chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.4
Sex: M
Vaccine: HIBV, IPV, PPV, RV5
Symptoms: Diarrhoea, Lethargy, Medication error, Moaning, Pyrexia
Clinical narrative: Information has been received from a consumer concerning his 18 week old son with no medical history and no drug allergies, who on 07-DEC-2007 was vaccinated with a second dose of PEDVAXHIB (OMPC).  Concomitant suspect vaccinations included ROTATEQ and pneumococcal vaccine (manufacturer unspecified).  Other concomitant vaccinations included poliovirus vaccine, and DtAP (unspecified).  On 08-DEC-2007 the patient experienced diarrhea, fever, was moaning, and was very lethargic.  It was reported that the patient's symptoms lasted for about thirty six hours, but the patient was still experiencing diarrhea.  The physician was contacted by phone.  No laboratory diagnostics were performed.  At the time of the report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Sex: M
Vaccine: HIBV
Symptoms: Body temperature increased, Crying, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning her son (age unknown), who on 06-DEC-2007 was vaccinated with a first dose of Hib conj vaccine (OMPC).Subsequently the patient experienced a low grade fever of 99.2F and has been crying. The patient's temperature was measured rectally. The patient did not seek medical attention. At the time of the report, the patient had not recovered. No product quality complaint was involved.
Age: 0.4
Sex: F
Vaccine: HBHEPB, HIBV
Symptoms: Anorexia, Cold sweat, Dysuria, Erythema, Injection site vesicles
Clinical narrative: Information has been received from a consumer concerning a 20 week old female with no drug allergies, who on 04-DEC-2007 was vaccinated with a first dose of PedvaxHIB. Concomitant suspect vaccinations included Comvax vaccine. On 04-DEC-2007 the patient developed a huge blister at the injection site, cold sweat, red face, loss of appetite, and decreased urination. The patient sought unspecified medical attention. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Abdominal pain, Erythema, Malaise, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 39 month old daughter with a history  of "fever with all vaccines" who when she was 'less then 1 year old was vaccinated with a dose of Hib conj vaccine (OMPC). On approximately 10-DEC-2007 was vaccinated with a dose of Hib conj vaccine (OMPC). There was no concomitant medication. On 11-DEC-2007 the patient experienced "very high fever, constant throwing up, and leg also became swollen and red." The patient was described as "violently ill." Unspecified medical attention was sought. At the time of the report, the patient was recovering. It was reported that her "stomach still hurts." Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/18/20078. Previous vaccines included: ACTHIB (lot # ub878aa) on 03-Nov-2004, FLUARIX (lot # UT2459HA) (date not reported), HAVARIX (lot #AHAVB2066A) (date not reported), PEDIARIX (lot # AC21B30AA) on 03-Oct-2004 and PREVNAR (lot # 80865) on 03-Nov-2004. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Streptococcus test, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 39 month old daughter with a history  of "fever with all vaccines" who when she was 'less then 1 year old was vaccinated with a dose of Hib conj vaccine (OMPC). On approximately 10-DEC-2007 was vaccinated with a dose of Hib conj vaccine (OMPC). There was no concomitant medication. On 11-DEC-2007 the patient experienced "very high fever, constant throwing up, and leg also became swollen and red." The patient was described as "violently ill." Unspecified medical attention was sought. At the time of the report, the patient was recovering. It was reported that her "stomach still hurts." Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/18/20078. Previous vaccines included: ACTHIB (lot # ub878aa) on 03-Nov-2004, FLUARIX (lot # UT2459HA) (date not reported), HAVARIX (lot #AHAVB2066A) (date not reported), PEDIARIX (lot # AC21B30AA) on 03-Oct-2004 and PREVNAR (lot # 80865) on 03-Nov-2004. Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Abscess limb, Cellulitis, Induration, Nodule, Swelling
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age not specified), who on an unspecified date was vaccinated with the second dose of PedvaxHIB (lot # not reported). Subsequently the patient developed an abscess on both of her thighs. The patient sought medical attention, though treatment details were not provided. After an unknown duration of time, the patient recovered from the events. Additional information has been requested. Initial and follow up information has been received from a physician, concerning a 27 week old female infant with no known medical conditions or allergies, who on 23-AUG-2007 was vaccinated with the second dose of PEDVAXHIB (lot # unknown). There was no illness at the timeof vaccination. On 27-AUG-2007, the infant presented to the physician as a new patient after she had developed 'nodular swellings, firm in consistency; cellulitis and abscess of both thinghs.' Treatment details were not provided. After an unknown duration of time, the patient recovered from the events. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: FLU3, HIBV, PNC
Symptoms: Nausea, Stomach discomfort, Vomiting
Clinical narrative: Information has been received from a consumer and follow up from a medical assistant concerning a 12 month old white female with no pertinent medical history, drug reactions/allergies or illness at time of vaccination, who on 30-NOV-2007 was vaccinated intramuscularly (site not reported) with the third (also reported as fourth dose) 0.5ml dose of PEDVAXHIB (OMPC) (lot #656522/0437U).  On the same day the patient was concomitantly vaccinated intramuscularly with a fourth dose of PREVNAR (lot # B54015D) and FLUZONE (influenza virus split virion 3v vaccine inactivated) (lot #UT2460BA).  Subsequently starting on 13-Dec-2007 at 11:30am, the patient experienced 4 incidents of vomiting (previously reported as 3).  The patient was very sick to the stomach and had nausea during the following week.  The patient did not receive medical attention and no diagnostic lab test were performed.  On 20-Dec-2007, the patient recovered.  No additional information is expected.
Age: 0.4
Sex: F
Vaccine: HIBV, UNK
Symptoms: Pyrexia
Clinical narrative: Initial and follow up information has been received from a consumer, concerning her 6 month old daughter with no pertinent medical history, drug reactions/allergies or concomitant medication use, who in July or August 2007 was vaccinated (site and route not reported) with the 1st dose of the Hib conj vaccine (OMPC) (lot# 656520/0435U). The patient was vaccinated with other vaccines on the same day as the Hib conj vaccine was given but mother can not recall which ones. The patient's mother reported that "right after Hib conj vaccine the patient developed a fever that lasted about 3 to 5 days". The patient did receive unspecified medical attention, no diagnostic lab test were performed. On a unspecified day the patient recovered from the fever. Follow up information received from the physician indicated that he was not aware of an adverse event, and indicated the child had no reaction. The child also had no illness at the time of vaccination, and no pertinent medical history. He reported the child was fine and had "no issue," though he confirmed the child was vaccinated on 03-OCT-2007, with lot # 656520/0435U, as reported above, from a recalled lot. Additional information is not expected.
Age: 0.4
Sex: M
Vaccine: HIBV
Symptoms: Injection site mass
Clinical narrative: Information has been received from a consumer concerning her 22 week old grandson who on approximately 29-NOV-2007 was vaccinated (route and site not reported) with Hib conj vaccine (OMPC) (lot# not reported). Per the grandmother, the patient received his 4 month check-up vaccines developed "bumps on both of his thighs where the injections were given". Patient's grandmother was unsure which vaccines the patient received 2 weeks ago and thinks it was the Hib conj vaccine. It is unknown if the patient received medical attention. At the time of this report the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: HIBV
Symptoms: Adverse event
Clinical narrative: Information has been received from a consumer concerning his son who was vaccinated (date, route and site not report) with PedvaxHIB (lot#not reported). The caller stated that his son was administered a recalled lot of the PedvaxHIB and experienced an AE but did not provide the AE description. No additional information is expected.
Age: 0.6
Sex: M
Vaccine: HIBV
Symptoms: Diarrhoea, Insomnia, Stomach discomfort, Vomiting
Clinical narrative: Information has been received from a consumer concerning his 24 week old son with no pertinent medical history, drug reactions/allergies who in November 2007 (exact date not reported), was vaccinated (route and site not reported) with a dose of PEDVAXHIB (OMPC) (lot# not reported).  The patient was taking medication but specifics were unknown.  On approximately 10-NOV-2007, the patient experienced stomach problems, diarrhea and vomiting, all 3 issues caused him sleeping problems.  The patient's father stated that the symptoms occurred a day after receiving the PEDVAXHIB vaccine.  The patient did receive unspecified medical attention, no diagnostic tests were performed.  At the time of this report the patient had not recovered.  Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site vesicles, Respiratory disorder
Clinical narrative: Information has been received from a consumer, concerning her 26 month old child, who on 26-OCT-2007 was vaccinated with a dose of PedvaxHIB (lot # not reported). On 30-OCT-2007, the child developed 12 blisters at the injection site, and "upper respiratory problems" (details not specified). After 4 weeks, the child recovered from the blisters, however at the time of this report, he had not recovered from the upper respiratory problems. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician, via a company representative, concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a dose of PedvaxHIB (lot # not reported, though indicated "one of the recalls lot"). Subsequently the patient developed an injection site reaction (details not provided). The patient sought unspecified medical attention. At the time of this report, the patient was recovering from the event. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Irritability, Pyrexia, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning an 18 weeks old male infant with a history of formula interolance and reflux (treated with LEVSIN) drops and ZANTAC)), who on 11-DEC-2007 was vaccinated IM in the left thigh with the first dose, 0.5 ml, of PedvaxHIB (lot #656522/0437U). Previous vaccination in the series on 18-OCT-2007 was indicated to be from another manufacturer. Concomitant therapy included DTaP-IPV and Prevnar. On 11-DEC-2007, 3 hours after vaccination, the child developed a fever of 102.9 F. On 12-DEC-2007 the child developed 5 separate bouts of diarrhea. On 13-DEC-2007 the child had watery stools, vomited twice and was cranky and irritable when examined in the physician's office. At the time of this report, the child was recovering from the events. The physician did not feel the events were related to PedvaxHIB, other than on a temporal basis. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pain in extremity, Rash papular, Swelling
Clinical narrative: Information has been received from a pediatrician, concerning a 17 week old male infant, who on 05-DEC-2007 was vaccinated IM in the left leg with a dose 0.5 ml, of PEDVAXHIB (OMPC) (lot #656521/0436U).  Concomitant vaccine therapy included a dose in the left leg of PREVNAR and a dose in the right leg of PEDIARIX.  On 06-DEC-2007 ("24 hours after injection"), the infant developed fussiness or irritability.  In addition, he developed a knot on his left thigh, which is sore and swollen.  On 14-DEC-2007, the infant was scheduled to see the physician.  At the time of this report, the outcome of the events was unknown.  Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: HIBV
Symptoms: Gait disturbance, Injection site reaction, Local reaction
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 15 month old male child, who on an unspecified date was vaccinated with a dose of PEDVAXHIB (OMPC) (lot # not reported).  Subsequently the child developed a "very bad localized reaction" (details not provided) at the injection site.  The physician indicated that the child couldn't walk due to the symptoms.  At the time of this report, the outcome of the events was unknown.  Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: HIBV, PNC, RV5
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Information has been received from an office manager at a physician's office, via a company representative, concerning an approximately 18 week old ("4 months) female infant, who on 11-DEC-2007 was vaccinated with a dose, 0.5 ml, of PEDVAXHIB (OMPC) (lot # not reported, but specified as from recalled lot).  Concomitant therapy included PREVNAR and ROTATEQ (MSD) (lot # not reported).  On 11-DEC-2007, following the vaccination, the patient developed increasing redness and irritation at the injection site.  At the time of this report, the patient had not recovered.  The patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/18/2008. Initial and follow up information has been received from an office manger at a physician's office, concerning an approximately 18 week old female infant with no pertinent medical history and no known allergies, who on 25-SEP-2007 was vaccinated with the first dose (lot #657385/0820U) with no symptoms reported, and on 11-DEC-2007 was vaccinated wit the second dose, 0.5 ml PEDVAXHIB (OMPC) (lot # not reported, but specified as from recalled lot). Concomitant therapy with the second dose on 11-DEC-2007 included PREVNAR and ROTATEQ (MSD) (lot # not reported). There was no illness at the time of vaccination. On 14-DEC-2007 (previously reported as 11-DEC-2007), following at the injection site. The infant's twin sibling was vaccinated with the second dose of PEDVAXHIB (OMPO) on the same date, and experienced no adverse event. At the time of this report, the patient had recovered (date and duration not specified). The infant did not require a visit to the physician. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HIBV
Symptoms: Flatulence, Nasal congestion
Clinical narrative: Information has been received from a nurse concerning an 18 week old patient (gender not reported) with a history of gas who on 07-DEC-2007 was vaccinated (route and site not reported) with a 0.5 ml dose of PedvaxHIB (lot#656520/0435U). Dose of the series of PedvaxHIB vaccine which was given was unknown. Concomitant therapy included INFANTS MYLICON DROPS. On 13-DEC-2007, the patient developed stuffiness, nasal congestion and gas. The patient's mother was convinced that the patient had these experiences because of the "recall of the vaccine". The patient did receive unspecified medical attention but at the time of this report it is unknown if the patient recovered. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HIBV
Symptoms: Body temperature increased, Gait disturbance, Muscle haemorrhage, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 15 month old female with no pertinent medical history who on 12-NOV-2007 was vaccinated intramuscularly into the left leg with a 0.5 ml dose of PEDVAXHIB (OMPC) (Lot #656522/0437U).  Concomitant medication included PEDIARIX and PREVNAR. On the night of 13-NOV-2007, the patient developed a fever which later resolved.  On 13-NOV-2007, the next day, the child called out "owie" and stiffened her left leg, was walking with straight leg. and hadnot wanted to bend her left leg since. No redness, warmth or other known injury reported. On 17-NOV-2007 at the physician's office, the patient's pulse was 120 and her temperature was 16.1C. Her physical examination was reported as a well appearing, well nourished in no distress, normal mood and affect. Bilateral thighs symmetric and normal in appearnace. Left thigh not tender to palpation. She did not resist flexion at the knee, but this can be overcome by persistence. The leg bends easily without crying or apparent pain. She walked with slight antalgic gait, but is bending her left knee now. The physician's impression and plan was reported as leg pain, suspect muscular hematoma following immunizations and refusal to bend knee in response to pain. No evidence for other pathology at this time. Advised passive stretches by bending at the knee and holding, and heat (either warm baths or warm compresses). Patient's mother was instructed to call if fever or worsening. There was no laboratory or diagnostic tests performed.  At the time of the report the patient's outcome was reported as recovered.  Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: HIBV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 15 month old female with no pertinent medical history who on 12-NOV-2007 was vaccinated intramuscularly into the left leg with a 0.5 ml dose of PEDVAXHIB (OMPC) (Lot #656522/0437U).  Concomitant medication included PEDIARIX and PREVNAR. On the night of 13-NOV-2007, the patient developed a fever which later resolved.  On 13-NOV-2007, the next day, the child called out "owie" and stiffened her left leg, was walking with straight leg. and hadnot wanted to bend her left leg since. No redness, warmth or other known injury reported. On 17-NOV-2007 at the physician's office, the patient's pulse was 120 and her temperature was 16.1C. Her physical examination was reported as a well appearing, well nourished in no distress, normal mood and affect. Bilateral thighs symmetric and normal in appearnace. Left thigh not tender to palpation. She did not resist flexion at the knee, but this can be overcome by persistence. The leg bends easily without crying or apparent pain. She walked with slight antalgic gait, but is bending her left knee now. The physician's impression and plan was reported as leg pain, suspect muscular hematoma following immunizations and refusal to bend knee in response to pain. No evidence for other pathology at this time. Advised passive stretches by bending at the knee and holding, and heat (either warm baths or warm compresses). Patient's mother was instructed to call if fever or worsening. There was no laboratory or diagnostic tests performed.  At the time of the report the patient's outcome was reported as recovered.  Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 19 week old female who on 27-NOV-2007 was vaccinated with a 0.5 ml second dose of PEDVAXHIB (OMPC) (Lot #"1164U").  Concomitant vaccination on the same day included PEDIARIX and PREVNAR.  On 01-DEC-2007 the patient developed a rash on her face and backside of her neck.  There was no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  At the time of the report the patient had not recovered.  The patient did not have any AE with the first dose of PEDVAXHIB (OMPC).  Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Crying, Irritability
Clinical narrative: Information has been received from a consumer concerning her 4 month old female infant with no pertinent medical history who in October 2007, was vaccinated with a first dose of PedvaxHIB. The patient did not have irritability or crying. On 10-DEC-2007 the patient was vaccinated with a second dose of PedvaxHIB. Concomitant vaccinations on the same day included DTaP and poliovirus vaccine. On 10-DEC-2007 the patient had an increase in irritability and increased crying. 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: 1.3
Sex: M
Vaccine: HIBV
Symptoms: Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old male who on 30-NOV-2007 was vaccinated with a dose of PEDVAXHIB (OMPC) (Lot #657380/0377U).  Concomitant therapy included montelukast sodium (MSD).  On 11-DEC-2007 the patient experienced a localized reaction.  The nurse described the reaction as a "strawberry" size and reaction.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Age: 0.99
Sex: M
Vaccine: HIBV
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/18/2008. Initial and follow-up information has been received from a consumer concerning her 12 month old son with no pertinent medical history who on approximately 14-JUL-2005 was vaccinated with a dose of hib conj vaccine (OMPC). In November 2007 the patient was vaccinated with a dose of Hib conj vaccine (OMPC) (Lot# 656522/0437U). There was no concomitant medication. On 27-NOV-2007, the patient experienced a lump, the size of a penny, at the injection site and injection site swelling. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. Subsequently, the patient recovered. Follow-up information indicated that the adverse events were not related to the vaccination. Additional information is not expected.
Age: 0.35
Sex: F
Vaccine: DTAP, HBHEPB, PNC, RV5
Symptoms: Injection site mass
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/18/2008. Initial and follow up information has been received from a consumer (included medical records), concerning her approximately 18 week old ("4 month old") infant daughter with no pertinent medical history, who in September 2007, was vaccinated in the right thigh (previously reported as left leg) with the first dose of COMVAX (lot #655548/1243F) (previously reported as Hib conj vaccine (OMPC), with no events noted.  On 26-NOV-2007 at 2:30 pm, the infant was vaccinated IM in the right thigh with the second dose of COMVAX (lot # 657179/0223U) (previously reported as Hib conj vaccine (OMPC), in the left thigh with the second dose of DTaP (unspecified) (AVENTIS) (lot #C2797AA), and in the left thigh with the second dose of PREVNAR (WYETH) (lot #805100K). Concomitant therapy on 26-NOV-2007 included the second dose, oral, of ROTATEQ (lot #656393/0240U). Following the vaccinations on 26-NOV-2007, her daughter developed bumps at the injection sites of both legs. The mother called the physician and was informed "there wasn't anything to be concerned" about. On 02-DEC-2007 the infant recovered from the events. Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: HIBV
Symptoms: Rash generalised
Clinical narrative: Information has been received from a consumer concerning her 19 week old daughter with no allergies who on 29-NOV-2007, was vaccinated with a second 0.5 ml dose of PedvaxHIB. Suspect concomitant therapy included Rotateq, for the treatment of prophylaxis (duration and doses not reported). on 06-DEC-2007 one week after the vaccination, the patient developed a rash from head to toe. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient was recovering. It was reported that the patient did not have any adverse event from the first dose in October 2007. No product quality complaint was involved. Additional information has been requested.
Age: 0.7
Sex: F
Vaccine: HIBV
Symptoms: Diarrhoea, Oedema peripheral, Rash generalised, Vomiting
Clinical narrative: Information has been received from a consumer concerning a 9 month old female who in August 2007, was vaccinated with a first dose of PedvaxHIB, and in November 2007 with her second dose. It was reported that the patient developed legs swollen, vomiting, diarrhea and chronic rash all over the body after getting the first and second doses of PedvaxHIB. Unspecified medical attention was sought. The patient had not recovered at the time of the report. No further information is available.
Age: 4.0
Sex: F
Vaccine: FLUX, HIBV
Symptoms: Erythema, Induration, Oral mucosal blistering, Pyrexia
Clinical narrative: Information has been received from a grandmother concerning her 4.5 year old granddaughter with no reported allergies or medical history who on approximately 26-NOV-2007, "three weeks ago," was vaccinated IM in the leg with a 0.5 mL dose of PedvaxHIB. Concomitant therapy included vaccination with a dose of influenza virus vaccine (unspecified) in the opposite leg. On approximately 26-NOV-2007, the same day as the vaccination, the patient's leg that was vaccinated with PedvaxHIB "became all red and hard as a rock" for two weeks. The patient sought unspecified medical attention. On approximately 17-DEC-2007, "just this week," the patient developed an "uncontrollable fever and blisters inside her mouth." The patient was brought to the emergency room and was treated with unspecified antibiotics and pain medication. The patient was not admitted to the hospital. At the time of this report, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HIBV
Symptoms: Laryngitis, Malaise, Pain, Pyrexia
Clinical narrative: Information has been received from a physician who in December 2007 was vaccinated with a dose of PedvaxHIB. Subsequently the patient had fallen ill, had a pretty high fever, achy, couldn't get out of bed, and also had laryngitis. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HIBV
Symptoms: Erythema
Clinical narrative: Information has been received from a physician concerning a 3 month old patient who 12-DEC-2007 was vaccinated with a dose of Hib conj vaccine (OMPC). Subsequently the patient experienced some slight redness. They have not seen the patient since then. They are going to follow up with the patient. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 0.92
Sex: M
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Nasal congestion, Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning her 11 month old son with mild nose congestion and a history of jaundice and phototherapy at birth who on 21-SEP-2007 was vaccinated intramuscularly into the right leg with a second dose of Comvax (Lot #656519/0259U). Concomitant suspect vaccination on the same day included ProQuad. Other concomitant vaccination on the same day included DTaP. On 01-OCT-2007, ten days post vaccination, the mother reported that the patient developed a slight rash on the abdomen. On 02-OCT-2007, day 11 the patient developed a fever of 99.9 axillary with rash becoming raised and spreading over the face, chest, back arms and legs. The rash became slightly itchy. "Doctor consulted since Dr. out, and mother informed it was probably MMR reaction which could require supportive care and close monitoring". The mother was told to take child to urgent care if symptoms escalated or the emergency room if any life threatening signs or symptoms developed. The mother was advised to use BENADRYL if itching was a problem. The child was not experiencing any other problems and was eating and playing normally. At the time of the report the patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture, Body temperature increased, Culture urine, Full blood count, Urine analysis
Clinical narrative: Information has been received from a health professional concerning a 2 week old female with no pertinent medical history who on 09-OCT-2007 was vaccinated intramuscularly into the left leg with a first dose of hepatitis B virus vaccine rHBsAg 9yeast) (+) Hib conj vaccine (OMPC) (Lot #656520/0435U). Concomitant suspect vaccination on the same day included ROTATEQ. Other concomitant vaccination on the same day included PREVNAR and PEDIARIX. On 09-OCT-2007 the patient developed an increased temperature of 102.5. A urine analysis, urine and blood culture and complete blood cell counts were performed, results not reported. Subsequently, the patient recovered. No further information is available.
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Erythema, Injection site erythema, Injection site mass, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 4 year old grand daughter with juvenile arthritis and history of allergic reaction to child hood shots who on 07-DEC-2007 was vaccinated with a dose of Hib conj vaccine (OMPC) (lot # unknown). Concomitant therapy included methotrexate and naproxen. The reporter that after one day of receiving Hib conj vaccine (OMPC) on 09-DEC-2007 her grand daughter developed red streaks on her right arm and the entire arm was swollen. Her right arm was three times bigger than her left arm and was very red and warm. She was prescribed extra strength BENADRYL and an antimicrobial (unspecified). She no longer had a swollen arm and the pain had gone away except at the injection site where she still had a red knot. The knot was the size of a half dollar. No further information was available. The patient was recovering. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Skin striae, Skin warm
Clinical narrative: Information has been received from a consumer concerning her 4 year old grand daughter with juvenile arthritis and history of allergic reaction to child hood shots who on 07-DEC-2007 was vaccinated with a dose of Hib conj vaccine (OMPC) (lot # unknown). Concomitant therapy included methotrexate and naproxen. The reporter that after one day of receiving Hib conj vaccine (OMPC) on 09-DEC-2007 her grand daughter developed red streaks on her right arm and the entire arm was swollen. Her right arm was three times bigger than her left arm and was very red and warm. She was prescribed extra strength BENADRYL and an antimicrobial (unspecified). She no longer had a swollen arm and the pain had gone away except at the injection site where she still had a red knot. The knot was the size of a half dollar. No further information was available. The patient was recovering. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Diet refusal, Injection site bruising, Injection site erythema, Injection site mass, Injection site rash
Clinical narrative: Information has been received from a consumer concerning her 15 month old female child who on 11-DEC-2007 was vaccinated with a dose of PedvaxHIB lot # 657385/0677U. Concomitant therapy included other vaccination (unspecified). The reporter reported that within hours after receiving the vaccine her daughter's injection site was really red, hot, bruised, had a rash, and was swollen. She also reported that the child had a low grade fever around 101 degrees, was fussy and she was not eating right. It was reported that within a couple days swelling went from her behind to her leg in a round circle. She still had a knot at the injection site. The reporter mentioned that the child was taken to the physician, and the physician put her on unspecified antimicrobial therapy. She was recovering. Additional information has been requested. Follow-up information received 4/15/08. The concomitant therapy has been changed from study vaccination (unspecified) to therapy unspecified (other unspecified vaccination). Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Injection site swelling, Injection site warmth, Irritability, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 15 month old female child who on 11-DEC-2007 was vaccinated with a dose of PedvaxHIB lot # 657385/0677U. Concomitant therapy included other vaccination (unspecified). The reporter reported that within hours after receiving the vaccine her daughter's injection site was really red, hot, bruised, had a rash, and was swollen. She also reported that the child had a low grade fever around 101 degrees, was fussy and she was not eating right. It was reported that within a couple days swelling went from her behind to her leg in a round circle. She still had a knot at the injection site. The reporter mentioned that the child was taken to the physician, and the physician put her on unspecified antimicrobial therapy. She was recovering. Additional information has been requested. Follow-up information received 4/15/08. The concomitant therapy has been changed from study vaccination (unspecified) to therapy unspecified (other unspecified vaccination). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Local reaction
Clinical narrative: Information has been received from a physician, via a company representative, concerning a patient (age and gender not specified), who on an unspecified date was vaccinated with a dose of PEDVAXHIB (OMPC) (lot # not reported).  Subsequently the patient developed a localized reaction (details not provided).  At the time of this report, the outcome of the events was unknown.  Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Body temperature increased, Irritability, Restlessness
Clinical narrative: Initial and follow up information has been received from a consumer and the doctor's office concerning her 5 month old daughter (previously reported as 4 month old) with oesophageal acid reflux and hearing deficit, who in October 2007, was vaccinated with a first dose of PEDVAXHIB (OMPC) and on 12-DEC-2007 she received IM her second dose of PEDVAXHIB (OMPC) in right thigh lot #655547/0076U.  On same day, concomitant therapy included PREVNAR lot #B54016H and PEDIARIX lot #AL21B124CA.  Other concomitant therapy included ranitidine HC1 (ZANTAC).  On 12-DEC-2007 the reporter reported that her daughter developed fever of 102.7 after the second vaccination and she was very restless.  The reporter reported that her daughter's temperature had returned to normal but she was still restless.  She mentioned that her daughter tolerated the first dose of PEDVAXHIB (OMPC) fine.  No other information available at this time.  In a follow up report from the doctor's office it was reported that the patient was also irritable.  The child has recovered on an unknown day.  No other information is expected.
Age: 0.01
Sex: M
Vaccine: DTP, HBHEPB, HIBV, IPV, PNC, RV5
Symptoms: Injection site mass
Clinical narrative: Information has been received from a consumer concerning her 3 weeks old son who on 07-DEC-2007 was vaccinated with a first dose of Hib conj vaccine (OMPC) (lot # unknown). Concomitant therapy included ROTATEQ and unspecified vaccination. The reporter that her son had a bump at the injection site that would not go away. No further information was provided. Unspecified medical attention was sought. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on2/18/2008. Initial and follow up information has been received from a consumer and a healthcare professional from a physician's office concerning approximately a ten week old male infant with constipation who on 07-DEC-2007 was vaccinated with a first dose of PEDVAXHIB (OMPC) (lot # not reported). In follow up report it was indicated that on 07-DEC-2007 concomitant suspect therapy included a first dose of ROTATEQ (MSD) lot # 657673/0904U and on same day the infant received into right leg a first dose of COMVAX (OMPC) lot # 657380/0377U (route not reported.). Other concomitant therapy included DTP, poliovirus vaccine and PREVNAR. On approximately 12-DEC-2007 the patient experienced injection site bump. The patient's injection site bump persisted. In the follow up report it was reported that the physician's office was not informed about the injection site bump. Additonal information is not expected.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Cough, Pyrexia, Urticaria
Clinical narrative: Information has been received from a nurse concerning her 28 month old son who on 19-NOV-2007 was vaccinated (route and site not reported) with PEDVAXHIB (OMPC) (lot # not reported).  The patient was concomitantly vaccinated with DTaP (unspecified) (manufacturer unknown) and VAQTA (unspecified-manufacturer unknown) on the same day.  On 17-DEC-2007, post vaccination, the patient developed generalized hives, fever and a cough.  The nurse treated her son with diphenhydramine hydrochloride (BENADRYL).  At the time of this report the patient's outcome was not reported.  No additional information is expected.
Age: 1.1
Sex: M
Vaccine: HIBV, UNK
Symptoms: Crying, Injection site erythema, Irritability
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 usage, who on 05-DEC-2007 was vaccinated (route and site not reported) with PEDVAXHIB (OMPC) (lot # not reported).  On the same day, the patient was concomitantly vaccinated with other vaccines, reporter did specify which ones.  In December 2007 (exact date not reported), the patient experienced redness at the injection site, prolonged crying and was irritable.  The consumer reported that patient received one of the recalled lot's but did not have lot number.  Patient did receive unspecified medical attention.  No diagnostic lab test were performed.  At the time of this report the patient had not recovered.  No additional information is expected.
Sex: U
Vaccine: HIBV
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a child (age and gender unknown), who, on an unspecified date, was vaccinated with a dose of of Hib conj vaccine (OMPC). Subsequently, the patient experienced diarrhea, vomiting, and a low grade fever. The physician was contacted by phone. at the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a female with no pertinent medical history or allergies, who on 09-OCT-2007 was vaccinated with an oral 2 ml first dose of ROTATEQ.  There was no concomitant medication.  In November 2007, the patient experienced intussusception and was seen by a physician.  The patient was hospitalized and underwent surgery.  Subsequently, on an unspecified date, the patient recovered from intussusception.  No product quality complaint was involved.  The reporter considered intussusception to be an important medical event and to be life threatening.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Culture stool negative, Diarrhoea, Occult blood positive
Clinical narrative: Information has been received from a registered nurse concerning a 9 week old female with no pertinent medical history or drug allergies who on 04-DEC-2007 and 05-FEB-2008 was vaccinated PO with her first and second doses of ROTATEQ (lot# 657673/0904U, lot# 659772/1636U).  There was no concomitant medication.  On approximately 11-DEC-2007 1 week after the first dose, the patient experienced diarrhea.  In December 2007, the patient's stool sample was positive for heme.  The patient was treated with electrolyte oral solution (PEDIALYTE).  The diarrhea continued and the infant was seen in an emergency room while the family was out of town on vacation.  No treatment was required in the emergency room.  On 07-JAN-2008 the infant was examined in the physician's office and a stool culture at the time was negative for heme, rotavirus and other pathogens.  The infant was then switched to a soy-based formula.  On 11-FEB-2008 the patient experienced profuse diarrhea.  The patient's mother contacted the physician's office by phone and supportive corrective fluids were recommended.  The patient's profuse diarrhea persisted.  There was no product quality complaint.  Upon internal review, heme-positive stool was determined to be an other important medical event.  Additional information has been requested.
Age: 0.29
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning an 8-month-old female who on 22-AUG-2007 was vaccinated orally, with the "first dose of series" of Rotateq (lot# 656196/0026U).  On 22-JAN-2008 the patient developed intussusception.  On 24-Jan-2008 the patient had surgery.  The patient was hospitalized but the length of stay was unknown.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  The reporter considered intussusception to be an other important medical event (surgery).  Additional information has been requested. 5/2/08-records received for DOS 1/24/08-presented to ED with C/O blood and mucous stool and bilious vomiting times 2 days since 01/23/08.  7/22/08-records received for DOS 1/24/08-exploratory laparoscopy, laparoscopic reduction of ileocecal intussusception.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Nervous system disorder, Paraesthesia
Clinical narrative: Initial information has been received from a female whose husband on 12-NOV-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 16-NOV-2007 the wife developed shingles.  It was reported that the shingles were initially located around her right torso, nerves 8 to 2.  The patient had symptoms of tingling, numbness and burning, and was hospitalized.  The patient had no lesions.  The symptoms had spread down her leg to her foot.  The patient had no history of shingles.  The patient was treated with VALTREX.  At the time of the report, the patient had not recovered.  Additional information received from the patient indicated the physician's assessment determined that she did not have shingles.  Follow up information from the patient's physician indicated that the patient's neurological symptoms had been diagnosed as probable multiple sclerosis.  Current patient status was not reported.  No further information is available.
Age: 1.1
Sex: F
Vaccine: VARCEL, UNK
Symptoms: Blood test, Bronchitis, Chest X-ray, Culture, Depression
Clinical narrative: Information has been received from a consumer concerning her 6 year old daughter with constipation and a history of respiratory syncytial virus infection (RSV), who when she was a year old, on 27-AUG-2002, was vaccinated with a first dose of VARIVAX.  The reporter indicated that on 17-JAN-2008, the patient developed a spot on her face that she kept itching, and was given diphenhydramine (BENADRYL) to help with the itching.  The next morning (18-JAN-2008), the patient woke up with "a bunch of red spots on her face".  The reporter indicated that on the same day (18-JAN-2008), she went to the hospital, had a culture done (unspecified), and was diagnosed with herpes zoster.  The shingles were reported to have been on her ear, face, gum line, throat, chest, and neck.  The reporter indicated that the patient had an ear infection in the right ear due to the shingles and was given a form of acyclovir and penicillin.  The reporter indicated that the patient had an allergic reaction to the penicillin.  She described the reaction as the patient would pass out, had cramping, and vomiting.  The reporter indicated that on unspecified dates, the patient was hospitalized twice.  The first hospitalization was reportedly for 5 days, and the second hospitalization for 8 days.  It was reported that while in the hospital (date and hospitalization not specified), she developed bronchitis.  The reporter stated that on 11-FEB-2008, the patient was going back to the hospital "because she had not been on medication for a couple days".  Additional information from the reporter on 14-FEB-2008, indicated that the patient was back in the hospital for 14 days so she could receive medication intravenously (specific medication not reported).  The reporter stated that "the physicians are testing her immune system to see why she still is having trouble getting rid of the shingles".  The reporter also indicated that the patient is starting to get depressed because of the shingles on her face.  Additional information from the physician's office indicated that they had no record of vaccinations being administered at that office, and that she was last seen in their office in 2006.  At the time of this report the patient had not recovered.  A product quality complaint was not reported.  It was reported that the patients brother (WAES# 0802USA026660), with a history of pneumonia (hospitalized, 02-JAN-2000), who was 10 months of age when a sibling received VARIVAX on 09-DEC-1999.  In January 2000 (date not specified), he was hospitalized for full blown varicella.  It is indicated that the patient has developed lung problems, skin problems, allergies, and asthma. 3/4/08-records received for DOS 1/18/08- Varicella Zoster-mandible. dermatitis questionalble stap vs strep vs virus etiology. with gingivistomatitis. Right otitis media, asthma exacerbation, vomiting. constipaion. Presented with 'mosquito bite' on right cheeck with itiching 2 days ago C/O right otalgia, heaving diarrhea.