chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Rhinorrhoea, Skin ulcer, Viral infection
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a health professional concerning an 11 year old female who on 19FEB2003 at 13:00 was vaccinated SC in the deltoid with a first dose of varicella virus vaccine live. The patient's three siblings were vaccinated the same day. On approximately 30SEP2003 she had full blown chickenpox and was treated with acyclovir. It was reported that two of her siblings  (WAES#0311USA01047 and 0401USA005383) also developed chickenpox. The reporter expressed a concern with the lot. Unspecified medical attention was sought. There was no product quality complaint involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Follow-up information indicated that the patient was seen on 08-Jun-2003 and she developed a rash and fever on 07-Jun-2003 (previously reported as approximately 03-Sep-2003), some cough and minimal runny nose were noted. It was noted that all the patient's vaccinations were up to date and she had no immune disorders. Lesions were classic dew drop appearance and disseminiated throughtout her body with a few in her oral cavity and oral pharynx. No secondary infection was noted. Lesions were in various stages and were vesicular in nature, because of the severity of her rash and her age the patient was started on acyclovir 800 mg QID for 5 days. She was also given hydroxyzine hydrochloride (Atarax) 25mg q 6 hours for itching. Subsequently the patient recovered. The patient received additional vaccinations on 22-Jan-2003 at 13:37 which included a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live which was given SC in the thigh, a first dose of diphtheria toxoid (+) tetanus toxoid given IM in the thigh, a first dose of poliovirus vaccine inactivated (unspecified) which was given SC in the deltoid and a first dose of hepatitis virus vaccine (unsepcified) given IM in the thigh. No further information is expected.
Age: 46.0
Sex: M
Vaccine: ANTH, SMALL, UNK
Symptoms: Rash
Clinical narrative: Rash on the under side of left arm, groin area, upper legs and buttocks.
Age: 1.0
Sex: U
Vaccine: IPV, MMR, VARCEL
Symptoms: Decreased appetite, Pyrexia, Rash maculo-papular
Clinical narrative: Developed fever up to 102 on a 4th day after vaccination, On a 10thnday developed coalescent maculo papula rash starting on the faceand spreading to the rest of the body. No fever, child was active with decreased appetite. Seen in the office the next day after rash occured. Had normal exam except for the rash.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Anxiety, Eye swelling, Flushing, Lacrimation increased, Malaise
Clinical narrative: After shots, began sneezing and c/o not feeling well.  Said he hurt and spit up a few times.  Possible anxiety attack, but given his history of a heart condition, was sent to ER for evaluation and monitoring.  Face was red, eyes were puffy swollen and watering and nose was running.  Received Benadryl in ER and was better so discharged home.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pain, Rhinorrhoea, Sneezing, Vomiting
Clinical narrative: After shots, began sneezing and c/o not feeling well.  Said he hurt and spit up a few times.  Possible anxiety attack, but given his history of a heart condition, was sent to ER for evaluation and monitoring.  Face was red, eyes were puffy swollen and watering and nose was running.  Received Benadryl in ER and was better so discharged home.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash erythematous, Rash papular
Clinical narrative: Diffuse varicelliform (erythematous, papular) eruption, with irritability and fever, of onset seven days after Varivax & MMR were administered.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Severe varicelliform eruption, primarily on right leg, occurring approximately ten days after vaccinations given as below; Varivax was given in the right leg.
Age: 2.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Pneumonitis, Rash vesicular
Clinical narrative: Mild varicelliform rash and pneumonitis occurring a week after vaccine adminstration.
Age: 6.0
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Ophthalmoplegia
Clinical narrative: 3/22/04 Interpreter for mother called office.  Said child began experiencing some eyelid paralysis on L about 1 week ago (3/15/04).  Says it is steadily getting worse & now L side of face is visibly different from the R, especially noticeable when she smiles.  Child went to family friend (chiropractor) then to neurologist.  3/31/04. Dr. says to test for diabetes & do CT scan.  4/2/04 interpreter says face (recovering, not totally gone yet) is getting better on its own.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Angiopathy, Chest pain, Cough, Dyspnoea, Hypotension
Clinical narrative: Patient awoke with chest pain, dyspnea, and distended neck veins.  Admitted to hospital (see diagnostic test below).  Symptoms resolved without intervention.  Nurse follow up on 05/27/04 states: "Per review of hospital d/c summary, please add to Box 7: Low blood pressure (TACHYCARDIA), hypotension (HYPOTENS), effusion on echocardiogram (EFFUS PERICARD), dry cough (COUGH INC), and perimyocarditis (MYOCARDITIS - the term PERICARDITIS is already in Box 12). Please also change FLATUL to VASC DIS in Box 7 (for distended neck veins)."
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Laboratory test abnormal, Myopericarditis, Pericardial effusion, Pericarditis, Tachycardia
Clinical narrative: Patient awoke with chest pain, dyspnea, and distended neck veins.  Admitted to hospital (see diagnostic test below).  Symptoms resolved without intervention.  Nurse follow up on 05/27/04 states: "Per review of hospital d/c summary, please add to Box 7: Low blood pressure (TACHYCARDIA), hypotension (HYPOTENS), effusion on echocardiogram (EFFUS PERICARD), dry cough (COUGH INC), and perimyocarditis (MYOCARDITIS - the term PERICARDITIS is already in Box 12). Please also change FLATUL to VASC DIS in Box 7 (for distended neck veins)."
Age: 1.24
Sex: M
Vaccine: HEP
Symptoms: Erythema, Injection site abscess, Pyrexia
Clinical narrative: Redness to left thigh noted on patients visit to clinic on 5-20-2004.  Serosangenous drainage noted from upper left thigh.  Temp:100.6 F Referred to emergency room.
Age: 1.2
Sex: M
Vaccine: DTAP, DTP, FLUX, HEP, HIBV, IPV, MMR
Symptoms: Abnormal behaviour, Clumsiness, Diarrhoea, Ear pain, Gastrointestinal disorder
Clinical narrative: Fever immediately. Rash 6 days later. Speech delay, head banging, mobility clumsyness, stomach problems, loose stool, butt rash, vomiting, chronic colds, ear aches. All, but the head banging which is in the past 6 months have taken place after the shot. Follow up: selective hearing, phonating, walking okay.
Age: 1.2
Sex: M
Vaccine: DTAP, DTP, FLUX, HEP, HIBV, IPV, MMR
Symptoms: Pharyngitis, Pyrexia, Rash, Rhinitis, Vomiting
Clinical narrative: Fever immediately. Rash 6 days later. Speech delay, head banging, mobility clumsyness, stomach problems, loose stool, butt rash, vomiting, chronic colds, ear aches. All, but the head banging which is in the past 6 months have taken place after the shot. Follow up: selective hearing, phonating, walking okay.
Age: 1.3
Sex: F
Vaccine: DTAP, HBHEPB, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rhinorrhoea
Clinical narrative: My daughter developed a fever of 101.5 rectal on the day after the shots (5/13/04).  She had 1 loose stool this day also and then no abnormal stools thereafter.  On the 2nd day post vaccines she had a fever of 103.5 rectal (5/14/04).  On the 3rd day her temperature was 102 rectal (5/15/04).  The 4th day she was fever free.  She was taken to the doctor on 5/16/04.  A CBC was done and was normal as was she on exam by the doctor (5/15/04).  On 5/17/04 she developed a runny nose.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Tenderness
Clinical narrative: A nurse reported the occurrence of an injection site reaction in a 4 year old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed for prophylaxis. The subject's medical history included asthma and chronic constipation. The subject received no concurrent medications. On 19FEB2003, the subject received her fifth injection of Infanrix. On that date, she also received injections of inactivated poliomyelitis virus vaccine and measles, mumps and rubella virus vaccine. On 19 February 2003, the post-immunization, the subject developed an injection site reaction characterized by a 2.5 cm by 3 cm area of swelling, redness, and tenderness at the site of Infanrix administration. The subject was seen by the physician, who prescribed applications of ice to the site. The reporting nurse considered the injection site reaction to be related to Infanrix administration. The injection site reaction resolved after an unspecified period of time.
Age: 6.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Injection site mass, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a RN and described the occurrence of an injection site reaction in a 6 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 09April2003, the pt received Infanrix in the right thigh. ON 09April2003, the pt also received Poliomyelitis vaccine inactivated (IPOL), Haemophilus influenzae type B vaccine, and 7 valent pneumococcal conjugate vaccine (Prevnar). At an unspecified time after the immunizations, on 09Apr03, the pt experienced an injection site reaction characterized by swelling and pain. On 11Apr03, the pt also began to experience a fever which was treated with Tylenol for four days. Initially, it had been reported that the pt was hospitalized due to fever; however, on follow up, it was reported that the pt was not hospitalized. On 15May2003, approximately one month after immunization with Infanrix, the pt was seen at the physician's office. Examination of the injection site revealed a small, persistent non-tender nodule. Outcome of the fever was not reported. The nurse considered that the events were not serious and that they were probably related to vaccination with Infanrix.
Age: 6.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Injection site mass, Injection site pain, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a RN and described the occurrence of an injection site reaction in a 6 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 09April2003, the pt received Infanrix in the right thigh. ON 09April2003, the pt also received Poliomyelitis vaccine inactivated (IPOL), Haemophilus influenzae type B vaccine, and 7 valent pneumococcal conjugate vaccine (Prevnar). At an unspecified time after the immunizations, on 09Apr03, the pt experienced an injection site reaction characterized by swelling and pain. On 11Apr03, the pt also began to experience a fever which was treated with Tylenol for four days. Initially, it had been reported that the pt was hospitalized due to fever; however, on follow up, it was reported that the pt was not hospitalized. On 15May2003, approximately one month after immunization with Infanrix, the pt was seen at the physician's office. Examination of the injection site revealed a small, persistent non-tender nodule. Outcome of the fever was not reported. The nurse considered that the events were not serious and that they were probably related to vaccination with Infanrix.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a RN and described the occurrence of fever in a 2 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 08May03, the pt received the first dose of Infanrix. On 08May2003 the pt also received Poliomyelitis vaccine inactivated (IPOL), Haemophilus influenzae type b vaccine, and 7-valent pneumococcal conjugate vaccine. On 09May2003, the pt experienced an injection site reaction characterized by redness and swelling and pain at the site of the Infanrix administration. Also on 09May03 the pt was taken to an ER with a fever greater than 102 degrees Fahrenheit and vomiting. The pt was treated with Motrin. A sepsis work up was completed and sepsis was ruled out. The injection site events resolved outcome of the fever and vomiting was not reported. The reporting nurse did not consider the events to be serious.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Vomiting
Clinical narrative: This case was reported by a RN and described the occurrence of fever in a 2 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 08May03, the pt received the first dose of Infanrix. On 08May2003 the pt also received Poliomyelitis vaccine inactivated (IPOL), Haemophilus influenzae type b vaccine, and 7-valent pneumococcal conjugate vaccine. On 09May2003, the pt experienced an injection site reaction characterized by redness and swelling and pain at the site of the Infanrix administration. Also on 09May03 the pt was taken to an ER with a fever greater than 102 degrees Fahrenheit and vomiting. The pt was treated with Motrin. A sepsis work up was completed and sepsis was ruled out. The injection site events resolved outcome of the fever and vomiting was not reported. The reporting nurse did not consider the events to be serious.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a RN and described the occurrence of fever in a 2 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 08May03, the pt received the first dose of Infanrix. On 08May2003 the pt also received Poliomyelitis vaccine inactivated (IPOL), Haemophilus influenzae type b vaccine, and 7-valent pneumococcal conjugate vaccine. On 09May2003, the pt experienced an injection site reaction characterized by redness and swelling and pain at the site of the Infanrix administration. Also on 09May03 the pt was taken to an ER with a fever greater than 102 degrees Fahrenheit and vomiting. The pt was treated with Motrin. A sepsis work up was completed and sepsis was ruled out. The injection site events resolved outcome of the fever and vomiting was not reported. The reporting nurse did not consider the events to be serious.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Pyrexia, Rash
Clinical narrative: This case was reported by a physician and described the occurrence of a rash in a 19 month old female who received DTAP (Infanrix) for prophylaxis. On 07/22/03, the pt received the fourth dose of Infanrix (Lot # DTPA596A2).  On the same date, she also received an injection of combination Hib/Hep B vaccine (Comvax).  On 07/22/03, at an unspecified time post-immunization, the pt experienced a rash and fever of 102 degrees Fahrenheit. She was seen by the physician. The events resolved on 07/26/03.  This reporter considered the events were possibly related to vaccination with Infanrix.
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Rash, Rash maculo-papular
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a registered nurse at a health department concerning a 12 month old male pt, a triplet, brother with no pertinent medical history who on 30DEC2003 at 10:00 was vaccinated subcutaneously in the left leg with a first dose of varicella virus vaccine live (643527/0765M). Concomitant vaccine therapy included a fourth dose given intramuscularly in the right leg of Hib conj vaccine (tet toxoid) (ACTHIB) (batch UE133AAB), a fourth dose given intramuscularly in the left leg of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot #494383), and a first dose given subuctaneously in the right leg of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #645626/0396N). Concomitant therapy included carbionoxamine maleate (SILDEC-DM). The patient was noted to have a runny nose and dry skin at the time of vaccination. On 06-Jan-2004 the patient was also vaccinated intramuscularly in the left leg with a fourth dose of diphtheria toxoid (+) pertussis acellular 3+component vaccine (+) tetanus toxoid (Infanrix) (lot #DTPa589A2), a third dose given intramuscularly in the left leg of poliovirus vaccine inactivated (IPOL) (batch #WI582) and a second dose given intramuscularly in the right leg of influenza virus split virion 3v vaccine inactivated (Fluzone) (batch UU13AA). On 07JAN2004 at 08:00 the patient's mother called the physician's office noting that her son had developed a fine rash with 50 macular papular areas on both thighs. It was also described as a chicken pox like rash. There was no pruritis, vesicles, or pustules noted. The patient also developed nasal congestion. No diagnostic studies were performed. No treatment was required. The mother was advised to observe the patient and treat him as needed for a fever or pruitis, not to give him aspirin (ASA), and to consider making an MD appointment. On 09-Jan-2004 the patient was seen by a physician. The physician noted "something viral." It was noted that the patient had not yet recovered. There was no product quality complaint reported. Additional information is not expected. The reporter also mentioned that the patient's brothers also developed a chicken pox like rash with some nasal congestion folllowing vaccination with varicella virus vaccine live (WAES#0401USA00576) (WAES#0401USA00864).
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Nasal congestion, Rash vesicular, Viral infection
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a registered nurse at a health department concerning a 12 month old male pt, a triplet, brother with no pertinent medical history who on 30DEC2003 at 10:00 was vaccinated subcutaneously in the left leg with a first dose of varicella virus vaccine live (643527/0765M). Concomitant vaccine therapy included a fourth dose given intramuscularly in the right leg of Hib conj vaccine (tet toxoid) (ACTHIB) (batch UE133AAB), a fourth dose given intramuscularly in the left leg of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot #494383), and a first dose given subuctaneously in the right leg of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #645626/0396N). Concomitant therapy included carbionoxamine maleate (SILDEC-DM). The patient was noted to have a runny nose and dry skin at the time of vaccination. On 06-Jan-2004 the patient was also vaccinated intramuscularly in the left leg with a fourth dose of diphtheria toxoid (+) pertussis acellular 3+component vaccine (+) tetanus toxoid (Infanrix) (lot #DTPa589A2), a third dose given intramuscularly in the left leg of poliovirus vaccine inactivated (IPOL) (batch #WI582) and a second dose given intramuscularly in the right leg of influenza virus split virion 3v vaccine inactivated (Fluzone) (batch UU13AA). On 07JAN2004 at 08:00 the patient's mother called the physician's office noting that her son had developed a fine rash with 50 macular papular areas on both thighs. It was also described as a chicken pox like rash. There was no pruritis, vesicles, or pustules noted. The patient also developed nasal congestion. No diagnostic studies were performed. No treatment was required. The mother was advised to observe the patient and treat him as needed for a fever or pruitis, not to give him aspirin (ASA), and to consider making an MD appointment. On 09-Jan-2004 the patient was seen by a physician. The physician noted "something viral." It was noted that the patient had not yet recovered. There was no product quality complaint reported. Additional information is not expected. The reporter also mentioned that the patient's brothers also developed a chicken pox like rash with some nasal congestion folllowing vaccination with varicella virus vaccine live (WAES#0401USA00576) (WAES#0401USA00864).
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash macular, Rash pruritic
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a RN at a health dept. concerning a 12 month old male pt, a triplet brother, with no pertinent medical history who on 30Dec2003 was vaccinated subcutaneously in the left leg  with a first dose of varicella virus vaccine live (643527/0765M). Concomitant vaccine therapy included a fourth dose given intramuscularly in the right leg of Hib conj vaccine (tet toxoid) (ACTHIB) (batch #UE113AB), a fourth dose given intramuscularly in the left leg of pneumococcal 4 6B 9V 14 18C 19F 23P conj vaccine (CRM197) (Prevnar (lot #494383), and a first dose given subcutaneously in the right leg of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #645626/0396N). Concomitant therapy included carbinoxamine maleate (SILDEC-IM). The patient was noted to have a runny nose and dry skin at the time of vaccination. On 06-Jan-2004 the patient was also vaccinated intramuscularly in the left leg with a fourth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (Infanrix) (lot #DTPa589A2), a third dose given intramuscularly in the left leg of poliovirus vaccine inactivated (IPOL) (batch #W1582) and a second dose given intramuscularly in the right leg of influenza virus split virion by vaccine inactivated (Fluzone) (batch UU13AA). On 07Jan2004 at 08:00 the patient's mother called the physician's office noting that her son had a generalized rash with 20-30 macular areas on his back and abdomen. It was also described as a chicken pox-like rash. There were no pustules noted, only a fine rash. The patient also developed nasal congestion. No diagnostic studies were performed. No treatment ws required. The mother was advised to observe patient and treat him as needed for a fever or pruritis, not to give him aspirin (ASA), and to consider making an MD appointment. On 09-Jan-2004 the patient was seen by a physician. The physician noted "something viral." It was noted that the patient had not yet recovered. There was no product quality complaint reported. Additional information is not expected. The reporter also mention that the patient's brothers also developed a chicken pox like rash with some nasal congestion following vaccination with varicella virus vaccine live (WAES#0401USA00576) (WAES#0401USA00865).
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a RN at a health dept. concerning a 12 month old male pt, a triplet brother, with no pertinent medical history who on 30Dec2003 was vaccinated subcutaneously in the left leg  with a first dose of varicella virus vaccine live (643527/0765M). Concomitant vaccine therapy included a fourth dose given intramuscularly in the right leg of Hib conj vaccine (tet toxoid) (ACTHIB) (batch #UE113AB), a fourth dose given intramuscularly in the left leg of pneumococcal 4 6B 9V 14 18C 19F 23P conj vaccine (CRM197) (Prevnar (lot #494383), and a first dose given subcutaneously in the right leg of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #645626/0396N). Concomitant therapy included carbinoxamine maleate (SILDEC-IM). The patient was noted to have a runny nose and dry skin at the time of vaccination. On 06-Jan-2004 the patient was also vaccinated intramuscularly in the left leg with a fourth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (Infanrix) (lot #DTPa589A2), a third dose given intramuscularly in the left leg of poliovirus vaccine inactivated (IPOL) (batch #W1582) and a second dose given intramuscularly in the right leg of influenza virus split virion by vaccine inactivated (Fluzone) (batch UU13AA). On 07Jan2004 at 08:00 the patient's mother called the physician's office noting that her son had a generalized rash with 20-30 macular areas on his back and abdomen. It was also described as a chicken pox-like rash. There were no pustules noted, only a fine rash. The patient also developed nasal congestion. No diagnostic studies were performed. No treatment ws required. The mother was advised to observe patient and treat him as needed for a fever or pruritis, not to give him aspirin (ASA), and to consider making an MD appointment. On 09-Jan-2004 the patient was seen by a physician. The physician noted "something viral." It was noted that the patient had not yet recovered. There was no product quality complaint reported. Additional information is not expected. The reporter also mention that the patient's brothers also developed a chicken pox like rash with some nasal congestion following vaccination with varicella virus vaccine live (WAES#0401USA00576) (WAES#0401USA00865).
Age: 5.0
Sex: F
Vaccine: HIBV, MMR, OPV, VARCEL, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning an otherwise healthy 5 year old white female with allergies to cefzil and shrimp and unremarkable past medical history who is not immunocompromised who on 6/4/99, was vaccinated in the left deltoid with a dose of varicella virus vaccine live (lot # 630408/0293J). It was not known if there was an illness at the time of vaccination. Subsequently the patient developed zoster, which the physician described as V1 distribution on left, and a rash with pain and a low grade fever. The physician referred the patient to an ophthalmologist and is treating the symptoms with acetaminophen and acyclovir. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a physician indicated that on 1/5/04, the patient developed herpes zoster in V1 distribution on the left. It was also noted that post-vaccine zoster, the child never had wild type or vaccine related varicella. The outcome was reported as recovered on 1/20/04. No further information is expected.
Age: 5.0
Sex: F
Vaccine: HIBV, MMR, OPV, VARCEL, VARCEL
Symptoms: Herpes zoster, Pain, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning an otherwise healthy 5 year old white female with allergies to cefzil and shrimp and unremarkable past medical history who is not immunocompromised who on 6/4/99, was vaccinated in the left deltoid with a dose of varicella virus vaccine live (lot # 630408/0293J). It was not known if there was an illness at the time of vaccination. Subsequently the patient developed zoster, which the physician described as V1 distribution on left, and a rash with pain and a low grade fever. The physician referred the patient to an ophthalmologist and is treating the symptoms with acetaminophen and acyclovir. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a physician indicated that on 1/5/04, the patient developed herpes zoster in V1 distribution on the left. It was also noted that post-vaccine zoster, the child never had wild type or vaccine related varicella. The outcome was reported as recovered on 1/20/04. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Sarcoma, Swelling
Clinical narrative: Information has been received from a consumer concerning her mother who was vaccinated with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed a small swelling under her jaw and was diagnosed with sarcoma. Unspecified medical attention was sought. It was noted that the pt's experience was still being treated. No further information was provided. Upon internal medical review sarcoma was considered an other important medical event. (OMIC) No further information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Feeling hot
Clinical narrative: At left arm: Cellulitis-redness, hot to touch, started on Keflex. Admitted to Hospital 5/23/04.   Nurse follow up on 06/18/04 states: "Remove: Rhinitis, Pharyngitis."
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Amenorrhoea, Bacterial infection, Blister, Candidiasis, Dermatitis
Clinical narrative: anthrax1:red, raised itchy pimple like lesions on both arms from elbows up to shoulders similar to heat rash. anthrax2: soreness. anthrax3: red pimple like, fluid filled blisters that itched, were sore, had a burning sensation a numbness. It was more wide spread affecting areas on her trunk including her breast as well as her arms and legs.Says rash was constant from December98 until after Feb2000. She was treated with different medications (calamine and benadryl lotion, atarax, hydrocortisone, triamcinolone and nizoral creams, Betamethsone ointment and keflex) to name a few. The lesions were biopsied and diagnosed as Nummular eczema. Also began experiencing recurrent UTI (NOV98, DEC98, FEB99); amenorrhea: no pds from December 98 until Jan2000; episodes of "thrush and tender gums"; headaches with photosensitivity, "loose stools on and off" from Oct 99 thru Dec 99 and extreme fatigue. Anthrax4: soreness that resolved in 2-3 days. Had an exacerbation of rash on her forearms as well as new eruption of erythematous, pruritic, "blister-like lesions on her chest and neck 5 days after immunization. See in Sep for patch test postive for formaldehyde and nickel. Treated with steroid creams and advised against receiving further anthrax vaccinations. Received a Medical Board that found her "fit for duty" and recommended resumption of anthrax. Anthrax5: in less than 24 hours again reports having an eruption of "blister like, itchy rash on my arms and legs" and again advised to receive "no further anthrax vaccinations". Current problems: nummular eczema, poly-cystic ovarian disease, fatigue, problems with short term memory, insomnia.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Diarrhoea, Eczema nummular, Erythema, Fatigue, Headache
Clinical narrative: anthrax1:red, raised itchy pimple like lesions on both arms from elbows up to shoulders similar to heat rash. anthrax2: soreness. anthrax3: red pimple like, fluid filled blisters that itched, were sore, had a burning sensation a numbness. It was more wide spread affecting areas on her trunk including her breast as well as her arms and legs.Says rash was constant from December98 until after Feb2000. She was treated with different medications (calamine and benadryl lotion, atarax, hydrocortisone, triamcinolone and nizoral creams, Betamethsone ointment and keflex) to name a few. The lesions were biopsied and diagnosed as Nummular eczema. Also began experiencing recurrent UTI (NOV98, DEC98, FEB99); amenorrhea: no pds from December 98 until Jan2000; episodes of "thrush and tender gums"; headaches with photosensitivity, "loose stools on and off" from Oct 99 thru Dec 99 and extreme fatigue. Anthrax4: soreness that resolved in 2-3 days. Had an exacerbation of rash on her forearms as well as new eruption of erythematous, pruritic, "blister-like lesions on her chest and neck 5 days after immunization. See in Sep for patch test postive for formaldehyde and nickel. Treated with steroid creams and advised against receiving further anthrax vaccinations. Received a Medical Board that found her "fit for duty" and recommended resumption of anthrax. Anthrax5: in less than 24 hours again reports having an eruption of "blister like, itchy rash on my arms and legs" and again advised to receive "no further anthrax vaccinations". Current problems: nummular eczema, poly-cystic ovarian disease, fatigue, problems with short term memory, insomnia.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Hypoaesthesia, Insomnia, Memory impairment, Ovarian disorder, Photosensitivity reaction
Clinical narrative: anthrax1:red, raised itchy pimple like lesions on both arms from elbows up to shoulders similar to heat rash. anthrax2: soreness. anthrax3: red pimple like, fluid filled blisters that itched, were sore, had a burning sensation a numbness. It was more wide spread affecting areas on her trunk including her breast as well as her arms and legs.Says rash was constant from December98 until after Feb2000. She was treated with different medications (calamine and benadryl lotion, atarax, hydrocortisone, triamcinolone and nizoral creams, Betamethsone ointment and keflex) to name a few. The lesions were biopsied and diagnosed as Nummular eczema. Also began experiencing recurrent UTI (NOV98, DEC98, FEB99); amenorrhea: no pds from December 98 until Jan2000; episodes of "thrush and tender gums"; headaches with photosensitivity, "loose stools on and off" from Oct 99 thru Dec 99 and extreme fatigue. Anthrax4: soreness that resolved in 2-3 days. Had an exacerbation of rash on her forearms as well as new eruption of erythematous, pruritic, "blister-like lesions on her chest and neck 5 days after immunization. See in Sep for patch test postive for formaldehyde and nickel. Treated with steroid creams and advised against receiving further anthrax vaccinations. Received a Medical Board that found her "fit for duty" and recommended resumption of anthrax. Anthrax5: in less than 24 hours again reports having an eruption of "blister like, itchy rash on my arms and legs" and again advised to receive "no further anthrax vaccinations". Current problems: nummular eczema, poly-cystic ovarian disease, fatigue, problems with short term memory, insomnia.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus, Rash erythematous, Sensory disturbance, Skin burning sensation, Tenderness
Clinical narrative: anthrax1:red, raised itchy pimple like lesions on both arms from elbows up to shoulders similar to heat rash. anthrax2: soreness. anthrax3: red pimple like, fluid filled blisters that itched, were sore, had a burning sensation a numbness. It was more wide spread affecting areas on her trunk including her breast as well as her arms and legs.Says rash was constant from December98 until after Feb2000. She was treated with different medications (calamine and benadryl lotion, atarax, hydrocortisone, triamcinolone and nizoral creams, Betamethsone ointment and keflex) to name a few. The lesions were biopsied and diagnosed as Nummular eczema. Also began experiencing recurrent UTI (NOV98, DEC98, FEB99); amenorrhea: no pds from December 98 until Jan2000; episodes of "thrush and tender gums"; headaches with photosensitivity, "loose stools on and off" from Oct 99 thru Dec 99 and extreme fatigue. Anthrax4: soreness that resolved in 2-3 days. Had an exacerbation of rash on her forearms as well as new eruption of erythematous, pruritic, "blister-like lesions on her chest and neck 5 days after immunization. See in Sep for patch test postive for formaldehyde and nickel. Treated with steroid creams and advised against receiving further anthrax vaccinations. Received a Medical Board that found her "fit for duty" and recommended resumption of anthrax. Anthrax5: in less than 24 hours again reports having an eruption of "blister like, itchy rash on my arms and legs" and again advised to receive "no further anthrax vaccinations". Current problems: nummular eczema, poly-cystic ovarian disease, fatigue, problems with short term memory, insomnia.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Urinary tract infection
Clinical narrative: anthrax1:red, raised itchy pimple like lesions on both arms from elbows up to shoulders similar to heat rash. anthrax2: soreness. anthrax3: red pimple like, fluid filled blisters that itched, were sore, had a burning sensation a numbness. It was more wide spread affecting areas on her trunk including her breast as well as her arms and legs.Says rash was constant from December98 until after Feb2000. She was treated with different medications (calamine and benadryl lotion, atarax, hydrocortisone, triamcinolone and nizoral creams, Betamethsone ointment and keflex) to name a few. The lesions were biopsied and diagnosed as Nummular eczema. Also began experiencing recurrent UTI (NOV98, DEC98, FEB99); amenorrhea: no pds from December 98 until Jan2000; episodes of "thrush and tender gums"; headaches with photosensitivity, "loose stools on and off" from Oct 99 thru Dec 99 and extreme fatigue. Anthrax4: soreness that resolved in 2-3 days. Had an exacerbation of rash on her forearms as well as new eruption of erythematous, pruritic, "blister-like lesions on her chest and neck 5 days after immunization. See in Sep for patch test postive for formaldehyde and nickel. Treated with steroid creams and advised against receiving further anthrax vaccinations. Received a Medical Board that found her "fit for duty" and recommended resumption of anthrax. Anthrax5: in less than 24 hours again reports having an eruption of "blister like, itchy rash on my arms and legs" and again advised to receive "no further anthrax vaccinations". Current problems: nummular eczema, poly-cystic ovarian disease, fatigue, problems with short term memory, insomnia.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Injection site induration, Injection site reaction, Swelling
Clinical narrative: 4-16-04: babysitter brings her into clinic today after spoke to mother this am, babysitter has had child overnight, states arm was tender yesterday and last night, and swelling was up to shoulder. Babsitter states she has been giving tylenol to keep child from running a temp b/c has had a history of febrile seizures in the past. Babysitter states no fever noted but arm became red, swollen and tender yesterday. Babysitter states swelling has decreased and not as tender as was last night. Upon exam by RNs noted a large area around 3 inch long and 2" below acromion process on left upper arm. Also noted erythema, firmness and cellulitis in mid portion of affected area. Child was playful and swinging arms bilaterally today. Instructed babysitter to continue tylenol as affected area fell warm to touch and also give benadryl. Cool compresses to site today 24hours and warm compresses tomorrow 24hours. Babysitter states child will be at home with mother tomorrow. Will call and follow up on appearance of site tomorrow. Severe localized reaction to DTaP, instructed babysitter that child should not have any futher Td. Also called and left message on home phone for mother and will also attempt to speak to mother tomorrow. 4/17/04: Unable to reach mother at home, spoke with babysitter again, said arm looking better, thinks cool compresses helped, mother picked up earlier. 4/19/04: spoke with mother this am, said child was doing better today, still has around 2 inch area that is red. Discussed with mother the fact reaction was classic Td reaction. Informed mother that would not booster with Td. Have a call into MD and will notify if find out anything different. 4/26/04: spoke with mother this am, symptoms basically resolved but still as small discolored area on arm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Tenderness
Clinical narrative: 4-16-04: babysitter brings her into clinic today after spoke to mother this am, babysitter has had child overnight, states arm was tender yesterday and last night, and swelling was up to shoulder. Babsitter states she has been giving tylenol to keep child from running a temp b/c has had a history of febrile seizures in the past. Babysitter states no fever noted but arm became red, swollen and tender yesterday. Babysitter states swelling has decreased and not as tender as was last night. Upon exam by RNs noted a large area around 3 inch long and 2" below acromion process on left upper arm. Also noted erythema, firmness and cellulitis in mid portion of affected area. Child was playful and swinging arms bilaterally today. Instructed babysitter to continue tylenol as affected area fell warm to touch and also give benadryl. Cool compresses to site today 24hours and warm compresses tomorrow 24hours. Babysitter states child will be at home with mother tomorrow. Will call and follow up on appearance of site tomorrow. Severe localized reaction to DTaP, instructed babysitter that child should not have any futher Td. Also called and left message on home phone for mother and will also attempt to speak to mother tomorrow. 4/17/04: Unable to reach mother at home, spoke with babysitter again, said arm looking better, thinks cool compresses helped, mother picked up earlier. 4/19/04: spoke with mother this am, said child was doing better today, still has around 2 inch area that is red. Discussed with mother the fact reaction was classic Td reaction. Informed mother that would not booster with Td. Have a call into MD and will notify if find out anything different. 4/26/04: spoke with mother this am, symptoms basically resolved but still as small discolored area on arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Pain
Clinical narrative: Local reaction: redness, warmth, pain and induration.
Age: 1.2
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cough, Injection site induration, Injection site rash, Rhinorrhoea
Clinical narrative: 2 days after DTaP/ HIB, developed fine bumps with knot at site; then spread to upper extremities and trunk: had cough/ rhinorhea 4 days later.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Varicella like erythema/illness over 3-4 days. Symptomatic treatment.
Age: 1.4
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth, Irritability, Joint range of motion decreased, Oedema peripheral
Clinical narrative: 1 day after DPT shot, mother noted swelling around injection site that had increased by today. 10x15cm area of erythema, swelling, heat. No fever, limitation of movement noted. Has been a bit fussier than usual.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Feeling hot, Injection site erythema, Nausea, Tenderness
Clinical narrative: 5-18-04: approx 8 hrs after injection, began with redness and tenderness at site. Also felt fatigue. 5-19-04: started with transient nausea, felt feverish although no temp taken. Arm soreness with redness continues. Will see primary doctor today for evaluation. All symptoms remain today.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: 4x4.75 inch area of erythema left deltoid area (DTaP).
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia
Clinical narrative: Pt immunized with Hep B vaccine #3 in the left deltoid around 5:30pm. Mom returned to clinic at 6.53pm, with a report that child was experiencing numbness in the left fourth and fifth finger as well as the outer/lateral edge of his left hand. All of this presented in the car ride home.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: Decrease in appetite. Fever 24 hours after vaccine. Irritability.
Age: 11.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash papular, Rash pustular, Rash vesicular, Skin ulcer
Clinical narrative: Had varicella vaccine 12/7/1998. Has varicella infection today 5/20/04 around 50 lesions, papules, pustules and vesicles- 1 scabbed over. Know chickenpox exposure in school 2 weeks prior.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site induration, Pain, Tenderness
Clinical narrative: induration, warmth, sensitivity, pain. Treated with ibuprofen; advised heat compressx 10-20 min Q2-4hours.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Site of MMR/RD with 10cm red plaque/warm.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: Left side (arm, shoulder, neck and side of face) swollen, painful and hot with body aches. Resolved in 12hours.
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Myalgia
Clinical narrative: Family says diffuse arthralgias and myalgias started the day of the vaccine and have continued for the last 3 weeks.
Age: 5.0
Sex: F
Vaccine: DT, UNK
Symptoms: Injection site rash
Clinical narrative: Rash at site of injection. No respiratory problems.
Age: 55.0
Sex: U
Vaccine: PPV
Symptoms: Pain, Sensory disturbance, Swelling
Clinical narrative: 5 hours after painful swelling upper arm and transient loss of sensation in fingers: recovered in 72 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Mother described area from shoulder area from shoulder to elbow swollen and red. Notified child's doctor who recommended Benadryl. Follow up with mother indicated problem resolved.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Body temperature increased, Erythema, Feeling hot, Injection site reaction, Oedema
Clinical narrative: Leg very swollen from groin to knee, hot, red, hand, increased temp. Extreme local reaction 1 1/2 hrs onset from vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Skin nodule
Clinical narrative: redness, warmth, induration; no treatment given.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Convulsion, Dyskinesia, Loss of consciousness, Pyrexia, Rash
Clinical narrative: Developed low grade fever early 5:00 am 6/07 when came into our bedroom. Continued thru day. We went for walk 6/07 afternoon complained she was too hot (101.5). Came in for drink. She collapsed onto floor. Had (unconscious) seizure w/ jerking for approx 2-3 min. Rash on day 3.
Age: 0.75
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever & shakes.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Pruritus, Rash
Clinical narrative: About 200-240 pox marks, very itchy.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Erythema, Oedema
Clinical narrative: redness, swelling to left deltoid.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives immediately after MMR administered- ice pack to leg- hives resolved within 20 minutes.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Diagnosed with chickenpox on 5/15/04.
Age: 41.0
Sex: F
Vaccine: DT, HEP
Symptoms: Erythema, Injection site reaction, Oedema, Pyrexia
Clinical narrative: Red swollen tender- local at site of Td booster, temp 102 degrees.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: red swollen arm.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Developed diarrhea & vomiting- 24 hr. 3/2/04 called PH office re: signs returned call- left message. 3/4/04 telephone call had returned back to work on 3/3/04. Instructed to call physician to determine is she should receive #3.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Eczema, Erythema, Rash
Clinical narrative: Noted after immunization of varicella- Eczema like rash, red in 4 inch ring form.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema, Skin nodule
Clinical narrative: 05/13/04- the parent noted reddened upper left deltoid- reddened & warm to touch, swollen, hardened approx. size 4" x 5". 05/14/04 area a little less red, less hard. Child using arm. No complaints of pain.