chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site oedema, Injection site urticaria
Clinical narrative: Immediately after injection-severe edema erythema to injection site followed by local urticaria. Then was ? Gave Benadryl oral med. Reaction was at DTaP site left thigh.
Age: 5.0
Sex: M
Vaccine: DT, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Swelling, redness.
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Swelling of R thigh starting 26 hrs post injections. Was given 3/4tsp post ER visit on 1/3/03 7:30pm, none before. Swelling decreased but not gone 1/6/03. Rectal temp 101.8 at ER 1/3/03 7:30pm.
Age: 1.3
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Irritability, Pyrexia, Vomiting
Clinical narrative: Vomiting for 12 hrs fever > 104, fussiness.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Pyrexia
Clinical narrative: Mother states pt had a fever last evening of 105.0 rectally. Pt rec'd his #4 DTaP, #3 Comvax 1/8/03 at approx. 1100. Fever today is 103.3 rectally. Mother states she's giving pt Tylenol q 4hrs. Inst. to call PMD for further inst.
Age: 69.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Eye disorder, Fatigue, Heart rate irregular, Pain
Clinical narrative: Sharp pains in hands and feet. A seasonal allergy to a year-round problem-taking four prescriptions at present. Periods of extreme fatigue-erratic heart beat. Skin blotches. Irritation of scalp, face, arms, legs. Recently discovered anerism in left eye. The follow up states it is difficult to pin point the day and hour of the personal changes of my wellbeing. In some instances the changes were subtle and gradual. I would report them to my personal physician as they occurred but to no avail as to medcial explanations. Possibly the "aging process." Still something wasn't right. I will attempt ot lay out a time frame: 1999 Apirl/May started experiencing periods of extreme fatigue. 2-3 occurrences a month to date. 2000-2003 allergy problems occurred other than the normal hayfever season (July-Sept frost) and have continued year-round to date and am taking four prescribed medications for treatment. 2000 Mid-year-2003 skin blothces on upper body-much like hives and go very uncomfrotable scalp irritation. Using prescribed medication to date. 2000-2003 sleep problems-consulted doctor to no avail. Minor joint pain escalated in hands, feet, shoulders-in areas not associated with any broken bones. Doctor recommended over the counter medication recnetly taken off the prescribed list-on going pain. 2002 April an anerism was discovered in my left eye. Connon in diabetics but I'm not diabetic. Under observation by th clinic again no medical explanation. My life-style has not changed in 20-30 years same home, same type of job, same wife. I work full time, no palns for retirement unless health fails. I have sought medical explanations without results. It wasn't until I read about the LYMErix vaccine being taken off the market and possible side effects did some possible answers appear? Contacting health and related agencies only produced to many similarities in symptoms and coincidences. My intent for taking the vaccine was for preventative medicine purposes, not possible health problems.
Age: 69.0
Sex: M
Vaccine: LYME
Symptoms: Rash macular, Skin irritation, Urticaria
Clinical narrative: Sharp pains in hands and feet. A seasonal allergy to a year-round problem-taking four prescriptions at present. Periods of extreme fatigue-erratic heart beat. Skin blotches. Irritation of scalp, face, arms, legs. Recently discovered anerism in left eye. The follow up states it is difficult to pin point the day and hour of the personal changes of my wellbeing. In some instances the changes were subtle and gradual. I would report them to my personal physician as they occurred but to no avail as to medcial explanations. Possibly the "aging process." Still something wasn't right. I will attempt ot lay out a time frame: 1999 Apirl/May started experiencing periods of extreme fatigue. 2-3 occurrences a month to date. 2000-2003 allergy problems occurred other than the normal hayfever season (July-Sept frost) and have continued year-round to date and am taking four prescribed medications for treatment. 2000 Mid-year-2003 skin blothces on upper body-much like hives and go very uncomfrotable scalp irritation. Using prescribed medication to date. 2000-2003 sleep problems-consulted doctor to no avail. Minor joint pain escalated in hands, feet, shoulders-in areas not associated with any broken bones. Doctor recommended over the counter medication recnetly taken off the prescribed list-on going pain. 2002 April an anerism was discovered in my left eye. Connon in diabetics but I'm not diabetic. Under observation by th clinic again no medical explanation. My life-style has not changed in 20-30 years same home, same type of job, same wife. I work full time, no palns for retirement unless health fails. I have sought medical explanations without results. It wasn't until I read about the LYMErix vaccine being taken off the market and possible side effects did some possible answers appear? Contacting health and related agencies only produced to many similarities in symptoms and coincidences. My intent for taking the vaccine was for preventative medicine purposes, not possible health problems.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: Seen 2 days after immunization. Had approximately 14x14cm area of tender, warm, erythema on left lateral arm, with 2-3cm diameter area of small blisters at the injection site.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: + erythema, induration, warmth at all three injection sites. DTAP/HIB left leg 7cm oval shape. Prevnar right leg 5cm round
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Left upper arm swelling from injection site to just above elbow, warm to touch and red. Patient complaining of pain and itching.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion
Clinical narrative: 6 month old with history of seizure 12/17/02, about 13 hours after receiving PPV
Age: 1.6
Sex: F
Vaccine: HEP, HIBV, IPV, VARCEL
Symptoms: Urticaria
Clinical narrative: Varicella was given in right leg. White bumps had appeared with red surrounding them. Within seconds of giving shot. Gave Benadryl.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Infection
Clinical narrative: Broke out in chicken pox.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Agitation, Arthralgia, Diarrhoea, Myalgia, Rash
Clinical narrative: Arthralgias, pruritic lesions x3, scalp, finger, temporal region left side, Tylenol for discomfort. Other symptoms, crying, achy, diarrhea, no temperature.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Febrile convulsion
Clinical narrative: Was nursing child in bed about 3-4am. Child noted to be "shaking" and was not arousable. Was febrile at the time. Seizure lasted about a minute. Seen at ER. Exam ok. Has family history of seizure in in brother and sister. Has had 2-3 seizures since the first episode.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Injection site mass
Clinical narrative: Right thigh 1" red swollen lump. Treated with ice pack and Tylenol.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Urticaria
Clinical narrative: Approximately 4.5 hrs, post vaccination employee broke out into a rash,described 'fine little hives'. She was treated in the ER (where she works ) with Benadryl. Rash resolved within 48 hours. Employee did not alert employee health nurse of possibly  having tonsillitis prior to vaccination.
Age: 1.3
Sex: M
Vaccine: HIBV
Symptoms: Decreased appetite, Eczema, Irritability, Rash, Urticaria
Clinical narrative: Broke out with rash in late evening after receiving Act-Hib #4 vaccine on the same day, Seen in the health clinic for well child check-up. Rash continued to spread & seen on 01/07/03 for evaluation; Other symptoms including decreased appetite; Crankiness, but no fever or trouble breathing; Dx: urticaria second degree.
Age: 0.8
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Torso covered with hives
Age: 1.0
Sex: M
Vaccine: HIBV, PNC, VARCEL
Symptoms: Abnormal behaviour, Dermatitis bullous, Nasal congestion, Pyrexia
Clinical narrative: Received shot on 12/05; On 12/09/02, had nasal congestion, thick green drainage from nose; No fever (Mother reports she had an URI also) slight cough, On 12/13 had fever of 102, Mom treated with tepid bath. On Morning of 12/04 had temp of 101; Mother again gave tepid bath ; No other fever noted. Yesterday morning was acting clingy, wanted to be held; No fever; Mother noted child had broke out with chicken pox all over his body, Head to toe; Some places appear to still be "under the skin" other places look like chicken pox.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: Pt called health department 05/27/02 to report a reaction to Td received on 12/23/02.  (See attached faxed report); 1/07/03; Pt reported that adverse reaction was completely gone in 1 week of receiving the vaccine.
Age: 11.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Dermatitis bullous, Skin ulcer
Clinical narrative: Varivax vaccine given on 12/12/02, mom came to clinic today with child starting with rash on 12/030/02; Approx 57 active chicken pox lesions on body.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Per  @ ER: 14 X 18 cm Erythema to left deltoid from NT; local reaction to MMR
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: (The child) received a varivax vaccine 08/13/01,she had a break through case 2 weeks ago that mom counted over 200 pox. Other siblings that were vaccinated at the same time also had break through cases, but with just a few pox.  Follow up on 01/22/2003: "Information received is correct."
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Headache, Hypoaesthesia, Malaise
Clinical narrative: States he had gone to college & upon leaving building experience sudden dizziness & H/A& malaise, lips numb for short time; happened 45 minutes to 1 hr after receiving MMR, dizziness last for 5 hour (7 pm); Frontal headache continued past 10:30 8-10 hr when he went to sleep; Next day feels ok.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Rash, Urticaria
Clinical narrative: 01/03/03 at 4:15 pm, developed hives all over arms and neck. Took two of Benadryl. Hives/Rash was gone by 01/04/04 in am.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Pt was seen 1/11/03 at ER and had cellulitis on left thigh. Rx'd with Augmentin. Rechecked in office on 1/13/03 and had improved.
Age: 27.0
Sex: U
Vaccine: MMR, TTOX
Symptoms: Fatigue, Headache, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Within 24 hours of injection, developed a fever, headache, right arm swelling, nausea, vomiting and fatigue. Prescribed Tylenol.
Age: 27.0
Sex: U
Vaccine: MMR, TTOX
Symptoms: Vomiting
Clinical narrative: Within 24 hours of injection, developed a fever, headache, right arm swelling, nausea, vomiting and fatigue. Prescribed Tylenol.
Age: 44.0
Sex: F
Vaccine: TTOX
Symptoms: Flushing, Headache, Hypokinesia, Injection site erythema, Injection site swelling
Clinical narrative: Within 30 minutes, post vax of TD, pt felt flushed. Later that evening, she developed a fever of 101F, swelling and erythema at the injection site. Her "arm was useless, couldn't pick it up" per pt. Pt reported feeling pain into the neck, shoulders and head. Ibuprofen did not help. Took Goody body ache powder Saturday night and felt better by Sunday AM.
Age: 44.0
Sex: F
Vaccine: TTOX
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: Within 30 minutes, post vax of TD, pt felt flushed. Later that evening, she developed a fever of 101F, swelling and erythema at the injection site. Her "arm was useless, couldn't pick it up" per pt. Pt reported feeling pain into the neck, shoulders and head. Ibuprofen did not help. Took Goody body ache powder Saturday night and felt better by Sunday AM.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 4cm X 8cm red and warm to touch area on right thigh.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Pt reported pain, bruising and heat in area where MMR immunization was given. Called pt on 12/3/02 (previous attempts to reach pt were unsuccessful) and arm is no longer sore, bruise is gone (reported by pt). Doctor's assessment localized reaction.
Age: 2.0
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Pt given vaccine on 1/10/03. Went to ER on 1/11/03 for swelling in leg. Went to office on 1/13/03. Swelling from knee to thigh in left leg.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Injection site oedema, Pain
Clinical narrative: Pain left arm - site swollen - site red but could be from vaccination application - patient unsure - no elevated temperature.  12/19/2002 - Arm continues to be sore - Continue with IBA Prophen
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site atrophy, Keloid scar
Clinical narrative: Keloid formation following a robust primary reaction to initial vaccinia vaccination on 4/2/02.
Age: 45.0
Sex: M
Vaccine: FLU3, TYP, YF
Symptoms: Erythema, Injection site hypersensitivity, Oedema
Clinical narrative: Red swollen arm at injection site, spreading erythema to distance of 10x10cm
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Patient received DTaP, HIB, IPV and Prevnar on 1/7. No apparent immediate problems but was found dead at home 1/12 AM. Apparent SIDS; autopsy pending.
Age: 56.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Neck pain
Clinical narrative: Received Lymerix vaccine 1999-2000 (3 doses); developed severe neck, back and shoulder pain in Nov. 2000; received various treatments from 8 different doctors including current treatment which is physical therapy, acupuncture and medication. Annual follow up on 01/28/04: "Pt did not recover from adverse events.  Continued pain in joints."
Age: 38.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Anxiety, Epistaxis, Headache, Hearing impaired, Neuroma
Clinical narrative: Severe tinnitus, hearing loss, acoustic neuroma. I will forward medical report upon request. Head pain, anxiety, nosebleeds.  Annual follow up on 01/28/04: "Pt did not recover from adverse events. Very severe tinnitus which has made my life a living hell! I am suffering greatly from the severe tinnitus!
Age: 38.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus, hearing loss, acoustic neuroma. I will forward medical report upon request. Head pain, anxiety, nosebleeds.  Annual follow up on 01/28/04: "Pt did not recover from adverse events. Very severe tinnitus which has made my life a living hell! I am suffering greatly from the severe tinnitus!
Age: 38.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Condition aggravated, Headache, Pain, Tinnitus
Clinical narrative: Severe tinnitus, hearing loss, acoustic neuroma. I will forward medical report upon request. Head pain, anxiety, nosebleeds.  Annual follow up on 01/28/04: "Pt did not recover from adverse events. Very severe tinnitus which has made my life a living hell! I am suffering greatly from the severe tinnitus!
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Cellulitis, Injection site induration, Pyrexia, Rash, White blood cell count increased
Clinical narrative: Received immunizations and got a silver dollar size hard lump - cellulitis in upper left thigh. Reaction started right away. Child was taken to the ER and hospitalized for 3 days. Was put on Cleftin (antibiotic). Nurse follow up on 06/08/04 states: Add: fever, RASH.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Rash
Clinical narrative: Pt experienced rash, itching. Tx'd Atarax, prednisone taper.
Age: 1.3
Sex: F
Vaccine: DT, HBHEPB, PNC
Symptoms: Injection site rash, Rash papular
Clinical narrative: Papular rash on left thigh, confluent near injection site and more sparse on rest of thigh. Few papules on right arm and chin, also. No fever.
Age: 4.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: DTAP given in left deltoid and within 30 minutes, mother returned to clinic and child had redness (slightly raised) and warm area surrounding DTAP injection site extending up to clavicle. No distress. Use ice. Seen by PMD.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Dizziness, Nausea, Tongue black hairy
Clinical narrative: Pt received Hep-B #1 and PPD on 1/8/03. Pt awoke at 02:00 the following AM c/o abdominal cramping, nausea and dizziness. Pt self medicated with tablet Pepto-Bismol with turned her tongue black. Returned to clinic on 1/9/03 for evaluation. Pt denies any complaints of nausea or cramping on 1/10/03 and dizziness improved.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Arm/shoulder area to elbow is red, swollen, hot, underarm hurts/shoulder blade area on back. Arm actually hurt from the very beginning of shot. No treatment. Lasted 4 days.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Right thigh with erythema and a hardened area approx. 7cm X 3cm. No fever. Child jumping, running and playing. Advised warm compresses, warm bath and Tylenol or Motrin.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Back pain
Clinical narrative: Thoracic (posterior) rib pain.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Injection site swelling
Clinical narrative: Developed 2 round, raised, reddish lesions 1/4cm X 1/4cm and 1/2cm X 1/2cm around injection site. Left cheek redness noted as well. Recovered with Atarax in office.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Malaise, Nasal congestion, Pyrexia, Rash vesicular
Clinical narrative: Vesicular rash, chills and fever, mild congested discharge and malaise.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Vaccine/pill Typhoid would not stay down or dissolve. Came up 24 hours-12 hours later. Worthless.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Myalgia
Clinical narrative: Pt received Smallpox vaccination on Friday, 1/10/03. On Saturday, she first noticed myalgias without fever. This has continued through today, although severity has decreased. She was sent home from work Monday and Tuesday, 1/13/03 and 1/14/03.
Age: 38.0
Sex: M
Vaccine: ANTH, ANTH, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt presented with edema, tenderness to right upper arm, significant swelling noted with area of erythema around injection site. Motor/neuro muscular function normal in extremity. Treated with st?? dose pack, Benadryl and heat with resolution in 72 hours.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Soldier developed fever and chills about 8 hours after receiving 1st Anthrax vaccination. Temperature to 103.1F at home. Did not seek medical aid until 2 days after fever resolved. Developed nausea, vomiting and diarrhea.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Pain
Clinical narrative: Soldier developed right shoulder pain, 1 day after receiving Anthrax vaccine in left tricep. Notably his symptoms began after completing a 6 mile foot march with a 70 lb back sack.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Agitation, Diarrhoea, Rash
Clinical narrative: Diarrhea, rash, inconsolable crying, 10 days after MMR. Note: Had 2 pt with similar symptoms, same lot#. Treatment: Supportive care.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Anorexia, Diarrhoea, Hypothermia, Nausea, Rash
Clinical narrative: Nausea, vomiting, diarrhea, temperature of 97.7F, anorexia and rash. This is the 2nd pt with these symptoms in this lot of MMR II.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, temperature of 97.7F, anorexia and rash. This is the 2nd pt with these symptoms in this lot of MMR II.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pyrexia, Staring
Clinical narrative: Staring spell, lasting 1 hours. ER evaluation done. Temperature 102F.
Age: 5.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Infection, Skin ulcer
Clinical narrative: Patient recieved varicella vaccine on 11/14/2002.  Recieved call from mother of patient stating that beginning on 01/15/2003, patient began to break out with chicken pox.  At 10:30 am, 1/16/2003, patient had over 100 varicella lesions over trunk and legs
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion
Clinical narrative: oN 1-8-03 infant received DTAP, Comvax, IPV & Prevnar w/o incident.  Instructed on s/e & use of tylenol.  On 1-9-03 infant believed to have had a seizure and was taken to hospital by ambulance to have a CAT Scan and be seen by neurologist.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Depressed level of consciousness, Eye swelling, Ocular hyperaemia, Pruritus
Clinical narrative: Report 2001014331-1 describes anaphylactic reaction in an 11 year old female who received hepatitis B vaccine recombinant for prophylaxis of hepatitis B. This report was received from the vaccinee's mother and has been verified by the pediatrician. The vaccinee's mother submitted this report directly to the CDC. The vaccinee had seasonal and animal allergies, chronic allergic rhinitis, eczema, and sensitivity to nickel. She had no history of asthma. Her concomitant medications included loratadine 10 mg daily and mometasone furoate one spray into each nostril once daily. She took diphenhydramine as needed. On 1/3/00, the vaccinee received her first injection of Engerix-B. Her mother reported that, two to three hours post vaccination, the child developed hives with itching all over face and neck. The pediatrician stated that the mother notified the health department physician who administered the vaccine that the child had developed a rash; the child was not examined by that physician. At some later date, the child was taken to a local emergency room. It was uncertain whether the child had developed urticaria or impetigo. The mother reported that the child was treated with an itch cream which helped a little. The hives resolved after approximately 3 weeks. The vaccinee was seen by an allergist, who instructed her to take loratadine and diphenhydramine hydrochloride prior to administration of the second injection of Engerix B. On 6/11/01, the vaccinee received her second injection of Engerix B at her pediatrician's office. Per the mother, within hours the patient's eyelids turned blood red and were swollen shut. The patient fell asleep and was not easily aroused. The mother thought that the drowsiness was related to diphen hydramine hydrochloride administration. The allergist was called; the patient was taken to his office, where she was treated with epinephrine on 6/11/01. The patient's mother reported that her daughter had experienced an anaphylactic reaction which resolved following treatment with an Epi-pen. On 7/18/01, the pediatrician reported that the child had developed swollen eyes, chest tightness, and hives on 6/11/01, after immunization. The child was taken to the allergist's office. The allergist administered epinephrine and guaifenesin. The events resolved on 6/12/01. The pediatrician considered the swollen eyes, chest tightness, and hives to be of moderate intensity. She considered these events to be possibly related to either Engerix-B administration, the child's history of atopy (allergic rhinitis/eczema), or to possible cross-reactivity between thimerosal and the child's history of nickel sensitivity. The pediatrician reported that the child will not receive the third injection of Engerix-B. The reported events are considered medically serious due to the intervention required.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Somnolence, Urticaria
Clinical narrative: Report 2001014331-1 describes anaphylactic reaction in an 11 year old female who received hepatitis B vaccine recombinant for prophylaxis of hepatitis B. This report was received from the vaccinee's mother and has been verified by the pediatrician. The vaccinee's mother submitted this report directly to the CDC. The vaccinee had seasonal and animal allergies, chronic allergic rhinitis, eczema, and sensitivity to nickel. She had no history of asthma. Her concomitant medications included loratadine 10 mg daily and mometasone furoate one spray into each nostril once daily. She took diphenhydramine as needed. On 1/3/00, the vaccinee received her first injection of Engerix-B. Her mother reported that, two to three hours post vaccination, the child developed hives with itching all over face and neck. The pediatrician stated that the mother notified the health department physician who administered the vaccine that the child had developed a rash; the child was not examined by that physician. At some later date, the child was taken to a local emergency room. It was uncertain whether the child had developed urticaria or impetigo. The mother reported that the child was treated with an itch cream which helped a little. The hives resolved after approximately 3 weeks. The vaccinee was seen by an allergist, who instructed her to take loratadine and diphenhydramine hydrochloride prior to administration of the second injection of Engerix B. On 6/11/01, the vaccinee received her second injection of Engerix B at her pediatrician's office. Per the mother, within hours the patient's eyelids turned blood red and were swollen shut. The patient fell asleep and was not easily aroused. The mother thought that the drowsiness was related to diphen hydramine hydrochloride administration. The allergist was called; the patient was taken to his office, where she was treated with epinephrine on 6/11/01. The patient's mother reported that her daughter had experienced an anaphylactic reaction which resolved following treatment with an Epi-pen. On 7/18/01, the pediatrician reported that the child had developed swollen eyes, chest tightness, and hives on 6/11/01, after immunization. The child was taken to the allergist's office. The allergist administered epinephrine and guaifenesin. The events resolved on 6/12/01. The pediatrician considered the swollen eyes, chest tightness, and hives to be of moderate intensity. She considered these events to be possibly related to either Engerix-B administration, the child's history of atopy (allergic rhinitis/eczema), or to possible cross-reactivity between thimerosal and the child's history of nickel sensitivity. The pediatrician reported that the child will not receive the third injection of Engerix-B. The reported events are considered medically serious due to the intervention required.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP
Symptoms: Crying, Cyanosis, Loss of consciousness, Rash
Clinical narrative: Report 2001028863-2 describes a 4 month old male who turned blue after receiving an injection of hepatitis B vaccine recombinant. Medical history was not specified. There were no concurrent conditions and no concurrent medications. He had no adverse experiences following receipt of prior immunizations. On 11/15/01, the vaccinee received his second injections of Engerix-B and diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Within five minutes post-immunization, the infant began crying, turned blue, experienced a decrease in oxygen saturation to 96%, appeared to either fall asleep or pass out, and developed a rash on the face and body. The infant was observed in the physician's office for two hours. The rash lasted 1.5 hours. The other events had also resolved, and the infant was sent home. The reporting physician considered the events to be possibly related to Infanrix and Engerix-B administration. The vaccinee received another injection of Infanrix on 2/5/02 and he did not experience an adverse event.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Crying, Irritability, Loss of consciousness, Pyrexia, Urticaria
Clinical narrative: Report 2001028435-2 describes a 2 month old male who turned blue after receiving an injection of hepatitis B vaccine recombinant. Medical history was not specified. Concurrent conditions included an upper respiratory infection. There were no concurrent medications. On 11/15/01, the vaccinee received injections of Engerix B, diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed, Haemophilus influenzae type B conjugate vaccine, and inactivated poliomyelitis virus vaccine. Within five minutes post-immunization, the infant began crying, turned blue, appeared to either fall asleep or pass out, developed an urticarial rash on the face and body, experienced fussiness and had a low grade fever. The infant was observed in the physician's office for two hours. The rash lasted 1.5 hours. The other events had also resolved and the infant was sent home. The reporting physician considered the events to be possibly related to Infanrix and Engerix B administration.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis
Clinical narrative: The vaccinee had no adverse experiences following receipt of prior immunizations. On 3/13/02, the vaccinee received her 2nd injection of Engerix-B. "A few hours", post immunization, she experienced sweating. The vaccine provider was consulted. Treatment and outcome were not specified.
Age: 82.0
Sex: M
Vaccine: HEP
Symptoms: Cardiac arrest, Liver function test abnormal
Clinical narrative: Hepatitis B surface antigen positive, liver function tests NOS abnormal. Report A0368551A describes Hep B antigenemia and elevated liver enzymes in a 82 y.o. male who received Hep B recombinant vaccine (Engerix-B). This report was filled additionally with VAERS by the vaccine provider. The vaccine was an insulin-dependent diabetic and had renal failure. "Hepatic function was not an issue" from the viewpoint of medical history. There was no history of alcohol or tobacco use. Prior to receiving Engerix-B, the PT had been HBsAg and HBsAb negative. His liver enzymes had been normal. Concurrent medications were not specified. On unspecified dates, the vaccinee received his first and second 40 mcg injections of Engerix-B, respectively. They were both from lot ENG5183A4. Subsequently, "he seroconverted to HBsAg positive and has remained positive since (as of 5/16/02)." His liver enzymes had been normal but were elevated subsequent to receiving Engerix-B. On 2/6/02, the HBsAg was positive On 2/19/02, the anti-HBs EIA was negative, the anti-HBc-EIA was negative, the anti-HBc was negative, the anti-HBc IgM was negative, and the HBsAg-EIA was positive. On 5/7/02, the AST (aspartate transaminase) was 171IU. The reporter stated that the antigenemia and elevated liver enzymes were possibly related to Engerix-B administration. The subject expired on 5/28/02. The cause of death was cardiac arrest. The events persisted until his death. The reporter stated that the fatal cardiac arrest was not related to either Engerix-B administration, antigenemia, or elevated liver function tests.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dry mouth, Nausea, Paraesthesia
Clinical narrative: This report describes dry mouth in a 37 y.o. female who received Hep B vaccine recombinant (Engerix-B). Medical history and concurrent conditions were not provided. Concurrent medications included acetaminophen and a "sleep aid." On 7/12/02, the vaccinee received her second injection of Hep B vaccine recombinant. W/in 2 hrs she experienced dry mouth, nausea, lightheadness, and tingling in fingers. The vaccinee was seen by a physician. Treatment was not specified. The reporting physician considered the event to be probably related to Hep B vaccine recombinant administration. As of 7/12/02, the events were unresolved.
Sex: M
Vaccine: OPV, IPV
Symptoms: Laboratory test abnormal, Lung neoplasm malignant, Pleural mesothelioma
Clinical narrative: Information has been received regarding a case in litigation concerning a male who has sustained bystander exposure to inhaled, used, handles or been otherwise exposed to asbestos and asbestos containing products for a substantial length of time. Sometime in the 1960s the pt was vaccinated with poliovirus vaccine (manuf unk) OPV or IPV. In approximately August 2001, the pt was diagnosed with mesothelioma. The reporter stated the exposure to asbestos, asbestos containing products and the SV-40 virus, caused severe and permanent injury including but not limited to breathing difficulties, asbestosis, lung and or other cancer, mesothelioma and or other lung damage including death. Subsequently the pt died. The cause of death was not specified. The reporter also stated the only source of SV-40 the pt could have been exposed to was SV-40 in the polio vaccine. The mesothelioma, asbestosis, dyspnea, lung cancer and malignant neoplasm were considered to be other important medical events (OMIC).
Sex: M
Vaccine: OPV, IPV
Symptoms: Dyspnoea, Lung neoplasm malignant, Neoplasm malignant, Pleural mesothelioma
Clinical narrative: Information has been received regarding a case in litigation concerning a male who has sustained bystander exposure to inhaled, used, handles or been otherwise exposed to asbestos and asbestos containing products for a substantial length of time. Sometime in the 1960s the pt was vaccinated with poliovirus vaccine (manuf unk) OPV or IPV. In approximately August 2001, the pt was diagnosed with mesothelioma. The reporter stated the exposure to asbestos, asbestos containing products and the SV-40 virus, caused severe and permanent injury including but not limited to breathing difficulties, asbestosis, lung and or other cancer, mesothelioma and or other lung damage including death. Subsequently the pt died. The cause of death was not specified. The reporter also stated the only source of SV-40 the pt could have been exposed to was SV-40 in the polio vaccine. The mesothelioma, asbestosis, dyspnea, lung cancer and malignant neoplasm were considered to be other important medical events (OMIC).
Age: 38.0
Sex: M
Vaccine: ANTH, ANTH, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt presented with edema, tenderness to right upper arm and significant swelling noted in an area of erythema around injection site. Motor/neuro/vascular function normal in extremity. Treated with steroid dose pack, Benadryl and heat with resolution in 72 hours.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Unevaluable event
Clinical narrative: Got call on 1/10/03 from ER. Succumbed to SIDS.
Sex: F
Vaccine: IPV, OPV
Symptoms: Dyspnoea, Lung neoplasm malignant, Neoplasm malignant
Clinical narrative: Information has been received regarding a case in litigation concerning a female who has sustained bystander exposure to inhaled, used, handles or been otherwise exposed to asbestos and asbestos containing products for a substantial length of time. Sometime in the 1950s the pt was vaccinated with poliovirus vaccine (manuf unk) OPV or IPV. In approximately July 2001, the pt was diagnosed with mesothelioma. The reporter stated the exposure to asbestos, asbestos containing products and the SV-40 virus, caused severe and permanent injury including but not limited to breathing difficulties, asbestosis, lung and or other cancer, mesothelioma and or other lung damage including death. Subsequently the pt died. The cause of death was not specified. The reporter also stated the only source of SV-40 the pt could have been exposed to was SV-40 in the polio vaccine. The mesothelioma, asbestosis, dyspnea, lung cancer, lung injury and malignant neoplasm were considered to be other important medical events (OMIC).
Sex: F
Vaccine: IPV, OPV
Symptoms: Dyspnoea, Lung disorder, Neoplasm malignant
Clinical narrative: Information has been received regarding a case in litigation concerning a female who has sustained bystander exposure to inhaled, used, handles or been otherwise exposed to asbestos and asbestos containing products for a substantial length of time. Sometime in the 1950s the pt was vaccinated with poliovirus vaccine (manuf unk) OPV or IPV. In approximately July 2001, the pt was diagnosed with mesothelioma. The reporter stated the exposure to asbestos, asbestos containing products and the SV-40 virus, caused severe and permanent injury including but not limited to breathing difficulties, asbestosis, lung and or other cancer, mesothelioma and or other lung damage including death. Subsequently the pt died. The cause of death was not specified. The reporter also stated the only source of SV-40 the pt could have been exposed to was SV-40 in the polio vaccine. The mesothelioma, asbestosis, dyspnea, lung cancer, lung injury and malignant neoplasm were considered to be other important medical events (OMIC).
Sex: M
Vaccine: HEP
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during the period from March 1995 through June 1996. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Follow up info was received that included the pt's immunization info as follows: hep B vaccine recombinant (manuf unk) on 3/3/95 (lot # not reported), 4/19/95 (lot # not reported; and 11/29/95 (in left thigh) (lot # 1651b2); concomitant therapy included diphtheria toxoid+pertussis vaccine+tetanus toxoid (manuf unk-lot # not reported) on 4/19/95, 6/28/95, 8/23/95 and 6/26/96; poliovirus vaccine inactivated (manuf unk-lot # not reported) on 4/19/95, 6/28/95, 8/23/95; haemophilus influenzae type B (manuf unk-lot # not reported) on 4/19/95, 6/28/95, 8/26/95 and 6/26/95 (lot 5H61050) and MMR II on 2/28/96 (lot 614459/0873B). Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical event (OMIC). No further info is available.
Sex: M
Vaccine: DTP, HEP, IPV
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her son who was vaccinated with various childhood vaccines including DPT, polio, and hepatitis B vaccine (manufacturer unknown) also reported as hepatitis. The reporter stated the vaccines contained thimerosal. Subsequently the child developed autism. The patient sought unspecified medical attention. The mother believes the vaccines containing thimerosal caused the autism. Upon internal review the autism was considered to be other important medical event (OMIC). Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Speech disorder, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 15 month old male child with no allergies or medical history who in April 1999, was vaccinated with a dose of MMR II (lot 628011/1545H). There were no concomitant medications. It was reported that within hours of receiving the vaccination in April 1999, the pt developed a high fever and hives. It was also noted that "prior to receiving the vaccination he had 25 words but since the day after receiving MMR II he has only a few words." Unspecified medical attention was sought. The mother was concerned that the vaccine may have contained thimerosal. Upon internal review, prior to vaccination he had 25 words but since day after receiving vaccine he has only a few words, was determined to be an other important medical event (OMIC). Additional info has been requested. Reported on 02/27/2003: "Follow up information from a nurse indicated that the patient had left the responsible physician practice in 07/1999, and his last office visit at that practice was on 06/23/1999.  Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Hyperhidrosis, Productive cough
Clinical narrative: A report was received from a regulatory authority on 1/6/03, indicating that a female vaccinee was hospitalized for a productive cough, increased SOB and sweating, after receiving Fluvirin on 10/31/2002. After vaccination (time of onset not provided) the vaccinee experienced a productive cough with clear sputum, increased SOB and sweating and was hospitalized (date not provided). The vaccinee recovered after 3 days on 11/3/02. There was insufficient information to determine the reporter's causality assessment.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye disorder, Headache, Hyperhidrosis, Nausea
Clinical narrative: Mild headache 10/17/02 until 11/18/02 when had onset very severe headache unresponsive to multiple meds. Progressed to Rt 3rd cranial nerve palsy which persists. 10/16/02-had flu shot. 10/17/02-bad headaches on Rt side of head only (started on Rt side 10/17/02. 11/21/02 with unreal severe headache). 11/18/02-middle of night, woke up to a severe headache on Rt side and faint feeling. 11/21/02-middle of night, woke up to the unreal severe headache. Had to go get medicine. Fainting, nausea, hot/cold sweats, pain was unbearable. 11/25/02-saw MD-got two temple injections-did not help pain. 11/27/02-got 1 shot immetrex in leg and prescriptions filled. 11/28/02-Thanksgiving day-eye started closing. 12/2-5/02-in hospital and eye closing more. By 12/5/02-eye closed. 12/10/02-appt with MD. 12/11/02-muscles around eye seems to be loosening up, causing less headaches and can seem to move eye today. 60 day follow up states pt has not recovered. Has CNS vascular with severe headaches and total ? 3rd C N palsy which has improved with large doses of steroids. Headaches started day after injection. (unknown) any realtionship
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paralysis
Clinical narrative: Mild headache 10/17/02 until 11/18/02 when had onset very severe headache unresponsive to multiple meds. Progressed to Rt 3rd cranial nerve palsy which persists. 10/16/02-had flu shot. 10/17/02-bad headaches on Rt side of head only (started on Rt side 10/17/02. 11/21/02 with unreal severe headache). 11/18/02-middle of night, woke up to a severe headache on Rt side and faint feeling. 11/21/02-middle of night, woke up to the unreal severe headache. Had to go get medicine. Fainting, nausea, hot/cold sweats, pain was unbearable. 11/25/02-saw MD-got two temple injections-did not help pain. 11/27/02-got 1 shot immetrex in leg and prescriptions filled. 11/28/02-Thanksgiving day-eye started closing. 12/2-5/02-in hospital and eye closing more. By 12/5/02-eye closed. 12/10/02-appt with MD. 12/11/02-muscles around eye seems to be loosening up, causing less headaches and can seem to move eye today. 60 day follow up states pt has not recovered. Has CNS vascular with severe headaches and total ? 3rd C N palsy which has improved with large doses of steroids. Headaches started day after injection. (unknown) any realtionship
Age: 0.08
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Decreased appetite, Dyskinesia, Irritability, Pallor
Clinical narrative: Jerking and staring spells, pale, fussy, decreased appetite. Vomited twice. On Phenobarbital.
Age: 0.08
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Staring, Vomiting
Clinical narrative: Jerking and staring spells, pale, fussy, decreased appetite. Vomited twice. On Phenobarbital.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Vaccine administered 1/14/03-seen in ER later that evening for fever. WBC 23,000-seen in office 1/15, temp 101.6, sent home. ER again 1/15 WBC 39,000, admitted.
Age: 37.0
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Disturbance in attention, Mood swings, Paralysis
Clinical narrative: After receiving 1st shot, soreness in arm occurred. Doctor stated its normal. 10/6/99 After receiving second shot all appeared ok until 3 to 4 weeks later. I became paralyzed, temperature. Then during the course of the year, other symptoms occurred. Second shot on 11/8/99.The follow up states, "memory loss reported following LYMErix vaccination on 11/8/99-onset within 3-4 wks. He states this is contributing factor to an auto accident he had on 12/6/99." On 60-day follow up report received 4/23/2003, reporter states, "increased joint pain in legs and arms - concentration and focus on projects at hand are extremely short. Level of frustration is increasing. Mood swings are increasing - capability of working in current status is limited - can't perform work as normal".
Age: 37.0
Sex: M
Vaccine: LYME
Symptoms: Pyrexia
Clinical narrative: After receiving 1st shot, soreness in arm occurred. Doctor stated its normal. 10/6/99 After receiving second shot all appeared ok until 3 to 4 weeks later. I became paralyzed, temperature. Then during the course of the year, other symptoms occurred. Second shot on 11/8/99.The follow up states, "memory loss reported following LYMErix vaccination on 11/8/99-onset within 3-4 wks. He states this is contributing factor to an auto accident he had on 12/6/99." On 60-day follow up report received 4/23/2003, reporter states, "increased joint pain in legs and arms - concentration and focus on projects at hand are extremely short. Level of frustration is increasing. Mood swings are increasing - capability of working in current status is limited - can't perform work as normal".
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Pruritus, Rash, Swelling, Testicular disorder
Clinical narrative: Testicular swelling after AVA #4. This service member recently returned from deployment to Turkey. His unit's administrative NCO SGT contacted the VHC to report that this member had had some adverse events after the Anthrax vaccine and inquired if he should receive an exemption to the next AVA which is due in 6 months. On the evening of shot, he developed pruritic rash on posterior neck and upper back, resolved by morning. Since he was in the field, he did not have access to a mirror to inspect the rash. He developed testicular swelling with pain and discomfort 1-2 days after shot. Symptoms lasted 2-3 days, then resolved. He did not seek medical care, therefore has no documentation of this event. He reported the symptoms later to the Flight surgeon who encouraged him to report them to the VHC.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Local reaction with erythema and edema of RUE about 25cm. Pt denies any other symptoms. He also had myalgia of RUE.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pruritus
Clinical narrative: Pt had a localized reaction to Anthrax vaccine on left arm of a 3cm X 5cm area of induration and redness plus itching and swelling at site.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Skin burning sensation
Clinical narrative: Burning feeling to face with erythema to face. Symptoms began 24 hours after vaccination and have persisted for 24 hours.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Swelling
Clinical narrative: Pain and swelling just above the elbow joint.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Contusion, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: Injection painful at time of administration with bleeding and bruising occurring immediately. Shortly thereafter, site observed to be hot to touch with silver-dollar sized redness and swelling at site. In ensuing days, starting very soon, experienced muscle and joint aching. Heat persisted until 12/09/02. Some nausea, intermittently. Redness and swelling persisted for about 5 days and associated soreness at site.