chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Full blood count normal, Headache, Lumbar puncture normal, Malaise, Meningism
Clinical narrative: Patient presented to ER on 8/29/05 with a 5 day hx. of neck pain, malaise, photophobia and nausea and vomiting. Had been seen 5 days prior with what the patient thought was a possible reaction to the smallpox vaccination he received on 8/19/05. He was ordered Z-pak at that time and was confined to quarters. He thought that he was feeling better so he returned to field duty. He represented again the morning of 8/29/05 and he was then referred to the ER, at which time he was evaluated and consultation with another campus was sought. He was transferred to the Hospital where he was admitted for questionable meningitis. He was given IV therapy and was given Zofran for his nausea and Toradal for pain. Diagnoses at time of discharge: viral syndrome with meningismus. He was discharged from the hospital on 8/30/05 with orders for strict bed rest and follow up in am of 8/31/05. On 8/31/05 he returned with an increase in his sx. Uncontrollable emesis and photophobia. He was then transferred back to the hospital where he was then readmitted. He is currently hospitalized. 01/09/2006 Review of discharge summaries. Admission of 8/29/05-8/30/05 was for viral syndrome with meningismus. Symptoms included 5-day history of HA, neck pain, photophobia, persistent vomiting, myalgias, and ever. Head CT was normal. He was treated with Zofran and Toradol. LP was WNL. Admission of 8/31/05-9/05/2005 was for HA with meningismus and photophobia s/p recent smallpox vaccine. Additional symptoms include persistent nausea and vomiting. Treated for HA with Toradol IV.  Follow-up: An initial VAERS was filed on this patient in August 2005. A VAERS update was then filed in November 2005. The patient's headaches have significantly decreased in frequency-now only having one severe headache every 3 months.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Myalgia, Nausea, Neck pain, Photophobia, Spinal X-ray normal
Clinical narrative: Patient presented to ER on 8/29/05 with a 5 day hx. of neck pain, malaise, photophobia and nausea and vomiting. Had been seen 5 days prior with what the patient thought was a possible reaction to the smallpox vaccination he received on 8/19/05. He was ordered Z-pak at that time and was confined to quarters. He thought that he was feeling better so he returned to field duty. He represented again the morning of 8/29/05 and he was then referred to the ER, at which time he was evaluated and consultation with another campus was sought. He was transferred to the Hospital where he was admitted for questionable meningitis. He was given IV therapy and was given Zofran for his nausea and Toradal for pain. Diagnoses at time of discharge: viral syndrome with meningismus. He was discharged from the hospital on 8/30/05 with orders for strict bed rest and follow up in am of 8/31/05. On 8/31/05 he returned with an increase in his sx. Uncontrollable emesis and photophobia. He was then transferred back to the hospital where he was then readmitted. He is currently hospitalized. 01/09/2006 Review of discharge summaries. Admission of 8/29/05-8/30/05 was for viral syndrome with meningismus. Symptoms included 5-day history of HA, neck pain, photophobia, persistent vomiting, myalgias, and ever. Head CT was normal. He was treated with Zofran and Toradol. LP was WNL. Admission of 8/31/05-9/05/2005 was for HA with meningismus and photophobia s/p recent smallpox vaccine. Additional symptoms include persistent nausea and vomiting. Treated for HA with Toradol IV.  Follow-up: An initial VAERS was filed on this patient in August 2005. A VAERS update was then filed in November 2005. The patient's headaches have significantly decreased in frequency-now only having one severe headache every 3 months.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Viral infection, Vomiting, West Nile virus test negative, White blood cell count normal
Clinical narrative: Patient presented to ER on 8/29/05 with a 5 day hx. of neck pain, malaise, photophobia and nausea and vomiting. Had been seen 5 days prior with what the patient thought was a possible reaction to the smallpox vaccination he received on 8/19/05. He was ordered Z-pak at that time and was confined to quarters. He thought that he was feeling better so he returned to field duty. He represented again the morning of 8/29/05 and he was then referred to the ER, at which time he was evaluated and consultation with another campus was sought. He was transferred to the Hospital where he was admitted for questionable meningitis. He was given IV therapy and was given Zofran for his nausea and Toradal for pain. Diagnoses at time of discharge: viral syndrome with meningismus. He was discharged from the hospital on 8/30/05 with orders for strict bed rest and follow up in am of 8/31/05. On 8/31/05 he returned with an increase in his sx. Uncontrollable emesis and photophobia. He was then transferred back to the hospital where he was then readmitted. He is currently hospitalized. 01/09/2006 Review of discharge summaries. Admission of 8/29/05-8/30/05 was for viral syndrome with meningismus. Symptoms included 5-day history of HA, neck pain, photophobia, persistent vomiting, myalgias, and ever. Head CT was normal. He was treated with Zofran and Toradol. LP was WNL. Admission of 8/31/05-9/05/2005 was for HA with meningismus and photophobia s/p recent smallpox vaccine. Additional symptoms include persistent nausea and vomiting. Treated for HA with Toradol IV.  Follow-up: An initial VAERS was filed on this patient in August 2005. A VAERS update was then filed in November 2005. The patient's headaches have significantly decreased in frequency-now only having one severe headache every 3 months.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Discomfort, Fatigue, Headache, Hypoaesthesia, Injection site erythema
Clinical narrative: Presented to ER on 8/23/05 with c/o L arm discomfort, mainly in shoulder with some burning and numbness down his arm. Reports feeling tired early am of the 23rd. Was then doing physical activity of running and stretching exercises at which time his sx. increased and he also c/o headache. Elevated temperature noted of 100.5. Baseball size area of redness at the vaccination site to the L upper arm. Tylenol ordered and confined to barracks til Monday when he was to follow up. Followed up on Monday (8/24/05), L arm with 7cm area of redness. Orders for rest and fluids given. Also ordered Ibuprofen 800mg tid.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pyrexia, Thermal burn
Clinical narrative: Presented to ER on 8/23/05 with c/o L arm discomfort, mainly in shoulder with some burning and numbness down his arm. Reports feeling tired early am of the 23rd. Was then doing physical activity of running and stretching exercises at which time his sx. increased and he also c/o headache. Elevated temperature noted of 100.5. Baseball size area of redness at the vaccination site to the L upper arm. Tylenol ordered and confined to barracks til Monday when he was to follow up. Followed up on Monday (8/24/05), L arm with 7cm area of redness. Orders for rest and fluids given. Also ordered Ibuprofen 800mg tid.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Dizziness, Headache, Hypoaesthesia, Injection site pain, Skin burning sensation
Clinical narrative: Presented to ER on 8/23/05 with c/o L arm discomfort, mainly in shoulder with some burning and numbness down his arm. Reports feeling tired early am of the 23rd. Was then doing physical activity of running and stretching exercises at which time his sx. increased and he also c/o headache. Elevated temperature noted of 100.5. Baseball size area of redness at the vaccination site to the L upper arm. Tylenol ordered and confined to barracks til Monday when he was to follow up. Followed up on Monday (8/24/05), L arm with 7cm area of redness. Orders for rest and fluids given. Also ordered Ibuprofen 800mg tid.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Headache, Injection site pain, Injection site swelling, Vomiting
Clinical narrative: Presented on 8/24/05 with c/o emesis and headache and localized swelling and pain to the small pox site (L arm).
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Cough, Influenza like illness, Insomnia, Pyrexia
Clinical narrative: Presented on 8/24/05 with c/o flu like sx. following his smallpox vaccination 9 days prior. Noted with elevated temp of 100.5. C/O chills, shakes, and inability to sleep for the past 3 days. Started with cough the am of the 24th. Has been using Tylenol/Ibuprofen for fever and chills.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Tremor
Clinical narrative: Presented on 8/24/05 with c/o flu like sx. following his smallpox vaccination 9 days prior. Noted with elevated temp of 100.5. C/O chills, shakes, and inability to sleep for the past 3 days. Started with cough the am of the 24th. Has been using Tylenol/Ibuprofen for fever and chills.
Age: 31.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site reaction, Pruritus, Rash, Thermal burn
Clinical narrative: Presented on 8/26/05 with rashy areas on legs and arms that started the previous night. Burning and itching present. Was prescribed Benadryl for the itch and diagnosed with rxn. following immunization. Had received Smallpox vaccination on 8/19/05. Followed up on 8/31/05 with continued rash to arms and legs with new onset of rash to the face. Referred to dermatology for rash sx.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Amnesia, Chest pain, Dizziness, Lymphadenopathy, Myalgia
Clinical narrative: Presented on 8/25/05 with c/o myalgia, dizziness, and emesis. Lt. Axillary lymphadenopathy noted. Amoxicillin and Motrin ordered. Placed on quarters for 24 hours and No P.T. for 5 days. Returned on 8/26/05 with c/o chest pain and memory loss. MD evaluated and noted patient to be alert and in no acute distress. Mental status was normal (AOx3) Placed on quarters for an additional 24 hours. No further c/o have been noted.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Vomiting
Clinical narrative: Presented on 8/25/05 with c/o myalgia, dizziness, and emesis. Lt. Axillary lymphadenopathy noted. Amoxicillin and Motrin ordered. Placed on quarters for 24 hours and No P.T. for 5 days. Returned on 8/26/05 with c/o chest pain and memory loss. MD evaluated and noted patient to be alert and in no acute distress. Mental status was normal (AOx3) Placed on quarters for an additional 24 hours. No further c/o have been noted.
Age: 1.31
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Large red swelling at site of DTaP injection on right thigh with some fluid/vesicles, started about 72 hours after vaccination, resolved somewhat over next three days.
Age: 26.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Musculoskeletal stiffness
Clinical narrative: Pt. was requested by school to recieve an MMR due to lack of proof for second MMR. MMR given on 8/26/05 and patient comes in today c/o stiff neck.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Malaise, Pain
Clinical narrative: Presented on 8/25/05 with c/o fever, aches, malaise and pain especially in the L shoulder. Vaccination site with 10cm local cellulitis. Had smallpox vaccination on 8/15/05. Tylenol #3 ordered for pain, profile for arm. Seen again on 8/26/05 and profile was extended to 8/29/05 due to continued pain in L arm. Decreased redness and induration to the vaccination site was noted on 8/26/05.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia
Clinical narrative: Presented on 8/25/05 with c/o fever, aches, malaise and pain especially in the L shoulder. Vaccination site with 10cm local cellulitis. Had smallpox vaccination on 8/15/05. Tylenol #3 ordered for pain, profile for arm. Seen again on 8/26/05 and profile was extended to 8/29/05 due to continued pain in L arm. Decreased redness and induration to the vaccination site was noted on 8/26/05.
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Antinuclear antibody negative, Arthralgia, Arthritis, Disturbance in attention, Fibromyalgia
Clinical narrative: THE LAST OF THE THREE SERIES OF VACCINATIONS WAS GIVEN ON 4/4/00.  I CONTINUED TO BE INFORMED THAT I HAVE LYME'S DISEASE AND GO ON EXTENDED COURSES OF ORAL ANTIBIOTICS FOR SEVERAL WEEKS.  I WAS SENT TO A RHEUMATOLOGIST WHO INFORMED ME THAT I HAD ARTHRITIS AND FIBROMYALGIA. I HAVE BEEN ON MEDICATION EVER SINCE AND STILL HAVE JOINT PAIN, NEUROPATHY, AND PROBLEMS WITH MEMORY AND CONCENTRATION. Per 60 day follow up report-Rheumatoid arthritis and fibromyalgia. Currently taking Humira and Methotrexate. Rheumatoid arthritis and fibromyalgia.
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Memory impairment, Neuropathy, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: THE LAST OF THE THREE SERIES OF VACCINATIONS WAS GIVEN ON 4/4/00.  I CONTINUED TO BE INFORMED THAT I HAVE LYME'S DISEASE AND GO ON EXTENDED COURSES OF ORAL ANTIBIOTICS FOR SEVERAL WEEKS.  I WAS SENT TO A RHEUMATOLOGIST WHO INFORMED ME THAT I HAD ARTHRITIS AND FIBROMYALGIA. I HAVE BEEN ON MEDICATION EVER SINCE AND STILL HAVE JOINT PAIN, NEUROPATHY, AND PROBLEMS WITH MEMORY AND CONCENTRATION. Per 60 day follow up report-Rheumatoid arthritis and fibromyalgia. Currently taking Humira and Methotrexate. Rheumatoid arthritis and fibromyalgia.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Blister, Rash
Clinical narrative: Rash appeared to upper neck (posterior) with two vesicle type appearances <10 minutes after vaccine administration. Instructed mother to use calamine lotion to area, give Benadryl if needed, and to report any further symptoms.
Age: 1.32
Sex: F
Vaccine: MMR, PNC
Symptoms: Ocular hyperaemia, Otitis media, Pyrexia, Rash
Clinical narrative: 4 days of 103 to 104 fever, red eyes, Rash and on day 5 developed ear infection in both ears.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Chills, Dizziness, Pyrexia
Clinical narrative: On the evening of the 2nd shot symptoms were dizziness, stomach ache, low grade fever and chills, went to bed real early for the night. Felt fine by morning. Didn't get any homework done, teacher didn't except any late work. We should have planned shot for Friday when no homework was due.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema, Injection site reaction, Pain
Clinical narrative: Redness,swelling and tightness at injection site warm to the touch, Fever of 100 and achiness.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Redness,swelling and tightness at injection site warm to the touch, Fever of 100 and achiness.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Hypersensitivity, Injection site induration, Oedema
Clinical narrative: Swelling and redness noticed by mother left arm deltoid region has a 6cm x 10cm area of redness and induration.
Sex: F
Vaccine: JEV
Symptoms: Rash papular, Urticaria
Clinical narrative: Client developed a few small, non itchy papules in left axilla after J-Vax 1. Denies itching and throat/airway swelling. Developed hives on back in axillary area 5 days after 2nd J-Vax (given on right arm).
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Arthropathy, Asthenia, Hypokinesia, Pain, Paraesthesia
Clinical narrative: Arm painful at time of injection due to increased physical activity. Within 3 days other arm pain left arm resolved. Right arm continued to get worse. The pain at onset then started causing problem with joint (elbow). Unable to straighten at times. Has weakness, tingling in fingers of right hand at times.
Age: 0.33
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Laboratory test abnormal, Lethargy, Pyrexia, Urine analysis abnormal
Clinical narrative: Temp 102.5 lethargy for 24 hours. sepsis evaluation, clinical follow up.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash vesicular, Skin ulcer
Clinical narrative: Vesicular lesion on upper upper, lower limbs, thorax very itching for last 48 hours.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Condition aggravated, Suicidal ideation, Uterine haemorrhage
Clinical narrative: This 15 yr old female subject was enrolled in a blinded study for the prophylaxis of genital herpes disease and herpes simplex virus type 2 (HSV-2) infection in healthy young females. Medical conditions at the time of the event included anxiety and depression. Concomitant medications included norgestimate + ethinyl estradiol (Ortho Tri Cyclen). The subject received IM investigation product single dose on 22Feb05, 15Mar05 and on 27Jul05. (site of injection was unspecified). The subject had been randomized to receive the comparator vaccine in this trial, a marketed formulation of Havrix (360 EIU + 0.25mg Al in 0.5mL). Lot number was HA221A2. On 09Aug05, 13 days after the third dose of investigational product, this 15 yr old subject experienced depression with suicidal ideation. She was hospitalized from 23Aug to 25Aug05. The investigator considered the events as medically important. The events were unresolved at time of reporting. The subject's father reported that the subject's depression worsened after his daughter started using birth control pills, which were prescribed for dysfunctional uterine bleeding. The investigator considered there was reasonable possibility that the depression with suicidal ideation may have been caused by investigational product. The investigator also considered the events to be possibly associated with the subject's medical conditions, anxiety and depression.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC
Symptoms: Medication error
Clinical narrative: Patient given both Pediarix and Hep B (instead of HIb). Follow up dated 9/8/05 states, infant had no adverse event. We were told that this should be reported because of the two injections given of the same medicine Hep B.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Gait disturbance, Pain, Pyrexia, Rash macular, Swelling
Clinical narrative: Patient complained of pain in leg in AM of 08/24/2005.  Low grade temperature, limping around.  ER visit 08/24/2005 evening because site was swollen, blotchy down to knee.  Patient is using Benadryl, no temperature now.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling
Clinical narrative: Swollen right arm - upper arm, seen about 24 hours after immunization.  Improved in 48 hours.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Patient seen in our office 08/23/2005, complained of possible vaccine reaction.  On exam right thigh (knee to groin) was warm, red, and swollen.  No complaint of pain or itch, but patient was limping at that time.  Ice, elevation, and oral Benadryl was recommended, and follow up in 24 hours on 08/24/2005.  Patient presents with still warmth and redness to same area, but decreased swelling and minimal to no limp.  No complaint of pain or itch.  Recommended close monitoring and follow up if no resolution in 2 days.
Age: 1.49
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Patient developed erythema over right thigh the morning after vaccination.  Approximately a 2x2cm area of erythema without induration with mild tenderness to palpation observed.  No other symptoms reported.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Rash
Clinical narrative: Red rash 3cm x 4cm over deltoid site.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Local irritation with swelling 1 day after administration, 20 cm x 10cm red swollen pruritic area, left thigh front.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Rash maculo-papular
Clinical narrative: 1 inch red splotches on arms next day after injections leading to red splotches over entire body with very red cheeks on face, per Mother of child.  Private physician seen with no treatment done.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Right arm swelling and erythema next day after the vaccine.  The reaction resolved 6 days later.  Treated with Benadryl.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Dyspnoea, Electrocardiogram abnormal, Pericarditis, Pyrexia
Clinical narrative: This is a male who received small pox vaccine on 12 Aug05 prior to deployment and 8 days later developed symptoms and findings consistent with pericarditis.  He was air evaced and will be further air evaced in the next few days for further management. I do not know what other vaccines the patient received prior to deployment. Follow-up: I'm sorry I will be unable to assist much with locating records for patient (VAERS# 243326). I am currently working in a forward deployed. Our logistics situation precludes the maintenance and storage of medical records. The service member in question was seen here complaining of substernal chest pain approximately one week after receiving a Small Pox Vaccination. He did have an active lesion at the vaccination site indicative of a "take." On physical examination he had a pericardial rub, and his EKG demonstrated diffuse ST segment elevation in all leads. He was observed for a 24 hour period and his symptoms failed to resolve on Indomethacin. He was transferred by an Evacuation Team. From there, it is my understanding that he was found to have a pericardial effusion and transferred to the medical center. I am sorry I can't provide more specifics for you, but I'm sure you understand that in the forward deployed areas we don't have the capacities of a major medical center. You may want to contact the medical center for more follow-up information. To the best of my knowledge, the service member has not returned to his unit, and I have no way of locating him from here. I hope this information helps in your search for more information.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Pericardial effusion, Pericarditis, Troponin
Clinical narrative: This is a male who received small pox vaccine on 12 Aug05 prior to deployment and 8 days later developed symptoms and findings consistent with pericarditis.  He was air evaced and will be further air evaced in the next few days for further management. I do not know what other vaccines the patient received prior to deployment. Follow-up: I'm sorry I will be unable to assist much with locating records for patient (VAERS# 243326). I am currently working in a forward deployed. Our logistics situation precludes the maintenance and storage of medical records. The service member in question was seen here complaining of substernal chest pain approximately one week after receiving a Small Pox Vaccination. He did have an active lesion at the vaccination site indicative of a "take." On physical examination he had a pericardial rub, and his EKG demonstrated diffuse ST segment elevation in all leads. He was observed for a 24 hour period and his symptoms failed to resolve on Indomethacin. He was transferred by an Evacuation Team. From there, it is my understanding that he was found to have a pericardial effusion and transferred to the medical center. I am sorry I can't provide more specifics for you, but I'm sure you understand that in the forward deployed areas we don't have the capacities of a major medical center. You may want to contact the medical center for more follow-up information. To the best of my knowledge, the service member has not returned to his unit, and I have no way of locating him from here. I hope this information helps in your search for more information.
Sex: M
Vaccine: HIBV
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib-Titer vaccine was received from a consumer, the mother, of a male patient who received a dose on an unspecified date. The patient also received on unspecified dates, a second dose of Hepatitis B vaccine, a third dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis and a dose of Haemophilus B Conjugate Vaccine. The reporter indicated her son has autism. Relevant medical history was not provided. Indication for Hib-Titer vaccine was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Additional suspect medication included Hepatitis B vaccine, Diphtheria/Tetanus Toxoids/Acellular Pertussis vaccine, and Haemophilus B Conjugate vaccine. Concomitant medications were not reported. On an unspecified date, the patient received a dose of Hib-Titer. The reporter stated her son has autism. The date of the event was unspecified. The patient's outcome is unknown. Product Quality has confirmed that Hib-Titer vaccine, lot number P1156AB, is not a valid product lot number. The reporter chose not to give any further details. Follow up is being conducted. No additional information was available at the time of this report.
Age: 59.0
Sex: F
Vaccine: HEPA, YF, HEPA, TD, YF
Symptoms: Hepatic neoplasm, Pain
Clinical narrative: Initial report received from another company on 8/25/05. This case was reported to the other company by a consumer and the events have not been medically confirmed by a physician or other health care professional. A 58 year old female patient with a medical history of breast cancer, had received an injection of YF-VAX, lot number unknown, on 4/22/05. The route and site of administration were unknown. That same day, she received a first dose of Havrix, lot number AHAVB043BA, administered in the right arm. On an unspecified date in July 2005, three months post vaccination, the patient experienced rib pain. She was seen at a physician's office. As per the consumer, "a PET scan and ultrasound showed a mass in the liver. A biopsy showed that it was not cancerous". The events were ongoing at the time of reporting to the other company on 8/19/05 and the patient had not recovered. (OMIC)
Age: 59.0
Sex: F
Vaccine: HEPA, YF, HEPA, TD, YF
Symptoms: Back pain, Pain
Clinical narrative: Initial report received from another company on 8/25/05. This case was reported to the other company by a consumer and the events have not been medically confirmed by a physician or other health care professional. A 58 year old female patient with a medical history of breast cancer, had received an injection of YF-VAX, lot number unknown, on 4/22/05. The route and site of administration were unknown. That same day, she received a first dose of Havrix, lot number AHAVB043BA, administered in the right arm. On an unspecified date in July 2005, three months post vaccination, the patient experienced rib pain. She was seen at a physician's office. As per the consumer, "a PET scan and ultrasound showed a mass in the liver. A biopsy showed that it was not cancerous". The events were ongoing at the time of reporting to the other company on 8/19/05 and the patient had not recovered. (OMIC)
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Faecal incontinence, Laboratory test abnormal, Myelitis, Paralysis, Urinary incontinence
Clinical narrative: Initial report received from a health care professional on 25Aug05. A 19 yr old female pt with a medical history of Turner's syndrome, had received an injection of Menactra, lot number not reported, on 14Jul05. 14 days later, on 28Jul05, the pt experienced complete paralysis from T-6 down. She also developed complete bowel and bladder dysfunction. She was hospitalized for six days. An MRI revealed abnormalities from C-3 down, however, no specifics were provided by the reporter. The pt was discharged from the hospital and sent to a rehabilitation facility. She has since recovered from the events.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Headache, nausea, dizziness, temperature 99 degrees.  Symptoms began today, call if worse.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: Localized reaction
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TD
Symptoms: Brain injury, Convulsion, Fall, Heart rate decreased, Heart rate irregular
Clinical narrative: Patient took injections well; in no apparent distress. Walked to check out, stood there, then passed out, hit the floor. Unconscious. Doctor notified. Carried to exam room. Vitals taken, vomited 2 times. Transferred to hospital. Per follow up report-Pain in right foot braced- going to OT/PT, on Valproic and Depelote for seizure control, home school. Medical record states fever, depressed heart rate, sub dural hematoma, congenital venous malformation, respirtory failure, arrhythmia, sub dural hematoma. msv. Patient fainted at front desk-brain damage. Patient has foot doct as resdual of accident and continues to see patient.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TD
Symptoms: Laboratory test abnormal, Loss of consciousness, Pain in extremity, Pyrexia, Respiratory failure
Clinical narrative: Patient took injections well; in no apparent distress. Walked to check out, stood there, then passed out, hit the floor. Unconscious. Doctor notified. Carried to exam room. Vitals taken, vomited 2 times. Transferred to hospital. Per follow up report-Pain in right foot braced- going to OT/PT, on Valproic and Depelote for seizure control, home school. Medical record states fever, depressed heart rate, sub dural hematoma, congenital venous malformation, respirtory failure, arrhythmia, sub dural hematoma. msv. Patient fainted at front desk-brain damage. Patient has foot doct as resdual of accident and continues to see patient.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TD
Symptoms: Subdural haematoma, Syncope, Venous insufficiency, Vomiting
Clinical narrative: Patient took injections well; in no apparent distress. Walked to check out, stood there, then passed out, hit the floor. Unconscious. Doctor notified. Carried to exam room. Vitals taken, vomited 2 times. Transferred to hospital. Per follow up report-Pain in right foot braced- going to OT/PT, on Valproic and Depelote for seizure control, home school. Medical record states fever, depressed heart rate, sub dural hematoma, congenital venous malformation, respirtory failure, arrhythmia, sub dural hematoma. msv. Patient fainted at front desk-brain damage. Patient has foot doct as resdual of accident and continues to see patient.
Sex: U
Vaccine: UNK
Symptoms: Medication error
Clinical narrative: While injection Decavac IM Needle was loose and approx 1/4 solution dripped down arm. I called immunization hotline who stated it would be ok to administer another dose to opposite arm.
Age: 74.0
Sex: F
Vaccine: YF
Symptoms: Rash macular
Clinical narrative: rash (blotchy) on left dorsal foot and lower let as well as right foot and lower leg within 5 days post vaccination with yellow fever vac no urticaria, vesicles, edema.
Age: 54.0
Sex: F
Vaccine: HEPA, TD, TYP, YF
Symptoms: Anxiety, Depression, Disturbance in attention, Heart rate increased, Rash
Clinical narrative: On 7/31/05 patient experienced flat dark pink rash throughout body. Complained of itching; used Caladryl lotion. Lasted 5 days. On 8/2/05 patient complained of anxiety attack while at work, felt heart racing, lost focus, went home from work and stayed at home for 1 week. While at home, complained of overwhelmed feeling, could not sleep. Complained of not wanting to live; described it as Deep Depressive State.  She states she saw a counselor on 8/10/05 where she had another acute anxiety episode. Was taken to ER where blood tests and US were performed. Doesn't know results. On 8/11/05 patient was hospitalized for evaluation and treatment. She was released on 8/15/05 and is now on anti-depression meds Lexopril. She states that she was on other medication before the acute episodes.
Age: 54.0
Sex: F
Vaccine: HEPA, TD, TYP, YF
Symptoms: Sleep disorder
Clinical narrative: On 7/31/05 patient experienced flat dark pink rash throughout body. Complained of itching; used Caladryl lotion. Lasted 5 days. On 8/2/05 patient complained of anxiety attack while at work, felt heart racing, lost focus, went home from work and stayed at home for 1 week. While at home, complained of overwhelmed feeling, could not sleep. Complained of not wanting to live; described it as Deep Depressive State.  She states she saw a counselor on 8/10/05 where she had another acute anxiety episode. Was taken to ER where blood tests and US were performed. Doesn't know results. On 8/11/05 patient was hospitalized for evaluation and treatment. She was released on 8/15/05 and is now on anti-depression meds Lexopril. She states that she was on other medication before the acute episodes.
Age: 40.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: Dizzy, lightheaded, episodes of vertigo, dull headache.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Asthenia, Dizziness, Headache, Pain
Clinical narrative: Tetanus booster given 8/29/05 2 p.m. Around 4:30 a.m. I felt aches and pains in body and slight fever. By 6:15 it was 102 and my body hurt all over. By 7:30 temperature was up to 103.4 and getting no relief with Tylenol or Advil. Went back to doctor. They said they had never seen this reaction before and wanted to draw blood to test for West Nile Virus, Liver problems and other various viruses. I made them aware that it was from the tetanus shot. No treatment other than tylenol/advil/heat pack on body to relieve aches. Temperature rose to 103.8 that evening. Joints ached, spine hurt very bad. That night most of the fever broke. Next day I had temperature ranging from 100.4 to 101.4 but body still ached in joints as bad as day before. Head ache and weak too. Next day no fever, minor joint aches, but extremely weak. Dizzy.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Tetanus booster given 8/29/05 2 p.m. Around 4:30 a.m. I felt aches and pains in body and slight fever. By 6:15 it was 102 and my body hurt all over. By 7:30 temperature was up to 103.4 and getting no relief with Tylenol or Advil. Went back to doctor. They said they had never seen this reaction before and wanted to draw blood to test for West Nile Virus, Liver problems and other various viruses. I made them aware that it was from the tetanus shot. No treatment other than tylenol/advil/heat pack on body to relieve aches. Temperature rose to 103.8 that evening. Joints ached, spine hurt very bad. That night most of the fever broke. Next day I had temperature ranging from 100.4 to 101.4 but body still ached in joints as bad as day before. Head ache and weak too. Next day no fever, minor joint aches, but extremely weak. Dizzy.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Conjunctivitis, Erythema, Injection site oedema, Injection site pain, Pain
Clinical narrative: Sat 1/15 began to experience eruptions on scalp, painful, reddened, raised, 2-3 mm diameter, posterior and R side of scalp. Area of vaccination became swollen and reddened. Red streaking toward R axilla began Sunday 1/16. Noted scattered pustules appearing on lower anterior neck and upper chest on Tuesday 1/18. One pustule on R upper anterior thigh, one on lateral dorsal L hand. Redness of lower lid L eye noted Tuesday 1/18 - pt states site is painful.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous
Clinical narrative: Sat 1/15 began to experience eruptions on scalp, painful, reddened, raised, 2-3 mm diameter, posterior and R side of scalp. Area of vaccination became swollen and reddened. Red streaking toward R axilla began Sunday 1/16. Noted scattered pustules appearing on lower anterior neck and upper chest on Tuesday 1/18. One pustule on R upper anterior thigh, one on lateral dorsal L hand. Redness of lower lid L eye noted Tuesday 1/18 - pt states site is painful.
Age: 0.53
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Dyskinesia, Muscle twitching, Opisthotonus
Clinical narrative: Pt. had involuntary jerking and twitching of body. Also had arching of back.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypokinesia, Injection site induration, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a female who on 8/19/05 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 8/19/05, the patient developed redness, swelling, and induration that extended beyond the shoulder into the chest region. It was noted that the patient could not move her arm. It was also noted that the reaction required an additional office visit for the patient. Unspecified medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Redness, swelling and induration were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Pain
Clinical narrative: Information has been received from a male physician who five years ago in 2000, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, he experienced a local injection site reaction and achiness. Unspecified medical attention was sought. The physician treated himself with ibuprofen. Subsequently, he recovered. No product quality complaint was involved. Local injection site reaction and achiness were considered to be other important medical events (OMIC). Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Gait disturbance, Injury, Pyrexia
Clinical narrative: Seizure, 104.8 temp. Hospitalized for 2 days; test were done, no infections 7 days after MMR. Acting different, falls all the time, can't walk as good. EEG normal. No treatment. Nothing to do but monitored; gave Tylenol and Motrin.
Age: 0.41
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Dyspnoea, High-pitched crying, Vomiting
Clinical narrative: Mother described client experiencing high pitched crying episode approximately 1.5 days after receiving immunizations on 8/9/05. Crying reported to last approximately 1 hour - very shrill cry. Client experience episode of vomiting and questionable difficulty breathing. Transported by EMS to hospital.
Age: 1.42
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site reaction, Oedema, Rash
Clinical narrative: Local reaction, rash, swelling over 2 day period treated with Benadryl and cold compressors.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Injection site pain, Malaise, Nausea
Clinical narrative: Vaccine received at 10:00AM, 2 hours later felt dizzy/shaky.  Later that night - fever, malaise, severe body ache, headache, facial pain, very sleepy. Pain at injection site, no swelling, no redness.  Neck pain, nausea.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Neck pain, Pain, Pyrexia, Somnolence, Tremor
Clinical narrative: Vaccine received at 10:00AM, 2 hours later felt dizzy/shaky.  Later that night - fever, malaise, severe body ache, headache, facial pain, very sleepy. Pain at injection site, no swelling, no redness.  Neck pain, nausea.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Woke in AM with welts, raised, and itchy covers most of body, except face.  Started scratching legs on 08/25/2005 approximately 08:00PM.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Feeling hot, Infection, Oedema
Clinical narrative: 08/10/2005 Given Menactra intramuscularly left arm.  08/12/2005 Mom called, arm is red, slightly swollen, hot to touch.  Afebrile, has not given Tylenol.  PHN C/T normal potential problems.  If Mom concerned more than normal call doctor.  08/12/2005 child went to doctor.  He assessed not reaction to vaccine - maybe infection.  He prescribed antibiotic.  08/15/2005 Mom states patient was doing better even on 08/12/2005 after seeing doctor.  Doing well now, no more problems.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Rash vesicular
Clinical narrative: 2 crops of vesicular lesion distal to smallpox innoculation - 2 days post vaccine.  Patient afebrile and asymptomatic.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of left thigh surrounding injection site.  ER prescribed Augmentin.  Seen in office on 08/26.  Redness decreasing and some swelling present.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Oedema peripheral
Clinical narrative: Immunization received 08/10/2005 that night the left upper arm swelled, turned red and hot from shoulder to elbow.
Age: 31.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Swelling, redness and heat over insertion site, beginning less than 24 hours after vaccine administered.  Worsened to 3rd day, then began to resolve.  Seen at clinic 5 days after administration.  10mm lump at insertion site, slight discoloration around site, not redness, just darker color.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Rash pruritic, Swelling
Clinical narrative: 08/18/2005 patient presents to clinic with swelling and redness in left deltoid.  Pruritus, no fever, no history of asthma, no pain, denies any history of localized reaction from other vaccines (had both IPV and DTAP in the past).  Swelling, Erythema, on left outer arm.  Swelling measures 16cm x 13 1/2cm, no acute distress, lungs clear to auscultation, temperature 98.3 degrees, Heart: regular rhythm and rate, active/alert.  Range of motion within normal limits.  Strength bilateral arms 4+/4.  Referred to primary care doctor.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Rash, Urticaria
Clinical narrative: Patient got TD and went to school.  School nurse called and patient had whelps on arm at injection site, and rash like area on chest.  No other problems.  Patient sent to ER, patient got injections Decadron and Benadryl.  Patient had improved, per father.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Nasal congestion, Nasopharyngitis, Postnasal drip
Clinical narrative: History past year seeing doctor for complaint of colds, stuffed nose, post nasal drainage.  Prescribed high protein diet nose spray and now allergy shots.  Developed headache sometime in June almost every day - between eyes and at base of neck.  Ibuprofen helps.  Parents questions relation to vaccine and headache.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Crying, Flatulence, Pyrexia, Rhinorrhoea
Clinical narrative: Parent brought child back to clinic, child had copious nasal secretions and saliva pourins, but was breathing okay, crying.  The Mom reported that this same reaction happened after child received Varicella vaccine 11/03.  Doctor called and ordered 3cc of Benadryl given STAT, secretions discontinued, breathing became more open in the nasal passages - child slept, was advised to go to family doctor.  Mom stated patient seemed to have a mild fever - gave him Advil - had excessive flatulence, stomach pain.  All subsided by Saturday, 08/13/2005.
Age: 5.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Nonspecific reaction
Clinical narrative: None specified.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Epididymitis, Groin pain, Orchitis, Swelling
Clinical narrative: 9 days post MMR developed testicular pain, swelling and had Orchitis and Epididymitis on exam and ultrasound.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Oedema, Shoulder pain
Clinical narrative: Edema notes:  Associated shoulder pain, restricted range of motion.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TD
Symptoms: Dizziness, Headache, Hypotension, Vomiting
Clinical narrative: 5 minutes after vaccines patient became dizzy, complained of headache, and vomited 1 time.  Hypotensive, observed in clinic for 2 hours.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Rash papular, Skin ulcer
Clinical narrative: Trunk with 20 eryth papules vesicles, several lesions, 25 papules on face.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left arm swollen and red
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Chills, Headache, Injection site erythema, Injection site mass, Nausea
Clinical narrative: Headache, chills, red hard area at injection site measuring 3-4" diameter, nausea, vomiting, fever up to 102.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache, chills, red hard area at injection site measuring 3-4" diameter, nausea, vomiting, fever up to 102.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction, Lymphadenopathy
Clinical narrative: R arm cellulitis at site of Dtap and right axillary reactive adenopathy.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Red, swollen, warm to touch, 7" x 3". Noticed 8/17/05 PM.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Arm, red, swollen, and warm to touch at site of immunization. Augmentin 600 ES 1 teaspoon BID x 7days.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Had chicken pox disease after Varivax given on 5/19/1995
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Feeling hot, Injection site oedema, Pyrexia
Clinical narrative: Hot, swollen, itchy area approx 3" diameter left arm injection site. Ran a fever and felt over the weekend (shot on 8/26).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Heart rate increased, Pyrexia, Restlessness
Clinical narrative: He had a low grade fever all day the next day as well, treated with Tylenol. Fever 102 given Motrin in ER. Was chilled upon going to bed. Mother went into room around 11PM or so, due to hearing pt hit the wall. He was thrashing in bed, had a fever high, pulse (140). We were advised to go to the ER due to the pulse by nurse. We had to stay in a room with child on a heart monitor until pulse normalized. Pulse was 170 in ER.  Hopefully, no problems in the future.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles
Clinical narrative: Child developed erythema and swelling over left upper arm after vaccination. She also developed 4-5 vesicles around injection site. Redness and swelling improved, but vesicles still present 3 days after vaccination.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Reddened rash on face, arms, legs, and torso. C/o itching all over. Few hives noted on face and legs.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Reddened rash on face, arms, legs, and torso. C/o itching all over. Few hives noted on face and legs.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Tenderness
Clinical narrative: Erythema 6cm pain and tenderness 24 hrs after immunization.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Drug ineffective
Clinical narrative: No immunity levels noted per Hep B surface ag etc. Please call office for details.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Urticaria
Clinical narrative: At approx 13:45 client was given immunization with in about 20-25 min clients face was red and swollen with welts and indurated covered her entire buttocks down her legs all the way down, face was also covered. No SOB.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Induration, erythematous right deltoid
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Shingles lasting 3 weeks. Chiropractic treatment, narcotic pain medication, anti itch medication.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Headache, Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Left arm (inject site) swollen, red, painful, fever 102, HA
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: DT 0.5ml IM on 8/22/05. Awoke on 8/23 with fever, myalgia and arthralgia and HA.
Age: 1.26
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Rash papular, Skin ulcer
Clinical narrative: Pt developed different crops of papulovesicular lesions on face, legs and trunk, no fever.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Rash, Rash pustular, Viral infection
Clinical narrative: Rash, 3 trunk pinpoint, 1 right neck vesicle, 1 forehead scratched, 1 left arm pustule.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: right deltoid swelling, erythema 6cm x 7cm mild pruritus, local treatment ibuprophen, Benadryl, Ice, notify if symptoms increase.