chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Depressed level of consciousness, Gait disturbance, Hyperreflexia, Hypoaesthesia, Laboratory test abnormal
Clinical narrative: Possible transverse myelitis, i.e. sudden onset of weakness, decreased sensation, numbness of upper and lower extremities, up to sternum with urinary retention. Sudden onset 10/12/03. States got influenza vaccination 10/08/2003.  Nurse follow up on 07/27/04 states: "chest pain; nausea; vomiting; constipation; back pain; balance impaired. Per annual report-Pt has hyper reflexion, mild spasticity, gait disturbance and urinary incontinence. Pt work up at hospital with neurologist and neurosurgeon.  Neurologist thinks it secondary to cervical myelopathy secondary cervical stenomi-pt underwent surgery care.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasticity, Myelitis transverse, Myelopathy, Nausea, Urinary incontinence
Clinical narrative: Possible transverse myelitis, i.e. sudden onset of weakness, decreased sensation, numbness of upper and lower extremities, up to sternum with urinary retention. Sudden onset 10/12/03. States got influenza vaccination 10/08/2003.  Nurse follow up on 07/27/04 states: "chest pain; nausea; vomiting; constipation; back pain; balance impaired. Per annual report-Pt has hyper reflexion, mild spasticity, gait disturbance and urinary incontinence. Pt work up at hospital with neurologist and neurosurgeon.  Neurologist thinks it secondary to cervical myelopathy secondary cervical stenomi-pt underwent surgery care.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary retention, Vomiting
Clinical narrative: Possible transverse myelitis, i.e. sudden onset of weakness, decreased sensation, numbness of upper and lower extremities, up to sternum with urinary retention. Sudden onset 10/12/03. States got influenza vaccination 10/08/2003.  Nurse follow up on 07/27/04 states: "chest pain; nausea; vomiting; constipation; back pain; balance impaired. Per annual report-Pt has hyper reflexion, mild spasticity, gait disturbance and urinary incontinence. Pt work up at hospital with neurologist and neurosurgeon.  Neurologist thinks it secondary to cervical myelopathy secondary cervical stenomi-pt underwent surgery care.
Age: 42.0
Sex: M
Vaccine: LYME
Symptoms: Amblyopia, Amnesia, Arthralgia, Arthritis, Back pain
Clinical narrative: Severe arthritis, back aches, headache, muscle aches, chronic fatigue. GI distress. Pain killers (hydrocodone). Follow up per medical record: back pain, numbness of limbs, lack of concentration, memory loss, joint pains, rash, itching, photo sensitivity, blurred vision.
Age: 42.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Gastrointestinal disorder, Headache, Myalgia, Paraesthesia
Clinical narrative: Severe arthritis, back aches, headache, muscle aches, chronic fatigue. GI distress. Pain killers (hydrocodone). Follow up per medical record: back pain, numbness of limbs, lack of concentration, memory loss, joint pains, rash, itching, photo sensitivity, blurred vision.
Age: 42.0
Sex: M
Vaccine: LYME
Symptoms: Photosensitivity reaction, Pruritus, Rash, Thinking abnormal
Clinical narrative: Severe arthritis, back aches, headache, muscle aches, chronic fatigue. GI distress. Pain killers (hydrocodone). Follow up per medical record: back pain, numbness of limbs, lack of concentration, memory loss, joint pains, rash, itching, photo sensitivity, blurred vision.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Contusion, Idiopathic thrombocytopenic purpura, Petechiae, Thrombocytopenia
Clinical narrative: 5/10/04 Bruising on child began. 5/20/04 Petechiae noted on arms/legs/head. CBC with differential test revealed platelet count at 2 (thrombocytopenia). Hospitalized - 1st dose of immunoglobulin. 5/21/04 2nd dose of immunoglobulin as platelets at 4. 5/22/04 Platelet count at 37 - released from hospital.  Nurse follow up on 07/29/04 states: "ITP." Per annual report-We have not had any problems for over a year now. I am concerned about the MMR booster that she is to receive at 5 years of age, however. Also perhaps it would be better for children to have their vaccines spread over a period of time. As you can see, on 4/19/2004, my daughter was vaccinated against 5 diseases at one time.
Sex: F
Vaccine: DTAP, MMR
Symptoms: Eye swelling, Headache, Urticaria
Clinical narrative: Pt in around 2.25 to get MMR and DTaP. Given around 2.25pm. Approximately 2.35 mom called to say child had headache: gave 3 Tylenol chewable.  Had ice-cream was  when mom noticed both eyelids swelling. Seen in office 3.15. Both eye lids urticarial lesions. No other signs or symptoms. Given 1 tsp (12.5mg) Benadryl . Hives in 20-30 minutes.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Discomfort, Swelling
Clinical narrative: Leg swelling and discomfort in left leg, from groin to knee.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Cough, Erythema, Pruritus, Rash
Clinical narrative: 1. 1012 : vaccine administered. 1500: presented with itchy red rash on chest, itching both UE and complaints of coughing. 1622 : symptoms diminishing without intervention. 1700: reports complete symptom resolution.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: redness, swelling, measuring 9"x7", warm to touch, non-tender.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Chest pain, Dizziness, Dysphagia, Malaise, Muscle spasms
Clinical narrative: dose 1: Rabavert given on 6/30/2004. Dose 2: Rabavert given 07/07/2004. Patient stated she had general malaise and dizziness for 24 hours after first dose of vaccine. Dose #3 Rabavert with-held on 7/14/04. Patient stated she had a 20 minute episode of left chest/ breast muscle pain/ spasm on evening of second dose, along with difficulty swallowing. She did not seek medical attention and it abated 20 minutes. She also experienced malaise for 24 hours after second dose of Rabavert.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia
Clinical narrative: dose 1: Rabavert given on 6/30/2004. Dose 2: Rabavert given 07/07/2004. Patient stated she had general malaise and dizziness for 24 hours after first dose of vaccine. Dose #3 Rabavert with-held on 7/14/04. Patient stated she had a 20 minute episode of left chest/ breast muscle pain/ spasm on evening of second dose, along with difficulty swallowing. She did not seek medical attention and it abated 20 minutes. She also experienced malaise for 24 hours after second dose of Rabavert.
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema
Clinical narrative: large erythematous patch over entire upper arm.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Pyrexia, Vomiting
Clinical narrative: Vaccinated 7/12/04 , 1:45pm. Almost 12 hours later, developed fever, vomiting, dizziness. About 10-12 hours later the fever and vomiting were gone; dizziness was gone the following day.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: Shot given 7/12/004. Hospitalized 7/18/04 for cellulitis. Discharged 7/15/04.  Nurse follow up on 08/30/04 states: "Local reaction to vaccine."
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Pain
Clinical narrative: Left arm redness, induration, pain within 24 hours of pre-K boosters. Lasted greater than three days: self resolved.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site induration
Clinical narrative: 10x7 cm erythema, induration.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Mom stated pt ran 104 right temperature x 3 days.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR
Symptoms: Agitation, Fatigue, Pyrexia, Screaming
Clinical narrative: DTaP and MMR given (both in left thigh) on 7/13. Fever to 104.3 degrees max (7/13-7/15) 7/16 woke up at 1:30 am screaming inconsolably until 5:00am. Went to ER. Normal exam. 7/16 AM came to office. Exam normal. Except teething molars. Baby seen in office later on 7/16/04: normal exam except appears tired.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Injection site induration, Swelling
Clinical narrative: Hard, red, swollen area 6.5x5mm.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, VARCEL
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness with swelling approximately 2 inches wide to left thigh. Warm to the touch. No treatment.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling, Skin discolouration
Clinical narrative: Right arm with pink area and puffiness approximately 12.5x10cm. Prescribed Benadryl every 6 hours for 24 hours.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Anorexia, Crying, Screaming
Clinical narrative: On 7/13/2004 around 1600 had 4 months shot given: Pediarix , HIB + Prevnar. Immediately started screaming inconsolably. Lasted 30 minutes in clinic, slept for 1 hours, woke up crying, 1 hour and half to 10:30 PM. Woke up around 7am crying again. Refused breakfast and cups of juice in cup.
Age: 23.0
Sex: M
Vaccine: HEP, HEPA, MMR, YF
Symptoms: Erythema, Swelling
Clinical narrative: large local reaction, Swelling to elbow, Erythema.
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Skin irritation, Swelling
Clinical narrative: Leg swollen, red and irritated. Tx: Benadryl 1 tsp q 6 hours. Derma Smooth oil BID to area.
Age: 0.5
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HEP
Symptoms: Irritable bowel syndrome, Pyrexia
Clinical narrative: All three vaccines administered 7/20/04. Low grade fever (palpable) within 2 hours. Then, high fever 105 degrees F on 7/21/04 documented in hospital. Child also very irritable. No infection found. Pt seen 7/21 and 7/22/04: Prescriptions given.
Age: 1.8
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Varicella given 7/16/04. Child's mother reported a small number of chickenpox covering body - very sporadic. No illness reported.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left upper arm elbow to shoulder, red hot, onset today approx. 12:00 pm. Tx cold follwed by warm moist pcaks, Benedryal.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: C/O sore arm on 7-21-04.  7-22-04 awoke at 8:30 Am with red, swollen arm with blisters mom describes these appear to have fluid, denies fever - eating, sleeping, playing without problems, no other sign of illness.
Age: 1.8
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Mother called to say child had broke out in chickenpox.  Wanted info on vaccine (received 10-15-03) and risk to pregnant sibling and infant in the home.  Pregnant sibling will consult w/OB provider
Age: 38.0
Sex: M
Vaccine: TYP
Symptoms: Nausea, Vomiting
Clinical narrative: Acute onset of nausea and vomiting within about 12 hours after third dose of oral typhoid vaccine requiring ER visit and IV fluids.  Resolved by 48 hours after vaccine.  Vaccine filled at pharmacy and taken at home.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Pt.had fever and fussing the night after vaccination was given and was given tylenol. Pt. then woke up at 2:30 am screaming and mother was able to console and get back to sleep. The same day he woke up from nap at 6:30 pm and wouldn,t stop screaming, so mother took him to ER then 6-16-04.  Pt was running temperature of 100.2 degrees in the hospital.  They were discharged from hospital with diagnosis of immunization side effect, told to continue with tylenol for 24 hours and to call or come back if continued or worsening symptoms.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: High Fever, Small rash, starting on 7/25. Doctor checked on 7/26, no visable signs of reason for fever. Dr. recomended fever reducers if patient temp over 101.9.
Age: 0.14
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Encephalitis, Sudden infant death syndrome
Clinical narrative: SIDS death 7/1/04.  Nurse follow up on 10/05/04 states: "Focal chronic encephalitis."
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Cardiac arrest, Nasal congestion, Neonatal asphyxia, Sudden infant death syndrome
Clinical narrative: Patient presented to ER in cardiac arrest. Was coded, pronounced dead that evening less than 28 hours following immunizations.  Nurse follow up on 07/27/04 states: "SIDS." Follow up report: this report was received from the CDC in response to a Freedom of Information request by GSK. It described the occurrence of sudden infant death syndrome in a  month old male patient who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. The patient's medical history included "mild" familial macroencephaly, candidiasis, seborrheic dermatiti, otitis media (4FEB2004), and wheezing bronchitis. Concurrent medications included Cefzil for an unspecifed indication. On 3MAY2004, the patient received the third dose of Pediarix. On the same day, the patient also received an injection of Haemophilus influenzae type b conjugate vaccine. Approximately one day following receipt of the immunizations, on 4MAY2004, the patient "was found unresponsive and without vital signs in the rather small crib where he had been laiddown to sleep a few hours before and had last been seen apparentl alive and well less than one hour before." Emergency medical personnel were summoned; they began cardiopulmonary resuscitaiton and transported the patient to the ER. Resuscitation attempts were unsuccessful, and the patient was pronounced dead less than 28 hours after receipt of the immunizations. An autopsy was performed on 5MAY2004. It was noted in the autopsy report that the infant was rebuct, well nourished, and had no anomalies or distinguishing features. There were no petechiae of the conjuncive eyelids, or finefacial skin. Bloody mucoid fluid purging from the nostrils was observed. It was also noted that there was osme blood mucoid staining in the infant's bassinet. Both lungs were "congested and slightly edematous with a few pleural petechiae and some scattered subpleural hemorrhagic blotchy patches but no focal lesions are noted about the pleural surfaces or cut sections." Histological examinaiton of the lungs revealed "intense vascular congestion and scattered foci of fank intra-alveiolar and interstitial hemorrhage especially in the lowe lobes". "Minimal" focal atelectasis was observed. Petechiae were observed over the inferior surace of the thymus. Other autopsy findings included generalized visceral congestion, a moderately "dusky" and congested brain, and chronic viscid mucus otitis of both middle ears. Blood analyses for ethanol and a drug screen were both negative. The forensic pathologist wrote, "the death may be attributed to the phenomenon of sudden unexplained death with asphyxia not able to be excluded." The causeof death was recorded as "Sudden Infant Death."
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Left thigh 2.5x6cm redness and swelling. Left axillary .75cm redness. Prescription: Duricef 500mg qd 10 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 7/21/04: pt received Dtap and IPV right arm 7/19/04. That night pt started fever of 101 degrees. Arm injection sites started swelling 7/20/04. Painful to touch. Instructed to apply cold compresses. Take Benadryl OTC and Tylenol for fever. 7/21/04: 1500 Pt's mother called.  Swelling worsened. Streaking. Very hot to touch. To be seen by physician. 7/21/04: Diagnosis: cellulitis to right deltoid. Treatment Cephalexin 250mg/5ml 1 tsp qid po x 10days. To continue Benadryl and ice. To follow up next week or sooner if need be.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: Fever with each dose of Pediarix or Prevnar.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash maculo-papular, Rash vesicular
Clinical narrative: red macular papular lesions with some early vesicles over trunk.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Haematoma, Injection site inflammation, Injection site mass, Injection site nodule
Clinical narrative: vaccinated with Pediarix in left thigh 1/20/04. Parents notices lump at that site 3/2/04, and were seen (thought to be calcified hematoma. ) Lump persisted so x-rayed on 4/21/04 and MRI done 5/25 because of increased size. Required surgical excision biopsy 6/2/04 which showed accrotizing granulomatous inflammation with no evidence of acid-fast fungal or bacterial organisms.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Headache, Lymphadenopathy, Rash
Clinical narrative: Approximately within week after receiving MMR, client complained of chills and headaches lasting 3 days. No fever. On 7/20/04 client complained of rash on face and neck with swollen glands.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Grand mal convulsion, Laboratory test abnormal
Clinical narrative: Brief apparent grand mal seizure. CT negative. EEG: episodic. Glowing of background,rhythm. Episode in 1995: EEG then negative.
Age: 1.5
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site reaction
Clinical narrative: Area of cellulitis x 2 cm around area of Varivax shot site: redness and warmth present x 4 days.
Age: 1.08
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Febrile convulsion
Clinical narrative: Mother states that child had "small" seizure a few hours after shot. Seen at emergency room. She also reports that child had another seizure a month later in April and again a month after in May. Is currently under doctor's care for febrile seizures. Mother and uncle unknown to history of seizures. This was unknown to us until today 7/20/04.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Diarrhoea, Oedema, Vomiting
Clinical narrative: Mother states child had tennis ball sized knot come up on left thigh two days after immunizations. Had two loose stools on 7/19/04. Has started spitting up feedings since immunizations. Has appointment with pediatrician.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Inflammation, Injection site inflammation, Swelling
Clinical narrative: Swelling/ redness / local inflammation at the injection site. Left deltoid area.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling, Tenderness
Clinical narrative: Swelling of right deltoid area (right deltoid). Started Saturday 7/10/04. Tender to touch. Temp 105 oral.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Muscle twitching
Clinical narrative: On 7/21/04 foster mother said she noticed facial twitching after last immunization (right side of face).
Age: 23.0
Sex: F
Vaccine: ANTH, HEP, SMALL
Symptoms: Dyspnoea, Hypoaesthesia, Tremor
Clinical narrative: Vaccinated left deltoid 15JUL20040. Presented 23JUL04 complaining of hand trembling and numbness x qd, transient SOB (resolved). Self-medicated with Allegra and acetaminophen.
Age: 4.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Anaphylactic reaction, Urticaria
Clinical narrative: Anaphylaxis (hives, low perfusion) . Treatment given: > Epinephrine 1:1000 SQ 0.2ml. > Supplemental O2.
Age: 0.5
Sex: F
Vaccine: HIBV, PNC
Symptoms: Cellulitis, Inflammation, Pyrexia
Clinical narrative: Local inflammation , possible cellulitis; fever.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: pain, redness, swelling.
Sex: U
Vaccine: HEPA
Symptoms: Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Muscle aches: entire body. Fever 102+ within -18 degrees of injection (Hep A)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot
Clinical narrative: arm red, slightly warm to touch. 2"x3" inch area (right deltoid area.) No fever.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: right deltoid + arm red, swollen and warm to touch.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Nonspecific reaction
Clinical narrative: Pt received DTaP and had reaction to Left deltoid.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Right deltoid and arm red swollen and warm to touch
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Baby running fever 104, rash, itching
Age: 1.17
Sex: F
Vaccine: DT, HIBV, IPV, MMR
Symptoms: Convulsion, Postictal state, Pyrexia
Clinical narrative: Fever to 102F generalized tonic-clonic convulsion lasting approx. 30 seconds, minimal post-Ictal phase.
Age: 9.0
Sex: M
Vaccine: IPV, TD
Symptoms: Rash macular
Clinical narrative: Macular type rash on upper body
Age: 50.0
Sex: F
Vaccine: TTOX
Symptoms: Hypotonia, Similar reaction on previous exposure to drug, Weight decreased
Clinical narrative: From initial information received on 24May04 from a physician regarding an adverse event. It was reported that a 50 year old female pt received a TET TOX Booster USP vaccination at a travel clinic (manufacturer, lot number and route of administration not reported) sometime during the summer of 2003. Two to three months following vaccination, the pt experienced muscle weakness and weight loss. The pt had previously experienced the muscle weakness, muscle wasting and weight loss following a tetanus vaccination (lot number, manufacturer, and route of administration not reported) over ten years ago and she had been diagnosed with post pneumonia paralytic syndrome. The physician stated that she is not sure if the events are related to the vaccination. The pt was not hospitalized, but her symptoms were ongoing at the time of this report.
Age: 42.0
Sex: F
Vaccine: HEPAB, MMR, TTOX
Symptoms: Chest discomfort, Fatigue, Hypersensitivity, Injection site rash, Myalgia
Clinical narrative: From initial information received on 30Jul03 from manufacturer, by a registered nurse, regarding an adverse event occurring in the US, it was reported that a 42 year old female pt received, on an unspecified date, a dose of Tetanus Toxoid (manufacturer Aventis Pasteur, lot number and route/site were not reported), MMR II vaccine, manufacturer, lot number and route/site were not reported and second dose of Twinrix, manufacturer, lot number not reported, given in the right deltoid. On the same unspecified date, the pt experienced chest tightness, aches all over her body and fatigue. Along with developing a rash on the arm where the MMR was injected. Reportedly, the pt has an allergy to yeast. The events resolved after seven days. From additional information received on 06Oct03, no record was kept for this event per the reporter. No further information is anticipated, this case is considered closed.
Age: 45.0
Sex: M
Vaccine: MMR, TTOX, UNK
Symptoms: Hyperkinesia
Clinical narrative: From initial information received on 09Oct2003 from a physician regarding an adverse event occurring, it was reported that a 45 year old male pt received a dose of Tetanus Toxoid ADS USP, lot number U1044AA, given intra-muscularly in the left deltoid, a dose of MMR, manufacturer, lot number 021N, given in either the right leg or right arm (extremity not specified) and Tubersol 5 TU, lot number C1260AA, route and site not reported, on 21Jul03. Sometime after the vaccinations were given, the pt complained of pain with certain sudden movements of his left arm, briefly but recurrent. No episodes of swelling, redness or fever were reported after the vaccination. Reportedly, the events still persist and the pt has not recovered.
Age: 52.0
Sex: F
Vaccine: TTOX
Symptoms: Balance disorder, Dizziness, Gaze palsy, Hyperhidrosis, Hypotonia
Clinical narrative: From initial information received on 21Oct03 from a health care professional regarding an adverse event occurring, it was reported that a 52 year old female pt received a dose of TET TOX ADS USP, lot number U0823AA, administered IM in the right arm on 14Oct03 at 3:30PM. On 17Oct03 at 7:30AM, the pt experienced acute vomiting due to dizziness, equilibrium loss (could not walk), soreness at the administration site, swollen glands, total muscle weakness, restlessness, poor focus, sweating, inability to sleep, and was unable to see straight. The pt had also received Tubersol 5 TU, lot number C1619AA, administered ID on 20Oct03 and the results were reported as being within normal limits. Reportedly, the pt did not recover from these events.
Age: 52.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site pain, Insomnia, Lymphadenopathy, Restlessness, Visual disturbance
Clinical narrative: From initial information received on 21Oct03 from a health care professional regarding an adverse event occurring, it was reported that a 52 year old female pt received a dose of TET TOX ADS USP, lot number U0823AA, administered IM in the right arm on 14Oct03 at 3:30PM. On 17Oct03 at 7:30AM, the pt experienced acute vomiting due to dizziness, equilibrium loss (could not walk), soreness at the administration site, swollen glands, total muscle weakness, restlessness, poor focus, sweating, inability to sleep, and was unable to see straight. The pt had also received Tubersol 5 TU, lot number C1619AA, administered ID on 20Oct03 and the results were reported as being within normal limits. Reportedly, the pt did not recover from these events.
Age: 52.0
Sex: F
Vaccine: TTOX
Symptoms: Vomiting
Clinical narrative: From initial information received on 21Oct03 from a health care professional regarding an adverse event occurring, it was reported that a 52 year old female pt received a dose of TET TOX ADS USP, lot number U0823AA, administered IM in the right arm on 14Oct03 at 3:30PM. On 17Oct03 at 7:30AM, the pt experienced acute vomiting due to dizziness, equilibrium loss (could not walk), soreness at the administration site, swollen glands, total muscle weakness, restlessness, poor focus, sweating, inability to sleep, and was unable to see straight. The pt had also received Tubersol 5 TU, lot number C1619AA, administered ID on 20Oct03 and the results were reported as being within normal limits. Reportedly, the pt did not recover from these events.
Age: 28.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Hypoaesthesia
Clinical narrative: From initial information received on 24May04 from another manufacturer, regarding an adverse event occurring, it was initially reported by a registered nurse that a 28 year old female pt received a dose of TET TOX ADS USP, lot number not reported, administered in the right arm and a first dose of Engerix B, lot number Eng5521A2, administered in the left arm on 15Apr04. The routes of administration were not reported. Approximately seven days later, the pt experienced numbness of the lower right inner calf muscle. As of 18May04, the numbness has improved.
Age: 66.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Erythema, Injection site mass, Pruritus
Clinical narrative: 4 days post yellow fever and Hep A vaccines she developed red itchy nodules at vaccine sites.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Oedema peripheral, Weight decreased
Clinical narrative: Patient reported edema started 3 days post-vaccination. Patient sought medical care 12 days after vaccination.  Mild edema noted in hands, feet, and face, no other symptoms.   No treatment was given and patient was not on any OTC medication. Upon recheck 24 hours later, patient was normal in all respects and had lost 6 verified pounds of weight.
Age: 48.0
Sex: F
Vaccine: DT
Symptoms: Erythema, Feeling hot, Headache, Lymphadenopathy, Malaise
Clinical narrative: General malaise began within 24 hours of administration.  C/O: Headache, low grade fever, body aches, swollen glands under arm closest to site, large area of erythema, warmth, swelling on Right upper arm.
Age: 48.0
Sex: F
Vaccine: DT
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: General malaise began within 24 hours of administration.  C/O: Headache, low grade fever, body aches, swollen glands under arm closest to site, large area of erythema, warmth, swelling on Right upper arm.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Injection site mass, Pyrexia
Clinical narrative: There has been a large lump in the patient's leg since the shot was administered on July 8, 2004.  The lump has gotten considerably smaller, but it is still there today.  The child was also feverish and cried for about 2 hours on the night that she received the vaccination.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Panniculitis
Clinical narrative: In 1990 pt had 2 doses of Anthrax vaccine in L deltoid. She has had recurrent episodes of panniculitis at the site of injection since that time
Age: 6.0
Sex: F
Vaccine: DT, IPV, MMR
Symptoms: Cellulitis, Erythema, Feeling hot, Joint range of motion decreased, Pain
Clinical narrative: Vx given @ 2pm. Child given Motrin that eve.  Sat. a.m. child's R. leg aching. Early afternoon, mild swelling on R. thigh.  By eve., thigh twice normal size. Swelling extended fr. hip to knee.  Child unable to bend knee.  Skin hot, red and very hard. Dx cellulitis @ E.R. & placed on augmentin for 10 days.
Age: 6.0
Sex: F
Vaccine: DT, IPV, MMR
Symptoms: Swelling
Clinical narrative: Vx given @ 2pm. Child given Motrin that eve.  Sat. a.m. child's R. leg aching. Early afternoon, mild swelling on R. thigh.  By eve., thigh twice normal size. Swelling extended fr. hip to knee.  Child unable to bend knee.  Skin hot, red and very hard. Dx cellulitis @ E.R. & placed on augmentin for 10 days.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pain
Clinical narrative: About five minutes after receiving tetanus booster injection, I experienced nausea and broke out in a cold sweat.  I felt I might pass out for maybe five minutes, and then it all abated spontaneously.  Exactly the same thing happened to me ten years ago when I got my last tetanus booster.  I have no known allergies and have not experienced these symptoms in this way at any other time.  (I also had mild arm soreness a day later.)
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Drug ineffective, Febrile convulsion, Laboratory test abnormal, Leukopenia, Pyrexia
Clinical narrative: -complex febrile seizure x2 of 20-30 minute duration with temp of 103 degrees F - leukopenia  - fine pink papular dermatosis consistent with measles. Treatments; Ceftriaxone 500 mg IM x1 ibuprofen 100 mg po q6h x3, and APAP 100 mg po q4h x10 doses. Fever and seizures resolved and wbc improved on day of discharge.  Nurse follow up on 08/02/04 states: "Complete."
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Rash morbilliform
Clinical narrative: -complex febrile seizure x2 of 20-30 minute duration with temp of 103 degrees F - leukopenia  - fine pink papular dermatosis consistent with measles. Treatments; Ceftriaxone 500 mg IM x1 ibuprofen 100 mg po q6h x3, and APAP 100 mg po q4h x10 doses. Fever and seizures resolved and wbc improved on day of discharge.  Nurse follow up on 08/02/04 states: "Complete."
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Hyperhidrosis, Pallor, Speech disorder, Syncope
Clinical narrative: 7/27/04 @ 12:50 pm, patient was given MMR vaccine SQ x 1 in her left arm. Approximately, 3 to 4 minutes later, she complained of feeling lightheaded and began to faint.  She was pale and diaphoretic but never lost consciousness.  She was unable to talk for about 1 minute.  She maintained respirations and a pulse: VS HR=76-78, BP=110/70, O2 Sat=98%RA at 12:55pm / HR=96-110, BP=110/62, O2Sat=98%RA at 12:59pm. EMS was called. By the time of their arrival at approx. 1:00pm, she was alert and oriented and able to walk to the gurney without incident.
Age: 1.1
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Diabetes mellitus, Ketoacidosis
Clinical narrative: Development of diabetic ketoacidosis and type I diabetes mellitus.  Nurse follow up on 07/29/04 states: "No new information."
Age: 0.0
Sex: M
Vaccine: SMALL
Symptoms: Eye disorder
Clinical narrative: pt developed a pustule on inner lower eyelid OS about 7 days after receiving the vaccine; pt was cultured and started on viroptic drops.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Abnormal behaviour, Blood pressure increased, Dysphonia, Heart rate increased, Pain
Clinical narrative: 15 minutes after immunizations, patient complained of scratchy/ funny feeling in throat (patient had skittles for the first time right before shots). PE NL BPs/ Pulse ox. No wheezes or hives. Given epi/ Benadryl . Sent to ER for observation.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Pallor, Rhinorrhoea, Salivary hypersecretion, Throat tightness
Clinical narrative: 15 minutes after immunizations, patient complained of scratchy/ funny feeling in throat (patient had skittles for the first time right before shots). PE NL BPs/ Pulse ox. No wheezes or hives. Given epi/ Benadryl . Sent to ER for observation.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Dry throat, Sensory disturbance
Clinical narrative: 15 minutes after immunizations, patient complained of scratchy/ funny feeling in throat (patient had skittles for the first time right before shots). PE NL BPs/ Pulse ox. No wheezes or hives. Given epi/ Benadryl . Sent to ER for observation.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Dizziness, Eye pain, Fatigue, Headache
Clinical narrative: This case was reported by a nurse and described the occurrence of vision disturbance in a 20 year old female patient who received hepatitis B vaccine recombinant. The patient's medical history was notable for visual disturbance and fatigue following administration of Vicoden, and myopia corrected with glasses. On 6/24/04, the patient received the first dose of Engerix-B (lot ENG5540A2). On the same day, the patient received a Tuberculin skin test. At an unspecified time following the administration of Engerix-B, on 6/24/04, the patient experienced reduced visual acuity, vision disturbances characterized as haziness and  feeling of pressure in both eyes, fatigue, headache, and dizziness. The patient sought medical attention, however, no lab tests or vision tests were performed. The events resolved on 6/25/04. Comment: Reduced visual acuity was assessed as medically serious (OMIC).
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Visual acuity reduced, Visual disturbance
Clinical narrative: This case was reported by a nurse and described the occurrence of vision disturbance in a 20 year old female patient who received hepatitis B vaccine recombinant. The patient's medical history was notable for visual disturbance and fatigue following administration of Vicoden, and myopia corrected with glasses. On 6/24/04, the patient received the first dose of Engerix-B (lot ENG5540A2). On the same day, the patient received a Tuberculin skin test. At an unspecified time following the administration of Engerix-B, on 6/24/04, the patient experienced reduced visual acuity, vision disturbances characterized as haziness and  feeling of pressure in both eyes, fatigue, headache, and dizziness. The patient sought medical attention, however, no lab tests or vision tests were performed. The events resolved on 6/25/04. Comment: Reduced visual acuity was assessed as medically serious (OMIC).
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site induration, Swelling
Clinical narrative: Information has been received from a healthcare professional concerning a 66 year old white male with high cholesterol, high blood pressure, and allergies to metroprolol tartrate, Indapamide, Caroxlyn, enalapril maleate, potassium bicarbonate(+)potassium citrate, guanfacine HCl, and nifedipine who on 6/2/04 was vaccinated SC in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 647657/0947N). Concomitant therapy included atenolol, aspirin, valsartan, simvastatin, and finasteride. The healthcare professional reported that on 6/2/04, the patient developed a swollen arm which was hard to the touch. There was swelling and redness of arm 33cm around. On 6/4/04, unspecified medical attention was sought and the patient was given an unspecified medication to treat his arm. The patient subsequently recovered. The reporter felt that the patient's swelling and redness of the arm were other important medical events (OMIC). No additional information is expected.
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a female consumer concerning her adult son with ventricular septal defect who in 1964 was vaccinated with MMR. Subsequently, the patient developed an adverse reaction and reportedly almost lost his life. No product quality complaint involved. The reporter considered adverse reaction to be immediately life-threatening. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal behaviour, Apraxia, Crying, Eye movement disorder, Infantile spasms
Clinical narrative: This is an initial consultation for this eight month old child who was referred by an occupational therapist because of her concern over abnormality in development. Recently she performed a development assessment on this child and felt that his overall development was at an approximate two month level.  The mother notes that the infant never had very good eye contact, but the parents were following development closely, and the baby seemed to do everything on time. This included a reciprocal social smile, cooing and holding his head up well. The parents date difficulties to around the time of his four month DTP vaccination. After that, the baby stopped smiling and seemed to be increasingly irritable. In fact, the irritability seemed to be fairly characteristic, with the child throwing his head forward and then crying. He had significant spitting up, and these symptoms were attributed to reflux. He was placed initially on Zantac, and subsequently on Prevacid. At this time, he is taking Prevacid 15mg capsule daily and Zantac 1ml twice daily. Despite this, the mother feels that he still remains irritable and does not smile spontaneously as he used to. His development has not only stagnated but he has lost skills that he seemed to have in the past. The mother notes that almost every morning he will have several of these episodes with the head flexing forward followed by crying, typically in clusters of five to six episodes. Sometimes his body will seem briefly rigid. He also has episodes of the eyes fluttering up and down, also associated with these episodes. The spitting up remains quite constant and does not particularly seem associated with the irritability. There was a recent opthalmogic evaluation by the doctor and the ocular mechanism was felt to be normal. The doctor noted that the infant would track objects at a distance but not close objects.   Nurse follow up on 07/28/04 states: "Infantile spasms."
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Muscle rigidity, Vomiting
Clinical narrative: This is an initial consultation for this eight month old child who was referred by an occupational therapist because of her concern over abnormality in development. Recently she performed a development assessment on this child and felt that his overall development was at an approximate two month level.  The mother notes that the infant never had very good eye contact, but the parents were following development closely, and the baby seemed to do everything on time. This included a reciprocal social smile, cooing and holding his head up well. The parents date difficulties to around the time of his four month DTP vaccination. After that, the baby stopped smiling and seemed to be increasingly irritable. In fact, the irritability seemed to be fairly characteristic, with the child throwing his head forward and then crying. He had significant spitting up, and these symptoms were attributed to reflux. He was placed initially on Zantac, and subsequently on Prevacid. At this time, he is taking Prevacid 15mg capsule daily and Zantac 1ml twice daily. Despite this, the mother feels that he still remains irritable and does not smile spontaneously as he used to. His development has not only stagnated but he has lost skills that he seemed to have in the past. The mother notes that almost every morning he will have several of these episodes with the head flexing forward followed by crying, typically in clusters of five to six episodes. Sometimes his body will seem briefly rigid. He also has episodes of the eyes fluttering up and down, also associated with these episodes. The spitting up remains quite constant and does not particularly seem associated with the irritability. There was a recent opthalmogic evaluation by the doctor and the ocular mechanism was felt to be normal. The doctor noted that the infant would track objects at a distance but not close objects.   Nurse follow up on 07/28/04 states: "Infantile spasms."
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Abscess, Similar reaction on previous exposure to drug
Clinical narrative: Patient developed bilateral abscesses one in each Quadricep, requiring incision/ drainage and IV antibiotics: approximately 3 weeks after administration. Also long standing nodule left thigh from vaccine at 2 months of age.
Age: 0.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Coma, Hypotonia, Pallor
Clinical narrative: Pallor, unresponsive, hypotonic for 5-10 minutes. Occurred 2 minutes after injections. Follow up: note child did not die.  Nurse follow up on 08/19/04 states: "Vasovagal reflex."
Age: 1.25
Sex: F
Vaccine: DTAP, MMR
Symptoms: Febrile convulsion, Hypoxia, Respiratory depression
Clinical narrative: Seizure less than 1 hour long with fever. Needed intubation for respiratory depression after numerous doses of anticonvulsants. Transported via helicopter from out of state to local hospital.  Nurse follow up on 09/03/04 states: "Complete."
Age: 37.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Blister, Post vaccination autoinoculation, Skin ulcer
Clinical narrative: Post-vaccination autoinoculation. On 7/5 presented to medical center with 2 vesicular pustular lesions on neck, right shoulder and a few on chest. No fever, no general malaise, good appetite, pleasant affect. Developed a possible lesion on left eye when seen by optometrist. No corneal damage, no vision problems. Treated with Verioptic for 9 days.  Nurse follow up on 08/02/04 states: "Complete."  Nurse follow up on 08/03/04 states: "vaccinia, vaccinia ocular."
Age: 0.32
Sex: M
Vaccine: DTP, HBHEPB, IPV
Symptoms: Agitation, Chills, Crying, Eye movement disorder, Pyrexia
Clinical narrative: Approximately 3-4 hours after receiving DPT vaccine, my son started crying unconsolably. He ran a slight fever, couldn't be comforted, and every so often would shiver/begin to shake. He was seen to have his eyes roll back and his mouth quiver. If I shook him lightly he seemed to stop. Called doctor; told was nothing; now suffers from speech delays and processing problems. Will enter regular education, but received special education assistance.  Nurse follow up on 08/19/04 states: "No new information." Per follow up report-Patient continues to demonstrate difficulties in speech and language, processing, and academic development. He will begin kindergarten this year, but I suspect he will have a difficult time keeping up with the curriculum.
Age: 0.32
Sex: M
Vaccine: DTP, HBHEPB, IPV
Symptoms: Speech disorder
Clinical narrative: Approximately 3-4 hours after receiving DPT vaccine, my son started crying unconsolably. He ran a slight fever, couldn't be comforted, and every so often would shiver/begin to shake. He was seen to have his eyes roll back and his mouth quiver. If I shook him lightly he seemed to stop. Called doctor; told was nothing; now suffers from speech delays and processing problems. Will enter regular education, but received special education assistance.  Nurse follow up on 08/19/04 states: "No new information." Per follow up report-Patient continues to demonstrate difficulties in speech and language, processing, and academic development. He will begin kindergarten this year, but I suspect he will have a difficult time keeping up with the curriculum.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Eye movement disorder, High-pitched crying, Muscle twitching, Pallor, Pyrexia
Clinical narrative: Approximately 3 days after DTaP, patient had a 2 hour, high-pitched crying episode. In middle of episode about 1 minute episode of shaking/twitching of whole body. Eyes rolled back, turned pale. Temperature 100. Went to ER but not evaluated. Normal exam 9 days later by myself.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Tremor
Clinical narrative: Approximately 3 days after DTaP, patient had a 2 hour, high-pitched crying episode. In middle of episode about 1 minute episode of shaking/twitching of whole body. Eyes rolled back, turned pale. Temperature 100. Went to ER but not evaluated. Normal exam 9 days later by myself.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Crying, Lethargy, Pyrexia, Tremor
Clinical narrative: Patient with prolonged crying (8 hours), shaking legs, lethargy for 48 hours, Fever less than 102 for 48 hours. On Tylenol and Motrin.
Age: 0.61
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Apnoea, Blood test, Convulsion, Developmental delay, Electroencephalogram abnormal
Clinical narrative: Seizure disorder with initial seizure episode 6 days after administration of 4 month immunizations. Evolved into infantile spasmhildrens and subsequently hemi-myoclonic tonic seizures. Patient received IM ACTH therapy for 8 weeks and is currently on Tegretol and Keppra for seizure control. Nurse follow up on 07/29/04 states: "ALTE; capillary hemangiomas." Multiple records are rec'd. from the reporting PMD's office. The initial ER visit on 2/4/04 refers to this event as possible seizure episode, ALTE. A second episode occured in the ER that date and child was transferred to a higher level of care facility for a 2-day admission. The neuro eval in house, suggested epilepsy, idiopathic complex partial seizures. At that time, 5 capillary hemangiomas were observed and child was also found to have a mild RSV infection. The ER record refers to a 3-day history of nasal congestion for this child and her sibs just prior to this AE. She was treated w/ Pediacare at home. On 2/8/04 child returned to the ER due to 2 similar episodes. She was apparently being treated for BOM at the time and was given Sudafed at home. There was no temp elevation in the ER. She was again transferred to the hospital, treated w/ anti seizure meds and ACTH. The initial MRI and EEG did not suggest the diagnosis of infantile spasm. An inpt record for a 6/30/04 admission notes presence of hemi-myoclonic-tonic type seizures w/ a (R) sided focal onset felt to be consistent w/ DGX of idiopathic mixed seizure disorder. The discharge notes for the 2/5-2/6/04 admission refer to findings of (+) RSV results, bronchiolitis and seizure disorder aggravated by viral etiology. The discharge note for 2/9/04 notes a diagnosis of seizure and (+) RSV.  Per the follow up report-developmental delay-mild. Still on seizure medication but seizure free for about 1 year.