chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site swelling, Pharyngitis, Pyrexia, Rhinitis
Clinical narrative: Mom reported via phone patient had approx. quarter sized reddend raised area at site of injection.  Child had low grade fever and has continued to be playful.  Mom states child had appointment with pediatrician for cold sypmtoms and showed area to physician at that visit.
Age: 0.0
Sex: F
Vaccine: SMALL
Symptoms: Conjunctivitis, Infection transmission via personal contact
Clinical narrative: Pt. does take checks and dressing changes for vaccinees from whom VIG is obtained.  Vaccinated against smallpox as a child, but not recently.  Saw her PMD for a red left eye on 5/8/03 and was treated with erythromycin drops.  No improvement.  Seen by an ophthalmologist on 5/20/03.  Diagnosed as having purulent conjuctivitis and started on Vigomox drops.  Seen in follow-up 5/20/03.  Because eye was still draining and history of possible vaccinia exposure, Viroptic solution added to tx.
Age: 40.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Abdominal pain upper, Chills, Myalgia, Pyrexia
Clinical narrative: Fever, chills, sore muscles, severe stomach pains treated with antibiotics specifically designed for gall bladder.
Age: 52.0
Sex: F
Vaccine: SMALL
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Became ill with severe muscle aches, high fever, headache, N/V
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Skin ulcer
Clinical narrative: Noted localized vaccinia left arm with scabbing. Approximately 15 lesions.
Age: 66.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Erythema
Clinical narrative: This is a place-holder VAERS.  County will also submit one.   Pt. is a re-vaccinee.  CDC Clinical Team was contacted by State Health Dept. because scab had not fallen off by 5/15/03.  Scab well-formed with few mm surrounding erythema.  No pain, tenderness, or drainage.  On 5/21/03, pt. noted scab had fallen off spontaneously.  Examined subsequently by Health Department physician who found vaccination site was well-healed and saw no need for swab.
Age: 66.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Asthenia, Injection site reaction, Pain
Clinical narrative: This is a place-holder VAERS.  County will also submit one.   Pt. is a re-vaccinee.  CDC Clinical Team was contacted by State Health Dept. because scab had not fallen off by 5/15/03.  Scab well-formed with few mm surrounding erythema.  No pain, tenderness, or drainage.  On 5/21/03, pt. noted scab had fallen off spontaneously.  Examined subsequently by Health Department physician who found vaccination site was well-healed and saw no need for swab.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Dizziness, Insomnia, Visual disturbance
Clinical narrative: On 5/08/03, patient left work early, feeling dizzy and "seeing spots". Had trouble sleeping that same night. Began having chest pain at 3AM on 5/09/03 which persisted. "Feels like lungs are cramping". Called Health Department at 11AM. Directed to local ER.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Convulsion, Injection site warmth, Syncope
Clinical narrative: Patient became hot with injection.  Patient fainted and seizure (20 sec). BP 80/40 directly with seizure. Patient awoke aware of seizure. BP at discharge 98/62.  Patient states "She used to faint with shots".
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Dermatitis
Clinical narrative: HAND DERMATITIS
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: A pharmacist reported the occurrence of an injection site reaction in a 4 year old male who received Infanrix for prophylaxis. The subject had no known drug allergies. Concurrent conditions and medications were not specified. On 5/8/02, the subject received his fifth injection of Infanrix (9538A2) into the right deltoid. On the same day, the subject also received injections of IPOL, MMR II, both administered subcutaneously into the left upper arm. Two days later, the subject developed an injection site reaction at the Infanrix injection site characterized by soreness, induration and a 4cm by 5cm area of erythema. On an unspecified date, the injection site reaction resolved. This report is linked to report A0389698A, A0389700A, A0389701a and A0365783A due to the same reporter.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site warmth
Clinical narrative: A physician reported the occurrence of an injection site reaction in a 5-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent medical conditions and concurrent medications were not specified. On 07/31/2002 the pt received his 5th injection of Infanrix (lot DTPA526A9) into the left arm. On the same day he received an injection of measles, mumps and rubella virus vaccine (MMR II, Merck). One day later, on 08/01/2002 the pt developed an injection site reaction characterized by an 11-cm by 9.5-cm area of redness, warmth and hardness at the site of Infanrix administration. The reporter considered the injection site reaction to be probably related to Infanrix administration. Comment: This report has been linked to reports A0376897A and A0376899A due to same reporter.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Oedema peripheral
Clinical narrative: A health care professional the occurrence of limb swelling in a 3 year old female who was vaccinated with Infanrix for prophylaxis. The reporter submitted a report directly to VAERS. There were no pre-existing physician-diagnosed allergies, birth defects, or medical conditions. There was no illness at the time of vaccination. The subject experienced no adverse events following previous vaccinations. On 8/13/02, the subject received her fourth injection of Infanrix (5882). The Infanrix injection was administered with a 25 gauge 1 inch needle. Four hours post-vaccination, the "child awakened with swollen, hot to touch upper left arm." The left arm was swollen "from elbow to shoulder." The reporter stated that the events were possibly related to Infnarix administration. Information receivd from the reporter on 10/1/02 indicated that the events were serious (OMIC) for unspecified reasons and the outcoems of the events were unknown. This report is serious because the reporter stated that the events jeopardized the pt or required intervention. The reporter indicated hta tthe child received Infanrix 5882; however this is not a valid lot number.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, MMR, DTAP, HBHEPB, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 15 month old male who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history or concurrent conditions. He experienced no adverse events following previous immunizations. Concurrent medications were unspecified. On 8/28/02 at 9:30, the subject received his fourth injection of Infanrix (545B9). On the same date, he received injection sof Comvax and MMR II. At 16:30, the subject's left leg had a "very" red, swollen area which measured 8.5cm by 9cm and was warm to the touch and had a knot. The subject had a temperature of 99.5 deg F and was fussy. The subject was seen in the ER. The injection site reaction resolved on 9/4/02. The fever and fussiness resolved on an unspecified date. The reporter stated that the injection site reaction was related to Infanrix administration; the relation of the fever and fussiness to Infanrix administration was not specified.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, MMR, DTAP, HBHEPB, MMR
Symptoms: Irritability, Pyrexia
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 15 month old male who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history or concurrent conditions. He experienced no adverse events following previous immunizations. Concurrent medications were unspecified. On 8/28/02 at 9:30, the subject received his fourth injection of Infanrix (545B9). On the same date, he received injection sof Comvax and MMR II. At 16:30, the subject's left leg had a "very" red, swollen area which measured 8.5cm by 9cm and was warm to the touch and had a knot. The subject had a temperature of 99.5 deg F and was fussy. The subject was seen in the ER. The injection site reaction resolved on 9/4/02. The fever and fussiness resolved on an unspecified date. The reporter stated that the injection site reaction was related to Infanrix administration; the relation of the fever and fussiness to Infanrix administration was not specified.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, MMR, DTAP, HBHEPB, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site oedema, Irritability
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 15 month old male who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history or concurrent conditions. He experienced no adverse events following previous immunizations. Concurrent medications were unspecified. On 8/28/02 at 9:30, the subject received his fourth injection of Infanrix (545B9). On the same date, he received injection sof Comvax and MMR II. At 16:30, the subject's left leg had a "very" red, swollen area which measured 8.5cm by 9cm and was warm to the touch and had a knot. The subject had a temperature of 99.5 deg F and was fussy. The subject was seen in the ER. The injection site reaction resolved on 9/4/02. The fever and fussiness resolved on an unspecified date. The reporter stated that the injection site reaction was related to Infanrix administration; the relation of the fever and fussiness to Infanrix administration was not specified.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, MMR, DTAP, HBHEPB, MMR
Symptoms: Pyrexia
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 15 month old male who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history or concurrent conditions. He experienced no adverse events following previous immunizations. Concurrent medications were unspecified. On 8/28/02 at 9:30, the subject received his fourth injection of Infanrix (545B9). On the same date, he received injection sof Comvax and MMR II. At 16:30, the subject's left leg had a "very" red, swollen area which measured 8.5cm by 9cm and was warm to the touch and had a knot. The subject had a temperature of 99.5 deg F and was fussy. The subject was seen in the ER. The injection site reaction resolved on 9/4/02. The fever and fussiness resolved on an unspecified date. The reporter stated that the injection site reaction was related to Infanrix administration; the relation of the fever and fussiness to Infanrix administration was not specified.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site oedema, Oedema, Vasodilation procedure
Clinical narrative: A medical assistant reported the occurrence of right thigh and knee swelling in a 4 year old female who recieved Infanrix. The vaccinee's medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee had no adverse experiences following receipt of prior immunizations. On 4/23/02,the vaccinee received her fifth injection of Infanrix into the right leg. On that date, she also received injections of IPOL, hep A and MMR II. That evening, the vaccinee experienced swelling of her right thigh and knee. The vaccinee was taken to the emergency room, where she was administered steroids and released. The thigh and knee swelling resolved on 4/29/02. The reporter considered these events to be probably related to Infanrix administration.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Oedema peripheral
Clinical narrative: A medical assistant reported the occurrence of right thigh and knee swelling in a 4 year old female who recieved Infanrix. The vaccinee's medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee had no adverse experiences following receipt of prior immunizations. On 4/23/02,the vaccinee received her fifth injection of Infanrix into the right leg. On that date, she also received injections of IPOL, hep A and MMR II. That evening, the vaccinee experienced swelling of her right thigh and knee. The vaccinee was taken to the emergency room, where she was administered steroids and released. The thigh and knee swelling resolved on 4/29/02. The reporter considered these events to be probably related to Infanrix administration.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A physician reported the occurrence of injection site cellulitis in a 4 year old male who received Infanrix. The vaccinee's medical history, concurrent conditions, and concurrent medications were not specified. On 4/23/02, the vaccinee received his fifth injection of Infanrix (531A2). On that date, he also received injections of IPOL, MMR II, and hep A vaccine. On 4/25/02, his entire right thigh swelled. It was red, very painful, and hot to the touch. The subject was seen by the physician, who made a diagnosis of injection site cellulitis and prescribed unspecified antibiotics. As of 4/29/02, the pt was "fine."
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site reaction, Oedema peripheral
Clinical narrative: A physician reported the occurrence of injection site cellulitis in a 4 year old male who received Infanrix. The vaccinee's medical history, concurrent conditions, and concurrent medications were not specified. On 4/23/02, the vaccinee received his fifth injection of Infanrix (531A2). On that date, he also received injections of IPOL, MMR II, and hep A vaccine. On 4/25/02, his entire right thigh swelled. It was red, very painful, and hot to the touch. The subject was seen by the physician, who made a diagnosis of injection site cellulitis and prescribed unspecified antibiotics. As of 4/29/02, the pt was "fine."
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Pain
Clinical narrative: A physician reported the occurrence of injection site cellulitis in a 4 year old male who received Infanrix. The vaccinee's medical history, concurrent conditions, and concurrent medications were not specified. On 4/23/02, the vaccinee received his fifth injection of Infanrix (531A2). On that date, he also received injections of IPOL, MMR II, and hep A vaccine. On 4/25/02, his entire right thigh swelled. It was red, very painful, and hot to the touch. The subject was seen by the physician, who made a diagnosis of injection site cellulitis and prescribed unspecified antibiotics. As of 4/29/02, the pt was "fine."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Arthralgia, Injection site hypersensitivity, Pruritus, Somnolence
Clinical narrative: A physician reported the occurence of an injection site reaction in a 4-year-old male who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The medical history included allergies codeine and ceftibuten (Cedax).  The subject had no reported adverse experiences following receipt of prior immunizations.  There were no concurrent medications.  On 05/13/2002, the subject received an injection of Infanrix.  On that date, he also received an injection of inactivated poliomyelitis virus vaccine (IPOL).  One day later, on 05/14/2002, the subject developed an injection site reaction characterized by "a red, itchy, swollen right thigh.  The swelling was from the top of the knee to the top of his right thigh."  In addition, it was reported that he experience pain in the right knee and increased sleep.  Treatment was not provided.  The reporting physician considered the events possibly related to Infanrix.  The most recent information, received on 09/09/2002, indicated that the events had resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: A physician reported the occurence of an injection site reaction in a 4-year-old male who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The medical history included allergies codeine and ceftibuten (Cedax).  The subject had no reported adverse experiences following receipt of prior immunizations.  There were no concurrent medications.  On 05/13/2002, the subject received an injection of Infanrix.  On that date, he also received an injection of inactivated poliomyelitis virus vaccine (IPOL).  One day later, on 05/14/2002, the subject developed an injection site reaction characterized by "a red, itchy, swollen right thigh.  The swelling was from the top of the knee to the top of his right thigh."  In addition, it was reported that he experience pain in the right knee and increased sleep.  Treatment was not provided.  The reporting physician considered the events possibly related to Infanrix.  The most recent information, received on 09/09/2002, indicated that the events had resolved.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Injection site mass, Oedema, Pain
Clinical narrative: A medical assistant reported the occurrence of injection site cellulitis in a 5-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The vaccine provider submitted this report directly to the Centers for Disease Control and Prevention (CDC). The pt's medical history, concurrent conditions and concurrent medications were not reported. The pt experienced no adverse events following previous immunizations. On 03/19/2003 the pt received her 5th injection of Infanrix (lot DTPA541E9). On the same date, she received injections of inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur), and measles, mumps and rubella vaccine (MMR II, Merck). Later that evening, she developed injection site edema and was seen by the physician. A diagnosis of injection site cellulitis was made. The reporting medical assistant considered the injection site cellulitis to be related to Infanrix administration. As of 04/01/2003, the outcome of the event was unknown. Comment: This is one of two subjects who experienced injection site cellulitis after receiving Infanrix lot DTPA541E9. For the report of the other subject, please see report A0401928A.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site oedema
Clinical narrative: A medical assistant reported the occurrence of injection site cellulitis in a 5-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The vaccine provider submitted this report directly to the Centers for Disease Control and Prevention (CDC). The pt's medical history, concurrent conditions and concurrent medications were not reported. The pt experienced no adverse events following previous immunizations. On 03/19/2003 the pt received her 5th injection of Infanrix (lot DTPA541E9). On the same date, she received injections of inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur), and measles, mumps and rubella vaccine (MMR II, Merck). Later that evening, she developed injection site edema and was seen by the physician. A diagnosis of injection site cellulitis was made. The reporting medical assistant considered the injection site cellulitis to be related to Infanrix administration. As of 04/01/2003, the outcome of the event was unknown. Comment: This is one of two subjects who experienced injection site cellulitis after receiving Infanrix lot DTPA541E9. For the report of the other subject, please see report A0401928A.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Erythema multiforme, Urticaria
Clinical narrative: Severe hives about 10 days after vaccines with no other etiology. Eventual need of steroids/antihistamines.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Severe hives about 10 days after vaccines with no other etiology. Eventual need of steroids/antihistamines.
Sex: M
Vaccine: HIBV, MMR
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a male child who, for the first two years of his life, was vaccinated with injections containing the "dangerous and highly toxic" mercury based preservative thimerosal. The alleged result of these vaccinations is that the pt now suffers from, and allegedly in the future will continue to suffer from, the toxic neurological effects of mercury poisoning. Immunization records were received and reported that the pt was vaccinated with his second and third doses of hep B vaccine recombinant (620760/1281D) given in the right thigh on 2/18/96 and 9/21/97 and his first dose of MMR II (621083/0901E) given in the left thigh on 2/13/98; a first dose of hep B vaccine (Engerix B) (2140A2) given in the right thigh on 12/2/96, oral poliovirus vaccine (Orimune) (0750M given 12/2/96, 07552 given on 2/18/97 and 4/21/97), Hib conjugate vaccine (ActHib) (6K81379 given in the left thigh on 4/21/97 and 0918980 given in the right thigh on 2/13/98), ActHib/DTP and alum (0795480 given in the left thigh on 12/2/96; 0804280 given in the left thigh on 2/18/96, Tripedia 6B81390 given in the left thigh on 4/21/97. Upon internal review toxic neurological effect and mercury poisoning were determined to be other important medical events (OMIC). No further info is available. Follow up on 5/22/03: New version to update the medical assessment. Case is closed.
Sex: F
Vaccine: HEP, HIBV, IPV, PNC
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: From faxed correspondence received on 7/22/02, it was reported: This case is in follow up to report(s) previously submitted on 7/21/02. Information has been received regarding a case in litigation concerning a female child who was vaccinated with a second and third dose of hepatitis B vaccine recombinant on 10/25/99, and 4/19/00. Concomitant therapy included a dose of varicella virus vaccine live on 2/9/00, MMR vaccine live (second generation on 2/9/00), a dose of Streptococcus pneumonia vaccine on 4/19/00; a first, second, third and fourth dose of hemophilus B conjugate vaccine on 4/7/99, 5/21/99, 7/15/99, and 4/19/00; a first dose of hepatitis B vaccine on 7/15/99; a first, second, and third diphtheria toxoid/pertussis vaccine/teta on 4/7/99, 5/21/99 and 7/15/99; a first and second dose of poliovirus vaccine on 4/7/99 and 5/21/99. The alleged result of these vaccinations is that the patient suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. This is an amended report. The fill numbers have been added for hepatitis B vaccine recombinant. Upon internal review, mercury poisoning and neurological disorders were considered to be other important medical events (OMIC). No further information is available. This report is corrected as amended. Follow up on 5/22/03: New version to update the medical assessment. Case is closed.
Sex: M
Vaccine: HIBV, MMR
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: From faxed correspondence received on 7/22/02, it was reported: This is in follow up to report(s) previously submitted on 7/12/02. Information has been received from a legal firm regarding a case in litigaiton concerning a male child who was vaccinated with a first, second, and third dose of hepatitis B vaccine recombinant in the left thigh on 1/17/94 (lot # 1069W reported, invalid for the product), in the right thigh 3/11/94 and 7/13/94 (route of administration not specified (lot #'s 610581/1692W and 610862/0594A respectively). Concomitant therapy included MMR (second generation) in the left thigh (route of administration not specified) on 4/12/95 (lot # 612418/1128A); HIB conjugate vaccine (ACT-HIB) in the right thigh on 4/12/95 (lot # M010M) (route administration not specified); a first, second, third and fourth dose of diphtheria toxoid (+) hemophilus B conjugate vaccine (+) pertussis vaccine (+) tetanus toxoid in the left thigh on 3/11/94 (route of administration not specified), 5/12/94 (IM), 7/13/94 and 7/7/95 (route of administration not specified); a first, second and third dose of oral poliovirus vaccine on 3/11/94, 5/12/94 and 7/13/94 (lot #'s 0684H, 0203C and 0700H); a dose of purified protein derivative on 11/3/94. The alleged result of these vaccinations is that the patient suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. This is an amended report. The fill numbers have been added for hepatitis B vaccine recombinant and MMR (second generation). Upon internal review, toxic neurological effects and mercury poisoning were considered to be other important medical events (OMIC). No further information is available. This report is corrected as amended. Follow up on 5/22/03: New version to update the medical assessment. Case is closed.
Sex: F
Vaccine: HEP
Symptoms: Dehydration, Dyspnoea, Hypernatraemia, Hyperventilation, Hypothermia
Clinical narrative: Irritability developed about 2 hrs post vaccine given. Infant subsequently developed fever of 102 degrees rectal. This all resolved within 24 hrs. Blood and CSF cultures were negative. The medical record states after the hep B vaccine was given, htey documented respiratory distress, hyperthermia and later hypothermia, jaundice, tachypnea, dehydration, hypernatremia and suspected sepsis. All problems were treated and resolved by discharge.
Sex: F
Vaccine: HEP
Symptoms: Irritability, Jaundice, Pyrexia
Clinical narrative: Irritability developed about 2 hrs post vaccine given. Infant subsequently developed fever of 102 degrees rectal. This all resolved within 24 hrs. Blood and CSF cultures were negative. The medical record states after the hep B vaccine was given, htey documented respiratory distress, hyperthermia and later hypothermia, jaundice, tachypnea, dehydration, hypernatremia and suspected sepsis. All problems were treated and resolved by discharge.
Age: 30.0
Sex: M
Vaccine: TD
Symptoms: Chills, Feeling hot, Injection site swelling, Pain, Pyrexia
Clinical narrative: DT vaccine administered 05/01/03 in left deltoid. Pt complained of allergic reaction 05/04/03 with fever, body aches and chills. Left arm swollen with heat in it. Tx with Prednisone 40 mg PO x1, Benadryl 50 mg PO x1 and MD appt in AM.
Age: 35.0
Sex: M
Vaccine: TD
Symptoms: Chills, Pain, Pruritus, Pyrexia, Tenderness
Clinical narrative: DT vaccine administered 05/01/03 to left deltoid. On 05/04/03 pt complained of itching, tenderness to left arm, chills, fever and body aches. Tx with Prednisone 40 mg PO x1, Benadryl 50 mg PO x1 and MD appt next AM.
Age: 1.9
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Pt had major localized reaction to immunizations in left arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema, Pyrexia
Clinical narrative: Right arm swollen, fever - not taken (11:00 AM 3/27/03).
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pain in extremity, Petechiae, Pyrexia
Clinical narrative: 10 day s/p vaccine...hurting on the "insides", morning foot pains, palatal petichial, low grade fever.
Age: 1.7
Sex: M
Vaccine: DTAPH
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 863 cm erythema and induration. Keflex.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Hypotension, Hypoxia
Clinical narrative: This is an ex-24 week gestation extremely low birth weight male, on ventilator support for subglottic stenosis. One hour after vaccines and Tylenol he became hypoxic requiring very high pressures then nitric oxide inhalation. Ten hours later he became hypotensive. Sixty hours later he was almost back to baseline.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Dyspnoea, Pallor, Vision blurred
Clinical narrative: Immediately after receiving the MMR in her leg, pt became pale, weak and complained of her eyes being blurry. She said she was having trouble breathing. I gave her some water and sat with her in the waiting room until she felt better. MD's office was very busy.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Tenderness
Clinical narrative: After MMR given slightly red at site, no other problems until 5/14/03 7:00 AM arm at site became red, warm and tender to touch. No fever, no seizures, no N/V.
Age: 0.7
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site induration, Irritability, Pyrexia
Clinical narrative: Fussy, feverish, right leg hard and red.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site oedema, Pyrexia
Clinical narrative: Fever up to 103.4 starting a few hours after shots and redness, heat, induration and swelling in left arm. Mom applied ice packs and gave Tylenol. Next day no fever. One week later arm back to normal. Mom feels local reaction was severe. Swelling was around arm "like an arm band" and very hard.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Local swelling and redness. Ice, Benadryl, Tylenol.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site warmth
Clinical narrative: Local inflammatino - erythema, induration, heat, no pain. Left deltoid injection approx 4.5 cm x 14 cm lateral upper left arm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: Patient's mother states that pt's right thigh is warm to the touch, hard and redness is present. Also a blue area the size of a softball surrounds injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Pt had local reaction to DTaP right deltoid. Red, swollen, and hot to touch.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Pt had local reaction to DTaP left deltoid - swollen, red and hot to touch.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Pt had local reaction to DTaP and Hib thighs bilat swollen, red and hot to touch.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Tenderness
Clinical narrative: Pt had local reaction to DTaP right deltoid - red, hot to touch, swollen 3.5" x 4" - now tender.
Age: 1.2
Sex: F
Vaccine: PNC
Symptoms: Erythema, Pyrexia, Rash erythematous
Clinical narrative: Received 3rd dose of Prevnar on 5/16/03. Mother called on 5/23/03 to report child had mild red rash starting 5/18/03. Rash became worse on 5/21/03. Red blotchy slightly raised rash on trunk, arms and legs. Mother took child to MD on 5/21/03 and MD thought rash due to Prevnar. Child had slight fever 100 degrees on 5/20/03.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Pruritus
Clinical narrative: Swelling, redness and induration with itching over right deltoid adjacent to site of injection.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Feeling hot, Injection site erythema, Pain
Clinical narrative: Right deltoid area red, warm and painful to touch. Mother gave Tylenol, applied cool compresses. Area of redness measured 5 x 9 cm wide. Parent was to schedule follow up appointment if condition not improving. Pt doing well 5/21/03; no redness, soreness of arm.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Right deltoid area red, warm and painful to touch.  Mother gave Tylenol, applied cool compresses.  Area of redness measured 8 x 11 cm wide.  Parent would schedule follow up appointment  (if condition not improving) to be scheduled.  Patient doing well, no redness or soreness of arm 05/21/2003.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Local swelling, erythema, pain in left deltoid
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Facial palsy
Clinical narrative: Patient received vaccine Hep A on 05/06/2003 in late morning.  Patient went to school and in afternoon developed right side facial pain and weakness.  Diagnosis as Ball's Palsy.  (Patient had similar symptoms twice and recovered, not associated with vaccines).  In past 5 days much better.
Age: 4.3
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site swelling
Clinical narrative: Patient's mom complained to dr. stating that patient received 2 shots on left arm and developed a big welt after that then went away.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: 6cm diameter area of warm, red, slightly swollen area over left upper arm.  No induration or s/s cellulitis.  Sx care.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Screaming
Clinical narrative: Unconsolable crying for 5 hours.  No fever or swelling on either leg.  Acting better on 05/15 @ 09:40 am.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, TYP, VARCEL
Symptoms: Injection site induration
Clinical narrative: Left upper arm 10 x 12 cm induration
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Eye swelling, Injection site hypersensitivity, Respiratory disorder, Urticaria, Wheezing
Clinical narrative: Went home within 10 min complained of itching, hives started on ears, back of neck, down back abdominal.  Mom gave patient 1/2 tsp Benadryl then called clinic.  Told to come over.  Mom put patient in car, seemed to have problem breathing.  Mom called Ambulance.  Eyes were swollen, ambulance evaluated patient was wheezing.  Pulse oximeter reading 98%.  Mom drove patient to medic followed to clinic at mom's request.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Pyrexia
Clinical narrative: Temperature 102.7, starting few hours after DTAP.  Irritable without able to be consoled xx 2 hrs.  Then intermittently irritable, still with fever to 102 after 48 hrs after vaccines.  Some loose stools started.  Consolable, active.
Age: 1.2
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Body temperature increased, Skin ulcer
Clinical narrative: Developed chicken pox lesions starting 04/16/2003.  Had only a few, possible slight fever.  Lesions were scabbed over and healing by 04/21/2003.  Light case.
Age: 1.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever 101-102 right after in 6 hours of immunizations.  Lasted for 24 hours.
Age: 1.11
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema
Clinical narrative: 05/01/2003: Telephone call from mother of patient- states patients right arm, red, warm and swollen to elbow.  Seen by PMD on 05/01/2003 and patient started on augmentin/amoxicillin.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Prevnar injection given 05/16/2003, left thigh mom noted redness and swelling next day.  Improving.
Age: 58.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Right deltoid became swollen (3 in) reddened 24 hours after injection.  Patient did not report it until 05/16/2003.
Age: 2.6
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Urticaria
Clinical narrative: Patient right deltoid became red and swollen day after shot.  Patient then developed hives which lasted a week.
Age: 20.0
Sex: M
Vaccine: TTOX
Symptoms: Psychomotor hyperactivity
Clinical narrative: About 5 min after receiving a tetanus injection, donor slipped from chair to the floor.  Was moving arms, donor recovered in about 2 minutes.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain
Clinical narrative: Complained of right arm soreness, redness and inflammation noted to site, ibuprofen PRN, heat x 2 days.
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Feeling hot, Injection site erythema, Pruritus
Clinical narrative: Received rabies immunoglobin with in 2 hours, front of forearm had red circle with white inside of that it was warm to touch.  Also the two places on thighs were shots given were red and warm.  All 3 places were itching.  1 shot Benadryl given.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Influenza like illness, Injection site induration, Injection site pain
Clinical narrative: Pain, redness, induration at injection site; onset within 24 hours of injection, treated with antibiotic by another physician.  Feverishness.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: MMR #1 and Varivax #1 received on 05/06/2003. Fever and rash developed 05/14-05/15/03. Eval. in office 05/15/2003. Rash is papular discrete, non confluent, , blanchable. Rash on trunk, face, groin, not on hands/feet.
Age: 12.0
Sex: M
Vaccine: HEP, TD
Symptoms: Urticaria
Clinical narrative: Vaccines given 05/12/2003. Patient developed systemic hives (over whole body) on 05/13/2003. He was on Augmentin as well.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Pyrexia, Rash maculo-papular
Clinical narrative: Fever apprx. 12 hours after injection to 105. Pain 8 hours after injection. Erythema, warmth 24-48 hours after injection. Fever persisted. 8 x 10 cm induration.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pyrexia, Urticaria
Clinical narrative: Multiple hives, increase fever >104 degrees, irritable, no resp. difficult, good PO intake.
Age: 31.0
Sex: F
Vaccine: SMALL
Symptoms: Back pain, Headache, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: 05/14/2003 fever, headache. 05/15/2003 back ache, sore throat> self medicated with Motrin 800mg PO apprx 96 hours w/o relief. Was seen in ED on 05/16/2003. Discharges "back pain". Rx for Motrin and Vicodin given.
Age: 31.0
Sex: M
Vaccine: TTOX
Symptoms: Headache, Nausea
Clinical narrative: Shot was given on 05/20/2003. On 05/26/2003, donor c/o being sick at stomache and H/A. Initially claimed s/sx were b/c of tetanus shot, present today stating he had virus and wants to donate.
Sex: F
Vaccine: TD
Symptoms: Myalgia, Oedema
Clinical narrative: Muscular (deltoid) pain and swelling beginning 5 days after injection and persisting until at least day 12.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ecchymosis, Petechiae, Platelet disorder
Clinical narrative: Pt seen in ER on 04/21/2003 for ecchymoses and petechai. Platelet count was 5,000. Diagnosed with ITP. Treated with WinRho and sent home. Repeated platelet 236,000 on 04/25/2003 in follow up in clinic.
Age: 1.6
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Phone call to MD reporting hives all over at 09:07pm 05/16/2003. No fever no respiratory distress, alert and active. Told to administer Benadryl.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Contusion, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site oedema
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 5 year old female who received Infanrix for prophylaxis. The subject's medical history included history a possible allergy to an unspecified vaccine. Initially, the reporting nurse stated that this subject "always" reacted to vaccinations. However, on follow-up, the nurse stated the subject had experienced no adverse events following previous immunizations. No concurrent conditions or concurrent medications were reported. In March 2002, the subject received her fifth injection of Infanrix 9531A2); the nurse was unsure into which arm the Infanrix had been injected. On that date, the subject also received inactivated poliomyelitis virus vaccine (IPOL) injected into the left arm.Twenty-four hours post-immunization, she developed swelling at the Infanrix injection site, measuring four inches by four inches. Two weeks post-immunization, she experienced itching and bruising at the injection site. Additionally, the subject experienced injection site pain, erythema, and induration. The subject was seen by a physician; no treatment was given. The events resolved. The nurse considered the injection site reaction to be related to Infanrix administration.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site pain, Injection site reaction, Pruritus
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 5 year old female who received Infanrix for prophylaxis. The subject's medical history included history a possible allergy to an unspecified vaccine. Initially, the reporting nurse stated that this subject "always" reacted to vaccinations. However, on follow-up, the nurse stated the subject had experienced no adverse events following previous immunizations. No concurrent conditions or concurrent medications were reported. In March 2002, the subject received her fifth injection of Infanrix 9531A2); the nurse was unsure into which arm the Infanrix had been injected. On that date, the subject also received inactivated poliomyelitis virus vaccine (IPOL) injected into the left arm.Twenty-four hours post-immunization, she developed swelling at the Infanrix injection site, measuring four inches by four inches. Two weeks post-immunization, she experienced itching and bruising at the injection site. Additionally, the subject experienced injection site pain, erythema, and induration. The subject was seen by a physician; no treatment was given. The events resolved. The nurse considered the injection site reaction to be related to Infanrix administration.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site oedema
Clinical narrative: A nurse reported the occurrence of "excessive" swelling at the injection site in a 2 year old vaccinee of unspecified gender who received Infanrix. The subject's medical history, concurrent condition, and concurrent medications were not specified. On an unspecified date, the vaccinee received the fourth injection of Infanrix (531A2). Subsequently, the vaccinee experienced "excessive" swelling at the injection site. As of 3/27/02, the outcome of the event was unknown.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site oedema
Clinical narrative: A nurse reported the occurrence of "excessive" injection site swelling in a 5 year old vaccinee of unspecified gender who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the vaccinee received the fifth injection of Infanrix (531A2). Subsequently, the subject developed "excessive" injection site swelling. The reporter stated that the event was probably related to Infanrix administration. As of 3/27/02, the outcome of the event was unknown.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site oedema
Clinical narrative: A nurse reported the occurrence of "excessive" swelling at the injection site in a 4 year old vaccinee of unspecified gender who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the vaccinee received the fifth injection of Infanrix (531A2). Subsequently, the vaccinee developed "excessive" injection site swelling. The reporter stated that this event was probably related to Infanrix administration. As of 3/27/02, the outcome of the event was unknown.
Sex: U
Vaccine: DTAP
Symptoms: Injection site oedema
Clinical narrative: A nurse reported the occurrence of "excessive" injection site swelling in a vaccinee of unspecified age and gender who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the vaccinee received an injection of Infanrix; it was not known if the vaccinee had received previous injections of Infanrix. Subsequently, the vaccinee developed "excessive" injection site swelling. The reporter stated that the event was probably related to Infanrix administration. As of 3/27/02, the outcome of the event was unknown.
Sex: U
Vaccine: DTAP
Symptoms: Contusion, Injection site oedema, Injection site rash, Injection site reaction, Urticaria
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a child of unspecified ate and gender who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not specified. In March 2002, the vaccinee received the fifth injection of Infanrix. Six days later, the vaccinee developed an injection site reaction characterized by a rash, swelling, and a welt. Additionally, the injection site became black and blue. The reporter stated that these events were probably related to Infanrix administration. As of 3/27/02, the outcomes of the events were unknown.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: A pharmacist reported the occurrence of an injection site reaction in a 16 month old female who recieved Infanrix for prophylaxis. The subject had no known drug allergies or adverse experiences following previous immunizations. Concurrent conditions and concurrent medications were not specified. On 10/18/01, the subject received her fourth injection of Infanrix. On the same day, the subject received the second injection of the MMR II and her fourth injection of the Hib-Titer. One day later, the subject developed injection site soreness and swelling in the left thigh. On an unspecified date, the events resolved. The reporter considered the events to be related to Infanrix administration. This report has been linked to A0389698A, A0389699A, A0389700A, and A0389701A due to same reporter.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema
Clinical narrative: Report A0365868A describes limb swelling in a 5 year old male who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not provided. The subject had no adverse experiences following receipt of prior immunizations. On an unspecified date, the subject received his fifth injection of Infanrix. Subsequently, on 4/13/02, he experienced "abnormal swelling of the arm." The event was reported to have resolved on an unspecified date and the reporting nurse considered the event to be related to Infanrix administration.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Decreased appetite, Hypokinesia, Oedema, Pyrexia
Clinical narrative: This report describes the occurrence of brachial plexus neuritis in a 4 month old male who received Infanrix. This report was received from the vaccinee's mother, who is a physical therapist. The vaccinee had no relevant medical history. Concurrent conditions and concurrent medications were not specified. Following previous vaccinations, the vaccinee experienced "just normal things, like swelling, slight fever, crying, lack of appetite (mild to moderate only)." On 3/26/02, the vaccinee received his second injection of Infanrix. On that date, he also received injections of inactivated poliomyelitis virus vaccine (IPOL), combination Haemophilus influenzae type B conjugate/hep B (Comvax), and Prevnar. Three hours post immunization, the vaccinee "was not using his left arm as much" and had a loss of appetite. The subject was seen by a physician, who reportedly made a diagnosis of brachial plexus neuritis. The mother reported that no treatment was given. The mother stated that the vaccinee had "80% of use (of left arm) within evening." The loss of appetite lasted "only for several days." The mother stated that the brachial plexus neuritis and loss of appetite had improved. The mother is a physical therapist and will be given her child therapy as soon as the physician approves. As of 4/16/02, the events were ongoing.