chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site hypersensitivity, Tenderness
Clinical narrative: 06/15/2005 Left deltoid has 3cm x 3 cm area of redness and tenderness at site of injection of tetanus booster. Pt advised to monitor, use ice. Application TID x 2 days and take Motrin 400mg with food TID x 2 days, per FNP.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a pharmacist intern and described the occurrence of paresthesia in a 23 year old male patient who received hepatitis B vaccine recombinant (Engerix-B).  Medical history included malaria and typhoid.  Concurrent medications included Prilosec.  On 12/30/2003, the patient received the first dose of Engerix-B.  A few days following administration of Engerix-B, on an unspecified date in January 2004, the patient experienced paresthesia of the left thumb and of the right mid-lateral leg.  On an unspecified date, the events resolved.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a physician and described the occurrence of an injection site reaction in a 5 year old male pt who received Infanrix. On 5/7/04, the pt received a dose of Infanrix (lot DTPA630B2). The physician stated that the Infanrix was injected with a "5/8 inch needle". On the same date, the pt also received injections of IPOL and MMRII. Three days following the Infanrix, on 5/10/04, the pt experienced a "local skin reaction" at the injection site of Infanrix. The event resolved on an unspecified date. The physician considered the injection site reaction to possibly 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 physician and described the occurrence of an injection site reaction in a 5 year old female pt who received Infanrix. On 5/7/04, the pt received a dose of Infanrix. The physician stated that the Infanrix was injected with a "5/8 inch needle". On the same date, the pt also received injections of IPOL and MMRII. Two days following the administration of Infanrix, on 5/9/04, the pt experienced an infection at the injection site of Infanrix. The pt was seen at a physician's office and treated with an antibiotic. The event resolved on an unspecified date. The physician considered the injection site infection to possibly be related to vaccination with Infanrix.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a physician and described the occurrence of an injection site reaction in a 5 yr old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On 10May04, the pt received a dose of Infanrix (dose number not specified, lot DTPA630B2). The physician stated that the Infanrix was injected with a "5/8 inch needle". On the same date, the pt also received injections of Poliomyelitis virus vaccine (IPOL), and measles mumps and rubella virus vaccine (MMRII). One day following the admin of Infanrix, on 11May04, the pt experienced a local skin reaction at the injection site of Infanrix. The event resolved on an unspecified date. The physician considered the injection site reaction to possibly be related to vaccination with Infanrix.
Age: 28.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Hypoaesthesia
Clinical narrative: This case was reported by a nurse and described the occurrence of numbness in the calf muscle in a 28 yr old female pt who received hep B vaccine recombinant (Engerix). Concurrent medication included birth control pills. On 15Apr04, the pt received the first dose of Engerix B (lot ENG5521A2) in her left arm. On the same day, the pt received an injection of Tetanus toxoid in the right arm and tuberculin skin test (site unspecified). Approx seven days after the admin of Engerix B, on 22Apr04, the pt experienced numbness of the lower right inner calf muscle. The immunization series with Engerix B was discontinued. As of 19May04, the numbness was unresolved.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Dizziness, Dyspnoea, Headache
Clinical narrative: This case was reported by a nurse and described the occurrence of joint pain in a 14 year old female patient who received Hep-B.    On 09 July 2004, the patient received the first dose of Engerix-B in the left arm. "Several hours after receiving" Energeix-B, on 09 July 2004, the patient experienced joint pain, headache, and dizziness.  The following day, on July 10 2004, the patient "had an episode where she felt like she was breathing through a straw."  The patient was seen at a physician's office.  The breathing difficulty resolved on 10 July 2004 and all other events resolved on 12 July 2004.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site inflammation, Injection site reaction, 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 male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. On 8/12/04, the patient received the fifth dose of Infanrix in the left arm. The following day, on 8/13/04, the patient experienced an injection site reaction at the site of Infanrix administration characterized by swollen, inflamed, warm and sore. The patient was seen in the emergency room and was treated with Tylenol with codeine. The event resolved on 8/17/04. The nurse considered the event to possibly be related to vaccination with Infanrix.
Age: 6.0
Sex: F
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 6 year old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. On 8/25/04, the patient received the fifth dose of Infanrix in the left arm. One day later, on 8/26/04, the patient experienced an injection site reaction at the site of Infanrix administration characterized as swollen, inflamed, warm, and sore. The patient was treated with Tylenol. The event resolved on 8/28/04. The nurse considered the event to possibly be related to vaccination with Infanrix.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Musculoskeletal stiffness
Clinical narrative: This case was reported by a nurse and described the occurrence of a left-sided neck stiffness in a 41 year old male patient who received hep-B vaccine.    The patient's medical history included "good health" and no known drug allergies.    On 30 July 2004, the patient received the first dose of Energix-B in the left arm.  At an unspecified time following the administration of Energix-B, on 30 JULY 2004, the patient experienced left-sided neck stiffness.  The event resolved on 01 AUG 2004.  The nurse considered the event to be related to vaccination with Energix-B.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Musculoskeletal stiffness
Clinical narrative: This case was reported by a nurse and described the occurence of left-sided neck stiffness in a 47 year old male patient who received hep-B vaccine.    The patient's medical history included "good health" and no known drug allergies.    On 30 JULY 2004, the patient received the first dose of Energix-B in the left arm.  At an unspecified time following the vaccination the patient experienced left-sided neck stiffness.  The event resolved on 01 AUG 2004.  The nurse considered the event to be related to vaccination with Energix-B.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Pyrexia
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 08/18/2004, the patient received the fourth dose of Infanrix in the left thigh (lot DTPA6324A2).  On 08/18/2004, the patient also received an injection of poliomyelitis virus vaccine (IPOl, Aventis Pasteur).  The nurse reported that the IPOL was administered elsewhere.  Approximately 24 hours after the administration of the fourth dose of Infanrix, on 08/19/2004, the patient experienced a fever of 99 degrees Fahrenheit and an injection site reaction characterized as warmth and redness at the site of Infanrix administration.  On 08/20/2004, the patient was seen by a physician, who made a diagnosis of injection site cellulitis and prescribed cephalexin and acetaminophen.  The events resolved on 08/21/2004.  The nurse considered the events to probably be related to vaccination with Infanrix.
Age: 0.51
Sex: M
Vaccine: DTAP, FLU3, PNC
Symptoms: Anaphylactic reaction, Face oedema, Hypersensitivity, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of a possible anaphylactic reaction in a 6 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt's medical history was notable for breast feeding (during the month of Sep 2004). On 28Sep04, the pt received the third dose of Infanrix (lot DTPA6339B2). On 28Sep04, the pt also received injections of 7-valent pneumococcal conjugate vaccine (Prevnar) and influenza virus vaccine (Fluzone; cultures grown in fertilized chicken eggs). Approx two hrs after the administration of Infanrix on 28Sep04, the pt experienced a possible anaphylactic reaction characterized as facial swelling and urticaria. The pt was seen at a physician's office. The anaphylactic reaction was considered life threatening and required clinical intervention. The pt was treated with Benadryl and Elidel. The event resolved on 28Sep04. The physician also reported that, on 28Sep04, the pt's mom was eating eggs. The pt was subsequently found to have class 4 reaction to egg white and egg yolk. The reporting physician considered the anaphylactic reaction to possibly be related to vaccination with Infanrix.
Age: 0.38
Sex: M
Vaccine: HIBV, IPV, DTAP, HIBV, IPV, PNC, DTAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of hives in a 4 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 12/20/2001, the patient received a dose of Infanrix.  Approximately one day following the administration of Infanrix, on 12/21/2001, the patient experienced hives and a low grade fever.  The events resolved on an unspecified date.  Report received via Wyeth Research.
Age: 0.51
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, HEP
Symptoms: Rash
Clinical narrative: This case was reported by a physician's assistant and described the occurrence of rash in a 6 month old female patient who had received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  This report was received via Wyeth.  On 02/23/2004 the patient received a dose of Engerix-B.  Two days later, on 02/25/2004, the patient experienced rash.  The outcome of the event is unknown.
Age: 61.0
Sex: F
Vaccine: HEP, TD, HEP, TTOX
Symptoms: Oedema, Pruritus, Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of hives in a 60 year old female patient who received hepatitis B vaccine recombinant.  On 04/06/2004, the patient received the first dose of Engerix-B vaccine.  On the same day, the patient received an injection of tetanus toxoid.  Approximately 4 days following the administration of Engerix-B, on 04/10/2004, the patient experienced hives all over her body.  The patient was seen at a physician's office and treated with medrol and prednisone.  The event improved.  The immunization series with Engerix-B was discontinued.  The nurse considered the hives to possibly be related to vaccination with Engerix-B and tetanus toxoid.
Age: 61.0
Sex: F
Vaccine: HEP, TD, HEP, TTOX
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of hives in a 60 year old female patient who received hepatitis B vaccine recombinant.  On 04/06/2004, the patient received the first dose of Engerix-B vaccine.  On the same day, the patient received an injection of tetanus toxoid.  Approximately 4 days following the administration of Engerix-B, on 04/10/2004, the patient experienced hives all over her body.  The patient was seen at a physician's office and treated with medrol and prednisone.  The event improved.  The immunization series with Engerix-B was discontinued.  The nurse considered the hives to possibly be related to vaccination with Engerix-B and tetanus toxoid.
Age: 0.51
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Apnoea, Cardiac arrest, Pneumonitis, Stupor, Viral infection
Clinical narrative: Seen in ER at hospital. Term stated in Autopsy report is Asystole. Additional CoStarts from Discharge Summary rec'd on 07/25/2005 -- Apnea, Stupor, heart arrest.  Autopsy Report received which stated COD as interstitial pneumonitis c/w viral pneumonia.  Manner of death: natural.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Fibromyalgia
Clinical narrative: Time symptoms began 1989. I have fibromyalgia among other health problems.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Injection site warmth
Clinical narrative: Site surrounding DTaP developed redness, warmth, and swelling. RX: Claritin and oral Benadryl.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site pain, Nausea, Oedema
Clinical narrative: The first Sx was intense sharp pain below injection site. Chills and a bit of nausea, temp of almost 101 and swelling in upper arm. Next day noted redness beneath site. Redness, pain fever ajacent to injection site. No tx.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: The first Sx was intense sharp pain below injection site. Chills and a bit of nausea, temp of almost 101 and swelling in upper arm. Next day noted redness beneath site. Redness, pain fever ajacent to injection site. No tx.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure decreased, Hypoaesthesia, Injection site erythema, Medication error, Paraesthesia
Clinical narrative: Information has been received from the wife of a 71 year old male with cancer, high blood pressure, Type II diabetes mellitus and no allergies, who on 5/23/05 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 647681/0986N). Concomitant therapy included losartan potassium and atenolol. On 5/24/05, the patient received an injection of betamtheasone with marcaine in his right arm. He initially had a local recation with redness. On 5/28/05, five days after vaccination, he vomited and developed bilateral parathesis, with numbness, swelling and tingling. He had a systemic reaction with fever and low blood pressure. He was taken to the ER. Diphenhydramine, acetaminophen (+) oxycodone and bedrest were prescribed. The patient's wife, who is a licensed practical nurse, suggested that when the pneumococcal 23v polysaccharide vaccine was given, a nerve may have been hit. At the time of report, the patient had not recovered. No product quality complaint was involved. The patient's wife considered that local reaction with redness, vomited, bilateral parathesis, systemic reaction, fever, and low blood pressure were considered to be disabling and other important medical events (OMIC). No further information is expected.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Swelling, Vomiting
Clinical narrative: Information has been received from the wife of a 71 year old male with cancer, high blood pressure, Type II diabetes mellitus and no allergies, who on 5/23/05 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 647681/0986N). Concomitant therapy included losartan potassium and atenolol. On 5/24/05, the patient received an injection of betamtheasone with marcaine in his right arm. He initially had a local recation with redness. On 5/28/05, five days after vaccination, he vomited and developed bilateral parathesis, with numbness, swelling and tingling. He had a systemic reaction with fever and low blood pressure. He was taken to the ER. Diphenhydramine, acetaminophen (+) oxycodone and bedrest were prescribed. The patient's wife, who is a licensed practical nurse, suggested that when the pneumococcal 23v polysaccharide vaccine was given, a nerve may have been hit. At the time of report, the patient had not recovered. No product quality complaint was involved. The patient's wife considered that local reaction with redness, vomited, bilateral parathesis, systemic reaction, fever, and low blood pressure were considered to be disabling and other important medical events (OMIC). No further information is expected.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Leukocytosis, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Body stiffening and fever. Evaluation in ER: NL PE and sepsis work up including LP done. All was WNL.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Autism, Diarrhoea, Hypokinesia, Irritability, Pyrexia
Clinical narrative: Called doctor. 24 hours fever, spots, irritability, diarrhea. Regressed after shot. Was walking, talking, fine motor. Lost all of those. Medical Records received stated patient experienced autism.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Speech disorder
Clinical narrative: Called doctor. 24 hours fever, spots, irritability, diarrhea. Regressed after shot. Was walking, talking, fine motor. Lost all of those. Medical Records received stated patient experienced autism.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: Seizure
Age: 19.0
Sex: F
Vaccine: MEN, VARCEL
Symptoms: Contusion, Rash papular
Clinical narrative: Scattered small red papules on chest/arms of pt. Small bruise on upper arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site discolouration, Injection site hypersensitivity, Rash macular, Rash pruritic
Clinical narrative: Received vaccines on 06/16/05. On A.M. of 06/18/05, noticed rash and itching on left thigh. On exam, blotchy, blanched, hot erythematous patch around site of DTaP.
Age: 18.0
Sex: M
Vaccine: RAB
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Pt awoke with sudden onset shaking, chills, feeling febrile (temp not taken,) severe HA and fatigue. generalized body aches and fatigue. Felt better by 8 or 9 AM
Age: 18.0
Sex: M
Vaccine: RAB
Symptoms: Tremor
Clinical narrative: Pt awoke with sudden onset shaking, chills, feeling febrile (temp not taken,) severe HA and fatigue. generalized body aches and fatigue. Felt better by 8 or 9 AM
Age: 13.0
Sex: U
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Had headache, dizziness, nausea, starting 20 minutes after administration of Menactra and Hepatitis A vaccine.  Also developed neck stiffness the next day.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Parents here for 4 month shots - states infant had severe reaction after 1st set of immunizations at 2 months old (given on 04/14/2005).  Had inconsolable crying for period lasting up to an hours time for 3-4 days.  102 degrees fever for 3-4 days despite Tylenol, every 4 hours, also vomiting, moaning, arching of back with crying.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Malaise, Nausea, Pain
Clinical narrative: Arm pain, fever, headache, malaise, nausea, light headedness.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Arm pain, fever, headache, malaise, nausea, light headedness.
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Unintended pregnancy
Clinical narrative: Pt was given the MMR vaccine on 4/27/05 because her titres drawn 4/18/05 showed non immune to rubeola. Unbeknownst to pt, she was approx 2-3 weeks pregnant at the time. She came to the employee health office 6/9/05 with the above info.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Feeling hot, Injection site mass, Pruritus
Clinical narrative: Employee stated that about 1330 she started itching all over body. T 99. The itching progressed from chest to back, down legs. Injection site hot, indurated. Benadryl 25mg PO given and Prednisone prescribed.
Age: 1.28
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Cellulitis, Feeling hot, Injection site oedema, Lymphadenopathy, Rash papular
Clinical narrative: Left anterior thigh swelling, warmth, tenderness with 2 papules surrounding possible injection site and reactive left inguinal lymphadenopathy. Swelling started on 16th and had evaluation at ER on 16th. Came to office today. He was placed on Augmentin to return for follow up of cellulitis on Mon. 6/20/05.
Age: 1.28
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Tenderness
Clinical narrative: Left anterior thigh swelling, warmth, tenderness with 2 papules surrounding possible injection site and reactive left inguinal lymphadenopathy. Swelling started on 16th and had evaluation at ER on 16th. Came to office today. He was placed on Augmentin to return for follow up of cellulitis on Mon. 6/20/05.
Age: 0.07
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Erythema, Hypersensitivity, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Full body rash. Numerous red, slightly raised areas. Diameter for 1/8" - 3/4". Majority approx 1/4" - 1/2". No apparent itching. No fever. MD diagnosed condition as hives, allergic reaction to MMR. Condition resolved by 6/18/05 in AM. Tx Benadryl 1/2 teas q 4-6 hrs. Needed only 2x.
Age: 0.07
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Full body rash. Numerous red, slightly raised areas. Diameter for 1/8" - 3/4". Majority approx 1/4" - 1/2". No apparent itching. No fever. MD diagnosed condition as hives, allergic reaction to MMR. Condition resolved by 6/18/05 in AM. Tx Benadryl 1/2 teas q 4-6 hrs. Needed only 2x.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of erythema in a 4 year old female patient who received diphtheria and tetanus toxoid and acellular pertussis vaccine absorbed (Infanrix).  The vaccine provider submitted this report directly to VAERS.  On an unspecified date, the patient received the fifth dose of Infanrix (lot DTPA627A2).  At an unspecified time following administration of Infanrix on 02/18/2004, the patient experienced a severe injection site reaction characterized by redness and swelling.  The patient was seen by the physician, who prescribed an unspecified antibiotic.  The event resolved 2 days later possibly related to the use of Infanrix.  The reported stated additional patients experienced injection site redness and swelling following receipt of Infanrix lot DTPA627A2, but no patient identifiers were provided.
Sex: U
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: This case was reported by a health professional to a sales representative and described the occurrence of limb swelling in a child who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The reporter stated that 4 children experienced the same event, however patient identifiers were not provided.  On an unspecified date in March 2004, the patient received the fifth dose of Infanrix (lot DTPA599C9).  At an unspecified time following the administration of Infanrix, the patient experienced swelling of the limb.  The outcome of the event is unknown.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Injection site induration, Injection site swelling, Pruritus
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).  The patient's past medical history included Eczema.  On 03/15/2004, the patient received the 5th dose of Infanrix (DTPA630B2) in her left thigh.  Approximately 2 days after administration of Infanrix, on 03/17/2004, the patient experienced an injection site reaction characterized as swelling, pruritus, warmth, and hardening.  The nurse described the injection site as 6 to 7cm in diameter.  The patient was treated with diphenhydramine hydrochloride, paracetamol, and ice.  The outcome of the events is unknown.  The nurse considered the injections site reaction to possibly be related to vaccination with Infanrix.  Report received via Merck and Co, Inc.
Age: 0.18
Sex: M
Vaccine: DTP, HIBV, IPV, PNC
Symptoms: Crying, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling injection site in a 2 month old male patient who had received diphtheria and tetanus toxoids and acellular pertussis vaccine for prophylaxis.  A physician or other healthcare professional has not verified this report.  Concurrent vaccinations included IPV, HIB vaccine and Prevnar.  On 04/05/2004 the patient received the first dose of DTPa.  At the time of injection, the patient experienced bleeding that was more than normal.  On the same day that he received vaccination with DTP, the patient experienced swelling around the injection site, crying, and a fever of 100.0 degrees.  The bleeding resolved, the swelling improved, the crying was unresolved, and the outcome of fever was unknown at the time of reporting.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: This case was reported by a physician and described the occurrence of cellulitis in a patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The physician reported that the adverse event occurred in several patients, however, no patient identifiers were provided.  Upon follow up, only one patient was identified.  On an unspecified date, the patient received the last dose in the vaccination series of Infanrix (lot DTPA627A2).  At an unspecified time following the administration of Infanrix, the patient experienced cellulitis and a local reaction.  The events resolved.  The location and treatment of the reported events were not specified.  The physician considered the events to be nonserious and to be related to vaccination with Infanrix.  The physician stated that this report was initially reported as a potential quality assurance problem.    Comment:  Cellulitis was assessed as medically serious by GSK.
Age: 0.18
Sex: F
Vaccine: DTAP
Symptoms: Medication error, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 2 month old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  A physician or other healthcare professional has not verified this report.  On 03/25/2004, the patient inadvertently received simultaneous doses of Infanrix in the right and left hip for the first two doses of the Infanrix series.  This is sooner than the recommended interval of 4 to 8 weeks between the first and second doses.  The lot number for the Infanrix dose in the left hip is DTPA616A2.  At an unspecified time following the administration of Infanrix, on 03/25/2004, the patient experienced fever and was seen at a physician's office.  She was treated with acetaminophen and the fever resolved on 03/26/2004.
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site oedema, Injection site reaction
Clinical narrative: This case was reported by a health professional to a distributor and described the occurrence of an injection site reaction in a male child who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On 14Apr04, the pt received the fourth dose of Infanrix (lot DTPA622A2). At an unspecified time following the administration of Infanrix, on 14Apr04, the pt experienced an injection site reaction characterized by swelling, warmth, redness and induration. The pt was seen at a physician office. The event was unresolved. The health professional considered the injection site reaction to probably be related to vaccination with Infanrix.
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: This case was reported by a health professional to a distributor and described the occurrence of an injection site reaction in a male child who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On 14Apr04, the pt received the fifth dose of Infanrix (lot DTPA622A2). At an unspecified time following the administration of Infanrix, on 14Apr04, the pt experienced an injection site reaction characterized by swelling, warmth, redness, and induration. The pt was seen at a physician's office. The event was unresolved. The health professional considered the injection site reaction to probably be related to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of erythema in a 4 yr old male pt who received diphtheria adn tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The vaccine provider submitted this report directly. On an unspecified date, the pt received the fifth dose of Infanrix (lot 627A2). At an unspecified time following admin of Infanrix on 29Jan04, the pt experienced a severe injection site reaction characterized by redness and swelling. The pt was seen by the physician, who prescribed an unspecified antibiotic. The pt was seen by the physician. The event resolved six days later on 04Feb04. In the nurse practitioner's opinion, the events were possibly related to the use of Infanrix.
Age: 5.0
Sex: M
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 erythema in a 5 yr old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The vaccine provider submitted this report directly. On an unspecified date, the pt received the fifth dose of Infanrix (lot DTPA627A2). At an unspecified time following administration of Infanrix on 11Feb04, the pt experienced a severe injection site reaction characterized by redness and swelling. The pt was seen by the physician, who prescribed an unspecified antibiotic. The event resolved after an unspecified period. In the nurse practitioner's opinion, the events were possibly related to the use of Infanrix.
Sex: F
Vaccine: DTAP
Symptoms: Eye irritation, Medication error, Pruritus
Clinical narrative: This case was reported by an adult female nurse and described the occurrence of eye pruritus that she experienced after she was inadvertently exposed to diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On 28Apr04, the nurse was administering Infanrix (lot DTPA 622A2) to a pt. The reporter stated that, during the admin of Infanrix, the syringe came off the needle and vaccine squirted into (my) eye. She also stated that , the syringes were not the prefilled syringes made by manf. The nurse's eye was washed with water and flushed with an eye wash. Following the flush, the nurse's eye was itching slightly. The reporter stated that she did not know if the eye itching was from exposure to the vaccine. The eye itching was unresolved.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of an injection site reaction in a child who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The physician reported that five pt's developed an injection site reaction following the admin of Infanrix, however, pt identifiers were not provided. On an unspecified date, the pt received the fifth dose of Infanrix (lot DTPA 632A2) in the arm. At an unspecified time following the admin of Infanrix, the pt experienced an injection site reaction characterized by swelling and redness. The pt was seen at a physician's office. The outcome of the events is unk.
Sex: U
Vaccine: DTAP
Symptoms: Injection site oedema, Injection site reaction
Clinical narrative: This case was reported by a nurse to a sales rep and described the occurrence of an injection site reaction in a child who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The nurse reported that several children experienced swelling following the admin of Infanrix, however, pt identifiers were not provided. On an unspecified date, the pt received the fourth or fifth dose of Infanrix. At an unspecified period time following the admin of Infanrix, the pt experienced an injection site reaction characterized as swelling. The outcome of the event is unk.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash macular
Clinical narrative: Macular rash on neck, on 6/15 spreading to shoulders, back, chest and abdomen, sparing thighs and arms, reportedly starting 6/21, evaluated 6/23.
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Anorexia, Diarrhoea, Dizziness, Hepatic enzyme abnormal, Nausea
Clinical narrative: Received TD Wednesday, 6-15-05.  On Thursday, 6-16-05, awakened in AM with nausea and lack of appetite.  He consumed only fluids on Thursday.  Evaluated by physician on Friday:  nausea, dizziness, diarrhea, and loss of appetite.  States liver enzymes were elevated.  He states that on Monday his liver enzymes were decreased from Friday.  The nausea, diarrhea, and dizziness continued through Wednesday, when they decreased and were gone by the evening.
Age: 48.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema, Injection site warmth, Rash erythematous
Clinical narrative: Pt returned to clinic with a circular raised erythemous area of 3.5cm, a dark erythemous area at 5cm, and a mild erythemous at 8.5cm circular pattern. The area was hot and tender to touch. Denies SOB, nausea, vomiting, wheezing or cough. Pt was seen today by provider. TX: cool compress, Ibuprofen 800mg 3 times a day, Gatifloxacin 400mg 1 tab q day x7 days. RTC in 4 days for reevaluation, or sooner if symptoms worsen.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Dehydration, Erythema, Haematuria, Mucous membrane disorder, Oedema peripheral
Clinical narrative: Patient received Menactra 6/20/05. 1 day later developed fever 102, swelling and rednesss of hands and feet, and a diffuse maculopapular pruritic rash. 6/22 seen in ER with mild dehydration and diffuse rash. Treated with benadryl. 6/23/05 worsening rash, now over oral mucosa, persistent fever, 3+ hematuria. Admitted to hospital with R/O Stevens Johnson Syndrome  7/25/06 Medical records x 30 pgs received/reviewed. Final diagnosis was confirmed as allergic reaction to Menactra vaccine vs viral syndrome. Pt was treated with Tylenol and Benadryl while hospitalized. Throat and urine cultures were neg(-). Chest x-ray was neg. Pt to FU with PCP within 1 week. Records submitted for scanning. Paper report filed/sem
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, Rash maculo-papular, Rash pruritic
Clinical narrative: Patient received Menactra 6/20/05. 1 day later developed fever 102, swelling and rednesss of hands and feet, and a diffuse maculopapular pruritic rash. 6/22 seen in ER with mild dehydration and diffuse rash. Treated with benadryl. 6/23/05 worsening rash, now over oral mucosa, persistent fever, 3+ hematuria. Admitted to hospital with R/O Stevens Johnson Syndrome  7/25/06 Medical records x 30 pgs received/reviewed. Final diagnosis was confirmed as allergic reaction to Menactra vaccine vs viral syndrome. Pt was treated with Tylenol and Benadryl while hospitalized. Throat and urine cultures were neg(-). Chest x-ray was neg. Pt to FU with PCP within 1 week. Records submitted for scanning. Paper report filed/sem
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Chills, Disturbance in attention, Fatigue, Headache
Clinical narrative: FEVER, CHILLS, SEVERE HEADACHE, JOINT AND MUSCULAR ACHES, FATIGUE (FEVER, CHILLS, HEADACHES SUBSIDED AFTER 2-3 DAYS OF BED REST-NOT ABLE TO DO MUCH ELSE; FATIGUE LASTED APPROXIMATELY 1-2 WEEKS; JOINT AND MUSCULAR ACHES STILL PRESENT. KNEES AND LEGS SOMETIMES SWELL-UP FOR NO REASON. MRI'S ON BOTH KNEES REVEALED NO MAJOR DAMAGE THAT WOULD CAUSE SWELLING. I ALSO NOW EXPERIENCE MAJOR MEMORY AND CONCENTRATION PROBLEMS.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Memory impairment, Myalgia, Oedema peripheral, Pyrexia
Clinical narrative: FEVER, CHILLS, SEVERE HEADACHE, JOINT AND MUSCULAR ACHES, FATIGUE (FEVER, CHILLS, HEADACHES SUBSIDED AFTER 2-3 DAYS OF BED REST-NOT ABLE TO DO MUCH ELSE; FATIGUE LASTED APPROXIMATELY 1-2 WEEKS; JOINT AND MUSCULAR ACHES STILL PRESENT. KNEES AND LEGS SOMETIMES SWELL-UP FOR NO REASON. MRI'S ON BOTH KNEES REVEALED NO MAJOR DAMAGE THAT WOULD CAUSE SWELLING. I ALSO NOW EXPERIENCE MAJOR MEMORY AND CONCENTRATION PROBLEMS.
Age: 43.0
Sex: F
Vaccine: HEPA, IPV, MNQ, TYP
Symptoms: Back pain, Feeling hot, Headache, Hypokinesia, Injection site erythema
Clinical narrative: Day 1 small reddened area. Pain at site. Throughout night c/o HA, back and neck pain. Day 2 increase swelling of upper arm, redness, pain and discomfort. Day 3 increase swelling, hot at site, decreased range of motion.
Age: 43.0
Sex: F
Vaccine: HEPA, IPV, MNQ, TYP
Symptoms: Injection site oedema, Injection site pain, Neck pain
Clinical narrative: Day 1 small reddened area. Pain at site. Throughout night c/o HA, back and neck pain. Day 2 increase swelling of upper arm, redness, pain and discomfort. Day 3 increase swelling, hot at site, decreased range of motion.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt had varicella vaccine on 7/30/04. She presents to office today with mild case of chickenpox.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Back pain, Chest discomfort, Dizziness, Neck pain, Pain
Clinical narrative: Patient complaining of body aches, fever, 1000mg of Tylenol given to control fever.  Everyday after vaccination had 102 degree temperature, neck and back aches and dizziness.  Had tightness when breathing, no runny nose.  On 4th day (Thurs) had temperature of 103.9 and seen by doctor who ruled out an ear infection and concluded vaccine was culprit.  Patient was fine by Sunday.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Pyrexia, Throat tightness
Clinical narrative: Patient complaining of body aches, fever, 1000mg of Tylenol given to control fever.  Everyday after vaccination had 102 degree temperature, neck and back aches and dizziness.  Had tightness when breathing, no runny nose.  On 4th day (Thurs) had temperature of 103.9 and seen by doctor who ruled out an ear infection and concluded vaccine was culprit.  Patient was fine by Sunday.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash, Somnolence
Clinical narrative: Child received immunizations on 06/20/2005 at 1:00pm.  When awakened at 7AM, 06/21/2005, rash noted on trunk - close together, pimple-like.  Temperature 100 - given infant Tylenol.   Rash spread to face throughout day and slightly on extremities.  06/21/2005 - 06/22/2005 - Child more sleepy, no interruption in appetite.  Seen by Dr on 06/23/2005 - Rash nearly resolved.  Doctor felt rash may be from MMR injection or any other allergies.  Doctor did feel child should receive 2nd dose of MMR when appropriate.
Age: 4.0
Sex: F
Vaccine: IPV, PNC, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Father describes generalized rash resemble erythema matiforma lesion all over body itchy - treated with Benadryl and baking soda bath.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hive 24 hrs after immunization. fever T102.
Age: 0.38
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Urticaria
Clinical narrative: <10 hives 48 hrs after immunization
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: 2.6cm x 16.2cm erythema and warmth over left thigh.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a health professional to a sales rep and described the occurrence of an injection site reaction in a 5 yr old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On an unspecified date, the pt received the fifth dose of Infanrix in the left arm (lot DTPA630B2). At an unspecified time following the admin of Infanrix, the pt experienced an injection site reaction. The pt weas seen at the physician's office. The outcome of the event is unk. The health professional considered the event to probably be related to vaccination with Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Injection site nodule, Injection site rash, Injection site reaction
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of an injection site reaction in a child who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The physician reported that several pt's experienced an injection site reaction following the admin of Infanrix, however, pt identifiers were not provided. On an unspecified date, the pt received a dose of Infanrix (dose number not specified). At an unspecified time following the admin of Infanrix, the pt experienced an injection site characterized by a rash and golf ball size knots. The outcome of the events is unk.
Age: 1.26
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 15 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). Concurrent medical history included bullous myringitis. Concurrent medications included Amoxicillin. On 10May04, the pt received the fourth dose of Infanrix (lot DTPA630B2). Approx one day following the admin of Infanrix, on 11May04, the pt experienced a localized injection site reaction characterized by swelling, redness, and induration covering a 10cm area of the thigh. The pt was seen at a physician's office. On 15May04, the events resolved. The nurse considered the injection site reaction to 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 an injection site reaction in a 4 yr old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). At the time of the administration of Infanrix, in May 2004, the pt had bronchitis and was receiving azithromycin (Zithromax). On 20May04, the pt received the fifth dose of Infanrix (lot DTPA612A9) in the left thigh. On the same day, the pt also received injections of measles, mumps and rubella virus vaccine (MMR II) and poliomyelitis virus vaccine (Ipol). One day following the admin of Infanrix, on 21May04, the pt experienced an injection site reaction characterized as a red, raised and hot to touch area from the groin to above the knee around the site of injection for Infanrix and a fever of 100.5 F. The pt was seen at a physician's office and was treated with ice and ibuprofen. The events resolved on 22May2004. The nurse considered the events to probably be related to vaccination with Infanrix.
Age: 35.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Medication error
Clinical narrative: This case was reported by a medical assistant and described the occurrence of an injection site reaction in a 34 year old female pt who inadvertently received an expired dose of Infanrix. On 5/17/04, the pt received the 1st dose of Infanrix in the left arm (lot DTPA57342-incorrect lot number). The expiration date for this lot of Infanrix is 4/4/04. Infanrix is not recommended for immunizing individuals 7 years of age or older. On 5/17/04, the pt also received a dose of hepatitis B vaccine. The site of the administration of hepatitis B vaccine was not specified. Approximately 3 days after the administration of Infanrix and hepatitis B vaccine, the pt experienced an injection site reaction characterized as redness "3 cm" in diameter. The injection site resolved on 5/22/04. The medical assistant considered the injection site reaction to be related to vaccination with Infanrix and hepatitis B vaccine.
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Medication error
Clinical narrative: This case was reported by a physician and described the occurrence of an injection site reaction in a male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine. On an unspecified date, the pt received a SC dose of this vaccine. The recommended route of administration for this vaccine is IM. At an unspecified time, post/vax, the pt experienced an injection site reaction. The pt was seen at a physician's office. The injection site reaction resolved on an unspecified date.
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: This case describes the occurrence of cellulitis in a female pt who received Infanrix for prophylaxis. On 5/24/04, the pt received the 1st dose of Infanrix. Later that same day, she developed cellulitis requiring treatment with unspecified antibiotics. The cellulitis resolved (outcome date not specified). The reporting nurse administered the vaccine. Comment: Cellulitis is considered medically serious.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of an injjection site reaction in a 4 year old female pt who received Infanrix. This case was received from the pt's parent; a physician or other health care professional has not verified this report. On 4/6/04, the pt received a dose of Infanrix in the right arm. At an unspecified time, post/vax, on 4/6/04, the pt experienced an injection site reaction characterized by swelling that extended to involve the entire shoulder area, warmth, redness and pruritus. The following day, on 4/7/04, the pt experienced injection site hives. The pt was seen at a physician's office and was treated with topical Benadryl. The events resolved on 4/16/04.
Age: 1.54
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a physician and described the occurrence of an injection site reaction in a 17 month old female pt who received Infanrix. On 5/10/04, the pt received a dose of Infanrix. The physician stated that the Infanrix was injected with a "5/8 inch needle". On the same date, the pt also received an injection of IPOL. One day following the administration of Infanrix, on 5/11/04, the pt experienced a "local skin reaction" at the injection site of Infanrix which was treated with acetaminophen and cool compresses. The immunization series with Infanrix was discontinued. The event resolved on an unspecified date. The physician considered the injection site reaction to possibly be related to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, 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 4 year old male pt who received Infanrix. On 6/10/04, the pt received the 1st dose of Infanrix, but dose number 5 in the DTP immunization series, in the left arm. On 6/10/04, the pt also received an injection of IPOL in the left arm. Approximately 1 day post immunization, on 6/11/04, the pt experienced an injection site reaction characterized as swelling, redness and warmth "in the arm". The pt was seen at a physician's office and was treated with ibuprofen (Motrin). The event "resolved in one week" on an unspecified date in 6/04. The nurse considered the events to be related to vaccination with Infanrix.