chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Decreased appetite, Difficulty in walking, Injection site erythema, Injection site hypersensitivity, Pyrexia
Clinical narrative: On 07/06/2001, mother stated thigh became red and tender to touch and her daughter was having difficulty walking, fever, crying, decreased appetite and slept poorly on the night of 07/05/2001.
Age: 1.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Screaming, Sleep disorder
Clinical narrative: On 07/06/2001, mother stated thigh became red and tender to touch and her daughter was having difficulty walking, fever, crying, decreased appetite and slept poorly on the night of 07/05/2001.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PPV
Symptoms: Convulsion, Crying, Screaming, Vomiting
Clinical narrative: The baby was crying non-stop for four hours and was inconsolable, no fever, vomited and possible seizure and took the baby to the hospital and was released after exam.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Injection site erythema, Injection site warmth, Oral intake reduced, Pyrexia
Clinical narrative: 1 hour, post vax, pt started crying and wouldn't eat. He was screaming and shaking (possible seizure). His upper left leg was bright red and hot. Started fever on 3/12/02 at 07:00 of 102.3F.  Gave Tylenol. Went to MD at 09:00.  MD checked baby and told to continue Benadryl. Pt's fever was 104.5F at 13:00. MD said to change to Motrin if he had a fever after 14:00. Went to ER at 15:00. Both legs were purple. No temperature at ER; stayed about 2 hours. Cold packs and gave him Benadryl. Slept. Told to continue Benadryl for 48 hours.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Screaming, Skin discolouration, Tremor
Clinical narrative: 1 hour, post vax, pt started crying and wouldn't eat. He was screaming and shaking (possible seizure). His upper left leg was bright red and hot. Started fever on 3/12/02 at 07:00 of 102.3F.  Gave Tylenol. Went to MD at 09:00.  MD checked baby and told to continue Benadryl. Pt's fever was 104.5F at 13:00. MD said to change to Motrin if he had a fever after 14:00. Went to ER at 15:00. Both legs were purple. No temperature at ER; stayed about 2 hours. Cold packs and gave him Benadryl. Slept. Told to continue Benadryl for 48 hours.
Age: 0.9
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site inflammation, Nausea, Urticaria, Vomiting
Clinical narrative: Pt's mother called and reported wheals on both legs at injection site, hot to touch, nausea, vomiting.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Anorexia, Drug ineffective, Pyrexia, Rash, Sleep disorder
Clinical narrative: On 07/27/2002, child having fever of 104 deg F. and sometimes higher, rash all over, some swelling of neck and cheeks, no appetite, not sleeping well. He was seen in ER on 02/27/2002. Physician stated it was measles (after examinations). On 03/04/2002, mom stated child was seen by family doctor on 03/01/2002. Measle test not back but x-ray showed some fluid in the lungs. He was put on Albuteral and Zithromal. On 03/04/2002 mom stated rash is almost gone and fever is down.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Swelling
Clinical narrative: On 07/27/2002, child having fever of 104 deg F. and sometimes higher, rash all over, some swelling of neck and cheeks, no appetite, not sleeping well. He was seen in ER on 02/27/2002. Physician stated it was measles (after examinations). On 03/04/2002, mom stated child was seen by family doctor on 03/01/2002. Measle test not back but x-ray showed some fluid in the lungs. He was put on Albuteral and Zithromal. On 03/04/2002 mom stated rash is almost gone and fever is down.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Agitation, Torticollis
Clinical narrative: Prolonged irritability, mild to torticollis.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site swelling, Pruritus, Skin ulcer
Clinical narrative: Immediate induration, swelling and pruritus, 30 minutes, post vax. Two weeks later, had 2 areas (2cm X 2cm) of early vesicular lesions on same arm. Rx'd Acyclovir.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Malaise
Clinical narrative: 2 days, post vax, pt had fatigue and malaise which resolved after 24 hours. Mom called after the fact.
Age: 1.3
Sex: F
Vaccine: HBHEPB
Symptoms: Cold sweat, Swelling face, Tremor
Clinical narrative: Approx. 1 1/2 hours, post vax, mother called and stated that child's face was tightening and child was shaky, intermittently, breathing was fine, color pink. Child did not feel warm; however, she felt "clammy". Instructed mother to take child to closest ER for further evaluation.
Age: 1.2
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Balance disorder, Convulsion, Crying, Dyskinesia, Pyrexia
Clinical narrative: On 1/28/02 at 05:00, pt had a fever of 103.2F with a body rash (hands, face, back, trunk, thighs) and increased crying. Motrin was given. Saw "jerking" movements. PCP states possible seizures. Saw PCP on 1/28/02. Noticed child was had imbalance and nurse referred mom back to PCP for evaluation of "imbalance".
Age: 1.2
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Rash
Clinical narrative: On 1/28/02 at 05:00, pt had a fever of 103.2F with a body rash (hands, face, back, trunk, thighs) and increased crying. Motrin was given. Saw "jerking" movements. PCP states possible seizures. Saw PCP on 1/28/02. Noticed child was had imbalance and nurse referred mom back to PCP for evaluation of "imbalance".
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Rash
Clinical narrative: Rash
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Chest discomfort, Throat tightness
Clinical narrative: Developed chest tightness, throat tightness after the vaccination. No fever, no hives. Prescribed antihestamine and steroid dose pack.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Multiple varicella rash on neck, abdomin, back and arms
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Received DTaP and IPV in the right arm on 03/12/2002. On 03/15/2002 mom noticed red area on deltoid 12cm x 10cm hot to touch. Mom stated no fever and pt did not complain of discomfort. Mom did not see rash.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Urticaria
Clinical narrative: Hives began on 03/06/2002 in the morning. Parent gave Benadryl at home.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Dysphagia, Dyspnoea, Pharyngeal oedema
Clinical narrative: After the hep b vaccination, the pt complained of trouble breathing, throat swelling with trouble swallowing. The pt was given Benadryl. Her blood pressure was 110/60. She was transported to the hospital and released home.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and swelling on right upper arm 9cm x 6 cm.
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Fatigue, Urticaria
Clinical narrative: Awakened in AM with hives. The pt saw the doctor on 03/12/2002 and was given Decondron, Medrol dose pack and was agian seen in the office on 03/14/2002 with still visible hives. The pt stated weakness and tiredness. Pt has multiple allergies and is followed by the allergist. Follow up states it is not possible to determine whether this reaction was related to hepatitis A vaccine or not since there is no current recommendation for booster vaccination and patient has received 2 dose of vaccine. Revaccination
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Erythema, Malaise, Oedema peripheral
Clinical narrative: The evening of vaccination, the pt developed left lower extremity and left upper extremity pain and chills. The next day, left lower extremity swelling, erythema, malaise, caphalgia. The treatment for cellulitis started on 03/08. and hemorrhages noted on 03/11 on seven fingers.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: The evening of vaccination, the pt developed left lower extremity and left upper extremity pain and chills. The next day, left lower extremity swelling, erythema, malaise, caphalgia. The treatment for cellulitis started on 03/08. and hemorrhages noted on 03/11 on seven fingers.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Crying, Pain
Clinical narrative: Hep a given during day on 01/28/2002 at about 6pm. The pt began crying uncontrollably with complaints of "blood hurting." No fever. Mom called ER and gave Tylenol and soon after the pt fell asleep and was fine in the morning.
Age: 4.5
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Autism, Pyrexia
Clinical narrative: Developed high fever (103F) one month after MMR. MMR given 7/16/98. Developed fever and seen in urgent care without fever and ??. 8/22/98 - dx'd with autism several months later
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Influenza like illness, Nausea
Clinical narrative: The day of the vaccination, the pt developed extreme dizziness that lasted 36 hrs with nausea and flu-like symptoms that lasted three days.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Injection site reaction
Clinical narrative: 24hours post-vaccination, the pt developed redness at site of injection followed by marked swelling, hot to touch. Seen in the doctor's office and was prescribed Benadryl.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Severe redness and swelling to site L deltoid.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, PPV
Symptoms: Unevaluable event
Clinical narrative: Physician ordered IPV. Pt given .5cc pneumovax (adult) in error. Spoke with pt's mother and she stated that the pt has no problems.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Headache, Rash papular
Clinical narrative: Papular rash, joint pain, headache. no treatment.
Age: 38.0
Sex: F
Vaccine: HEPAB
Symptoms: Asthenia, Blood pressure increased, Contusion, Headache, Nausea
Clinical narrative: Injection given IM L deltoid, bruising, weakness, headache, nausea, (weakness was generalized). increase in B/P. Physician advised pt not to take another vaccine. Increased BP meds to help lower B/P.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Multiple sites - some scab's, mainly on torso and face.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Convulsion, Laboratory test abnormal, Pyrexia
Clinical narrative: Temperature of 104.6F rectal at 22:20, 102.8F rectal at 23:25, 100.9F rectal at 00:15. Generalized seizure lasting approx 1-3 min observed by parents. Vaccines given 3/11/02 at approx 11:30. D/C from ER at 00:55 on 3/12/02.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pruritus, Rash
Clinical narrative: Pt had hepatitis B vaccine - within 15 min got facial rash, throat and neck discomfort. Rash ad itch on chest, some nausea.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Injection site pain, Oedema peripheral
Clinical narrative: 2/27/02-Patient received MMR, Comvax, varivax slight redness and swelling of arms noted, then resolved.  3/7/02-slight redness noted on left deltoid region then progressively worsened and tender to touch  3/8/02-Clinic appointment-diagnosis cellulitis left deltoid region (1 cm firm red tender) 3/11/02- Cellulitis-improving
Age: 10.0
Sex: M
Vaccine: HEP, IPV, MMR, TD
Symptoms: Anxiety, Cold sweat, Listless, Mydriasis
Clinical narrative: via Spanish translator-child restarted immunizations d/+, no records available. Mother states child previous immunized. innuizations given. Child increased anxiety, listlessness, no  LOC, pupil dilated, BP 134/88 standing  skin cold, clammy. Pt responded post 15 mins. of Trendelenburg. School notify 2/21/2002.   No symptoms or treatment
Age: 9.0
Sex: M
Vaccine: IPV, TD
Symptoms: Erythema induratum, Oedema
Clinical narrative: Pt received 2 vaccines on 3/6/02-came into our clinic @ 2040 on 3/8/02 with c/o right arm with redness (allergic reaction vs infection) and swelling. Treated with Keflex and Benadryl. Several CM of erythema and induration.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Lymphadenopathy, Pharyngolaryngeal pain, Pyrexia, Rash
Clinical narrative: MMR and Hepatitis B #1 administered on 1/24/02. On 2/2/02, pt developed a sore throat, runny nose, swollen lymph nodes pre and post  auricular and groin, lethargy. This progressed to a fine rash on her back, chest, face and buttocks Temp of 100.2 accompanied the above symptoms.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Rhinorrhoea
Clinical narrative: MMR and Hepatitis B #1 administered on 1/24/02. On 2/2/02, pt developed a sore throat, runny nose, swollen lymph nodes pre and post  auricular and groin, lethargy. This progressed to a fine rash on her back, chest, face and buttocks Temp of 100.2 accompanied the above symptoms.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local swelling sight redness in leg at site of 4th injection. (otherwise well-no fever)
Age: 1.2
Sex: F
Vaccine: HBHEPB, MMR
Symptoms: Irritability, Rash
Clinical narrative: 3/12/02 mother called HD, pt was irritable last night - pt was and is teething now. Mother gave pt motrin. This afternoon 1pm mother noted that pt has dots on her torso, no c/o pruritis or ?. Rash is 3 hrs in duration
Age: 19.0
Sex: M
Vaccine: TYP
Symptoms: Anorexia, Cough, Headache, Pyrexia
Clinical narrative: Pt received oral typhoid vaccine. forth observatioin 3/6,8,10,12. On 3.12.02, he developed fever 103.6, headache, dry cough, chills, anorexia, Symptoms still present
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Otitis media, Pharyngitis, Pyrexia, Rhinitis
Clinical narrative: Had fever-went to ER Had vomiting and diarrhea & cold symptoms 3/1/02 Diagnosis with Otitis Media. Unlikely due to vaccine per nurse practioner but diagnosis as immunization reaction @ hospital
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Had fever-went to ER Had vomiting and diarrhea & cold symptoms 3/1/02 Diagnosis with Otitis Media. Unlikely due to vaccine per nurse practioner but diagnosis as immunization reaction @ hospital
Age: 1.6
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site mass, Injection site warmth
Clinical narrative: Immunization given on 2/27/02-Mom called 3/1/02 and states LT where immunizations given is warm to touch, swollen size of fifty cent piece and golf ball size. States area is soft, not hard, No fever, no difficulty moving legs, not sore to touch.
Age: 1.08
Sex: M
Vaccine: IPV, MMR
Symptoms: Dry skin, Erythema, Feeling hot, Pyrexia
Clinical narrative: HJeart rate 150, BP 80/60, T-99.2 degrees F @ 1140 am. skin very warm to touch and dry. skin red like a sunburn on arms, shoulders, back, legs and cheeks. 1212 pm T-96.7 degrees F, pulse 120. Decrease in red, warm skin
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Rash erythematous
Clinical narrative: Developed red, raised rash to arms, torso, back, legs @ approximately 7:00 pm 3-13-02.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Pain
Clinical narrative: Red, swollen, tender at surrounding injection site on right deltoid area since 03/13/2002.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: A sales representative reported that an infant rec'd Prevnar and subsequently developed a high fever. The infant was brought to the hospital and was admitted. No additional info was available as of the date of this report. Additional information rec'd on 2/5/02 from sales rep. A HCP reported that a pt rec'd 1st dose of Prevnar , 2nd dose of Infanrix (DTaP), 2nd dose of Act-HIB, and 2nd dose of Engerix-B on 1/24/02. On 1/25/02, the pt developed a high fever and seizures. The infant was brought to the hospital and was admitted. She was discharged from the hosp and she recovered. No additional info was available as of the date of this report. A copy of this report has been forwarded to the manufacturer's of the vaccines. Follow up info rec'd 3/14/02. approx 12 hrs post immunization, at 1:30am on the day of admission 1/25/02, the infant was found to be shaking and stiff. The infant developed generalized tonic clonic activity lasting for about 6 minutes. The infant was transported by ambulance to the ER. In the ER she was drowsy and foaming in the  mouth. While in the ER during a physical exam, the pt experienced another seizure. On admission a physical exam revealed temperature 102.8F HR 177; RR 30W/9-92" and nasal congestion. She was treated with Diazepam IM. The fever resolved. The pt remained asymptomatic and was discharged home after 24 hrs.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Aspartate aminotransferase increased, Convulsion, Heart rate increased, Musculoskeletal stiffness, Nasal congestion
Clinical narrative: A sales representative reported that an infant rec'd Prevnar and subsequently developed a high fever. The infant was brought to the hospital and was admitted. No additional info was available as of the date of this report. Additional information rec'd on 2/5/02 from sales rep. A HCP reported that a pt rec'd 1st dose of Prevnar , 2nd dose of Infanrix (DTaP), 2nd dose of Act-HIB, and 2nd dose of Engerix-B on 1/24/02. On 1/25/02, the pt developed a high fever and seizures. The infant was brought to the hospital and was admitted. She was discharged from the hosp and she recovered. No additional info was available as of the date of this report. A copy of this report has been forwarded to the manufacturer's of the vaccines. Follow up info rec'd 3/14/02. approx 12 hrs post immunization, at 1:30am on the day of admission 1/25/02, the infant was found to be shaking and stiff. The infant developed generalized tonic clonic activity lasting for about 6 minutes. The infant was transported by ambulance to the ER. In the ER she was drowsy and foaming in the  mouth. While in the ER during a physical exam, the pt experienced another seizure. On admission a physical exam revealed temperature 102.8F HR 177; RR 30W/9-92" and nasal congestion. She was treated with Diazepam IM. The fever resolved. The pt remained asymptomatic and was discharged home after 24 hrs.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Pyrexia, Somnolence, Tremor
Clinical narrative: A sales representative reported that an infant rec'd Prevnar and subsequently developed a high fever. The infant was brought to the hospital and was admitted. No additional info was available as of the date of this report. Additional information rec'd on 2/5/02 from sales rep. A HCP reported that a pt rec'd 1st dose of Prevnar , 2nd dose of Infanrix (DTaP), 2nd dose of Act-HIB, and 2nd dose of Engerix-B on 1/24/02. On 1/25/02, the pt developed a high fever and seizures. The infant was brought to the hospital and was admitted. She was discharged from the hosp and she recovered. No additional info was available as of the date of this report. A copy of this report has been forwarded to the manufacturer's of the vaccines. Follow up info rec'd 3/14/02. approx 12 hrs post immunization, at 1:30am on the day of admission 1/25/02, the infant was found to be shaking and stiff. The infant developed generalized tonic clonic activity lasting for about 6 minutes. The infant was transported by ambulance to the ER. In the ER she was drowsy and foaming in the  mouth. While in the ER during a physical exam, the pt experienced another seizure. On admission a physical exam revealed temperature 102.8F HR 177; RR 30W/9-92" and nasal congestion. She was treated with Diazepam IM. The fever resolved. The pt remained asymptomatic and was discharged home after 24 hrs.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: A sales representative reported that an infant rec'd Prevnar and subsequently developed a high fever. The infant was brought to the hospital and was admitted. No additional info was available as of the date of this report. Additional information rec'd on 2/5/02 from sales rep. A HCP reported that a pt rec'd 1st dose of Prevnar , 2nd dose of Infanrix (DTaP), 2nd dose of Act-HIB, and 2nd dose of Engerix-B on 1/24/02. On 1/25/02, the pt developed a high fever and seizures. The infant was brought to the hospital and was admitted. She was discharged from the hosp and she recovered. No additional info was available as of the date of this report. A copy of this report has been forwarded to the manufacturer's of the vaccines. Follow up info rec'd 3/14/02. approx 12 hrs post immunization, at 1:30am on the day of admission 1/25/02, the infant was found to be shaking and stiff. The infant developed generalized tonic clonic activity lasting for about 6 minutes. The infant was transported by ambulance to the ER. In the ER she was drowsy and foaming in the  mouth. While in the ER during a physical exam, the pt experienced another seizure. On admission a physical exam revealed temperature 102.8F HR 177; RR 30W/9-92" and nasal congestion. She was treated with Diazepam IM. The fever resolved. The pt remained asymptomatic and was discharged home after 24 hrs.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: A sales representative reported that an infant rec'd Prevnar and subsequently developed a high fever. The infant was brought to the hospital and was admitted. No additional info was available as of the date of this report. Additional information rec'd on 2/5/02 from sales rep. A HCP reported that a pt rec'd 1st dose of Prevnar , 2nd dose of Infanrix (DTaP), 2nd dose of Act-HIB, and 2nd dose of Engerix-B on 1/24/02. On 1/25/02, the pt developed a high fever and seizures. The infant was brought to the hospital and was admitted. She was discharged from the hosp and she recovered. No additional info was available as of the date of this report. A copy of this report has been forwarded to the manufacturer's of the vaccines. Follow up info rec'd 3/14/02. approx 12 hrs post immunization, at 1:30am on the day of admission 1/25/02, the infant was found to be shaking and stiff. The infant developed generalized tonic clonic activity lasting for about 6 minutes. The infant was transported by ambulance to the ER. In the ER she was drowsy and foaming in the  mouth. While in the ER during a physical exam, the pt experienced another seizure. On admission a physical exam revealed temperature 102.8F HR 177; RR 30W/9-92" and nasal congestion. She was treated with Diazepam IM. The fever resolved. The pt remained asymptomatic and was discharged home after 24 hrs.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injection site oedema, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt experienced low-grade fever (99.9 degrees F on oral temeperture) nausea, vomiting, dizziness and localized swelling @ left deltoid (site of pneumococcal vaccine administered 3/18/01) within hours of this injection Inadvertently previous vaccine given 5/22/01 was missed on chart. Review initially by the treating physician. Pt instructed to call 3/20.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Nonstop inconsolable crying for 4 hrs beginning about 3 hrs after immunizations. Crying stopped. Treated with ibuprofen and tylenol.
Age: 0.08
Sex: F
Vaccine: DTAP
Symptoms: Sleep disorder, Vomiting
Clinical narrative: From 3/12-3/15, slept for about 9 hours/day instead of 15 hours, Daughter was spitting up a lot after every feeding.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Erythema, Injection site induration, Oedema
Clinical narrative: Redness and swelling to right thigh, where Hepatitis b was given right thigh nontender and mildly indurated. Pt came in for TB reading and mom pointed out swollen right thigh. Reported to doctor and prescribed Benadryl and APAP Also, advised to apply cool compresses to shot site.
Age: 0.7
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Pt presents with 6x6 red area over Prevnar injection area. Has lump size of pea. Pt without pain.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Hypoaesthesia, Injection site inflammation, Injection site pain, Neck pain
Clinical narrative: Pt states that she had pain in her L arm radiating into her heck which began approx 2 hrs after receiving the vaccine on 10/19/01. It increased to the point of numbness in her  hand and pain radiating to her L eye, she had constant pain in arm and neck and experienced a low grade fever, 99.8-100F. She had difficulty lifting her arm She took anti-inflammatory medications (ES tylenol and on does of tylenol with codeine). She saw the doctor on 10/23/01. He felt a nerve was inflamed and prescribed Naproxen in the evening and during the day if necessary. She took on does Tuesday evening and on dose Wednesday AM but discontinued this after experiencing severe nausea. By this time she stated that the eye pain was much better and the numbness had subsided. She continued to self medicate with ES tylenol. 11/14/01 she stated she is back to normal. It got a little better each day without further treatment.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Pt states that she had pain in her L arm radiating into her heck which began approx 2 hrs after receiving the vaccine on 10/19/01. It increased to the point of numbness in her  hand and pain radiating to her L eye, she had constant pain in arm and neck and experienced a low grade fever, 99.8-100F. She had difficulty lifting her arm She took anti-inflammatory medications (ES tylenol and on does of tylenol with codeine). She saw the doctor on 10/23/01. He felt a nerve was inflamed and prescribed Naproxen in the evening and during the day if necessary. She took on does Tuesday evening and on dose Wednesday AM but discontinued this after experiencing severe nausea. By this time she stated that the eye pain was much better and the numbness had subsided. She continued to self medicate with ES tylenol. 11/14/01 she stated she is back to normal. It got a little better each day without further treatment.
Age: 1.75
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Skin ulcer
Clinical narrative: Clusters of discreet 0.5 erythematous annular lesions B/L thighs adjacent to injection site - 2 days after vaccine.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, TD
Symptoms: Cellulitis, Injection site erythema, Injection site reaction
Clinical narrative: Rec'd vaccines 3/8/02. Called office 3/10/02 with red at shot site on R thigh. Dx with cellulitis VS Prevnar redness. Put on Keflex.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hyperaesthesia, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: On 03/14/2002 left arm swollen and red since 03/13/2002. Received shots on 03/12/2002, hurts to touch. Left arm 3" x 5" red mild induration, reaction to DTaP. Was given Benadryl at night.
Age: 5.0
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site mass
Clinical narrative: 1 cm firm lump under skin of left thigh
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Hives starting with redness on back and stomach by morning of Dec 16, 2001, raised spots. disappeared within 3 days.
Age: 1.0
Sex: M
Vaccine: HBHEPB
Symptoms: Feeling hot, Fluid retention, Skin irritation
Clinical narrative: Left lateral thigh with fluid/firmness and 2 1/2 x 2 1/2 cm pink gflat irritation (-) warm to touch, non-tender
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose increased, Blood sodium decreased, Flushing, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Pt complained of feeling ill, with chills, flushed face, injection site with erythema and induration. Temperature max of 103.1F. The next day (1/2/02), RN noted pt was lethargic, nauseated, pain at injection site with bright red and warm wheal 8cm X 6cm. Treated with ice packs and acetaminophen. Symptoms resolved within 7 days.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Lethargy, Malaise
Clinical narrative: Pt complained of feeling ill, with chills, flushed face, injection site with erythema and induration. Temperature max of 103.1F. The next day (1/2/02), RN noted pt was lethargic, nauseated, pain at injection site with bright red and warm wheal 8cm X 6cm. Treated with ice packs and acetaminophen. Symptoms resolved within 7 days.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia, Urticaria, White blood cell count decreased
Clinical narrative: Pt complained of feeling ill, with chills, flushed face, injection site with erythema and induration. Temperature max of 103.1F. The next day (1/2/02), RN noted pt was lethargic, nauseated, pain at injection site with bright red and warm wheal 8cm X 6cm. Treated with ice packs and acetaminophen. Symptoms resolved within 7 days.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Hypoaesthesia, Paraesthesia
Clinical narrative: Approx. 17 hours post vaccination, the pt noted numbness in right arm down to middle of right thumb. This increased to include occasional coldness and numbness of whole thumb, occasional tingles of right arm. Saw a physician on 11/05/2001 and was given muscle relaxer. On 11/08/2001 he felt numbness had decreased slightly.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pruritus
Clinical narrative: The pt had an enlarging redness, initially on left thigh on 3/12/02 and had increased redness. Then on 3/13/02, had increased redness and itching began.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Varivax vaccine failure
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Chills
Clinical narrative: Two hours after the vaccination, the pt developed chills, 8-12hrs later she developed abdomin cramping which lasted until 03/15/2002. Had similar reaction to the first dose. Symptoms improved by 03/15/2002.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling and erythema at the injection site.
Age: 3.75
Sex: F
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: 6cm X 6cm
Age: 0.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Hypotonia, Loss of consciousness, Pallor, Vomiting
Clinical narrative: Vomited within 3 hrs post vaccination, limp, pale, unconscious. Contacted 911 and within minutes vital signs stabolized.
Age: 4.0
Sex: F
Vaccine: HBHEPB, VARCEL
Symptoms: Drug ineffective
Clinical narrative: Erupted with pox on 03/12/2002. Had received varivax on 09/28/1998 and had about 30 lesions on 03/13/2002. When seen by PCP, mildly pruritic, afebrile.
Age: 1.08
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash maculo-papular, Rhinorrhoea
Clinical narrative: Rash (maculo-papular) started around mouth, 10 days post vax, and spread on to body. Fever to 101F and rhinorrhea.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Throat tightness
Clinical narrative: Pt had TD on 2/4/02 and on 2/15/02, pt called stating that 24 hours, post vax, she had facial numbness across cheeks, pressure in throat and this passed. She was seen on 2/15/02 in the doctor's office.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Back pain, Vaccine positive rechallenge
Clinical narrative: Backache, 10 hours after 1st IM exposure dose. Backache within 15 minutes of 2nd dose.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Eye disorder, Injection site swelling, Injection site warmth, Nausea, Paraesthesia
Clinical narrative: About 2 hours, post vax, the pt developed chills, nausea, "eyes felt hot", legs and arms tingled and late in the day, temperature was 101F. Also arm was swollen and hard. Rx'd with Tylenol; next day all signs and symptoms had subsided.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: About 2 hours, post vax, the pt developed chills, nausea, "eyes felt hot", legs and arms tingled and late in the day, temperature was 101F. Also arm was swollen and hard. Rx'd with Tylenol; next day all signs and symptoms had subsided.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mom noted increased redness, swelling and warmth at the injection site on her left thigh on 3/12/02. On 3/13/02, pt was seen in office with swelling, redness and warmth. She was started on Duricef.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Injection site at left deltoid had a firm nodule 1cm X 1cm in tissue/muscle with mild swelling and erythematous area 4cm X 4cm. This developed 1 week after injection.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: The pt complained of itchy hands and feet first; then entire body with diffuse urticaria over torso and extremities. Gave Benadryl 25mg immediately; Decadron 20mg, IM and appt made with allergist. Gave Orapred X 9 days.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Rash onset in the evening of 3/12/02 which involved to the appearance of chickenpox covering face, trunk and extremities. Had a dense cluster of blisters approx. 2" in diameter over left deltoid region. Denies fever or other symptoms. Given Zovirax oral suspension.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Somnolence
Clinical narrative: Fell asleep 2 minutes after shot. C/O headache, dizziness. No treatment.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Feeling abnormal, Irritability, Oral intake reduced, Pyrexia
Clinical narrative: 9 days later, pt had a 102F fever and stopped eating for 2 days. He acted very dazed and fuzzy which lasted 2 days with symptoms but fussy a few days prior.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Localized erythema noted to medial right thigh. Site had a firm surrounding.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling, erythematous treated with Benadryl and follow-up tomorrow to rule out cellulitis. Complete involvement of deltoid.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Local reaction to injection site with erythema from L upper arm to elbow on 3/14/02 - improved when seen on 3/15/02 area around upper arm still swollen and leg 3cm in diameter. No systemic effects, no hives, now wheezing. RX Zyrtec and cool soaks.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Reporting varicella with many lesions and in the eye; is to see ophthamologist. Placed on Zovirax 800mg qid X 5 days. Under present care. (2nd Varivax given on 4/24/98; lot 1578E/SC/Deltoid)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Lymphadenopathy, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: On 3/15/02 at 04:30, pt developed a fever of 102F, swollen lymph nodes and a sore throat. Went to PMD on 3/15/02 and PMD not sure if related to vaccine or virus. No treatment.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: 5-10 lesions
Age: 1.6
Sex: M
Vaccine: DTAP, HEP, DTAP, HEP, DTAP, HEP
Symptoms: Erythema
Clinical narrative: 10 cm by 8 cm redness on left upper arm. No induration and no pus.
Age: 1.6
Sex: M
Vaccine: DTAP, HEP, DTAP, HEP, DTAP, HEP
Symptoms: Injection site erythema
Clinical narrative: 10 cm by 8 cm redness on left upper arm. No induration and no pus.
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Convulsion, Eye movement disorder, Hypoventilation, Pyrexia, Roseola
Clinical narrative: On the evening of 1/24/02, the pt had increased temperature of 99.5F (by ear) which went down to normal after a bath. Throughout 1/25/02, had not noticed fever until 16:15. At that time, the child experienced a seizure with eyes rolled back, shaking body, foaming at the mouth and a muffled cry. Also had shallow breathing. Ambulance was called. Administered O2 and transported to the hospital. Temperature of 104F was noted. The pt remained at the hospital for 5 hours until temperature decreased to normal. States seizure lasted about 20 minutes. The doctor said it was either due to immunizations, roseola or an unknown virus.
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Salivary hypersecretion, Tremor, Viral infection
Clinical narrative: On the evening of 1/24/02, the pt had increased temperature of 99.5F (by ear) which went down to normal after a bath. Throughout 1/25/02, had not noticed fever until 16:15. At that time, the child experienced a seizure with eyes rolled back, shaking body, foaming at the mouth and a muffled cry. Also had shallow breathing. Ambulance was called. Administered O2 and transported to the hospital. Temperature of 104F was noted. The pt remained at the hospital for 5 hours until temperature decreased to normal. States seizure lasted about 20 minutes. The doctor said it was either due to immunizations, roseola or an unknown virus.
Age: 1.4
Sex: F
Vaccine: DTAP, MMR
Symptoms: Hypokinesia, Injection site pain, Injection site warmth, Irritability
Clinical narrative: Leg pain started on 3/13/02; not bearing weight; warm to touch; not swollen; irritable; not red; and playful but cries occasionally.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Varivax vaccine failure
Sex: M
Vaccine: HEP
Symptoms: Autism
Clinical narrative: On an unspecified date, the child received Engerix-B and other, unspecified vaccines. The child was subsequently determined to have autism. Additional information has been requested. As of 4/18/02, the outcome of the event was not known to the reporter. The reporter considered autism to be possibly related to Engerix B. This report of autism is considered medically serious (OMIC).
Age: 65.0
Sex: M
Vaccine: TD
Symptoms: Muscle spasms, Muscular weakness, Pain
Clinical narrative: 48 hours, post vax, pt had muscle spasms for about 30 minutes. 2-3 days later, had another episode of spasms X 2. 2 months later, muscle feels "weaker" not able to use arm in the same way since injection. Had an injury (very deep wound) in the same arm (barbed wire pierced arm), 2 days before shot. It is an aching pain a of the time and it never seems to go away now.  Had an active life-style before "shot". Pt was referred to the MD of his choice.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, OPV, PNC
Symptoms: Febrile convulsion, Meningitis
Clinical narrative: Patient had generalized seizure, fever. Had fever of 101.4 at admission. Possible atypical febrile seizure, possible meningistis.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cyanosis, Febrile convulsion, Irritability, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: Baby received DTAP, IPV, HIB and Prevnar on 1/9/02 and became fussy and febrile and may have had a seizure: brief episode of stiffening, turning slightly blue and a few twitches which lasted 1-2 minutes. According to mom, it stopped before EMS arrived.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Irritability
Clinical narrative: Exacerbated fussiness.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Dyspnoea, Heart rate increased, Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: According to the pt's mother the child developed shortness of breath, increased heart rate, swollen reddened injection site. He was taken to the doctor's office and monitered for several hours and discharged. Had a fever for  days after injection up to 103 deg. F.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Hyperaemia, Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Erythema, hyperemia, swelling at the injection site of DTaP associated with fever of 103 deg. F. in 2nd day of reaction.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Left arm was red, hard and swollen the size of a baseball. Mom states that his entire upper arm was swollen yesterday (3/14/02). Temperature on 3/14/02 was 99F-101F.
Age: 36.0
Sex: M
Vaccine: FLUX, MEA
Symptoms: Chills, Injection site hypersensitivity, Injection site induration, Pain, Pyrexia
Clinical narrative: Received TD on 03/05, on 03/06 he developed body aches, subjective fevers and chills without an obvious source. Area of immunization with 2cm induration and tenderness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Local reaction at left deltoid where DTAP and IPV were given 24 hours ago. Mild uniform erythema extended from shoulder to elbow. Indurated about 6cm central deltoid.
Age: 1.2
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: Fever of 103-104deg F. 4-6 hrs after the vacciantion with DTaP, IPV and MMR. Continued fever for 24 hrs. Increased to 105.4 in the clinic. Treated with Advil.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Muscular weakness
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old male with a history of a splenectomy following a motor vehicle accident in 1995 who on 02/13/2002 was vaccinated with pneumococcal vaccine 23 polyvalent in his right deltoid. The nurse reported that the pt was well at the time of the vaccination. On 02/14/2002 the pt called into the office and spoke to the on-call physician complaining that his right arm was red and swollen. The pt was instructed to go to the ER. The pt did not received treatment at ER and was not admitted to the hospital but was seen in his physician's office on 02/15/2002. The nurse reported that on the 02/15/2002 office visit the pt's arm "looked bad." The nurse reported that the pt was missing work because he was a right armed painter and could not work. The pt was diagnosed with cellulitis and treated with a 10 day course of Keflex. On 02/18/2002 the pt was seen again in his physician's office and the redness had gone away, however the pt was still complaining of pain and weakness. The pt was prescribed Keflex for 4 more days. On 02/22/2002 the pt was seen again for another problem and the cellulitis had resolved. Upon internal review, the cellulitis was considered to be an other medical event. Additional info has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pruritus, Urticaria
Clinical narrative: Initial and follow-up information has been received from an RN and a PA concerning a 67 year old (DOB reported as 8/1/34 and 8/8/34) Caucasian female pt who on 10/23/01 at 12:00 was vaccinated IM in the right deltoid with the 2nd dose (lot 637263/1448K) of pneumococcal vaccine 23 polyvalent (Dose 1 in 1996, with no known reaction). Concomitant therapy on 10/17/01 at 13:10, included a dose (lot E04861KA) IM in the left deltoid of influenza virus vaccine (Fluvirin) (number of previous doses uncertain). On 10/23/01, within a few hours, post vax, the pt experienced erythema and warmth at the injection site. The pt presented to the physician's office on 10/24/01 at 11:00 for the reaction. It was noted that the area was 7" X 11" with induration that was raised. Erythema of the right arm was present from the injection site around to the center of the inner bicep. The reaction was characterized as having a "welt" or hive appearance consistent with "a reaction seen with preservative in injectable medication". It was noted that the pt did not experience shortness of breath or chest pains, but that minor pruritus was present (reported that "none were serious"). The pt was subsequently hospitalized for 3 days and treated with IV antibiotics (not specified), diphenhydramine hydrochloride (Benadryl) (50mg as directed) and warm and moist compresses (20 minutes on and off). It was noted that the pt refused all tests and follow-up treatment. The pt "was concerned that this was Anthrax". Subsequently, the pt recovered from the experience. No further information is available.
Age: 1.08
Sex: M
Vaccine: HEP
Symptoms: Autism, Drug toxicity
Clinical narrative: Information has been received from a consumer concerning her approx. 13 month old male son that might "be allergic to dairy products" who on 10/4/99 was vaccinated with the 1st dose of Hep-B recombinant (yeast). Subsequently, the pt developed autism (date not reported). The mother reported that she had at least 8 injections of globulin, immune (Rhogam), which she stated had "high doses of mercury", during all of her pregnancies because she is RH negative. It was reported that her physician "never gave her the option to give her son thimerosal free" Hep-B vaccine recombinant (yeast), "nor told her the dangers of it". She stated that she was having the pt's hair tested to check for mercury poisoning. The pt has a 7 year old sister who has a learning disability, whom the reporter is also having tested for mercury poisoning. The mother did not know if the globulin, immune (Rhogam) she received, or the childhood vaccinations her children received "caused the children's health problems" (vaccine (s) not specified for the sister). Unspecified medical attention was sought. The pt's autism persisted. Upon internal review, autism and mercury poisoning were determined to be "Other Important Medical Events". Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: PNC, PPV
Symptoms: Injection site induration, Injection site pain
Clinical narrative: An investigator reported that an unidentified child rec'd Prevnar and Pnu-Imune-23 vaccines on 2/4/02, as part of the GMA local study: evaluation of the immunogenicity of pneumococcal conjugate vaccine and routine pediatric immunizations in HIV-infected children treated with highly active anti-retrovial therapy (HAART). Post immunization, the child developed a vaccine reaction that was rated grade 3. According to the protocol, grade 3 adverse reactions require a clinic visit within 48 hrs of the event. This case was considered serious since vaccine reaction (grade 3) was medically important in this case. The investigator assessed the relationship between vaccine reaction (not expected per package insert) and Prevnar as possibly related. The investigator assessed the relationship between vaccine reaction and Pnu-Imune 23 as definitely related. The medical monitor assessment is unknown. Follow up: On 31JAN2002, the paitent developed pain at injection site meauring 5cm x 9cm, and induration at the injection site measuring 3cm x 6cm developed. The patient was treated with Tylenol and ibuprofen. Outcome details were not provided.