chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Anorexia, Crying, Screaming
Clinical narrative: A two month old female pt had received an intra muscular dose of ActHib, lot number UE868AA, in the right thigh, a first IM dose of Daptacel, lot number C2406AA, in the left thigh a SC dose of Ipol. lot number X1050, in the left thigh, and an IM dose of Prevnar,lot number 817697, in the right thigh on 4/24/06at 12:30pm. 90 minutes post immunization, the pt had inconsolable crying that lasted two hours, and would not feed. It was reported, that the pt had previously received a second IM dose of Hepatitis B vaccine, lot number 1096R, in the left thigh, on 2/25/06. The pt has no reported averse reactions to prior vaccinations. The recovery status of the pt was not reported. Follow up information received on 5/30/06. Per the responsible physician the pt received the first dose of Hepatitis B vaccine on 2/25/06 and the second dose on 3/28/06. Following immunization received on 4/24/06 the pt cried for three hours. Settled after 30 minutes in a warm bath and then slept, fed fine. Symptoms resolved. No further information is expected. The reporter for this case is the same for cases 200600952 and 200600953.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Anorexia, Crying, Screaming
Clinical narrative: A two month old female pt had received an intra muscular dose of ActHib, lot number UE868AA, in the right thigh, a first IM dose of Daptacel, lot number C2406AA, in the left thigh a SC dose of Ipol. lot number X1050, in the left thigh, and an IM dose of Prevnar,lot number 817697, in the right thigh on 4/24/06at 12:30pm. 90 minutes post immunization, the pt had inconsolable crying that lasted two hours, and would not feed. It was reported, that the pt had previously received a second IM dose of Hepatitis B vaccine, lot number 1096R, in the left thigh, on 2/25/06. The pt has no reported averse reactions to prior vaccinations. The recovery status of the pt was not reported. Follow up information received on 5/30/06. Per the responsible physician the pt received the first dose of Hepatitis B vaccine on 2/25/06 and the second dose on 3/28/06. Following immunization received on 4/24/06 the pt cried for three hours. Settled after 30 minutes in a warm bath and then slept, fed fine. Symptoms resolved. No further information is expected. The reporter for this case is the same for cases 200600952 and 200600953.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 5 month old male, who on 05Jul06, was vaccinated with a first 2ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot653754/0139F). It was reported by the pt's parents to the physician that the pt experienced diarrhea for one week, beginning on 05Jun06. On 05Jul06 the pt was vaccinated with a second 2ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot653661/0146F). On 05Jul06 the pt again experienced diarrhea lasting for one week. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/10/2006.  Follow-up information from a physician indicated that on 06-JUN-2006 the patient experienced diarrhea for six days,with approximately six stools per day and no dehydration.  Following the second dose of ROTATEQ the patient experienced loose stools for two days.  It was noted that the patient's parents requested a third dose.  It was reported that the patient recovered.  Additional information is not expected.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Diarrhoea, Diarrhoea, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 5 month old male, who on 05Jul06, was vaccinated with a first 2ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot653754/0139F). It was reported by the pt's parents to the physician that the pt experienced diarrhea for one week, beginning on 05Jun06. On 05Jul06 the pt was vaccinated with a second 2ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot653661/0146F). On 05Jul06 the pt again experienced diarrhea lasting for one week. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/10/2006.  Follow-up information from a physician indicated that on 06-JUN-2006 the patient experienced diarrhea for six days,with approximately six stools per day and no dehydration.  Following the second dose of ROTATEQ the patient experienced loose stools for two days.  It was noted that the patient's parents requested a third dose.  It was reported that the patient recovered.  Additional information is not expected.
Age: 1.5
Sex: F
Vaccine: DTAP, HEP, IPV, DTAP, HEP, IPV, DTAP, HEP, IPV
Symptoms: Injection site hypersensitivity, Injection site reaction, Listless, Rash, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible seizure in an 18 month old female subject who was vaccianted with hepatitis B vaccine recombinant Engerix B, diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) and inactivated poliomyelitis virus vaccine IPOL for prophylaxis. The subjects medical history included a pre existing allergy to ceftriaxone sodium Rocephin. There were no concurrent medications. On 7/22/06 at approx 9:15am, the subject received 3rd dose of Engerix B 10 mcg, IM left thigh lot number AHBVB289CA. On the same day, the subject received 4th dose of Tripedia lot number U1397AB and 3rd dose of IPOL lot number Y1051-2. On 7/22/06, when the subject first received the vaccine around 9:15am, the mother of the subject noticed some redness at the injection site left anterior thigh for Engerix B. The mother of the subject did not mention the redness to the healthcare professional while she was in the office because she thought it was just local and she took the subject home. Later in the day on 7/22/06, approx ten hours following vaccination, the subject developed hives all over around 7:00pm. Between 7:30 - 8:00pm, she developed vomiting and sleepiness. By 8:30pm, the subject was so lethargic that the paramedics were called and the subject was transported to the ER. The exact onset time of the lethargy was unknown. She was not admitted and remained in the ER until the early hours of 7/23/06. On 7/23/06, relevant test included a normal CT scan, although the ER physician ruled that the subject had experienced a possible seizure, based on the mothers description of what happened. The onset time of the possible seizure was unknown. This case was assessed as medically serious by manufacturer (OMIC). On 7/23/2006 the events were resolved.
Age: 1.5
Sex: F
Vaccine: DTAP, HEP, IPV, DTAP, HEP, IPV, DTAP, HEP, IPV
Symptoms: Convulsion, Injection site erythema, Injection site reaction, Lethargy, Listless
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible seizure in an 18 month old female subject who was vaccianted with hepatitis B vaccine recombinant Engerix B, diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) and inactivated poliomyelitis virus vaccine IPOL for prophylaxis. The subjects medical history included a pre existing allergy to ceftriaxone sodium Rocephin. There were no concurrent medications. On 7/22/06 at approx 9:15am, the subject received 3rd dose of Engerix B 10 mcg, IM left thigh lot number AHBVB289CA. On the same day, the subject received 4th dose of Tripedia lot number U1397AB and 3rd dose of IPOL lot number Y1051-2. On 7/22/06, when the subject first received the vaccine around 9:15am, the mother of the subject noticed some redness at the injection site left anterior thigh for Engerix B. The mother of the subject did not mention the redness to the healthcare professional while she was in the office because she thought it was just local and she took the subject home. Later in the day on 7/22/06, approx ten hours following vaccination, the subject developed hives all over around 7:00pm. Between 7:30 - 8:00pm, she developed vomiting and sleepiness. By 8:30pm, the subject was so lethargic that the paramedics were called and the subject was transported to the ER. The exact onset time of the lethargy was unknown. She was not admitted and remained in the ER until the early hours of 7/23/06. On 7/23/06, relevant test included a normal CT scan, although the ER physician ruled that the subject had experienced a possible seizure, based on the mothers description of what happened. The onset time of the possible seizure was unknown. This case was assessed as medically serious by manufacturer (OMIC). On 7/23/2006 the events were resolved.
Age: 1.5
Sex: F
Vaccine: DTAP, HEP, IPV, DTAP, HEP, IPV, DTAP, HEP, IPV
Symptoms: Rash, Somnolence, Urticaria, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible seizure in an 18 month old female subject who was vaccianted with hepatitis B vaccine recombinant Engerix B, diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) and inactivated poliomyelitis virus vaccine IPOL for prophylaxis. The subjects medical history included a pre existing allergy to ceftriaxone sodium Rocephin. There were no concurrent medications. On 7/22/06 at approx 9:15am, the subject received 3rd dose of Engerix B 10 mcg, IM left thigh lot number AHBVB289CA. On the same day, the subject received 4th dose of Tripedia lot number U1397AB and 3rd dose of IPOL lot number Y1051-2. On 7/22/06, when the subject first received the vaccine around 9:15am, the mother of the subject noticed some redness at the injection site left anterior thigh for Engerix B. The mother of the subject did not mention the redness to the healthcare professional while she was in the office because she thought it was just local and she took the subject home. Later in the day on 7/22/06, approx ten hours following vaccination, the subject developed hives all over around 7:00pm. Between 7:30 - 8:00pm, she developed vomiting and sleepiness. By 8:30pm, the subject was so lethargic that the paramedics were called and the subject was transported to the ER. The exact onset time of the lethargy was unknown. She was not admitted and remained in the ER until the early hours of 7/23/06. On 7/23/06, relevant test included a normal CT scan, although the ER physician ruled that the subject had experienced a possible seizure, based on the mothers description of what happened. The onset time of the possible seizure was unknown. This case was assessed as medically serious by manufacturer (OMIC). On 7/23/2006 the events were resolved.
Age: 1.5
Sex: F
Vaccine: DTAP, HEP, IPV, DTAP, HEP, IPV, DTAP, HEP, IPV
Symptoms: Convulsion, Injection site hypersensitivity, Lethargy, Somnolence, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible seizure in an 18 month old female subject who was vaccianted with hepatitis B vaccine recombinant Engerix B, diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) and inactivated poliomyelitis virus vaccine IPOL for prophylaxis. The subjects medical history included a pre existing allergy to ceftriaxone sodium Rocephin. There were no concurrent medications. On 7/22/06 at approx 9:15am, the subject received 3rd dose of Engerix B 10 mcg, IM left thigh lot number AHBVB289CA. On the same day, the subject received 4th dose of Tripedia lot number U1397AB and 3rd dose of IPOL lot number Y1051-2. On 7/22/06, when the subject first received the vaccine around 9:15am, the mother of the subject noticed some redness at the injection site left anterior thigh for Engerix B. The mother of the subject did not mention the redness to the healthcare professional while she was in the office because she thought it was just local and she took the subject home. Later in the day on 7/22/06, approx ten hours following vaccination, the subject developed hives all over around 7:00pm. Between 7:30 - 8:00pm, she developed vomiting and sleepiness. By 8:30pm, the subject was so lethargic that the paramedics were called and the subject was transported to the ER. The exact onset time of the lethargy was unknown. She was not admitted and remained in the ER until the early hours of 7/23/06. On 7/23/06, relevant test included a normal CT scan, although the ER physician ruled that the subject had experienced a possible seizure, based on the mothers description of what happened. The onset time of the possible seizure was unknown. This case was assessed as medically serious by manufacturer (OMIC). On 7/23/2006 the events were resolved.
Age: 1.5
Sex: F
Vaccine: DTAP, HEP, IPV, DTAP, HEP, IPV, DTAP, HEP, IPV
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible seizure in an 18 month old female subject who was vaccianted with hepatitis B vaccine recombinant Engerix B, diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) and inactivated poliomyelitis virus vaccine IPOL for prophylaxis. The subjects medical history included a pre existing allergy to ceftriaxone sodium Rocephin. There were no concurrent medications. On 7/22/06 at approx 9:15am, the subject received 3rd dose of Engerix B 10 mcg, IM left thigh lot number AHBVB289CA. On the same day, the subject received 4th dose of Tripedia lot number U1397AB and 3rd dose of IPOL lot number Y1051-2. On 7/22/06, when the subject first received the vaccine around 9:15am, the mother of the subject noticed some redness at the injection site left anterior thigh for Engerix B. The mother of the subject did not mention the redness to the healthcare professional while she was in the office because she thought it was just local and she took the subject home. Later in the day on 7/22/06, approx ten hours following vaccination, the subject developed hives all over around 7:00pm. Between 7:30 - 8:00pm, she developed vomiting and sleepiness. By 8:30pm, the subject was so lethargic that the paramedics were called and the subject was transported to the ER. The exact onset time of the lethargy was unknown. She was not admitted and remained in the ER until the early hours of 7/23/06. On 7/23/06, relevant test included a normal CT scan, although the ER physician ruled that the subject had experienced a possible seizure, based on the mothers description of what happened. The onset time of the possible seizure was unknown. This case was assessed as medically serious by manufacturer (OMIC). On 7/23/2006 the events were resolved.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Cellulitis, Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Redness, swelling, area warm to touch, painful, erythema 12 by 8.5 centimeter at left thigh. Treated for cellulitis with KEFLEX, treated for pain with TYENOL. Has follow up.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Convulsion, Fall, Injury, Musculoskeletal stiffness, Staring
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male, with no medical history, who on 7/25/06 was vaccinated with the first dose of hepatitis A virus vaccine inactivated. 0.5ml IM (lot 654377/0510F). There was no concomitant medication. On 7/25/06, less than two minutes following the vaccination, the pt experienced a seizure and fell. Pt fell after stiffening up with arms to side, jaw clenched, and a blank stare. The pt ans mother came to the desk to check out and the pt got a piece of candy. Seizure lasted about 10 to 13 seconds. While falling the pt hit his head. Pt (because of fall) was immediately sent for CT imaging which was normal. The mother reported that the pt was tired for the rest of the day, but otherwise normal. The next day 7/26/06 the pt was recovered. The pt had no previous history of seizure disorder. Upon internal review, the seizure was considered to be an other important medical event (OMIC). Follow up information received from registered nurse, on 8/3/06, stating that she spoke with the pts mother and the pt is fine. She confirmed that the last vaccination of the pt was in 2001 (she did not indicate what vaccine was given). She confirmed that the pt had no illness at the time of the vaccination and that he was not taking any medications. He had no allergies. The pt arrived at the doctors office at 9:36am. The nurse estimated that the vaccine was given at 10:15am. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Asthenia, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a pt (age and gender not reported) who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot651321/1036P). Subsequently, the day after vaccination, the pt developed severe arm soreness, high fever, nausea, vomiting and weakness. The pt sought unspecified medical attention. At the time of this report, the outcome was unk. The physician requested a lot check of lot 651321/1036P. The physician felt that the pt's severe arm soreness, high fever, nausea, vomiting and weakness were disabling. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Asthenia, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a pt (age and gender not reported) who on an unspecified date was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651231/1036P). Subsequently, the day after vaccination, the pt developed severe arm soreness, high fever, nausea, vomiting and weakness. The pt sought unspecified medical attention. Subsequently, the pt recovered. The physician requested a lot check of lot 651321/1036P. The physician felt that the pts severe arm soreness, high fever, nausea, vomiting and weakness were disabling. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Anaemia, Depression, Pyelonephritis, Unintended pregnancy
Clinical narrative: Initial report received on 6/6/06 from a health care professional. An 18 year old female pt, with no past medical history, had received an injection of Menactra, lot number unknown, on 2/15/06. Route and site of administration were not reported. It was determined that the pt was pregnant at the time of vaccination. The pts last menstrual period was 12/25/05, and her estimated date of delivery is 10/01/06. The pt had no prior pregnancies. The pt had two ultrasounds in order to determine gestational age that showed normal 20 weeks. Per the reporter, there was no adverse event. Follow up information received on 6/30/06. Per the reporter, the lot number for Menactra was 61656AC and it was given IM on 2/15/06. This was the first dose of Menactra the pt had received. It was not known that the pt was pregnant at the time of the vaccination with Menactra. The pregnancy was confirmed at the later date. The pt was originally evaluated in the physicians office on 2/15/06 for breast tenderness after cheerleader cheerleader practice. The date of the pts last menstrual period was reported as 12/05. The expected date of delivery was not reported. An ultrasound was completed on 6/27/06 at 20 weeks gestation revealing that the fetus had a mild ventriculomegaly versus hydrocephalus. Per the reporter, the pt (the mother) has not experienced any adverse events. Follow up information received on 8/4/06. Per the reporter, the mother , who is the pt, was hospitalized for an episode of pyelonephritis. The date of hospitalization was not reported. The pt was treated in the hospital with IV antibiotics and placed on Macrodantin by mouth on 6/26/06. The Macrodantin will be continued throughout the remainder of the pregnancy. The pt was also started on Wellbutrin XL for depression on 6/26/06. The pt was treated with IV Fe Iron for severe chronic anemia. The date the pt was treated with tin IV iron was not reported. An alpha feto protein test was normal on 5/5/06. Per the reporter, the pt also had an ultrasound done on 6/1/06, but the result were not reported. Another ultrasound was completed on 7/5/06 that showed the fetus to have hydrocephalus. The patient had an amniocentesis on 7/25/06, and the result was pending at the time of this report. The pts expected date of delivery was reported as 10/21/06. After medical review of this new information, and the pts hospitalization, this case has been upgraded to serious (OMIC). The information regarding the fetus is reported in case 200601628 (Serious case).
Age: 13.0
Sex: M
Vaccine: DTP
Symptoms: Encephalopathy
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 8/1/06 from the pts parent. A male pt had received an injection of DTP USP, lot number 2A41126, on an unspecified date. The age of the pt was reported as 13 although the pts age at the time of the event was not specified. Per the reporter, the pt had suffered encephalopathy as a result of receiving the injection. On set date of the event was not reported. Recovery status was not reported. Additional medically relevant information was not provided.
Age: 1.02
Sex: M
Vaccine: HBHEPB, MMRV, PNC
Symptoms: Agitation, Convulsion, Crying, Eye movement disorder, Skin discolouration
Clinical narrative: Looked dazed, began shaking all over, eyes turned to back of head, became purple, after approx 3mins, started crying and became very sleepy. HX present illness: syncopal episode, evening of admission noted to walk across floor and began looking dazed and began shaking all over. Mother picked him and noted that his eyes were turning back in his head and he became "purple". Began crying after about 3 minutes of shaking and then became sleepy. Brought to ER. No HX of seizure but mother mentioned that child had one or two previous episodes of looking dazed and "turning purple" without the shaking. Week prior to this admission child was seen in this ER because his left foot turned in and he was limping. Child examined and no etiology was found at that time thought he was just trying to walk and that was the cause of his limping.  Admitted for observation. No seizure activity noted during hospitalization.  PE: Temp 99.5, WNL Tympanic membranes are normal tubes are inserted and both are dry. Impression: Possible Seizure DC DX: Syncopal episode, possible seizure activity.  .
Age: 1.02
Sex: M
Vaccine: HBHEPB, MMRV, PNC
Symptoms: Somnolence, Staring, Syncope, Tremor
Clinical narrative: Looked dazed, began shaking all over, eyes turned to back of head, became purple, after approx 3mins, started crying and became very sleepy. HX present illness: syncopal episode, evening of admission noted to walk across floor and began looking dazed and began shaking all over. Mother picked him and noted that his eyes were turning back in his head and he became "purple". Began crying after about 3 minutes of shaking and then became sleepy. Brought to ER. No HX of seizure but mother mentioned that child had one or two previous episodes of looking dazed and "turning purple" without the shaking. Week prior to this admission child was seen in this ER because his left foot turned in and he was limping. Child examined and no etiology was found at that time thought he was just trying to walk and that was the cause of his limping.  Admitted for observation. No seizure activity noted during hospitalization.  PE: Temp 99.5, WNL Tympanic membranes are normal tubes are inserted and both are dry. Impression: Possible Seizure DC DX: Syncopal episode, possible seizure activity.  .
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Asthenia, Depression, Disturbance in attention
Clinical narrative: Short term memory loss, blurred vision, bad memory no strength, dizziness, poor tolerance to bright light, ache joints, acid reflux, night sweats, rashes, photophobia, pain in muscle and joints, depression, loss of concentration and others.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Gastrooesophageal reflux disease, Myalgia, Night sweats, Photophobia
Clinical narrative: Short term memory loss, blurred vision, bad memory no strength, dizziness, poor tolerance to bright light, ache joints, acid reflux, night sweats, rashes, photophobia, pain in muscle and joints, depression, loss of concentration and others.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Rash, Vision blurred
Clinical narrative: Short term memory loss, blurred vision, bad memory no strength, dizziness, poor tolerance to bright light, ache joints, acid reflux, night sweats, rashes, photophobia, pain in muscle and joints, depression, loss of concentration and others.
Age: 21.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Erythema, Headache, Swelling
Clinical narrative: Local erythema, swelling, headache, Ibuprofen, DECADRON.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV
Symptoms: Cellulitis, Feeling hot, Injection site swelling, Tenderness
Clinical narrative: Left thigh swollen, warm, tender on injection site for Pediarix about 3" by 3" cellulitis left thigh, treated with KEFLEX, ATARAX, compresses.
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Feeling hot, Injection site swelling, Pruritus
Clinical narrative: Raised area, warm to touch welted, size, size dime to quarter, head or pin, itchy.  BENADRYL at 12:45.  No fever.  Mom called back at 4 pm, patient doing ok with BENADRYL.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Dizziness, fatigue, nausea began 2:00am on 8/8/06, Tylenol, Pepto Bismol given, Began feeling better at 9:00pm on 8/8/06.
Age: 13.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Pain, Pain in jaw
Clinical narrative: Body ache and jaw pain started the next day vaccinated, body ache subsided and jaw pain persist, resolved by 7/23/06.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Swelling, redness and warmth 3cm x 3cm and mild redness several inches down arm and around injection site.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Blood pressure increased, Condition aggravated, Heart rate increased
Clinical narrative: Pulse over 100, HBP increase, Treatment Toprol 50mg.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Anxiety, Chest pain, Disturbance in attention, Sleep disorder
Clinical narrative: Loss of memory, chest pain, stomach problems, unable to concentrate, sleep problems, Anxiety.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Stomach discomfort
Clinical narrative: Loss of memory, chest pain, stomach problems, unable to concentrate, sleep problems, Anxiety.
Sex: U
Vaccine: ANTH
Symptoms: Fluid retention, Skin ulcer
Clinical narrative: I developed little ulcer on different part of my body with clear liquid then make scab (Black) and disappeared. Another appeared some time. I have more than 2 on the body.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Condition aggravated, Urticaria
Clinical narrative: Hives, Spreading all over, started in am before shots. Had reaction to Robitussin DM and then continues to spread after immuns given 8/7/06.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Erythema, Injection site reaction, Urticaria
Clinical narrative: 14:35 erythema over upper chest 2cm wheal at injection site. Benadryl 12.5/5ml 1 1/2 tsp given PO.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: 6 hours later urticarial rash all over gave Benadryl PO.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: Right leg itchy, swollen, red and hot to touch >10cm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Rash
Clinical narrative: Redness around injection site, spots on back. Benadryl for anti itch reasons.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Tenderness
Clinical narrative: redness, erythema, tenderness at the site of injection left arm on Augmentin.
Age: 45.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Arthralgia, Ear pain, Headache, Myalgia, Pyrexia
Clinical narrative: Fever ranging from 100 to 103 for at least 48 hours after immunization headache, muscle joint ache, earache and ringing and kidney pain also during same 48 hours period.
Age: 45.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Renal pain, Tinnitus
Clinical narrative: Fever ranging from 100 to 103 for at least 48 hours after immunization headache, muscle joint ache, earache and ringing and kidney pain also during same 48 hours period.
Age: 46.0
Sex: M
Vaccine: HEP, TDAP, TYP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Patient received a Tdap vaccine along with other inactivated vaccines and PPD with Tubersol to the LFA. He  returned with a local reaction to the vaccine measuring about 6cm x 7cm.  The area was indurated slightly, definitely erythematous.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5cm red raised, localized reaction L arm.
Age: 11.0
Sex: M
Vaccine: DTAP, IPV, TDAP
Symptoms: Arthralgia, Face oedema, Fatigue, Hypoaesthesia, Pyrexia
Clinical narrative: Child presented with 102 degree temp on 08/11/06 pm.  Awakened on Sat, 08/12/06 with 102 - 103 temp and facial swelling and numbness, hurting severely in joints, and tired.  Collapsed on sofa stating he was so tired and hurting and could not feel his cheeks, also felt like he had a baseball in his throat.  I immediately gave hime Benadryl and Tylenol.  I called my pediatrician's office and spoke to the physician on call. He recommended the Benadryl and if symptoms progressed any, to call him and bring him to the ER.
Age: 11.0
Sex: M
Vaccine: DTAP, IPV, TDAP
Symptoms: Throat tightness
Clinical narrative: Child presented with 102 degree temp on 08/11/06 pm.  Awakened on Sat, 08/12/06 with 102 - 103 temp and facial swelling and numbness, hurting severely in joints, and tired.  Collapsed on sofa stating he was so tired and hurting and could not feel his cheeks, also felt like he had a baseball in his throat.  I immediately gave hime Benadryl and Tylenol.  I called my pediatrician's office and spoke to the physician on call. He recommended the Benadryl and if symptoms progressed any, to call him and bring him to the ER.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Ear pain, Feeling cold, Headache, Hot flush, Malaise
Clinical narrative: TC from patient with report that she received TC yesterday @ approximately 8:30 a.m. and then @ midnight last night had hot/cold flashes, aching ers, felt like jaw was locking up, jaw popping, nausea, body aches.  States "I felt like I was going to die.:  Also got TB skin test yesterday.  Now has HA, jaw and neck are sore but overall feels much better.  Denies illness at time of shot yesterday.  CHN informed patient that if s/sx worsen, to see PMD or go to ER and not to receive further TC without informing provider of this reaction.  Patient denies previous Td shot because her dad was a chiropractor and didn't believe in shots.  Patient states she got TC for graduate school.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Neck pain, Pain, Pain in jaw
Clinical narrative: TC from patient with report that she received TC yesterday @ approximately 8:30 a.m. and then @ midnight last night had hot/cold flashes, aching ers, felt like jaw was locking up, jaw popping, nausea, body aches.  States "I felt like I was going to die.:  Also got TB skin test yesterday.  Now has HA, jaw and neck are sore but overall feels much better.  Denies illness at time of shot yesterday.  CHN informed patient that if s/sx worsen, to see PMD or go to ER and not to receive further TC without informing provider of this reaction.  Patient denies previous Td shot because her dad was a chiropractor and didn't believe in shots.  Patient states she got TC for graduate school.
Age: 0.24
Sex: F
Vaccine: RV5, RV5, DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Intestinal obstruction, Intussusception
Clinical narrative: Patient developed intermittent severe crying WITH failure to pass stool for one day. She got RotaTeq a week prior to onset of illness. KUB and Barium enema were suggestive of Intussusception. Reduction of intusussception made by barium enema hydrostatic pressure. Patients symptoms resolved.
Age: 0.24
Sex: F
Vaccine: RV5, RV5, DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Constipation, Crying, Intussusception
Clinical narrative: Patient developed intermittent severe crying WITH failure to pass stool for one day. She got RotaTeq a week prior to onset of illness. KUB and Barium enema were suggestive of Intussusception. Reduction of intusussception made by barium enema hydrostatic pressure. Patients symptoms resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had 20cm x 20cm redness +warmth, +edema at the injection site. Treatment; Augmentin 600mg x 10 days.
Age: 0.63
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Unevaluable event
Clinical narrative: No adverse symptoms.  No treatment given.
Age: 19.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Gait disturbance, Hypokinesia, Pain
Clinical narrative: Pt received Tdap (LA) and Menactra Vacccines (RA) on 8/8/06.  On 8/9/06 she developed left wrist pain that evolved into B/L wrist pain and hand pain by 8/10.  Pt was unable to use hands due to pain on 8/11-8/13.  Movement of hands caused sig pains.  Ice helped to relieve symptoms.     By evening of 8/12 hand and wrist pain resolved and knee and upper arm pain emerged.  On 8/13 pt described sig pains on moving her upper arms a certain way and a general dull ache otherwise.  Pt also limped at that time due to knee pains. Today (8/14) patients symptoms have begun resolving though upper arm pain and knee pains persist. 01/30/07-records received and reviewed. DOS 8/14/06-patient with history of left wrist pain on 8/9/07 day after vaccination. On 8/10 fingers hurt bilaterally. Then over weekend developed knee pains. Arm pain started Sunday night, hands felt swollen over weekend and it hurt to use her hands. Moving them caused shooting pains. Now has moving pain. On 8/14/07 feeling in arms and hands better without fevers. Slight rash in shot where vaccine was administered. Strength WNL. Reflexes normal. Impression: Acute neuropathy. 8/22/06 patient symptoms resolved by August 16, 2006. To college.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: No adverse signs or symptoms.  No treatment given.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: 9:30 P.M.08/04/2006 ELEV. TEMP 102.1 TOTAL BODY ACHES ( SEVERE )FEVER LASTING FOUR DAYS. HEADACHE LASTING FIVE DAYS. SUNDAY 08/06/2006 NOTICED REDNESS, SWELLING AND THE INJECTION SITE FEELING HOT , REDNESS PERSISTED FOR SEVEN DAYS.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: 9:30 P.M.08/04/2006 ELEV. TEMP 102.1 TOTAL BODY ACHES ( SEVERE )FEVER LASTING FOUR DAYS. HEADACHE LASTING FIVE DAYS. SUNDAY 08/06/2006 NOTICED REDNESS, SWELLING AND THE INJECTION SITE FEELING HOT , REDNESS PERSISTED FOR SEVEN DAYS.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site pain
Clinical narrative: Patient received vaccine 8/7/06. Per patient report, itching and pain at vaccination site 8/8. Worsening pain, redness, edema, and induration on 8/11. Fever and headache developed 8/12. To clinic for evaluation 8/14. Afebrile but 7x7cm region of tenderness, erythema, and induration over injection site noted. To follow-up with patient later this week.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Patient received vaccine 8/7/06. Per patient report, itching and pain at vaccination site 8/8. Worsening pain, redness, edema, and induration on 8/11. Fever and headache developed 8/12. To clinic for evaluation 8/14. Afebrile but 7x7cm region of tenderness, erythema, and induration over injection site noted. To follow-up with patient later this week.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Amnesia, Anger, Anxiety, Arthralgia, Back pain
Clinical narrative: Ache: Bones, Joints and muscle, Aches Whole body Acid relux: Mood: anxiety, Blood pressure high, Blood: High Cholesterol, Concentration: trouble, Depression, gastritis, Hypetension, memory loss, trouble remembering information, memory:short term memory loss, Mood swings, Mood Anxious, mood angry, mood irritable, nasal runny nose, pain legs, pain lower back, pain knees and hips, pain lower back, pain back. Respiratory problems, sinusitis, sleep problems, tendon disorder, vision poor tolerance of bright light, weigh gain.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blood cholesterol increased, Depression, Disturbance in attention, Gastritis, Gastrooesophageal reflux disease
Clinical narrative: Ache: Bones, Joints and muscle, Aches Whole body Acid relux: Mood: anxiety, Blood pressure high, Blood: High Cholesterol, Concentration: trouble, Depression, gastritis, Hypetension, memory loss, trouble remembering information, memory:short term memory loss, Mood swings, Mood Anxious, mood angry, mood irritable, nasal runny nose, pain legs, pain lower back, pain knees and hips, pain lower back, pain back. Respiratory problems, sinusitis, sleep problems, tendon disorder, vision poor tolerance of bright light, weigh gain.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Hypertension, Insomnia, Irritability, Memory impairment, Mood swings
Clinical narrative: Ache: Bones, Joints and muscle, Aches Whole body Acid relux: Mood: anxiety, Blood pressure high, Blood: High Cholesterol, Concentration: trouble, Depression, gastritis, Hypetension, memory loss, trouble remembering information, memory:short term memory loss, Mood swings, Mood Anxious, mood angry, mood irritable, nasal runny nose, pain legs, pain lower back, pain knees and hips, pain lower back, pain back. Respiratory problems, sinusitis, sleep problems, tendon disorder, vision poor tolerance of bright light, weigh gain.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Myalgia, Pain, Photophobia, Rhinorrhoea, Sinusitis
Clinical narrative: Ache: Bones, Joints and muscle, Aches Whole body Acid relux: Mood: anxiety, Blood pressure high, Blood: High Cholesterol, Concentration: trouble, Depression, gastritis, Hypetension, memory loss, trouble remembering information, memory:short term memory loss, Mood swings, Mood Anxious, mood angry, mood irritable, nasal runny nose, pain legs, pain lower back, pain knees and hips, pain lower back, pain back. Respiratory problems, sinusitis, sleep problems, tendon disorder, vision poor tolerance of bright light, weigh gain.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Tendon disorder, Visual disturbance, Weight increased
Clinical narrative: Ache: Bones, Joints and muscle, Aches Whole body Acid relux: Mood: anxiety, Blood pressure high, Blood: High Cholesterol, Concentration: trouble, Depression, gastritis, Hypetension, memory loss, trouble remembering information, memory:short term memory loss, Mood swings, Mood Anxious, mood angry, mood irritable, nasal runny nose, pain legs, pain lower back, pain knees and hips, pain lower back, pain back. Respiratory problems, sinusitis, sleep problems, tendon disorder, vision poor tolerance of bright light, weigh gain.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Pyrexia
Clinical narrative: Received #1 dose of Hepatitis A and #2 dose of varicella on August 7,2006. The morning of August 10, she developed dizziness, fever, stomach cramps and diarrhea. Mother denies any rashes. Mother reported that her other two children also received vaccines on August 7 and developed similiar symptoms on  August 11, 2006. Mother states that symptoms are resolving.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Abdominal pain, Arthralgia, Back pain, Pyrexia, Vomiting
Clinical narrative: Received Tdap, #2 dose of Hepatitis A, and #2 dose of Varicella on August 7, 2006. On the morning of August 11, 2006 she developed fever, stomach cramps, vomitting, joint and lower back pain. Mother denies any rashes. Mother reported that her other two children also received vaccines on August 7, and developed similiar symptoms, one on August 10, and the other on August 11. Mother states that symptoms are resolving.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Pt. developed tender, solid muscular nodule at site of vaccination.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Abdominal pain, Pyrexia, Vomiting
Clinical narrative: Received #2 dose of Hepatitis A and #2 dose of varicella on August 7, 2006. On the morning of August 11, he developed fever, stomach cramps, and vomiting. Mother denies any rashes. This morning August 14, he continues to have a low grade fever and vomited twice. Mother reported that her other two children received vaccines on August 7, 2006 and developed similiar symptoms, one on August 10, and the other on August 11.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Coma, Crying, Hypotonia, Stupor
Clinical narrative: Possible hypotonic-hyporesponsive episode: approximately 48 hours after receiving immunizations, patient was sleeping next to mom on his stomach with his head to the side on a firm mattress with just a sheet over it.  Mom noticed that it looked like he was not breathing and picked him up and tried to arouse him.  He remained unresponsive with decreased tone from usual (not completely floppy but significantly so, very small spontaneous movements) and closed eyes despite vigorous patting and calling his name.  Slightly pale perhaps but never blue or purple.  Mom called 911, ambulance arrived within approximately 3 minutes and baby was brought to ambulance and then Kaiser ER.  Upon her arrival to ER mom reports that baby still not very responsive for some amount of time (?30-45 minutes) after which he become more responsive, cried vigorously, back to his normal tone and movements. Observed in ER overnight.  Workup including EKG, CXR, CBC/d and lytes and blood culture was within normal limits. Slept more than usual for one day following incidient but fed vigorously, and has been awake and alert since. No fever, no symptoms of infection or other illness.  Excellent feeding with normal stool and UOP.  No known ill contacts.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Pruritus, Tenderness
Clinical narrative: Approximately 7 cm of induration, erythema, itching and severe tenderness.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site pain, Pruritus
Clinical narrative: Pt had severe local reaction: marked tenderness, 8 cm diameter erythema, 6 cm diameter thick induration, + itching.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chest discomfort, Loss of consciousness, Pallor, Syncope
Clinical narrative: This female subject was enrolled in a blind study. On 8/2/06, she received a booster of combined diphtheria, tetanus acellular pertussis containing small amount of diphtheria and pertussis (Boostrix) or tetanus toxoid, reduced diphtheria toxoid and acellular pertussis absorbed vaccine Adacel IM U deltoid. This subject received Boostrix. Medical conditions Since 1990, the subject is suffering from hiatal hernia. Since 2005, the subject is taking Nexium for gastroesophageal reflux disease. On 8/2/06, same day after the 1st dose of Blinded vaccine, this 43 year old subject developed pain in her stomach, syncope, tightness in jaw and chest and was pale. She collapsed, an ambulance was called and she was taken to the ER where she was admitted. Worked up for syncope was negative. On 8/3/06, the subject was discharged. At the time of the report, it was not know what caused the symptoms. The events were unresolved at time of reporting. Investigator causality was unknown at the time of reporting.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Bacterial infection, Chills, Febrile convulsion, Pyrexia, Sepsis
Clinical narrative: Pt received Pediarix/HIB/Prevnar at 4 month immun check up. Pt developed high fever that same evening 104.5, chills, vs ? febrile seizure, WBC 27,000, hospitalized with (Aug 1st) septic bacteremia work up. BC positive contaminate (neg staph), discharged home Aug 3rd improved. 8/17/06 Received medical records from hospital which reveal patient was hospitalized for septic w/u 8/1/06-8/3/06.  Temp on admit was 105.4.  Afebrile on d/c.  Blood c/s + for coag neg staph species & received IV antibiotics.  Final dx: febrile reaction, possible febrile seizure & vaccine reaction vs infection./ss 8/17/06 Received medical records from PCP which revealed patient seen approx 2 wks prior to vax for runny nose & difficulty feeding, dx: viral infection & otitis media.  Developed fever, cough & SOB; d: URI w/coughing spasm.  Treated both times with antibiotics.   Cough & fever continued; dx: pharyngitis & congestion.  Office note on vax day indicates child was well.  8/4/06 note s/p hospitalization reveals patients + blood c/s felt to be contaminant./ss
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: White blood cell count increased
Clinical narrative: Pt received Pediarix/HIB/Prevnar at 4 month immun check up. Pt developed high fever that same evening 104.5, chills, vs ? febrile seizure, WBC 27,000, hospitalized with (Aug 1st) septic bacteremia work up. BC positive contaminate (neg staph), discharged home Aug 3rd improved. 8/17/06 Received medical records from hospital which reveal patient was hospitalized for septic w/u 8/1/06-8/3/06.  Temp on admit was 105.4.  Afebrile on d/c.  Blood c/s + for coag neg staph species & received IV antibiotics.  Final dx: febrile reaction, possible febrile seizure & vaccine reaction vs infection./ss 8/17/06 Received medical records from PCP which revealed patient seen approx 2 wks prior to vax for runny nose & difficulty feeding, dx: viral infection & otitis media.  Developed fever, cough & SOB; d: URI w/coughing spasm.  Treated both times with antibiotics.   Cough & fever continued; dx: pharyngitis & congestion.  Office note on vax day indicates child was well.  8/4/06 note s/p hospitalization reveals patients + blood c/s felt to be contaminant./ss
Age: 19.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Midline Abdominal numbness, numbness of the hands.
Age: 10.0
Sex: F
Vaccine: HEPA, MMRV, TDAP
Symptoms: Injection site oedema, Pruritus
Clinical narrative: Swollen deltoid, itching at the place where injection was given.
Age: 45.0
Sex: F
Vaccine: MNQ
Symptoms: Anorexia, Arthralgia, Asthenia, Blister, Dysphonia
Clinical narrative: Client received Menactra on 8/11/06, However c/o fever, body ache, joint pain, muscle pain, headache, loss of appetite and generalized weakness throughout weekend. Assessed client upon return on 8/14/06 client c/o hoarseness and low grade fever. Red blisters x2 noted to left arm with red streaks noted around left upper arm. Client did not seek medical care during 3/5.
Age: 45.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Client received Menactra on 8/11/06, However c/o fever, body ache, joint pain, muscle pain, headache, loss of appetite and generalized weakness throughout weekend. Assessed client upon return on 8/14/06 client c/o hoarseness and low grade fever. Red blisters x2 noted to left arm with red streaks noted around left upper arm. Client did not seek medical care during 3/5.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Pt developed red, hot, swollen 8x7cm area to left deltoid within 2 days of MMR. TX'd for cellulitis with Augmentin. 8/14 erythema and swelling resolved.