unknown. It was reported to the Center for Disease Control. Additional information is not expected.


VAERS ID: 455355 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: West Virginia  
Vaccinated:2012-04-24
Onset:2012-05-04
   Days after vaccination:10
Submitted: 2012-05-10
   Days after onset:6
Entered: 2012-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4165AB / 2 UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC093AA / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 917245 / 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41DB273A / 2 MO / PO

Administered by: Public       Purchased by: Unknown
Symptoms: Body temperature decreased, Cardiac arrest, Convulsion, Renal failure, Respiratory arrest, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin
Current Illness: URI/OM treated 4/20/12 -$g improved 4/24/12; no fever; GATS/ACTS GERD; Nares nl; Lungs nl; TM nl; RTM LR returning; ROM acute
Preexisting Conditions: 37 wk AGA; Apgar 6 - 1, 9 - 5; Frenulectomy 12/29/11; Neonatal screen nl
Allergies:
Diagnostic Lab Data: Seen at ER
CDC Split Type:

Write-up: Received shots on 4/24/12 (3pm appointment time). 5/4/12 went down for nap -$g checked in 90 min & not breathing. ER chart received. CPR started at scene 1543. At ER 1553 in triage. Asystole on strip. 1608 temp 96.7. By 1608 pulse without compression, epinephrine drip. Renal failure by next day. No spont respiration. Seizures (+) after event.


VAERS ID: 455358 (history)  
Form: Version 1.0  
Age: 1.03  
Sex: Male  
Location: Florida  
Vaccinated:2012-03-01
Onset:2012-03-05
   Days after vaccination:4
Submitted: 2012-03-26
   Days after onset:20
Entered: 2012-05-11
   Days after submission:46
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1531AA / 3 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0872AA / 1 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F18963 / 4 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0976AA / 1 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Autopsy, Death, Toxicologic test
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-05
   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: LOTRIMIN cream BID - Rx written on 3/1/12
Current Illness: None
Preexisting Conditions: Eczema 3/1/12; Tinea corporis 3/1/12
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt. died of unknown causes. Autopsy. Toxicology testing in process.


VAERS ID: 455522 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Ohio  
Vaccinated:2012-02-29
Onset:2012-03-07
   Days after vaccination:7
Submitted: 2012-05-14
   Days after onset:67
Entered: 2012-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR CA0300AA / 1 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Cyanosis, Death, Endotracheal intubation, Fall, Intensive care, Nervous system disorder, Pulse absent, Resuscitation, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (broad), Angioedema (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-03-11
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lipitor, ECBASA, Diltiazem CD, HCTZ, albuterol
Current Illness:
Preexisting Conditions: Hypertension, IHSS, Bradycardia, Hypercholesterolemia, Allergic Rhinitis, Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt returned from arduous bike ride, took long time in bathroom, wife entered, pt started to speak, turned blue and fell to floor. CPR attempted, EMS took to ER where pulseless. Ventricular tachycardia found. Intubated, CCU care, minimal brain activity, died on 4th day.


VAERS ID: 455738 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Virginia  
Vaccinated:2012-05-03
Onset:2012-05-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2012-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4193AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1522AA / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F51182 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1709AA / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt received vaccines on 5/3/12. Died on 5/4/12.


VAERS ID: 455795 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: Ohio  
Vaccinated:2012-05-14
Onset:2012-05-15
   Days after vaccination:1
Submitted: 2012-05-17
   Days after onset:2
Entered: 2012-05-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3753AA / 1 RL / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0570AA / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916617 / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1544AA / 1 MO / PO

Administered by: Public       Purchased by: Other
Symptoms: Autopsy, 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: 2012-05-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nystatin
Current Illness: Thrush (mother states tx with Nystatin)
Preexisting Conditions: Per mother: Newborn screening showed Cystic Fibrosis Marker
Allergies:
Diagnostic Lab Data: Autopsy performed: results pending
CDC Split Type:

Write-up: None observed directly, within 30 min, after vaccine administration at the Health Dept. Mother notified Health Dept. on 5/17/2012 to report that her infant had expired at home in the early AM of 5/15/2012. She stated she called 911 when she determined her infant was unresponsive and that the Emergency Personnel had pronounced her "dead" on arrival.


VAERS ID: 456061 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-05-22
Entered: 2012-05-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adverse reaction, Death, Pneumonia streptococcal
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012114885

Write-up: This is a spontaneous report by a non contactable nurse. This nurse reported through Pfizer sales representative for a 12-year-old male patient who was administered a dose of PREVNAR 13 on an unknown date. Relevant medical history and concomitant medication were not reported. The patient experienced streptococcus pneumoniae for which he was hospitalized in 2012. In 2012, he experienced unspecified condition due to which he passed away. At the time of the report it was unknown if the autopsy was performed.


VAERS ID: 456170 (history)  
Form: Version 1.0  
Age: 0.82  
Sex: Female  
Location: Washington  
Vaccinated:2012-05-09
Onset:2012-05-10
   Days after vaccination:1
Submitted: 2012-05-24
   Days after onset:14
Entered: 2012-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC029CA / 3 RL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 456560 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Female  
Location: Unknown  
Vaccinated:2012-05-09
Onset:2012-05-09
   Days after vaccination:0
Submitted: 2012-05-30
   Days after onset:21
Entered: 2012-05-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cyanosis, Death
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1205USA04761

Write-up: Information has been received from a consumer concerning her 10 month old niece with no known allergies who on 09-MAY-2012 was vaccinated with a dose of RECOMBIVAX HB (dose, route and lot # not provided). The consumer stated that on 09-MAY-2012, the patient received the vaccine during the day and then went to sleep for a few hours and woke up at 7:00 pm that evening without any issues. The patient then went to sleep again at 10 pm followed by the mother discovering the baby later that night deceased at an unspecified time. The baby''s skin was blue in color when the mother discovered her indicating that the baby passed away. Additional information has been requested.


VAERS ID: 456644 (history)  
Form: Version 1.0  
Age: 0.51  
Sex: Male  
Location: New York  
Vaccinated:2012-05-24
Onset:2012-05-28
   Days after vaccination:4
Submitted: 2012-06-01
   Days after onset:4
Entered: 2012-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B305CA / 3 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. UH416AB / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F65442 / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1474AA / 3 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Abnormal behaviour, Apnoeic attack, Autopsy, Cardiac arrest, Death, Diarrhoea, Flatulence, Haematochezia, Intussusception, Irritability, Mechanical ventilation, Resuscitation, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-29
   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: amoxicillin (started same day, not prior to vaccines)
Current Illness: Otitis media, cough
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Xray: No focal pulmonary consolidation. Multiple prominent air filled bowel loops. No free air.
CDC Split Type:

Write-up: On 5/28/2012 began having diarrhea. On 5/29/12 am, he was a little fussy in the morning - mom gave gripe water and baby oragel. The babysitter called dad in the afternoon saying that the patient was not himself. When the dad picked him up he said the child was "out of it". Went to grandfathers house and called EMS. On EMS arrival patient had pulse in the 140''s and RR in the 30''s, by the time patient arrived at the ED patient was apneic and asystolic with bag valve mask ventilation being performed. Resusscitation was unsuccessful and the patient passed away. Upon attempt at a rectal temperature, bloody stool was noted in the diaper. There was also a palpable mass in the abdomen. The medical examiner confirmed the presence of intussusception on the autopsy.


VAERS ID: 456713 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-05-31
Entered: 2012-06-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER U2395BA / 1 UN / UN
VARCEL: VARICELLA (VARILRIX) / GLAXOSMITHKLINE BIOLOGICALS 0727U / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis meningococcal
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-26
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: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201205620

Write-up: Initial report was received on 29 May 2012 from an electronic lay press article. A 19-year-old female had received an injection of MENINGOCOCCAL VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time developed meningococcal meningitis. The patient was taken to the hospital on 25 May 2012 and died on 26 May 2012. No further information was available at the time of the report. The patient''s outcome was fatal. Documents held by sender: None.


VAERS ID: 457286 (history)  
Form: Version 1.0  
Age: 1.03  
Sex: Male  
Location: Massachusetts  
Vaccinated:2010-05-25
Onset:2010-06-13
   Days after vaccination:19
Submitted: 2012-06-12
   Days after onset:730
Entered: 2012-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E47469 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1233Y / 1 LL / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Convulsion, Meningitis streptococcal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-15
   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: Fluoride drops 0.25mg qd
Current Illness: Upper respiratory infection, with a loose cough
Preexisting Conditions: Rash to Augmentin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient developed seizures that were caused by streptococcal meningitis, 19A.


VAERS ID: 457319 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Unknown  
Vaccinated:2011-12-01
Onset:2011-12-06
   Days after vaccination:5
Submitted: 2012-06-12
   Days after onset:188
Entered: 2012-06-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-06
   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: 2012032567

Write-up: This social media report (initial receipt: 04-Jun-2012) concerns a 7-year-old female patient. On ??-Dec-2011 the patient received her fatal dose of flu vaccine (manufacturer, brand name and batch number were not reported) and was pronounced dead about 92 hours later on 06-Dec-2011. The cause of death was not reported.


VAERS ID: 457374 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: Kentucky  
Vaccinated:2012-05-16
Onset:2012-06-10
   Days after vaccination:25
Submitted: 2012-06-13
   Days after onset:3
Entered: 2012-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B326AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH428AB / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F30921 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB268A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Viral gastroenteritis; diaper rash
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant died.


VAERS ID: 457526 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Indiana  
Vaccinated:2012-05-02
Onset:2012-05-04
   Days after vaccination:2
Submitted: 2012-06-13
   Days after onset:40
Entered: 2012-06-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB538BA / 1 UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B079CA / UNK UN / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR G1130 / 1 UN / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UH284AA / 1 UN / SC

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Death, Joint swelling, Muscle spasms, Myalgia, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-21
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CRESTOR; PLAVIX; ASA; DIOVAN
Current Illness: None
Preexisting Conditions: Coronary Artery Disease; Hyperlipidemia; Hypertension
Allergies:
Diagnostic Lab Data: Cardiologist thought he had arrhythmic death.
CDC Split Type:

Write-up: Dr. experienced muscle aching and spasm on 4 May. He also had joint pain and swelling. This resolved by 9 May 12. He died in his sleep on 21 May 12.


VAERS ID: 457541 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2011-11-02
Onset:2011-11-05
   Days after vaccination:3
Submitted: 2012-06-13
   Days after onset:221
Entered: 2012-06-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA676AA / UNK AR / UN

Administered by: Private       Purchased by: Private
Symptoms: Cardiac failure congestive, Death, Dialysis, Immunosuppression, Mixed connective tissue disease, Neuropathy peripheral, Pneumonia primary atypical, Polymyositis, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Peripheral neuropathy (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-23
   Days after onset: 200
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 65 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: HTN; Arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Began with bilateral neuritis type symptoms both arms. Proceeded to "walking pneumonia", CHF polymyositis, mixed connective tissue disease, kidney failure & death. Tx- 2 inj of steroids, long term high dose steroids, immune suppression, dialysis & death.


VAERS ID: 457904 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2012-06-04
Onset:2012-06-07
   Days after vaccination:3
Submitted: 2012-06-21
   Days after onset:14
Entered: 2012-06-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1224AA / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Completed suicide, Death, Gun shot wound
SMQs:, Suicide/self-injury (narrow), Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-07
   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:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1206USA02932

Write-up: Information has been received from a physician concerning a 14 year old male with no pertinent medical history and no drug allergies who was vaccinated intramuscularly with the first and second 0.5ml dose of GARDASIL (Lot# not reported) respectively on 02-APR-2012 and 04-JUN-2012. There was no concomitant medication. On 07-JUN-2012 the patient committed suicide. He shot himself in head. Physician stated this young male was happy go lucky, healthy, and never had any psychiatric issues in the past. It was not known if the patient sought for medical attention. On 07-JUN-2012 the patient died of suicide. Additional information has been requested.


VAERS ID: 457967 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2012-06-22
Onset:2012-06-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2012-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0271AE / 2 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Cardiac arrest
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: 2012-06-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient suffered cardiac arrest episode.


VAERS ID: 458211 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-06-25
Entered: 2012-06-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cardiomyopathy, Death
SMQs:, Cardiomyopathy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012US053744

Write-up: Case number PHHY2012US053744 is an initial literature report received on 20 Jun 2012. Authors searched for adverse events following H1N1, which were reported to the the Vaccine Adverse Event Reporting System from 01 Oct 2009 to 31 Jan 2010. This case refers to a patient (age and sex not reported). The patient was vaccinated with H1N1 (manufacturer and batch number: unknown) on an unspecified date. On an unknown date after vaccination the patient died due to cardiomyopathy. The causality of the event cardiomyopathy was not reported. Authors stated that the adverse event profile after H1N1 in VAERS was consistent with that of seasonal influenza vaccines, although the reporting rate was higher after H1N1 than seasonal influenza vaccines, this may be, at least in part, a reflection of stimulated reporting. Death, Guillain Barre Syndrome and anaphylaxis reports after H1N1 vaccination were rare (each <2 per million doses administered).


VAERS ID: 458218 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-06-25
Entered: 2012-06-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Heart disease congenital
SMQs:, Congenital, familial and genetic disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Heart disease congenital
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012US053750

Write-up: Case number PHHY2012US053750 is an initial literature report received on 20 Jun 2012. Authors searched for adverse events following H1N1, which were reported to the Vaccine Adverse Event Reporting System from 01 Oct 2009 to 31 Jan 2010. This case refers to a patient (age and sex not reported). The patient''s medical history included of congenital heart disease (not specified). The patient was vaccinated with H1N1 (manufacturer and batch number: unknown) on an unspecified date. On an unknown date after vaccination the patient died to congenital heart disease. No other information was available. Authors stated that the adverse event profile after 2009-H1N1 in VAERS was consistent with that of INFLUENZA, although the reporting rate was higher after 2009-H1N1 than INFLUENZA, this may be, at least in part, a reflection of stimulated reporting. Death, Guillain Barre Syndrome and anaphylaxis reports after 2009-H1N1 vaccination were rare (each <2 per million doses administered).


VAERS ID: 458280 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Maryland  
Vaccinated:2012-06-27
Onset:2012-06-28
   Days after vaccination:1
Submitted: 2012-06-28
   Days after onset:0
Entered: 2012-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4268AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F51336 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1674AA / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-28
   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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None - will have autopsy
CDC Split Type:

Write-up: SIDS within 24 hours.


VAERS ID: 458329 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-06-27
Entered: 2012-06-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Cerebrospinal fluid, $g45mg/d, Elevated; WBC count, 10 mm^2
CDC Split Type: WAES1206USA04109

Write-up: It was reported in a published article, that up to 215 patient developed Guillain-Barre syndrome (GBS) after vaccination with a dose of Hep B. There were 215 cases (mean age 31.15 + 19.67 years) of GBS reported after Hep B vaccination from 1990 to 2009. Among the vaccinated patients, 161 (74.9%) developed GBS within 6 weeks, 28 (13.0%) after 6 weeks, and for the remaining 26 patients (12.1 %) the time between vaccination and developing GBS was unknown. The distribution of GBS within the first 6 weeks after vaccination was unbalanced: 97 (51%) of GBS cases were reported within the first two weeks with a peak in the first week after vaccination. Hospitalization and disability were reported in 170 (79.1%) and 45 (20.9%) cases, respectively. GBS occurred in 134 cases (62.3%) with Hep B administrated as a single vaccine and in 81 cases (37.7%) when it was combined with other vaccines. At the time of the report, the patient''s statuses were unknown. OBJECTIVE: To determine the rates and characteristics of Guillain-Barre syndrome (GBS) after administration of Hep B. BACKGROUND: There are isolated reports of GBS after Hep B vaccination. DESIGN/METHODS: We used data from the Vaccine Adverse Event Reporting System supplemented by data from the center for biologics and research under the freedom of information act. RESULTS: There were 215 cases (mean age 31.15 plus or minus 19.67 years) of GBS reported after Hep B vaccination from 1990 to 2009. Among the vaccinated patients, 161 (74.9%) developed GBS within 6 weeks, 28 (13.0%) after 6 weeks, and for the remaining 26 patients (12.1 %) the time between vaccination and developing GBS was unknown. The distribution of GBS within the first 6 weeks after vaccination was unbalanced: 97 (51%) of GBS cases were reported within the first two weeks with a peak in the first week after vaccination. Hospitalization and disability were reported in 170 (79.1%) and 45 (20.9%) cases, respectively. GBS occurred in 134 cases (62.3%) with Hep B administered as a single vaccine and in 81 cases (37.7%) when it was combined with other vaccines. Based on the data obtained from the Health Survey from 2000 to 2005, it is estimated that an average of 54 millions of patients are vaccinated with influenza vaccine each year. The reporting rate of post- hepatitis vaccine GBS is 4.5 cases per million vaccinations, which is in the range expected for the general population. CONCLUSIONS/RELEVANCE: Although our results suggest that the reporting rate of GBS post- Hep B overlaps with the incidence of GBS in the general population, the unbalanced distribution of reported cases in the first 6 weeks after vaccination suggest that some cases of GBS are caused by Hep B. These results warrant continuous and careful analysis of GBS after Hep B vaccination. Follow up information has been received from a physician who reported that he did not have patient identifiers. The physician reported that they used a database and the Freedom of Information act in researching the article. Follow up information has been received from an article, that reported up to a total of 189 patients with post-hepatitis vaccination Guillain-Barre Syndrome (GBS) were reported between 1990 and 2009 (93 men, 95 women, one not categorized). The mean patient age was 30.65 plus or minus 20.1 years. Miller-Fisher syndrome, a variant of GBS, was reported in four patients (2.12%). Thirty-one patients (16.4%) reported an antecedent respiratory or gastrointestinal viral illness before GBS onset. The distribution of GBS occurrence in the first six weeks after hepatitis vaccine administration demonstrates a peak occurrence in the first two weeks. Among the reported patients, 133 (70.37%) developed GBS within six weeks of vaccine administration, 30 (15.87%) after six weeks, and for the remaining 26 (13.76%) the time between vaccination and GBS occurrence was not specified. The diagnosis was further supported by elevated cerebrospinal fluid protein concentration ($g45 mg/dL), with fewer than 10 white blood cells/mm^2, or by electrodiagnostic study findings consistent with primary demyelination. Hospitalization was reported in 154 patients (81.5%), disability was reported in 34 (18%) patients, and death was reported in three (1.6%). GBS occurred in 115 (61%) patients when the hepatitis vaccine was administered as a single vaccine. And in 74 (39%) patients when it was combined with other vaccines. The onset interval of reported GBS after hepatitis vaccination (mean onset 20 days) was significantly longer than reports of non-GBS adverse events (median onset one day), which was statistically significant (p < 0.05). Most (90%) of non-GBS adverse reactions after the hepatitis vaccine occurred within the first week after vaccination, with 41% of adverse events occurring in the first 24 hours. The data demonstrated a wide fluctuation in the reporting rate of GBS from the VAERS database between 2000 and 2008. The incidence of the Miller-Fisher variant of GBS in our study, 2.12% of the total number of patients with GBS, is within the range reported by other studies conducted in the western hemisphere, where this variant is estimated at 1% to 7% of the total number of patients with GBS. The reporting rate of an antecedent respiratory or gastrointestinal viral illness before the onset of GBS in our study was lower than that observed in unvaccinated subjects, where 40% to 70% of such patients with GBS reported a preceding illness. Patients with Miller-Fisher syndrome, a variant of GBS, were also included in the analysis. Although the author''s results suggest that the reporting rate of post-hepatitis GBS overlaps with the incidence of GBS in the general population, the unbalanced distribution of reported patients in the first six weeks after vaccination, with a peak occurrence in the first two weeks, suggested that the hepatitis vaccine may potentially trigger GBS. This is one of several reports received from the same source. No further information is available.


VAERS ID: 458335 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-06-27
Entered: 2012-06-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Cerebrospinal fluid, $g45 mg/d, Elevated; WBC count, 10 mm^2
CDC Split Type: WAES1206USA04506

Write-up: It was reported in a published article, that up to 215 patient developed Guillain-Barre syndrome (GBS) after vaccination with a dose of hepatitis B virus vaccine rHBsAg. There were 215 cases (mean age 31.15 + 19.67 years) of GBS reported after hepatitis B virus vaccine rHBsAg vaccination from 1990 to 2009. Among the vaccinated patients, 161 (74.9%) developed GBS within 6 weeks, 28 (13.0%) after 6 weeks, and for the remaining 26 patients (12.1 %) the time between vaccination and developing GBS was unknown. The distribution of GBS within the first 6 weeks after vaccination was unbalanced: 97 (51 %) of GBS cases were reported within the first two weeks with a peak In the first week after vaccination. Hospitalization and disability were reported In 170 (79.1%) and 45 (20.9%) cases, respectively. GBS occurred in 134 cases (62.3%) with hepatitis B virus vaccine rHBsAg administrated as a single vaccine and in 81 cases (37.7%) when it was combined with other vaccines. At the time of the report, the patient''s statuses were unknown. OBJECTIVE: To determine the rates and characteristics of Guillain-Barre syndrome (GBS) after administration of hepatitis B virus vaccine rHBsAg. BACKGROUND: There are isolated reports of GBS after hepatitis B virus vaccine rHBsAg vaccination. DESIGN/METHODS: We used data from the Vaccine Adverse Event Reporting System supplemented by data from the center for biologics and research under the freedom of information act. RESULTS: There were 215 cases (mean age 31.15 + 19.67 years) of GBS reported after hepatitis B virus vaccine rHBsAg vaccination from 1990 to 2009. Among the vaccinated patients, 161 (74.9%) developed GBS within 6 weeks, 28 (13.0%) after 6 weeks, and for the remaining 26 patients (12.1 %) the time between vaccination and developing GBS was unknown. The distribution of GBS within the first 6 weeks after vaccination was unbalanced: 97 (51 %) of GBS cases were reported within the first two weeks with a peak In the first week after vaccination. Hospitalization and disability were reported In 170 (79.1%) and 45 (20.9%) cases, respectively. GBS occurred in 134 cases (62.3%) with hepatitis B virus vaccine rHBsAg administered as a single vaccine and in 81 cases (37.7%) when it was combined with other vaccines. Based on the data obtained from the National Health Interview Survey from 2000 to 2005, it is estimated that an average of 54 millions of patients are vaccinated with influenza vaccine each year. The reporting rate of post- hepatitis vaccine GBS is 4.5 cases per million vaccinations, which is in the range expected for the general population. CONCLUSIONS/RELEVANCE: Although our results suggest that the reporting rate of GBS post- hepatitis B virus vaccine rHBsAg overlaps with the incidence of GBS in the general population, the unbalanced distribution of reported cases In the first 6 weeks after vaccination suggest that some cases of GBS are caused by hepatitis B virus vaccine rHBsAg. These results warrant continuous and careful analysis of GBS after hepatitis B virus vaccine rHBsAg vaccination. Follow up information has been received from a physician who reported that he did not have patient identifiers. The physician reported that they used a database and the Freedom of Information act in researching the article. Follow up information has been received from an article, that reported up to a total of 189 patients with post-hepatitis vaccination Guillain-Barre Syndrome (GBS) were reported between 1990 and 2009 (93 men, 95 women, one not categorized). The mean patient age was 30.65 + 20.1 years. Miller-Fisher syndrome, a variant of GBS, was reported in four patients (2.12%). Thirty-one patients (16.4%) reported an antecedent respiratory or gastrointestinal viral illness before GBS onset. The distribution of GBS occurrence in the first six weeks after hepatitis vaccine administration demonstrates a peak occurrence in the first two weeks. Among the reported patients, 133 (70.37%) developed GBS within six weeks of vaccine administration, 30 (15.87%) after six weeks, and for the remaining 26 (13.76%) the time between vaccination and GBS occurrence was not specified. The diagnosis was further supported by elevated cerebrospinal fluid protein concentration ($g45 mg/dL), with fewer than 10 white blood cells/mm^2, or by electro diagnostic study findings consistent with primary demyelination. Hospitalization was reported in 154 patients (81.5%), disability was reported in 34 (18%) patients, and death was reported in three (1.6%). GBS occurred in 115 (61%) patients when the hepatitis vaccine was administered as a single vaccine. And in 74 (39%) patients when it was combined with other vaccines. The onset interval of reported GBS after hepatitis vaccination (mean onset 20 days) was significant longer than reports of non-GBS adverse events (median onset one day), which was statistically significant (p < 0.05). Most (90%) of non-GBS adverse reactions after the hepatitis vaccine occurred within the first week after vaccination, with 41% of adverse events occurring in the first 24 hours. The data demonstrated a wide fluctuation in the reporting rate of GBS from the VAERS database between 2000 and 2008. The incidence of the Miller-Fisher variant of GBS in our study, 2.12% of the total number of patients with GBS, is within the range reported by other studies conducted in the western hemisphere, where this variant is estimated at 1% to 7% of the total number of patients with GBS. The reporting rate of an antecedent respiratory or gastrointestinal viral illness before the onset of GBS in our study was lower than that observed in unvaccinated subjects, where 40% to 70% of such patients with GBS reported a preceding illness. Patients with Miller-Fisher syndrome, a variant of GBS, were also included in the analysis. Although the author''s results suggest that the reporting rate of post-hepatitis GBS overlaps with the incidence of GBS in the general population, the unbalanced distribution of reported patients in the first six weeks after vaccination, with a peak occurrence in the first two weeks, suggested that the hepatitis vaccine any potentially trigger GBS. This is one of several reports received from the same source. No further information is available.


VAERS ID: 458346 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-06-28
Entered: 2012-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Neurodevelopmental disorder; Nervous system disorder; Physical disability; Cerebral palsy; Mental disability
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012US054996

Write-up: Case number PHHY2012US054996 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a patient (age and sex not specified). The patient''s medical history included severe to profound neurologic and neurodevelopmental disabilities, including physical limitations, cerebral palsy and intellectual disability. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On an unspecified date after vaccination, the patient developed influenza. On an unknown date the patient died due to multiple organ failure. No other information pertaining to this patient was available. Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.


VAERS ID: 458350 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Female  
Location: Missouri  
Vaccinated:2012-06-27
Onset:2012-06-27
   Days after vaccination:0
Submitted: 2012-06-28
   Days after onset:1
Entered: 2012-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4058AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F53376 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1711AA / 2 MO / PO

Administered by: Unknown       Purchased by: Public
Symptoms: Cyanosis, Death
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-27
   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: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Family noticed baby was blue and called 911. Baby was coded and pronounced at approx 1755. At this time I do not have exact times.


VAERS ID: 458414 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Texas  
Vaccinated:2012-05-15
Onset:2012-05-17
   Days after vaccination:2
Submitted: 2012-06-28
   Days after onset:42
Entered: 2012-06-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B323BA / 1 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UT1524AB / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F2N290 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1554NA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Blood culture negative, Blood test abnormal, Body temperature increased, CSF test normal, Culture negative, Culture stool negative, Culture urine negative, Death, Dehydration, Occult blood negative, Rotavirus test negative, Rotavirus test positive, 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), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-05-17
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Vomiting; Diarrhoea; Dehydration; Hospitalisation
Allergies:
Diagnostic Lab Data: Diagnostic laboratory, 05/11/12, "rotavirus results were negative"; Diagnostic laboratory, 05/18/12, blood test reflected dehydration; Stool culture, 05/18?12, negative; Stool rotavirus antigen, 05/18?/12, positive; Urine culture, 05/11/12, negative; Cerebrospinal fluid, 05/11/12, negative; Body temp, 05/18/12, 100.1 F; Upper respiratory, 05/11/12, negative; Blood culture, 05/11/12, negative; Stool for fecal, 05/11/12, negative; Stool culture, 05/11/12, negative
CDC Split Type: WAES1206USA04094

Write-up: Information has been received from a physician concerning a 13 week old (reported as 3 month) female patient with a history of vomiting, diarrhoea, dehydration and hospitalization (the patient was hospitalized from 11-MAY-2012 to 14-MAY-2012 due to vomiting, diarrhoea, dehydration) with a negative results of medical test including stool cultures, "rotavirus", fecal blood cell, urine, blood, cerebral spinal fluid and respiratory cultures (the patient was administered unspecified antibiotics and was rehydrated) who on 15-MAY-2012 was vaccinated with a 2.0 ml first dose of ROTATEQ, (Lot # not reported). There was no concomitant medication. On 18-MAY-2012 the patient was found unresponsive at home after a nap. The patient was admitted to the hospital. Her rectal temperature was 100.01 and blood tests reflected dehydration. The patient was given IV fluids and supportive measures. The patient was pronounced dead on 18-MAY-2012. The physician reported, at autopsy, negative stool culture and positive rotavirus antigen ID. The caused of death has not yet been determined. Additional information has been requested. All adverse events were determined as significant disability, life threatening and other important medical events.


VAERS ID: 458458 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2011-02-19
Submitted: 2012-06-29
   Days after onset:495
Entered: 2012-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Chest X-ray abnormal, Cough, Death, Hypotension, Influenza A virus test positive, Mechanical ventilation, Oxygen saturation decreased, Pyrexia, Sepsis, Tachypnoea, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Neurodevelopmental disorder; Nervous system disorder; Physical disability, Unable to speak or move; Cerebral palsy; Mental disability
Preexisting Conditions: Pneumonia aspiration, Multiple hospital admissions.
Allergies:
Diagnostic Lab Data: Body temperature, 38.5 degrees C, High; Chest X-ray, Abnormalities, Significant, Abnormalities noted on chest radiography; Chest X-ray, Lung opacities, Significant, On illness day 7, chest radiography showed diffuse lung opacities that progressed to complete opacity of both lungs. Influenza A virus test positive, Positive, Significant, He tested positive for influenza A by rapid influenza diagnostic test. Oxygen saturation decreased, 88%, Low
CDC Split Type: PHHY2012US054673

Write-up: Case number PHHY2012US054673 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a male patient (age not specified). The patient''s medical history included of severe to profound neurologic and neurodevelopmental disabilities, including physical limitations. With his neurologic impairment, he was able to make sounds but unable to speak or move on his own volition. He had multiple prior admissions for aspiration pneumonia and a history of abnormalities noted on chest radiography. He was vaccinated with season influenza vaccine 2010/2011 (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On 19 Feb 2011, he had fever of 101.2 F (38.4 C), and his oxygen saturation was 88% on room air. Empiric treatment with ciprofloxacin was initiated. On illness day 2, he developed mild cough and wheezing and was given supplemental oxygen. On illness day 3, he became tachypneic and required increased respiratory suctioning. On illness day 5, he was hospitalized with fever of 101.3 F (38.5 C) and respiratory rate of 24 breaths-per-minute; empiric treatment with piperacillin/tazobactam and vancomycin was initiated. On illness day 6, he tested positive for influenza A by rapid influenza diagnostic test (RIDT) and was treated with oseltamivir (60 mg twice daily). On the same day, he developed both acute respiratory distress syndrome requiring mechanical ventilation and sepsis with hypotension requiring vasopressor support. On illness day 7, chest radiography showed diffuse lung opacities that progressed to complete opacity of both lungs. He died on illness day 8, Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.


VAERS ID: 458605 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-07-02
Entered: 2012-07-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1206USA04974

Write-up: Information has been received from a pharmacist concerning his over 65 year old mother who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number, dose and route not reported). Subsequently on an unspecified date the patient died. The cause of death was unknown. The reporter felt that the patient''s death was not related to therapy with PNEUMOVAX 23. No further information is available.


VAERS ID: 458613 (history)  
Form: Version 1.0  
Age: 0.76  
Sex: Male  
Location: New York  
Vaccinated:2012-06-27
Onset:2012-06-30
   Days after vaccination:3
Submitted: 2012-07-02
   Days after onset:2
Entered: 2012-07-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4131AA / UNK LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F53376 / 3 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Aspiration tracheal, Blood test, CSF culture, Chest X-ray, Computerised tomogram head, Death, Differential white blood cell count, Full blood count, Laboratory test, Resuscitation, Skeletal survey, 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: 2012-06-30
   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: None
Current Illness: None - Well child
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: CBC with diff; Chem 7; X-ray chest; CT scan brain; Skeletal survey; Blood; CSF culture; Culture of tracheal aspirate
CDC Split Type:

Write-up: The baby found unresponsive in the morning on 6/30/12. Resuscitation attempts done by Paramedics and in the ER failed.


VAERS ID: 458702 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Indiana  
Vaccinated:2012-05-18
Onset:2012-05-21
   Days after vaccination:3
Submitted: 2012-05-30
   Days after onset:9
Entered: 2012-07-05
   Days after submission:36
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4277AC / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 918173 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1847AA / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-21
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death: 2-3 days following immunizations.


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