chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Meningitis aseptic
Clinical narrative: This patient was immunized on 2/19/01. That evening the patient developed a fever of 101 rectally, which continued until the day of admission. On 02/21/01, the patient developed strabismus of the left eye. The patient admitted to the hospital on 02/23/2001 with a diagnosis of viral meningitis. On 02/25/01, the patient developed right eye strabismus with developing improvement of the left eye. The patient was discharged clinically stable. A physician reported via a company representative that an 8 month old male received his second injection of prevnar on an unspecified date. Subsquently, the child was hospitalized for aseptic meningitis. Follow up information received on 03/16/2001, from the child's physician revealed that on 02/19/2001, the child received vaccination with Hib-Titer and Tripedia vaccines along with his third dose of prevnar, not his second dose as previously reported. The child has since recovered. From follow-up information received on 05/01/2001, it was reported that for the request for the discharge summary with complete diagnosis and the results of cerebrospinal fluid examination need records from hospital. Additional patient, vaccine and the adverse event onset information were provided. From follow-up telephone conversation, it was stated that the reporting facility did not receive any records from the hospital because they did not admit the patient. The patient and family have since moved without forwarding information.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: The patient had redness, swollen right arm, erythematous area of 5 cm diameter around the site of injection.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMR, OPV
Symptoms: Autism, Gastrointestinal disorder, Infection, Rash, Speech disorder
Clinical narrative: This patient had a loss of expressive / receptive speech, gastrointestinal problems, following his 06/10/98 vaccinations. Also Strabismus, visual problems, autism diagnosis, candidiasis, and rashes. The follow up received on 7/5/01 states, "pt is a 2 year 3 month old boy who has been referred to the clinic by his parents for a full developmental assessment. Pt lives with his parents, and his older brother. Pt was accompanied to the clinic by his parents. This evaluation occurred over two visits. During the first visit, Dr. interviewed pt's parents to obtain relevant developental, medical, and family history. On the second visit, pt was assessed formally by Dr. to obtian an estimate of his current level of functioning. Following this, both Drs. observed his unstructured play. Also a spart of this evaluation. Drs. reviewed any previous evaluations. This second clinic visit concluded with an extensive parent conference during which results of psychological testing, diagnositic impressions, and recommendations were discussed. Pt's parents report the following concerns: speech and language delay, lack of eye contact, toe walking and hand flapping, finger pulling to communicate, recent increase in temper, and tuning out. His parents reported that he has also been diagnosed as having candida yeast overgrowth and Giardia in addition, to casein and gluten intolerance. They are seeking this evaluation to understand his diagnosis and prognosis. They also report that he has visual problems, which  consist of strabismus. They have questions regarding hwo his visual problems could be affecting his development. Pt's parents reported htat they were concerned about his developemtn when, in October of 1998, onc eo fhis eye started to drift inward. At the same time he became unreponsive to their verbal overtures. For example, he woul dnot respond when his name was called. In November and December his parents noted that pt's motor skills had changed. In genearl, he appeared to have balance."
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMR, OPV
Symptoms: Strabismus, Visual disturbance
Clinical narrative: This patient had a loss of expressive / receptive speech, gastrointestinal problems, following his 06/10/98 vaccinations. Also Strabismus, visual problems, autism diagnosis, candidiasis, and rashes. The follow up received on 7/5/01 states, "pt is a 2 year 3 month old boy who has been referred to the clinic by his parents for a full developmental assessment. Pt lives with his parents, and his older brother. Pt was accompanied to the clinic by his parents. This evaluation occurred over two visits. During the first visit, Dr. interviewed pt's parents to obtain relevant developental, medical, and family history. On the second visit, pt was assessed formally by Dr. to obtian an estimate of his current level of functioning. Following this, both Drs. observed his unstructured play. Also a spart of this evaluation. Drs. reviewed any previous evaluations. This second clinic visit concluded with an extensive parent conference during which results of psychological testing, diagnositic impressions, and recommendations were discussed. Pt's parents report the following concerns: speech and language delay, lack of eye contact, toe walking and hand flapping, finger pulling to communicate, recent increase in temper, and tuning out. His parents reported that he has also been diagnosed as having candida yeast overgrowth and Giardia in addition, to casein and gluten intolerance. They are seeking this evaluation to understand his diagnosis and prognosis. They also report that he has visual problems, which  consist of strabismus. They have questions regarding hwo his visual problems could be affecting his development. Pt's parents reported htat they were concerned about his developemtn when, in October of 1998, onc eo fhis eye started to drift inward. At the same time he became unreponsive to their verbal overtures. For example, he woul dnot respond when his name was called. In November and December his parents noted that pt's motor skills had changed. In genearl, he appeared to have balance."
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Left thigh with 11cm X 8cm area of erythema, edema and warmth. Temperature of 100F (R).
Age: 1.6
Sex: M
Vaccine: PNC
Symptoms: Diarrhoea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Vomiting and diarrhea developed immediately, post vax. Vomiting stopped after 3 days; diarrhea continued for 2 weeks. Pt had this same reaction with Prevnar #2 & #3 though not with #1.
Age: 2.0
Sex: M
Vaccine: FLU3, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 5cm area of redness and swelling on left deltoid reported the evening following injection day. Doctor on call, recommended that mother give Tylenol for discomfort and ice to area. Seen the following AM. No change in treatment.
Age: 1.25
Sex: F
Vaccine: DTAP, PNC
Symptoms: Rash
Clinical narrative: Vaccine given on 3/12/01. Pt's mom states this morning, she noticed a rash patch on left thigh and right arm. Now she has "patchy" rash all over her body except her face. Mom doesn't recall the temperature last night. States "not that high".
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: High-pitched crying
Clinical narrative: High-pitched screaming for more than an hour on day of shots.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: The pt experienced a fever of 105 the same evening of the vax.
Age: 71.0
Sex: M
Vaccine: LYME
Symptoms: Aphasia, Memory impairment
Clinical narrative: My concern is that the series of the 3 Lymerix vaccinations have affected my memory and loss of words in conversations. I would like to know if there is any information that might or might not verify my problem.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Within 12-24 hours post 7th anthrax vax, the pt noted an onset of mild erythema, swelling, tenderness in an area of 3cm x 4cm around the injection site. Similar reaction occurred with 6th shot but not with any others.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Blister, Rash, Sensory disturbance
Clinical narrative: Extreme sensitivity in pads and tips of all fingers, followed by subdermal bumps and blisters. Blisters eventually (over 3-4 days) worked to surface and broke (water only). I reported effects to clinic then but was told it wasn't a symptom. Blisters eventually stopped appearing over 4 months period.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Pleural effusion, Pyrexia
Clinical narrative: Fever, pleural effusion, Eosinophils in fluid and marked Eosinophils in peripheral blood.
Age: 20.0
Sex: F
Vaccine: FLU3, HEPA, TYP, YF
Symptoms: Chest discomfort, Dyspnoea, Periorbital oedema, Pruritus, Rash
Clinical narrative: Roughly 1 hour, post vax, developed chest tightness, SOB, itchy rash, with pruritus, mild wheezing and periorbital edema but vitals stable. Received Epi, Benadryl and albuterol nebulizer. Resolved, sent home with prednisone.
Age: 20.0
Sex: F
Vaccine: FLU3, HEPA, TYP, YF
Symptoms: Wheezing
Clinical narrative: Roughly 1 hour, post vax, developed chest tightness, SOB, itchy rash, with pruritus, mild wheezing and periorbital edema but vitals stable. Received Epi, Benadryl and albuterol nebulizer. Resolved, sent home with prednisone.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Rash, Visual field defect
Clinical narrative: On 1/14/01, lost peripheral vision in right eye for 20-30 minutes. Rash on chest on 1/16/01. Upper left arm hurts on occasion; possibly pulled muscle?
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Mom phoned clinic on 2/2/01 with complaint of fever. No provider available. Advised to give Motrin for fever and monitor. Mother denies redness or swelling. Advised to seek ER if no improvement. On 2/6/01, presents in clinic with complaint of still having fever. Reports the site of injection swelled up 2 times normal size. No swelling at this time. No fever.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Pyrexia, Skin discolouration
Clinical narrative: Started to run a fever approx. 1 week, post vax. On 10/3/00, her whole body turned purple. Her temperature in the ER was 105F (R).
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Varivax lesions.
Age: 7.0
Sex: M
Vaccine: DT, HEP, IPV
Symptoms: Tic
Clinical narrative: Pt's mother stated he displayed marked increase in tics, post vax. He had tics prior to vaccines. Affect of increased tics more noticeable after environmental stimulation. In clinic only minimal evidence of tics activity on 3/13/01. Note: mother believes older sibling had permanent (neurologic) changes following immunizations.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Leukocytosis, Purpura
Clinical narrative: Purpuric rash and arthralgia
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 50 mm X 80 mm reddened, hot to touch and indurated area. Prescribed Dicloxacillin.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythematous, edematous right thigh in vastus lateralis. Mother given instructions to use Tylenol and apply ice to local area.
Age: 3.0
Sex: M
Vaccine: DTP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed swelling, warmth and erythema at injection site, 24 hours, post vax, extending from deltoid to elbow and left anterior chest. No fever. Started on steroids, antihistamines and some antibiotics.
Age: 39.0
Sex: M
Vaccine: HEP, HEPA, TD, TYP
Symptoms: Asthenia, Heart rate increased, Pain in jaw, Pyrexia, Urticaria
Clinical narrative: Had a fever under 100F for 3 days; rapid pulse that lasted for 1.5 days; hives for which took Claritin and it went away after about 4 hours; weakness for 4 days and jaw soreness that lasted 2 days.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Anorexia, Diarrhoea, Fontanelle bulging, Heart rate increased, Injection site erythema
Clinical narrative: On 3/7/01, developed a shrill cry at approx. 18:30. Right leg was red and warm. Bulging fontanel, P-170 (mom is a nurse). Took to ER and they recommended Advil instead of Tylenol. On 3/8/01, pt was irritable with no appetite. On 3/9/01, pt was not sleeping well and had 2 loose stools. On 3/10/01, had a fine red, rash on trunk and back of neck, a shrill cry and took to Urgent Care and was told to "watch him". On 3/11/01, eating better and was his happy self and rash was fading.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Injection site warmth, Rash, Screaming, Sleep disorder
Clinical narrative: On 3/7/01, developed a shrill cry at approx. 18:30. Right leg was red and warm. Bulging fontanel, P-170 (mom is a nurse). Took to ER and they recommended Advil instead of Tylenol. On 3/8/01, pt was irritable with no appetite. On 3/9/01, pt was not sleeping well and had 2 loose stools. On 3/10/01, had a fine red, rash on trunk and back of neck, a shrill cry and took to Urgent Care and was told to "watch him". On 3/11/01, eating better and was his happy self and rash was fading.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Verbal report; redness (1/2" X 1"), slight swelling and tenderness to site of DTAP.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Mild case of varicella on 3/7/01.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Discomfort, Injection site reaction, Pruritus
Clinical narrative: Pt presented to clinic 2 days, post vax, with large local reaction on the left thigh. Pt didn't appear to be in distress. Mom says he complained of itchiness at the site. As per doctor, advised her to use warm compresses and give Tylenol for discomfort. She's to follow-up if no improvement.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Parotitis
Clinical narrative: Parotitis
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Significant swelling of the left arm with erythema of the skin, involving the forearm as well. Measurements: left bicep 9 1/4"; left forearm 7 1/2"; right bicep 7 1/2"; right forearm 7 1/4".
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Pain, redness and swelling within 3-4 hours, post vax. Later in the day on 3/8/01 had diarrhea and swelling of finger on left hand. On 3/9/01, had rash and pruritus at injection area and during the day it developed in a generalized body rash with itching. On 3/10/01, the rash and pruritus diminished. Treatment: put heat at injection site on 3/8/01 and 3/9/01. Called her doctor and he ordered Tylenol and rest.
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Rash
Clinical narrative: Pain, redness and swelling within 3-4 hours, post vax. Later in the day on 3/8/01 had diarrhea and swelling of finger on left hand. On 3/9/01, had rash and pruritus at injection area and during the day it developed in a generalized body rash with itching. On 3/10/01, the rash and pruritus diminished. Treatment: put heat at injection site on 3/8/01 and 3/9/01. Called her doctor and he ordered Tylenol and rest.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Diarrhoea, Eye swelling, Injection site pain, Pruritus
Clinical narrative: On 10/3/00, had fever of 102F within 24 hours and diarrhea. Then eyes were swollen; itchy neck; red splotches on neck and legs. Received Motrin during this time every 6 hours from time of vaccination. At this time pain "doubled" from Hep-B. Mom wanted to refuse Hep-B #3. PMD signed medical exemption for anaphylactic reaction.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: On 10/3/00, had fever of 102F within 24 hours and diarrhea. Then eyes were swollen; itchy neck; red splotches on neck and legs. Received Motrin during this time every 6 hours from time of vaccination. At this time pain "doubled" from Hep-B. Mom wanted to refuse Hep-B #3. PMD signed medical exemption for anaphylactic reaction.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt stated that she experienced extreme pain and swelling at the injection site and entire arm was red and swollen. Symptoms continued and worsened, unrelieved by pain relievers, so she went to ER for treatment.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Dermatitis, Eye swelling, Herpes zoster, Hypersensitivity, Infection
Clinical narrative: Pt states she began experiencing pimply areas on her neck, 2 hours, post vax. She continued experiencing skin dermatitis, swollen eyes and low-grade fever up to 3/8/01. Went to MD and was told she had skin dermatitis as a result of a reaction to the shot and also was dx'd with shingles. She was given Famvir 500mg TID.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Pt states she began experiencing pimply areas on her neck, 2 hours, post vax. She continued experiencing skin dermatitis, swollen eyes and low-grade fever up to 3/8/01. Went to MD and was told she had skin dermatitis as a result of a reaction to the shot and also was dx'd with shingles. She was given Famvir 500mg TID.
Age: 9.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Blister, Dysuria, Erythema, Infection, Oral mucosal blistering
Clinical narrative: Vaccine given on 3/5/01. Symptoms of fever to 102.6F; itching and pox appeared on 3/8/01 PM. Initial 72 pox with 4 in mouth area, 17 blisters and red spot on remaining. Child broke out worse and was seen by PMD on 3/9/01. Used Tylenol, Benadryl and Motrin for discomfort. Mother reports has pox everywhere; over 1,000 in mouth, ears, throat, nose. Had difficulty urinating.
Age: 9.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Pruritus, Pyrexia
Clinical narrative: Vaccine given on 3/5/01. Symptoms of fever to 102.6F; itching and pox appeared on 3/8/01 PM. Initial 72 pox with 4 in mouth area, 17 blisters and red spot on remaining. Child broke out worse and was seen by PMD on 3/9/01. Used Tylenol, Benadryl and Motrin for discomfort. Mother reports has pox everywhere; over 1,000 in mouth, ears, throat, nose. Had difficulty urinating.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Left thigh with 7 X 4 cm redness superficial with marked swelling and induration of thigh approx. 10 X 12cm; noted approx. 18 hours, post vax. Treated with Benadryl and Motrin.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Asthenia, Dyspnoea, Influenza like illness, Liver function test abnormal
Clinical narrative: The pt, a 77 year old female, reported that within 3 days, post vax, she developed flu-like symptoms of general aching all over her body, weakness, loss of appetite; physical condition continued to worsen each day. By the 4th day, she experienced difficulty breathing. She was seen in the ER where, after X-ray, 1 liter of fluid was removed from her lung. Eleven days, post vax, she developed itchiness, rashes and small blisters on her back, inner thighs and ankles. The fronts of her legs had red, feverish lumps beneath the surface of skin, with fluid retention around her ankles. The rash subsided within a week, but the heavy welts on her feet and palms of hands and itching persisted for 10 more days. All adverse events, except the ankle edema have completely resolved. The ankle edema continues to be treated with HCTZ, 25 mg per day. The pt stated that the dx of "pleural virus" was made. No additional information is available.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain, Pleural effusion, Pruritus, Skin nodule
Clinical narrative: The pt, a 77 year old female, reported that within 3 days, post vax, she developed flu-like symptoms of general aching all over her body, weakness, loss of appetite; physical condition continued to worsen each day. By the 4th day, she experienced difficulty breathing. She was seen in the ER where, after X-ray, 1 liter of fluid was removed from her lung. Eleven days, post vax, she developed itchiness, rashes and small blisters on her back, inner thighs and ankles. The fronts of her legs had red, feverish lumps beneath the surface of skin, with fluid retention around her ankles. The rash subsided within a week, but the heavy welts on her feet and palms of hands and itching persisted for 10 more days. All adverse events, except the ankle edema have completely resolved. The ankle edema continues to be treated with HCTZ, 25 mg per day. The pt stated that the dx of "pleural virus" was made. No additional information is available.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria, Viral infection
Clinical narrative: The pt, a 77 year old female, reported that within 3 days, post vax, she developed flu-like symptoms of general aching all over her body, weakness, loss of appetite; physical condition continued to worsen each day. By the 4th day, she experienced difficulty breathing. She was seen in the ER where, after X-ray, 1 liter of fluid was removed from her lung. Eleven days, post vax, she developed itchiness, rashes and small blisters on her back, inner thighs and ankles. The fronts of her legs had red, feverish lumps beneath the surface of skin, with fluid retention around her ankles. The rash subsided within a week, but the heavy welts on her feet and palms of hands and itching persisted for 10 more days. All adverse events, except the ankle edema have completely resolved. The ankle edema continues to be treated with HCTZ, 25 mg per day. The pt stated that the dx of "pleural virus" was made. No additional information is available.
Age: 33.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: A physician reported that a 33 year old female inadvertently, received an injection of Diphtheria and Tetanus Toxoids Adsorbed Ultrafined, Pediatric on 3/14/00 and experienced an injection site reaction characterized by swelling, redness and pain. The pt also developed a fever. On 3/16/00, she was treated with Augmentin and recovered on 3/23/00. Information received from the vaccine provider on 4/20/00 supplied pt data and stated that the pt recovered.
Age: 0.57
Sex: F
Vaccine: DTPHIB
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: The infant inadvertently received an injection of Tetramune from a lot that had expired. The report was received 8 days post vax and no adverse experience had occurred at that time. Additional information received on 1/30/01 from the physician indicated that the infant developed a "slight" fever and "slight" redness at the injection site. She recovered after a "few" days.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Erythema, Hypersensitivity, Hypotension, Hypoventilation
Clinical narrative: Information has been received from a registered nurse concerning a 32 year old white female with a Codeine allergy and a Hep B surface antibody level of "0" after three doses of Hep B vaccine recombinant (yeast) who on 03/10/00 was vaccinated with a fourth dose of Hep B vaccine recombinant. There was no concomitant medication. Within one hour post vaccination, the patient developed an allergic reaction which consisted of scattered hives and rash over arms, chest, back, and legs, redness on the trunk, and itching. The symptoms increased two hours post vaccination. It was also reported, on the same day, that the patient experienced feeling weak and drowsy. The patient was seen by a physician in the ER and received therapy with Benadryl and Celestone. The patient denied respiratory distress and shortness of breath. The patient also received therapy at home with Medrol dose pack and Benadryl. On 03/10/00, the patient recovered. On approximately 04/10/00, the patient had a Hep B antibody titer level of "0". Information provided by the reporter indicated a "probable assessment". Upon medical review it was determined that the patient's allergic reaction was an "other medical event". No further info is available.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Somnolence, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 32 year old white female with a Codeine allergy and a Hep B surface antibody level of "0" after three doses of Hep B vaccine recombinant (yeast) who on 03/10/00 was vaccinated with a fourth dose of Hep B vaccine recombinant. There was no concomitant medication. Within one hour post vaccination, the patient developed an allergic reaction which consisted of scattered hives and rash over arms, chest, back, and legs, redness on the trunk, and itching. The symptoms increased two hours post vaccination. It was also reported, on the same day, that the patient experienced feeling weak and drowsy. The patient was seen by a physician in the ER and received therapy with Benadryl and Celestone. The patient denied respiratory distress and shortness of breath. The patient also received therapy at home with Medrol dose pack and Benadryl. On 03/10/00, the patient recovered. On approximately 04/10/00, the patient had a Hep B antibody titer level of "0". Information provided by the reporter indicated a "probable assessment". Upon medical review it was determined that the patient's allergic reaction was an "other medical event". No further info is available.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Haematemesis, Headache
Clinical narrative: Information has been received from a physician concerning a 12 year old Caucasian male who was vaccinated with a 1st, 2nd, and 3rd dose of Hep B on an unknown date, in August 1999, and on 02/06/00 respectively. It was reported that in approximately August 1999 after the 2nd dose of the vaccine, the patient developed aches, fever, nausea, rash, pains, vomiting (until he was vomiting up blood), abdominal pain, and severe headaches. The symptoms "finally eased up". The symptoms would go away for a few days and then come back. In follow up it was reported that on 09/06/00 he received the 3rd dose of the Hep B vaccine. On 09/18/00, the patient again experienced abdominal pain with cramping, malaise, headache, diarrhea, fatigue, and vomiting.  The outcomes of the patient's experiences were the patient's abdominal pain had subsided, the patient had no headache for two weeks, and the patient was in a "good mood". the physician considered the patient's experiences after the 3rd dose of vaccine (abdominal pain with cramping. malaise, headache, diarrhea, fatigue and vomiting) to have resulted in a significant disability. At the time of follow up on 01/31/01, the patient was "back to normal x 2 weeks" (recovered). No additional info expected.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Malaise, Muscle spasms, Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 year old Caucasian male who was vaccinated with a 1st, 2nd, and 3rd dose of Hep B on an unknown date, in August 1999, and on 02/06/00 respectively. It was reported that in approximately August 1999 after the 2nd dose of the vaccine, the patient developed aches, fever, nausea, rash, pains, vomiting (until he was vomiting up blood), abdominal pain, and severe headaches. The symptoms "finally eased up". The symptoms would go away for a few days and then come back. In follow up it was reported that on 09/06/00 he received the 3rd dose of the Hep B vaccine. On 09/18/00, the patient again experienced abdominal pain with cramping, malaise, headache, diarrhea, fatigue, and vomiting.  The outcomes of the patient's experiences were the patient's abdominal pain had subsided, the patient had no headache for two weeks, and the patient was in a "good mood". the physician considered the patient's experiences after the 3rd dose of vaccine (abdominal pain with cramping. malaise, headache, diarrhea, fatigue and vomiting) to have resulted in a significant disability. At the time of follow up on 01/31/01, the patient was "back to normal x 2 weeks" (recovered). No additional info expected.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 year old Caucasian male who was vaccinated with a 1st, 2nd, and 3rd dose of Hep B on an unknown date, in August 1999, and on 02/06/00 respectively. It was reported that in approximately August 1999 after the 2nd dose of the vaccine, the patient developed aches, fever, nausea, rash, pains, vomiting (until he was vomiting up blood), abdominal pain, and severe headaches. The symptoms "finally eased up". The symptoms would go away for a few days and then come back. In follow up it was reported that on 09/06/00 he received the 3rd dose of the Hep B vaccine. On 09/18/00, the patient again experienced abdominal pain with cramping, malaise, headache, diarrhea, fatigue, and vomiting.  The outcomes of the patient's experiences were the patient's abdominal pain had subsided, the patient had no headache for two weeks, and the patient was in a "good mood". the physician considered the patient's experiences after the 3rd dose of vaccine (abdominal pain with cramping. malaise, headache, diarrhea, fatigue and vomiting) to have resulted in a significant disability. At the time of follow up on 01/31/01, the patient was "back to normal x 2 weeks" (recovered). No additional info expected.
Age: 0.8
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Laboratory test abnormal, Pyrexia, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 10 month old Asian female who on 6/19/00 was vaccinated IM with a 1st dose of Hep-B, a 1st dose of Prevnar, a 1st dose of DTP, a 1st dose of Hib-Titer and a 1st dose of IPOL. On 6/20/00, the pt experienced a fever of 103-104F. The fever was treated with acetaminophen and ibuprofen and persisted until 6/26/00. On 6/27/00, the pt's temperature was 100F. The fever resolved on 6/28/00. On 6/25/00, the pt experienced generalized maculo-papular rash. The rash persisted as of 6/27/00, when the pt was seen by the physician. The pt recovered by 7/11/00. Upon internal review the pt's fever was considered an "Important Medical Event". No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: No data provided.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Bronchitis, Chest discomfort, Dyspnoea, Malaise, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a registered nurse concerning a 42 year old female, was vaccinated with a 1st, 2nd, and 3rd dose of Hepatitis B vaccine on 05/28/99, 06/28/99, and 01/19/00 respectively. After the 1st and 2nd dose, the patient "felt funny". Prior to receiving her 3rd dose, the patient was seen by her physician as she had recently recovered from bronchitis. The patient was advised to receive the 3rd dose, and at 9 AM on 01/19/00, she was administered the vaccine. Two hours after the 3rd dose, the patient "felt funny". By 5 PM, the patient had developed a more "significant" reaction than after the previous two vaccinations and reported extreme tightening in the chest and sore throat. By 7 AM on 01/20/00, the patient had developed difficulty breathing and went to her physician where the doctor administered Benadryl and Prednisone. The patient's experiences of difficulty breathing, sore throat, and tightening in the chest were considered to be other important medical events. The patient recovered and has not had any problems since. Additional info not expected.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Anorexia, Asthenia, Coma, Contusion, Diarrhoea
Clinical narrative: Vomiting, diarrhea, weakness, paleness, no appetite, bruising, tenderness at site, drowsiness, unresponsive and bleeding at the injection site up to 30 minutes after administered.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site haemorrhage, Injection site pain, Pallor, Vomiting
Clinical narrative: Vomiting, diarrhea, weakness, paleness, no appetite, bruising, tenderness at site, drowsiness, unresponsive and bleeding at the injection site up to 30 minutes after administered.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Within 1/2 hour of shots the pt developed a fever of 106 (rectal) with "measles" type rash. The child was fussy the rest of the afternoon. Given Motrin and Tylenol alternately.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: The parent stated that the pt experienced an elevated temp to 105 with Motrin being given at 4 hours. The pt went to the ER with unknown labs. This event lasted 48 hours.
Age: 4.0
Sex: M
Vaccine: FLU3, PNC
Symptoms: Pyrexia
Clinical narrative: The pt developed a temp of 103.2. The pt's mother gave him Tylenol prior to school in the AM.
Age: 1.7
Sex: M
Vaccine: PNC
Symptoms: Agitation, Crying, Erythema, Oedema
Clinical narrative: 20-25 minutes of unconsolable crying, uncontrolled crying, swelling, and slight redness.
Age: 47.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Arthralgia, Arthritis, Arthropathy, Feeling hot, Tendonitis
Clinical narrative: Approximately 6 months post vax, the pt complained of pain in her left elbow. She was seen by an orthopedist who diagnosed her with tendonitis and prescribed unspecified anti-inflammatory medicine and exercises. Per the pt, the orthopedist "did not relate the complaint to Lymerix". The pt experienced joint warmth as well. Six months later, in 3/00, the right elbow became painful. At that time, the pt did not seek treatment. In 2/01, the pt complained of right knee pain and was seen by the physician. The pt stated that MRI of right knee confirmed arthritis under knee cap and torn cartilage". Per the pt, the bilateral elbow pain has not resolved as well as the knee pain. As of 3/13/01, the outcome of the events is ongoing.
Age: 47.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Arthralgia, Arthritis
Clinical narrative: Approximately 6 months post vax, the pt complained of pain in her left elbow. She was seen by an orthopedist who diagnosed her with tendonitis and prescribed unspecified anti-inflammatory medicine and exercises. Per the pt, the orthopedist "did not relate the complaint to Lymerix". The pt experienced joint warmth as well. Six months later, in 3/00, the right elbow became painful. At that time, the pt did not seek treatment. In 2/01, the pt complained of right knee pain and was seen by the physician. The pt stated that MRI of right knee confirmed arthritis under knee cap and torn cartilage". Per the pt, the bilateral elbow pain has not resolved as well as the knee pain. As of 3/13/01, the outcome of the events is ongoing.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Oedema peripheral, Pain
Clinical narrative: This child received immunizations of DTaP #5 on 03/13/01 on left upper arm and came in on Friday, 03/15/01 with a complaint of left arm pain, redness, swollen and hard with circumference of 9 3/8'' (+) erythema and edema. Will follow up tomorrow on      03/16/01 to recheck site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Oedema
Clinical narrative: This child received DTaP, IPV, and MMR on 2/21/01. The mother reported arm swollen, hard, and red. The doctor put the child on antibiotics (pending for doctors note).
Age: 1.0
Sex: F
Vaccine: MEN, MMR
Symptoms: Cough, Pharyngeal oedema, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: This child had a rash, elevated temp, runny nose, cough, and swollen glands.
Age: 1.6
Sex: M
Vaccine: DTAP, IPV, MUR
Symptoms: Cough, Dyspnoea, Laryngitis, Pyrexia, Urticaria
Clinical narrative: This patient's mother called at 8 PM on 02/12/2001, stated that the baby had welts on his left thigh 30 minutes after the immunizations. Given on 02/09/01. By 12 noon on 02/10/01, the baby broke out with hives all over his body. The baby developed a croupy cough, a temperature of 103F, and difficulty breathing. Went to the ER on 02/11/01 AM and was given Benadryl and sent home.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Influenza, Pyrexia
Clinical narrative: This child had a Hepatitis B injection #2, 01/23/01. After school symptoms of an achy stomach, temp of 99.0 at 3:30 PM, and 102.7 at 4:50 PM. No pain or redness at the injection site. No problem with first Hepatitis B shot. The patient was seen in the doctors office the next day 01/24/01, it is believed that he has the flu, the Hep B shot from the day before causing the reaction is totally coincidental.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Headache, Infection
Clinical narrative: The patient's mother called on 03/16/01, stated the child had a headache and marks on his body. He was seen in the doctors office positive chicken pox approximately 20 total.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Infection
Clinical narrative: This patient's mother called on 03/16/2001 and stated the child broke out with the chicken pox in the face, elbows, ears, and stomach.
Age: 1.25
Sex: F
Vaccine: DTAP, HBPV, IPV
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: This infant became unconscious a few hours after the vaccine. Started vomiting. Called a nurse help line for advise. The child was taken to the ER.  Follow up:  Since I have had both my children experience severe allergic reactions to vaccines (which have been reported), I expect a follow up phone call interview.
Age: 9.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Rash erythematous, Rash macular
Clinical narrative: On 03/07/2001, the patient received MMR #2 and Hep B #1. From 03/08/01, he had a skin rash, maculo erythematous trunk and face. No fever, no systemic symptoms.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Shoulder pain
Clinical narrative: This patient complained of pain in the left shoulder area. She was examined at the doctors office on 12/09/00 ( 2 month later) and found no physical signs of reaction nor disability (no swelling, no ecchymosis, no wasting, full range of motion intact, sensory and motor intact.) Expected re-examination on 03/09/01, but did not go.  Follow up: adverse event onset date/time is not clear.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, MUR
Symptoms: Irritability, Pyrexia, Tachycardia
Clinical narrative: This infant had Advil, went to the ER at 10:30 PM, had a temperature of 104, HR > 200 bpm. He was placed on a monitor, given Tylenol. Fussiness and temp began 1 hour post-vaccination and continued for 48 hours.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Angioneurotic oedema, Urticaria
Clinical narrative: It was reported that a 2 year old male patient received a ProHIBit vaccination on 03/30/00. The same day the patient developed hives and angioedema. The patient was treated with Epinephrine, Benadryl, Tagamet, and Pedispred.
Age: 11.0
Sex: F
Vaccine: HIBV
Symptoms: Erythema, Pyrexia
Clinical narrative: It was reported that an 11 year old female patient received a ProHIBit vaccination on 08/25/00. Reportedly the patient developed a large area of erythema and fever. Onset date not reported. Further info requested.
Age: 11.0
Sex: F
Vaccine: HIBV
Symptoms: Erythema, Pyrexia
Clinical narrative: It was reported that an 11 year old female patient received a ProHIBit vaccination on 08/25/00. Reportedly the patient developed large area of erythema and a fever. Onset date not reported. Further info requested.
Age: 14.0
Sex: M
Vaccine: HEP, TD, HEP, TD
Symptoms: Dyspnoea, Feeling hot, Injection site erythema, Injection site oedema, Oedema
Clinical narrative: Afebrile with localized erythema, warmth, edema and tenderness at injection site. At 22:30, edema greater than expected from left shoulder to elbow and also, shortness of breath until 01:00. Treated with Tylenol and ice packs.
Age: 14.0
Sex: M
Vaccine: HEP, TD, HEP, TD
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Afebrile with localized erythema, warmth, edema and tenderness at injection site. At 22:30, edema greater than expected from left shoulder to elbow and also, shortness of breath until 01:00. Treated with Tylenol and ice packs.
Age: 0.25
Sex: F
Vaccine: PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Information has been received from an investigator regarding a 3 month old female who received her first dose of Prevnar as part of a post-marketing safety surveillance trial. At 39 days, post vax, the infant died due to Sudden Infant Death Syndrome. Both the medical monitor and the investigator agree that this event was not related to the vaccine.  A follow up report received 4/13/2001 adds: Upon further review, this case is being forwarded to as a 15 day alert report per agreement with the FDA. MANUFACTURER'S NOTE: Upon case review on 04/11/2001, this report was found to be a duplication of report with case ID #HQ7326116FEB2001. Therefore, this case has been canceled and informational contents merged with HQ7326116FEB2001.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Within 48 hours post vax, the baby died from SIDS in the ER department.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Convulsion
Clinical narrative: The pt experienced a seizure on 2/22/01 at 4:00 PM.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: This infant had a febrile seizure, temp of 105; five days after his MMR, Varicella, and Prevnar, immunization.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Lethargy, Staring, Tic, Tremor
Clinical narrative: This infant was immunized on 03/15/01. The mother reports the child developed "tic" in which the child twitched head to one side. On the night of 03/17/01, the child had 2-3 generalized shaking episodes which lasted 3 seconds each, followed by a glazed / lethargic look. This was not typical seizure activity. However unsure. Patient to see a neurologist.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Injection site erythema
Clinical narrative: This infant was screaming for 2 hours after her injection and redness appeared at the sight on the left thigh.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Muscle disorder, Oedema, Pain, Rash macular
Clinical narrative: This infant had DTaP and Prevnar injected at separate sites of the right upper arm. No sterile abscess, but muscle swollen, slightly tender, red blotches on upper arm 7 cm x 2 cm around the injection site, 3; 1 x 1 cm 65 inch posteriorly upper arm and 2 smaller blotches below the injection site. 3 x 2 cm and 1 cm diameter not warm or indurated, no hives.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site reaction, Rash papular
Clinical narrative: This infant had a papular rash at each  injection site.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cyanosis, Dyskinesia, Muscle twitching, Pyrexia, Respiratory disorder
Clinical narrative: This child had a temp of 104, irregular breathing, cyanosis, twitching, and jerking, this all was observed at home by the parents. The infant was taken to an after hours clinic. Onset of symptoms approximately 1 hour after receiving vaccine. Apnea monitor ordered.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Agitation, Screaming
Clinical narrative: This infant took a small nap after his shots. He woke up around 1 PM, with inconsolable crying and screaming until around 5:30 PM when he napped again.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema
Clinical narrative: This child had a large erythema reaction to Prevnar. Erythema measures 9 cm x 5.5 cm.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Irritability, Pyrexia, Screaming
Clinical narrative: This infant had a fever of 103 (2 hours after his vaccine temp 102), he cried for 6 hours, and the fever persisted for 24 hours. The patient was treated with Motrin at home he was very irritable.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Cellulitis, Dermatitis bullous, Injection site reaction
Clinical narrative: This patient had cellulitis at the injection site, with a varicella type rash.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: This patient had urticaria to the face, seen within 1 hour of reaction at the pediatric clinic.
Age: 1.4
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: This child developed a fever, erythema and swelling developed on her left deltoid (6 x 7 cm) and a smaller area of erythema on the right deltoid.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC
Symptoms: Rash, Urticaria
Clinical narrative: This patient came into the health dept at 10:30 AM of immunization, no adverse reactions at the time of immunizations. The mother brought the child back to the health dept at 1:30 PM with systematic rash and welts. He was sent to the ER. Treated with Benadryl and sent home.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 3cm X 3cm redness with raised area at right upper arm. Area is warm to the touch. Pt denies any soreness, pain or discomfort.
Age: 31.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain, Type III immune complex mediated reaction
Clinical narrative: Left shoulder pain, post vax. Arthus reaction the next day on 11/21/00. Treated with heat and elevation.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint stiffness, Rash
Clinical narrative: Rash, aching joints, especially knees, stiffness. Advised to treat with OTC NSAIDS such as ibuprofen or Aleve. Recheck in office if persists 4 weeks, post vax. On 3/21/01, improving.
Age: 2.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Depressed level of consciousness, Febrile convulsion, Tremor
Clinical narrative: 2 hours, post vax, pt experienced seizure (shaking for 2 minutes) followed by decrease in level of consciousness. Taken to Pediatric ER at hospital. Review of systems were negative. Impression: Febrile seizure (pt was running 99F-100F) for several days. Given Motrin and released.
Age: 11.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Abdominal pain upper, Headache, Influenza like illness, Vomiting
Clinical narrative: On 1/24/01, pt developed flu-like symptoms of headache, stomachache, vomiting. Also complained of stomach pain on and off for the next 30 days. Vomiting lasted only 1 day.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Dizziness, Headache, Pharyngeal oedema, Pharyngolaryngeal pain
Clinical narrative: Headache, 30 minutes, post vax. Had a headache and dizziness the next day. Fever of 102F on 2/21/01. Fever and headache continued until to 2/25/01. Mild swollen and sore throat and treated with antibiotic (Zithromax) but only took 4 days secondary to stomach pain.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Headache, 30 minutes, post vax. Had a headache and dizziness the next day. Fever of 102F on 2/21/01. Fever and headache continued until to 2/25/01. Mild swollen and sore throat and treated with antibiotic (Zithromax) but only took 4 days secondary to stomach pain.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Pain
Clinical narrative: On 3/14/01, used a 1" needle. On 3/15/01, had shooting pain down left arm when she raised it. Also has pain when she rotates arm. No redness or swelling. Applying cold compresses bid. I 600mg.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Breakthrough case of varicella-spots, but no fever. Confirmed by doctor. No treatment.
Age: 20.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Dyspnoea, Erythema, Eye swelling, Throat tightness
Clinical narrative: Pt complaining of swelling around the eyes, tightening of the throat and difficulty breathing, approx. 20 minutes, post vax. Pt also had redness in front of neck area that extended to behind ear lobes. Treated with 50mg Benadryl IM, 4 puffs albuterol inhaler and Epinephrine.