chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site streaking, Pain, Pyrexia, Urticaria
Clinical narrative: Within 24 hours of recieving 2nd varivax patient developed fever (Tm=102) and local urticaria and pain.  Rash involve area around injection site and had streaking down to forearm.  No local erythema, no local induration, no local warmth, no local tenderness at time of exam.  No SOB.  Rash improved slightly with benadryl
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, MMRV
Symptoms: Blister, Injection site erythema, Rash, Varicella
Clinical narrative: On 4/8/07, 10 days after receiving his 15 month shots.  The child developed some redness on his left thigh near the injection site where he received his MMRV vaccination.  On 4/9/07 he developed bumpy blisters on the left side.  Mother was advised that the child should be treated as though he had chicken pox and isolated from other kids as he is contagious.
Age: 51.0
Sex: M
Vaccine: VARCEL
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia, Rash
Clinical narrative: Pain and swelling at the injection site. Fever, chillls, Rash.
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: RASH AND ITCHING OVER FACE ARMS CHEST BACK. SEEN BY DR. 10ML OF BENADRYL GIVEN PO PER DR. DR. INSTRUCTED MOTHER TO GIVE ANOTHER DOSE IN 6 HRS. IF CHILD GET WORST TO GO TO THE HOSPITAL.  CHILD LEFT ABOUT 4:45 NAD.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at site of vaccine from 1 day to six days later
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: 10 minutes after administration of Gardasil in left deltoid, patient reported feeling a little dizzy.  She was seated and instructed to hold her head down between her knees, with some improvement.  Vital signs included B/P 76/50 (left arm) [B/P from 20 minutes earlier was 98/70]. Patient was monitored for 45 minutes, given Gatorade 12 oz and 16 oz water.  Symptoms of dizziness completely resolved, with persistent stable B/P in the 90s/60s, both arms, sitting and standing.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Blood test, Computerised tomogram, Guillain-Barre syndrome, Lumbar puncture, Nerve conduction studies
Clinical narrative: Guillain Barre Syndrome 05/15/07-records received from facility for DOS 3/26-4/9/07-DC DX: Probably Guillain Barre Syndrome. IVIg therapy. Admitted with ascending motor weakness, paresthesias and diplopia three days prior to admission. Right facial droop, urinary retention lethargy and mild encephalopathy.  HX of traveling across country. Onset of symptoms sudden progressive blurry vision then weakness in bilateral lower extremities with tingling sensations in hands and feet.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Guillain Barre Syndrome 05/15/07-records received from facility for DOS 3/26-4/9/07-DC DX: Probably Guillain Barre Syndrome. IVIg therapy. Admitted with ascending motor weakness, paresthesias and diplopia three days prior to admission. Right facial droop, urinary retention lethargy and mild encephalopathy.  HX of traveling across country. Onset of symptoms sudden progressive blurry vision then weakness in bilateral lower extremities with tingling sensations in hands and feet.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome 05/15/07-records received from facility for DOS 3/26-4/9/07-DC DX: Probably Guillain Barre Syndrome. IVIg therapy. Admitted with ascending motor weakness, paresthesias and diplopia three days prior to admission. Right facial droop, urinary retention lethargy and mild encephalopathy.  HX of traveling across country. Onset of symptoms sudden progressive blurry vision then weakness in bilateral lower extremities with tingling sensations in hands and feet.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Axillary pain, Injection site pain, Swelling
Clinical narrative: The patient developed neck swelling and pain on the side of the injected deltoid muscle approx 24 hours after injection. She then developed swelling and pain in the left axilla about 72 hours after injection. She has had no skin reaction and no reaction at the site of the injection. She denies numbness, tingling, weakness. She has no history of immunization/vaccine reaction. Her last tetanus toxoid administration was over 10 years prior.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, erythema, pruritis day after vaccine given.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Pain
Clinical narrative: 2 inch diameter red lump at site, where Tdap was given. painful 8/10 pain scale, lasted 1 1/2 weeks long. Ice applied, but did not help, difficult to use R arm. Took Tylenol which helped.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Haematochezia, Muscle spasms, Surgery, Vomiting
Clinical narrative: Pt adm Rotateq; 4/4/07, presented with cramps, abd pain, bloody stools. 4/6/07 - Surgery. Adm to hospital. 17:00 hrs - 4/5/07 vomiting. 04/17/07-records received from receiving facility for DOS 4/6/07-DC Intussusception. Transferred to facility for surgery. Seen in ER with C/O vomiting and bloody stools times 2. Afebrile. Abdomen non distended,mass not palpable constantly crying.  Barium enema:colonic obstruction secondary to intussusception which extends to level of splenic flexure. Three attempts made at hydrostatic reduction unsuccessful.  04/25/07-records received from receiving facility for DOS 04/06-04/10/07-DC DX: status post intussusception requiring operative intervention. Exploratory laparotomy, reduction of intussusception ileocecectomy with hand sew primary end to end anastomosis. HX colicky with a rotavirus with current jelly stools and barium enema that was consistent with intussusception. Ileus resolved on second post op day.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Gastroenteritis viral, Haematochezia, Insomnia, Intestinal obstruction, Intestinal resection
Clinical narrative: Pt adm Rotateq; 4/4/07, presented with cramps, abd pain, bloody stools. 4/6/07 - Surgery. Adm to hospital. 17:00 hrs - 4/5/07 vomiting. 04/17/07-records received from receiving facility for DOS 4/6/07-DC Intussusception. Transferred to facility for surgery. Seen in ER with C/O vomiting and bloody stools times 2. Afebrile. Abdomen non distended,mass not palpable constantly crying.  Barium enema:colonic obstruction secondary to intussusception which extends to level of splenic flexure. Three attempts made at hydrostatic reduction unsuccessful.  04/25/07-records received from receiving facility for DOS 04/06-04/10/07-DC DX: status post intussusception requiring operative intervention. Exploratory laparotomy, reduction of intussusception ileocecectomy with hand sew primary end to end anastomosis. HX colicky with a rotavirus with current jelly stools and barium enema that was consistent with intussusception. Ileus resolved on second post op day.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Sleep disorder, Vomiting, X-ray abnormal
Clinical narrative: Pt adm Rotateq; 4/4/07, presented with cramps, abd pain, bloody stools. 4/6/07 - Surgery. Adm to hospital. 17:00 hrs - 4/5/07 vomiting. 04/17/07-records received from receiving facility for DOS 4/6/07-DC Intussusception. Transferred to facility for surgery. Seen in ER with C/O vomiting and bloody stools times 2. Afebrile. Abdomen non distended,mass not palpable constantly crying.  Barium enema:colonic obstruction secondary to intussusception which extends to level of splenic flexure. Three attempts made at hydrostatic reduction unsuccessful.  04/25/07-records received from receiving facility for DOS 04/06-04/10/07-DC DX: status post intussusception requiring operative intervention. Exploratory laparotomy, reduction of intussusception ileocecectomy with hand sew primary end to end anastomosis. HX colicky with a rotavirus with current jelly stools and barium enema that was consistent with intussusception. Ileus resolved on second post op day.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intestinal resection, Intussusception, Surgery
Clinical narrative: Pt adm Rotateq; 4/4/07, presented with cramps, abd pain, bloody stools. 4/6/07 - Surgery. Adm to hospital. 17:00 hrs - 4/5/07 vomiting. 04/17/07-records received from receiving facility for DOS 4/6/07-DC Intussusception. Transferred to facility for surgery. Seen in ER with C/O vomiting and bloody stools times 2. Afebrile. Abdomen non distended,mass not palpable constantly crying.  Barium enema:colonic obstruction secondary to intussusception which extends to level of splenic flexure. Three attempts made at hydrostatic reduction unsuccessful.  04/25/07-records received from receiving facility for DOS 04/06-04/10/07-DC DX: status post intussusception requiring operative intervention. Exploratory laparotomy, reduction of intussusception ileocecectomy with hand sew primary end to end anastomosis. HX colicky with a rotavirus with current jelly stools and barium enema that was consistent with intussusception. Ileus resolved on second post op day.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: The place where I received my flu shot is very sore. It has been over 2 weeks and it is painful to lift my arm.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: The place where I received my flu shot is very sore. It has been over 2 weeks and it is painful to lift my arm.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Muscle spasms
Clinical narrative: Dizziness on day of vaccine, 10/25/06 and also today. Muscle cramping evening of 10/26/06 and also today, lasted 90 min, today x 15 min heat, analgesic helped.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Injection site warmth, Muscle spasms
Clinical narrative: Dizziness on day of vaccine, 10/25/06 and also today. Muscle cramping evening of 10/26/06 and also today, lasted 90 min, today x 15 min heat, analgesic helped.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen site, hot day after itchy a few days after and hot. Treated with heating pad to site, Tylenol for pain, with some improvement.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pain in extremity
Clinical narrative: Baseball size area of Redness, hot and painful radiates to L shoulder and down L arm.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Tenderness
Clinical narrative: 3 inch x 2 1/2 red area, hot, painful, tender
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Photosensitivity reaction, Pruritus, Rash, Skin warm
Clinical narrative: Raised, red rash on bilateral arms, chest and top of feet. Rash is hot and itchy. DX as photo sensitive rash. Seen on 10/01/06 and 10/2/06. Prescribed Atarax 25 mg, 1-2 tabs PO 4 times per day prn, Hydrocortisone cream 1% BID, Methylprednisolone 4 mg as prescribed, descending doses x 6 days.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Oedema peripheral
Clinical narrative: No fever local left arm red from shoulder to elbow, swollen.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Intussusception
Clinical narrative: Patient presented with bloody diarrhea 4/8/7. DX of intussusception - Surgically reduces. Had Rotateq 2/16/07. No known association. 06/06/07-received observation note for DOS 4/9/07-DC Probably intussusception. Two day history of low grade fever and vomiting, decreased appetite. On day of admission developed bloody diarrhea. Transferred to another facility 6/21/07-records received from receiving facility for DOS 4/10-4/13/07-DC DX: Intussusception and necrotic cecum. Presented with 24 hour history of emesis and bloody mucous per rectum.  Exploratory laparotomy and reduction of ileocolic intussusception with ileal cecetomy and primary ileal colostomy.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Intussusception, Surgery
Clinical narrative: Patient presented with bloody diarrhea 4/8/7. DX of intussusception - Surgically reduces. Had Rotateq 2/16/07. No known association. 06/06/07-received observation note for DOS 4/9/07-DC Probably intussusception. Two day history of low grade fever and vomiting, decreased appetite. On day of admission developed bloody diarrhea. Transferred to another facility 6/21/07-records received from receiving facility for DOS 4/10-4/13/07-DC DX: Intussusception and necrotic cecum. Presented with 24 hour history of emesis and bloody mucous per rectum.  Exploratory laparotomy and reduction of ileocolic intussusception with ileal cecetomy and primary ileal colostomy.
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Body temperature increased, Injection site erythema, Myalgia, Nausea, Pain in extremity
Clinical narrative: Woke AM with temp 100.9, shaky, muscle aches, 3/4 red circle L arm Tdap inj site, nausea, leg aches - but were better about 9 at time call retn. Mom says was fine the next day. Ice-cool compress inj site, supportive care, rest Tylenol, Motrin, Temp and comfort observation.
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Tremor
Clinical narrative: Woke AM with temp 100.9, shaky, muscle aches, 3/4 red circle L arm Tdap inj site, nausea, leg aches - but were better about 9 at time call retn. Mom says was fine the next day. Ice-cool compress inj site, supportive care, rest Tylenol, Motrin, Temp and comfort observation.
Age: 3.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: PT L thigh muscle became red and edematous localized soreness by evening of injections. (after riding a horse in afternoon). Taken to PCP the following day. Cool packs, Benadryl and Ibuprofen and antibiotic (mother did not know which) started antibiotics soreness for 2 days.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Rt leg thigh swollen, red, warm to touch painful. See progress note
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: R arm swelling and redness with some pain after receiving Imm. Later that night, no fever or decreased ROM. Pt given RX for Artrax 8mg PRN. Taking Amoxicillin for OM
Age: 1.03
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion, Crying, Dyskinesia, Erythema, Fear
Clinical narrative: Had shots At 3:30 PM. Woke up at 4 AM crying, with fever 104 rectal, both legs red, swollen. Mom gave Motrin at 5am, cool bath done. 7:30AM, crying and seizures - "child appeared scared - jerked, shaking for about 5 mins. Mom took to Dr at 9 AM.
Age: 1.03
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Oedema peripheral, Pyrexia, Tremor
Clinical narrative: Had shots At 3:30 PM. Woke up at 4 AM crying, with fever 104 rectal, both legs red, swollen. Mom gave Motrin at 5am, cool bath done. 7:30AM, crying and seizures - "child appeared scared - jerked, shaking for about 5 mins. Mom took to Dr at 9 AM.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Had vaccines on 12/01/06. When lifting left arm has a tightness and feels a twitching or spasm. Sore at site noticed next day and has continued.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling, itching at site where MMR was given LA. Initially ice used. Seen at medical center on 3/27/07. Redness continues size 30mm x 40mm erythema. No induration., No more pain. Applied hydrocortisone cream without improvement.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Induration, Pain, Skin warm
Clinical narrative: Evacuated in RUE 4/1/07. Temp 98.9 2" right deltoid, redness, warmth, induration and pain. Denies itchiness. No rash noted. Dx: Right arm cellulitis - ?? allergic reaction.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Flushing, Sneezing, Urticaria
Clinical narrative: Approximately 5 minutes after Varicella vaccine administered patient developed sneezing, coughing, hives, facial flushing - received IM Benadryl in office and transported to ER for further management / observation, received PO steroid in ER.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Oedema peripheral, Skin warm
Clinical narrative: Right arm at injection site became sore and started to swell - progressed down arm into hand within hours. Seen 4/6/07 - arm and hand swollen, erythema and warmth medical aspect. Tx - Methylprednisone dose pack; Keflex 250 mgm QID x 7 days.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Electroencephalogram abnormal, Grand mal convulsion, Headache, Hypoaesthesia, Nausea
Clinical narrative: 22 Days after receiving the above vaccines, she experienced numbness in her right hand and a headache and nausea. The next morning those symptoms were resolved. After being awake for 10 minutes she had a grand mal seizure. Duration 2-3 minutes. Emergency evaluation revealed a normal exam. PMH - significant for epilepsy. Dx 11/05 on Lamictal last seizure 1/06.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching.
Age: 10.0
Sex: M
Vaccine: TYP
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: Headache, fever, malaise
Age: 24.0
Sex: U
Vaccine: UNK
Symptoms: Drug exposure during pregnancy, No adverse effect
Clinical narrative: Patient received vaccine but was unaware that she was pregnant. No symptoms at this time.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Diarrhoea, Dry mouth, Dry throat, Flatulence, Headache
Clinical narrative: nausea, headache, diarrhea, gas, low-grade fever, dry mouth/trought
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Nausea, Pyrexia
Clinical narrative: nausea, headache, diarrhea, gas, low-grade fever, dry mouth/trought
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Nausea
Clinical narrative: Nausea, congestion in head and chest.
Age: 0.31
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cardiac failure congestive, Skin discolouration, Swelling, Ultrasound Doppler
Clinical narrative: swollen purple right thigh (left) 5 hrs after shots. HIB + Prevnar gave im left leg. Synagis given in same leg 2-3 d before. Was seen at ER 4/407
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Full blood count, Hypoaesthesia, Laboratory test, Paraesthesia, Red blood cell sedimentation rate increased
Clinical narrative: About 30 minutes after vaccination, patient states that he experienced numbness/tingling in both legs from above the knee down to an in his feet. Sxs continue to date.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Urine analysis
Clinical narrative: About 30 minutes after vaccination, patient states that he experienced numbness/tingling in both legs from above the knee down to an in his feet. Sxs continue to date.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Rash papular
Clinical narrative: Developed red papular rash on 10 m day after receiving immunization. Covered his entire body. Advised to take Alavert by PCP
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Hyperhidrosis, Nasal congestion, Pyrexia
Clinical narrative: Woke up next day terribly congested, fever, sweat. Worse in the mornings.
Age: 3.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash erythematous
Clinical narrative: Erythematous rash on left proximal thigh and right proximal thigh
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: Erythema, swelling and tenderness within 24 hrs. No respiratory symptoms, Benadryl given. Will monitor to rule out cellulitis
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site swelling, Rash, Rash macular, Tenderness
Clinical narrative: Swelling around injection site left leg tenderness, splotchy rash
Age: 2.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, Erythema and swelling to injection site Left upper arm from shoulder to approx. 2 inches above elbow. Dr 11:30 on 3/30/07 treated with Amoxicillin x 7 days and Zyrtec. Spoke with parent on 4/2/07 and stated childs arm was no longer swollen, red or warm
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Dtap and HIB given on 3/28/07. On 3/29/07 Left thigh (Dtap) had 9 cm Red, Raised warm area with tenderness. Right thigh (HIB) had 4 cm Red, Raised warm area. Prescription of Cephalex in 250 mg given
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Severe swelling at injection site near blistering
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Pt had reddened area to right thigh from inj site to below knee. Rash was approximately 8 in in duration. No further tx was necessary
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia
Clinical narrative: Paresthesia - Both breasts TX Elavic 25 mg Q H 5x2
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Headache, Skin disorder
Clinical narrative: Headache, joint pains, skin problems.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Onset of erythema and edema at injection site within 24-48 hrs of vaccine. About 48 hrs 10x12 cm area of erythema and induration.
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Sore at site immediately at time of shot. C/O of soreness at site 3/9/07 which progressed all week. Went to doctor 3-16-07 could not move arm or shoulder pt believes shot was given to high "Above deltoid and slightly to the back"
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: Fever 103 on 4-4-07. Had vaccines x 3 on 4-3-07
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Right thigh swelled after immunization approx 1 day after, still present 11 days after red, swollen, hard approx 2 inches in diameter
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site urticaria
Clinical narrative: w/in 5 mins after adminstration leg swelled (+) wheal approximately 6 cm in diameter (+) red (+) firm nodule under skin - .2 ml Benadryl 50/1 given IM; Patient monitor in office 1 hour
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Intussusception
Clinical narrative: Information has been received concerning a female with no medical history or allergies who on 17-JAN-2007 was vaccinated with a first PO dose of Rotateq (lot # 655082/0779F). Concomitant vaccination included a first IM dose of PEDIARIX (lot # AK21BN79B1) in the left thigh, PEDVAXHIB (lot # 654398/0784F) in the right thigh and PREVNAR (lot # 831258A). There were no other concomitant therapies. There was no illness at the time of vaccination. On 15-MAR-2007 at 07:00 the patient developed intussusception and was hospitalized. The patient underwent a barium enema and an air enema. Subsequently, the patient recovered from intussusception. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Laboratory test
Clinical narrative: Information has been received concerning a female with no medical history or allergies who on 17-JAN-2007 was vaccinated with a first PO dose of Rotateq (lot # 655082/0779F). Concomitant vaccination included a first IM dose of PEDIARIX (lot # AK21BN79B1) in the left thigh, PEDVAXHIB (lot # 654398/0784F) in the right thigh and PREVNAR (lot # 831258A). There were no other concomitant therapies. There was no illness at the time of vaccination. On 15-MAR-2007 at 07:00 the patient developed intussusception and was hospitalized. The patient underwent a barium enema and an air enema. Subsequently, the patient recovered from intussusception. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Barium enema, Intussusception
Clinical narrative: Information has been received concerning a female with no medical history or allergies who on 17-JAN-2007 was vaccinated with a first PO dose of Rotateq (lot # 655082/0779F). Concomitant vaccination included a first IM dose of PEDIARIX (lot # AK21BN79B1) in the left thigh, PEDVAXHIB (lot # 654398/0784F) in the right thigh and PREVNAR (lot # 831258A). There were no other concomitant therapies. There was no illness at the time of vaccination. On 15-MAR-2007 at 07:00 the patient developed intussusception and was hospitalized. The patient underwent a barium enema and an air enema. Subsequently, the patient recovered from intussusception. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TTOX, HPV4, MNQ, TTOX, HPV4, MNQ, TTOX
Symptoms: Chromatopsia, Dyspnoea, Hypotension, Injection site pain, Oral pain
Clinical narrative: Information has been received from a physician, concerning a 14 year old female patient with a drug hypersensitivity to pertussis and a sulfonamide allergy, who on 03-APR-2007 was vaccinated with the first dose of Gardasil (Lot # 655322/0091U) (dose and route not provided). Concomitant vaccines administered on 03-APR-2007 included MENACTRA. On 3-APR-2007, the patient experienced blurry vision, tingling in her mouth and throat, and low blood pressure (not specified) "within 30 seconds of vaccination with Gardasil. "The patient was given epinephrine and albuterol in the physician's office, and was then sent to the ER. Treatment in the ER included steroids (unspecified). The physician indicated that the patient recovered on the same day, 03-APR-2007. The physician considered the blurry vision, tingling of the mouth and throat, and low blood pressure to be disabling, life threatening, and an other medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TTOX, HPV4, MNQ, TTOX, HPV4, MNQ, TTOX
Symptoms: Pharyngolaryngeal pain, Photopsia
Clinical narrative: Information has been received from a physician, concerning a 14 year old female patient with a drug hypersensitivity to pertussis and a sulfonamide allergy, who on 03-APR-2007 was vaccinated with the first dose of Gardasil (Lot # 655322/0091U) (dose and route not provided). Concomitant vaccines administered on 03-APR-2007 included MENACTRA. On 3-APR-2007, the patient experienced blurry vision, tingling in her mouth and throat, and low blood pressure (not specified) "within 30 seconds of vaccination with Gardasil. "The patient was given epinephrine and albuterol in the physician's office, and was then sent to the ER. Treatment in the ER included steroids (unspecified). The physician indicated that the patient recovered on the same day, 03-APR-2007. The physician considered the blurry vision, tingling of the mouth and throat, and low blood pressure to be disabling, life threatening, and an other medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TTOX, HPV4, MNQ, TTOX, HPV4, MNQ, TTOX
Symptoms: Hypotension, Paraesthesia oral, Throat irritation, Vision blurred
Clinical narrative: Information has been received from a physician, concerning a 14 year old female patient with a drug hypersensitivity to pertussis and a sulfonamide allergy, who on 03-APR-2007 was vaccinated with the first dose of Gardasil (Lot # 655322/0091U) (dose and route not provided). Concomitant vaccines administered on 03-APR-2007 included MENACTRA. On 3-APR-2007, the patient experienced blurry vision, tingling in her mouth and throat, and low blood pressure (not specified) "within 30 seconds of vaccination with Gardasil. "The patient was given epinephrine and albuterol in the physician's office, and was then sent to the ER. Treatment in the ER included steroids (unspecified). The physician indicated that the patient recovered on the same day, 03-APR-2007. The physician considered the blurry vision, tingling of the mouth and throat, and low blood pressure to be disabling, life threatening, and an other medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TTOX, HPV4, MNQ, TTOX, HPV4, MNQ, TTOX
Symptoms: Hypotension, Paraesthesia, Paraesthesia oral, Vision blurred
Clinical narrative: Information has been received from a physician, concerning a 14 year old female patient with a drug hypersensitivity to pertussis and a sulfonamide allergy, who on 03-APR-2007 was vaccinated with the first dose of Gardasil (Lot # 655322/0091U) (dose and route not provided). Concomitant vaccines administered on 03-APR-2007 included MENACTRA. On 3-APR-2007, the patient experienced blurry vision, tingling in her mouth and throat, and low blood pressure (not specified) "within 30 seconds of vaccination with Gardasil. "The patient was given epinephrine and albuterol in the physician's office, and was then sent to the ER. Treatment in the ER included steroids (unspecified). The physician indicated that the patient recovered on the same day, 03-APR-2007. The physician considered the blurry vision, tingling of the mouth and throat, and low blood pressure to be disabling, life threatening, and an other medical event. Additional information has been requested.
Sex: U
Vaccine: HEP, HIBV, DTAP, FLUX, HEP, HIBV, IPV, MMR
Symptoms: Asthma, Autism, Cognitive disorder, Disturbance in social behaviour, Ear disorder
Clinical narrative: This case was considered medically important. Additional information pertaining to the reporting product, additional serious events, medical history, vaccines and dates of administration has been received. Information regarding Hib-Titer vaccine was received from an attorney regarding an 18-month-old patient who experienced autism, speech disorder, neurodevelopmental disorder, thimerosal toxicity and neurodevelopmental delay. The patient received the fourth dose on 10-Mar-1998. The patient developed autism in Jul-1999. On unspecified dated, the patient experienced thimerosal toxicity, neurodevelopmental delay, speech disorder and neurodevelopmental disorder. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: HEP, HIBV, DTAP, FLUX, HEP, HIBV, IPV, MMR
Symptoms: Food allergy, Learning disability, Metal poisoning, Nervous system disorder, Neurodevelopmental disorder
Clinical narrative: This case was considered medically important. Additional information pertaining to the reporting product, additional serious events, medical history, vaccines and dates of administration has been received. Information regarding Hib-Titer vaccine was received from an attorney regarding an 18-month-old patient who experienced autism, speech disorder, neurodevelopmental disorder, thimerosal toxicity and neurodevelopmental delay. The patient received the fourth dose on 10-Mar-1998. The patient developed autism in Jul-1999. On unspecified dated, the patient experienced thimerosal toxicity, neurodevelopmental delay, speech disorder and neurodevelopmental disorder. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: HEP, HIBV, DTAP, FLUX, HEP, HIBV, IPV, MMR
Symptoms: Otitis media, Psychomotor skills impaired, Rhinitis allergic, Social avoidant behaviour, Speech disorder
Clinical narrative: This case was considered medically important. Additional information pertaining to the reporting product, additional serious events, medical history, vaccines and dates of administration has been received. Information regarding Hib-Titer vaccine was received from an attorney regarding an 18-month-old patient who experienced autism, speech disorder, neurodevelopmental disorder, thimerosal toxicity and neurodevelopmental delay. The patient received the fourth dose on 10-Mar-1998. The patient developed autism in Jul-1999. On unspecified dated, the patient experienced thimerosal toxicity, neurodevelopmental delay, speech disorder and neurodevelopmental disorder. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: HEP, HIBV, DTAP, FLUX, HEP, HIBV, IPV, MMR
Symptoms: Speech disorder developmental, Stereotypy
Clinical narrative: This case was considered medically important. Additional information pertaining to the reporting product, additional serious events, medical history, vaccines and dates of administration has been received. Information regarding Hib-Titer vaccine was received from an attorney regarding an 18-month-old patient who experienced autism, speech disorder, neurodevelopmental disorder, thimerosal toxicity and neurodevelopmental delay. The patient received the fourth dose on 10-Mar-1998. The patient developed autism in Jul-1999. On unspecified dated, the patient experienced thimerosal toxicity, neurodevelopmental delay, speech disorder and neurodevelopmental disorder. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: HEP, HIBV, DTAP, FLUX, HEP, HIBV, IPV, MMR
Symptoms: Autism, Developmental delay, Metal poisoning, Neurodevelopmental disorder, Reaction to preservatives
Clinical narrative: This case was considered medically important. Additional information pertaining to the reporting product, additional serious events, medical history, vaccines and dates of administration has been received. Information regarding Hib-Titer vaccine was received from an attorney regarding an 18-month-old patient who experienced autism, speech disorder, neurodevelopmental disorder, thimerosal toxicity and neurodevelopmental delay. The patient received the fourth dose on 10-Mar-1998. The patient developed autism in Jul-1999. On unspecified dated, the patient experienced thimerosal toxicity, neurodevelopmental delay, speech disorder and neurodevelopmental disorder. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: HEP, HIBV, DTAP, FLUX, HEP, HIBV, IPV, MMR
Symptoms: Speech disorder
Clinical narrative: This case was considered medically important. Additional information pertaining to the reporting product, additional serious events, medical history, vaccines and dates of administration has been received. Information regarding Hib-Titer vaccine was received from an attorney regarding an 18-month-old patient who experienced autism, speech disorder, neurodevelopmental disorder, thimerosal toxicity and neurodevelopmental delay. The patient received the fourth dose on 10-Mar-1998. The patient developed autism in Jul-1999. On unspecified dated, the patient experienced thimerosal toxicity, neurodevelopmental delay, speech disorder and neurodevelopmental disorder. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: HEP, HIBV, DTAP, FLUX, HEP, HIBV, IPV, MMR
Symptoms: Abnormal behaviour, Asthma, Autism, Cognitive disorder, Developmental delay
Clinical narrative: This case was considered medically important. Additional information pertaining to the reporting product, additional serious events, medical history, vaccines and dates of administration has been received. Information regarding Hib-Titer vaccine was received from an attorney regarding an 18-month-old patient who experienced autism, speech disorder, neurodevelopmental disorder, thimerosal toxicity and neurodevelopmental delay. The patient received the fourth dose on 10-Mar-1998. The patient developed autism in Jul-1999. On unspecified dated, the patient experienced thimerosal toxicity, neurodevelopmental delay, speech disorder and neurodevelopmental disorder. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: HEP, HIBV, DTAP, FLUX, HEP, HIBV, IPV, MMR
Symptoms: Food allergy, Learning disability, Mental disorder, Mental impairment, Metal poisoning
Clinical narrative: This case was considered medically important. Additional information pertaining to the reporting product, additional serious events, medical history, vaccines and dates of administration has been received. Information regarding Hib-Titer vaccine was received from an attorney regarding an 18-month-old patient who experienced autism, speech disorder, neurodevelopmental disorder, thimerosal toxicity and neurodevelopmental delay. The patient received the fourth dose on 10-Mar-1998. The patient developed autism in Jul-1999. On unspecified dated, the patient experienced thimerosal toxicity, neurodevelopmental delay, speech disorder and neurodevelopmental disorder. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: HEP, HIBV, DTAP, FLUX, HEP, HIBV, IPV, MMR
Symptoms: Nervous system disorder, Neurodevelopmental disorder, Otitis media, Rhinitis allergic, Social avoidant behaviour
Clinical narrative: This case was considered medically important. Additional information pertaining to the reporting product, additional serious events, medical history, vaccines and dates of administration has been received. Information regarding Hib-Titer vaccine was received from an attorney regarding an 18-month-old patient who experienced autism, speech disorder, neurodevelopmental disorder, thimerosal toxicity and neurodevelopmental delay. The patient received the fourth dose on 10-Mar-1998. The patient developed autism in Jul-1999. On unspecified dated, the patient experienced thimerosal toxicity, neurodevelopmental delay, speech disorder and neurodevelopmental disorder. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: HEP, HIBV, DTAP, FLUX, HEP, HIBV, IPV, MMR
Symptoms: Speech disorder, Stereotypy
Clinical narrative: This case was considered medically important. Additional information pertaining to the reporting product, additional serious events, medical history, vaccines and dates of administration has been received. Information regarding Hib-Titer vaccine was received from an attorney regarding an 18-month-old patient who experienced autism, speech disorder, neurodevelopmental disorder, thimerosal toxicity and neurodevelopmental delay. The patient received the fourth dose on 10-Mar-1998. The patient developed autism in Jul-1999. On unspecified dated, the patient experienced thimerosal toxicity, neurodevelopmental delay, speech disorder and neurodevelopmental disorder. The outcome is unknown. No additional information was available at the time of this report.
Age: 1.26
Sex: M
Vaccine: MMR, VARCEL, DTAP, HIBV, DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Abnormal faeces, Ankyloglossia congenital, Arachnoid cyst, Audiogram abnormal
Clinical narrative: Follow-up information was received that provided suspect vaccines, additional adverse events, medical history and laboratory test results. This case was considered medically important. Medical records regarding Hib-Titer Vaccine were received from an attorney regarding a male patient who received the fourth dose on 03-Jun-1999 along with the fourth dose of Dtap at 15 months of age and experience autism,intellectual incapacity, learning disability, disorders and impairment, cognition in the borderline to mildly impaired range, encephalopathy, delayed and deviant speech and language development, mercury poisoning, high frequently sensorineural hearing loss and neurodevelopmental disorder. On 03-Jun-1999, the patient received the fourth dose of Hib-Titer along with another childhood vaccine. The child allegedly experienced mercury poisoning as a result of exposure to cumulative toxic levels of mercury. On 18-Sep-2000, the patient was diagnosed with autism. On an unspecified date, the child experienced intellectual incapacity, learning disability, disorders and impairment, cognition in the borderline to mildly impaired range, encephalopathy, delayed and deviant speech and language development, high frequency sensorineural hearing loss, and neurodevelopmental disorder. It was unknown if the patient recovered from the events. DNA Test for fragile X (results: negative) was done on 04-Nov-2000. Hair metal test (results: Mercury:0.39 ug/g (normal <0.4) and hair metal test (results: Lead: 2.3 ug/g (normal: < 1.0) were done on 20-May-2001. Nuclear magnetic resonance imaging brain (results: posterior fossa arachnoid cyst) was done in Aug-2001. No additional information was available at the time of this report.
Age: 1.26
Sex: M
Vaccine: MMR, VARCEL, DTAP, HIBV, DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Autism, Bacterial infection, Blood immunoglobulin G, Blood zinc decreased, Brain stem auditory evoked response abnormal
Clinical narrative: Follow-up information was received that provided suspect vaccines, additional adverse events, medical history and laboratory test results. This case was considered medically important. Medical records regarding Hib-Titer Vaccine were received from an attorney regarding a male patient who received the fourth dose on 03-Jun-1999 along with the fourth dose of Dtap at 15 months of age and experience autism,intellectual incapacity, learning disability, disorders and impairment, cognition in the borderline to mildly impaired range, encephalopathy, delayed and deviant speech and language development, mercury poisoning, high frequently sensorineural hearing loss and neurodevelopmental disorder. On 03-Jun-1999, the patient received the fourth dose of Hib-Titer along with another childhood vaccine. The child allegedly experienced mercury poisoning as a result of exposure to cumulative toxic levels of mercury. On 18-Sep-2000, the patient was diagnosed with autism. On an unspecified date, the child experienced intellectual incapacity, learning disability, disorders and impairment, cognition in the borderline to mildly impaired range, encephalopathy, delayed and deviant speech and language development, high frequency sensorineural hearing loss, and neurodevelopmental disorder. It was unknown if the patient recovered from the events. DNA Test for fragile X (results: negative) was done on 04-Nov-2000. Hair metal test (results: Mercury:0.39 ug/g (normal <0.4) and hair metal test (results: Lead: 2.3 ug/g (normal: < 1.0) were done on 20-May-2001. Nuclear magnetic resonance imaging brain (results: posterior fossa arachnoid cyst) was done in Aug-2001. No additional information was available at the time of this report.
Age: 1.26
Sex: M
Vaccine: MMR, VARCEL, DTAP, HIBV, DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Cerebral disorder, Cognitive disorder, Croup infectious, Deafness, Deafness neurosensory
Clinical narrative: Follow-up information was received that provided suspect vaccines, additional adverse events, medical history and laboratory test results. This case was considered medically important. Medical records regarding Hib-Titer Vaccine were received from an attorney regarding a male patient who received the fourth dose on 03-Jun-1999 along with the fourth dose of Dtap at 15 months of age and experience autism,intellectual incapacity, learning disability, disorders and impairment, cognition in the borderline to mildly impaired range, encephalopathy, delayed and deviant speech and language development, mercury poisoning, high frequently sensorineural hearing loss and neurodevelopmental disorder. On 03-Jun-1999, the patient received the fourth dose of Hib-Titer along with another childhood vaccine. The child allegedly experienced mercury poisoning as a result of exposure to cumulative toxic levels of mercury. On 18-Sep-2000, the patient was diagnosed with autism. On an unspecified date, the child experienced intellectual incapacity, learning disability, disorders and impairment, cognition in the borderline to mildly impaired range, encephalopathy, delayed and deviant speech and language development, high frequency sensorineural hearing loss, and neurodevelopmental disorder. It was unknown if the patient recovered from the events. DNA Test for fragile X (results: negative) was done on 04-Nov-2000. Hair metal test (results: Mercury:0.39 ug/g (normal <0.4) and hair metal test (results: Lead: 2.3 ug/g (normal: < 1.0) were done on 20-May-2001. Nuclear magnetic resonance imaging brain (results: posterior fossa arachnoid cyst) was done in Aug-2001. No additional information was available at the time of this report.
Age: 1.26
Sex: M
Vaccine: MMR, VARCEL, DTAP, HIBV, DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Dermatitis diaper, Developmental delay, Diarrhoea, Disturbance in social behaviour, Electroencephalogram
Clinical narrative: Follow-up information was received that provided suspect vaccines, additional adverse events, medical history and laboratory test results. This case was considered medically important. Medical records regarding Hib-Titer Vaccine were received from an attorney regarding a male patient who received the fourth dose on 03-Jun-1999 along with the fourth dose of Dtap at 15 months of age and experience autism,intellectual incapacity, learning disability, disorders and impairment, cognition in the borderline to mildly impaired range, encephalopathy, delayed and deviant speech and language development, mercury poisoning, high frequently sensorineural hearing loss and neurodevelopmental disorder. On 03-Jun-1999, the patient received the fourth dose of Hib-Titer along with another childhood vaccine. The child allegedly experienced mercury poisoning as a result of exposure to cumulative toxic levels of mercury. On 18-Sep-2000, the patient was diagnosed with autism. On an unspecified date, the child experienced intellectual incapacity, learning disability, disorders and impairment, cognition in the borderline to mildly impaired range, encephalopathy, delayed and deviant speech and language development, high frequency sensorineural hearing loss, and neurodevelopmental disorder. It was unknown if the patient recovered from the events. DNA Test for fragile X (results: negative) was done on 04-Nov-2000. Hair metal test (results: Mercury:0.39 ug/g (normal <0.4) and hair metal test (results: Lead: 2.3 ug/g (normal: < 1.0) were done on 20-May-2001. Nuclear magnetic resonance imaging brain (results: posterior fossa arachnoid cyst) was done in Aug-2001. No additional information was available at the time of this report.