chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Cyanosis, Fall, Pallor, Posture abnormal, Staring
Clinical narrative: Fell to floor after getting vaccines. Pt was pale and staring straight ahead with 2 shakes of head. RN was able to arouse pt and handed pt to father. After about 1min child became unresponsive, pale with cyanotic lips again. Turned head to right with 2-3 slight shakes. Episode lasted 3-4 seconds. Able to arouse again. No incontinence. No post ictal behavoir. Oriented to father. Ambulance arrived and transported pt to hospital.  HR 84 RR 32
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Fell to floor after getting vaccines. Pt was pale and staring straight ahead with 2 shakes of head. RN was able to arouse pt and handed pt to father. After about 1min child became unresponsive, pale with cyanotic lips again. Turned head to right with 2-3 slight shakes. Episode lasted 3-4 seconds. Able to arouse again. No incontinence. No post ictal behavoir. Oriented to father. Ambulance arrived and transported pt to hospital.  HR 84 RR 32
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pruritus
Clinical narrative: L Deltoid muscle was extremely painful, pain also felt in L side of neck on day of administration.     Approx 36 hours later, L deltoid reddened, somewhat swollen, in an area about 5x8 inches, and extending into armpit.   Some itching, not severe.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Computerised tomogram normal, Full blood count
Clinical narrative: Seizure activity 3-4 hrs after receiving vaccine on 5/5/09, seen in ER - Head CT and CBC WNL, admitted to Hosp. Plans for o/c 5/7/09 - Temp in ER 100.2  5/14/09 MR received for ER visit 5/5-6/2009 with DX:  Febrile seizure s/p vaccination. Pt presented after 2 episodes of tonic-clonic jerking lasting ~5 minutes with foaming at the mouth initially, the 2nd lasting 1-2 minutes. Pt had been acting funny since immunizations.  T=102'F in ER where pt had a 3rd seizure. Post-ictal after. No further seizures. D/C for outpt f/u. Additional ICD9 codes: 780.31 Febrile convulsions.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Brain natriuretic peptide, Catheterisation cardiac, Chest pain, Computerised tomogram, Haemoptysis
Clinical narrative: Coughing up blood, chest pain, and acute onset. Complete heart failure. Two thrombi also noted in left ventricle. Pt has defibrillator now on Chronic meds.  5/26/09 Hospital records received DOS 1/12/09 to 1/22/09. FINAL DIAGNOSIS: Cardiomyopathy, Ventricular Thrombosis. Post vaccination presented with DOE, SOB, PND, productive cough, hemoptysis, CHF.  6/2/09 Hospital inpatient records received DOS 1/11/09 1/21/09. FINAL DIAGNOSIS: Non-ischemic dilated cardiomyopathy, left apical thrombosis. Post vaccination presented with DOE, SOB, Orthopnia, PND, productive cough, later hemoptysis. JVP elevated. Left sided chest pain. Patient in congestive heart failure. Crackles noted lung fields. Rhonchi and egophony. Expiratory wheeze. Pitting extremities.  ICD-9 Codes: 4280 CHF unspecified, *486 Pneumonia organism unspecified, 4254 Primary cardiomyopathies, 7904 Nonspecific elevation of levels of transaminase/LDH, 7931 Nonspecific abnormal findings on radiological/other examination of lung field, 4168 Chronic pulmonary heart disease, 3051 Tobacco use disorder, 42989 Ill-defined heart disease, 38910 Sensorineural heart disease, V6222 Personal history of return from military deployment, V705 6 Health examination of defined subpopulations.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Intracardiac thrombus
Clinical narrative: Coughing up blood, chest pain, and acute onset. Complete heart failure. Two thrombi also noted in left ventricle. Pt has defibrillator now on Chronic meds.  5/26/09 Hospital records received DOS 1/12/09 to 1/22/09. FINAL DIAGNOSIS: Cardiomyopathy, Ventricular Thrombosis. Post vaccination presented with DOE, SOB, PND, productive cough, hemoptysis, CHF.  6/2/09 Hospital inpatient records received DOS 1/11/09 1/21/09. FINAL DIAGNOSIS: Non-ischemic dilated cardiomyopathy, left apical thrombosis. Post vaccination presented with DOE, SOB, Orthopnia, PND, productive cough, later hemoptysis. JVP elevated. Left sided chest pain. Patient in congestive heart failure. Crackles noted lung fields. Rhonchi and egophony. Expiratory wheeze. Pitting extremities.  ICD-9 Codes: 4280 CHF unspecified, *486 Pneumonia organism unspecified, 4254 Primary cardiomyopathies, 7904 Nonspecific elevation of levels of transaminase/LDH, 7931 Nonspecific abnormal findings on radiological/other examination of lung field, 4168 Chronic pulmonary heart disease, 3051 Tobacco use disorder, 42989 Ill-defined heart disease, 38910 Sensorineural heart disease, V6222 Personal history of return from military deployment, V705 6 Health examination of defined subpopulations.
Age: 0.45
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Blood test, Chest X-ray, Computerised tomogram abnormal, Diarrhoea, Pyrexia
Clinical narrative: Seizure - 11 AM 4/28/09 - taken by ambulance to E.R. In-patient 2/28/09 - 4/29/09 - high fever. 4-30-09 - Back to Dr. office, severe diarrhea.  5/18/09 Hospital records received DOS 4/28/09 to 4/29/09. FINAL DIAGNOSIS: Febrile seizure, questionable left perihilar infiltrate on x-ray Post vaccination: febrile seizure, fever, cough, congestion of nose, loose stools, erthema of injection site on thigh. Skin hot pink dry. Fussy ICD-9: 780.31 Febrile Convulsions (Simple), Unspecified
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Rash
Clinical narrative: Symptoms: 1. Rash 2. local swelling.  Suspect Drug #1 Dosing:  one time vaccine dose.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Computerised tomogram abnormal, Convulsion, Febrile convulsion, Grand mal convulsion
Clinical narrative: Pt was adopted at about 7 m/o from a foreign country. Her shot records weren't available to us. With consultation, the recommendations was to immune the child assuming none was previous given. Family actually initiated the consultation on their own and was in agreement with the immunizations as recommended by the AAP/CDC. Other than mild motor delay, she was thriving. On 14 day her 1st y/o WCC, she was behind on immunization and she rec'd 6 shots as listed. In early AM of 10/2, she preceded to have seizure. Her sz episode was GTC in nature and estimated to be between 10-15 min. Over the next 24 hrs, she had recurrent sz. Temp of 103 was documented by EMT at the scene (at home). She was initiated stabilized at a local community hospital where a LP was performed, as was head CT. She was then transferred to another hospital, where she was evaluated by Peds Neuro who dx her w/ complex febrile sz. She had had regular outpt f/u's w/ Peds Neuro and no AED was recommended. Pt clinically continues to do very well. Adoptive parents subsequently brought in immunization record which revealed that she had rec'd the following back at home (Please see copy submitted by adoptive mom). Family requested that a report be filed via VAERS.  5/7/09-records submitted with VAERS report. 2/3/09-seen in office for follow-up visit for seizures associated with fever. Complex febrile seizure. URI with elevated temperature. First seizure generalized tonic-clinic in nature with temperature 103, followed by another seizure.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Redness and swelling at injection site/entire upper arm; Left swelling 2-3 times normal size of arm.  Fever, vomiting
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Cellulitis L thigh - fever 101.7 given Rx Keflex 5/1/09. Seen in office 5/7/09 - given Rx for Omnicef. Flu office visit in 1 week.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abasia, Balance disorder, Catecholamines urine normal, Creatinine urine, Dehydration
Clinical narrative: 3/10/09 - AM shaking arm when reaching, falling over after waking in am by 3/16/09 condition in am + pm - falling over, trouble balancing 3/19 - not able to walk w/out holding our hand sensitive to height change 3/22/09 - Vomiting 1 X daily until 3/27 then sick all day 3/29/09- ER visit for vomiting & dehydration - received 20 fran As of 4/25/09 sick on and off and cannot walk normally/balance issues - lazy speech
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Fall, Gait disturbance, Malaise, Nuclear magnetic resonance imaging brain normal, Speech disorder
Clinical narrative: 3/10/09 - AM shaking arm when reaching, falling over after waking in am by 3/16/09 condition in am + pm - falling over, trouble balancing 3/19 - not able to walk w/out holding our hand sensitive to height change 3/22/09 - Vomiting 1 X daily until 3/27 then sick all day 3/29/09- ER visit for vomiting & dehydration - received 20 fran As of 4/25/09 sick on and off and cannot walk normally/balance issues - lazy speech
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Tremor, Vomiting
Clinical narrative: 3/10/09 - AM shaking arm when reaching, falling over after waking in am by 3/16/09 condition in am + pm - falling over, trouble balancing 3/19 - not able to walk w/out holding our hand sensitive to height change 3/22/09 - Vomiting 1 X daily until 3/27 then sick all day 3/29/09- ER visit for vomiting & dehydration - received 20 fran As of 4/25/09 sick on and off and cannot walk normally/balance issues - lazy speech
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Reddness & swelling noted at injection site
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Erythema, Oedema peripheral, Pyrexia, Rash
Clinical narrative: Fever 103 degrees. Diarrhea. Vomiting. Rash / red / swollen right arm. Antibiotics by PCP.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Fever 103 degrees. Diarrhea. Vomiting. Rash / red / swollen right arm. Antibiotics by PCP.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash papular
Clinical narrative: Papulo-vesicular rash over torso / proximal extremities and fever present x 2 days.
Age: 19.0
Sex: F
Vaccine: HEP, HPV4, HPV4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: April 29, 09 - Injection given R shoulder. Client describes pain in R shoulder joint, trouble lifting arm. Pain was immediate after shot then next day, went away 2 days, pain back, not as bad.
Age: 19.0
Sex: F
Vaccine: HEP, HPV4, HPV4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: April 29, 09 - Injection given R shoulder. Client describes pain in R shoulder joint, trouble lifting arm. Pain was immediate after shot then next day, went away 2 days, pain back, not as bad.
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Convulsion, Respiratory arrest
Clinical narrative: PE had a seizure like episode and stopped breathing per mom. Pt was admitted to hospital for observation.
Age: 1.01
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site discharge, Injection site erythema, Injection site mass, Skin lesion
Clinical narrative: Given 12 mo vaccines on 4/24/09.  Initially had a knot (no reddness or drainage) at site of PCV + VZV shots.  She now has some redness of skin with serosanguinous drainage & lesion leg.  Meds prescribed:  Clindamycin plamitate 75mg/5m/granules Hydroxyzine HCL 10mg/5m/syrup.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: 6 cm x 7 cm area of erythema with slight induration, minimally tender.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warmth erythema at injection site.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Clinical narrative: Difficult to distinguish at present if 10cm X 10cm erythematous non-tender induration is early cellulitis vs immune response vs sensitivity.
Age: 17.0
Sex: F
Vaccine: FLU3, IPV, TYP, YF
Symptoms: Chest discomfort, Crying, Nausea
Clinical narrative: Pt had vaccines (shots) for flu, polio, & yellow fever- She also started oral typhoid vaccine on 5/05/09.  She awoke 5/06/09 @ 6am with nausea by 9am was crying & shaking & felt "tight" in chest.  Returned home- We advised mom to take her to her doctor's office, Dr advised D/C oral typhoid.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Erythema, Rash papular
Clinical narrative: Erythematous papules to face & neck with possible angioedema & urticaria as per parent description.  Seen at local hospital.  Reaction 6 hours post vaccines.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Tenderness
Clinical narrative: Received vaccination in left arm on April 14, 2009. On April 16th, noted tenderness on left hip which spread to groin. Pain continued and days later a rash developed. It was determined that I had developed shingles!! Still in pain.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Several areas other various locations of diamond shape rash. C/o itching 0 SOB or other signs of distress.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope after vaccination given, patient passed out, lost consciousness for about 3 seconds, then spontaneously woke up. Patient was given water to drink and instructed to stay seated for several minutes before leaving with mother. - Mother was called into room immediately.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, and warmth.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Ultrasound scan normal
Clinical narrative: Left thigh - No initial local reaction until 4 day post injection, 0 fever 0 change in appetite, sleep or play.  9 days post injection site increased size, warm and increased reddened area.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm were ZOSTAVAX was given got warm, swollen & sore.  It was the size of a half dollar
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Head discomfort, Headache
Clinical narrative: Sever headache and feeling of inside of scull on fire - lasted 3 hr and lifted. Went to ER.
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Cold sweat, Dizziness, Feeling hot, Nausea, Skin warm
Clinical narrative: Appx 0930 - vaccination administered 0933 - pt. stated "light - headed, clammy, body feels tense, "really hot" BP = 120/80 P = 76 RR = 20 0945 - "increased Hot Feeling" ---> VSS, no apparent resp. difficulty nor distress --> 0956 Notified Dr --> 1005 - employer reported "increased lightheadness & nausea BP = 132/86 P = 76 m, increased body heat, less tense feel like jello - I feel like I could slide off the chair.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Tension
Clinical narrative: Appx 0930 - vaccination administered 0933 - pt. stated "light - headed, clammy, body feels tense, "really hot" BP = 120/80 P = 76 RR = 20 0945 - "increased Hot Feeling" ---> VSS, no apparent resp. difficulty nor distress --> 0956 Notified Dr --> 1005 - employer reported "increased lightheadness & nausea BP = 132/86 P = 76 m, increased body heat, less tense feel like jello - I feel like I could slide off the chair.
Age: 81.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Flushing, Headache, Injection site erythema, Injection site mass
Clinical narrative: Patient felt a lump on left arm after administration of vaccine, and evaluated 5/1/09. Returned 5/5/09 with redness/ warmth at injection site and complaints of headache, diarrhea, face flushing, exacerbated blood pressure. Pt started on Keflex 500mg 45x 1day x 10 days. )(184/100).
Age: 81.0
Sex: F
Vaccine: TD
Symptoms: Injection site warmth
Clinical narrative: Patient felt a lump on left arm after administration of vaccine, and evaluated 5/1/09. Returned 5/5/09 with redness/ warmth at injection site and complaints of headache, diarrhea, face flushing, exacerbated blood pressure. Pt started on Keflex 500mg 45x 1day x 10 days. )(184/100).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). There were no concurrent medications. There was no relevant medical history and the subject had not experienced any adverse events following previous vaccinations. There were no concurrent medications. On 3 April 2009 the subject received 1st dose of KINRIX (0.5 ml, unknown, left arm). On 3 April 2009, less than one day after vaccination with KINRIX, the subject experienced injection site redness and localized reaction. On 04 April 2009, she experienced arm redness from shoulder to elbow and pain at site when pressed. The mother of the subject, who was a pharmacist, reported to the pediatric office that her daughter experienced a localized reaction to KINRIX, which was administered on 03 April 2009. The subject began to experience redness at the injection site, which was noted on the evening of 03 April 2009. On 04 April 2009, the mother noted the redness on the deltoid area spread to just above the elbow. There was also pain associated with the site when pressed. The events remained unchanged on 05 April 2009. On 06 April 2009, the mother of the subject called the pediatric office to report that her daughter's symptoms had improved. There was less swelling and redness. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL and TYLENOL. At the time of reporting the events were improved. The healthcare professional considered the events were probably related to vaccination with KINRIX. Follow-up received from healthcare professional on 04 May 2009: Concurrent medical conditions included left otitis media, which was considered no likely associated with the reported events. The healthcare professional considered it "possible but unlikely" that the events could have been associated with suspected transmission of an infectious agent via a medicinal product, and that the events were not associated with erroneous administration. On 08 April 2009 the events were resolved. The healthcare professional considered the events were related to vaccination with KINRIX. The healthcare professional had reported this case to the Regulatory Authority (reference number 343649).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Local reaction, Swelling, Transmission of an infectious agent via a medicinal product
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). There were no concurrent medications. There was no relevant medical history and the subject had not experienced any adverse events following previous vaccinations. There were no concurrent medications. On 3 April 2009 the subject received 1st dose of KINRIX (0.5 ml, unknown, left arm). On 3 April 2009, less than one day after vaccination with KINRIX, the subject experienced injection site redness and localized reaction. On 04 April 2009, she experienced arm redness from shoulder to elbow and pain at site when pressed. The mother of the subject, who was a pharmacist, reported to the pediatric office that her daughter experienced a localized reaction to KINRIX, which was administered on 03 April 2009. The subject began to experience redness at the injection site, which was noted on the evening of 03 April 2009. On 04 April 2009, the mother noted the redness on the deltoid area spread to just above the elbow. There was also pain associated with the site when pressed. The events remained unchanged on 05 April 2009. On 06 April 2009, the mother of the subject called the pediatric office to report that her daughter's symptoms had improved. There was less swelling and redness. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL and TYLENOL. At the time of reporting the events were improved. The healthcare professional considered the events were probably related to vaccination with KINRIX. Follow-up received from healthcare professional on 04 May 2009: Concurrent medical conditions included left otitis media, which was considered no likely associated with the reported events. The healthcare professional considered it "possible but unlikely" that the events could have been associated with suspected transmission of an infectious agent via a medicinal product, and that the events were not associated with erroneous administration. On 08 April 2009 the events were resolved. The healthcare professional considered the events were related to vaccination with KINRIX. The healthcare professional had reported this case to the Regulatory Authority (reference number 343649).
Age: 12.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Dizziness
Clinical narrative: A 12-year-old female patient, who has no known allergies, no concurrent illnesses or pre-existing medical conditions, had received on 17 April 2009 in the afternoon a right arm dose of MENACTRA (lot number U2730AA).  Since receiving the vaccine on 17 April 2009, the patient had been experiencing dizziness off and on, but could still play on the weekends.  "Negative work up and negative for shingles?"  (Not legible).  Per the reporter, the patient had not been evaluated by a physician, and no relevant diagnostic tests/laboratory data were performed.  The recovery status of the patient was unknown at the time of this report.  Documents held by sender:  None
Age: 12.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Dizziness, Laboratory test normal
Clinical narrative: A 12-year-old female patient, who has no known allergies, no concurrent illnesses or pre-existing medical conditions, had received on 17 April 2009 in the afternoon a right arm dose of MENACTRA (lot number U2730AA).  Since receiving the vaccine on 17 April 2009, the patient had been experiencing dizziness off and on, but could still play on the weekends.  "Negative work up and negative for shingles?"  (Not legible).  Per the reporter, the patient had not been evaluated by a physician, and no relevant diagnostic tests/laboratory data were performed.  The recovery status of the patient was unknown at the time of this report.  Documents held by sender:  None
Age: 12.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Dizziness, Headache
Clinical narrative: A 12-year-old female patient, who has no known allergies, no concurrent illnesses or pre-existing medical conditions, had received on 17 April 2009 in the afternoon a right arm dose of MENACTRA (lot number U2730AA).  Since receiving the vaccine on 17 April 2009, the patient had been experiencing dizziness off and on, but could still play on the weekends.  "Negative work up and negative for shingles?"  (Not legible).  Per the reporter, the patient had not been evaluated by a physician, and no relevant diagnostic tests/laboratory data were performed.  The recovery status of the patient was unknown at the time of this report.  Documents held by sender:  None
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Dizziness, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: This non serious case was received on 17 April 2009 from a health care professional. A 13 year old male patient received MENACTRA (lot number U2823AA) on 09 April 2009 at 13:00. Around 20:00 or about 8 hours later, the patient developed swelling and pain at the injection site > 5 cm. 12-18 hours post vaccination the patient developed dizziness, nausea, and headache which lasted about 24 hours. The swelling and pain lasted for four days. The patient recovered from the events. List of Documents held by Sender: none.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: This non serious case was received on 17 April 2009 from a health care professional. A 13 year old male patient received MENACTRA (lot number U2823AA) on 09 April 2009 at 13:00. Around 20:00 or about 8 hours later, the patient developed swelling and pain at the injection site > 5 cm. 12-18 hours post vaccination the patient developed dizziness, nausea, and headache which lasted about 24 hours. The swelling and pain lasted for four days. The patient recovered from the events. List of Documents held by Sender: none.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood culture
Clinical narrative: On April 11 patient developed fever, nausea and vomiting and a headache. She took Tylenol and saw her PCP on 13 April and was treated with antibiotic. On 14 April she went to the emergency room due to vomiting and fever. Tests were performed and she was released. She returned the same evening to the hospital due to severity of headache and was admitted to the hospital for 2 days. She was seen by by an Infectious Diseases specialist on 21 April. At that time she was afebrile and recovering, but experiencing significant fatigue and malaise. The Infectious Disease specialist concluded that she had an adverse reaction to yellow fever vaccination. That she had both neurotropic (aseptic meningitis) and viscerotropic (elevated Transaminases) and appeared to be recovering. She was advised not to receive any further yellow fever vaccination.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: C-reactive protein increased, Chest X-ray normal, Chills, Cough, Culture urine negative
Clinical narrative: On April 11 patient developed fever, nausea and vomiting and a headache. She took Tylenol and saw her PCP on 13 April and was treated with antibiotic. On 14 April she went to the emergency room due to vomiting and fever. Tests were performed and she was released. She returned the same evening to the hospital due to severity of headache and was admitted to the hospital for 2 days. She was seen by by an Infectious Diseases specialist on 21 April. At that time she was afebrile and recovering, but experiencing significant fatigue and malaise. The Infectious Disease specialist concluded that she had an adverse reaction to yellow fever vaccination. That she had both neurotropic (aseptic meningitis) and viscerotropic (elevated Transaminases) and appeared to be recovering. She was advised not to receive any further yellow fever vaccination.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: Facial pain, Headache, Hyperhidrosis, Lumbar puncture, Lymphocyte percentage decreased
Clinical narrative: On April 11 patient developed fever, nausea and vomiting and a headache. She took Tylenol and saw her PCP on 13 April and was treated with antibiotic. On 14 April she went to the emergency room due to vomiting and fever. Tests were performed and she was released. She returned the same evening to the hospital due to severity of headache and was admitted to the hospital for 2 days. She was seen by by an Infectious Diseases specialist on 21 April. At that time she was afebrile and recovering, but experiencing significant fatigue and malaise. The Infectious Disease specialist concluded that she had an adverse reaction to yellow fever vaccination. That she had both neurotropic (aseptic meningitis) and viscerotropic (elevated Transaminases) and appeared to be recovering. She was advised not to receive any further yellow fever vaccination.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: Malaise, Nausea, Neck pain, Neutrophil count, Neutrophil percentage increased
Clinical narrative: On April 11 patient developed fever, nausea and vomiting and a headache. She took Tylenol and saw her PCP on 13 April and was treated with antibiotic. On 14 April she went to the emergency room due to vomiting and fever. Tests were performed and she was released. She returned the same evening to the hospital due to severity of headache and was admitted to the hospital for 2 days. She was seen by by an Infectious Diseases specialist on 21 April. At that time she was afebrile and recovering, but experiencing significant fatigue and malaise. The Infectious Disease specialist concluded that she had an adverse reaction to yellow fever vaccination. That she had both neurotropic (aseptic meningitis) and viscerotropic (elevated Transaminases) and appeared to be recovering. She was advised not to receive any further yellow fever vaccination.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Respiratory tract congestion, Transaminases increased, Urine analysis
Clinical narrative: On April 11 patient developed fever, nausea and vomiting and a headache. She took Tylenol and saw her PCP on 13 April and was treated with antibiotic. On 14 April she went to the emergency room due to vomiting and fever. Tests were performed and she was released. She returned the same evening to the hospital due to severity of headache and was admitted to the hospital for 2 days. She was seen by by an Infectious Diseases specialist on 21 April. At that time she was afebrile and recovering, but experiencing significant fatigue and malaise. The Infectious Disease specialist concluded that she had an adverse reaction to yellow fever vaccination. That she had both neurotropic (aseptic meningitis) and viscerotropic (elevated Transaminases) and appeared to be recovering. She was advised not to receive any further yellow fever vaccination.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: Viral infection, White blood cell count decreased
Clinical narrative: On April 11 patient developed fever, nausea and vomiting and a headache. She took Tylenol and saw her PCP on 13 April and was treated with antibiotic. On 14 April she went to the emergency room due to vomiting and fever. Tests were performed and she was released. She returned the same evening to the hospital due to severity of headache and was admitted to the hospital for 2 days. She was seen by by an Infectious Diseases specialist on 21 April. At that time she was afebrile and recovering, but experiencing significant fatigue and malaise. The Infectious Disease specialist concluded that she had an adverse reaction to yellow fever vaccination. That she had both neurotropic (aseptic meningitis) and viscerotropic (elevated Transaminases) and appeared to be recovering. She was advised not to receive any further yellow fever vaccination.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: Fatigue, Headache, Lumbar puncture, Malaise, Meningitis aseptic
Clinical narrative: On April 11 patient developed fever, nausea and vomiting and a headache. She took Tylenol and saw her PCP on 13 April and was treated with antibiotic. On 14 April she went to the emergency room due to vomiting and fever. Tests were performed and she was released. She returned the same evening to the hospital due to severity of headache and was admitted to the hospital for 2 days. She was seen by by an Infectious Diseases specialist on 21 April. At that time she was afebrile and recovering, but experiencing significant fatigue and malaise. The Infectious Disease specialist concluded that she had an adverse reaction to yellow fever vaccination. That she had both neurotropic (aseptic meningitis) and viscerotropic (elevated Transaminases) and appeared to be recovering. She was advised not to receive any further yellow fever vaccination.
Age: 42.0
Sex: F
Vaccine: MEN, YF, YF
Symptoms: Nausea, Pyrexia, Transaminases increased, Vaccination complication, Vomiting
Clinical narrative: On April 11 patient developed fever, nausea and vomiting and a headache. She took Tylenol and saw her PCP on 13 April and was treated with antibiotic. On 14 April she went to the emergency room due to vomiting and fever. Tests were performed and she was released. She returned the same evening to the hospital due to severity of headache and was admitted to the hospital for 2 days. She was seen by by an Infectious Diseases specialist on 21 April. At that time she was afebrile and recovering, but experiencing significant fatigue and malaise. The Infectious Disease specialist concluded that she had an adverse reaction to yellow fever vaccination. That she had both neurotropic (aseptic meningitis) and viscerotropic (elevated Transaminases) and appeared to be recovering. She was advised not to receive any further yellow fever vaccination.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA, FLU3, HEPA
Symptoms: Vomiting
Clinical narrative: Within 12 hours of administration of vaccines, patient began vomiting every 30 minutes. The patient was transported to the ED.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Crohn's disease, Gastroenteritis viral, Laboratory test abnormal, X-ray with contrast lower gastrointestinal tract, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Information has been received from a 24 year old female with citric allergy who on an unspecified date was vaccinated with a single dose of MMR II . Consumer who is now 38 year old, reported that she received MMR II when she was young and then when she was 24 years old she went to the hospital for 2 days because of a stomach virus and while she was in the hospital she had some upper and lower gastrointestinal tests done and was diagnosed with Crohn's disease. At the time of reporting the patient had not recovered. This is one of several reports received from the same source. Additional information is not expected.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her brother who on an unspecified date was vaccinated with MMR II and then developed autism on an unknown date. It is unknown if the patient sought medical attention. Upon internal review, autism was determined to be an other important medical event. This is one of several reports received from the same source. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Musculoskeletal stiffness, Ocular hyperaemia, Pruritus
Clinical narrative: Information has been received from a 74 year old female registered nurse with no allergies and a history of hip replacement, 2 TIA (transient ischaemic attack) in 1989 and chickenpox as a child who on 18-JUN-2008 was vaccinated with ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included PLAVIX, LIPITOR, BENICAR, baby ASPIRIN, calcium (unspecified), cranberry pill twice a day and multivitamins (unspecified). On 24-APR-2009 the nurse thought she had a bug bite on the back of the neck that was itchy. This "bug bite" spread across the shoulders and down the right arm but not all the way. On 25-APR-2009 the nurse noticed her right eye was getting red so she used CLEAR EYES but it didn't get any better. On 04-MAY-2009 the nurse was diagnosed with shingles. The nurse reported that the area of "bug bite" was still burning and itching and her right eye was still red. The nurse sought medical attention by phone call and office visit. The nurse took 2 ALEVE and the physician prescribed "FAMCICLOVIR 50mg 3 times daily and generic ELAVIL 10mg for sleep". No lab diagnostic studies were performed. At the time of the report, on 04-MAY-2009, the nurse had not recovered from the shingles. The reporting nurse considered shingles to be disabling as her neck was very stiff. Additional information has been requested.
Sex: U
Vaccine: PNC
Symptoms: Autism
Clinical narrative: This case was considered medically important.  Information regarding PREVNAR was received from a consumer, the mother of a patient who experienced autism.  The patient received the fourth dose on an unspecified date.  Additional suspect medication included previous doses of PREVNAR.  On an unspecified date, the patient experienced autism.  The outcome was unknown.  The mother stated the child had received a total of 36 vaccines (dates and trade names not reported).  No additional information was available at the time of this report.
Sex: U
Vaccine: DTAP
Symptoms: Erythema
Clinical narrative: This case was received on 01 May 2009, via another manufacturer (document number 956545). The event occurred to a subject enrolled in a study. Subject identification number: 361540. A child received a DTaP vaccine (manufacturer and lot not reported), and experienced severe erythema during study week 24. The reporter assessed the event as definitely related to the vaccine. The subject also experienced another serious adverse event while enrolled in this study, which is captured in case number 2009-01942.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein normal, Caesarean section, Condition aggravated, Drug exposure during pregnancy, Gene mutation identification test negative
Clinical narrative: Initial report received from a health care professional on 15 August 2008. A 39 year old, female patient, with a medical history of no known allergies and gestational diabetes, received a 0.5 ml intramuscular, left deltoid injection of ADACEL, lot number C2936AA, on 31 July 2008. The patient was pregnant at the time of vaccination. Her last menstrual period was 05 July 2008 and her estimated date of delivery is 10 August 2009. She denied having any current medications. She has a history of 5 previous pregnancies, with a 5 full term deliveries and normal/viable pregnancy outcomes. It was reported a pregnancy test done on 14 August 2008 was positive. Per the reporter, there was no known adverse event. Follow-up received from a health care professional on 22 September 2008. The reporter amended the patient's estimated date of delivery from 10 August 2009 to 10 April 2009. No additional information was provided. Follow-up information was received from a health care professional on 04 May 2009; it was determined, based upon this new information, that the case should be upgraded to serious. On 23 January 2009 the patient, who had a history of gestational diabetes in previous pregnancies, underwent a three-hour glucose tolerance test which was positive for gestational diabetes. She was referred to "Sweet Success". The following prenatal testing was normal: Genetic screening (CG screen) on 03 September 2008, alpha fetoprotein on 30 October 2008, ultrasound on 24 November 2008, and fetal stress test on 24 March 2009. Serology on 27 October 2008 revealed low ferritin, and the patient was diagnosed with iron deficiency anemia. On 26 March 2009, at 37 weeks gestation, the patient gave birth via C-section to a female infant weighing 6 pounds 14 ounces. Apgar scores were 9/10 at one minute, and 9/10 at five minutes. No congenital anomalies were noted, and there were no complications of labor or delivery.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Gestational diabetes, Glucose tolerance test abnormal, Iron deficiency anaemia, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Initial report received from a health care professional on 15 August 2008. A 39 year old, female patient, with a medical history of no known allergies and gestational diabetes, received a 0.5 ml intramuscular, left deltoid injection of ADACEL, lot number C2936AA, on 31 July 2008. The patient was pregnant at the time of vaccination. Her last menstrual period was 05 July 2008 and her estimated date of delivery is 10 August 2009. She denied having any current medications. She has a history of 5 previous pregnancies, with a 5 full term deliveries and normal/viable pregnancy outcomes. It was reported a pregnancy test done on 14 August 2008 was positive. Per the reporter, there was no known adverse event. Follow-up received from a health care professional on 22 September 2008. The reporter amended the patient's estimated date of delivery from 10 August 2009 to 10 April 2009. No additional information was provided. Follow-up information was received from a health care professional on 04 May 2009; it was determined, based upon this new information, that the case should be upgraded to serious. On 23 January 2009 the patient, who had a history of gestational diabetes in previous pregnancies, underwent a three-hour glucose tolerance test which was positive for gestational diabetes. She was referred to "Sweet Success". The following prenatal testing was normal: Genetic screening (CG screen) on 03 September 2008, alpha fetoprotein on 30 October 2008, ultrasound on 24 November 2008, and fetal stress test on 24 March 2009. Serology on 27 October 2008 revealed low ferritin, and the patient was diagnosed with iron deficiency anemia. On 26 March 2009, at 37 weeks gestation, the patient gave birth via C-section to a female infant weighing 6 pounds 14 ounces. Apgar scores were 9/10 at one minute, and 9/10 at five minutes. No congenital anomalies were noted, and there were no complications of labor or delivery.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MMR, MNQ
Symptoms: Chest discomfort, Dizziness, Headache
Clinical narrative: Pt & Foster Mother walked into Center. Pt received immunizations 05/04/09. Pt now c/o of dizziness, headache & chest discomfort. Follow-up phone call later in day-Foster Mother reports pt. is feeling better.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: At 48 hours, significant Local Reaction - Site erythematous, warm to touch - Softball size area.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, TTOX, VARZOS
Symptoms: Erythema, Feeling hot, Injection site haematoma, Malaise, Oedema peripheral
Clinical narrative: On 3/12/09 Tetanus/Diptheria toxoid was given in the left arm along with influenza and pneumonia which were given in the right arm.  That night the patient complained of left arm swelling and not feeling well along with a fever.  On 3/16/09 pt has large area on left upper arm red,itchy, hot and swollen.  There is a 4inch bruised area around the injection site.  She no longer has a fever.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, TTOX, VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: On 3/12/09 Tetanus/Diptheria toxoid was given in the left arm along with influenza and pneumonia which were given in the right arm.  That night the patient complained of left arm swelling and not feeling well along with a fever.  On 3/16/09 pt has large area on left upper arm red,itchy, hot and swollen.  There is a 4inch bruised area around the injection site.  She no longer has a fever.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Biopsy, Rash papular
Clinical narrative: papular rash back of both hands and both elbows since getting small pox 16 Apr 2009.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Biopsy skin abnormal, Dermatitis, Rash papular, Skin lesion
Clinical narrative: papular rash back of both hands and both elbows since getting small pox 16 Apr 2009.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Cellulitis, Injection site swelling, Injection site warmth, No reaction on previous exposure to drug
Clinical narrative: Elevated temperature of 100 F within 24 hours of injection as well as tenderness; both were controlled with Tylenol. After 24-hours warmth and swelling around injection site increased. 05/08/09 0730 pt reported swelling radiated from neck to to elbow by the afternoon of 05/07/09. Pt works at a health center and sought medical advice from a physician who diagnosed possible cellulitis. Pt reports may be prescribed antibiotics 05/08/09 when at work. Pt denies a history of DTaP adverse drug reaction as confirmed by parent.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Elevated temperature of 100 F within 24 hours of injection as well as tenderness; both were controlled with Tylenol. After 24-hours warmth and swelling around injection site increased. 05/08/09 0730 pt reported swelling radiated from neck to to elbow by the afternoon of 05/07/09. Pt works at a health center and sought medical advice from a physician who diagnosed possible cellulitis. Pt reports may be prescribed antibiotics 05/08/09 when at work. Pt denies a history of DTaP adverse drug reaction as confirmed by parent.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: reddness swelling upper arms
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: ONE WEEK AFTER SHINGLES VACCINE CLIENT HAD DEVELOPED RASH ON ENTIRE BODY AND IT LASTED FOR ONE MONTH. NO FEVER NOR ITCHING ACCOMPANIED.  IT RESOLVED BY ITSELF.
Age: 32.0
Sex: F
Vaccine: SMALL
Symptoms: Drug exposure during pregnancy
Clinical narrative: Vaccinated with ACAM2000 during pregnancy Pregnancy resulted in full term healthy delivery
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: GAVE 3RD HEP A
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, IPV, PPV, RVX
Symptoms: Cough, Dysphonia, Wheezing
Clinical narrative: My son was given his 2 month  routine Vaccines which included the Rotavirus. This was done on Wednesday May 6, 2009 about 10:30am. On Friday about 3 pm my son awoke from his nap, and had more hoarseness, some audtory wheezing and a cough that sounded loose as he wanted to clear his throat. Although his breathing continued to be with in reason, NO retraction or change in skin color, his father and I are watching him closely.
Age: 37.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Injection site abscess, Injection site mass, Injection site pain
Clinical narrative: Small lump Lt upper arm at injection site noted soon after vaccination 4-3-09.  Presented for care on 5-1-09 with 2d history increasing size of lump and pain at site.  Tx with Bactrim DS #14 and warm compresses.  Saw PMD 5-6-09 who changed her antibiotic and scheduled her for drainage of infected abscess at site 5-11-09
Age: 37.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Injection site cyst, Injection site erythema, Injection site infection, Injection site mass, Injection site pain
Clinical narrative: Small lump Lt upper arm at injection site noted soon after vaccination 4-3-09.  Presented for care on 5-1-09 with 2d history increasing size of lump and pain at site.  Tx with Bactrim DS #14 and warm compresses.  Saw PMD 5-6-09 who changed her antibiotic and scheduled her for drainage of infected abscess at site 5-11-09