chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Pruritus, Tenderness
Clinical narrative: Redness, swelling, around left arm, covering 3/4 area itchy, hard, mildly tender.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: Approximately 5-7 days after receiving MMR vaccine (2nd doses), patient developed left sided pantitis, no fever.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Dizziness, Headache, Injection site pain
Clinical narrative: Pain at injection site, swelling, headache, muscle aches, joint aches, nausea no vomiting, chills, no rash, fever 103.4 11:30 pm treated with MOTRIN 400 mg temperature decreased 102.7  9/26/06 this am 98.4, dizziness, heart rate 140, pale.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Pallor, Pyrexia, Swelling
Clinical narrative: Pain at injection site, swelling, headache, muscle aches, joint aches, nausea no vomiting, chills, no rash, fever 103.4 11:30 pm treated with MOTRIN 400 mg temperature decreased 102.7  9/26/06 this am 98.4, dizziness, heart rate 140, pale.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Headache, Platelet disorder, Prothrombin time prolonged, Pruritus, Purpura
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 9/14/06 from another manufacturer, who received the initial report from a nurse. The other manufacturers reference number is WAES0608USA04992. A five year old male pt with a past medical history of dermatitis, and no known allergies had received a fourth subcutaneous done of IPOL, lot number Y2050, a fifth IM dose of Infanrix , lot number AC14B036AA, and a first SC dose of ProQuad, lot number 652679/1137R, on 8/21/06 at 14:00pm. The route of administration was not reported for any of the vaccines administered. Ninety minutes post immunization, the pt developed an erythematous (reddish, purplish), non blanching, irregular border rash in two spots which had spread to five spots behind the right ear, on the left ear, on the side of the face near the ear, on the hairline, and down the jaw line. The size of these spots were 4-10 mm and the centers were not elevated. Other faint sites were developing. The pt also developed a headache and a little itching. The pt was monitored at the physicians office and treated with Benadryl. It was reported that it was presumed that the pt valsalved and extrasvasated blood purpura. Lab work performed included a WBC of 8,900, platelet 313,000, PT 11.5, and PTT 29. Subsequently, the pt recovered. There were no product quality complaints involved for the other manufacturer. The pts events were considered by the other manufacturer to be other important medical events.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Rash, White blood cell disorder
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 9/14/06 from another manufacturer, who received the initial report from a nurse. The other manufacturers reference number is WAES0608USA04992. A five year old male pt with a past medical history of dermatitis, and no known allergies had received a fourth subcutaneous done of IPOL, lot number Y2050, a fifth IM dose of Infanrix , lot number AC14B036AA, and a first SC dose of ProQuad, lot number 652679/1137R, on 8/21/06 at 14:00pm. The route of administration was not reported for any of the vaccines administered. Ninety minutes post immunization, the pt developed an erythematous (reddish, purplish), non blanching, irregular border rash in two spots which had spread to five spots behind the right ear, on the left ear, on the side of the face near the ear, on the hairline, and down the jaw line. The size of these spots were 4-10 mm and the centers were not elevated. Other faint sites were developing. The pt also developed a headache and a little itching. The pt was monitored at the physicians office and treated with Benadryl. It was reported that it was presumed that the pt valsalved and extrasvasated blood purpura. Lab work performed included a WBC of 8,900, platelet 313,000, PT 11.5, and PTT 29. Subsequently, the pt recovered. There were no product quality complaints involved for the other manufacturer. The pts events were considered by the other manufacturer to be other important medical events.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Headache, Pruritus, Purpura, Rash erythematous, Skin discolouration
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 9/14/06 from another manufacturer, who received the initial report from a nurse. The other manufacturers reference number is WAES0608USA04992. A five year old male pt with a past medical history of dermatitis, and no known allergies had received a fourth subcutaneous done of IPOL, lot number Y2050, a fifth IM dose of Infanrix , lot number AC14B036AA, and a first SC dose of ProQuad, lot number 652679/1137R, on 8/21/06 at 14:00pm. The route of administration was not reported for any of the vaccines administered. Ninety minutes post immunization, the pt developed an erythematous (reddish, purplish), non blanching, irregular border rash in two spots which had spread to five spots behind the right ear, on the left ear, on the side of the face near the ear, on the hairline, and down the jaw line. The size of these spots were 4-10 mm and the centers were not elevated. Other faint sites were developing. The pt also developed a headache and a little itching. The pt was monitored at the physicians office and treated with Benadryl. It was reported that it was presumed that the pt valsalved and extrasvasated blood purpura. Lab work performed included a WBC of 8,900, platelet 313,000, PT 11.5, and PTT 29. Subsequently, the pt recovered. There were no product quality complaints involved for the other manufacturer. The pts events were considered by the other manufacturer to be other important medical events.
Age: 0.19
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, MNQ, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: This female subject was enrolled in the prophylactic blind study. On 8/9/2006 she received the 1st dose of combined haemophilus influence type vaccine and meningitis C and Y vaccine conjugated on tetanus toxoid (Hib MENCY II, IM right upper thigh), combined  diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix, IM left upper thigh) and Pneumococcal vaccine (Prevnar, IM left lower thigh). Following the parents, the subject was a healthy baby born at term. On 9/20/2006, the subject was put down to sleep at about 5-6 pm with a bottle of formula. The subject woke up at about 11pm and did not want any formula. Pacifier was placed in mouth and she fell asleep at about 11:30pm. On 9/21/2006, 43 days after the 1st dose of Hib MENCY TT, 43 days after the 1st dose of Pediarix, 43 days after the 1st dose of Prevnar, at about 5:30 am, this four month old subject was found dead lying on her back. One blanket with a wrapped piece of candy was found in her crib. One piece of sleeper was moist in the posterior neck upper back with odor of formula. An autopsy was performed, the results were pending. Investigator causality was unknown at the time of reporting.
Age: 0.19
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, MNQ, PNC
Symptoms: Unevaluable event
Clinical narrative: This female subject was enrolled in the prophylactic blind study. On 8/9/2006 she received the 1st dose of combined haemophilus influence type vaccine and meningitis C and Y vaccine conjugated on tetanus toxoid (Hib MENCY II, IM right upper thigh), combined  diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix, IM left upper thigh) and Pneumococcal vaccine (Prevnar, IM left lower thigh). Following the parents, the subject was a healthy baby born at term. On 9/20/2006, the subject was put down to sleep at about 5-6 pm with a bottle of formula. The subject woke up at about 11pm and did not want any formula. Pacifier was placed in mouth and she fell asleep at about 11:30pm. On 9/21/2006, 43 days after the 1st dose of Hib MENCY TT, 43 days after the 1st dose of Pediarix, 43 days after the 1st dose of Prevnar, at about 5:30 am, this four month old subject was found dead lying on her back. One blanket with a wrapped piece of candy was found in her crib. One piece of sleeper was moist in the posterior neck upper back with odor of formula. An autopsy was performed, the results were pending. Investigator causality was unknown at the time of reporting.
Age: 1.01
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Rash on set 9/26/06 raised red areas, blanching, fever x 2 days up to 102.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a health professional concerning a 39-year-old female employee, with no medical history and no allergies, who on 17-AUG-2006 was vaccinated with a 0.5 ml subcutaneous dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot#652483/0148F).  There was no concomitant medication.  On 06-SEP-2006 the patient experienced cellulitis at the injection site that required her to be hospitalized for two days.  The patient was treated with IV antibiotics and released.  No product quality complaint was involved.  No other information was provided.  The reporter considered the patient's reaction to be an other important medical event.  Additional information has been requested. (OMIC)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site induration
Clinical narrative: 8 by 4 cm of erythema on right thigh with induration contiguous with MMR-Varicella immunization.  Symptoms reported resolved 4 days after immunization given.
Age: 6.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Coma, Fall, Pallor, Visual disturbance
Clinical narrative: After last vaccine was administered, client got off mothers lap and left room to join uncle in the hallway.  Uncle stated the client had fallen down.  Client then covered her eyes and said she could not see.  Mother help client back to exam room.  Client became unresponsive and pale approximately 3:50 pm, emergency medical services called, oxygen given, vitals continued to be monitored.  4:02 she opened her eyes slightly only, 4:03 emergency medical services resumed treatment.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Injection site warmth, Swelling
Clinical narrative: Large blisters (50 cent size), arm warm and swollen from shoulder to elbow.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Myalgia, Neck pain, Tenderness
Clinical narrative: Patient to health department 9/13/06 states neck right side starting hurting 9/12/06 pm, no redness at site of injection in right arm but has supraclavicular node, right chest and tenderness. Patient stated muscles very sore top of right shoulder, clavicle area and tropes versus muscle back of right shoulder.  Sent to private medical doctor give to note- patient did not keep appointment.
Age: 1.26
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Irritability
Clinical narrative: Febrile seizure 20-30 seconds 9 days after MMR administered. Emergency medical services visited, no treatment given, no rash , positive cranky.  twin brother with seizure 2 days after.
Age: 0.26
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Erythema, Somnolence
Clinical narrative: 15 month male twin with 20-30 seconds seizure on 9/24/06.  Emergency medical services evaluated sleepy but otherwise normal.  No treatment given, in office today, red throat but normal exam.
Age: 0.52
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion
Clinical narrative: seizure
Age: 11.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MNQ
Symptoms: Unevaluable event
Clinical narrative: Patient given Pediarix, IPOL, Menactra, Adacel and Menactra ordered.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Swelling
Clinical narrative: Left arm shoulder and upper left torso swelling done to wrist.  Child brought to hospital seen by doctor will also follow up with medical doctor as needed.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Patient has the chicken pox.
Age: 24.0
Sex: M
Vaccine: SMALL, ANTH, FLUN3, HEPAB, SMALL
Symptoms: Blister, Injection site vesicles
Clinical narrative: 9 days post smallpox vaccination pt presented with pustular lesions spreading from the site of the vaccination to his shoulder and back.
Age: 24.0
Sex: M
Vaccine: SMALL, ANTH, FLUN3, HEPAB, SMALL
Symptoms: Diarrhoea, Haematemesis, Headache, Influenza like illness, Pain
Clinical narrative: 9 days post smallpox vaccination pt presented with pustular lesions spreading from the site of the vaccination to his shoulder and back.
Age: 24.0
Sex: M
Vaccine: SMALL, ANTH, FLUN3, HEPAB, SMALL
Symptoms: Pruritus, Rash papular, Rash pustular
Clinical narrative: 9 days post smallpox vaccination pt presented with pustular lesions spreading from the site of the vaccination to his shoulder and back.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Pericarditis, Pyrexia
Clinical narrative: Chest pain/pericarditis symptoms beginning approx 7 days post vaccination.  Fever of 101. Given NSAIDs and narcotic pain relief. Hospitalization length unknown (still in hospital).  10/30/06 Received medical records from hospital which reveal patient contacted cardiology outpatient clinic for appt on 10/10 which was 14 days after his return from deployment with c/o chest pain & tendonitis of shoulder.  Seen in cardiology clinic on 10/12/06 with dx: pericarditis s/p small pox vax.  Chest pain now 2/10, constant & worse supine, tx w/Motrin.  No DOE & + occasional palpitations.   Was to have echocardiogram & Holter monitor as outpatient, continue Motrin & rest. Dx: pericarditis s/p small pox vax, overall improving.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Alopecia, Back pain, Rash
Clinical narrative: SKIN RASH, HAIR LOSS, SEVERE BACK PAIN
Age: 1.44
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: 12 hours after receiving vaccinations, my daughter developed a case of hives, which completely covered her body from neck to toes. (It was almost like one giant connecting hive). I called the doctors office and they wanted to see her right away.  I was told that they had never seen a case of hives like that as a reaction to the vaccinations.  Exactly 72 hours later, her hives went completely away.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS AT SITE OF INJECTION.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right upper extremity deltoid area local redness and swelling measuring 4 inches across, lasted several days, no induration or infection, no fever.
Age: 25.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Feeling hot, Formication, Hyperaesthesia, Injection site erythema
Clinical narrative: Received both Tdap & Hep B (& PPD skin test on 9-25-06 as part of Immunization Program for new students).  Today when she returned for PPD reading, she reported significant swelling, tenderness, & redness at site of the Tdap.  Reports crescendo of symptoms beginning 12 hrs after injection for 1.5 days, then decrescendo to present time.  Also reports transcient "twitching of muscle", "crawling sensation of skin" & light touch sensitivity at site of injection at 1-2 days but since resolved. Felt warm (both locally & systemically) but did not document temp.  Denies any chills or shaking at any time.  On examination: 6 X 6 patch of mild erythema & edema on left deltoid, tender to touch.  Advised: ice, Tylenol as directed prn pain, & f/u if not continuing to resolve over next 1 week.
Age: 25.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site pain, Injection site swelling, Muscle twitching, Oedema
Clinical narrative: Received both Tdap & Hep B (& PPD skin test on 9-25-06 as part of Immunization Program for new students).  Today when she returned for PPD reading, she reported significant swelling, tenderness, & redness at site of the Tdap.  Reports crescendo of symptoms beginning 12 hrs after injection for 1.5 days, then decrescendo to present time.  Also reports transcient "twitching of muscle", "crawling sensation of skin" & light touch sensitivity at site of injection at 1-2 days but since resolved. Felt warm (both locally & systemically) but did not document temp.  Denies any chills or shaking at any time.  On examination: 6 X 6 patch of mild erythema & edema on left deltoid, tender to touch.  Advised: ice, Tylenol as directed prn pain, & f/u if not continuing to resolve over next 1 week.
Age: 25.0
Sex: M
Vaccine: YF
Symptoms: Flushing, Rhinorrhoea, Wheezing
Clinical narrative: Pt called and stated 30 minutes after receiving the vaccine, started runny nose, flush face, and wheezing.  He self medicated with Zyrtec and now feeling fine.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Nausea, Pain, Vomiting
Clinical narrative: This is a 70-year-old woman here with a sore arm and lightheadedness.  She received a pneumonia vaccine yesterday at 11:00 a.m.  It was moderately painful when she received it and she was well until a few hours later when she noticed increasing pain in her left shoulder which became very severe and excruciating. She treated it with Advil, Tylenol, had a glass of wine.  She vomited last evening, hardly slept at all last night, took a total of 1-1/2 oxycodone that she had left from a previous prescription. It helped minimally.  This morning vomited again and attempted to take a shower, became weak and lightheaded and had to lay down. Now she is too weak to stand and feels lightheaded, mildly nauseous.  No diarrhea, no dysuria, no clear fevers.  Denies chills or sweats.  She has had one previous Pneumovax approximately ten years ago.  General health is good, has an ALLERGY TO PENICILLIN, CODEINE.  She is on hydrochlorothiazide for hypertension, no other meds.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Local reaction with erythema, no fever ( at injection site) left thigh.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Dyspnoea, Irritability, Pyrexia
Clinical narrative: Infant was crying, seem irritable, positive fever and had transient difficulties breathing, seen in emergency department and recovered without incident.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Convulsion, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: 8/29/06, 15:09, pt called complaining of left deltoid swollen, redness and no axillary swelling. fatigue, arm pain, seizure, flu-like symptoms, nausea.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Nausea
Clinical narrative: 8/29/06, 15:09, pt called complaining of left deltoid swollen, redness and no axillary swelling. fatigue, arm pain, seizure, flu-like symptoms, nausea.
Age: 1.04
Sex: M
Vaccine: UNK
Symptoms: Blister
Clinical narrative: Blister filled bumps on trunk of body, hairline, ears and arms.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever X 1 day; nausea, headache X 1 day and body pain.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Actual chicken pox disease.
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Received phone call from county human resources dept that pt called his family MD on 9/27/06 PM and told his MD he has a rash all over and was very itchy. Pt instructed by MD to take Benadryl which cleared the rash.
Age: 0.09
Sex: M
Vaccine: HEP, DTAP, HIBV, MMR
Symptoms: Autism, Autism, Conjunctivitis, Cough, Developmental delay
Clinical narrative: Information has been received regarding a case in litigation concerning a 1 day old male (birth weight 8lbs 13ox), with a family history of three siblings, two older girls, age eight and nine who have speech problems. The mothers brother also had some speech difficulty which was said to be related to hearing problems. On 5/16/1996, the pt was vaccinated with hepatitis B (dose not reported). Concomitant therapy included MMR vaccine 10/24/1997 and 10/18/2001 (dose not reported). Other concomitant therapy included varicella virus 6/14/1997 DPT 7/19/1996 10/5/1996 12/14/1996, Dtap 10/24/1997 and 10/15/2001, poliovirus live oral OPV/IPV 7/19/1996 10/5/1996 12/14/1996 and 10/15/2001 and Hib Conj vaccine Hib Titer 7/19/1996 10/5/1996 12/14/1996 and 10/24/1997. In 1998 the pt was diagnosed with autism. In 1998-99, the pt was coded as a student with developmental delay. On 3/23/1999 and educational assessment was performed due to concerns with the pts speech and language development. On 5/19/1999, an neurological evaluation was performed results reported were that the pt has a speech and language delay. The pts hearing had been checked and it was normal. There was a history of these developmental problem in other members of the family. On 6/24/1999, Fragile X syndrome test was performed with normal results (25-40 CGG repeat size). On an unspecified date, a psychological assessment was performed, questioned. The pt did not demonstrate an interest in a variety of toys. The had multiple developmental delays and he met the DSM IV criteria for the diagnosis of autistic disorder. On 2/4/02, and educational evaluation was performed results reported were that an IEP was developed with the following services, speech language, cognition and motor. Upon internal review, autism was considered to be an other important medical event (OMIC). Information received on 9/12/06 contained the following adverse experiences, eczema and dry skin rash 11/9/1996, fever and diarrhea 4/21/1997 which was treated Pedialyte, viral URI 5/17/1997 which was treated with pediacare, acetaminophen (Tylenol) and pseudoephedrine hydrochloride (Dimetapp), cold, cough and runny nose 10/28/1997, viral URI 1/2/1998, bilateral conjunctivitis and URI 6/15/1998, and borderline normal hearing to a mild hearing loss 12/17/2001. No further information is available. All available medical records will be provided upon request. Follow-up information received 4-16-08. Vaccine recipient did not recover from the adverse events reported for this vaccination. There are no residual symptoms listed.
Age: 0.09
Sex: M
Vaccine: HEP, DTAP, HIBV, MMR
Symptoms: Diarrhoea, Dry skin, Eczema, Hypoacusis, Nasopharyngitis
Clinical narrative: Information has been received regarding a case in litigation concerning a 1 day old male (birth weight 8lbs 13ox), with a family history of three siblings, two older girls, age eight and nine who have speech problems. The mothers brother also had some speech difficulty which was said to be related to hearing problems. On 5/16/1996, the pt was vaccinated with hepatitis B (dose not reported). Concomitant therapy included MMR vaccine 10/24/1997 and 10/18/2001 (dose not reported). Other concomitant therapy included varicella virus 6/14/1997 DPT 7/19/1996 10/5/1996 12/14/1996, Dtap 10/24/1997 and 10/15/2001, poliovirus live oral OPV/IPV 7/19/1996 10/5/1996 12/14/1996 and 10/15/2001 and Hib Conj vaccine Hib Titer 7/19/1996 10/5/1996 12/14/1996 and 10/24/1997. In 1998 the pt was diagnosed with autism. In 1998-99, the pt was coded as a student with developmental delay. On 3/23/1999 and educational assessment was performed due to concerns with the pts speech and language development. On 5/19/1999, an neurological evaluation was performed results reported were that the pt has a speech and language delay. The pts hearing had been checked and it was normal. There was a history of these developmental problem in other members of the family. On 6/24/1999, Fragile X syndrome test was performed with normal results (25-40 CGG repeat size). On an unspecified date, a psychological assessment was performed, questioned. The pt did not demonstrate an interest in a variety of toys. The had multiple developmental delays and he met the DSM IV criteria for the diagnosis of autistic disorder. On 2/4/02, and educational evaluation was performed results reported were that an IEP was developed with the following services, speech language, cognition and motor. Upon internal review, autism was considered to be an other important medical event (OMIC). Information received on 9/12/06 contained the following adverse experiences, eczema and dry skin rash 11/9/1996, fever and diarrhea 4/21/1997 which was treated Pedialyte, viral URI 5/17/1997 which was treated with pediacare, acetaminophen (Tylenol) and pseudoephedrine hydrochloride (Dimetapp), cold, cough and runny nose 10/28/1997, viral URI 1/2/1998, bilateral conjunctivitis and URI 6/15/1998, and borderline normal hearing to a mild hearing loss 12/17/2001. No further information is available. All available medical records will be provided upon request. Follow-up information received 4-16-08. Vaccine recipient did not recover from the adverse events reported for this vaccination. There are no residual symptoms listed.
Age: 0.09
Sex: M
Vaccine: HEP, DTAP, HIBV, MMR
Symptoms: Pyrexia, Rash, Rhinorrhoea, Speech disorder, Upper respiratory tract infection
Clinical narrative: Information has been received regarding a case in litigation concerning a 1 day old male (birth weight 8lbs 13ox), with a family history of three siblings, two older girls, age eight and nine who have speech problems. The mothers brother also had some speech difficulty which was said to be related to hearing problems. On 5/16/1996, the pt was vaccinated with hepatitis B (dose not reported). Concomitant therapy included MMR vaccine 10/24/1997 and 10/18/2001 (dose not reported). Other concomitant therapy included varicella virus 6/14/1997 DPT 7/19/1996 10/5/1996 12/14/1996, Dtap 10/24/1997 and 10/15/2001, poliovirus live oral OPV/IPV 7/19/1996 10/5/1996 12/14/1996 and 10/15/2001 and Hib Conj vaccine Hib Titer 7/19/1996 10/5/1996 12/14/1996 and 10/24/1997. In 1998 the pt was diagnosed with autism. In 1998-99, the pt was coded as a student with developmental delay. On 3/23/1999 and educational assessment was performed due to concerns with the pts speech and language development. On 5/19/1999, an neurological evaluation was performed results reported were that the pt has a speech and language delay. The pts hearing had been checked and it was normal. There was a history of these developmental problem in other members of the family. On 6/24/1999, Fragile X syndrome test was performed with normal results (25-40 CGG repeat size). On an unspecified date, a psychological assessment was performed, questioned. The pt did not demonstrate an interest in a variety of toys. The had multiple developmental delays and he met the DSM IV criteria for the diagnosis of autistic disorder. On 2/4/02, and educational evaluation was performed results reported were that an IEP was developed with the following services, speech language, cognition and motor. Upon internal review, autism was considered to be an other important medical event (OMIC). Information received on 9/12/06 contained the following adverse experiences, eczema and dry skin rash 11/9/1996, fever and diarrhea 4/21/1997 which was treated Pedialyte, viral URI 5/17/1997 which was treated with pediacare, acetaminophen (Tylenol) and pseudoephedrine hydrochloride (Dimetapp), cold, cough and runny nose 10/28/1997, viral URI 1/2/1998, bilateral conjunctivitis and URI 6/15/1998, and borderline normal hearing to a mild hearing loss 12/17/2001. No further information is available. All available medical records will be provided upon request. Follow-up information received 4-16-08. Vaccine recipient did not recover from the adverse events reported for this vaccination. There are no residual symptoms listed.
Age: 0.09
Sex: M
Vaccine: HEP, DTAP, HIBV, MMR
Symptoms: Neurodevelopmental disorder, Speech disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a 1 day old male (birth weight 8lbs 13ox), with a family history of three siblings, two older girls, age eight and nine who have speech problems. The mothers brother also had some speech difficulty which was said to be related to hearing problems. On 5/16/1996, the pt was vaccinated with hepatitis B (dose not reported). Concomitant therapy included MMR vaccine 10/24/1997 and 10/18/2001 (dose not reported). Other concomitant therapy included varicella virus 6/14/1997 DPT 7/19/1996 10/5/1996 12/14/1996, Dtap 10/24/1997 and 10/15/2001, poliovirus live oral OPV/IPV 7/19/1996 10/5/1996 12/14/1996 and 10/15/2001 and Hib Conj vaccine Hib Titer 7/19/1996 10/5/1996 12/14/1996 and 10/24/1997. In 1998 the pt was diagnosed with autism. In 1998-99, the pt was coded as a student with developmental delay. On 3/23/1999 and educational assessment was performed due to concerns with the pts speech and language development. On 5/19/1999, an neurological evaluation was performed results reported were that the pt has a speech and language delay. The pts hearing had been checked and it was normal. There was a history of these developmental problem in other members of the family. On 6/24/1999, Fragile X syndrome test was performed with normal results (25-40 CGG repeat size). On an unspecified date, a psychological assessment was performed, questioned. The pt did not demonstrate an interest in a variety of toys. The had multiple developmental delays and he met the DSM IV criteria for the diagnosis of autistic disorder. On 2/4/02, and educational evaluation was performed results reported were that an IEP was developed with the following services, speech language, cognition and motor. Upon internal review, autism was considered to be an other important medical event (OMIC). Information received on 9/12/06 contained the following adverse experiences, eczema and dry skin rash 11/9/1996, fever and diarrhea 4/21/1997 which was treated Pedialyte, viral URI 5/17/1997 which was treated with pediacare, acetaminophen (Tylenol) and pseudoephedrine hydrochloride (Dimetapp), cold, cough and runny nose 10/28/1997, viral URI 1/2/1998, bilateral conjunctivitis and URI 6/15/1998, and borderline normal hearing to a mild hearing loss 12/17/2001. No further information is available. All available medical records will be provided upon request. Follow-up information received 4-16-08. Vaccine recipient did not recover from the adverse events reported for this vaccination. There are no residual symptoms listed.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Coma, Crying, Hypotonia, Pallor, Somnolence
Clinical narrative: Episode of extreme crying, went limp, unresponsive and drowsy thru back to baseline 3 minutes in duration. 10/2/06 Received medical records from provider which included hospital records & revealed patient experienced prolonged irritability episode w/o evidence of apnea with a period of screaming then becoming pale, limp & unresponsive.  Taken to ER & monitored overnight.  Exam was WNL & d/c home./ss
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 9/25/06, mother called and said client had a red rash around injection site on left arm, starting on 9/23/06. Has gotten some bigger. Saw MD. Site warm, red area 3" X 2" on left arm at site of DTAP injection. Instructed to watch area. No medication.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Pyrexia
Clinical narrative: Pneumovax given 9/20. Pt c/o 9/21 AM, site discomfort/low-grade temp 9/22. Rx by MD. Cellulitis; Rocephin, IM, Augmentin PO?9/24. Rx by MD, Rocephin IM/continue Augmentin. 9/25 follow-up office visit.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Alopecia, Amnesia, Anxiety, Arthralgia, Asthenia
Clinical narrative: Ache joints and muscle, mood anxiety, dizzy spells, high cholesterol, cold and flu-like symptoms, concentration difficulty, cramp leg, depression, energy loss, hair falling out, pockets of infection in throat, liver failure, memory loss and trouble remembering recent information, pain lower back and knee, shortness of breath, insomnia, vision spotted, voice alteration, weakness. The study performed provides scintigraphic evidence suggesting the presence of mild diffuse parenchymal liver disease.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Back pain, Blood cholesterol increased, Depression, Disturbance in attention, Dizziness
Clinical narrative: Ache joints and muscle, mood anxiety, dizzy spells, high cholesterol, cold and flu-like symptoms, concentration difficulty, cramp leg, depression, energy loss, hair falling out, pockets of infection in throat, liver failure, memory loss and trouble remembering recent information, pain lower back and knee, shortness of breath, insomnia, vision spotted, voice alteration, weakness. The study performed provides scintigraphic evidence suggesting the presence of mild diffuse parenchymal liver disease.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Dysphonia, Dyspnoea, Hepatic failure, Influenza like illness, Insomnia
Clinical narrative: Ache joints and muscle, mood anxiety, dizzy spells, high cholesterol, cold and flu-like symptoms, concentration difficulty, cramp leg, depression, energy loss, hair falling out, pockets of infection in throat, liver failure, memory loss and trouble remembering recent information, pain lower back and knee, shortness of breath, insomnia, vision spotted, voice alteration, weakness. The study performed provides scintigraphic evidence suggesting the presence of mild diffuse parenchymal liver disease.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Laryngitis, Liver disorder, Mood swings, Muscle spasms, Myalgia
Clinical narrative: Ache joints and muscle, mood anxiety, dizzy spells, high cholesterol, cold and flu-like symptoms, concentration difficulty, cramp leg, depression, energy loss, hair falling out, pockets of infection in throat, liver failure, memory loss and trouble remembering recent information, pain lower back and knee, shortness of breath, insomnia, vision spotted, voice alteration, weakness. The study performed provides scintigraphic evidence suggesting the presence of mild diffuse parenchymal liver disease.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Visual acuity reduced
Clinical narrative: Ache joints and muscle, mood anxiety, dizzy spells, high cholesterol, cold and flu-like symptoms, concentration difficulty, cramp leg, depression, energy loss, hair falling out, pockets of infection in throat, liver failure, memory loss and trouble remembering recent information, pain lower back and knee, shortness of breath, insomnia, vision spotted, voice alteration, weakness. The study performed provides scintigraphic evidence suggesting the presence of mild diffuse parenchymal liver disease.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Localized Rx to IPV. No signs of infection. Localized warm, firm swelling at site recent IPV.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 7cm X 8cm area red induration left deltoid.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Unevaluable event
Clinical narrative: Complications from Anthrax vaccine (unevaluable reaction). Subject, age 24, reportedly died 9/2/06 from complications resulting from an Anthrax vaccine he received while serving in military.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Anxiety, Arthralgia, Cardiac failure, Completed suicide, Convulsion
Clinical narrative: Complications from Anthrax vaccine (unevaluable reaction). Subject, age 24, reportedly died 9/2/06 from complications resulting from an Anthrax vaccine he received while serving in military.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Depression, Hypoaesthesia, Neurological symptom, Tunnel vision, Visual disturbance
Clinical narrative: Complications from Anthrax vaccine (unevaluable reaction). Subject, age 24, reportedly died 9/2/06 from complications resulting from an Anthrax vaccine he received while serving in military.
Sex: M
Vaccine: DTPHIB, HEP
Symptoms: Autism, Drug toxicity, Mental retardation severity unspecified, Nervous system disorder, Speech disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine Engerix B and or unidentified hep B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced serious and permanent neurological injuries which were attributed to toxic mercury exposure. The following information was received via medical records, history of this pregnancy was notable for maternal fall in the bathtub during during the 1st trimester. The mother of the subject had received prenatal care. The subject was born at 391/7 weeks of gestation via elective C section. One and five minute Apgar scores were 8 and 8. The subject weighed 3.6 kg at birth. The subjects medical history included bilateral otitis media, bottle feeding, brainstem auditory evoked response abnormal, chronic cough, congenital abnormality of diaphragm, eczema, excessive weight gain, motor vehicle accident, overweight, pre auricular sinus congenital, rhinorrhea and serious effusion of ear. On the date of birth, 1/1/1995 the subject received the 1st dose of hepatitis B vaccine (unknown manufacturer). On 9/9/1996, the subject received the 4th dose of Tetramune, 1st dose of MMR II and Varivax. On 1/29/2006, the subject received the 3rd dose of hepatitis B (Recombivax). And the third dose of IPV. On 1/7/1997 at approx 19 months of age, approx 19 months after the 1st dose of hepatitis B vaccine (unk manufacturer) and 12 months after the 3rd dose of Recombivax, the subject was in a motor vehicle accident and was seen in an ER. AT the time of the accident, the subject was noted to have a developmental delay, and language delay. The subject was evaluated and was diagnosed with autism. At the time of the initial reporting, 9/26/06, the outcome of the events was not reported. Autism was assessed as medically serious by manufacturer (OMIC).
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Back pain, Difficulty in walking, Eye swelling, Headache
Clinical narrative: A 17 year old female with intermittent chest pain and a history of allergies had received her first left deltoid dose of Menactra, lot number U2154CA, on 9/12/06. That evening, the pt experienced increased temp (temp not reported), body sweats and injection site soreness. The next day, the pt continued with increased temp and was experiencing neck ache, back ache, puffy eyes, and continued body sweats. The next day, her temp was 10130 deg F for which she took Tylenol, and her eyes were still puffy. The following day, the pt was evaluated by her physician and she reported symptoms of muscle spasm, headache, and continued elevated temp (temp not reported), puffy eyes, neck ache, back ache and body sweats. The physicians office complaining of same symptoms, and the physician referred her to the ER. On arrival to the ER the pt complained of additional symptoms of photosensitivity, and she was admitted for further evaluation. A spinal tap was performed ans was positive for some type of infection, however the viral and bacterial cultures were neg. All other lab work was normal. Treatment received was not reported, and the pt was discharged on 9/19/2006, three days after admission. The pt was seen in the physicians office the day after she was discharged from the hospital on 9/19/2006, complaining of low grade fever, headache, upper and lower back pain, pain from the top of her legs to her feet, and difficulty walking due to her pain and symptoms of weakness. New lab work was ordered, but the results were pending at the time of this report. The pt was to have a neurological consult. At the time of this report, the pt had not recovered from these adverse events.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Hyperhidrosis, Infection, Injection site pain, Muscle spasms, Neck pain
Clinical narrative: A 17 year old female with intermittent chest pain and a history of allergies had received her first left deltoid dose of Menactra, lot number U2154CA, on 9/12/06. That evening, the pt experienced increased temp (temp not reported), body sweats and injection site soreness. The next day, the pt continued with increased temp and was experiencing neck ache, back ache, puffy eyes, and continued body sweats. The next day, her temp was 10130 deg F for which she took Tylenol, and her eyes were still puffy. The following day, the pt was evaluated by her physician and she reported symptoms of muscle spasm, headache, and continued elevated temp (temp not reported), puffy eyes, neck ache, back ache and body sweats. The physicians office complaining of same symptoms, and the physician referred her to the ER. On arrival to the ER the pt complained of additional symptoms of photosensitivity, and she was admitted for further evaluation. A spinal tap was performed ans was positive for some type of infection, however the viral and bacterial cultures were neg. All other lab work was normal. Treatment received was not reported, and the pt was discharged on 9/19/2006, three days after admission. The pt was seen in the physicians office the day after she was discharged from the hospital on 9/19/2006, complaining of low grade fever, headache, upper and lower back pain, pain from the top of her legs to her feet, and difficulty walking due to her pain and symptoms of weakness. New lab work was ordered, but the results were pending at the time of this report. The pt was to have a neurological consult. At the time of this report, the pt had not recovered from these adverse events.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Pain, Photosensitivity reaction, Pyrexia
Clinical narrative: A 17 year old female with intermittent chest pain and a history of allergies had received her first left deltoid dose of Menactra, lot number U2154CA, on 9/12/06. That evening, the pt experienced increased temp (temp not reported), body sweats and injection site soreness. The next day, the pt continued with increased temp and was experiencing neck ache, back ache, puffy eyes, and continued body sweats. The next day, her temp was 10130 deg F for which she took Tylenol, and her eyes were still puffy. The following day, the pt was evaluated by her physician and she reported symptoms of muscle spasm, headache, and continued elevated temp (temp not reported), puffy eyes, neck ache, back ache and body sweats. The physicians office complaining of same symptoms, and the physician referred her to the ER. On arrival to the ER the pt complained of additional symptoms of photosensitivity, and she was admitted for further evaluation. A spinal tap was performed ans was positive for some type of infection, however the viral and bacterial cultures were neg. All other lab work was normal. Treatment received was not reported, and the pt was discharged on 9/19/2006, three days after admission. The pt was seen in the physicians office the day after she was discharged from the hospital on 9/19/2006, complaining of low grade fever, headache, upper and lower back pain, pain from the top of her legs to her feet, and difficulty walking due to her pain and symptoms of weakness. New lab work was ordered, but the results were pending at the time of this report. The pt was to have a neurological consult. At the time of this report, the pt had not recovered from these adverse events.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Back pain, Eye swelling, Headache, Hyperhidrosis, Laboratory test abnormal
Clinical narrative: A 17 year old female with intermittent chest pain and a history of allergies had received her first left deltoid dose of Menactra, lot number U2154CA, on 9/12/06. That evening, the pt experienced increased temp (temp not reported), body sweats and injection site soreness. The next day, the pt continued with increased temp and was experiencing neck ache, back ache, puffy eyes, and continued body sweats. The next day, her temp was 10130 deg F for which she took Tylenol, and her eyes were still puffy. The following day, the pt was evaluated by her physician and she reported symptoms of muscle spasm, headache, and continued elevated temp (temp not reported), puffy eyes, neck ache, back ache and body sweats. The physicians office complaining of same symptoms, and the physician referred her to the ER. On arrival to the ER the pt complained of additional symptoms of photosensitivity, and she was admitted for further evaluation. A spinal tap was performed ans was positive for some type of infection, however the viral and bacterial cultures were neg. All other lab work was normal. Treatment received was not reported, and the pt was discharged on 9/19/2006, three days after admission. The pt was seen in the physicians office the day after she was discharged from the hospital on 9/19/2006, complaining of low grade fever, headache, upper and lower back pain, pain from the top of her legs to her feet, and difficulty walking due to her pain and symptoms of weakness. New lab work was ordered, but the results were pending at the time of this report. The pt was to have a neurological consult. At the time of this report, the pt had not recovered from these adverse events.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Meningitis, Muscle twitching, Neck pain, Pain, Pyrexia
Clinical narrative: A 17 year old female with intermittent chest pain and a history of allergies had received her first left deltoid dose of Menactra, lot number U2154CA, on 9/12/06. That evening, the pt experienced increased temp (temp not reported), body sweats and injection site soreness. The next day, the pt continued with increased temp and was experiencing neck ache, back ache, puffy eyes, and continued body sweats. The next day, her temp was 10130 deg F for which she took Tylenol, and her eyes were still puffy. The following day, the pt was evaluated by her physician and she reported symptoms of muscle spasm, headache, and continued elevated temp (temp not reported), puffy eyes, neck ache, back ache and body sweats. The physicians office complaining of same symptoms, and the physician referred her to the ER. On arrival to the ER the pt complained of additional symptoms of photosensitivity, and she was admitted for further evaluation. A spinal tap was performed ans was positive for some type of infection, however the viral and bacterial cultures were neg. All other lab work was normal. Treatment received was not reported, and the pt was discharged on 9/19/2006, three days after admission. The pt was seen in the physicians office the day after she was discharged from the hospital on 9/19/2006, complaining of low grade fever, headache, upper and lower back pain, pain from the top of her legs to her feet, and difficulty walking due to her pain and symptoms of weakness. New lab work was ordered, but the results were pending at the time of this report. The pt was to have a neurological consult. At the time of this report, the pt had not recovered from these adverse events.
Age: 47.0
Sex: M
Vaccine: ANTH, FLUX, HEP, SMALL
Symptoms: Arthralgia, Back pain, Pain, Thinking abnormal
Clinical narrative: Articulation pains; lower back pain, left arm pain, disorder mental, unknown things.  11/16/06 Received medical records from VAMC which reveal patient experienced chronic low back pain, left knee & shoulder pain.  MRI showed discogenic & degenerative changes of facet DJD & right neural foramina narrowing. No radiculopathy.  Left shoulder subacromial bursitis.  Patient received multiple rounds of PT/OT & continues in chronic pain clinic. Other medical history includes neurosis, histrionic, acute stress reaction, organic affective syndrome, gen anxiety, HTN, osteoarthorsis of knee, LS spondylosis, Major depression with psychosis (with at least 2 hospitalizations, last d/c 1/06)), RVT of right leg, dyslipidemia.