chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: SMALL, TDAP, SMALL, TDAP
Symptoms: Dyspnoea, Haematemesis, Pulmonary infarction, Thrombosis
Clinical narrative: Was having a hard time breathing, went to clinic let them know about shots recieved and stuff. The PA did a chest xray and thought my condition was pneumonia and prescribed antibiotics. A week later started to spit blood when I started coughing. Went to the ER and they though I had TB, pneumonia, Hepatitis and then did a CAT scan and found a blood clot in left lung with infact, and the right was smaller. Did the scan on legs and hip area and found no area where a clot may of broke off. Presently on blood thinners (warfarin) until September.
Age: 52.0
Sex: M
Vaccine: FLU3, HEPA, IPV, MMR
Symptoms: Rash
Clinical narrative: rash
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint swelling, Pain
Clinical narrative: swelling in joints, severe pain
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Haemoglobin decreased, Laboratory test, Packed red blood cell transfusion, Pallor, Weight gain poor
Clinical narrative: This male subject was enrolled in a prophylactic study. On 16 February 2011, he received the 1st, 2nd dose of Sanofi Pasteur's PENTACEL (IM R thigh), ENGERIX B (IM L thigh), Wyeth's PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 10 May 2011, 83 days after the 1st dose of PENTACEL, 83 days after the 1st dose of ROTARIX, 83 days after the 1st dose of ENGERIX B, 83 days after the 1st dose of PREVNAR 13, this four-month-old subject developed pallor, low hemoglobin. The subject was hospitalised and the event was disabling. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the pallor, low hemoglobin may have been caused by PENTACEL, ROTARIX, ENGERIX B and PREVNAR 13 and that the event was possibly due to rule out viral infection, diamond black fan anemia and transient. Investigator Comments: Subject presented to the clinic on follow up for poor weight gain on 10May2011, it was noticed by the primary investigator that the subjects color was pallor. Hemoglobin was performed and was found to be significantly low at 4.4 g/dl, the subject was sent to the hospital for admission. Upon admission a 1/2 of a unit of packed red blood cells was administered followed by 2 more transfusions over the next day for a total of 3 transfusions. More labs were ran and a hematologist was contacted for consult. Upon review of labs he was unable to make a definitive diagnosis and would like to rule out Diamond blackfan anemia, Transient Erdythroblastopenia or viral illness. Child was discharged on 11May2011 and will follow up with primary investigator in 3 weeks, at that time more labs will be ran with hope to have a final diagnosis. Primary Investigator is unable to rule out possibility to vaccinations.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Disorientation, Dizziness, Syncope
Clinical narrative: Roughly 1-2 hrs after injection pt felt - disoriented - chills - dizzy - fainted. Pt was then taken to the ER.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Patient developed cellulitis of left arm (site of Tdap injection) 4 hours after injection and small local reaction (redness & swelling) of right arm (site of VARIVAX injection) treated with cold compress, BENADRYL, oral antibiotic.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Chills, Nausea, Oedema peripheral, Pain
Clinical narrative: Client stated that by the time she got home - about 6:00 pm she was experiencing chills, severe body aches, nausea, vomited x 2, swollen and tender arm; unable to undress. Ct developed a fever; 101 degrees F treat it with Ibuprofen. Ct stated the fever broke at about 0200 am on 5/18/11. At 1526 on 5/19/11 ct stated to be feeling "much better" and experiencing "normal soreness". Phone call to client on 5/23/11. Ct stated to have completely recovered.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Tenderness, Vomiting
Clinical narrative: Client stated that by the time she got home - about 6:00 pm she was experiencing chills, severe body aches, nausea, vomited x 2, swollen and tender arm; unable to undress. Ct developed a fever; 101 degrees F treat it with Ibuprofen. Ct stated the fever broke at about 0200 am on 5/18/11. At 1526 on 5/19/11 ct stated to be feeling "much better" and experiencing "normal soreness". Phone call to client on 5/23/11. Ct stated to have completely recovered.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Cellulitis - injectoin site - started with rash, redness & pain in the area. Prescribed Cephalexin 500 mg 1 TID x 10 days. Also had feverish feeling the day after injection.
Age: 21.0
Sex: M
Vaccine: YF
Symptoms: Chest discomfort, Dyspnoea, Oropharyngeal pain, Throat irritation, Throat tightness
Clinical narrative: Approx 40 min after YF injection client driving home began having symptoms of sore throat, itchiness & need to clear his throat. Within 15 min after that he began to experienced chest tightness & throat tightness & difficulty breathing. Taken by mom to urgent care & given IV prednisone, BENADRYL, epinephrine. Discharged about 3-3 1/2 hrs later with ZYRTEC & BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid swelling < 24 hours s/p immunization warm, painful, with red bump.
Age: 1.8
Sex: M
Vaccine: DTAP, IPV, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: (L) thigh area diffuse deep pink inflammation with central punctate spot. Red, swollen.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blood test normal, Chills, Fatigue, Pain
Clinical narrative: Pt. had ongoing exhaustion, body aches, chills & fever upon receiving the GARDASIL immunization. He missed several days of school/went in late due to exhaustion. These symptoms were most pronounced 1-3 wks after the shot. I took him to his doctor on 4/18/11 to request blood work and see if he was anemic.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Pt. had ongoing exhaustion, body aches, chills & fever upon receiving the GARDASIL immunization. He missed several days of school/went in late due to exhaustion. These symptoms were most pronounced 1-3 wks after the shot. I took him to his doctor on 4/18/11 to request blood work and see if he was anemic.
Age: 25.0
Sex: F
Vaccine: HEPA, PPV, TDAP
Symptoms: Headache, Nausea, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Acute left arm swelling, pain over deltoid. Fever to 103, headaches, nausea, vomiting, diffuse aches.
Age: 25.0
Sex: F
Vaccine: HEPA, PPV, TDAP
Symptoms: Vomiting
Clinical narrative: Acute left arm swelling, pain over deltoid. Fever to 103, headaches, nausea, vomiting, diffuse aches.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmth & redness to (L) deltoid area. Tx: ice & Ibuprofen.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration
Clinical narrative: 8cm diameter indurated, erythematous, circumferential reaction.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Cold sweat, Fall, Feeling hot, Head injury
Clinical narrative: Child went to mother's classroom after receiving shots. Fainted - fell backwards on head. Had only strawberry milk for breakfast. Just finished P.E. class - was hot sweaty. Mom stated was "out" about minute. Was awake, warm, clammy when I reached room. Mom took to M.D. later that day. Missed next day. School nurse reported child vomited - thought maybe virus rather than from head injury.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Skin warm, Syncope, Vomiting
Clinical narrative: Child went to mother's classroom after receiving shots. Fainted - fell backwards on head. Had only strawberry milk for breakfast. Just finished P.E. class - was hot sweaty. Mom stated was "out" about minute. Was awake, warm, clammy when I reached room. Mom took to M.D. later that day. Missed next day. School nurse reported child vomited - thought maybe virus rather than from head injury.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling, Vaccination complication
Clinical narrative: Rxn to pneumonia shot. Left upper arm redness/swelling. Pharmacy: ATARAX 25 mg, MEDROL Dose pak, AUGMENTIN 875 mg.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Computerised tomogram abnormal, Full blood count normal, Inflammation, Mumps antibody test, Swelling face
Clinical narrative: (R) facial swelling; No T; CT scan (+) (R) parotid inflammation. CBC ok; clindamycin, AUGMENTIN.
Age: 0.76
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 9 month old infant patient who on 12-APR-2010 was vaccinated with a dose of VAQTA instead of hepatitis B virus vaccine because the products looked the same. The reporter stated that the VAQTA "had the same looking packaging as the hepatitis B virus vaccine". No adverse effects were reported. Follow up information received from a registered medical assistant. It was reported that the 9 month old infant patient pre-existing allergies, birth defects, medical conditions and no illness at time of vaccination, who on 12-APR-2010 was vaccinated with a first dose of VAQTA (lot # 666030/1397Y, IM) instead of hepatitis B virus vaccine. There were no labs or diagnostic tests performed. No adverse effects were reported. This is an amended report. The answers to the questions of where the patient was vaccinated at and what the vaccine was purchased with were updated. Additional information is not expected.
Age: 0.79
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a child who on 27-APR-2010 was supposed to get hepatitis B virus vaccine but was vaccinated IM with 0.5 ml dosed of VAQTA by accident. The patient was not experiencing any known symptoms. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician's assistant concerning a 9 year old female patient who on 05-MAY-2010 was vaccinated with a dose of pediatric VAQTA (lot# not reported). On 05-MAY-2010, shortly after receiving the vaccination, the patient developed pain at the injection site. No medical attention was sought. At the time of this report, the patient had recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female patient who "one or two months ago" approximately in March 2010, received a second adult dose of VAQTA (Lot # 666802/1684Y). The child's mother noted that on a computer generated record it said that the child received a dose of GARDASIL (Lot # 662304/1013Y) but on the hand written medical legal record it was recorded as VAQTA (Lot # not recorded on the chart). No adverse reaction was noted. The first dose of VAQTA was given on 02-SEP-2005. The patient sought unspecified medical attention. Follow up information has been received from the registered nurse who reported that the medical assistant was 95% sure she gave the patient a dose of pediatric VAQTA and that there was a clerical error in which HPV vaccine printed out on the record. It was reported that the parent wanted to be 100 percent sure her child did not receive GARDASIL but there were no commercially available test for this. Also since this would have been the second dose of VAQTA it would be pointless to run hepatitis A antibody testing. There was no adverse reaction in this case. No further information is available.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site swelling, Oedema peripheral, Tic
Clinical narrative: Information has been received from a physician concerning a 14 year old daughter with asthma, and allergies to penicillin and amoxicillin who 1 and ? years ago (in November 2008), was vaccinated intramuscularly with a pediatric dose of VAQTA. On 15-MAY-2010, the physician administered her daughter's second pediatric dose of VAQTA in her right arm. Concomitant therapy included montelukast sodium. Subsequently, her daughter developed swelling of the injected arm about 8cm. The physician mentioned that her daughter had swelling after every vaccination, but the worse than others before. Her daughter developed a bilateral tic of the periorbital muscles on Sunday (16-MAY-2010). She also stated that she was better today but not resolved. No laboratory diagnostics studies were performed. Additional information is not expected.
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a "young" female patient who "last week", on approximately 12-MAY-2010 was vaccinated with a pediatric dose of VAQTA (lot number not reported). "Last week, after getting the vaccine", on approximately 12-MAY-2010 the patient experienced a 104 degree fever. Unspecified medical attention was sought. No lab studies were performed. The outcome of the patient was not reported. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 9 month old female infant who on 26-MAY-2010 was inadvertently vaccinated with a dose of VAQTA (lot # 667009/0095Z) instead of hepatitis B virus vaccine due to human error. This was not a PQC. No adverse symptoms noted. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 59 day old male patient who on 14-JUN-2010 was vaccinated with a dose of VAQTA instead of hepatitis B virus vaccine (dose and lot #667261/0261Z). Suspect vaccine included ROTATEQ (date, dose and lot not reported). Other concomitant vaccine included a dose of DTaP, a dose of PREVNAR, a dose of HIB (unspecified carrier) and a dose of poliovirus vaccine and ROTATEQ (dates, doses and lot numbers not reported). The physician reported that was a human error and was not product confusion. No adverse symptoms noted. The patient sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis A, Hepatitis A virus test positive
Clinical narrative: Information has been received from a registered nurse concerning a patient who received complete series of VAQTA and had tested positive for Hepatitis A. It was unknown if the patient sought medical attention. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Incorrect dose administered, Nasopharyngitis, Vomiting
Clinical narrative: Information has been received from a physician concerning a 24 months old male patient who in approximately June 2009 was vaccinated with the first dose of VAQTA, IM at 12 months of age, and his second dose at 18 months of age, in approximately January 2010. Inadvertently, the patient received a third dose of VAQTA "this week", at the 24 months of age, on approximately 21-JUN-2010. No adverse effects were reported. The patient did not seek medical attention. Follow up information has been received from a physician concerning the patient with a history of cleft lip repair and no illness at the time of vaccination, who on 23-JUN-2010 at 11:00 a.m., was vaccinated IM with an "extra" dose of VAQTA (lot# 665164/1100Y) in his right thigh and a second SC dose of MMR II, in his left thigh. On approximately 26-JUN-2010, "3-4" days later, the patient had vomiting and cold. The physician considered the events to be not serious and did not require emergency room or doctor visit. At the time of the report, the outcome of the patient was unknown. Additional information is not expected.
Age: 0.76
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from an office assistant and a nurse concerning a 9 month old patient who on 28-JUN-2010 at less than 12 months of age was vaccinated intramuscularly with the first dose of 0.5 mL dose of VAQTA (LOT# 667261/0261Z, expiration 19-DEC-2012). The patient was not experiencing any known symptoms. No further is available at this time of reporting. Follow-up information has been received from a registered nurse concerning the 9 month old female patient with no illness at time of vaccination and no pre-existing allergies, birth effects and medical conditions who on 28-JUN-2010 (also reported on 29-JUN-2010) at 11:30 was vaccinated intramuscularly at quadriceps of right arm with the first dose of VAQTA. It was reported that the patient was given hepatitis A vaccine instead of hepatitis B vaccine at 9 months of age. Patient experienced no adverse reactions. There were no relevant diagnostic tests and laboratory data. No further information is available.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning an 18 month old patient who on 22-JUN-2010 was vaccinated with a first pediatric dose of VAQTA (Lot# 667261/0261Z). The nurse reported that the patient developed a severe rash the morning after administration of VAQTA. The patient was examined in the office on 23-JUN-2010 and 25-JUN-2010. The rash was located on the anterolateral thigh and across the trunk. At the time of this report, the patient's outcome was unspecified. Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an 1 month old male who on an unspecified date was vaccinated with a dose of VAQTA (Lot #666030/1397Y) instead of hepatitis B vaccine. No information was provided as to how the patient was presently doing. No further information was provided. No medical attention was sought. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Antibody test, Coxsackie viral infection, Coxsackie virus test positive, Haematology test, Oropharyngeal pain
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and no known drug reactions or allergies who in 2007 was vaccinated with the first dose of VAQTA (Lot # not valid). There was no concomitant medication. The physician reported the patient was vaccinated with the second dose of VAQTA on 23-JUL-2010 and on 26-JUL-2010, the patient was seen at the office with sore throat and rash on her extremities and trunk, but not on her hands or face. The next day, on 27-JUL-2010, the patient went to the ER due to facial swelling and was placed on prednisone (manufacturer unspecified) for allergies and released. The patient developed a rash all over her body. The physician stated blood titers were drawn and the patient also showed recent infection with Coxsackie B, so he stated there were confounding factors. The patient had had follow up with dermatologist and allergist. At the time of the report the patient was recovering. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Rash generalised, Swelling face
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and no known drug reactions or allergies who in 2007 was vaccinated with the first dose of VAQTA (Lot # not valid). There was no concomitant medication. The physician reported the patient was vaccinated with the second dose of VAQTA on 23-JUL-2010 and on 26-JUL-2010, the patient was seen at the office with sore throat and rash on her extremities and trunk, but not on her hands or face. The next day, on 27-JUL-2010, the patient went to the ER due to facial swelling and was placed on prednisone (manufacturer unspecified) for allergies and released. The patient developed a rash all over her body. The physician stated blood titers were drawn and the patient also showed recent infection with Coxsackie B, so he stated there were confounding factors. The patient had had follow up with dermatologist and allergist. At the time of the report the patient was recovering. Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 31 day old male patient with no pertinent medical history and no drug reactions/allergies who on 11-AUG-2010, was accidentally vaccinated IM in the thigh with a first pediatric dose of VAQTA (Lot#: not reported) instead of hepatitis B virus vaccine. There was no concomitant medication and no lab diagnostics studies were performed. The registered nurse stated that the patient was in the office for 10 -15 minutes and no adverse effect was noted in that time period. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 24 month old female who on 03-AUG-2009 was vaccinated with the first dose of VAQTA with no problems, and the second dose (lot # 668349/0795Z) was given on 09-AUG-2010. On 11-AUG-2010 the patient's mother called to report a fever of 102 degrees Fahrenheit and was told to wait and see how it resolves. On 13-AUG-2010 the patient came in to an office visit and had a visible facial rash and was still febrile with an unknown temperature. This AE is recorded according to the second dose that was given on 09-AUG-2010. At the time of reporting, the patient's status was unknown. Additional information has been requested.
Age: 1.66
Sex: F
Vaccine: HEPA
Symptoms: Irritability, Pyrexia, Streptococcus test negative, Swelling face
Clinical narrative: Information has been received from a physician concerning a 19 month old female who on 28-JUL-2010 was vaccinated with the first dose of VAQTA. On 29-JUL-2010, the patient presented to the office with a fever of 102 degrees Fahrenheit. They were told to watch and wait regarding the fever. On 31-JUL-2010 the patient presented to the office again, and although afebrile, was irritable and had a swollen face. At this point, the patient was tested for strep which came back negative and was given ORAPRED and AUGMENTIN. This AE is recorded in regards to the VAQTA. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Age: 1.51
Sex: M
Vaccine: HEPA
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning an 18 month old male patient with possible asthma and a history of bronchitis who on 22-JUN-2010 was vaccinated with the first dose of VAQTA (lot#667261/0261Z). On 22-JUN-2010 the patient developed a body rash. On 23-JUN-2010, the patient presented to the physician's office and was prescribed ORAPRED for the rash as well as BENADRYL. The patient made a return visit on 02-JUL-2010 for a separate unknown reason, however his issue with the body rash had resolved. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Information has been received from a physician concerning his 9 year old son who at the end of 2008 was vaccinated with first dose of VAQTA (Lot # not provided). In June 2009 and on 17-AUG-2010 the patient received the second and third dose of VAQTA (Lot # not provided). The patient has no relevant medical history, concomitant medications or relevant past drug history. On 17-AUG-2009 the patient received the third dose into his left arm. On 18-AUG-2010, the patient had one episode of bloody diarrhea. It was unknown if there was any relevant laboratory data. As of 18-AUG-2010, it was unknown if the patient will continue to receive VAQTA and he did not experience bloody diarrhea at the time of this report. Additional information has been requested.
Age: 0.01
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received an office manager concerning 3 day old newborn female who on 03-SEP-2010 was inadvertently vaccinated with VAQTA (lot # not reported) instead of hepatitis B virus vaccine due to staff error. No adverse effects reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.09
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 34 day old patient who on 01-OCT-2010 was vaccinated intramuscularly with a 0.5 ml dose of VAQTA (Lot # no reported) instead of hepatitis B virus vaccine. No adverse reactions were reported. Follow up information had been received from the medical assistant concerning a 34 day old male patient who on 01-OCT-2010 was vaccinated with a first dose of VAQTA (Lot # 667859/0569Z) in the left. No adverse reactions were reported. Additional information is not expected.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed nurse of practice concerning a 6 month old patient who on 05-JUL-2010 was inadvertently vaccinated with VAQTA IM. The office meant to administer "ENGERIX". Thus the patient missed the dose of "ENGERIX". No known adverse effect. It is unspecified the patient sought medical attention. Follow up information on 26-OCT-2010 has been received from the nurse who reported that a 6 month old male with no illness at time of vaccination, no allergy, no birth defects who on 05-JUL-2010 was vaccinated with the first dose of VAQTA (lot # 666550/1537Y) IM on left arm. Suspect therapy included the third dose of ROTATEQ (lot # 665161/1632Y). Other concomitant vaccines included the third dose of PENTACEL (lot # C31016AH) IM right arm and the third dose of PREVNAR 13 (Pfizer) (lot# E47473) IM left arm. No lab was performed. The patient experienced no adverse reaction to these vaccines. No further information is available.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Allergy test negative, Full blood count normal, Irritable bowel syndrome, Paraesthesia oral
Clinical narrative: Information has been received from a medical assistant concerning a 13 year old female with no pertinent medical history and no known drug allergies who on 31-JUL-2009 was vaccinated intramuscularly with the first 0.5 mL dose of VAQTA (LOT# 663913/0206Y) and on 28-SEP-2010 was vaccinated intramuscularly (IM) with the second 0.5 mL dose of dose of VAQTA (LOT# 668749/0988Z). There was no concomitant medication. On 28-SEP-2010 that evening after receiving her second dose of VAQTA the patient experienced stomach cramping. She was experiencing irritable bowel like symptom such as diarrhea after eating. On 01-OCT-2010 the patient experienced tingling in her tongue for 20 minutes The complete blood cell count "CBC" was tested for possible nut allergy. Unspecified medical attention was sought. At this time of reporting, the patient has not recovered. Follow-up information has been received from the medical assistant concerning the 13 year old female student with no illness at time of vaccination who on 29-SEP-2010 (previous reported as on 28-SEP-2010 that evening) after receiving VAQTA (IM left arm, LOT# 668749/0988Z) experienced abdominal pain. The patient put on calcium carbonate (+) famotidine (+) magnesium hydroxide daily. Food radioallergosorbent test (RAST) nut allergies done which was all negative. Ultrasound of gallbladder was pending. Complete blood cell count was within normal range. At the time of this report, the patient was still having some symptoms. Follow-up information has been received from the medical assistant who reported that the patient was no longer having abdominal pain as of 11-NOV-2010. No further information is available.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood bilirubin unconjugated increased
Clinical narrative: Information has been received from a physician concerning a 17 year old male patient who on an unspecified date was vaccinated with a pediatric dose of VAQTA (Lot # and route not reported). The physician reported that despite vaccination, on an unknown date the patient still contracted Hepatitis A. At the time of the report, the outcome of the patient was not reported. The patient sought unspecified medical attention. Follow up information was received from the physician who reported that on 08-CT-2010 at 8:30 am, the patient was vaccinated intramuscularly into the right arm with the second dose of VAQTA (Lot # 666802/1684Y). The physician reported that the patient developed hemolytic anemia due to  Hepatitis A infection, which was confirmed by an Hep. A antibodies test, and Epstein-Barr virus infection. A blood test performed on 08-OCT-2010 showed: Red blood cell count 3.39, Blood hemoglobin test 10.2L, Whole blood hematocrit 29.1 M, ean platelet volume 8.9, Neutrophil count 26, Lymphocyte count 55 Reticulocyte count 6.4, Blood reticulocyte count 0.22, Glucose test 140, Plasma carbon dioxide test 31, Bilirubin test 3.1, Indirect plasma bilirubin test 2.8, LHD 2224, AST 49, ALK PHOS 95, ALT 61. Hepatitis A Antibody test- Reactive positive. At the time of the report, the outcome of the patient was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Blood glucose increased, Blood lactate dehydrogenase increased, Carbon dioxide increased, Epstein-Barr virus infection, Haematocrit decreased
Clinical narrative: Information has been received from a physician concerning a 17 year old male patient who on an unspecified date was vaccinated with a pediatric dose of VAQTA (Lot # and route not reported). The physician reported that despite vaccination, on an unknown date the patient still contracted Hepatitis A. At the time of the report, the outcome of the patient was not reported. The patient sought unspecified medical attention. Follow up information was received from the physician who reported that on 08-CT-2010 at 8:30 am, the patient was vaccinated intramuscularly into the right arm with the second dose of VAQTA (Lot # 666802/1684Y). The physician reported that the patient developed hemolytic anemia due to  Hepatitis A infection, which was confirmed by an Hep. A antibodies test, and Epstein-Barr virus infection. A blood test performed on 08-OCT-2010 showed: Red blood cell count 3.39, Blood hemoglobin test 10.2L, Whole blood hematocrit 29.1 M, ean platelet volume 8.9, Neutrophil count 26, Lymphocyte count 55 Reticulocyte count 6.4, Blood reticulocyte count 0.22, Glucose test 140, Plasma carbon dioxide test 31, Bilirubin test 3.1, Indirect plasma bilirubin test 2.8, LHD 2224, AST 49, ALK PHOS 95, ALT 61. Hepatitis A Antibody test- Reactive positive. At the time of the report, the outcome of the patient was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Haemoglobin normal, Haemolytic anaemia, Hepatitis A, Hepatitis A antibody positive, Hepatitis A virus test positive
Clinical narrative: Information has been received from a physician concerning a 17 year old male patient who on an unspecified date was vaccinated with a pediatric dose of VAQTA (Lot # and route not reported). The physician reported that despite vaccination, on an unknown date the patient still contracted Hepatitis A. At the time of the report, the outcome of the patient was not reported. The patient sought unspecified medical attention. Follow up information was received from the physician who reported that on 08-CT-2010 at 8:30 am, the patient was vaccinated intramuscularly into the right arm with the second dose of VAQTA (Lot # 666802/1684Y). The physician reported that the patient developed hemolytic anemia due to  Hepatitis A infection, which was confirmed by an Hep. A antibodies test, and Epstein-Barr virus infection. A blood test performed on 08-OCT-2010 showed: Red blood cell count 3.39, Blood hemoglobin test 10.2L, Whole blood hematocrit 29.1 M, ean platelet volume 8.9, Neutrophil count 26, Lymphocyte count 55 Reticulocyte count 6.4, Blood reticulocyte count 0.22, Glucose test 140, Plasma carbon dioxide test 31, Bilirubin test 3.1, Indirect plasma bilirubin test 2.8, LHD 2224, AST 49, ALK PHOS 95, ALT 61. Hepatitis A Antibody test- Reactive positive. At the time of the report, the outcome of the patient was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Lymphocyte percentage increased, Mean platelet volume normal, Neutrophil percentage, Red blood cell count decreased, Reticulocyte count
Clinical narrative: Information has been received from a physician concerning a 17 year old male patient who on an unspecified date was vaccinated with a pediatric dose of VAQTA (Lot # and route not reported). The physician reported that despite vaccination, on an unknown date the patient still contracted Hepatitis A. At the time of the report, the outcome of the patient was not reported. The patient sought unspecified medical attention. Follow up information was received from the physician who reported that on 08-CT-2010 at 8:30 am, the patient was vaccinated intramuscularly into the right arm with the second dose of VAQTA (Lot # 666802/1684Y). The physician reported that the patient developed hemolytic anemia due to  Hepatitis A infection, which was confirmed by an Hep. A antibodies test, and Epstein-Barr virus infection. A blood test performed on 08-OCT-2010 showed: Red blood cell count 3.39, Blood hemoglobin test 10.2L, Whole blood hematocrit 29.1 M, ean platelet volume 8.9, Neutrophil count 26, Lymphocyte count 55 Reticulocyte count 6.4, Blood reticulocyte count 0.22, Glucose test 140, Plasma carbon dioxide test 31, Bilirubin test 3.1, Indirect plasma bilirubin test 2.8, LHD 2224, AST 49, ALK PHOS 95, ALT 61. Hepatitis A Antibody test- Reactive positive. At the time of the report, the outcome of the patient was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Reticulocyte percentage increased
Clinical narrative: Information has been received from a physician concerning a 17 year old male patient who on an unspecified date was vaccinated with a pediatric dose of VAQTA (Lot # and route not reported). The physician reported that despite vaccination, on an unknown date the patient still contracted Hepatitis A. At the time of the report, the outcome of the patient was not reported. The patient sought unspecified medical attention. Follow up information was received from the physician who reported that on 08-CT-2010 at 8:30 am, the patient was vaccinated intramuscularly into the right arm with the second dose of VAQTA (Lot # 666802/1684Y). The physician reported that the patient developed hemolytic anemia due to  Hepatitis A infection, which was confirmed by an Hep. A antibodies test, and Epstein-Barr virus infection. A blood test performed on 08-OCT-2010 showed: Red blood cell count 3.39, Blood hemoglobin test 10.2L, Whole blood hematocrit 29.1 M, ean platelet volume 8.9, Neutrophil count 26, Lymphocyte count 55 Reticulocyte count 6.4, Blood reticulocyte count 0.22, Glucose test 140, Plasma carbon dioxide test 31, Bilirubin test 3.1, Indirect plasma bilirubin test 2.8, LHD 2224, AST 49, ALK PHOS 95, ALT 61. Hepatitis A Antibody test- Reactive positive. At the time of the report, the outcome of the patient was not reported. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician and a certified medical assistant concerning a 13 month old male patient who in September 2010 (reported as "last month") was vaccinated with a first dose of VAQTA. On 25-OCT-2010 the patient was scheduled to receive hepatitis B virus vaccine, inadvertently received the second dose of VAQTA inadvertently via intramuscular route (lot # 668912/1087Z, expiration date not available). The two doses were given to the patient "one month apart as opposed to 6-18 months apart". No adverse reaction was noted. Patient sought unspecified medical attention. Follow-up information has been received from the certified medical assistant concerning the male patient with murmur who on 25-OCT-2010, 4:00 PM was vaccinated IM with a second dose of VAQTA (in right thigh) and a first dose of unspecified vaccine (lot # U3720A, manufacturer: Sanofi Pasteur) (in left thigh). The patient did not require emergency room or doctor visit (previously reported as "sought unspecified medical attention"). Additional information is not expected.
Age: 0.3
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 14 week old (three months and 14 days old) patient who on 02-NOV-2010 was vaccinated IM with a pediatric 0.5 ml dose of VAQTA (lot number not provided) in pace of hepatitis B virus vaccine. No adverse effect was reported. Additional information has been requested.
Age: 0.87
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from registered nurse (R.N.) concerning a 10 1/2 month old male who on 08-NOV-2010 was vaccinated with a dose of VAQTA (lot number 669108/1215Z) instead of RECOMBIVAX. No adverse effect known. The patient didn't seek medical attention. Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a caller concerning an approximately 30 day old (reported as one month old) male who in approximately October 2010 (reported as "about a month ago") was vaccinated IM with the first 0.5ml dose of VAQTA instead of hepatitis B virus vaccine by accident. There had been no side effects experienced by the patient. It was reported that therapy with VAQTA was discontinued after the first dose. It was unknown if the patient sought medical attention. No further information is available.
Age: 21.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 21 year old patient who on 29-NOV-2010 was vaccinated with a dose of the pediatric formulation of VAQTA (lot number not provided). No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site haemorrhage, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered medical assistant concerning an 8 year old male with medical history of bleeding from other vaccination sites in the past and no drug allergies who on 08-DEC-2010 was vaccinated IM in left deltoid with a 0.5 ml dose of VAQTA (lot# 668913/1088Z, expired date 25-JUL-2013). There was no concomitant medication. On 08-DEC-2010 following vaccination with VAQTA in the deltoid, blood squirted from the site of the vaccination when the needle was removed. The bleeding stopped immediately, but then continued as a small trickle. Pressure was applied and the site was bandaged. Patient was kept at the office for observation for 20 minutes then released. No lab diagnostics studies performed. Patient sought medical attention by office visit On 08-DEC-2010 patient recovered. The reporter stated that she had seen bleeding from other vaccination sites in the past. No name of products, number of occurrences, dates or other information were available about previous bleeding occurrences from other vaccination sites. Follow-up information was received from the registered medical assistant who reported that that on 08-DEC-2010 4:00 PM, the patient was vaccinated in left arm with the second 0.5 ml dose of VAQTA. The medical assistant reported that there was no adverse reaction. The question was whether there was any contraindication if vaccine was given into an artery. No further information is available.
Age: 0.1
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse (L.N.P.) concerning an approximately 30 day old patient (reported as "one month of age"), who on 20-DEC-2010 was inadvertently vaccinated with a 0.5 ml dose of VAQTA (Lot # not reported) IM instead of hepatitis B virus vaccine. No adverse effects were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 0.09
Sex: M
Vaccine: HEPA
Symptoms: Eating disorder, Hypersomnia, Irritability, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse, a physician and the patient's mother, concerning a "4 weeks old" male with no pertinent medical history and no known drug allergies who on 10-JAN-2011 was vaccinated with pediatric VAQTA, s-dose, 25u, "injection". There was no concomitant medication. On 10-JAN-2011, the patient was vaccinated the pediatric VAQTA instead of the Hep B. by a nurse in doctor's office. Initial report was reported on 10-JAN-2011 by a nurse, no adverse event. On 11-JAN-2011, the patient's mother described his son experienced sleeping more not really eating since he had gotten the vaccination 10-JAN-2011. She was not sure what the name of the vaccine was but told it was a Merck vaccine. The symptom was not recovered at the time of reporting. Follow up report was reported on 11-JAN-2011 4:35 pm by physician, said the patient experienced cranky, irritable and not eating well after vaccination, and the child recovered on 11-JAN-2011. The patient sought medical attention via office visit. No lab diagnostics studies performed. Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 9 month old male with no pertinent medical history who in January 2011, was vaccinated with VAQTA (lot number not provided) instead of hepatitis B virus vaccine. No adverse event seen. Additional information has been requested.
Age: 0.09
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 31 day old male who on 24-FEB-2011 was vaccinated with a dose of VAQTA instead of hepatitis B virus vaccine. No adverse symptoms noted. The patient sought unspecified medical attention. This is one of the several reports from the same source. Additional information has been requested.
Age: 0.09
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 31 day old male who on 24-FEB-2011 was vaccinated with a dose of VAQTA (lot#: 669749/1628Z, exp on 18-OCT-2013) instead of hepatitis B virus vaccine. No adverse symptoms noted. The patient sought an unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 24 month old female patient with no illness at time of vaccination and no drug reactions or allergies, who on 02-MAR-2011 at 11:00 was vaccinated with a second dose of VAQTA (Lot # 669749/1628Z) in the left upper thigh and a first dose of MMR II (Lot # 668234/0830Z) in the left lower thigh. On 02-MAR-2011 at 11:00 the patient passed out during 2-3 minutes after receiving shots. It was not related to crying or breath holding. The patient's blood pressure was normal after some oral fluids. The patient was fine and was sent home. On 02-MAR-2011, the patient was recovered. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Medical assistant concerning a 6 month old patient who on 16-MAR-2011 was inadvertently vaccinated intramuscularly with a pediatric dose of VAQTA instead of a dose of hepatitis B vaccine. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 9 month old patient who on 16-MAR-2011, was vaccinated with a dose of VAQTA, 0.5 mL, IM. The patent who was intended to receive hepatitis B virus vaccine, inadvertently was administered VAQTA. No adverse symptoms reported. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 6 month old infant who on 16-MAR-2011, was vaccinated with VAQTA (lot # 669749/1628Z) 0.5mL, intramuscularly instead of hepatitis B virus vaccine. No adverse effect was reported. Additional information has been requested.
Age: 0.45
Sex: F
Vaccine: DTAP, RVX
Symptoms: Decreased appetite, Dyskinesia, Fatigue, Irritability, Vomiting
Clinical narrative: 3 days of Fussiness, Tired, Loss of Appetite, Slightly Vomiting and Occasionally arm jerking when falling asleep.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Prevnar 13 was the only vaccination administered to patient on 5/17/2011 at well child visit at doctor's office.  Redness, swelling, heat started at injection site on right thigh over the course of 12 hours post injection. 18 hours post injection induration to area started.  At 24 hours post injection the area of redness/ swelling/ heat/ induration was from right knee to buttock. These symptoms worsened with area enlarging until patient returned to doctor on 5/21/2011 and received antibiotic, clindamycin.  Antibiotics started on 5/21 and symptoms began to resolve within 48 hours and area healed within 96 hours.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dermatitis allergic
Clinical narrative: Allergic dermatitis
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt called 5/27/11 AM stating: Shoulder hurt ~1-2hrs post injection. Pain significant, "felt like tetanus shot". Pain not sufficiently releived by OTC NSAIDs &/or APAP. Pt called again ~noon 5/27/11 spoke with vaccine administrator. No swelling, redness or incresed temp at site. No bump, nodule or bruising evident. 5/28/11 pt stated pain still there, "felt like arm hit with baseball bat". Pt wondered if shot given "Too high in up the arm". Pain releived only by immobilizing arm. Told to contact physician.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Patient states she developed an itchy rash on her back along her bra line and on some other areas of her body that resembles the zoster rash
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Diarrhoea, Nausea, Rash pruritic
Clinical narrative: Diarrhea, nausea, itchy rash, joint aches, weakness.