chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Cognitive disorder, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Unable to process movement and sound at the same time for a window of 2-4 hrs. Increase temp 102 x 12 hours. Nausea and vomiting x 12 hours. Headache, swelling at injection site/severe redness. Swollen and very painful lymph nodes x 48.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy, Nausea, Pain, Vomiting
Clinical narrative: Unable to process movement and sound at the same time for a window of 2-4 hrs. Increase temp 102 x 12 hours. Nausea and vomiting x 12 hours. Headache, swelling at injection site/severe redness. Swollen and very painful lymph nodes x 48.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Skin lesion, Varicella
Clinical narrative: Fever x 2 wks and Varicella lesions.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Approximately 10 cm local reaction of redness and swelling Left arm. Treatment: warm soaks.
Age: 1.04
Sex: F
Vaccine: HIBV, MMRV
Symptoms: Rash maculo-papular
Clinical narrative: Maculo-papular rash over neck, face, trunk, back, upper arms and thighs. Light pink, distinct, macules 2-3mm in size. Resolved in 48 hour.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Urticaria
Clinical narrative: 2/26/07 6pm - Hives over arms and legs and Temp 102 ax. Resolved mid after next day.
Age: 4.67
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Body temperature increased, Diarrhoea
Clinical narrative: Child received immunization about 2 pm at clinic.  Mom reported child had diarrhea about 1 hour after the shot; cried for 2 hour and had temp of 105 deg. Mom reports she called the local ER and she was told child was having reaction to flu shot and never to get anymore. Child did not go to physician or to the ER. Mom reports she did give pt oral Tylenol.
Age: 2.33
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: (102) fever, right leg pain-not weight bearing; present at 2 days follow-up-pending.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pruritus
Clinical narrative: Left upper arm red, edematous and itchy. Ice to left upper arm, Benadryl 12-5 every 6 hours for itch.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Where the vaccine was administered, the site became a raised red itchy bump. (2-20-07) on February 24th 2007 in the morning, awoke to find red itchy bumps on stomach, right arm, lower back, face and legs.
Age: 22.0
Sex: M
Vaccine: TD
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Pt developed redness, swelling, tenderness, at site as well as fever (he didn't measure) stiff neck, headache, redness at axilla left upper arm at swollen lymph nodes.
Age: 22.0
Sex: M
Vaccine: TD
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: Pt developed redness, swelling, tenderness, at site as well as fever (he didn't measure) stiff neck, headache, redness at axilla left upper arm at swollen lymph nodes.
Age: 1.28
Sex: F
Vaccine: DTAP, TD
Symptoms: Wrong drug administered
Clinical narrative: Patient was given adult TD instead of DTaP. No signs or symptoms. Patient's mother instructed to bring child back within 72 hours to get correct injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Oedema peripheral, Rash
Clinical narrative: Seen in hospital on 2-21-07 by doctor for rash on face (right) and left leg edematous. Given ibuprofen.  Observation of site x 24 hrs and follow up with primary physician.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Musculoskeletal stiffness, Skin warm
Clinical narrative: 2 areas of redness, firmness and heat 2 1/2-3 cm on right thigh.
Age: 13.0
Sex: M
Vaccine: TD
Symptoms: Abdominal pain upper, Body temperature increased, Full blood count, Headache, Injection site pain
Clinical narrative: Temp 102-103 deg, approx 24 hour after injection, complained of stomach ache, headache, pain at injection site, red (swollen) rash. (no other IRI 5x's), no cough, no sick contacts).
Age: 13.0
Sex: M
Vaccine: TD
Symptoms: Rash erythematous
Clinical narrative: Temp 102-103 deg, approx 24 hour after injection, complained of stomach ache, headache, pain at injection site, red (swollen) rash. (no other IRI 5x's), no cough, no sick contacts).
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin M, Drug ineffective, Rash vesicular, Varicella zoster virus serology positive
Clinical narrative: Spreading raised papular vesicular clustered rash down. Right upper arm from right trapezius area over 12 hours started 2/25/07. Pt seen 2/26/07 started on Zovirax-labs enclosed. Pictures enclosed.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMRV, PNC
Symptoms: Computerised tomogram normal, Febrile convulsion, Full blood count, Lumbar puncture, Urine analysis normal
Clinical narrative: Prolonged febrile seizure > 30 minutes lifesquad to ER, seizures meds, infant transferred to Children's ER, admitted to ICU.  03/26/2007 MR received for a 2 day hospital stay following transfer from local facility to pediatric hospital.  Infant had a 1 day hx. of tactile fever, mild congestion, and decreased activity.  Pt. noted by mom to have whole body shaking of generalized tonic/clonic type. Seizure activity >30 minutes. Initially treated at primary facility with Diastat and Ativan with subsequent apnea resulting in intubation .   PE:  ETT in place.  Skin slightly mottled. Cool extremities. Intermittant 4 extremity twitches and shivers.  Babinski decreased. Otherwise WNL.  Txd with antibiotics, NS fluid bolus for decreased perfusion with good results, Phosphenytoin for seizure control.  No further seizure activity observed.  Extubated and weaned to RA without difficulty. Initial Assessment:  Febrile Seizure likely 2' to MMR vaccine. Final DX: New Onset Seizure.
Age: 54.0
Sex: M
Vaccine: JEV
Symptoms: Hypoaesthesia, Joint swelling, Laboratory test
Clinical narrative: S/S: Swollen joints, numbness. Rx: Indocin, Keflex.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Induration, Oedema peripheral, Pain of skin, Skin warm
Clinical narrative: Received PPV 23 (Pneumovax) 3-7-07. Seen 3-8-07 with cellulitis below injection site (dorsum of arm swollen, indurated, hot, tender). Treated with Cleocin and Medrol pak and "steroid injection at Urgent Care. T=97.9.
Age: 1.53
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Erythema, Haematoma
Clinical narrative: 2 x 2 cm area to right upper thigh erythema, hematoma. Benadryl and Motrin OTC PRN.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Insomnia, Pruritus, Rash generalised
Clinical narrative: Rash developed with itching. Started between shoulder blades evening of 3-6-07. Next day gradually spread to cover whole body. Difficulty sleeping 3-7-07 d/t itching. Mom gave Benadryl 3/8/07 am with no relief. Physician gave rx for Hydroxyzine 25 mg 3-4 times daily PRN.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood pressure, Brain death, Cyanosis, Death, Infection
Clinical narrative: Infant found in crib not breathing and cyanotic, parent began CPR and call 911. Child placed on life support and later declared brain dead. Taken off life support and pronounced dead. Child treated with various medication for infection , blood pressure.  7/20/07 Received Autopsy Report which reveals COD as unexplained sudden death; ischemic brain injury & diffuse cerebral edema; coagulopathy; metabolic acidosis; & stool positive for rotavirus (possible false (+) secondary to vax 5 days prior.  Patient had undergone organ retrieval & autopsy was limited to lungs, uterus, ovaries, trachea, esophagus, distal colon & brain.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Life support, Respiratory arrest
Clinical narrative: Infant found in crib not breathing and cyanotic, parent began CPR and call 911. Child placed on life support and later declared brain dead. Taken off life support and pronounced dead. Child treated with various medication for infection , blood pressure.  7/20/07 Received Autopsy Report which reveals COD as unexplained sudden death; ischemic brain injury & diffuse cerebral edema; coagulopathy; metabolic acidosis; & stool positive for rotavirus (possible false (+) secondary to vax 5 days prior.  Patient had undergone organ retrieval & autopsy was limited to lungs, uterus, ovaries, trachea, esophagus, distal colon & brain.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema multiforme
Clinical narrative: Erythema - multiform face, trunk, face and legs.
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Erythema, Pain, Skin warm, Tenderness
Clinical narrative: erythema, tender warm to touch, sore
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash papular
Clinical narrative: Developed a papular rash the evening of the vaccine. Started on opposite arm vaccine was given. Visited HCP 12 days later and has now spread across chest, back and down arms. Chief complaint of extreme itching.
Age: 1.19
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Convulsion, Depressed level of consciousness, Dyskinesia, Pyrexia
Clinical narrative: Client in for well child visit and did have 2nd flu vaccine (first administered on 1/9/07 by RN using lot #U2175HA). The lot number for the 2nd flu shot was UT2176BA. The 2nd flu shot was administered in the am before 12pm. Accordind to Mother, the child awoke from sleep at about 10:30pm with altered LOC. The child was also starting to seize with jerking movements. At the time the child awoke, the Mother called 911 and temp 101. When the ambulance arrived approx. 30 min. after the call, the Mother states the temp was 103. On the day that the 2nd flu shot was administered, the child was also ill with an acute otitis media and anemia and was being treated with omnicef 125 1 1/4 tsp /day and ferisol drops BID. Child in today for well child visit and appears well. Advised Mother to discuss incident with her child's physician before getting another flu shot for her child in the future.  03/23/2007 MR received for an ED visit for parental report of first seizure at home on the day of Flu vax.  Child had been running a fever.  His eyes rolled back and then began shaking all over. This lasted appox. 1 minute after which he awoke and took a bottle.  PE: Crying and fretful.  Temp=103'F. Skin feels hot.  TMs red bilaterally.  Otherwise WNL.  TXd with Tylenol and Motrin with fever reduction.  DC home. Discharge DX:  Febrile Seizure.
Age: 0.19
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Barium double contrast, Intussusception
Clinical narrative: Intususception diagnosed by hospital. 04/24/07-records received  from facility for DOS 03/13-03/16/07. DC DX: Intussusception. C/O fussy for 2 days large emesis, bloody stools. Multiple mucousy bloody stools. Abdomen fullness palpated in right lower quadrant. Unsuccessful attempt at reduction via enema. Laparotomy including appendectomy.
Age: 0.19
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Barium double contrast, Emergency care examination abnormal, Intussusception
Clinical narrative: Intususception diagnosed by hospital. 04/24/07-records received  from facility for DOS 03/13-03/16/07. DC DX: Intussusception. C/O fussy for 2 days large emesis, bloody stools. Multiple mucousy bloody stools. Abdomen fullness palpated in right lower quadrant. Unsuccessful attempt at reduction via enema. Laparotomy including appendectomy.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Screaming
Clinical narrative: Two episodes of intense screaming, the first 2 hours long, starting 2 hours after the immunizations, and the second 90 minutes long, about 16 hours after the shots.  Patient has since been fussy, and has only taken about 6 ounces of formula overnight.
Age: 0.2
Sex: F
Vaccine: HIBV, PNC, RV5, TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse effect, Wrong drug administered
Clinical narrative: NO ADVERSE EVENTS NOTICED AT THIS TIME. CALLED CDC AND WAS TOLD THAT INFANT SHOULD BE CALLED IN AND VACCINATED WITH THE CORRECT VACCINE AS SOON AS POSSIBLE. CALLED MOTHER AND SHE STATES SHE WILL BRING CHILD IN FOR THE CORRECT SHOT.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Dysphagia, Throat tightness
Clinical narrative: Day following vaccination reports sore and tightening throat, difficulting swallowing.Took over the counter tylenol , herbal and lemon teas and symptoms subsided after 2-3 days
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Gianotti-Crosti syndrome, Pruritus, Rash, Rash papular
Clinical narrative: Patient developeda rash 3-7-07. Papules with halos on arms legs face, sparce on trunk. Very itchy non febrile limited response to po Benadryl.Seen in office  3-8-07 dignosed with classic Gianotti-Crosti.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Intussusception, Laboratory test, Ultrasound scan
Clinical narrative: Intussusception  dxd by US   treated with enema resolved and d/cd from hospital 03/20/07-records received from facility for DOS: 3/10/07-DX:Bloody diarrhea, dehydration, abdominal pain, vomiting. HX:bloody stools for 2 days. PE:WNL, abdomen soft nondistened and nontender.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium enema, Blood culture negative, Dehydration, Diarrhoea haemorrhagic
Clinical narrative: Intussusception  dxd by US   treated with enema resolved and d/cd from hospital 03/20/07-records received from facility for DOS: 3/10/07-DX:Bloody diarrhea, dehydration, abdominal pain, vomiting. HX:bloody stools for 2 days. PE:WNL, abdomen soft nondistened and nontender.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia, Intussusception, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Intussusception  dxd by US   treated with enema resolved and d/cd from hospital 03/20/07-records received from facility for DOS: 3/10/07-DX:Bloody diarrhea, dehydration, abdominal pain, vomiting. HX:bloody stools for 2 days. PE:WNL, abdomen soft nondistened and nontender.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Blood culture negative, Dehydration, Diarrhoea haemorrhagic
Clinical narrative: Intussusception  dxd by US   treated with enema resolved and d/cd from hospital 03/20/07-records received from facility for DOS: 3/10/07-DX:Bloody diarrhea, dehydration, abdominal pain, vomiting. HX:bloody stools for 2 days. PE:WNL, abdomen soft nondistened and nontender.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Laboratory test, Ultrasound scan abnormal
Clinical narrative: Intussusception  dxd by US   treated with enema resolved and d/cd from hospital 03/20/07-records received from facility for DOS: 3/10/07-DX:Bloody diarrhea, dehydration, abdominal pain, vomiting. HX:bloody stools for 2 days. PE:WNL, abdomen soft nondistened and nontender.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting, X-ray abnormal
Clinical narrative: Intussusception  dxd by US   treated with enema resolved and d/cd from hospital 03/20/07-records received from facility for DOS: 3/10/07-DX:Bloody diarrhea, dehydration, abdominal pain, vomiting. HX:bloody stools for 2 days. PE:WNL, abdomen soft nondistened and nontender.
Age: 14.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Second dose of Tdap given to patient as part of primary Td series.  Pt. rec'd Tdap 6/19/2006 and 3/8/2007
Age: 38.0
Sex: F
Vaccine: DT, HEP
Symptoms: Hypokinesia, Muscle atrophy, Muscle spasms, Pain in extremity
Clinical narrative: Reported to me on 2/19/2007: Pain in left arm that won't go away.  so intense that it wakes me up at night, can be deep and cause the bicep to cramp on several occasions, limited range of motion.  Was advised to see her PCP. Spoke with her last week - PCP thinks that it's tendinitis - was placed on Naproxin - doing much better.   (Reason this is reported was because one of the rare side effect is deep aching pain and muscle wasting in upper arm)  <Had a difficult time  entering #13 for Vaccinations given - there is not the correct manufacturer for Tetanus Diphtheria - Aventis Pasteur>
Age: 0.7
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Chills, Posture abnormal
Clinical narrative: Reported by caregiver that child had an episode of body "shivering" about five times and than head would hang down.  This occurred over about two minutes.  The child returned to normal activity right after shivering episode.  This happened at about 1:00 on March 12, 2007.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Screaming
Clinical narrative: Infant screamed uncontrollably for 4 to 5 hours.  03/15/2007 MR received from hospital visit for c/o crying spells following vax which have continued for 4-5 hours.  PE: WNL except for crying vigorously and irritability. Afebrile. Impression:  Crying reaction, likely to pertussis vaccine.  No cardiorespiratory compromise.  No apnea or fever.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction, Oedema peripheral, Tenderness
Clinical narrative: Patient presented to clinic with swelling erythema,  mild tenderness over Left deltoid, then consistent with local reaction then left our custody and chose to go to ER- called to tell us she was there.
Age: 39.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right arm received shot on 2/27 on 3/1 had a small dot that has progressed to the size of an egg by 3/5. Area is red, swollen and painful. Did receive both in Right arm due to lymphedema of Left arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Breath sounds, Injection site erythema, Malaise, Oxygen saturation normal, Pruritus
Clinical narrative: Approximately 5-10 minutes after below immunizations c/o "not feeling well, itching" red rash to forehead and along right side facial/neck region. MD present, and 1 1/2 tsp (12.5 mg/5 ml) oral Benadryl at 10:15a. Br sounds - clear bil, no SOB/cough. Left deltoid region (DTaP site) sl redness, no rash. Vital sign remain stable; 02 Sat 99%. Dc'd at 10:30a, instructed to give Benadryl PO q6 hours per ER if symptoms return.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash
Clinical narrative: Approximately 5-10 minutes after below immunizations c/o "not feeling well, itching" red rash to forehead and along right side facial/neck region. MD present, and 1 1/2 tsp (12.5 mg/5 ml) oral Benadryl at 10:15a. Br sounds - clear bil, no SOB/cough. Left deltoid region (DTaP site) sl redness, no rash. Vital sign remain stable; 02 Sat 99%. Dc'd at 10:30a, instructed to give Benadryl PO q6 hours per ER if symptoms return.
Sex: M
Vaccine: HEP
Symptoms: Blood pressure, Dysgeusia, Dyspnoea, Flushing, Nausea
Clinical narrative: Immediately after receiving Hep B injection - employee stated he had bitter then metallic taste in mouth. He then states he felt short of breath, face flushed, and he had some nausea. BP 124/71 - 75 - R=20. Monitored employee for 1/2 hour. Five minutes after injection employee states he feels "fine".  By 10 minutes all symptoms were gone. BP 106-67 - 79-16.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Similar reaction on previous exposure to drug
Clinical narrative: Mother of patient states she noticed "very fine" bumps at site of injections on both thighs less than 24 hrs. following vaccinations. Mom says pt has only "2 or 3 bumps" on abdomen. Mom says she saw same reaction following vaccinations on previous visits.  Denies fever. States mild redness and swelling and mild tenderness to touch noted at injection site also.  Mom states no distress apparent.  No bandage applied to injection sites following vaccination on this date.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient came in to clinic on 3/12/07 - 3d after immunization. Mother reports one day after immunization swelling and redness started at Left deltoid imm site, increase swelling x 2 days. On 3/13/07 redness and swelling diminished. She was d/c'd from office.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dyskinesia, Fall, Hyperhidrosis, Pain in extremity, Staring
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female student with no pertinent medical history who on 16-Jan-2007, at 14:45, was vaccinated, into the left deltoid, with a first dose of Gardasil (lot #655619/1427F) concomitantly with a first dose of Havrix (lot AHAVB143BA) in the left arm and a first dose of Menactra (lot U1968AA) into the right deltoid. On 16-Jan-2007, at 14:45, while sittings on table, the patient complained of severe pain in the left arm. As the patient was complaining, she fell forward, and the licensed practical nurse laid her down. The patient's eyes were fixed staring at the ceiling and her body started jerking wildly and thrashing. The patient went from jerking and trashing to "jumping up and asking what happened." The patient was guided back to the table and her body started jerking and thrashing with her eyes fixed on the ceiling and non-reactive. Subsequently, the patient came to diaphoretic. In January 2007, the patient recovered. No further information is available.
Sex: F
Vaccine: MNQ
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Initial information received on 31 October 2006 and follow-up information received on 01 November 2006. An 18-year-old female received an initial dose of Menactra, lot number U1535AA, administered intra-muscularly in the left arm on 25 August 2006, Her past medical history included asthma/reactive airway disease and mononucleosis in May 2000. The patient had a viral infection/upper respiratory infection on 16 Aug 2006. On 09 September 2006, 15 days post immunization, the patient developed numbness in her fingers and toes. She was seen by a physician on 11 September 2006 and 14 September 2006 and was diagnosed with Guillain Barre syndrome. The diagnosis was made by a private medical doctor on unknown date. A representative spoke with the patient's neurologist and stated that "this is a confirmed level 1 GBS case". At the time of this report, the patient had recovered except for residual tingling and numbness in her hands and feet.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: seriousness criteria other medically significant. Initial report received on 20 November 2006, who originally received the report from a health care professional. A 19-year-old male patient, with a history of allergic rhinitis, had received a first dose, left arm, intramuscular injection of Menactra, lot number U2135AA, on 20 September 2006. Two weeks post-immunization, on 05 October 2006, the patient developed Guillain Barre syndrome. Diagnostic performed, and treatment received were not reported. At the time of this report, the patient had recovered.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: CSF protein increased, Guillain-Barre syndrome, Muscular weakness, Paraesthesia
Clinical narrative: Initial report received on 11 December 2006, who originally received the report from a health care professional. A 13-year-old female patient, who was taking Zyrtec, Guafanesin, and Tylenol, had received a dose of Menactra log number U2114AA, on 15 August 2006. The route and site of administration were not reported. The patient subsequently received a first dose, intramuscular injection (site unknown) of Gardasil, (lot number not reported), and a Pneumococcal 23-valent vaccine, manufacturer unknown, (lot number, route and site of administration not reported) on 22 November 2006. The patient developed Guillain Barre syndrome on 30 November 2006, 107 days post immunization with Menactra, and eight days post immunization with the Gardasil and Pneumococcal 23 valent vaccine. The patient was admitted to the hospital on 01 Dec 2006 with chief complaint of ascending weakness bilaterally, in the upper and lower extremities. Clinical symptoms suggested Guillain Barre Syndrome with primarily motor weakness and some altered sensation. A neurology consult was made, and the patient was diagnosed with Guillain Barre Syndrome. The CSF fluid showed elevated protein. At the time of this report, the recovery status of the patient was unknown.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, FLUX, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Erythema, Flushing, Pruritus
Clinical narrative: Initial report received from a health care professional on 12 December 2006. A 19 year old, female patient (with a medical history of no known allergies) developed a flushed, red and itchy face, 2 days after she received Fluzone (lot number U2240AA) intramuscularly in the left deltoid, Menactra (lot number U2159AA) intramuscularly in the right deltoid and Gardasil (lot number unknown) on 20 November 2006. On 23 November 2006, the patient called to report red spots on hands. The patient did not have any illness at the time of vaccination. She was treated with Benadryl. She was not seen at the doctors office and has moved. It was reported that she recovered.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, FLUX, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Erythema, Flushing, Hypersensitivity, Pruritus, Skin burning sensation
Clinical narrative: Initial report received from a health care professional on 12 December 2006. A 19 year old, female patient (with a medical history of no known allergies) developed a flushed, red and itchy face, 2 days after she received Fluzone (lot number U2240AA) intramuscularly in the left deltoid, Menactra (lot number U2159AA) intramuscularly in the right deltoid and Gardasil (lot number unknown) on 20 November 2006. On 23 November 2006, the patient called to report red spots on hands. The patient did not have any illness at the time of vaccination. She was treated with Benadryl. She was not seen at the doctors office and has moved. It was reported that she recovered.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, FLUX, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Erythema, Flushing, Pruritus, Rash macular
Clinical narrative: Initial report received from a health care professional on 12 December 2006. A 19 year old, female patient (with a medical history of no known allergies) developed a flushed, red and itchy face, 2 days after she received Fluzone (lot number U2240AA) intramuscularly in the left deltoid, Menactra (lot number U2159AA) intramuscularly in the right deltoid and Gardasil (lot number unknown) on 20 November 2006. On 23 November 2006, the patient called to report red spots on hands. The patient did not have any illness at the time of vaccination. She was treated with Benadryl. She was not seen at the doctors office and has moved. It was reported that she recovered.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Nausea, Syncope
Clinical narrative: Nausea extreme fatigue also fatigue after #1 Gardasil and Menactra on 1/3/07 (not reported).
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea extreme fatigue also fatigue after #1 Gardasil and Menactra on 1/3/07 (not reported).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dyspnoea, Pallor, Pharyngolaryngeal pain, Wheezing
Clinical narrative: Initial report received on 06 March 2007 from a health care professional. An 11-year-old male patient, with past medical history of asthma (treated with albuterol) and flow murmur, had received a first, right deltoid, intramuscular injection of Menactra, lot number U1974AB; and a first dose, left deltoid, intramuscular injection of Boostrix vaccine (manufacturer reported), lot number AC52B014AA, on 05 March 2007 at 14:20p.m. to 14:35 p.m. Approximately five to ten minutes later, around 14:40 p.m., the patient complained of a sore throat and trouble breathing. He was pale and had mild wheezing. The physician ordered an Xopenex treatment. Three minutes later, the patient's oxygen saturation was checked via pulse oximetry, and it was 89-91%. His respirations were 20, and his blood pressure was 70/32. A second blood pressure reading revealed a pressure of 88/54, and at that time, the patient's oxygen saturation had increased to 99%. The patient felt better and was breathing easier, but some wheezing was still noted. Twenty-five minutes after the first Xopenex treatment, a second Xopenex treatment was administered (15:05 p.m.). The patient's oxygen saturation subsequently increased to 95%. The physician re-assessed the patient and released  him to home with his mother. The patient recovered.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Blood pressure decreased, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Oxygen saturation normal
Clinical narrative: Initial report received on 06 March 2007 from a health care professional. An 11-year-old male patient, with past medical history of asthma (treated with albuterol) and flow murmur, had received a first, right deltoid, intramuscular injection of Menactra, lot number U1974AB; and a first dose, left deltoid, intramuscular injection of Boostrix vaccine (manufacturer reported), lot number AC52B014AA, on 05 March 2007 at 14:20p.m. to 14:35 p.m. Approximately five to ten minutes later, around 14:40 p.m., the patient complained of a sore throat and trouble breathing. He was pale and had mild wheezing. The physician ordered an Xopenex treatment. Three minutes later, the patient's oxygen saturation was checked via pulse oximetry, and it was 89-91%. His respirations were 20, and his blood pressure was 70/32. A second blood pressure reading revealed a pressure of 88/54, and at that time, the patient's oxygen saturation had increased to 99%. The patient felt better and was breathing easier, but some wheezing was still noted. Twenty-five minutes after the first Xopenex treatment, a second Xopenex treatment was administered (15:05 p.m.). The patient's oxygen saturation subsequently increased to 95%. The physician re-assessed the patient and released  him to home with his mother. The patient recovered.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Pallor, Pharyngolaryngeal pain, Wheezing
Clinical narrative: Initial report received on 06 March 2007 from a health care professional. An 11-year-old male patient, with past medical history of asthma (treated with albuterol) and flow murmur, had received a first, right deltoid, intramuscular injection of Menactra, lot number U1974AB; and a first dose, left deltoid, intramuscular injection of Boostrix vaccine (manufacturer reported), lot number AC52B014AA, on 05 March 2007 at 14:20p.m. to 14:35 p.m. Approximately five to ten minutes later, around 14:40 p.m., the patient complained of a sore throat and trouble breathing. He was pale and had mild wheezing. The physician ordered an Xopenex treatment. Three minutes later, the patient's oxygen saturation was checked via pulse oximetry, and it was 89-91%. His respirations were 20, and his blood pressure was 70/32. A second blood pressure reading revealed a pressure of 88/54, and at that time, the patient's oxygen saturation had increased to 99%. The patient felt better and was breathing easier, but some wheezing was still noted. Twenty-five minutes after the first Xopenex treatment, a second Xopenex treatment was administered (15:05 p.m.). The patient's oxygen saturation subsequently increased to 95%. The physician re-assessed the patient and released  him to home with his mother. The patient recovered.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Felt light headed about 10 minute after vaccine administration.  He then passed out for a few seconds.  He was still light headed 24 hours after vaccine administration and was sent home on quarters (sick leave) for 24 hours.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Right upper arm swelling, pain, erythema, fever, sx began 24 hours. Treated with ibuprofen and antibiotics.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: MMR vaccine administered 2-12-08 for negative Rubella titer
Sex: M
Vaccine: SMALL
Symptoms: Basal cell carcinoma, Biopsy skin abnormal
Clinical narrative: This case was considered medically important. Information regarding Dryvax was received from a literature source regarding a 32-year-old male patient who received a dose on an unspecified date, and three years later developed basal cell carcinoma in the dermal vaccination scar. On an unspecified date, three years following smallpox vaccination, the patient developed basal cell carcinoma in the dermal vaccination, confirmed by a shave-skin biopsy (see test results below). Treatment and patient outcome were not reported and are unknown. The author noted that this patient's basal cell carcinoma had a short latent interval and an apparent interaction between the live vaccination and scarring. The author's concluded that the relatively short interval from the time of vaccination to the development of carcinoma necessitates further studies on the carcinogenic potential of different strains of vaccinia. Biopsy skin (results: shave skin biopsy of tumor identified, nodular basal cell carcinoma) was done on an unspecified date. See attached literature article. No additional information was available at the time of this report.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a licensed practical nurse, for the Pregnancy Registry for Gardasil concerning a 25 year old female with drug hypersensitivity to ENTEX, erythromycin, codeine, LORTAB, and IMITREX and a history of pregnancy who on 21-NOV-2006 was vaccinated with first dose of Gardasil (lot # 654702/0011U) IM. On 22-JAN-2007, the patient was vaccinated with second dose of Gardasil (lot # 654702/0011U), IM. Concomitant therapy included amitriptylline hydrochloride. The patient sought medical attention. On an unspecified date, urine beta-human chorionic gonadotropin test was positive for pregnancy. The patient's last menstrual period was December 2006 (gestation: first trimester), expected date of delivery is approximately September 2007. No other information was available at the time of reporting. Additional information was received from a health professional from the physician's office via telephone. It was reported that the patient terminated her pregnancy (date not reported), not because of Gardasil but for other reasons. The outcome of the induced abortion was not reported. Upon internal review, abortion induced was determined to be an Other Important Medical Event. No additional information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Eosinophil count increased, Headache, Neck pain
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who on 03-JAN-2007 was vaccinated with Gardasil (lot # not reported). On 11-FEB-2007, the patient experienced neck pain, and headache. Medical attention was sought. The patient was hospitalized. The patient had an "eosinophil type reaction" also. Laboratory evaluation revealed elevated eosinophils. The outcome of the neck pain, headache, and eosinophil type reaction was snot reported. No further information was available at the time of reporting. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Eye infection, Eye swelling, Face and mouth X-ray normal, Swelling face
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 05-MAR-2007 was vaccinated IM with the first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 05-MAR-2007, two hours post-vaccination, the patient developed swollen eyes and face and went to an emergency room. The patient underwent sinus films, which were noted to be negative, and was administered BENADRYL and unspecified antibiotics for a possible eye infection. The patient was released that same evening. On 07-MAR-2007, the physician contacted the patient and reported that there was "not much improvement." The patient's swollen eyes and face persisted. Eye and face swelling were reported as other important medical events. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Brain neoplasm
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of varicella vaccine. Subsequently the patient developed a brain tumor. There was no product quality complaint involved. No further information was available. Additional information is not expected. Upon internal review the patient's brain tumor was determined to be an other important medical event. The patient's sibling (WAES0703USA01528) had the same experience after vaccination with varicella vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Brain neoplasm
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of Varivax. Subsequently the patient developed a brain tumor. There was no product quality complaint involved. No further information was available. Additional information is not expected. Upon interval review the patient's brain tumor was determined to be an other important medical event. The patient's sibling (WAES # 0703USA01528) had the same experience after vaccination with Varivax.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Blood culture negative, Body temperature increased, CSF culture negative, Culture urine negative, Electroencephalogram normal
Clinical narrative: Patient received 2nd set of shots (Pediarix, HIB, Prevnar)-the following day had febrile seizure with temp 39.2 deg. EEG/MRI/LP normal.   05/24/2007 MR received for a 2 night admission (1/7-9/2007) for c/o an episode of  body stiffness and shaking of the 4 extremities and  rolling back of the eyes. Infant had had a cough x 4 days and a temp of 102.6 was  noted in the ER. PE: (+) for Nasal congestion and systolic innocent murmur.  Discharge DX:  Febrile seizure.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Febrile convulsion, Lumbar puncture normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient received 2nd set of shots (Pediarix, HIB, Prevnar)-the following day had febrile seizure with temp 39.2 deg. EEG/MRI/LP normal.   05/24/2007 MR received for a 2 night admission (1/7-9/2007) for c/o an episode of  body stiffness and shaking of the 4 extremities and  rolling back of the eyes. Infant had had a cough x 4 days and a temp of 102.6 was  noted in the ER. PE: (+) for Nasal congestion and systolic innocent murmur.  Discharge DX:  Febrile seizure.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: CSF culture negative, Chest X-ray normal, Computerised tomogram normal, Drug screen negative, Full blood count
Clinical narrative: 2 days after vaccination pt suffered new Grand Mal Seizure, seen and treated in local ER.  03/26/2007 MR received for an ER visit for c/o seizure activity at home x 2. PE:  Infant was initially flaccid, but began moving all extremities w/in 15 minutes.  Temp was 101.3'F in the ambulance.  Extraoccular motion is somewhat wandering.  Mild diaper rash. Otherwise WNL.  Diagnosis:  Febrile Seizure.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Grand mal convulsion, Lumbar puncture normal, Urine analysis normal
Clinical narrative: 2 days after vaccination pt suffered new Grand Mal Seizure, seen and treated in local ER.  03/26/2007 MR received for an ER visit for c/o seizure activity at home x 2. PE:  Infant was initially flaccid, but began moving all extremities w/in 15 minutes.  Temp was 101.3'F in the ambulance.  Extraoccular motion is somewhat wandering.  Mild diaper rash. Otherwise WNL.  Diagnosis:  Febrile Seizure.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Appeared patient fainted just after vaccine was given, sl diaphoretic pale, recovered quickly after ammonia inhaler was used. Patient rested water was given, left office feeling well.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Loss of consciousness, Scan brain, Tremor
Clinical narrative: Patient walked to lobby after shot and passed out, then body shook. She was helped back to exam room and observed. She hit back of head and no bump forward. Iced area for 30 minutes. She left in 45 minutes in good condition. Ct scan normal next day.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Eye rolling, Fall, Head injury
Clinical narrative: Patient walked to lobby after shot and passed out, then body shook. She was helped back to exam room and observed. She hit back of head and no bump forward. Iced area for 30 minutes. She left in 45 minutes in good condition. Ct scan normal next day.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope, Tremor
Clinical narrative: Patient walked to lobby after shot and passed out, then body shook. She was helped back to exam room and observed. She hit back of head and no bump forward. Iced area for 30 minutes. She left in 45 minutes in good condition. Ct scan normal next day.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Computerised tomogram, Convulsion, Diplopia, Dizziness
Clinical narrative: Patient walked to lobby after shot and passed out, then body shook. She was helped back to exam room and observed. She hit back of head and no bump forward. Iced area for 30 minutes. She left in 45 minutes in good condition. Ct scan normal next day.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Injection site pain, Loss of consciousness, Musculoskeletal stiffness, Nausea, Syncope
Clinical narrative: Patient walked to lobby after shot and passed out, then body shook. She was helped back to exam room and observed. She hit back of head and no bump forward. Iced area for 30 minutes. She left in 45 minutes in good condition. Ct scan normal next day.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: Patient walked to lobby after shot and passed out, then body shook. She was helped back to exam room and observed. She hit back of head and no bump forward. Iced area for 30 minutes. She left in 45 minutes in good condition. Ct scan normal next day.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Apnoea, Choking, Febrile convulsion
Clinical narrative: Child had 3 minute febrile sz approximately 10 hours after shots given. Child's fever probably from fifth dz. Had apnea/dusty spell became child and choked on a baby aspirin mom gave child for her fever. T104 by EMS. I don't feel this is vaccine related. Tx- Motrin only
Age: 1.16
Sex: F
Vaccine: MMRV, HPV4
Symptoms: Rash papular
Clinical narrative: Broke in papular lesions started the day prior to being seen, and has continued to spread.
Age: 1.16
Sex: F
Vaccine: MMRV, HPV4
Symptoms: Inappropriate schedule of drug administration, Rash papular
Clinical narrative: Broke in papular lesions started the day prior to being seen, and has continued to spread.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Myalgia
Clinical narrative: Two days after injection, complained of joint pains, myalgia not relieved with use if Ibuprofen missed 2 days of school.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Myalgia
Clinical narrative: Generalized myalgia, arthralgia after 2nd injection (HPV). TX with Motrin 200 mg - 400 mg Q 4 hours x 2 days. Pt missed 2 days of school.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema, Oedema peripheral
Clinical narrative: 1st Injection with slight erythema and edema. 2nd Injection noted slight edema and erythema, then next am woke with swollen area over most of deltoid area, continue to increase over next 24 hours - arm swollen from elbow to shoulder and continues for 8 days. Resolved completely.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5cm local erythematous swelling at injection site.
Age: 12.0
Sex: F
Vaccine: HPV4, MMRV, TDAP
Symptoms: Body temperature increased, Fatigue, Pharyngolaryngeal pain, Pyrexia, Rash
Clinical narrative: Six hours s/p injections developed fever, rash up right arm, right side of neck and face. Also developed sore throat in 24 hours. Temp = 102. Rash responded to Benadryl except for local injection sites. Is having RLQ pain but that started before injections. Generally feels fatigued as well. No rash on left arm.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Left deltoid: 5 x 3 cm nodule with erythema warmth tenderness. Cellulitis treated with Keflex TID x 7 days and warm compresses.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV, PNC
Symptoms: Urticaria
Clinical narrative: 2-19-07 Patient was given ProQuad, Hep A and Prevnar and a prescription for amoxicillin. Developed severe hives over entire body 3-1-07. Now improving on 3-6-07.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Patient c/o arm swelling 7 days after 1st injection.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza serology, Poor quality drug administered, Vaccination failure
Clinical narrative: After receiving the vaccine in fall/winter of 06, she contracted flu strain A in February of 2007 and flu strain B in March of 2007. The pediatrician and I believe the immunization to be a placebo or false immunization.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Urticaria
Clinical narrative: Hives come days after vaccine, red on arm.
Age: 1.22
Sex: M
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: Received  ProQuad and began Augmentin 2-23-07. Developed hives over entire body beginning 3-4-07. Hive now resolving with Atarax therapy.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Tinnitus
Clinical narrative: "Dizziness, ringing in ears" per patient. Treatment: Patient laid down for 15-20 minutes, sx's resolved. Vital signs were stable before, during and after sx's.