chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity, Radiculitis brachial
Clinical narrative: Left arm brachial neuritis. Developed 4 days after receive annual influenza vaccine. Left arm weakness and pain. Currently taking pain medication (Lyrica, Tramadol). He has been in physical therapy 6/27/08 Reviewed clinic vax records & medical records 11/9/2007-5/19/08.   FINAL DX: left idiopathic brachial plexitis r/t influenza vaccination. Note of 11/9 reveals patient experienced left arm pain day after vaccination which continued to worsen w/decreased mobility & then unable to lift left arm.  Included left upper back, shoulder & deltoid aching & tingling w/occasional sharp shooting pain.  Had to use right arm to lift left arm above chest level.  Referred to neurology.  Very slowly improving w/meds & PT.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Labia enlarged, Urine analysis normal
Clinical narrative: Labia minora swelling.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Cardiac monitoring, Chest X-ray, Electrocardiogram, Nervousness, Throat tightness
Clinical narrative: After got in car had difficulty restriction throat like shot throat with NOVOCAINE & base of tongue.  Drove self to fire dept.  BP 220/90.  Sent to hospital trembling inside.  No sweating, no rash, no difficulty breathing.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Dizziness, Headache, Muscular weakness, Pain in extremity
Clinical narrative: Pain in both arms, headache, dizziness and weak legs and arms.
Age: 9.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema
Clinical narrative: Pt. got shot Friday 6-13-08.  Saturday am mom noticed redness, Saturday evening took her to ER, was given pain meds & sent home.  Sunday noticed it had gotten worse, went back to ER, gave her SEPTRA.  When pt. went to clinic it was better at 7 cm, now arm is better.  Spot almost gone.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dysarthria, Memory impairment
Clinical narrative: Patient reported to Dr. office on 6/10/08 and reported dizziness, slurred speech and forgetfulness after first vaccine on 3/18/08, no report prior to 6/10/08.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy lymph gland, Local swelling, Lymphadenopathy
Clinical narrative: Patient phoned student health clinic on 6/11/08. She was back home and says she had a reaction to the HPV vaccine, which she got on 5/14/08. Says got "swollen lymph nodes" in the groin area which were biopsied. Says developed swollen nodes a few days after vaccine, but did not go to get seen until back home over 1 wk later. Is due to have other nodes biopsied soon.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Developed redness, swelling, pain & itching at injection site where she received varicella vaccine the night she received it.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Abdominal pain upper, Flushing, Hypersensitivity, Nasal congestion, Paraesthesia oral
Clinical narrative: Patient given HEP A and VZV vaccines.  Complained of stomach pain, became flush, tongue tingling.  Patient given Benadryl.  At 4PM patient taken by parent to MD as symptoms increased with facial swelling and nasal congestion.  Given Prednisone and referral to allergist.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Swelling face
Clinical narrative: Patient given HEP A and VZV vaccines.  Complained of stomach pain, became flush, tongue tingling.  Patient given Benadryl.  At 4PM patient taken by parent to MD as symptoms increased with facial swelling and nasal congestion.  Given Prednisone and referral to allergist.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: States she developed a vesicle type rash on 6-13-08 - saw M.D. on 6-16-08 NAD <20 areas. None at site of injection. Only other symptom was general malaise. Info given to me by nurse
Age: 0.4
Sex: F
Vaccine: HIBV
Symptoms: Pruritus, Rash generalised
Clinical narrative: Fine rash all over baby - itching, several hours after injection given.  Office closed.  Infant took to ER.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Chest X-ray normal, Convulsion, Full blood count normal, Lumbar puncture normal, Pyrexia
Clinical narrative: Fever to 103.8 (maximum) x 2 days 6/14-6/16.  Seizure - 6/16 - brief.  Mild rash 6/17.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Rash
Clinical narrative: Fever to 103.8 (maximum) x 2 days 6/14-6/16.  Seizure - 6/16 - brief.  Mild rash 6/17.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Body temperature increased, Erythema, Rash papular, Rash pustular
Clinical narrative: Mild chicken pox rash with 2-3mm pink papules and tiny 1-2mm pustules and vesicles on an erythematous based scattered on her cheeks, posterior neck, post-auricular area, upper back and very few on anterior chest wall.  Low grade temperature elevation (100).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Mild chicken pox rash with 2-3mm pink papules and tiny 1-2mm pustules and vesicles on an erythematous based scattered on her cheeks, posterior neck, post-auricular area, upper back and very few on anterior chest wall.  Low grade temperature elevation (100).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash rubelliform
Clinical narrative: Received MMR 4/30/2008 3 days after, developed rubella like rash
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria, Vaccination failure
Clinical narrative: Pt presents for 15m immunizations today. Mother states after last vaccines, pt broke out in hives covering whole body the next morning. Seen doctor - states reaction to varicella vaccine - hives present one week.
Age: 46.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Dizziness, Eye movement disorder, Feeling cold, Mydriasis, Palpitations
Clinical narrative: Pt called to report the following incident which happened later the same day she received MMR vaccine.  While coaching a ball game "I became dizzy to the point of having to leave the field, and my heart was racing.  My friend said my eyes were completely dilated, one was not focusing, the other was aimed way off to left.  This lasted about a minute, but the racing heart continued.  I felt very cold and had goose bumps afterward.  It has not happened again, and the shot was the only thing different about that day."  Per doctor, pt was instructed this is incident will be recorded and sent to CDC to see if it is r/t MMR, but no knowledge of connection to vaccine administration at this time. This is in follow-up to report (s) previously submitted on 7/25/2008. Information has been received from a licensed practical nurse concerning a 46 year old (also reported as a 18 year old) female with an allergy to codeine and sulfonamide, who on 12-Jun-2008 at 13:15 was vaccinated in the deltoid with a dose of MMR II (Lot # 655123/1216F). The patient was not sick at the time of the vaccination. The patient reported that the symptoms lasted about one minute, but the racing heart continued.  Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Piloerection, Vision blurred
Clinical narrative: Pt called to report the following incident which happened later the same day she received MMR vaccine.  While coaching a ball game "I became dizzy to the point of having to leave the field, and my heart was racing.  My friend said my eyes were completely dilated, one was not focusing, the other was aimed way off to left.  This lasted about a minute, but the racing heart continued.  I felt very cold and had goose bumps afterward.  It has not happened again, and the shot was the only thing different about that day."  Per doctor, pt was instructed this is incident will be recorded and sent to CDC to see if it is r/t MMR, but no knowledge of connection to vaccine administration at this time. This is in follow-up to report (s) previously submitted on 7/25/2008. Information has been received from a licensed practical nurse concerning a 46 year old (also reported as a 18 year old) female with an allergy to codeine and sulfonamide, who on 12-Jun-2008 at 13:15 was vaccinated in the deltoid with a dose of MMR II (Lot # 655123/1216F). The patient was not sick at the time of the vaccination. The patient reported that the symptoms lasted about one minute, but the racing heart continued.  Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Blood culture, Convulsion, Culture urine, Pyrexia
Clinical narrative: Fever and seizure on evening of the day he got vaccination.  Pt. admitted in hospital.  Got spinal tap & started on antibiotics.  Also urine & blood cultures send. 7/14/08-records received for DOS 6/17/08-:Fever with possible seizure. Temp taken by parent 104, upon admission 99. This occurred night of vaccination. Eyes rolling to back of head, upper extremities shaking.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Blood culture, Convulsion, Culture urine, Lumbar puncture, Pyrexia
Clinical narrative: Fever and seizure on evening of the day he got vaccination.  Pt. admitted in hospital.  Got spinal tap & started on antibiotics.  Also urine & blood cultures send. 7/14/08-records received for DOS 6/17/08-:Fever with possible seizure. Temp taken by parent 104, upon admission 99. This occurred night of vaccination. Eyes rolling to back of head, upper extremities shaking.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pain
Clinical narrative: L forearm erythema 5x6 cm2 and mild pain.  Pain killer/TYLENOL, ibuprofen as needed.
Age: 0.8
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 9-month-old female with no pre-existing allergies, birth defects or medical conditions who on 05-MAR-2007 at 18:00 pm at a "well-child check-up" was vaccinated intramuscularly with a first dose of VAQTA instead of a dose of hepatitis B virus vaccine. No medical attention was sought and no diagnostic laboratory tests were performed. Subsequently, no adverse reactions were reported. No product quality complaint was involved. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Dysphemia
Clinical narrative: Information has been received from a health professional concerning a 3 year old male who on 27-JUL-2006 was vaccinated with VAQTA. On 24-Mar-2007, the patient began to stammer. The patient received the first vaccine of VAQTA on 27-Jul-2006 and had a similar response which resolved with time. As of 02-Apr-2007, the patient was recovering from his experience. Medical attention was sought. Additional information has been requested.
Age: 1.6
Sex: F
Vaccine: DTAPH, HEPA, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a consumer concerning her daughter an 18 month old female with otitis media since 24-MAR-2007 and reactive airways disease and a history of being a premature baby, gastroenteritis rotavirus, bilateral otitis media and ear tube insertion who on 29-MAR-2007 at 5:30 pm was vaccinated with a dose of VAQTA (lot # 652295/0250U). Concomitant vaccination administered that day included a fourth dose of SYNAGIS (lot # 510134), a dose of IPOL (lot 3Z0548-s), and a dose of TRIHIBIT (lot # C2628AA). Concomitant therapy included PULMICORT, albuterol, CIPRODEX and AUGMENTIN. On 31-MAR-2007 the patient's parent noticed on the right thigh that the three vaccination sites were clearly visible. Two of the sites were flat and the third injection site was raised and hard and red-extending from that site was a 2.5 inch in diameter red area which was hard swollen and warm to the touch. The patient had no fever and was acting normal. The pediatrician was notified. Pain medication was recommended and she was instructed to call back if it became worse. The patient was given acetaminophen and ibuprofen for a day and held a warm wash cloth to the thigh. As of the evening of 01-APR-2007 the area was not as red. The warmth and swelling had resolved but the area around the injection site was still hard and raised. The patient recovered completely on 04-APR-2007. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old female with no allergies and medical history who on 10-APR-2007 was vaccinated IM with 0.5 ml first dose of VAQTA. There was no concomitant medication. On 11-APR-2007 the patient developed a 7x5 mm raised, red itchy area around injection site. Unspecified medical attention was sought. No diagnostic laboratory test were performed. A product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 44 month old male with no known allergies or pertinent medical history who on 12-APR-2007 was vaccinated in his left arm with a 0.5 ml (25U) first dose of VAQTA (lot # 656017/1280F). There were no illnesses at the time of vaccination. There was no concomitant medication. Immediately after vaccination on 12-APR-2007 the patient's arm became swollen and red. The area was reported to be 10 cm x 5 cm. Medical attention was sought and the patient was treated with ice packs and BENADRYL. No lab tests were performed. On 13-APR-2007 the patient recovered from the adverse events. There was no product quality complaint involved. No further information was provided. The physician requested a lot check of the vaccine, a lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information is not expected. This is one of several reports from the same source.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 7-year-old male with no known allergies or pertinent medical history who on 05-APR-2007 was vaccinated in his left arm with a 0.5 ml (25U) first dose of VAQTA (lot# 656017/1280F). There were no illnesses reported at the time of vaccination. There was no concomitant medication. On 07-APR-2007 (previously reported as 10-APR-2007) the patient's left arm was swollen and red at the injection site. Medical attention was sought. The area was reported to be 10 cm x 5 cm. The patient was treated with ice packs and BENADRYL. No lab tests were performed. On 12-APR-2007 the patient recovered from the adverse events. There was no product quality complaint involved. No further information was provided. The physician requested a lot check of the vaccine, a lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information is not expected. This is one of several reports from the same source.
Age: 14.0
Sex: M
Vaccine: DTAP, HEPA, MNQ
Symptoms: Inappropriate schedule of drug administration, Local reaction
Clinical narrative: Information has been received from a physician concerning a 14-year-old male with allergies to SUPRAX, AMOXIL and penicillin who on 16-JAN-2007 was vaccinated in the right arm with the second dose of VAQTA (Lot #656497/1213F). Concomitant vaccinations administered on that same day included the first dose in the right arm of MENACTRA (Lot #U1976AB) and the first dose of DTaP (Lot #C2492BA). There was no illness at the time of vaccination. On 17-JAN-2007, the patient experienced a localized reaction (was not diagnosed as cellulitis). The patient was not seen or treated by the physician. On approximately 19-JAN-2007, the patient recovered from the localized reaction. This is one of several reports from the same source. No further information is available.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Medication error, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a newborn patient who on 22-AUG-2007 was vaccinated IM with a 0.5 ml dose of VAQTA (Lot#657842/0494U) instead of hepatitis B virus vaccine (manufacturer unknown). There were no symptoms reported. This event was a result of human error, not product confusion. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Hepatitis A antibody negative, Vaccination failure
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated in the past (date uncertain) with a dose of VAQTA. At an unspecified date the patient had a "negative titer". The patient sought unspecified medical attention. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with a dose of VAQTA. Subsequently the patient experienced an unspecified reaction. The patient contacted the office. Subsequently, the patient recovered from unspecified reaction to vaccine. No other information was available. No product quality complaint was involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: DTAP, HEPA, JEV, MNQ, PPV, TYP
Symptoms: Anorexia, Chills, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 26 year old with a history of mild asthma who on 18-SEP-2007 was vaccinated with a dose of VAQTA. Concomitant vaccinations administered that same day included a dose of Japanese encephalitis vaccine, a dose of PNEUMOVAX-23, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and dose of MENACTRA, and a dose of typhoid pills. Other concomitant medication included ORTHO EVRA. Subsequently the patient experienced chills, lack of appetite and a fever on an off. It was unknown whether medical attention was sought. No labs or diagnostic studies were performed. The patient was treated with ibuprofen (WYETH) which helped the symptoms subside. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Photosensitivity reaction, Rash generalised, Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 17 year old female who in approximately 2006 was vaccinated with a dose of VAQTA. On that same day, 3 to 4 hours post vaccination the patient developed a measles like rash from her feet to all over her body but not her face. The rash lasted for 2 months and seemed to worsen with sun exposure. The patient sought medical attention at a dermatologist who thought the rash was viral in nature. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a "child" who was vaccinated with a dose of VAQTA on an unspecified date. Subsequently, the patient developed a high fever. It was reported that the child was seen at a local emergency room and the physician there stated that the reason for the high fever was the vaccine. It was unknown if the child was hospitalized, however, it was reported that the child recovered. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 7 day old patient who on 31-OCT-2007 inadvertently received a 0.5 ml intramuscular dose of was vaccinated with VAQTA instead of hepatitis B virus vaccine.  It was reported that the patient had not developed any known symptoms.  The reporter stated that the incident was due to human error and not product confusion.  A product quality complaint was not reported.  Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an 8-month-old male who on 07-NOV-2007 was vaccinated with a 0.5mL dose of VAQTA (Lot # 659187/1259U) instead of a dose of hepatitis B vaccine, recomb (manufacturer unknown). The parents have not notified the office of any adverse effects. No additional information is available. Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: HEPA
Symptoms: Cough, Rhinorrhoea, Sinus congestion, Vomiting
Clinical narrative: Information has been received from a consumer reporting on her 8-month-old male son who on 07-NOV-2007 was vaccinated with a dose of VAQTA.  On an unspecified date the patient experienced vomiting, cough, sinus congestion and a runny nose.  The patient sought medical attention via an office visit.  The patient's mother plans to follow-up with another pediatrician.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a mother concerning her 10 month old daughter who on 12-OCT-2007 was to received RECOMBIVAX HB, (MSD) and was mistakenly given a single dose of VAQTA.  Current patient status was not reported.  A product quality complaint was not reported.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Inappropriate schedule of drug administration, Medication error, No adverse event, Wrong drug administered
Clinical narrative: Information and follow-up information has been received from a physician concerning an 8 week old white male with no pre-existing medical conditions or allergies who on 13-NOV-2007 at 11:30 was inadvertently vaccinated IM with the first "pediatric dose" of VAQTA (lot# 657840/0797U) in the right anterolateral thigh.  There was no illness at the time of vaccination.  On that same day, an order was given for inactivated PEDVAXHIB but the nurse grabbed the vial of VAQTA because the vial and box looked the same as the PEDVAXHIB.  The patient was not experiencing any known symptoms.  The patient did not seek any medical attention.  There was no product quality complaint.  Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 41 year old female with a history of spontaneous hives (cause unknown: occurring since high school) and no drug allergies, who on 12-NOV-2007 was vaccinated IM with a 1 mL dose of VAQTA (lot number: 658170/0760U). There were no concomitant medications. The patient experienced urticaria over the anterior portion of the hips and buttocks the same say of vaccination. The patient was administered over the counter BENADRYL for the event. The nurse reported that on 21-NOV-2007 the patient came into the office to receive hepatitis B virus vaccine rHBsAg (yeast) (MSD) and still had the hives so the patient did not receive the vaccine. There were no lab diagnostic studies performed. The patient did not received any further VAQTA. There was no product quality complaint. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 41 year old Asian female who on 12-NOV-2007 was vaccinated with a dose of VAQTA (lot#658170/0760U) intramuscularly in the left deltoid.  On 12-NOV-2007 the patient experienced hives on buttocks and hips bilaterally.  Subsequently, the patient recovered.  No further information is available.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A, Laboratory test, Malaise, Pyrexia, Vaccination failure
Clinical narrative: Information has been received from a registered nurse concerning a 43 year old female with a history of type 2 diabetes and no drug reactions/allergies, who on 05-JAN-2001 was vaccinated IM with a first "standard" dose of VAQTA (lot number: 630782/0896K).  On 06-JUL-2001 the patient was vaccinated with a second dose of VAQTA (lot number: 630781/1362X).  Concomitant therapy included metformin, AMARYL and PREVACID.  Nurse reported that an employee who received the vaccination series was diagnosed with hepatitis A in October 2007.  Nurse not sure if VAQTA was the brand used, but she provided the lot numbers.  The patient sought unspecified medical attention through her primary care physician with symptoms of malaise and fever and was diagnosed with hepatitis A after lab diagnostic studies (unspecified) were performed.  Patient did not have any jaundice.  No other details.  The outcome was reported as not recovered.  There was no product quality complaint.  Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Neurological symptom
Clinical narrative: Information has been received from a registered nurse concerning a male who was vaccinated with a dose of VAQTA.  On that same day, the patient experienced neurological symptoms.  The patient contacted the nurse for medical attention.  The outcome was unknown.  There was no product quality complaint.  This is one of two reports from the same patient.  Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Exposure to communicable disease, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an approximately over 60 year old male with a history of hepatitis A exposure in approximately 2007 who on 19-JUN-2007 was vaccinated with his first dose of VAQTA after hepatitis A exposure.  On 21-NOV-2007 the patient was administered with the second dose of VAQTA too soon.  No adverse reaction was noted.  Medical attention was sought in the physician's office.  There was no product quality complaint.  No further information is available.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 4 year old patient who on 18-DEC-2007 was vaccinated with two 0.5 ml doses of VAQTA (no lot numbers provided) rather than one dose.  The patient was to receive a "handful of other vaccines and accidentally vaccinated with 2 of the same."  It was unknown whether medical attention was sought.  There was no product quality complaint.  Follow-up information from a pediatric office indicated that the 4 year old male was given the first and second doses of VAQTA (lot# 657842/0494U) in the left anterolateral thigh by mistake at his 4 year check-up.  There was no illness at the time of vaccination.  The patient was supposed to receive a dose of MMR II and a dose of VAQTA.  It was also noted that the patient's sibling was to receive the other dose of VAQTA.  The patient did not seek medical attention.  No labs or diagnostic studies were performed.  Subsequently the patient recovered.  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 3 year old male who in October 2007, was vaccinated IM with a 0.5 ml dose of VAQTA (no lot number provided). Suspect vaccination at that time included a dose of influenza virus vaccine (unspecified) ("Flu shot"). Subsequently the patient developed injection site swelling and redness. The patient sought unspecified medical attention and was noted to be "improved." There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a practice manager concerning a patient who was vaccinated with a third dose of VAQTA instead of the flu vaccine. It was reported the pediatric patient was difficult to control before vaccination and was accidentally vaccinated with VAQTA instead of the flu vaccination when the nurse was trying to restrain him.  The child was previously vaccinated with VAQTA in 2003 and 2004. There were no symptoms noted. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a healthcare worker (office manager) concerning a patient who on an unspecified date was vaccinated with VAQTA. Concomitant suspect vaccination included VARIVAX. Subsequently the patient developed " knots" at the injection site. It was unknown if the patient recovered. No further information was available. Additional information has been requested.
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a healthcare worker (office manager) concerning a patient who on an unspecified date was vaccinated with VAQTA.  Concomitant suspect vaccination included VARIVAX.  Subsequently the patient developed "knots" at the injection site.  It was unknown if the patient recovered.  No further information was available.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose VAQTA. Subsequently the patient experienced an unspecified allergic reaction to the vaccine. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: DTAP, HEPA, HIBV
Symptoms: Pyrexia, Visual disturbance
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with a dose of VAQTA this past summer, 2007.  Concomitant vaccinations given at the same time included a dose of DTPA (unspecified) and a dose of HIB (unspecified carrier).  On an unspecified date following vaccinations, in the summer of 2007, the patient experienced fever and difficulty focusing.  No outcomes were reported.  No product quality complaint was involved.  Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Food intolerance, Hepatitis A antibody negative, Hepatitis viral, Hepatomegaly
Clinical narrative: Information has been received from a female consumer with sulfonamide allergy who on 01-MAY-2006 was vaccinated with a dose of VAQTA (lot# 652507/0886R). The patient also noted that she may have received HAVRIX. On approximately 15-MAY-2006 two to four weeks after vaccination, the patient's liver swelled nd she experienced hepatitis symptoms. The patient also experienced exhaustion, pain and severe food sensitivity. The patient sought medical attention through a physician. Lab diagnostic studies performed included a blood test and hepatitis tests. The patient was not recovered at the time of this report. There was no product quality complaint. Follow-up information on 24-MAR-2008: The consumer reported she was told by the health department that she received HAVRIX (lot # "0886R"). Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Laboratory test, Pain
Clinical narrative: Information has been received from a female consumer with sulfonamide allergy who on 01-MAY-2006 was vaccinated with a dose of VAQTA (lot# 652507/0886R). The patient also noted that she may have received HAVRIX. On approximately 15-MAY-2006 two to four weeks after vaccination, the patient's liver swelled nd she experienced hepatitis symptoms. The patient also experienced exhaustion, pain and severe food sensitivity. The patient sought medical attention through a physician. Lab diagnostic studies performed included a blood test and hepatitis tests. The patient was not recovered at the time of this report. There was no product quality complaint. Follow-up information on 24-MAR-2008: The consumer reported she was told by the health department that she received HAVRIX (lot # "0886R"). Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from an office manager concerning a 3-month-old male who on 25-JAN-2008 was vaccinated intramuscularly with a 0.5 ml dose of VAQTA (659187/1259U) instead of a dose of hepatitis B virus vaccine.  The reason for the product confusion was employee error.  No further information why this occurred was available because the employee no longer works there.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 17 year old male who was vaccinated with a single dose of VAQTA. Concomitant vaccines administered the same day included MENACTRA. The patient developed a high fever of 104 degrees fahrenheit and was hospitalized for an unspecified amount of time after receiving a dose of VAQTA. The event was considered to be a significant disability. Subsequently, the patient recovered. No product quality complaint was involved. The event was considered to be immediately life-threatening and an other important medical event by the reporter. Additional information has been requested.
Age: 0.92
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Inappropriate schedule of drug administration, Oedema peripheral, Rash, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an 11-month-old female, who in December 2006, was vaccinated with a dose of VAQTA. Suspect vaccination included PROQUAD (Oka/Merck upgrade process) (MSD). It was reported that the patient developed swelling in her extremities, hives and rash and was hospitalised for five days. The patient's status was unknown. No product quality was involved. This information is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Anaphylactic reaction, Cough, Paraesthesia, Throat tightness
Clinical narrative: Information has been received from a physician concerning an 18-year-old male with no pertinent medical history who is "highly allergic" to dairy, who on 12-JUL-2007 was vaccinated intramuscularly with a 0.5 milliliter first dose of VAQTA  (lot # 657307/0442U). Concomitant vaccination included a dose of ADACEL. Within 20 minutes of leaving the office the patient began to experience an anaphylactic reaction: coughing and tingling and tightness of his throat. The patient administered EPI-PEN and BENADRYL to himself and was taken to the emergency room. He was treated with intravenous steroids and monitored prior to being discharged home with a prescription to prednisone for 2 days. On 13-Jul-2007 the physician spoke with the patient who stated he had not experienced any further problems. No product quality complaint was involved. The reporter considered the events to be life threatening. Lot check results received on 02-Aug-2007: 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 government and was released by the regulatory agency. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: DTAP, HEPA, MMRV
Symptoms: Swelling, Urticaria
Clinical narrative: Information has been received from a physician concerning a female with a history of failure to thrive and no drug reactions/allergies who in May 2007, was vaccinated with a dose of VAQTA. Concomitant therapy included a dose of PROQUAD (Oka/Merck upgrade process) (MSD) and a dose of DTaP (unspecified). After the patient went home, she developed generalized hives and swelling. She returned to the pediatrician's office where she received epinephrine, steroids, and BENADRYL. Subsequently, the patient recovered. There were no lab diagnostic studies performed. There was no product quality complaint. The events were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 1.56
Sex: F
Vaccine: HEPA
Symptoms: Abnormal faeces, Diarrhoea, Incorrect dose administered, Pallor
Clinical narrative: Information has been received from a pharmacist concerning an 18 month old female with no medical history or allergies who on 20-MAR-2008 was vaccinated IM with two doses of VAQTA.  There was no concomitant medication.  It was reported that the patient received the two doses at her 18 month old wellness check.  Her appearance was noted to be more pale than usual.  No diagnostic laboratory tests were performed.  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  Additional information has been received which indicated that on 21-MAR-2008 at 09:00 AM, the patient had diarrhea and very foul stools. It was reported that the patient was given TYLENOL one hour prior to the patient's wellness check on 20-MAR-2008. The patient recovered on 09-APR-2008. No further information is expected. requested.
Age: 1.1
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Staring
Clinical narrative: Information has been received from a healthcare worker (office manger) concerning a 13 month old white male with "NKA" who on 05-OCT-2007 was vaccinated with a second dose of PROQUAD (lot number: 658032/0985U) in the left thigh. On 05-OCT-2007 at 7:00 the patient's mother stated that the patient laid around and started. The patient had an elevated temperature of 102-104. There was no relevant diagnostic tests and laboratory data. There was no illness at time of vaccination (health child). The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician concerning a 43 year old male smoker who in June 2007, was vaccinated with a first dose of VATQA (lot # 657842/0494U), and a second dose VAQTA (lot # 657842/0494U) in July 2007. Concomitant therapy included hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown), and PRILOSEC. On an unknown date the patient has experienced fatigue, which was noted to have been "discovered in office chart review". At the time of reporting the patients status was unknown. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Diarrhoea, Expired drug administered, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 12 month old white male, with a history of diarrhea, who on 18-JAN-2007 was vaccinated with a subcutaneous expired first dose in the left anterior thigh of MMR II (Lot# 648157/0603R).  Concomitant vaccines administered on the same day included a dose of VARIVAX and a dose of PREVNAR.  The patient was noted to have diarrhea at the time of vaccination.  There were no adverse events following prior vaccination.  It was reported that the patient experienced additional diarrhea for two weeks from 18-JAN-2007.  The patient was reported to be recovered on 15-FEB-2007.  There were no laboratory or diagnostic tests performed.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles, Vaccination failure
Clinical narrative: Information has been received from a health care professional concerning a patient with a history of slight immunocomprimise who was vaccinated with a dose of MMR II. Subsequently "a couple of weeks ago" in March 2007 the patient developed measles. The patient was administered immunoglobulin. The patient's present status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Malabsorption, Measles antibody, Mumps antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old male, with no medical history or allergies, who was vaccinated with a first dose of MMR II, in 1984 and 1991 respectively. There were no concomitant medications. Subsequently, the patient had not seroconverted for mumps antibody. Lab diagnostic studies performed: antibody testing for measles, mumps and rubella. It was reported that the nurse "will administer another dose of MMR II". There was no product quality complaint involved. On 02-APR-2007 the patient experienced malabsorption. Additional information has been requested.
Age: 32.0
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative, Vaccination failure
Clinical narrative: Information has been received from a health professional concerning a 32 year old patient who was vaccinated with a dose of MMR II.  Subsequently, the patient experienced a low mumps titer.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Injection site cyst
Clinical narrative: Information has been received from a health professional concerning a 22 year old female with no known allergies who, "21 years ago," in approximately 1986, was vaccinated with a dose of MMR II.  Post vaccination the patient developed a cyst at the injection site.  The patient recovered.  At the time of this report, no other information was available.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information is not expected.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, No adverse event, Rubella antibody negative
Clinical narrative: Information has been received from a female pharmacist who at the age of 13, in approximately 1991, was vaccinated subcutaneously with her second dose of 0.5 ml MMR II.  The pharmacist does not recall at what age she received her first dose of MMR II.  In JUL-2006 the patient underwent a titer test.  The results showed no immunity to any of the vaccine components.  The pharmacist was vaccinated subcutaneously with her third dose of MMR II in AUG 2006.  A subsequent titer test was performed which showed that she was immune.  The pharmacist did not know if she had seroconverted after she received the vaccine as a child.  No reaction was reported with this vaccination.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Vaccination failure
Clinical narrative: Information has been received from a female pharmacist who at the age of 13, in approximately 1991, was vaccinated subcutaneously with her second dose of 0.5 ml MMR II.  The pharmacist does not recall at what age she received her first dose of MMR II.  In JUL-2006 the patient underwent a titer test.  The results showed no immunity to any of the vaccine components.  The pharmacist was vaccinated subcutaneously with her third dose of MMR II in AUG 2006.  A subsequent titer test was performed which showed that she was immune.  The pharmacist did not know if she had seroconverted after she received the vaccine as a child.  No reaction was reported with this vaccination.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning an 18-week-old patient who on 01-SEP-2006 was vaccinated with a subcutaneous injection of a dose of MMR II instead of hib conj vaccine (OMPC). The health professional states this was not "confusion" between the two vaccines. No problems were reported. It is unspecified if medical attention was sought. No product quality complaint was involved. Follow up information received from a doctor states "inadequate patient information. We know of no adverse reaction recently". No more information is expected.
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Blood pressure increased, Dizziness, Hyperhidrosis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 48 year old male with diabetes and asthma and no allergies who on 11-APR-2007 was vaccinated SC with a dose of MMR II. Concomitant therapy included unspecified anti-inflammatory drugs. On 19-APR-2007 the patient received second dose of MMR II (Lot# 654985/1181F) about 1 week after first vaccination. The first vaccination was not documented resulting in the second vaccination. The patient experienced dizziness and was diaphoretic immediately after vaccination. The patient's blood pressure was slightly elevated. The patient was sent to the Emergency room for evaluation. No diagnostic laboratory tests were performed. At the time of report, the patient has not recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a person working in a physician's office concerning a patient, with no medical history and no allergies, who on 22-JAN-2007 was vaccinated with a first subcutaneous dose of MMR II (Lot# 651035/1047R). There was no illness at the time of vaccination. On 01-FEB-2007 the patent experienced fever for 5 days, and then, on 05-FEB-2007 the patient developed a skin rash. After one week, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative, Vaccination failure
Clinical narrative: Information has been received from a female consumer who in 1995 thinks she was vaccinated with MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3.  She reports that she was tested for antibodies "against MMR viruses" and the test showed she had low antibodies or no antibodies, the reporter was uncertain.  The consumer reported that her immunization records show she received MMR in 1978 and measles + rubella in 1989.  The consumer reported that her physician wants to get revaccinated because she is interested in becoming pregnant.  There was no product quality complaint.  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 5 year old female with no allergies and no medical history who on 08-APR-2003 was vaccinated with a 0.5ml subcutaneous dose in the right leg of MMR (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Lot #644234/0925M).  "Two weeks after the administration of the vaccine", on approximately 22-APR-2003, the patient developed a rash and fever. Subsequently, the patient recovered.  No other details were provided at the time of this report.  Unspecified medical attention was sought.  No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 26-APR-2007 was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There were no concomitant medications. Seven days after receiving the measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), on 03-MAY-2007, the patient developed a generalized "measles like" rash (number of lesions unspecified). No other information was available at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.