chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.6
Sex: M
Vaccine: DTAP
Symptoms: Depressed level of consciousness, Eye disorder
Clinical narrative: Patient noted to be asleep and then began groaning and eyes were half open. He could not be aroused with stimulation. The episode lasted 45 seconds to 1 minute. Then the patient's eyes opened wide and he came around. Patient was seen by neurology.
Age: 1.9
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Patient received Varivax 11/28/00. On 6/11 patient noted to have a rash all over. Patient was diagnosed with chickenpox during office visit on 6/11/01.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Joint stiffness, Pyrexia
Clinical narrative: Three days post vaccine, patient developed a fever. One week post vaccine, the patient had pain and difficulty moving her joints all over. Daily tasks, such as climbing stairs and getting out of bed, were difficult to perform.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Patient broke out in chickenpox after receiving the varicella vaccine several years prior.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient developed a 10cm x 12cm area of erythema and induration at injection site.
Age: 12.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Rash erythematous
Clinical narrative: Patient developed a raised rash all over the body approximately 1.5 days after being vaccinated. Mother treated with Benadryl and a topical cream. The rash would disappear and reappear about every 4 hours when the Benadryl wore off. The rash lasted for about 5 days.
Age: 6.0
Sex: F
Vaccine: RAB
Symptoms: Lethargy, Pyrexia, Somnolence
Clinical narrative: Patient developed a fever of 102.5 and lethargy. She slept most of the day on 5/12, 5/13 and part of the day on 5/14.
Age: 6.0
Sex: F
Vaccine: RAB
Symptoms: Lethargy, Pyrexia, Somnolence
Clinical narrative: Patient developed lethargy and a temperature of 101 for 1 day. She slept all afternoon on 5/19.
Age: 7.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Patient developed a rash on left arm and neck within 24 hours after receiving vaccine. The rash resolved itself within a few days.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient became febrile and vomited several times. Fever responded to Tylenol but returned. The fever lasted 24 hours, and the vomiting lasted 12 hours.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient was noted to be febrile and nauseated the day following injection. She was given Tylenol which decreased her temperature.
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: The pt developed the measles.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient developed a 5 x 8 cm area of erythema, heat and induration at site of injection. She was treated with Tylenol and ice.  Follow up on 10/25/02: "From mailed correspondence received on 08/27/01, it was reported, "Reviewed, no additional information at this time." This case is closed."
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient developed a 5 x 8 cm area of erythema, heat and induration at site of injection. She was treated with Tylenol and ice.  Follow up on 10/25/02: "From mailed correspondence received on 08/27/01, it was reported, "Reviewed, no additional information at this time." This case is closed."
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Sudden infant death syndrome
Clinical narrative: The baby died from SIDS.
Age: 40.0
Sex: F
Vaccine: ANTH, HEP, HEPA
Symptoms: Anaemia, Spleen disorder, Thrombocytopenia, Thrombocytopenic purpura
Clinical narrative: The pt was dx'd with thrombocytopenia purpura on 8/2/00. She required multiple plasmapheresis exchanges and splenectomy (occurred on 12/20/00).  Follow up on 06/19/2001: "Patient has recovered from adverse event.  Patient is back on full duty, and workdays missed was 35-40 days.  Patient has been evaluated by a physician or health care provider for this event. "
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Anxiety, Dysphagia, Muscle contractions involuntary, Muscle spasms, Muscle twitching
Clinical narrative: On 8/10/00, pt was given Tetanus booster for puncture wound on left foot with localized tetany. DOI 8/1/00 and on 8/5/00, pt began having fasciculations and cramping in the left foot. On 8/15/00, pt was having multiple generalized symptoms with neck stiffness, dysphagia, multiple muscle spasms, anxiety, photophobia, phonophobia which were progressing and is currently still having multiple symptoms. It is uncertain if symptom progression after the booster on 8/10/00 are related, but pt did have previous reaction or symptoms after Tetanus booster. Case was reported to health dept as Tetanus. The annual follow up received on 6/27/02 states improved but remains with muscle twitching and intermittent paresthesias and peripheral neuropathy sx pt is approximately 80% resolved.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal stiffness, Paraesthesia, Phobia, Photophobia, Tetany
Clinical narrative: On 8/10/00, pt was given Tetanus booster for puncture wound on left foot with localized tetany. DOI 8/1/00 and on 8/5/00, pt began having fasciculations and cramping in the left foot. On 8/15/00, pt was having multiple generalized symptoms with neck stiffness, dysphagia, multiple muscle spasms, anxiety, photophobia, phonophobia which were progressing and is currently still having multiple symptoms. It is uncertain if symptom progression after the booster on 8/10/00 are related, but pt did have previous reaction or symptoms after Tetanus booster. Case was reported to health dept as Tetanus. The annual follow up received on 6/27/02 states improved but remains with muscle twitching and intermittent paresthesias and peripheral neuropathy sx pt is approximately 80% resolved.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Anaemia, Dyspnoea, Hypotonia, Injection site erythema, Pyrexia
Clinical narrative: After the 1st set of vaccines, DTAP, IPV, Hib at 5 months of age, pt developed fever up to 102F, shortness of breath, limp and erythema extending for about 30" from knees. Pt admitted to ICU for observation of fever. No other episodes. Work-up neg except for anemia. After 2nd set of vaccines DTAP, PIV, Hib, another episode of shortness of breath; fever up to 101F; no LOC.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Vaccine positive rechallenge
Clinical narrative: After the 1st set of vaccines, DTAP, IPV, Hib at 5 months of age, pt developed fever up to 102F, shortness of breath, limp and erythema extending for about 30" from knees. Pt admitted to ICU for observation of fever. No other episodes. Work-up neg except for anemia. After 2nd set of vaccines DTAP, PIV, Hib, another episode of shortness of breath; fever up to 101F; no LOC.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site urticaria, Rash erythematous
Clinical narrative: Immediately after the MMR was given the pt developed a 3x4cm area of pink, blanching rash with central raised urticarial lesions observed for 10 minutes. The area of pink rash decreased. No other rash lesions noted. Instructed to use cool compress, and Benadryl as needed. Return to clinic if symptoms worsen.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Oral intake reduced
Clinical narrative: Approximately 2 days post vax, the pt became more fussy, and eating decreased. This persisted for at least one week. She was seen in the office on 5/26/01 and 5/31/01. There was not fever. She gained 10 ounces in that time period.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Unevaluable event
Clinical narrative: No information provided.
Age: 1.15
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: The pt developed a large hive around where the MMR vaccine was give. The pt's doctor looked at it and ordered Benadryl. The pt stayed for 20 minutes to assure the Benadryl worked and the hive is better. Hive is better and less swollen. Cold compress was applied at short intervals with positive results.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: The pt's developed cellulitis, swelling, redness and warmth to the left arm. The pt also had a fever of 101 for 24 hours. The right arm had redness, warmth at the injection site.
Age: 0.7
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: The pt experienced swelling of the left leg, moves leg,  but not freely as right leg. The pt was taken to the MD for exam. The pt also ran a fever.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Insomnia, Pyrexia, Somnolence
Clinical narrative: The pt slept for 24-36 hours post vax, had a low grade fever, then had normal behavior during the daytime but fitful, wakeful sleep at night. This persisted through the evening of 6/10.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Urticaria
Clinical narrative: About 30 minutes post vax, the pt developed hives over elbows, knees, buttocks. No wheezing was noted. Given Benadryl by mouth and observed at the health center for 2 hours before releasing.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Headache, Injection site erythema, Injection site oedema, Pyrexia, Vomiting
Clinical narrative: The pt experienced a fever beginning 2 hours post vax with swelling of arm which was localized. The swelling resolved but evolved into red blotchiness. The pt also experienced a headache and vomiting.
Age: 1.6
Sex: M
Vaccine: HEP, PNC
Symptoms: Pyrexia
Clinical narrative: The pt came in on 6/8/01 with a fever greater than 101.
Age: 3.8
Sex: F
Vaccine: PNC, PNC, PNC
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: The pt experienced localized redness and swelling at the injection site, fever. Treated with warm wash cloth and Tylenol. By by 6/10 AM.
Age: 3.8
Sex: F
Vaccine: PNC, PNC, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: The pt experienced localized redness and swelling at the injection site, fever. Treated with warm wash cloth and Tylenol. By by 6/10 AM.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling jittery, Headache, Pain, Pyrexia, Skin burning sensation
Clinical narrative: The pt felt a burning pain to the front of the arm 25 minutes post vax which lasted 20 minutes. 12 hours later the pt had feet jitters, then 48 hours later a temp of 99 and body aches and headaches.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema, Pyrexia
Clinical narrative: The pt experienced swelling, redness and a temperature.
Age: 0.2
Sex: M
Vaccine: BCG
Symptoms: Agitation, Irritability, Malaise, Pyrexia
Clinical narrative: Following vaccine the pt became ill, was fussy, crying, and fever. The child remained ill for weeks. The administering hospital researched and discovered route should have been by per cutaneous disc. No disc was supplied with the vaccine.
Age: 76.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: The pt experienced wheals in the left deltoid, feels warm to the touch. The area measured 3 1/2 x 4 1/2 inches in size.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Headache, Hearing impaired, Similar reaction on previous exposure to drug, Visual acuity reduced
Clinical narrative: On 5/29/01 the pt developed a headache following the receipt of the meningococcal vaccine 4 days prior. The pt complained of not being able to hear, or see, was dizzy. She then was sent to the ER. Told was reaction to "shot".
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: The pt was presented with mild varicella.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The pt's left upper arm was red, warm to the touch on 6/5/01, gave Benadryl and was worse the following day. There was a 5 x 8 area of erythema and warmth. No discomfort with movement.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: The pt's left upper arm was red, warm to the touch on 6/5/01, gave Benadryl and was worse the following day. There was a 5 x 8 area of erythema and warmth. No discomfort with movement.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site mass, Injection site oedema, Rash erythematous
Clinical narrative: The pt's left thigh was enlarged, red, raised around the vaccine injection site with a firm nodule. Non-tender. Treated with Benadryl.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Screaming
Clinical narrative: The pt experienced a red and swollen injection site with a fever and prolonged crying for longer than 6 hours.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Blood thyroid stimulating hormone decreased, Dizziness, Nausea, Pain, Vomiting
Clinical narrative: The pt went to the ER for symptoms of light headedness, nausea, vomiting and upper body aches and on 10/13/00 states that she is still experiencing these symptoms. Went to MD and TSH was slightly low and medicine was adjusted.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 4 days post vax, the pt developed redness at the injection site. Seen in our office with an indurated area and 10cm x 4 1/2 cm erythema warm and tender. Diagnosed with cellulitis. Treated with Augmentin and cool compresses.
Age: 10.0
Sex: M
Vaccine: DTAP, OPV, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Erythema, Infection
Clinical narrative: The pt experienced Varicella vaccine failure. Was vaccinated in 1996 and was seen in the office with approx 30 spots, red based, fluid filled first appearing on 6/3/01.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Screaming
Clinical narrative: The night of 5/11/01, the pt began screaming and it continued through 5/12/01.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Coma, Dyskinesia, Headache, Hypersensitivity, Nausea
Clinical narrative: 1 minute post vax the pt slumped over in the chair, eyes closed, non-responsive, right leg and both arms with jerky movement. After 1 minute he opened his eyes and appeared dazed. He reported nausea and headache. Student was very pale and 911 was called. The student was taken by family to MD. MD felt it was an allergic reaction and referred them to an allergist.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Pallor, Syncope
Clinical narrative: 1 minute post vax the pt slumped over in the chair, eyes closed, non-responsive, right leg and both arms with jerky movement. After 1 minute he opened his eyes and appeared dazed. He reported nausea and headache. Student was very pale and 911 was called. The student was taken by family to MD. MD felt it was an allergic reaction and referred them to an allergist.
Age: 14.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Vision blurred
Clinical narrative: The pt felt dizzy, had blurry vision, right after vax. The pt also felt tired, but was talkative. No SOB. Epinephrine given and symptoms resolved. The pt also sweated.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The pt experienced erythema and swelling on the left deltoid area. No fever.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 1 day post vax, the pt experienced a red and swollen thigh. No fever, no tenderness. Walks normally. Seen in clinic. 9 x 5 1/2 cm area of erythema and induration. No fever, no tenderness. Recommended cool compresses and Tylenol.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: The pt was presented to the office with varicella.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: The pt experienced a fever of 103.7 the night of the vax and also redness at the injection site of polio.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Pyrexia, Rash
Clinical narrative: 9 days post vax, the pt developed a fever of 104.5 and had a seizure. The next day developed a rash. Seen at the ER.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: The pt was taken to the ER with a 1 3/4 inch raised red area at the injection site with some itching. No pain or SOB. The pt was told it was a reaction. No treatment ordered.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: On approx. 2/7/01, the pt developed a mild chickenpox rash. The pt sought medical attention. The nurse reported on FOLLOW-UP that the patient developed chicken pox after exposure to a classmate with the illness. Subsequently, the patient recovered. No further information is available.
Age: 32.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Joint stiffness, Lymphadenopathy, Pain
Clinical narrative: Information has been received from an RN concerning a 32 year old Caucasian female who on 3/20/01 was vaccinated with MMRII (lot 634686/0822K) SC, in the right upper arm. On 3/26/01, the pt experienced enlarged lymph nodes. Previously, the nurse reported that on 4/5/01, the pt experienced swollen bilateral lymph nodes in her groin and right axillary region and severe joint pain in both hands and hips. In follow-up, the nurse reported that on 4/5/01, the pt experienced "stiff joints (knees, ankles, hips) and both hands/wrists are stiff". On 4/10/01, the pt's right hand was swollen, numb, stiff, tingling and painful. The pt was seen by her PMP. On 4/14/01, the pt was seen in the ER with severe pain in her hands. The nurse reported that the pt's blood testing for underlying diseases were negative. The pt had nerve conduction tests that showed acute right brachial plexopathy. The nurse stated that the symptoms have continued to the present. The nurse reported that the hand pain, upper extremity edema, lymphadenopathy, muscular skeletal stiffness, and plexopathy were all disabling. Additional information has been requested. F/U on 7/2/01, the RN reported that the pt had been out of work two months and had recently returned to work and is doing better. Additional info has been requested. **Follow-up report on 10/10/02: Add'l follow-up info, received on 8/5/02, revealed that the PT continues to have mild pain in her hands and stiff joints. On 4/16/01, the PT was Dx's w/brachial neuritis. The PT's enlarged lymph nodes revealed w/in 8-9 mts and the right hand swelling resolved in 4 mts. It was noted that the PT was vax'd due to "rubella negative status". Previous vax info. was not provided. Add'l info. is not expected.*
Age: 32.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Hypoaesthesia, Joint stiffness, Joint swelling, Lymphadenopathy
Clinical narrative: Information has been received from an RN concerning a 32 year old Caucasian female who on 3/20/01 was vaccinated with MMRII (lot 634686/0822K) SC, in the right upper arm. On 3/26/01, the pt experienced enlarged lymph nodes. Previously, the nurse reported that on 4/5/01, the pt experienced swollen bilateral lymph nodes in her groin and right axillary region and severe joint pain in both hands and hips. In follow-up, the nurse reported that on 4/5/01, the pt experienced "stiff joints (knees, ankles, hips) and both hands/wrists are stiff". On 4/10/01, the pt's right hand was swollen, numb, stiff, tingling and painful. The pt was seen by her PMP. On 4/14/01, the pt was seen in the ER with severe pain in her hands. The nurse reported that the pt's blood testing for underlying diseases were negative. The pt had nerve conduction tests that showed acute right brachial plexopathy. The nurse stated that the symptoms have continued to the present. The nurse reported that the hand pain, upper extremity edema, lymphadenopathy, muscular skeletal stiffness, and plexopathy were all disabling. Additional information has been requested. F/U on 7/2/01, the RN reported that the pt had been out of work two months and had recently returned to work and is doing better. Additional info has been requested. **Follow-up report on 10/10/02: Add'l follow-up info, received on 8/5/02, revealed that the PT continues to have mild pain in her hands and stiff joints. On 4/16/01, the PT was Dx's w/brachial neuritis. The PT's enlarged lymph nodes revealed w/in 8-9 mts and the right hand swelling resolved in 4 mts. It was noted that the PT was vax'd due to "rubella negative status". Previous vax info. was not provided. Add'l info. is not expected.*
Age: 32.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Nervous system disorder, Radiculitis brachial
Clinical narrative: Information has been received from an RN concerning a 32 year old Caucasian female who on 3/20/01 was vaccinated with MMRII (lot 634686/0822K) SC, in the right upper arm. On 3/26/01, the pt experienced enlarged lymph nodes. Previously, the nurse reported that on 4/5/01, the pt experienced swollen bilateral lymph nodes in her groin and right axillary region and severe joint pain in both hands and hips. In follow-up, the nurse reported that on 4/5/01, the pt experienced "stiff joints (knees, ankles, hips) and both hands/wrists are stiff". On 4/10/01, the pt's right hand was swollen, numb, stiff, tingling and painful. The pt was seen by her PMP. On 4/14/01, the pt was seen in the ER with severe pain in her hands. The nurse reported that the pt's blood testing for underlying diseases were negative. The pt had nerve conduction tests that showed acute right brachial plexopathy. The nurse stated that the symptoms have continued to the present. The nurse reported that the hand pain, upper extremity edema, lymphadenopathy, muscular skeletal stiffness, and plexopathy were all disabling. Additional information has been requested. F/U on 7/2/01, the RN reported that the pt had been out of work two months and had recently returned to work and is doing better. Additional info has been requested. **Follow-up report on 10/10/02: Add'l follow-up info, received on 8/5/02, revealed that the PT continues to have mild pain in her hands and stiff joints. On 4/16/01, the PT was Dx's w/brachial neuritis. The PT's enlarged lymph nodes revealed w/in 8-9 mts and the right hand swelling resolved in 4 mts. It was noted that the PT was vax'd due to "rubella negative status". Previous vax info. was not provided. Add'l info. is not expected.*
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Within 3-4 hours post vax, the pt became very cranky, cried, didn't eat well, had to be held and started running a fever of 102-103. Within 6 hours post vax, the pt was running a fever of 104. The fever would go down some with treatment with Tylenol, but by the 4 hour next dose time, temp was rising. Had to be treated every 4 hours with Tylenol for 4 days. Temp didn't go below 102 even with treatment of Tylenol. The pt was not sleeping well or eating well, became pale with red, bluish circles around eyes. Rash started on hands then spread to torso, looked like little red dots, hands had red patches on knuckles and fingers. Stayed cranky, cried constantly if wasn't held or sleeping. Fluid intake was very little.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Decreased appetite, Erythema, Irritability, Pallor, Pyrexia
Clinical narrative: Within 3-4 hours post vax, the pt became very cranky, cried, didn't eat well, had to be held and started running a fever of 102-103. Within 6 hours post vax, the pt was running a fever of 104. The fever would go down some with treatment with Tylenol, but by the 4 hour next dose time, temp was rising. Had to be treated every 4 hours with Tylenol for 4 days. Temp didn't go below 102 even with treatment of Tylenol. The pt was not sleeping well or eating well, became pale with red, bluish circles around eyes. Rash started on hands then spread to torso, looked like little red dots, hands had red patches on knuckles and fingers. Stayed cranky, cried constantly if wasn't held or sleeping. Fluid intake was very little.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Rash, Skin discolouration, Sleep disorder
Clinical narrative: Within 3-4 hours post vax, the pt became very cranky, cried, didn't eat well, had to be held and started running a fever of 102-103. Within 6 hours post vax, the pt was running a fever of 104. The fever would go down some with treatment with Tylenol, but by the 4 hour next dose time, temp was rising. Had to be treated every 4 hours with Tylenol for 4 days. Temp didn't go below 102 even with treatment of Tylenol. The pt was not sleeping well or eating well, became pale with red, bluish circles around eyes. Rash started on hands then spread to torso, looked like little red dots, hands had red patches on knuckles and fingers. Stayed cranky, cried constantly if wasn't held or sleeping. Fluid intake was very little.
Age: 0.75
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Bacterial infection, Hearing impaired, Meningitis
Clinical narrative: Information has been received from a health professional concerning a 9 month old female who was vaccinated on approx. 3/26/01 with a dose of haemophilus b conjugate vaccine + Hep-B vaccine recombinant (yeast). On 5/5/01, the pt developed meningitis and bacteremia. Upon internal review the pt's experiences were considered an "Important Medical Event". No further information is available. The follow-up states that the pt was admitted to the hospital. Relevant lab tests indicate that the pt had a positive blood culture. It was noted that on 11/22/2000 and 01/16/2001 the pt was vaccinated with a first dose IM in the right leg and a second dose IM in the left leg  of HibTITER. Follow-up info has been received from a health care professional who reports the pt had residual hearing loss on the right side. Upon internal review, residual hearing loss was considered an other important medical event. Additional info has been requested.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Coagulopathy, Convulsion, Dermatitis bullous, Drug level decreased, Gangrene
Clinical narrative: It was reported that a 57 year old male with stage IV non-Hodgkin's Lymphoma who was vaccinated with pneumococcal vaccine 23 polyvalent at the time of his splenectomy for stage IV non-Hodgkin's. Three years, post vax, the pt developed fevers, chills, hypotension and a generalized seizure. The pt was treated with antibiotics for 4 weeks. He was treated with ceftriaxone, vancomycin and rifampin. Although the pt had been vaccinated against Streptococcus pneumoniae at the time of his splenectomy, he showed a protective antibody response to only 8 of 12 serotypes tested. A Gram's stain of the CSF showed gram-positive organisms in pairs and short chains, but cultures of the CSF were negative. A latex-agglutination test was positive for Streptococcus pneumoniae. During the next several days, disseminated intravascular coagulation and symmetric areas of pallor developed on the back of both hands and the soles of the feet, with overlying bulla. Cultures of the bullous fluid were sterile. The lesions progressed to dry gangrene. All blood cultures remained negative. The arterial supply to each of the arms and legs remained patent. The pt was revaccinated. It was noted that the pt's appearance was typical of symmetric peripheral gangrene associated with Streptococcus pneumoniae bacteremia in a pt whose spleen had been removed. Upon internal review, the pt's experiences were determined to be "Other Medical Events". Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Hypotension, Laboratory test abnormal, Pneumonia, Pyrexia, Skin discolouration
Clinical narrative: It was reported that a 57 year old male with stage IV non-Hodgkin's Lymphoma who was vaccinated with pneumococcal vaccine 23 polyvalent at the time of his splenectomy for stage IV non-Hodgkin's. Three years, post vax, the pt developed fevers, chills, hypotension and a generalized seizure. The pt was treated with antibiotics for 4 weeks. He was treated with ceftriaxone, vancomycin and rifampin. Although the pt had been vaccinated against Streptococcus pneumoniae at the time of his splenectomy, he showed a protective antibody response to only 8 of 12 serotypes tested. A Gram's stain of the CSF showed gram-positive organisms in pairs and short chains, but cultures of the CSF were negative. A latex-agglutination test was positive for Streptococcus pneumoniae. During the next several days, disseminated intravascular coagulation and symmetric areas of pallor developed on the back of both hands and the soles of the feet, with overlying bulla. Cultures of the bullous fluid were sterile. The lesions progressed to dry gangrene. All blood cultures remained negative. The arterial supply to each of the arms and legs remained patent. The pt was revaccinated. It was noted that the pt's appearance was typical of symmetric peripheral gangrene associated with Streptococcus pneumoniae bacteremia in a pt whose spleen had been removed. Upon internal review, the pt's experiences were determined to be "Other Medical Events". Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Autism
Clinical narrative: Information has been received from a consumer concerning her son with no past medical history who at 16 month old in approx. 3/98 was vaccinated with MMRII. There were no concomitant medication. It was reported that her son has "autistic tendencies". It was also noted that her son was not very verbal to begin with and after he was vaccinated, he stopped speaking. Upon internal review, "autistic tendencies" was determined to be an "Other Important Medical Event". Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Mental retardation severity unspecified, Nervous system disorder
Clinical narrative: Information has been received from a registered pharmacist concerning her mother's approx. 22 year old female niece who was vaccinated with MMRII "as a child". She could not report any specifics on the date of the vaccination, the lot # or the name of the pediatrician who administered the vaccine. She reported that the pt received the vaccine "when she was still in a walker". The registered pharmacist reported that the pt was a "dry birth" and that the pt was "fine" until she received her MMRII vaccine. The registered pharmacist reported that the pt developed neurological problems. She reported that the pt "has a mind of a 3 year old" and has learning disabilities. She reported that "she attends a special school for the Mentally Handicapped". The pt did not seek medical attention. Upon internal review, neurological problems was determined to be an "Other Important Medical Event". Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Drug ineffective, Herpes zoster, Infection, Injection site erythema
Clinical narrative: Information has been received from an RN concerning a 4 year old female, who on 5/7/01, was vaccinated with MMRII, in the leg. Concomitant therapy, also given on 5/7/01, included DPT and poliovirus vaccine. It was also reported that the pt had received her varicella virus vaccine live, on approx. 6/27/97, in the pt's left leg in which she received the MMRII, DPT, tuberculin purified protein derivative and poliovirus vaccinations became hot and swollen. On the next day, the pt's symptoms worsened and she was dx'd with cellulitis. The child was treated with cephalexin (Keflex) and subsequently, recovered from the cellulitis. On approx. 5/18/01, the pt developed a "very severe case of chicken pox with approx. 50 lesions, on the left leg around the injection site". Upon internal review the cellulitis is considered an "Other Medical Event". Additional information has been requested. F/U It was further reported that on 5/10/01 she was seen again and that the area was more extensive. As of 5/17/01, the cellulitis was resolving. Subsequently on 5/24/01 the pt recovered. It was also reported that the pt had rec'd one dose of varicella virus vaccine live (site unknown) at one yr of age on approximately 6/27/97 and on approximately 5/17/01 developed chicken pox (WAES01091138). Upon internal review the cellulitis was considered to be an other important medical event. No further info is expected. F/U states: Information has been received from a physician and an RN concerning her 4 year old white female, family member, with an allergy to sulfa, no illness at the time of vaccination and reported to be in "otherwise good health" who on 5/7/01 (also reported as 5/9/01) was vaccinated with the 2nd dose of MMRII, SC, in the right thigh (lot 637433/0149L). Concomitant therapy, that day, included the 5th dose of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia), IM, in the left thigh (lot V02998A), 1 dose of tuberculin purified protein derivative (Tubersol) (site not reported) and the 4th dose of poliovirus vaccine (IPOL), SC, in the left thigh (lot R1437). It was noted that the child was being vaccinated for kindergarten. Subsequently, on approx. 5/7/01 (also reported as 5/10/01), the pt's left leg in which she received Tripedia and IPOL became hot and swollen. On the next day, the pt's symptoms worsened. That morning, on 5/8/01, she had redness and swelling of the left thigh, was seen in urgent care and was dx'd with cellulitis. The child was treated with cephalexin (Keflex). It was further reported that on 5/10/01, she was "seen again" and that the area was more extensive. As of 5/17/01, the cellulitis was resolving. Subsequently, on 5/24/01, the pt recovered. It was also reported that the pt had received 1 dose of varicella virus vaccine live (site unkown) at 1 year of age, on approx. 6/27/97 and on approx. 5/17/01, developed chicken pox (WAES01091138). No further info is expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an RN concerning a 4 year old female, who on 5/7/01, was vaccinated with MMRII, in the leg. Concomitant therapy, also given on 5/7/01, included DPT and poliovirus vaccine. It was also reported that the pt had received her varicella virus vaccine live, on approx. 6/27/97, in the pt's left leg in which she received the MMRII, DPT, tuberculin purified protein derivative and poliovirus vaccinations became hot and swollen. On the next day, the pt's symptoms worsened and she was dx'd with cellulitis. The child was treated with cephalexin (Keflex) and subsequently, recovered from the cellulitis. On approx. 5/18/01, the pt developed a "very severe case of chicken pox with approx. 50 lesions, on the left leg around the injection site". Upon internal review the cellulitis is considered an "Other Medical Event". Additional information has been requested. F/U It was further reported that on 5/10/01 she was seen again and that the area was more extensive. As of 5/17/01, the cellulitis was resolving. Subsequently on 5/24/01 the pt recovered. It was also reported that the pt had rec'd one dose of varicella virus vaccine live (site unknown) at one yr of age on approximately 6/27/97 and on approximately 5/17/01 developed chicken pox (WAES01091138). Upon internal review the cellulitis was considered to be an other important medical event. No further info is expected. F/U states: Information has been received from a physician and an RN concerning her 4 year old white female, family member, with an allergy to sulfa, no illness at the time of vaccination and reported to be in "otherwise good health" who on 5/7/01 (also reported as 5/9/01) was vaccinated with the 2nd dose of MMRII, SC, in the right thigh (lot 637433/0149L). Concomitant therapy, that day, included the 5th dose of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia), IM, in the left thigh (lot V02998A), 1 dose of tuberculin purified protein derivative (Tubersol) (site not reported) and the 4th dose of poliovirus vaccine (IPOL), SC, in the left thigh (lot R1437). It was noted that the child was being vaccinated for kindergarten. Subsequently, on approx. 5/7/01 (also reported as 5/10/01), the pt's left leg in which she received Tripedia and IPOL became hot and swollen. On the next day, the pt's symptoms worsened. That morning, on 5/8/01, she had redness and swelling of the left thigh, was seen in urgent care and was dx'd with cellulitis. The child was treated with cephalexin (Keflex). It was further reported that on 5/10/01, she was "seen again" and that the area was more extensive. As of 5/17/01, the cellulitis was resolving. Subsequently, on 5/24/01, the pt recovered. It was also reported that the pt had received 1 dose of varicella virus vaccine live (site unkown) at 1 year of age, on approx. 6/27/97 and on approx. 5/17/01, developed chicken pox (WAES01091138). No further info is expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Abasia, Arthralgia, Crying, Synovitis
Clinical narrative: Information has been received from a pharmacist concerning his 35 month old son, with no known allergies or past medical history, who on 5/24/01, was vaccinated with 1 dose of varicella virus vaccine live. There was no concomitant medication. On 5/28/01, the child was crying and fell "several" times. He was taken to the ER for pain in his left knee and inability to bear weight on his left leg. Diagnostic testing including CBC, sed rate and x-rays were performed (results not provided). Transient synovitis was dx'd. At the time of reporting, the child could not bear weight on his left leg due to the "extreme" pain in his left knee. The child had no hip pain. Additional information has been requested. Upon internal review, transient synovitis was considered to be an "Other Important Medical Event".
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Autism, Diarrhoea, Gastrointestinal disorder
Clinical narrative: The pt experienced diarrhea, autism and leaky gut syndrome. The 60 day follow-up states autism and diarrhea.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abnormal behaviour, Autism, Dehydration, Diarrhoea, Eye disorder
Clinical narrative: The first symptoms appeared on 2/23/98 which were fever, vomiting diarrhea, dehydration. These occurred immediately following; a loss of eye contact and interest in engagement with others, repetitive movements and speech, echoalic speech, insomnia, destructive behavior without remorse or understanding of what was done. FOLLOW UP information received on 08/02/02 states, "Autism-socially impaired, sensory integration dysfuntion, speech delay, self-regulatory dysfunction".
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Personality disorder, Pyrexia, Speech disorder, Vomiting
Clinical narrative: The first symptoms appeared on 2/23/98 which were fever, vomiting diarrhea, dehydration. These occurred immediately following; a loss of eye contact and interest in engagement with others, repetitive movements and speech, echoalic speech, insomnia, destructive behavior without remorse or understanding of what was done. FOLLOW UP information received on 08/02/02 states, "Autism-socially impaired, sensory integration dysfuntion, speech delay, self-regulatory dysfunction".
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion
Clinical narrative: Within 12 hours of receiving vaccine, patient experienced generalized tonic-clonic seizure lasting several minutes. She recovered fully.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash macular
Clinical narrative: Patient developed a fever and little red blotches about 10mm in size.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Patient's entire deltoid area became red, swollen, painful and hot to touch approximately 12 hours after injection. A small blister approximately 3cm from injection site was also noted. He was treated with Tylenol and ice.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed cellulitis, redness, heat and swelling on right thigh secondary to injection.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Injection site erythema, Injection site warmth
Clinical narrative: Patient developed inconsolable screaming for 1.5 hours. His left thigh developed mild redness and warmth to the touch.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Patient developed a temperature of 103.8 and slight swelling at injection site.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Patient became dyspneic 30 minutes post immunization. He was seen in the ER where questionable wheezing was noted. He was given prednisone and albuterol with rapid relief.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Injection site pain, Malaise, Myalgia, Pain
Clinical narrative: Patient developed painful upper arm in the deltoid area secondary to vaccine. She also complained of weakness, soreness of the legs, generalized malaise and muscle aches. She was offered Tylenol.
Age: 4.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Patient developed chicken pox.
Age: 30.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed an area of redness, swelling and warmth at injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site mass, Injection site pain, Rash
Clinical narrative: Patient developed a rash on arm approximately 3" by 4" in size. He also had a hard lump approximately the size of a dime and discomfort in the upper arm. He was treated with Benadryl.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Approximately 6 hours post vaccine, patient developed redness and pain in upper arm. She was seen in the clinic on 6/8/01 and had an 11 x 11 cm red, warm area. She was given ibuprofen for pain and Keflex.
Age: 27.0
Sex: M
Vaccine: TYP
Symptoms: Facial palsy
Clinical narrative: Patient developed Bell's Palsy approximately 4 hours after receiving typhoid vaccine. Symptoms have not worsened or improved since then.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Approximately 4 hours post vaccine, patient developed redness, induration and warmth in upper arm which spread to involve entire outer aspect of upper arm by 4/27/01. Patient was given Keflex for rule out cellulitis. Telephone call to patient's mother on 4/28/01 revealed the redness had lessened.
Age: 13.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Dermatitis bullous, Injection site erythema, Injection site induration, Skin discolouration
Clinical narrative: On June 7, patient developed pox-vesicular spots on face, head and buttocks which crusted over in 5 days. On June 9, patient developed localized reaction at site characterized by a hard, red, bluish area 2" in diameter. Lidocaine spray decreased the redness.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Loss of consciousness, Mydriasis, Pallor
Clinical narrative: Within 20 minutes of receiving vaccine, patient complained of passing out, headache and dizziness. Her pupils were slightly dilated and her color was pale. She had occasional tremors to the right hand.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Tremor
Clinical narrative: Within 20 minutes of receiving vaccine, patient complained of passing out, headache and dizziness. Her pupils were slightly dilated and her color was pale. She had occasional tremors to the right hand.
Age: 1.8
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia
Clinical narrative: Patient developed fever immediately following Hib.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: No data provided.
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Diarrhoea, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Approximately 30 minutes after vaccine, patient developed headache. Then he began with nausea and vomiting accompanied by fever and chills. Patient had diarrhea throughout the night.
Age: 52.0
Sex: U
Vaccine: TD
Symptoms: Respiratory disorder, Throat tightness, Tongue oedema
Clinical narrative: Approximately 30 minutes after receiving vaccine, patient developed a feeling of warmth at the back of the throat, some throat tightness and tongue swelling. Patient was given Benadryl.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient developed chills, fever and aching. She complained of fatigue and swelling in injection area the size of a tennis ball. On exam 6/6/01 there was no visible or palpable lesion at site of injection.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Pruritus
Clinical narrative: developed red, pruritic warm swelling of left upper arm with erythematous induration. Treated with Cephalexin and Benadryl.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: The pt experienced probable cellulitis, was warm, red, tender around injection site on arm. Treated with Cephalexin.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Oedema peripheral
Clinical narrative: The pt's right leg swelled from the knee to the hip.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Diarrhoea, Lethargy, Pain, Pyrexia, Somnolence
Clinical narrative: The pt experienced immediate emesis during the office appt. The pt continued throwing up over the next 2 1/2 days, was lethargic and was taking a bottle poorly. She went to bed on 5/27/01 and died during the night. Autopsy showed no cause suspecting SIDS.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Staring, Sudden infant death syndrome, Vomiting
Clinical narrative: The pt experienced immediate emesis during the office appt. The pt continued throwing up over the next 2 1/2 days, was lethargic and was taking a bottle poorly. She went to bed on 5/27/01 and died during the night. Autopsy showed no cause suspecting SIDS.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Lethargy, Oral intake reduced, Sudden infant death syndrome, Vomiting
Clinical narrative: The pt experienced immediate emesis during the office appt. The pt continued throwing up over the next 2 1/2 days, was lethargic and was taking a bottle poorly. She went to bed on 5/27/01 and died during the night. Autopsy showed no cause suspecting SIDS.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Infection, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: On 6/7/01, patient developed red dots and itching of right shoulder. On 6/8/01, she had one large red area approximately the size of a half dollar with a white dot in the middle.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: On 6/7/01, patient developed red dots and itching of right shoulder. On 6/8/01, she had one large red area approximately the size of a half dollar with a white dot in the middle.