chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.1
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Fear, Metabolic function test, Musculoskeletal stiffness
Clinical narrative: About 3 days after receiving his 2 month immunizations our son woke up from sleep gasping for air, very stiff and acting scared. This lasted a few minutes before he just "snapped out of it" ate, and went back to sleep. The next morning we called our doctor because my husband and I believed he'd had a possible seizure. We'd noticed a few jerky movements but since it was so late at night and the lights were off it was hard to tell for sure. We did bring him in to our doctor who did not think it was a seizure. Since then he has been diagnosed with a Generalized Seizure Disorder.
Age: 9.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Anaphylactic reaction, Dizziness, Dysphagia, Headache, Mumps
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of anaphylaxis in a 9-year-old female subject who was vaccinated with Havrix, GlaxoSmithKline, Engerix B for prophylaxis. There was no relevant medical history or concurrent medications. The subject had not experienced any adverse events following previous vaccinations. On 5 February 2002, the subject received 1st dose of Havrix (unknown), 1st dose of Engerix B (unknown). According to the subject's mother, both vaccines were mixed into one syringe and given as one injection, however, the medical records indicated that hepatitis A vaccine in the right thigh and the hepatitis B vaccine was given in the left thigh. It was unknown which method of administration was correct. On an unspecified day in 2002, at an unspecified time after vaccination with Engerix B and Havrix, the subject presented to the physician with fever, headache, nausea, dizziness, and swelling below and above the jaw on either side of her mouth. At the time of first seeing the subject, the physician thought she looked as if she had mumps. The subject's tongue was swollen and it was hard for her to swallow. Anaphylaxis to the vaccine (s) was diagnosed. The subject was treated in the emergency room. It was unknown if the subject was hospitalized. It was unknown to which vaccine or ingredient the subject reacted. At the time of reporting, she had not received any subsequent doses of Havrix or Engerix B since these events occurred. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified.
Age: 9.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Nausea, Pyrexia, Swelling face, Swollen tongue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of anaphylaxis in a 9-year-old female subject who was vaccinated with Havrix, GlaxoSmithKline, Engerix B for prophylaxis. There was no relevant medical history or concurrent medications. The subject had not experienced any adverse events following previous vaccinations. On 5 February 2002, the subject received 1st dose of Havrix (unknown), 1st dose of Engerix B (unknown). According to the subject's mother, both vaccines were mixed into one syringe and given as one injection, however, the medical records indicated that hepatitis A vaccine in the right thigh and the hepatitis B vaccine was given in the left thigh. It was unknown which method of administration was correct. On an unspecified day in 2002, at an unspecified time after vaccination with Engerix B and Havrix, the subject presented to the physician with fever, headache, nausea, dizziness, and swelling below and above the jaw on either side of her mouth. At the time of first seeing the subject, the physician thought she looked as if she had mumps. The subject's tongue was swollen and it was hard for her to swallow. Anaphylaxis to the vaccine (s) was diagnosed. The subject was treated in the emergency room. It was unknown if the subject was hospitalized. It was unknown to which vaccine or ingredient the subject reacted. At the time of reporting, she had not received any subsequent doses of Havrix or Engerix B since these events occurred. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: No adverse effect
Clinical narrative: Rotateq #1 given on 6-4-07. No s/s, no adverse reaction, no treatment.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Patient received Zostavax vaccine in place of Varicella.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: No fever, redness, slight swelling, RA, warm to touch, slightly firm advised to go to ER. Treatment per ER physician Claritin, Benadryl, Ibuprofen 200mg.
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Red and swollen - Motrin and Keflex
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Pyrexia, Urticaria
Clinical narrative: Started with welts 7/12/07 on leg (12:30 a.m.) spreading 7-13-07 all over (face, legs, body and arms), had fever for 2 days 3 days ago no fever now, not uncomfortable.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Skin lesion
Clinical narrative: Painful lesion left side of face near mouth x 5 days. Treated with oral antiviral and antibiotics and topical steroids as well as NSAID for lymphadenopathy.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Conjunctivitis, Crying, Rash, Screaming
Clinical narrative: Mom returned to clinic 2 weeks after conjunctiva with complaint of increased arching, no looking at mom, decrease play with brother, faint rash, screaming and crying at least 1/2 of the day. 12/10/07-records received for DOS 6/06-8/14/07-developmental delay, questionable seizures. Shaking head from side to side. Unsuccessful attempts at MRI.  12/26/07-records received-office visit 2/26/07-seen for atypical development. Four days after immunizations observed rocking head side-to-side. Futher regression continued. 4/23/07 visit Receiving OT and PT and hypertonia has given way to hypotonia. Improving with therapy. Appears to have been a transient illness. 9/17/07- office visit-Demonstrating atypical signs in development. Consistent with autism. 11/12/07-receiving hyperbaric oxygen treatments. Finger nails bright pink.
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Erythema, Induration
Clinical narrative: Redness and induration developed night of 7/11/07 (got vaccines on 7/11/07) and seen 7/13/07 for 10 x 8.5cm redness by 5cm x 5cm induration - treated for cellulitis.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female, with no medical history and no known allergies, who on 15-JAN-2007, at 10:06 a.m. was vaccinated with a first subcutaneous dose in the right thigh of ProQuad (Lot# 655842/1330F). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. It was reported that the patient woke up the following morning, on 16-JAN-2007, at 10:30 a.m., with a fever of 102.8. The patient was treated with TYLENOL and MOTRIN. It was reported that the patient also developed a large swelling and redness at the injection site. The fever lasted one day only and the patient was reported as recovery on 17-JAN-2007. Unspecified medical attention sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated the first dose of ProQuad. Subsequently, the patient experienced breakthrough chicken pox (number of lesions unspecified). Patient outcome was unknown. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 41 month old female with a history of pneumonia and failure to gain weight who on 26-FEB-2007 was vaccinated SC with a 0.5 ml dose of ProQuad (lot # 656641/1555F). There was no concomitant medication. Subsequently the patient experienced injection site reaction that was red and swollen. On 08-MAR-2007 the patient developed a rash on the abdomen that goes up to the neck, back and legs. Unspecified medical attention was sought. No laboratory tests were performed. The nurse requested a lot check. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. This is one of several cases from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a nurse concerning a 12 month old female who on 27-FEB-2007 was vaccinated subcutaneously (SC) with ProQuad. The nurse reported that the consumer's mother contacted the doctors office stating that her daughter had developed "a red rash and red spots all over body." The patient sought unspecified medical attention. No labs were reported. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Body temperature increased, Injection site swelling, Lacrimation increased, Pyrexia, Rhinorrhoea
Clinical narrative: Information has been received from a physician concerning a 12 month old female, with no know medical history and no allergies, who on 08-MAR-2007 was vaccinated with a subcutaneous dose of ProQuad (Lot # 653354/0300F). The patient was "healthy without illness" prior to the immunization. Concomitant therapy included TYLENOL and MOTRIN. On 11-MAR-2007, the patient experienced fever over 100.F watery eyes, runny nose and swelling at the injection site (arm). On 12-MAR-2007, the patient was brought into the physician's office and the patient's temperature was 100.3 and there was swelling at the injection site, watery eyes and runny nose. The physician reported the duration of events to be one day. It was reported that the patient recovered. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a physician concerning a 14 month old female who on 14-MAR-2007 was vaccinated in the right leg with 0.5 ml, one dose, of ProQuad, and immediately developed a welt at the injection site. Concomitant therapy Vaqta, which the patient also received that same day, in the left leg without any reaction. Unspecified medical attention was sought. The patient's status at the time of the report was unknown. There was no product quality complaint. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: MMRV
Symptoms: Pruritus, Rash papular, Rash pustular
Clinical narrative: Information has been received concerning a 17-month-old female who on 19-DEC-2006 was vaccinated intramuscularly with a dose of ProQuad (lot #656165/1387F). Concomitant therapy included AMOXIL. On 25-FEB-2007, 68 days post vaccination, the patient experienced a papular rash and 20 pustules diffuse on the trunk. The patient complained of itchiness. Subsequently, on 05-MAR-2007, the patient recovered from papular rash and itchiness. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Diarrhoea, Gastroenteritis viral, Pyrexia, Rash morbilliform, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 month male with no pertinent medical history, a possible penicillin allergy, and who may have been on an "antibiotic" for "OM" when he was vaccinated on 23 FEB 2007, at 10:30 AM, subcutaneously into the left thigh with a first dose, a 0.5 ml, dose of ProQuad (Lot # 656550/1531F). Five days after vaccination, on 01 MAR 2007, the patient developed a diffuse, non-pruritic, measle like rash. The patient also had vomiting and diarrhea (viral gastroenteritis) and was on an antibiotic for "OM". The patient had a fever of 102 to 103F. In the beginning of March, patient was prescribed Augmentin and developed a rash. Medical attention was sought, at which time it was thought the patient may be allergic to penicillin. No laboratory or diagnostic tests were performed. Subsequently, the patient recovered. No product quality complaint was involved. Further information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered (R.N.) concerning a, 4-year-old male with no known allergies who had a current illness of an upper respiratory infection. On 08-Mar-2007 he was vaccinated in the right arm (route unknown) with a first dose of ProQuad (lot#656166/1397F). Concomitant therapy "given in the other arm" included a dose of DTaP and a dose of poliovirus vaccine. Approximately 10-20 minutes after receiving the vaccinations, the patient experienced a bright red splotchy spot at injection site of ProQuad. This spot was 2 inches to stay in the office with the child to monitor. The arm became splotchy red but cleared after 30 minutes. No laboratory or diagnostic tests were performed. The outcome was reported as recovered. No product quality complaint was involved. No further information is expected.
Age: 48.0
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a 48 year old female registered nurse who on 21-MAR-2007 at 19:28 was sprayed in the eye with ProQuad. It was reported that as the nurse was administering a dose of vaccine it sprayed that as the nurse was administering a dose of vaccine it sprayed from the needle into her eye. The nurse experienced eye irritation. The nurse irrigated her eye for one minute. She was not nursing or pregnant. She was advised to thoroughly irrigate the eye and then seek medical attention if there were any symptoms. Prescription drug treatment was not required. The patient was not hospitalized. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 15-month-old female who in the end of January 2007 or the beginning of February, was vaccinated with ProQuad. The patient experienced rash within 1 week of vaccination. Unspecified medical attention was sought. No laboratory or diagnostic testing was performed. The outcome was reported as recovered. There was no product quality complaint involved. No additional information to report. Additional information has been requested.
Age: 1.06
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old female with no medical history or allergies who on 12-MAR-2007 was vaccinated in her left leg with ProQuad (lot# 656308/1392F). Concomitant vaccinations included Hib conj vaccine (unspecified carrier), Prevnar and hepatitis A vaccine (inactive) MSD. On 19-MAR-2007 the patient experienced quarter size red inflammed area at the injection site. Medical attention was sought. As of 22-Mar-2007 the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 12-month-old male who on 03-NOV-2006 was vaccinated with a 0.5 ml dose of MMR II (Lot # 654477/0973F). On 22-MAR-2007, the patient experienced a zoster-like rash. Unspecified medical attention was sought. The outcome at the time of this report was not recovered. No additional information available. There was no product quality complaint. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: FLU3, HIBV, MMRV, PNC
Symptoms: Arthropod bite, Blister, Blister, Convulsion, Excoriation
Clinical narrative: Information has been received from a registered nurse concerning a 24 month old female, with no pertinent medical history, drug reactions or allergies, who on 18-MAY-2006 was vaccinated subcutaneously with 0.5 ml dose of MMRV (Lot # 653203/1138R). There was no concomitant medication. Ten months post vaccination with MMR, in approximately MAR2007, the patient developed a widespread outbreak of chickenpox. The patient was examined on 16 MAR 2007, and was found to have widespread vesicular lesions on bilateral hands, bilateral legs and the trunk. The patient was afebrile. A follow up exam is scheduled for 30 MAR 2007. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.  01/04/08 This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from a registered nurse concerning a 22 month old female with no medical history or pre existing allergies who on 18-MAY-2006 was vaccinated subcutaneously into the right arm with a first dose of PROQUAD (Oka/Merck upgrade process) (Lot # 653203/1138R). Concomitant vaccine therapy that same day included a second dose intramuscularly, into the left leg of FLUZONE (Lot #U1788BA), a fourth dose intramuscularly into the right leg with ACTHIB (Lot # UE778AA) and a third dose, intramuscularly into the left leg of PREVNAR (Lot # B0863AF). There was no illness at the time of vaccination. On 16-MAR-2007 the patient presented at the walk in clinic with blister like lesions on the hands, legs, and trunk, and was subsequently diagnosed with varicella. The patient was afebrile. On 30-MAR-2007 the patient presented for a follow up doctor visit with scattered papular lesions on the legs, thighs, belly, and arms with scratch marks. The doctor's impression at that time was scabies. Treatment was permethrin cream. On 07 APR 2007 the patient presented to the walk in clinic with a complaint of a rash, which was diagnosed as allergic dermatitis. On 12 Mary 2007 the patient presented to a dermatologist, with erythematous papules on the right arm and right leg with excoriation. It was the impression of the physician that the patient had probable insect bites. A topical cream (unspecified) was prescribed, along with diphenhydramine hydrochloride elixir for pruritus, as well as calamine lotion. On 13 JUL 2007 a well child visit was conducted, at which time it was reported that the child was recovered. No lab diagnostic studies were performed. There was no product quality complaint. There were no adverse events reported with prior vaccinations: ACTHIB 30-Jun-2005, 16-Aug-2005, 05-Oct-2005, and PREVNAR 30-Jun-2005, 16-Aug-2005, 05-Oct-2005 and FLUZONE 15-Feb-2006.
Age: 1.05
Sex: F
Vaccine: FLU3, HIBV, MMRV, PNC
Symptoms: No reaction on previous exposure to drug, Rash erythematous, Rash vesicular, Varicella, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 24 month old female, with no pertinent medical history, drug reactions or allergies, who on 18-MAY-2006 was vaccinated subcutaneously with 0.5 ml dose of MMRV (Lot # 653203/1138R). There was no concomitant medication. Ten months post vaccination with MMR, in approximately MAR2007, the patient developed a widespread outbreak of chickenpox. The patient was examined on 16 MAR 2007, and was found to have widespread vesicular lesions on bilateral hands, bilateral legs and the trunk. The patient was afebrile. A follow up exam is scheduled for 30 MAR 2007. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.  01/04/08 This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from a registered nurse concerning a 22 month old female with no medical history or pre existing allergies who on 18-MAY-2006 was vaccinated subcutaneously into the right arm with a first dose of PROQUAD (Oka/Merck upgrade process) (Lot # 653203/1138R). Concomitant vaccine therapy that same day included a second dose intramuscularly, into the left leg of FLUZONE (Lot #U1788BA), a fourth dose intramuscularly into the right leg with ACTHIB (Lot # UE778AA) and a third dose, intramuscularly into the left leg of PREVNAR (Lot # B0863AF). There was no illness at the time of vaccination. On 16-MAR-2007 the patient presented at the walk in clinic with blister like lesions on the hands, legs, and trunk, and was subsequently diagnosed with varicella. The patient was afebrile. On 30-MAR-2007 the patient presented for a follow up doctor visit with scattered papular lesions on the legs, thighs, belly, and arms with scratch marks. The doctor's impression at that time was scabies. Treatment was permethrin cream. On 07 APR 2007 the patient presented to the walk in clinic with a complaint of a rash, which was diagnosed as allergic dermatitis. On 12 Mary 2007 the patient presented to a dermatologist, with erythematous papules on the right arm and right leg with excoriation. It was the impression of the physician that the patient had probable insect bites. A topical cream (unspecified) was prescribed, along with diphenhydramine hydrochloride elixir for pruritus, as well as calamine lotion. On 13 JUL 2007 a well child visit was conducted, at which time it was reported that the child was recovered. No lab diagnostic studies were performed. There was no product quality complaint. There were no adverse events reported with prior vaccinations: ACTHIB 30-Jun-2005, 16-Aug-2005, 05-Oct-2005, and PREVNAR 30-Jun-2005, 16-Aug-2005, 05-Oct-2005 and FLUZONE 15-Feb-2006.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Information has been received from a nurse concerning a 12 month old male who on 16-MAR-2007 was vaccinated with 0.5 ml first dose of MMRV. Concomitant therapy included Cephalexin (KEFLEX). Ten days later, on 26-MAR-2007, the patient experienced a red local reaction on the injection site. Unspecified medical attention was sought. No laboratory tests were performed. Subsequently, the patient recovered from his experience. There was no product quality complaint involved.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 15-month-old female with Down's Syndrome who in the end of January 2007 or the beginning of February, was vaccinated with ProQuad. The patient experienced rash within 1 week of vaccination. Unspecified medical attention was sought. No laboratory or diagnostic testing was performed. The outcome was reported as recovered. There was no product quality complaint involved. No additional information to report. Follow up information indicated that no additional information could be provided. No additional information is expected.
Age: 1.1
Sex: F
Vaccine: MMRV
Symptoms: Blister, Pyrexia, Rash erythematous, Rash maculo-papular, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 13 month old female, a birth twin, with an unspecified allergy and a history of premature birth who on 21-MAR-2007 was vaccinated into the left thigh with MMRV (Lot # 653205/1131R). The patient developed a varicella like rash on 31 MAR 2007. The patient was examined on 02 APR 2007 at which time the patient presented with a scattered erythematous macular papular rash all over her body. The rash initially started as an erythematous rash on the chest and abdomen with vesicles. The patient was considered recovered as of 09 APR 2007. There was no concomitant therapy reported. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. The patient's twin sister (WAES # 0704USA00419) who was also vaccinated on the same day developed an erythematous rash, with more lesions and a fever. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: MMRV
Symptoms: Blister, Pyrexia, Rash erythematous, Rash maculo-papular, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 13 month old female, a birth twin, with an undefined allergy and a history of premature birth who on 21-MAR-2007 was vaccinated into the left thigh with MMRV (Lot # 653205/1131R). The patient developed a varicella like rash on 31 MAR 2007. The patient was examined on 02 APR 2007 at which time the patient presented with a scattered erythematous macular papular rash all over her body. The rash initially started as an erythematous rash on the chest and abdomen with vesicles. The patient was considered recovered as of 09 APR 2007. There was no concomitant therapy reported. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. The patient's twin sister (WAES # 0704USA00400) who was also vaccinated on the same day developed an erythematous rash, with fever lesions and without fever. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Heat therapy, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a Nurse concerning a 1 year old male who on 27-MAR-2007 was vaccinated with a dose of MMRV. On 29-MAR-2007 the patient was seen in the doctor's office for redness, warmth and pain at the thigh injection site. Warm compress and an unknown cream were recommended as treatment. As of 04-Apr-2007 the patient has been recovering from redness, warmth and pain at the thigh injection site. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Cold compress therapy, Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an office manager concerning a 5-month-old female with a history of vaccination with a dose of MMRV with no reaction and no other pertinent medical history or known allergies who on 02-APR-2007 was vaccinated SC in the right anterior thigh with a dose of MMRV (Lot # 656160/1396F). Concomitant vaccines administered on that same day included a dose of DTaP (+) tetanus toxoid, a dose of poliovirus vaccine inactive (unspecified and a IM dose in the right thigh of Vaqta. The office manager reported that on 04-APR-2007 the patient presented to the office with large swelling, redness, heat and bruising at the injection site (exact date of onset not provided). No laboratory/diagnostic test were performed. The patient was treated with cold compress as needed. At the time of this report, the patient's event persisted. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Overdose, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old female patient who on 29-MAR-2007 was vaccinated subcutaneously with a 0.5 mL dose of ProQuad (lot# 654474/0815F). Concomitant vaccination on the same day included a dose of varicella (lot# 654529/1045F). The nurse reported that the office confused the ProQuad vaccine with the MMRII in the freezer. Unspecified medical attention was sought. No problems were reported. A product quality complaint was not involved. The patient's twin sister had a similar experience after therapy with ProQuad (WAES # 0704USA01454). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Overdose, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old female who on 19-MAR-2007 was vaccinated subcutaneously with a 0.5 mL dose of ProQuad (lot# 654474/0815F). Concomitant therapy included Varivax (lot# 654756/1335F). The nurse reported the office confused the ProQuad with the MMR II in the freezer. The patient received a dose of ProQuad and a dose of Varivax during the same visit. The patient sought unspecified medical attention. No problems reported. Additional information has been requested. This is one of several reports from the same source.
Age: 11.0
Sex: F
Vaccine: MMRV
Symptoms: Overdose, Wrong drug administered
Clinical narrative: Information has been received from a pediatrician concerning a 11 year old female patient who received a dose of ProQuad. It was noted that the patient was to get plain varicella but because she already had her 12-13 month dose of MMR II and her 4-5 yr old dose. She did not need this MMR II.
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Overdose, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old female patient who on 29-MAR-2007 was vaccinated subcutaneously with a 0.5 mL dose of ProQuad (lot# 654474/0815F). Concomitant vaccination on the same day included a dose of Varivax (lot# 656567/1512F). The nurse reported that the office confused the ProQuad vaccine with MMR II in the freezer. Unspecified medical attention was sought. No problems were reported. A product quality complaint was not involved. The patient's twin sister had a similar experience after therapy with ProQuad (WAES # 0704USA01031). Additional information has been requested. This is one of several reports from the same source.
Age: 1.08
Sex: M
Vaccine: HBHEPB, HEPA, MMRV
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a registered nurse (R.N.) in a physicians office concerning a 13-month-old male who on 28-MAR-2007 was vaccinated with a subcutaneous "first dose, single dose vial" of ProQuad (lot # 656160/1396F). Concomitant therapy included a dose of Comvax and a dose of Vaqta. The nurse reported that the patient developed "fine red pin-point on the trunk of his body". The patient's parent notified the office of the experience on 09-APR-2007. The patient sought unspecified medical attention. It was unspecified if the patient recovered. No product quality complaint was involved. No more information is expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Agitation, Disturbance in attention, Irritability, Lymphadenopathy
Clinical narrative: Information has been received from the mother of a 5 year old male who on 20-MAR-2007 was vaccinated SC with ProQuad. Concomitant therapy included Revaxis. On 24-MAR-2007, four days after vaccination the patient experienced irritability, agitation, lack of concentration and swollen lymph nodes. Subsequently, the patient recovered from irritability, agitation, lack of concentration and swollen lymph nodes. I was reported that unspecified medical attention was sought and the patient recovered after stopping therapy. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Body temperature increased, Injection site vesicles, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 4 year old female who on 15-MAR-2007 was vaccinated with a 0.5 mL dose of ProQuad. Concomitant vaccination administered that day included a dose of poliovirus vaccine, a dose of DTaP (+) tetanus toxoid and a dose of hepatitis A (manufacturer unknown). Subsequently the patient developed a fever of 103 and blisters at injection site that lasted 3 days. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. It was reported that the patient had a similar experience after vaccination with varicella (WAES#0706USA01159)
Age: 1.0
Sex: F
Vaccine: MMRV, PNC
Symptoms: Body temperature increased, Irritability, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 month old female with no pertinent medical history and no drug reactions/allergies who on 29-MAR-2007 was vaccinated with ProQuad (Lot # 656647/0101U). Concomitant vaccinations included Prevnar. On 05-APR-2007, the patient experienced fussiness and fever. The fever started out at 102 F and climbed to 103-104 and lasted for 48-72 hours. On 09-APR-2007, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site mass, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 4 1/2 year old male who on 03-APR-2007 was vaccinated SC with a second dose of ProQuad (lot # 656887/0150U). Concomitant therapy included ibuprofen (MOTRIN). On 04-APR-2007 the patient experienced a red-hot, raised, and sensitive to the touch sensation around the injection site. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a health professional concerning a 5 year old male who, "last week," in April 2007, was vaccinated with a 0.5 ml subcutaneous dose of ProQuad. "Last week," in April 2007, the patient developed a rash on her right arm, 4 by 3 inches, at the injection site. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Overdose, Wrong drug administered
Clinical narrative: Information has been received from two physicians concerning a 5 year old male who on 18-APR-2007 was vaccinated with a dose of ProQuad and a dose of Varivax  on the same day. It was reported that the patient received ProQuad instead of MMRII. Unspecified medical attention was sought. No symptoms were noted. It was reported that this was a nursing error and not related to the vaccine. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 2 and half year old male with unremarkable med history and no allergies who "about two weeks ago" on approximately 04-APR-2007 was vaccinated subcutaneously with a 0.5 ml dose of Proquad. Concomitant vaccinations included PEDIARIX and Hib conj vaccine. "About two weeks ago" approximately 04-APR-2007 the patient experienced redness and swelling at injection site. Medical attention was sought. The patient's outcome was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMRV
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 15 month old female who on 12-APR-2007 was vaccinated subcutaneously in her thigh with a dose of Proquad. On 16-APR-2007 the patient experienced a 2 cm area of inguinal lymphadenopathy. The child did not experience fever. Medical attention was sought. As of 19-Apr-2007 the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 24-month-old patient who on 19-APR-2007 was vaccinated with a dose of ProQuad (Lot # 656887/0150U) instead of hepatitis A virus vaccine inactivated (manufacturer unknown). It was noted that the patient was previously vaccinated with ProQuad (at 1-year of age). No symptoms have been reported. The event occurred due to "nursing error", not product confusion. No further information is available. There was no product quality complaint. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Skin lesion
Clinical narrative: Information has been received from a nurse in a physician's office concerning a 4-5 years old male who was vaccinated with a dose of Proquad. Subsequently two days after the vaccination the patient experienced lesions. It was unknown how many lesions the patient had. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: HBHEPB, HEPA, MMRV
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old male with no known allergies or pertinent medical history who on 29-MAR-2007 at 11:00 was vaccinated SC in the right thigh with a first dose of ProQuad (lot # 656160/1396F). Additional suspect vaccination administered at the same time included a third dose of Comvax (lot # 654908/0999F) given IM in the left thigh and a first dose of Vaqta (lot # 656017/1280F) given IM in the right thigh. There was no illness at the time of vaccination. On 09-APR-2007 at 14:00 the patient developed a red pinpoint non-raised rash on his trunk. The patient's mother called the office to report this. A follow-up call with the patient's mother on 10-APR-2007 indicated that the rash was almost completely gone that morning.  The patient had no other symptoms. The patient recovered on 10-APR-2007. The patient had no adverse events following prior vaccination. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Body temperature, Rash, Rash papular, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 25 month old white female with no medical history or allergies who on 14-MAR-2006 was vaccinated SC on the right arm with 0.5 ml first dose of Proquad (Lot # 651815/0950R). At the time of vaccination the patient did not have any illness. There was no concomitant medication. On 17-APR-2007 the patient developed a rash. The patient was seen by the physician on 19-APR-2007 and rash was reported as "red based areas with questionable blisters, no crusting, no itching, no discomfort, no drainage noted". The patient had not experienced any fevers. The patient was referred to a dermatologist and was seen on 20-APR-2007 and rash was reported as "chicken pox". Number of lesions on arms and back were not noted by nurse. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the registered nurse who reported that on 17-APR-2007 the patient developed rash on arms and back. The rash was non-pruritic which spread to face, legs, chest. The number of lesions were too numerous to count on arms and legs. There were fewer lesions on face, chest and back. The patient was afebrile but did not act ill. The lesions were described as red based papules blister with no crust. On 19-APR-2007 patient was seen by a physician and was referred to a dermatologist who confirmed varicella as the diagnosis and prescribed "Exoclin". No diagnostic laboratory tests were undertaken. On 24-APR-2007 the patient was recovered. The patient had no adverse events following prior vaccination. No further information is expected.
Age: 1.01
Sex: M
Vaccine: MMRV
Symptoms: Rash generalised, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 2 year old male who on 17-APR-2007 was vaccinated with a first dose dose of ProQuad. On 22-APR-2007 the patient developed more than 100 lesions. The patient's medical status was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.  10/06/2007 This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from a nurse practitioner concerning an approximately 24 month old male with a history of seasonal allergies, who on 17-APR-2006 was vaccinated with a first dose of PROQUAD (Oka/Merck upgrade process) "0044R". One year post vaccination on 24-APR-2007 the patient developed more than 100 vesicular lesions all over the body. No illnesses were reported at the time of the vaccination. No laboratory diagnostics studies performed. The patient recovered on an unspecified date. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTP, IPV, MMRV
Symptoms: Pharyngolaryngeal pain, Pruritus, Throat tightness
Clinical narrative: Information has been received from a physician concerning a 5 year old male who on 24-APR-2007 at 14:55 was vaccinated SC with first dose of Proquad. Concomitant therapy included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine. On 24-APR-2007 "within 30 minutes) of vaccination with Proquad, and while still at the doctor's office the patient complained of itching. It was reported that the child was experiencing "throat pain" and "throat tightening". The child was treated with two teaspoons of BENADRYL, 0.3ml of 1:1000 epinephrine, and 35mg of prednisone in a syrup formulation. The parent brought the child home and at 16:30 the child was brought to the emergency room. It was reported that child was in the Emergency Room until 21:00. At the time of report, child's symptoms had resolved and he was at home. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Angioedema, Rash, Skin lesion
Clinical narrative: Information has been received from a physician concerning a patient on 30-MAR-2007 was vaccinated with ProQuad. It was reported that after the vaccine on 04-APR-2007 the patient experienced giant urticaria and was prescribed prednisolone Na phosphatase (ORAPRED) 7.5 mg twice daily. On 07-APR-2007 the patients mother reported that the child had a significant outbreak of rash that was generalized and contained about 400 lesions. Unspecified medical attention was sought. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, Injection site dryness, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 40 year old female with no known medical history or allergies, who on 04-APR-2007 was vaccinated in the left arm with a subcutaneous first dose of ProQuad (lot number 657263/0292U) Concomitant medication included a left forearm tuberculin test. There was no illness at the time of vaccination. On 05-APR-2007 the patient developed a vaccine site reaction that was described as red, raised, hot to touch and rough-feeling about a centimeters diameter at the injection site. On 6-APr-2007 the symptoms had resolved within 24 hours. Unspecified medical attention was sought, the patient had no adverse events following prior vaccination. No product quality was involved. Additional information was received from the physician who reported that the patient developed a reaction to the vaccination in the left arm that was described as red, raised, hot to touch and felt rough 2-3cm across. It was reported that the patient recovered 06-APR-2007. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: MMRV
Symptoms: Off label use
Clinical narrative: Information has been received from a physician concerning a 40 year old female with no known medical history or allergies, who on 04-APR-2007 was vaccinated in the left arm with a subcutaneous first dose of ProQuad (lot number 657263/0292U) Concomitant medication included a left forearm tuberculin test. There was no illness at the time of vaccination. On 05-APR-2007 the patient developed a vaccine site reaction that was described as red, raised, hot to touch and rough-feeling about a centimeters diameter at the injection site. On 6-APr-2007 the symptoms had resolved within 24 hours. Unspecified medical attention was sought, the patient had no adverse events following prior vaccination. No product quality was involved. Additional information was received from the physician who reported that the patient developed a reaction to the vaccination in the left arm that was described as red, raised, hot to touch and felt rough 2-3cm across. It was reported that the patient recovered 06-APR-2007. Additional information is not expected.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, MMRV, PNC
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: Information has been received from a health professional concerning a 12 month old female who on 13-APR-2007 was vaccinated with Proquad. Concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, VAQTA, and PREVNAR. On 27-APR-2007, the patient developed  rash from head to toe characterized as a "fine" and "raised" measles-like rash. At the time of this report the patient was recovering. Unspecified medical attention was sought. No other information was provided. No product quality complaint was involved. Additional information has been requested.  10/06/2007 This is in follow-up to report(s) previously submitted on 7/6/2007. Follow-up information received from a licensed professional nurse states that there is no change. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old white male who on 10-APR-2007 was vaccinated with the first dose Proquad (Lot # 657265/0293U) IM. On 11-APR-2007, the patient experienced fever up to 104.1 x 2 days. Subsequently on 13-APR-2007, the patient recovered from fever up to 104.1 x 2 days. No further information is available.
Age: 1.27
Sex: F
Vaccine: MMRV
Symptoms: Rash vesicular
Clinical narrative: Information was received from a physician concerning an 18 month old female who on 15-MAR-2007 (also reported as April 2007) was vaccinated with a dose of Proquad (Oka/Merck upgrade process), lot number 656445/1482F. Concomitant therapy included amoxicillin which was to treat an upper respiratory infection which was present at the time of vaccination. It was reported that "on 01-MAY-2007 the patient developed a varicella like rash that was spreading fast, all over her body that look like bug bites". The doctor requested VZV analysis. Unspecified medical attention was sought. The patient's medical status was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no medical history or allergies who on 01-MAY-2007 at 9:45 AM was vaccinated SC on right arm with second dose of ProQuad (Lot # 656313/0298U). Concomitant therapy on same date and time included an IM fifth dose on left arm with Infanrix (Lot # AC14B040BA) and a SC fourth dose on left arm with IPOL (Lot # z0457). There was no illness at the time of vaccination. On 02-MAY-2007 the patient developed a red, painful swollen arm that was warm to touch after vaccination. Unspecified medical attention was sought. On 03-MAY-2007 the patient recovered. No diagnostic laboratory procedures were undertaken. A product quality complaint was not involved. Additional information has been received from the registered nurse who reported that in the AM of 02-MaY-2007 the patient had a painful, red swollen arm that was warm to touch. The patient recovered. No further information is expected. This is one of several reports received from same source.