chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Received 1 year vaccines on 9/21/07.  That night with fever to 102.  9/22/07 with vomiting and low appetite and slight fever (-100).  Vomiting through 9/25, no diarrhea.  Fussy and not acting herself.  9/26 generalized macular/papular rash.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Swelling, hives, shoulder pain on arm where injection was received (began 1 hr post injection and continued for 4 days). Nausea, dizziness, fever, fatigue (continued for 4-5 days after injection). Treated with Benadryl.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia
Clinical narrative: Swelling, hives, shoulder pain on arm where injection was received (began 1 hr post injection and continued for 4 days). Nausea, dizziness, fever, fatigue (continued for 4-5 days after injection). Treated with Benadryl.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Hypokinesia, Injected limb mobility decreased, Muscular weakness, Tenderness
Clinical narrative: Weak tender muscles in both arms and legs starting after injection and she had difficulty lifting injected arm above head.  She went to her family doctor and received several blood tests and MD started her on an Antibiotic.  Patient said weakness in non- injection arm is starting to go away in last part of December.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and edema @ site of varicella vaccine, 2 1/4 inches in diameter (48mm); no burning, itching, or sensitivity to touch.
Age: 50.0
Sex: M
Vaccine: FLU3, IPV, PPV, TYP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: PT. RETURNED TO CLINIC ON 1-2-08 AND REPORTED REDNESS AT SITE OF PNEUMOCOCCAL INJ. LEFT ARM. SITE HAD AREA OF REDNESS AND EDEMA PRESENT MEASURING 115MM X 115MM. PT. DID NOT REPORT ANY OTHER S/S.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site bruising, Injection site erythema, Injection site mass
Clinical narrative: Child receive Prevnar and hib inj. in RVL on 12-26-07. She brought her other child in 1-03-08 for immz. I asked her how her other child tolerated his immz because he is very small (10 lbs) She stated he had a bump on his leg. I observed a 1" hard lump. No warmth, pink color, very light small bruise on the upper part of the childs right thigh. The nursing staff instructed her to put warm wash cloth on leg, and massage gently to help absorb the lump. She has a routine DR. appt. on Mon. 01-06-08. The nursing staff asked to have her Dr. look at the leg and if the lump gets larger, red or warm or the child develops a fever to see her Dr. immediately. My concern is centered around the fact that this child is so small and the length of time the leg has had this lump. We have a nurse that is visiting this family and I also asked her to check this child at next visit.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Exposure to communicable disease, Inappropriate schedule of drug administration, Injection site erythema, Medication error
Clinical narrative: Patient said that the injection site was red for 10 days, and that she got an itchy, blistery rash on her left-side of back, 3 days after she received vaccine.  She also mentioned that her mom had a bad case of shingles.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Sick relative
Clinical narrative: Patient said that the injection site was red for 10 days, and that she got an itchy, blistery rash on her left-side of back, 3 days after she received vaccine.  She also mentioned that her mom had a bad case of shingles.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Alanine aminotransferase normal, Blood albumin decreased, Chapped lips, Conjunctivitis, Culture stool positive
Clinical narrative: Time of vaccination not precisely known (mom stated the child received an oral vaccine along with other vaccines within 1 week of admission), patient also received other 2 month shots at that time but again we were not able to obtain the immunization record; Presented with fevers from 10/1/07 with subsequent diffuse maculopapular rash, nonpurulent conjunctivitis, L cervical lymphadenopathy (by history it was visible but had resolved by admission), red cracked lips, foot swelling.  Fevers lasted until patient treated for Kawasaki disease on 10/9. Patient was treated with IVIG 2grams/kg and high dose aspirin until day #14, then 40.5mg Aspirin qd.   Patient subsequently had peeling of his hands and feet in classic KD fashion.  01/22/2008 MR received for DOS 10/7-10/2007 with DX:  Kawasaki Disease.  Infant presented to ER with 1 week hx of fever, 3 day hx of rash on hands, legs, feet, and back, vomiting, cough, congestion, diarrhea, increased urination, decreased appetitie and red eyes.   PE (+) for erythematous sclera bilaterally, crusted nares, enlarged subauricular lymph nodes, 2/6 systolic murmur, and erythematous rash.  Dry lips and red tongue noted by ID consultant as well as swelling of hands and feet.  TX with IVIG and high dose ASA. Peeling skin noted at f/u appt 12/5/07.  Also episodes of "zoning out".  No seizure activity noted.  otherwise doing well
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Echocardiogram normal, Erythema, Haemoglobin decreased, Immunoglobulins, Kawasaki's disease
Clinical narrative: Time of vaccination not precisely known (mom stated the child received an oral vaccine along with other vaccines within 1 week of admission), patient also received other 2 month shots at that time but again we were not able to obtain the immunization record; Presented with fevers from 10/1/07 with subsequent diffuse maculopapular rash, nonpurulent conjunctivitis, L cervical lymphadenopathy (by history it was visible but had resolved by admission), red cracked lips, foot swelling.  Fevers lasted until patient treated for Kawasaki disease on 10/9. Patient was treated with IVIG 2grams/kg and high dose aspirin until day #14, then 40.5mg Aspirin qd.   Patient subsequently had peeling of his hands and feet in classic KD fashion.  01/22/2008 MR received for DOS 10/7-10/2007 with DX:  Kawasaki Disease.  Infant presented to ER with 1 week hx of fever, 3 day hx of rash on hands, legs, feet, and back, vomiting, cough, congestion, diarrhea, increased urination, decreased appetitie and red eyes.   PE (+) for erythematous sclera bilaterally, crusted nares, enlarged subauricular lymph nodes, 2/6 systolic murmur, and erythematous rash.  Dry lips and red tongue noted by ID consultant as well as swelling of hands and feet.  TX with IVIG and high dose ASA. Peeling skin noted at f/u appt 12/5/07.  Also episodes of "zoning out".  No seizure activity noted.  otherwise doing well
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Lymphadenopathy, Oedema peripheral, Platelet count increased, Pyrexia, Rash maculo-papular
Clinical narrative: Time of vaccination not precisely known (mom stated the child received an oral vaccine along with other vaccines within 1 week of admission), patient also received other 2 month shots at that time but again we were not able to obtain the immunization record; Presented with fevers from 10/1/07 with subsequent diffuse maculopapular rash, nonpurulent conjunctivitis, L cervical lymphadenopathy (by history it was visible but had resolved by admission), red cracked lips, foot swelling.  Fevers lasted until patient treated for Kawasaki disease on 10/9. Patient was treated with IVIG 2grams/kg and high dose aspirin until day #14, then 40.5mg Aspirin qd.   Patient subsequently had peeling of his hands and feet in classic KD fashion.  01/22/2008 MR received for DOS 10/7-10/2007 with DX:  Kawasaki Disease.  Infant presented to ER with 1 week hx of fever, 3 day hx of rash on hands, legs, feet, and back, vomiting, cough, congestion, diarrhea, increased urination, decreased appetitie and red eyes.   PE (+) for erythematous sclera bilaterally, crusted nares, enlarged subauricular lymph nodes, 2/6 systolic murmur, and erythematous rash.  Dry lips and red tongue noted by ID consultant as well as swelling of hands and feet.  TX with IVIG and high dose ASA. Peeling skin noted at f/u appt 12/5/07.  Also episodes of "zoning out".  No seizure activity noted.  otherwise doing well
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rotavirus test positive, Skin exfoliation, Virus culture positive, Virus serology test positive, White blood cell count increased
Clinical narrative: Time of vaccination not precisely known (mom stated the child received an oral vaccine along with other vaccines within 1 week of admission), patient also received other 2 month shots at that time but again we were not able to obtain the immunization record; Presented with fevers from 10/1/07 with subsequent diffuse maculopapular rash, nonpurulent conjunctivitis, L cervical lymphadenopathy (by history it was visible but had resolved by admission), red cracked lips, foot swelling.  Fevers lasted until patient treated for Kawasaki disease on 10/9. Patient was treated with IVIG 2grams/kg and high dose aspirin until day #14, then 40.5mg Aspirin qd.   Patient subsequently had peeling of his hands and feet in classic KD fashion.  01/22/2008 MR received for DOS 10/7-10/2007 with DX:  Kawasaki Disease.  Infant presented to ER with 1 week hx of fever, 3 day hx of rash on hands, legs, feet, and back, vomiting, cough, congestion, diarrhea, increased urination, decreased appetitie and red eyes.   PE (+) for erythematous sclera bilaterally, crusted nares, enlarged subauricular lymph nodes, 2/6 systolic murmur, and erythematous rash.  Dry lips and red tongue noted by ID consultant as well as swelling of hands and feet.  TX with IVIG and high dose ASA. Peeling skin noted at f/u appt 12/5/07.  Also episodes of "zoning out".  No seizure activity noted.  otherwise doing well
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Localized immunization reaction with redness and induration at the site of immunization.
Age: 24.0
Sex: F
Vaccine: FLUN3, HEPAB
Symptoms: Rash
Clinical narrative: Member received Twinrix, ppd, and flu mist on 8 December 2007. A couple of days later patient C/O rash on face, neck, and upper body. Rash lasted 7 to 10 days.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site urticaria, Vomiting
Clinical narrative: Within 12 hours after flu vaccine given my daughter started to vomit and complain of a severe headache.  She is still having these symptoms 18 hours later.  She has a huge welt and redness where the shot was given on her arm also.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cellulitis, Headache, Local reaction, Malaise
Clinical narrative: Muscle aches, severe local reactions, nausea, malaise, cellulitis, severe arm pain, headache, weakness lasting a week.  Treatment: 500 mg Keflex 4 times per day, 7 days; hot compresses on arm, visit to ER.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: Muscle aches, severe local reactions, nausea, malaise, cellulitis, severe arm pain, headache, weakness lasting a week.  Treatment: 500 mg Keflex 4 times per day, 7 days; hot compresses on arm, visit to ER.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Hypokinesia, Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Moderate-severe pain @ injection site persisting x 1 month extending to shoulder joint, and occasionally down to wrist.  Still unable to lift arm above shoulder level, to twist it, or cross it over chest without significant increased pain.  On Ibuprofen/Tylenol combo x 1 month. (pain has not resolved). (Note: manufacturer was Sanofi Pasteur (Adacel), but that option wasn't available in the list).
Age: 1.34
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Genital rash, Insomnia, Lethargy, Measles
Clinical narrative: The baby got a rash the day after the vaccination.  Ten days later she got a fever.  Then a couple days later she got what appears to be full blown measles all over her entire body and genitals.  The physician commented she had never seen anything like it before.  The baby is usally quiet and easy, has been extremely lethargic, doesnt want to move sometimes, screams when left alone, wont sleep alone, doesnt have much of an appetite.  Her genitals are very sore and red. I know that you can get a couple of bumps here and there but not a complete body full of red clusters. I know the mmr was given, she was also given the chicken pox vaccine, and one other I cant recall.  Whatever vaccine is standard for 15 month visits.
Age: 1.34
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Screaming
Clinical narrative: The baby got a rash the day after the vaccination.  Ten days later she got a fever.  Then a couple days later she got what appears to be full blown measles all over her entire body and genitals.  The physician commented she had never seen anything like it before.  The baby is usally quiet and easy, has been extremely lethargic, doesnt want to move sometimes, screams when left alone, wont sleep alone, doesnt have much of an appetite.  Her genitals are very sore and red. I know that you can get a couple of bumps here and there but not a complete body full of red clusters. I know the mmr was given, she was also given the chicken pox vaccine, and one other I cant recall.  Whatever vaccine is standard for 15 month visits.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Basophil count normal, Blood gases normal, Body temperature, C-reactive protein normal, Cardiac monitoring
Clinical narrative: Information has been received from a physician concerning a 20 week old white female with a history of prenatal asymmetric ventricles and macrocephaly, no drug reaction/allergies or illnesses at time of vaccination who on 10-DEC-2007, in the pm, was vaccinated (route not reported) in the left thigh with COMVAX. The patient was concomitantly vaccinated in the right leg with 2 doses of DAPTACEL (lot C2800AA), in the left leg with 2nd dose of PREVNAR (lot A0147), right leg with 2nd dose of IPOL (lot R087021) and oral 2nd dose of ROTATEQ (lot 0903U). It was previously reported that the following vaccinations were given; DAPTACEL (lot C2765AA) on 21-Sep-2007, PREVNAR (lot A0125) on 21-Sep-2007, IPOL on 21-Sep-2007 and a oral dose of ROTATEQ (lot 657661/0973U) on 21-Sep-2007. On 14-DEC-2007, at 1:00pm post vaccination, the patient developed a rash on lower extremities that spread to the face and scalp (non-blanchable lesions on both legs approximately 0.3cm in diameter and 2 or 3 lesions with the same characteristics noted on the right side of her face), induration at the injection site (measuring 4 x 5.2cm on the left side and 2 x 1.8cm on the right), increased body temperature (98.2) and she was irritable and lethargic. It was noted that patient developed unconsolable crying 2 hours prior to presentation at the pediatrician's office. The patient was taken to the doctor's office where a physical exam was performed and the only abnormal finding was lumps on the thighs and the lesions that were consistent with petechiae rash. The physician decided that the patient should be taken to the emergency room due to the fact she received a recall lot of COMVAX and her clinical presentation. The plan was discussed with pediatric infectious disease physician by phone. He stated that he felt the likelihood of the symptoms being related to the patient's vaccination were very slim. He stated that probably etiology was a viral illness. Given the young age of the patient and the presentation the plan was to cover the patient with IV antibiotics until cultures were 24 or 48 hours negative or viral cause was isolated. The antibiotics were selected upon the result. Viral cultures were sent to DSI as well as Enterovirus PCR and CSF. The plan was discussed with the family and they were in agreement. The patient was admitted to the hospital and laboratory diagnostic tests were performed (blood work and a "battery of test"). All cultures were negative and lab test were within normal limits. The patient was treated with IV antibiotics until she was released from the hospital. The patient was hospitalized for 4 days and recovered on 17-Dec-2007. No additional information is expected. All available medical records will be provided upon request.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Computerised tomogram normal, Crying, Haematocrit normal, Haemoglobin normal, Injection site induration
Clinical narrative: Information has been received from a physician concerning a 20 week old white female with a history of prenatal asymmetric ventricles and macrocephaly, no drug reaction/allergies or illnesses at time of vaccination who on 10-DEC-2007, in the pm, was vaccinated (route not reported) in the left thigh with COMVAX. The patient was concomitantly vaccinated in the right leg with 2 doses of DAPTACEL (lot C2800AA), in the left leg with 2nd dose of PREVNAR (lot A0147), right leg with 2nd dose of IPOL (lot R087021) and oral 2nd dose of ROTATEQ (lot 0903U). It was previously reported that the following vaccinations were given; DAPTACEL (lot C2765AA) on 21-Sep-2007, PREVNAR (lot A0125) on 21-Sep-2007, IPOL on 21-Sep-2007 and a oral dose of ROTATEQ (lot 657661/0973U) on 21-Sep-2007. On 14-DEC-2007, at 1:00pm post vaccination, the patient developed a rash on lower extremities that spread to the face and scalp (non-blanchable lesions on both legs approximately 0.3cm in diameter and 2 or 3 lesions with the same characteristics noted on the right side of her face), induration at the injection site (measuring 4 x 5.2cm on the left side and 2 x 1.8cm on the right), increased body temperature (98.2) and she was irritable and lethargic. It was noted that patient developed unconsolable crying 2 hours prior to presentation at the pediatrician's office. The patient was taken to the doctor's office where a physical exam was performed and the only abnormal finding was lumps on the thighs and the lesions that were consistent with petechiae rash. The physician decided that the patient should be taken to the emergency room due to the fact she received a recall lot of COMVAX and her clinical presentation. The plan was discussed with pediatric infectious disease physician by phone. He stated that he felt the likelihood of the symptoms being related to the patient's vaccination were very slim. He stated that probably etiology was a viral illness. Given the young age of the patient and the presentation the plan was to cover the patient with IV antibiotics until cultures were 24 or 48 hours negative or viral cause was isolated. The antibiotics were selected upon the result. Viral cultures were sent to DSI as well as Enterovirus PCR and CSF. The plan was discussed with the family and they were in agreement. The patient was admitted to the hospital and laboratory diagnostic tests were performed (blood work and a "battery of test"). All cultures were negative and lab test were within normal limits. The patient was treated with IV antibiotics until she was released from the hospital. The patient was hospitalized for 4 days and recovered on 17-Dec-2007. No additional information is expected. All available medical records will be provided upon request.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Irritability, Laboratory test, Lethargy, Lipids, Lymphocyte count normal
Clinical narrative: Information has been received from a physician concerning a 20 week old white female with a history of prenatal asymmetric ventricles and macrocephaly, no drug reaction/allergies or illnesses at time of vaccination who on 10-DEC-2007, in the pm, was vaccinated (route not reported) in the left thigh with COMVAX. The patient was concomitantly vaccinated in the right leg with 2 doses of DAPTACEL (lot C2800AA), in the left leg with 2nd dose of PREVNAR (lot A0147), right leg with 2nd dose of IPOL (lot R087021) and oral 2nd dose of ROTATEQ (lot 0903U). It was previously reported that the following vaccinations were given; DAPTACEL (lot C2765AA) on 21-Sep-2007, PREVNAR (lot A0125) on 21-Sep-2007, IPOL on 21-Sep-2007 and a oral dose of ROTATEQ (lot 657661/0973U) on 21-Sep-2007. On 14-DEC-2007, at 1:00pm post vaccination, the patient developed a rash on lower extremities that spread to the face and scalp (non-blanchable lesions on both legs approximately 0.3cm in diameter and 2 or 3 lesions with the same characteristics noted on the right side of her face), induration at the injection site (measuring 4 x 5.2cm on the left side and 2 x 1.8cm on the right), increased body temperature (98.2) and she was irritable and lethargic. It was noted that patient developed unconsolable crying 2 hours prior to presentation at the pediatrician's office. The patient was taken to the doctor's office where a physical exam was performed and the only abnormal finding was lumps on the thighs and the lesions that were consistent with petechiae rash. The physician decided that the patient should be taken to the emergency room due to the fact she received a recall lot of COMVAX and her clinical presentation. The plan was discussed with pediatric infectious disease physician by phone. He stated that he felt the likelihood of the symptoms being related to the patient's vaccination were very slim. He stated that probably etiology was a viral illness. Given the young age of the patient and the presentation the plan was to cover the patient with IV antibiotics until cultures were 24 or 48 hours negative or viral cause was isolated. The antibiotics were selected upon the result. Viral cultures were sent to DSI as well as Enterovirus PCR and CSF. The plan was discussed with the family and they were in agreement. The patient was admitted to the hospital and laboratory diagnostic tests were performed (blood work and a "battery of test"). All cultures were negative and lab test were within normal limits. The patient was treated with IV antibiotics until she was released from the hospital. The patient was hospitalized for 4 days and recovered on 17-Dec-2007. No additional information is expected. All available medical records will be provided upon request.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Mass, Monocyte count normal, Neutrophil count normal, Petechiae, Platelet count normal
Clinical narrative: Information has been received from a physician concerning a 20 week old white female with a history of prenatal asymmetric ventricles and macrocephaly, no drug reaction/allergies or illnesses at time of vaccination who on 10-DEC-2007, in the pm, was vaccinated (route not reported) in the left thigh with COMVAX. The patient was concomitantly vaccinated in the right leg with 2 doses of DAPTACEL (lot C2800AA), in the left leg with 2nd dose of PREVNAR (lot A0147), right leg with 2nd dose of IPOL (lot R087021) and oral 2nd dose of ROTATEQ (lot 0903U). It was previously reported that the following vaccinations were given; DAPTACEL (lot C2765AA) on 21-Sep-2007, PREVNAR (lot A0125) on 21-Sep-2007, IPOL on 21-Sep-2007 and a oral dose of ROTATEQ (lot 657661/0973U) on 21-Sep-2007. On 14-DEC-2007, at 1:00pm post vaccination, the patient developed a rash on lower extremities that spread to the face and scalp (non-blanchable lesions on both legs approximately 0.3cm in diameter and 2 or 3 lesions with the same characteristics noted on the right side of her face), induration at the injection site (measuring 4 x 5.2cm on the left side and 2 x 1.8cm on the right), increased body temperature (98.2) and she was irritable and lethargic. It was noted that patient developed unconsolable crying 2 hours prior to presentation at the pediatrician's office. The patient was taken to the doctor's office where a physical exam was performed and the only abnormal finding was lumps on the thighs and the lesions that were consistent with petechiae rash. The physician decided that the patient should be taken to the emergency room due to the fact she received a recall lot of COMVAX and her clinical presentation. The plan was discussed with pediatric infectious disease physician by phone. He stated that he felt the likelihood of the symptoms being related to the patient's vaccination were very slim. He stated that probably etiology was a viral illness. Given the young age of the patient and the presentation the plan was to cover the patient with IV antibiotics until cultures were 24 or 48 hours negative or viral cause was isolated. The antibiotics were selected upon the result. Viral cultures were sent to DSI as well as Enterovirus PCR and CSF. The plan was discussed with the family and they were in agreement. The patient was admitted to the hospital and laboratory diagnostic tests were performed (blood work and a "battery of test"). All cultures were negative and lab test were within normal limits. The patient was treated with IV antibiotics until she was released from the hospital. The patient was hospitalized for 4 days and recovered on 17-Dec-2007. No additional information is expected. All available medical records will be provided upon request.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Rash, Serology normal, Viral infection, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 20 week old white female with a history of prenatal asymmetric ventricles and macrocephaly, no drug reaction/allergies or illnesses at time of vaccination who on 10-DEC-2007, in the pm, was vaccinated (route not reported) in the left thigh with COMVAX. The patient was concomitantly vaccinated in the right leg with 2 doses of DAPTACEL (lot C2800AA), in the left leg with 2nd dose of PREVNAR (lot A0147), right leg with 2nd dose of IPOL (lot R087021) and oral 2nd dose of ROTATEQ (lot 0903U). It was previously reported that the following vaccinations were given; DAPTACEL (lot C2765AA) on 21-Sep-2007, PREVNAR (lot A0125) on 21-Sep-2007, IPOL on 21-Sep-2007 and a oral dose of ROTATEQ (lot 657661/0973U) on 21-Sep-2007. On 14-DEC-2007, at 1:00pm post vaccination, the patient developed a rash on lower extremities that spread to the face and scalp (non-blanchable lesions on both legs approximately 0.3cm in diameter and 2 or 3 lesions with the same characteristics noted on the right side of her face), induration at the injection site (measuring 4 x 5.2cm on the left side and 2 x 1.8cm on the right), increased body temperature (98.2) and she was irritable and lethargic. It was noted that patient developed unconsolable crying 2 hours prior to presentation at the pediatrician's office. The patient was taken to the doctor's office where a physical exam was performed and the only abnormal finding was lumps on the thighs and the lesions that were consistent with petechiae rash. The physician decided that the patient should be taken to the emergency room due to the fact she received a recall lot of COMVAX and her clinical presentation. The plan was discussed with pediatric infectious disease physician by phone. He stated that he felt the likelihood of the symptoms being related to the patient's vaccination were very slim. He stated that probably etiology was a viral illness. Given the young age of the patient and the presentation the plan was to cover the patient with IV antibiotics until cultures were 24 or 48 hours negative or viral cause was isolated. The antibiotics were selected upon the result. Viral cultures were sent to DSI as well as Enterovirus PCR and CSF. The plan was discussed with the family and they were in agreement. The patient was admitted to the hospital and laboratory diagnostic tests were performed (blood work and a "battery of test"). All cultures were negative and lab test were within normal limits. The patient was treated with IV antibiotics until she was released from the hospital. The patient was hospitalized for 4 days and recovered on 17-Dec-2007. No additional information is expected. All available medical records will be provided upon request.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Convulsion, Death, Malaise, Meningitis, Overdose
Clinical narrative: Received vaccinations on 12/04/2007 and by 12/07/2007 she was sick. High Fever, seizures, vomiting, screaming in pain when moved. Sent home. Went to hospital on 12/09/2007 and was admitted for meningitis. Patient died at Hospital on 12/12/2007.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Pain, Pyrexia, Screaming, Vomiting
Clinical narrative: Received vaccinations on 12/04/2007 and by 12/07/2007 she was sick. High Fever, seizures, vomiting, screaming in pain when moved. Sent home. Went to hospital on 12/09/2007 and was admitted for meningitis. Patient died at Hospital on 12/12/2007.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Back pain, Hypokinesia, Oedema peripheral, Pain in extremity
Clinical narrative: After 3 weeks, I start feeling joint pain on my right knee. The next day I wake with pain of my left foot and the circle of pain started. The next day my other knee didn't work, my middle finger on the left hand swelled and I could bend it.  The right pinky start hurting and my back also hurts.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Swelling
Clinical narrative: After 3 weeks, I start feeling joint pain on my right knee. The next day I wake with pain of my left foot and the circle of pain started. The next day my other knee didn't work, my middle finger on the left hand swelled and I could bend it.  The right pinky start hurting and my back also hurts.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Dizziness, Nausea, Pyrexia, Tremor
Clinical narrative: Within 20 minutes of vaccine admistration, pt felt lightheadedness, which turned into nausea. Nausea worsen within 1-1 1/2 hours. Pt had 5 episodes of emesis, and feeling shakes, fevers and chills. Pt had similar sxs to prior dose but less severe.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Vomiting
Clinical narrative: Within 20 minutes of vaccine admistration, pt felt lightheadedness, which turned into nausea. Nausea worsen within 1-1 1/2 hours. Pt had 5 episodes of emesis, and feeling shakes, fevers and chills. Pt had similar sxs to prior dose but less severe.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Urticaria, treatment Benadryl.
Age: 1.81
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Urticarial rash starting 2 days after vaccination and persisting for over 1 week. Fever to 102 beginning about 1 week after vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Induration, Pain, Pruritus
Clinical narrative: 12-10-07 Received Zostavax, Lot # 1414U Right Subq, Treatment: Benadryl PRN. 12-11-07 Slight redness, sore to touch. 12-12-07 Induration, 8cm x 3cm, warm to touch, knot felt, fiery red, Outside of induration, 12cm x 6cm, warm to touch, red, itching. 12-13-07 Same as 12-12 except tiny blisters in induration. 12-14-07 Same. 12-15-07 Same. 12-16-07 Same. 12-17-07 Induration, 6cm x 2.5cm, redness getting lighter, outer redness gone, no heat noted, only few blisters remain, slight itching. 12-18-07 Induration, 6cm x 2.5cm, redness getting lighter, all blisters gone, itching occasional. 12-19-24-07 Same as 12-18-07. 12-25-07 Same except redness is still visible but is peeling as if blistered from the sun. 12-26-29-07 Redness is still visible, but no peeling, itching. 12-30-07 Same as 29th, but I am going to submit report.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation, Skin nodule, Skin warm
Clinical narrative: 12-10-07 Received Zostavax, Lot # 1414U Right Subq, Treatment: Benadryl PRN. 12-11-07 Slight redness, sore to touch. 12-12-07 Induration, 8cm x 3cm, warm to touch, knot felt, fiery red, Outside of induration, 12cm x 6cm, warm to touch, red, itching. 12-13-07 Same as 12-12 except tiny blisters in induration. 12-14-07 Same. 12-15-07 Same. 12-16-07 Same. 12-17-07 Induration, 6cm x 2.5cm, redness getting lighter, outer redness gone, no heat noted, only few blisters remain, slight itching. 12-18-07 Induration, 6cm x 2.5cm, redness getting lighter, all blisters gone, itching occasional. 12-19-24-07 Same as 12-18-07. 12-25-07 Same except redness is still visible but is peeling as if blistered from the sun. 12-26-29-07 Redness is still visible, but no peeling, itching. 12-30-07 Same as 29th, but I am going to submit report.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Localized erythema and induration at site of injection of Varivax.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Localized reaction at site of injection with erythema and induration secondary to Varivax.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling tenderness at site without erythema or fluctuance (5cm diameter).
Age: 13.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain upper, Anaphylactic reaction, Diarrhoea, Rash generalised, Tachycardia
Clinical narrative: Pt presented with stomach pain and diarrhea 12 hours after vaccine administration and body rash, welts, and tachycardia about 26 hours after vaccine administration.  Pt treated & diagnosed by Dr. at ambulatory care center.  Dx was anaphylaxis from vaccine & Dr. advised hospitalization, family declined.
Age: 13.0
Sex: M
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Pt presented with stomach pain and diarrhea 12 hours after vaccine administration and body rash, welts, and tachycardia about 26 hours after vaccine administration.  Pt treated & diagnosed by Dr. at ambulatory care center.  Dx was anaphylaxis from vaccine & Dr. advised hospitalization, family declined.
Age: 0.2
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Blood glucose increased, Blood test normal, CSF cell count normal, Depressed level of consciousness, Lethargy
Clinical narrative: Infant was found supine in crib, having emesis around mouth, pale color and very listless upon attempt to arouse. Parents brought infant immediately to pediatrician and was evaluated immediately upon arrival. 10 minutes from home, color pale, not cyanotic, lethargic and mildly tachypneic. 9-1-1 called and face mask oxygen given.  1/8/08 Received vax record which confirms dose & lot #s as reported./ss 1/18/08 Reviewed hospital medical records which reveal patient experienced vomiting & pallor followed by unresonsive episode.    Admitted 12/20-12/22/2007. No further episodes while hospitalized.  D/C to home on apnea monitor. FINAL DX: ALTE.
Age: 0.2
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Listless, Obstruction, Oxygen supplementation, Pallor, Tachypnoea
Clinical narrative: Infant was found supine in crib, having emesis around mouth, pale color and very listless upon attempt to arouse. Parents brought infant immediately to pediatrician and was evaluated immediately upon arrival. 10 minutes from home, color pale, not cyanotic, lethargic and mildly tachypneic. 9-1-1 called and face mask oxygen given.  1/8/08 Received vax record which confirms dose & lot #s as reported./ss 1/18/08 Reviewed hospital medical records which reveal patient experienced vomiting & pallor followed by unresonsive episode.    Admitted 12/20-12/22/2007. No further episodes while hospitalized.  D/C to home on apnea monitor. FINAL DX: ALTE.
Age: 0.2
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Urine analysis normal, Vomiting, X-ray normal
Clinical narrative: Infant was found supine in crib, having emesis around mouth, pale color and very listless upon attempt to arouse. Parents brought infant immediately to pediatrician and was evaluated immediately upon arrival. 10 minutes from home, color pale, not cyanotic, lethargic and mildly tachypneic. 9-1-1 called and face mask oxygen given.  1/8/08 Received vax record which confirms dose & lot #s as reported./ss 1/18/08 Reviewed hospital medical records which reveal patient experienced vomiting & pallor followed by unresonsive episode.    Admitted 12/20-12/22/2007. No further episodes while hospitalized.  D/C to home on apnea monitor. FINAL DX: ALTE.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Erythema, Oedema peripheral, Red blood cell sedimentation rate normal
Clinical narrative: Hand swelling, discomfort, erythema
Age: 1.1
Sex: M
Vaccine: FLU3, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Accidental overdose, Inappropriate schedule of drug administration, Medication error
Clinical narrative: Child given 4th dose of IPV at shot appointment.  Child did not need this dose of vaccine.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Intense erythema, tenderness and induration at left deltoid with erythema around shot spot.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient had a 6 by 3 in reaction.  Very red, swollen and hot to touch.  No other symptoms were noted.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Acute respiratory distress syndrome, Amniocentesis normal, Blood human chorionic gonadotropin, Caesarean section, Cervical incompetence
Clinical narrative: Initial and follow up information has been received from a physician's assistant for the Merck Pregnancy registry, concerning a 17 year old white female with no medical history and a history of 0 previous pregnancies who on 30-OCT-2006 was vaccinated with the first dose of Gardasil (lot #653650/0697F) 0.5 ml intramuscularly. On 2-JAN-2007 the patient received her second dose of Gardasil (lot #654389/0961F) 0.5 ml intramuscularly. Subsequently, the patient presented with a pregnancy (pregnancy test found positive). The patient's LMP was 24-DEC-2006. The patient sought unspecified medical attention. Additional follow up information has been received: From 13-FEB-2007 to 29-JUL-2007 the patient received prenatal vitamins. On 20-MAR-2007 an ultrasound was performed, results were not reported. From 25-APR-2007 to 29-JUL-2007 the patient received nifedipine 20 mg PO Q 4 hours for preterm labor. On 03-MAY-2007 and 04-MAY-2007 she received 12 mg bethamethasone for prevention of respiratory distress syndrome. On 02-MAY-2007 she received general anesthesia for circlagic placement due to incompetent cervix. From 20-JUN-2007 to 29-JUL-2007 the patient received PREVACID 30 mg daily for gastroesophageal reflux disease (GERD). On 29-JUL-2007 the patient underwent amniocentesis for fetal lung maturity. The result indicated mature fetal lungs. On 30-JUL-2007 2 liveborn female infants were delivered at 31 weeks from LMP. Weight of twin A was 2425 g; APGAR score was 9/9. Weight of twin B was 2405 g; APGAR score was 8/9. The infants were normal; there were no congenital anomalies. However both twins had other complications/abnormalities: placentas. Twin A massive chronic villitis. Twin B focal chronic villitis. It was noted that the mother had a complication during pregnancy: gestational thrombocytopenia. She also had a complication during labor/delivery, specifically arrest of dilation resulting in c-section. Upon internal review, premature infant births at 31 weeks and arrest of dilation resulting in c-section were considered other important medical events. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Gastrooesophageal reflux disease, Premature labour, Thrombocytopenia, Ultrasound scan
Clinical narrative: Initial and follow up information has been received from a physician's assistant for the Merck Pregnancy registry, concerning a 17 year old white female with no medical history and a history of 0 previous pregnancies who on 30-OCT-2006 was vaccinated with the first dose of Gardasil (lot #653650/0697F) 0.5 ml intramuscularly. On 2-JAN-2007 the patient received her second dose of Gardasil (lot #654389/0961F) 0.5 ml intramuscularly. Subsequently, the patient presented with a pregnancy (pregnancy test found positive). The patient's LMP was 24-DEC-2006. The patient sought unspecified medical attention. Additional follow up information has been received: From 13-FEB-2007 to 29-JUL-2007 the patient received prenatal vitamins. On 20-MAR-2007 an ultrasound was performed, results were not reported. From 25-APR-2007 to 29-JUL-2007 the patient received nifedipine 20 mg PO Q 4 hours for preterm labor. On 03-MAY-2007 and 04-MAY-2007 she received 12 mg bethamethasone for prevention of respiratory distress syndrome. On 02-MAY-2007 she received general anesthesia for circlagic placement due to incompetent cervix. From 20-JUN-2007 to 29-JUL-2007 the patient received PREVACID 30 mg daily for gastroesophageal reflux disease (GERD). On 29-JUL-2007 the patient underwent amniocentesis for fetal lung maturity. The result indicated mature fetal lungs. On 30-JUL-2007 2 liveborn female infants were delivered at 31 weeks from LMP. Weight of twin A was 2425 g; APGAR score was 9/9. Weight of twin B was 2405 g; APGAR score was 8/9. The infants were normal; there were no congenital anomalies. However both twins had other complications/abnormalities: placentas. Twin A massive chronic villitis. Twin B focal chronic villitis. It was noted that the mother had a complication during pregnancy: gestational thrombocytopenia. She also had a complication during labor/delivery, specifically arrest of dilation resulting in c-section. Upon internal review, premature infant births at 31 weeks and arrest of dilation resulting in c-section were considered other important medical events. Additional information is not expected.
Sex: U
Vaccine: PNC, RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a person working in a physician's office concerning a male patient who, on 13-DEC-2007, was vaccinated with a dose ROTATEQ (Lot# 657665/1460U). Concomitant vaccines included a dose of PREVNAR and a dose of Hib conj vaccine (manufacturer unknown). In December 2007, "in the last two weeks", the patient developed blood in the stool. The patients recovered with no hospital visit or hospitalization required. Upon internal review, the patient's bloody stool was considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: PT RECEIVED HER FIRST GARDASIL ON 7/16/2007.  WHILE PT WAS AT THE OFFICE HAD NO COMPLAINTS.  SHE HAD THE GARDASIL WHILE AWAY AT COLLEGE.  SHE RETURNED TO US LAST WEEK FOR FU AND REPORTED THAT AFTER BOTH 1ST & 2ND INJECTIONS SHE HAD HIVES AND THROAT SWELLING.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pharyngeal oedema, Urticaria, Vaccine positive rechallenge
Clinical narrative: PT RECEIVED HER FIRST GARDASIL ON 7/16/2007.  WHILE PT WAS AT THE OFFICE HAD NO COMPLAINTS.  SHE HAD THE GARDASIL WHILE AWAY AT COLLEGE.  SHE RETURNED TO US LAST WEEK FOR FU AND REPORTED THAT AFTER BOTH 1ST & 2ND INJECTIONS SHE HAD HIVES AND THROAT SWELLING.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pruritus, Injection site rash
Clinical narrative: Headache, 1" x 3" red rash at injection site, itching, 92 heart rate.
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Medication error
Clinical narrative: Had varicella on 01/31/07 MMR was given 01/17/07 so invalid dose.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Depressed level of consciousness, Dizziness, Pain in extremity, Pallor
Clinical narrative: After 1st dose HPV had episode lasting about 40 min of decreased consciousness, also excessive pain in arm.  After 3rd dose HPV had episode following day when felt faint, lasted about 40 min.  2 days after HPV3 had episode per mom's description:  Was in shower, Yelled 'mom' and turned white, slumped down in shower, turned pale, took 40 min to return to normal awareness.  Is fine now.
Age: 25.0
Sex: M
Vaccine: TYP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Member received Typhoid vaccination in left deltoid 1/3/08 - Noticed itchy red rash on left shoulder on 1/4/08 upon awakening.  Used anti-itch cream with some results.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Muscular weakness, Myalgia, Neuralgic amyotrophy
Clinical narrative: Received Flu shot on November 15, 2007. Developed fever that night. On November 16, had fever and generalized muscle soreness, most pronounced in shoulders. November 17 and 18: progressive loss of strength and motor function in the hands, fatigue, continued fever and increasing muscle soreness. November 18th: fever resolved, but saw physician at clinic for continued soreness, fatigue, and loss of motor function in the hands. Referred to Neurology on November 20. Diagnosed with Parsonage-Turner Syndrome (acute brachial neuritis). Motor function in hands resolved without treatment within 2 weeks following visit with Dr., with minor residual weakness.  Fatigue continued to present.  01/18/2008 MR received for Clinic visits 11/18/07 and 1/02/2008. Pt c/o fever, bil hand pain initially then hips and ankles, and muscle weakness.  Weakness to hands (L>R) noted on PE. Reflexes 1+ in upper extremities, 2+ lower. Seen by neurology 11/20/07 for EMG and NCS DX: Acute Brachial Neuritis. Seen again 01/02/08 with fatigue and nausea since visit in Nov.  Exam WNL.  Impression: Nausea, Possible GERD, Fatigue
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Neurological examination abnormal, Pyrexia, Radiculitis brachial
Clinical narrative: Received Flu shot on November 15, 2007. Developed fever that night. On November 16, had fever and generalized muscle soreness, most pronounced in shoulders. November 17 and 18: progressive loss of strength and motor function in the hands, fatigue, continued fever and increasing muscle soreness. November 18th: fever resolved, but saw physician at clinic for continued soreness, fatigue, and loss of motor function in the hands. Referred to Neurology on November 20. Diagnosed with Parsonage-Turner Syndrome (acute brachial neuritis). Motor function in hands resolved without treatment within 2 weeks following visit with Dr., with minor residual weakness.  Fatigue continued to present.  01/18/2008 MR received for Clinic visits 11/18/07 and 1/02/2008. Pt c/o fever, bil hand pain initially then hips and ankles, and muscle weakness.  Weakness to hands (L>R) noted on PE. Reflexes 1+ in upper extremities, 2+ lower. Seen by neurology 11/20/07 for EMG and NCS DX: Acute Brachial Neuritis. Seen again 01/02/08 with fatigue and nausea since visit in Nov.  Exam WNL.  Impression: Nausea, Possible GERD, Fatigue
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Influenza, Pneumonia, Respiratory syncytial virus infection
Clinical narrative: 9 days after Varicella Vaccine given, he developed a cough.  On the 10th day after vaccination (12/28/07), he was diagnoesd with pneumonia and hospitalized overnight.  Also diagnosed with RSV and Influenza Type B.  1/8/08 Reviewed hospital medical records which reveal patient experienced cough, congestion, irritability, reduced oral intake x 5 days & developed dehydration.  Admitted 12/31/2007-1/1/2008. Tx w/antibiotics. FINAL DX: RSV, Influenza B & dehydration.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pyrexia, Rash
Clinical narrative: Per patient when she got home later that day it was very large and raised 5cm. X 5cm.  That night she could not move it and it had fever.  The next day the fever and pain had gone and a large goose egg remained.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: Insomnia, Malaise, Pain, Pyrexia
Clinical narrative: Employee came by on 01/07/08 to report that he had begun feeling poorly yesterday. Complains of aches, fever, and just not feeling well.  Difficulty sleeping.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Abortion threatened, Blood gonadotrophin decreased, Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: PATIENT WAS UNAWARE SHE WAS PREGNANT AT TIME OF FLU MIST ADMINISTRATION. AFTERWARDS SHE FOUND OUT SHE WAS PREGNANT.  IT APPEARS SHE WAS APPROXIMATELY 4 WKS PREGNANT AT TIME OF ADMINISTRATION.  PATIENT IS NOW EXPERIENCING THREATENED ABORTION. SHE HAS BEEN BLEEDING AND CRAMPING FOR LAST SEVERAL WEEKS.  THERE IS STILL FETAL HEART SOUNDS, BUT PER OB-GYN ER NOTE, APPEARED TO BE TISSUE PROTRUDING FROM CERVICAL OS.