chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 5 year old male with no pertinent medical history and no known drug allergies who on 19-AUG-2006 was vaccinated IM with 0.5 mL dose of Vaqta (lot# 652509/0036F). There was no concomitant medication. On 19-AUG-2006 the patient developed fever of 104 degrees F. On 20-AUG-2006 the patient also had one episode of vomiting. He felt dizzy, but on 21-AUG-2006 he felt much better and walked around. Additional information is not expected.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Alanine aminotransferase increased, Hepatitis A antibody positive, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a patient who on approximately 30-JUL-2006 was vaccinated with a first dose of Vaqta. Concomitant vaccination on the same day included a first dose of Recombivax HB (manufacturer unknown). On 30-AUG-2006 it was reported that the patient was vaccinated "one month ago" and then performed liver function test. The patient had positive hepatitis A IgM and borderline liver enzyme (ALT) elevations. The patient sought unspecified medical attention. There was no product quality complaint involved. No further information is available.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect route of drug administration, Loss of consciousness
Clinical narrative: Information has been received from a healthcare professional concerning a 12 year old male who on 01-SEP-2006 was vaccinated subcutaneously with a dose of Vaqta. There was no concomitant medication. It was reported that on 01-SEP-2006 the patient "passed out" within a minute of receiving Vaqta. Patient woke up after a minute and a half. Patient received the vaccination via a subcutaneous injection. An ambulance was called. Unspecified medical attention was sought. It was reported that the adverse event improved, "yes, on therapy". No product quality complaint. Current status was not recovered. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a health professional concerning an approximately 4 year old male who was vaccinated with a 0.5 mL dose of hepatitis A virus vaccine inactivated. Subsequently the patient experienced diarrhea for 2 days. Subsequently, the patient recovered. The patient sought unspecified medical attention. There was no product quality complaint reported. There were no reported diagnostic lab tests performed. No further information is available.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Muscle tightness
Clinical narrative: Information has been received from a medical assistant concerning a patient who on 02-OCT-2006 was inadvertently vaccinated with only half of the recommended dose (about 0.2 mL) of Vaqta (lot # 652509/0036F). The medical assistant also mentioned that the patient's muscles tensed during administration. No symptoms have been reported. There was no product quality complaint. No further information is available.
Sex: U
Vaccine: HEPA
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a pharmD concerning a patient who on 16-OCT-2006 was vaccinated with hepatitis A virus vaccine inactivated. On 16-OCT-2006 the patient developed itching at the injection site after an immunization with hepatitis A virus vaccine inactivated. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Antibody test positive, Dizziness, Fatigue, Hepatic enzyme increased, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 34 year old male with a history of thalassaemia who on 15-SEP-2006 was vaccinated with a 0.5 mL IM dose of hepatitis A virus vaccine inactivated. Subsequently the patient had positive IgM antibody and elevated liver enzymes. The patient experienced fatigue, dizziness, and tiredness. The patient went to the emergency room but was not admitted. There was no treatment. It was noted that the patient had blood work performed on 15-SEP-2006 but the results were not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Hepatic function abnormal, Jaundice
Clinical narrative: Information has been received from a physician concerning a 11 year old male who on 10-OCT-2006 was vaccinated intramuscular with hepatitis A virus vaccine inactivated. The physician reported that the patient who received hepatitis A virus vaccine inactivated developed jaundice and abnormal liver function. The patient was sent to the emergency room for treatment. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Hepatitis A antibody negative, Laboratory test
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of hepatitis A virus vaccine inactivated. Subsequently the patient does not have a titer count. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 9 week old male who on 27-NOV-2007 was vaccinated IM in the right vastus lateralis with one first dose of hepatitis A virus vaccine inactivated (lot # 654814/0804F). Concomitant vaccination included a first dose of Prevnar given IM in the left vastus lateralis and a first dose of Pediarix (lot # AC21B069AA) given IM in the left vastus lateralis. On 30-NOV-2006 the patient's mother reported that the patient developed a slight fever after the injections on 27-NOV-2006. Additional vaccination included a first dose of Recombivax HB (lot # 653301/0278F) given IM in the right vastus lateralis on 01-DEC-2006. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental exposure, Eye irritation, Ocular hyperaemia
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female certified medical assistant who on 30-NOV-2006 splashed hepatitis A virus vaccine inactivated  into her eyes during administration. The medical assistant was complaining of burning and had redness in her eyes. The medical assistant's eyes were flushed with an unspecified solution and "getting better", she was reported to be recovering. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Accidental exposure, Pruritus
Clinical narrative: Information has been received from a certified medical assistant stating that she was unpacking a shipment of hepatitis A virus vaccine inactivated (direct from the manufacturer) and the gelpack inside had leaked onto the contents. The caller states that on 07-DEC-2006, she was exposed to the gel on her hands and that is now experiencing itchiness on her body. Caller herself has itchiness on her chin and the tip on her tongue. There is no swelling. Called indicated that she will take Clarinex. There was no product complaint. It was unknown if the caller sought medical attention. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Computerised tomogram normal, Hepatic enzyme increased, Malaise
Clinical narrative: Information has been received from a 71 year old retired male consumer who on 12-JAN-2006 and 20-OCT-2006 was vaccinated with a first and second (0.5 ml) dose of hepatitis A virus vaccine inactivated respectively. Additional suspect vaccination included a first and second dose of hepatitis B virus vaccine rHBsAg on 20-OCT-2006 and 20-NOV-2006 respectively. Other concomitant vaccination included a dose of influenza virus vaccine (unspecified) on 20-NOV-2006. There was no illness at the time of vaccination. In late November 2009, the patient experienced not feeling well and high liver enzyme levels. Medical attention was sought, two CAT scans and unspecified blood work was performed the only results reported were "high liver enzyme levels." At the time of the report the patient was recovering. Additional information from the physician indicated that on 29-NOV-2006 the patient had persistent transaminitis (elevated SGOT and elevated SGPT) and persistently elevated alkaline phosphatase. It was reported that a CT scan performed showed a normal appearing liver. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HEP, HEPA
Symptoms: Adverse event
Clinical narrative: Information has been received from a female consumer who on an unspecified date was vaccinated with a "combination formulation" of hepatitis A virus vaccine inactivated and hepatitis B virus vaccine rHBsAg (manufacturer unspecified) which contained thimerosal. Subsequently, she had an unspecified "reaction". There was no product quality complaint involved. No further information was available. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Blood immunoglobulin M increased
Clinical narrative: Information has been received from a physician concerning a patient who on approximately 08-DEC-2006 was vaccinated with a dose of hepatitis A virus vaccine inactivated. On approximately 29-DEC-2006 the patient presented with a positive IgM. The physician declined to share any further information, but stated that she will be conducting another IgM test, and if that was positive she would call back to share more. There was no product quality complaint. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Blood thyroid stimulating hormone increased, Full blood count, Wrong drug administered
Clinical narrative: Information has been received from a doctor of pharmacy student concerning a 28-year-old female, with no pertinent medical history or allergies, who on 19-DEC-2006 was vaccinated intramuscularly with a dose of hepatitis A virus vaccine inactivated. Concomitant vaccination given on the same day included a dose of DTaP (manufacturer unknown). Concomitant therapy included Ortho-Cyclen. On 22-DEC-2006 routine blood work was performed as part of a complete physical exam. All results were within normal limits except the thyroid stimulating hormone value was elevated to 7.02. Unspecified medical attention was sought. Follow-up is planned with the healthcare provider. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Body temperature increased, Nasal congestion, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12-month-old female with no previous medical history or drug reactions/allergies who on 27-DEC-2007 was vaccinated with hepatitis A virus vaccine inactivated, Varivax virus vaccine live, and hepatitis B virus vaccine (unspecified) (manufacturer unknown). There were no other concomitant medications. On 05-JAN-2007, the patient
Age: 1.1
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased, Cough, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 13-month-old male patient born prematurely at 36 weeks with a positive Coombs test, and "photo treatment days 3 to 5", who on 19-DEC-2006 was vaccinated with a first dose of hepatitis A virus vaccine inactivated. On 18-JAN-2007 the patient was mistakenly vaccinated intramuscularly in the deltoid with a second dose of hepatitis A virus vaccine inactivated (lot# 656000/1095F). There was no apparent illness at the time of vaccination. Subsequently, one day after the second dose, the patient developed a fever up to 103 degrees Fahrenheit and a severe, deep, wet cough. It was reported that the symptoms lasted over four days and that he was re-examined on day four. He had a temperature of 101 degrees Fahrenheit without any local findings on physical examination. It was reported that at the time of this report the patient had recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Gianotti-Crosti syndrome, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 24 month female twin with a history of premature birth, minor resolved intraventricular hemorrhage, resolved retinopathy of prematurity, and patent ductus arteriosus resolved with indomethacin who on 12-JAN-2007 was vaccinated IM with a 0.5 mL dose of hepatitis A virus vaccine inactivated. Illness at the time of vaccination included an ear infection. On 19-JAN-2007, the patient experienced a papular vesicular rash. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. It was noted that the patient's twin was vaccinated at the same time and did not developed a rash. A product quality complaint was not involved. Additional information has been received from the physician who reported that the patient came into her office on 26-JAN-2007 with complaints of a rash. The rash was trunk-sparing affecting the arms, legs, neck, and face. It was red, papulo-vesicular and crusting. There was minimal to no pruritus and was possibly tender. The patient had also been amoxicillin for otitis, started on 12-JAN-2007. The patient's twin was vaccinated the same day and lives in the same household without a rash. There were no contacts with any similar rashes. The working diagnosis was Gianotti-Crosti disease. No diagnostic laboratory tests were performed. No further information is expected.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Lip swelling, Rash, Swelling face
Clinical narrative: Information has been received from a registered nurse concerning an 18 month old female who on 31-JAN-2007 was vaccinated with a 0.5 ml dose of hepatitis A virus vaccine inactivated. On 31-JAN-2007, after vaccination, the patient experienced a rash on her face, lips and neck. Shortly after developing the rash the patient had swelling of the lips and face. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Initial information has been received from a nurse practitioner concerning a 19 year old, female, who reportedly developed a rash with Ceclor, whose reported weight was 175 pounds (lbs) and whose reported height was 66 and 1/2 inches (in), who had no illness at the time of vaccination, who on 15-DEC-2006 was vaccinated intramuscularly, into the arm with her first dose of Gardasil, (lot # 653978/0955F), (WAES # 0701USA00254). On 28-DEC-2006 (also reported as 28-DEC-2007), the patient was vaccinated into the left arm with hepatitis A virus vaccine inactivated (Lot # AHAUB1Y1AA), (manufacturer unknown). It was reported that on 01-JAN-2007, the patient developed hives and rash on chest. At the time of report it was unknown if the patient recovered. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Crying, Head banging, Photophobia
Clinical narrative: Information has been received from a physician concerning an 18-month-old male twin with no pertinent medical history and no drug reactions/allergies who on 08-FEB-2007 was vaccinated IM with the first 656495/1209F). There was no concomitant medication. On 08-FEB-2007, after the patient was released from care, he experienced 3 hours of uncontrollable crying. His mom administered Motrin to him one hour prior to returning to the office. he was additionally given Tylenol at the office and Benadryl one hour after the Tylenol. The physician noted that the child seemed sensitive to light and was banging his head. A follow-up was made the next day, in which the parent stated that the child was fine and playing. The outcome was recovered on 09-FEB-2007. The twin brother who was also vaccinated experienced no adverse effect. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested. 02/11/2010 Follow up information was received from a physician who reports that on 08 FEB 2007, within 9 minutes of vaccine the patient developed photophobia,  head shaking and banging, uncontrolled crying and holding his head. The event lasted for 2-3 hours. The patient had not illness at the time of vaccination. The patient was recovered at the time of reporting. No further information is expected.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 59 year old female patient with Percocet and penicillin allergies who on 01-FEB-2007 was vaccinated with the first dose of hepatitis A virus vaccine inactivated (Lot #656495/1209F) in the left deltoid. Concomitant vaccination on 01-FEB-2007 included the first dose of hepatitis B virus vaccine rHBsAg (Lot # 653788/0412F) in the right deltoid. Subsequently on 01-MAR-2007, the patient was administered a second dose of hepatitis A virus vaccine inactivated (Lot # 655999/1010F) in the right deltoid one month after the first dose. Concomitant vaccination on 01-MAR-2007 included the second dose hepatitis B virus vaccine rHBsAg (Lot # 653788/0412F) in the left deltoid. There was no illness at the time of vaccination. On 14-MAR-2007, the patient complained of leg pains. The outcome of the leg pains was not reported. Additional information has been requested.
Age: 1.55
Sex: M
Vaccine: HEPA
Symptoms: Blood culture, Body temperature increased, C-reactive protein, Full blood count, Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning an 18 month old male with no medical history who on 28-FEB-2007 was vaccinated intramuscularly with a dose of hepatitis A virus vaccine inactivated (lot# 656320/1281F). Concomitant therapy included Pediarix, poliovirus vaccine and influenza virus vaccine (unspecified). On 28-FEB-2007 the patient experienced injection site reaction in left thigh that consisted of redness, swelling, and pain in the left thigh, and 102 degrees fever. The patient's injection site reaction in left thigh and 102 degrees fever persisted. The patient sought unspecified medical attention. He was seen by the physician and still having the symptoms. The reporter felt that injection site reaction in left thigh and 102 degrees fever were related to therapy with hepatitis A virus vaccine inactivated. A lot check has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 1.55
Sex: M
Vaccine: HEPA
Symptoms: Injection site reaction, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 18 month old male with no medical history who on 28-FEB-2007 was vaccinated intramuscularly with a dose of hepatitis A virus vaccine inactivated (lot# 656320/1281F). Concomitant therapy included Pediarix, poliovirus vaccine and influenza virus vaccine (unspecified). On 28-FEB-2007 the patient experienced injection site reaction in left thigh that consisted of redness, swelling, and pain in the left thigh, and 102 degrees fever. The patient's injection site reaction in left thigh and 102 degrees fever persisted. The patient sought unspecified medical attention. He was seen by the physician and still having the symptoms. The reporter felt that injection site reaction in left thigh and 102 degrees fever were related to therapy with hepatitis A virus vaccine inactivated. A lot check has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information ahs been received from a registered nurse concerning a 14 year old female with a "cardiac history" and no drug reactions/allergies who on 26-FEB-2007 was vaccinated intramuscularly in the right arm one dose of VAQTA (lot # 656320/1281F). Concomitant therapy included GARDASIL, ADACEL and MENACTRA. On 26-FEB-2007 the patient experienced an injection site reaction from the vaccination. The reaction consisted of redness, swelling and pain in the right arm. The patient sought unspecified medical attention. The patient was seen by the physician on 01-MAR-2007 and was still having the symptoms. No diagnostic laboratory tests were performed. At the time of the report the patient was recovering. There was no product quality complaint. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the CBER and was released by the regulatory agency. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Adverse event, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 4 year old male (chart # 1160) who on 05-FEB-2007 was vaccinated with a dose of hepatitis A virus vaccine inactivated (lot#656495/1209F). There was no concomitant medication. In February 2007, the patient experienced skin was raised 10" x 10" around the injection site. The patient received hepatitis A virus vaccine inactivated in the right leg. The right leg measured 34 cm in length compared to 26 cm for the left. Unspecified medical attention was sought, the adverse event improved, "on therapy". Subsequently, the patient recovered from the injection site reaction on an unknown date. No Product Quality complaint. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Drug hypersensitivity, Viral infection, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a mother who called in to report that her 5 year old daughter, with a drug hypersensitivity to amoxicillin and ZITHROMAX, was vaccinated intramuscularly with a pediatric dose of VAQTA (lot# 654814/0786F) on 06-MAR-2007. There was no concomitant medication. On the evening of 06-MAR-2007, the patient began experiencing vomiting and a stomach ache. The patient's vomiting and stomach ache persisted. Additional information has been requested. 02/11/2010 Follow-up information from the nurse was received which indicated that the patient siblings also developed stomach aches and vomiting and some neighbors also developed these symptoms. The nurse believed that the symptoms were something going through the neightborhood and unrelated. RECOMBIVAX HB. Additional information ahs been received from the registered nurse who reported that the patient's other siblings and neighbors had stomach aches and vomiting. The reporter felt that the patient's events were not related to therapy with RECOMBIVAX HB and that is was "probably a viral infection." No further information is expected.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema multiforme, Urticaria
Clinical narrative: Information has been received from a physician concerning a child (demographics not provided) who on an unspecified date was vaccinated with hepatitis A virus inactivated. The physician reported that the child developed erythema multiforme. The patient sought unspecified medical attention. Further information has been received from the physician concerning this 16 year old male who on 07-MAR-2007 at 4:00 PM was vaccinated with the first dose of hepatitis a virus vaccine in the deltoid (Lot# 656993/0001U). Two days after, on 09-MAR-2007 the patient had started with hives. The patient went to the physicians office on 12-MAR-2007 and was diagnosed with erythema multiforme. The patient was given prednisone for five days. It was reported that the patient was getting better two days after this. The patient recovered as of 18-MAR-2007. No further information is expected.
Age: 42.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Abdominal pain, Chills, Muscle spasms, Nausea, Oral herpes
Clinical narrative: Information has been received from a Pharm. D. health care student concerning a 42 year old female who on 14-APR-2006 was vaccinated with hepatitis A virus vaccine inactivated IM. The patient also received ENGERIX - B administered on 14-APR-2006. The pharmacy student reported that the patient received her third dose of hepatitis A virus vaccine inactivated in the series and on 14-APR-2006 the patient experienced abdominal pain, nausea, and chills. As of 20-APR-2006, the patient was still having those symptoms in addition to stabbing pain from the pelvic bone to the epigastrium, cramps and cold sores. the patient had no known exposure to anyone who had been ill. No further information was available at the time of reporting. The patient sought unspecified medical attention. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pain
Clinical narrative: Information has been received from a Pharm. D. health care student concerning a 42 year old female who on 14-APR-2006 was vaccinated with hepatitis A virus vaccine inactivated IM. The patient also received ENGERIX - B administered on 14-APR-2006. The pharmacy student reported that the patient received her third dose of hepatitis A virus vaccine inactivated in the series and on 14-APR-2006 the patient experienced abdominal pain, nausea, and chills. As of 20-APR-2006, the patient was still having those symptoms in addition to stabbing pain from the pelvic bone to the epigastrium, cramps and cold sores. the patient had no known exposure to anyone who had been ill. No further information was available at the time of reporting. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: RAB
Symptoms: Electrocardiogram normal, Electroencephalogram normal, Loss of consciousness, Musculoskeletal pain, Syncope
Clinical narrative: Apparent vaso vagal syncopal episode 20 hours after receiving his first rabies vaccine (for pre-exposure prophylaxis prior to travel).  He noted aching in both shoulders.  Loss of consciousness for about 5 seconds.  No other known precipitators to the syncopal event. 8/8/07-records received for DOS 5/30/07-Syncopal episode. Felt hot and sweaty, blacked out, uper body arms and shoulders twitching and shaking. Unconscious. Confused. Family history of Brugada Syndrome.   On 6/1/07-Procainamide Challenge and Implanted Reveal device
Age: 15.0
Sex: M
Vaccine: RAB
Symptoms: Syncope vasovagal
Clinical narrative: Apparent vaso vagal syncopal episode 20 hours after receiving his first rabies vaccine (for pre-exposure prophylaxis prior to travel).  He noted aching in both shoulders.  Loss of consciousness for about 5 seconds.  No other known precipitators to the syncopal event. 8/8/07-records received for DOS 5/30/07-Syncopal episode. Felt hot and sweaty, blacked out, uper body arms and shoulders twitching and shaking. Unconscious. Confused. Family history of Brugada Syndrome.   On 6/1/07-Procainamide Challenge and Implanted Reveal device
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient was administered her 2nd dose of Gardasil on 5/21/07. After 10 minutes the patient was exiting the office and experienced syncope.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: 1st dose of Gardasil received on 5/31/07. Patient experienced syncope after 10-15 minutes.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: 1st dose of Gardasil received on 3/26/07. Patient experienced syncope after 10-15 minutes.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Throat irritation
Clinical narrative: 4:07p c/o pruritis, erythema at injection site, ice pack/3 tsp Benadryl 12.5 mg/5cc PO, 420p still c/o pruritis "weird" sensation in throat no resp difficulty, EMS notified 0.2cc Epinephrine SC L arm (1:1000)
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pulse abnormal, Skin warm
Clinical narrative: Information has been received from a healthcare worker concerning a 57 year old female secretary with a history of right lower lobe pneumonia (15-FEB-2007), rhinitis and fatigue and no known allergies who on 09-APR-2007 at 12:30 was vaccinated into the left arm with a first dose of Pneumovax 23 (Lot #655588/0883F) during follow up for her resolved pneumonia. There was no concomitant medication. On 10-APR-2007, the patient developed cellulitis from injection site to left elbow. The left elbow to upper arm was hot, red swollen and painful. There was no fever and distal pulse were 2+ to 3+. The patient was given LEVAQUIN 750 mg orally once a day for 10 days. The patient was to follow-up in 48 hours. On 25-APR-2007, the patient recovered. No product quality complaint was involved. Cellulitis from injection site to left elbow and left elbow to upper arm hot, red, swollen and painful were considered to be other important medical events. This is one of two reports received from the same source. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Drug exposure during pregnancy
Clinical narrative: Information has been received from a 25 year old female certified medical assistant with a history of chickenpox at 5 years of age and no allergies who on 31-MAY-2007 administered a dose of Zostavax (lot # 657558/0461U). Concomitant therapy included prenatal vitamins (unspecified). While withdrawing the vaccine from the vial, it sprayed into her eyes and face. At the time of exposure, the reporter was 15 weeks pregnant. She wiped her face down with alcohol and flushed her eyes with water. Two hours later, she reported feeling fine. Unspecified medical attention was sought and no diagnostic laboratory tests were performed. A product quality complaint was not involved. Vaccine sprayed into eyes and face was considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HBHEPB, HEPA, MMRV, PNC
Symptoms: Erythema, Induration
Clinical narrative: 1 1/2 cm x 1 1/2 cm area of induration and 3cm x 5cm area of erythema.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Cyanosis
Clinical narrative: Patient developed blueness around mouth when placed supine after receiving Rotateq. Self resolved when placed upright.
Sex: F
Vaccine: HPV4
Symptoms: Induration, Inflammation, Myalgia
Clinical narrative: Prolonged inflammation (hard deltoid muscle, tender to touch) 3-4 weeks after injection
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Vaccine MMR given 5/29/07 called 5/31/07 was  was seen at pulmonologist office. Felt was more than just local reaction large hot red area back of right arm fever 101, cold compresses Ibuprofen, Keflex
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site warmth, Local reaction
Clinical narrative: Large local reaction on R upper arm warm to touch covered upper 1/2 of arm. Given Augmentin 500 mg PO 1 tam Bid cool compresses. Questionable Cellulitis.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Electrocardiogram, Fall, Syncope
Clinical narrative: After giving last immunization. Pt was asked how she felt fine. 2-3 min later asked her again, she said fine. She then fell back on the bed and fainted. Doctor called into the room to examine patient. Pt reacted 2-3 min later.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Headache, Oedema peripheral, Rash
Clinical narrative: Arm very swollen, 5" square red, very hot, and very heavy, headache and tired lasted this way 10 days, sore joints and rash on arm
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Sensation of heaviness, Skin warm
Clinical narrative: Arm very swollen, 5" square red, very hot, and very heavy, headache and tired lasted this way 10 days, sore joints and rash on arm
Age: 4.0
Sex: M
Vaccine: HEPA, MMRV, MNQ
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: patient inadvertently given Menactra vaccine. No adverse reaction noted.
Age: 15.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Bone pain, Erythema, Headache, Malaise, Pyrexia
Clinical narrative: Received shots - Menactra/Varivax and within 24 hours bone achiness general malaise and headache and low grade fever. Redness on R arm and R sternum area also redness on L arm but no distal to it
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Light case of chicken pox reports mom no fever, no meds
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Child received vaccine 10/16/03 and had outbreak of chickenpox 4/07 had mild case reports parent, no fever or treatment given
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site warmth, Throat irritation
Clinical narrative: Subcutaneous (L) arm Varivax injection given. Bled small amt. Immediately (L) upper arm 3-4" in diameter became very red and hot, we had child stay 1/2 hour later she c/o of itchy throat. Motrin 1 1/2 and Benadryl 2 tsp given. 15 min later small area size of 1/2 dollar remained red and child had no more itching.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Diarrhoea, Feeling hot, Headache, Hyperhidrosis, Neck pain
Clinical narrative: patient reports feeling hot and sweaty the evening after she received Menommune. Patient states she did not have fever, did have 2 episodes diarrhea that PM. Next day, had pounding headache and neck pain. Neck pain next day _> went to PMD given muscle relaxer and pain med. Recovered 5/26/07.
Age: 73.0
Sex: M
Vaccine: TTOX
Symptoms: Muscle tightness
Clinical narrative: reoccurring muscle tightening in shoulders, back and midrift areas affects movement balance Started day after injection-end Jan 07-Still occurring 5/27/07
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Hypersomnia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, soreness and itchy feeling in location of vaccine for 5 days following. Swollen lymph nodes for 3 days following. Drowsiness for 3 days following - slept through weekend when 10 hours awake in 72 hour period.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Lymphadenopathy
Clinical narrative: Swelling, redness, soreness and itchy feeling in location of vaccine for 5 days following. Swollen lymph nodes for 3 days following. Drowsiness for 3 days following - slept through weekend when 10 hours awake in 72 hour period.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 5/23 patient exhibited 3 cm firm red spot, hot to touch at site of Varivax injection
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Rash papular
Clinical narrative: Developed rash within 25 hour after vaccine admin. Papular rash over Bilat arms/Trunk. no SOB no cyanosis. went to ER and received prednisone and Benadryl. Rash is resolved. Nml appetite
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying
Clinical narrative: Unconsolable crying for 3 hours or more.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying
Clinical narrative: Unconsolable crying for 3 hours or more.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Asthenia, Dizziness, Erythema, Fatigue
Clinical narrative: Reactions to first vaccination given on 03 April 2007 (Bioport Corp, Lot#FAV102 Dosage 0.5ml, VIS Ver. 16 Dec 05) were, Migraine lasting for days with no relief, hot/cold flashes, weakness always feeling tired, body and joints aches, dizziness and fatigue lasting for 12 days. Symptoms started within 12 hrs after getting vaccinated. Second vaccination PT had the same symptoms with a large swelling in the left arm from the shoulder to the elbow. The area was bright red in color with a golf ball size knot 9cm in diameter in the area of the vaccination. PT stated edema started around Sunday afternoon with the redness and swelling early Monday morning. Symptoms lasting for 2 ½ to 3 weeks. Treatment warm pack over area for 15 mins., Motrin 800mg  1tablet 3X a day.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Hot flush, Injection site mass, Migraine, Oedema, Oedema peripheral
Clinical narrative: Reactions to first vaccination given on 03 April 2007 (Bioport Corp, Lot#FAV102 Dosage 0.5ml, VIS Ver. 16 Dec 05) were, Migraine lasting for days with no relief, hot/cold flashes, weakness always feeling tired, body and joints aches, dizziness and fatigue lasting for 12 days. Symptoms started within 12 hrs after getting vaccinated. Second vaccination PT had the same symptoms with a large swelling in the left arm from the shoulder to the elbow. The area was bright red in color with a golf ball size knot 9cm in diameter in the area of the vaccination. PT stated edema started around Sunday afternoon with the redness and swelling early Monday morning. Symptoms lasting for 2 ½ to 3 weeks. Treatment warm pack over area for 15 mins., Motrin 800mg  1tablet 3X a day.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Pain
Clinical narrative: Reactions to first vaccination given on 03 April 2007 (Bioport Corp, Lot#FAV102 Dosage 0.5ml, VIS Ver. 16 Dec 05) were, Migraine lasting for days with no relief, hot/cold flashes, weakness always feeling tired, body and joints aches, dizziness and fatigue lasting for 12 days. Symptoms started within 12 hrs after getting vaccinated. Second vaccination PT had the same symptoms with a large swelling in the left arm from the shoulder to the elbow. The area was bright red in color with a golf ball size knot 9cm in diameter in the area of the vaccination. PT stated edema started around Sunday afternoon with the redness and swelling early Monday morning. Symptoms lasting for 2 ½ to 3 weeks. Treatment warm pack over area for 15 mins., Motrin 800mg  1tablet 3X a day.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Pt. received vaccine on 5-23-07 (3:30)pm and on 5-24-07 at 2:00am patient woke up itching real bad.  Patient decribed reaction as whelps and hives on the trunk of the body (front and back) and on the right ear.  She state she found some over the counter antihistamines and took them.  She went to her primary doctor (Family Practice) when the office opened on 5-24-07. She said they began giving shots of steroids while in the office and oral meds to take at home.  Pt. states her doctor said if she had not taken the antihistamines during the night she would have been in the hospital.  She continued on antihistamines until Sat. 5-26-07.  On 5-26-07 patient stated the antihistamines caused her lips to swell so she stopped all meds.  Pt. states she didn't have to follow-up with her PCP anymore.
Sex: M
Vaccine: HEP
Symptoms: Influenza like illness, Myalgia, Tremor
Clinical narrative: muscle ache, tremors, flu-like symptoms
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Pain, Rash vesicular, Swelling, Tenderness
Clinical narrative: Very red, swollen, little larger than quarter sized, and tender 05182007, give tyl for pain and apply ice, mom called back on 05252007 to report Chicken pox rash, advised to give her benadryl
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: pt received Pneumnovax injection 06/06/07, 30 minutes later, he notice gradual increasing swelling and pain in shoulder and upper arm.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema, Pain, Swelling
Clinical narrative: Received vaccine 6/4/07. States she began having sweelling, redness and pain the morning of 6/5/07. On 6/5/07, left deltoid area with 65 mm x 55 mm erythema and edema. No increased skin temperature.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Cold sweat, Discomfort, Dizziness, Fatigue
Clinical narrative: Extremely dizzy, nausea, tiredness, loss of appetite, pale color, no fever but very uncomfortable/"clammy". Had vaccine (3rd of series) on June 5 and symptoms began the following day. Are still present today, but doing better.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pallor
Clinical narrative: Extremely dizzy, nausea, tiredness, loss of appetite, pale color, no fever but very uncomfortable/"clammy". Had vaccine (3rd of series) on June 5 and symptoms began the following day. Are still present today, but doing better.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Very sore left arm 2 days after administration of vaccine; moderate swelling of upper L arm with limited range of motion due to soreness; deltoid muscle was hard. 3 days after administration, patient presented to walk-in clinic for treatment & was given Benadryl & Medrol Dosepak. 3 days later, symptoms were improving. Localized reaction. Missed six days of work.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Abdominal pain, Full blood count, Grand mal convulsion, Loss of consciousness, Metabolic function test
Clinical narrative: Received DTaP(Glaxo), MMRV(Merck), IPV(Sanofi), Hep A(Merck) at 1015 AM. She was fine after administration and went home. She complained of abdominal pain then had a brief 45-60 sec tonic clonic seizure with loss of consciousness approximately 1 hour later. She was post ictal per mother. She was not febrile. When I examined Patient in clinic at 1145 shortly after seizure, she was had a normal affect and neurological exam.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Postictal state
Clinical narrative: Received DTaP(Glaxo), MMRV(Merck), IPV(Sanofi), Hep A(Merck) at 1015 AM. She was fine after administration and went home. She complained of abdominal pain then had a brief 45-60 sec tonic clonic seizure with loss of consciousness approximately 1 hour later. She was post ictal per mother. She was not febrile. When I examined Patient in clinic at 1145 shortly after seizure, she was had a normal affect and neurological exam.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Immediately after DTap was administered client developed redness and swelling at injection site size of 50 cents.  Ice pack applied and Benadryl Liquid 3/4 tsp given. Client observed for 20 minutes and signs and symptoms improved before leaving clinic.  No SOB or difficulty breathing.
Age: 18.0
Sex: F
Vaccine: MNQ, PPV, TDAP
Symptoms: Injection site swelling
Clinical narrative: PT REPORTS INCREASED SWELLING TO INJECTION SITE THE SIZE OF A BASEBALL.
Age: 0.92
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: For the first dose of pediarix, there was redness and swelling at the injection site and a knot that lasted over a month. The second pediarix shot gave him a fever of 103.1 which could have gone higher if I hadn't been taking his temperature and giving him fever medicine around the clock.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Decreased appetite, Diarrhoea, Discomfort, Faeces discoloured, Irritability
Clinical narrative: Fever to 102, loose/green/mucoid stools - both beginning 6/6 am.  Discomfort, poor eating, fussiness.  No signs of dehydration
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Mucous stools, Pyrexia
Clinical narrative: Fever to 102, loose/green/mucoid stools - both beginning 6/6 am.  Discomfort, poor eating, fussiness.  No signs of dehydration
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Local reaction
Clinical narrative: Extensive local inflammatory reaction.
Age: 46.0
Sex: M
Vaccine: TD
Symptoms: Borrelia burgdorferi serology negative, Coordination abnormal, Dyspnoea, Guillain-Barre syndrome, Hyperaesthesia
Clinical narrative: On 5/20/07 patient noted paresthesias in hands and feet, weakness in hands and legs, decreased dexterity.  Minimal amount of shortness of breath upon exertion. Some mild skin sensations in weeks before these symptoms, unable to exactly date beginning of those symptoms.  Admitted for probable Guillain-Barre syndrome on 06/05/07 and treated with IVIG.  6/8/07 Received partial hospital medical records which reveal patient initially seen in ER on 3/31 for treatment of dog bite on left lower leg received in line of duty (police officer).  Received wound care & Td injection.  Lot # confirms VAERS report.  Patient admitted to hospital 6/4/07 after experienced paresthesias of hands & feet associated w/weakness of legs & decreased dexterity & weakness of hands.  Symptoms began abruptly 12 days prior to admission.  Neuro exam on admit revealed areflexia throughout.  LP done on admission & PICC line placed for IVIG.  No D/C summary w/records.  Call to med records to request d/c summary.  6/12/07 Received EMG/NCS report from neurologist which reveals very diminished peroneal amplitude & slowed tibial conduction velocity, prolonged motor latency & median sensory latency w/diminished amplitude. F wave latencies prolonged in median & ulnar nerves.  Unable to determine clear tibial nerve F wave.  Study felt to be c/w GBS. 1/11/2010 Continued weakness and bouts of numbness in hands and feet.
Age: 46.0
Sex: M
Vaccine: TD
Symptoms: Hypoaesthesia, Motor dysfunction, Muscular weakness, Paraesthesia, Sensory disturbance
Clinical narrative: On 5/20/07 patient noted paresthesias in hands and feet, weakness in hands and legs, decreased dexterity.  Minimal amount of shortness of breath upon exertion. Some mild skin sensations in weeks before these symptoms, unable to exactly date beginning of those symptoms.  Admitted for probable Guillain-Barre syndrome on 06/05/07 and treated with IVIG.  6/8/07 Received partial hospital medical records which reveal patient initially seen in ER on 3/31 for treatment of dog bite on left lower leg received in line of duty (police officer).  Received wound care & Td injection.  Lot # confirms VAERS report.  Patient admitted to hospital 6/4/07 after experienced paresthesias of hands & feet associated w/weakness of legs & decreased dexterity & weakness of hands.  Symptoms began abruptly 12 days prior to admission.  Neuro exam on admit revealed areflexia throughout.  LP done on admission & PICC line placed for IVIG.  No D/C summary w/records.  Call to med records to request d/c summary.  6/12/07 Received EMG/NCS report from neurologist which reveals very diminished peroneal amplitude & slowed tibial conduction velocity, prolonged motor latency & median sensory latency w/diminished amplitude. F wave latencies prolonged in median & ulnar nerves.  Unable to determine clear tibial nerve F wave.  Study felt to be c/w GBS. 1/11/2010 Continued weakness and bouts of numbness in hands and feet.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, warmth around injection site size of tennis ball. No treatment necessary, just Advil prn and ice to right shoulder
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Asthenia, Fatigue, Syncope
Clinical narrative: Syncope occured about 30 seconds after the vaccines were given. Patient was placed in supine position with legs raised, she woke up a few seconds later. No oxygen was needed. Patient felt week and tired. She rested for a few minutes(15 minutes), color returned to her face and she stated she "felt better". After 30 minutes, patient left clinic walking and talking. Mother was encouraged to observe for any changes in appearance and cognitive characteristics and to report them as soon as possible.