chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.76
Sex: F
Vaccine: HIBV
Symptoms: Lethargy, Vomiting
Clinical narrative: PT SLEEPING AND WOKE UP VOMITING , LETHARGIC AND NOT MAKING GOOD EYE CONTACT PER MOTHER, UPON ARRIVAL TO ER, STILL LETHARGIC, SHORTLY BECAME MORE ALERT AND TALKATIVE WITH PARENTS.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Chest discomfort, Eye movement disorder, Fall, Headache, Lethargy
Clinical narrative: I was at the front desk setting up a follow-up date for my daughter's second shot for Hepatitis A vaccine when I turned my head toward her and it seemed she was coming toward me.  I noticed that there was no recognition in her eyes (a vacant stare) and as I went to grab her because she kept coming towards me (she was falling)she fell to the floor.  Her arms and legs immediately extended straight and her hands were shaking.  Her eyes rolled back in their sockets.  As I screamed for someone to help me, the doctor came and requested oxygen.  Doctor asked if my daughter was allergic to latex, which I informed him that I did not know.  She then came to and the doctor and myself moved her back into a room.  Doctor checked her pulse and gave me a bag of ice for the bump on her head.  After about 20-30 minutes, the doctor and nurse came in and checked on my daughter again.  We sat her up at which time my daughter stated she felt pressure on her chest as she was breathing.  Doctor checked her heartbeat and had the nurse give my daughter Benadryl.  About 30 minutes later, they checked on her and we left.  I stayed home to monitor my daughter (returned home around 2:30 p.m. - her appointment was at 11:00 a.m.)and she  slept for about 3 hours.  This morning (2/14/06) her head is sore and she stated she felt that she was moving in slow motion or that her body was lethargic.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Staring, Tremor
Clinical narrative: I was at the front desk setting up a follow-up date for my daughter's second shot for Hepatitis A vaccine when I turned my head toward her and it seemed she was coming toward me.  I noticed that there was no recognition in her eyes (a vacant stare) and as I went to grab her because she kept coming towards me (she was falling)she fell to the floor.  Her arms and legs immediately extended straight and her hands were shaking.  Her eyes rolled back in their sockets.  As I screamed for someone to help me, the doctor came and requested oxygen.  Doctor asked if my daughter was allergic to latex, which I informed him that I did not know.  She then came to and the doctor and myself moved her back into a room.  Doctor checked her pulse and gave me a bag of ice for the bump on her head.  After about 20-30 minutes, the doctor and nurse came in and checked on my daughter again.  We sat her up at which time my daughter stated she felt pressure on her chest as she was breathing.  Doctor checked her heartbeat and had the nurse give my daughter Benadryl.  About 30 minutes later, they checked on her and we left.  I stayed home to monitor my daughter (returned home around 2:30 p.m. - her appointment was at 11:00 a.m.)and she  slept for about 3 hours.  This morning (2/14/06) her head is sore and she stated she felt that she was moving in slow motion or that her body was lethargic.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth, Pruritus
Clinical narrative: 2/14/06 11:00 AM - COMPLAINED OF ITCHING ON UPPER RIGHT ARM.MOM NOTICED RED, HOT, HARD BUMP THE SIZE OF A QUARTER.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Muscular weakness, Pain
Clinical narrative: Extreme pain  for a week, limited motion and weakness left  shoulder and arm since 12/8/05. Treatment: Vicodin, Prednisone, Physical therapy.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Bacterial infection, Medication error, Pathogen resistance
Clinical narrative: This case was reported by nurse and described the occurrence of methicillin resistant staphylococcus aureus infection in a 7 year old female subject who was inadvertently vaccinated with the incorrect dose of hepatitis A vaccine inactivated (Havrix) for prophylaxis. On an unspecified date in 10/2005 the subject received 1st dose of Havrix in the right deltoid. The nurse reported that the subject inadvertently received the adult dose of Havrix. The subject was scheduled to received the pediatric dose of Havrix. The adult, 1ml, dose of Havrix is recommended for immunizing individuals 19 years of age and older. Approximately two months after the 1st dose of Havrix, on an unspecified date in 01/2006, the subject experienced methicillin resistant staphylococcus aureus infection in her hip. The subject was treated with antibiotics. The nurse reported that the subject was not hospitalized at the time of initial reporting. Feb 13 2004. the nurse also stated that, the patients entire family is receiving prophylactic treatment with Bactroban nasal. The outcome of the methicillin resistant staphylococcus aureus infection was unknown at the time of reporting. The nurse considered the incorrect dose of vaccine administered to probably be related to vaccination with Havrix. The nurse considered the methicillin resistant staphylococcus aureus infection to not be related to vaccination with the adult dose of Havrix. Comment: methicillin resistant staphylococcus aureus infection was assessed as medically serious by manufacturer (OMIC).
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Bacterial infection, Medication error, Pathogen resistance
Clinical narrative: This case was reported by nurse and described the occurrence of methicillin resistant staphylococcus aureus infection in a 12 year old female subject who was inadvertently vaccinated with the incorrect dose of hepatitis A vaccine inactivated (Havrix). for prophylaxis. On an unspecified date on October 2005 the subject received 1st dose of Havrix in the right deltoid muscle. The nurse reported that the subject inadvertently received the adult dose of Havrix, instead of the scheduled pediatric dose. The adult, 1 ml, dose of Havrix is recommended for immunizing individuals 19 years of age and older. Approximately three months after the 1st dose of Havrix, on an unspecified date in Feb 2006, the subject experienced methicillin resistant staphylococcus aureus infection on her chin and lower lip. The subject was seen at a physicians office and treated with antibiotics. The nurse reported that the subject was not hospitalized at the time of initial reporting, 2/13/2006. The nurse also stated that, the patients entire family is receiving prophylactic treatment with Bactroban nasal. The outcome of the methicillin resistant staphylococcus aureus infection was unknown at the time of reporting. The nurse considered the methicillin resistant staphylococcus aureus infection to not be related to vaccination with adult dose of Havrix. Comment: methicillin resistant staphylococcus aureus infection was assessed as medically serious by manufacturer (OMIC).
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Hyperplasia, Injection site hypersensitivity, Injection site induration, Injection site nodule
Clinical narrative: This case was reported in a literature article and described the occurrence of a cutaneous lymphoid hyperplasia in a 55 year old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of influenza vaccine (unknown, right deltoid). Within days of vaccination with Influenza vaccine, the subject developed an erythematous, non tender 1cm nodule within the inoculation site. Over the ensuing eighteen months, it gradually enlarged, and became pruritic and indurated. A biopsy revealed marginal zone B cell lymphoma. A staging evaluation including computed tomography scans of the chest and abdomen had no evidence of disease beyond the deltoid area. A four week course of radiotherapy resulted in a complete clinical regression. The patient developed recurrent disease on the contralateral anterior shoulder eighteen months after her initial presentation. She was not aware of any predisposing events localized to this site. The 1 CM recurrent lesions was excised with no further treatment. Histopathologically, both tumors had similar findings. the nodular proliferation's were characterized by a cellular lymphoplasmatic perivascular and periadnexal infiltration with mild cytologic atypia. Both tumors occupied the full thickness of the reticular dermis. There were no well formed germinal centers. The infiltrations were composed of small to medium sized lymphocytes, histiocytes and sheets of peripherally located plasma cells. Classic marginal zone of monocytoid lymphocytes were not conspicuous. The majority of the lymphoid cell were positive for the pan T cell markers CD3 and CD5. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the events were resolved. The author considered the events were related to vaccination with influenza vaccine.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Lymphoma, Neoplasm, Pruritus, Skin ulcer
Clinical narrative: This case was reported in a literature article and described the occurrence of a cutaneous lymphoid hyperplasia in a 55 year old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of influenza vaccine (unknown, right deltoid). Within days of vaccination with Influenza vaccine, the subject developed an erythematous, non tender 1cm nodule within the inoculation site. Over the ensuing eighteen months, it gradually enlarged, and became pruritic and indurated. A biopsy revealed marginal zone B cell lymphoma. A staging evaluation including computed tomography scans of the chest and abdomen had no evidence of disease beyond the deltoid area. A four week course of radiotherapy resulted in a complete clinical regression. The patient developed recurrent disease on the contralateral anterior shoulder eighteen months after her initial presentation. She was not aware of any predisposing events localized to this site. The 1 CM recurrent lesions was excised with no further treatment. Histopathologically, both tumors had similar findings. the nodular proliferation's were characterized by a cellular lymphoplasmatic perivascular and periadnexal infiltration with mild cytologic atypia. Both tumors occupied the full thickness of the reticular dermis. There were no well formed germinal centers. The infiltrations were composed of small to medium sized lymphocytes, histiocytes and sheets of peripherally located plasma cells. Classic marginal zone of monocytoid lymphocytes were not conspicuous. The majority of the lymphoid cell were positive for the pan T cell markers CD3 and CD5. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the events were resolved. The author considered the events were related to vaccination with influenza vaccine.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site reaction, Pruritus
Clinical narrative: This case was reported in a literature article and described the occurrence of a cutaneous lymphoid hyperplasia in a 55 year old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of influenza vaccine (unknown, right deltoid). Within days of vaccination with Influenza vaccine, the subject developed an erythematous, non tender 1cm nodule within the inoculation site. Over the ensuing eighteen months, it gradually enlarged, and became pruritic and indurated. A biopsy revealed marginal zone B cell lymphoma. A staging evaluation including computed tomography scans of the chest and abdomen had no evidence of disease beyond the deltoid area. A four week course of radiotherapy resulted in a complete clinical regression. The patient developed recurrent disease on the contralateral anterior shoulder eighteen months after her initial presentation. She was not aware of any predisposing events localized to this site. The 1 CM recurrent lesions was excised with no further treatment. Histopathologically, both tumors had similar findings. the nodular proliferation's were characterized by a cellular lymphoplasmatic perivascular and periadnexal infiltration with mild cytologic atypia. Both tumors occupied the full thickness of the reticular dermis. There were no well formed germinal centers. The infiltrations were composed of small to medium sized lymphocytes, histiocytes and sheets of peripherally located plasma cells. Classic marginal zone of monocytoid lymphocytes were not conspicuous. The majority of the lymphoid cell were positive for the pan T cell markers CD3 and CD5. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the events were resolved. The author considered the events were related to vaccination with influenza vaccine.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pseudo lymphoma, Skin ulcer
Clinical narrative: This case was reported in a literature article and described the occurrence of a cutaneous lymphoid hyperplasia in a 55 year old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of influenza vaccine (unknown, right deltoid). Within days of vaccination with Influenza vaccine, the subject developed an erythematous, non tender 1cm nodule within the inoculation site. Over the ensuing eighteen months, it gradually enlarged, and became pruritic and indurated. A biopsy revealed marginal zone B cell lymphoma. A staging evaluation including computed tomography scans of the chest and abdomen had no evidence of disease beyond the deltoid area. A four week course of radiotherapy resulted in a complete clinical regression. The patient developed recurrent disease on the contralateral anterior shoulder eighteen months after her initial presentation. She was not aware of any predisposing events localized to this site. The 1 CM recurrent lesions was excised with no further treatment. Histopathologically, both tumors had similar findings. the nodular proliferation's were characterized by a cellular lymphoplasmatic perivascular and periadnexal infiltration with mild cytologic atypia. Both tumors occupied the full thickness of the reticular dermis. There were no well formed germinal centers. The infiltrations were composed of small to medium sized lymphocytes, histiocytes and sheets of peripherally located plasma cells. Classic marginal zone of monocytoid lymphocytes were not conspicuous. The majority of the lymphoid cell were positive for the pan T cell markers CD3 and CD5. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the events were resolved. The author considered the events were related to vaccination with influenza vaccine.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Granuloma, Hyperplasia, Injection site hypersensitivity, Injection site inflammation, Injection site nodule
Clinical narrative: This case was reported in a literature article and described the occurrence of lymphoid hyperplasia in a 65 year old female subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of influenza vaccine (unknown, right deltoid). Within days of vaccination with influenza vaccine, the subject developed a pruritic nodule at the injection site. Within a few days after the injection the nodule grew to 2 cm in diameter. Despite therapy with antibiotics and warm compresses, the lesion continued to increase in size. A biopsy performed 6 weeks after initial presentation revealed granulomatous and mixed cellular infiltration that was interpreted as reactive in nature. No pathologist microorganisms were identified histologically or in cultures obtained from lesional tissue. Within a month after initial biopsy, the nodule had enlarged to 5 cm and had begun to ulcerate. The lesion was resected, and revealed a similar reactive histology compared to the initial biopsy. Over the next 2 years, the lesion continued to increase in size and ulcerate, despite numerous attempts at resection and various courses of oral and topical corticosteroid therapy. Cultures for infectious microorganisms were consistently negative. Ultimately, a course of low dose radiotherapy was administered three years after the initial presentations and resulted in complete regression of the lesions and healing of the overlying epidermis. The patient has not had a recurrence within a nine year follow up period after radiation treatment. Histologically, all tissues had similar findings. The epidermis was ulcerated, and the full thickness of the reticular dermis was effaced by a sheet of cells extending into subcutaneous fat. The inflammatory proliferation was comprised of a cellular, atypical but polymorphic lympho histiocytic population of mononuclear cells. The proliferation was characterized by mostly small to medium sized lymphocytes, some with a plasmacytoid appearance on a histiocytic background. Larger immunoblastic cells made up a small component of the infiltration. In addition, there were scattered area of necrotizing granulomatous inflammation within the cellular dermal. This case was assessed as medically serious my manufacturer (OMIC). At the time of reporting the events were resolved. The author considered the events were related to vaccination with influenza vaccine.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pruritus, Skin ulcer
Clinical narrative: This case was reported in a literature article and described the occurrence of lymphoid hyperplasia in a 65 year old female subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of influenza vaccine (unknown, right deltoid). Within days of vaccination with influenza vaccine, the subject developed a pruritic nodule at the injection site. Within a few days after the injection the nodule grew to 2 cm in diameter. Despite therapy with antibiotics and warm compresses, the lesion continued to increase in size. A biopsy performed 6 weeks after initial presentation revealed granulomatous and mixed cellular infiltration that was interpreted as reactive in nature. No pathologist microorganisms were identified histologically or in cultures obtained from lesional tissue. Within a month after initial biopsy, the nodule had enlarged to 5 cm and had begun to ulcerate. The lesion was resected, and revealed a similar reactive histology compared to the initial biopsy. Over the next 2 years, the lesion continued to increase in size and ulcerate, despite numerous attempts at resection and various courses of oral and topical corticosteroid therapy. Cultures for infectious microorganisms were consistently negative. Ultimately, a course of low dose radiotherapy was administered three years after the initial presentations and resulted in complete regression of the lesions and healing of the overlying epidermis. The patient has not had a recurrence within a nine year follow up period after radiation treatment. Histologically, all tissues had similar findings. The epidermis was ulcerated, and the full thickness of the reticular dermis was effaced by a sheet of cells extending into subcutaneous fat. The inflammatory proliferation was comprised of a cellular, atypical but polymorphic lympho histiocytic population of mononuclear cells. The proliferation was characterized by mostly small to medium sized lymphocytes, some with a plasmacytoid appearance on a histiocytic background. Larger immunoblastic cells made up a small component of the infiltration. In addition, there were scattered area of necrotizing granulomatous inflammation within the cellular dermal. This case was assessed as medically serious my manufacturer (OMIC). At the time of reporting the events were resolved. The author considered the events were related to vaccination with influenza vaccine.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Granuloma, Injection site hypersensitivity, Injection site nodule, Pruritus, Pseudo lymphoma
Clinical narrative: This case was reported in a literature article and described the occurrence of lymphoid hyperplasia in a 65 year old female subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of influenza vaccine (unknown, right deltoid). Within days of vaccination with influenza vaccine, the subject developed a pruritic nodule at the injection site. Within a few days after the injection the nodule grew to 2 cm in diameter. Despite therapy with antibiotics and warm compresses, the lesion continued to increase in size. A biopsy performed 6 weeks after initial presentation revealed granulomatous and mixed cellular infiltration that was interpreted as reactive in nature. No pathologist microorganisms were identified histologically or in cultures obtained from lesional tissue. Within a month after initial biopsy, the nodule had enlarged to 5 cm and had begun to ulcerate. The lesion was resected, and revealed a similar reactive histology compared to the initial biopsy. Over the next 2 years, the lesion continued to increase in size and ulcerate, despite numerous attempts at resection and various courses of oral and topical corticosteroid therapy. Cultures for infectious microorganisms were consistently negative. Ultimately, a course of low dose radiotherapy was administered three years after the initial presentations and resulted in complete regression of the lesions and healing of the overlying epidermis. The patient has not had a recurrence within a nine year follow up period after radiation treatment. Histologically, all tissues had similar findings. The epidermis was ulcerated, and the full thickness of the reticular dermis was effaced by a sheet of cells extending into subcutaneous fat. The inflammatory proliferation was comprised of a cellular, atypical but polymorphic lympho histiocytic population of mononuclear cells. The proliferation was characterized by mostly small to medium sized lymphocytes, some with a plasmacytoid appearance on a histiocytic background. Larger immunoblastic cells made up a small component of the infiltration. In addition, there were scattered area of necrotizing granulomatous inflammation within the cellular dermal. This case was assessed as medically serious my manufacturer (OMIC). At the time of reporting the events were resolved. The author considered the events were related to vaccination with influenza vaccine.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Skin ulcer
Clinical narrative: This case was reported in a literature article and described the occurrence of lymphoid hyperplasia in a 65 year old female subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of influenza vaccine (unknown, right deltoid). Within days of vaccination with influenza vaccine, the subject developed a pruritic nodule at the injection site. Within a few days after the injection the nodule grew to 2 cm in diameter. Despite therapy with antibiotics and warm compresses, the lesion continued to increase in size. A biopsy performed 6 weeks after initial presentation revealed granulomatous and mixed cellular infiltration that was interpreted as reactive in nature. No pathologist microorganisms were identified histologically or in cultures obtained from lesional tissue. Within a month after initial biopsy, the nodule had enlarged to 5 cm and had begun to ulcerate. The lesion was resected, and revealed a similar reactive histology compared to the initial biopsy. Over the next 2 years, the lesion continued to increase in size and ulcerate, despite numerous attempts at resection and various courses of oral and topical corticosteroid therapy. Cultures for infectious microorganisms were consistently negative. Ultimately, a course of low dose radiotherapy was administered three years after the initial presentations and resulted in complete regression of the lesions and healing of the overlying epidermis. The patient has not had a recurrence within a nine year follow up period after radiation treatment. Histologically, all tissues had similar findings. The epidermis was ulcerated, and the full thickness of the reticular dermis was effaced by a sheet of cells extending into subcutaneous fat. The inflammatory proliferation was comprised of a cellular, atypical but polymorphic lympho histiocytic population of mononuclear cells. The proliferation was characterized by mostly small to medium sized lymphocytes, some with a plasmacytoid appearance on a histiocytic background. Larger immunoblastic cells made up a small component of the infiltration. In addition, there were scattered area of necrotizing granulomatous inflammation within the cellular dermal. This case was assessed as medically serious my manufacturer (OMIC). At the time of reporting the events were resolved. The author considered the events were related to vaccination with influenza vaccine.
Age: 1.26
Sex: F
Vaccine: HIBV, MMR
Symptoms: Blood test, Childhood disintegrative disorder, Convulsion, Developmental delay, Electroencephalogram
Clinical narrative: High fever (105) with seizure of approx 20 minutes. Required Ativan X 3. Left with left hemiparesis and developmental regression. Most Sn/Sx have resolved. Now with mild-moderate speech delays. 60 day Follow-up Information: She probarly have minimal developmental delays of speech/fine motor - she had regression of her development and has recovered and catching up and is close to normal for age. Therapy and formal evaluation is not accepted by parents at the present time.
Age: 1.26
Sex: F
Vaccine: HIBV, MMR
Symptoms: Full blood count, Headache, Hemiparesis, Lumbar puncture, Pyrexia
Clinical narrative: High fever (105) with seizure of approx 20 minutes. Required Ativan X 3. Left with left hemiparesis and developmental regression. Most Sn/Sx have resolved. Now with mild-moderate speech delays. 60 day Follow-up Information: She probarly have minimal developmental delays of speech/fine motor - she had regression of her development and has recovered and catching up and is close to normal for age. Therapy and formal evaluation is not accepted by parents at the present time.
Age: 1.26
Sex: F
Vaccine: HIBV, MMR
Symptoms: Speech disorder developmental
Clinical narrative: High fever (105) with seizure of approx 20 minutes. Required Ativan X 3. Left with left hemiparesis and developmental regression. Most Sn/Sx have resolved. Now with mild-moderate speech delays. 60 day Follow-up Information: She probarly have minimal developmental delays of speech/fine motor - she had regression of her development and has recovered and catching up and is close to normal for age. Therapy and formal evaluation is not accepted by parents at the present time.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Chills, Lymphangitis, Pyrexia
Clinical narrative: Fever and chills x2 day, cellulitis and lymphangitis at site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site swelling, Pyrexia
Clinical narrative: Client complaint left arm hurts.  Left arm warm to touch at injection site. Client Afebrile 97.4, site swollen, circular shaped like 50 cent size. Parent instructed to use compresses on swollen area.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Heart rate increased, Myalgia, Pyrexia, Throat tightness
Clinical narrative: Throat tightness, muscle aches, low grade fever, fast heart beat, weakness, started 1 hour after receiving immunization.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: Pt received a combination vaccine but doesn't know which one.  At night Pt. had a set of seizures, taken to ER stay a few hours and released next day. Had another set of seizures on the 2/5/06. Doctor advised to observe pt. since had appt with neurologist the next day. Went to neurologist on the 2/6 and tests were run.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: Pt received a combination vaccine but doesn't know which one.  At night Pt. had a set of seizures, taken to ER stay a few hours and released next day. Had another set of seizures on the 2/5/06. Doctor advised to observe pt. since had appt with neurologist the next day. Went to neurologist on the 2/6 and tests were run.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Headache, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Increased requirements for sleep-fatigue; arthralgia: neck pain, thumb swelled to double, knee pain, both hands painful and stiff, feet-ankles-calfs-knees painful and stiff; headaches daily.  All occurred after MMR.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Oedema peripheral
Clinical narrative: Increased requirements for sleep-fatigue; arthralgia: neck pain, thumb swelled to double, knee pain, both hands painful and stiff, feet-ankles-calfs-knees painful and stiff; headaches daily.  All occurred after MMR.
Age: 0.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Bacterial infection, Convulsion, Drug ineffective
Clinical narrative: Information regarding Hib Titer vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received from a healthcare professional regarding a 3 month old female patient who experienced H influenza b bacteremia, seizure, haemophilus influenzae infection and blood culture positive for H influenzae B. At 3 months of age, the patient received a dose on 2/7/2005. the patient also received a dose of Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) and a dose of Pediarix (diphtheria vaccine/tetanus vaccine/acellular pertussis vaccine/polio virus inactivated/hepatitis B vaccine) on 2/7/2005 Relevant medical history was not provided. The indication for Hib titer vaccine was immunization. Product was administered on 2/7/2005. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On 2/8/2005, the infant seemed to be generally ill and experienced a seizure and a fever. She was seen in a emergency room where she was intubated and admitted to the ICU. A blood culture grew Haemophilus influenzae type B (haemophilus bacteremia) ( drug ineffective). A subsequent unspecified blood test was reportedly positive for influenza A and a diagnosis of Haemophilus influenza infection (Haemophilus infection) was made. Treatment included Rocephin (Ceftriaxone) and the infant recovered. No additional information was available at the time of this report. This report was received from a manufacturer (Ref No A0550337A).
Age: 1.48
Sex: M
Vaccine: DTAP
Symptoms: Crying, Erythema, Oedema peripheral, Rash
Clinical narrative: 2-14-06 Patient's mom reports child cried from 4am-8am unconsoleable. Slept well after that.  Alert and playful. Red rash on face 2-13-06 prior to vaccine given on 2-14-06 rash spread to trunk with feet and hands bright red and swollen. Mother declined appt so no treatment given.
Age: 1.01
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Arthritis, Arthropathy, Joint effusion, Myositis
Clinical narrative: 12/27/2005 vaccinations, 12/29 DX DM RX Amoxil, Given vaccination left leg, Febrile 01/05 to 01/16, X Diffuse Myositis, no osteomyositis, positive bilat knee effusions, right hip effusion, felt reactive arthritis no septic.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Pain, Radiculitis brachial, Skin burning sensation
Clinical narrative: Patient appears to exhibit brachial neuritis in shoulder. Pain, weakness, burning. Not yet receiving treatment started about few weeks post vaccination.
Age: 1.26
Sex: M
Vaccine: MMR, PNC
Symptoms: Convulsion
Clinical narrative: Seizure
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: Abdominal pain, Constipation, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: 2 hours after injection of TD left deltoid, pain up left arm to neck and pain right upper arm and shoulder. Low grade temp, muscle stiffen, abdominal pain, constipation x 5 days. no local reaction at injection site.
Age: 1.34
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Skin nodule
Clinical narrative: Lump under skin on right leg.
Sex: U
Vaccine: HEP, HEPA, IPV, MMR, TD, VARCEL
Symptoms: Syncope
Clinical narrative: Child was to receive 7 Immunizations plus PPD and fainted after #6. Was placed in shock position. BP normal, pulse and resp normal. rested and felt better after about 30 minutes. Went home. F/U next day, was doing well.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Screaming
Clinical narrative: Hard inconsolable crying for more than three hours.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site reaction, Injection site warmth, Pruritus, Skin discolouration
Clinical narrative: Tylenol given at 3 pm day of shot 2/9/2006. On 2/10/2006 child woke up and his arm felt funny. Black and blue at site of injection, Red hot to touch from shoulder to elbow and child was itching just posterior to site of top injection. Child was afebrile. No treatment done B/C mom stated child refused. On 2/13/2006 area child was itching developed scabs and arm from shoulder to elbow slight red but not warm. Cool dry to touch.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC
Symptoms: Medication error
Clinical narrative: On 2-8-06 a Pediarix #2, PCV-7 #2, and Hib #2 was ordered to be given to patient along with well child check.  While reviewing the billing sheet for the client which had written out (Dtap, Hep B, IPV) for Pediarix and PCV-7, Hep B and gave those injections. Pt received two Hep B doses on that date. No adverse reaction occurred to patient.  Immunization error was explained to from of patient. Mom and patient were monitored after the injection was given.
Age: 1.54
Sex: M
Vaccine: HEPA
Symptoms: Face oedema
Clinical narrative: Child exposed to hepatitis by babysitter from another country.  Babysitter hospitalized for hepatitis workup.  Child given hep A #1 9am.  Returned to clinic c facila edema.  12.5 mg enadryl PO given.  Observed x 1 H.  D/C to home, stable.  RTC 2/10/06 Benadry 12.5 mg PO q 6hr x 5; Zantac 25 mg PO BID; Prelone 25 mg PO x 2 d, 15 mg PO x 2 d, 7.5 mg PO x 2 d.  2/10/06 - NOTE: Parent reports babysitter hospitalized for unknown type hepatitis.  Child exposed by babysitter.  Child seen 2/10/06 stable, refer Peds allergy.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, MMR, TD
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: REDNESS, SWELLING TO SITE. LYMPH NODES SWOLLEN.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Rash
Clinical narrative: Local reaction on left arm, redness, warm to touch, slight swelling. A week later rash on top of both feet, raised and itchy.
Age: 7.0
Sex: F
Vaccine: HEP, IPV, MMR, TTOX
Symptoms: Unevaluable event
Clinical narrative: none
Age: 45.0
Sex: M
Vaccine: ANTH, UNK
Symptoms: Amblyopia, Arthralgia, Back pain, Blood cholesterol increased, Dizziness
Clinical narrative: Aches joints, acid reflux, high colesterol, vertigo, dizziness, bumps on hand, depresions, headaches, ringing in ears, numbness & tingling arms, pain legs, pain groins, pain lower back, pain kness, insomnio, blister in mouth, amblyopia, digestive problems, hemorrhoids, reflux, etc.
Age: 45.0
Sex: M
Vaccine: ANTH, UNK
Symptoms: Dyspepsia, Gastrooesophageal reflux disease, Groin pain, Haemorrhoids, Headache
Clinical narrative: Aches joints, acid reflux, high colesterol, vertigo, dizziness, bumps on hand, depresions, headaches, ringing in ears, numbness & tingling arms, pain legs, pain groins, pain lower back, pain kness, insomnio, blister in mouth, amblyopia, digestive problems, hemorrhoids, reflux, etc.
Age: 45.0
Sex: M
Vaccine: ANTH, UNK
Symptoms: Hypoaesthesia, Insomnia, Oral mucosal blistering, Rash, Tinnitus
Clinical narrative: Aches joints, acid reflux, high colesterol, vertigo, dizziness, bumps on hand, depresions, headaches, ringing in ears, numbness & tingling arms, pain legs, pain groins, pain lower back, pain kness, insomnio, blister in mouth, amblyopia, digestive problems, hemorrhoids, reflux, etc.
Age: 45.0
Sex: M
Vaccine: ANTH, UNK
Symptoms: Vertigo
Clinical narrative: Aches joints, acid reflux, high colesterol, vertigo, dizziness, bumps on hand, depresions, headaches, ringing in ears, numbness & tingling arms, pain legs, pain groins, pain lower back, pain kness, insomnio, blister in mouth, amblyopia, digestive problems, hemorrhoids, reflux, etc.
Age: 45.0
Sex: M
Vaccine: ANTH, UNK
Symptoms: Amblyopia, Arthralgia, Back pain, Blister, Blood cholesterol increased
Clinical narrative: Aches joints, acid reflux, high colesterol, vertigo, dizziness, bumps on hand, depresions, headaches, ringing in ears, numbness & tingling arms, pain legs, pain groins, pain lower back, pain kness, insomnio, blister in mouth, amblyopia, digestive problems, hemorrhoids, reflux, etc.
Age: 45.0
Sex: M
Vaccine: ANTH, UNK
Symptoms: Bursitis, Cough, Depression, Dizziness, Dyspepsia
Clinical narrative: Aches joints, acid reflux, high colesterol, vertigo, dizziness, bumps on hand, depresions, headaches, ringing in ears, numbness & tingling arms, pain legs, pain groins, pain lower back, pain kness, insomnio, blister in mouth, amblyopia, digestive problems, hemorrhoids, reflux, etc.
Age: 45.0
Sex: M
Vaccine: ANTH, UNK
Symptoms: Gastrooesophageal reflux disease, Groin pain, Haematochezia, Headache, Hypoaesthesia
Clinical narrative: Aches joints, acid reflux, high colesterol, vertigo, dizziness, bumps on hand, depresions, headaches, ringing in ears, numbness & tingling arms, pain legs, pain groins, pain lower back, pain kness, insomnio, blister in mouth, amblyopia, digestive problems, hemorrhoids, reflux, etc.
Age: 45.0
Sex: M
Vaccine: ANTH, UNK
Symptoms: Insomnia, Pain in extremity, Paraesthesia, Rash, Rhinitis
Clinical narrative: Aches joints, acid reflux, high colesterol, vertigo, dizziness, bumps on hand, depresions, headaches, ringing in ears, numbness & tingling arms, pain legs, pain groins, pain lower back, pain kness, insomnio, blister in mouth, amblyopia, digestive problems, hemorrhoids, reflux, etc.
Age: 45.0
Sex: M
Vaccine: ANTH, UNK
Symptoms: Tinnitus, Vertigo
Clinical narrative: Aches joints, acid reflux, high colesterol, vertigo, dizziness, bumps on hand, depresions, headaches, ringing in ears, numbness & tingling arms, pain legs, pain groins, pain lower back, pain kness, insomnio, blister in mouth, amblyopia, digestive problems, hemorrhoids, reflux, etc.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Child received vaccine 6/30/04. Presented to office 7/12/04 and parent reported that child had had significant redness and swelling at site of vaccine. Also experienced vomiting (no fever, no diarrhea) for approximately 2 weeks after vaccine given. Mother reported that she also experienced similar effects after having Hepatitis A vaccine.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: MENACTRA ADMINISTERED CORRECTLY IM IN LEFT DELTOID. DEVELOPED PAIN, LOCALIZED TENDERNESS WITH FAINT ERYTHEMA/TACTILE WARMTH IN DELTOID MUSCLE. NO SYSTEMIC SYMPTOMS. TREATED WITH WARM SOAKS, IBUPROFEN, LUE ELEVATION, REST.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient complained to parents of being itchy on the night of vaccine administration.  The day after administration, patient still complained of itching and mom noted hives all over.  Mom has been instructed to give patient Benadryl.  And mom was instructed to watch for any new or changing symptoms, and if so take patient to ER.
Age: 0.36
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Convulsion
Clinical narrative: Seizure, Acute life threatening event 11/05/2005. 3/16/06-Review of d/c summary confirms diagnosis of seizure disorder. Child was admitted on 11/5/05 and discharged on 11/8/05. Additional symptom of apnea was noted. Child was started on phenobarbital.
Age: 31.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Headache, Influenza like illness, Nasal congestion, Pain
Clinical narrative: Flu-like symptoms, aching, nasal congestion, fatigue, headache for four days. Developed hives on day 6 and 7 (elbows, knees) after injection.  No treatment sought.
Age: 31.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Flu-like symptoms, aching, nasal congestion, fatigue, headache for four days. Developed hives on day 6 and 7 (elbows, knees) after injection.  No treatment sought.
Age: 57.0
Sex: F
Vaccine: HEP, UNK
Symptoms: Chills, Pruritus, Urticaria
Clinical narrative: Evening at 9pm, noticed scalp felt itchy, it was extremely itchy by 1 AM. Took over the counter antihistamine which calmed itchiness enough to fall sleep. That morning woke up with a full blown case of hives. Hives appeared on abdomen, neck (back and front), ears. As day progressed hives continued to appear over entire body. Contacted administering doctor and personal general practioner. The GP advised use of Benadryl, Aveeno bath, hydrocortisone cream. The administering doctor prescribed non predinose series. Only took first dose on Saturday because General Practitioner prescribed Prednisone, Benadryl and Thymidine. Those medications helped a bit, some hives started to disappear and itching was not as intense. However until 2/14 new hives were still appearing. Pt. mentions that during first days also had chills, not sure whether there was fever.
Age: 57.0
Sex: F
Vaccine: HEP, UNK
Symptoms: Urticaria
Clinical narrative: Evening at 9pm, noticed scalp felt itchy, it was extremely itchy by 1 AM. Took over the counter antihistamine which calmed itchiness enough to fall sleep. That morning woke up with a full blown case of hives. Hives appeared on abdomen, neck (back and front), ears. As day progressed hives continued to appear over entire body. Contacted administering doctor and personal general practioner. The GP advised use of Benadryl, Aveeno bath, hydrocortisone cream. The administering doctor prescribed non predinose series. Only took first dose on Saturday because General Practitioner prescribed Prednisone, Benadryl and Thymidine. Those medications helped a bit, some hives started to disappear and itching was not as intense. However until 2/14 new hives were still appearing. Pt. mentions that during first days also had chills, not sure whether there was fever.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Received adult Td booster 2-13-06 subsequently developed L arm (deltoid) redness (circumferential) distal to injection site to level of elbow.  No wheeze no fever no hypotension. Question itch.  Treated with local ice, Benadryl, Keflex.
Age: 0.59
Sex: F
Vaccine: HIBV
Symptoms: Agitation, Decreased appetite, Feeling hot, Injection site haemorrhage, Injection site reaction
Clinical narrative: Follow-up information provided lot number, expiration date, and age of child. Information regarding Hib-Titer Vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received from a nurse regarding a 7 month old female patient who received a third dose on 28 May 1997 and developed a localized reaction in the left leg following her injection.  Injection site redness, injection site warmth and injection site swelling characterized the local reaction. The patient also experienced decreased appetitie-infant would only take a bottle, irritability and was hard to put to sleep. She was diagnosed on an unspecified date with "hematoma in muscle of left thigh".  Medical History: The patient's concurrent illness includes cardiac murmur functional (Reporter indicated patient was seen by a cardiologist in June of 1999).  Product Details: Indication for Hib-Titer vaccine was immunization. Product was administered on 28 May 1997. Dose regiment was 1 dose (intramuscular). Concomitant Therapy: Concomitant medications were not reported. Event Details: On 28 May 1997, the patient received a third dose of Hib-Titer and on the same day, developed a localized reaction in the left leg following her injection (injection site reaction). Injection site redness (injection site erythema), injection site warmth (injection site warmth) and injection site swelling ( injection site swelling) characterized the local reaction.  The patient also experienced decreased appetite-infant would only take a bottle (decreased appetite), irritability (agitation) and was hard to put to sleep (insomnia). She was diagnosed on an unspecified date with "hematoma in muscle of left thigh" (injection site hemorrhage). The reporter indicated that the patient recovered.  Related Case: See related case(s): HQWYE586112JAN05 (adverse event, non-expedited). No additional information was available at the time of this report.
Age: 0.59
Sex: F
Vaccine: HIBV
Symptoms: Injection site swelling, Insomnia
Clinical narrative: Follow-up information provided lot number, expiration date, and age of child. Information regarding Hib-Titer Vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received from a nurse regarding a 7 month old female patient who received a third dose on 28 May 1997 and developed a localized reaction in the left leg following her injection.  Injection site redness, injection site warmth and injection site swelling characterized the local reaction. The patient also experienced decreased appetitie-infant would only take a bottle, irritability and was hard to put to sleep. She was diagnosed on an unspecified date with "hematoma in muscle of left thigh".  Medical History: The patient's concurrent illness includes cardiac murmur functional (Reporter indicated patient was seen by a cardiologist in June of 1999).  Product Details: Indication for Hib-Titer vaccine was immunization. Product was administered on 28 May 1997. Dose regiment was 1 dose (intramuscular). Concomitant Therapy: Concomitant medications were not reported. Event Details: On 28 May 1997, the patient received a third dose of Hib-Titer and on the same day, developed a localized reaction in the left leg following her injection (injection site reaction). Injection site redness (injection site erythema), injection site warmth (injection site warmth) and injection site swelling ( injection site swelling) characterized the local reaction.  The patient also experienced decreased appetite-infant would only take a bottle (decreased appetite), irritability (agitation) and was hard to put to sleep (insomnia). She was diagnosed on an unspecified date with "hematoma in muscle of left thigh" (injection site hemorrhage). The reporter indicated that the patient recovered.  Related Case: See related case(s): HQWYE586112JAN05 (adverse event, non-expedited). No additional information was available at the time of this report.