chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Injection site warmth, Multi-organ failure, Surgery
Clinical narrative: Left upper arm where the vaccination was injected became red, hot to touch, sore even to touch and my mother could not lift her arm to her waist.  She then became ill with flu lie symptoms.  She went to her primary physician on 10/19/07 but he dismissed her symptoms as a virus and sent her home with pain pills and antibiotics.  By Sunday, 10/21/07, cellulitis had set in, spread, and she was admitted to the medical center.  She suffered multi vital organ failure and many surgeries to cut out the fleah eating bacteria she contracted.
Age: 59.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Cellulitis, Intensive care, Mechanical ventilation, Pain in extremity
Clinical narrative: Left upper arm where the vaccination was injected became red, hot to touch, sore even to touch and my mother could not lift her arm to her waist.  She then became ill with flu lie symptoms.  She went to her primary physician on 10/19/07 but he dismissed her symptoms as a virus and sent her home with pain pills and antibiotics.  By Sunday, 10/21/07, cellulitis had set in, spread, and she was admitted to the medical center.  She suffered multi vital organ failure and many surgeries to cut out the fleah eating bacteria she contracted.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Nausea, Pain, Pneumonia pneumococcal, Streptococcal bacteraemia
Clinical narrative: my grandmother drove herself to get her flu shot on Tuesday, October 16th. On Wednesday, she felt very "achy" and nauseous, although she was tolerating liquids. No vomiting. Then on Thursday, the 18th, she couldn't walk. It took her an hour and a half to get out of bed. 911 was called and she was taken to the local er.  1/18/08 Reviewed hospital medical records which reveal patient experienced generalized weakness, left hip pain & severe back pain.  In ER, had leukocytosis & presumed sepsis.  Admitted 10/18-11/3/2007.  Tx w/IV antibiotics.  ID, Ortho, Urology consults done.  Transferred to SNF for rehab & to decide re nephrectomy or hospice FINAL DX: Renal cell carcinoma; severe DDD of spine; pneumococcal bacteremia; pneumococcal pneumonia.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Pain in extremity, Skin nodule, Tenderness
Clinical narrative: Received on Monday--fine that day.  Arm got reallty sore on Tuesday-Wednesday & Thursday.  On Thursday I had the chills in the afternnon and that evening.  It is 1 week later to the day and I still have a knot in my arm that is a bit tender
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Shots were given in left arm. Arm became swollen and red with a streak of red radiating to the arm pit. Arm was very soar to the touch and hurt when moved.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Swelling
Clinical narrative: Received Influenza vaccination on 10/26/07.  Describes a 3-day delay, then increased pain, localized swelling, non-erythematous.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Chills - High Fever - Aches (my whole body hurt) - Lethargic - Headache - swelling, redness, and pain at the injection site
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Chills - High Fever - Aches (my whole body hurt) - Lethargic - Headache - swelling, redness, and pain at the injection site
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Patient received influenza vaccination and while walking to waiting room patient passed out.  Patient turned pale and mother carried him back to a room.  Vitals were monitored and legs elevated.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Blood pressure increased, Catheterisation cardiac normal, Chest pain, Chills
Clinical narrative: Approximately 30 min after receiving flu shot pt c/o chest pain, severe headache and chills. Stated she felt like her asthma was acting up. BP slightly elevated at 184/88. She wanted to go home and lay down. Recommended she go to ER. Went to ER w/ employee. During a 4 day stay she failed a stress test, had 2 CAT scans and a heart cath that was neg. Hospital stated she had a systemic rxn to flu shot.   11/30/07 Reviewed hospital medical records which reveal patient experienced substernal chest pain, sweating, SOB & HA approx 30 min s/p flu vax.  Admitted 11/5-11/8/2007. FINAL DX: atypical chest pain w/possible drug reaction vs musculoskeletal pain; bronchial asthma; uncontrolled DM.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Condition aggravated, Headache, Vaccination complication
Clinical narrative: Approximately 30 min after receiving flu shot pt c/o chest pain, severe headache and chills. Stated she felt like her asthma was acting up. BP slightly elevated at 184/88. She wanted to go home and lay down. Recommended she go to ER. Went to ER w/ employee. During a 4 day stay she failed a stress test, had 2 CAT scans and a heart cath that was neg. Hospital stated she had a systemic rxn to flu shot.   11/30/07 Reviewed hospital medical records which reveal patient experienced substernal chest pain, sweating, SOB & HA approx 30 min s/p flu vax.  Admitted 11/5-11/8/2007. FINAL DX: atypical chest pain w/possible drug reaction vs musculoskeletal pain; bronchial asthma; uncontrolled DM.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site infection, Injection site nodule, Pain in extremity, Pyrexia
Clinical narrative: began low feaver by noon on day of vaccine.  by 10pm high feaver 102 + the high fever lasted until thrusday afternoon.  arm pain increasing daily.  on friday at noon, visited local doctor to discover an infection at the injecetion site.  currently taking antibiotics, however pain is still present and persistent.  a hard knot can be felt under the skin at injection site as of 11/12/07
Age: 25.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: Sore arm day of and up to three days after.  No flu symptoms.
Age: 52.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Fall, Hyperhidrosis, Injected limb mobility decreased, Injection site pain
Clinical narrative: At 10:15 am on Nov. 7, 2007 I received the PPV immunization.  Through the day my arm got more and more sore.  By 6 pm I could not lift my arm more than a foot above my body.  I also started feeling generally sick, with a fever and chills and feeling pretty bad all around.  I went to bed about 11 pm, my usual time, having stayed on the couch the better part of the afternoon and all evening.  At 1:30 am the next day I woke with a pulsing, throbbing pain in my arm where I had received the PPV shot.  I went downstairs to take two aspirin to relieve the pain.  In the bathroom I blacked out twice but remained standing.  I went to the kitchen to get milk to take the aspirin with.  I blacked out and fell at least once, perhaps twice, in the kitchen while getting the milk.  Each time I woke up on the floor with no recollection as to how I got there.  Luckily I did not hit my head or any other parts of my body when I fell.  I was clearly not thinking rationally, and I was not thinking clearly.  I was driven to take the aspirin and get back to bed, but my brain was not functioning well.  Each time I awoke on the floor I remember thinking, I have to get up, but I had no feeling that things were not right.  I climbed upstairs toward our bedroom (although I have no recollection of walking or climbing the stairs), and I blacked out and fell again in the upstairs hallway.  Again, luckily, I did not hit my head on anything severely when I fell.  I awoke and found myself on the floor, but I did not know how I had gotten there.  Again my driving thought was to get back to bed.  My wife kept asking me if I was okay and I guess I said I was, but my mind was not functioning much at that time.  I was just driving myself to get back into bed.  I got into bed, where I broke out in a complete, drenching sweat over all of my body.  My fever also increased dramatically, but after the sweat came out completely I started to cool off somewhat.  I kept telling my wife I did not want to go to the hospital (although this was not a rational person speaking, especially when I was downstairs and just after I got back into bed).  I fell asleep fairly soon (~15 minutes or so) and slept fairly well that night.  My arm was very sore for the next 24 hours, and I could not lift it more than a foot or two all day.  I took four aspirins during the day to help relieve the arm ache.  I rested that entire day and did not work that day.  Toward that evening the pain where the shot was given started to decline, and I started to feel somewhat normal.  The next day I could lift my arm higher and the pain continued to subside.  By day three I was back to almost normal.  I had had no alcohol to drink on the day of my PPV shot and only the .5 milligram Ativan at night as per my usual routine, so I am sure it was the PPV shot that had caused my severe reaction.  My left arm, where I got my flu shot at the same time as the PPV shot, felt fine from the time of the shot.
Age: 52.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Loss of consciousness, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: At 10:15 am on Nov. 7, 2007 I received the PPV immunization.  Through the day my arm got more and more sore.  By 6 pm I could not lift my arm more than a foot above my body.  I also started feeling generally sick, with a fever and chills and feeling pretty bad all around.  I went to bed about 11 pm, my usual time, having stayed on the couch the better part of the afternoon and all evening.  At 1:30 am the next day I woke with a pulsing, throbbing pain in my arm where I had received the PPV shot.  I went downstairs to take two aspirin to relieve the pain.  In the bathroom I blacked out twice but remained standing.  I went to the kitchen to get milk to take the aspirin with.  I blacked out and fell at least once, perhaps twice, in the kitchen while getting the milk.  Each time I woke up on the floor with no recollection as to how I got there.  Luckily I did not hit my head or any other parts of my body when I fell.  I was clearly not thinking rationally, and I was not thinking clearly.  I was driven to take the aspirin and get back to bed, but my brain was not functioning well.  Each time I awoke on the floor I remember thinking, I have to get up, but I had no feeling that things were not right.  I climbed upstairs toward our bedroom (although I have no recollection of walking or climbing the stairs), and I blacked out and fell again in the upstairs hallway.  Again, luckily, I did not hit my head on anything severely when I fell.  I awoke and found myself on the floor, but I did not know how I had gotten there.  Again my driving thought was to get back to bed.  My wife kept asking me if I was okay and I guess I said I was, but my mind was not functioning much at that time.  I was just driving myself to get back into bed.  I got into bed, where I broke out in a complete, drenching sweat over all of my body.  My fever also increased dramatically, but after the sweat came out completely I started to cool off somewhat.  I kept telling my wife I did not want to go to the hospital (although this was not a rational person speaking, especially when I was downstairs and just after I got back into bed).  I fell asleep fairly soon (~15 minutes or so) and slept fairly well that night.  My arm was very sore for the next 24 hours, and I could not lift it more than a foot or two all day.  I took four aspirins during the day to help relieve the arm ache.  I rested that entire day and did not work that day.  Toward that evening the pain where the shot was given started to decline, and I started to feel somewhat normal.  The next day I could lift my arm higher and the pain continued to subside.  By day three I was back to almost normal.  I had had no alcohol to drink on the day of my PPV shot and only the .5 milligram Ativan at night as per my usual routine, so I am sure it was the PPV shot that had caused my severe reaction.  My left arm, where I got my flu shot at the same time as the PPV shot, felt fine from the time of the shot.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood pressure decreased, Diarrhoea, Dizziness, Hyperhidrosis
Clinical narrative: profusley sweating,blood presure dropped,faint-dizzy,nausea,diarrhea,weakness.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Syncope
Clinical narrative: profusley sweating,blood presure dropped,faint-dizzy,nausea,diarrhea,weakness.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Pain, Urticaria
Clinical narrative: Local reaction. Raised wheal 2.25 in (5.5 cm) in diameter, painful and reddened, appeared within 5 hours. Remains raised/painful >48 hours after injection. Ice applied periodically.
Age: 56.0
Sex: U
Vaccine: FLUX
Symptoms: Chills, Nasopharyngitis, Pain, Pyrexia, Similar reaction on previous exposure to drug
Clinical narrative: aBOUT 5 HOURS AFTER RECIEVING SHOT I BEGAN TO ACHE ALL OVER APPROX8 HRS AFTER SHOT i BEGAN WHEEZING BADLY LIKE I WAS DROWNING IN FLUIDS AND I GOT CHILLS AND FEVER I WAS SHAKING SO BAD i COULD NOT EVEN TALK  I GOT UNDER ELECTRIC BLANKET ON HIGH AND COVERED UP, EVEN MY HEAD UNDER 4 MORE QUILTS.2 DAYS LATER I GOT A COLD THAT I STILL HAVE AND MY BODY IS STILL ACHING ALL OVER.WILL PROB SEE DR TOMMORROW  tHIS IS THE 2ND TIME TO TAKE THE FLU SHOTAND THE SAME REACTION BOTH TIMES COLD LAST ABOUT 6 WEEKS
Age: 56.0
Sex: U
Vaccine: FLUX
Symptoms: Tremor, Wheezing
Clinical narrative: aBOUT 5 HOURS AFTER RECIEVING SHOT I BEGAN TO ACHE ALL OVER APPROX8 HRS AFTER SHOT i BEGAN WHEEZING BADLY LIKE I WAS DROWNING IN FLUIDS AND I GOT CHILLS AND FEVER I WAS SHAKING SO BAD i COULD NOT EVEN TALK  I GOT UNDER ELECTRIC BLANKET ON HIGH AND COVERED UP, EVEN MY HEAD UNDER 4 MORE QUILTS.2 DAYS LATER I GOT A COLD THAT I STILL HAVE AND MY BODY IS STILL ACHING ALL OVER.WILL PROB SEE DR TOMMORROW  tHIS IS THE 2ND TIME TO TAKE THE FLU SHOTAND THE SAME REACTION BOTH TIMES COLD LAST ABOUT 6 WEEKS
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Pyrexia, Staring
Clinical narrative: Arm from shoulder to elbow was red and swelled up double the size of her arm.  Ran a fever of 101.  I called and was told this was normal.  Day after vaccine my daughter would not respond to me after consistently calling her name in the car for about 30 seconds.  I almost stopped the vehicle but she finally responded.  She was having a staring spell which she has never had before.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Muscular weakness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Received pneumonia vaccine on Friday 11/9/07, on Saturday night I was up during the night and could not sleep, left arm was sore but not red. Sunday I had muscle aches and fever up to 100.8,I took Tylenol extra strength for pain and fever around the clock. Last night 11/10/07 fever broke and muscle weakness stopped. Today 11/11 I put ice on the site, area is red about two inches around the sight. Left message on my Doctor's answering service Monday 11/11/07 regarding these symptoms.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Sleep disorder
Clinical narrative: Received pneumonia vaccine on Friday 11/9/07, on Saturday night I was up during the night and could not sleep, left arm was sore but not red. Sunday I had muscle aches and fever up to 100.8,I took Tylenol extra strength for pain and fever around the clock. Last night 11/10/07 fever broke and muscle weakness stopped. Today 11/11 I put ice on the site, area is red about two inches around the sight. Left message on my Doctor's answering service Monday 11/11/07 regarding these symptoms.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dysphagia, Eye discharge, Nausea
Clinical narrative: I felt totally fine prior to vaccination. 3 hours after receiving the vaccine, cough and some wheezing developed.  It was uncomfortable to swallow, like a big lump was in my throat.  I developed shaking chills, purulent drainage from my eyes.  I also became nauseous and vomited.  I used Maxair inhaler and Benadryl for the tight cough and wheeze.  Fortunately, symptoms were relieved after several hours and I opted not to be seen for treatment.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Purulent discharge, Sensation of foreign body, Tremor, Vomiting, Wheezing
Clinical narrative: I felt totally fine prior to vaccination. 3 hours after receiving the vaccine, cough and some wheezing developed.  It was uncomfortable to swallow, like a big lump was in my throat.  I developed shaking chills, purulent drainage from my eyes.  I also became nauseous and vomited.  I used Maxair inhaler and Benadryl for the tight cough and wheeze.  Fortunately, symptoms were relieved after several hours and I opted not to be seen for treatment.
Age: 4.0
Sex: M
Vaccine: RUB
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Parent contacted clinic within 24 hrs of vaccine administration, stating that injection site had an area of redness approximately 3-4 inches across. Mild low grade fever for 12 hours only. Negative arthralgia, negative myalgia
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: localized swelling in Left neck and  clavical area. Vaccine given in left arm.  Ibuprofin 800 mg q 8 hours for two days
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site irritation, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequently adverse events. On an unspecified date on or after 21 October 2001 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site irritation, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.
Sex: U
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.
Sex: U
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.
Sex: U
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.
Sex: U
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subject adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth of redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Information has been received from a physician concerning a 60 year old female with stomach virus, allergy to Levaquin and drug hypersensitivity to codeine who on 10-OCT-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (invalid lot# 0761409). There was no concomitant medication. In October 2007, the physician reported that "after receiving Zostavax (Oka/Merck) the patient had severe motor weakness of all extremities, but with no sensory loss, onset reported as 26-Oct-2007. The patient then saw a neurologist then admitted the patient immediately to the hospital. At the hospital the patient was diagnosed with Guillain-Barre Syndrome and was hospitalized for 6 days. Unspecified medical attention was sought. No product quality complaint. The physician reported that the patient is recovering and is going through physical therapy" Guillain-Barre Syndrome was considered serious due to hospitalization, immediately life-threatening and disabling. Upon internal review, Guillain-Barre Syndrome was also considered an Other Important Medical Event. Additional information has been requested.  11/19/07-records received for DOS 10/30-11/4/07-DC DX: Guillain-Barre syndrome. Benign essential hypertension, severe cerebromicrovascular disease, headache and low grade fever related to intravenous gamma globulin (presumed).  Presented with several day history of pure ascending paralysis approximately two weeks after they vacationed in which she had a multitude of mosquito bites. Treated with IV gamma globulin.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a retired 77 year old female with asthma, aortic stenosis, paroxysmal atrial fibrillation, left ventricular hypertrophy, coronary artery disease, and elevated cholesterol, who was vaccinated with Zostavax (Oka/Merck) (lot#"6743U"). The patient developed a mild case of shingles after having been vaccination with Zostavax (Oka/Merck). The patient was seen in the office and ordered valacyclovir hydrochloride (VALTRIX). Additional information received from a nurse practitioner reported that the patient developed a rash on 04-SEP-2007, and was seen on 07-SEP-2007 for shingles. Treatment included famiciclovir (FAMVIR) and deltasone (PREDNISONE). It was reported that the patient had recovered. No product quality complaint was reported. No further information was available. The patients shingles were considered to be an other important event by the reporter. Additional information is not expected.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal tenderness, Blood test normal, Body temperature increased, Culture stool negative, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included "other 2 month recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Additional information has been requested.  11/15/2007 Vax record received from PCP and info updated in VAERS database. 12/21/2007 MR received for DOS 6/11/2007 with DX: Acute Gastroenteritis.  Dehydration.  Somewhat lethargic.  Child presented to ER with 2 day hx of diarrhea, vomiting, low grade fever, and decreased UO and energy level. PE (+) for sleepiness, doughy abdomen with decreased BS, and a tubular mass in the LUQ. Bloody stool noted during admission, but pt D/C same day.  No D/C Summ written. Child transfered to higher level of care. 12/31/07 MR received from transfer facility for DOS 6/11-14/2007 with primary DX:  Cecal polyp from ischemia.  Presented as above.  IS noted on contrast enema, partially reduced.  Taken to OR for exploratory lap for Intussusception.  IS was reduced. Polyp noted in ileocecal valve which appeared to be acting as lead point.  A limited ileoceccectomy was also performed. D/C on post-op day 3 in stable cond.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Laboratory test abnormal, Lethargy
Clinical narrative: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included "other 2 month recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Additional information has been requested.  11/15/2007 Vax record received from PCP and info updated in VAERS database. 12/21/2007 MR received for DOS 6/11/2007 with DX: Acute Gastroenteritis.  Dehydration.  Somewhat lethargic.  Child presented to ER with 2 day hx of diarrhea, vomiting, low grade fever, and decreased UO and energy level. PE (+) for sleepiness, doughy abdomen with decreased BS, and a tubular mass in the LUQ. Bloody stool noted during admission, but pt D/C same day.  No D/C Summ written. Child transfered to higher level of care. 12/31/07 MR received from transfer facility for DOS 6/11-14/2007 with primary DX:  Cecal polyp from ischemia.  Presented as above.  IS noted on contrast enema, partially reduced.  Taken to OR for exploratory lap for Intussusception.  IS was reduced. Polyp noted in ileocecal valve which appeared to be acting as lead point.  A limited ileoceccectomy was also performed. D/C on post-op day 3 in stable cond.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Mucous stools, Somnolence, Surgery, Urinary system X-ray, Urine output decreased
Clinical narrative: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included "other 2 month recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Additional information has been requested.  11/15/2007 Vax record received from PCP and info updated in VAERS database. 12/21/2007 MR received for DOS 6/11/2007 with DX: Acute Gastroenteritis.  Dehydration.  Somewhat lethargic.  Child presented to ER with 2 day hx of diarrhea, vomiting, low grade fever, and decreased UO and energy level. PE (+) for sleepiness, doughy abdomen with decreased BS, and a tubular mass in the LUQ. Bloody stool noted during admission, but pt D/C same day.  No D/C Summ written. Child transfered to higher level of care. 12/31/07 MR received from transfer facility for DOS 6/11-14/2007 with primary DX:  Cecal polyp from ischemia.  Presented as above.  IS noted on contrast enema, partially reduced.  Taken to OR for exploratory lap for Intussusception.  IS was reduced. Polyp noted in ileocecal valve which appeared to be acting as lead point.  A limited ileoceccectomy was also performed. D/C on post-op day 3 in stable cond.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included "other 2 month recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Additional information has been requested.  11/15/2007 Vax record received from PCP and info updated in VAERS database. 12/21/2007 MR received for DOS 6/11/2007 with DX: Acute Gastroenteritis.  Dehydration.  Somewhat lethargic.  Child presented to ER with 2 day hx of diarrhea, vomiting, low grade fever, and decreased UO and energy level. PE (+) for sleepiness, doughy abdomen with decreased BS, and a tubular mass in the LUQ. Bloody stool noted during admission, but pt D/C same day.  No D/C Summ written. Child transfered to higher level of care. 12/31/07 MR received from transfer facility for DOS 6/11-14/2007 with primary DX:  Cecal polyp from ischemia.  Presented as above.  IS noted on contrast enema, partially reduced.  Taken to OR for exploratory lap for Intussusception.  IS was reduced. Polyp noted in ileocecal valve which appeared to be acting as lead point.  A limited ileoceccectomy was also performed. D/C on post-op day 3 in stable cond.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Henoch-Schonlein purpura, Rash, Urine analysis
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 1 year old male with no pertinent medical history or drug allergies who on 24-SEP-2007 was vaccinated SC with a 0.5 ml dose of MMR (LOT# 655486/0426U). Suspect vaccination administered on that same day included a dose of Varivax. The patient developed a rash and was diagnosed with Henoch Schonlein purpura during an emergency room visit on 03-OCT-2007. Lab diagnostic studies performed included a urinalysis. The patient was not admitted to the hospital. Subsequently, the patient recovered. There was no product quality complaint. Upon internal review, Henoch Schonlein purpura was determined to be an other important medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Intra-uterine death
Clinical narrative: Information has been received for the Merck Pregnancy Registry for Gardasil from a 20 year old female with no pertinent medical history or drug reactions/allergies who in August 2007, was vaccinated with a first dose of Gardasil (lot# unknown) 0.5 mL injection. There was no concomitant medication. On an unspecified date, the beginning of September 2007, the patient became pregnant. Seven weeks into the pregnancy the development of the baby had stopped and the baby was pronounced dead. The patient can not miscarriage until 12 weeks into the pregnancy which she had an appointment not do so the week of 12-NOV-2007 but the day of the week was unknown. The patient was supposed to receive her second dose of Gardasil on 09-OCT-2007, around the same time 06-OCT-2007 "4 weeks ago" the baby was pronounced dead, which makes her think Gardasil and the baby's death is a coincidence. No further information was provided. The patient's last menstrual period was unknown but the patient is 11 weeks pregnant. Upon internal review intra-uterine death and fetal disorder was considered to be an other medical event (OME) Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Information has been received from a nurse concerning a female (age not reported) with a history of convulsion who on approximately 25-OCT-2007 "a week ago" was vaccinated with Gardasil (lot# unknown). Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). Other concomitant therapy included divalproex sodium (DEPAKOTE) to control seizures. The nurse reported that the patient had a seizure within 15 minutes after receiving the Gardasil. It was unknown if the patient had sought medical attention. On an unspecified date the patient had recovered from the seizure. There was no additional information. Follow-up information was received that on an unspecified date the patient had a seizure 2 days after the vaccination of Gardasil. No further information was given. Upon internal review, seizure is considered to be an other medical event (OME). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a 16 year old female consumer with no previous medical history, and an allergy to penicillin, who was vaccinated at an unknown date, with the first dose of Gardasil. There was no concomitant medication. The patient reported that she did not know that she was one week pregnant at the time of vaccination. On 25-May-2007 she found out that she was pregnant. It was reported that on 25-Jul-2007 the patient had a miscarriage. Unknown medical attention was sought. The patient was recovered. No product quality complaint was involved. Upon internal review miscarriage considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported that there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 30 October 2007. A five-year-old male with history of reactive airway disease and possible allergies to peanuts and amoxicillin had received a left deltoid intramuscular injection of Fluzone SV  2007-2008 (lot number U2530AA) on 27 October 2007 and within a few hours of the vaccination, he started developing soreness and swelling near the left deltoid injection site. The following day, the patient was taken to "Ready Care", as the swelling had extended to his elbow. Treatment with Septa was initiated. The patient was seen by his pediatrician on 29 October 2007 and was dose of epinephrine and was started on Benadryl. By October 2007, the swelling had extended to the patient's wrist. At the time of this report, the patient had not recovered. No additional information was provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Computerised tomogram normal, Global amnesia
Clinical narrative: Pt developed transient global amnesia-memory loss x 12 hrs after the vaccine. fully recovered.  11/27/07 Reviewed hospital medical records which reveal patient experienced acute onset of memory loss & recall for only events that happened 10/20.  Admitted 10/20-10/21/2007.  Memory returned approx 6-10 hours from initial onset & within 24 hours of admit was completely back to normal. FINAL DX: memory loss, transient, probably secondary to transient global amnesia. 12/21/07 Reviewed pcp medical records which consisted of H&P from hospitalization 10/20/07.  No new information.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Soreness and swelling at injection sight ran low grade fever and general feeling of illness