chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.1
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 13 month old female pt in daycare who on 03/15/02 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (Lot # 639132/0502L).  The nurse stated that the pt may have been vaccinated with improperly stored varicella virus vaccine live.  On 03/15/02, the pt was concomitantly vaccinated SC in the left thigh with a first dose of MMRII (Lot # 641019/1215L)and a first dose of Prevnar IM in the left thigh (Lot # 484-132). Unspecified medical attention was sought. On 01/13/04, the pt developed a pus filled rash on his trunk. A product quality complaint was not involved. The reporter also mentioned other pt's who may have been vaccinated with improperly stored varicella virus vaccine live (WAES # 0403USA02035, 0403USA02038, 0403USA02039 & 0403USA02036).  These pt's included other children in the same daycare who also reported having chickenpox within the same time period (WAES # 0403USA02038 & 0403USA02039).  Another child in the same daycare also reported having chickenpox within the same time period, but had not previously received varicella virus vaccine live. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a RN concerning a 7 year old pt who on 07/24/97 was vaccinated with a dose of varicella virus vaccine live (Lot # 621197/0349E). On 01/14/04 the pt was seen at the office with chickenpox less than 50 lesions. It was noted that the pt had a fever of 100F which began on 01/12/04.  Treatment included Benadryl and Tylenol.  There was no product quality complaint involved. Additional information has been requested. A pt from the same source had a similar experience (WAES # 0401USA01049). **Follow up information it was noted that the patient recovered. No additional information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a first grade female pt who on 04/24/98 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed chickenpox. Unspecified medical attention was sought.  There was no product quality complaint involved. Additional information has been requested. It was noted that pt's from the same source had a similar experience (WAES # 0403USA02109, 0403USA02110, 0403USA02111, 0403USA02112, 0403USA02113, 0403USA02114, 0403USA02115). ** Follow up information was received from the registered nurse who indicated that the patient was diagnosed with chickenpox on or about 01/17/2004. No further information is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a first grade male pt who on 11/17/98 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed chickenpox. Unspecified medical attention was sought.  There was no product quality complaint involved. Additional information has been requested. It was noted that pt's from the same source had similar experience. (WAES # 0403USA02088, 0403USA02110, 0403USA02111, 0403USA02112, 0403USA02113, 0403USA02114, 0403USA02115). **Follow up information was received from the registered nurse who indicated that the patient was vaccinated at another facility. Chickenpox was diagnosed on or about 01/17/2004. No further information is expected.
Sex: M
Vaccine: VARCEL
Symptoms: 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 concerning a first grade male pt who on 03/20/98 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. Follow-up information was received from the registered nurse who indicated that the patient was vaccinated at an unknown location and not at her facility. Chickenpox was diagnosed on or about 17-Jan-2004. No further information is expected. It was noted that pt's from the same source had a similar experience.  (WAES # 0403USA02088, 0403USA02109, 0403USA02111, 0403USA02112, 0403USA02113, 0403USA02114, 0403USA02115).
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: This is in follow-up report(s) previously submitted on 5/14/2004. Information has been received from a RN concerning a first grade male pt who on 12/18/97 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed chickenpox. Unspecified medical attention was sought. A product quality complaiant was not involved. Follow-up information was received from the registered nurse who indicated that the patient was vaccinated at an unknown location, and nto at her facility. Chickenpox was diagnosed on or about 17-Jan-2004. No further information is expected. It was noted that pt's from the same source had a similar experience. (WAES # 0403USA02088, 0403USA02109, 0403USA02110, 0403USA02112, 0403USA02113, 0403USA02114, 0403USA02115).
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, 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 concerning a first grade female pt who on 04/22/99 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed chickenpox. Unspecified medical attention was sought. A prodsuct quality complaint was not involved. Follow-up information was recevied from the registered nurse who indicated that the patient was not vaccinated at her facility. Chickenpox was diagnosed on or about 17-Jan-2004. No further information is expected. It was noted that pt's from the same source had a similar experience. (WAES # 0403USA02088, 0403USA02109, 0403USA02110, 0403USA02111, 0403USA02113, 0403USA02114, 0403USA02115).
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, 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 concerning a kindergarten male pt who on 04/29/99 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. Follow-up information was received from the registered nurse who indicated that the physician diagnosed the patient with chickenpox on approximately 17-Jan-2004. No further informatin is expected. It was noted that pt's from the same source had a similar experience. (WAES # 0403USA02088, 0403USA02109, 0403USA02110, 043USA02111, 0403USA02112, 0403USA02114, 0403USA02115).
Age: 1.17
Sex: F
Vaccine: DT, HIBV, MMR, OPV, VARCEL
Symptoms: Drug ineffective, 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 concerning a first grade 6 year old  female pt who on 04/16/98 was vaccinated with a dose of varicella virus vaccine live (lot #622850/0537E). Concomitant therapy included a fourth dose in the left deltoid of Hib conj vaccine (OMPC) (lot #626030/003H), a fourth dose IM in the right deltoid diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (lot #F451-495), a first dose SQ in the right arm of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #625228/1596N) and a third dose PO of poliovirus vaccine inactivated (unspecified) (lot #F0786C). On 17-Jan-2004, the patient developed chickenpox. There was no relevant diagnostic tests and or laboratory data, no illness at the time of vaccination, and no past medical history. It was noted that the patient recovered. There was no product quality complaint involved. No further information is avaiable. It was noted that pt's from the same source had a similar experience (WAES # 0403USA02088, 0403USA02109, 0403USA02110, 0403USA02111, 0403USA02112, 0403USA02113, 0403USA02115).
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, 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 concerning a third grade male pt who on 25Sep1996 was vaccinated with a first dose of varicella virus vaccine live. No other vaccines were given on the same date or in the months before and after. Follow-up information was received from the registered nurse who indicated that the patient was not vaccinated at her facility. The patient was vaccinated elsewhere, the location of which was unknown. It was noted that reporter's office began providing immunizations to the patient in 2000. Chickenpox was diagnosed on 19-Jan-2004. No further information is expected. It was noted that pt's from the same source had a similar experience (WAES 0403USA02086, 0403USA02109, 0403USA02110, 0403USA02111, 0403USA02112, 0403USA02113, 0403USA02114).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Infection transmission via personal contact
Clinical narrative: Information has been received from a physician's office concerning a less than 1 year old female whose 7 year old white brother was vaccinated IM with a first dose of varicella virus vaccine live. It was noted that the female contracted chickenpox. The reporter indicated that the brother also developed chickenpox. No further information is expected.
Age: 0.58
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Infection transmission via personal contact
Clinical narrative: Information has been received from a RN concerning a 7 month old pt who had not been vaccinated because of his age but came down with the chickenpox. The RN reported his older sibling who had been vaccinated with varicella virus vaccine live "broke out with a moderate case of chicken pox" two weeks later, reported as 26Apr03. Unspecified medical attention was sought. The reporter mentioned that two other siblings also "broke out with moderate cases of chickenpox" following vaccination with varicella virus vaccine live. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old Caucasian male with seasonal allergies only who on 3/24/03 in the PM was vaccinated with a first dose of varicella virus vaccine live (lot # 644089/1064M), SC in the right arm. There was no concomitant medication or illness at the time of vaccination. Subsequently, the patient's younger brother had developed chicken pox after the patient had been vaccinated. Subsequently, the patient developed a very mild case of chicken pox. The patient recovered. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning an otherwise healthy 6 year old Caucasian female with no allergies who on 6/16/95 was vaccinated with one dose of varicella virus vaccine live SC. On 5/17/97, the patient developed lesions all over her body. The reporter noted that causality is unknown. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Skin ulcer
Clinical narrative: Information has been received from a health care professional concerning a 27 year old Caucasian female patient with allergy to penicillin and a history of possible febrile urinary tract infection who on 11/19/97 was vaccinated with the first dose of varicella virus vaccine live SC in the left deltoid. Concomitant therapy included ciprofloxacin hydrochloride. On 12/1/97 the patient developed small, red, raised blemish at the injection site which did not vesiculate or blister. On 12/2/97 through 12/22/97 she also developed 1 to 2 lesions that appeared every 2 to 3 days, one of which appeared by her right ear. These lesions were described as looking like an ant sting bite and they never vesiculated, blistered or crusted over. On 12/10/97 she also reported two lesions on the inner lining of her nose. On 12/28/97 the lesions resolved and on 12/29/97 she returned to work. It was reported that patient's non-vaccinated child had a similar experience. No further details is available.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a third dose of varicella virus vaccine live. Subsequently the patient experienced a lack of response. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site vesicles
Clinical narrative: Information has been received from a company representative concerning his 14 year old son who was vaccinated with first dose of varicella virus vaccine live. Two-week post vaccination, the patient experienced pain and blistering at injection site. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: HEPA, TD, YF
Symptoms: Chills, Pain, Pyrexia, Swelling, Tremor
Clinical narrative: 5/13/04 Client notified Immunization nurse of swelling and pain to left upper arm with fever, body aches, chills and trembling. Symptoms started 1 day after receiving vaccines.
Age: 75.0
Sex: F
Vaccine: TD
Symptoms: Pain
Clinical narrative: Became sore very soon after injections, increasing over the next 3-4 days.  Went to the doctor, he x-rayed it and there were no findings.  She read her paperwork recently and realized she needed to report it.
Age: 26.0
Sex: M
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, and body ache for three days.
Age: 62.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, Body ache for 2 days
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The injection site was the right deltoid.  Client presented and was seen at the Health Department on 5/25/04 at 4:30 pm.  The site was pink and edematous, measuring 75cmx50cm.  A 3cmx5cm ulceration was noted inside the edematous area.  Site warm to the touch and child stated area hurt when palpated.  Referred to ER for physician follow up.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR
Symptoms: Antisocial behaviour, Apathy, Aphasia, Autism, Drug toxicity
Clinical narrative: From initial information received regarding a case in litigation on 5/17/03 concerning an adverse event occurring in the USA, it was reported that an 18 month old male patient received an MMR vaccination, lot number and route of administration unknown on 2/15/00 and developed autism spectrum disorder and pervasive developmental disorder. At the age of 18 months, the boy was withdrawn, unable to speak and was unresponsive to his environment. His injuries included the loss of language skills, motor skills and affect. The child could no longer maintain eye contact with those around him, could no longer point his finger to recognize items and could no longer interact with his mother and father and others in his social environment. It was reported that the child had received numerous injections containing toxic mercury in the form of thimerosal in at least 14 doses administered between 12/4/98 and 11/9/01. It was also reported that thimerosal used in vaccines and the MMR vaccine individually and/or jointly combined caused the child's autism spectrum disorder. A summary of the child's vaccination are as follows: On 12/4/98 the child was vaccinated with HEPATITIS B, lot number and route of administration unknown. On 12/29/98 at approximately 2 months of age, the child received three vaccine injections including IPOL, ACTHIB, and TRIPEDIA (lot numbers and routes of administration unknown). On 2/26/99 at approximately four months of age, the child received three more vaccine injections including IPOL, ACTHIB, and TRIPEDIA (lot numbers and routes of administration unknown) On 4/27/99 at approximately six months of age, the child received two more vaccine injections including TRIPEDIA and ACTHIB (lot numbers and routes of administration unknown). On 7/29/99 at approximately nine months of age, the child received vaccination with HEPATITIS B (lot number and route of administration unknown). On 2/15/00 at approximately sixteen months of age, the child received vaccination with MMR vaccine (lot number and route of administration unknown). On 5/12/00 at eighteen months of age, the child received two more vaccine injections including IPOL and ACTHIB (Lot numbers and routes of administration unknown). On 11/7/00 at two years of age, the child received FLUZONE (lot number and route of administration unknown) and PREVNAR (lot number and route of administration unknown). On 12/7/00 at twenty-five months of age, the child received FLUZONE (lot number and route of administration unknown). On 6/25/01 the child was diagnosed as having autism spectrum disorder/pervasive developmental disorders. On 11/9/01 at three years of age, the child was vaccinated again with his final FLUZONE dose (lot number and route of administration unknown). The patient did not recover from these events.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR
Symptoms: Hypokinesia, Speech disorder
Clinical narrative: From initial information received regarding a case in litigation on 5/17/03 concerning an adverse event occurring in the USA, it was reported that an 18 month old male patient received an MMR vaccination, lot number and route of administration unknown on 2/15/00 and developed autism spectrum disorder and pervasive developmental disorder. At the age of 18 months, the boy was withdrawn, unable to speak and was unresponsive to his environment. His injuries included the loss of language skills, motor skills and affect. The child could no longer maintain eye contact with those around him, could no longer point his finger to recognize items and could no longer interact with his mother and father and others in his social environment. It was reported that the child had received numerous injections containing toxic mercury in the form of thimerosal in at least 14 doses administered between 12/4/98 and 11/9/01. It was also reported that thimerosal used in vaccines and the MMR vaccine individually and/or jointly combined caused the child's autism spectrum disorder. A summary of the child's vaccination are as follows: On 12/4/98 the child was vaccinated with HEPATITIS B, lot number and route of administration unknown. On 12/29/98 at approximately 2 months of age, the child received three vaccine injections including IPOL, ACTHIB, and TRIPEDIA (lot numbers and routes of administration unknown). On 2/26/99 at approximately four months of age, the child received three more vaccine injections including IPOL, ACTHIB, and TRIPEDIA (lot numbers and routes of administration unknown) On 4/27/99 at approximately six months of age, the child received two more vaccine injections including TRIPEDIA and ACTHIB (lot numbers and routes of administration unknown). On 7/29/99 at approximately nine months of age, the child received vaccination with HEPATITIS B (lot number and route of administration unknown). On 2/15/00 at approximately sixteen months of age, the child received vaccination with MMR vaccine (lot number and route of administration unknown). On 5/12/00 at eighteen months of age, the child received two more vaccine injections including IPOL and ACTHIB (Lot numbers and routes of administration unknown). On 11/7/00 at two years of age, the child received FLUZONE (lot number and route of administration unknown) and PREVNAR (lot number and route of administration unknown). On 12/7/00 at twenty-five months of age, the child received FLUZONE (lot number and route of administration unknown). On 6/25/01 the child was diagnosed as having autism spectrum disorder/pervasive developmental disorders. On 11/9/01 at three years of age, the child was vaccinated again with his final FLUZONE dose (lot number and route of administration unknown). The patient did not recover from these events.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR
Symptoms: Aphasia, Autism, Coma, Drug toxicity, Gaze palsy
Clinical narrative: From initial information received regarding a case in litigation on 5/17/03 concerning an adverse event occurring in the USA, it was reported that an 18 month old male patient received an MMR vaccination, lot number and route of administration unknown on 2/15/00 and developed autism spectrum disorder and pervasive developmental disorder. At the age of 18 months, the boy was withdrawn, unable to speak and was unresponsive to his environment. His injuries included the loss of language skills, motor skills and affect. The child could no longer maintain eye contact with those around him, could no longer point his finger to recognize items and could no longer interact with his mother and father and others in his social environment. It was reported that the child had received numerous injections containing toxic mercury in the form of thimerosal in at least 14 doses administered between 12/4/98 and 11/9/01. It was also reported that thimerosal used in vaccines and the MMR vaccine individually and/or jointly combined caused the child's autism spectrum disorder. A summary of the child's vaccination are as follows: On 12/4/98 the child was vaccinated with HEPATITIS B, lot number and route of administration unknown. On 12/29/98 at approximately 2 months of age, the child received three vaccine injections including IPOL, ACTHIB, and TRIPEDIA (lot numbers and routes of administration unknown). On 2/26/99 at approximately four months of age, the child received three more vaccine injections including IPOL, ACTHIB, and TRIPEDIA (lot numbers and routes of administration unknown) On 4/27/99 at approximately six months of age, the child received two more vaccine injections including TRIPEDIA and ACTHIB (lot numbers and routes of administration unknown). On 7/29/99 at approximately nine months of age, the child received vaccination with HEPATITIS B (lot number and route of administration unknown). On 2/15/00 at approximately sixteen months of age, the child received vaccination with MMR vaccine (lot number and route of administration unknown). On 5/12/00 at eighteen months of age, the child received two more vaccine injections including IPOL and ACTHIB (Lot numbers and routes of administration unknown). On 11/7/00 at two years of age, the child received FLUZONE (lot number and route of administration unknown) and PREVNAR (lot number and route of administration unknown). On 12/7/00 at twenty-five months of age, the child received FLUZONE (lot number and route of administration unknown). On 6/25/01 the child was diagnosed as having autism spectrum disorder/pervasive developmental disorders. On 11/9/01 at three years of age, the child was vaccinated again with his final FLUZONE dose (lot number and route of administration unknown). The patient did not recover from these events.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR
Symptoms: Autism, Neurodevelopmental disorder, Speech disorder
Clinical narrative: From initial information received regarding a case in litigation on 5/17/03 concerning an adverse event occurring in the USA, it was reported that an 18 month old male patient received an MMR vaccination, lot number and route of administration unknown on 2/15/00 and developed autism spectrum disorder and pervasive developmental disorder. At the age of 18 months, the boy was withdrawn, unable to speak and was unresponsive to his environment. His injuries included the loss of language skills, motor skills and affect. The child could no longer maintain eye contact with those around him, could no longer point his finger to recognize items and could no longer interact with his mother and father and others in his social environment. It was reported that the child had received numerous injections containing toxic mercury in the form of thimerosal in at least 14 doses administered between 12/4/98 and 11/9/01. It was also reported that thimerosal used in vaccines and the MMR vaccine individually and/or jointly combined caused the child's autism spectrum disorder. A summary of the child's vaccination are as follows: On 12/4/98 the child was vaccinated with HEPATITIS B, lot number and route of administration unknown. On 12/29/98 at approximately 2 months of age, the child received three vaccine injections including IPOL, ACTHIB, and TRIPEDIA (lot numbers and routes of administration unknown). On 2/26/99 at approximately four months of age, the child received three more vaccine injections including IPOL, ACTHIB, and TRIPEDIA (lot numbers and routes of administration unknown) On 4/27/99 at approximately six months of age, the child received two more vaccine injections including TRIPEDIA and ACTHIB (lot numbers and routes of administration unknown). On 7/29/99 at approximately nine months of age, the child received vaccination with HEPATITIS B (lot number and route of administration unknown). On 2/15/00 at approximately sixteen months of age, the child received vaccination with MMR vaccine (lot number and route of administration unknown). On 5/12/00 at eighteen months of age, the child received two more vaccine injections including IPOL and ACTHIB (Lot numbers and routes of administration unknown). On 11/7/00 at two years of age, the child received FLUZONE (lot number and route of administration unknown) and PREVNAR (lot number and route of administration unknown). On 12/7/00 at twenty-five months of age, the child received FLUZONE (lot number and route of administration unknown). On 6/25/01 the child was diagnosed as having autism spectrum disorder/pervasive developmental disorders. On 11/9/01 at three years of age, the child was vaccinated again with his final FLUZONE dose (lot number and route of administration unknown). The patient did not recover from these events.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Convulsion, Pyrexia
Clinical narrative: From initial information received on 18May2004 from a health care professional regarding an adverse event, it was reported that a 19  month old male pt received his fourth dose of ACTHIB, administered in the right thigh (route of administration not reported), his fourth dose of DAPTACEL, administered IM in the right thigh and a dose of IPOL, administered SC in the left thigh on 06May2004. The following day, on 07May2004 at 10:00AM, the pt developed a fever of 102.0 degrees F (38.9 C) and was given ibuprofen fifteen minutes later. At approximately 10:30AM the child experienced a seizure and was taken to the ER. The pt was hospitalized one day. Upon arrival, the pt's temperature has increased to 104 degrees F (40 C). The seizure lasted 45 minutes and no other symptoms were noted. The pt's recovery status was not reported.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Infection, Injection site erythema, Injection site infection, Injection site mass, Injection site reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a healthy 9 year old female patient who on 4/14/04 was vaccinated in the left posterior deltoid with a dose of varicella virus vaccine live (lot # 641787/0758M) during a preventative exam. Concomitant vaccination on 4/14/04 included a dose of hepatitis A virus vaccine inactivated in the other arm. Subsequently in approximately 4/04, the patient's mother reported the patient's arm became very hot, red, and swollen. The area was 10 cm by 8 cm. The mother reported the redness and warmth lasted for four to five days, at which time, the patient was at the beach. When the patient returned, the arm swelling continued. On 5/4/04, the patient was seen with a swollen arm and a mass was noted on her left upper arm. Examination of the left posterior deltoid showed a 1.5 by 2 cm hard, discrete and mobile mass that was non-tender, palpable in muscle mass with no overlying erythema. The reporter stated the mass was at the injection site of the varicella virus vaccine live. It was noted that the patient had developed a skin infection at the injection site. The patient was not treated with any medications and was not complaining of any pain. The nurse referred the patient to a pediatric surgeon. On 5/13/04, the patient was seen by the pediatric surgeon. The surgeon suspected a possible cyst or deep abscess or that an abscess may have healed and the mass was scar tissue. The surgeon wanted a sonogram of the patient's arm and wanted to see her again in one month. The patient was not hospitalized. The sonogram was scheduled for 5/22/04 and the next exam with the surgeon was scheduled for 7/8/04, unless the results warrant something sooner. The reporter felt this case was serious and unresolved.  Upon internal review, the patient's experience was considered to be an other important medical event (OMIC). The reporter also mentioned another patient who developed a skin infection at the injection site post vaccination with varicella virus vaccine live (lot # 641787/0758M). The reporter was very concerned about this lot number and requested a lot check. The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. Follow up on 06/08/04 states: "The sonogram showed a 1.6 by 0.7 cm solid hyperechoic mass in the left arm. At the time of the report, the pt was not complaining of pain or discomfort and they were just observing the pt. The next exam with the surgeon was scheduled for 07/08/04.  The reporter felt this case was serious and unresolved.  Additional information has been requested."
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Laboratory test abnormal, Oedema peripheral
Clinical narrative: Information has been received from a nurse practitioner concerning a healthy 9 year old female patient who on 4/14/04 was vaccinated in the left posterior deltoid with a dose of varicella virus vaccine live (lot # 641787/0758M) during a preventative exam. Concomitant vaccination on 4/14/04 included a dose of hepatitis A virus vaccine inactivated in the other arm. Subsequently in approximately 4/04, the patient's mother reported the patient's arm became very hot, red, and swollen. The area was 10 cm by 8 cm. The mother reported the redness and warmth lasted for four to five days, at which time, the patient was at the beach. When the patient returned, the arm swelling continued. On 5/4/04, the patient was seen with a swollen arm and a mass was noted on her left upper arm. Examination of the left posterior deltoid showed a 1.5 by 2 cm hard, discrete and mobile mass that was non-tender, palpable in muscle mass with no overlying erythema. The reporter stated the mass was at the injection site of the varicella virus vaccine live. It was noted that the patient had developed a skin infection at the injection site. The patient was not treated with any medications and was not complaining of any pain. The nurse referred the patient to a pediatric surgeon. On 5/13/04, the patient was seen by the pediatric surgeon. The surgeon suspected a possible cyst or deep abscess or that an abscess may have healed and the mass was scar tissue. The surgeon wanted a sonogram of the patient's arm and wanted to see her again in one month. The patient was not hospitalized. The sonogram was scheduled for 5/22/04 and the next exam with the surgeon was scheduled for 7/8/04, unless the results warrant something sooner. The reporter felt this case was serious and unresolved.  Upon internal review, the patient's experience was considered to be an other important medical event (OMIC). The reporter also mentioned another patient who developed a skin infection at the injection site post vaccination with varicella virus vaccine live (lot # 641787/0758M). The reporter was very concerned about this lot number and requested a lot check. The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. Follow up on 06/08/04 states: "The sonogram showed a 1.6 by 0.7 cm solid hyperechoic mass in the left arm. At the time of the report, the pt was not complaining of pain or discomfort and they were just observing the pt. The next exam with the surgeon was scheduled for 07/08/04.  The reporter felt this case was serious and unresolved.  Additional information has been requested."
Age: 1.17
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Agitation, Cellulitis, Erythema, Injection site induration, Injection site infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 month old female pt with no known medical history who on 20Apr2004 was vaccinated in the right anterior thigh at her well visit with a dose of varicella virus vaccine live. Concomitant vaccination on 20Apr2004 included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) at another site. On 03May2004, the pt was seen by the nurse practicioner with swelling and redness of the leg that had started 12 hours prior. It was noted that the pt developed a skin infection at the injection site. The pt was afebrile and could stand on her leg. The patient was treated with amoxicillin (+) clavulanate potassium (AUGMENTIN) for 24 hours. On 04May2004, the pt was seen again for a follow-up visit. The pt was febrile, very irritable when her leg was manipulated and could stand on her leg, "but really wasn't" The area was a 6.5 cm by 8.5 cm, "non-fluctuate", erythematous, slightly bluish and hardened area on the right anterior thigh. The area had increased in size from 3.5 by 6 cm the day before. At that time, the nurse arranged for admission to the hospital. On the evening of 04May2004 the pt was hospitalized for cellulitis at the injection site. The pt was treated with intravenous antibiotics. Two and a half days later, the pt was discharged and recovered. The nurse saw the pt for follow up and the pt was walking fine. A product quality complaint was not involved. The reporter also mentioned another pt who developed a skin infection at the injection site post vaccination with varicella virus vaccine live. The reporter was very concerned about this lot number and requested a lot check. 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. Additional information has been requested. Follow up information received from a nurse practitioner indicated that she had no further information to report. No additional information is expected.
Age: 1.17
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Pyrexia, Skin discolouration, Swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 month old female pt with no known medical history who on 20Apr2004 was vaccinated in the right anterior thigh at her well visit with a dose of varicella virus vaccine live. Concomitant vaccination on 20Apr2004 included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) at another site. On 03May2004, the pt was seen by the nurse practicioner with swelling and redness of the leg that had started 12 hours prior. It was noted that the pt developed a skin infection at the injection site. The pt was afebrile and could stand on her leg. The patient was treated with amoxicillin (+) clavulanate potassium (AUGMENTIN) for 24 hours. On 04May2004, the pt was seen again for a follow-up visit. The pt was febrile, very irritable when her leg was manipulated and could stand on her leg, "but really wasn't" The area was a 6.5 cm by 8.5 cm, "non-fluctuate", erythematous, slightly bluish and hardened area on the right anterior thigh. The area had increased in size from 3.5 by 6 cm the day before. At that time, the nurse arranged for admission to the hospital. On the evening of 04May2004 the pt was hospitalized for cellulitis at the injection site. The pt was treated with intravenous antibiotics. Two and a half days later, the pt was discharged and recovered. The nurse saw the pt for follow up and the pt was walking fine. A product quality complaint was not involved. The reporter also mentioned another pt who developed a skin infection at the injection site post vaccination with varicella virus vaccine live. The reporter was very concerned about this lot number and requested a lot check. 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. Additional information has been requested. Follow up information received from a nurse practitioner indicated that she had no further information to report. No additional information is expected.
Age: 2.5
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, High-pitched crying, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 30 month old male with reactive airway disease, chronic sinusitis, other respiratory conditions, immune problems and low immunoglobulin G (IgG) (patient noted to be sick all of his life) who on 4/29/04 was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646712/1179N). There were no other vaccinations administered on that day. Other concomitant therapy included R2D, fluticasone propionate, mometasone furoate, levalbuterol HCl and clindamycin. The physician reported that on 4/30/04, the patient developed arm tenderness and was shrieking in pain. Ice and diphenhydramine HCl were recommended as treatment. On 5/1/04, the patient developed a fever, vomiting, and his arm was swollen. On that same day, the patient was seen in the ER. On 5/2/04, the patient was again seen in the ER. On 5/3/04, the patient was hospitalized for three days as his arm was red, hot and swollen in addition to the arm tenderness, fever, and vomiting. In May 2004, the patient recovered from his events and was scheduled for a follow up visit with his physician. The physician also reported that two other patient developed non-serious adverse events after being vaccinated with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.  Follow UP: The physician also reported that two other patients developed non-serious adverse events after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES $s 0405USA01170 AND 0405USA01171). Additional information is not expected.  Follow up on 09/09/04 states: "There were no relevant diagnostic tests or lab tests performed.  The reporter considered the pt's experience to be an other important medical event (OMIC).  Additional information is not expected."
Age: 2.5
Sex: M
Vaccine: PPV
Symptoms: Tenderness, Vomiting
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 30 month old male with reactive airway disease, chronic sinusitis, other respiratory conditions, immune problems and low immunoglobulin G (IgG) (patient noted to be sick all of his life) who on 4/29/04 was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646712/1179N). There were no other vaccinations administered on that day. Other concomitant therapy included R2D, fluticasone propionate, mometasone furoate, levalbuterol HCl and clindamycin. The physician reported that on 4/30/04, the patient developed arm tenderness and was shrieking in pain. Ice and diphenhydramine HCl were recommended as treatment. On 5/1/04, the patient developed a fever, vomiting, and his arm was swollen. On that same day, the patient was seen in the ER. On 5/2/04, the patient was again seen in the ER. On 5/3/04, the patient was hospitalized for three days as his arm was red, hot and swollen in addition to the arm tenderness, fever, and vomiting. In May 2004, the patient recovered from his events and was scheduled for a follow up visit with his physician. The physician also reported that two other patient developed non-serious adverse events after being vaccinated with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.  Follow UP: The physician also reported that two other patients developed non-serious adverse events after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES $s 0405USA01170 AND 0405USA01171). Additional information is not expected.  Follow up on 09/09/04 states: "There were no relevant diagnostic tests or lab tests performed.  The reporter considered the pt's experience to be an other important medical event (OMIC).  Additional information is not expected."
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypersensitivity, Pallor, Peripheral coldness, Pyrexia
Clinical narrative: Mom reports arms and legs were cold and pale and history of groaning/moaning. Patient had fever temp 100.4 in clinic and noted moaning. Admitted for septic work up.  Nurse follow up on 06/18/04 states: "Vaccine reaction."
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Chills, Hypoventilation, Pruritus
Clinical narrative: Itching reported 15-20min after injection no rash seen. IM Benadryl given. 15 min after Benadryl reported chills. Sent home. Took more Benadryl. Slept. Awoke at 4PM. Reported chest tightness. Unable to take deep breath. Sent to ER.
Age: 49.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Hypokinesia, Injury, Paraesthesia, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis after AVA #1 and SPV. Symptoms initiated about 3 weeks post vaccines. This is a 50 year old who received Anthrax #1 and Smallpox vaccine on January 28, 2003. Two days later he was hit in the head and knocked unconscious. He suffered a concussion and was sent home. While being wheeled through the airport he noticed a short electrical jolt pass through his right index finger. He reports that after he was home, within a few weeks he noticed a progressive change in his mobility. It became difficult for him to get in and out of a chair and to go up and down stairs. He also experienced difficulty in closing his fingers. He began experiencing joint pain in his hands, ankles, and knees. During this time, he also had an electrical jolt pass through his left index finger. He went to his PCP and was referred to a physician who diagnosed him with rheumatoid arthritis. He was given methotrexate for his joint pain. Eventually he was able to see a [Dr] at the [University]. [The Dr. ]prescribed Enbrel for [pt].
Age: 49.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Syncope
Clinical narrative: Rheumatoid arthritis after AVA #1 and SPV. Symptoms initiated about 3 weeks post vaccines. This is a 50 year old who received Anthrax #1 and Smallpox vaccine on January 28, 2003. Two days later he was hit in the head and knocked unconscious. He suffered a concussion and was sent home. While being wheeled through the airport he noticed a short electrical jolt pass through his right index finger. He reports that after he was home, within a few weeks he noticed a progressive change in his mobility. It became difficult for him to get in and out of a chair and to go up and down stairs. He also experienced difficulty in closing his fingers. He began experiencing joint pain in his hands, ankles, and knees. During this time, he also had an electrical jolt pass through his left index finger. He went to his PCP and was referred to a physician who diagnosed him with rheumatoid arthritis. He was given methotrexate for his joint pain. Eventually he was able to see a [Dr] at the [University]. [The Dr. ]prescribed Enbrel for [pt].
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis after AVA #4.
Age: 37.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Rash pustular, Urticaria
Clinical narrative: Member had systemic rash, concentrated mix of hives and pustules. Rash covered torso, bilateral upper extremities, and face/head. Member seen at ER; treated with Benadryl and released. No current complaints.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient had #3 Anthrax on 5/24/04 in left arm SC at 10:00. Patient stated on 5/25/04 at approximately 19:00, left arm got very red, hot, swollen with shooting pain down to hand. This continued for approximately 1 hour. Patient called MD on call; was told to go the ER> Patient went to ER and was told to use ice packs 20 minutes every 4 hours while awake. Placed on Benadryl 25mg PO every 4-6 hours and Motrin 800mg every 8 hours for 72 hours. Called patient today and she says she's feeling better and less swelling, less pain and less erythema.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Dermatitis atopic, Eczema, Rash
Clinical narrative: Eczematous rash, most likely atopic eczema. Developed about 3 months after 4th injection in primary anthrax vaccine absorbed vaccination series. Exacerbation after 5th injection in 1/03.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Cyanosis, Peripheral vascular disorder
Clinical narrative: Crying unconsolable for 4 hours. Legs blue for 15 minutes per mom.
Age: 34.0
Sex: F
Vaccine: ANTH, FLU3, TYP
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: After being administered with Anthrax vaccine, the same day experienced pain, swelling, itching in the arm. Continues symptoms 2 days after. Symptoms worse; reaction locally is 4"x4".
Age: 1.08
Sex: F
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: Seizure activity; seeing pediatrician. CT scan negative. LP negative; CXR normal
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom called on 5/11/04 to report that on 5/8/04, her daughter developed, redness and swelling on right upper arm at site of immunizations. Mom took daughter to doctor at 6:30 PM on 5/8 for evaluation of symptoms. Per mom, doctor advised ice packs and Benadryl. As of 5/11/04, daughter is doing much better and symptoms are resolving.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Neck pain, Pyrexia
Clinical narrative: Seven days post vaccination child woke up complaining of a sore neck. Mom stated she thought child had an ear infection so she gave the child Motrin for the pain and mild fever. She also stated that after a few hours the child's neck appeared swollen on one side and there was a slight rash on the front of her neck. Mom also stated that she took the child to the doctors' office that morning and the doctor diagnosed the child as having mumps. Mom stated that the child was fine in three days. Mom told the nurse at the clinic where the vaccine was given on 5/20/04 about this reaction while she was receiving vaccines for her son.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: Reaction unevaluable.
Age: 0.9
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Patient had local reaction to site; swollen; redness, and rash on face and torso. Benadryl 1.5 teaspoon given PO per physician order. Reaction appeared within 5 minutes after injection.
Age: 0.2
Sex: M
Vaccine: HIBV
Symptoms: Crying, Irritability, Lethargy, Oral intake reduced, Vomiting
Clinical narrative: Vomiting, crying began 2 hours after injection. Decreased oral intake, lethargy and fussiness continued for about 3 days.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient received Pneumococcal vaccine 5/20/04 1-2 PM. Fatigue at 5:00 PM. About 6:00 PM nausea and emesis, temp > 101 degrees F, nausea and vomiting of half hour. Increased arm soreness. 5/21/04 2:00 AM Went to ER. Treated with IV fluid, IV phenergam, PO Tylenol. Severe headache at 6:00 AM, nausea with emesis. Phenergan supp, temp 103. 5/22/04 Nausea with emesis, temp 100, large local 3x8cm at injection site. Given Allegra 190 and Zyrtec 150 with relief.