chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Severe erythema, pain, and swelling in deltoid at site of Pneumovax, starting several hours after injection.  Resolved over 5 days with per mouth Cefzil, Benadryl, ice.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Balance disorder, Chills, Fall, Fatigue, Feeling hot
Clinical narrative: Patient was alert/responsive throughout.  Several minutes after vaccine administration, patient lost balance and fell.  She tried to get up, but was unable.  She was helped to her feet and walked to a chair.  En route, patient's legs became weak and she was laid on floor.  After several minutes, she was helped to her feet and sat in chair with head down and warm cloth on her head.  Left pharmacy 17:00 under parental supervision.  Complained of warmth and nausea.  19:00 mom reported chills/fatigue.  21:00 patient reported arm weakness but ok.  Patient returned to work 11/29/2003, complained of injection site soreness only.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Gait disturbance, Injection site pain, Muscular weakness, Nausea
Clinical narrative: Patient was alert/responsive throughout.  Several minutes after vaccine administration, patient lost balance and fell.  She tried to get up, but was unable.  She was helped to her feet and walked to a chair.  En route, patient's legs became weak and she was laid on floor.  After several minutes, she was helped to her feet and sat in chair with head down and warm cloth on her head.  Left pharmacy 17:00 under parental supervision.  Complained of warmth and nausea.  19:00 mom reported chills/fatigue.  21:00 patient reported arm weakness but ok.  Patient returned to work 11/29/2003, complained of injection site soreness only.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Chills, Cyanosis, Pallor, Pyrexia
Clinical narrative: Approximately 1 hour after meal, infant began to moan, mom checked on patient, infant was pale, lips blue, limbs/chine quivering, noted to still be breathing.  Temperature 100.4 (rectal).  Patient then noted not to making good eye contact.  Paramedics called.  Episode lasted about 10 minutes.  Following patient acting normal.  Epostictal period.  No emesis, no choking, at ER Temperature 101.7 (rectal).
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Complained of discomfort in left upper arm after injection given.  Trouble with pain when moves arm in certain ways.  Pain still persists.  I puke with my nurse (unable to read). 11/16 no discomfort.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Left thigh with 2 visible injection sites.  No purulence or tense edema.  Majority of anterior aspect is red, warm, small area medially that extends to posterior aspect at distal thigh.  Significant local reaction.
Age: 31.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injection site oedema, Pain
Clinical narrative: Patient noted edema extending from injection site right deltoid to right axilla, sore and uncomfortable PM date received.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Feeling hot, Oedema, Pain
Clinical narrative: Starting about 2 inches below injection site, arm swollen, red, hot.  Swollen area 4-5 inches in worst part-with vivid red outline pain.  Whole arm and hand swollen by day 2.  Major site of swelling and redness moved progressively lower on arm.  Pain-especially when it  progressed to elbow-5-6 days duration.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Feeling hot, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Complained of knot and redness, fever, dizziness, soreness in arm.  Observed on 11/26/2003-redness, warmth and knot app. 16 mil in size.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Complained of knot and redness, fever, dizziness, soreness in arm.  Observed on 11/26/2003-redness, warmth and knot app. 16 mil in size.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Constipation, Cough, Diarrhoea, Erythema, Insomnia
Clinical narrative: Info has been received from a physician concerning a 10-week-old "healthy" female, breast-fed, with a history of jaundice and diaper rash, who on 04/10/2001 and 06/11/2001 (also reported as 06/19/2001) was vaccinated with the 1st (lot #638792/1825K, administered in the left side) and 2nd doses of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Concomitant therapy, on those same dates, included the 1st and 2nd doses of poliovirus vaccine inactivated (IPOL) (lot #T0757, 1st dose, administered in the right side), Streptococcus pneumoniae vaccine (Prevnar) (lot #474-729, 1st dose, administered in the right side) and alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia) (Lot #995A2), 1st dose administered in the left side), respectively. The pt had congestion and rhinorrhea at the time of both vaccination episodes. On 04/23/2001, the child was seen for a sick visit and was afebrile. It was documented that on 04/21/2001 the pt experienced a temperature of 99. The physician documented the presence of minimal thrush on the pt's tongue and problems with bowel movements. The pt's last bowel movement was on 04/22/2001, but she had not had one, prior to that on 04/18/2001. The bowel movement was described as soft, large, and watery. The had been given apple juice 1 oz. x 1 day. On 05/26/2001, the pt was seen for an upper respiratory infection (incidental finding). She had a "deep" cough and was coughing so hard that she expelled emesis that morning. She had been fussy and irritable for 4 days. At that time, she was afebrile and having loose stools daily. She had "yellow" rhinorrhea for 1 week. It was noted that she was taking ibuprofen (Motrin) and that her sibling had RSV at the time. On 07/11/2001, she was seen for a well-child visit and received her immunizations as reported above. On 07/30/2001, she was again seen by the physician. It was noted that the upper respiratory infection symptoms were resolving. At that time the pt had a red macular rash on her trunk, palms, and soles. She had a fever for 3 days, up to 100.7, was fussy and sleep decreased. The physician's impression was a viral syndrome. She had been taking acetaminophen (Tylenol) and ibuprofen (Motrin). On 08/14/2001, she was seen for a well-child visit, at which time she was afebrile (97.4) and noted to be teething (incidental finding). Upper respiratory infection and teething were considered to be incidental findings. This info was received in follow-up to a case reported through the Pregnancy Registry. The pt's mother was vaccinated with varicella virus vaccine live, while pregnant with this child (WAES #00062591). Additional info is not expected.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Irritability, Pyrexia, Rash macular, Upper respiratory tract congestion, Viral infection
Clinical narrative: Info has been received from a physician concerning a 10-week-old "healthy" female, breast-fed, with a history of jaundice and diaper rash, who on 04/10/2001 and 06/11/2001 (also reported as 06/19/2001) was vaccinated with the 1st (lot #638792/1825K, administered in the left side) and 2nd doses of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Concomitant therapy, on those same dates, included the 1st and 2nd doses of poliovirus vaccine inactivated (IPOL) (lot #T0757, 1st dose, administered in the right side), Streptococcus pneumoniae vaccine (Prevnar) (lot #474-729, 1st dose, administered in the right side) and alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia) (Lot #995A2), 1st dose administered in the left side), respectively. The pt had congestion and rhinorrhea at the time of both vaccination episodes. On 04/23/2001, the child was seen for a sick visit and was afebrile. It was documented that on 04/21/2001 the pt experienced a temperature of 99. The physician documented the presence of minimal thrush on the pt's tongue and problems with bowel movements. The pt's last bowel movement was on 04/22/2001, but she had not had one, prior to that on 04/18/2001. The bowel movement was described as soft, large, and watery. The had been given apple juice 1 oz. x 1 day. On 05/26/2001, the pt was seen for an upper respiratory infection (incidental finding). She had a "deep" cough and was coughing so hard that she expelled emesis that morning. She had been fussy and irritable for 4 days. At that time, she was afebrile and having loose stools daily. She had "yellow" rhinorrhea for 1 week. It was noted that she was taking ibuprofen (Motrin) and that her sibling had RSV at the time. On 07/11/2001, she was seen for a well-child visit and received her immunizations as reported above. On 07/30/2001, she was again seen by the physician. It was noted that the upper respiratory infection symptoms were resolving. At that time the pt had a red macular rash on her trunk, palms, and soles. She had a fever for 3 days, up to 100.7, was fussy and sleep decreased. The physician's impression was a viral syndrome. She had been taking acetaminophen (Tylenol) and ibuprofen (Motrin). On 08/14/2001, she was seen for a well-child visit, at which time she was afebrile (97.4) and noted to be teething (incidental finding). Upper respiratory infection and teething were considered to be incidental findings. This info was received in follow-up to a case reported through the Pregnancy Registry. The pt's mother was vaccinated with varicella virus vaccine live, while pregnant with this child (WAES #00062591). Additional info is not expected.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old white child patient with no known allergies and no past medical history who on 11/18/02 at 3:30 PM was vaccinated IM in the left thigh with a third dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (lot #643661/0723M). Concomitant medication that day at 3:30 PM included SCQ in the right thigh a first dose of MMR (lot # 642695/0490M). The patient had otitis media at the time of vaccination. On 11/19/02, the patient developed marked swelling, warmth, overlying erythema and a large lump at the injection site. Unspecified medical attention was sought. The reporter expressed a concern regarding the lot number 643661/0723M. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Follow up information has been received from a medical assistant indicated that the patient recovered. There were no lab data or diagnostic studies reported. The reporter indicated that other patient's experienced adverse events. No further information is expected.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR
Symptoms: Decreased appetite, Feeling hot, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Info has been received from a medical assistant concerning 2 children patients who were vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B  vaccine recombinant (yeast) (lot #643661/0723M). Subsequently the patients developed marked swelling, redness and warmth at the injection site. The patients still had a hard lump at the site one month later. Unspecified medical attention was sought. The reporter expressed a concern regarding the lot number 643661/0723M. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow up info has been received from a medical assistant concerning a 12-month-old female pt with no known allergies and no past medical history who on 09/16/2002 was vaccinated IM in the right thigh with a 3rd dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (Lot #643661/0723M). Concomitant therapy included SQ in the left thigh a 1st dose of measles-mumps-rubella vaccine (MMR II) (Lot #642695/0490M). There was no illness at the time of vaccination. On 09/17/2002 the pt developed marked a hard lump at the injection site with swelling, redness, and warmth. The injection site area was described as being the size of a fifty cent piece. The pt was also noted to be fussy with a temperature and decreased appetite. Medical attention was sought and a complete blood count was obtained but the results were not reported. Subsequently, on 09/21/2002, the pt recovered, however it was reported that the "site is still hard". No further info is expected.Follow Up: The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and REsearch was released. No further information is available. The reporter indicated that other pts experienced adverse evetns WAES0211USA02173 AND WAES0212USA01740. No further information is expected.
Age: 1.25
Sex: U
Vaccine: HBHEPB
Symptoms: Infection
Clinical narrative: Info has been received from a physician concerning a 2 year old pt who was vaccinated with a 1st and 2nd dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) on 11/03/2000 and 11/26/2001, respectively. There was no concomitant medication. Subsequently, the pt developed a break through Hib infection. At the time of infection, the pt was on amoxicillin trihydrate (+) clavulanate potassium (Augmentin). The strain of the infection was "untypable". Unspecified medical attention was sought. At the time of the report, on 12/17/2003, the pt's outcome was unknown. It was reported that the pt's immunization history included a dose of hepatitis B vaccine (manufacturer unknown) on 09/26/2000 and a 1st and 2nd dose of HIB vaccine (manufacturer unknown) on 01/05/2001 and 08/22/2001, respectively. Additional info has been requested.
Age: 0.08
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Pain
Clinical narrative: Info has been received concerning a 56-day-old male child with no known allergies and no past medical history who on 09/17/2002 at 3:30 PM was vaccinated in the right thigh with a 1st  dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast ) (Lot #643661/0723M). There was no concomitant medication. There was no illness at time of vaccination. On 09/17/2002 at 3:30 PM the pt developed injection site swelling and redness. It was reported that a "knot" still remains and the pt is showing tenderness to the area by guarding it. The reporter expressed a concern regarding the lot #643661/0723M. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also indicated that other patients developed adverse events (WAES #0211USA02414 and WAES #0211USA02173). No further info is expected.
Sex: M
Vaccine: HBHEPB
Symptoms: Irritability, Medication error, Restlessness
Clinical narrative: Information has been received from a consumer concerning a male twin with no known allergies and a history of anaemia who in approximately January 2003, was vaccinated "SC and not IM" in the "fatty part" of his thigh with a "7.5mcg" dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant. Concomitant therapy included ibuprofen and Tylenol. A day after vaccination, the pt started to be "fussy and restless." Unspecified medical attention was sought. The reporter mentioned that a second pt had a similar experience with Comvax (WAES0301USA02266). Additional info has been requested.
Age: 0.08
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Agitation, Screaming
Clinical narrative: This report was received from manufacturer for Infanrix and was assigned manufacturer report number A0390426A. This was originally reported by a consumer concerning a 59 day old male pt with no allergies and no medical conditions who on 12/20/02 was vaccinated with a dose of Comvax. Concomitant vaccination in the thigh included an IM dose of Infanrix. It was not known if the pt had received previous doses of Infanrix. There was no concomitant medication. At an unspecified time post vaccination on 12/20/02, the reporter stated, "My child had a severe reaction, uncontrollable crying for three hours." The pt's pediatrician recommended Children's Tylenol, which "significantly" helped treat the event. The reporter stated that the event was probably related to Infanrix administration. As of 12/30/02, the event had resolved. Additional info is not expected.
Age: 8.0
Sex: F
Vaccine: HBHEPB, HIBV
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning an 8 year old female pt who in approximately 1995, when she was an infant, was vaccinated with Haemophilus B conjugte vaccine (+) hep B vaccine recombinant "or" Haemophilus B conjugate vaccine. On approximately 1/20/03, the pt developed h. influenza. Additional info is not available.
Sex: F
Vaccine: HBHEPB
Symptoms: Irritability, Medication error, Restlessness
Clinical narrative: Information has been received from a consumer concerning a female twin who in approximately January 2003, was vaccinated "SC and not IM" in the "fatty part" of her thigh with a "7.5mcg" dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant. A day after vaccination, the pt started to be "fussy and restless." Unspecified medical attention was sought. The reporter mentioned that a second pt had a similar experience with Haemophilus B conjugate vaccine (+) hep B vaccine recombinant (WAES0301USA02015). Additional info has been requested.
Sex: M
Vaccine: HBHEPB
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist concerning a male pt who was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant. Subsequently the pt developed an "allergic reaction." Unspecified medical attention was sought. Additional info has been requested.
Age: 0.5
Sex: F
Vaccine: HBHEPB
Symptoms: Contusion, Injection site erythema, Injection site mass, Rash pustular
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 6 month old female who on 1/30/03 was vaccinated with the second dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant. The LPN reported initially, in January 2003, the pt developed a knot at the site and a quarter size red area. Three weeks later, in February 2003, the area resembled a pimple or boil. The pt's mother, a physician, squeezed the area an pus was released (color not known). During the last week of February 2003, area was stained like a bruised red mark. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional info is not expected.
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site reaction, Laboratory test abnormal
Clinical narrative: It was reported in a published article, title as stated above that an infant "by eight months of age" had received "all of her childhood vaccinations." It was reported that the pt was vaccinated with Haemophilus B conjugate vaccoine (+) hpe B vaccine. Other reported therapy included diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and a conjugated pneumococcal vaccine. It was reported that the pt "under one year of age" developed a severe local delayed reaction which resulted in "extensive cutaneous scarring to almost all of her childhood vaccinations received by eight months of age." Specific immunoglubulin titers, patch testing, gram stain and culture of aspirated fluid were done. The results were reported to be that specific immunoglobulin titers were unusually elevated indicating a vigorous immune response to these vaccines. A gram stain revealed numerous white blood cells, but no organisms. A culture was negative. Patch testing was positive at 48 and 72 hours for aluminum, but negative for thimerosal and formaldehyde. The etiology of the lesions in this pt were reported as "very likely to be secondary to a DTH reaction to the aluminum adjuvant contained "in" the vaccinations received." Sterile abscess was reportedly to be "unlikely" given the multiplicity of lesions and the high vaccine-specific immunoglobulin titers, both of which were atypical features of sterile abscess. It was reported that given the potential for permanent disfigurement, physicians should be cognizant of the possibility of local DTH reactions to adjuvants in vaccinations that enhance immunogenicity, but can cause severe cutaneous side effects. In patients showing signs of DTH like reactions to vaccines, preparations devoid of these components should be sought and administered in place of those containing the offending agents. Additional info has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Anaphylactic reaction, Face oedema, Oedema peripheral, Rash, Tongue oedema
Clinical narrative: Information has been received from a medical assistant concerning a 11 week old male pt who on 10/16/98 or 10/19/98 was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant (625231/1598E is invalid for this product). Concomitant medication administered on 10/16/98 included doses of poliovirus vaccine inactivated, and diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. The reporter stated that on 10/23/98 the pt developed symptoms of swelling of the hands, feet, face and tongue, and also had a "pimple rash" on his upper back, but did not have any difficulty breathing. The reporter confirmed that the pt was diagnosed with an "anaphylactic reaction" at the hospital, and not a "prophylactic-like reaction" to Haemophilus B conjugate vaccine (+) hep B vaccine recombinant, as previously reported. The reporter stated that the pt received his 2 month vaccinations at another facility. At the time of the report, the pt was "four and a half years old." He had not received anymore of his childhood immunizations since the 2 month vaccines and his parents wanted to get him "caught up" on vaccinations. The medical assistant questioned whether there was a suggested "skin testing technique, to see if he will react adversely again." She also reported that she was contacted "other pharmaceutical companies" in reference to this case and requested any protocols for allergy testing of their vaccines. Upon internal review, anaphylactic reaction was determined to be an other important medical event (OMIC). Additional info has been requested.
Age: 2.2
Sex: M
Vaccine: HBHEPB
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a medical assistant and a physician concerninga 26 month old male who is a nonsmoker who on 3/15/01 was vaccinated in the right thigh with a first dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant (637766/1586K); on 5/29/01 he was vaccinated in the left thigh with a second dose of Haemophilus B conjugate vaccine (+) hep b vaccine recombinant (637766/1586K), and on 3/25/02 he was vaccinated in the right thigh with a third dose of Hameophilus B conjugate vaccine (+) hep B vaccine recombinant (638594/1824K). The pt completed the series on 3/25/02. On 3/31/03 a Hepatitis BSAb test was done with a result of 4 MIU/ML. On 4/9/03, it was reported that a titer done "last week" was negative for antibodies and that the pt was given a blood test and he was found "not to be immune to hep B or Haemophilus B." It was reported that the pt received the three doses of the vaccine according to the appropriate dosing schedule. Unspecified medical attention was sought. No product quality complaint was noted. No further info is expected.
Age: 0.5
Sex: F
Vaccine: HBHEPB
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a consumer concerning her daughter with no pertinent medical history who on 12/17/02 was vaccinated with a dose of Hib conj-hep B vaccine (643885/0829M). There were no concomitant medication. The reporter indicated that "her doctor told her that the vaccines were not working." She did note that her child had not contracted hep B. She could not provide any additional info. Unspecified medical attention was sought. The pt also received a dose of hep B vaccine recombinant (640329/0818L-dose given on 7/15/03; lot # for dose given on 4/1/03 not reported) on 7/15/02 and 4/1/03 (WAES0304USA00271). Additional info has been requested.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site rash, Rash erythematous, Rash maculo-papular
Clinical narrative: This report was received from manufacturer research for Haemophilus B conjugated vaccine (+) hep B vaccine and was assigned manufacturer control number HQWYE036305MAY03. A female pt was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant. The reporter indicated that the pt developed a generalized, erythematous, macular-papular rash. The outcome of the event was reported as unknown. This was originally reported by a physician. Additional info was received from the physician which indicated that on 2/13/03 an 18 week old female with no allergies or medical history was vaccinated IM in the left thigh with a second dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant (643037/0652M). Concomitant vaccinations on the same day an time included a second dose in the left thigh of Prevnar (491183), a dose in the right thigh of Tripedia (U08508A) and a dose in the right thigh of IPOL (W006B). It was noted that the pt had no problems with an intiial dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant on 12/18/02. There was no illness at the time of vaccination. The pt's mother reported that on 3/14/03 a rash began on the left leg around the injection site Comvax or Prenvar. The reporter indicated that the rash started in the left thigh where the Prevnar dose was administered. The rash subsequently spread to the entire body but there were no respiratory symptoms. It was reported that the pt recovered. It was also noted that the pt and the pt's sibling had no adverse events following prior vaccination. On 4/14/03 the pt was vaccinated in the right thigh with a dose of Tripedia (U08508A) and a dose in the left thigh of IPOL (W0703). On 4/22/03 the pt was vaccinated with a third dose in the left thigh of Prevnar (492893). At the time of vaccination, the pt had bronchitis which was noted to be improving. Concomitant medications included Pulmicort, Xopenex, and Benadryl. On 4/26/03, at six months of age, the pt developed an injection site reaction characterized by a "knot" and a rash following the receipt of her third dose of Prevnar. It was reported that the pt recovered. The physician noted that because of the similar symptoms that developed after the third dose of Prevnar was given at six months of age, "this is the likely culpiro (not "Haemophilus B conjugate vaccine (+) hep B vaccine recombinant). The physician also noted, "we believe this reaction was due to another vaccine" (Prevnar). No further info is expected. Info was received on 6/17/03 which pertained to events that occurred four months after vaccination with Haemophilus B conjugate vaccine (+) hep B vaccine recombinant. This info contained the following adverse experiences: injection site reaction characterized by a "knot" and a rash 4/26/03. Bronchitis (approximately 4/22/03.
Age: 1.6
Sex: F
Vaccine: DTAP, HBHEPB, DTAP, HBHEPB
Symptoms: Pyrexia, Rash papular
Clinical narrative: Information has been received from a physician concerning a 19 month old female pt who on 7/22/03 was vaccinated with an IM third dose of Comvax (645488/0142N). Concomitant therapy, "also administered" on 7/22/03 included an IM fourth dose of Infanrix (596A2). On 7/22/03, the pt developed a "papular rash-generalized" and a moderate fever of "101." The pt was treated with Zyrtec syrup. It was noted that the pt still had the rash. Follow up info revealed that on 7/26/03, the pt had recovered. No further info is expected.
Age: 1.6
Sex: F
Vaccine: DTAP, HBHEPB, DTAP, HBHEPB
Symptoms: Pyrexia, Rash papular
Clinical narrative: This report was received from manufacturer for Infanrix and was assigned manufacturer number A0418397A. This report concerns an 19 month old female who on 7/22/03 was vaccinated IM with a third dose of Comvax. Concomitant vaccination the same day included a fourth dose of Infanrix given IM. On 7/23/03 the pt experienced a rash and fever of 102 F and was seen by a physician. As of 7/25/03 the pt had not recovered. Follow-up info from the physician indicated that the pt developed a fever of 101 and a generalized papular rash on 7/22/03. The pt recovered on 7/26/03. This was originally reported by a physician. Additional info has been requested.
Age: 1.2
Sex: U
Vaccine: HBHEPB
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: Information has been received from a RN concerning a 14 month old pt who on 8/7/03 was vaccinated with a dos eof Comvax (643889/0855M). The Comvax was given for the third dose of hep B vaccine recombinant and the fourth dose of Haemophilus B conjugate vaccine. On approximately 9/2/03, a month after vaccination, the pt still had swelling and induration at site of injection on the leg. The pt will be seen in the physician's office on 9/3/03. Unspecified medical attention was sought. There was no product quality complaint. Follow up info indicated that the "mother never brought the child in for evaluation." The reporter noted that the findings of the office concluded that the adverse events were not a result from the Comvax. No further info is expected.
Age: 0.3
Sex: U
Vaccine: HBHEPB
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 4 month old pt who was vaccinated with a dose of Comvax. Subsequently the pt experienced fever > 101. The lot number was not provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: From telephone contact received on 6/19/02, it was reported that a 27 year old female received TD ADS vaccine on 6/24/02. Within 24 hours post vaccination, patient developed pain, redness and swelling at injection site, also numbness in entire arm. Patient seen in doctor's office on 6/26/02 and treated. Reactions completely resolved.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Balance disorder, Bursitis, Coordination abnormal, Feeling hot, Hot flush
Clinical narrative: From telephone contact received on 7/12/02, it was reported that a 27 year old female received dose of TD ADS in the left deltoid on 6/27/02. Patient's arm was sore for the next day. Patient reported that when she woke up on 6/29, she got up and went out for a walk and while walking she lost her balance. Patient experienced visual disturbances, hot flashes through her whole body (warm sensation). Her head felt like little needles were sticking her in her head, was also nauseated. Patient was seen by the doctor on 6/29/02 who said it was an allergic reaction to the TD. Tylenol #3 prescribed for pain in her arm. On 7/4/02, she had another episode where she almost fainted during the day. She was seen by the doctor on 7/5/02 and prescribed with hydrocodone. Soreness in the patient's arm continued for several weeks and is still slightly sore. Prednisone prescribed on 7/11/02 for pain and inflammation in arm. Patient stated she is starting to do better as time passes but then has periods of exacerbation with regard to pain in her arm, unable to move it without the assistance of her other hand. Patient isn't sure if this was reported or not. From additional information received on 11/4/02, the reporting physician provided the patient's birth date. The patient had an MRI of the left shoulder on 8/6/02, which was consisted with bursitis. Per the physician, the patient has had no follow up since this, so assumption is symptoms have resolved (she has been in twice since, for unrelated problems). The adverse event coding was updated (deleted injection site reaction and added codes for ataxia, bursitis and hypokinesia. This case is closed.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Injection site inflammation, Nausea, Pain, Visual disturbance
Clinical narrative: From telephone contact received on 7/12/02, it was reported that a 27 year old female received dose of TD ADS in the left deltoid on 6/27/02. Patient's arm was sore for the next day. Patient reported that when she woke up on 6/29, she got up and went out for a walk and while walking she lost her balance. Patient experienced visual disturbances, hot flashes through her whole body (warm sensation). Her head felt like little needles were sticking her in her head, was also nauseated. Patient was seen by the doctor on 6/29/02 who said it was an allergic reaction to the TD. Tylenol #3 prescribed for pain in her arm. On 7/4/02, she had another episode where she almost fainted during the day. She was seen by the doctor on 7/5/02 and prescribed with hydrocodone. Soreness in the patient's arm continued for several weeks and is still slightly sore. Prednisone prescribed on 7/11/02 for pain and inflammation in arm. Patient stated she is starting to do better as time passes but then has periods of exacerbation with regard to pain in her arm, unable to move it without the assistance of her other hand. Patient isn't sure if this was reported or not. From additional information received on 11/4/02, the reporting physician provided the patient's birth date. The patient had an MRI of the left shoulder on 8/6/02, which was consisted with bursitis. Per the physician, the patient has had no follow up since this, so assumption is symptoms have resolved (she has been in twice since, for unrelated problems). The adverse event coding was updated (deleted injection site reaction and added codes for ataxia, bursitis and hypokinesia. This case is closed.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: From telephone contact received on 8/6/02, it was reported that a 21 year old female received TD vaccine (lot # U0523AA) on 8/1/02 in left deltoid. Approximately 6 hours later, patient's arm felt very sore and redness appeared. On 8/2/02, the injection site was swollen, red, hot, and hard. On 8/3/02, area of swelling measured 2 inches in diameter, unable to perform daily activities without severe pain, also felt malaise and fatigue. Swelling subsided after 8/3/02, area still hard and sore to touch. Patient's last Tetanus vaccination was approximately 11 years ago. Patient also reported that her co-worker also had a large local reaction with this same lot number. Additional reports needed to obtain information.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Injection site warmth, Malaise
Clinical narrative: From telephone contact received on 8/6/02, it was reported that a 21 year old female received TD vaccine (lot # U0523AA) on 8/1/02 in left deltoid. Approximately 6 hours later, patient's arm felt very sore and redness appeared. On 8/2/02, the injection site was swollen, red, hot, and hard. On 8/3/02, area of swelling measured 2 inches in diameter, unable to perform daily activities without severe pain, also felt malaise and fatigue. Swelling subsided after 8/3/02, area still hard and sore to touch. Patient's last Tetanus vaccination was approximately 11 years ago. Patient also reported that her co-worker also had a large local reaction with this same lot number. Additional reports needed to obtain information.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Chest pain, Erythema, Face oedema, Injection site pain, Injection site swelling
Clinical narrative: From telephone contact received on 8/7/02, it was reported that a 39 year old female received a dose of TD vaccine on 8/5/02. Within 24 hours, patient developed pain and swelling at injection site, left chest pain, neck pain, redness and stiffness and puffiness of face, and fever of 102 degrees F. Patient was seen at the hospital 2 times and unresolved.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Neck pain, Pyrexia
Clinical narrative: From telephone contact received on 8/7/02, it was reported that a 39 year old female received a dose of TD vaccine on 8/5/02. Within 24 hours, patient developed pain and swelling at injection site, left chest pain, neck pain, redness and stiffness and puffiness of face, and fever of 102 degrees F. Patient was seen at the hospital 2 times and unresolved.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Tenderness
Clinical narrative: From faxed correspondence received on 8/15/02, it was reported that a 64 year old female received Td vaccine on 8/1/02. Patient developed a 10cmx12cm warm and erythematous area in left deltoid. Tenderness disappeared two days after vaccination. Patient was given Keflex 500mg orally four times a day for cellulitis.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Difficulty in walking, Eye pain, Injection site erythema, Pain
Clinical narrative: From telephone correspondence received at AP on 08/22/2002, it was reported that a 47 year old female received TD ADS vaccine on 08/19/2002.  The pt developed redness and soreness at the site, body aches, stiffness in her neck, pain in her eyes and difficulty walking on 08/21/2002.  The pt went to the ER. Spinal tap for meningitis and CT scan were performed and the results were negative. Test for West Nile virus was negative. The pt was released from the ER.
Age: 57.0
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: From telephone correspondence received at AP on 08/28/2002, it was reported that a 57 year old patient received TD ADS ADULT (Lot # U0528AA, Exp Date 04/2004) in the right deltoid on 08/19/2002.  On 08/22/2002, the patient developed swelling at the site, swelling, redness and heat from shoulder to wrist with low-grade fever.  The physician recommended cold to area and Tylenol.  It is not reported whether the patient recovered from these adverse events.  See report U2002-00683 with the same reporter.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: From a telephone contact received on 09/03/2002, it was reported that a 16 year old female received one dose of TD ADS ADULT vaccine (Lot # U0529AA) in the left deltoid on 08/30/2002.  The patient presented at the MD office on 09/01/2002 with a 4 cm circular area of erythema, induration, swollen, hot and tender to touch.  The MD diagnosed it as cellulitis.  No other symptoms were reported.  The date of prior booster is not known at this time.  See case U2002-00702 with the same reporter.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis
Clinical narrative: From telephone contact received on 09/03/2002, it was reported that a 16-year-old female received one dose of Td ADS Adult vaccine in the deltoid area (site not confirmed with regard to left or right). The lot # is U0527AA. The pt was diagnosed with cellulitis at the injection site. See case U200200701 with same reporter.
Age: 55.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis
Clinical narrative: From telephone contact received at manufacturer, on 09/24/2002, it was reported that a 55-year-old male pt, was vaccinated with TD ADS Adult (lot #U0736AA, expiration date 05/06/2004) on 09/18/2002. The pt was seen by a physician on 09/21/2002 with a cellulitis of the shoulder. It was not reported whether the pt recovered from this adverse event.
Sex: U
Vaccine: TD
Symptoms: Cellulitis, Fatigue, Headache, Influenza like illness, Injection site reaction
Clinical narrative: From telephone contact received at AP on 10/02/2002, it was reported that an adult patient (no age or sex was provided) received TD ADS ADULT (Lot # U0525AA) on an unspecified date.  The  patient experienced general fatigue, flu-like signs and symptoms, headaches, and cellulitis at the site of injection at an unspecified date.  It is unknown whether the patient recovered from these adverse events.  There is also another patient from this facility with the same reactions that will also need a report filed.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Information has been received on 08/16/2002 concerning a 12 year old female patient who was vaccinated with a dose of TD ADS ADULT (Lot # U0814AA) IM in the left deltoid.  No date of administration was reported.  Patient developed fever, redness and pain at site of injection.  Patient was diagnosed with cellulitis and treated with Augmentin 500mg twice a day for 5 days.  Outcome was not reported.  See cases U2002-00798 and U2002-00799, same reporter.
Age: 37.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Dizziness, Heart rate increased, Pain
Clinical narrative: From telephone contact received at AP, it was reported that a 37 year old male patient received TDS ADS ADULT (Lot # U0530AA) on 10/04/2002 at 09:30AM. Within 1 hour after vaccination, the patient experienced arthralgia, body aches, dizziness, and rapid heart rate of 115 beats per minute.  Her blood pressure was within normal limits.  She was observed at the clinic and vital signs were stable.  Reportedly, the patient recovered fully from these adverse events.
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Injection site mass, Injection site pain, Pain, Pyrexia
Clinical narrative: From telephone contact received at AP on 10/18/2002, it was reported that a 45 year old male patient received TD ADS ADULT (Lot # U0522AA) on 09/20/2002.  Approximately eight hours later, the patient developed soreness at the injection site, fever, "knots" in his arm and general body aches.  These symptoms lasted for two days and the patient missed work.  Reportedly, these adverse events have fully resolved.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Muscle spasms
Clinical narrative: From telephone correspondence received at AP on 10/28/2002, it was reported that a 41 year old adult female was vaccinated with TD ADS ADULT, Lot # U0530AA, on 10/24/2002.  The patient experienced spasms in arm where injection was administered and went to ER.  The reporter did not know if spasms were still persisting at the time of the report.  The patient's treating physician at the vaccine facility wanted to know if there were other problems with this lot number, and was informed that there were no other adverse reports.  It remains unknown whether the patient recovered.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Pain, Pain in jaw
Clinical narrative: From telephone correspondence received at AP on 10/28/2002, it was reported that on 10/21/2002 a 31 year old adult female received TD ADS ADULT, Lot # U0819AA, IM in the left deltoid, at a hospital ER.  On 10/24/2002 she called physician's office with pain in her jaw on the left side of face, along with soreness, pain, numbness, and tingling in her left arm.  The doctor saw her on 10/25/2002 and prescribed Ibuprofen every 6 hours, with ice to the left arm and observation.  It was not reported whether the patient recovered.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: From telephone correspondence on 7/2/02 and faxed correspondence received on 10/9/02, it was reported that a 37 year old adult female was vaccinated with TD ADS ADULT, lot # U0527AA on 6/28/02. Patient experienced severe pain and extreme swelling of the arm, and ran elevated temperatures for several days. The swelling and pain remained for approximately a week. Patient recovered.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Muscular weakness, Pyrexia
Clinical narrative: From telephone contact on 7/2/02 and additional faxed information received on 10/9/02, it was reported that a 31 year old adult female was vaccinated with TD ADS ADULT, lot # U0527AA, on 6/28/02 at 12:00 PM. On 6/28/02 at 12:15 PM< she experienced pain, swelling, and head at the injection site (arm), along with low grade fever and arm weakness. Patient recovered. The case is closed.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Swelling, Tenderness
Clinical narrative: From telephone correspondence on 7/2/02 and additional faxed information received on 10/16/02, it was reported that a 37 year old adult female was vaccinated with TD ADS ADULT, lot # U0527AA, on 6/28/02. On 6/28/02 at 6:00 PM, she experienced tenderness and swelling, which lasted for three days. Patient was prescribed Motrin every 6 to 8 hours as needed, and she recovered.
Age: 52.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Joint range of motion decreased
Clinical narrative: From information received on 11/1/02, it was reported that a 52 year old male patient was administered TD ADS (lot # U0525AA) on 10/5/02. Within 24 hours he experienced a sore arm and redness at the injection site. Reportedly he now has complete immobility of the arm in which the vaccination was administered.
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Headache, Hypoaesthesia, Myalgia, Pyrexia
Clinical narrative: From telephone contact received on 11/5/02, it was reported that a 15 year old male was vaccinated with TD ADS ADULT (lot number U0820AA) on 11/4/02. The next morning, the patient presented with fever of 100.9 F, myalgia, headache, and numbness in his right foot. The patient was sent to the emergency room for evaluation. It is not reported whether the patient recovered.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Ecchymosis, Haematoma
Clinical narrative: From telephone correspondence received on 11/5/02, it was reported that a 31 year old male adult was vaccinated with TD ADS ADULT, lot # U0820AA, on 10/22/02. 24 hours post injection the patient developed a 2cm x 1cm area of ecchymosis and SC hematoma with arm soreness. Patient recovered. Per the physician, the patient has not had a tetanus vaccine for at least 10 years. The case is closed.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Pain
Clinical narrative: From telephone call received on 12/23/02 from a physician regarding a 32 year old female patient who came in with a splinter in her foot. Physician gave her a Td booster on 12/14/02 (lot # U0821AA, expiration date 7/8/04). After 24 hours, the patient developed pain in her left deltoid where the vaccine was administered, which extended from her shoulder to her wrist. On a pain scale of 1 to 10, she described her pain as 7. Pain alternated from throbbing to achiness and involved her left chest also. Patient stated at time she felt weird. Tylenol and Advil did not alleviate her symptoms. The symptoms peaked at 36 hours and she was seen by physician on 12/19/02. Her range of motion was good and pain was subsiding by 12/22/02. The case is closed.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Chills, Decreased appetite, Injection site erythema, Injection site swelling
Clinical narrative: From initial information received on 1/30/03, it was reported that a 40 year old male patient received TD ADS ADULT (lot number U0824AA) given IM in the left deltoid on 1/15/03. On 1/16/03, the patient experienced redness and swelling, the size of a grapefruit, at the injection site. The patient also experienced a fever of 101 degrees, decreased appetite, chills for 3 days and joint pain. The patient reportedly recovered from these events. This case is closed.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: From initial information received on 1/30/03, it was reported that a 40 year old male patient received TD ADS ADULT (lot number U0824AA) given IM in the left deltoid on 1/15/03. On 1/16/03, the patient experienced redness and swelling, the size of a grapefruit, at the injection site. The patient also experienced a fever of 101 degrees, decreased appetite, chills for 3 days and joint pain. The patient reportedly recovered from these events. This case is closed.