chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAP
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional via a sales representative and describes the occurrence of limb swelling in a subject of unspecified age and gender who was vaccinated with Infanrix for prophylaxis. Initially the healthcare professional reported "six to seven pts, however, no pt identifiers were provided. On an unspecified date in "April 2005 and before 6/24/05" the subject received a dose of Infanrix (dose and lot number not specified). On an unspecified date in "April 2005 and before 6/24/05", at an unspecified time after vaccination with Infanrix, the subject experienced swelling of limb. At the time of reporting, on 6/24/05, the event was resolved. The healthcare professional considered the event was possibly related to vaccination with Infanrix.
Age: 0.51
Sex: M
Vaccine: DTAP
Symptoms: Aphasia, Medication error, Neurodevelopmental disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of developmental delay in a 7 month old male subject who was vaccinated with Hep-B (Engerix-B) and Infanrix for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. The subject received Engerix-B on 6/11/03 (lot number unknown, 7/11/03 (lot ENG5375A2) and 3/16/04 (lot ENG5396A2). This represents a 0, 1 and 9 months schedule, rather than the recommended schedule of 0, 1 and 6 months. The subject received Infanrix on 8/18/03 (lot DTPA610A2), 10/10/03 (lot DTPA610A2), 12/12/2003 (lot DPTA616A2) and 12/17/04 (lot DTPA632A3). On unspecified dates, the subject also received HIB influenza, MMRII, Prevnar and IPOL. On an unspecified date in January 2004, approximately 6 months after the 2nd dose of Engerix-B and 1 month after the 3rd dose of Infanrix, the subject experienced developmental delay. At an unspecified time later, the subject's mother stated that her son "stopped speaking" (impaired communication). The subject was seen at a physician's office. The mother stated that "blood work" had been performed, including unspecified tests for lead poisoning and analysis of organic acids and amino acids, however, "blood analysis" did not reveal any "toxins". The mother also stated that the subject was receiving unspecified therapy to "remove toxins". At the time of reporting, on 7/7/05, the events were unresolved.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of cellulitis in the right lower extremity in a 4 year old female subject who was vaccinated with Infanrix for prophylaxis. Medical history included sulfa allergy. On 7/12/05, the subject received the 5th dose of Infanrix in the right thigh (lot DTPA596A2). On 7/12/05, the subject also received injections of MMRII, in the right thigh and IPOL in the left thigh. On 7/14/05, 2 days following the receipt of the vaccinations, the subject experienced "cellulitis in the right lower extremity". The subject was seen at a physician's office. The subject was treated with an injection of Rocephin and was prescribed oral Augmentin. At the time of initial reporting, 7/14/05, the cellulitis in the right lower extremity was ongoing. The nurse considered the cellulitis in the right lower extremity to probably be related to vaccination with Infanrix. Comment: Cellulitis in the right lower extremity was assessed as Medically Serious by mfr.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of a swollen arm in a 5 year old male subject who was vaccinated with Infanrix, plus a separate injection of hepatitis A vaccine. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On 7/13/05, the subject received the 5th dose of Infanrix in the right arm (lot AC14A009BA) and a dose of hepatitis A vaccine (dose number and site of injection not provided). On 7/13/05, the subject also received MMRII and IPOL and a tuberculin skin test. The administration sites for the MMRII, IPOL and tuberculin skin test, the consumer stated that the subject experienced "swelling and redness of the entire right arm", and that the arm was "hot to touch and itching". The consumer also stated that the subject, "experienced a fever of 101F that comes and goes and restlessness". The subject was seen at a physician's office and an ER. The events had improved at the time of initial reporting, 7/19/05.
Sex: U
Vaccine: DTAP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a MA and described the occurrence of latex allergy in a child of unspecified age and gender who was vaccinated with Infanrix for prophylaxis. On an unspecified date on or before 8/2/05, the subject received a dose of Infanrix (dose number not provided), (lot AC14A011AA). At an unspecified time after vaccination with Infanrix, on or before 8/2/05, the subject experienced a "possible" latex allergy. The subject was seen by an "allergist physician" and was tested for latex allergy. The MA reported that, "the child tested positive for latex allergy, but it was unclear that the child had an allergic reaction". The MA reported that the Infanrix that the subject received "came from a single dose vial" and that she, "does not believe the Infanrix is the cause" of the latex allergy. The outcome of the event was not reported.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described a 4 year old subject of unspecified gender who experienced redness at the injection site subsequent to receiving Infanrix. Initially the nurse reported "many of their 4 year old pt's, however, no pt identifiers were provided. On an unspecified date, the subject received an injection of Infanrix (dose and lot numbers not specified). At an unspecified time after administration of Infanrix, the subject experienced redness at the injection site. At the time of reporting, on 8/12/05, the outcome of the event was unknown.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site redness in a 4 year old male subject who was vaccinated with Infanrix for prophylaxis. On 8/12/05, the subject received the 5th dose of Infanrix in the left thigh (lot AC14B002AA). On an unspecified date on or after 8/12/05 and on or before 8/15/05, less than 1 week after vaccination with Infanrix, the subject experienced injection site redness and injection site swelling. Th subject was treated with ibuprofen and warm compress. The events resolved on an unspecified date on or after 8/12/05 and on or before 8/15/05. The nurse considered the events to possibly be related to vaccination with Infanrix.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling injection site in an 18 month old female subject who was vaccinated with Infanrix for prophylaxis. On 8/4/05, the subject received the 4th dose of Infanrix in the left thigh (lot AC14B002AA). On 8/9/05, 5 days after vaccination with Infanrix, the subject experienced injection site swelling. The subject was treated with ibuprofen and warm compress. The events resolved on an unspecified date on or after August 2005 and on or before 8/15/05. The nurse considered the events to possibly be related to vaccination with Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site swelling in a 5 year old female subject who was vaccinated with Infanrix for prophylaxis. On 8/11/05, the subject received the 5th dose of Infanrix in the left thigh (lot AC14B002AA). On 8/13/05, 2 days after vaccination with Infanrix, the subject experienced injection site swelling and injection site redness. The subject was treated with ibuprofen and warm compress. The events resolved on an unspecified date on or after 8/13/05 and on or before 8/15/05. The nurse considered the events to possibly be related to vaccination with Infanrix.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site swelling in an 18 month old male subject who was vaccinated with Infanrix for prophylaxis. On 8/9/05, the subject received the 4th dose of Infanrix in the left thigh (lot AC14B002AA). On an unspecified date on or after 8/9/05 and on or before 8/15/05, less than 1 week after vaccination with Infanrix, the subject experienced injection site redness and injection site swelling. The subject was treated with ibuprofen and warm compress. The events resolved on an unspecified date on or after 8/9/05 and on or before 8/15/05. The nurse considered the events to possibly be related to vaccination with Infanrix.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site swelling in a 5 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 08Aug05 the subject received the 5th dose of Infanrix in the left thigh (lotAC14B002AA). On an unspecified date on or after 08Aug05 and on or before 15Aug05, less than one week after vaccination with Infanrix, the subject experienced injection site redness and injection site swelling. The subject was seen at a physician's office. The nurse described the injection site swelling as about the size of a grapefruit, about 8 to 10 cm. The subject was treated with steroid and antihistamine. The events resolved on an unspecified date on or after 08Aug05 and on or before 15Aug05. The nurse considered the events to possibly be related to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in a 4 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On an unspecified date in Aug 2005, on or before 11Aug05, the subject received the 5th dose of Infanrix in the right thigh (lot AC14006BA incorrect lot number). On the same day, the subject also received an injection of inactivated poliomyelitis virus vaccine (IPOL) in the right thigh and measles, mumps and rubella virus vaccine (MMR II) in the right arm. On 11Aug05, less than one month after vaccination with Infanrix, the subject experienced fever, and 10cm swelling in the right leg (at the injection site) that was red and warm. The subject was seen in an ER. The events resolved on 15Aug05. The nurse considered the events to be related to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in a 4 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 09Aug05 the subject received the 5th dose of Infanrix in the right thigh (lot AC14006BA-incorrect lot number). On 09Aug05, the subject also received vaccination with inactivated poliomyelitis virus vaccine (Ipol) and measles, mumps and rubella virus vaccine (MMRII) in the right arm. On 11Aug05, 2 days after vaccination with Infanrix, the parents of the subject called the physician's office and reported that the subject experienced a fever of 100 degrees F and large swelling at the Infanrix injection site that was 7 inches long by 5 inches in diameter, slightly elevated, and was red, warm and painful to the touch. The events resolved on 16Aug05. The nurse considered the events to be related to vaccination with Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 yr old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. Medical history included grand mal seizure. Concurrent medications included Carbamazepine (Tegretal). On 29Aug05 the subject received the 5th dose of Infanrix in the left arm (lot AC14A006BA). On 29Aug05 the subject was also vaccinated with measles, mumps, and rubella virus vaccine and inactivated poliomyelitis virus vaccine (Ipol) at unspecified sites of administration. On 30Aug05, 1 day after vaccination with Infanrix, the subject experienced an injection site reaction characterized as redness, swelling, pain and warmth. The injection site reaction resolved on an unspecified date on or after 30Aug05 and on or before 06Sep05. The nurse considered the injection site reaction to possibly be related to vaccination with Infanrix.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling in a 2 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. Concurrent medical conditions included eczema. On 29Aug05 the subject received a dose of Infanrix in the left arm (dose number not provided; lot AC14A006BA). On 29Aug05 the subject was also vaccinated with measles mumps and rubella virus vaccine (MMRII) and inactivated poliomyelitis virus vaccine (Ipol) at unspecified sites of administration. On 30Aug05, 1 day after vaccination with Infanrix, the subject experienced swelling down to the elbow and an injection site reaction characterized as redness, pain and warmth. The injection site reaction resolved on an unspecified date on or after 30Aug05 and on or before 06Sep05. The nurse considered the injection site reaction to probably be related to vaccination with Infanrix.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 5 yr old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 02Sep05 the subject received the 5th dose of Infanrix in the left arm (lot DTPA592A9). On 02Sep05 the subject was also vaccinated with measles mumps and rubella virus vaccine (MMRII) and inactivated poliomyelitis virus vaccine (Ipol) at unspecified sites of admin. On an unspecified date after vaccination with Infanrix, on or after 02Sep05 and on or before 06Sep05, the subject experienced an injection site reaction characterized as redness and swelling. The injection site reaction resolved on an unspecified date on or after 02Sep05 and on or before 06Sep05. The nurse considered the injection site reaction to probably be related to vaccination with Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 yr old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  On 29Aug05 the subject received the 5th dose of Infanrix in the left arm (lot AC14A006BA). On 29Aug05 the subject was also vaccinated with measles, mumps and rubella virus vaccine (MMRII) and inactivated poliomyelitis virus vaccine (Ipol) at unspecified sites of administration. On 30Aug05, 1 day after vaccination with Infanrix, the subject experienced an injection site reaction characterized as redness, swelling, pain and warmth. The injection site reaction resolved on an unspecified date on or after 30Aug05 and on or before 06Sep05. The nurse considered the injection site reaction to probably be related to vaccination with Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling injection site in a 4 yr old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The subject had no known drug allergies. On 12Sep05 the subject received 5th dose of Infanrix in the left leg (AC14A006BA). On 12Sep05, the subject was also vaccinated with inactivated poliomyelitis virus vaccine (Ipol) in the left leg, measles, mumps and rubella virus vaccine (MMR II) in the right leg. At an unspecified time following the administration of Infanrix, on or after 12Sept05 and on or before 15Sep05, the nurse reported that the subject experienced, a large swollen area at the injection site (in the left leg) the size of a small grapefruit that was red and warm to touch. The subject was seen at a physician's office. The events resolved on an unspecified date on or after 15Sept05 and on or before Oct 2005.
Age: 1.85
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling injection site in a 22 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The subject had no known drug allergies. On 12Sept05 the subject received 4th dose of Infanrix in the left leg (lot AC14A006BA). On 12Sept05, the subject was also vaccinated with measles, mumps and rubella virus vaccine (MMRII) in the right leg, Haemophilus influenzae type b conjugate vaccine (manf unspecified) in the right leg and Varicella virus vaccine (Varivax) in the left arm. On 15Sep05, 3 days after vaccination with Infanrix, the nurse reported that the subject experienced, swelling the size of a medium grapefruit at the injection site (in the left leg) that was red and warm to touch. The subject was seen at a physician's office. The events resolved on an unspecified date on or after 15Sep05 and on or before 12Oct05.
Sex: U
Vaccine: DTAP
Symptoms: Crying, Screaming
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of crying in an infant of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manf unspecified) for prophylaxis. On an unspecified date before 19Sep05, the subject received a dose of Dtpa (dose number and lot number not provided). At an unspecified time after vaccination with Dtpa, the subject experienced crying. The crying resolved after seven hours. The vaccination course with Dtpa was discontinued.
Sex: U
Vaccine: DTAP
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of swollen lymph node in an infant of unspecified gender between four and six months of age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The physician reported that two subjects experienced swollen lymph nodes following vaccination with Infanrix, however, subject identifiers were not provided. On an unspecified date on or before 24Oct05, the subject received a dose of Infanrix (dose number and lot number not provided. At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 24Oct05, the subject experienced severe swollen lymph nodes. The subject was seen in an emergency room. The outcome of the swollen lymph nodes was not reported.
Sex: U
Vaccine: DTAP
Symptoms: Feeling hot, Lymphadenopathy
Clinical narrative: This case was reported by a physician to a sales rep and described the occurrence of swollen lymph node in an infant of unspecified gender between four and six months of age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On an unspecified date on or before 24Oct05, the subject received a dose of Infanrix (dose number and lot number not provided). At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 24Oct05, the subject experienced severe swollen lymph nodes that were hot to touch. The subject was seen in an ER. The outcome of the events were not reported.
Age: 17.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician and described the occurrence of sore arm in a 17 yr old female subject who was inadvertently vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). At the time of administration of Infanrix, the subject was taking Azithromycin for bronchitis. On 25OCt05 the subject inadvertently received a dose of Infanrix in the left arm (dose number and lot number not provided). Infanrix is not recommended for immunizing individuals 7 years of age or older. On 25Oct05, the subject was also vaccinated with influenza virus vaccine (Fluzone). The site of the injection of the Fluzone was not provided. On 25Oct05, less than one day after vaccination with Infanrix and Fluzone the subject experienced a sore arm. At the time of initial reporting, 27Oct05, the sore arm was ongoing.
Sex: F
Vaccine: DTAP
Symptoms: Angioneurotic oedema
Clinical narrative: The case was reported by a pharmacist and described the occurrence of angioedema in a female subject of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (manf unspecified) for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received a dose of Dtpa (manf unsp). At an unspecified time after vaccination with Dtpa, the subject experienced angioedema. This case was assessed as medically serious by manf (OMIC). At the time of reporting the outcome of the event was unspecified. Report received via manf.
Sex: U
Vaccine: DTAP
Symptoms: Drug toxicity
Clinical narrative: This case was reported by a consumer and described the occurrence of a reaction to aluminum in a child of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manf unk) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On an unspecified date on or before 16Nov05, the subject received a dose of Dtpa (dose number and lot number not provided). At an unspecified time after vaccination with Dtpa, on an unspecified date on or before 16Nov05, the subject experienced, a reaction to the aluminum in the Dtpa. The subject was seen at a physician's office. The outcome of the event was not reported. Follow up will not be available. Report received via manf.
Age: 1.67
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site redness in a 20 month old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 11Jan06 the subject received 4th dose of Infanrix in the right thigh (lotAC14A007AA). On 11Jan06, less than one day after vaccination with Infanrix, the subject experienced injection site redness and injection site swelling. The nurse described the size of the injection site redness as 6 inches by 4 inches. The events resolved on 13Jan06. The nurse considered the events to possibly be related to vaccination with Infanrix.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of welt injection site in a 4 yr old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The nurse reported that more than one 4 yr old experienced a welt at the injection site following the administration of Infanrix, however, a specific number of subjects was not provided. On an unspecified date on or before 18Jan06, the subject received a dose of Infanrix (dose number and lot number not provided). At an unspecified time following the administration of Infanrix, on an unspecified date on or before 18Jan06, the subject experienced welt injection site. The outcome of the event was not reported. The nurse reported to the sales rep that, this vaccine has caused this reaction (a welt at the injection site).
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse to a sales rep and described the occurrence of welt injection site in a 5 yr old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The nurse reported that more than one 5 yr old experienced a welt at the injection site following the administration of Infanrix, however, a specific number of subjects was not provided. On an unspecified date on or before 18Jan06, the subject received a dose of Infanrix (dose number and lot number not provided). At an unspecified time following the administration of Infanrix, on an unspecified date on or before 18Jan06, the subject experienced welt injection site. The outcome of the event was not reported. The nurse reported to the sales rep that this vaccine has caused this reaction (a welt at the injection site).
Age: 0.17
Sex: U
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pruritus, Tenderness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 2 month old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On an unspecified date before 01Feb06. The subject received a dose of Infanrix (dose number and lot number not provided). At an unspecified time after vaccination with Infanrix, on an unspecified date before 01Feb06, the subject experienced swelling injection site, injection site tenderness, injection site warmth, injection site redness and injection site pruritus. The outcome of the events was not reported.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Irritability
Clinical narrative: This case was reported by a physician and described the occurrence of fussiness in a 2 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On an unspecified date in Dec 2005, the subject received 1st dose of Infanrix. At an unspecified time following the administration of the 1st dose of Infanrix, on an unspecified date on or after Dec 2005 and before 03Feb06, the subject experienced fussiness. The fussiness resolved after only a few hours. On 03Feb06 the subject inadvertently received a dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Boostrix) rather than the intended 2nd dose of Infanrix. Boostrix is recommended for immunizing individuals 10 through 18 yrs of age. The physician considered the inadvertent administration of incorrect vaccine to probably be related to vaccination with Boostrix.
Sex: U
Vaccine: DTAP
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: This case was reported by a physician to a sales rep and described the occurrence of lymph node swelling in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The physician reported to the sales representative that several subjects experienced adverse events following the administration of Infanrix, however, a specific number of subjects was not provided. On an unspecified date before 01Mar06, the subject a dose of Infanrix (dose number and lot number not provided). At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 01Mar06, the subject experienced lymph node swelling, fever and pain. The outcome of the events was not reported.
Age: 1.48
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of injection site cellulitis in a 17 month old male subject who was vaccinated with Infanrix for prophylaxis. On 2/27/06, the subject received 3rd dose of Infanrix in the left quadriceps muscle (lot AC14B021AA). On 2/27/06, the subject also received injections of ActHib (lot VE785AA), in the left thigh and MMRII (lot 0826R), in the left arm. On 2/28/06, 1 day after vaccination with Infanrix, the subject experienced injection site cellulitis, swelling injection site and injection site redness at the site of the Infanrix administration. The subject was seen at a physician's office. The reporter stated that the swelling and redness at the injection site "increased in size over the next 2 days". The events resolved on 3/8/06. The physician considered the events to be related to vaccination with Infanrix.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Injection site reaction, Swelling
Clinical narrative: This case was reported by a medical assistant and described the occurrence of aseptic cellulitis in a 4 year old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject had no pre-existing medical conditions. There were no concurrent medications. On 2/7/06 the subject received 5th dose of Infanrix in the left arm (lot AC14A007AA). On 2/7/06, the subject also received injections of inactivated poliomyelitis virus vaccine (lot Y0824-2), and live MMR (lot 0293R). The injection site for IPOL and MMR II were not reported. On 2/9/06, two days after vaccination with Infanrix, the subject experienced aseptic cellulitis, which was described as a local reaction, a swollen left arm the size of a palm that was pink and non-tender. The subject was seen at a physician's office. The subject was treated with ice and rubbing of the area. The events resolved on 2/10/06. The medical assistant considered the events to be related to vaccination with Infanrix. Comment: Cellulitis was assessed as medically serious (OMIC).
Age: 1.66
Sex: M
Vaccine: DTAP
Symptoms: Injection site abscess, Injection site swelling, Skin discolouration
Clinical narrative: This case was reported by an MA and described the occurrence of injection site abscess in a 18 month old male subject who was vaccinated with Infanrix for prophylaxis. The subject's medical history included pneumonia and sinus problems. There were no concurrent medications. On 2/21/06, the subject received 4th dose of Infanrix in the left thigh (lot AC14A007AA). On 3/1/06, 8 days after vaccination with Infanrix, the subject experienced injection site abscess, "purple color" at the injection site and injection site swelling described as "swollen, not warm, 4 by 5 diameter, nontender". The subject was seen at a physician's office and was treated with Amoxicillin trihydrate. At the time of follow-up reporting, 3/17/06, the events were improved. The MA considered the events to probably be related to vaccination with Infanrix.
Age: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by an MA and described the occurrence of "reddish area at injection site" in an 18 month old female subject who was vaccinated with Infanrix for prophylaxis. On 3/15/06, the subject received 4th dose of Infanrix (lot AC14A007AA, left arm). On 3/16/06, 1 day after vaccination with Infanrix, the subject experienced an injection site reaction characterized as a "reddish area" and "hot to touch". The subject was treated with ice. The event resolved on or before 3/17/06. The MA considered the events were probably related to vaccination with Infanrix. Follow-up info was received via the reporting MA on 4/11/06. It was confirmed that the events resolved and were possibly related to treatment with Infanrix. The subject had been advised to use Benadryl for treatment. The subject has received treatment with Infanrix before. No additional info was provided.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site pain, Pain, Pharyngolaryngeal pain, Pyrexia, Wheezing
Clinical narrative: Info has been received from an RN concerning a 33 month old male with asthma and an egg allergy who on 4/26/05 was vaccinated with Hep-A virus vaccine inactivated (lot 648527/0888P). On 4/27/05, the pt developed body soreness, injection site soreness, sore throat, wheezing and a fever of 103F. The pt's experience persisted and on 4/29/05, the pt was prescribed an unspecified cough medicine with an antihistamine, unspecified steroids and an antibiotic (NOS). The nurse reported the events as non-serious. At the time of the report the pt had not recovered. Additional info has been requested.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Info has been received from a health professional concerning a 23 year old white female who on 7/28/04 was vaccinated with a dose of MMRII. Subsequently, the pt became pregnant (LMP 5/22/04). The pt had no prior pregnancies. The pt took prenatal vitamins during her pregnancy. The pt had ultrasounds on 10/15/04 and on 12/16/04 (results not reported). The pt had an upper respiratory infection 19 weeks from LMP and on 2/11/05. At 19 weeks LMP the pt was given azithromycin (Zithromax), "Z-pack", butoconazole nitrate (Gynezol), terconarole (Terazol). The pt had a viral GI upset in 12/04. In 2/05, the pt had taken metoclopramide hydrochloride (Reglan) (10 mg), promethazine hydrochloride (Phenergan), and benzonatate (Tessalon). On 3/1/05 (40 weeks from LMP) the pt gave birth to a normal 6 lb 9 oz male. There were no complications and no congenital anomalies. No further info is available.
Sex: F
Vaccine: MMR, MU
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness, Photophobia, Pyrexia
Clinical narrative: Info has been received from an adult female RN who on 3/7/05 was vaccinated with either MMRII or the concomitant suspect therapy Mumps virus vaccine live. On approximately 3/17/05, about 10 days following vaccination, the pt developed headache, neck stiffness, light sensitivity, low-grade fever and joint pain. The pt reported that she sought unspecified medical attention. On approximately 3/20/05, the pt was noted to be recovering from the neck stiffness, light sensitivity, low-grade fever and joint pain as the pt had reported that "most of her symptoms lasted about 4 days only." At the time of this report, the pt had not recovered from the headaches. Additional info has been requested.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 21 yr old female with no past medical history and no drug allergies who in 1989 and in 1997 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. In 2005 a titer was negative for measles. Unspecified medical attention was sought. The pt was reported to be not recovered. No product quality complaint involved. There were also reported to be no lab diagnostic tests performed. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient who was vaccinated (date unspecified) with MMR as a child. On 3/31/05, the patient's titer was negative for rubella. No additional information available at this time. There was no product quality complaint involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a 25 year old female registered nurse who in 1998 was vaccinated with MMR. The patient reported that her titer was negative. Unspecified medical attention was sought. The patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female (less than 2 years old), the nurse's niece, who, on an unspecified date, was vaccinated with a dose of MMR. Concomitant vaccination at the same time included a dose of varicella virus vaccine live (lot # unknown). Subsequently, the patient developed a fever of 104 F that persisted for 1 week. Subsequently, the patient recovered from fever on an unspecified date. The patient sought unspecified medical attention. Follow up information from a pediatric practice manager (also reported as registered nurse) and physician indicated that the physician was not aware of any problems with administering MMR vaccine to any of his patient's. There was no product quality complaint. Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a 34 year old female with an unknown vaccination history. On an unspecified date the patient was possibly vaccinated with MMR. On an unspecified date, the patient was noted to have a negative mumps titer. It was reported that the patient was noted to be otherwise healthy. It was reported that the patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 34 year old female who as a child was vaccinated with MMR vaccine live. Subsequently, the patient wanting to get pregnant had titers done. The measles titer was reportedly low. The patient's OB/GYN requested that she receive MMR again. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Pneumonia, Pyrexia, Rash
Clinical narrative: Initial and follow up information has been received from a consumer (also reported as mother of patient and office manager), and a physician, concerning the consumer's daughter, a waitress, who had no reported medical history and at the age of 15 months, in approximately December 1986, was vaccinated with a dose of MMR (lot # unknown). Subsequently, the patient developed a fever of 104 F, total body rash, and pneumonia after vaccination. The mother reported that her daughter was taken to the emergency room and was treated with acetaminophen. The physician confirmed that the patient's experience was neither life threatening nor disabling and that the patient was not hospitalized following vaccination with MMR. There was no illness at the time of vaccination. Follow up information from the reporter indicated that the patient recovered on an unspecified date. There was no product quality complaint involved. It is noted that the patient had a recent rubella titer that was positive. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Irritability, Pruritus, Rash
Clinical narrative: Info has been received from an RN concerning a 27 month old white female with no allergies or medical history who on 12/12/03 was vaccinated, SC, with a 1st dose of MMRII. There was no illness at the time of vaccination. On 4/7/05, the pt developed a rash with spots on her back that were itchy. She was noted to be cranky but afebrile. The rash started on her right arm and scabbed over. It spread to her face and back. It was also noted that she had the fifths disease. The pt was seen in the physician's office. Subsequently,. the pt recovered. No further info is expected.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 23 year old, white, female, RN with no known drug allergy and no medical history who in approximately, October 1982, was vaccinated with MMR. In approximately June 1993, the patient was revaccinated with MMR. In June 1993, it was reported that the patient had negative serum immunoglobulin G test (IGG) for mumps and rubeola. It was reported that on 10/18/00, the patient had a positive MMR titer. The reporter stated that on 2/16/05, the patient had a negative mumps and measles titer. It was reported that labs were negative on 2/16/05. On 2/16/05, varicella titer was also negative. The patient had stated that she has had positive titers in the past. It was reported that labs were negative on 5/31/05. The patient sought unspecified medical attention. At the time of the report it was unknown if the patient recovered. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning a 3 and 1/2 year old male with no known drug allergies and reportedly no medical history who in August 2002, was vaccinated SC with a 0.5ml dose of MMR. Concomitant therapy that day included varicella virus vaccine live, poliovirus vaccine inactivated (unspecified). It was reported that in August 2002, the patient developed a fever up to 104 degrees, which started 9 days after vaccination and lasted for 3 days. The patient also developed a rash on his face, neck, and stomach. It was reported that the patient had received MMR, varicella virus vaccine live, and poliovirus vaccine inactivated all in the same day. The patient sought unspecified medical attention. Subsequently, the patient recovered from fever up to 104 degrees, rash on face, rash on neck, and rash on stomach. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Petechiae, Pyrexia, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with a dose of MMR. The physician reported that 10 days post vaccination the patient developed a fever and a macular papular rash. The fever resolved, however, the rash turned into petechiae. The patient does not have thrombocytopenia. The physician was unsure if the rash was related to the vaccination or not. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 15 month old son who several weeks ago, in approximately April 2005, was vaccinated with MMR. Concomitant therapy included HIB conjugate vaccine (manufacturer unknown). Two weeks ago, in April 2005, the patient developed a rash on his face and trunk that lasted a couple of days. Unspecified medical attention was sought. It was reported that the physician did not feel that the rash was related to the MMR vaccine. Subsequently, the patient recovered from rash on face and trunk that lasted a couple of days. There was no product quality complaint involved. Follow up information from the physician's office indicated that the patient not known. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Infection, Pyrexia, Rash morbilliform
Clinical narrative: Info has been received from an LPN concerning a 12 month old female with no pre-existing allergies or medical conditions who on 3/30/05 was vaccinated, SC, in the left thigh with the 1st dose of MMRII (lot 648475/0315P). On 4/8/05, the pt developed a low-grade fever and red spots on her outer right thigh. On 4/9/05, it appeared to be a sparsely scattered rash across her body and more heavily in her skin folds, very tiny bumps. 4/11/05, it was reported that the rash looked like a measles rash all over. The "breakthrough" was mostly on her upper torso with some on her arms and legs. She even had some lesions on the mouth. The pt had a low-grade fever of approximately 99.7F. Unspecified medical attention was sought. The pt was given Tylenol and Benadryl. Subsequently, the pt recovered. Additional info is not expected.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a health professional concerning a 44 year old female with a history of anxiety and sinusitis who on 2/23/05 was vaccinated with a dose of MMR (lot # 645521/0297N). Laboratory evaluations performed on 3/29/05 and 4/19/05 showed seroconversion for rubella and mumps but not for measles. Unspecified medical attention was sought. At the time of this report, no symptoms were reported. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 35 year old, white, female psychiatric office specialist with thrombocytopenia and a history of hysterectomy, back injury, and two pregnancies, who during childhood may have been vaccinated with MMR. Concomitant therapy included conjugated estrogens, Premarin, dipyridamole, and unspecified therapy. Subsequently, on 4/22/05, laboratory data revealed that patient's titer was negative for rubella and titer was also negative for measles. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a certified medical assistant concerning a 5 year old white male who on 4/26/05 was vaccinated SQ with a 0.5ml dose of MMR that was diluted with bacteriostatic water. On 4/26/05, the patient developed redness, pain and swelling at the injection site. Unspecified medical attention was sought. Subsequently, the redness, pain, and swelling at the injection site resolved after three days. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Info has been received from an RN concerning a 30 year old female pt with no known drug allergies who in 1992 and 2002 was vaccinated with 2 doses of MMRII. at other facilities. There was no concomitant medication. On 4/26/05, titer was drawn and the client failed to seroconvert to measles only. The pt sought unspecified medical attention. There was no product quality complaint involved. Additional info has been requested.