chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: ANTH, HPV4, ANTH, HPV4, ANTH, HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: 22 year old female reports miscarriage on 28AUG2010. She reports first date of last menstrual period as 20JUL2010 and positive serum pregnancy test on 23AUG2010. No exam of fetus. First pregnancy.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Rash macular
Clinical narrative: Generalized erythematous macular rash.
Age: 47.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Arthralgia, Axillary pain, Joint swelling, Lymph node pain, Pyrexia
Clinical narrative: Pt reports "extreme pain" (9/10) markedly swollen, shoulder joint painful, tenderness into axillary area. Fever and joint pain (knees and hips).
Age: 46.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Asthenia, Injected limb mobility decreased, Lymphadenopathy, Pain
Clinical narrative: Pt describes "debilitating pain" similar to a "dislocated shoulder". Pain 7/10 started 1-2 hours after injection. Decreased strength (90%) unable to lift arm. Swollen glands in neck & axillary region. Sx lasted 3 days then intermittent.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Loss of consciousness
Clinical narrative: After having vaccines, pt. fell onto the floor, lost consciousness and had a possible seizure. Taken to E.R. for evaluation. Released and referred to neuro.
Age: 52.0
Sex: M
Vaccine: RAB
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever to 101F on 9/01, then erythema to injection site (left anterior thigh) on 9/02. Pt presented to Emergency Department 9/02 & was initiated on a cellulitis protocol (cefazolin 1g IV q 8 hrs) & given ibuprofen 600mg po prn. Pt remains in Emergency Department receiving treatment at this time.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Headache, Mental status changes, Myalgia, Neuralgia
Clinical narrative: Patient presented to Emerg Dept with fever, chills, mental status change, headache, myalgia and left arm neuralgia pain; symptoms with 24 hours of vaccination. (hx mild flu symptoms with influenza vaccine).
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Patient presented to Emerg Dept with fever, chills, mental status change, headache, myalgia and left arm neuralgia pain; symptoms with 24 hours of vaccination. (hx mild flu symptoms with influenza vaccine).
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Patient fainted 10 minutes after receiving HPV vaccine at the waiting room. Patient had had no breakfast. Event occurred at 11:00am. BP 87/58 Patient was awake within 30 seconds.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: MENACTRA and TDaP placed in (R) arm 8/31/10. (+) Swelling/erythema started that evening and has persisted through 9/3. (+) Mild tenderness. Swelling and erythema at site - 8.5 x 9 cm on (R) deltoid.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dysphonia, Eye pain, Fatigue, Headache
Clinical narrative: Patient came to pharmacy on 9-2-10 at about 11.15 AM to report that about 3 hours after her flu shot she felt weak, tired, no fever, hoarseness, eyes hurt, arm hurt and she awoke w. headache today.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site rash
Clinical narrative: Circular rash 8cm x 9cm around injection site. Patient's 1st PREVNAR 13 - but 4 previous doses of PREVNAR 7.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV1
Symptoms: Irritability, Skin discolouration
Clinical narrative: Very irritable after vax. Later briefly unattended in stroller - mother touch child "grey" but breathing - color responded to picking him up. No sx since.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Initially started with a headache, then developed fever of 101, then left arm became red and swollen to elbow. Symptoms lasted 3-4 days. MD called and suggested cold compresses and Ibuprofen as needed.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Removing bandaid from upper left arm and noted redness, warmth, itching, and swelling that encompassed back of left upper arm.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 6"x 4" erythematous, warm area spreading from site of previous vaccines given on left thigh
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Headache, Injection site pain, Injection site swelling
Clinical narrative: I would like this letter about my July 13, 2010 treatment to be placed in my file. I saw you on July 13, 2010 about my respiratory problems over the prior 4 months, including difficulty breathing, coughing and exhaustion. After I had a second set of lung function tests and two courses of oral steroids, you indicated that you thought the most likely explanation for my condition was reactive asthma. At that visit you advised that I get a pneumonia vaccination that day. I twice indicated that I was worried about  getting the vaccination before I was well and asked to wait a couple months. You stated that there was no cause to worry and that there are no adverse reactions to the vaccine. Approximately 6 hours after receiving the vaccination, I was very ill. I had a high fever (eventually up to 104 degrees), serious headaches, major left arm pain and swelling from the elbow to the shoulder where I received the vaccination, and I was weak and dizzy. A friend eventually took me into urgent care. I was ill for 5 days. I do not intend to receive the second dose after five years. This concerns me as I realize that pneumonia is a more dangerous condition for older individuals. I have done some research, and reviewed the CDC two page information sheet on the vaccine and Merck's posted sheet on its PNEUMOVAX 23 (I don't know if I received this vaccination or a different one; what vaccine did I receive?) 1. I note that the CDC sheet claims less than 1% of people develop a fever, muscle aches, or more severe reaction. Yet the Merck sheet seems to say that in a clinical trial, for subjects 50-64 years of age (which includes me), 35.5% of subjects had a vaccine-related systemic adverse experience. I don't understand the discrepancy. 2. Per the CDC sheet, I ask that you report the reaction I had by filing a Vaccine Adverse Event Reporting Systems form.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: I would like this letter about my July 13, 2010 treatment to be placed in my file. I saw you on July 13, 2010 about my respiratory problems over the prior 4 months, including difficulty breathing, coughing and exhaustion. After I had a second set of lung function tests and two courses of oral steroids, you indicated that you thought the most likely explanation for my condition was reactive asthma. At that visit you advised that I get a pneumonia vaccination that day. I twice indicated that I was worried about  getting the vaccination before I was well and asked to wait a couple months. You stated that there was no cause to worry and that there are no adverse reactions to the vaccine. Approximately 6 hours after receiving the vaccination, I was very ill. I had a high fever (eventually up to 104 degrees), serious headaches, major left arm pain and swelling from the elbow to the shoulder where I received the vaccination, and I was weak and dizzy. A friend eventually took me into urgent care. I was ill for 5 days. I do not intend to receive the second dose after five years. This concerns me as I realize that pneumonia is a more dangerous condition for older individuals. I have done some research, and reviewed the CDC two page information sheet on the vaccine and Merck's posted sheet on its PNEUMOVAX 23 (I don't know if I received this vaccination or a different one; what vaccine did I receive?) 1. I note that the CDC sheet claims less than 1% of people develop a fever, muscle aches, or more severe reaction. Yet the Merck sheet seems to say that in a clinical trial, for subjects 50-64 years of age (which includes me), 35.5% of subjects had a vaccine-related systemic adverse experience. I don't understand the discrepancy. 2. Per the CDC sheet, I ask that you report the reaction I had by filing a Vaccine Adverse Event Reporting Systems form.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature normal, Chills, Ear pain, Headache, Nausea
Clinical narrative: Chills, nausea 8-27-10 T 99 degrees 8-30-10 left earache, headache T. 97 degrees.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Throat tightness
Clinical narrative: Throat became tight.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Bacterial infection, CSF culture positive, Gram stain, Headache, Influenza like illness
Clinical narrative: Flu like symptoms, headache, nausea, stiff neck, vomiting, sore throat. Onset of disease 1/17/10. Pat. was admitted to hospital 1/18/10 and released 1/25/10. Neisseria meningitidis was isolated from CSF. Pat. was treated and 9 people received prophylaxis. Specimen was sent to CDC on 2/2/10 for PCR serogroup. It was confirmed to be "Y".
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Meningitis bacterial, Musculoskeletal stiffness, Nausea, Neisseria test positive, Oropharyngeal pain
Clinical narrative: Flu like symptoms, headache, nausea, stiff neck, vomiting, sore throat. Onset of disease 1/17/10. Pat. was admitted to hospital 1/18/10 and released 1/25/10. Neisseria meningitidis was isolated from CSF. Pat. was treated and 9 people received prophylaxis. Specimen was sent to CDC on 2/2/10 for PCR serogroup. It was confirmed to be "Y".
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Polymerase chain reaction, Vomiting
Clinical narrative: Flu like symptoms, headache, nausea, stiff neck, vomiting, sore throat. Onset of disease 1/17/10. Pat. was admitted to hospital 1/18/10 and released 1/25/10. Neisseria meningitidis was isolated from CSF. Pat. was treated and 9 people received prophylaxis. Specimen was sent to CDC on 2/2/10 for PCR serogroup. It was confirmed to be "Y".
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Differential white blood cell count abnormal, Haemoglobin normal, Platelet count normal, Pyrexia, Viral upper respiratory tract infection
Clinical narrative: Pt seen for health maintenance exam on 8/26/10. Patient had screen CBC, ESR, Rheumatoid factor for screen of joint sxs at visit -> all normal. Pt had hx of clear rhinorrhea without fever for several days before visit -> suspected URI. Exam was unremarkable at health maintenance exam. Patient given PCV-13 vaccine and discharge home. Patient called provider on call on 8/27/10 at 1015 pm with another onset of fever of 104.6 degrees F. Patient had no sign of local irritation, continued with rhinorrhea but had no other sxs (no cough, no rash). Patient continued to have intermittent fever x 36hrs and was ultimately evaluated 8/28/10 at a local urgent care center. Laboratory assessment is as documented on page 1. Assessment was suspected viral upper respiratory tract illness. Pt was discharged home. F/u phone call 8/30/10 - fever resolved, pt doing well. I am very suspicious that the fever was vaccine related.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: White blood cell count normal
Clinical narrative: Pt seen for health maintenance exam on 8/26/10. Patient had screen CBC, ESR, Rheumatoid factor for screen of joint sxs at visit -> all normal. Pt had hx of clear rhinorrhea without fever for several days before visit -> suspected URI. Exam was unremarkable at health maintenance exam. Patient given PCV-13 vaccine and discharge home. Patient called provider on call on 8/27/10 at 1015 pm with another onset of fever of 104.6 degrees F. Patient had no sign of local irritation, continued with rhinorrhea but had no other sxs (no cough, no rash). Patient continued to have intermittent fever x 36hrs and was ultimately evaluated 8/28/10 at a local urgent care center. Laboratory assessment is as documented on page 1. Assessment was suspected viral upper respiratory tract illness. Pt was discharged home. F/u phone call 8/30/10 - fever resolved, pt doing well. I am very suspicious that the fever was vaccine related.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B antibody, Rash, Vomiting
Clinical narrative: Employee called office approx 1130am, and stated that when she came home from work she vomited X2, and had mild rash on face and abdomen.  Denies any other symptoms.  Denies acute distress.  Sent to Medical Center for evaluation.  Seen by Dr.  Unknown if this is a Hepatitis B reaction per Dr.  Employee stated that she had the vaccine previously on her immunization questionnaire.  Hepatitis B surface antibody was negative.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site discolouration, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt received PNEUMOVAX vaccine on 8/10/10. Started with (L) arm pain/purplish discoloration at injection site, next morning, felt left arm pain, "hot feeling" and left palm tingling. Pt was to f/u to recheck in 2 d but did not f/u. Also pt FTKA on 8/27 and pt. did not f/u.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Muscle spasms, Myalgia, Neck pain, Pyrexia
Clinical narrative: 5 days of neck pain, fever, muscle spasm, muscle pain, neck pain. Pt seen at office on 9/3/10 - pt sent to ER after I called CDC.
Age: 5.0
Sex: F
Vaccine: FLUN3, PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 2 1/2 inch redness across, swollen, warm to the touch.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 18 year old female patient who on 06-SEP-2007, was intramuscularly vaccinated with a 0.5 mL first dose of GARDASIL. On 21-MAY-2009, the patient was intramuscularly vaccinated with a 0.5 mL second dose of GARDASIL (Lot# 662300/0100Y). On 05-AUG-2010, the patient was intramuscularly vaccinated with a 0.5 mL third dose of GARDASIL (Lot# 665768/1377Y). There was no concomitant medication. On 05-AUG-2010, after the vaccination, a urine pregnancy test was performed to the patient and the result was positive. It was reported that the patient LMP was on beginning of May 2010, and the estimated date of delivery (EDD) is 05-FEB-2011. It was noted that the patient was intending to terminate the pregnancy. Additional information has been received from the registered nurse who stated that on 10-AUG-2010, in the morning, the patient planned to terminate her pregnancy. The patient told to the registered nurse that she had an appointment scheduled for the termination. The registered nurse reported that she had not confirmed this and that she would probably not see this patient again since they were a walk-in sexually transmitted infection clinic. Follow up information has been received from the registered nurse concerning the female patient with a history of a delivered baby boy on 19-APR-2010 and no birth defects or infant complications in the previous pregnancy who on 05-AUG-2010 was vaccinated with a third dose of GARDASIL (Lot# 665768/1377Y). The nurse reported that on 05-AUG-2010 at 10 weeks from LMP, the patient experienced elective termination. It was unknown if the products of conception were examined and if the fetus was normal. Upon internal review the elective termination was considered to be an other important medical event. No further information is available.
Age: 19.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Convulsion, Dyskinesia, Syncope
Clinical narrative: Initial and follow-up information has been received from a physician and a phone call to a medical assistant, concerning a 19 year old male patient with environmental allergies (cats) and no known relevant medical history, who on 17-AUG-2010 was vaccinated with the first dose of GARDASIL (lot # 666163/0664Z), intramuscularly and then a dose of VARIVAX (lot # 665912/1772Y, route not provided) and fainted. After the patient fainted he started to have a seizure, which was reported as having "jerking" movements, within a minute of receiving GARDASIL in the physician's office. No laboratory test was performed. The patient recovered before leaving the physician's office on 17-AUG-2010. The events were considered to be other important medical events by the physician. No further information is available.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 30 year old female patient no known pertinent medical history and no known drug reactions/allergies, who was vaccinated with the first dose of GARDASIL route and lot# not reported, on 01-NOV-2006, the second dose on 03-JAN-2007, and the third dose on 09-MAY-2007. Concomitant drug included unspecified birth control medicine. In 2009 the patient experienced seizures starting on an unspecified date. The patient's outcome was unknown. No diagnostic laboratory tests were performed. Upon internal review, seizures was determined to be an other important medical event. Follow-up information has been received on 31-AUG-2010 from a physician who reported that the patient did not have past history of seizures and the patient also did not have a family history of seizures. The patient received three doses of GARDASIL at another unspecified physician's office on the following dates, first dose on 01-NOV-2006, Lot number 653938/0954F, second dose on 03-JAN-2007, Lot number 655165/1425F and third dose on 09-MAY-2007, Lot number 657622/0388U. The patient had some health issues after she had received the series. The patient was seeing a neurologist. At this time of reporting the cause for seizures was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy lymph gland, Full blood count, Lymphadenopathy, Mononucleosis heterophile test, Neck pain
Clinical narrative: Information has been received from a resident physician in her 20's with no pertinent medical history, who in approximately September 2008 (also reported as August 2008) was vaccinated intramuscularly with the first dose (reported as 0.5mg dose) of GARDASIL (Lot # not reported). On an unspecified dates, she was vaccinated with the second and third doses (reported as 0.5mg doses) of GARDASIL (Lot # not reported). There were no concomitant medications. The physician reported that on August 2008, she experienced a lymphadenopathy while receiving a dose of GARDASIL. She stated that she had lymph nodes under her arms as well as neck pain and was hospitalized. A biopsy was performed and her condition was determined to be benign. Also a CBC test and Monostat tests were performed (result not provided). At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: PNC
Symptoms: Muscle atrophy
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 4-year-old female patient who experienced muscle atrophy (described as pitting). At 4 years of age, the patient received a dose on an unspecified date. Patient received PREVNAR therapy on an unknown date in her right thigh. On an unspecified date, the patient experienced muscle atrophy described as "pitting." At time of report, patient had not yet recovered. No further information was provided.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Idiopathic thrombocytopenic purpura
Clinical narrative: This case was considered medically important.  Information regarding PREVNAR 13 was received from a physician regarding a 4-year-old male patient who experienced idiopathic thrombocytopenic purpura.  The patient received a dose on an unspecified date in 2010.  The patient experienced idiopathic thrombocytopenic purpura on an unknown date in 2010.  The event has resolved.  No additional information was available at the time of this report.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site discolouration, Muscle atrophy
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 6-month-old male patient who experienced white spot and muscle atrophy (described as pitting). At 6 months of age, the patient received the third dose on 26-Jan-2010. The patient also received the second dose of PENTACEL (Aventis-Pasteur), a dose of Hepatitis B Vaccine (manufacturer unknown) and the third dose of ROTATEQ (Merck & Co Inc) on 26-Jan-2010. Patient received the third dose of PREVNAR therapy on 26-Jan-2010, at the age of 6 months. In February of 2010, a white spot appeared on his left thigh where the vaccine was given and his muscle started to atrophy described as pitting. On 25-Aug-2010 at the age of 13 months, the patient visited the clinic again and the muscle atrophy and pitting was 3 plus deep and quarter-sized. Treatment was not provided. At time of report, patient had not recovered.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Haematochezia
Clinical narrative: Mom reports blood in stool. Began 8/17/10, noticed one episode. Restarted again 8/26/10, then 8/27/10 and also 8/28/10. Unable to test stool patient out of state.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoaesthesia facial, VIIth nerve paralysis
Clinical narrative: Pt c/o facial numbness & limited cheek movement. Diagnosed with Bell's Palsy 9/1/10.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Pt received vaccine (FLUVIRIN) 9/2/10. Approx 4 pm vomited approx. 430 PM and twice more between 430 PM and 7 PM. Called pt, 10:45 AM on 9/3/10- pt no vomiting since 9/2/10 but still has some nausea. States did not eat all day on 9/2/10 prior to vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: 9/1 - injection administered. 9/2 - patient works at store and came to pharmacy to show red circular area. 9/3 - patient returned to Rx said was getting better - applied HC 1% cream b/c of itch.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Rash
Clinical narrative: Pt was injected with TDAP vaccine in the (R) shoulder. Pt c/o tenderness to injection site and rash on chest. Denies any n/v/d/f/c.h. Pt is to report to acute care for further treatment.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mass
Clinical narrative: Shot administered on Wednesday but redness and a knot appeared this morning (Friday).
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection site pain, sore arm, swelling (no fever reported). Pt iced arm, kept elevated - contacted Primary Care Physician who prescribed prednisone.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: Patient had first generalized seizure 1 mos after receiving 3rd HPV shot has had severe subsequent seizures.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4
Symptoms: Convulsion, Depressed level of consciousness, Electroencephalogram abnormal, Grand mal convulsion, Impaired driving ability
Clinical narrative: Patient had first generalized seizure 1 mos after receiving 3rd HPV shot has had severe subsequent seizures.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4
Symptoms: Muscle twitching
Clinical narrative: Patient had first generalized seizure 1 mos after receiving 3rd HPV shot has had severe subsequent seizures.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Vomiting
Clinical narrative: Headache, vomiting within several hours of receiving vaccine.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: Simple febrile seizure X 5 minutes on 9/1/10. To ER.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Heart rate decreased, Presyncope, Somnolence
Clinical narrative: Vasovagal response. Pt decreased BP, decreased pulse - drowsy - lasted about 5 minutes.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Broke out with a rash all over body, legs, arms after the vaccine.
Age: 14.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Hypersensitivity, Throat tightness
Clinical narrative: Patient with complaints of "throat tightening" approximately 15 minutes after receiving HAVRIX. Mom provided pt. with BENADRYL and took pt. to emergency room. ER provided care for allergic reaction and discharged to home in stable condition.
Age: 14.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Feeling abnormal, Headache, Throat tightness
Clinical narrative: Patient with complaints of "throat tightening" approximately 15 minutes after receiving HAVRIX. Mom provided pt. with BENADRYL and took pt. to emergency room. ER provided care for allergic reaction and discharged to home in stable condition.
Age: 1.11
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dizziness, Heart rate increased
Clinical narrative: On 7/21 received 4 vaccines - 2 in each leg. At night the following symptoms started and continued for 3 days: fever 105, loss of energy, loss of appetite, dizziness, diarrhea, accelerated heart beat even if no fever, red protruding hives, difficulty breathing, even with TYLENOL fever only went down to 100 degrees. Taken to ER on 8/27 given more TYLENOL and finally fever went down. Symptoms continued over weekend, larger red hives. Called doctor on 8/30 no doctor visit. Today the symptoms are diminishing, no longer has rapid heart beat. Some vax were not documented on vax record by provider might have receive double doses.
Age: 1.11
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pyrexia, Urticaria
Clinical narrative: On 7/21 received 4 vaccines - 2 in each leg. At night the following symptoms started and continued for 3 days: fever 105, loss of energy, loss of appetite, dizziness, diarrhea, accelerated heart beat even if no fever, red protruding hives, difficulty breathing, even with TYLENOL fever only went down to 100 degrees. Taken to ER on 8/27 given more TYLENOL and finally fever went down. Symptoms continued over weekend, larger red hives. Called doctor on 8/30 no doctor visit. Today the symptoms are diminishing, no longer has rapid heart beat. Some vax were not documented on vax record by provider might have receive double doses.
Age: 10.0
Sex: M
Vaccine: FLUN3, HEPA, TDAP
Symptoms: Abdominal discomfort, Asthenia, Decreased appetite, Oedema peripheral
Clinical narrative: Right shoulder swollen for 3 days after vaccine, decreased energy, decreased appetite, and mild GI discomfort.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 9/1/2010 0800 - PT'S R. UPPER ARM - SWELLING APPROX 6 INCHES IN LENGTH, 4 INCHES IN DIAMETER.  SWOLLEN AREA IS RED, HARD, EXTREMELY WARM TO THE TOUCH AND PAINFUL.  ICE PACK APPLIED.  1-500MG ACETAMINOPHEN TABLET GIVEN.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature normal, Chest X-ray normal, Computerised tomogram head, Computerised tomogram normal, Dyspnoea
Clinical narrative: Pt. arrived at ER in mother's arms.  Mom stated child was having difficulty breathing. Pt. was limp and had a blank stare.  Vital signs stable T98.6, P85, R24, O2 100% RA. Pt. responded after a few minutes to tactile stimuli. Pt. appeared post-ictal.  Pt. was monitored X 2 hrs. and was discharged home after she became more alert and talking. Ambulated on own.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Full blood count normal, Hypotonia, Metabolic function test normal, Postictal state, Staring
Clinical narrative: Pt. arrived at ER in mother's arms.  Mom stated child was having difficulty breathing. Pt. was limp and had a blank stare.  Vital signs stable T98.6, P85, R24, O2 100% RA. Pt. responded after a few minutes to tactile stimuli. Pt. appeared post-ictal.  Pt. was monitored X 2 hrs. and was discharged home after she became more alert and talking. Ambulated on own.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Syncope
Clinical narrative: Pt. arrived at ER in mother's arms.  Mom stated child was having difficulty breathing. Pt. was limp and had a blank stare.  Vital signs stable T98.6, P85, R24, O2 100% RA. Pt. responded after a few minutes to tactile stimuli. Pt. appeared post-ictal.  Pt. was monitored X 2 hrs. and was discharged home after she became more alert and talking. Ambulated on own.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Fever. If this continues I will take him to doctors or ER. Im calling in sick from work.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Body temperature increased, Fatigue, Injection site erythema, Injection site induration
Clinical narrative: Father states noticed firm red left lateral thigh yesterday morning after waking up.  Child also had temp of 100 degrees.  Dad states child did not complain of pain, but was acting more tired than usual.  Mom called office around 4pm on 9/2/10; gave Motrin and applied ice with some relief.  Seen today with 5 1/2 cm by 4cm area redness to left thigh.  Child has full range of motion, denies pain, and is actively playing without signs of distress.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Mom states noticed thigh very red and firm to touch after child was swimming in afternoon of 9/2/10.  Child complained of pain when Mom touched red area, but tolerated regular activity.  Mom denied fever.  Did not give Tylenol or Motrin.  Did not apply compress.
Age: 72.0
Sex: M
Vaccine: FLU(H1N1), VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: duplicate vaccination. No reaction, given 10/3/08
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: none, duplicate vaccination, previous vaccination 1/3/08
Age: 64.0
Sex: F
Vaccine: HEPA, IPV, TYP
Symptoms: Asthenia, Blood test abnormal, Decreased appetite, Dizziness, Dysphonia
Clinical narrative: Lack of hunger, fever, extreme tiredness, weakness, nausea, hoarseness, slight dizziness; blood tests showed hepatitis virus in the liver; further tests now being done.
Age: 64.0
Sex: F
Vaccine: HEPA, IPV, TYP
Symptoms: Fatigue, Hepatitis viral, Nausea, Pyrexia
Clinical narrative: Lack of hunger, fever, extreme tiredness, weakness, nausea, hoarseness, slight dizziness; blood tests showed hepatitis virus in the liver; further tests now being done.
Age: 12.0
Sex: F
Vaccine: HEPA, MEN, TDAP, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over body.  Itching on hands and feet.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: none, duplicate vaccination given previously 01/09/2009
Age: 1.0
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Balance disorder, Dizziness, Staring
Clinical narrative: dizziness, imbalance, staring
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injected limb mobility decreased, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, heat and bruising at site. Painful swollen lymph nodes at axilla on side of injection, low grade fever 100.0, nausea, tiredness, limited ROM, swollen fingers on side of injection.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Lymph node pain, Lymphadenopathy, Nausea, Oedema peripheral
Clinical narrative: Pain, swelling, heat and bruising at site. Painful swollen lymph nodes at axilla on side of injection, low grade fever 100.0, nausea, tiredness, limited ROM, swollen fingers on side of injection.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Pain, swelling, heat and bruising at site. Painful swollen lymph nodes at axilla on side of injection, low grade fever 100.0, nausea, tiredness, limited ROM, swollen fingers on side of injection.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Dehydration, Diarrhoea, Injected limb mobility decreased, Injection site haematoma, Injection site pain
Clinical narrative: Pain, warmth, bruising swelling at site of injection. Bilateral swelling of lymph nodes in axilla and up into neck. Fever, lethargy decreased rom, diarrhea.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Lethargy, Lymphadenopathy, Pyrexia
Clinical narrative: Pain, warmth, bruising swelling at site of injection. Bilateral swelling of lymph nodes in axilla and up into neck. Fever, lethargy decreased rom, diarrhea.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Eyelid oedema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became very red, swollen and hot to touch. Patient states had lethergy, sore throat, very itchy at site, aches in arm, nasal congestion, tightness sensation in arms, puffy eyes.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Lethargy, Nasal congestion, Oropharyngeal pain, Pain in extremity, Sensory disturbance
Clinical narrative: Injection site became very red, swollen and hot to touch. Patient states had lethergy, sore throat, very itchy at site, aches in arm, nasal congestion, tightness sensation in arms, puffy eyes.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Nuclear magnetic resonance imaging, Periarthritis, Rotator cuff syndrome, X-ray
Clinical narrative: Zostavax vaccine was administered too close to the deltoid resulting in supraspinatous tendonitis and adhesive capsilitis.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Injection site reaction, Nausea
Clinical narrative: She has had a headache, nausea and a temperature of 98 degrees when her temp is usually 97. Also, a reaction at the injection site and the band-aid site also. Kinda shaped like the band-aid, but she claims no problems with these bandaids before.
Age: 43.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Abnormal sensation in eye, Diarrhoea, Eye pruritus, Headache, Rash erythematous
Clinical narrative: Itchy rash behind left knee onset at night, in the morning diarrhea X2, morning mild headache took ibuprofen, red itchy rash appeared on right leg then later in the morning on her face and around noon on her back. No more diarrhea since the morning. Ibuprofen Around noon eyes felt dry/itchy. About 1PM given generic Zyrtec one tablet orally.
Age: 43.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Rash pruritic
Clinical narrative: Itchy rash behind left knee onset at night, in the morning diarrhea X2, morning mild headache took ibuprofen, red itchy rash appeared on right leg then later in the morning on her face and around noon on her back. No more diarrhea since the morning. Ibuprofen Around noon eyes felt dry/itchy. About 1PM given generic Zyrtec one tablet orally.
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Local swelling, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Client clalled and voice c/o severe sore throat and swelling of the neck glands five days after receiving MMR#1 vaccine.  Encouraged client to notify his PVT MD with his c/o severe sore throat and swelling of glands.  Client called on Monday 8/30/10.  Follow up called placed on 9/1/10.  Client states he did not see his PVT MD and that his throat soreness and gland swelling is slowly improving.  Advised client he must have a note from his PVT MD before getting MMR #2.
Age: 1.8
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Insomnia, Psychomotor hyperactivity
Clinical narrative: ABRUPT BEHAVIOR CHANGE AFTER VACCINE, WOULD NOT SLEEP SIGNIFICANT INCREASE IN ACTIVITY AFTER VACCINE
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Cough, Lip swelling, Urticaria
Clinical narrative: Swollen lips, slight cough without difficulty breathing, hives on fingers and ankle.  Child's grandmother gave her Benadryl. Child's grandmother stated that the Benadryl seemed to help alleviate the symptoms.
Age: 62.0
Sex: M
Vaccine: PPV, TD
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: About 10 hours after vaccination, I developed very bad headache. The next day I had a fever in excess of 103 degrees, body aches, and the headache.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: A RASH THAT LOOKS SIMILAR TO SHINGLES
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: According to Pt Father Itchy, warm to touch redness and swollen.  Treatment: Tylenol 160 mg 1 1/2 tsp Q4H PRN for pain, Benadryl  1 1/2 tsp  PRN Q8H for itching.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Hypoaesthesia, Joint stiffness, Pain
Clinical narrative: right foot going numb
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient received vaccine, ~10 minutes later she reported feeling dizzy & lightheaded. She was given a glass of water and was helped into a reclining position with her head below her feet.  Her Blood Pressure was 126/89, pulse 78 approximately 10 minutes after onset of symptoms.  She remained in the reclining position for approximately 20 minutes.  She reported feeling "OK" about 30-35 minutes after vaccine administration.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Nausea, Swollen tongue
Clinical narrative: Patient reports swollen eyes, nausea, and felt like her tongue was swelling a few hours after receiving the vaccine. No hospitalization required. Patients eyes were swollen the next day when she came into the pharmacy.  She took an antihistamine this morning.
Age: 4.0
Sex: M
Vaccine: DTAP, MEA, VARCEL
Symptoms: Injection site erythema, Injection site movement impairment, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Child claimed injection site was in pain.  Stated, "Hurt a lot" and he had trouble moving arm around. Injection site was swollen, red, and hot to the touch.
Age: 47.0
Sex: M
Vaccine: JEV, JEV
Symptoms: Lip swelling, No reaction on previous exposure to drug, Urticaria, Wheezing
Clinical narrative: Initial report was received 27 August 2010 from a health care professional. A 47-year-old male patient with no reported medical history, had received a second dose of JE-VAX, lot number EJN234A (route and site of administration not reported) and one day later, he developed wheezing, swelling in his upper lip, and urticaria on his arms and legs. The event required a doctors visit; however, at the time of the report, information was not provided regarding corrective treatments and laboratory or diagnostic testing. On 18 August 2010, eight days prior to the event onset, the patient had previously been vaccinated with "TYPIM", TWINRIX and BOOSTRIX (lot numbers, routes and site of administration not reported). On 17 August 2010, the patient had received a first dose of JE-VAX (lot number, route and site of vaccination not reported) with no adverse event reported. The event outcome was not recovered. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 47.0
Sex: M
Vaccine: JEV, JEV
Symptoms: Lip swelling, Urticaria, Wheezing
Clinical narrative: Initial report was received 27 August 2010 from a health care professional. A 47-year-old male patient with no reported medical history, had received a second dose of JE-VAX, lot number EJN234A (route and site of administration not reported) and one day later, he developed wheezing, swelling in his upper lip, and urticaria on his arms and legs. The event required a doctors visit; however, at the time of the report, information was not provided regarding corrective treatments and laboratory or diagnostic testing. On 18 August 2010, eight days prior to the event onset, the patient had previously been vaccinated with "TYPIM", TWINRIX and BOOSTRIX (lot numbers, routes and site of administration not reported). On 17 August 2010, the patient had received a first dose of JE-VAX (lot number, route and site of vaccination not reported) with no adverse event reported. The event outcome was not recovered. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Mydriasis, Nausea, Visual impairment
Clinical narrative: Initial report received from a patient's parent on 30 August 2010. A 14-year-old female child, with a history of wide spectrum Autism, received on 23 August 2010 an intramuscular injection of MENACTRA, lot number not reported. The patient had no illness at the time of vaccination, no other vaccinations within 4 weeks prior to date of MENACTRA and takes no medications. The patient at 18 months had the adverse events of fever, crying and irritable following vaccination with MMR. On 25 August 2010, 38 hours after vaccination, the patient became nauseous, dizzy and could not see while walking around. The patient's pupils were fully dilated and she passed out for 10 seconds. The patient came around and after a few minutes she went about 15 steps and stated she couldn't see and passed out again for a moment. She sat for awhile, and then was able to walk to the car. The patient was taken directly to the doctor's office. The outcome was reported as recovered. Documents held by sender: None.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a physician that he heard from a parent of one of his patients who also heard from elsewhere concerning a female who was vaccinated with a 0.5ml dose of GARDASIL, IM. "Some time passed, then she died". The cause of death was not reported. The patient received unspecified medical attention. Died was considered to be disabling and immediately life-threatening. No further information is available.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Allergic colitis, Allergy test negative, Aspartate aminotransferase normal, Biopsy colon, Blood potassium increased
Clinical narrative: Information has been received from a registered nurse concerning her 17 week old niece with no known pertinent medical history and drug reactions/allergies who had been vaccinated with a first dose of ROTATEQ (lot# not reported) at 8 weeks of age. A couple of days after the first dose, the patient developed slight, sporadic rectal bleeding. On 21-JUL-2010, the patient was vaccinated with a second dose of ROTATEQ (lot# not reported). On 21-JUL-2010, immediately after receiving the second dose (reported as "in the evening"), the baby had blood in the stools; the bleeding has continued and she had passed two clots, clots ranged from pea to dime size; in the week preceding this report, there were clots every day and seven BMs without pus per day. No other significant symptoms; baby was sometimes irritable and sometimes looked like she had gas pain. Initially it was thought there was a milk allergy, so diet was changed and baby continued with breast milk; allergy testing came back negative; blood work showed an increased AST (56) and an increased potassium level; baby now was on a "special formula". Colonoscopy performed on 25-AUG-2010; according to the registered nurse, the physician said the results were the "worse he had seen in 30 years"; biopsy results pending. She had been diagnosed with severe ulcerative colitis. Unspecified medical attention was sought. The patient did not recover from severe ulcerative colitis. On 27-AUG-2010, additional information was received from a licensed practical nurse who added that the first dose of ROTATEQ was given on 21-MAY-2010, lot # 665272/0203Z, along with a dose of PREVNAR, PENTACEL, and a dose of hepatitis B virus vaccine (thimerosal free), lot# 666183/1481Y. The second dose of ROTATEQ was administered on 21-JUL-2010, lot # 668213/0512Z, along with a dose of PENTACEL. It was reported that the baby was recently placed on Nutramigen formula. The condition was not disabling or life threatening. Additional allergy testing would be done in three months. In a note from the pediatric GI, the event was suspected to be either allergic colitis or lymphoid nodules in the colon caused by the ROTATEQ. Pathology report was not yet back from the colonoscopy. Upon internal review, rectal haemorrhage was considered to be other important medical events. The reporter requested lot checks for ROTATEQ. A lot check has been initiated. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Colitis ulcerative, Colonoscopy abnormal, Flatulence, Frequent bowel movements, Haematochezia
Clinical narrative: Information has been received from a registered nurse concerning her 17 week old niece with no known pertinent medical history and drug reactions/allergies who had been vaccinated with a first dose of ROTATEQ (lot# not reported) at 8 weeks of age. A couple of days after the first dose, the patient developed slight, sporadic rectal bleeding. On 21-JUL-2010, the patient was vaccinated with a second dose of ROTATEQ (lot# not reported). On 21-JUL-2010, immediately after receiving the second dose (reported as "in the evening"), the baby had blood in the stools; the bleeding has continued and she had passed two clots, clots ranged from pea to dime size; in the week preceding this report, there were clots every day and seven BMs without pus per day. No other significant symptoms; baby was sometimes irritable and sometimes looked like she had gas pain. Initially it was thought there was a milk allergy, so diet was changed and baby continued with breast milk; allergy testing came back negative; blood work showed an increased AST (56) and an increased potassium level; baby now was on a "special formula". Colonoscopy performed on 25-AUG-2010; according to the registered nurse, the physician said the results were the "worse he had seen in 30 years"; biopsy results pending. She had been diagnosed with severe ulcerative colitis. Unspecified medical attention was sought. The patient did not recover from severe ulcerative colitis. On 27-AUG-2010, additional information was received from a licensed practical nurse who added that the first dose of ROTATEQ was given on 21-MAY-2010, lot # 665272/0203Z, along with a dose of PREVNAR, PENTACEL, and a dose of hepatitis B virus vaccine (thimerosal free), lot# 666183/1481Y. The second dose of ROTATEQ was administered on 21-JUL-2010, lot # 668213/0512Z, along with a dose of PENTACEL. It was reported that the baby was recently placed on Nutramigen formula. The condition was not disabling or life threatening. Additional allergy testing would be done in three months. In a note from the pediatric GI, the event was suspected to be either allergic colitis or lymphoid nodules in the colon caused by the ROTATEQ. Pathology report was not yet back from the colonoscopy. Upon internal review, rectal haemorrhage was considered to be other important medical events. The reporter requested lot checks for ROTATEQ. A lot check has been initiated. Additional information has been requested.