chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTP
Symptoms: Erythema, Feeling hot, Inflammation
Clinical narrative: This case was reported by a physician and described the occurrence of swelling of limb in his 5 year old son who received diphtheria and tetanus toxoids and acellular pertussis vaccine for prophylaxis.  The patient has a history of allergies to casein, whey, gluten, soy, chicken, pork, beef, eggs, and milk.  The patient's concurrent medications were not reported.  On an unspecified date in May 2004, the patient received a dose of diphtheria and tetanus toxoids and acellular pertussis vaccine.  Approximately 2 days later, on an unspecified date in May 2004, the patient experienced swelling of his limb, from his calf to his hip.  The physician stated that the area was swollen to basketball size, red, hot and inflamed.  Medical attention was sought and the patient was treated with acetaminophen and ibuprofen.  The event resolved.  Report received via Merck and Co.,Inc.
Age: 1.29
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Pyrexia
Clinical narrative: This case was reported by a medical assistant and described the occurrence of injection site cellulitis in a 15 month old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On an unspecified date, the patient received a dose of Infanrix.  At an unspecified date, the patient received a dose of Infanrix.  At an unspecified time following the administration of Infanrix, the patient experienced a fever.  The outcome of the fever was not specified.  On 07/01/2004, the patient received the fourth dose of Infanrix in the left arm.  Approximately one day following the administration of Infanrix, on 07/02/2004, the patient developed an area of deep, redness, and pain the size of a quarter at the injection site, there was no swelling.  On 07/07/2004, the patient was seen by the vaccine provider, who made a diagnosis of injection site cellulitis and prescribed cephalexin.  The medical assistant said that the patient did not come in for a recheck so she felt that the patient was ok.  The medical assistant initially considered the injection site reaction to probably be related to vaccination with Infanrix and a problem with the specific lot number of Infanrix.  Subsequently she stated that the injection site cellulitis was possibly related to vaccination with Infanrix.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction, Pain, Rash erythematous
Clinical narrative: This case reported by a medical assistant and described the occurrence of injection site cellulitis in a 15 month old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 06/29/2004, the patient received the fourth dose of Infanrix (DTPA614A9) in the left arm.  Approximately two days following the administration of Infanrix, on 07/01/2004, the patient developed cellulitis at the injection site that was characterized as a red, raised area that was painful.  The reaction extended to involve the entire deltoid area.  The patient was seen at a physician's office and treated with Augmentin.  The medical assistant said that the patient did not come in for a re-check so she felt that the patient was ok.  The medical assistant considered the injection site reaction to probably be related to vaccination with Infanrix and a problem with the specific lot number of Infanrix.  Subsequently she stated that the injection site cellulitis was possibly related to vaccination with Infanrix.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis, Diarrhoea, Feeling hot, Injection site erythema, Injection site mass
Clinical narrative: Redness, swelling, and hot at site of inj, swelling and redness covered about 4 inch in area with hard lump, diarrhea, low grade fever. Developed sinusitis, bronchitis, following viral onset.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Pyrexia, Sinusitis, Viral infection
Clinical narrative: Redness, swelling, and hot at site of inj, swelling and redness covered about 4 inch in area with hard lump, diarrhea, low grade fever. Developed sinusitis, bronchitis, following viral onset.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a medical assistant and described the occurrence of an injection site reaction in a 5 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 06/30/2004, the patient received the fifth dose of Infanrix (lot DTPA614A9) in the left arm.  Approximately one day following the administration of Infanrix, on 07/01/2004, the patient developed an area of deep redness and pain the size of a quarter at the injection site; there was no swelling.  The patient was seen at a physician's office and was treated with Duricef.  The event resolved on an unspecified date.  The medical assistant initially considered the injection site cellulitis to probably be related to vaccination with Infanrix and a problem with specific lot number of Infanrix.  Subsequently she stated that the injection site cellulitis was possibly related to vaccination with Infanrix.
Age: 1.27
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: This case was reported by a medical assistant and described the occurrence of injection site cellulitis in a 15 month old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 06/30/2004, the patient received the fourth dose of Infanrix (lot DTPA614A9) in the left arm.  Approximately one day following the administration of Infanrix.  On 07/01/2004, the patient experienced injection site cellulitis characterized by red, raised painful area at the injection site.  The injection site reaction extended to involve the entire deltoid area.  The patient was seen at a physician's office and received treatment with amoxicillin.  The medical assistant stated, "I haven't heard back, so I assume the treatment we prescribed was successful."  The medical assistant initially considered the injection site cellulitis to probably be related to vaccination with Infanrix.  Subsequently she stated that the injection site cellulitis was possibly related to vaccination with Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction, Swelling
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of injection site cellulitis in a child who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The reporter stated that several children experienced injection site cellulitis following the administration of Infanrix; however, patient identifiers were not provided.  On an unspecified date in 2004, the patient received a dose of Infanrix.  At an unspecified time following the administration of Infanrix, on an unspecified date in 2004, the patient experienced swelling of the injected limb.  The child returned to the immunization clinic, where a diagnosis of injection site cellulitis was made.  The child was referred to the primary care physician for further treatment.  The reporter could not confirm that the child was seen by the primary physician or that any treatment was prescribed.  The outcome of the event is unknown.  The reporter also stated that they stopped using this lot number and switched over to a new lot number and have not seen any further occurrences of limb swelling.
Age: 0.5
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection, site reaction in a 6 month old patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On an unspecified date in July 2004, the patient received the second dose of Infanrix in the leg (lot DTPA590B9).  The day after the vaccine was received on an unspecified date in July 2004, the patient experienced an injection site reaction characterized as redness and inflammation.  The patient was seen at a physician's office.  The outcome of the events is unknown.  The nurse considered the injection site reaction to probably be related to vaccination with Infanrix.
Age: 0.5
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 9 month old patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On an unspecified date in July 2004, the patient received the second dose of Infanrix in the leg.  The day after the vaccine was received on an unspecified date in July 2004, the patient experienced an injection site reaction characterized as redness and inflammation.  The patient was seen at a physician's office.  The outcome of the events is unknown.  The nurse considered the injection site reaction to probably be related to vaccination with Infanrix.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 year old patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On an unspecified date in July 2004, the patient received the fifth dose of Infanrix in the leg (lot DTPA590B9).  The day after the vaccine was received, on an unspecified date in July 2004, the patient experienced an injection site reaction characterized as redness and inflammation.  The patient was seen at a physician's office.  The outcome of the events is unknown.  The nurse considered the injection site reaction to probably be related to vaccination with Infanrix.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in a 6 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 07/28/2004, the patient received the third dose of Infanrix.  At an unspecified time following the administration of Infanrix, on 07/28/2004, the patient experienced fever and fussiness.  The patient was treated with acetaminophen.  The outcome of the events is unknown.
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Irritability, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in a 2 month old female pt who received Infanrix. On 7/26/04, the pt received the 1st dose of Infanrix. At an unspecified time following the administration of Infanrix, on 7/26/04, the pt experienced fever and fussiness. The pt was treated with Tylenol. The outcome of the events is unknown.
Sex: U
Vaccine: DTAP
Symptoms: Injection site mass
Clinical narrative: This case was reported by a pharmacist and described a dose of an injection site reaction in a pt who received Infanrix. On an unspecified date in 2003, the pt received a dose of Infanrix. On an unspecified date in 2003, at an unspecified period of time following the administration of Infanrix, the pt experienced a "bump" at the injection site. The bump at the injection site hardened "over the pasy year". The pt was seen at a physician's office. The injection site reaction was ongoing at the time of initial reporting. The reporting pharmacist, considered the events to be unrelated to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of a swollen leg in a 4 year old male pt who received Infanrix. On 7/22/04, the pt received the 5th dose of Infanrix in the left thigh (lot DTPA614A9). Approximately 1 day after the 5th administration of Infanrix, on 7/23/04, the pt experienced a swollen leg. The pt was seen at a physician's office and was treated with steroids. The event resolved on 7/29/04. The nurse considered the swollen leg to possibly be related to vaccination with Infanrix.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: This case was reported by a physician and described the occurrence of an injection site reaction in a 4 year old female pt who received Infanrix. On 8/4/04, the pt received the 5th dose of Infanrix in the right hip (lot DTPA633A2). Approximately 2 days following the administration of Infanrix, on 8/6/04, the pt experienced an injection site reaction characterized as inflammation, redness and was "warm to touch". The pt was seen at a physician's office and was treated with unspecified anti-inflammatories and antihistamines. The event resolved on an unspecified date in 8/04. The reporting physician considered the injection site reaction to probably be related to the lot of Infanrix administered.
Age: 6.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: This case was reported by a physician and described the occurrence of an injection site reaction in a 5 year old female pt who received Infanrix. On 8/4/04, the pt received the 5th dose of Infanrix in the left thigh (lot DTPA634A2). On 8/4/04, the pt also received an injection of MMRII in the right thigh. Approximately 2 days following administration of Infanrix, on 8/6/04, the pt experienced an injection site reaction on the left thigh that was characterized as inflammation, redness and was "warm to touch". The pt was seen at a physician's office and was treated with unspecified anti-inflammatories and antihistamines. The event resolved on an unspecified date in 8/04. The reporting physician considered the injection site reaction to probably be related to the lot of Infanrix administered.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: This case was reported by a physician and described the occurrence of an injection site reaction in a 4 year old female pt who received Infanrix. On 8/4/04, the pt received the 5th dose of Infanrix, in the left thigh. On 8/4/04, the pt also received an injection of IPOL, in the right thigh. At an unspecified time following the injection of Infanrix, on 8/4/04, the pt experienced an injection site reaction on the left thigh that was characterized as inflammation, redness and was "warm to touch". The pt was seen at a physician's office and was treated with unspecified anti-inflammatories and antihistamines. The event resolved on an unspecified date in 8/04. The reporting physician considered the injection site reaction to probably be related to the lot of Infanrix administered.
Age: 26.0
Sex: F
Vaccine: DTAP, TD
Symptoms: Injection site swelling, Medication error
Clinical narrative: This case was reported by a physician and described the occurrence of an injection site reaction in a 26 year old female pt who received Infanrix. On 8/6/04, the pt received a dose of tetanus and diphtheria toxoids in her right thigh. On 8/6/04, the pt also, inadvertently, received a dose Infanrix, in her left thigh. Approximately 5 days after the administration of Infanrix, on 8/11/04, the pt experienced an injection site reaction on her left thigh characterized as swelling. The injection site reaction occurred "at the site of the Infanrix injection". The outcome was unknown. The reporting physician considered the events to probably be related to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a health professional and described the occurrence of a swollen arm in a 4 year old male pt who received Infanrix. On 8/9/04, the pt received the 5th dose of Infanrix in the left arm. On 8/9/04, the pt also received injections of Varivax, in the right leg and IPOL in the right arm. Approximately 1 day after the administration of Infanrix, 8/10/04, the pt experienced swelling of the "whole left arm" and an injection site reaction of the left arm characterized as a painful "softball-sized rash with raised hives that is 4 inches long and 3 inches wide". The pt was seen at a physician's office and was treated with Zyrtec and ice. The event resolved on 8/13/04. The health professional considered the events to probably be related to vaccination with Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of injection sit cellulitis in a 4 year female pt who received Infanrix. The nurse reported that "at least" 6 other pts experienced cellulitis at the injection site following the administration of Infanrix "from 2 lot numbers"; however, pt identifiers were not provided for these additional pts. In each case, injection site cellulitis and with injection site swelling occurred following administration of the 4th or 5th dose of Infanrix. On 8/16/04, the pt received the 4th dose of Infanrix in the right leg. This dose of Infanrix was either from lot DTPA622A2 or DTPA598B2. Approximately 3 days after the administration of Infanrix, on 8/19/04, the pt experienced swelling at the injection site. The pt was seen by a physician who made the dx of injection site cellulitis. The event was ongoing at the time of initial reporting. The nurse considered the events to probably be related to vaccination with Infanrix.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site cellulitis in a 30 month old female pt who received Infanrix. On 8/18/04, the pt received the 4th dose of Infanrix in the left thigh (lot DTPA598A2). On 8/18/04, the pt also received injections of MMRII and Varivax. Approximately "48 hours" after the administration of Infanrix, on 8/20/04, the pt experienced an injection site reaction at the site of the Infanrix administration. The pt was seen by a physician, who noted a reaction "local to the injection site, but larger and more red and hot than normally seen". A dx of injection cellulitis was made. The pt was treated with "comfort and supportive measures". The event resolved on an unspecified date. The nurse considered the injection site cellulitis to probably be related to vaccination with Infanrix.
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 injection site cellulitis in a 5 year old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (infanrix).  On 08/04/2004, the patient received the 5th dose of Infanrix int he right thigh (lot DTPA5982A2).  On 08/04/2004, the patient also received injections of measles, mumps and rubella virus vaccine (MMRII, Merck) and poliomyelitis virus vaccine (Ipol, Aventis Pasteur).  Approximately on day after the administration of Infanrix, on 08/05/2004, the patient experienced an injection site reaction at the site of the Infanrix administration.  The patient was seen by a physician, who noted a reaction local to the injection site, but larger and more red and hot than normally seen.  A diagnosis of injection site cellulitis was made.  The patient was treated with support and comfort measures.  The event resolved on an unspecified date.  The nurse considered the injection site cellulitis to probably be related to vaccination with Infanrix.
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 injection site cellulitis in a 4 year old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 08/17/2004, the patient received the 5 dose of Infanrix in the arm (lot dTPA598A2).  On 08/17/2004, the patient also received injections of measles, mumps and rubella virus vaccine (MMR II, Merck) and poliomyelitis virus vaccine (Ipol, Aventis Pasteur).  Approximately 48 hours after the administration of Infanrix, on 08/19/2004, the patient experienced an injection site reaction at the site of the Infanrix administration.  The patient was seen by a physician, who noted a reaction local to the injection site, but larger and more red and hot than normally seen.  A diagnosis of injection site cellulitis was made.  The patient was prescribed cefprozil (Cefzil).  The event improved on 08/20/2004.  The nurse considered the injection site cellulitis to probably be related to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: This case was reported by a nurse described the occurrence of injection site cellulitis in a 4 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 08/18/2004, the patient received the 5th dose of Infanrix in the right thigh (lot DTPA 598A2).  On 08/18/2004, the patient also received injections of measles, mumps and rubella virus vaccine and poliomyelitis virus vaccine.  Approximately 48 hours after the administration of Infanrix, on 08/20/2004, the patient experienced an injection site reaction at the site of Infanrix administration.  The patient was seen by a physician, who noted a reaction local to the injection site, but larger and more red and hot than normally seen.  A diagnosis of injection site cellulitis was made.  The patient was prescribed cephalexin (Keflex).  The event resolved on an unspecified date.  The nurse considered the injection site cellulitis to be related to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of a swollen leg in a 4 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 08/03/2004, the patient received the fifth dose of Infanrix in the left thigh (lot DTPA614B9).  At an unspecified time following the fifth administration of Infanrix, on 08/03/2004, the patient experienced a swollen left leg.  The nurse reported that the left leg was swollen, from the upper thigh to the knee area.  The patient was seen at a physician's office considered the swollen leg to possibly be related to vaccination with Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP, 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 a swollen thigh in a 5 year old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 08/24/2004, the patient received the fifth dose of Infanrix in the left thigh.  On 08/24/2004, the patient also received injections of poliomyelitis virus vaccine, and measles, mumps and rubella virus vaccine.  The nurse reported that the IPOL and MMR II were administered elsewhere.  Approximately 24 hours after the administration of the 5 dose of Infanrix, on 08/25/2004, the patient experienced an injection site reaction at the site of Infanrix administration characterized as redness and warm to the touch and swelling of the entire left thigh.  The patient was seen at a physician's office.  The events resolved on 08/27/2004.  The nurse considered the events to probably be related to vaccination with Infanrix.
Age: 0.16
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of a injection site reaction in a 2 month old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This case was initially reported by a nurse who stated that two patient's experienced an injection site reaction following the administration of Infanrix, however, identifiers were only provided for one patient. On 8/26/04, the patient received the first dose of Infanrix in the right thigh. On 8/26/04, the patient also received injections of poliomyelitis virus vaccine and Haemophilus influenzae type B conjugate vaccine in the left thigh. Immediately following the administration of Infanrix, on 8/26/04, the patient experienced redness and swelling at the injection site on the right thigh. The event resolved approximately 10 minutes later. The reporting physician considered the event to probably be related to vaccination with Infanrix.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 5 year old pt who received Infanrix. On 8/25/04, the pt received the 5th dose of Infanrix in the left arm (lot DTPA622A2). At an unspecified time following the 5th administration of Infanrix, in 8/04, the pt experienced an injection site reaction at the site of Infanrix administration characterized as swollen, inflammed, warm and sore. The pt was seen in the ER and was treated with antibiotics and Benadryl. The event was ongoing at the time of initial reporting. The nurse considered the event to probably be related to vaccination with Infanrix. The nurse stated that she became aware of this pt "only by word of mouth. No formal complaint; pt not seen."
Sex: U
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a medical assistant and described  the occurrence of swelling at the injection site in a pt who received Infanrix. On an unknown date, the pt received Infanrix (lot DTPA612A9). At an unknown time, the pt experienced "severe" swelling at the injection site. The event resolved. The medical assistant considered the events were probably related to vaccination with Infanrix. The medical assistant also stated that "one additional, unidentified pt experienced swelling at the injection site".
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of a swelling at the injection site in a 5 year old male pt who received Infanrix. On an unspecified date in 2004, the pt received the 5th dose of Infanrix (lot DTPA639B2). Concurrently, the pt also received injections of MMRII and IPOL. At an unknown time after the administration of Infanrix, the pt experienced swelling at the injection site which was "5 by 7 cm". The events resolved. The nurse cosidered the events to possibly be related to vaccination with Infanrix.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of a swelling at the injection site in a 5 year old male pt who received Infanrix. On an unspecified date in 2004, the pt received the 5th dose of Infanrix (lot DTPA639B2). Concurrently the pt also received injections of MMRII and IPOL. At an unknown time after the administration of the 5th dose of Infanrix, the pt experienced swelling at the injection site which was "7 inches". The events resolved. The nurse considered the events to possibly be related to vaccination with Infanrix.
Age: 1.5
Sex: M
Vaccine: DTAP, DTAPHEPBIP, FLU3, PNC
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a physician and described an 18 month old male pt who inadvertently received separate injections of diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated polio virus vaccine combined (Pediarix) and diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) on the same day. On 10/1/04, the pt received the 3rd dose of Pediarix. On 10/1/04, the pt also received an injection of Fluzone and Prevnar. Later that day, the pt experienced soreness at an unspecified injection site. The physician reported that no intervention was required and the pt was instructed to take ibuprofen and acetaminophen as needed to relieve soreness. Approximately 3 days later, on 10/4/04, the injection site soreness had resolved. In the physician's opinion, the soreness at an unspecified injection site was related to the erroneous administration of Infanrix.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site oedema, Injection site reaction
Clinical narrative: This case was reported by a medical assistant and described the occurrence of injection site cellulitis in a 24 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). Concurrent medication included acetaminophen (Tylenol). On 06Oct04, the pt received the fourth dose of Infanrix in the left him (lot DTPA614C9). Approx one day following the fourth dose of Infanrix, on 07Oct04, the pt developed swelling at the injection site that went from 9.5cm by 7 cm to 20cm in one day. The pt was hospitalized for three days with a diagnosis of injection site cellulitis. The events had improved as of the time of initial reporting.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: This case was reported by a medical assistant and described the occurrence of injection site cellulitis in a 5 year old male pt who received Infanrix. On 10/6/04, the pt received the 5th dose of Infanrix in the right arm. Within 1 week of the 5th administration of Infanrix, on an unspecified date in 10/04, the pt experienced an unspecified injection site reaction; a dx of injection site cellulitis was made. The event had improved as of the time of initial reporting.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swelling and redness at the injection site in a pt who received Infanrix. The physician reported "several patients" had experienced swelling and redness at the injection site; however no pt identifiers were provided. On an unspecified date in 2003, the pt received Infanrix. At an unknown time later in 2003, the pt experienced localized swelling and redness at the injection site. The physician stated they had used "a 7/8 inch needle to administer the injections". At the time of reporting, the events had resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Irritability, Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of hives in a 4 year old male pt who received Infanrix. On 2/10/04, the pt received the 5th dose of Infanrix in the left arm. On the same day, the pt received injections of MMRII and IPOL. The sites of administration for MMRII and IPOL were not provided. Approximately 7 days later, on 2/17/04, the pt experienced hives at the injection site of Infanrix and irritability. At an unspecified time following the injection site hives, on an unspecified date in 2/04, the pt experienced "hives all over the body". The hives and irritability resolved after "several months". The nurse reported that the pt had a biopsy of the skin; however, the biopsy was not performed in the physician's office and the results were not known. In the nurse's opinion, the events were possibly related to vaccination with Infanrix.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of an urticarial rash in a 3 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 05/25/2004, the patient received the third dose of Infanrix.  On the same day, the patient also received injections of hepatitis B vaccine and poliomyelitis virus vaccine.  The site of injection for these three vaccinations was not provided.  On minute after the administration of the immunizations, on 05/25/2004, the patient experienced an urticarial rash over face and body.  The physician also reported that at the time of the event the patient, had no problem breathing.  The patient was treated with diphenhydramine.  The event resolved on 05/25/2004.  The physician considered the event to be serious and to require intervention to prevent life threatening sequelae.  The physician reported that the patient has received hepatitis B and IPOL again without incident.  The physician considered the urticarial rash to probably be related to vaccination with Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a child who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The nurse reported that two children had experienced an injection site reaction following the administration of Infanrix from the same lot; however no patient identifiers were provided.  On an unspecified date, the patient received a dose of Infanrix (lot DTPA592B9); dose number not specified.  Approximately two days following the administration of Infanrix, on an unspecified date, the patient experienced an injection site reaction characterized as localized swelling, redness, and induration.  The injection site reaction resolved on an unspecified date.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of redness and swelling at the injection site in a 4 year old patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  Initially, the reporter stated there were five to six patients who experienced redness and swelling at the injection site after receiving Infanrix; however, no patient identifiers were reported.  On an unspecified date, the patient received Infanrix.  At an unspecified time later, the patient experienced localized redness and swelling at the injection site.  As of 11/24/2004, the outcome of the events was unknown.  The reporting physician considered the events were possibly related to vaccination with Infanrix.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: This case was reported by a physician and described the occurrence of a swelling at the injection site in a 4 year old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 12/22/2004, the patient received the fifth dose of Infanrix in the arm.  The physician stated that during the administration of the fifth dose of Infanrix, the needle was not attached to the syringe properly and the dose squirted out.  On the same date, the nurse administered another dose of Infanrix properly.  The physician stated the patient may have received slightly more than 0.5ml of Infanrix, but no 1.0ml.  On 12/22/2004, the patient also received an injection of poliomyelitis virus vaccine in a different arm from the arm that was injected with Infanrix.  At an unknown time following the administration of Infanrix, on 12/22/2004, the patient experienced a local reaction at the injection site of the Infanrix injections manifested as swelling, redness, and itching.  The injection site reaction resolved on an unspecified date on or before 01/26/2005.  The reporting physician considered the events to be related to vaccination with Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of an injection site reaction in a patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The physician reported that 2 patients developed the exact same reactions following the administration of Infanrix, however, patient identifiers were not provided.  On 12/27/2004, the patient received a dose of Infanrix in the left leg.  The physician stated that the patient received a booster dose of Infanrix, however, the dose number was not provided.  Approximately 3 days following the administration of Infanrix, on 12/30/2004, the patient experienced an injection site reaction characterized as swelling and redness.  The patient was seen at the physician's office.  The physician recommended cold compresses and observation.  The injection site reaction resolved on an unspecified date on or before 01/03/2004.  The reporting physician considered the injection site reaction 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 an injection site reaction in a 5 year old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On an unspecified date in 2002, the patient received the fifth dose of Infanrix in the left arm (lot DTPA531A2).  At an unspecified time following the administration of the fifth dose of Infanrix, on 05/10/2002, the patient experienced an injection site reaction characterized as redness and swelling.  The outcome of the injection site reaction was not reported.  The nurse considered the injection site reaction to be related to vaccination with Infanrix.
Age: 0.12
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Crying
Clinical narrative: This case was reported by a nurse and described the occurrence of crying in a 6 week old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 12/14/2004, the patient received the first dose of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed.  On 12/14/2004, the patient also received an injection of Haemophilus influenzae type b conjugate vaccine.  At an unspecified time following the administration of the immunization, on12/14/2004, the patient experienced crying.  The crying resolved after 2 to 3 hours on 12/14/2004.  The nurse reported that the patient had, no fever or local reaction.  The nurse considered the crying to possibly be related to vaccination with Infanrix.  On 12/17/2004, the patient received the first dose of Engerix-B.  The nurse reported that no crying or side effects were reported following the administration of the first dose of Engerix-B.  Approximately 2 months later, on 02/17/2005, the patient also received an injection of poliomyelitis vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration, 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 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The patient had no pre-existing medical conditions.  On 02/14/2005, the patient received the fifth dose of Infanrix in the left thigh.  On the same day, the patient also received the second dose of measles, mumps and rubella virus vaccine, the second dose of inactivated poliomyelitis virus vaccine, and the second dose of Hepatitis A vaccine inactivated (Havrix) at unspecified site of administration.  At an unspecified time following the fifth dose of Infanrix, on 02/14/2005, the patient experienced an injection site reaction at the site of the Infanrix administration characterized as swollen, hard, red, warm, and painful.  The outcome of the injection site reaction was not reported.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration, 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 year old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The patient had no pre-existing medical conditions.  On 03/02/2005, the patient received the fifth dose of Infanrix in the right thigh.  On the same day, the patient also received the second dose of measles, mumps and rubella virus vaccine, the fourth dose of inactivated poliomyelitis virus vaccine at unspecified sites of administration.  At an unspecified time following the fifth dose of Infanrix, on 03/02/2005, the patient experienced an injection site reaction at the site of the Infanrix administration characterized as swollen, hard, red, warm, and painful.  The outcome of the injection site reaction was not reported.
Age: 1.29
Sex: F
Vaccine: DTAP, MMR, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 15 month old female who received Infanrix. On 3/8/05, the pt received the 4th dose of Infanrix, in the right thigh (lot AC14A009BA). On the same day, the pt also received the 1st dose of MMRII, the 1st dose of Prevnar, at unspecified sites of administration. At an unspecified time following the 4th dose of Infanrix. On 3/8/05, the pt experienced an injection site reaction at the site of the Infanrix administration characterized as swollen, hard, red, warm and painful. The outcome of the injection site reaction was not reported.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 yr old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt had no pre-existing medical conditions. On 28Feb05, the pt received the fifth dose of Infanrix in the right thigh (lot AC14A009BA). On the same day, the pt also received the second dose of measles, mumps and rubella virus vaccine (MMR II) and the second dose of inactivated poliomyelitis virus vaccine (IPOL) at unspecified sites of administration. At an unspecified time following the fifth dose of Infanrix, on 28Feb05, the pt experienced an injection site reaction at the site of the Infanrix administration characterized as swollen, hard, red, warm, and painful. The outcome of the injection site reaction was not reported.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The nurse reported that three pt experienced an injection site reaction following the administration of Infanrix, however, pt identifiers were not provided. On an unspecified date on or before 14Mar05, the pt received a dose of Infanrix. The site of administration and dose number of Infanrix were not provided. At an unspecified time following the administration of Infanrix, on an unspecified date on or before 14Mar05, the pt experienced an injection site reaction characterized as red and swollen. The outcome of the injection site reaction was not reported. The nurse considered the injection site reaction to probably be related to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: This case was reported by a health professional and described the occurrence of injection site cellulitis in a 4 yr old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt has no pre-existing medical conditions. On 07Feb05, the pt received the fifth dose of Infanrix in the left leg (lot DTPA620B9). On 07Feb05, the pt also received injections of measles, mumps and rubella virus vaccine (MMR II) and inactivated poliomyelitis virus vaccine (IPOL). The health professional stated that the MMR II and IPOL injections were administered in separate areas from the site of the Infanrix administration. At an unspecified time following the fifth dose of Infanrix, on 07Feb05 the pt experienced swelling and redness at the injection site of Infanrix. The pt was seen in an ER and was diagnosed with injection site cellulitis. The pt was treated with hydroxyzine hydrochloride (Atarax). The outcome of the injection site cellulitis was not reported. The vaccine provider considered the injection site cellulitis to be possibly related to this lot of Infanrix.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult female between the ages of 18 to 25 years old who did not respond to the hep B vaccine (Unk manf). The pt's medical history, concurrent conditions, and concurrent medications were not reported. The nurse reported that the pt had received her vaccination series prior to 1999. At an unspecified date in 2003, a hep B surface antibody titer
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 55 yr old female pt who had a decreased response to the hep B vaccine recombinant (Engerix B) immunization series. On unspecified dates, the pt received three doses of Engerix B. Approx six weeks following the third dose of Engerix B, on 14Nov03, a hep B surface antibody titer was 2 mIU/mL. The nurse did not have the lot number for Engerix B available, but she did mention that five other pts received Engerix B from the same lot number and expiration date and all had a high titer of hep b surface antibody.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 22 yr old male pt who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. Initially the nurse reported that 13 other pt's did not respond to the Engerix B immunization series (no pt identifiers were provided). On follow up, however, 10 other pt's were identified. On an unspecified date in 2002 or 2003, the pt received the third dose of Engerix B (lot number not specified). Approx 6 to 12 weeks later, a hep B surface antibody titer was negative. The nurse stated that, all injections were given IM in the deltoid muscle with a 1 inch needle. All vaccine is refrigerated and the temp is monitored daily. The nurse considered the event to be probably related to vaccination with Engerix B.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a nurse and described  the occurrence of an itchy rash in a 25 yr old male pt who received hep B vaccine recombinant (Engerix B).  The pt was not taking any concurrent medications. She had no history of allergy to thimerosal. On 28Oct2003, the pt received the first dose of Engerix B (lot ENG5447A6) in her left arm. Prior to the vaccination, isopropyl alcohol was applied to the injection site. Following the vaccination, an adhesive bandage was applied to the injection site. At an unspecified time following the admin of Engerix B, on 28Oct03, the pt developed an itchy rash that spread from her left shoulder to her left elbow. The events resolved approx one week later, on an unspecified date in Nov 2003.