chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash
Clinical narrative: Day of injection, local reactionw/swelling et redness.  Tuesday evening had H/A et took tylenol.  Woke Wednesday am et notices one bump above lt eye around eyebrow.  Later this day had another bump.  Thought something had bit her.  Woke Thursday morning with several bumps.  Went to dermatologist. Rx Valtrex tidx 7 days.  Now in eye et around eye et above in hairline.  Pain "5" on scale of 0-10 w/10 worse pain.  Tylenol every 4-6 hrs.  Will see Dr 2/15/07. This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been recieved from a health professional concerning a 72 year old female with no known medical history , or allergies who on 06-Feb-2007 at 10:30 was vaccinated subcutaneously with a forst dose of ZOSTAVAX vaccine (Merck) (lot # 656608/0032U). There was no illness at the time of vaccination. There was no concomitant medication. On the day of the injection the patient developed a local reaction with swelling and redness. That evening the patient developed a headache, and took some TYLENOL. When the patient awoke the following morning, 07 Feb 2007, shenoticed one bump over the left eye around the eyebrow. Later that same day she noticed another bump, and questioned if it was an insect bite. On 08 FEB 2007 the patient had several bumps, and was seen by a dermatologist and diagnosed with shingles. The patient was prescribed VALTREX TID X 7 days, bumps "now in eye and around eye, and up into the hairline. On an scale of one to ten, with ten being the worst pain, the patient was experiencing pain at a level five. The patient was seen by the doctor on 15 FEB 2007. The patient was considered recovered on 20 FEB 2007. There was no product quality complaint involved. No laboratory tests were performed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Herpes zoster, Injection site erythema, Rash
Clinical narrative: Day of injection, local reactionw/swelling et redness.  Tuesday evening had H/A et took tylenol.  Woke Wednesday am et notices one bump above lt eye around eyebrow.  Later this day had another bump.  Thought something had bit her.  Woke Thursday morning with several bumps.  Went to dermatologist. Rx Valtrex tidx 7 days.  Now in eye et around eye et above in hairline.  Pain "5" on scale of 0-10 w/10 worse pain.  Tylenol every 4-6 hrs.  Will see Dr 2/15/07. This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been recieved from a health professional concerning a 72 year old female with no known medical history , or allergies who on 06-Feb-2007 at 10:30 was vaccinated subcutaneously with a forst dose of ZOSTAVAX vaccine (Merck) (lot # 656608/0032U). There was no illness at the time of vaccination. There was no concomitant medication. On the day of the injection the patient developed a local reaction with swelling and redness. That evening the patient developed a headache, and took some TYLENOL. When the patient awoke the following morning, 07 Feb 2007, shenoticed one bump over the left eye around the eyebrow. Later that same day she noticed another bump, and questioned if it was an insect bite. On 08 FEB 2007 the patient had several bumps, and was seen by a dermatologist and diagnosed with shingles. The patient was prescribed VALTREX TID X 7 days, bumps "now in eye and around eye, and up into the hairline. On an scale of one to ten, with ten being the worst pain, the patient was experiencing pain at a level five. The patient was seen by the doctor on 15 FEB 2007. The patient was considered recovered on 20 FEB 2007. There was no product quality complaint involved. No laboratory tests were performed. No further information is expected.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC
Symptoms: Culture throat negative, Irritability, Pyrexia, Rash morbilliform, Rash papular
Clinical narrative: onset 9 days after administration of fever to 101 and fussiness, followed by onset 11 days after administration of Proquad of a papular rash that appeared measle-like and included two lesions in the posterior pharynx.  Fever resolved on 12th post vaccine day. Patient treated with acetominophen and diphenhydramine for symptoms.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Computerised tomogram, Fatigue, Hypoaesthesia, Hypoaesthesia facial, Hypoaesthesia oral
Clinical narrative: Pt's mother states pt c/o numbness that started in her fingertips, moved down her arms to her face, lips, mouth, throat and ended.  Ha/migraine. Pt was nausious, sensitive to light, shakey.  Pt was seen by Dr ct scan done.  Symptoms started at 7:00am on 2/26/07 and pt remained tired until 3/1/07.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Laboratory test, Migraine, Nausea, Pharyngeal hypoaesthesia, Photosensitivity reaction
Clinical narrative: Pt's mother states pt c/o numbness that started in her fingertips, moved down her arms to her face, lips, mouth, throat and ended.  Ha/migraine. Pt was nausious, sensitive to light, shakey.  Pt was seen by Dr ct scan done.  Symptoms started at 7:00am on 2/26/07 and pt remained tired until 3/1/07.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Tremor
Clinical narrative: Pt's mother states pt c/o numbness that started in her fingertips, moved down her arms to her face, lips, mouth, throat and ended.  Ha/migraine. Pt was nausious, sensitive to light, shakey.  Pt was seen by Dr ct scan done.  Symptoms started at 7:00am on 2/26/07 and pt remained tired until 3/1/07.
Age: 58.0
Sex: M
Vaccine: YF
Symptoms: Blood test normal, Cough, Pruritus, Rash, Sneezing
Clinical narrative: Hives, rash, itching, coughing, sneezing.  Discussed with nurse and doctor at State Department Immunization Center by telephone.  Visited personal physician.
Age: 58.0
Sex: M
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: Hives, rash, itching, coughing, sneezing.  Discussed with nurse and doctor at State Department Immunization Center by telephone.  Visited personal physician.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia, Occult blood positive
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with the first dose of Rotateq. The nurse reported that the patient subsequently developed blood in stool and diarrhea. The patient had a positive hemoccult. At the time of this report, the outcome was unknown. Upon internal review, blood in stool was determined to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Pallor, Somnolence, Syncope
Clinical narrative: Information has been received from physician concerning a 16 year old female patient who on approximately 05-JAN-2007 ("7 weeks ago") was vaccinated with the first dose, 0.5ml, IM, of Gardasil. There was no concomitant medication. The physician reported that the patient stated she "did not feel well when checking out and turned white and fainted when being taken back into the examining room." The physician clarified that the patient "did not lose consciousness or hit her head because he caught the patient." He confirmed the patient fainted "within 5 minutes" of the vaccination, and remained "groggy for up to 30 minutes" after the vaccination. The patient was then "considered recovered," and left the office. The physician considered the events to be disabling. Additional information has been requested.
Age: 1.54
Sex: M
Vaccine: HEP
Symptoms: Autism, Blood heavy metal increased, Blood lead increased
Clinical narrative: This case was reported by a consumer and described the occurrence of autism in a 1-year-old male subject who was vaccinated with Engerix B for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On an unspecified date on or after 01 February 2003 and before 03 march 2003, the subject received the 1st dose of hepatitis B vaccine (unspecified Manufacturer). On 03 March 2003, the subject received 2nd dose of Engerix B. On 18 August 2003 the subject received 3rd dose of Engerix B. On an unspecified date in August 2004, approximately one year after vaccination with the 3rd dose of Engerix B, the subject was diagnosed with autism. The consumer reported that, on an unspecified date before 02 March 2007, at an unspecified time following the 3rd dose of Engerix B, bloodwork showed heavy metals, including lead but not mercury. The subject was seen by various doctors. At the time of initial reporting, 03 March 2007, outcome of the heavy metals and lead in the blood was not reported and the autism was ongoing. Autism was assessed as medically serious by manufacturer.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: Warmth, tender, red covers all lateral and posterior left arm, itchy and mildy tender.   Treated warm compress/anti-histamine
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: At injection site redness and swelling 6.5 cm x 4 cm. Induration with small amount of bruising. Painful to touch. Patient using ice, Ibuprofen and Benadryl for treatment.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Fatigue, Hypersomnia, Somnolence
Clinical narrative: Previously stable narcolepsy, escalated to weeks of sleep. tired, unable to stay awake 3/13/07 to improvement 3/1/07.
Sex: F
Vaccine: HPV4
Symptoms: Bradycardia, Chills, Pyrexia, Vomiting
Clinical narrative: Fever, chills, bradycardia, vomiting.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 101 to 102 for 2-5 days after vaccination onset 1-2 days after. Has recovered completely.
Age: 74.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Injection site induration, Rash
Clinical narrative: Developed hark lump L arm at injection site. Then rash/bruising over R flank.
Age: 0.26
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rash, Rash generalised
Clinical narrative: Rash on face and entire body. No fever.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Area of erythema, and induration, approx 3 in diameter, non tender but warm to touch over  deltoid area.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Rash erythematous
Clinical narrative: Erythematous rash on LT arm 2cm x 3cm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: Immediate redness, warmth and swelling at injection site on 2/7/07. On 2/23/07 patient still with red, non indurated, non tender, blanching plaque measuring 7.5x7cm at injection site.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration
Clinical narrative: Local approximate 4" diameter indurated reaction which mom reports was twice that size 1 day ago.
Age: 1.02
Sex: M
Vaccine: HIBV, IPV
Symptoms: Dry skin, Erythema, Rash
Clinical narrative: About three days after getting his third dose of Polio (IPV) and fourth dose of Hib, patient developed a rash, mostly on his legs, and concentrated behind his knees.  It was not itchy.  It consisted of bright red patches of rough, dry skin, from below dime-sized to about half-dollar sized.  His neck was also a little red and rashy-looking, but not in patches.  He has been prone to rashes since the age of 2 months, when he recieved his first vaccine.  There was no treatment, since he didn't seem bothered.  The rash very slowly diminished, with occasional new patches appearing.  It has been more than a month since the shots, and the rash is still noticeable, though mostly restricted to the area behind his knees.  His neck is still a little red as well.                                         I do not know the manufacturer for the vaccines - I picked the first one because I could not submit the form without it.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Eczema, Listless, Psychomotor hyperactivity, Rash
Clinical narrative: Started with a rash that resembled eczema and spreaded all over his body within a week after a flu vaccination containing thimerosal.  Behavioral he became hyper and listless.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Diarrhoea, Dyspnoea, Tachycardia, Varicella
Clinical narrative: Had pox on chest and hands, tightness in chest, shortness of breath, rapid heart beat & diarrhea
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Anorexia, Crying, Lethargy, Pyrexia, Screaming
Clinical narrative: High-pitched screaming, inconsolable crying, fever over 101.0 F lasting 3 days, lethargy, refusal to eat
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Chest discomfort, Formication
Clinical narrative: Starting with my third anthrax shot I started feeling like I had ants crawling all over my face, just my face, and that there was a solid block in my chest
Age: 11.0
Sex: M
Vaccine: DTAP, HEPA, MEN, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Right shoulder, one 3cm red raised, warm area, left shoulder 2 seperate 2cm red raised warm areas
Age: 1.27
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Pruritus, Pyrexia, Skin lesion
Clinical narrative: Low grade fever 11 and 12 days after administration of MMR, Varicella, and DTap vaccines.  Followed by bright erythematous 2-6 mm itching lesions without vesicles on day 12-13 after immunization.
Age: 26.0
Sex: M
Vaccine: HEPAB
Symptoms: Facial palsy
Clinical narrative: Bell's Palsy
Age: 0.3
Sex: F
Vaccine: 6VAX-F, HIBV, PNC
Symptoms: Anorexia, Crying, Hypersomnia, Injection site induration, Pyrexia
Clinical narrative: high fever of 102.5, administered Tyelnol...fever came back, uncontrollable crying, lump in left leg where shots were recieved- massaged with cold compress, slept for long periods, not eating throughout day.  Fever came back that evening.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Significant erythema and swelling at site (thigh)
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Bowel movement irregularity, Constipation, Flatulence, Irritability, Pain
Clinical narrative: Until the time of the Rotateq vaccine administration (Jan 29, 2007)my son had a regular bowel pattern of once daily.  After the vaccine my son's bowel pattern changed drastically.  He stopped having a daily bowel movement and began going 5-7 days between bowel movements.  This was accompanied by gas, fussiness and at times painful screaming.  In order to relieve his symptoms I has to resort to warm baths, abdominal massages, rectal stimulation with a thermometer and eventually gylcerine suppositories and prune juice.  We had to consult our primary care facility regarding his constipation and even went to an emergency room at one point due to my son's apparent pain and the new Rotateq advisory posted on Feb. 13th.  This altered bowel pattern and painful symptoms lasted for a month before my son began to resume his daily pattern this past week.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Screaming
Clinical narrative: Until the time of the Rotateq vaccine administration (Jan 29, 2007)my son had a regular bowel pattern of once daily.  After the vaccine my son's bowel pattern changed drastically.  He stopped having a daily bowel movement and began going 5-7 days between bowel movements.  This was accompanied by gas, fussiness and at times painful screaming.  In order to relieve his symptoms I has to resort to warm baths, abdominal massages, rectal stimulation with a thermometer and eventually gylcerine suppositories and prune juice.  We had to consult our primary care facility regarding his constipation and even went to an emergency room at one point due to my son's apparent pain and the new Rotateq advisory posted on Feb. 13th.  This altered bowel pattern and painful symptoms lasted for a month before my son began to resume his daily pattern this past week.
Age: 0.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Female patient who has had previous shingles was administered the Zostavax vaccine and one month later had a shingles outbreak.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Meconium abnormal, Sudden infant death syndrome
Clinical narrative: SIDS category II, light meconium at birth PPV given in delivery room.
Age: 0.27
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: SIDS
Age: 0.38
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 19-week-old male on 16-NOV-2006 and 18-JAN-2007 was vaccinated PO with the first and second 2.0ml doses, respectively, of Rotateq (lot #654663/0942F). Illness at the time of vaccination included bronchiolitis (with cough), otitis media and pharyngitis. Concomitant therapy included Pulmicort, Tylenol and Dimetapp (NEW FORMULA). The physician reported that on 18-JAN-2007, the patient developed a fever and had a tonic-clonic seizure. The patient was seen in the emergency room where a full sepsis work up was performed (results not provided). The patient was subsequently hospitalized (length unspecified). At the tiem of this report, the outcome was unknown. Additional information has been requested.
Age: 0.38
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature increased, Grand mal convulsion, Laboratory test, Nasopharyngitis, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 19-week-old male on 16-NOV-2006 and 18-JAN-2007 was vaccinated PO with the first and second 2.0ml doses, respectively, of Rotateq (lot #654663/0942F). Illness at the time of vaccination included bronchiolitis (with cough), otitis media and pharyngitis. Concomitant therapy included Pulmicort, Tylenol and Dimetapp (NEW FORMULA). The physician reported that on 18-JAN-2007, the patient developed a fever and had a tonic-clonic seizure. The patient was seen in the emergency room where a full sepsis work up was performed (results not provided). The patient was subsequently hospitalized (length unspecified). At the tiem of this report, the outcome was unknown. Additional information has been requested.
Age: 0.38
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Sepsis
Clinical narrative: Information has been received from a physician concerning a 19-week-old male on 16-NOV-2006 and 18-JAN-2007 was vaccinated PO with the first and second 2.0ml doses, respectively, of Rotateq (lot #654663/0942F). Illness at the time of vaccination included bronchiolitis (with cough), otitis media and pharyngitis. Concomitant therapy included Pulmicort, Tylenol and Dimetapp (NEW FORMULA). The physician reported that on 18-JAN-2007, the patient developed a fever and had a tonic-clonic seizure. The patient was seen in the emergency room where a full sepsis work up was performed (results not provided). The patient was subsequently hospitalized (length unspecified). At the tiem of this report, the outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Apnoeic attack, Death, Livedo reticularis, Lividity, Loss of consciousness
Clinical narrative: Initial report received on 22 February 2007 from an other manufacturer, reference number WAES0702USA01111, who received the original report. This report is verbatim from the other manufacturer report. "Information has been received from an agency concerning a 2-month-old female with no medical history who on 10-JAN-2007, at approximately 10:30, was vaccinated PO with the first dose of Rotateq (Lot# 655082/0779F). Concomitant vaccinations administered on that same day and time included the first IM dose in the lower thigh of Comvax (Lot# 6554424/0268F), the first IM dose in the left thigh of DTaP(Lot # U1965BA), the first sc dose in the left arm of IPOL (Lot Y1032) and the first IM dose in the right upper thigh of Prevnar (Lot# B08658F). There was no illness or other concomitant drug therapy at the time of vaccination. On 13-JAN-2007, at approximately 0500, the patient was dead on arrival at the Emergency Room (ER). Additional information via medical records concerning a 9-week-old female revealed that EMS responded to a call from the patient;s aunt indicating that she was pulseless and apneic. The patient's aunt noted that the patient was on her stomach and that a small amount of milk was coming from the mouth. Upon arrival EMS noted that the patient was wrapped in a blanket and was unconscious, unresponsive, pulseless and apneic. Her pupils were fixed and dilated with rigidity and lividity of her extremities. There was also nottling of her skin with blood pooling noted. There was no sign of obvious trauma or injury. The patient was transported to the ER for pronouncement. The cause if death was unknown. No further information is available."
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Muscle rigidity, Mydriasis, Pulse absent, Pupil fixed, Unresponsive to stimuli
Clinical narrative: Initial report received on 22 February 2007 from an other manufacturer, reference number WAES0702USA01111, who received the original report. This report is verbatim from the other manufacturer report. "Information has been received from an agency concerning a 2-month-old female with no medical history who on 10-JAN-2007, at approximately 10:30, was vaccinated PO with the first dose of Rotateq (Lot# 655082/0779F). Concomitant vaccinations administered on that same day and time included the first IM dose in the lower thigh of Comvax (Lot# 6554424/0268F), the first IM dose in the left thigh of DTaP(Lot # U1965BA), the first sc dose in the left arm of IPOL (Lot Y1032) and the first IM dose in the right upper thigh of Prevnar (Lot# B08658F). There was no illness or other concomitant drug therapy at the time of vaccination. On 13-JAN-2007, at approximately 0500, the patient was dead on arrival at the Emergency Room (ER). Additional information via medical records concerning a 9-week-old female revealed that EMS responded to a call from the patient;s aunt indicating that she was pulseless and apneic. The patient's aunt noted that the patient was on her stomach and that a small amount of milk was coming from the mouth. Upon arrival EMS noted that the patient was wrapped in a blanket and was unconscious, unresponsive, pulseless and apneic. Her pupils were fixed and dilated with rigidity and lividity of her extremities. There was also nottling of her skin with blood pooling noted. There was no sign of obvious trauma or injury. The patient was transported to the ER for pronouncement. The cause if death was unknown. No further information is available."
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Apnoea, Death, Livedo reticularis, Lividity, Loss of consciousness
Clinical narrative: Initial report received on 22 February 2007 from an other manufacturer, reference number WAES0702USA01111, who received the original report. This report is verbatim from the other manufacturer report. "Information has been received from an agency concerning a 2-month-old female with no medical history who on 10-JAN-2007, at approximately 10:30, was vaccinated PO with the first dose of Rotateq (Lot# 655082/0779F). Concomitant vaccinations administered on that same day and time included the first IM dose in the lower thigh of Comvax (Lot# 6554424/0268F), the first IM dose in the left thigh of DTaP(Lot # U1965BA), the first sc dose in the left arm of IPOL (Lot Y1032) and the first IM dose in the right upper thigh of Prevnar (Lot# B08658F). There was no illness or other concomitant drug therapy at the time of vaccination. On 13-JAN-2007, at approximately 0500, the patient was dead on arrival at the Emergency Room (ER). Additional information via medical records concerning a 9-week-old female revealed that EMS responded to a call from the patient;s aunt indicating that she was pulseless and apneic. The patient's aunt noted that the patient was on her stomach and that a small amount of milk was coming from the mouth. Upon arrival EMS noted that the patient was wrapped in a blanket and was unconscious, unresponsive, pulseless and apneic. Her pupils were fixed and dilated with rigidity and lividity of her extremities. There was also nottling of her skin with blood pooling noted. There was no sign of obvious trauma or injury. The patient was transported to the ER for pronouncement. The cause if death was unknown. No further information is available."
Age: 0.2
Sex: F
Vaccine: HIBV, RV5, RV5
Symptoms: Culture stool positive, Diarrhoea, Haematochezia, White blood cell count normal
Clinical narrative: Information has been received from a physician concerning a 11 week old female with no medical history or allergies who on 06-JAN-2007 was vaccinated with a 2.0 ml first oral dose of Rotateq (lot #654504/0695F). There was no concomitant medication. Ten days after vaccination, on approximately 26-JAN-2007, the patient developed mucous like diarrhea. It was reported that the patient also had "specks of red in diarrhea, which were thought to be blood" A stool culture came back negative and the patient's mother was advised to take the baby a GI specialist. Subsequently, the patient recovered, there was no product quality complaint involved. The patient's hematochezia was considered to be an other medical event. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: HIBV, RV5, RV5
Symptoms: Culture stool negative, Diarrhoea, Diarrhoea haemorrhagic, Haematochezia
Clinical narrative: Information has been received from a physician concerning a 11 week old female with no medical history or allergies who on 06-JAN-2007 was vaccinated with a 2.0 ml first oral dose of Rotateq (lot #654504/0695F). There was no concomitant medication. Ten days after vaccination, on approximately 26-JAN-2007, the patient developed mucous like diarrhea. It was reported that the patient also had "specks of red in diarrhea, which were thought to be blood" A stool culture came back negative and the patient's mother was advised to take the baby a GI specialist. Subsequently, the patient recovered, there was no product quality complaint involved. The patient's hematochezia was considered to be an other medical event. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Lethargy, Palpitations
Clinical narrative: felt very different, very tired, lethargic, after last shot to today.  took me 4 yrs to get pregnant.  joint soreness to today, heart palpitations recently w/no answer for.      not sure of exact dates of vaccination - see doctor's file.
Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Pregnancy
Clinical narrative: felt very different, very tired, lethargic, after last shot to today.  took me 4 yrs to get pregnant.  joint soreness to today, heart palpitations recently w/no answer for.      not sure of exact dates of vaccination - see doctor's file.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Local reaction, Pyrexia, Skin warm
Clinical narrative: The Pt.'s left upper arm developed exuberent local reaction with erthyema, warmth, tenderness with systemic fatigue, fever.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: The Pt.'s left upper arm developed exuberent local reaction with erthyema, warmth, tenderness with systemic fatigue, fever.
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness
Clinical narrative: dizziness upon waking up and getting out of bed in morning past 3 days after day 7 rabies vaccination.
Age: 25.0
Sex: M
Vaccine: HEP, TD, TYP
Symptoms: Chest X-ray normal, Computerised tomogram abnormal, Computerised tomogram normal, Diplopia, Dysarthria
Clinical narrative: Around Dec 11, 2006 service member began experiencing an unsteady gait and unsteadiness. His symptoms progressed over the next 2 days to including worsening gait. By Mid day on 13 Dec he noted that he had double vision, worse with distance and no diplopia with reading and slurred speech. He was evaluated and admitted on 12/13/06. He was given fluids and oxygen, with no treatment overnight. By the next morning, his speech had returned to normal, but his diplopia and imbalance was still present. He was given 2 days if IV steroids and noted improvement of all his symptoms. He was discharged on 18 December. He continues to have visual symptoms. He experienced a headache on 26 Dec which was over his right eye and extended to the back of his head, he had not experienced a headache prior and has not experienced a significant headache since. No problems swallowing, weakness, or numbness. No fever during symptoms. Denies cough, chest pain, dyspnea, bowel/bladder dysfunction. No previous history of double vision, dysarthria, episodes of vision loss, weakness or numbness of any body part. See clinical summary.  Pt. reported to ER with c/o 3 day hx of vertigo, unsteady gait, horizontal diplopia, and hazy vision.  He was also noted to have slurred speech. Opthalmic exam 12/14/2006 showed motility as significantly abnormal with complete deficit of the adduction of the left medial rectus.  Good function of all ocular muscles except on the right gaze there was complete absence of the function of the right medial rectus. On the complete left gaze there was a slight deficit  on the right medial rectus. Impression:  Left medial longitudinal folliculus lesion resulting in left internuclear opthalmoplegia.  The lesion causing this is in the left brainstem ventral to the medial longitudinal folliculus in the region between the 3rd and 4th cranial nerve nuclei.  The most common cause is probably multiple sclerosis in his age group, however he may have a longitudinal folliculitis defect.  Neurology consult 12/15/2006 PE WNL except Extra-occular movements demonstrate a Right Internuclear Opthalmoplegia. Impression: R/O MS. R/O peripheral vestibulopathy.  R/O  brain stem tumor or cerebral aneurysm. 03/27/2007 Updated records received.  Pt. reports new symptom of right eye dimness, and the colors not as crisp as his left eye. Assessment:  Initially reported as Optic Neuritis, then Strabismus Non-paralytic Esotropia.
Age: 25.0
Sex: M
Vaccine: HEP, TD, TYP
Symptoms: Echocardiogram normal, Fluid replacement, Full blood count abnormal, Gait disturbance, Glycosylated haemoglobin
Clinical narrative: Around Dec 11, 2006 service member began experiencing an unsteady gait and unsteadiness. His symptoms progressed over the next 2 days to including worsening gait. By Mid day on 13 Dec he noted that he had double vision, worse with distance and no diplopia with reading and slurred speech. He was evaluated and admitted on 12/13/06. He was given fluids and oxygen, with no treatment overnight. By the next morning, his speech had returned to normal, but his diplopia and imbalance was still present. He was given 2 days if IV steroids and noted improvement of all his symptoms. He was discharged on 18 December. He continues to have visual symptoms. He experienced a headache on 26 Dec which was over his right eye and extended to the back of his head, he had not experienced a headache prior and has not experienced a significant headache since. No problems swallowing, weakness, or numbness. No fever during symptoms. Denies cough, chest pain, dyspnea, bowel/bladder dysfunction. No previous history of double vision, dysarthria, episodes of vision loss, weakness or numbness of any body part. See clinical summary.  Pt. reported to ER with c/o 3 day hx of vertigo, unsteady gait, horizontal diplopia, and hazy vision.  He was also noted to have slurred speech. Opthalmic exam 12/14/2006 showed motility as significantly abnormal with complete deficit of the adduction of the left medial rectus.  Good function of all ocular muscles except on the right gaze there was complete absence of the function of the right medial rectus. On the complete left gaze there was a slight deficit  on the right medial rectus. Impression:  Left medial longitudinal folliculus lesion resulting in left internuclear opthalmoplegia.  The lesion causing this is in the left brainstem ventral to the medial longitudinal folliculus in the region between the 3rd and 4th cranial nerve nuclei.  The most common cause is probably multiple sclerosis in his age group, however he may have a longitudinal folliculitis defect.  Neurology consult 12/15/2006 PE WNL except Extra-occular movements demonstrate a Right Internuclear Opthalmoplegia. Impression: R/O MS. R/O peripheral vestibulopathy.  R/O  brain stem tumor or cerebral aneurysm. 03/27/2007 Updated records received.  Pt. reports new symptom of right eye dimness, and the colors not as crisp as his left eye. Assessment:  Initially reported as Optic Neuritis, then Strabismus Non-paralytic Esotropia.
Age: 25.0
Sex: M
Vaccine: HEP, TD, TYP
Symptoms: Haemoglobin decreased, Headache, Lymphocyte count increased, Monocyte count, Neutrophil count increased
Clinical narrative: Around Dec 11, 2006 service member began experiencing an unsteady gait and unsteadiness. His symptoms progressed over the next 2 days to including worsening gait. By Mid day on 13 Dec he noted that he had double vision, worse with distance and no diplopia with reading and slurred speech. He was evaluated and admitted on 12/13/06. He was given fluids and oxygen, with no treatment overnight. By the next morning, his speech had returned to normal, but his diplopia and imbalance was still present. He was given 2 days if IV steroids and noted improvement of all his symptoms. He was discharged on 18 December. He continues to have visual symptoms. He experienced a headache on 26 Dec which was over his right eye and extended to the back of his head, he had not experienced a headache prior and has not experienced a significant headache since. No problems swallowing, weakness, or numbness. No fever during symptoms. Denies cough, chest pain, dyspnea, bowel/bladder dysfunction. No previous history of double vision, dysarthria, episodes of vision loss, weakness or numbness of any body part. See clinical summary.  Pt. reported to ER with c/o 3 day hx of vertigo, unsteady gait, horizontal diplopia, and hazy vision.  He was also noted to have slurred speech. Opthalmic exam 12/14/2006 showed motility as significantly abnormal with complete deficit of the adduction of the left medial rectus.  Good function of all ocular muscles except on the right gaze there was complete absence of the function of the right medial rectus. On the complete left gaze there was a slight deficit  on the right medial rectus. Impression:  Left medial longitudinal folliculus lesion resulting in left internuclear opthalmoplegia.  The lesion causing this is in the left brainstem ventral to the medial longitudinal folliculus in the region between the 3rd and 4th cranial nerve nuclei.  The most common cause is probably multiple sclerosis in his age group, however he may have a longitudinal folliculitis defect.  Neurology consult 12/15/2006 PE WNL except Extra-occular movements demonstrate a Right Internuclear Opthalmoplegia. Impression: R/O MS. R/O peripheral vestibulopathy.  R/O  brain stem tumor or cerebral aneurysm. 03/27/2007 Updated records received.  Pt. reports new symptom of right eye dimness, and the colors not as crisp as his left eye. Assessment:  Initially reported as Optic Neuritis, then Strabismus Non-paralytic Esotropia.
Age: 25.0
Sex: M
Vaccine: HEP, TD, TYP
Symptoms: Oxygen supplementation, Platelet count normal, Red blood cell count decreased, Thyroxine decreased, Tri-iodothyronine free
Clinical narrative: Around Dec 11, 2006 service member began experiencing an unsteady gait and unsteadiness. His symptoms progressed over the next 2 days to including worsening gait. By Mid day on 13 Dec he noted that he had double vision, worse with distance and no diplopia with reading and slurred speech. He was evaluated and admitted on 12/13/06. He was given fluids and oxygen, with no treatment overnight. By the next morning, his speech had returned to normal, but his diplopia and imbalance was still present. He was given 2 days if IV steroids and noted improvement of all his symptoms. He was discharged on 18 December. He continues to have visual symptoms. He experienced a headache on 26 Dec which was over his right eye and extended to the back of his head, he had not experienced a headache prior and has not experienced a significant headache since. No problems swallowing, weakness, or numbness. No fever during symptoms. Denies cough, chest pain, dyspnea, bowel/bladder dysfunction. No previous history of double vision, dysarthria, episodes of vision loss, weakness or numbness of any body part. See clinical summary.  Pt. reported to ER with c/o 3 day hx of vertigo, unsteady gait, horizontal diplopia, and hazy vision.  He was also noted to have slurred speech. Opthalmic exam 12/14/2006 showed motility as significantly abnormal with complete deficit of the adduction of the left medial rectus.  Good function of all ocular muscles except on the right gaze there was complete absence of the function of the right medial rectus. On the complete left gaze there was a slight deficit  on the right medial rectus. Impression:  Left medial longitudinal folliculus lesion resulting in left internuclear opthalmoplegia.  The lesion causing this is in the left brainstem ventral to the medial longitudinal folliculus in the region between the 3rd and 4th cranial nerve nuclei.  The most common cause is probably multiple sclerosis in his age group, however he may have a longitudinal folliculitis defect.  Neurology consult 12/15/2006 PE WNL except Extra-occular movements demonstrate a Right Internuclear Opthalmoplegia. Impression: R/O MS. R/O peripheral vestibulopathy.  R/O  brain stem tumor or cerebral aneurysm. 03/27/2007 Updated records received.  Pt. reports new symptom of right eye dimness, and the colors not as crisp as his left eye. Assessment:  Initially reported as Optic Neuritis, then Strabismus Non-paralytic Esotropia.
Age: 25.0
Sex: M
Vaccine: HEP, TD, TYP
Symptoms: Troponin I, White blood cell count increased
Clinical narrative: Around Dec 11, 2006 service member began experiencing an unsteady gait and unsteadiness. His symptoms progressed over the next 2 days to including worsening gait. By Mid day on 13 Dec he noted that he had double vision, worse with distance and no diplopia with reading and slurred speech. He was evaluated and admitted on 12/13/06. He was given fluids and oxygen, with no treatment overnight. By the next morning, his speech had returned to normal, but his diplopia and imbalance was still present. He was given 2 days if IV steroids and noted improvement of all his symptoms. He was discharged on 18 December. He continues to have visual symptoms. He experienced a headache on 26 Dec which was over his right eye and extended to the back of his head, he had not experienced a headache prior and has not experienced a significant headache since. No problems swallowing, weakness, or numbness. No fever during symptoms. Denies cough, chest pain, dyspnea, bowel/bladder dysfunction. No previous history of double vision, dysarthria, episodes of vision loss, weakness or numbness of any body part. See clinical summary.  Pt. reported to ER with c/o 3 day hx of vertigo, unsteady gait, horizontal diplopia, and hazy vision.  He was also noted to have slurred speech. Opthalmic exam 12/14/2006 showed motility as significantly abnormal with complete deficit of the adduction of the left medial rectus.  Good function of all ocular muscles except on the right gaze there was complete absence of the function of the right medial rectus. On the complete left gaze there was a slight deficit  on the right medial rectus. Impression:  Left medial longitudinal folliculus lesion resulting in left internuclear opthalmoplegia.  The lesion causing this is in the left brainstem ventral to the medial longitudinal folliculus in the region between the 3rd and 4th cranial nerve nuclei.  The most common cause is probably multiple sclerosis in his age group, however he may have a longitudinal folliculitis defect.  Neurology consult 12/15/2006 PE WNL except Extra-occular movements demonstrate a Right Internuclear Opthalmoplegia. Impression: R/O MS. R/O peripheral vestibulopathy.  R/O  brain stem tumor or cerebral aneurysm. 03/27/2007 Updated records received.  Pt. reports new symptom of right eye dimness, and the colors not as crisp as his left eye. Assessment:  Initially reported as Optic Neuritis, then Strabismus Non-paralytic Esotropia.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Computerised tomogram, Intussusception, Ultrasound scan, X-ray
Clinical narrative: Intussusception R lower quadrant. 03/26/07-records received from facility for DOS 02/19-02/21/07-DC DX: Intussusception.  Vomiting, non-bilious however became bilious with small amounts of blood while in hospital. Several loose stools heme positive.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Computerised tomogram, Inappropriate schedule of drug administration, Intussusception, Ultrasound scan, X-ray
Clinical narrative: Intussusception R lower quadrant. 03/26/07-records received from facility for DOS 02/19-02/21/07-DC DX: Intussusception.  Vomiting, non-bilious however became bilious with small amounts of blood while in hospital. Several loose stools heme positive.
Age: 0.37
Sex: U
Vaccine: RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Stool analysis abnormal
Clinical narrative: Information has been received from a health professional concerning a 4 month old patient who on 13-FEB-2007 was vaccinated with a second dose of Rotateq. It was reported that the patients mother called and came into the office and stated that the patient had a bloody stool late on the 16-FEB-2007 or early on the 17-FEB-2007. The patient's mother brought the patient's diaper back in on 19-FEB-2007, and it tested positive for bloody stool. Subsequently the patient was back to normal and there was only one bloody stool. Upon internal review, the patient's bloody stool was considered to be another important medical event. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a 2 ml oral dose of Rotateq. Subsequently the patient developed bloody stools. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's bloody stool was determined to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a second dose of Rotateq. Subsequently the patient developed rotavirus and was hospitalized for three days. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Choking, Rash
Clinical narrative: Information has been received from a physician a 6 year old female who in February 2007, was vaccinated with a dose of Vaqta (duration and does not reported). Suspect therapy included Varivax (duration and dose not reported). It was reported in February 2007, that on an unspecified date, a patient received Vaqta and Varivax during the same visit and experienced an immediate choking response. The patient was given an EPI-PEN and was monitored in the office prior to being sent some. While the patient was at home she developed a rash (the date the rash occurred was unknown). No product Quality complaint. The physician considered the choking response to be serious due to an Other Important Medical Event. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Information has been received from a physician concerning a 3-year-old female who was vaccinated "a year and a half ago" with a dose of Vaqta. Concomitant therapy included Motrin or Tylenol. Subsequently, on an unspecified date the patient experienced Stevens-Johnson syndrome. Unspecified medical attention was sought. The reporter did not identify any serious criteria and no outcome was reported. No product quality complaint was involved. Upon internal review, Stevens-Johnson was determined to be an other important medical event. Additional information has been requested.
Age: 1.24
Sex: M
Vaccine: DTAP, HBHEPB, MMRV, PNC, DTAP, HBHEPB, MMRV, PNC
Symptoms: Autopsy, Death, Mental status changes
Clinical narrative: Information has been received from a physician concerning a 15-month-old male with a history of jaundice at birth, who on 24-JAN-2007 was vaccinated with a 0.5ml dose of ProQuad (lot #656160/1396F, expiration date 16-MAY-2008). Concomitant vaccinations included: Prevnar (lot #B08639A), Tripedia (lot # C2552AA) and Comvax (lot reported as 653660/0257F). Subsequently, on 11-FEB-2007 the patient experienced a mental state change and was hospitalized. The patient underwent a CT scan that was non conclusive at the time of this report. It was reported that the patient experienced unexpected rapid deterioration and died on 12-FBE-2007. An autopsy was performed, however, results were not yet available. The cause of death was unknown at the time of this report. The patients adverse experiences were considered to be life threatening and disabling. Additional information has been requested.  4/24/07 Received medical records from PCP which reveal patient experienced good health on day of vax.  Later on day of vax developed swollen left leg & patient had difficulty walking that day.  Next day was resolved when seen by PCP. Dx suspected Prevnar reaction.  On 1/26 seen in ER for abdominal distention, vomiting & diarrhea.  ER dx w/ileus.  Seen by PCP 1/27 & dx w/resolving ileus secondary to acute gastroenteritis.  Next note is of t/c from parent that patient deceased on 2/12/07.  PCP requested autopsy report on 2/28/07.  Vax record included w/med records from PCP. 4/24/07 PCP also forwarded med records from 2/12/07 hospitalization which reveal patient experienced altered mental status, fussiness, congestion, swollen face, increased sleepiness & pallor.  Patient had been seen at outying Urgent Care center then transported to outlying ER via ambulance for fever, wheezes & respiratory difficulty w/a single apneic period reported.  Child then transported to another hospital for PICU higher level of care. On admit there, very lethargic, pale, crying & opening eyes intermittently.  There was crusty nares, inspiratory wheezing & crackles & coarse breath sounds, no neck rigidity, hypotonia.  Started on antibiotics & LP obtained. Seizures were noted in PICU & loaded w/dilantin.  Emergently intubated following AM for dilated pupils, responsiveness to deep pain w/decerebrate posturing & respiratory difficulty.  Treated w/high dose steroids for possible ADEM.  Condition deteriorated over the day, patient declared brain dead & deceased. ER DX: meningitis vs encephalitis.  PICU Dx: brain stem dysfunction. 10/2/07 Reviewed Autopsy Report which revals COD as undetermined & manner of death as undetermined.