chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Convulsion, Irritability, Oral intake reduced, Sepsis, Sleep disorder
Clinical narrative: Pt was normally developing infant.  After 1st vaccination series 9/19/02 Pt became fussy and would not sleep or eat well.  He was followed by MD for possible colic.  After 2nd vaccination series on 11/22/02, fussiness increased and appetite decreased, along with decreased sleeping.  Pt was referred to a gastroenterologist; he diagnosed seizure activity and referred to neurologist, MD and to MD (cardiologist).  He was placed on ACTH and zonegram.  Childs condition worsened over the next several months and he expired on 3/18/03.  Dr. reportedly told family that he could not rule out an adverse reaction to immunizations as a cause of the seizure activity.
Age: 50.0
Sex: U
Vaccine: SMALL
Symptoms: Hypokinesia, Joint stiffness, Joint swelling
Clinical narrative: Vaccinated with Smallpox vaccine (Lot#40200770 and Diluent Lot # 802236A) on 03/11/2003 @ Health Department on left upper arm. Take check varied on 3/18/2003 as major by R.N. Started with C/o shortness of breath while performing routine gardening activites on 3/38-29-2003. Within the next 2-3 days developed stiffness and swelling in all joints both of upper and lower extremities. Impaired mobility and dexterity of both hands. Incapacitating for normal work activities in practice for Monday 3/31/03, 04/01 and 04/02/2003. After information regarding cardiac recommendation, seen by M.D. and EKG, CBC, and CPK obtained. All testing reported as normal. Resumed office duties on 04/03/03 with residual stiffness of joints.  Denies chest pain or other cardiac symptoms.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Acne, Blister, Cellulitis, Erythema, Pyrexia
Clinical narrative: 28 yo vaccinated 3/26 and on 4/2 noted that the skin underneath the opsite was very red and had some small pimples develop. It became very painful and the redness then began to spread circumferentially around the arm. The pimples began to have some clear fluid underneath but did not look exactly like the vaccination site (which was big and about to scab already). He felt like he had fevers at night and came in to ER on Sat. (4/5) Temp was 100.4, he was talking, nontoxic. He was admitted and placed on unasysn for one dose and then switched to oxacillin with some improvement over the next 2 days. No cultures were sent as there was no drainage to culture. He was discharged on 4/7.  The presumptive discharge diagnosis was reaction to the adhesive (opsite) with ? mild cellulitis.
Age: 55.0
Sex: F
Vaccine: SMALL
Symptoms: Chest discomfort, Derealisation, Dyspnoea, Irritability, Pain
Clinical narrative: 4/1/03, 8:30 am, experiencing compressed feeling to chest and mid back area, shortness of breath, feeling guarded, "spacey," feeling irritable.  Then experienced also sporadic pain to rt arm just above elbow that occurred about 20 times in course of a few hours.  Went to ER at 7 pm.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Discomfort, Skin ulcer, Tenderness
Clinical narrative: Rash like pimples on chest, stomach, back of neck.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Rash
Clinical narrative: Rash like pimples on chest, stomach, back of neck.
Age: 62.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: 3-26-03 Vaccine administered and client traveled for meetings.  When she arrived and removed her jacket, she noticed red, vesicle type eruptions on her lower left arm and hand.  These eventually spread to the entire left arm, left shoulder, across the upper back and some to the face.  The vesicles were itchy and red but she did not experience fever, illness or pain.  She presented to the Emergency Room where she was diagnosed with acute cutaneous hypersensitivity reaction.  She was given rx's for Benadryl and Zyrtec.
Age: 62.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash vesicular
Clinical narrative: 3-26-03 Vaccine administered and client traveled for meetings.  When she arrived and removed her jacket, she noticed red, vesicle type eruptions on her lower left arm and hand.  These eventually spread to the entire left arm, left shoulder, across the upper back and some to the face.  The vesicles were itchy and red but she did not experience fever, illness or pain.  She presented to the Emergency Room where she was diagnosed with acute cutaneous hypersensitivity reaction.  She was given rx's for Benadryl and Zyrtec.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Fatigue, Headache, Malaise, Pericarditis, Rash
Clinical narrative: Onset of chest pain 14 days after smallpox immunization ST elevation in inferior leads. Troponin I 15, CK 242, CK - MB 22.5, MB % 9-3. Elevated w/coronary catherization 3/31/03 normal. Ejection function oneche = 50%. Dx'd with pericarditis. Tx'd with Indomethacin.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Tonsillitis
Clinical narrative: Onset of chest pain 14 days after smallpox immunization ST elevation in inferior leads. Troponin I 15, CK 242, CK - MB 22.5, MB % 9-3. Elevated w/coronary catherization 3/31/03 normal. Ejection function oneche = 50%. Dx'd with pericarditis. Tx'd with Indomethacin.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Myocardial infarction, Pericarditis
Clinical narrative: Onset of chest pain 14 days after smallpox immunization ST elevation in inferior leads. Troponin I 15, CK 242, CK - MB 22.5, MB % 9-3. Elevated w/coronary catherization 3/31/03 normal. Ejection function oneche = 50%. Dx'd with pericarditis. Tx'd with Indomethacin.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Laboratory test abnormal, Pericarditis
Clinical narrative: Onset of chest pain 14 days after smallpox immunization ST elevation in inferior leads. Troponin I 15, CK 242, CK - MB 22.5, MB % 9-3. Elevated w/coronary catherization 3/31/03 normal. Ejection function oneche = 50%. Dx'd with pericarditis. Tx'd with Indomethacin.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: Patient died on 3/19/03. Cause of death SIDS. Death occurred two days after immunizations. No problems reported before or after shots.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Patient died on 3/19/03. Cause of death SIDS. Death occurred two days after immunizations. No problems reported before or after shots.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Abnormal behaviour, Agitation, Crying, Drug withdrawal syndrome, Hypotonia
Clinical narrative: My son cried with DTaP. The second he did not and the third he did not. He became hypotonic and constipated right after 3rd shot. He screamed for hours each day. I was told it was colic. He was 5 months old. Too old for colic. The MD lost his lot number and I signed no consent form. He did give him the vaccine containing thimersol. PDD-NOS, sensory integration disorder, vision problems and still hyptonic.  Mother believe whatever happened started w first DTaP. He cried. By the shot he was not progressing pain. Third shot again no crying, 2nd DTaP. Hypotonic- lost strength in movement. Like a sponge. Never expressed differnt emotions. Starting licking left leg only- result never mind. A 60-day follow up report received 6/23/2003 adds: (from mother) My child still has hypotonia (low muscle tone) expressive and receptive language disabilities. Clumsy movements. On autistic spectrum (PDD). Learning disabilities. Possible mental retardation. My child was fine for his 1st shot. He cried. Very engaging baby beginning to roll over. Full term - 11 lbs at birth. 2nd shot-no crying. 3rd shot-no crying on administration-became constiipated for days after shot. Cried every days for 5-6 hours straight for over a month to 2 months at least. Dr lied and said my son received no thimerosol (said it was colic). He never kept lot numbers (which is a law) I still can't get paper trail. I have filed with the State of PA to get help in retrieving this info. Our life and my son's life and our daughters' lives have been changed forever. This should have never happened. Thank you.  Annual follow up on 04/21/04: "Pt has not recovered from adverse event.  My son has been diagnosed with autism.  He has high mercury levels in his system which came from the thimerosal.  He has speech and language impairment.  Sensory integration and has high titers to Polio vaccine.  1-32 is normal range his is 320!! The Dr. lied to me about being mercury free.  My son lost his muscle tone after shot, screamed constantly became constipated and then had diarrhea for almost 1 and half years.  Afterwards, the Dr. never kept lot #'s which is a law! He said he lost them on a slip of paper.  My son struggles everyday to speak and do things, which should come naturally to him.  What an injustice to him.  Thank you."
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Laboratory test abnormal, Sensory disturbance, Visual disturbance
Clinical narrative: My son cried with DTaP. The second he did not and the third he did not. He became hypotonic and constipated right after 3rd shot. He screamed for hours each day. I was told it was colic. He was 5 months old. Too old for colic. The MD lost his lot number and I signed no consent form. He did give him the vaccine containing thimersol. PDD-NOS, sensory integration disorder, vision problems and still hyptonic.  Mother believe whatever happened started w first DTaP. He cried. By the shot he was not progressing pain. Third shot again no crying, 2nd DTaP. Hypotonic- lost strength in movement. Like a sponge. Never expressed differnt emotions. Starting licking left leg only- result never mind. A 60-day follow up report received 6/23/2003 adds: (from mother) My child still has hypotonia (low muscle tone) expressive and receptive language disabilities. Clumsy movements. On autistic spectrum (PDD). Learning disabilities. Possible mental retardation. My child was fine for his 1st shot. He cried. Very engaging baby beginning to roll over. Full term - 11 lbs at birth. 2nd shot-no crying. 3rd shot-no crying on administration-became constiipated for days after shot. Cried every days for 5-6 hours straight for over a month to 2 months at least. Dr lied and said my son received no thimerosol (said it was colic). He never kept lot numbers (which is a law) I still can't get paper trail. I have filed with the State of PA to get help in retrieving this info. Our life and my son's life and our daughters' lives have been changed forever. This should have never happened. Thank you.  Annual follow up on 04/21/04: "Pt has not recovered from adverse event.  My son has been diagnosed with autism.  He has high mercury levels in his system which came from the thimerosal.  He has speech and language impairment.  Sensory integration and has high titers to Polio vaccine.  1-32 is normal range his is 320!! The Dr. lied to me about being mercury free.  My son lost his muscle tone after shot, screamed constantly became constipated and then had diarrhea for almost 1 and half years.  Afterwards, the Dr. never kept lot #'s which is a law! He said he lost them on a slip of paper.  My son struggles everyday to speak and do things, which should come naturally to him.  What an injustice to him.  Thank you."
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Cough, Dystonia, Haemorrhage, Rhinitis
Clinical narrative: 5 days after receiving DTaP, HIB, IPV, and Prevnar developed seizures. Admitted to hospital on 03/15/2003 for sull sepsis work up (neg), MRI of head/EEG led to follow up by pediatric neurologist as requested. The hospital discharge summary received on 1/8/04 states paroxysmal dystonic arm movements, drooling, right caudate subacute hemorrhage, cough, and sneezing. Patient still having complex partial seizures.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Salivary hypersecretion
Clinical narrative: 5 days after receiving DTaP, HIB, IPV, and Prevnar developed seizures. Admitted to hospital on 03/15/2003 for sull sepsis work up (neg), MRI of head/EEG led to follow up by pediatric neurologist as requested. The hospital discharge summary received on 1/8/04 states paroxysmal dystonic arm movements, drooling, right caudate subacute hemorrhage, cough, and sneezing. Patient still having complex partial seizures.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Anorexia, Bacterial infection, Drug ineffective, Injection site oedema, Pallor
Clinical narrative: Got shot 2/25/03, went home, had high fever-loss of appetite, hives-paleness, swelling of throat-weakness. Swelling of leg-shot was given-reaction treated antibiotics. Pt's fever grew to 107 in transport he became very ill, he was admitted into ICU, for treatment, on antibiotics, and later found it to be Streptococcus bacteria in his blood.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Pharyngeal oedema, Pyrexia, Sepsis, Urticaria
Clinical narrative: Got shot 2/25/03, went home, had high fever-loss of appetite, hives-paleness, swelling of throat-weakness. Swelling of leg-shot was given-reaction treated antibiotics. Pt's fever grew to 107 in transport he became very ill, he was admitted into ICU, for treatment, on antibiotics, and later found it to be Streptococcus bacteria in his blood.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Hypokinesia, Injection site hypersensitivity
Clinical narrative: Tx started on presentation to medical 2/3/03. Large are erythema from site on right arm extending below elbow and decreasing ROM of elbow. Measures > 120 mm. That involved Rx- Prednisone 20 mg PO 2 days x 5 - Hydroceftson (topical) 1% AAA TID - Ice to site. For 3rd Anthrax premedicated NOC at 40 mg prednisone. Received another 40 mg prednisone at time of vax, which was given IM. No adverse response to 3rd Anthrax.
Age: 1.5
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Rash vesicular, Skin ulcer
Clinical narrative: Onset of rash 3/30/03. No exposure to ill persons known. No apparent pruritus. Temp 99 deg. Green nasal D/C. Rash nape of neck, 2 on forehead, several on ??? pubic. All erythematous, several vesicular center. Approx 20 skin lesions. Given Amoxicillin, Cardec DM, Tylenol, Benadryl if scratching.
Age: 0.3
Sex: M
Vaccine: HBHEPB, IPV, PNC
Symptoms: Crying, Pyrexia, Vasodilation procedure
Clinical narrative: 4 hrs after receiving immunizations, PT started running temperature, crying inconsolably then by 8 hrs after vax had 104 R temp and had very red cheeks so was taken to ER for evaluation. Back to normal w/in 24 hrs.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: 4-6 hrs after receiving immunizations he started running fever which gradually increased to 104 rectal, had to be held and rocked due to unconsolable crying. Was back to normal w/in 24 hrs.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Infection, Pyrexia
Clinical narrative: Temp 105 deg 3/20/03 PT seen at MD's office and then sent to ER. Mom phoned on 3/21/03 9 a.m. Child Dx'd with ear infection and recovering.
Age: 5.2
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site reaction, Vasodilation procedure
Clinical narrative: Local reaction at left arm at inject site. Increased warmth, swelling, redness, tender.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Rash pruritic, Urticaria
Clinical narrative: 3/14/03 8:25 - Report of vaccinee via Spanish interpreter, and client reports awoke 3/12 a.m. with dizziness and itchy "rough rash" on belly, arms, back of hands, elbows, knees, can feel it not see it. Also dizzy. Worked 3/13/03 When went to work 3/14 supervisor advised her to call. 3/14/ Tx by Kitinkers Saw Medral PCP as as urticaria (hives)
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Oedema, Pain, Vasodilation procedure
Clinical narrative: Arm very red and swollen. Tender to touch. PT slept x 48 hrs.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Vasodilation procedure
Clinical narrative: Mother states she noticed right arm swollen, red, warm to touch on Tues night. She brought child to clinic Fri, 2/7/03 15:15 p.m.
Age: 1.08
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: Significant redness and induration x 3. DTaP: 4 cm induration, 1 cm erythema; HIB: 2 cm induration & erythema (linear); Prevnar: 1 cm erythema, 1.5 cm induration.
Age: 7.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Rash maculo-papular, Rash pustular
Clinical narrative: Red papules and pustules on back, chest and extremities.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema, Vasodilation procedure
Clinical narrative: Left arm red, swollen and warm - augmentin 400 mg 8 hrs x 10 days.
Age: 2.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Blister, Rash pruritic
Clinical narrative: Bumps, blisters, itchy rash.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pain, Rash
Clinical narrative: Received immunization on Wednesday 3/19/03. Developed redden palms of hands, complained of left arm hurting, left arm = rash; taken to ER. Given Benadryl on Thursday 3/20/03. Developed rash over entire body on Friday 3/21/03. Taken to doctor.
Age: 1.25
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: 3/27/03 Well child exam; 2 vaccines given. 3/27/03 Midnight; temp 105 and brief seizure tonic/clonic. Patient quickly recovered and seems fine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site reaction, Injection site warmth
Clinical narrative: 6"x5" erythematous reaction, warm, non-indurated, non-tender left arm where DTaP given.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 3.5"x2.75" red, hot and sore.
Age: 1.3
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Choking, Cyanosis, Hypotonia, Pharyngitis, Pyrexia
Clinical narrative: Whiney but not ill at bedtime. Mom checked and found him choking face down in crib, had thrown up clear major drool. Was breathing, but lump, lips blue, eyes glazed. To ER by ambulance. Temp 102F. Doctor diagnosed viral episode. Was in ER 1.5 hours then home. Low fever but acting normal next day. Has bad cold cough and runny nose now. Fever reducer given in ER.
Age: 1.3
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Rhinitis, Rhinorrhoea, Vomiting
Clinical narrative: Whiney but not ill at bedtime. Mom checked and found him choking face down in crib, had thrown up clear major drool. Was breathing, but lump, lips blue, eyes glazed. To ER by ambulance. Temp 102F. Doctor diagnosed viral episode. Was in ER 1.5 hours then home. Low fever but acting normal next day. Has bad cold cough and runny nose now. Fever reducer given in ER.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Patient was seen in ER on 3/27/03 for AC cellulitis and in the clinic for ER follow up on 3/28/03 and 3/31/03. AC cellulitis.
Age: 1.5
Sex: F
Vaccine: DTAPH, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Large, localized reaction 3-4" diameter; red, swollen and warm to touch.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular
Clinical narrative: Broke out with varicella rash 4/1/03; mild case. No treatment.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Pain
Clinical narrative: Prolonged painful crying for 20-25 minutes approximately 4.5 hours after DTP, IPV, ACT, and Prevnar. After dose of Tylenol, baby settled down and had normal re-exam.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, VARCEL
Symptoms: Injection site oedema
Clinical narrative: Local edema left upper arm 2cmx2cm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain, Vasodilation procedure
Clinical narrative: Left deltoid area 5.5 cm x 3.5 cm area of redness, erythema, warmth & tenderness central area at inject site indurated 2 x 2 cm.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Injection site oedema, Injection site pain, Pain, Rash maculo-papular
Clinical narrative: PT had onset of pain and swelling in left deltoid with some LOM (limitation of motion) left shoulder on day after shot, persisting for at least 16 d. Also had onset rash c/w (consistent with) pityriasis rosea onset 2 days post Td booster - felt unrelated to immunization.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Sx: Redness / swelling to left upper arm. No induration. Tx: Antihistamine
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Woke up this morning w/"rash". Generalized but heavier in trunk. No fever. Given Benadryl for itching.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash erythematous
Clinical narrative: Woke up this morning w/"red spots" all over - more on trunk - few on face, arms and legs. Had fever 2 nights ago. Given Benadryl for itching.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Dizziness, Injection site hypersensitivity, Injection site mass, Pyrexia
Clinical narrative: 24 hrs after administration of vax - raised, red welt dime - silver dollar size at admin site (left deltoid), warmth. No induration. On 4/4 - non-raised, same size T 24 hrs post admin. 100.4. C/o tired, slight dizziness. On 4/4 redness at site continues - not raised, erythema present.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Rash maculo-papular, Vasodilation procedure
Clinical narrative: 24 hrs after administration of vax - raised, red welt dime - silver dollar size at admin site (left deltoid), warmth. No induration. On 4/4 - non-raised, same size T 24 hrs post admin. 100.4. C/o tired, slight dizziness. On 4/4 redness at site continues - not raised, erythema present.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Eye disorder, Oedema, Rash, Rash macular
Clinical narrative: Blotchy face and neck; swollen and hyperimic eyes approximately 4 hrs after vaccination. One dose of Benadryl (1mg/kg/dose); 40 hours after-rash disappeared.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Fall, Loss of consciousness
Clinical narrative: Pt received hep B vaccine. Left and went to lobby with mother and passed out. She hit her head on the floor when she fell. 137/81 P 71 3:40pm, 127/84 P 93 3:50pm, 119/79 P 99 4:05. Went to private MD to check knot on her head.
Age: 4.0
Sex: M
Vaccine: DTAPH, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Significant redness and swelling of injection site-diameter 10cm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Redness, swelling, warm to touch area on L shoulder measuring 7.5cm x 8.7cm area is painful to child.
Age: 3.2
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Injection site reaction
Clinical narrative: Local allergic reaction no systemic symptoms. Benadryl 1-1 1/2 tsp po q 6 hrs.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Cough, Decreased appetite, Hypotonia, Opisthotonus
Clinical narrative: Excessive sleeping for 2 1/2 days, limp, groggy very pale and cold, scrotum dingy gray color, staring (no blinking), frothy spit, weak cry, unfinished bottles 5 days. Constricting arms and legs grunting three days arching head backward, runny nose, coughing
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pallor, Rhinorrhoea, Somnolence, Staring
Clinical narrative: Excessive sleeping for 2 1/2 days, limp, groggy very pale and cold, scrotum dingy gray color, staring (no blinking), frothy spit, weak cry, unfinished bottles 5 days. Constricting arms and legs grunting three days arching head backward, runny nose, coughing
Age: 1.08
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash on legs, abdomen, and arms. None with significant fluids. No itch, afebrile. Recommended Aveeno bath and monitor rahs.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Pyrexia
Clinical narrative: Received four vaccines listed below. Went home and slept several hours. Woke and had high pitched scream x 1 1/2 hrs, then on and off over the next 24 hours. Also had fevers to 102 degrees.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Musculoskeletal stiffness, Pain
Clinical narrative: Pain, stiffness with limited movement in R upper and lower arm.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Injection site pain
Clinical narrative: Sever pain R shoulder.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: L upper arm swollen and red from elbow to shoulder. Ice applied fever 102 Tylenol given. Monday deltoid and shoulder still swollen. No more fever.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Swelling, redness, inc warmth of the L upper arm (from shoulder to elbow). 1st noticed Fri. 3/28/03 (DTaP, IPV given in L arm on 3/27/03).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria, Wheezing
Clinical narrative: Wheezing, hives, urticaria 1-1 1/2 hrs after imms. adm. Benadryl PO, Prelone PO, nebulization Tx responded to Tx.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: On 4/1/03 L upper arm-site of DTaP (3/31/03) has 15cm x 11cm area of erythema-not hot, not tender. Slightly swollen, pt not "ill" very active.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Full body rash-erythematous-vesicular 4-5 hrs after injection.
Age: 77.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site mass, Pruritus
Clinical narrative: "Knot" at area of shot since shot, itchy redness noted on 4/2/03.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Vomiting
Clinical narrative: markedly swollen and erythematous Rt arm (shoulder to elbow) within 24 hrs of receiving vaccine. No fever, vomited x 1.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC
Symptoms: Agitation
Clinical narrative: Inconsolable crying x 1 hr after vaccine administration.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Vax given 4/2/03 - PT reported punctate papules on abdomen on 4/4/03.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Convulsion, Injection site erythema, Injection site induration
Clinical narrative: Pt fell out at church 4/6/03 and began to shake all over. Mom states episode lasted 20-30 sec. No other symptoms. No further seizure activity. Has been fine ever since. Pt also had localized reaction at site. Mom states hard and red.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Fatigue, Hyperhidrosis, Nausea, Nervousness
Clinical narrative: Fatigue, weakness, trembling, feels hot, sweaty, nausea, nervousness post vax x > 1 week. Mild crawling type sensation in extremities. Temp 99.3
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Tremor
Clinical narrative: Fatigue, weakness, trembling, feels hot, sweaty, nausea, nervousness post vax x > 1 week. Mild crawling type sensation in extremities. Temp 99.3
Age: 6.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Per parent report, Rt arm swollen, sore, red, decreased mobility. ER determined this was vaccine reaction and ordered a steroid and Benadryl. Prednisone x 5 days.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting "the same amount" as before shots on Thurs. Low fever on same day of shots in the evening. Mom gave infant Tylenol drops. Fever resolved on Thurs. night.
Age: 2.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Arm reddened and warm to touch, approximately 3 inches in diameter, around injection site. Referred to private MD. Saw MD given several allergic medication antibiotic. Mother states was told it just a local reaction.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Pruritus, Vasodilation procedure
Clinical narrative: 3/14/03 Friday night after IPV injection site only red spot. 3/15/03 Sat a.m. left arm at site of IPV red, very swollen area 3" x 3.5" approx, arm feverish. Mom gave Benadryl 2x/day and Ibuprofen every? 6 hrs. 3/19/03 Arm still itching, slightly swollen, site not feverish, red. Mom gave Benadryl and Ibuprofen. 3/11/03 8:30 p.m. mom states child used her left arm throughout ??
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea, Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Mom stated child's R arm from shoulder to elbow had swelled by pm 2/28/03. Area was hot to the touch with a rash and it was firm. Had a fever of 105.7 that easily responded to Motrin and a cool bath. By 3/3/03 the arm was not swollen-just slightly firm and warm to the touch-no rash. By 3/7/03 arm was normal. Mom started that child's father had a previous reaction to a tetanus booster-he swelled up and had difficult breathing. He was told he was allergic to tetanus. Mom had previously told this nurse that child was allergic to tetanus-that he has had a bad local reaction after the 3rd dose. He had gotten the 1st three doses. I called H.D. there-all they had documented was that the child had an allergic reaction to DTaP-no description of what happened. Talked with mom again-started that child's arm swelled to the size of a baseball and was red and warm to the touch. No other sx. OK post one week. Discussed-give another dose of DTaP-deep IM-and observe. Child had no problems post 20 minutes.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: Mom stated child's R arm from shoulder to elbow had swelled by pm 2/28/03. Area was hot to the touch with a rash and it was firm. Had a fever of 105.7 that easily responded to Motrin and a cool bath. By 3/3/03 the arm was not swollen-just slightly firm and warm to the touch-no rash. By 3/7/03 arm was normal. Mom started that child's father had a previous reaction to a tetanus booster-he swelled up and had difficult breathing. He was told he was allergic to tetanus. Mom had previously told this nurse that child was allergic to tetanus-that he has had a bad local reaction after the 3rd dose. He had gotten the 1st three doses. I called H.D. there-all they had documented was that the child had an allergic reaction to DTaP-no description of what happened. Talked with mom again-started that child's arm swelled to the size of a baseball and was red and warm to the touch. No other sx. OK post one week. Discussed-give another dose of DTaP-deep IM-and observe. Child had no problems post 20 minutes.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Skin striae, Urticaria
Clinical narrative: Mom reported on 3/5/03 that child had a welt on right deltoid. No other Sx's. Mom then told RN that the last DTaP had caused a welt that lasted few days. Mom was instructed to apply compresses, massage that area and give Tylenol. Mom called back later to report area streak going around the arm. No other Sx's.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema, Vasodilation procedure
Clinical narrative: 3/28/03 - Mom called and reported that yesterday (3/27/03) she noticed her child's arm swollen - red, hot to touch - size of a baseball - states she panicked and called her pediatrician - MD told her to massage the area and use warm compresses - mother state her arm is much better seen today - redness and swelling left deltoid - size of golf ball - rash runs down to 1" above elbow - not crying or complaining of pain.
Age: 52.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema multiforme, Rash maculo-papular, Skin ulcer
Clinical narrative: Vaccinee developed multiple maculopapular lesions on hands without pain, itching, vesicles or pustules.  No spread to other areas.  Probable Dx: erythema multiforme
Age: 43.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Fatigue
Clinical narrative: Chest wall pain.  Non-radiating. Not worse with exertion. Not positional: No dyspnea or syncope.  Mild to medium fatigue for 2-3 days.
Age: 54.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain
Clinical narrative: Acute onselt of right sided chst pain; non-exertional.  Seen and evaluated in emergency department.
Age: 35.0
Sex: F
Vaccine: SMALL
Symptoms: Palpitations
Clinical narrative: Health Dept. employee. Reports two previous 2 day periods in June 2002 and in October 2002 where she experienced palpitations with occassional shortness of breath. She did not see a physician for these episodes.  She reports experiencing palpitations beginning 2 days following receipt of the smallpox vaccine (2/10/03) and this lasted until approximately 2 wks ago. She reports that she has not noticed any palpitations for approximately the past two wks. Significant family history-  mother died from MI at 62yo Father had first of many MI's at age 42yo and has had 2 bypass surgeries since. Father's family strong history in many members of cardiac disease early in adulthood.
Age: 41.0
Sex: M
Vaccine: HEP, IPV, MMR, TYP
Symptoms: Lymphadenopathy, Rash
Clinical narrative: swolen glands under my throat. Rash over my entire body. Including face.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: 31 yo male physician who developed erythematous, non-progressive, maculopapular rash 10 days after smallpox vaccination.  Lesions mostly on torso and upper extremities.  No pustules or vesicles present - no specimens sent for testing.  Patient was otherwise asymptomatic.
Age: 12.0
Sex: M
Vaccine: HEP, TD
Symptoms: Erythema, Feeling hot, Hypersensitivity, Injection site erythema, Injection site oedema
Clinical narrative: Bilateral swelling of hands & arms 15 min after shots hands red & blothy, appearance & swollen.  swelling started in hands that went up to shoulders.  TD site red, hot, swollen.  Left arm and had more swollen then right.  Saw Dr., dx. allergic reaction to TD, vascular spasms.  4/8/03- spoke with mother by the phone.  Child saw Dr.x2 yesterday, better today.  He is back in school.
Age: 12.0
Sex: M
Vaccine: HEP, TD
Symptoms: Oedema, Rash macular
Clinical narrative: Bilateral swelling of hands & arms 15 min after shots hands red & blothy, appearance & swollen.  swelling started in hands that went up to shoulders.  TD site red, hot, swollen.  Left arm and had more swollen then right.  Saw Dr., dx. allergic reaction to TD, vascular spasms.  4/8/03- spoke with mother by the phone.  Child saw Dr.x2 yesterday, better today.  He is back in school.
Age: 51.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Injection site pain, Palpitations
Clinical narrative: Approx 6 days post vax, PT began to experience chest pains, heart palpitations and pain in left arm. Still experiencing left arm pain everyday and heart palpitations periodically.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Arrhythmia, Asthenia, Chest pain, Dizziness, Malaise
Clinical narrative: 1 wk after vax, c/o'd weakness and malaise. 4/3/03 Dizziness in the a.m. Approx 2 p.m. had episode of irregular heartbeat for approx. 10 mins then tachycardia 130-140 BPM. Chest pain & burning sensation.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Tachycardia
Clinical narrative: 1 wk after vax, c/o'd weakness and malaise. 4/3/03 Dizziness in the a.m. Approx 2 p.m. had episode of irregular heartbeat for approx. 10 mins then tachycardia 130-140 BPM. Chest pain & burning sensation.
Age: 39.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Dyspnoea, Fatigue, Tachycardia
Clinical narrative: Approx 1 wk after vax, PT began experiencing fatigue, racing pulse (130-140); chest pain that radiated down arm and up neck on right side. Felt as if she couldn't catch her breath. This occurred every day for 4 days w/Sx's onsetting in late afternoon to early evening. Still experiencing evening fatigue and racing pulse but no chest pain.
Age: 43.0
Sex: F
Vaccine: SMALL
Symptoms: Cow pox, Pruritus, Rash, Rash maculo-papular, Rash vesicular
Clinical narrative: PT 8 days post vax began developing rash on upper arms, spreading down arms. No lesions on any other body part. Rash maculopapular becoming vesicular, numerous lesions back upper arms and pustules do not look like Vaccinia. Increased pruritus.  A follow up report received 6/4/2003 adds: (Pt) was followed by a dermatologist and found the rash was not due to smallpox vaccine. A biopsy of the lesion was done and found to not be smallpox related.
Age: 29.0
Sex: F
Vaccine: SMALL
Symptoms: Cow pox, Erythema, Influenza
Clinical narrative: PT contacted flight surgeon via phone & instigated to flu with HS, in the morning. Tx with Benadryl as Erythematous Tixinum, and later updated Dx to vaccinium as per MD.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Cow pox, Erythema, Rash pustular
Clinical narrative: ON day 9 after vax, PT noted erythema on left lower leg. On day 10, PT developed pustules in center of erythema. On exam, 7 pustules noted on LLE, 1 on RLE and 2 on back. PT denies pruritus but does not mild discomfort from clothing rubbing. No F/C/N/U/ Wt loss/ sweats.
Sex: F
Vaccine: SMALL
Symptoms: Pyrexia
Clinical narrative: Fever of 101.6 and unable to go to work.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Erythema multiforme, Headache, Pyrexia, Rash maculo-papular
Clinical narrative: Smallpox 10 days prior. On 3/31 Mn 03 - developed fever up to 103 with headache. Took Tylenol, Mondery? AM, noted red spots in face, neck, chest, back, abdomen - papular looking, variable sizes, irregular borders, some raised as papules, others non-raised. No pustules. Erythema multiform, doubt localized or generalized vaccinia.
Age: 21.0
Sex: U
Vaccine: SMALL
Symptoms: Erythema multiforme, Rash maculo-papular
Clinical narrative: Small red papular to small blotchy eruption on chest, spread over abdomen and both thighs, variable sizes, shapes. No pustules. Prob erythema multiforme, doubt vaccinia.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema multiforme, Headache, Rash maculo-papular
Clinical narrative: Few red spots, chest and back. (Papular looking eruptions) and mild variable signs, some flat. No ocylar, headache. Prob erythema multiforme. Doubt Vaccinia.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Face oedema, Injection site vesicles, Rash maculo-papular
Clinical narrative: PT presented on 3/28/03 to vax site w/small red maculopapular rash on cheeks of face. Started appeared on 3/27/03. Also c/o itchy eyes. Denied Hx of rashes. Referred PT to another health center for Benadryl. Employee health started Pt had presented in past w/similar rash.
Age: 53.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Condition aggravated, Headache, Hypertension, Oedema peripheral
Clinical narrative: 3/14 pt was experiencing headaches, left arm pain, chest pain and swelling of hands and feet.  Pt started to feel progressively worse over the weekend and was experiencing increase blood pressure 208/110, her physician removed her from work. 3/27/03, pt was admitted to the hospital for uncontrolled hypertension. Hospitalized about 4 days.
Age: 53.0
Sex: F
Vaccine: SMALL
Symptoms: Pain
Clinical narrative: 3/14 pt was experiencing headaches, left arm pain, chest pain and swelling of hands and feet.  Pt started to feel progressively worse over the weekend and was experiencing increase blood pressure 208/110, her physician removed her from work. 3/27/03, pt was admitted to the hospital for uncontrolled hypertension. Hospitalized about 4 days.
Age: 47.0
Sex: F
Vaccine: SMALL
Symptoms: Blister
Clinical narrative: Pt is an employee of Hospital.  She reported to Infection Control Representative at hospital on 4-3-03 that she was developing a very large "fever blister" on her lip that was producing a significant amount of drainage.  She saw her primary care physician on 4-4-03 and received antiviral medication (name of medication unknown). The "fever blister" promptly began to heal and is nearly gone now.  No other adverse effects noted, no other treatment treatment was needed.
Age: 59.0
Sex: F
Vaccine: SMALL
Symptoms: Arthralgia, Back pain, Muscular weakness, Pain, Rheumatoid factor
Clinical narrative: 02/26/03:  Some achiness, otherwise, no significant report.  3/10/03:  Pt complained of back pain, left work because her back "went out". This is historical in this vaccinee.  While home, pt developed joint pain and muscle weakness. From 3/10 to 4/1/03, increasing pain, several MD visits, MRI, rhumatoid profile, HLAB 27 tests. 4/8/03: Pt. continues in pain.  At home, unable to work
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenitis, Oedema, Pain
Clinical narrative: Patient received smallpox vaccination on 14 Mar 03.  Approx 7 days later he came in to clinic c/o L supraclavicular pain/swelling.  Work up for Virchow's node began w/ CXR and surgery consult for biopsy.  Results back 7 April 2003 and show diagnosis of Reactive Lymphadenitis, probably seconardy to smallpox vaccination.
Age: 50.0
Sex: F
Vaccine: SMALL
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Heart rate increased, Pyrexia
Clinical narrative: Onset 03/30/2003  Chest discomfort, short of breath, slight fever - Seen in ER  Rx with tylenol  04/03 Complained of heavy chest, Apprehension, Temp 101.9, Increased heart rate on exertion
Age: 1.6
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site reaction, Injection site warmth
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 19 month old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The nurse submitted a report directly to VAERS. There were no relevant medical history, concurrent conditions, or concurrent medication. On 2/17/03, the subject received his fourth injection of Infanrix. The subject also received an injection of inactivated poliomyelitis virus vaccine. On 2/18/03, one day post-immunization, the subject developed swelling of the right thigh to twice the size of the left thigh and a firm spot on the thigh measuring three inches. The subject was seen by the physician on 2/19/03. At that time, the physician observed a 4cmx5cm area of firm induration at the Infanrix injection site, as well as, redness and warmth at the injection site. The physician suspected cellulitis and prescribed cephalexin, ibuprofen, and diphenhydramine. The subject returned to the physician on 2/20/03 with a fever up to 102 degrees F and fussiness. The physician noted that the subject's throat was red. The physician also noted that the injection site cellulitis was much improved. The physician made a diagnosis of viral illness. On 2/26/03, the subject's father reported that the injection site cellulitis and fever had resolved on 2/23/03. The outcome of the viral illness was not provided. The most recent information was received from the nurst on 3/18/03. She indicated that the subject had not been seen by the physician since 2/20/03, so the outcome of the reported events were not known. She considered the injection site cellulitis to be related to Infanrix administration; the relationship tot he viral illness was not reported. The nurse indicated that the injection site cellulitis jeopardized the subject or required intervention. Therefore, this report has been reclassified as serious.
Age: 1.6
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Injection site reaction
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 19 month old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The nurse submitted a report directly to VAERS. There were no relevant medical history, concurrent conditions, or concurrent medication. On 2/17/03, the subject received his fourth injection of Infanrix. The subject also received an injection of inactivated poliomyelitis virus vaccine. On 2/18/03, one day post-immunization, the subject developed swelling of the right thigh to twice the size of the left thigh and a firm spot on the thigh measuring three inches. The subject was seen by the physician on 2/19/03. At that time, the physician observed a 4cmx5cm area of firm induration at the Infanrix injection site, as well as, redness and warmth at the injection site. The physician suspected cellulitis and prescribed cephalexin, ibuprofen, and diphenhydramine. The subject returned to the physician on 2/20/03 with a fever up to 102 degrees F and fussiness. The physician noted that the subject's throat was red. The physician also noted that the injection site cellulitis was much improved. The physician made a diagnosis of viral illness. On 2/26/03, the subject's father reported that the injection site cellulitis and fever had resolved on 2/23/03. The outcome of the viral illness was not provided. The most recent information was received from the nurst on 3/18/03. She indicated that the subject had not been seen by the physician since 2/20/03, so the outcome of the reported events were not known. She considered the injection site cellulitis to be related to Infanrix administration; the relationship tot he viral illness was not reported. The nurse indicated that the injection site cellulitis jeopardized the subject or required intervention. Therefore, this report has been reclassified as serious.
Age: 1.6
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Injection site warmth, Irritability, Pyrexia
Clinical narrative: A nurse reported the occurrence of injection site cellulitis in a 19 month old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The nurse submitted a report directly to VAERS. There were no relevant medical history, concurrent conditions, or concurrent medication. On 2/17/03, the subject received his fourth injection of Infanrix. The subject also received an injection of inactivated poliomyelitis virus vaccine. On 2/18/03, one day post-immunization, the subject developed swelling of the right thigh to twice the size of the left thigh and a firm spot on the thigh measuring three inches. The subject was seen by the physician on 2/19/03. At that time, the physician observed a 4cmx5cm area of firm induration at the Infanrix injection site, as well as, redness and warmth at the injection site. The physician suspected cellulitis and prescribed cephalexin, ibuprofen, and diphenhydramine. The subject returned to the physician on 2/20/03 with a fever up to 102 degrees F and fussiness. The physician noted that the subject's throat was red. The physician also noted that the injection site cellulitis was much improved. The physician made a diagnosis of viral illness. On 2/26/03, the subject's father reported that the injection site cellulitis and fever had resolved on 2/23/03. The outcome of the viral illness was not provided. The most recent information was received from the nurst on 3/18/03. She indicated that the subject had not been seen by the physician since 2/20/03, so the outcome of the reported events were not known. She considered the injection site cellulitis to be related to Infanrix administration; the relationship tot he viral illness was not reported. The nurse indicated that the injection site cellulitis jeopardized the subject or required intervention. Therefore, this report has been reclassified as serious.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Joint range of motion decreased, Pain
Clinical narrative: Extreme pain left arm, radiating to neck and fingers. Loss of strength and degree of range of motion to left shoulder for 6 months. Treatment: ASA and heating pad.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Autism, Oral intake reduced, Pyrexia, Somnolence
Clinical narrative: From initial correspondence received at manufacturer on 3/24/03 it was reported that a 5 year old female patient received an IPOL vaccination on 7/7/98, lot number not reported. In December of 2002, exact date not specified, the patient experienced autism, fever, somnolence and a feeding problem. The outcome of this patient is unknown.