chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Initial and follow-up information has been received from a physician and medical record concerning a 2 month old white female with gastroesophageal reflux since 2 weeks old, no acute illness at the time of being vaccinated, and no known drug allergies, and a history of hospitalization and born via caesearan section. No family history of asthma, seizures, birth defects, seasonal allergies. On 11-DEC-2007, the patient was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot # 657380/0377U) IM in the right upper thigh at approximately 9:45 AM. Concomitant therapy also given on 11-DEC-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, (PREVNAR) vaccine (CRM197), poliovirus vaccine and ROTATEQ vaccine live (human-bovine) (MSD). Other concomitant therapy included (ZANTAC). On 11-DEC-2007, approximately afternoon, the infant developed crying off and on for 48 hours, loose diarrhea for 48 hours, one episode of vomiting, was very fussy and inconsolable. There was no fever. The infant was examined by the physician. The injection sites looked good without erythema, swelling, nor drainage. Otherwise the exam was normal. The infant was referred to the emergency room because of symptoms concerning possible sepsis as the baby received hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC), vaccine lot that was recalled. The baby was evaluated and discharged home, On 13-DEC-2007, the patient became very fussy. As a precaution the patient was sent to an emergency room for evaluation. It was reported, the lot # administered was one of those in the recent recall. On 13-DEC-2007, the patient was seen in the emergency room. The emergency room record revealed that the infant was feeding well with no vomiting. BM's were normal, she wet her diaper fine, no sick contacts. Development was age appropriate. Vital signs revealed: temperature 98.9, pulse 199, repirations 24 and pulse oximetry 95%. Exam was normal, tanner stage 1. Laboratory evaluation revealed blood culture no growth after 5 days. Cell blood count and differential were performed: hemoglobin 8.7 gm/DL (low), hematocrit 25.3 % (low), red blood cell count 2.59 m/mm3 (low), neutrophild 26% (low), lymphocyte count 54% (high), monocycte count 13% (high), and eosinophil 6% (high). The rest of the CBC was normal. Impression was immunization reaction resolving, pain due to immunization, upper respiratory infection. Patient was sent home to follow-up with primary care physician as needed and to obtain results of lab tests. On 15-DEC-2007, the infant recovered. No additional information is expected'
Age: 0.6
Sex: M
Vaccine: HBHEPB, UNK
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning his approximately 8 month old son, a twin born premature, who in approximately November 2007, was vaccinated in the leg with a dose of COMVAX (lot 657380/0377U).  The patient was concomitantly vaccinated with unknown multiple vaccines at the same office visit.  Subsequently, the patient developed a red area at the injection site that lasted 4-5 days.  Subsequently, the patient recovered.   Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: HBHEPB
Symptoms: Arthropod bite, Incorrect dose administered, Injection site erythema, Injection site mass
Clinical narrative: Initial and follow up information has been received from a physician, via a company representative and a registered nurse, concerning a 18 week old white female infant with no illness at the time of vaccination and no medical history, who on an unspecified date was vaccinated with a first dose of COMVAX.  On 26-OCT-2007 the patient was vaccinated with the second dose, "7.5mcg," of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot # 657380/0377U) IM in the right leg.  There was no concomitant medication.  On 27-OCT-2007 the mother noticed that the injection site looked like a "spider bite" and advised the physician of this.  The redness lasted approximately 10 days (approximately 05-NOV-2007).  There was also a lump under the skin at the site.  Treatment included warm compresses.  At the time of this report, the infant continued to have a slight lump at the injection site.  The physician indicated that the infant was recovering from the lump.  This is a consolidation of two reports (WAES # 0801USA01136 and 0801USA03412) concerning the same patient.  No further information is expected.
Age: 24.0
Sex: F
Vaccine: HBHEPB
Symptoms: Accidental exposure, Induration, Ocular hyperaemia
Clinical narrative: Initial and follow up information has been received from a nurse practitioner, concerning a 24 year old female registered nurse who on 07-JAN-2008 was splashed in her eye when she was administering a dose of COMVAX (lot # not reported). The NP flushed the nurse's eye (details not reported). The RN developed redness and induration under her eyes, which lasted for 2 days and then resolved. Additional information is not expected.
Age: 0.16
Sex: F
Vaccine: HBHEPB
Symptoms: Injection site erythema, Injection site papule, Injection site swelling
Clinical narrative: Information has been received from a physician, via a company representative, concerning an approximately 9 week old (" 2 months old") female infant, who on 30-OCT-2007 was vaccinated with the first dose, "7.5mcg," of COMVAX. On 31-OCT-2007 the infant developed redness and swelling at the injection site that lasted for a month, and continued to have a bump at the injection site. The physician indicated that the infant was recovering from the events. Unspecified medical attention was sought for the infant. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Rash generalised
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 16 month old female with no illness at the time of vaccination and no drug reactions/allergies who on 29-NOV-2007 was vaccinated with a third dose of COMVAX (lot#657380/0377U) in the left arm IM. Concomitant therapy included PREVNAR (lot# "BG8702E") in the left arm IM. On 09-DEC-2007, 10 days post vaccination, the patient developed a rash over her entire body. There was no localized reactions at the injection site. It was unknown if any AE was involved with the first or second vaccinations. The patient received unspecified medical attention and subsequently, the patient recovered on 17-Dec-2007. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, PPV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a consumer concerning her 6 month old daughter who on 29-NOV-2007 was vaccinated with a 0.5 mL dose of COMVAX.  The patient was concomitantly vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and pneumococcal vaccine (unspecified) (manufacturer unknown).  On 29-NOV-2007, the patient experienced redness and a lump at the injection site.  The patient did not receive medical attention for the experience.  The redness subsequently went away, but the lump persisted.  At the time of this report, the patient was recovering.  No additional information is expected.
Age: 0.6
Sex: F
Vaccine: HBHEPB, UNK
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning his approximately 8 month old daughter, a twin born premature, who in approximately November 2007, was vaccinated in the leg with a dose of COMVAX (lot 657380/0377U). The patient was concomitantly vaccinated with unknown multiple vaccines at the same office visit. Subsequently, the patient developed a red area at the injection site that lasted 4-5 days. Subsequently, the patient recovered. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HBHEPB, RV5
Symptoms: Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning an about 4 month old patient with no medical history who on approximately 21-NOV-2007 (about 3 or 4 weeks ago) was vaccinated with a dose of COMVAX. Concomitant therapy included ROTATEQ. (Duration and dose not reported). Other concomitant therapy included PREVNAR and DTap (unspecified) + tetanus toxoid. Subsequent;y, the patient developed a rash at the injection site. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. On an unknown date, the patient recovered. No product quality complain was involved. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Chest X-ray abnormal, Dyspnoea, Lung infiltration, Oxygen saturation, Oxygen saturation normal
Clinical narrative: Initial and follow-up information has been received from a health care worker concerning a 5 month old white female with reflux, who on 16-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of COMVAX (Lot #657380/0377U). Concomitant suspect vaccination on the same day included ROTATEQ (MSD). Other concomitant vaccinations on the same day included, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine and (PREVNAR) (CRM197). Other concomitant medication included (PREVACID). On 23-NOV-2007, she was seen for episodes of irregular breathing. A chest X-ray showed infiltrates in one lung. On approximately, 28-NOV-2007, five days later a repeat chest x-ray showed infiltrates in the other lung. The infant was negative for respiratory syncytial virus (RSV). She was being monitored by pulse oximetry. At the time of the report the patient had not recovered. Follow-up indicated that it was determined that the patient probably did not have an adverse experience. It was reported that the patient made a full recovery on an unspecified date. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Respiratory disorder, Respiratory syncytial virus test negative
Clinical narrative: Initial and follow-up information has been received from a health care worker concerning a 5 month old white female with reflux, who on 16-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of COMVAX (Lot #657380/0377U). Concomitant suspect vaccination on the same day included ROTATEQ (MSD). Other concomitant vaccinations on the same day included, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine and (PREVNAR) (CRM197). Other concomitant medication included (PREVACID). On 23-NOV-2007, she was seen for episodes of irregular breathing. A chest X-ray showed infiltrates in one lung. On approximately, 28-NOV-2007, five days later a repeat chest x-ray showed infiltrates in the other lung. The infant was negative for respiratory syncytial virus (RSV). She was being monitored by pulse oximetry. At the time of the report the patient had not recovered. Follow-up indicated that it was determined that the patient probably did not have an adverse experience. It was reported that the patient made a full recovery on an unspecified date. Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site erythema, Injection site mass, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 15 month old male with an ear infection who on 27-NOV-2007 was vaccinated with hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) in his left leg. There was no concomitant medication. On 28-NOV-2007 the patient developed a large red lump on his left leg at the injection site and a fever. The physician also reported that the patients white blood cell count was 23,000 which he believed was rather high. No further information was reported. The patient recovered on an unspecified date. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: HBHEPB
Symptoms: Body temperature increased, Pyrexia, Urticaria
Clinical narrative: Information has been received from a consumer concerning a 13 month old male with no known drug allergies who was vaccinated with a dose of COMVAX. Subsequently the patient developed fever and hives all over the body. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: HBHEPB
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a nurse concerning a 2 month old female who on 11-DEC-2007 was vaccinated with her first dose of COMVAX (Lot #0376U/Batch #657379).  There was no concomitant medication.  The nurse reported that after receiving the vaccination the patient had small bubble at the injection site.  The nurse reported that the patients mother called them about this and they told the mother to put a cold compress on the bubble.  Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a consumer concerning her 18 month old son who was vaccinated with a third dose of COMVAX. Subsequently the patient experienced an injection site reaction. The patient had redness at the injection site. At the time of the report the patient's outcome was unknown. No further information is available.
Age: 0.3
Sex: F
Vaccine: HBHEPB
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a 4 month old female who at approximately 16 weeks of age was vaccinated with a second dose of COMVAX (lot 657380/0377U). Subsequently the patient experienced cellulitis. The patient was taken to urgent care and was treated with KEFLEX. Subsequently, the patient recovered. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 15 month old male with no pertinent medical history who on 19-NOV-2007 was vaccinated intramuscularly with a 0.5 ml dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (Lot #657379/0376U). There was no concomitant medication. On 20-NOV-2007, one day after vaccination, the patient developed redness, swelling and warmth at the injection site. On 21-NOV-2007, the patient was examined in the office. A diagnosis of cellulitis was made. The patient was prescribed SEPTRA. There was no laboratory or diagnostic tests performed. On 23-NOV-2007, the patient was examined and had fully recovered at that time. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Body temperature increased, Haematochezia, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 4 month old son with an unremarkable medical history who on 08-OCT-2007 was vaccinated with a first dose of COMVAX (Lot #657379/0376U). Concomitant suspect vaccination on the same day included ROTATEQ (MSD). Other concomitant vaccination on the same day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (-) tetanus toxoid, poliovirus vaccine inactivated (VERO) (IPOL) and (PREVNAR) (CRM197). On approximately 15-OCT-2007, one week later, the patient experienced a low grade fever. On approximately 29-OCT-2007, three weeks later, the patient experienced blood in his stool. Subsequently, the patient completely recovered. On 10-DEC-2007, the patient was vaccinated with a second dose of COMVAX without incident. Additional information is not expected.
Age: 0.4
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 4 1/2 month old male who was vaccinated with 2 doses of COMVAX (Lot #657380/0377U is for the first dose).  24 hours after receiving the first dose the patient developed redness and swelling at the injection site and it was hard.  When the patient received the second dose of COMVAX he experienced the same adverse event.  The lot number for the second dose was not provided but the physician mentioned it was not one of the recalled lots.  The patient sought medical attention.  Outcome is unknown.  Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: HBHEPB
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a physician concerning an 18 week old female who on 07-DEC-2007 was vaccinated (does not reported) with COMVAX (lot # 657380/0377U). The patient's mother called the office to inform them that on 10-DEC-2007 her daughter had developed redness at the injection site which was reported to be the size of a dime or nickel and hard at the injection site. The mother reported that the child did not seem to be in any pain. The mother was instructed to put a warm compress on the area and gently massage the area. At the the time of this report the mother had not contacted the office again and the physician was not aware of the patient's recovery status. Additional information has been requested.
Sex: M
Vaccine: HBHEPB
Symptoms: Rash
Clinical narrative: Information has been received from a physician assistant concerning a male who was vaccinated with hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC). On approximately 29-NOV-2007 the patient developed a severe skin rash. No lot number was given and no further information was provided. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: FLUX, HBHEPB, PNC, HBHEPB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning an 8 month old female who on 11-DEC-2007 was vaccinated with her third dose of COMVAX (Lot #0377U/Batch #657380) intramuscularly in the left thigh. Her second dose was received on 02-JUL-2007 intramuscularly in the left thigh (same lot and batch number). Concomitant therapy included influenza virus vaccine (unspecified), PREVNAR and TYLENOL. On 11-Dec-2007 the patient developed redness and swelling at the injection site. Patient's illnesses at the time of vaccination were an upper respiratory infection with nasal congestion and cough. Further information is not expected.
Age: 0.6
Sex: F
Vaccine: FLUX, HBHEPB, PNC, HBHEPB
Symptoms: Chest X-ray, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning an 8 month old female who on 11-DEC-2007 was vaccinated with her third dose of COMVAX (Lot #0377U/Batch #657380) intramuscularly in the left thigh. Her second dose was received on 02-JUL-2007 intramuscularly in the left thigh (same lot and batch number). Concomitant therapy included influenza virus vaccine (unspecified), PREVNAR and TYLENOL. On 11-Dec-2007 the patient developed redness and swelling at the injection site. Patient's illnesses at the time of vaccination were an upper respiratory infection with nasal congestion and cough. Further information is not expected.
Age: 0.6
Sex: F
Vaccine: FLUX, HBHEPB, PNC, HBHEPB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a consumer and follow-up information from a physician concerning a 7 month old female with a upper respiratory infection at time of vaccination, no pertinent medical history, drug reactions/allergies who on 11-DEC-2007 (also reported as 2-Jul-2007) was vaccinated in the left thigh (route not reported) with a second dose of COMVAX (lot #657380/0377U).  There was no concomitant medication usage.  On 11-DEC-2007, post vaccination, the patient developed tenderness, slight swelling and redness at the injection site.  Per the patient's mother, this had never happened with previous shots.  The patient did have a chest x-ray done (results not reported).  The patient did not receive medical attention.  The patient began to recover on 12-Dec-2007.  No additional information is expected.
Age: 0.6
Sex: F
Vaccine: FLUX, HBHEPB, PNC, HBHEPB
Symptoms: Chest X-ray, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a consumer and follow-up information from a physician concerning a 7 month old female with a upper respiratory infection at time of vaccination, no pertinent medical history, drug reactions/allergies who on 11-DEC-2007 (also reported as 2-Jul-2007) was vaccinated in the left thigh (route not reported) with a second dose of COMVAX (lot #657380/0377U).  There was no concomitant medication usage.  On 11-DEC-2007, post vaccination, the patient developed tenderness, slight swelling and redness at the injection site.  Per the patient's mother, this had never happened with previous shots.  The patient did have a chest x-ray done (results not reported).  The patient did not receive medical attention.  The patient began to recover on 12-Dec-2007.  No additional information is expected.
Age: 1.0
Sex: M
Vaccine: HBHEPB
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 22 month old son with no pertinent medical history, drug reactions/allergies or concomitant medication usage, who in March 2007 (exact date not reported), was vaccinated (route and site not reported) with COMVAX vaccine (lot # not reported). The patient was concomitantly vaccinated with VAQTA. In March 2007, post vaccination, the patient developed a rash. The patient did receive unspecified medical attention. No diagnostic test were performed. The patient recovered in a few days after the vaccination. No additional information is expected.
Age: 2.0
Sex: M
Vaccine: HBHEPB
Symptoms: Diarrhoea, Irritability
Clinical narrative: Initial and follow up information have been received from a physician and the mother of a 24 month old white son with no pertinent medical history or drug reactions/allergies who at 10:48 on 11-DEC-2007 was vaccinated intramuscularly (site not reported) with the third 0.5 ml dose of COMVAX (lot # 657380/0377U).  There was no concomitant medication usage.  On 11-DEC-2007 the patient became very fussy.  On 13-DEC-2007 the patient developed diarrhea.  Per the patient's mother, there were no symptoms after the first 2 doses of the vaccine were given.  The patient did receive unspecified medical treatment.  No diagnostic labs test were performed.  At the time of this report the patient was recovering.  Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: HBHEPB
Symptoms: Irritability, Rhinorrhoea
Clinical narrative: Information has been received from a consumer concerning her 13 month old son with no pertinent medical history, drug reactions/allergies or concomitant medication use who on 28-NOV-2007 was vaccinated (route and site not reported) with COMVAX (lot#657380/0377U).  Two or three days post vaccination, the patient developed crankiness and a runny nose.  Per the patient's mother, the child was not cranky prior to the vaccination.  The patient's crankiness has lessen but the patient still has a runny nose.  The patient did receive unspecified medical attention.  No diagnostic lab test were performed.  At the time of this report the patient was recovering.  Follow up information has been received from the physician's office.  They are reporting that they have no information regarding an adverse reaction.  No additional information is expected.
Age: 1.3
Sex: M
Vaccine: HBHEPB
Symptoms: Herpes virus infection
Clinical narrative: Information has been received from a healthcare professional concerning a 16 month old male who on 06-DEC-2007 was vaccinated (route and site not reported) with CONVAX (lot # not reported). On 09-DEC-2007, post vaccination, the patient contracted herpes. The patient received unspecified medical attention. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: HBHEPB
Symptoms: Crying, Irritability
Clinical narrative: Information has been received from an office nurse concerning a 9 month old male who on 12-DEC-2007 was vaccinated with COMVAX, (lot # not reported). In December 2007, the nurse reported that the mother called in to complain that the baby was experiencing fussiness and crying. The nurse reported that this was "one of the doses that was recalled". The outcome of the events was not reported. Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Initial and follow-up information has been received from a health professional and a consumer concerning a 53 day old female who on 03-DEC-2007 was vaccinated IM in the right thigh with her first dose of TRIPEDIA (lot C2797AA), vaccinated with the first dose of ROTATEQ oral (MSD; lot #6576699/1393U), and IM in the left thigh with a dose of IPOL (lot #A0301) and PREVNAR(lot # #B54013E). On 03-DEC-2007, the patient developed a fever and was throwing up. Unspecified medical attention was sought. The patient's fever and vomiting persisted. No additional information is expected.
Age: 0.5
Sex: M
Vaccine: HBHEPB
Symptoms: Body temperature increased, Otitis media, Pyrexia, Upper respiratory tract infection, Wheezing
Clinical narrative: Information has been received from a healthcare worker concerning a 6 month old male who on 06-DEC-2007 was vaccinated with a dose of COMVAX (Lot # 656269/1417F).  Concomitant therapy included ALBUTEROL and BACTRIM.  On 06-DEC-2007 the patient developed a high fever for two days after receiving COMVAX (102F on the first day and 103 on the second day).  On 12-DEC-2007 the patient was examined and diagnosed with an upper respiratory infection, otitis media and wheezing.  At the time of the report the patient had not recovered.  Additional information has been requested.
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site induration
Clinical narrative: Information has been received from a physician concerning a male (age not reported) who on an unspecified date was vaccinated with COMVAX (lot # 657380/0377U).  A day after receiving the vaccine, the patient experienced a knot, the size of a thumbnail, under the skin where the injection was given.  Medical attention was sought.  The physician reported that the knot was slowly going away.  At the time of reporting, the patient was recovering.  Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: HBHEPB
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from the agency (case #2007023-2447519) via a physician concerning a 15 month old male on 10-DEC-2007 was vaccinated with COMVAX (lot # 656271/1157U) 0.5 ml. On 10-DEC-2007, five hours after being vaccinated in the evening, the patient experienced a fever. On 12-DEC-2007, the patient was assessed in the emergency room for persistent fever (102-103). A CBC and blood culture were planned. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Decreased appetite
Clinical narrative: Information has been received from a consumer reporting on her 9-week-old male son who on 19-SEP-2007 was vaccinated with a dose of RECOMBIVAX HB (Lot # "1418F"). Concomitant vaccines administered on 19-SEP-2007 included ROTATEQ, Hib (MSD), DTP (manufacturer unspecified), poliovirus vaccine (manufacturer unspecified) and pneumococcal conj vaccine (manufacturer unspecified). On 20-SEP-2007 the patient experienced a "decrease in appetite" after vaccination. The patient sought unspecified medical attention. It was reported the patient's eating is not quite back to normal at the time of reporting. A product quality complaint was not involved. Follow-up information was received on 13-NOV-2007 and indicated the patient was seen during an office on 08-OCT-2007 (for follow-up) and his parents reported that his appetite was still not back to normal, but he appeared healthy and had not lost weight. Follow-up information received from a physician indicated a 9-week-old male received the following vaccines on 19-SEP-2007 at 09:30: first intramuscular dose of COMVAX (lot # 656270/1418F) administered in the right thigh (previously reported as RECOMBIVAX HB) (Lot # "1418F"); first intramuscular dose of DTaP (manufacturer Aventis) (lot # C2657AA) administered in the right thigh; first intramuscular dose of IPOL (lot # A0170) administered in the left thigh; first intramuscular dose PREVNAR (lot # 1354007E) administered in the left thigh and first oral dose of ROTATEQ (lot # 657660/0972U). Hib was deleted in follow-up. The physician reported that patient's mother stated on 20-SEP-2007 at 08:00 the patient had a very poor appetite for 3 weeks and the child did not lose any weight during this time. There were no illnesses at the time of vaccination. The patient did not have any pertinent medical history or allergies and no diagnostic labs were performed. On the 11-OCT-2007 (3 weeks later) the patient recovered. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Flatulence, Gastroenteritis, Laboratory test normal, Vomiting
Clinical narrative: Information has been received from medical records via a physician's office concerning a 15 week old baby girl with a history of dacryostenosis acquired and hip dysplasia who on 2-APR-2008 was administered her first dose of ROTATEQ 2.0 ml orally. Suspect vaccination administered on 2-APR-2008 included the first of HIB (manufacturer unknown) 0.5 ml IM. Concomitant vaccination also administered on that same day included the first dose of PEDIARIX 0.5 ml IM. On 15-May-2008 the baby's mother called the physician and reported the baby was gassy. The mother was recommended to give the baby gas drops and the baby was not any better. On 16-MAY-2008 the baby was seen by the physician and diagnostic impression was probable gastroenteritis. The baby's mother reported the baby had been gassy and doing a lot of vomiting. The baby was advised to have treatment with PEDIALYTE solution. On 16-JUN-2008 the baby had a well child visit and the baby's hip exam was normal. Symmetric leg creases. Spinous processes intact, no sacral dimples. Symmetric extremities and no deformities. On 16-JUN-2008 the patient received a second dose of PEDIARIX 0.5 ml IM, a dose of PREVNAR 0.5 ml IM and a second dose of ROTATEQ 2.0 ml orally. On 18-AUG-2008 the baby had a well child visit and the baby's hip exam was normal. Symmetric leg creases. Spinous processes intact, no sacral dimples. Symmetric extremities and no deformities. On 18-AUG-2008 the baby received a dose of TRIPEDIA injection 0.5 ml IM, a dose of ENGERIX B 0.5 ml IM, a dose of poliovirus inactivated injection 0.5ml subcutaneously or IM, a dose of PREVNAR 0.5 ml IM and a third dose of ROTATEQ 2.0 ml orally. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Eczema, Excoriation, Flatulence, Plagiocephaly
Clinical narrative: Information has been received from a physician via medical records, concerning a 2 months old male with diaper rash, allergies, plagiocephaly, hyperbilirubinaemia, and history of cephalohematoma and hospitalization, who on 07-MAR-2008, was vaccinated with ROTATEQ (657989/1838U). Concomitant therapy included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-comp vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX) (Lot # AC21B1AB), (PREVNAR) (Lot # 808702E) and (ACTHIB) (Lot # UF341AC). On 07-MAR-2008, the patient experienced intestinal gas. On 09-MAY-2008, the baby experienced eczema in face and trunk with excoriations in face (cheeks and forehead), and it was noticed that he had a flat occipital, plagiocephaly. The baby was vaccinated according to protocol with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ. The baby was 4 months of age. The patient was treated with Vaseline + 1% Hydrocortisone. On examination on 10-JUL-2008, it was noted that the baby still had Plagiocephaly. The baby was vaccinated according to protocol with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ. The baby was 6 months of age. No additional information is expected. The patient was also reported in WAES: 0707USA00777.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood bilirubin increased, Blood creatinine decreased, Condition aggravated, Cough, Decreased appetite
Clinical narrative: Information has been received from a physician and from the medical record which was reviewed concerning a nine week old female infant with no known allergies, upper respiratory infection and nasal congestion.  It was also reported that the infant had physical examination on 03-JUN-2008 and her hip was slightly lax and tight.  The infant had a history of physiological jaundice of infancy (on 02-JUN-2008 total serum bilirubin was 16.7 mg/dL).  On 04-AUG-2008 the infant was vaccinated with a first dose of ROTATEQ lot # 660877/0305X oral.  On 03-OCT-2008 the infant was vaccinated with a second dose of ROTATEQ lot # 660877/0305X oral.  Concomitant therapy included PEDIARIX, ACTHIB and PREVNAR.  On 11-AUG-2008 the infant had an office visit to the doctor's office.  It was reported that the infant had diarrhea for two days (2-3 x day).  On the same day she had fever and the temperature was 101 axillary.  She had decreased appetite but she was drinking small amount.  On 16-SEP-2008 the infant came to the doctor's office for check up.  It was reported in the medical record that the patient had not been able to sleep for about three days.  She had some coughing, some sneezing and had runny nose.  She had lots of drooling and she gags when she was about to be fed.  She had no fever at this visit.  Her laboratory result of complete blood count was showed red blood cell count of 3.85 10x6/uL and serum creatinine was 0.29 mg/dL.  On 24-SEP-2008 the infant for another visit to the doctor's office.  It was reported that the infant experienced chest congestion and nasal congestion for the last one week.  On 24-SEP-2008 the patient had fever and the temperature was 101.  She was prescribed amoxicillin 250mg/5cc twice a day by mouth.  The outcome of the events were unknown.  No other information was available.  Additional information has been requested. Follow reported that the physician could not comment on adverse reaction of ROTATEQ or any other vaccine regarding the patient. The parent did not report any signs or symptoms to the physician or office staff. If the physician received information regarding a suspected adverse reaction. The information would have been submitted. Additional information is not expected.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Drooling, Fluid intake reduced, Insomnia, Nasal congestion
Clinical narrative: Information has been received from a physician and from the medical record which was reviewed concerning a nine week old female infant with no known allergies, upper respiratory infection and nasal congestion.  It was also reported that the infant had physical examination on 03-JUN-2008 and her hip was slightly lax and tight.  The infant had a history of physiological jaundice of infancy (on 02-JUN-2008 total serum bilirubin was 16.7 mg/dL).  On 04-AUG-2008 the infant was vaccinated with a first dose of ROTATEQ lot # 660877/0305X oral.  On 03-OCT-2008 the infant was vaccinated with a second dose of ROTATEQ lot # 660877/0305X oral.  Concomitant therapy included PEDIARIX, ACTHIB and PREVNAR.  On 11-AUG-2008 the infant had an office visit to the doctor's office.  It was reported that the infant had diarrhea for two days (2-3 x day).  On the same day she had fever and the temperature was 101 axillary.  She had decreased appetite but she was drinking small amount.  On 16-SEP-2008 the infant came to the doctor's office for check up.  It was reported in the medical record that the patient had not been able to sleep for about three days.  She had some coughing, some sneezing and had runny nose.  She had lots of drooling and she gags when she was about to be fed.  She had no fever at this visit.  Her laboratory result of complete blood count was showed red blood cell count of 3.85 10x6/uL and serum creatinine was 0.29 mg/dL.  On 24-SEP-2008 the infant for another visit to the doctor's office.  It was reported that the infant experienced chest congestion and nasal congestion for the last one week.  On 24-SEP-2008 the patient had fever and the temperature was 101.  She was prescribed amoxicillin 250mg/5cc twice a day by mouth.  The outcome of the events were unknown.  No other information was available.  Additional information has been requested. Follow reported that the physician could not comment on adverse reaction of ROTATEQ or any other vaccine regarding the patient. The parent did not report any signs or symptoms to the physician or office staff. If the physician received information regarding a suspected adverse reaction. The information would have been submitted. Additional information is not expected.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pulmonary congestion, Pyrexia, Red blood cell count decreased, Retching, Rhinorrhoea
Clinical narrative: Information has been received from a physician and from the medical record which was reviewed concerning a nine week old female infant with no known allergies, upper respiratory infection and nasal congestion.  It was also reported that the infant had physical examination on 03-JUN-2008 and her hip was slightly lax and tight.  The infant had a history of physiological jaundice of infancy (on 02-JUN-2008 total serum bilirubin was 16.7 mg/dL).  On 04-AUG-2008 the infant was vaccinated with a first dose of ROTATEQ lot # 660877/0305X oral.  On 03-OCT-2008 the infant was vaccinated with a second dose of ROTATEQ lot # 660877/0305X oral.  Concomitant therapy included PEDIARIX, ACTHIB and PREVNAR.  On 11-AUG-2008 the infant had an office visit to the doctor's office.  It was reported that the infant had diarrhea for two days (2-3 x day).  On the same day she had fever and the temperature was 101 axillary.  She had decreased appetite but she was drinking small amount.  On 16-SEP-2008 the infant came to the doctor's office for check up.  It was reported in the medical record that the patient had not been able to sleep for about three days.  She had some coughing, some sneezing and had runny nose.  She had lots of drooling and she gags when she was about to be fed.  She had no fever at this visit.  Her laboratory result of complete blood count was showed red blood cell count of 3.85 10x6/uL and serum creatinine was 0.29 mg/dL.  On 24-SEP-2008 the infant for another visit to the doctor's office.  It was reported that the infant experienced chest congestion and nasal congestion for the last one week.  On 24-SEP-2008 the patient had fever and the temperature was 101.  She was prescribed amoxicillin 250mg/5cc twice a day by mouth.  The outcome of the events were unknown.  No other information was available.  Additional information has been requested. Follow reported that the physician could not comment on adverse reaction of ROTATEQ or any other vaccine regarding the patient. The parent did not report any signs or symptoms to the physician or office staff. If the physician received information regarding a suspected adverse reaction. The information would have been submitted. Additional information is not expected.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Sneezing
Clinical narrative: Information has been received from a physician and from the medical record which was reviewed concerning a nine week old female infant with no known allergies, upper respiratory infection and nasal congestion.  It was also reported that the infant had physical examination on 03-JUN-2008 and her hip was slightly lax and tight.  The infant had a history of physiological jaundice of infancy (on 02-JUN-2008 total serum bilirubin was 16.7 mg/dL).  On 04-AUG-2008 the infant was vaccinated with a first dose of ROTATEQ lot # 660877/0305X oral.  On 03-OCT-2008 the infant was vaccinated with a second dose of ROTATEQ lot # 660877/0305X oral.  Concomitant therapy included PEDIARIX, ACTHIB and PREVNAR.  On 11-AUG-2008 the infant had an office visit to the doctor's office.  It was reported that the infant had diarrhea for two days (2-3 x day).  On the same day she had fever and the temperature was 101 axillary.  She had decreased appetite but she was drinking small amount.  On 16-SEP-2008 the infant came to the doctor's office for check up.  It was reported in the medical record that the patient had not been able to sleep for about three days.  She had some coughing, some sneezing and had runny nose.  She had lots of drooling and she gags when she was about to be fed.  She had no fever at this visit.  Her laboratory result of complete blood count was showed red blood cell count of 3.85 10x6/uL and serum creatinine was 0.29 mg/dL.  On 24-SEP-2008 the infant for another visit to the doctor's office.  It was reported that the infant experienced chest congestion and nasal congestion for the last one week.  On 24-SEP-2008 the patient had fever and the temperature was 101.  She was prescribed amoxicillin 250mg/5cc twice a day by mouth.  The outcome of the events were unknown.  No other information was available.  Additional information has been requested. Follow reported that the physician could not comment on adverse reaction of ROTATEQ or any other vaccine regarding the patient. The parent did not report any signs or symptoms to the physician or office staff. If the physician received information regarding a suspected adverse reaction. The information would have been submitted. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 week old white male. The patient received a 0.5 ml first dose of ROTATEQ (lot #658384/1387U) po on 10-JUN-2008. The mother called the facility on 11-JUN-2008 and 13-JUN-2008 complaining the baby had 48 hrs of cramping and diarrhea. The patent recovered an approximately 12-JUN-2008. The mother did not seek medical attention at the time, but did report findings to the licensed practical nurse on 13-JUN-2008. No further information is available. This is one of several reports from the same reporter.
Sex: M
Vaccine: HEP
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nonspecific reaction in a male subject of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On unspecified dates over a decade ago, the subject received 2 doses of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with the Hepatitis B vaccine, the subject experienced nonspecific reaction. At the time of reporting the outcome of the event was unspecified.
Age: 42.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Grip strength decreased, Hypoaesthesia, Incorrect dose administered, Injection site streaking, Paraesthesia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm numbness in a 42-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent vaccination included MMRII (Merck) and TB vaccine (Sanofi) both given on 30 May 2008.  There were no concurrent medications.  On 30 May 2008 at 08:00 the subject received 1st dose of ENGERIX B at 0.5 ml left arm.  This was considered to be an inappropriate dose of drug administered as this adult subject received a pediatric dose of ENGERIX B.  On 30 May 2008, during vaccination with ENGERIX B, the nurse hit a nerve and the subject's arm jerked.  Immediately after vaccination with ENGERIX B, the subject experienced arm numbness and tingling and three red steaks were noted near the site of injection.  The subject also experienced loss of grip strength (losing his grip) and dropped the phone when he went to pick it up after injection.  At the time of reporting, the events were unresolved and tingling and loss of grip outcomes were unknown. Follow-up information was received on 26 June 2009, via pharmacist. Prior to receiving Engerix B, the subject's titers were negative for antibodies. The subject's "previous series of hepatitis b was completed three times in past, but current titers for antibodies were negative"; dates and manufacturers were not provided. It was reported that the subject received an adult booster of Engerix B at 1 ml in the left upper arm on 30 May 2008. A full adult does was given. Hepatitis B titer drawn 6-8 weeks after this injection, resulting in a positive titer for antibodies (surface antibody) on 08 August 2008, so no further hepatitis b injections were necessary. The events resolved on 30 May 2008 and were not related to Engerix B. The pharmacist associated the events with erroneous administration and probably nerve involvement.
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional (who was also the vaccination subject), via Merck, and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with ENGERIX B(GlaxoSmithKline). On an unspecified date, the subject received the 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown). At an unspecified time after vaccination with ENGERX B, the subject experienced not responding to therapy. The subject reported that he did not seroconvert following a three dose series of ENGERIX B. At the time of reporting, the outcome of the event was unspecified.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Injection site vesicles
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site blisters in a female subject of unspecified age who was vaccinated with ENGERIX B. Concurrent medication included NORVASC, Hormone replacement therapy and Antibiotics. On the morning of 13 May 2008, the subject received 2nd dose of ENGERIX B (1 cc, unknown, left arm). On 14 May 2008 at 7:00 a.m., approximately one day injection site blisters. The subject presented to a physician's office for an evaluation and the nurse treated her by covering the vesicles with gauze and a bandage to prevent breakage. The nurse stated that the subject did not have flu-like symptoms or fever, just the local reaction. In addition, the nurse stated that she did not know if she would administer the 3rd dose of ENGERIX B to the subject due to this event. At the time of reporting, the event was resolved. Follow-up information was received on 02 June 2008 via a nurse, who indicated that this case was reported to a Regulatory Agency (VAERS ID # was unspecified). The subject was a 51 year-old female who was reported to be recovering from an ear infection at the time of vaccination with ENGERIX B. The subject's medical history included allergies to Penicillin and pollen. The nurse reported that the injection site blisters had "dried up" and were improved as of 19 May 2008. The nurse stated that the event was considered to be related to vaccination with ENGERIX B per her facility medical director, but indicated that the event was not serious. In addition, the healthcare professional reported that the event could have been associated with the subject's medical history/concurrent illness of recovering from an ear infection. The immunization series with ENGERIX B was discontinued.