chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Tenderness, Tremor
Clinical narrative: Received his primary smallpox vaccine in his left arm (3 jabs). Approximately 2-3 days after receipt of smallpox vaccine, SM woke up around 2 a.m. and went to the Emergency Room because he was having difficulty breathing. In addition to breathing difficulties, he also experienced chest pain. The chest pain described as substernal, sharp pain that was worse with deep breaths and its intensity was rated as 8/10 using pain scale. Pain was accompanied by an increased heart rate and sensation of heart pounding harder than normal. Pain decreased with sitting straight up. Placed on oxygen and placed on monitor, pain resolved without treatment within 60 minutes of arriving at ER. No lab work or diagnostics were completed. He did not recall a specific diagnosis prior to discharge, but he was instructed to return if his symptoms returned. Within 7 days following of vaccine receipt, SM was on a plane, Upon arrival in country, he felt feverish and his hands were shaky. SM also experienced generalized body aches, fatigue and a fever which was 100deg in the local clinic. These symptoms completely resolved within 10 days. Within hours of arrival in " country", SM had a recurrence of chest pain. He did not experience associated problems breathing, but was told that he was ashen and was "not looking good". He was not able to seek medical evaluation or treatment at that time. His chest pain resolved after 24 hours of constant pain (6-7/10). He noted chest pain improved when sitting up, but after 20 minutes, the chest pain felt with living down. Chest pain was made worse with deep breaths. SM does not recall all of details ("kind of out of it"), but denies palpitations, coughing or swelling of feet and ankles. Around post-vaccine day 7, SM noted a "rash" on his left upper arm - "looked like second degree sunburn." He noted increased redness and warmth about the size of an orange which surrounded his smallpox vaccine site and extended up to his left shoulder. The redness was "blotchy" and there was streaking noted on the back of the arm. The majority of his left upper arm was edematous. He could feel tender, swollen lymph nodes under his left axilla and also noted some swollen glands in his neck. The area was tender to touch and the intensity of tenderness/pain is rated as 6-7/10 on pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). After his back pack strap hit his vaccine site bandage and rubbed the site, SM sought evaluation by the local medics. They monitored the site daily and delineating erythema with markers. No lab test or site cultures were obtained. SM received a course of oral antibiotics in addition to his doxycycline. The site began to improve by post-vaccination day 9 or 10 and th local reaction completely resolved by post-vaccination day 16. The scab fell off about 2 weeks later.
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Fall, Musculoskeletal stiffness, Tremor
Clinical narrative: Patient received 2 vaccines, nurse left room and 5 mins later heard loud noise. Nurse returned to room and found patient on floor, eyes open. Patient stiff not flaccid. Patient had mild tremoring in her extremities. Patient monitored for 20 min. Recheck BP 110/60, tremor had resolved. Patient was AxOx3, EDMI, PERLA. Patient advised to contact office with any problems.
Age: 35.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Dyspnoea, Rash generalised, Swollen tongue
Clinical narrative: 8/14/08 Phone call from patient reporting that the day after she received a MMR and Tdap (7/8/08) she had a rash all over; swelling of the tongue and difficulty breathing. She went to her private physician where she was treated with steroids and Benadryl. She stated she was better in a few days.
Age: 11.0
Sex: F
Vaccine: DTP
Symptoms: Balance disorder, Diagnostic procedure, Hypoaesthesia, Overdose, Pyrexia
Clinical narrative: Overdose of tetanus inoculation.  1st booster given October,2007. Due to error in medical record keeping,repeated booster mistakenly given Wednesday, August 13, 2008. By Friday, 2 days later, patient had a low fever, and said her lower legs were numb and felt "wobbly." Dr. initially suspected Guillaume-Barre' syndrome. About 2 hours later, patient stated that she could no longer feel her thighs. Doctor then ordered that patient go to the emergency room. ER doctors did not agree with Guillaume-Barre' diagnosis. Blood draws were "compromised" twice due to medical professional error. Since the doctors were ready to rule out Guillaume-Barre', it was agreed not to draw any more blood, and to discharge patient.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RVX, UNK
Symptoms: Injection site pain, Injection site swelling, Screaming
Clinical narrative: entire left leg swollen and painful with the slightest touch within 3 hours.  When it didn't go down and was worse I called the pediatrician who suggested ice and heat.  Gave tylenol for the pain and placed a warm pack on his leg for a short time, followed later with a cold pack.  Swelling went down 12 hours after onset, and pain diminished slowly over following 2 days.  During this time, he would scream if anything touched his leg, including pants
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Heart rate increased, Hypersensitivity, Hypotension, Oxygen supplementation
Clinical narrative: No rashes; no swelling in tongue or throat  ~ TMC Course:  patient brought to trauma bay and given 100% O2 on Nonbreather; vitals concerning for low BP and incr HR; given 2L IVF bolus; then meds for allergic reaction given (Solumedrol 125mg IV, Zantac 50mg IV, and Benadryl 50mg IV); Epinephrine was on standby but not given as patient seemed to improve a little with tx (ie. HR down to 108, BP up to upper 90s/60s, patient somewhat more comfortable).  Called ER and report given; patient transported.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Presented to clinic 8/21 with swelling from Left shoulder to elbow, diffuse erythema, no tenderness. No treatment was indicated.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Dizziness, Electrocardiogram, Epilepsy, Fatigue
Clinical narrative: On October 17, 2006 I recieved my first dose of the Vaccine.  I felt fine afterwards other than being a little dizzy.  I was a normal 19 year old college student, working, and doing sports.  A month and a week after my first dose of the vaccine I was hospitalized with seizures. I had many tests done and continued to have seizures.  They said there was no apparent cause for my seizures.  I am now 21 years old and am living with epilepsy.  It has changed every aspect of my life.  I just recently heard a talk show on CNN talking about people who have recieved gardasil and have had adverse side effects including seizures.  Now I am on two different seizure drugs and am struggling through school and I can no longer hold a steady job due to driving restrictions, fatique,etc.  10/21/08 Reviewed multiple hospital admission & ER records of 6/27-12/30/2006. FINAL DX: focal to secondary generalized seizure disorder; panic disorder.  11/25-11/27/2006 Hospital admission s/p 3 new witnessed generalized motor seizures while sleeping & bit her tongue; followed by HA, stiffness & confusion.  Tx w/dilantin & folic acid.    12/2/06 Seen in ER for possible family witnessed seizures x 2, patient found to be incontinent, postictal, HA, blurred vision, nausea, anxiety.  Found w/muscle tension & hyperventilation.  Labs revealed toxic dilantin level, 26.2.  Meds adjusted & d/c to home w/o further seizure activity.  12/26-12/30/2006  FINAL DX: multiple spells, seizure vs pseudoseizure; borderline personality disorder w/somatoform features; hx of panic disorder. Admission for video EEG after having increased frequency of seizure activity at home despite therapeutic levels of meds.  Neuropsych consult done & referred to outpatient psych.  D/C to home w/o antiseizure meds.    10/31/08 Reviewed OB/GYN clinic records of 10/06-9/2008. FINAL DX:none provided Records reveal patient had LEEP done 5/23/08.  Had been on Yaz & changed to other BCP.  11/11/08 Reviewed neuro clinic records of 11/28/2006-9/19/2008. FINAL DX: epilepsy w/complex partial seizures Records reveal patient experienced frequent spells esp at night w/incontinence & at least one episode of tongue biting.  During the day w/HA, feeling hot, sleepy but difficulty sleeping, occ SOB, eyes flutter, posturing of extremities, off balance, bad taste in mouth, unable to think or talk,  anxiety, panic, depression & stress from her condition.  Records included hospital admit of 12/4-12/5/2007 after having several seizures in 1 day.  Meds were increased & d/c to home.  Continued to have migraine HAs. Meds & schedules were adjusted. 1/26/2010 Follow up: Seizures, headaches, dizziness, fainting, tingling of hands and feet, joint pain, migraines.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Impaired work ability
Clinical narrative: On October 17, 2006 I recieved my first dose of the Vaccine.  I felt fine afterwards other than being a little dizzy.  I was a normal 19 year old college student, working, and doing sports.  A month and a week after my first dose of the vaccine I was hospitalized with seizures. I had many tests done and continued to have seizures.  They said there was no apparent cause for my seizures.  I am now 21 years old and am living with epilepsy.  It has changed every aspect of my life.  I just recently heard a talk show on CNN talking about people who have recieved gardasil and have had adverse side effects including seizures.  Now I am on two different seizure drugs and am struggling through school and I can no longer hold a steady job due to driving restrictions, fatique,etc.  10/21/08 Reviewed multiple hospital admission & ER records of 6/27-12/30/2006. FINAL DX: focal to secondary generalized seizure disorder; panic disorder.  11/25-11/27/2006 Hospital admission s/p 3 new witnessed generalized motor seizures while sleeping & bit her tongue; followed by HA, stiffness & confusion.  Tx w/dilantin & folic acid.    12/2/06 Seen in ER for possible family witnessed seizures x 2, patient found to be incontinent, postictal, HA, blurred vision, nausea, anxiety.  Found w/muscle tension & hyperventilation.  Labs revealed toxic dilantin level, 26.2.  Meds adjusted & d/c to home w/o further seizure activity.  12/26-12/30/2006  FINAL DX: multiple spells, seizure vs pseudoseizure; borderline personality disorder w/somatoform features; hx of panic disorder. Admission for video EEG after having increased frequency of seizure activity at home despite therapeutic levels of meds.  Neuropsych consult done & referred to outpatient psych.  D/C to home w/o antiseizure meds.    10/31/08 Reviewed OB/GYN clinic records of 10/06-9/2008. FINAL DX:none provided Records reveal patient had LEEP done 5/23/08.  Had been on Yaz & changed to other BCP.  11/11/08 Reviewed neuro clinic records of 11/28/2006-9/19/2008. FINAL DX: epilepsy w/complex partial seizures Records reveal patient experienced frequent spells esp at night w/incontinence & at least one episode of tongue biting.  During the day w/HA, feeling hot, sleepy but difficulty sleeping, occ SOB, eyes flutter, posturing of extremities, off balance, bad taste in mouth, unable to think or talk,  anxiety, panic, depression & stress from her condition.  Records included hospital admit of 12/4-12/5/2007 after having several seizures in 1 day.  Meds were increased & d/c to home.  Continued to have migraine HAs. Meds & schedules were adjusted. 1/26/2010 Follow up: Seizures, headaches, dizziness, fainting, tingling of hands and feet, joint pain, migraines.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient has a PCI at our facility. When we called that patient to follow up on her visit she told us that she was seen in an ER with a "chemical reaction to the pneumonia shot". She described her symptoms to be aching all over, fever 103.2, back of arm red, swollen and painful. She tells is that she was treated with doxycycline.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Immediate post-injection reaction, Joint swelling
Clinical narrative: Right after my first vaccine I immediatly fainted, since that day and throughout the last two vaccines i have had strange symptoms.  Feeling dizzy occurs all of the time and i have had extreme joint problems including swelling and horrible pain.  The dizzyness is continuous, but the joint pain comes and goes.  The joint pain and swelling mostly occurs where i had been given the vaccines(arm and thigh).  10/10/08 Reviewed rheumatology records of 1/24-3/11/08. FINAL DX: inflammatory polyarthralgia NOS Records reveal patient experienced intermittent right hip, left shoulder & right wrist pain x 3 mos along with myalgia of LEs, dizziness & lightheadedness s/p HPV vaccines 10/07 & 12/07.  Tx w/pain meds initially but no improvement.  3/08 tx w/steroid tx for possible seronegative RA.  No further records available.   10/3/08 Reviewed GYN medical records of 2/28/07-4/25/2008. FINAL DX: none provided Records reveal patient in usual state of good health on day of vaccination w/sexual dysfunction.  Joint pain reported on 4/25/08 & was being seen by rheumatologist.    10/24/08 Reviewed PCP medical records of 10/11/07-1/22/2008. FINAL DX: Records reveal patient experienced right wrist pain 10/11/07 w/x-ray normal.  12/12/07 c/o of dizziness, lightheadedness, feeling faint x 2-3 weeks.  Had fainted w/HPV #1.  Right wrist pain persisted & referred to ortho.  1/16/2008 c/o continued left shoulder joint pain, right wrist pain & right hip pain.  Referred to rheum.
Age: 1.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Abnormal behaviour, Antisocial behaviour, Aphasia, Autism, Decreased eye contact
Clinical narrative: within 24 hours. withdrawn, loss of speech, repetitive behaviors, loss of eye contact, loss of interest in other children and most people in general. He became Autistic within 24 hours. 1/26/2010 Follow-up: He became autistic withine 24 hours after receiving those shots.
Age: 1.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Social avoidant behaviour, Stereotypy
Clinical narrative: within 24 hours. withdrawn, loss of speech, repetitive behaviors, loss of eye contact, loss of interest in other children and most people in general. He became Autistic within 24 hours. 1/26/2010 Follow-up: He became autistic withine 24 hours after receiving those shots.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Body temperature increased, Crying, Diarrhoea, Diet refusal, Insomnia
Clinical narrative: Fever of 102 degrees, diarrhea, not eating, vomiting, rash all over body, fussy, crying, won't sleep, can't put the baby down or he cries. Fever gone after five days, eating better but still fussy, not sleeping good and rashy.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Irritability, Pyrexia, Rash generalised, Vomiting
Clinical narrative: Fever of 102 degrees, diarrhea, not eating, vomiting, rash all over body, fussy, crying, won't sleep, can't put the baby down or he cries. Fever gone after five days, eating better but still fussy, not sleeping good and rashy.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Abnormal behaviour, Crying, Diarrhoea, Diet refusal, Insomnia
Clinical narrative: Fever of 102, fussy, diarrhea, not eating, vomiting, not sleeping, crying, can't put him down, fussy, non interactive-not playing, cooing, babbling. Fever  and diarrhea gone after 5 days but still fussy, won't sleep and non interactive.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Irritability, Pyrexia, Vomiting
Clinical narrative: Fever of 102, fussy, diarrhea, not eating, vomiting, not sleeping, crying, can't put him down, fussy, non interactive-not playing, cooing, babbling. Fever  and diarrhea gone after 5 days but still fussy, won't sleep and non interactive.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Arthralgia, Cellulitis, Diarrhoea, Fatigue, Hypersensitivity
Clinical narrative: severe itching, initial injection site was swollen, hard, red,very hot and about the size of a 50 cent piece. after 1 hour was the size of a golf ball.  She complained her are, elbow and wrist was now hurting, she became very tired, and complained her neck hurt as well, I checked her glands felt swollen as well. She also has had severe diarrhea since receiving the vaccine.  2 hours later the spot had grown to around baseball size.  I was advised by clinic nurse to take her to the ER. The Dr. she saw said it was indeed an allergic reaction, and said to give her benedryl, motrin and gave her an antibiotic to treat the cellulitus it was causing, and to put ice packs on her arm to help ease the pain and swelling.  By morning the site was now the size of a softball or a bit larger, and was still very painfull.  The ER DR said to follow up with her pediatrician, and thought we should see an allergist as well to see what ingredients in the vaccine were causing her reaction.  He wondered about possible egg allergy or a possible form of penicillin in the vaccine, and suggested I get an ingredients list from the immunization clinic.  I have a follow up appt scheduled for Wednesday 08/27/2008.  She also had the very same reaction last year only in her leg, and we were not sure which vaccine had caused the reaction as she received 3 in the same area at that time, we now know it WAS indeed the varicella vaccine she is allergic to.  I gave her the second dose against my better judgement, under the advice of her doctors and pressure from her school to give it too her anyway.  Thankfully she is still here!!
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: severe itching, initial injection site was swollen, hard, red,very hot and about the size of a 50 cent piece. after 1 hour was the size of a golf ball.  She complained her are, elbow and wrist was now hurting, she became very tired, and complained her neck hurt as well, I checked her glands felt swollen as well. She also has had severe diarrhea since receiving the vaccine.  2 hours later the spot had grown to around baseball size.  I was advised by clinic nurse to take her to the ER. The Dr. she saw said it was indeed an allergic reaction, and said to give her benedryl, motrin and gave her an antibiotic to treat the cellulitus it was causing, and to put ice packs on her arm to help ease the pain and swelling.  By morning the site was now the size of a softball or a bit larger, and was still very painfull.  The ER DR said to follow up with her pediatrician, and thought we should see an allergist as well to see what ingredients in the vaccine were causing her reaction.  He wondered about possible egg allergy or a possible form of penicillin in the vaccine, and suggested I get an ingredients list from the immunization clinic.  I have a follow up appt scheduled for Wednesday 08/27/2008.  She also had the very same reaction last year only in her leg, and we were not sure which vaccine had caused the reaction as she received 3 in the same area at that time, we now know it WAS indeed the varicella vaccine she is allergic to.  I gave her the second dose against my better judgement, under the advice of her doctors and pressure from her school to give it too her anyway.  Thankfully she is still here!!
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Neck pain, Pain in extremity, Pruritus
Clinical narrative: severe itching, initial injection site was swollen, hard, red,very hot and about the size of a 50 cent piece. after 1 hour was the size of a golf ball.  She complained her are, elbow and wrist was now hurting, she became very tired, and complained her neck hurt as well, I checked her glands felt swollen as well. She also has had severe diarrhea since receiving the vaccine.  2 hours later the spot had grown to around baseball size.  I was advised by clinic nurse to take her to the ER. The Dr. she saw said it was indeed an allergic reaction, and said to give her benedryl, motrin and gave her an antibiotic to treat the cellulitus it was causing, and to put ice packs on her arm to help ease the pain and swelling.  By morning the site was now the size of a softball or a bit larger, and was still very painfull.  The ER DR said to follow up with her pediatrician, and thought we should see an allergist as well to see what ingredients in the vaccine were causing her reaction.  He wondered about possible egg allergy or a possible form of penicillin in the vaccine, and suggested I get an ingredients list from the immunization clinic.  I have a follow up appt scheduled for Wednesday 08/27/2008.  She also had the very same reaction last year only in her leg, and we were not sure which vaccine had caused the reaction as she received 3 in the same area at that time, we now know it WAS indeed the varicella vaccine she is allergic to.  I gave her the second dose against my better judgement, under the advice of her doctors and pressure from her school to give it too her anyway.  Thankfully she is still here!!
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: LEFT Leg swollen, pink area over swelling about 150 mm diameter, warm to touch. No pain or tenderness, but parents report there there had been pain and tenderness. Now improving 48 hours after injection
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PPV, RVX
Symptoms: Diarrhoea, Irritability, Lethargy, Pyrexia, Vomiting
Clinical narrative: Patient became very fussy and lethargic about a few hours after five different vaccines were administered. The next morning, she began vomiting, which continued for more than 24 hours. Then she experienced fever and diarrhea the following 24 hours. She remained fussy and leghargic the entire time. We called the doctor's office numberous times. In the meantime, she's on other medications administered orally, which she was unable to keep down.
Age: 38.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Contraindication to vaccination
Clinical narrative: SERVICE MEMBER RECIEVED THE SMALL POX VACCINE WHEN HE HAD A MEDICAL PERMANENT DEFFERRAL DUE TO HAVING PSORIASIS.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Abdominal pain, Intussusception, Lethargy, Mucous stools, Urinary system X-ray
Clinical narrative: Information has been received from a physician concerning an approximately 3 month old female who on approximately 18-JUN-2008 was vaccinated PO with the first dose of ROTATEQ.  It was reported that on approximately 28-JUL-2008, the physician saw a patient who was diagnosed with intussusception after receiving the first dose of ROTATEQ.  It was reported that unspecified medical attention was sought and the patient was hospitalized (date and duration unspecified).  The course of treatment and outcome are unknown.  There was no product quality complaint involved.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning an approximately 3 month old female who on approximately 18-JUN-2008 was vaccinated PO with the first dose of ROTATEQ.  It was reported that on approximately 28-JUL-2008, the physician saw a patient who was diagnosed with intussusception after receiving the first dose of ROTATEQ.  It was reported that unspecified medical attention was sought and the patient was hospitalized (date and duration unspecified).  The course of treatment and outcome are unknown.  There was no product quality complaint involved.  Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Aspiration pleural cavity, Chest X-ray abnormal, Hypertension, Oedema, Pleural effusion
Clinical narrative: Subject reports recently experiencing a severe systemic reaction to the anthrax vaccination after receiving 6th shot in series, on November 3, 2007.  She reports that the initial diagnosis was nephritis and nephropathy in addition to pleural effusion, secondary to the vaccine.  Subject reports that she gained and lost 30 pounds worth of edema over the course of a month.  Other symptoms include hair falling out at a rapid rate, kidneys still have not recovered, exhausted most of the day yet can't sleep on a regular schedule, blood pressure varies wildly but is almost always high, other pains that come and go such as stomach cramps, flank pain, and headaches, severe neck pain requiring an emergency room visit.  Her neck is still stiff.  Additional narrative from VAERS report #315580 received on 8/12/08: 30+ pounds of edema, bilat pleural effusions, HTN requiring treatment, thoracentesis.  Saw ID/pulm/neph.
Age: 37.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Proteinuria
Clinical narrative: Subject reports recently experiencing a severe systemic reaction to the anthrax vaccination after receiving 6th shot in series, on November 3, 2007.  She reports that the initial diagnosis was nephritis and nephropathy in addition to pleural effusion, secondary to the vaccine.  Subject reports that she gained and lost 30 pounds worth of edema over the course of a month.  Other symptoms include hair falling out at a rapid rate, kidneys still have not recovered, exhausted most of the day yet can't sleep on a regular schedule, blood pressure varies wildly but is almost always high, other pains that come and go such as stomach cramps, flank pain, and headaches, severe neck pain requiring an emergency room visit.  Her neck is still stiff.  Additional narrative from VAERS report #315580 received on 8/12/08: 30+ pounds of edema, bilat pleural effusions, HTN requiring treatment, thoracentesis.  Saw ID/pulm/neph.
Age: 37.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Abdominal pain upper, Alopecia, Aspiration pleural cavity, Blood pressure fluctuation, Chest X-ray abnormal
Clinical narrative: Subject reports recently experiencing a severe systemic reaction to the anthrax vaccination after receiving 6th shot in series, on November 3, 2007.  She reports that the initial diagnosis was nephritis and nephropathy in addition to pleural effusion, secondary to the vaccine.  Subject reports that she gained and lost 30 pounds worth of edema over the course of a month.  Other symptoms include hair falling out at a rapid rate, kidneys still have not recovered, exhausted most of the day yet can't sleep on a regular schedule, blood pressure varies wildly but is almost always high, other pains that come and go such as stomach cramps, flank pain, and headaches, severe neck pain requiring an emergency room visit.  Her neck is still stiff.  Additional narrative from VAERS report #315580 received on 8/12/08: 30+ pounds of edema, bilat pleural effusions, HTN requiring treatment, thoracentesis.  Saw ID/pulm/neph.
Age: 37.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Effusion, Fatigue, Flank pain, Headache, Hypertension
Clinical narrative: Subject reports recently experiencing a severe systemic reaction to the anthrax vaccination after receiving 6th shot in series, on November 3, 2007.  She reports that the initial diagnosis was nephritis and nephropathy in addition to pleural effusion, secondary to the vaccine.  Subject reports that she gained and lost 30 pounds worth of edema over the course of a month.  Other symptoms include hair falling out at a rapid rate, kidneys still have not recovered, exhausted most of the day yet can't sleep on a regular schedule, blood pressure varies wildly but is almost always high, other pains that come and go such as stomach cramps, flank pain, and headaches, severe neck pain requiring an emergency room visit.  Her neck is still stiff.  Additional narrative from VAERS report #315580 received on 8/12/08: 30+ pounds of edema, bilat pleural effusions, HTN requiring treatment, thoracentesis.  Saw ID/pulm/neph.
Age: 37.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Musculoskeletal stiffness, Neck pain, Nephritis, Nephropathy, Oedema
Clinical narrative: Subject reports recently experiencing a severe systemic reaction to the anthrax vaccination after receiving 6th shot in series, on November 3, 2007.  She reports that the initial diagnosis was nephritis and nephropathy in addition to pleural effusion, secondary to the vaccine.  Subject reports that she gained and lost 30 pounds worth of edema over the course of a month.  Other symptoms include hair falling out at a rapid rate, kidneys still have not recovered, exhausted most of the day yet can't sleep on a regular schedule, blood pressure varies wildly but is almost always high, other pains that come and go such as stomach cramps, flank pain, and headaches, severe neck pain requiring an emergency room visit.  Her neck is still stiff.  Additional narrative from VAERS report #315580 received on 8/12/08: 30+ pounds of edema, bilat pleural effusions, HTN requiring treatment, thoracentesis.  Saw ID/pulm/neph.
Age: 37.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Pain, Pleural effusion, Proteinuria, Renal failure, Sleep disorder
Clinical narrative: Subject reports recently experiencing a severe systemic reaction to the anthrax vaccination after receiving 6th shot in series, on November 3, 2007.  She reports that the initial diagnosis was nephritis and nephropathy in addition to pleural effusion, secondary to the vaccine.  Subject reports that she gained and lost 30 pounds worth of edema over the course of a month.  Other symptoms include hair falling out at a rapid rate, kidneys still have not recovered, exhausted most of the day yet can't sleep on a regular schedule, blood pressure varies wildly but is almost always high, other pains that come and go such as stomach cramps, flank pain, and headaches, severe neck pain requiring an emergency room visit.  Her neck is still stiff.  Additional narrative from VAERS report #315580 received on 8/12/08: 30+ pounds of edema, bilat pleural effusions, HTN requiring treatment, thoracentesis.  Saw ID/pulm/neph.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Headache, Joint swelling, Musculoskeletal discomfort, Oxygen saturation decreased
Clinical narrative: Serum sickness w/fever, arthritis (acute), wheezing.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Serum sickness w/fever, arthritis (acute), wheezing.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Inappropriate schedule of drug administration, Pyrexia, Serum sickness, Wheezing
Clinical narrative: Serum sickness w/fever, arthritis (acute), wheezing.
Age: 36.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Injection site discharge, Lymphadenopathy, Pyrexia
Clinical narrative: Extreme swelling of the Lymph node of left arm and fever reaching 102. Green discharge from inoculation site
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received for the Merck Pregnancy Registry for GARDASIL from a health professional concerning a 20 year old white female with no pertinent medical history, drug reactions/allergies.  On 24-OCT-2007 the patient was vaccinated with a first dose of GARDASIL (lot# 658488/1264U) 0.5 mL IM.  There was no concomitant therapy used.  On 24-OCT-2007 the patient tested positive on a home pregnancy test after receiving the first and only dose of GARDASIL.  Medical attention was sought.  The patient called the office.  No further information was available.  The date of the last menstrual period was 26-SEP-2007 and the estimated date of delivery is 02-JUL-2008.  Follow up information was received which reported that in February 2008 the patient had an elective termination at approximately 19 weeks of pregnancy.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse practitioner for the pregnancy registry for GARDASIL concerning a 17 years old female who on 07-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included PROZAC, XANAX, trazodone HCl and albuterol.  The nurse practitioner reported that the patient may have been pregnant when the first dose of GARDASIL.  No adverse reactions reported.  The last menstrual period was 18-JUN-2008.  Her due date is 25-MAR-2009.  The patient sought medical attention, she was seen by nurse practitioner.  There was no product quality complaint.  Additional information has been requested.  Follow up information has been received from a nurse practitioner that reported that the patient had an elective termination of her pregnancy last week at approximately 8 weeks estimated gestational age (EGA) (approximately 08-AUG-2008).  The nurse practitioner reported that she saw the patient on 13-AUG-2008 and she seemed to be doing well, following the termination of her pregnancy last week at approximately 8 weeks EGA.  The nurse practitioner stated that the decision to have the termination was not due to the GARDASIL.  The patient was also being treated with PROZAC, XANAX and trazodone HCl, and had concerns related to these medication as well as other concerns.  Upon internal review termination of her pregnancy was determined to be an other important medical event.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Monoplegia
Clinical narrative: Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL.  Subsequently, the patient developed paralysis in the arm.  It was unknown if the paralysis occurred in the injection site arm.  The patient recovered on an unknown date.  There was no product quality complaint.  Upon internal review, the patient's paralysis in the arm was considered an other important medical event.  Additional information is expected.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder, Herpes zoster, Neuralgia
Clinical narrative: Information has been received from a company representative concerning her father a 78 year old male with diabetes, asthma and seasonal allergy who in August 2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). In August 2008, the patient was diagnosed with herpes zoster. Herpes zoster was affecting his bowels and the patient was experiencing nerve pain. The patient's herpes zoster and nerve persisted. The patient did not seek medical attention. No product quality complaint was involved. Herpes zoster, affecting bowels and nerve pain were considered to be disabling. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Chest X-ray normal, Crying, Diet refusal, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a physician via GlaxoSmithKline, regarding a 2-month old male patient who experienced hypotonia, refusal to eat, pallor and inconsolable crying. The patient received the first dose on 21-Jul-2008. The patient also received the first dose of DIPHTHERIA (manufacturer unknown) and the first dose of PEDIARIX (GlaxoSmithKline) on 21-Jul-2008. The patient experienced hypotonia, refusal to eat, pallor and inconsolable crying and 21-Jul-2008, three to four hours after vaccinations. This was considered to be systemic reaction. Hours later the issue resolved, however, the patient was taken to a hospital Emergency Room for evaluation. Diagnostic tests were performed (see test results). All test results were normal. The physician considered the event of hypotonia to be possibly related to treatment with PEDIARIX. The physician questioned a specific lot of PEDIARIX, because she had another patient who had experienced adverse events after receiving the same lot of PEDIARIX. No additional information was available at the time of this report.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypotonia, Pallor
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a physician via GlaxoSmithKline, regarding a 2-month old male patient who experienced hypotonia, refusal to eat, pallor and inconsolable crying. The patient received the first dose on 21-Jul-2008. The patient also received the first dose of DIPHTHERIA (manufacturer unknown) and the first dose of PEDIARIX (GlaxoSmithKline) on 21-Jul-2008. The patient experienced hypotonia, refusal to eat, pallor and inconsolable crying and 21-Jul-2008, three to four hours after vaccinations. This was considered to be systemic reaction. Hours later the issue resolved, however, the patient was taken to a hospital Emergency Room for evaluation. Diagnostic tests were performed (see test results). All test results were normal. The physician considered the event of hypotonia to be possibly related to treatment with PEDIARIX. The physician questioned a specific lot of PEDIARIX, because she had another patient who had experienced adverse events after receiving the same lot of PEDIARIX. No additional information was available at the time of this report.
Age: 1.3
Sex: M
Vaccine: DTAPH, IPV
Symptoms: Body temperature increased, Febrile convulsion, Viral infection
Clinical narrative: Initial report received on 22 February 2007.  This subject was a 15 month-old male who experienced a febrile seizure while enrolled in a study.  The subject received four doses of PENTACEL; last dose prior to the event was administered on 20 February 2007.  The subject experienced a febrile seizure (length of seizure was not reported) around 17:20 p.m. on 21 February 2007, which was one day post-immunization.  The subject was not admitted to the hospital.  Treatments received and diagnostic tests performed were not reported.  The investigator considered the febrile seizure to be an important medical event.  The subject recovered.  Follow-up information received on 26 February 2007.  Twenty-five hours post-immunization, the subject experienced a febrile seizure at home that lasted approximately 30-90 seconds.  He was transported by ambulance to an emergency room for evaluation.  Upon arrival, he was awake, alert, and in no distress.  Temperature in the emergency room was 103.9 degrees Fahrenheit.  He was treated with Motrin and Tylenol and subsequently discharged to home.  No diagnostic testing was performed.  Past medical history was documented on the record as "healthy."  Emergency room diagnoses were febrile seizure and viral illness.  The investigator considered the event to be an important medical event.  The subject recovered from the event and continued in the study trial.  Follow-up information received on 19 August 2008 from the investigator.  The event of fever was removed as a symptom of the febrile seizure as it is implicit in the diagnosis.  The event of febrile seizure was reported by the investigator as related to the study vaccine.   Documents held by sender: emergency room record.
Sex: F
Vaccine: PER
Symptoms: Convulsion
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received from another manufacturer (reference numbers 45202312 and 1-3083040017) on 20 August 2008.  The other manufacturer received the report from a health care professional.  A one-year-old female patient received a dose of pertussis vaccine (manufacturer, trade name, and lot number not reported) 15 years ago.  An unspecified amount of time after receiving the vaccine, the patient experienced a seizure.  According to the reporter, the event took place "about 15 years ago".  The patient has fully recovered.  No other information was provided.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema nodosum, Laboratory test
Clinical narrative: Patient received her 3rd GARDASIL/HPV vaccination on 6/02/08.  She was seen in the ER on 6/21/08 with diagnosis of Erythema Nodosum.  ? related to vaccination. 9/10/08-records received for DOS 6/21/08-presentd to ED with C/O migraine and rash. DX:erythema nodosum. Physical exam on 11/27/07 C/O right anterior knee pain. 7/23/08 persistent knee pain waxing and waning lower leg rash/lumps with sensitivity. After third dose of HPV C/O stiff neck on right side, severe headache, nausea and dizziness which lasted for about 3 days.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: Immediately after vaccine was given, patient became pale and nauseous. Also, felt dizzy and light-headed. Feeling passed after laying down x few minutes.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ, UNK
Symptoms: CSF culture negative, CSF glucose normal, CSF protein normal, CSF white blood cell count increased, Enterovirus infection
Clinical narrative: Admit to hospital 8/20/08, HA, fever, nausea x 2days. HA following MENACTRA given 8/18/08 - sister also diagnosed meningitis and hospitalized 8/12/08; she also received vaccine 8/18/08  9/26/08 Reviewed hospital medical records of 8/20-8/23/2008. FINAL DX: viral meningitis, enterococcus. Records reveal patient experienced HA, photophobia, fever & nausea.  Younger sibling admitted w/same.  Tx w/IV antibiotics & antivirals.  Improved & d/c to home.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ, UNK
Symptoms: Gram stain negative, Headache, Meningitis viral, Nausea, Pyrexia
Clinical narrative: Admit to hospital 8/20/08, HA, fever, nausea x 2days. HA following MENACTRA given 8/18/08 - sister also diagnosed meningitis and hospitalized 8/12/08; she also received vaccine 8/18/08  9/26/08 Reviewed hospital medical records of 8/20-8/23/2008. FINAL DX: viral meningitis, enterococcus. Records reveal patient experienced HA, photophobia, fever & nausea.  Younger sibling admitted w/same.  Tx w/IV antibiotics & antivirals.  Improved & d/c to home.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ, UNK
Symptoms: CSF culture negative, Laboratory test abnormal, Meningitis, Pyrexia
Clinical narrative: Admit to hospital 8/20/08, HA, fever, nausea x 2days. HA following MENACTRA given 8/18/08 - sister also diagnosed meningitis and hospitalized 8/12/08; she also received vaccine 8/18/08  9/26/08 Reviewed hospital medical records of 8/20-8/23/2008. FINAL DX: viral meningitis, enterococcus. Records reveal patient experienced HA, photophobia, fever & nausea.  Younger sibling admitted w/same.  Tx w/IV antibiotics & antivirals.  Improved & d/c to home.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ, UNK
Symptoms: Culture positive, Foreign travel, Meningitis enteroviral
Clinical narrative: Admit to hospital 8/20/08, HA, fever, nausea x 2days. HA following MENACTRA given 8/18/08 - sister also diagnosed meningitis and hospitalized 8/12/08; she also received vaccine 8/18/08  9/26/08 Reviewed hospital medical records of 8/20-8/23/2008. FINAL DX: viral meningitis, enterococcus. Records reveal patient experienced HA, photophobia, fever & nausea.  Younger sibling admitted w/same.  Tx w/IV antibiotics & antivirals.  Improved & d/c to home.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: CSF culture negative, CSF white blood cell count increased, Gram stain negative, Headache, Pyrexia
Clinical narrative: Admit to hospital 8/21/08. Fever, vomiting x 2 days - HA after receiving vaccine. Brother admitted with meningitis to same hospital 8/20/08. He also received vaccine 8/18/08.  9/26/07 Reviewed hospital medical records of 8/21-8/23/2008. FINAL DX: enterococcal viral meningitis Records reveal patient experienced HA x 2 days.  Seen in outlying ER where LP (+).  Older sibling admitted w/same.  Fever, increased respiratory rate.  Tx w/IV antibiotics & antivirals.  Improved & d/c to home.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Vomiting
Clinical narrative: Admit to hospital 8/21/08. Fever, vomiting x 2 days - HA after receiving vaccine. Brother admitted with meningitis to same hospital 8/20/08. He also received vaccine 8/18/08.  9/26/07 Reviewed hospital medical records of 8/21-8/23/2008. FINAL DX: enterococcal viral meningitis Records reveal patient experienced HA x 2 days.  Seen in outlying ER where LP (+).  Older sibling admitted w/same.  Fever, increased respiratory rate.  Tx w/IV antibiotics & antivirals.  Improved & d/c to home.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: CSF culture negative, Laboratory test abnormal, Meningitis, Pyrexia
Clinical narrative: Admit to hospital 8/21/08. Fever, vomiting x 2 days - HA after receiving vaccine. Brother admitted with meningitis to same hospital 8/20/08. He also received vaccine 8/18/08.  9/26/07 Reviewed hospital medical records of 8/21-8/23/2008. FINAL DX: enterococcal viral meningitis Records reveal patient experienced HA x 2 days.  Seen in outlying ER where LP (+).  Older sibling admitted w/same.  Fever, increased respiratory rate.  Tx w/IV antibiotics & antivirals.  Improved & d/c to home.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Disorientation, Dizziness, Hypoventilation, Immediate post-injection reaction, Pallor
Clinical narrative: Client was sitting in chair and became pale, faint and disoriented just after receiving 3 vaccines.  She responded to touch, questions and commands.  Several minutes later she became faint again, was placed supine and given Od.  She was pale with shallow respiration's but took deep breaths when asked.  She c/o her arm tingling.  Because she remained pale and disoriented, 911 was called and she was taken to the ER.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Paraesthesia
Clinical narrative: Client was sitting in chair and became pale, faint and disoriented just after receiving 3 vaccines.  She responded to touch, questions and commands.  Several minutes later she became faint again, was placed supine and given Od.  She was pale with shallow respiration's but took deep breaths when asked.  She c/o her arm tingling.  Because she remained pale and disoriented, 911 was called and she was taken to the ER.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: 8/21/08 - at night - itching/swelling/firmness and redness noted at site where Varicella vaccine given on 8/20/08 (5 1/2 cm x 7 cm post left deltoid).  Recommend Benadryl as needed.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Body temperature, Headache, Neck pain, Oedema peripheral, Pain
Clinical narrative: Temp neck pain - headache, vomited - body aches - arm edema.  9/5/08 Reviewed PCP office records of 8/21/08 which reveal patient experienced neck pain & HA, afebrile.  FINAL DX: Vaccine reaction.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Temp neck pain - headache, vomited - body aches - arm edema.  9/5/08 Reviewed PCP office records of 8/21/08 which reveal patient experienced neck pain & HA, afebrile.  FINAL DX: Vaccine reaction.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall, Headache, Loss of consciousness, Muscle contracture, Syncope
Clinical narrative: Patient recovered MENACTRA and ADACEL. She then walked out into the waiting room and fainted. She stated her head hurt and she was on the floor. Mom witnessed her falling backwards and believes she hit her head on the office chair. She thinks she was unconscious for about 5-8 secs. when she opened her eyes then were both turned to the right for 3 secs. and she thinks her right arm had tonic arthritis. She had no further issues/symptoms
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Headache, Neck pain, Neutrophil percentage increased, Red blood cell sedimentation rate increased
Clinical narrative: T = 103, HA, Neck pain
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: White blood cell count increased
Clinical narrative: T = 103, HA, Neck pain
Age: 21.0
Sex: F
Vaccine: HPV4, MNQ, PPV, TDAP
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Swelling and pain and fever 38 deg C.
Age: 0.51
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Hives < 1 hour after administration. No cough, no resp. distress.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling
Clinical narrative: Lip swelling bottom > top lip began evening after receiving HPV vaccine. No lip swelling. No resp breathing difficulty. Patient presented to MD office 2nd day - exam showing mild swelling lower lip only. No wheeze/resp distress.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Moaning, Pyrexia, Scab
Clinical narrative: Mother noted that she was febrile and moaning 24 hrs after immunizations were given and discovered 3x2 cm red, warm induration inferior to scabbed VZV site.